June 17, 2009 Printable Version Newsletter Archive
LEGISLATIVE
  • HEALTH REFORM UPDATE: Senate, House Release Health Reform Proposals
  • Senate Approves Tobacco Bill
  • REGULATORY
  • FDA Issues Class I Recall for Medtronic Pacemakers
  • FDA to Hold Meeting on Transparency
  • QUALITY
  • Obama Addresses Health Care Reform at AMA
  • LEGISLATIVE

    HEALTH REFORM UPDATE: Senate, House Release Health Reform Proposals
    The Senate Committee on Health, Education, Labor and Pensions (HELP) today will begin to mark up its health care reform legislation, the Affordable Health Choices Act, released last week. The bill encourages adoption and use of health IT; promotes evidence-based medicine; facilitates health literacy; and includes strategies for tackling preventable medical errors and hospital readmissions, as well as better managing chronic conditions through care coordination, medical homes and community health teams. The ACC submitted a letter to the committee commending it for “tak[ing] the necessary steps towards improving the coordination and quality of care.” View the letter.

    In related news, three committees in the House have released a draft outline for health care reform, although it is not yet in bill form. The proposal of the committees, which include the House Energy and Commerce, Ways and Means, and Education and Labor, includes a repeal of the current sustainable growth rate and removes Medicare Part B drugs from the calculation of physician services spending. However, more details are needed to assess the extent and impact of these suggestions. More coverage is available at ACC’s The Lewin Report. ACC staff is working with leaders in the Senate and House as they continue to flesh out these and other proposals. For the latest information on health reform, visit http://qualityfirst.acc.org.

    Senate Approves Tobacco Bill
    The Senate on June 12 passed the “Family Smoking Prevention & Tobacco Control Act” (S. 982) in a 79-17 vote. The bill would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the FDA the authority to restrict tobacco marketing and sales to youth; require detailed disclosure of ingredients; allow FDA to require changes to tobacco products; and require larger, more specific health warnings. The FDA activity would be funded by a user fee on cigarette manufacturers, allocated by market share. The House on April 2 approved a similar version of the bill. The bill is awaiting the signature of President Obama, who is expected to sign it into law.

    “After many years of trying to pass this legislation, today Congress has taken a stand and this goes a long way in keeping tobacco products out of the hands of children. At long last Congress has chosen to end the special protections for the tobacco industry and protect our children and our nation's health instead” said ACC CEO Jack Lewin, M.D. The ACC’s full statement on the Family Smoking Prevention & Tobacco Control Act is available online.

    REGULATORY

    FDA Issues Class I Recall for Medtronic Pacemakers
    The Food & Drug Administration on June 12 classified Medtronic’s Kappa and Sigma pacemakers as a Class I recall, following a “Dear Physician” warning late last month. The Class I recall, related to about 21,300 Kappa and Sigma pacemakers, indicates these pacemakers have a wiring defect that causes the battery to stop responding or run out of battery. The company recommends replacing the pacemaker in patients who are pacemaker-dependent and have been implanted with one of the affected devices. More information is available from MedPage Today.

    FDA to Hold Meeting on Transparency
    The Food and Drug Administration (FDA) on June 24 will hold a public meeting in Washington, D.C., to solicit recommendations on how the agency can make more available useful and understandable information on its activities and decisions. The FDA in early June announced the formation of a taskforce to develop recommendations for enhancing the transparency of the agency’s operations and decision-making processes. The taskforce will identify information that the FDA should provide about its operations and activities, including enforcement actions and product approvals, and recommend ways in which the agency can better explain its operations with the appropriate concern for confidential information. Registration for the June 24 meeting must occur by June 17. Written or electronic comments are due by August 7. More information is available from the FDA.

    QUALITY

    Obama Addresses Health Care Reform at AMA
    President Obama on June 15 addressed the economic imperative for health care reform in a speech to attendees of the American Medical Association’s annual meeting in Chicago. He discussed costs, workforce issues, and medical malpractice, among other issues. Obama said that although the cost of health care reform is high, the “cost of inaction is greater” because they are an “escalating burden on our families and businesses” and a “ticking time bomb for the federal budget.” Read more about the speech in the New York Times.

    The ACC responded in a statement: “What really matters is how we can drive down costs for our patients and for our country, while ensuring patients have quality care. One of the ways we do that is by looking at the way doctors are compensated and reforming the system so that it’s based on the quality of care provided – not the quantity.” View the statement in full.

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