OIG has released Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, which adds new safe harbors to the anti-kickback statute to protect certain payment practices and business arrangements from sanctions. The rule updates the existing safe harbor regulations and enhances flexibility for providers and others to engage in health care business arrangements to improve efficiency and access to quality care while protecting programs and patients from fraud and abuse, according to the agency.
The rule also protects certain services that the OIG believes would pose a “low risk” to federal health programs if properly structured and with appropriate safeguards. The safe harbor changes in the rule include:
1) protection for certain cost-sharing waivers associated with pharmacy series for financially needy beneficiaries and emergency ambulance services;
2) protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers; and
3) protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare coverage Gap program.
The rule also codifies revisions to the CMP definition of remuneration.