Life Sciences

OIG advisory opinion: Little chance of anti-kickback violation from pharma donations to charity

Pharma Compliance Alert, September 27, 2006

Pharmaceutical companies and other healthcare stakeholders can provide funding to a charitable program for therapy management services and Medicare cost-sharing assistance, with little anti-kickback violation risk, according to an OIG advisory opinion issued last week.

The charity provides assistance with certain therapy management services and cost-sharing Medicare assistance to financially needy Medicare beneficiaries who are undergoing medical treatment for certain diseases. The funding for the program comes from individual donors, corporations, and foundations, including the manufacturers of the drugs in the program.

The OIG says it is unlikely that donor contributions would influence any Medicare beneficiary's selection of a particular provider, practitioner, supplier, or product because:

  • No donor or affiliate of any donor exerts direct or indirect control over Requestor or its program.

  • Assistance is awarded in an independent manner that severs any link between donors and beneficiaries.

  • Assistance is awarded without regard to any donor's interests or to the applicant's choice of provider, practitioner, supplier, or product.

  • Assistance is awarded based upon a reasonable, verifiable, and uniform measure of financial need that is applied in a consistent manner.

  • Donors don't receive any data that would allow a correlation between amount or frequency of its donations with the amount or frequency of the use of its products or services.

    Read the entire opinion on the OIG's Web site.

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