The Challenge of Providing Patient Assistance Under the ACA

The Challenge of Providing Patient Assistance Under the ACA

There’s a lot of ambiguity around how the government is going to view the private and public exchanges. An OIG opinion providing guidance on whether these plans will be viewed as public versus private plans could have far-reaching implications for how manufacturers provide patient assistance. If we look at some of the OIG guidance offered around Medicare Part D plans and the potential for anti-kickback penalties when offering direct assistance to these beneficiaries, we can start to hypothesize about some of the challenges pharmaceutical manufacturers will face.

Medicare Part D has been around since 2006 and the rules for manufacturer-funded support for these beneficiaries are well-defined. These plans include a coverage gap, or donut hole, that requires patients to pay more out of pocket until a certain total dollar amount is reached. When a patient hits the donut hole, typically manufacturer support programs can provide free drugs for those patients or refer them to 501c3 copay assistance foundations for financial support. If a Medicare Part D patient is accepted into a manufacturer’s patient assistance program (PAP), the program must support the patient with free drugs through the remainder of the calendar year.

Coverage through the exchange plans varies, but we know that some bronze-level plans only cover about 60% of medication costs. This can leave patients who require specialty medications instantly underinsured. If the OIG ultimately uses their Med D guidance as a proxy, it’s likely that manufacturers will be allowed to offer support to these patients with the same caveat - that patients must remain on the manufacturer program through the end of the calendar year.

For now, most manufacturers are taking a “wait and see” approach to directly supporting patients who are enrolled in qualified health plans within the exchanges. Until an official opinion is provided by the OIG, it’s hard to know where to turn. Our team is constantly monitoring the effect of healthcare reform. This week I’m moderating a panel discussion at CBI’s 15th Patient Assistance and Access Programs conference titled “ACA Across the Board – The Impact on Assistance Plans.” If you’re attending the conference, I hope you can join the session on Thursday, March 6 at 1:05 p.m. If you’re not attending, feel free to contact me when you’re ready to talk about potential changes to your patient support services