Have CMS and OIG Clarifications Had Any Effect on PAP Availability?

In a policy clarification the Centers for Medicare & Medicaid Services recently announced that pharmaceutical companies’ Patient Assistance Programs (PAPs) can provide Part D-covered drugs to Medicare drug benefit enrollees but the value of the donated drugs will not count towards the total beneficiary drug costs. In the past CMS said that drug payments PAPs made on behalf of Part D enrollees could count towards their true-out-of-pocket costs (TrOOP) unless the organizations qualified as group health plans, insurance, or other similar third-party payment arrangements. This announcement clarifies that PAPs can provide assistance for covered Part D drugs on behalf of Part D enrollees but only if it is done outside the Part D benefit.

While this announcement represents CMS’ current policy, guidance to PAPs about options in structuring assistance programs could change after the 2006 contract year. Currently, individual PAPs have flexibility in determining the forms of their donations to financially needy beneficiaries, including those with incomes too high to qualify for the low-income drug subsidy (LIS), but low enough that out-of-pocket drug costs are burdensome. CMS has not indicated how the guidance might change in future years.

Yet now that CMS and the Department of Health and Human Services Office of Inspector General (OIG) guidance to the PAPs has currently been clarified, are more of them beginning to offer benefits to Part D enrollees? How many PAPs are actually accepting people with Part D coverage into their programs? As discussed in an article two editions ago, only three PAPs were accepting some Part D enrollees. This small number directly contradicted what company press releases and the news media were saying about PAP availability to beneficiaries with Part D. While many company websites and their press releases stated they would accept Part D enrollees, PAP customer service representatives continued to deny access to these beneficiaries. For example, a few months ago Wen Daniels, Outreach Coordinator with California Health Advocates, called Novartis on behalf of a client taking cancer medication. The website clearly stated that low-income Medicare Part D beneficiaries who did not qualify for the LIS could participate in their cancer and transplant PAPs. When calling Novartis, however, the PAP customer service representative firmly said no. After some discussion, Daniels realized that her call went to the wrong ‘branch’ and was not in the oncology or transplant branch of Novartis. Yet the representative never asked what drug Daniels was calling for. Beneficiaries who mistakenly call the wrong ‘branch’ of a pharmaceutical company could run up against similar obstacles without knowing how to enroll in a PAP by self-navigating to the ‘correct’ branch.

The Rx Assist website provides a list of PAPs in terms of their relation to people on Medicare and those with Medicare Part D as well. The sections include PAPs that will: not accept anyone with Medicare; accept people with Medicare who do not have Part D; will accept anyone with Medicare Part D; and other situations. Yet, much of this information is also based on company press releases that may or may not reflect the reality that a beneficiary faces when actually trying to enroll. For example, RxAssist lists Johnson and Johnson as a PAP that accepts all Medicare beneficiaries. Yet in calling the PAP customer service representatives, advocates are often told that they do not accept or offer help to any beneficiary with Part D.

With so much contradicting information, many advocates say that they will not recommend PAPs as a reliable option for beneficiaries needing medications during their Part D coverage, or for those needing prohibitively expensive drugs (i.e for cancer, HIV, or multiple sclerosis treatment) until they actually see people being successfully enrolled into programs. Until then it may be best to encourage beneficiaries to continue calling the PAPs to see if their policies have changed. As pharmaceutical companies are still in the process of reviewing and revising their PAP policies, changes may likely occur. With this flux in mind, reviewed below is a summary of what some of the major pharmaceutical companies are currently offering based on information gathered from the ‘front lines’ of companies’ customer service representatives. California Health Advocates encourages advocates to post their success and/or failures with PAPs on the Part D Community Discussion page as an effective way to share this information with a large audience of Medicare advocates, professionals, providers, educators, and beneficiaries.

GlaxoSmithKline (GSK)

For the remainder of 2006, GSK’s Bridges to Access program is only available to two groups of Medicare beneficiaries: 1) Beneficiaries who are not enrolled in Medicare Part D and do not qualify for the low-income subsidy (LIS); 2) Beneficiaries who are enrolled in Part D, are not eligible for LIS, and who were participating in Bridges to Access before the beginning of Part D on January 1, 2006. GSK has not decided whether the PAP will remain available in 2007. To speak to a GSK customer service representative (CSR) about their PAP, call (866) 728-4368.

