The Centers for Medicare & Medicaid Services will reopen a national coverage determination on next-generation sequencing panels to address the healthcare community's concerns about the negative impact the current policy would have on patients' ability to access genetic testing to learn their risk for cancer.
Based on the language in the NCD, however, stakeholders thought the policy was 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 the risk of breast and ovarian cancer. Medicare contractors historically have covered such tests for patients who already had cancer but didn't limit testing depending on the cancer stage. 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.
Stakeholders argued that germline testing for early-stage cancer patients "didn't fall within the four corners of the national coverage determination," Jensen said. "We took that in and talked about that extensively in house, we talked to our lawyers, and we decided we're going to reopen this NCD."