In September 2021, the NGS MAC published a draft LCD that revised its coverage of solid tumor genomics.
On February 10, 2022, the LCD has been released in its final version. This triggers 45 days public notice before it becomes an effective or active version.
Find the final LCD L37810 here. Near the bottom, it contains links to its draft version, to a billing article, and to a Q&A on public comments received. The Q&A document has 10 points and summarizes the incoming comment and the MAC's reply effectively and concisely.
Redline for Changes
I've also taken the body of the LCD as a text document, and done a redline comparison between the September draft and the February final. Changes are limited.
One change is that that the original draft proposed that the original proposal covered CGP (comprehensive testing) only "when a more limited panel of 5-50 genes is insufficient" without further definition. This could have led to a lot of confusion during chart-by-chart audits of whether 5-50 gene tested had been ordered and proved insufficient (possibly inserting a turnaround time of a week or two besides.)
TMB is a reason for ordering CGP (because it requires a lot of sequenced DNA) but the LCD remarks that "current evidence fails to support the use of TMB as a biomarker for ICI treatment of all tumor types" and "limitations to precision medicine's impact, involving the widespread assumption of clinical utility of wholesale [CGP] testing, is coming under new scrutiny [FN 31-34]." (See also, recently, Andre' and colleagues.)
The final language allows CGP as necessary under basically the same conditions in the Cancer NGS NCD 90.2, that is, (1) the patient has advanced cancer, (2) has not been tested with CGP for the same content, and (3) decides to seek further treatment.
The test biomarkers must cover genes listed for FDA approved therapies, and points to the NCCN biomarkers compendium.
Notably, tests must be FDA approved or cleared. Or alternatively, the test must have published analytical validity evidence, OR, the test must be certified by a party such as New York State CLEP.
- This is not so different that the molecular testing standard in the 28 MOLDX states, which require a MolDx tech assessment review that is pretty exhaustive has many elements of a NYS CLEP review. And similarly to this LCD pointing to NCCN Biomarkers Guide, the MolDx program regularly updates tables of requirements for genes in tumor panels (for a type of tumor) and genes in hereditary panels.
- But also note, the LCD promises coverage if the genomic test is FDA approved or cleared. If it's FDA approved (as a CDx) then it falls under the domain of CMS NCD 90.2 and wouldn't really fall under this LCD at all.
To save you clicking and searching, I've put all the PDF documents plus the redline into a cloud zip file here.
The NGS MAC LCD is effective in New York/Connecticut and New England, as well as MN, WI, IL.
The LCD was turned around quickly, with a comment period September 30 to November 13, and a publication (notice period) on February 10 (4 months 10 days). Novitas recently produced a rapid pharmacogenetics LCD, L39063, comment June 10-July 24, released (noticed period) on October 28 (4 months 18 days).