Among the most popular modern buzzwords, up there with “millennial” and “leadership” is “transparency.” Especially with the dense thicket of jargon that surrounds the medical industry and political sphere, more and more individuals are calling for transparency regarding where money is coming from and going and who has a say in that movement. Of course, the field of pharmacogenomics is no different. With the importance of the data being handled and the technicalities of what happens, it’s absolutely urgent that clinics are open and transparent about what they’re doing with the money and data they have.
The US Department of Justice made an example out of a clinic that failed that remain honest and transparent regarding the whereabouts of its money. Noting a violation of the Anti-Kickback Statute, the DOJ settled for $3.5 million against Primex Clinical Laboratories and fined its CEO an additional $270,000. Two whistleblowers who were former employees of the company alerted the Justice Department as to the issues occurring at the company.
In the 1970s, Congress passed the Anti-Kickback Statute as a prevention measure against fraud against the US healthcare system. The statute explicitly prohibits any laboratory from offering doctors “remuneration” for patient referrals to keep everyone in the industry honest. Without the statute, Congress anticipated that clinics and other medical labs would pay doctors to send patients to them.
In the case of Primex Clinical Laboratories, the executives skirted the laws and offered cash incentives for doctors to send their patients’ DNA their direction, and offered an additional bonus if the DNA turned up anything of interest. After a thorough investigation, the DOJ decided that the incentives were against the law, and today, they’re paying a hefty fine as retribution.
It’s important to run a medical laboratory with the precision, accuracy, and respect for the law that’s necessary for a place of business and a place of repute. Transparency in procedures, finances, and legal matters is imperative to ongoing positive relationships with doctors, patients, and regulators.