Takeaway: Two years in the making, CMS's NCD appears to address most of industry's concerns and continues policy goal of expanded genetic testing

Yesterday, CMS finalized a National Coverage Decision for Next Generation Sequencing tests. In so doing, CMS has first and foremost cleared up some confusion about coverage of somatic and germline cancers. Secondly, it potentially expanded coverage to non-cancer genetic tests. Finally, CMS's decision takes another step to encourage application for FDA clearance by genetic labs.

You can compare current, proposed and final updated language here.

First, the confusion. The NCD that was released in March of 2018 and followed by sub-regulatory guidance to the MACs created a good bit of controversy. The NCD was interpreted as providing guaranteed national coverage for NGS tests that served as companion diagnostics but only for patients with stage three and four cancers, such as Foundation Medicine's F1 test. The original language and some follow-on guidance to the MACs also appeared to limit approvals of LDTs to NGS tests, or FDA cleared tests off-label, as long as it was for one test and only for stage three and four patients.

The confusion developed because the industry, and in some cases, Medicare approvals, had moved well beyond or did not conform to these restrictions.

So, CMS revisited the NCD and, well created more confusion. CMS proposed in Oct 2019, that Medicare guarantee national coverage for any FDA approved tests (not limited to companion diagnostics) in patients with ovarian or breast cancer, indications for germline testing, and risk factors for inherited cancer. So as Bruce Quinn pointed out, Foundation's tests is FDA approved but not germline. MYGN's BRCA test is germline but not NGS.

Another issue created in the proposed language was a restriction on repeat tests which would limit post-surgical monitoring, for example.

Finally, a third issue emerged around the limitation to germline testing ignoring the clinically demanded somatic testing.

In the final language released yesterday, CMS clarified that any NGS test that is FDA approved and either:

  • A somatic test in a patient with any type of advanced cancer
  • A germline test to detect breast or ovarian cancer with no stage restriction

The single use restriction has been replaced with a requirement that a patient cannot be tested repeatedly for the same genetic content (i.e. repeat BRCA tests).

Secondly, CMS indicated that it would leave it up to the MACs to approve local coverage for genetic tests that detect diseases other than cancer such as heart disease. The MACs, of course, have already approved tests for cardiac disease risk assessment so this language removes the uncertainty that has resulted from the original focus on cancer.

Finally, and most meaningful to the long term policy goal of more fully integrating genetic testing into the practice of medicine, the NCD in this less confusing state encourages application to the FDA for an in vitro diagnostic. FDA approval is an important step for physician adoption. CMS had tried to encourage FDA application through its parallel review process which was first used with EXAS Cologuard (R)  test. However, parallel review was never embraced due to uncertainties around coverage while engaging the expensive and prolonged FDA process.

MolDx currently has 25 tests awaiting LCD approval, no doubt delayed by this uncertainty.

CMS, having cleared up a number of inconsistencies and oddities, is now providing a guarantee of coverage that might work this time. Pricing, of course, will be determined by PAMA.

Call with questions.

Emily Evans
Managing Director – Health Policy



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