White Guide and Orange Guide Formatting Project - Pfizer

A special note about Medicare Part D patients:
Orange Guide – Chapter 11: Patient Assistance Programs
As described above, patients with prescription coverage through commercial plans or public plans like
Medicare Part D can apply for Hardship Assistance through several PHA programs if they are having
difficulty paying for their medicines. This assistance complies with the specific guidelines that have
been published about PAPs and Medicare Part D.
Under the Medicare Prescription Drug Improvement and Modernization Act, Medicare beneficiaries
may enroll in Part D and thereby have all or part of their prescription drug costs covered by the
government. Since its enactment, the Office of Inspector General (OIG) has cautioned that
manufacturer PAPs that donate their drugs that are payable under Medicare Part D are likely to
implicate kickback issues.
Cost-sharing subsidies provided by manufacturer PAPs present the typical risks of fraud and abuse
associated with kickbacks, such as steering beneficiaries to particular drugs, increasing costs to the
federal government, providing a financial advantage over competing drugs, and reducing beneficiary
incentives to use less expensive and equally as effective drugs. The OIG’s Special Advisory Bulletin
entitled Patient Assistance Programs for Medicare Part D Enrollees explains, for example, that
subsidies provided by manufacturer PAPs may lock beneficiaries into the manufacturer’s product, even
if there are other equally effective, less costly options.
PAPs that operate entirely outside Medicare Part D, however, minimize kickback risks. In these
circumstances, a Part D enrollee chooses to obtain medication without using the Part D insurance. The
enrolled Part D beneficiary will receive assistance through a PAP but will not file any claims for payment
with the Part D plan. The PAP assistance will not count toward the beneficiary’s true out-of-pocket
costs (TrOOP) or overall Part D spending.
Thus, in connection with providing patient assistance outside of Part D, Pfizer must ensure the
following:
That the applicable PAP includes safeguards that ensure that Part D plans are notified that
the drug is being provided outside the Part D benefit;
That the PAP provides assistance for the whole Part D coverage year or the portion of the
year remaining after the beneficiary received PAP assistance;
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Rev. 09/12
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