Loading…
Reported covered position: N/A
How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Medication Therapy Management Benefits Act of 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S. 274 Medication Therapy Management Empowerment Act of 2011. H.R. 891 Medication Therapy Management Benefits Act of 2011. Agency issues related to standardized medication action plans; accountable care organizations (ACOs); pharmacists' participation in CMS Innovation Center initiatives; coverage for outpatient drugs; transparency and reporting of physician investment interests (Sunshine Act); potential new paradigm for drugs; essential health benefits (EHB); and standardized pharmacy notice.
Medication Therapy Management Benefits Act of 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2013 · first_quarter · Q1
HCR(PL 111-152/111-148) concerning Medicare PartD;MTM;DME;center for medicare and medicaid innovation;transitions of care;pharmacy reibursement;agency issues concerning risk evaluation mitigation strategies;PDUFA;prescription drug monitoring program,drug abuse,safe drug supply chain;standardized medication action plans;ACOs;pharmacists role in CMS innovation center initiatives;personalized medication lists; standardized pharmacy notice;immunization;HIT; compounding; medicare Part B; SGR; DEA
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE
Source: Senate LDA
S. 274 - Medication Therapy Management Empowerment Act of 2011 H.R. 891 - Medication Therapy Management Benefits Act of 2011 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS-2011-0003-0002) Medicare Program: Hospital Inpatient Value-Based Purchasing Program (Docket Number: CMS-2011-0017-0001) Medicaid Program: Payment Adjustment for Provider Preventable Conditions Including Health Care Acquired Conditions Guidelines for Timely Medication Administration Response to the CMS 30-Minute Rule" Advance Notice of Methodological Changes for Calendar Year (CY) 2012 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2012 Call Letter Announcement of Calendar Year (CY) 2012 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Medicare Part D Payment Memo for Drugs for End-Stage Renal Disease Standardized Format for the Comprehensive Medication Review Action Plan and Summary Request for Comment Concept - Pharmacists participation in the CMS Innovation Center initiatives
Medication Therapy Management Benefits Act of 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S.274 Medication Therapy Management Empowerment Act of 2011 H.R.891 Medication Therapy Management Benefits Act of 2011 Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; standardized pharmacy notice. immunization; and health information technology. Communications with the Joint Select Committee on Deficit Reduction on preserving patient access to medication therapy management services in Medicare Part D, fair reimbursement in Medicare and Medicaid.
Medication Therapy Management Benefits Act of 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S. 2.74 Medication Therapy Management Empowerment Act of 2011. H.R. 891 Medication Therapy management Benefits Act of 2011. Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; essential health benefits; and standardized pharmacy notice.
Medication Therapy Management Benefits Act of 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S.274 Medication Therapy Management Empowerment Act of 2011 H.R.891 Medication Therapy Management Benefits Act of 2011 Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; standardized pharmacy notice; immunization; and health information technology.
Community Pharmacy Fairness Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Community Pharmacy Fairness Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Community Pharmacy Fairness Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Community Pharmacy Fairness Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Dextromethorphan Distribution Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Dextromethorphan Distribution Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform
Dextromethorphan Distribution Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Dextromethorphan Distribution Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Secure and Responsible Drug Disposal Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Secure and Responsible Drug Disposal Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
To amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Prescription Drug Affordability Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Prescription Drug Affordability Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Prescription Drug Affordability Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Prescription Drug Affordability Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Protecting Consumer Access to Generic Drugs Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Preserve Patient Access to Reputable DMEPOS Providers Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medicare Fraud Prevention Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program
To amend the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices with 20 or fewer employees.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
To amend the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices with 20 or fewer employees.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
To amend the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices with 20 or fewer employees.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform
To amend the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices with 20 or fewer employees.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Independence at Home Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medicare Fraud Prevention and Enforcement Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
FDA Food Safety Modernization Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Drug Overdose Reduction Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Drug Overdose Reduction Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Drug Overdose Reduction Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Drug Overdose Reduction Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Access to Frontline Health Care Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Access to Frontline Health Care Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform
Access to Frontline Health Care Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Access to Frontline Health Care Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Combat Methamphetamine Enhancement Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Combat Methamphetamine Enhancement Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
To amend the Controlled Substances Act to address the use of intrathecal pumps.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
To amend the Controlled Substances Act to address the use of intrathecal pumps.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
To amend the Controlled Substances Act to address the use of intrathecal pumps.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
To amend the Controlled Substances Act to address the use of intrathecal pumps.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Medication Therapy Management Benefits Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
Medication Therapy Management Benefits Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medication Therapy Management Benefits Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
Medication Therapy Management Benefits Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program
Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Medicare Home Infusion Therapy Coverage Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2011
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
To direct the Secretary of Health and Human Services to review utilization of diabetes screening benefits and make recommendations on outreach programs with respect to such benefits, and for other purposes.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
To amend part B of title XVIII of the Social Security Act to provide for an exemption of pharmacies and pharmacists from certain Medicare accreditation requirements in the same manner as such exemption applies to certain professionals.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
National Pain Care Policy Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Food and Drug Administration Globalization Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
RE-Aligning Care Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
Medicare Payment Advisory Commission (MedPAC) Reform Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Independence at Home Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Patient-Centered Outcomes Research Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
A bill to amend title XVIII of the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price.
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medicare Prescription Drug Coverage Improvement Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Medicare Home Infusion Therapy Coverage Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Combat Methamphetamine Enhancement Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Combat Methamphetamine Enhancement Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Combat Methamphetamine Enhancement Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Combat Methamphetamine Enhancement Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Medicare Prescription Drug Gap Reduction Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Secure and Responsible Drug Disposal Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Secure and Responsible Drug Disposal Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Medication Therapy Management Expanded Benefits Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
Medication Therapy Management Expanded Benefits Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program
Medication Therapy Management Expanded Benefits Act of 2010
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
Access to Durable Medical Equipment Act
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
National Pain Care Policy Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Community Choice Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
Caring for an Aging America Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Methadone Treatment and Protection Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Methadone Treatment and Protection Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
Methadone Treatment and Protection Act of 2009
Client: AMERICAN PHARMACISTS ASSOCIATION · Firm: AMERICAN PHARMACISTS ASSOCIATION
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2012 · fourth_quarter · Q4
HCR(PL 111-152/111-148) concerning Medicare PartD;MTM;DME;transitions of care;pharmacy reibursement; agency issues concerning risk evaluation mitigation strategies;prescription drug monitoring program,drug abuse,safe drug supply chain;standardized medication action plans;personalized medication lists;ACOs;pharmacists role in CMS Innovation Center initiatives;immunization;HIT; medication disposal;biosmiliars;EHB; compounding;SGR
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2012 · third_quarter · Q3
HCR(PL 111-152/111-148) concerning Medicare PartD;MTM;DME;center for medicare and medicaid innovation;transitions of care;pharmacy reimbursement;agency issues concerning risk evaluation mitigation strategies;PDUFA;prescription drug monitoring program,drug abuse,safe drug supply chain;standardized medication action plans;ACOs;pharmacists role in CMS innovation center initiatives;personalized medication lists; standardized pharmacy notice;immunization;HIT; compounding;medicare part B;SGR;DEA
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Natl Drug Control Policy (NDCP), SENATE
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2012 · second_quarter · Q2
HCR(PL 111-152/111-148) concerning Medicare PartD;MTM;DME;transitions of care;pharmacy reibursement; loan forgiveness;agency issues concerning risk evaluation mitigation strategies;PDUFA;prescription drug monitoring program,drug abuse,safe drug supply chain;standardized medication action plans;personalized medication lists;ACOs;pharmacists role in CMS Innovation Center initiatives;standardized pharmacy notice;immunization;HIT; medication disposal;biosmiliars;EHB
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2012 · first_quarter · Q1
Legislative and agency issues regarding the Patient Protection and Affordable Care Act (P.L. 111-148) - Appropriations for the medication therapy management grant program.
S. 274 Medication Therapy Management Empowerment Act of 2011. H.R. 891 Medication Therapy Management Benefits Act of 2011. Agency issues related to standardized medication action plans; accountable care organizations (ACOs); pharmacists' participation in CMS Innovation Center initiatives; coverage for outpatient drugs; transparency and reporting of physician investment interests (Sunshine Act); potential new paradigm for drugs; essential health benefits (EHB); and standardized pharmacy notice.
Legislative and agency issues regarding drug shortages, the reauthorization of the Prescription Drug User Fee Act (PDUFA), drug counterfeiting, supply chain integrity, drug diversion and controlled substance monitoring. Also, the Health Care and Education Reconciliation Act of 2010 (P.L. 111-145) and the Patient Protection and Affordability Act (P.L. 111-148) including sections concerning Medicare Part D changes; medication therapy management (MTM); accountable care organizations (ACOs); durable medical equipment (DME); Center for Medicare and Medicaid Innovation within CMS; transitions of care; essential health benefits (EHB); and providing adequate pharmacy reimbursement (AMP).
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2011 · fourth_quarter · Q4
Legislative and agency issues regarding the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152) and the Patient Protection and Affordable Care Act (P.L. 111-148) including sections concerning Medicare Part D changes; medication therapy management (MTM); accountable care organizations (ACOs); durable medical equipment (DME); Center for Medicare and Medicaid Innovation within CMS; transitions of care; essential health benefits; and providing adequate pharmacy reimbursement (AMP).
