Current laws can hinder alternative payment models and care arrangements that were unheard of when the laws were first enacted.
Many readers will agree that two of the more complex and frustrating fraud laws are the Anti-Kickback statute and the Stark self-referral law. Each has a set of regulations that can trap the unwary—or even the hypercautious—and can hinder alternative payment models and other care arrangements that were unheard of when the laws were first enacted.
Case in point: The Stark Law, formally known as The Ethics in Patient Referrals Act, has confounded healthcare providers for nearly 30 years and has spawned many regulations, exceptions, and safe harbors. The law has been criticized by many, and even its original sponsor, former Congressman Pete Stark, has been quoted as saying it should be repealed. But it remains on the books, continues to be the basis of fraud cases, and can be violated “innocently” because no intent to commit fraud is required. The Anti-Kickback statute is similarly complex and baffling to many.
There is some reason for hope, however. Seeking ways “to transform the healthcare system into one that pays for value,” and recognizing that “care coordination is a key aspect of systems that deliver value,” two agencies within the Department of Health and Human Services (HHS) have been asking interested parties to identify regulatory obstacles to achievement of that goal.
Early this summer the Centers for Medicare & Medicaid Services (CMS) asked for public comment on the Stark Law and received more than 300 replies. More recently, the HHS Office of Inspector General asked stakeholders for comments on the broad reach of the Anti-Kickback statute and its “beneficiary inducements” penalties as potential impediments to arrangements that would advance coordinated care.
It is unclear when or whether regulatory changes will result from these requests for information, but one can take heart that HHS is asking the right questions. Stay tuned.
- CMS Request for Information, 83 Fed. Reg. 29524, June 25, 2018
- OIG Request for Information, 83 Fed. Reg. 43607, Aug. 27, 2018
J. Stuart Showalter, JD, MFS, is a contributing editor for HFMA.