Some Medicare beneficiaries may still qualify for extra help in purchasing drugs through patient assistance programs, despite the new Medicare Part D drug benefit that started Jan. 1.
But pharmaceutical manufacturers that offer assistance will have to tread carefully to avoid running afoul of the federal antikickback statute, according to a special advisory bulletin from the Department of Health and Human Services' Office of Inspector General.
In the bulletin, Inspector General Daniel R. Levinson said that it would raise serious concerns if the manufacturer of a drug covered under the Part D program were to subsidize cost-sharing amounts for its product.
In the meantime, drug manufacturers that operate patient assistance programs do not need to rush to disenroll all their Medicare Part D beneficiaries. During the first year of the Medicare drug benefit, OIG officials will take into consideration whether the assistance program is taking “prompt, reasonable, verifiable, and meaningful steps to transition patients who enroll in Part D to alternative assistance models, such as independent charities.”
OIG said the practice of pharmaceutical company-sponsored programs offering assistance to Part D beneficiaries could steer patients to particular drugs, increase costs to Medicare, provide a financial advantage over competing drugs, and reduce beneficiaries' incentives to use less expensive alternatives.
The OIG bulletin also raised questions about the practice of bulk replacement in which drug makers donate their products to pharmacies, health centers, clinics, and other facilities.
Such programs would need to be evaluated on a case-by-case basis, according to OIG, but these arrangements could potentially violate the antikickback statute if the recipient of the free drugs is in a position to generate federal health care program business for the drug maker.
Alternative program designs could allow Medicare beneficiaries to continue to receive assistance. For example, a pharmaceutical manufacturer could donate its products to an independent, bona fide charity that provides cost-sharing subsidies for Part D drugs.
This action would raise few, if any, concerns under the antikickback statute as long as the patient assistance program was not functioning as a conduit for payments by the drug maker and did not unduly influence beneficiaries' drug choices.
Patient assistance programs are also less likely to run into legal trouble if the patients are not receiving Medicare Part D benefits at the same time, OIG said.
To eliminate the potential for fraud and abuse in such a case, the patient assistance program would need to notify the Part D plan that the drug is being provided so that no payment would be made and the cost of the subsidized drug would not be counted toward the beneficiary's true out-of-pocket costs.