ms KRISTINA LUNNER

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 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

HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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

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)

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)

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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)

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

HR 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

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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

HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform

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

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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

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

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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)

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

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 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices HR 1259 - Dextromethorphan Distribution Act of 2009 HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) (Public Law 111-152) Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] (Public Law 111-148) - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); improvements to the Medicare Part D MTM programs; exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MA-PD plans; improving formulary requirements for prescription drug plans and MA-PD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MA-PD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MA-PD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); Medicare vaccine coverage issues (Medicare Part B vs. Part D); and nominations to National Health Care Workforce Commission and Board of Governors of the Patient-Centered Outcomes Research (PCOR) Institute).] (26 CFR Part 54/ 29 CFR Part 2590/ 45 CFR Parts 146 and 148) Medical Loss Ratios; Request for Comments Regarding Section 2718 of the Public Health Service Act (RIN 0991-AB62) HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act; Request for Information HHS Draft Healthy People 2020 Objectives HHS Strategic Framework on Multiple Chronic Conditions Draft Report of the HHS Secretarys Advisory Committee on Genetics, Health, and Society on Genetics Education and Training of Health Care Professionals, Public Health Providers, and Consumers Concept Pharmacist Clinical Services Provisions in Health Care Reform

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

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

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)

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

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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)

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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

HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program

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

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

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)

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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

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)

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 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

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

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

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

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

HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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)

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

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

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)

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

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

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

HR 3108 - Medication Therapy Management Benefits Act of 2009 S 3543 - Medication Therapy Management Expanded Benefits Act of 2010 Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act (Public Law 111-148) - Patient Protection and Affordable Care Act (Sections on long-term care pharmacy waste reduction programs and pharmacists participation in Accountable Care Organizations (ACOs) (Docket Number: CMS-4085-F) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS6010IFC] Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records (CAG-00420N) CMS Proposed Decision Memo for Counseling to Prevent Tobacco Use 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans CMS April 30, 2010 Memorandum to Medicare Part D Sponsors on Draft guidance for implementing the Medicare Coverage Gap Discount Program CMS May 21, 2010 Memorandum to Medicare Part D Sponsors on revised guidance for implementing the Medicare Coverage Gap Discount Program

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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

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)

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

HR 2718/S 1110 - MedPAC Reform Act of 2009 HR 2307/S 1004 - Reaching Elders with Assessment and Chronic Care Management and Coordination Act Under Line 17: We would like to include the Dept of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the Office of Inspector General (OIG) S 1634 - The Medicare Prescription Drug Improvement Act of 2009 S 266 - Medicare Prescription Drug Gap Reduction Act of 2009 HR 203 - Medicare Fraud Prevention Act of 2009 HR 27 - Medicare Fraud Prevention and Enforcement Act of 2009 HR 616/S 511 - Access to Durable Medical Equipment Act HR 574/S 254 - Medicare Home Infusion Therapy Coverage Act of 2009 HR 2560/S 1131 - Independence At Home Act HR 1970/S 956 - Preserve Patient Access to the Reputable DMEPOS Providers Act of 2009 HR 3700/S 1951 - Fair Medicaid Drug Payment Act (From 110th Congress)/Concept to Include Medicaid Average Manufacturers Price Reimbursement Formula in Health Care Reform HR 3108 - Medication Therapy Management Benefits Act of 2009/Concept to Include Medication Therapy Management Provisions in Health Care Reform S 683 - Community Choice Act of 2009 HR 1392/S 1221 - Amends the Social Security Act to ensure more appropriate payment amounts for drugs and biologicals under Part B of the Medicare Program by excluding customary prompt pay discounts extended to wholesalers from the manufacturer's average sales price S AMDT 3320 to the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2010 (H.R.2847) [Section on the treatment of pharmacies under durable medical equipment accreditation requirements] (Public Law 110-275) Medicare Improvements for Patients and Providers Act of 2008 sections on Medicare DMEPOS (Docket Number CMS-4085-P) Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs (Docket Number: CMS1561IFC) Medicare Program; Changes to the Competitive Acquisition of Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) by Certain Provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Docket Number: CMS-1540-F) Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2007; Certain Provisions Concerning Competitive Acquisition for Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); Accreditation of DMEPOS Suppliers (Docket Number: CMS-6006-F) Medicare Program: Surety Bond Requirement for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) (Docket Number: CMS-0033-P) Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule (Docket Number: RIN 0991-AB58) Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (Docket Number: RIN 0991AB59) Proposed Establishment of Certification Programs for Health Information Technology (74 FR 28937) ONC Draft Recommendations for the Term "Meaningful Use" of Electronic Health Records CMS August 2009 Memo: Fraud, Waste and Abuse (FWA) Training Clarification (regarding changes to 42 C.F.R. 422.503(b)(4)(vi) and 42 C.F.R. 423.504 (b)(4)(vi)) Final 2010 Medicare Part D Call Letter on NDC Non-Matched List 2011 Preliminary Advanced Notice with Draft Call Letter to Medicare Plans 2011 Preliminary Advanced Notice with Final Call Letter to Medicare Plans Draft Medicare Part D Model Notices for Beneficiaries: Mail-Order and Excluded Provider GAO Report on Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs OIG Report on A Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices

