POLICY BRIEFINGS


HHS/CMS Regulatory Agenda


Comments are due by February 17th on the PPACA’s Physician Payments Sunshine Act which requires drug and device manufacturers to disclose payments made to physicians and hospitals (a final rule is expected in December 2014).  HHS will also release this month a proposed rule on requirements for Stage 2 of the Medicare and Medicaid meaningful use electronic health records (EHR) incentive program.  OMB is also reviewing the following: a proposed rule to revise the Medicare hospital outpatient prospective payment system (OOPS) for calendar year 2013 and to make changes to the ambulatory surgical center payment system list of services and rates (for June release and finalized November1); an annual proposed rule to revise payment policies under the physician fee schedule and make changes to payments under Medicare Part B for 2013 (for June release and finalized November 1); and an annual proposed rule to revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for 2013 (for release April 1 and finalized August 1).


Increase on Tax-Delinquent Medicare Providers


At a Senate Finance Committee markup of S. 1813, The Highway Investment, Job Creation and Economic Growth Act of 2012, a payfor was adopted which would increase the levy on tax-delinquent Medicare providers from the current 15% of such payments to 100%.


Guidance on Biosimilar Product Development


The FDA issued three guidance documents required under the PPACA to implement the approval pathway for biosimilar products.  The draft guidance on Scientific Considerations describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of a proposed product to the reference product.  The Quality Considerations draft guidance provides an overview of the analytical factors that are to be considered when assessing biosimilarity between a proposed therapeutic protein product and the reference product for the purpose of submitting a 351(k) application.  A Question and Answers document provides answers to common questions that may arise in the early stages of product development.  The House Energy and Commerce Health Subcommittee also held FDA hearings focusing on the biosimilar issue and the shortage of certain prescription drugs.


Recently Introduced Health Legislation


H.R. 3897 (PUBLIC HEALTH), to amend Title XXVII of the Public Health Service Act to provide religious conscience protections for individuals and organizations; CHABOT; to the Committee on Energy and Commerce, Feb. 3.

H. RES. 538 (CANCER PREVENTION), expressing support for designation of Feb. 4, 2012, as National Cancer Prevention Day; ISRAEL; to the Committee on Energy and Commerce, Feb. 3.

H.R. 3975 (MEDICAL DEVICES), to amend Title V of the Federal Food, Drug, and Cosmetic Act to extend the provisions of the Pediatric Medical Device Safety and Improvement Act; ROGERS of Michigan; to the Committee on Energy and Commerce, Feb. 8.

H.R. 3982 (HEALTH INSURANCE COVERAGE), to prohibit the secretary of health and human services from implementing certain rules relating to the health insurance coverage of sterilization and contraceptives approved by the Food and Drug Administration; LUETKEMEYER; to the Committee on Energy and Commerce, Feb. 8.

H.R. 3988 (FDA USER FEES), to amend the Federal Food, Drug, and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars; MURPHY of Pennsylvania; to the Committee on Energy and Commerce, Feb. 8.

S. 2082 (DISEASE AWARENESS), to establish the Cavernous Angioma CARE Center (Clinical Care, Awareness, Research and Education) of Excellence, and for other purposes; UDALL of New Mexico; to the Committee on Health, Education, Labor, and Pensions, Feb. 9.

S. 2092 (PUBLIC HEALTH), to amend Title XXVII of the Public Health Service Act to provide conscience protections for individuals and organizations; MANCHIN; to the Committee on Health, Education, Labor, and Pensions, Feb. 9.

S. 2097 (MEDICARE), to amend Title XVIII of the Social Security Act to provide for coverage of comprehensive cancer care planning under Medicare and to improve the care furnished to individuals diagnosed with cancer by establishing grant programs for provider education, and related research; LANDRIEU; to the Committee on Finance, Feb. 9.

H.R. 3995 (DRUGS), to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes; RUSH; jointly, to the committees on Energy and Commerce and the Judiciary, Feb. 9.

H.R. 4008 (DISEASE AWARENESS), to establish the Cavernous Angioma CARE Center (Clinical Care, Awareness, Research and Education) of Excellence, and for other purposes; HEINRICH; to the Committee on Energy and Commerce, Feb. 9.



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