Proposed Changes to Anti-Kickback Statute and Stark Law

October 10, 2019

The Department of Health and Human Services (“HHS”) has issued a press release announcing proposed changes to the Federal Anti-Kickback Statute and the Physician Self-Referral Law (commonly known as the “Stark Law”).  The proposed rules are designed to provide greater flexibility for health care providers while also strengthening safeguards to protect against fraud and abuse in an era that is transitioning to value-based care. 

Anti-Kickback Statute

According to HHS’ Office of Inspector General (“OIG”), the proposed rules are designed to “promote coordinated patient care and foster improved quality, better health outcomes, and improved efficiency.”  For example, new safe harbors would be added to strengthen cybersecurity and to encourage the use of certain tools provided to patients in order to improve quality and efficiency.  

Stark Law

The proposed changes to the Stark Law are also designed to encourage efficiency and innovation. The Centers for Medicare & Medicaid Services (“CMS”) has explained that, among other things, new exceptions for compensation arrangements would be permitted and may apply regardless of whether care is provided to a Medicare beneficiary or a non-Medicare patient.  

These proposed regulations are scheduled for official publication on October 17, 2019; comments will be due by December 31, 2019.  For additional detail on these proposed revisions please visit the links below. 

Anti-Kickback Statute

Stark Law

We will keep you updated as to issues that arise in response to these proposed changes.  Should you have any questions regarding the potential impact that the proposed regulations may have, please contact any of the attorneys in our Health Care Practice, or the attorney in the firm with whom you are regularly in contact.