H Res 1003 - Expressing support for the designation of January 10, 2010, through January 16, 2010, as National Influenza Vaccination Week HR 2891 - Access to Frontline Health Care Act of 2009 Under Line 17: We would like to include the Agency for Healthcare Research and Quality (AHRQ) S 750 - Caring for an Aging America Act HR 1259 - Dextromethorphan Distribution Act of 2009 S 1213 - A bill to amend title XI of the Social Security Act to provide for the conduct of comparative effectiveness research. HR 2345 - Amends the Fair Credit Reporting Act to provide for an exclusion from Red Flag Guidelines for health care practices S 1213 - Patient-Centered Outcomes Research Act of 2009 HR 756/S 660 - National Pain Care Policy Act of 2009 HR 4872/ Public Law 111-152 - Health Care and Education Reconciliation Act of 2010 [Sections on Medicare Part D Changes; CMS/IRS data match to identify fraudulent providers; funding to fight fraud, waste and abuse; 90-day period of enhanced oversight for initial claims of DME suppliers; excise tax on medical device manufacturers; and drugs purchased by covered entities.] HR 3962 - Affordable Health Care for America Act [Sections on: wellness program grants; administrative simplification; ensuring adequacy of provider networks; essential benefits package defined; requiring information transparency and plan disclosure; state prohibitions on discrimination against health care providers; protection of physician prescriber information; nondiscrimination on abortion and respect for rights of conscience; study and report on methods to increase electronic health record (EHR) use by small health care providers; contracts for the offering of exchange-participating health benefits plans; payment rates for items and services; modernized payment initiatives and delivery system reforms; provider participation under the public health insurance option; limitations on health care related expenditures including distributions for medicine qualified only if for prescribed drugs or insulin; excise tax on medical devices; permitting physician assistants to order post-hospital extended care services and to provide for recognition of attending physician assistants as attending physicians to serve hospice patients; resource-based feedback program for physicians in Medicare; modifications to the physician quality reporting initiative; home infusion therapy report to Congress; durable medical equipment (DME) program improvements; MedPAC study and report on bone mass measurement; payment for biosimilar biological products; study and report on DME competitive bidding process; reducing potentially preventable hospital readmissions; post-acute care services payment reform plan and bundling pilot program; Institute of Medicine study on geographic variation in health care spending and promoting high-value health care; implementation, and Congressional review, of proposal to revise Medicare payments to promote high-value health care; phase-in of payment based on fee-for-service costs; quality bonus payments for Medicare Advantage plans; improvements to Medicare Part D including elimination of coverage gap; discounts for certain Part D drugs in original coverage gap; repeal of provision relating to submission of claims by pharmacies located in or contracting with long-term care facilities; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under Part D; no mid-year formulary changes permitted; negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries; accurate dispensing in long-term care facilities and free generic fill; elimination of part D cost-sharing for certain non-institutionalized full-benefit dual-eligible individuals; intelligent assignment in enrollment; demonstration to promote access for Medicare beneficiaries with limited English proficiency by providing reimbursement for culturally and linguistically appropriate services; accountable care organization pilot program; medical home pilot program; coverage and waiver of cost-sharing for preventive services; expanding access to vaccines; expansion of Medicare-covered preventive services at Federally Qualified Health Centers; independence at home demonstration program; recognition of certified Diabetes Educators as certified providers for purposes of Medicare Diabetes outpatients self-management training services; comparative effectiveness research; establishment of national priorities for quality improvement; development of new quality measures; GAO evaluation of data collection process for quality measurements; multi-stakeholder pre-rulemaking input into selection of quality measures; application of quality measures; reports on financial relationships between manufacturers and distributors of covered drugs, devices, biologicals, or medical supplies under Medicare, Medicaid, or CHIP and physicians and other health care entities and between physicians and other health care entities; requirement for public reporting by hospitals and ambulatory surgical centers on health care-associated