S. 2.74 Medication Therapy Management Empowerment Act of 2011. H.R. 891 Medication Therapy management Benefits Act of 2011. Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; essential health benefits; and standardized pharmacy notice.
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2011 · third_quarter · Q3
S.48 Pharmacist Loan Repayment Eligibility Act of 2011 Agency issues relating to risk evaluation and mitigation strategies (REMS); the Prescription Drug User Fee Act (PDUFA); prescription drug monitoring programs; prescription drug abuse; and safety of the drug supply chain.
Legislative and agency issues regarding the Patient Protection and Affordable Care Act (P.L. 111-148) - Appropriations for the medication therapy management grant program. Communications with the Joint Committee on Deficit Reduction on maintaining funding for Medicare Part D provisions such as medication therapy management programs and preserving patient access to pharmacist provided care services.
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2011 · second_quarter · Q2
Legislative and agency issues regarding the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152) and the Patient Protection and Affordable Care Act (P.L. 111-148) including sections concerning Medicare Part D changes; medication therapy management (MTM); accountable care organizations (ACOs); durable medical equipment (DME); Center for Medicare and Medicaid Innovation within CMS; transitions of care; and providing adequate pharmacy reimbursement (AMP).
S.48 Pharmacist Loan Repayment Eligibility Act of 2011 Agency issues relating to risk evaluation and mitigation strategies (REMS); the Prescription Drug User Fee Act (PDUFA); prescription drug monitoring programs; prescription drug abuse; and safety of the drug supply chain.
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2011 · first_quarter · Q1
(Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] Under Line 17: We would like to add the Agency for Healthcare Research and Quality and the Institute for Medicine (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: FDA2011N0060) Positron Emission Tomography; Notice of Public Meeting; Request for Comment (Docket Number: FDA2000D1542; formerly Docket Number 00D0892) Draft Guidance on Positron Emission Tomography Drug Applications Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2010 · fourth_quarter · Q4
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS1503FC) Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2011; Final Rule (Docket Number: CMS-6034-P) Medicaid Program; Recovery Audit Contractors (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: FDA-2010-N-0308) Parallel Review of Medical Products (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements CMS Announcement of Calendar Year (CY) 2011: Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Changes to CMS True-Out-Of-Pocket Facilitator for Medicare Part D CMS 2011 Non-Matched NDC List CMS Medicare Part D Coverage Gap Discount Program
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2010 · third_quarter · Q3
SAMDT 4530 (to HR 5297 Small Business Lending Fund Act of 2010) - a small business health information technology financing program Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 4213 - American Jobs and Closing Tax Loopholes Act of 2010 in support of including Medicaid Federal Medical Assistance Percentage (FMAP) Funding (or in any stand alone legislation) (Public Law 111-148) Patient Protection and Affordable Care Act for Appropriations for the MTM Grant Program and for Programs to Establish Integrated and Coordinated Care Models (Public Law 111-5) American Recovery and Reinvestment Act of 2009 sections on Health Information Technology and Medicaid Federal Medical Assistance Percentage (FMAP) Funding
S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 HR 3108 - Medication Therapy Management Benefits Act of 2009 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 5389 - Medicare Clinical Pharmacist Practitioner Services Coverage Act of 2010 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs)] (Docket Number: CMS6010IFC) Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-2238-P2) Medicaid Program; Withdrawal of Determination of Average Manufacturer Price, Multiple Source Drug Definition, and Upper Limits for Multiple Source Drugs (Docket Number: CMS-6028-P) Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers (RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS0023IFC) Medicare Program; Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescription Drug Program (NCPDP SCRIPT 10.6) CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program CMS Medicare Part D Coverage Gap Discount Program - Manufacturer Agreements CMS September 10, 2010 Memorandum on Additional Guidance concerning Closing the Coverage Gap in 2011 CMS: Letter on Implementation of Retail Survey Price under the Deficit Reduction Act and the Patient Protection and Affordable Care Act (P.L. 111-148) - August 6, 2010
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2010 · second_quarter · Q2
HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2010 · first_quarter · Q1
President Obamas Proposed 2011 Budget for HHS and related Agencies Budgets (Public Law 111-148) Patient Protection and Affordable Care Act for Appropriations for the MTM Grant Program (Public Law 111-5) American Recovery and Reinvestment Act of 2009 sections on Health Information Technology Under Line 17: We would like to include the Office of the National Coordinator for Health Information Technology
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2009 · fourth_quarter · Q4
S 750 - Caring for an Aging America Act HR 2891 - Access to Frontline Health Care Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 1259 - Dextromethorphan Distribution Act of 2009 HR 1256 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 S 1679 Affordable Health Choices Act [Sections on: ensuring quality of care; affordable choices of health benefit plans; seeking the best medical advice; spending for Federally Qualified Health Centers; national strategy; presentation of drug information; center for health outcomes research and evaluation; administrative simplification; right choices program; grants to establish community health teams to support a medical home model; grants to implement medication therapy management services in treatment of chronic disease; national health care workforce commission; funding for National Health Service Corps; geriatric education and training, career awards, comprehensive geriatric education; nurse education, practice, and retention grants; increasing Access to clinical preventive services, and increase prevention and wellness provisions.] HR 3200 - America's Affordable Health Choices Act of 2009 [Sections on: ensuring adequacy of provider networks; essential benefits package defined; Health Benefits Advisory Committee; outreach and enrollment of exchange-eligible individuals and employers in Exchange-participating health benefits plan; payment rates for items and services; reducing potentially preventable hospital readmissions; post acute care services payment reform plan; requiring drug manufacturers to provide drug rebates for certain, full premium subsidy eligible individuals; phasedin elimination of coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out of pocket threshold under part D; permitting mid-year changes in enrollment; telehealth expansion and enhancements; intelligent assignment in enrollment; ensuring effective communication in Medicare; Accountable Care Organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; comparative effectiveness research; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; distribution of unused residency positions; require providers and suppliers to adopt programs to reduce waste, fraud, and abuse; payments to pharmacists (AMP); Task Force on Clinical Preventive Services; fully integrated dual eligible special needs plans; public health and workforce development; prevention and wellness; preventive cost sharing services; amendments to establish a medication therapy management grant program, pharmacy benefit manager transparency; and allowing direct price negotiations in Medicare Part D.] S 1796 - America's Healthy Future Act of 2009 [Sections on: health care coverage, including sections on the Health Benefits Advisory Committee, making coverage affordable, Medicaid coverage for the lowest income populations, Medicaid prescription drug coverage, changes to Medicaid payment for prescription drugs (AMP); Medicaid quality; promoting disease prevention and wellness including sections on Medicare (annual wellness visit, study on beneficiary access to immunizations, removing barriers to preventive services, and incentives for healthy lifestyles) and Medicaid (improving access to preventive services for eligible adults, incentives for healthy lifestyles, and Medicaid state plan option promoting health homes and integrated care); improving the quality and efficiency of health care including sections on physician value-based purchasing, quality infrastructure, Accountable Care Organizations, and CMS Innovation Center; strengthening primary care and other workforce improvements; Medicare Part D improvements including sections improving coverage in the Part D coverage gap, facilitation of reassignments of beneficiaries in low-income subsidy plans, strengthening formularies with respect to certain categories or classes of drugs, and limitation on removal or change of coverage of covered Part D drugs under a formulary; Medicare Advantage including section on Medicare Advantage payment; home health payment changes including section on durable medical equipment; improving Medicare for patients and providers, including sections on Medicare diabetes self-management training, and revisions to demonstration project on community health integration models in certain rural counties; administrative simplification including section on changes to HIPAA; ensuring Medicare sustainability including section on Medicare Commission; transparency and program integrity including sections on physician payment sunshine and prescription drug samples; fraud, waste, and abuse including sections on provider screening, provider compliance and penalties; revenue items including sections on employer health insurance reporting, and annual fee on clinical laboratories; the inclusion of PBM transparency and the medications therapy management grant program in section 213 of S1679; and changes to long-term care pharmacy utilization management provisions.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medial residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; institute of medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; and Indian Health Care Improvement.] HR 3590 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Amendments: Improvements in Medicare Part D MTM programs in Freshman Amendments; Modernize Americas health care system provide for a performance-based pharmacy reimbursement program under Medicare part D (S.A. 3119); Pharmaceutical Market Access and Drug Safety Act of 2009 (S.A. 2793) Provide for establishment and maintenance of chronic care pharmacy program (S.A. 3109).] Public Law 111-3 - Reauthorization of Childrens Health Insurance Plans on pharmacist appointment to MEDPAC [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement (Docket No. FDA-2009-N-0247) FDA Transparency Task Force; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number DEA321a) Identification of Institution-based Individual Practitioners (Docket No. FDA2009N0294) Regulation of Tobacco Products; Request for Comments AHRQ Proposed Collection Project: Health IT Community Tracking Study 2009 HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in 2009 H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2009 · third_quarter · Q3
