In the first week of the New Year, the OIG released an Advisory Opinion regarding copayment assistance programs. The requestor of the Opinion was a non-profit organization seeking to provide assistance to low-income patients. Specifically, the Advisory Opinion (OIG Advisory Opinion No. 14-11) stated that the non-profit’s proposed arrangement – which involved the provision of copayment assistance to financially needy patients (including Medicare and Medicaid beneficiaries) diagnosed with Crohn’s disease or ulcerative colitis – would not result in the imposition of civil monetary penalties or administrative sanctions, because the program would be an independent charity between the donors, patients, and providers and would assure “sufficient insulation” such that it could not be used by any donor as a conduit to steer patients to particular drugs or providers. The factors that the OIG took into consideration in blessing the program were that patients needed to qualify for the program based on income levels and Federal Poverty Guidelines and that eligibility would not take into account the patient’s providers, drugs, services, or insurance. The Advisory Opinion also stated that the program would use a preset sliding scale, which could result in financial assistance that would partially or fully subsidize the patient’s copayment costs. Ultimately, the OIG found that there was minimal risk of influencing referrals because of the insulation between donors and the charity, and because of measurable eligibility criteria.
This most recent OIG Advisory Opinion is in line with previous opinions on this subject and reinforces the OIG’s position on the unique circumstances in which copayment assistance may be provided through an independent 501(c)(3) charitable organizations. It is important to remember that OIG Advisory Opinions are not binding on the OIG except as applicable to the Requestor, and thus, this Advisory Opinion is only a window into the government’s thinking and that each proposed arrangement be evaluated on its own merits. That said, many of the factors analyzed by the OIG are relevant for providers addressing the collection of copayments from their own patients. Frier Levitt routinely advises pharmacies on copayment collection responsibilities and compliance with State and Federal law. Contact us today to learn more about copayment collection practices.
