The Health and Human Services Office of Inspector General (OIG) released today a proposed rule titled, 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.  The 94-page proposed rule is expected to be published tomorrow in the Federal Register.  The proposed rule would amend the safe harbors to the federal Anti-Kickback Statute (AKS); codify changes to the definition of “remuneration” in the Civil Monetary Penalties (CMP) regulations; and codify the gainsharing CMP provided in 42 U.S.C. 1320a–7a(b). Comments to the proposed rule must be submitted to the OIG within 60 days of publication in the Federal Register.

Specifically, the proposed rule would make the following changes to the AKS safe harbors:

  • Make a technical correction to the existing safe harbor for Referral Services;
  • Add protection for certain cost-sharing waivers;
  • Add protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Add protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Add protection for free or discounted local transportation services that meet specified criteria.

Additionally, the proposed rule would amend the definition of “remuneration” in the CMP regulations by adding certain statutory exceptions for copayment reductions for certain hospital outpatient department services; certain remuneration that poses a low risk of harm and promotes access to care; coupons, rebates, or other retailer reward programs that meet specified requirements; certain remuneration to financially needy individuals; and copayment waivers for the first fill of generic drugs.

All health care entities and other interested parties should carefully review the OIG proposed rule and consider providing substantive comments individually and/or through an industry organization.

Posted by Sarah K. diFrancesca

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