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Independent Laboratory Settles Medical Necessity Allegations

The Department of Justice (DOJ) recently announced a $1.99 million False Claims Act (FCA) settlement with GenomeDx Biosciences Corp. (“GenomeDx”), a laboratory headquartered in Vancouver, British Columbia with operations in San Diego.  The matter arose as the result of a qui tam case brought by two former employees in September 2017.   

The claims at issue relate to the Decipher® post-operative genetic test for prostate cancer patients (the “Decipher Test”), which reportedly is the only test offered by GenomeDx that is covered by Medicare.  The Decipher Test is used to measure the activity of genes in prostate tumors to assess the risk of cancer recurrence.  According to DOJ’s press release, GenomeDx submitted medically unnecessary claims to Medicare for the Decipher Test because patients did not have the specified risk factors required to qualify for reimbursement. 

DOJ did not file its own complaint containing more specific allegations, but, according to the relators’ complaint, GenomeDx knowingly failed to comply with the terms of Local Coverage Determination ID L36343, which sets forth specific coverage criteria for the Decipher Test.  The relators claimed (among other things) that GenomeDx routinely billed for pre-surgery biopsies even though the LCD allowed coverage only for tissue obtained through surgery using the same CPT code to bill both types of specimens.  While the treating physician rather than the laboratory performing the test is responsible for determining medical necessity, a laboratory must be mindful of the need to maintain clear documentation of medical necessity, especially when a national or local coverage determination applies. 

The relators made a few other vague yet sensational allegations that presumably were not part of the conduct covered by the settlement because they were not mentioned in the press release.  Everyone in the health care industry should be mindful that relators often make claims that the government chooses not to fully investigate or that the government cannot ultimately substantiate.  When reviewing a relator’s complaint filed in a matter that ultimately settles, one should never assume that such claims are true.  Moreover, a qui tam settlement rarely involves an admission of liability, even for the covered conduct.

©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume IX, Number 51
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About this Author

Karen Lovitch Mintz DC Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Medicare, Medicaid & Commercial Coverage & Reimbursement Health Care Transactions Health Care Transactional Due Diligence Health Care Enforcement & Investigations
Member

Karen focuses her practice on representing health care companies in regulatory, transactional, and operational matters. She has a substantial health care regulatory background and advises clients on matters pertaining to the federal anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-referrals, the Clinical Laboratory Improvement Amendments of 1988, and the federal Physician Payments Sunshine Act. Karen often applies her strategic insight on these matters to counsel companies on regulatory issues arising in connection with mergers and acquisitions and other...

202-434-7324
Cassandra L. Paolillo, Health care lawyer, Mintz Levin Law Firm
Associate

Cassie’s practice primarily involves advising health care clients on transactional and regulatory matters, including mergers and acquisitions, regulatory compliance, and general contracting.

Throughout her career, Cassie has worked with providers, payors, and individual patients, so she understands the unique challenges facing clients in the ever-changing health care landscape.

Prior to joining Mintz, Cassie worked as in-house counsel at a national senior living company. There she advised the business on matters related to state and federal health care regulations, physician...

617-348-1828
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