HR756/S660 - National Pain Care Policy Act of 2009 HR179 - Community AIDS and Hepatitis Prevention Act S1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR2891 - Access to Frontline Health Care Act of 2009 HR1259 - Dextromethorphan Distribution Act of 2009 HR1256 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. HR2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S256 - Combat Methamphetamine Enhancement Act of 2009 S750 - Caring for an Aging America Act S1213 - Patient-Centered Outcomes Research Act of 2009 HR676 - U.S. National Health Insurance Act on the inclusion of medication therapy management services S1679 & Draft Bill Affordable Health Choices Act (Sections on ensuring quality of care; affordable choices of health benefit plans; seeking the best medical advice; spending for Federally Qualified Health Centers (FQHCs); national strategy; presentation of drug information; center for health outcomes research and evaluation; administrative simplification; right choices program; grants to establish community health teams to support a medical home model; grants to implement medication management services in treatment of chronic disease; national health care workforce commission; funding for National Health Service Corps; geriatric education and training, career awards, comprehensive geriatric education; nurse education, practice, and retention grants; increasing Access to Clinical Preventive Services, and increase prevention and wellness provisions) HR3200 & Draft Bill - America's Affordable Health Choices Act of 2009 [Sections on ensuring adequacy of provider networks; essential benefits package defined; Health Benefits Advisory Committee; outreach and enrollment of exchange-eligible individuals and employers in Exchange-participating health benefits plan; payment rates for items and services; reducing potentially preventable hospital readmissions; post acute care services payment reform plan; requiring drug manufacturers to provide drug rebates for certain, full premium subsidy eligible individuals; phasedin elimination of coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out of pocket threshold under part D; permitting mid-year changes in enrollment; telehealth expansion and enhancements; intelligent assignment in enrollment; ensuring effective communication in Medicare; Accountable Care Organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; comparative effectiveness research; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; distribution of unused residency positions; require providers and suppliers to adopt programs to reduce waste, fraud, and abuse; payments to pharmacists; Task Force on Clinical Preventive Services; fully integrated dual eligible special needs plans (FIDESNP); public health and workforce development; prevention and wellness; preventive cost sharing services; Butterfield Amendment - Establishes an Medication Therapy Management Grant Program (House Engery and Commerce Committeee's HR3200); Weiner Amendment - Creates PBM Transparency (House Engery and Commerce Committeee's HR3200); and Schakowsky Amendment - Allows direct price negotiations in Medicare Part D (House Engery and Commerce Committeee's HR3200)] Draft Bill Access to Birth Control Act Chairman's Mark - America's Healthy Future Act of 2009 [sections on health care coverage including sections on the Health Benefits Advisory Committee, making coverage affordable, Medicaid coverage for the lowest income populations, Medicaid prescription drug coverage, changes to Medicaid payment for prescription drugs (AMP); Medicaid quality; promoting disease prevention and wellness including sections on Medicare (annual wellness visit, study on beneficiary access to immunizations, removing barriers to preventive services, and incentives for healthy lifestyles) and Medicaid (improving access to preventive services for eligible adults, incentives for healthy lifestyles, and Medicaid state plan option promoting health homes and integrated care); improving the quality and efficiency of health care including sections on physician value-based purchasing, quality infrastructure, Accountable Care Organizations, CMS Innovation Center; strengthening primary care and other workforce improvements; Medicare Part D improvements including sections improving coverage in the Part D coverage gap, facilitation of reassignments of beneficiaries in low-income subsidy plans, strengthening formularies with respect to certain categories or classes of drugs, and limitation on removal or change of coverage of covered Part D drugs under a formulary; Medicare Advantage including section on Medicare Advantage payment; home health payment changes including section on Durable Medical Equipment; improving Medicare for patients and providers including sections on Medicare Diabetes Self-Management Training, revisions to demonstration project on community health integration models in certain rural counties; administrative simplification including section on changes to HIPAA;ensuring Medicare sustainability including section on Medicare Commission; transparency and program integrity including sections on physician payment sunshine and prescription drug samples; fraud, waste, and abuse including sections on provider screening, provider compliance and penalties; revenue items including sections on employer health insurance reporting, annual fee on clinical laboratories; the inclusion of PBM transparency and the medications therapy management grant program in section 213 of S1679; and changes to long-term care pharmacy utilization management provisions] Concept - Role of Pharmacist-Provided Patient Care Services in any Integrated Care Model, Hospital Readmissions and Medication Therapy Management Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in 2009 H1N1 and seasonal flu immunization activities (Docket No. FDA2009N0294) Regulation of Tobacco Products; Request for Comments AHRQ Proposed Collection Project: Health IT Community Tracking Study 2009
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2009 · second_quarter · Q2
(Public Law 111-5) American Recovery and Reinvestment Act of 2009 Sections on Health Information Technology
HR1204 - The Community Pharmacy Fairness Act of 2009 S80 - Pharmaceutical Market Access Act of 2009 S525/HR1298 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR163 - Prescription Drug Affordability Act HR2400 - Strategies to Address Antimicrobial Resistance Act HR1706 - Protecting Consumer Access to Generic Drugs Act of 2009 (Docket No. DEA322I) Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Docket No. FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting (focused on the types of communications that patients receive at the pharmacy includes: medication guides; patients package inserts; and consumer medication information) (Docket Number: FDA2009D0001) Draft Guidance for Industry on Standards for Securing the Drug Supply ChainStandardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA-2008-S-0627) Expert and Consumer Evaluation of Consumer Medication Information -- 2008 (Docket No. FDA1977N0013) (formerly Docket No. 1977N0094L) Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph (Docket No. FDA2009D0181) Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability (Docket No. FDA2009N0138) Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2009 · first_quarter · Q1
(Docket Number: EPA-HQ-RCRA-2007-0932) Amendment to the Universal Waste Rule: Addition of Pharmaceuticals (Docket Number: DEA-316) Advanced Notice of Proposed Rule Making; Disposal of Controlled Substances by Persons not Registered with the Drug Enforcement Administration
HR1204 - The Community Pharmacy Fairness Act of 2009 S80 - Pharmacautical Market Access Act of 2009 S525/ HR1298 - Pharmacautical Market Access and Drug Safety Act of 2009 HR163 - Prescription Drug Affordability Act (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting (focused on the types of communications that patientss receive at the pharmacy includes: medication guides; patients package inserts; and consumer medication information. (Docket Number: FDA2009D0001) Draft Guidance for Industry on Standards for Securing the Drug Supply ChainStandardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA-2008-S-0627) Expert and Consumer Evaluation of Consumer Medication Information -- 2008 (Docket Number DoD2008HA0029; 0720AB22) Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Request for Information (RFI): HHS-FDA-RFI-09-002 (Special Notice)) FDA Sentinel Initiative Concept (No Language) FDA Risk Evaluation and Mitigation Strategies (REMS) for Opioid Anagesic Medications
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2008 · fourth_quarter · Q4
H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Public Law 110-425) H.R. 5839 - Safeguarding Americas Pharmaceuticals Act of 2008 H. Res. 1437 - Designates October as American Pharmacists Month H.R. 971 - Community Pharmacy Fairness Act H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology (PRO(TECH)T) Act of 2008 (Docket Number: FDA-2008-N-0162) Agency Information Collection Activities; Submission for Office of management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements (Docket Number: CMS0009P) HHS Proposed Rule on Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards (Docket Number: CMS-0013-P) HHS Proposed Rule HIPAA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS (Docket Number: DEA-2008-0009) DEA Proposed Rule for Electronic Prescriptions for Controlled Substances (Docket Number: FDA-2008-N-0466) FDA Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Anesthetic and Life Support Drug Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA2008D0417) Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings (Docket No. FDA2003N0313 (formerly Docket No. 2003N0342)) FDA Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number: FDA2008N0612) Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments (Public Law 110-85) Food and Drug Administration Amendments Act of 2007 Section on Adverse Event Reporting Requirement Concept (No Bill Language): Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept (No Bill Language): U.S. Office of Inspector General (OIG) Exclusions List of Certain Health Care Providers who Have Engaged in Fraudulent or Abusive Behavior from Participating in Federally Funded Health Care Programs
