Monday, April 29, 2019

CMS Reopens NGS Only For: Reconsideration of Evidence of Germline Tests for Targeted Treatments

On April 29, 2019, CMS posted an NCD reopening notice for its March 2018 NCD on uses of NGS in cancer patients.

Find the reopening notice here:

The NCD - as currently in force - has several rules, basically, cancer patients get automatic coverage for FDA-approved NGS tests like Foundation Medicine F1 CDx, for one time use, on-label, in patients with advanced cancer.   For other one-time tests in advanced cancer, LCDs may provide coverage even if the test isn't FDA-approved.

This NCD structure means patients with non-advanced cancer (e.g. breast cancer lumpectomy patients) seem to be excluded from NGS testing, and tests for multiple uses (minimal residual disease in leukemia) seem to be excluded.

There have been stakeholder concerns since January 2019 about the various domains of implied "non coverage," typically areas not actually reviewed and discussed in the text of the NCD.   See e.g. Genomeweb here.  MedTechDive here.

I've also raised concerns on innovation, meaning simple innovation, like simply migrated accepted platforms to NGS; here.

NCD Reopening is Narrow

The reopening domain of interest is limited SOLELY to "germline tests to identify those with hereditary cancer that may benefit from targeted therapies."   Any other comments will be considered off-topic.

Ironically, for example, this headline came in my inbox almost literally adjacent to the NCD reopening:
  • Novel NGS Method for Minimal Residual Disease Monitoring in AML   
  • Here.
  • But the CMS NGS NCD doesn't cover MRD monitoring now (more than 1 test), and the NCD reopening blocks this topic from the accepted comments, since it isn't related to germline testing.
CMS text below the break.   Comment period is open 30 days, from April 29 to May 29, 2019.   The revised NCD is due by October 29, in six months.

For an initial trade journal reading of the new NCD reopening, Susan Kelly at MedTechDive here.  Genomeweb here.

What Will Labs Think?

Myriad's next investor call is Tuesday, May 7, 2019, 4:30 ET, and so is Invitae's.


Next Generation Sequencing (NGS) is a technology to read the order of nucleotide molecules on DNA and more effectively provides detailed information on multiple types of genetic alternations simultaneously. NGS oncology panel tests also provide patients and their providers a more comprehensive genetic profile of cancer and information relevant to potential cancer treatments.

Section 90.2 of the Medicare National Coverage Determinations (NCD) Manual states conditions of coverage for NGS. Specifically, the Centers for Medicare & Medicaid Services (CMS) established coverage of NGS as a diagnostic laboratory test when performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, ordered by a treating physician, and specific criteria are met. These criteria apply to NGS tests of somatic and germline mutations.

To provide a complete picture of the cancer patient, a clinician may order both tests of somatic (cancer) and germline (inherited) mutations. It is important that tests detect these mutations accurately and produce valid results that are useful in guiding therapies to improve outcomes for patients with cancer. Therefore, CMS is internally opening this decision. Specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this reconsideration.

CMS is soliciting public comment relevant to the request. We are particularly interested in comments that include scientific evidence and address the scope of this reconsideration.

Comments: April 29-March 29, 2019.


Myriad has the only FDA-approved GERMLINE BRCA test, see FDA home page here.  FDA has a product classification for germline cancer-related mutations; it is not intrinsically tied to either CDx or NGS, here.  However, Myriad's test is based on Sanger for sequence and PCR for large dup-dels (e.g. BART); it's not an NGS test so it doesn't really even fall under the "NGS" NCD.