Recent changes to the federal Stark Law and Anti-Kickback Statute provide certain clarifications that could prove somewhat helpful to labs, but the reforms leave the industry on the outside looking in when it comes to participating in value-based care.
Some observers suggest that this could hamper efforts within the laboratory business to better leverage lab test data to impact patient health at the system and population level, a growing trend within the industry commonly referred to as Clinical Laboratory 2.0.
The new rules provided carve-outs for certain types of providers to allow for relationships that had traditionally been forbidden by the statutes due to fears of potential for fraud. For instance, the new carve-outs would allow a hospital to provide physician offices with care coordinators to help manage patients whose cases require ongoing care. Similarly, hospitals are now able to reward outside providers for hitting outcome goals that result in better coordinated care and reduced hospital admissions.
Labs, however, were not covered in these carve-outs, leaving the industry largely reliant on traditional fee-for-service business models even as many in the space have begun advocating for the power of lab data to support value-based care.