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    OIG further restricts charitable copay assistance programs

    PBMs attempt to limit pharmacy copay practices

    Independent charity patient assistance programs (PAPs) can help patients pay for prescription drugs. Recently, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Supplemental Special Advisory Bulletin on the subject of PAPs. The Supplement updates the OIG “Special Advisory Bulletin on Patient Assistance Programs for Medicare Part D Enrollees” published in the Federal Register on November 22, 2005 (http://bit.ly/partDpap), and expands upon the guidance issued in the 2005 Special Advisory.

    It is well established that PAPs have assisted patients who are unable to afford their cost-sharing obligations for their prescription drugs. The OIG recognizes that independent charities can help financially needy beneficiaries with their healthcare expenses and notes that pharmaceutical manufacturers can donate to these charities.

    Charities that are not sufficiently independent from drug-manufacturer donors, however, could be found to be operating PAPs that harm patients and federal healthcare programs alike. In those instances, depending on the facts, it could be alleged that such activities violate fraud, waste, and abuse laws.

    The Supplemental Bulletin expands upon the previous guidance, focusing particularly on disease funds and legitimate copay waivers for prescribed medications from such funds.

    Ned Milenkovich, PharmD, JD
    This article is not intended as legal advice and should not be used as such. When legal questions arise, pharmacists should consult with ...

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