Thursday, September 19, 2019

Public Comments on NGS NCD in June 2019: All Organizations Disagreed With It

On August 26, 2019, Genomeweb's Kelsy Ketchum ran an article on the ongoing issues with the CMS NCD for next-generation sequencing, which purports to create non-coverage for diagnostic domains never reviewed in the analysis.   (Article here; subscription).  I recently argued that this seems to directly violate the statute for how exclusions in NCDs have to be created (see here).

Ketchum's August article is based on the dozens of public comments submitted to CMS at the beginning of summer, as well as additional interviews with clinicians and health policy experts. 

The Timetable for CMS

The NCD is under a slow revision process now, which began with public comment in May 2019 and will take a next step with a CMS revision proposal in October 2019 (tracking sheet here.)   Public comments are available online, but it's pretty tedious to click through one at a time.

Now!  User-Friendly Access to the Public Comment Files

I've made two different collations to dramatically speed up the process and give the clinical and diagnostic community better access to the comments.
  • I've created a 25 page PDF, which brings together some large organization comments, like American Cancer Society and National Comprehensive Cancer Network. I've also included some key documents like Cornell's WSJ op ed in 2018, and the 60-organization protest letter in January 2019.  One-stop shopping.
  • I've also created a ZIP FILE with several dozen public comments, so you can see even more of the original sources.
Letters Did Not Pull Punches

The letters can take some pretty strong positions.  The ACS letter has a header, "CMS's Previous NCD Decision Was Misguided."  Ouch!

Friends of Cancer Research pushed back because of the adverse impacts on frontline therapies, special needs for repeat testing, and value of selected germline testing.  They conclude the scope of non-coverage must be narrowed, and I argued in a separate blog that statutory language requires that too (here).   For either the 25-page view or access to all 100-plus pages of comments, see the first or second links at the bullets above.


My own comment submitted to CMS in May 2019 is here.