Yesterday (October 17, 2019), the Office of Inspector General (“OIG”) and the Centers for Medicare and Medicaid Services (“CMS”), in conjunction with the U.S. Department of Health and Human Services’ (“HHS”) Regulatory Sprint to Coordinated Care, proposed long-awaited updates to the physician self-referral law (also known as “Stark”); the Anti-Kickback Statute (“AKS”); and the beneficiary inducements provision of the Civil Monetary Penalties Law (“CMPL”). The proposed rules seek public comment on: (1) modifications to current AKS and CMPL safe harbors and exceptions for EHR items and services, warranties, local transportation and personal services and management contracts and (2) new AKS safe harbors and CMPL/Stark exceptions granting protections to physicians and entities affiliated with one another through value-based arrangements. The new and modified safe harbors and exceptions are intended to account for and incentivize the transition of the delivery of healthcare from fee-for-service to pay-for-performance by permitting information sharing, care coordination, and joint resources among value-based enterprise participants. In addition, the proposed rules aim to eliminate the need for fraud and abuse waivers for various CMS-sponsored payment models (as currently in effect for the Medicare Shared Savings Program) by including a specific safe harbor and exception for such models.
The proposed rules, if finalized, would apply prospectively only. They would not apply to value-based compensation arrangements engaged in prior to the effective date of the final rule. Comments on the proposed rule are due by December 31, 2019. To review the proposed rules and instructions to submit comments, visit the following sites: https://www.federalregister.gov/documents/2019/10/17/2019-22027/medicare-and-state-healthcare-programs-fraud-and-abuse-revisions-to-safe-harbors-under-the (OIG Proposed Rule) and https://www.federalregister.gov/documents/2019/10/17/2019-22028/medicare-program-modernizing-and-clarifying-the-physician-self-referral-regulations (CMS Proposed Rule).