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Medicare Contractor Issues Comprehensive Genomic Profiling Draft LCDs Without Registry Requirement

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA yesterday released a number of draft local coverage determinations (LCD) related to comprehensive genomic profiling in specific disease settings without a requirement that labs performing such testing submit patient outcomes data to a registry.

As previously reported this past fall, Palmetto issued a final LCD for comprehensive genomic profiling in non-small cell lung cancer with a requirement that labs submit testing and patient data through registries. The coverage policy with this requirement would have created a novel reimbursement framework for companies performing comprehensive genomic profiling, such as Foundation Medicine and Caris Life Sciences.

The registry requirements were in line with efforts at the US Food and Drug Administration, the National Institutes of Health, and the National Cancer Institute to encourage data sharing on rare genomic variants and how they impact patients' health and ability to respond to drugs. There is a recognition within these government entities that conducting traditional clinical validity and utility studies on variants that show up so infrequently in the population is a limitation to advancing drugs and diagnostics for precision medicine. Registries may be an alternative mechanism through which drug developers, testing firms, researchers, regulators, and payors can learn more about these markers, and whether testing for them and guiding treatment based on their presence in cancer improves patients' outcomes.

However, yesterday, Palmetto reissued its final LCD of comprehensive genomic profiling for NSCLC absent the registry requirements. In addition, Palmetto issued three draft LCDs for comprehensive genomic profiling in metastatic colorectal cancer, metastatic melanoma, and advanced primary peritoneal, fallopian tube, and ovarian cancer. None of these proposals require data collection in registries but note that actionable alterations identified by such profiling tests can allow patients to be "genomically matched" to targeted drugs and immunotherapies.

In order to receive test coverage, patients cannot be previously tested by another NGS panel, the panel has to gauge all four classes of DNA alterations, the test has to meet Palmetto's criteria outlined in the "Analytical Performance Specifications for Comprehensive Genomic Profiling," and gauge certain disease-specific genes.

The previous iteration of the NSCLC LCD detailed an extensive list of requirements for a registry to be approved for data collection. Palmetto's Medical Director Elaine Jeter previously said that her group had had discussions with a number of data collection groups, including Flatiron Health, Syapse, CancerLinQ, and MED-C, that were interested in advancing registries that fulfill its criteria.

The previous version of the NSCLC LCD also asked registry administrators to submit certain data over time. For example, when there is an FDA-approved diagnostic for a particular biomarker, the registry administrators would have had to report to Palmetto concordance between that test and the comprehensive genomic profiling test.

These requirements are not in the new LCDs issued for comprehensive genomic profiling, but each determination includes a version of the following language:

"This contractor recognizes that evidence for clinical utility for CGP in advanced NSCLC patients is limited at the current time. However, this contractor believes the clinical studies currently in progress will identify a number of patients who will test positive for an actionable EGFR, ALK or ROS1 mutations or identify mutations despite prior negative test results in patients who will benefit from targeted therapy. In addition, CGP testing is likely to identify patients who will need referral/genetic counseling for hereditary cancer risk assessment when an APC, MYH, MLH1, MSH2, MSH6, PMS2, EPCAM, POLE, POLD1, BMPR1A, PTEN or STK11 alteration is identified in the test panel. The identification of other pathogenic genes, although not meeting Medicare's reasonable and necessary criteria for coverage, will likely direct patients into clinical trials. Continued coverage for CGP test for NSCLC will be dependent on annual review of publications and/or presentations of clinical utility data demonstrating CGP for NSCLC improves patient outcomes and/or directs or changes selection of therapies to improve patient outcomes."

Stakeholders can comment on the draft guidelines from Feb. 6 to March 23.