In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical Laboratory Association (CCLA) and a Medicare beneficiary filed a lawsuit against the U.S. Department of Health & Human Services. Plaintiffs charge that MACs “continue to develop and apply Local Coverage Determinations (LCDs) that result in policies depriving Medicare beneficiaries throughout the country of critical clinical laboratory tests.”
MORE ON: CCLA Suit
The lawsuit was filed in the federal district court of the District of Columbia. Counsel for the plaintiffs is Hooper, Lundy, & Bookman, PC. The action was taken because of how MACs have “virtually ignored” the input on molecular tests provided by the clinical laboratory industry.
MOLECULAR LABS HIRING MEDICAL DIRECTORS
In the past month, a number of lab companies offering molecular and genetic tests announced the hiring of new medical directors:
- Bio-Reference Laboratories, Inc., of Elmwood Park, New Jersey, said that Robert Daber, Ph.D. will have the dual role as Director of Research and Development and Director of Cancer Genetics at its main laboratory. Draper was formerly at the University of Pennsylvania.
- Vermillion Inc. of Austin, Texas, appointed Herbert Fritsche, Jr., Ph.D., as the Medical Director of the new CLIA laboratory facility that is now under construction. Fritsche was formerly at Health Discovery Corporation and the University of Texas, M.D. Anderson Cancer Center.
- 23andMe of Mountain View, California, announced the hiring of pathologist Jill Hagenkord, M.D., as Chief Medical Officer. She has previously held excutive positions at Invitae, Complete Genomics, iKaryos Diagnostics, and Creighton University School of Medicine.
- med fusion of Lewisville, Texas, appointed Jon L. Hart as its new CEO. Hart previously held executive positions with Aurora Diagnostics, Genzyme Genetics, Quest Diagnostics Incorporated, SmithKline Beecham Clinical Laboratories, and International Clinical Laboratories.
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