Johnson & Johnson

In general, beneficiaries with Medicare Part D and those without Part D who qualify for the LIS are not eligible for J&J’s PAP. Yet, despite contradictory information from some customer service representatives, people who can demonstrate medical and/or financial hardship may qualify for an exception. For information on J&J’s existing PAPs, call the Partnership for Prescription Assistance at (888) 4PPARX-NOW (1-888-477-2669), or visit the PPA website at www.pparx.org. Because J&J is only one of 45 companies represented in the PPA, beneficiaries can also call the PPA with non-J&J drugs to see if there is another program that accepts people with Medicare Part D.

Eli Lilly

Eli Lilly will continue operating its existing LillyAnswers PAP through the end of the year for Medicare beneficiaries who were enrolled in the program as of December 31, 2005 and have not yet signed up for the Medicare drug benefit. No new enrollees will be accepted. Certain low-income Medicare beneficiaries who have enrolled in the drug benefit and have applied for and been denied the Part D low-income subsidy, can obtain the osteoporosis treatment Forteo and the antipsychotic Zyprexa. These drugs covered under LillyMedicareAnswers do not count toward the $5,100 catastrophic coverage trigger. For questions or more information about Eli Lilly’s PAPs, call (877) 795-4559.


Merck will continue offering their PAP to low-income beneficiaries who are not enrolled in Part D. Beneficiaries who are enrolled in Part D and do not qualify for LIS may also qualify for Merck’s PAP based on financial and/or medical hardship. Beneficiaries can download PAP applications online or have them mailed to their homes. After receiving the application, they need to fill it out, have their doctor sign it and mail it back to Merck for review. If the review team at Merck decides the applicant qualifies for an exception, they will mail both the original application and an additional form back to the beneficiary. The beneficiary must fill out the additional form and again mail both the new and original application form back to Merck for PAP benefits to begin. The whole process takes about four to six weeks. For questions or additional information, call (800) 727-5400 or visit Merck’s website.


AstraZeneca has formed a new PAP entity and is now offering their PAP to both low-income beneficiaries who are not enrolled in Part D, and low-income beneficiaries who not eligible for LIS and are in the Part D coverage gap, or ‘donut hole.’ For more information, call AstraZeneca’s PAP Help Line at (800) 424-3727.


Novartis, the maker of several important cancer drugs including Gleevec, continues to offer their PAP to low-income beneficiaries who are not enrolled in Part D. Beneficiaries who are enrolled in a Part D plan and are taking Novartis transplant or oncology medications can also continue using the Novartis PAP as long as they meet certain eligibility criteria, do not qualify for and have been denied the LIS, and show financial hardship in affording their medications despite the Part D benefit coverage. When calling Novartis, these beneficiaries must explicitly state that they are inquiring about the PAP for transplant and oncology medications. The PAP for non-oncology medications has a different policy and applications are evaluated individually. For information on the Novartis PAP program for transplant and/or oncology drugs, call (800) 942-3424. For all other Novartis drugs, call (800) 620-3292, or visit their website.


Schering-Plow has two patient assistance programs for qualified Medicare beneficiaries regardless of whether they have Part D. The first, Commitment to Care, offers free outpatient prescription drugs for cancer and hepatitis. Qualified beneficiaries must demonstrate that their prescription drug expenses exceed three percent of their annual household income. The second program, SP-Cares, offers allergy, asthma, dermatology and cardiovascular prescription drugs, and also requires that a person’s drug expenses exceed three percent of their annual income. Beneficiaries who have not enrolled in Part D are required to apply to, and be rejected by, the low-income subsidy. They must also attest that they cannot find an affordable Part D plan in order to be eligible to participate in the PAP. Beneficiaries who are enrolled in Part D and want to apply must submit proof of spending at least three percent of their annual income on drugs through their Part D plan. For information or questions on Commitment to Care, call (800) 521-7157. For information on SP-Cares, call (800) 656-9485.


Pfizer continues to offer their PAP to low-income beneficiaries who are not enrolled in Part D. They may cover beneficiaries who drop Part D. For questions or additional information, call (800) 869-9979.

Karen Joy Fletcher

Our blogger Karen Joy Fletcher is CHA’s Communications Director. With a Masters in Public Health from UC Berkeley, she is the online “public face” of the organization, provides technical expertise, writing and research on Medicare and other health care issues. She is responsible for digital content creation, management of CHA’s editorial calendar, and managing all aspects of CHA’s social media presence. She loves being a “communicator” and enjoys networking and collaborating with the passionate people and agencies in the health advocacy field. See her current articles.