Medicare Coverage: NGS Testing of Early-Stage Cancer Patients Is Back in Play

The reimbursement outlook for those who provide next generation sequencing (NGS) testing to early-stage cancer of Medicare patients with hereditary risks is far brighter today than it was a few weeks ago. Late last year, CMS issued a National Coverage Determination (NCD) that would have barred Medicare from paying for such testing. But after pushback from lab industry and other healthcare organizations, CMS has decided to reopen the NCD.

The Original NCD
Before the new NCD, many Medicare Administrative Contractors (MACs) had issued local coverage determinations (LCDs) providing for coverage of NGS-based genetic testing to screen early-stage cancer patients for mutations associated with inherited cancer syndromes like BRCA mutations and Lynch syndrome. The new NCD wasn’t expected to have any impact on those LCDs because the MACs actually asked CMS to issue it for NGS testing of beneficiaries with advanced cancer; the request was also limited to a somatic-based test.

But CMS issued an NCD that it instructed MACs to apply to not just somatic but also germline NGS testing. And because an NCD supersedes an LCD, the agency’s no-coverage determination would have rendered Medicare early-stage cancer patients with a genetic predisposition based on family history or other acceptable criteria ineligible for NGS-based testing.

The Industry Pushback
The response from industry was immediate and potent. In a Jan. 31 letter to CMS administrator Seema Verma, a group of over 60 healthcare companies and organizations including the American Clinical Laboratory Association (ACLA) joined over 60 health care companies and organizations calling on CMS to revise the NCD. Denying NGS testing to early-stage cancer patients with hereditary risks would adversely impact cancer patient care and outcomes, the letter argued.

CMS Reopens the NCD
The pushback seems to have worked. On April 29, CMS released a tracking sheet announcing that it has decided to reopen the NCD. But the tracking sheet also emphasizes that CMS will only reconsider the evidence available for tests of germline mutations to identify patients with hereditary cancer who may benefit from targeted treatments based on their test results.

What Happens Next
Although it’s still unclear how or even if CMS will revise the NCD, we do at least have a pretty firm idea of what the timetable will be:

• May 29: Public comments on the NCD close;
• 29: Due date for CMS to issue a proposed decision memo on the NGS;
• 27, 2020: CMS to issue final version of NCD.