The California Clinical Laboratory Association (CCLA) has lost a recent challenge to a local coverage determination (LCD) involving genetic testing. CCLA claimed that Medicare Administrative Contractors (MACs) “are issuing LCDs that amount to blanket and inappropriate denials of Medicare coverage for certain clinical testing services.” It had also challenged LCD development processes in general and argued it’s unconstitutional for MACs to issue LCDs. The U.S. Department of Health and Human Services successfully sought to have the complaint dismissed. That complaint arose out of the denial of Medicare coverage for pharmacogenomic testing that had been ordered for an 82-year-old registered nurse in Virginia who had multiple chronic conditions. She had suffered allergic reactions to medications prescribed for those conditions so her physician had ordered the pharmacogenomic testing to determine appropriate treatment. The coverage determination giving rise to the dispute was Palmetto LCD L34499 which was the basis for denial of coverage for the pharmacogenomic testing. CCLA claimed that LCD and others threatened access to medically necessary lab services. Generally, challenges to LCDs must be brought through the administrative process rather than directly to court but there are exceptions allowing individual Medicare recipients like the nurse to bring a challenge in court,…
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