Anti-Kickback vs. Stark: When do these laws apply?
In today’s video, we give a brief refresher on the difference between Stark and anti-kickback laws.
Hi everyone, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you, navigate healthcare and FDA legal issues so you can grow your healthcare business.
First, Stark is the federal law that prohibits self-referral – referring to yourself. Every State has its own counterpart—for example, under California law, the self-referral prohibition is contained in PORA, also known as the Physician Ownership & Referral Act. There’s similar law in New York, Texas, other states.Stark prohibits certain financial or compensation relationships by a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, doctor of podiatric medicine, a doctor of optometry, or a chiropractor.
Stark only applies if there are designated health services, or DHS. These include clinical laboratory services; physical therapy services; occupational therapy services; home health services; outpatient prescription drugs; inpatient and outpatient hospitalization services; and certain other services.
If there’s no DHS, there’s no Stark issue, although there might be a self-referral issue under State law. If Stark applies, then you have to find an exception. And if there’s a self-referral prohibition under state law, you have to find an exception.
Two of the big federal exceptions include: a bona fide employment relationship, and personal service arrangements. Please look for more detail on our Healthcare and FDA Blog, which have a wealth of resources.
Kickbacks are broader and include any inducement or incentive to refer a patient. When you have a potential kickback, you look now for a potential “safe harbor.” The legal safe harbor has a number of criteria – basically the more and better your proposed arrangement fits these criteria, the safer the legal harbor. Again, we have a lot more detail on our blog, and we can analyze your arrangement during a Legal Strategy Session and beyond.
Thanks for watching. Please contact us with any questions. We have helped hundreds and hundreds, thousands of healthcare industry clients build their dream. We look forward to working with you on the journey to success!
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