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2008 · third_quarter · Q3
H.R. 6353 - Ryan Haight Online Pharmacy Consumer Protection Act of 2008 H.R. 5839 - Safeguarding Americas Pharmaceuticals Act of 2008 H. Res. 1437 - Designates October as American Pharmacists Month Under Line 17: We would like to include Office of the National Coordinator (ONC) for Health Information Technology H.R. 6357 - Protecting Records, Optimizing Treatment, and Easing Communication through Healthcare Technology (PRO(TECH)T) Act of 2008 H.R. 5491 - Pharmacy Technician Training and Registration Act of 2008 H.R. 4054 - Prevention Through Affordable Access Act (Docket Number: CMS0009P) HHS Proposed Rule on Health Insurance Reform; Modifications to the Health Insurance Portability and Accountability Act (HIPAA) Electronic Transaction Standards (Docket Number: CMS-0013-P) HHS Proposed Rule HIPPA Administrative Simplification: Modification to Medical Data Code Set Standards To Adopt ICD-10-CM and ICD-10-PCS (Docket Number: FDA-2006-N-5015) FDA Proposed Rule on Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (Docket Number: DEA-2008-0009) DEA Proposed Rule for Electronic Prescriptions for Controlled Substances (Docket Number: FDA-2008-N-0466) FDA Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing (Docket Number: FDA-2008-N-0038) FDA Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; Notice of Meeting (Docket Number: FDA2008D0417) Draft Guidance for the Public and the Food and Drug Administration Staff on Convening Advisory Committee Meetings (Docket Number: FDA-2005-N-0464) FDA Proposed Rule on Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs (Public Law 110-85) Food and Drug Administration Amendments Act of 2007 Section on Adverse Event Reporting Requirement (Public Law 100-293) Prescription Drug Marketing Act of 1987 (PDMA) (Public Law 102-353) Prescription Drug Amendment of 1992 (PDA) Comments to ONC on Use Case Draft Medication Gaps Document Draft AHIC Extension/Gap
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2008 · second_quarter · Q2
H.R. 1343 Health Centers Renewal Act of 2008 H.R. 2994 National Pain Care Policy Act of 2007 H.R. 1108/ S. 265 Family Smoking Prevention and Tobacco Control Act Under Line 17: We would like to include HHS - Office of Inspector General (OIG) (Docket Number: HRSA-RIN-0906-AA44) Resignation of Medically Underserved Populations and Health Professional Shortage Areas (Docket Number: OIG-126-PN) Proposed notice; Department of Health and Human Services Office of Inspector General (OIG); Draft OIG Supplemental Compliance Program Guidance for Nursing Facilities sections on pharmacies and pharmacists
H.R. 4053 Veterans Mental Health and Other Care Improvements Act of 2008 section on Pain Care Act H.R. 6122 Veterans Pain Care Act of 2008 S. 2669 Veterans Medical Personnel Recruitment and Retention Act of 2008 section on Incentive Pay
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2008 · first_quarter · Q1
Docket No. RIN 0919-AA01 Patient Safety and Quality Improvement Proposed Rule S. 2456 Influenza Vaccine Security Act S. 2465 Vaccines for Children Access Act of 2008 H.R. 4990 Vaccines for Children Access Act of 2008 H.R. 4702 Vaccines for Children Access Act of 2008 S. 2467 Vaccine Shortage Preparedness Act of 2008 H.R. 4703 Vaccine Shortage Preparedness Act of 2008 H.R. 4991 Vaccine Shortage Preparedness Act of 2008 S. 2476 Improved Vaccine Supply Act H.R. 4251 Flu Vaccine Availability Act of 2008 H.R. 4331 Attacking Viral Influenza Across Nations Act of 2008 S. 2466 Vaccines for the Uninsured Adult Act of 2008 H.R. 4705 Vaccines for the Uninsured Adult Act of 2008 H.R. 4993 Vaccines for the Uninsured Adult Act of 2008
S. Con. Res. 70 Concurrent Resolution on the Budget for Fiscal Year 2009 Public Law 110-181 National Defense Authorization Act of Fiscal Year 2008 President's FY 2009 Proposed Budget
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2007 · year_end · YA
S 2160 Veterans Pain Care Act of 2007
Delays in HIPPA required NPI registery Docket No. 2007N-0356 Comments and Statement Submitted on Behind the Counter Availability of Certain Drugs RE: Docket No. CMS-1385-FC. 42 CFR Parts.160. Medicare Program: Amendment if the E-Prescribing Exemption for Computer-Generated Facsimiles Docket No. 2007P-0074 Joint Meeting of the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee -Cough and Cold Medications use in Children Statements Submitted on the FDA Nonprescription Drugs Advisory Committee and the Endodrinologic and Metabolic Drugs Advisory Committee Over-the-Counter Use of Mevacor (lovastatin) Voluntary Restricted Distribution of 40mg Methadone to Hospitals Statements Submitted to Senate Judiciary Committee on "Electronic Prescribing of Controlled Substances: Addressing Health Care and Law Enforcement Proirities" Docket No. DEA 298 Combat Methamphetamine Epidemic Act 2005 Self-Certification S1276 Methamphetamine Production Prevention Act of 2007 HR 2747 Methamphetamine Production Prevention Act of 2007 HR 3580 Food and Drug Administration Amendments Act of 2007 HR 2900 Food and Drug Administration Amendments Act of 2007 S 1378 Dextromethorphan Distribution Act of 2007 HR 970 Dextromethorphan Distribution Act of 2007 S 1695 Biologics Price Competition and Innovation Act of 2007
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2007 · year_end · YY
HR 2994 National Pain Care Policy Act of 2007 72 FR 61886 - The propoosed draft guidance on Allocating and Targeting Pandemic Influenza Vaccine
Delays in HIPPA required NPI registery Docket No. 2007N-0356 Comments and Statement Submitted on Behind the Counter Availability of Certain Drugs RE: Docket No. CMS-1385-FC. 42 CFR Parts.160. Medicare Program: Amendment if the E-Prescribing Exemption for Computer-Generated Facsimiles
HR 3161 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 HR 2638 Department of Homeland Security Appropriations Act, 2008 HR 1585 National Defense Authorization Act
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2007 · mid_year · MM
H.R. 4 the Medicare Prescription Drug Price Negotiation Act of 2007 S. 3 the Medicare Prescription Drug Price Negotiation Act of 2007 H.R. 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007' Medicaid reimbursement for pharmacy Medicare - specific to vaccine administration Medicare – specific to the durable medical equipment prosthetics, orthotics, and supplies (DMEPOS)competitive bidding program Medicare – specific to payments for Epogen and reimbursement issues for the treatment of End Stage Renal Disease (ESRD). H.R. 3162 to reauthorize the State Children's Health Insurance Program (SCHIP) - Medicare related items President's 2008 budget – specific to pharmacy reimbursement in Medicaid CMS Docket CMS-2238-P/RIN 0938–AO20 re: Medicaid Program; Prescription Drugs - implementation of the Deficit Reduction Act of 2005 and AMP CMS Docket No. CMS-4124-P re: proposed Medicare Part D technical amendments. H.R. 3090 - Patient and Pharmacy Protection Act of 2007 S. 2013- Patient and Pharmacy Protection Act of 2007 Medicare Part D Prescription Drug Benefit - pharmacy issues Medication Therapy Management Services CMS re: Draft 2008 Part D Plan Call Letter Tamper-Resistant Prescription Pad Requirement in Medicaid
AMERICAN PHARMACISTS ASSOCIATION via AMERICAN PHARMACISTS ASSOCIATION
2006 · year_end · YY
S. 2664 Pharmacy Access Improvement (PhAIM) Act of 2006 S. 2551 Prompt Payment of Health Benefits Claims Act of 2006 S. 2563 Pharmacist Access and Recognition in Medicare (PhARM) Act of 2006 Implementation of the Deficit Reduction Act of 2005 - Pharmacy Reimbursement Implementation of Medicare Part D CMS 1270-P re: Durable Medical Equipment Competitive Bidding Program – CMS-4119-P re: proposing to allow the Secretary of the DHHS to share Part D claims data for research, analysis, reporting, and public health functions CMS re: Draft 2007 Coordination of Benefits Guidance Medicare Part B payment reforms. H.R. 5182 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2006
H.R. 1652 Access to Legal Pharmaceuticals Act H.R. 1808 Safe Online Drug Act of 2005 H.R. 1815 National Defense Authorization Act for Fiscal Year 2006 – Pharmacy Program H.R. 4769 Prescription Drug Abuse Elimination Act of 2006 H.R. 5122 John Warner National Defense Authorization Act for Fiscal Year 2007 – Pharmacy Program H.R. 5280 Dextromethorphan Distribution Act of 2006 H.R. 5384 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2007 – Prescription Drug Importation H.R. 5441 Department of Homeland Security Appropriations Act, 2007 – Prescription Drug Importation S. 334 Pharmaceutical Market Access and Drug Safety Act of 2005 S. 778 Pharmacy Consumer Protection Act of 2005 S. 809 Access to Legal Pharmaceuticals Act S. 2766 John Warner National Defense Authorization Act for Fiscal Year 2007 – Pharmacy Program S. 3807 Enhancing Drug Safety and Innovation Act of 2006 S. 3546 Dietary Supplement and Nonprescription Drug Consumer Protection Act Pharmacy Compounding Counterfeit Drugs Health Information Technology Implementation of the Combat Methamphetamine Epidemic Act of 2005 FDA Draft Compliance Policy Guide 160.900 on pedigree requirements under the Prescription Drug Marketing Act (PDMA) FDA Docket No. 2006N-0283 re: the proposed survey of physicians’ perceptions on the impact of early risk communication about medical products DEA Docket No. DEA-2911 re: retail sales of scheduled listed chemical products and self-certification of regulated sellers of scheduled listed chemical products CMS-1321-P re: proposed revisions to the payment policies under the physician fee schedule for calendar year 2007 DEA-287N re the issuing of multiple prescriptions for Schedule II Controlled Substances FDA Re: Draft Compliance Policy Guide 160.900 on pedigree requirements under the Prescription Drug Marketing Act Proposed revisions to the United States Pharmacopeia (USP) General Chapter <797> Pharmaceutical Compounding – Sterile Preparations. H.R. 1539 A bill to amend the Public Health Service Act with respect to the responsibilities of a pharmacy when a pharmacist employed by the pharmacy refuses to fill a valid prescription for a drug on the basis of religious beliefs or moral convictions, and for other purposes.
