Recent enforcement actions over allegations regarding assisting pharmaceutical manufacturers to pay improper kickbacks to Medicare beneficiaries are not the only issues currently impacting Patient Assistance Programs (PAPs). PBMs are also taking an increasingly hard stance over the use of PAPs by specialty and retail pharmacies across the country. Some PBM Provider Manuals include explicit terms and conditions regarding the use of financial hardship policies, but many are silent with regard to a patient’s use of third-party PAPs and the impact that may have on the pharmacy’s reimbursements. It is even less clear how PBMs will treat the use of a PAP that has been the subject of a settlement or enforcement action by the Department of Justice. Pharmacies should be aware that PBMs will go as far as recouping the total amount of reimbursements on claims where proof of copayment collection cannot be adequately demonstrated (this is particularly delicate in the cases where a patient has utilized a third-party patient assistance programs). Failure to collect copayments (or to provide proof of collection) can also lead to immediate termination from a PBM’s network.
Pharmacies need to be aware of these issues and take steps to avoid recoupments and possible termination. Pharmacies should also have comprehensive policies and procedures in place regarding, not only financial hardship programs but also the use of PAPs and other third-party assistance (including manufacturer-sponsored copayment coupons). If your pharmacy is undergoing a PBM audit that involves the use of third-party patient assistance programs or is seeking to implement policies and procedures regarding patient assistance programs, contact Frier Levitt today to speak to an attorney.