Monday, December 7, 2020

Liquid Biopsy for Screening: Action Continues With Legislation Introduced, HR 8845

Summary:  New legislation HR 8845 would provide Medicare coverage when the FDA approves multi-cancer liquid biopsy screening tests.  The bill would bypass a current bottleneck requiring USPTF review prior to CMS consideration.


It's been a busy several months for liquid biopsy cancer screening, with multiple funding rounds announced (probably capped by a proposed acquisition of GRAIL for $8B), a proposed NCD for liquid biopsy colorectal cancer screening, an NHS study in the UK announced, and now some major legislation.

The legislation is HR 8845 with the full bill text hereIt would update Social Security Act Section 1861 with a new benefit category, for FDA-approved multi cancer screening tests.  Currently, such tests could only be adopted as Medicare benefits if endorsed by the USPSTF, a process that could take 3-5 years after FDA approval.   

I've argued that USPSTF review has largely proved redundant to CMS review (both agencies write the same 40-page report on the same data).  

The bill is a little hard to read because it edits different phrases at different points in the statute, moving "and's" and "or's" and adding semicolons (it's like the CRISPR approach to legislative change) but I believe it directly creates coverage for FDA-approved tests.  Existing pricing rules would apply.

The bill is sponsored by Terry Sewell (D-AL), supported by Jodey Arrington (R-TX), Richard Hudson (R-NC), and Paul Ruiz (D-CA).  

See a news op ed by Hudson here.  See an article about the bill here.  See a rapid endorsement by the National Minority Quality Forum here.


For a painfully detailed June 2020 sponsored review of CRC policy, in Amer J Managed Care, here, PDF here.