June 18, 2019

June 18, 2019

Subscribe to Latest Legal News and Analysis

June 17, 2019

Subscribe to Latest Legal News and Analysis

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.

©1994-2019 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.


About this Author

Karen Lovitch, health care, Medicare, Compliance, Licensing, MIntz Levin

Karen is the Practice Leader of the firm’s Health Law Practice. She counsels health care clients on regulatory, transactional, and operational issues, including Medicare coverage and reimbursement, the development and implementation of health care compliance programs, and licensure and certification matters. In addition, Karen advises clients on the legal, practical, and fraud and abuse implications of business arrangements and sales and marketing practices. Her experience includes matters related to the anti-kickback statute, the Stark law, state statutes prohibiting kickbacks and self-...

Cassandra L. Paolillo, Health care lawyer, Mintz Levin Law Firm
Practice Group 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 Levin, 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 arrangements, reimbursement, fraud and abuse, and HIPAA/privacy.  She also oversaw all contracting matters for the company’s skilled nursing division. 

Cassie’s in-house experience informs current her practice, enabling her to anticipate and relate to clients’ legal and business needs.   

During her time at Suffolk University Law School, Cassie had the privilege of representing indigent clients before the Social Security Administration and Suffolk Probate Court as a student attorney with the school’s Health Law Clinic.  She also served as Editor-in-Chief of Suffolk’s Journal of Health & Biomedical Law.

Professional & Community Involvement

  • Member, American Health Lawyers Association
  • Member, Boston Bar Association