The Medicare NGS NCD grants national coverage for somatic testing in patients with advanced cancer if the test has FDA-approval or -clearance as a companion diagnostic, and has a FDA-approved or -cleared indication for use in that patient’s cancer. The NCD also covers germline tests when the test is FDA-approved or -cleared and the patient has breast or ovarian cancer.

Medicare communicates policy changes associated with NCDs to the Medicare Administrative Contractors (MACs) through change requests (CRs).  Recently, Medicare published two CRs associated with the NGS NCD, identifying covered tests and associated CPT and ICD-10 diagnosis codes.  These CRs (CR11655 and CR11749) indicated that MSK-IMPACT and MyMRD NGS Panel were nationally covered under the NGS NCD. Although MSK-IMPACT is FDA-cleared, it is not a companion diagnostic and MyMRD NGS Panel is neither FDA-approved nor -cleared. Because of their regulatory statuses, neither test should have been covered under the NGS NCD. Coverage of these tests drove confusion in the laboratory community, as it suggested that Medicare may be applying variable criteria to identify tests for coverage.

CR11655 and CR11749 were rescinded by CMS on June 19th, 2020 and May 1st, 2020 respectively. This clarified that MSK-IMPACT and MyMRD NGS Panel are not covered nationally under the NGS NCD.

Boston Healthcare continues to track CMS communications on the NGS NCD to understand the impact these may have on patient access to NGS tests. Our team actively monitors policy to assist our clients in effectively navigating the ever-changing policy environment. For innovators in the precision medicine and diagnostic space, these insights can assist in developing robust commercialization plans. If you are interested in learning more about how we can help, please contact us.