Whether you operated a traditional diagnostic lab, a toxicology lab, or one that performs high-complexity genetic and genomic testing, there were plenty of regulatory nightmares to keep you up at night in 2022. It seems “the watchdogs” were watching more than ever as it was a remarkable year from a government enforcement standpoint and laboratories.
The Office of Inspector General (OIG) started the year by issuing a fraud alert warning the public about the proliferation of COVID-19 testing scams.[1] The U.S. Department of Justice (DOJ) pursued a record number of high-profile investigations, recoveries, and convictions in the laboratory space.[2] Notably, several of these cases were initially reported by whistleblowers who also shared in the government recoveries.[3]
This update summarizes some of the recent trends in compliance and regulatory enforcement for laboratories. It also serves as a reminder to implement and maintain robust compliance policies and procedures in order to face these challenges.
The Challenge of Medical Necessity and Lab Orders
Claims for lab services must be reasonable and medically necessary in order to be paid. From a regulatory standpoint, this means that the service or test is used for “the diagnosis or treatment of an illness or injury or to improve the functioning of a malformed body member.”[4] Simply because the test was ordered and performed does not guarantee payment.
This year the government continued its scrutiny of medically...
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