The Department of Health and Human Services Office of Inspector General (OIG) recently published a proposed rule modifying the Anti-Kickback Statute (AKS) and the Civil Money Penalty (CMP) regulations. The proposed rule would modify three existing federal AKS safe harbors, add three new AKS safe harbors, add additional exceptions to the definition of “remuneration” under CMP regulations, and codify the Gainsharing CMP.
Key highlights of the proposed rule include:
- New AKS safe harbor provisions for Federally Qualified Health Centers Medicare Advantage (MA) Organization Agreements under § 1001.952(z) and for discounted local transportation under § 1001.952(bb).
- New exceptions to the definition of “remuneration” under the CMP protecting: copayment reductions for certain hospital outpatient department services; remuneration promoting access to care while posing a low risk of harm to patients and Federal health care programs; certain “retailer rewards programs;” the offer or transfer of items or services for free or at less than fair market value; and certain waivers by prescription drug program sponsors of a Part D plan or MA organization.
OIG published the proposed rule on October 3, 2014 and comments are due no later than December 2, 2014.
The HHS Proposed Rule is available at:
Department of Health and Human Services Office of Inspector General; 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; Proposed Rule, 79 Fed. Reg. 59717, 59717-59733 (Oct. 3, 2014).