Legislative and agency issues regarding the Patient Protection and Affordable Care Act (P.L. 111-148) - Appropriations for the medication therapy management grant program.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Legislative and agency issues regarding the Health Care and Education Reconciliation Act of 2010 (P.L. 111-152) and the Patient Protection and Affordable Care Act (P.L. 111-148) including sections concerning Medicare Part D changes; medication therapy management (MTM); accountable care organizations (ACOs); durable medical equipment (DME); Center for Medicare and Medicaid Innovation within CMS; transitions of care; and providing adequate pharmacy reimbursement (AMP).
S.274 Medication Therapy Management Empowerment Act of 2011 H.R.891 Medication Therapy Management Benefits Act of 2011 Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; standardized pharmacy notice. immunization; and health information technology. Communications with the Joint Select Committee on Deficit Reduction on preserving patient access to medication therapy management services in Medicare Part D, fair reimbursement in Medicare and Medicaid.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Legislative and agency issues regarding the Patient Protection and Affordable Care Act (P.L. 111-148) - Appropriations for the medication therapy management grant program.
S.274 Medication Therapy Management Empowerment Act of 2011 H.R.891 Medication Therapy Management Benefits Act of 2011 Agency issues related to standardized medication action plans; accountable care organizations; pharmacists' participation in the CMS Innovation Center initiatives; personalized medication lists; standardized pharmacy notice; immunization; and health information technology.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
(Public Law 111-148) Patient Protection and Affordable Care Act - Appropriations for the medication therapy management grant program Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ)
S. 274 - Medication Therapy Management Empowerment Act of 2011 H.R. 891 - Medication Therapy Management Benefits Act of 2011 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on long-term care pharmacy waste reduction programs, fraud, waste and abuse provisions, the Medicare durable medical equipment, prosthetics, orthotics, supplies (DMEPOS) accreditation requirements, the CMS Innovation Center, and pharmacists participation in Accountable Care Organizations (ACOs) and other integrated care models such as the Independence at Home demonstration program] (Docket Number: CMS-4144-P) Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes; Proposed Rule (Docket Number: CMS-1345-NC) Medicare Program: Request for Information Regarding Accountable Care Organizations and the Shared Savings Program (Docket Number: CMS5055N) Medicare Program: Community-Based Care Transitions Program (CCTP) Meeting (RIN 0991-AB58) ONC Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology; Final Rule (RIN 0991-AB76) ONC Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: CMS-0033-F) Medicare and Medicaid Programs; Electronic Health Record Incentive Program (Docket Number: CMS-2011-0003-0002) Medicare Program: Hospital Inpatient Value-Based Purchasing Program (Docket Number: CMS-2011-0017-0001) Medicaid Program: Payment Adjustment for Provider Preventable Conditions Including Health Care Acquired Conditions Guidelines for Timely Medication Administration Response to the CMS 30-Minute Rule" Advance Notice of Methodological Changes for Calendar Year (CY) 2012 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2012 Call Letter Announcement of Calendar Year (CY) 2012 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter CMS Medicare Part D Payment Memo for Drugs for End-Stage Renal Disease Standardized Format for the Comprehensive Medication Review Action Plan and Summary Request for Comment Concept - Pharmacists participation in the CMS Innovation Center initiatives
Pharmacist Loan Repayment Eligibility Act of 2011 (S.48) (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: FDA-2011-D-0074-0001) Draft Guidance for Industry on Medication Guides; Availability: Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies; Availability (Docket Number: FDA-2010-N-0633) Determination of System Attributes for Tracking and Tracing of Prescription Drugs; Public Workshop (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: FDA2011N0100) Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and Offered for Relief of Symptoms of Cold, Cough, or Alergy; Enforcement Action Dates (Docket Number: FDA-2011-N-0002) Joint Meeting of the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting Concept - Standardizing REMS programs, components and development of a potential tiered REMS System Concept - Designing Pilot Programs to Distribute Patient Medication Information Concept - Drug Disposal Concept - Preventing counterfeit prescription drugs from entering the supply chain
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
HR 2751 - FDA Food Safety Modernization Act (Sections on dietary supplements, establishment of foreign FDA offices; and the establishment of voluntary food allergy and anaphylaxis management guidelines) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) and the Institute of Medicine of National Academies HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demonstration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program (ACOs); national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal... medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0950-AA06) Health Insurance Issuers Implementing Medical Loss Ratio (MLR) Requirements Under the Patient Protection and Affordable Care Act; Interim Final Rule (Docket Number: 75FR65495) National Institutes for Health; Interagency Pain Research Coordinating Committee; Call for Nominations (Docket Number: 2010-28041) Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (Docket Number: CMS-0009-N) Health Insurance Reform; Announcement of Maintenance Changes to Electronic Data Transaction Standards Adopted Under the Health Insurance Portability and Accountability Act of 1996 (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (Docket Number: 75FR65359)AHRQ Common Formats for Patient Safety Data Collection and Event Reporting; Notice of availability NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS Request for Comment on the Development of the National Health Care Quality Strategy and Plan IRS Notice (2010-59) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 - Cafeteria Plans, Section 220 Archer MSAs, Section 223 Health Savings Accounts (P.L. 111-148, Section 9003) IRS Revised Notice (2011-5) on: Section 105 - Amounts Received under Accident and Health Plans, Section 106 Contributions by Employers to Accident and Health Plans, Section 125 Cafeteria Plans (P.L. 111-148, Section 9003) HHS National Health Care Quality Strategy and Plan IOM Study on the Determination of Essential Health Benefits in P.L. 111-148 Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
(Public Law 111-148) Patient Protection and Affordable Care Act - Appropriations for the MTM Grant Program and for Programs to Establish Integrated and Coordinated Care Models Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ)
S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2010 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 Under Line 17: We would like to include the Office of National Drug Control Policy (ONDCP) HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act S 80 - Pharmaceutical Market Access Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2010-N-0001) Third Annual Sentinel Initiative Public Workshop (Docket Number: FDA-2010-N-0128) Prescription Drug User Fee Act; Reopening of the Comment Period (Docket Number: FRL-9197-7) EPA Best Management Practices for Unused Pharmaceuticals at Health Care Facilities (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: DEA-338) Schedules of Controlled Substances: Placement of Propofol Into Schedule IV; Proposed Rule (Docket Number: FDA-2010-N-0273) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Quality System Regulations (Docket No. FDA-2010-N-0344) Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: FDA-2010-N-0477) Approval Pathway for Biosimilar and Interchangeable Biological Products; Public Hearing; Request for Comments (Docket Number: FDA2010N0486) Safe Use Initiative; Public Workshop; Request for Comments (RIN 0720AB45) DoD Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/ TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals (Docket Number: DEA316N) Procedures for the Surrender of Unwanted Controlled Substances by Ultimate Users; Notice of Meeting (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies FDA Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information Concept Standardizing REMS programs, components and development of a potential tiered REMS System Concept 2010 National Drug Control Strategy (ONDCP)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), SENATE, White House Office
HR 6012 - To direct the Secretary of Health and Human Services to review uptake and utilization of diabetes screening benefits and establish an outreach program with respect to such benefits, and for other purposes. HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 Drug Safety Discussion Draft Bill (builds on the Food and Drug Globalization Act - HR 759) - Amends the Federal Food, Drug, and Cosmetic Act to improve the safety of drugs, and for other purposes. (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute; and funding for the grant program established in the section on medication management (MTM) services in treatment of chronic disease).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (Docket Number: OCIIO-9992-IFC) Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information (RIN 0991AB57) Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act (Docket Number: FDA-2010-D-0431) Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers; Availability (Docket Number: FDA-2010-N-0449) Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy Products; Public Workshop; Request for Comments FDA Draft Guidance for Industry Tobacco Retailer Training Programs NAIC Regulation for Uniform Definitions and Standardized Rebate Calculation Methodology for Plan Years 2011, 2012 and 2013 per Section 2718 (b) of the Health Service Act HHS National Health Care Quality Strategy and Plan Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Opportunities for Pharmacist Clinical Services in Health Care Reform Provisions
