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Reported covered position: Senior Vice President, Government Affairs
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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
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
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. 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. 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.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)
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 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 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
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)
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)
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
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 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)
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
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 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
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
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)
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
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 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
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
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)
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
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, 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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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)
Methadone Treatment and Protection 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 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 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
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.
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
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
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)