market value by providing the following criteria that must satisfy the following : ( 1 ) an arrangement in writing , ( 2 ) a termination date , ( 3 ) compensation is set in advance , ( 4 ) such compensation is commercially reasonable if the cost was similar to the cost if there was no referral , ( 5 ) no anti-kickback laws are violated , ( 6 ) no other law is violated , and ( 7 ) remuneration requirements are met . 3 This rule will not only clarify the requirements to providers and physicians but likely make enforcing compliance less burdensome on the agency as well . Those on the receiving end of the compliance request should be prepared and stand ready to substantiate why services are commercially reasonable . Thankfully , the new rules also provide guidance on what it means to be commercially reasonable . Generally , reasonableness will be found if a value-based arrangement furthers a legitimate business purpose and is sensible , considering the characteristics of the parties . 4
While Stark has received its first major update in a generation , the protections remain as strong as ever ; these exceptions for coordination on value-based arrangements are narrow and the downside of running afoul runs deep . The modernization of the healthcare law is catching up to a modernized healthcare system . Hopefully , the law continues to progress toward facilitating a system that matches the values of those who comprise our healthcare workforce .
References
1 . Bradley , Paul . “ Predictive analytics can support the ACO model : using data to identify trends and patterns can help drive better outcomes .” Healthcare Financial Management , vol . 66 , no . 4 , Apr . 2012 , p . 102 +.
2 . Seema Verma , 2020 . HHS Makes Stark Law And Anti-Kickback Statute Reforms To Support Coordinated , Value-Based Care . [ online ] Available at : www . hhs . gov / about / news / 2020 / 11 / 20 / hhs-makes-stark-law-and-anti-kickback-statute-reformssupport-coordinated-value-based-care . html
3 . 42 C . F . R . § 411.357 ( l ) ( 2020 )
4 . 42 C . F . R . § 411.357 ( z ) ( 2020 )
AUTHOR
Daniel Moreno
West Virginia Medical Journal • June 2021 • 21