HR 5710 - National All Schedules Prescription Electronic Reporting Reauthorization Act of 2010 S 256/HR 2923 - Combat Methamphetamine Enhancement Act of 2009 S 3397/ HR 1359 - Secure and Responsible Drug Disposal Act of 2010 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HAMDT 740 (to HR 5822 Military Construction and Veterans Affairs and Related Agencies Appropriations Act, 2010) - a VA prescription drug re-labeling program HR 1204 - The Community Pharmacy Fairness Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting on Opioid REMS (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA-2010-N-0284 and 2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period (Docket Number: FDA2010N0437) Development and Distribution of Patient Medication Information for Prescription Drugs; Public Hearing (Docket Number: DEA 337N) Dispensing of Controlled Substances at Long-Term Care Facilities; Notice, Solicitation of Information (Docket Number: DEA-339S) Role of Authorized Agents in Communicating Controlled Substance Prescriptions to Pharmacies DEA National Drug Take-Back Day Concept Standardizing REMS programs, components and development of a potential tiered REMS System
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)
HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform
(Public Law 111-148) Patient Protection and Affordable Care Act for Appropriations for the MTM Grant Program (Public Law 111-5) American Recovery and Reinvestment Act of 2009 sections on Health Information Technology Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 4213 - American Jobs and Closing Tax Loopholes Act of 2010 in support of including Medicaid Federal Medical Assistance Percentage (FMAP) Funding (or in any stand alone legislation)
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation
H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office
HR 3854 - Small Business Investment and Financing Act of 2009 Section on Health Information Technology HR 3014 - Small Business Health Information Technology Financing Act (Public Law 111-5) American Recovery and Reinvestment Act of 2009 sections on Health Information Technology Under Line 17: We would like to include the Office of the National Coordinator for Health Information Technology
S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number FDA2009D0181) Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability (Docket Number FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number FDA1977N0013) (formerly Docket No. 1977N0094L) Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph (Docket Number FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number FDA2006N0238) (formerly Docket No. 2006N0062) Expanded Access to Investigational Drugs for Treatment Use (Docket Number FDA2006N0237) (formerly Docket No. 2006N0061) Charging for Investigational Drugs Under an Investigational New Drug Application (Docket Number FDA2009N0247) Food and Drug Administration Transparency Task Force; Reopening of Comment Period (Docket Number DEA321) Identification of Institution-based Individual Practitioners (Docket Number FDA2009N0374) Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number FDA-2009-N-0138) Liver Injury Related to the Use of Acetaminophen; Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee (DEA Information Collection 1117-0046) Self-Certification, Training and Logbooks for Regulated Sellers of Scheduled Listed Chemical Products (Docket Number FDA2008N0424) Postmarketing Safety Reporting for Combination Products (Docket Number FDA2009N0664) Risk Communication Advisory Committee; Notice of Meeting Concept - Medication Adherence Concept - Pharmacogenomics Concept - Oppose Liberalizing Prescription Drug Importation Concept - Agent of the Prescriber
HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act S 1634 - The Medicare Prescription Drug Improvement Act of 2009 Under Line 17: We would like to include the Office of the National Coordinator for Health Information Technology S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Managament Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform HR 3663 - Amends the Social Security Act to delay the October 1, 2009 deadline on which the accreditation requirement under the Medicare Program applies to suppliers of durable medical equipment that are pharmacies. (Public Law 111-72) S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket No. CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs Docket Number: CMS-10260 (OMB#: 0938-1051) Collection Activities; Medicare Advantage and Prescription Drug Program: Final Marketing Provisions (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter Draft Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, White House Office
Concept - veterans' prescription drug benefit and the importance of medication therapy management services
HR1204 - The Community Pharmacy Fairness Act of 2009 S80 - Pharmaceutical Market Access Act of 2009 HR1298/S525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR163 - Prescription Drug Affordability Act HR2400 - Strategies to Address Antimicrobial Resistance Act HR1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all Pharmacy-Based Communications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy includes: medication guides; patients package inserts; and consumer medication information (Docket Number FDA2009D0181) Draft Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products;Availability (Docket Number FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number FDA1977N0013) (formerly Docket No. 1977N0094L) Organ-Specific Warnings; Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Final Monograph (Docket Number FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number FDA2006N0238) (formerly Docket No. 2006N0062) Expanded Access to Investigational Drugs for Treatment Use (Docket Number FDA2006N0237) (formerly Docket No. 2006N0061) Charging for Investigational Drugs Under an Investigational New Drug Application (Docket Number FDA2009N0247) Food and Drug Administration Transparency Task Force; Reopening of Comment Period (Docket Number DEA321a) Identification of Institution-based Individual Practitioners (Docket Number FDA2009N0374) Educating the Public About Removal of Essential-Use Designation for Epinephrine; Public Workshop; Request for Comments (Docket Number FDA2009N0441) Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Docket Number FDA-2009-N-0138) Liver Injury Related to the Use of Acetaminophen; Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee and the Anesthetic and Life Support Drugs Advisory Committee (DEA Information Collection 1117-0046) Self-Certification, Training and Logbooks for Regulated Sellers of Scheduled Listed Chemical Products Concept - Oppose Liberalizing Prescription Drug Importation Concept - Misuse of Antibiotics in Agriculture
HR3239 - Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2010 sections on Medicare, Medicaid, SCHIP, emergency preparedness, AIDS assistance programs, CDC, and ONC funds Under Line 17: We would like to include the Office of the National Coordinator for Health Information Technology S1391 - Department of Defense Authorization Act for Fiscal Year 2010 section on eliminating funds to prevent prescription drug importation (S.AMDT 1467) (Public Law 111-5) American Recovery and Reinvestment Act of 2009 sections on Health Information Technology
S266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR203 - Medicare Fraud Prevention Act of 2009 HR27 - Medicare Fraud Prevention and Enforcement Act of 2009 Under Line 17: We would like to include the Office of the National Coordinator for Health Information Technology HR616/S511 - Access to Durable Medical Equipment Act HR574/S254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR2560/S1131 - Independence At Home Act HR1970/S956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR3700/S1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR3108 - Medication Therapy Managament Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform HR3663 - Amends the Social Security Act to delay the October 1, 2009 deadline on which the accreditation requirement under the Medicare Program applies to suppliers of durable medical equipment that are pharmacies. S683 - Community Choice Act of 2009 HR1392/S1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) [Document Number: CMS-10260 (OMB#: 0938-1051)] Collection Activities; Medicare Advantage and Prescription Drug Program: Final Marketing Provisions (74 FR 45206) HRSA Notice Regarding 340B Pricing Program - Children's Hospitals (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Indian Health Service, SENATE, White House Office
HR616/S511 - Access to Durable Medical Equipment Act HR203 - Medicare Fraud Prevention Act of 2009 HR27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR574 - Medicare Home Infusion Therapy Coverage Act of 2009 S266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR2560/S1131 - Independence At Home Act HR1970/S956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR3700/S1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturer Price Reimbursement Formula in Health Care Reform (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 Sections on Medicare DMEPOS (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Solicitation for Comments on the Draft CMS Model Transition Letter for Calendar Year 2010 Draft 2010 Medicare Part D Call Letter