infections; pharmacy benefit managers transparency requirements; increased funding and flexibility to fight fraud and abuse; enhanced penalties for false statements on provider or supplier enrollment applications; enhanced penalties for submission of false statements material to a false claim; enhanced penalties for delaying inspections; enhanced hospice program safeguards; enhanced penalties for individuals excluded from program participation; enhanced penalties for obstruction of program audits; exclusion of certain individuals and entities from participation in Medicare and State health care programs; enhanced CMS program protection authority; enhanced Medicare, Medicaid and CHIP program disclosure requirements relating to previous affiliations; require providers and suppliers to adopt programs to reduce waste, fraud and abuse; maximum period for submission of Medicare claims reduced to not more than 12 months; telehealth expansion and enhancements; physicians who order DME or home health services required to be Medicare enrolled physicians or eligible professionals; face-to-face encounter with patient required before eligibility certifications for home health services or DME; required repayments of Medicare and Medicaid overpayments; expanded application of hardship waivers for OIG exclusions to beneficiaries of any federal health care program; requiring provider and supplier payments under Medicare to be made through direct deposit or electronic funds transfer at insured depository institutions; under Medicaid and CHIP, required coverage of preventive services, tobacco cessation, medical home pilot program, inclusion of public health clinics under the vaccines for children program, accountable care organization pilot program, state option to disregard certain income in providing continued Medicaid coverage for certain individuals with extremely high prescription, payments to pharmacists (AMP), assuring adequate payment levels for services; report on Medicaid payments, health care acquired conditions, require providers and suppliers to adopt programs to reduce waste, fraud and abuse, overpayments, termination of provider participation under Medicaid and CHIP if terminated under Medicare or other State plan or Child health plan, Medicaid and CHIP exclusion from participation relating to certain ownership, control and management affiliations; requirement to report expanded set of data elements under Medicaid Management Information System to detect fraud and abuse, and extension of QI program; improved coordination and protection for dual-eligibles; assessment of Medicare cost-intensive diseases and conditions; establishment of Center for Medicare and Medicaid Innovation within CMS; frontline health providers loan repayment program; health workforce evaluation and assessment; improving accountability for approved medical residency training; other health care workforce issues; prevention and wellness; implementation of best practices in the delivery of health care; assistant Secretary for health information; expanded participation in 340B Program; improvements to 340B Program integrity; No Child Left Unimmunized Against Influenza: demonstration program using elementary and secondary schools as influenza vaccination centers; implementation of medication management services in treatment of chronic diseases; community-based collaborative care networks; Institute of Medicine conference on pain; pain research at NIH; public awareness campaign on pain management; licensure pathway for biosimilar biological products; Indian Health Care Improvement; and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] HR 3590/ Public Law 111-148 - Patient Protection and Affordable Care Act [Sections on: reinsurance for early retirees; non-discrimination in health care; essential health benefits requirements; financial integrity in Exchanges; MedPAC study on adequacy of Medicare payments for health care providers serving in rural areas; coverage of comprehensive tobacco cessation services for pregnant women in Medicaid; distributions for medicine qualified only if for prescribed drug or insulin; administrative simplification; payment for biosimilar biological products; approval pathway for biosimilar biological products; patient-centered outcomes research; special rules; prohibition against discrimination on assisted suicide; presentation of prescription drug benefit and risk information; provider screening and other enrollment requirements under Medicare, Medicaid, and CHIP; enhanced Medicare and Medicaid program integrity provisions; maximum period for submission of Medicare claims reduced to not more than 12 months; physicians who order items or services required to be Medicare enrolled physicians or eligible professionals; requirement for physicians to provide documentation on referrals to programs at high risk of waste and abuse; face to face encounter with patient required before physicians may certify eligibility for home health services or durable medical equipment