Interim Rule Adds Waivers to Physician Self-Referral Law

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Working toward the goal of encouraging participation in the Medicare Shared Savings Program and the Advance Payment Initiative, the Centers for Medicare and Medicaid Services (CMS), the Office of Inspector General (OIG), and the Department of Health & Human Services (HHS) last Thursday issued an interim final rule that sets forth waivers to the physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties laws.

The rule includes an accountable care organization (ACO) pre-participation waiver applicable to start-up accountable care arrangements, as well as an ACO participation waiver during the term of ACO participation or time thereafter.

Also provided by the rule are shared savings distribution waiver for payments earned under the program, a “compliance with physician self-referral law” waiver, and a patient incentive waiver for medically-related incentives aimed at encouraging preventive care and treatment compliance.

Eliminating health care fraud, improper referral payments, and under- and over-use of services and tests was the goal of the physician self-referral law, the federal anti-kickback statute, and certain civil monetary penalties law. However, hospitals, physicians, and other entities have argued that such legal obstacles would impede the formation, by organizations, groups, and individual providers, of legitimate ACOs in keeping with existing laws.

Conversely, the rule states that the legal provision waivers ensure that "the laws do not unduly impede development of beneficial ACOs, as well as that ACO arrangements are not misused for fraudulent or abusive purposes that harm patients or Federal health care programs.”

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

To read the rule, click here: http://www.ofr.gov/OFRUpload/OFRData/2011-27460_PI.pdf