On October 9, 2019, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS)(collectively, HHS) released a pair of proposed rulemakings that set forth changes under the Federal Anti-Kickback Statute (AKS), Civil Monetary Penalties Law (CMP) and Physician Self-Referral Law (the Stark Law) regulations to promote value-based and coordinated care arrangements. The proposed reforms are part of HHS’s Regulatory Sprint to Coordinated Care, which launched in 2018 with the goal of removing regulatory obstacles to better-coordinated and value-based care, and address comments received in response to requests for information (RFI) issued by OIG in June and August 2018.
There are substantial technical requirements that must be satisfied for eligible participants to avail themselves of the protections under the newly proposed and modified safe harbors. Significantly, a number of the proposed reforms explicitly exclude protection for pharmaceutical manufacturers and manufacturers of durable medical equipment, prosthetics, orthotics or supplies (DMEPOS), laboratories, as well as other industry stakeholders that may have an interest in value-based arrangements or otherwise contributing to care coordination. The proposed rules are scheduled to appear in the Federal Register on October 17, 2019. Comments are due on December 31, 2019, 75 days after the date of publication.
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