CMS, OIG finalize Stark and AKS overhaul – paving the way for value-based care

On Friday afternoon, November 20, 2020, the US Department of Health and Human Services (HHS) finalized two sweeping, interrelated rule change packages as part of the Department’s “Regulatory Sprint to Coordinated Care.” The Anti-Kickback Statute (AKS) and Medicare physician self-referral law (Stark Law) place different constraints on financial arrangements with sources of federal health care program (FHCP) referrals, but both statutes date back to the days when the vast majority of government health care funding flowed on a fee-for-service basis.

As members of DLA Piper’s health care regulatory team explained in detail last year when these rules were first proposed, the HHS Office of Inspector General (OIG) and Centers for Medicare and Medicaid Services (CMS) are attempting to grapple with the challenges of applying these statutory principles to an industry that has shifted dramatically over the years to focus more and more on value-based payment models. The agencies also took the opportunity to propose fixes to longstanding industry concerns regarding difficulties in interpreting and complying with the extensive and highly technical AKS and Stark Law regulations. In this alert – which is meant to be read in tandem with our complimentary analysis of the proposed rules – we highlight some of the most important ways in which HHS followed through on its ideas from last year or went in new directions based on public comments.