Earlier this year, the Office of Inspector General (OIG) revoked Advisory Opinion No. 10-06 previously issued in 2010 to a charitable Patient Assistance Program (PAP) that determined the financial assistance to Medicare beneficiaries, as described in the Advisory Opinion No. 10-06, did not violate the federal anti-kickback statute, 42 U.S.C. 1320a–7b. In revoking Advisory Opinion No. 10-06, the OIG referred to a Supplemental Advisory Bulletin regarding Independent Charity PAPs. The Supplemental Advisory Bulletin was issued based on experience gained by the OIG since 2005. Specifically, the bulletin pointed out that PAPs continue to present a risk of fraud, waste and abuse and a violation of federal regulation can create both criminal and civil liabilities under various regulations. Regulations include the federal anti-kickback statute, 42 U.S.C. 1320a–7b, prohibitions of inducements to Medicare and Medicaid Beneficiaries, 42 U.S.C. 1320a–7a(a)(5), and the False Claims Act, 31 U.S.C. 3729–33, among possible other regulations. To determine if a PAP is in compliance with complex federal regulations, a fact-specific inquiry into the specific nature, structure, sponsorship, and funding of a particular PAP is required.
The revocation of the 2010 advisory opinion signals stronger regulatory enforcement of PAPs by the OIG. Frier Levitt has experienced healthcare regulatory attorneys that can assist your organization in ensuring that it is in compliance with relevant federal and state laws. Contact us today to learn more.
