A nonprofit charitable group can help financially needy Medicare and Medicaid patients pay their cost-sharing amounts for advanced diagnostic testing used in treating HIV and colon cancer without risking federal civil penalties, the Department of Health and Human Services Office of Inspector General (OIG) said in a new advisory opinion.

The OIG said the patient assistance program posed little risk to federal health programs because the structure of the program minimized the risk for improper referrals or influence on beneficiaries' selection of providers and suppliers.

The OIG also noted in the advisory opinion that it had long-standing guidance that cleared aid to financially needy Medicare and Medicaid patients through bona fide charitable assistance programs. “Under a properly structured program, such donations should raise few, if any, concerns about improper beneficiary inducements,” the OIG said.

The organization that requested the advisory opinion is a charitable group that provides financial assistance to needy patients nationwide, including Medicare and Medicaid beneficiaries. The group specifically asked the OIG to analyze its program for helping beneficiaries pay their cost-sharing amounts for diagnostic tests used in caring for HIV-positive patients and colorectal cancer patients.

The OIG previously approved a separate assistance program operated by the group for helping financially needy patients pay for specialty therapeutics used to treat certain chronic conditions (No. 06-10).

Funding for the assistance program is donated by individuals, foundations, and corporations that include drugmakers, pharmacies, and suppliers of services for which the requestor provides financial assistance.

No Influence on Patients

While donors are able to earmark their contributions for assistance to either HIV-related services or colorectal cancer-related services, donors are prohibited from specifying which type of provider or product is used, according to the advisory opinion. Donors also are not provided the names of patients assisted through the program.

Patients are free to choose or switch products without regard to whether a donor is affiliated with a product or service for which a patient is seeking help, according to the advisory opinion.

The OIG said that among its reasons for approving the program was because the arrangement “insulates beneficiary decision-making from information attributing the funding of their benefit to any donor,” making it unlikely that beneficiaries would choose a product or service based on donors to the program.

“Similarly, there appears to be a minimal risk that donor contributions improperly influence referrals to any provider, practitioner, supplier, service, or product by Requestor,” the OIG said.

The advisory opinion is available at www.oig.hhs.gov/fraud/docs/advisoryopinions/2009/AdvOpn09-04.pdf.