Find the white paper in the cloud here.
Update - on March 6, 2019, CMS delayed "implementation" to April 8, 2019, and CMS remarked it is "sensitive" to concerns of stakeholders. Here.
I've clipped the introductory section below the break.
Overview
This is the story of an unusual chapter in Medicare’s
evolving policy structure for genomic medicine. A remarkable entry point occurs in January 2019, when some 60 major
organizations, including ACO and the Personalized Medicine Coalition, warning
of “significant policy overreach” and “unintended consequences.” What happened?
The process started in November
2017, when CMS proposed to cover the Foundation Medicine F1 test, which
measures over 300 tumor genes and was newly FDA-approved. At the same time, CMS proposed to non-cover
all lab-developed tests (even in cases where no FDA-approved test
existed). Extensive and urgent feedback
to CMS, even in the form of a Wall Street Journal editorial, led to a revised
final coverage policy in March 2018.
That final policy covered FDA-approved gene panel tests in
patients with advanced cancer, when next-generation sequencing technology was
used. NGS-based tests outside of FDA
labeling could be covered by local CMS contractors. Most policyholders moved on, while labs and
manufacturers accelerated efforts to obtain FDA test approvals, due to the
guarantee of CMS coverage that would follow.
The road turns. In November 2018, CMS issued instructions
to its contractors that clarified its intention that NGS tests were
“non-covered” in all cancer patients who did not have advanced cancer. This withdrew coverage, since nationwide
local MACs cover NGS testing, like testing by other sequencing techniques, in
likely hereditary breast and colon cancer.
In January 2019,
the Palmetto contractor and other contractors in the MolDx policy consortium
revised their BRCA-testing LCDs by reference to the NCD – apparently canceling
BRCA testing coverage if the patient had stage 1-2 cancer and if
the method was NGS.
Why does it make sense to block one benchtop method of DNA sequencing,
but cover others, for the same gene, and for same medical history, in exactly
the same patient? Or – does it make no
sense at all.
Is this an unintended consequence? For example, did CMS really intend to block approaches
to molecular microbiology in cancer
patients, asking the hospital microbiology lab to confirm before reporting
the test that they have metastatic
cancer? If you’ve had a cured stage 1-2
cancer in the past, for how many years into the future are you blocked from NGS
testing of any type? What happened to new
statements added for the final NCD that verbally restrict its scope not to all
NGS tests, but only to those for targeted drugs (e.g. the Foundation test)?
And most of all - what will happen next?
Short link:
http://tinyurl.com/GenomicsNCDWP
