Sunday, January 18, 2009

Weekend update / Miscellany

  • The big news of the past week was the United Healthcare and Aetna settlements with the NY Attorney General and the American Medical Association to replace the Ingenix usual reasonable and customary databases with an "independent" database created by a "qualified university" to be appointed by the NY Attorney General. A copy of the NY Attorney General's report is here. A copy of the Aetna settlement is here. The response by the managed care industry trade association is here. While this is a happy outcome for doctors who operate outside of health plan networks, it's not a good deal for consumers or doctors who participate in health plan networks.
  • Last October, the Department of Health and Human Services' Office of the National Coordinator of Health Information Technology held a conference on medical identity theft. Last week, Booz Allen issued a final report on that topic to the ONC. The New York Times reports today that privacy issues may interfere with the President elect's plans to include electronic medical record funding in the next stimulus package.
  • Eli Lilly & Co. conceded that it violated federal law by encourage the off label use of its blockbuster drug Zyprexa. explains that
    Lilly admitted to promoting the drug to elderly patients for off-label use as a treatment for dementia. The drug caused increased risk of death in this patient group. Zyprexa was approved in 1996 and will lose patent protection in 2011. It had annual sales of $4.7 billion in 2007.
    According to a U.S. Justice Department press release,

  • The global resolution [with Eli Lilly] includes the following agreements: A plea agreement signed by Eli Lilly admitting guilt to the criminal charge of misbranding. Specifically, Eli Lilly admits that between Sept. 1999 and March 31, 2001, the company promoted Zyprexa in elderly populations as treatment for dementia, including Alzheimer’s dementia. Eli Lilly has agreed to pay a $515 million criminal fine and to forfeit an additional $100 million in assets.
  • A civil settlement between Eli Lilly, the United States and various States, in which Eli Lilly will pay up to $800 million to the federal government and the states to resolve False Claims Act claims and related state claims by Medicaid and other federal programs and agencies including TRICARE, the Federal Employees Health Benefits Program, Department of Veterans Affairs, Bureau of Prisons and the Public Health Service Entities. The federal government will receive $438,171,544 from the civil settlement. The state Medicaid programs and the District of Columbia will share up to $361,828,456 of the civil settlement, depending on the number of states that participate in the settlement.
  • The qui tam relators will receive $78,870,877 from the federal share of the settlement amount.
  • A Corporate Integrity Agreement (CIA) between Eli Lilly and the Office of Inspector General of the Department of Health and Human Services. The five-year CIA requires, among other things, that a Board of Directors committee annually review the company’s compliance program and certify its effectiveness; that certain managers annually certify that their departments or functional areas are compliant; that Eli Lilly send doctors a letter notifying them about the global settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel or lodging. Eli Lilly is subject to exclusion from Federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.
  • CMS issued three Medicare national coverage determinations holding that
    Wrong surgical or other invasive procedures performed on a patient;

    Surgical or other invasive procedures performed on the wrong body part; and

    Surgical or other invasive procedures performed on the wrong patient.

    are "never events" for which no Medicare reimbursement will be made.

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