Rx Assistance Charity May Use Manufacturer Donations For Program, IG Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The design of the Rx assistance program would prevent donor contributions from influencing Medicare beneficiaries’ selection of product, an HHS Inspector General Advisory Opinion states. The proposed program will cover patients’ cost-sharing obligations for Medicare Part B drugs.
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A charity providing prescription drug assistance to low-income patients may accept financial donations from drug manufacturers because the group will not influence patients' choices of products, the HHS Inspector General said. "Because the requestor's particular design and administration of the proposed program will interpose an independent charitable organization between the donors and patients in a manner that effectively insulates beneficiary decision-making from information attributing the funding of their benefit to any donor, it appears unlikely that donor contributions would influence any Medicare beneficiary's selection of a particular provider, practitioner or supplier," an IG 1 Advisory Opinion posted Nov. 5 states. A non-profit charitable group asked IG to assess its proposal to establish and operate a patient assistance program to cover costs of Medicare Part B drugs used by financially needy patients. The group will pay all or part of cost-sharing obligations for patients with income less that 250% of the federal poverty level. The program will be limited to specific chronic or life-threatening diseases. Drug manufacturers are among those expected to provide funding for the program; the group will require that participating manufacturers make a three-year commitment to the program. Although the program implicates the anti-kickback statute, IG "would not seek to impose administrative sanctions" or impose civil monetary penalties, the advisory opinion states. IG noted that assistance will be available to any financially-qualified patient diagnosed with the specific conditions targeted by the program. In most cases, a physician will have already selected the patient's drug regimen before applying for aid, and patients will be free to switch providers, providers or product. In addition, "the program will not refer patients to any donor or other provider, supplier or product." "Donors will not be assured that the amount of financial assistance their patients, clients or customers receive will bear any relationship to the amount of their donations," IG said. "Indeed, donors will not be guaranteed that any of their patients, clients or customers will receive any financial assistance whatsoever from the requestor." "In these circumstances," the opinion says, "we do not believe that the contributions made by donors to the requestor can reasonably be construed as payments to eligible beneficiaries of the Medicare program." In previous advisory opinions, IG has said manufacturers should not directly assist patients using their products under Medicare Part B, but said manufacturers could contribute to an independent foundation or patient group that would help cover patients' cost-sharing obligations. - Scott Steinke |