under Medicare; enhanced penalties; adjustments to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program; termination of provider participation under Medicaid if terminated under Medicare or other State plan; Medicaid exclusion from participation relating to certain ownership, control, and management affiliations; health information technology enrollment standards and protocols; improvements to the physician quality reporting system; hospital readmissions reduction program; community-based care transitions program; Medicare Advantage payment; demostration project to evaluate integrated care around a hospitalization; state option to provide health homes for enrollees with chronic conditions; pediatric accountable care organization demonstration project; establishment of Center for Medicare and Medicaid Innovation within CMS; Medicare shared savings program; national pilot program on payment bundling; independence at home demonstration program; establishing community health teams to support the patient-centered medical home; Medicaid coverage for the lowest income populations; elimination of exclusion of coverage of certain drugs; providing adequate pharmacy reimbursement (AMP); exemption of certain pharmacies from DMEPOS accreditation requirements; payment adjustments for home health care; Medicare coverage gap discount program; immediate reduction in coverage Medicare Part D gap in 2010; improved information for subsidy eligible individuals reassigned to prescription drug plans and MAPD plans; improving formulary requirements for prescription drug plans and MAPD plans with respect to certain categories or classes of drugs; elimination of cost sharing for certain dual eligible individuals; uniform exceptions and appeals process for prescription drug plans and MAPD plans; Office of the Inspector General studies and reports; including costs incurred by AIDS drug assistance programs and Indian Health Service in providing prescription drugs toward the annual out-of-pocket threshold under part D; reducing wasteful dispensing of outpatient prescription drugs in long-term care facilities under prescription drug plans and MAPD plans; medication management (MTM) services in treatment of chronic disease; advancing research and treatment for pain care management; National Prevention, Health Promotion and Public Health Council; clinical and community preventive services; Medicare coverage of annual wellness visit providing a personalized prevention plan; removal of barriers to preventive services in Medicare; incentives for prevention of chronic diseases in Medicaid; community transformation grants; healthy aging, living well - evaluation of community-based prevention and wellness programs for Medicare beneficiaries; CDC and employer-based wellness programs; coverage of preventive health services; immunizations; community health insurance option; level playing field; State flexibility to establish basic health programs for low-income individuals not eligible for Medicaid; ensuring the quality of care; affordable choices of health benefit plans; national strategy to improve health care quality; interagency Working Group on Health Care Quality; quality measure development; quality measurement; data collection; public reporting; health care delivery system research; quality improvement technical assistance; demonstration program to integrate quality improvement and patient safety training into clinical education of health professionals; transparency reports and reporting of physician ownership or investment interests; prescription drug sample transparency; pharmacy benefit managers transparency requirements; national health care workforce commission; health care workforce assessment; public health workforce recruitment and retention programs; allied health workforce recruitment and retention programs; grants for State and local programs; training in family medicine, general internal medicine, general pediatrics, and physician assistantship; geriatric education and training: career awards, comprehensive geriatric education; United States Public Health Sciences Track; interdisciplinary, community-based linkages (to support the existing health care workforce); and Medicare vaccine coverage issues (Medicare Part B vs. Part D).] Public Law 111-31 - Family Smoking Prevention and Tobacco Control Act on smoking cessation, advertising and marketing of tobacco products; and sale and distribution of tobacco. [Regulation Identifier Number (RIN) 0991-AB54] HIPAA Administrative Simplification: Standards for Privacy of Individually Identifiable Health Information [Genetic Information Nondiscrimination Act of 2008 (GINA)] [Regulation Identifier Number (RIN) 0991AB55] HIPAA Administrative Simplification: Enforcement HHS Draft Healthy People 2020 Objectives Concept - Role of Pharmacist-Provided Patient Care Services in Health Care Reform Concept - Include Pharmacists and Pharmacies in H1N1 and seasonal flu immunization activities Concept - National Health Service Corp