HR756/S660 - National Pain Care Policy Act of 2009 HR179 - Community AIDS and Hepatitis Prevention Act S1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR2891 - Access to Frontline Health Care Act of 2009 HR1259 - The Dextromethorphan Distribution Act of 2009 HR1256 - Family Smoking Prevention and Tobacco Control Act on S.A. 1229 - Pharmaceutical Market Access and Drug Safety Act of 2009 (Docket Number: IRS-2006-0502) Employer Comparable Contributions to Health Savings Accounts Under Section 4980G (74 FR 28937) Draft Recommendations for the Term Meaningful Use" of Electronic Health RecordsConcept (Docket Number 105A) Updating the List of Hazardous Drugs for the NIOSH Alert: Additions and Deletions to the NIOSH Hazardous Drug List Concept (No Bill Language) Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Concept (No Bill Language) CBO Scoring of Prevention and Chronic Disease Management in Health Care Reform Draft Bill Access to Birth Control Act Draft Bill Affordable Health Choices Act (Sections on ensuring quality of care; affordable choices of health benefit plans; seeking the best medical advice; spending for Federally Qualified Health Centers (FQHCs); national strategy; presentation of drug information; center for health outcomes research and evaluation; administrative simplification; right choices program; grants to establish community health teams to support a medical home model; grants to implement medication management services in treatment of chronic disease; national health care workforce commission; funding for National Health Service Corps; geriatric education and training, career awards, comprehensive geriatric education; nurse education, practice, and retention grants; and increase prevention and wellness provisions) Draft Bill - America's Affordable Health Choices Act of 2009 HR3200 [(no bill name or number during reporting period) Sections on ensuring adequacy of provider networks; essential benefits package defined; Health Benefits Advisory Committee; outreach and enrollment of Exchange-eligible individuals and employers in Exchange-participating health benefits plan; payment rates for items and services; reducing potentially preventable hospital readmissions; post acute care services payment reform plan; requiring drug manufacturers to provide drug rebates for certain, full premium subsidy eligible individuals; phasedin elimination of coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out of pocket threshold under part D; permitting mid-year changes in enrollment; telehealth expansion and enhancements; intelligent assignment in enrollment; ensuring effective communication in Medicare; Accountable Care Organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; comparative effectiveness research; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; distribution of unused residency positions; require providers and suppliers to adopt programs to reduce waste, fraud, and abuse, payments to pharmacists; Task Force on Clinical Preventive Services; fully integrated dual eligible special needs plans (FIDESNP); public health and workforce development; prevention and wellness; and sections 212 (grants to establish community health teams to support a medical home model) and 213 (grants to implement medication management services in treatment of chronic disease) from the Senate HELP Committee's Draft Affordable Health Choices Act] Commented on Senate Finance Committee Report on Expanding Health Care Coverage and Senate Finance Committee Report on Transforming the Health Care Delivery System Concept Role of Pharmacist-Provided Patient Care Services in any Integrated Care Model and Medication Therapy Management Services in Health Care Reform
Filing targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE
HR756 - National Pain Care Policy Act of 2009 HR1259 - The Dextromethorphan Distribution Act of 2009 HR179 - Community AIDS and Hepatitis Prevention Act (Docket Number: IRS-2006-0502) Employer Comparable Contributions to Health Savings Accounts Under Section 4980G (Docket Number: HHS-OS-2008-0011) Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices In Violation of Federal Law; Proposed Rule (Docket Number: HHS_FRDOC_0001-0042) Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law; Final Rule (Docket Number: HHS-OPHS-2009-0001) Rescission of the Regulation Entitled Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law; Proposal Concept (No Bill Language) Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Concept (No Bill Language) Role of Pharmacist-Provided Patient Care Services in Health Care Reform
HR1 - American Recovery and Reinvestment Act of 2009 Sections on Health Information Technology
HR616/ S511 - Access to Durable Medical Equipment Act HR203 - Medicare Fraud Prevention Act of 2009 HR27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR574 - Medicare Home Infusion Therapy Coverage Act of 2009 S266 - Medicare Prescription Drug Gap Reduction Act of 2009 (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 Sections on Medicare DMEPOS and Protected Drug Classes (Docket Number: CMS 4138IFC4) Medicare Program: Medicare Advantage and Prescription Drug Programs MIPPA Drug Formulary & Protected Classes Policies (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-0009-P) CMS Proposed Rule on Modifications to the HIPAA Electronic Transaction Standards (Docket Number: CMS0013F) HIPAA Administrative Simplification: Modifications to Medical Data Code Set Standards To Adopt ICD10CM and ICD10PCS (Docket Number: CMS2244F) Medicaid Program; Premiums and Cost Sharing (Docket Number: CMS-4131-FC;-RIN 0938-AP24) Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Negotiated Pricing and Remaining Revisions; Final Rule; Medicare Program; Prescription Drug Benefit Program Payments to Sponsors of Retiree Prescription Drug Plans; Proposed Rule Draft 2010 Medicare Part D Call Letter
Filing targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), SENATE, White House Office
DRAFT Economic Stimulus Bill Section on Health Information Technology S. 3001 - National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417) Section on TRICARE
H.R. 6680 - The Community and AIDS and Hepatitis Act H.R. 2994/ S. 3387 - National Pain Care Policy Act of 2007 S. 2176 Methamphetaime Production Act (Public Law 110-415) Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Docket Number: HHS-OS-2008-0011) HHS Proposed Rule on Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices In Violation of Federal Law (Docket Number: AHRQ_FRDOC_0001-0054) Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance Availability (Docket Number: RIN 0919AA01) Patient Safety and Quality Improvement (Final Rule) (Docket Number: RIN 1545BE30) Employer Comparable Contributions to Health Savings Accounts Under Section 4980G (Public Law 109-41) Patient Safety & Quality Improvement Act of 2005
(Docket Number: EPA-HQ-RCRA-2007-0932) Amendment to the Universal Waste Rule: Addition of Pharmaceuticals (Docket Number: EPAHQOW2008 0517) Agency Information Collection Activities: Proposed Collection; Comment Request; Study of Unused Pharmaceuticals from Medical and Veterinary Facilities
H.R. 6331/ S. 3101 - Medicare Improvements for Patients and Providers Act of 2008 (P.L. 110-275) Sections on Medicaid AMP, Medicare Part D prompt payment, DME Competitive Bidding and Accredition, Prescription Drug Pricing, Long-Term Care pharmacies, and e-prescribing H.R. 4296/ S. 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 3700/ S. 1951 - Fair Medicaid Drug Payment Act of 2007 H.R. 3140 - Saving Our Community Pharmacies Act of 2007 S. 1827 - Pharmacist Access and Recognition in Medicare (PhARM) of 2007 H.R. 3025 - Medicare Prescription Drug Savings for Our Seniors Act of 2007 (Docket Number: CMS 4138- IFC) Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs Sections on Prompt Payment of Clean Claims, Prescription Drug Pricing, Long-Term Care Pharmacies, Special Needs Plans, and Medication Therapy Management (Docket Number: CMS-1404-FC) Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2009 Payment Rates. Final Rule with Comment Period (Docket Number: CMS-4121-F) CMS Final Rule on Prohibiting Midyear Changes to Medicare Advantage Plans (Docket Number: CMS-1403-P) CMS Amendment on Medicare Program; Revisions to Amendment of the E-Prescribing Exemption for Computer-Generated Facsimiles (Docket Number: CMS-7011-N) CMS Notice on Medicare Program: Request for Cosponsors for E-prescribing Educational Conference (Docket Number: CMS-2238-F) Medicaid Program; Multiple Source Drug Definition (Public Law 110-28 and Public Law 110-90) Medicaid's Tamper-Resistance Prescription Pad Requirement (Public Law 109-171) Deficit Reduction Act of 2005 Section on Average Manufacturers Price (AMP) (Public Law 108-173) Medicare Modernization Act (MMA) Section on Medicare Advantage and Medicare Part D Fraud, Waste, and Abuse Training Concept (No Bill Language): Medicare Part B "Provider Status" for Pharmacists Concept (No Bill Language): Changes to Medicare Part D Medication Therapy Management Benefit
H.R. 6122 - Veterans Pain Care Act of 2008 S. 2162 - Veterans' Mental Health and Other Care Improvements Act of 2008 (Public Law 110-387) Section on Pain Care Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE
H.R. 6331/ S. 3101 - Medicare Improvements for Patients and Providers Act of 2008 (P.L. 110-275) Sections on Medicaid AMP, Medicare Part D prompt payment, DME Competitive Bidding, Prescription Drug pricing, and e-prescribing H.Res. 1368 - Relating to the House procedures contained in section 803 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 H.R. 4296/ S. 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 3700/ S. 1951 - Fair Medicaid Drug Payment Act of 2007 H.R. 3140 - Saving Our Community Pharmacies Act of 2007 H.R. 6252/S. 3144 - Medicare DMEPOS Competitive Acquisition Reform Act of 2008 H.R. 5780 - Medicare Clinical Practitioner Services Coverage Act of 2008 H.R. 5613 - Medicaid Safety Net Act of 2008 H.R. 2408/ S. 2408 - Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 971 - Community Pharmacy Fairness Act S. 1827 - Pharmacist Access and Recognition in Medicare (PhARM) of 2007 S. 1474 - Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 H.R. 3025 - Medicare Prescription Drug Savings for Our Seniors Act of 2007 S. 1954 Pharmacy Access Improvement Act (PhAIM) of 2007 (Docket Number: CMS-4121-F) CMS Final Rule on Prohibiting Midyear Changes to Medicare Advantage Plans (Docket Number: CMS 4131-P) CMS Proposed Changes to Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefits Programs (Docket Number: CMS 4131F) CMS Final Rule on Medicare Program; Medicare Advantage and Prescription Drug Benefit Programs: Final Marketing Provisions (Docket Number: CMS-1403-P) CMS Amendment on Medicare Program; Revisions to Amendment of the E-Prescribing Exemption for Computer-Generated Facsimiles (Docket Number: CMS-1405-N) CMS Notice on Medicare Provider Feedback Group Town Hall Meeting (Docket Number: CMS-7011-N) CMS Notice on Medicare Program: Request for Cosponsors for E-prescribing Educational Conference (Public Law 110-28 and Public Law 110-90) Medicaid's Tamper-Resistance Prescription Pad Requirement (Public Law 109-171) Deficit Reduction Act of 2005 Section on Average Manufacturers Price (AMP)
S. 3001 - National Defense Authorization Act of Fiscal Year 2009 Section on TRICARE
