Tuesday, January 7, 2020

MolDx Posts Final LCDs for NGS Profiling of Solid Cancers and Myeloid Cancers

MolDx has finalized complex and important LCDs for comprehensive genomic profiling in cancer. Each of the two LCDs also has an accompanying coding & billing article, and a lengthy article which  is a response to public comments.

L38045 covers solid cancers, and L38047 covers myeloid cancers.  Expect other MACs in the MolDx policy system to roll out matching LCDs soon (WPS MAC, CGS MAC, Noridian MAC.)

One way to find these LCDs is to (first) go to the Palmetto MAC "LCDs, NCDs, Articles" page and (second) click on "future effective" LCDs.  Here.  Note, however, that after February 10, these become "effective" LCDs and will move to the "effective LCDs" link.

The Two LCDs - Each With Two Articles

When you open the two LCDs - L38045 and L38047 - near the bottom of each LCD is a link to its coding article and a link to its public comment Q&A article.   For L38045, see coding article A57831 and Q&A article A57830.  For L38047, these are found as A57387 and A57836.

You can find AMP's comments on the articles under the June 20 date at AMP's public policy webpage here.

MolDx doesn't use AMA CPT code 81455 (50 or more tumor genes) but wants large cancer tests coded as 81479 (molecular unlisted code).

You'll Also Want Article A57757

Note that you'll also want article A57757, which defines primary and recurrent tumors. Medicare's NGS National Coverage Decision 90.2 states that NGS tests can be provided only in advanced cancers and only one of the same test, per primary cancer.  MolDx defines a non-covered test as a second test on the same specimen on the same day, and a different primary cancer is a cancer that is "different enough to respond differently to therapy."  (To my eye, that suggests any tumor that stops responding to a prior effective therapy is different enough to escape the one-test-per-primary-cancer rule).   You may also want Article A54795 - which defines hotspot tests versus CGP or comprehensive genomic sequencing tests.  Find them using the document ID search box at CMS Coverage Database (here).

Grandfathered Tests Require TA's - and Fast

MolDx is also going to require that grandfathered NGS cancer tests, which might not have undergone detailed tech assessments in prior years, must have an approved TA on file as of February, 2020.  See article here.

Tech Assessment Documents

Some of the requirements for NGS tests are found not in LCDs, not in coding & billing articles, but rather in MolDx website technical assessment documents.  Entry point from the MolDx home page, here.  The TA assessments for NGS tests are exhaustive - MolDx doesn't let you by with just a CLIA certificate on file.

Cloud Copies of Documents Cited

I've put a Zip file with articles and LCDs cited in this blog, in the cloud - here.

Nerd Notes

L38045 states point blank that: "NGS is not a specific test but a sequencing methodology utilized to capture genomic information."   This is practically verbatim what stakeholders have been telling CMS regarding its NCD 90.2 - stakeholders like ACLA, CAP, AMP, 21st Century Coalition, NCCN, and others.  CMS seems to (??) view NGS as a "test" (sic), which is either "covered" or "not covered" in certain situations.  Thus, NGS is "not covered" in patients with cancer that is not advanced cancer, a nonsensical situation that means that even FDA approved HIV genotyping tests are "not covered" in these early cancer patients.   In this regard, the existing CMS NCD simply makes no sense at all.

The multi-level implementation of the LCD, with an LCD, an attached article, collateral articles for definitions, and then separate MolDx website documents like Tech Assessment spreadsheets with gene lists, means it would be very hard for a RAC or auditor to know if a given test was appropriate covered or not on any given day of service.  You'd need contemporary copies of all these documents, a real handful, for a particular date of service in the past.