Pharmaceutical Manufacturer Patient Assistance Program Information

Pharmaceutical manufacturers may sponsor patient assistance programs (PAPs) that provide financial assistance or drug free product (through in-kind product donations) to low income individuals to augment any existing prescription drug coverage.

PAPs can provide assistance to Part D enrollees and interface with Part D plans by operating "outside the Part D benefit" to ensure separateness of Part D benefits and PAP assistance. The PAP's assistance on behalf of the PAP enrollee does not count towards a Part D beneficiary's true-out-of-pocket cost (TrOOP). The calculation of TrOOP is important for determining whether an individual has reached the threshold for catastrophic coverage under the Part D benefit.

This overview page provides important information on CMS policy with respect to PAPs, and also provides some helpful links to other information contained on the Office of the Inspector General's Web site.   

For PAPs operating outside of Part D, please review:

CMS's Coordination of Benefits & Recovery (COB&R) guidance, linked below, provides a useful overview of CMS' policy with respect to PAPs and their interaction with Part D plans.

The Outside the Benefit Q&A document provides further details and examples relating to CMS' policy on PAPs operating outside the Part D Benefit.

The PAP Attestation document. This document is required for PAs wishing to enter into data file exchanges with CMS to determine which of their beneficiaries are enrolled in Part D plans, in order to ensure separateness of Part D benefits and PAP assistance. (Data file exchanges are referenced in the CMS, change to COB&R guidance.)

Click the selection that best matches your area of interest. Please check back, as we will continue to update these resources regularly.