Final Rules have been issued for both the Stark Law (“Stark”) and the Anti-Kickback Statute (“AKS”). Healthcare providers and their counsel have been awaiting these new rules for some time now. In the days ahead, Phillips Murrah healthcare counsel will be studying the 627 pages of the Stark Final Rules and the 1,000 pages of the AKS Final Rules in order to advise our clients with regard to these changes.
The Final Rules for Stark establish new and permanent exceptions for value-based arrangements which will apply broadly to care provided for all patients and not just Medicare patients. Stark will continue to act to limit overutilization of services, fraud and other abuse in the healthcare industry but will offer increased flexibility for current strategies and activities to encourage value-based arrangements, coordination and improvement of care which are both reasonable and beneficial to patients.
The Final Rule includes seven new safe harbors and modifications of four existing safe harbors. In addition, there is a new exception for Civil Monetary Penalties Act for Beneficiary Inducements. Of interest to counsel for both physicians and hospitals is the Final Rule’s clarification of Fair Market (“FMV”) as related to physician compensation. FMV has been a continued troublesome of scrutiny and debate by all participants in the healthcare industry. Also significant for many healthcare clients are the modifications and clarification of provisions related to cyber security and digital technology.