NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services have officially reopened its national coverage determination for next-generation sequencing for advanced cancer patients in order seek public comments on germline testing.
"To provide a complete picture of the cancer patient, a clinician may order both tests of somatic (cancer) and germline (inherited) mutations. It is important that tests detect these mutations accurately and produce valid results that are useful in guiding therapies to improve outcomes for patients with cancer," CMS said in internally reopening the NCD at the request of its Coverage and Analysis Group. "Specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this reconsideration."
The reopening of this NCD is the result of a controversy that started earlier this year when Medicare contractor Palmetto GBA revised a local coverage determination (LCD) for BRCA1 and BRCA2 genetic testing to restrict coverage for NGS panels when performed in individuals with early-stage disease. Palmetto's revision came at CMS's direction to align the terms of the LCD with an NCD it issued a year ago for NGS testing for advanced cancer patients.
Lab and advocacy organizations had significant concerns about this policy shift. Based on the language in the NCD, stakeholders thought the terms of the original NCD were restricted to when NGS panels were used to detect somatic mutations driving patients' cancer and to predict which drugs they would best respond to. BRCA testing can be used to direct treatment of PARP inhibitors in advanced cancer patients, however, this type of testing is most readily performed to detect germline mutations in BRCA1/2 and gauge risk of breast and ovarian cancer.
Knowledge of one's genetic risk for cancer is most useful for guiding prevention strategies if this information is known earlier in the disease trajectory. Medicare contractors historically covered testing for assessing hereditary cancer risk for patients who already had cancer but didn't limit testing depending on cancer stage. Sixty organizations wrote to CMS, asking the agency to clarify its position and ensure that early-stage cancer patients would still have Medicare coverage for NGS-based hereditary cancer risk testing.
The language CMS uses in reopening the NCD suggests the agency is trying to narrow the terms of its NGS national coverage policy to focus just on somatic and germline testing when done in advanced cancer patients to guide therapeutic decisions, and specify that all other types of NGS assessments, including testing performed on early-stage patients for cancer risk assessment, are not within the scope of the coverage terms.
The government payor is accepting public comments from April 29 to May 29 and expects to issue a draft decision on October 29. CMS said it is particularly interested in comments referencing scientific evidence on the ability of germline testing to identify treatment benefit for individuals with a hereditary cancer syndrome.