As if Stark Law and the Anti-Kickback Statute aren’t complicated enough, they can also lead to False Claims Act issues, explains Charles Oppenheim, Partner at the law firm of Hopper, Lundy & Bookman and author of the chapter “The Stark Law and Anti-Kickback Statute as FCA Risks” in the new HCCA book False Claims in Healthcare.
In the case of Stark Law, where there is strict liability, something as simple as faulty paperwork can be highly problematic. If the documents don’t match up, no matter how innocent the mistake, an entity is prohibited from billing for services. And, when it comes to the Anti-Kickback Statute, the law is intent-based. So even if the remuneration is fair market value, corrupt intent can have drastic consequences.
To prevent issues from occurring, and effectively remediate them should they occur, he offers several recommendations in this podcast. First, have well-designed policies and procedures when it comes to entering into new relationships, including policies for when not to enter into a relationship. Second, document how fair market value is determined, how you entered into the relationship and alternatives considered.
Should a potential violation be identified, bring in experts who understand the subtleties of these very complex laws. And, he notes, don’t despair. It is quite possible that the relationship falls into an exception. For example, CMS has proven more flexible of late in its documentation requirements.
Should you need to make a disclosure, consider the Self-Referral Disclosure Protocol (SRDP). It can take some time, but the outcomes can be more positive than many think.
Finally, he advises healthcare entities to remember that we will one day come to the end of this pandemic emergency. During this crisis CMS issued a narrow waiver on Stark Law that many took advantage of while medical practices were in deep financial troubles. It’s important to document what you did and be prepared for the end of the emergency and, quite possibly, the end of the waivers.
To learn more, listen in to this podcast, and check out our new publication False Claims in Healthcare.