On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician self-referral (Stark Law) regulations, which was published in the Federal Register on October 17, 2019.
CMS’s Proposed Rule was released together with the HHS Office of Inspector General’s (OIG) proposed rule updating the anti-kickback statute and civil monetary penalty law regulations as part of HHS’s Regulatory Sprint to Coordinated Care, which aims to promote value-based care. HHS identified the regulations as they stand now as potential obstacles to value-based purchasing arrangements for providers and suppliers participating in federal health care programs and the commercial sector. The proposals were launched following a series of HHS Requests for Information soliciting stakeholder feedback on (1) Stark Law burden reduction, (2) AKS and CMP refinements, and (3) reforms to the Health Insurance Portability and Accountability Act.
The proposed changes are delineated in a pair of rules issued by the Centers for Medicare and Medicaid Services (CMS) (proposed rule; fact sheet) (Stark Law) and the Office of Inspector General (OIG) (proposed rule; fact sheet) (AKS and CMP). The OIG rule also includes a new safe harbor for cybersecurity items, services, and modifications to the existing safe harbor for Electronic Health Records (EHRs).
While these proposed regulatory changes are expansive and relatively complicated, the overall direction of the changes to Stark, AKS, and CMP policies is to provide greater flexibility to providers engaging in value-based purchasing arrangements. The comment window extends through December 31, 2019. Given the potential impact of these proposed changes, there will likely be robust stakeholder feedback with finalization of the changes potentially coming sometime in the middle of 2020.