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Ready for Some Rulemaking? Revisions Coming to the Stark Law, Anti-Kickback Statute, and CMP Laws This Summer

Long-awaited revisions to the regulations implementing the Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties (CMP) Laws are on their way.

On June 5, 2019, CMS sent a Proposed Rule titled “Modernizing and Clarifying the Physician Self-Referral Regulations” to the Office of Management and Budget (OMB) for review.  That same day, OIG sent a Proposed Rule to OMB titled “Revisions to the Safe Harbors under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement.” Assuming that OMB approves the proposed rules and does not send them back to the agencies for reconsideration, we will likely see the proposed rules issued for public comment sometime this summer.

According to statements earlier this year by HHS Deputy Secretary Eric Hargan, the proposed rules will attempt to modernize the scope of the Stark Law, Anti-Kickback Statute, and CMP Laws to better synchronize these key fraud and abuse regulations with important HHS initiates, such as coordinated care and value-based payment reforms.  We suspect they will, in some fashion, take into account the public comments CMS received in response to its Request for Information regarding the Stark Law issued on June 20, 2018, and the public comments OIG received in response to its August 27, 2018 Request for Information regarding the Anti-Kickback Statute and CMP Laws.

When the proposed rules come out, the health care industry will have a brief window to review the rules and provide comments to the agencies before the rules become final.  Don’t get caught flat-footed.  Get your team ready for a rapid response. Arent Fox has deep fraud and abuse expertise and extensive experience assisting health care clients prepare informed and persuasive comments in response to proposed regulations.


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