Life Sciences

OIG advisory opinion: Pharma, other donations to cancer charity pose little kickback risk

Pharma Compliance Alert, September 6, 2006

Pharmaceutical companies and other healthcare stakeholders can provide funding to a charitable program for subsidized Medicare Part D costs, with little anti-kickback violation risk, according to an OIG advisory opinion issued last week.

The OIG issued the opinion to a nonprofit, tax-exempt charitable organization that proposed a program to subsidize Part D premium and cost-sharing obligations for financially needy patients with end-stage renal disease and chronic kidney disease. Pharmaceutical companies and others, such as insurance companies and dialysis providers and suppliers, would provide funding for the program.

The OIG found that it is "unlikely that donor contributions would influence any Medicare beneficiary's selection of a particular provider, practitioner, supplier, or product." The OIG came to this conclusion because:

  • The donors don't exert any control over the charity or its programs

  • Assistance is given independently, severing any link between donors and patients

  • Assistance is given without regard to donor interests or to the applicant's choice of product, provider, practitioner, supplier, or insurance plan

  • Assistance is based upon a reasonable, verifiable, and uniform measure of financial need

  • The charity will not provide donors with any data that would allow them to correlate the amount or frequency of its donations with the amount or frequency of the use of its products or services

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

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