Thursday, July 29, 2021

CMS Prematurely Proposed Pricing for Colon Cancer LBx Screening Tests; Likely to Back Down

In January 2021, CMS established a creative national policy for coverage of FDA-approved, liquid biopsy colon cancer screening tests.  They will be covered every 3 years for patients 50-85 years old, if the test is 74% sensitive and 90% specific.  The quirk is, no such FDA-approved test exists yet. 

In May 2021, surprising many stakeholders, CMS created a new G-code, G0327, to describe liquid biopsy tests under the NCD.   (See CR12280, 5/20/2021, here.)  In late June 2021, CMS surprised stakeholders even more by suddenly adding the code to the summer lab test pricing process as a revised, 100th agenda item (agenda here).  At the June 24 public meeting, there were verbal comments that trying to price this code (for hypothetical future tests) was a bad idea, and after the meeting, many stakeholders submitted their written concerns to CMS.

At the July 29 meeting of CMS's professional advisory panel for lab tests, CMS introduced G0327 as an agenda item, but also stated, G0327 was likely to be removed from consideration this year, as there is no predicate or index test to be used to evaluated crosswalks or required resources. CMS used this slide during the webinar:

click to enlarge
Problems include:
  • G0327 was introduced to the agenda just before the June 24 meeting, but regulations require 30 days public notice.
  • CMS has no information to set the rate.
  • There may be substantial variability among future tests.
  • Some of the future tests, when created, may be priced by ADLT methods.
  • There's lack of clarity as to the scope of G0327.
  • CMS crosswalks tests to "comparable" tests but here, there's no index test against which to match a "comparable" test.  No FDA-approved test with the future required labeling exists.
  • CMS can't gapfill the code either, as MACs will have no comparable tests, no resources, no methods, no prices or charges to use in the gapfill pricing process.
Commenting groups included AdvaMed, AMP, BloodPac, 21st Century Coalition, Guardant, POC Test Association, Bruce Quinn Associates LLC, and others.

I've uploaded an auto-transcript of today's CMS comments on G0327 - here.   I would add, I would think, CMS would set this code as status "N" not payable since no tests are yet authorized under the NCD the code applies to.

CMS has created codes for NCDs before, that weren't actually used.  In creating an NCD for amyloid PET scans in September 2013, and created a generic A9599 code for amyloid PET scan tracers.  However, it deleted this generic code, which was never priced, when specific codes for specific tracers began to appear (e.g. A9586, florbetapir, Amyvid.)