As reported in some trade journals (e.g. Genomeweb, here), United Healthcare has released a new policy, "Molecular Profiling to Guide Cancer Treatment," effective 10/1/2015. See UHC Policy 2015T0576A, online here.
The eight-page policy states that multiple or NGS sequencing is "proven and medically necessary to guide systemic chemotherapy in patients with stage IV non small cell lung cancer" when two criteria are met. First, molecular profiling is used ONLY to test for EGFR, HER2, RET, and ALK gene rearrangements (with a citation to current NCCN practice guidance.) This sounds like they might expect a "don't ask, don't tell" stance on the several hundred other genes found in some commercial panels. But although profiling is to be used "only" for the four named genes, the policy refers to 5-50 gene CPT codes, which wouldn't technically apply if only 4 genes were tested.
Second, the laboratory must be approved by the New York State Department of Health (which has explicit standards for setting up NGS assays, orthogonal control quality testing, etc). The policy then states then indications other than the above are explicitly not covered.
The policy may face challenges in staying up to date; for example, in August 2015 a NEJM article found that NSCLC had good responses to BRAF drugs when V600E mutations were present (here, here) - an indication not yet found in the UHC policy. In a conference report in September 2015, in a Foundation Medicine study of lung cancer patients under 40, 6% had ROS1 rearrangements, another gene not in the UnitedHealthcare list (here). FMI reported that 76% of 68 patients under 40 had druggable mutations, 44% of the patients having ALK mutations which are vastly less common in unselected populations. The report is part of the Genomics of Young Lung Cancer Study (GoYLC).
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To discuss how the changing healthcare system and Medicare policy affects your company, association, or investments, contact Dr Quinn through FaegreBD Consulting.