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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)

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

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 SRes 539 - A resolution designating May 24, 2010, as "Prescription Drug Disposal Awareness Day S 256 - Combat Methamphetamine Enhancement Act of 2009 S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act HR 163 - Prescription Drug Affordability Act HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps (Docket Number: FDA2010N0184) Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Patient Information Prototypes (Docket Number: FDA2010N0001) Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Docket Number: FDA-2009-N-0247) FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability (Docket Number: FDA2010N0168) Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors; Public Workshop; Request for Comments (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Meetings on Reauthorization; Public Meetings (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA-2010-N-0001) Pharmaceutical Supply Chain; Public Workshop (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA-2009-N-0582) Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner (Docket Number: FDA-2010-N-0136) Request for Comment on Implementation of the Family Smoking Prevention and Tobacco Control Act (Docket Number: DEA-328P) Implementation of the Methamphetamine Production Prevention Act of 2008 (Docket Number: FDA2010N0001) Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Opioid REMS) (Docket Number: FDA-2010-N-0284, FDA-2009-D-0461) Risk Evaluation and Mitigation Strategies; Notice of Public Meeting (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability ONDCPs 2010 National Drug Control Policy FDA Safe Use Initiative Concept - Reauthorization of Prescription Drug User Fee Act Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

S 754 - The Methadone Treatment and Protection Act of 2009 HR 2855 - The Drug Overdose Reduction Act S 256 - Combat Methamphetamine Enhancement Act of 2009 HR 1706 - Protecting Consumer Access to Generic Drugs Act of 2009 HR 3018 - Amend the Controlled Substance Act to address the use of intrathecal pumps HR 1204 - The Community Pharmacy Fairness Act of 2009 S 80 - Pharmaceutical Market Access Act of 2009 HR 1298/S 525 - Pharmaceutical Market Access and Drug Safety Act of 2009 HR 163 - Prescription Drug Affordability Act (Docket Number FDA2009D0461) FDA Draft Guidance for Industry: Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications (Docket Number FDA2008N0038) Risk Communication Advisory Committee; Notice of Meeting on the types of communications that patients receive at the pharmacy including: medication guides; patients package inserts; and consumer medication information (Docket Number: FDA-2008-P-0380) Citizen Petition: Requesting a FDA Action on a "One Document Solution" for all pharmacy-based communications (Docket Number: FDA2009N0295) Providing Effective Information to Consumers About Prescription Drug Risks and Benefits; Public Workshop (Docket Number: FDA2009N0143) Risk Evaluation and Mitigation Strategies for Certain Opioid Drugs; Notice of Public Meeting (Docket Number: FDA2009N0247) Food and Drug Administration Transparency Task Force; Request for Comments (Docket Number: DEA321) Identification of Institution-based Individual Practitioners (Docket Number: FDA-2009-D-0001) Guidance for Industry on Standards for Securing the Drug Supply Chain--Standardized Numerical Identification for Prescription Drug Packages; Availability (Docket Number: FDA2010N0128) Prescription Drug User Fee Act; Public Meeting (Docket Number: DEA-218I) Electronic Prescriptions for Controlled Substances; Final Rule (Docket Number: FDA2004N0449) (formerly Docket Number: 2004N0439) Current Good Manufacturing Practice for Positron Emission Tomography Drugs Notice Regarding 340B Drug Pricing ProgramContract Pharmacy Services Concept - Medication Adherence Concept - Pharmacogenomics Concept - DEA Agent of the Prescriber Concept - Oppose Liberalizing Prescription Drug Importation

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)

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