On October 9, the Department of Health and Human Services (HHS) announced proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the Federal Anti-Kickback Statute.
The proposed rules seek to provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated care for patients. The proposals would ease the compliance burden for healthcare providers across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse.
The proposed rules are part of HHS’s “Regulatory Sprint to Coordinated Care,” which seeks to promote value-based care by examining federal regulations that impede efforts among providers to better coordinate care for patients.
The Stark Law’s new value-based exceptions, under the proposed rule issued by the Centers for Medicare & Medicaid Services (CMS), acknowledge that incentives are different in a healthcare system that pays for value, rather than the volume, of services provided. The proposed rule intends to provide proper safeguards that ensure the Stark Law will continue to provide meaningful protection against overutilization and other harms, while giving physicians and other healthcare providers added flexibility to improve the quality of care for their patients.
The proposed changes to the regulations related to the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law issued by the Office of Inspector General (OIG) would, if finalized, address the longstanding concern that these laws unnecessarily limit the ways in which healthcare providers can coordinate care for patients. The changes would offer flexibility for beneficial innovation and improved coordinated care through, for example, outcome-based payment arrangements that reward improvements in patient health. The changes would also make it easier for physicians and other healthcare providers to ensure they are complying with the law by offering specific safe harbors for these arrangements.
The proposed rule provides examples involving coordinated care, value-based care, data sharing, and patient engagement activities that, depending on the facts, could currently be difficult to fit under existing protections and could potentially be protected by the Stark Law, Anti-Kickback Statute, or Civil Monetary Penalties Law proposals if all applicable conditions are met:
Read the OIG Proposed Rule here.
Read the CMS Proposed Rule here.