Medicare Compliance & Reimbursement

Tread carefully when offering PAPs to Medicare Part D benes.

Pharmaceutical providers that wish to offer patient assistance programs to help Medicare Part D beneficiaries get drugs may need to make donations through an independent charity to avoid violating fraud and abuse laws.

A pharmaceutical manufacturer that uses its own PAP to subsidize its own Part D-payable products may risk fraud and abuse allegations, according to an HHS Office of the Inspector General Special Advisory Bulletin.

"The bulletin makes clear that lawful avenues exist for pharmaceutical manufacturers and others to help ensure that all Part D beneficiaries can afford medically necessary drugs," notes IG Daniel Levinson.

These "lawful avenues" include making cash donations to "bona fide independent charity PAPs that are not affiliated with a manufacturer and operate without regard to donor interests," the bulletin says.

For manufacturers that have Medicare beneficiaries already participating in their PAPs and will soon enroll in the Part D benefit, Levinson recommends transitioning the beneficiaries to "alternative assistance models," such as patient advocacy and support organizations' programs.

"Nothing in any OIG laws or regulations prevents pharmaceutical manufacturers or others from helping uninsured patients and Medicare beneficiaries who have not enrolled in Part D with their outpatient prescription drugs," the bulletin clarifies.