Case status: The case is before the U.S. District Court for the Southern District of New York.
Why doctors should care: The Continuum case will provide significant guidance to health providers about the ACA 60-day overpayment rule, said Houston health law attorney Micheal E. Clark, who chairs the America Bar Association Health Law Section. As it stands, the federal rule is somewhat unclear, leading to confusion for doctors about their reporting obligations, he said.
Michael E. Clark
“The agency hasn’t really defined what is ‘knowing,’ what is reasonable knowledge of a known overpayment,” Mr. Clark said in an interview. “It’s a gray area. [The ruling] will be very informative about what this is actually going to mean.”
3. Ameritox v. Millennium Laboratories
Summary: Ameritox revolves around whether a laboratory’s giveaway of urine specimen cups to physicians amounted to an illegal kickback. In 2012, lab testing company Ameritox sued Millennium in a Florida district court alleging that Millennium harmed its business by giving the urine cups to doctors in violation of the Stark Law. Physicians used the cups – which have chemically activated strips that contain patient information – to monitor patients’ use of pain medications. Millennium unlawfully obtained physician referrals through free cup agreements, according to Ameritox’s complaint. A federal jury found Millennium had violated the Stark Law as well as the Anti-Kickback Statute by providing the free cups in exchange for referrals and Ameritox was awarded $11 million. Attorneys for both parties did not return messages seeking comment.
Case status: Millennium appealed, and the case is before the 11th U.S. Circuit Court of Appeals. The federal Justice Department has weighed in on the side of Ameritox, arguing that the cup giveaway violated Stark Law and the Anti-Kickback Statute.
Why doctors should care: The Ameritox case makes it clear that doctors should never accept free point-of-care testing cups or similar medical equipment from a lab, said health law attorney Adrienne Dresevic of Southfield, Mich. The case also highlights the broad spectrum of “remuneration,” when it comes to free items or services to doctors, she noted. Under the Anti-Kickback Statute, remuneration refers to the transfer of anything of value, directly or indirectly, overtly or covertly, in cash or in kind.
Adrienne Dresevic
“The takeaways in Ameritox are applicable to other relationships, such as in the radiology realm,” Ms. Dresevic said in an interview. “Physicians should closely scrutinize any free items or services offered to them to ensure it falls within the exception to what is considered ‘remuneration.’ ”
Exceptions to remuneration could include payments that are a return on an investment interest, such as a dividend or interest income. However, physicians should ensure they are familiar with all exceptions to the law before entering into such agreements, experts advise.
The Ameritox case is important for physicians because more laboratories are approaching doctors with various “arrangements,” and touting that the arrangements are compliant with federal regulations, Ms. Dresevic added. Many doctors are taking the labs’ word for the arrangements’ legality, leading to serious legal risk.
“Physicians need to know how to look beyond what the laboratory representative is presenting to them and make their own determinations, sometimes with the help of health care counsel, regarding the legality of a particular arrangement,” she said.
On Twitter @legal_med