In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules).
These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The Final Rules represent CMS’s recognition that the healthcare delivery and payment environment has changed from the “fee-for-service” model under which the Stark Law was developed, and that, in its current form, the Stark Law can impede the development of value-based relationships. In connection with this change, the Final Rules introduce new Stark Law exceptions and revise or re-evaluate many existing Stark Law exceptions and definitions.
UPDATE: In December, the Government Accountability Office (GAO) found that the Final Rules’ January 19, 2021 effective date violated the Congressional Review Act, which requires major rules to have a 60-day delay in the effective date from the date of publication in the Federal Register. This, together with the Biden administration’s recent Regulatory Freeze memo could be used to delay the Final Rules’ effective date.