OIG Proposes Safe Harbor and CMP Exception Expansion
October 3, the Office of Inspector General (OIG) proposed a rule amending expansion of federal Anti-kickback Statute safe harbors and the civil monetary penalty (CMP) rules. The proposed rule expands safe harbors that protect certain activities from Anti-kickback Statute prohibition and adds new safe harbors, such as (Excerpted from the October 9 Ropes & Gray, LLP, Alert):
- Part D cost-sharing waivers by pharmacies;
- Cost-sharing waivers for government owned and operated emergency ambulance services;
- Payments between Medicare Advantage plans and federally qualified health centers;
- Drug discounts under the Medicare Coverage Gap Program; and
- Free and discounted local transportation for established patients of certain providers.
The proposed rule also would codify in regulation existing statutory provisions, including:
- Exceptions to both the federal anti-kickback statute and the civil monetary penalties law that would protect against liability for certain inducements to beneficiaries; and
- The long-standing statutory prohibition on gainsharing, for which OIG solicits comments on how to interpret in a way more accepting of such arrangements than the agency’s historic position.
The OIG is asking for comments on the proposed rule by December 2, 2014.
For more information, see the October 3 proposed rule, “Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing,” in the Federal Register.