April 19, 2006 Printable Version Newsletter Archive
SAFETY & QUALITY
  • FDA Recalls Reagent Used To Help Diagnose Cardiac Disease
  • LEGISLATIVE
  • Decline in Heart Disease, Strokes Reason For Continued Funding
  • Prescription Niacin Covered Under Medicare Part D
  • HEALTH INSURANCE
  • Mass. Governor Signs Most of Health Care Bill Into Law
  • AMA Study Finds Health Insurance Mergers Limiting Choice
  • TOBACCO
  • Arkansas Passes Smokefree Restaurant Law
  • UPCOMING EVENTS
  • Save The Dates
  •  
    SAFETY & QUALITY

    FDA Recalls Reagent Used To Help Diagnose Cardiac Disease
    Ortho-Clinical Diagnostics and FDA notified healthcare professionals of a Class 1 recall of VITROS Immunodiagnostic Products Signal Reagent, a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease. A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests. Customers with the affected lot numbers should discontinue using any remaining reagent and should follow the enhanced Quality Control (QC) procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians.

    LEGISLATIVE

    Decline in Heart Disease, Stroke Reason For Continued NIH Funding
    The ground-breaking research on the causes and treatment of heart disease, supported in large part by NIH, is largely responsible for the decline in cardiovascular disease, according to NIH Director Elias Zerhouni. In recent testimony before Congress on the NIH budget, Zerhouni cited the 63 percent decline in cardiovascular disease and the 70 percent decline in strokes over the last 30 years as justification for continued investment in cardiovascular and other health care research. Without recent developments such as drug coated stents, safe levels of blood pressure and cholesterol lowering therapies, heart attacks would still account for 1.2 to 1.3 million deaths per year instead of the actual 515, 000 deaths experienced today, he said. According to Zerhouni, “the estimated total cumulative investment in cardiovascular research at the NIH per American over the past 30 years, including the doubling period, is about $110, or about $4 for each American per year over the entire period.”

    Prescription Niacin Covered Under Medicare Part D
    The Centers for Medicare and Medicaid Services (CMS) has decided to provide Part D coverage of prescription Niacin products (Niaspan®, Niacor®). CMS sent a letter to Part D plans in February saying Niacin products would be excluded from Part D drug coverage because they are prescription vitamins. However, after reviewing the issue more closely, the agency has determined the drugs do not serve as nutritional supplements or address a vitamin deficiency. As a result, the products will not be considered prescription vitamins for purposes of Part D coverage, and will not be universally excluded from coverage under the Medicare prescription drug program.
    HEALTH INSURANCE

    Mass. Governor Signs Most of Health Care Bill Into Law
    Massachusetts Governor Mitt Romney signed most of a sweeping new healthcare bill into law last week. The bill will require all state residents to have health insurance by July 1, 2007, and require businesses with more than 10 workers to pay $295 per employee annually if the companies do not provide insurance. Romney vetoed the fee, but the state legislature is expected to override the veto. Massachusetts is the first state to try to insure nearly all of its residents through an individual mandate to buy insurance.

    AMA Study Finds Health Insurance Mergers Limiting Choice
    Health insurance mergers have created oligopolies and near monopolies in many parts of the country, limiting consumer and provider choice, according to an American Medical Association study released this week. With more than 400 mergers involving health insurers and managed-care companies taken place in the past decade, the study found that in 56 percent of the regions examined in 2005, a single health insurer had a market share of 50 percent or more. One insurer had at least a one-third share in 95 percent of the markets studied. For more on the study, click here.
    TOBACCO
    Arkansas Passes Smokefree Restaurant Law
    Arkansas Governor Mike Huckabee signed smokefree restaurant legislation into law last week.  
    The law, which also requires offices to be smokefree, will take effect in 90 days. California, Delaware, New York, Connecticut, Maine, Massachusetts, Rhode Island, Montana, Vermont, Washington, New Jersey, Utah, Colorado, Florida, Idaho, Hawaii, North Dakota, Puerto Rico, Guam and Washington, D.C., have all passed comprehensive smokefree restaurant legislation.
    UPCOMING EVENTS
    Save The Dates:
    • May 1-5: The Senate leadership has designated this week as “Health Week,” during which it will debate and vote on several health care measures, including the “Medical Care Access Protection Act of 2006” (S. 22), a medical liability reform bill.  Stay tuned for more information and ways you can get involved.
    • Sept. 17-19: ACC’s 2006 Legislative Conference at the Renaissance Mayflower Hotel in Washington, D.C. Registration opens soon. Stay tuned to www.acc.org for more information.
    • Oct. 18-20: The 5th Annual Medical Directors’ Institute at the Lansdowne Resort in Leesburg, Virginia. For more information contact Mia Thomas at mthomas@acc.org.

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