On October 28, 2015, the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG) released a final rule finalizing waivers of application of the Stark Law, the anti-kickback statute and the civil monetary penalties (CMP) provisions relating to beneficiary inducements to specified arrangements involving Medicare Shared Savings Program (MSSP) accountable care organizations (ACOs). The final rule became effective upon its publication in the Federal Register on October 29, 2015. 

The final rule finalizes the waivers as they were issued in an interim final rule with comment period (IFC) dated November 2, 2011, and includes the following limited changes and clarifications:

  • The final rule does not finalize waivers of the application of the CMP law relating to gainsharing arrangements due to statutory changes made by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which occurred after the publication of the IFC and limited the gainsharing CMP to prohibit only reductions or limitations in “medically necessary” services.
  • In the pre-participation and the participation waivers, the ACO governing body must make a meaningful determination that an arrangement is reasonably related to the purposes of the MSSP and cannot merely “rubber stamp” its approval of an arrangement.
  • As used in the pre-participation waiver, the term “home health supplier” means “a provider, supplier or other entity that is primarily engaged in furnishing home health services.” 

The finalized waivers are:

  1. ACO Pre-Participation Waiver
  2. ACO Participation Waiver
  3. Shared Savings Distribution Waiver
  4. Compliance with Physician Self-Referral (Stark) Law Waiver
  5. Patient Incentives Waiver

CMS and OIG are jointly finalizing the waivers to provide stakeholders with a coordinated approach to the application of the fraud and abuse laws in connection with the MSSP. CMS and OIG have concluded, based on their experience to date, that the waivers are necessary to carry out the MSSP and that they are adequately protecting beneficiaries and federal health care programs while promoting innovative structures within the MSSP. They will continue to monitor the development of ACOs and shared savings arrangements and will consider future rulemaking if warranted.