Thursday, October 14, 2021

Brief Blog: NGS MAC to Hold Public Meeting on Tumor Genomic Profiling

The NGS MAC (with 3 upper midwestern states and NY/New England) has traditionally had very low payments per capita for genomic testing, except for two tests controlled by NCDs (Cologuard in Wisconsin and Foundation Medicine F1 in Massachusetts).   They have proposed a new LCD for tumor-based genomic testing, aka comprehensive genomic profiling or CGP.   You may want to track a public comment meeting on this important LCD to be held on October 20, 2021 at 1 ET.


Find the NGS MAC policy page here.

Find the page for pending meetings here.  There's a "registration" link.


Right now, draft (proposed) policies are a little harder to find than they used to be.  MACs used to link to a common CMS database in a way that took readers right to that MAC and its short list of proposed policies.  Now, in my experience, those MAC links just dump the reader off at the home page for CMS policy searches.   And, once you're there, CMS has made it harder to look for the topic "proposed policies" (or, completed-pending-active policies).   I've written to CMS and complained.

The policy in question is DL37810, "Genomic Sequence Analysis Panels for the Treatment of Solid Organ Neoplasms."    

At the CMS search page:

Type in Dl37810.

I get DL37810 at this link:

I had a "brief blog" on the LCD when it was proposed in late September (here).  It guarantees coverage for 5-50 gene tests in lung cancer and colon cancer.  It then has another section that provides coverage for larger tests (e.g. 300 genes) when smaller tests are "insufficient."   The coverage section isn't very clear on when this occurs, and the discussion section discusses numerous policy topics (from racial equity in biomarker testing to using large sequencing bins to report TMB).   

There's also a closing sentence that states, "Given the abundant (if conflicting) literature, and widespread societal support for NGS CGP testing in advanced cancer, National Government Services reservedly deems such testing appropriate for advanced somatic cancers, consistent with CMS NCD 90.2 (1)."  This might be interpreted to mean that CGP testing is covered in patients with advanced cancer (assuming patients meet 3 or 4 rules listed in the NCD), but it's not clear to me if this easily agrees with the phrase that each patient must be tested to whether a 50 gene panel for him/her was "insufficient."  Comments run from 9/30 to 11/13.