H.R. 5348 - American Health Benefits Program (AHBP) Act H.R. 6680 - The Community and AIDS and Hepatitis Act H.R. 2994/ S. 3387 - National Pain Care Policy Act of 2007 H.R. 5348 - American Health Benefits Program (AHBP) Act S. 1693 - Wired for Health Care Quality Act H.R. 4991 - Vaccine Shortage Preparedness Act of 2008 H.R. 4992 - Medicare Improvement Act of 2007 H.R. 4993 - Vaccines for the Uninsured Adult Act of 2008 S. 2476 - Improved Vaccine Supply Act H.R. 1108/ S. 625 - The Family Smoking Prevention and Tobacco Control Act (Docket Number: HHS-OS-2008-0011) HHS Proposed Rule on Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices In Violation of Federal Law (Docket Number: RIN-0906-AA44) HHS Proposed Rule on Designation of Medically Underserved Populations and Health Professional Shortage Areas
H.R. 6122 - Veterans Pain Care Act of 2008 H.R. 6445 - The Veterans Health Care Enhancement Act of 2008 Section on Pain Care Act S. 2669 - Veterans' Medical Personnel Recruitment and Retention Act of 2008
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, White House Office
H. Con. Res. 342 Expressing the sense of Congress that the Food and Drug Administration's (FDA) new policy restricting women's access to medications containing estriol does not serve the public interest H.R. 6353/ S. 980 Ryan Haight Online Pharmacy Consumer Protection Act of 2008 H.R. 5839 Safeguarding Americas Pharmaceuticals Act of 2008 (Public Law 110-85) Food and Drug Administration Amendment Act of 2007 (FDAAA) sections on Standardization of Prescription Drug Identifiers (Docket Number: FDA-2008-N-0120) and Technology Prescription Drug Identifiers ( Docket Number FDA-2008-N-0120) and Prescription Drug User Fee Act (PDUFA) (Docket Number: FDA-N-0157) FDA Prescription Drug Labeling and Medication Guide (Docket Number DEA218P) Electronic Prescriptions for Controlled Substances (Docket Number: FDA-2008-N-0281-0001) Pilot Program To Evaluate Proposed Name Submissions; Concept Paper; Public Meeting (Docket Number: FDA-2006-N-5015) Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling (Docket Number: FDA-2008-N-0257-0001) Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan (Docket Number: FDA-2008-N-0162) Agency Information Collection Activities; Proposed Collection; Comment Request: Prescription Product Labeling: Medication Guide Requirements [related to the Paperwork Reduction Act of 1995] DRAFT Food and Drug Globalization Act of 2008 sections on drug and medical devices
DRAFT Fiscal 2009 Agriculture Appropriations section on FDA Funding
H.R. 3700/ S. 1951 Fair Medicaid Drug Payment Act of 2007 H.R. 3140 Saving Our Community Pharmacies Act of 2007 S. 3101/ H.R. 6331 Medicare Patients and Providers Act of 2008 sections on AMP, Prompt Payment of Part D Claims, DME Competitive Bidding, and Prescription Drug Pricing Updates H.R. 6252/ S. 3144 Medicare DMEPOS Competitive Acquisition Reform Act of 2008 H.R. 5780 Medicare Clinical Practitioner Services Coverage Act of 2008 H.R. 5613 Medicaid Safety Net Act of 2008 H.R. 2408/ S. 2408 Medicare Electronic Medication and Safety Protection (E-MEDS) Act of 2007 H.R. 971 Community Pharmacy Fairness Act S. 1827 Pharmacist Access and Recognition in Medicare (PhARM) of 2007 S. 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 H.R. 3025 Medicare Prescription Drug Savings for Our Seniors Act of 2007 S. 1954 Pharmacy Access Improvement Act (PhAIM) of 2007 (Public Law 110-28 and Public Law 110-90) Medicaid's Tamper-Resistance Prescription Pad Requirement (Public Law 109-171) Deficit Reduction Act of 2005 section on Average Manufacturers Price (AMP) (Docket Number: CMS -4119-F) Medicare Program; Medicare Part D Claims Data (Docket Number: CMS 4131P) Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs; Proposed Rule (Docket Number: CMS-2238-IFC) Medicaid Program; Multiple Source Drug Definition DRAFT and FINAL CMS 2009 Medicare Part D Call Letter (Docket Number: CMS0016F and CMS0018F) Medicare Program; Standards for E-Prescribing Under Medicare Part D and Identification of Backward Compatible Version of Adopted Standard for EPrescribing and the Medicare Prescriptions Drug Program (Version 8.1); Final Rule (Docket Numeber: CMS-2008-0009-0002)Medicare Program; Option for Prescription Drug Plans to Lower their Premiums for Low-Income Subsidy Beneficiaries
Filing targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
S. 1200 Indian Health Care Improvement Act Amendments of 2008
Docket No. FDA-2008-N-0120 Standards for Standardized Numerical Identifier, Validation, Track and Trace, and Authentication for Prescription Drugs Docket No. FDA-2008-N-0121 Technologies for Prescription Drug Identification Validation, Track and Trace, or Authentication Docket No. DEA-303P New Single Sheet Format for US Official Order Form for Schedule I & II Controlled Substances Docket No. DEA-287F Issuance of Multiple Prescriptions of Schedule II Controlled Substances Docket Number FDA-2008-D-0053 Good Reprint Practices for Distribution of Medical or Scientific References Publications or Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Docket No. FDA 2007N-0480 Maximizing the Public Health Benefit of Adverse Event Collection throughout a Product's Marketed Life Cycle
H.R. 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 H.R. 971 Community Pharmacy Fairness Act of 2007 H.R. 3700 Fair Medicaid Drug Payment Act of 2007 Public Law 110-28 and Public Law 110-90 Medicaid: Implementation of the Tamper-Resistant Prescription Pad Requirement H.R. 3140 Saving Our Community Pharmacies Act of 2007 S. 1954 Pharmacy Improvement Act (PhAIM) of 2007 S. 1827 Pharmacist Access and Recognition in Medicare (PhARM) of 2007 S. 1951 Fair Medicaid Drug Payment Act of 2007 S. 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims S. 2161 Community Pharmacy Fairness Act Docket No. CMS-4133-P Medicare Program: Option for Prescription Drug Plans to Lower Their Premiums for Low-Income Subsidy Beneficiaries S. 2464 Medicare Improvement Act of 2007 H.R. 4704 Medicare Improvement Act of 2007 H.R. 4992 Medicare Improvement Act of 2007 CMS 2009 Draft and Final 2009 Call Letter to Medicare Part D Plans Docket No. CMS-0016-P Medicare Program: Proposed Standards for e-Prescribing under Medicare Part D Docket No. CMS-2238-ICF Medicaid Program; Multiple Source Drug Definition
Filing targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), SENATE
Medicare Part D Prescription Drug Benefit Tamper-Resistant Prescription Pad Requirement in Medicaid HR 3090 Patient and Pharmacist Protection Act of 2007 S 1951 Fair Medicaid Drug Payment Act of 2007 HR 3140 Patient Access to Medicaid Generic Prescription Drug Act of 2007 HR 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 HR 971 Community Pharmacy Fairness Act HR 3700 Fair Medicaid Drug Payment Act of 2007 HR 3140 Saving Our Community Pharmacies Act of 2007 S 1954 Pharmacy Improvement Act (PhAIM) of 2007 S 1827 Pharmacist Access and Recognition in Medicare (PhARM) of 2007S 1951 Fair Medicaid Drug Payment Act of 2007 S 1474 Fair and Speedy Treatment (FAST) of Medicare Prescription Drug Claims Act of 2007 S 2161 Community Pharmacy Fairness Act of 2007 S 2031 Patient and Pharmacist Protection Act of 2007S 1951 Fair Medicaid Drug Payment Act of 2007 S 2250 Ambulatory Surgical Center Medicare Payment Modernization Act of 2007 HR 1832 Ambulatory Surgical Center Medicare Payment Modernization Act of 2007 HR 3162 Children's Health and Medicare Protection Act of 2007 Docket No. CMS 2238-FC 72FR39142 - Submitted to the House Small Business Committee "Medicaid Drug Reimbursements: Are CMS Cuts Bad Medicine for Small Businesses and Beneficiaries?"
HR 3161 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2008 HR 2638 Department of Homeland Security Appropriations Act, 2008 HR 1585 National Defense Authorization Act
HR 2994 National Pain Care Policy Act of 2007 72 FR 61886 - The propoosed draft guidance on Allocating and Targeting Pandemic Influenza Vaccine
Filing targets: HOUSE OF REPRESENTATIVES, SENATE, UNDETERMINED
S 2160 Veterans Pain Care Act of 2007
Medicare Part D Prescription Drug Benefit Tamper-Resistant Prescription Pad Requirement in Medicaid HR 3090 Patient and Pharmacist Protection Act of 2007 S 1951 Fair Medicaid Drug Payment Act of 2007
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
ONC re: comments on the medication management draft detailed use case and patient medication and allergy information exchange between consumers and health care provider. H.R. 2184 the Enhanced Health Care Value for All Act of 2007 H.R. 2994 the National Pain Care Policy Act of 2007 Immunization distribution
H.R. 2900 the FDA Amendments Act of 2007 S. 1082 FDA Revitalization Act Prescription Drug Importation S. 184 the Safe IMPORT Act S. 242 the Pharmaceutical Market Access and Drug Safety Act of 2007 S. 251 the Pharmaceutical Market Access Act of 2007 Senate Amendment 1010 to S. 1082 re prescription drug importation Internet Pharmacy S. 596 the Safe Internet Pharmacy Act of 2007 FDA Docket No. 2007N-0121 re: Medication Guides (MedGuides) S. 1695 Biologics Price Competition and Innovation Act of 2007 FDA Docket No. 2007N-0114 re: Electronic distribution of prescription information FDA Docket No. 2007N-0179 re: Risk Minimization Action Plans (RiskMAPs) Authorized generics Follow-on Biologics HRSA Docket E7–334 – Multiple contract pharmacies re: 340B Drug Pricing Program-Contract Pharmacy Services HRSA Docket E7–335 – Patient definition re: 340B Drug Pricing Program Patient Definition FDA Docket No. 2007D–0101 – Draft guidance on advisory committee member conflicts of interest FDA Docket No. 1977N-0094L, RIN 0910-AF36 re: changes to the warnings and other labeling for over-the-counter analgesie drug products Pharmacy Compounding Draft bill, the Safe Drug Compounding Act of 2007 Bioidentical Hormones FDA Docket 2007N-0005 re: recommendations for the Prescription Drug User Fee Act (PDUFA)
Specifi to Labor/HHS funding, AHRQ comparative cost-effectiveness funding, and the National Immunization Program at the Centers for Disease Control and Prevention. H.J. Res 20 Making further continuing appropriations for the fiscal year 2007 FY 2008 Labor, Health and Human Services and Education Appropriations Bill.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE
H.R.2841 Medicare Safe Needle Disposal Coverage Act of 2005 H.R. 6111 An act to amend the Internal Revenue Code of 1986 to extend expiring provisions, and for other purposes – Vaccine Reimbursement H.R. 6164 National Institutes of Health Reform Act of 2006 H.R. 1020 National Pain Care Policy Act of 2005
S. 3708 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2007 – General Health Agency Funding S. 3660 District of Columbia Appropriations Act, 2007 H.R. 5647 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropraitions Act, 2007 - General Health Agency Funding
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE