Dive Brief:

• In a new draft national coverage determination published Tuesday, CMS proposed extending coverage of next generation sequencing tests to earlier-stage cancers and patients whose genetics may put them at risk for developing cancer. Those changes reflect concerns raised by the healthcare industry earlier this year related to a March 2018 draft.

• "The Oct. 29 draft NCD appears to remove the prior restrictions on germline testing for breast and ovarian cancer and more explicitly cover FDA-approved tests regardless of cancer stage," analysts at Cowen wrote in a note to investors Tuesday. "The policy also appears to give local Medicare contractors more discretion over coverage of non-FDA approved NGS tests for diagnoses other than breast and ovarian cancer."

• CMS Administrator Seema Verma framed the proposal as a way to give physicians and patients the information they need to select the most effective treatment. 

Dive Insight:

CMS issued the current NCD in March 2018 but the controversy around its implications only gained momentum 11 months later, when 63 healthcare organizations wrote to Verma to protest its impact on patient access to NGS tests. The objections centered on the restriction of NGS tests to patients with "recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer."

That stipulation prohibited the use of NGS testing for germline mutations, which can show whether a patient is genetically predisposed to a certain cancer. CMS' position on germline testing contradicted earlier local coverage decisions.

CMS reopened the NCD in April, raising expectations that the agency would drop the restrictions it imposed last year. Those expectations appear to have been met by the release of the revised NCD.

The agency reached the revised position after reviewing 82 comments filed in the month after it reopened the current NCD. More than half of the comments came from patient advocates or caregivers. In its analysis of the feedback, CMS said respondents supported its decision to reopen the NCD, adding that some commenters questioned the focus on late-stage cancers and others called on the agency to permit repeat testing. The revised NCD limits coverage to patients not "previously tested using NGS."

Today’s proposal would extend #Medicare coverage of NGS tests to certain types of ovarian & breast cancer that may be caused by hereditary factors, allowing both clinicians and patients to identify the treatments that work best for them. https://t.co/PJNvnaPkDV

— Administrator Seema Verma (@SeemaCMS) October 29, 2019

The Cowen analysts presented the proposed NCD as a mixed blessing for medical genetic testing company InVitae, noting that while the coverage of hereditary cancer tests is a positive, a requirement for FDA approval or clearance is a negative. Myriad Genetics, the other genetic testing company covered by Cowen, is not expected to be affected as it uses a different method of DNA sequencing (Sanger, rather than NGS). 

CMS is accepting comments on the proposed NCD for 30 days.