Issue link: http://viewer.e-digitaledition.com/i/709194
T H E S TA R K L A W, o r phy sici a n sel f-refer r a l statute, prohibits physi- c i a n s f r o m r e f e r r i n g D e s i g n a t e d H e a l t h S e r v i c e s p a y a b l e b y Med ica re to ent it ies i n which they (or an immedi- ate fa mily member) have a f ina ncia l relationship (ownership, investment or compensation), unless a specif ic reg u lator y exception applies. Sta rk fur ther prohibits a ffected entities from present- ing, or causing to be presented, claims to Medicare for payment of ser vices referred. Ever y cla im submit ted in v iolation of Sta rk i s i n fec t ed , rega rd less of med ica l necessit y. Physicia ns "must refund a ll collected a mounts on a timely basis." Stark violations can a lso trigger t he Fa lse Cla ims Act , pa r ticu la rly if ref unds (deemed to be "i ll-got ten ga in") a re not timely made, wh ich ca n resu lt i n per-cla i m f i nes of $5,500 or $11,000 a nd the trebling of da mages — a l l w it hout t he gover nment 's hav ing to prove crimina l intent. W hat ca n prov iders who have v iolated t he Sta rk Law do to avoid potentia l f ina ncia l ruin? In 2010, Cong ress enacted the A ffordable Ca re Act, which a mong other things, established a Self-Referra l Disclosure Protocol (SR DP) by which providers may volunta rily disclose actua l or potentia l violations of Sta rk. The ACA autho- r i zes CMS t o reduce repay ment s due for Sta rk violations. O n M a y 6 , 2 016 , C M S p u b l i s h e d a rev i sed SR DP sel f- d i s c l o s u r e f o r m intended to "strea m- l i n e a n d s i m p l i f y " t h e S R D P p r o c e s s b y r e du c i n g t h e b u r d e n on disclosing providers and CMS for rea ch i n g fa i r resolut ion s of Sta rk violations at reduced costs. A provider cannot use the SR DP to obtain an opinion from CMS a s to whether a n actua l or potentia l violation of Sta rk has occurred. It is separate from CMS's advisor y opinion process, which is available only prospectively. However, the fact that a provider may already be subject to a government inquiry — investigation, audit or routine oversight — does not automatically preclude CMS's accepting an SR DP disclosure. W hat counts is the provider's intent a nd good faith e¥ort to cooperate with CMS with the goal of resolving overpayment liability exposure for con- duct it has identified and corrected. The provider must either state that the financia l relationship was non-compliant with Stark, or certify noncom- pliance because it cannot certify that the financial relationship complied with Stark. A provider's initiating the SR DP process stays the 60 -day over pay ment return obligation a nd expa nds the time a provider may ta ke to perform its interna l audit and submit supporting materia ls to CMS. Once CMS receives the information, it will con- sider specif ic facts and circumstances, including the nature and ex tent of non-compliant behavior, timeliness of self-disclosure, cooperation with CMS requests, litigation risk a ssociated w it h the disclosed matter, a nd the f ina ncia l position of the disclosing par ty. Once CMS works through this process, it will ma ke a one-time, ta ke-it-or- leave-it monetar y offer to the disclosing provider, which has the option of accepting the proposed overpayment resolution (at which time payment is due) or w it hd raw i n g it s SR DP subm ission a nd ta king the a lternate path of contesting the overpayment dema nd. Historica lly, CMS ha s been w i lling to set tle SR DP subm issions for pen n ies on t he dol la r. Providers, with advice of lega l counsel, should consider SR DP i f t hey believe t hey may have triggered the booby trap. Joe Feltes is an attor ney with Bu ckingham , Doolittle & Burroughs in Canton and a member of its Health & Medicine Practice G roup. He is also the managing partner of Buckingham Canton . For more information about the law firm , go to www.bdblaw.com or email Mr. Feltes at JFeltes@ BDBL AW.com . ■ Dismantling the Booby Trap FEDER AL JUDGE ALBERT DIA Z OBSERVED, "IT SEEMS A S IF E VEN FOR WELLš INTENTIONED HE ALTHCARE PROVIDERS, THE STARK L AW HA S BECOME A BOOBY TR AP RIGGED WITH STRICT LIABILIT Y AND POTENTIALLY RUINOUS E XPOSURE …" BY JOSEPH J. FELTES, JD 1 8B U S I N E S S S E C T I O N