CMS, OIG to relax self-referral, anti-kickback laws with ACO waivers

To the relief of many healthcare organizations that worried about the legal barriers to forming an accountable care organization (ACO), the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), and the Department of Health & Human Services (HHS) yesterday issued an interim final rule that establishes waivers to the physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law, with the goal of encouraging participation in the Medicare Shared Savings Program and the Advance Payment Initiative. The interim final rule, which is open for comments, will authorize the Secretary to waive certain fraud and abuse laws.  

The physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law are aimed at fighting against healthcare fraud, improper referral payments, and unnecessary under- or overuse of services or tests. However, ACO advocates, including hospitals and physicians, argued that those legal barriers would prevent organizational, group, and individual providers from forming legitimate ACOs under the current laws.

With legal provision waivers, "the laws do not unduly impede development of beneficial ACOs, while also ensuring that ACO arrangements are not misused for fraudulent or abusive purposes that harm patients or Federal health care programs," the rule states.

Allowing for the goals of Shared Savings--better health for populations and individuals, as well as lower growth in expenditures--there will be five waivers:

  • ACO pre-participation waiver that applies to start-up accountable care arrangements
  • ACO participation waiver during the term of the ACO participation or time thereafter
  • Shared savings distributions waiver for payments earned under the program
  • Compliance with physician self-referral law waiver
  • Patient incentive waiver for medically related incentives to encourage preventive care and treatment compliance

CMS oversees the physician self-referral law. OIG is responsible for enforcing civil monetary penalties. OIG, with the Department of Justice, is responsible for the federal anti-kickback statute.

For more information:
- read the CMS rule (.pdf)

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