On November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services Office of the Inspector General (“OIG”) released their highly-anticipated final rules to modernize and clarify existing Physician Self-Referral Law (“Stark”) regulations and safe harbors to the Anti-Kickback Statute (“AKS”), while also amending the beneficiary inducement provisions of the Civil Monetary Penalties (“CMP”) Law. Together, these final rules are part of HHS’ “Regulatory Sprint to Coordinated Care,” and are aimed at reducing regulatory barriers to care coordination and accelerating the transformation of the healthcare system into one that is value-based and promotes coordinated care. The OIG also released a final rule removing AKS safe harbor protections for rebates involving prescription pharmaceuticals and creating an additional safe harbor for certain point-of-sale reductions in prices on prescription pharmaceuticals and pharmacy benefit manager services fees. These rules can be found at the links below:
- Stark Final Rule
- AKS and CMP Final Rule
- Pharmaceutical Rebate and Point-of-Sale Reduction AKS Safe Harbor Amendments
The final rules allow for significant changes and potential innovation in the health care industry, removing previous regulatory barriers by providing three new value-based exceptions under Stark as well as seven new safe harbors under the AKS. Existing safe harbors of the AKS were also modified, and a new exception under the beneficiary inducements CMP was codified to allow for increased adoption of telehealth technologies and patient engagement. Further, clarifications to existing Stark definitions and regulations will allow health care providers to revisit and rethink potential compensation methodologies with physicians. With the bulk of these final rules set to become effective on January 19, 2021, health care providers will need to quickly take stock of existing and potential health care arrangements within a new framework of regulations.
Given the import of above, Butler Snow’s health care attorneys are working to promptly review the thousands of pages of guidance in order to provide a detailed analysis of the impact of these final rules in the coming weeks.