Stark, AKS, and CMP Reforms on the Horizon with New HHS Proposed Rules

“We serve patients poorly when government regulations gather dust in the attic: they become even more stale and liable to wreak havoc throughout the health care system. Administrative costs are driving up the cost of health care in America – to the tune of hundreds of billions of dollars. The Stark proposed rule is an important next step in President Trump’s health care agenda for Americans. We are updating our antiquated regulations to decrease burden for providers and helping bring down these increasingly escalating costs.”

– Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma.

The Department of Health and Human Services (HHS) announced today the release of several proposed changes to the regulations that interpret the Physician Self-Referral Law (the Stark Law), the Civil Monetary Penalty Law (CMP), and the Federal Anti-Kickback Statute (AKS). The proposed revisions are intended to provide greater clarity to health care professionals.

HHS’ Regulatory Sprint to Coordinated Care is examining federal regulations that may obstruct providers’ efforts to efficiently coordinate care for patients. The proposed rules would help to ease the compliance burdens many health care providers across the industry face as they move to value based care and innovative payment models. In a health care system that pays for value of services provided rather than volume, HHS acknowledges that incentives for providers are different. The proposed changes give providers added flexibility to improve patient quality of care while implementing meaningful protection against overutilization and other harms. As a corollary to the increased flexibility, CMS is “proposing strong safeguards to protect patients from fraud and abuse by bad actors who might seek to misuse the new flexibilities.”

Participants in the health industry understand that Stark/AKS/CMP can sometimes limit the ways in which health care providers coordinate care for their patients. These proposed rules, if finalized, would help. The proposed changes would offer specific safe harbors for coordinated care arrangements, affording added reassurance that providers/suppliers can evolve their practices while still being compliant.

HHS’ press release regarding these proposed changes includes examples of coordinated care, value-based care, data sharing, and patient engagement activities that would be problematic under the current law, but that would be permissible under the proposed regulatory changes. The press release can be found here.

If finalized, these proposed rules would be an unprecedented opportunity for providers to work together to deliver models of high-value, coordinated care.

For more information regarding Stark, CMP, and AKS, please contact Clinton Mikel, Esq. at (248) 996-8510 or at

Contact Information