Summary

On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) and the U.S. Department of Health and Human Services, Office of Inspector General (OIG) published in the Federal Register (79 FR 62356 et seq) a notice to continue the interim final rule published in the Federal Register on November 2, 2011 (2011 Interim Final Rule). The 2011 Interim Final Rule related to a waiver of certain federal fraud and abuse laws in connection with an accountable care organization’s (ACO) participation in the Medicare Shared Savings Program (Shared Savings Program). The 2011 Interim Final Rule is extended until November 2, 2015 unless a final ACO waiver rule takes effect on an earlier date.

The 2011 Interim Final Rule established waivers of the application of three federal “fraud and abuse” laws: the physician self-referral statute (commonly referred to as the Stark Statute); the Anti-Kickback Statute; and certain provisions in the Civil Monetary Penalties Law with respect to ACOs participating in the Shared Savings Program. The Shared Savings Program was created as part of the enactment of the Affordable Care Act.

CMS noted that it is working on a proposed rule relating to the Shared Savings Program. To ensure the “final” waiver of federal fraud and abuse laws is aligned with the Shared Savings Program, CMS is extending the “end date” of the interim final rule. 

CMS reiterated in the publication of this extension of the 2011 Interim Final Rule that its goal remains “to balance effectively the need for ACO certainty, innovation, and flexibility in the Shared Savings Program with protections for beneficiaries and the Medicare program.”

CMS is requesting additional input from ACO stakeholders with respect to the waiver of the fraud and abuse laws. Specifically, CMS noted it is seeking additional information regarding:

• how and to what extent ACOs are using the waivers;
• whether the existing waivers serve the needs of ACOs and the Medicare program;
• whether the waivers adequately protect the Medicare program and beneficiaries from harms associated with referral payments or payments to reduce or limit services; and
• whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking by CMS or OIG.

CMS states that it is committed to moving forward with and encouraging the participation of ACOs in the Shared Savings Program. The extension of the 2011 Interim Final Rule until November 2015 with respect to the waiver of certain federal fraud and abuse laws may encourage continued innovation in ACOs and perhaps encourage additional parties to participate in the Shared Savings Program.