The original NCD, in February 2018, focused on companion diagnostic tumor tissue tests (e.g. the Foundation Medicine F1 test). It gave special coverage benefits to tumor tests that were approved as FDA companion diagnostics.
Stakeholders complained during 2018 and in early 2019 that the NCD inadvertently tended to block coverage of germline NGS tests, since the NCD focused coverage boundaries on "advanced cancer" patients. CMS posted a draft revision of the NCD in October 2019, and the final revision now.
See the full NCD here:
CMS also issued a press release, here.
See coverage at Genomeweb here. At MedCity News here. HealthtechDive here. Healthcare Finance News here. Health Payer Intelligence here. Becker's Hospital News, here.
In the press release, CMS Administrator Seema Verma is quoted: “We recognize that cancer patients shoulder a heavy burden, so we’re leaving no stone unturned in supporting women’s health and getting all patients the care they need. NGS testing provides clinically valuable information to guide patients and physicians in developing a personalized treatment plan....Innovative technologies are transforming medicine, and at every turn, President Trump has shown a dogged determination to give Americans access to them”
Below, I primarily quote the text. For a later blog that dissects some of the quirks and weirdness, here.
I've cut and pasted the pivotal text (the coverage text) below. This is the NEW text, the text that is related to germline sequencing.
My head is spinning a bit from the fact they refer to "Patients with Somatic (Acquired) and Germline (Inherited) Cancer." Normally you would refer to germline sequencing tests for inherited mutations and somatic sequencing tests for acquired mutations - not "germline and acquired cancers."
The full NCD coverage section, including both old and new text,
is clipped below (as provided by CMS in its "Appendix B."