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- CAP Asks First Coast and Novitas to Revise Proposed Genetic Testing for Oncology LCD
The CAP and 44 other health care organizations expressed deep concern over First Coast’s and Novitas’s proposed local coverage determination (LCD) framework that outsources review to three third-party compendia to govern coverage policy. In addition, the CAP engaged separately to raise additional concerns regarding the revised LCD. The CAP and other groups said in a September 8 letter if the LCD is not revised, Medicare beneficiaries with cancer will lose access to clinically appropriate genetic testing – and their treatment teams will lose access to critically important tools for diagnosing and managing their disease. Furthermore, the policies appear not to comply with requirements for issuing LCDs, as set forth in the Social Security Act and the Medicare Program Integrity Manual.
As a result of the statutory mandates of the 21st Century Cures Act of 2016, the Centers for Medicare & Medicaid Services (CMS) updated Chapter 13 of the Medicare Program Integrity Manual, detailing changes to the LCD process, which makes clear that a Medicare contractor must make its own review of the scientific evidence used to support a local coverage determination. In its own letter also submitted on September 8, the CAP recommended that First Coast and Novitas remove any reference to third party compendia from their final LCDs. The CAP also recommended First Coast and Novitas allow for additional genetic testing for hereditary cancer syndromes, which are considered germline testing, as science advances and additional tests become available that help contribute to the management of patient care.
In addition, the CAP requested the following CPT codes be added to ensure uniform coverage for tests currently covered under the Biomarkers for Oncology LCD, which will be superseded by the final Genetic Testing for Oncology LCD.
81503 |
Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1, beta-2 microglobulin, transferrin, and pre-albumin), utilizing serum, algorithm reported as a risk score |
81538 |
Oncology (lung), mass spectrometric 8-protein signature, including amyloid A, utilizing serum, prognostic and predictive algorithm reported as good versus poor overall survival |
81540 |
Oncology (tumor of unknown origin), mRNA, gene expression profiling by real-time RT-PCR of 92 genes (87 content and 5 housekeeping) to classify tumor into main cancer type and subtype, utilizing formalin-fixed, paraffin-embedded tissue, algorithm reported as a probability of a predicted main cancer type and subtype |
The CAP will continue to work with and provide feedback to First Coast and Novitas to ensure proposed coverage policies for Genetic Testing for Oncology are in the best interest of patients.