In Healthcare Risk Management, Health Care Partner Addresses Proposed “Value-Based” Changes to Stark and Anti-kickback Regulations

Two separate Healthcare Risk Management articles feature extensive remarks from health care partner Tom Bulleit (Washington, D.C.) concerning proposed changes to the regulations implementing the federal health care programs Anti-Kickback Statute and the Stark Law that prohibits physician self-referral. The purpose of this set of proposals is to improve the ability of health industry players to engage in value-based arrangements.

Mr. Bulleit explains that for the most part, the proposed changes would be a “win” for doctors, hospitals, and other direct providers of healthcare services to patients, by removing potential Stark and Anti-kickback barriers to payment arrangements that reward better outcomes, but may not fit within existing safe harbors, such as for discounts and warranties.  

In contrast, Mr. Bulleit notes that the proposals would provide relatively little relief to makers of prescription drugs and suppliers of durable medical equipment, prosthetics, orthotics, and supplies. The fate of the proposals for other medical device makers is uncertain, because the agency has asked for comment on whether MedTech’s value-based arrangements should be treated the same as pharma.