Forty-five health care organizations recently cosigned a letter urging Novitas and First Coast Service Options (FCSO) to address concerns about their recently proposed local coverage determination (LCD) framework for genetic testing for oncology.
On Sep. 8, the College of American Pathologists (CAP) along with the American Clinical Laboratory Association and other groups wrote to express their concern with the proposed framework, which would outsource review to three third-party compendia to govern coverage policy. Among their concerns are that, if implemented, these changes would cause Medicare beneficiaries with cancer to lose access to clinically necessary diagnostic testing and would cause treatment teams to lose access to critical tools for diagnosing and managing cancer.
Additionally, according to the CAP, such a policy would not comply with the requirements for issuing LCDs as outlined in the Social Security Act and the Medicare Program Integrity Manual. Changes to the LCD process, as a result of the statutory mandates of the 21st Century Cures Act of 2016, indicate that a Medicare contractor must make its own review of the scientific evidence used to support an LCD.
In its own letter, the CAP recommended that Novitas and FCSO remove all references to third-party compendia from final LCDs, allow for additional genetic testing for hereditary cancer syndromes, and add CPT codes 81503, 81538, and 81540 to ensure uniform coverage for tests continues following the final Genetic Testing for Oncology LCD.