In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark), the federal Anti-Kickback Statute (AKS) and the beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP Law). The proposed rules take steps to create a framework to support value-based payment models and promote improvements in technology infrastructure.
Perhaps most notable, however, are the strides taken by CMS toward adding flexibility and attempting to clarify the Stark regulations. Those who were hoping for less complexity may be disappointed, but simplicity was likely an unrealistic expectation given the complexity of our healthcare system and the underlying statutory mandates. Nonetheless, the healthcare industry should be pleased with clarifications and changes that may allow them to avoid Stark self-disclosures in seemingly innocuous circumstances and defend against frivolous whistleblower lawsuits.
The changes in the proposed rules include:
- New Value-Based Exceptions and Safe Harbors.
- Enabling Technology Infrastructure Improvements.
- Other Notable Proposals, Clarifications and Commentary.
Bass, Berry & Sims has prepared a detailed overview of the proposed changes accessible here. In addition, redline documents showing the proposed textual changes to the current Stark regulations are available here and to the AKS regulations are available here. The proposed rules published in the Federal Register are available here and here.
Comments to the proposed rules are due to the respective agencies by 5:00 p.m. on December 31, 2019. Given the number of industry stakeholders these proposals impact, the agencies are likely to receive hundreds of comments; meaning it may be some time before CMS and the OIG issue a final rule.