I've had the chance to talk to a number of stakeholder groups and read the NCD several times, as well as underlying documents such as the FDA approval review for FMI F1 CDx.
Here, I post a 20 page (7000 word) white paper on the NCD and its potential implications.
Version: 03, January 2, 2018. * HERE * - click arrow upper right to download.
This white paper was downloaded 450 times (December 25-January 5). More after the break.
Key Figure, Summary, and List of "Unintended Consequences" Discussed.
SUMMARY
On November 30, 2017, the
Medicare agency released a wide-ranging coverage decision that governs all uses
of next-generation sequencing technologies in all Medicare patients with
cancer. The proposal is open for public
comment until January 17, 2019, and the policy will become effective in March,
2017.
Under the proposal, diagnostic
tests that use NGS technologies are covered only in patients who have an
advanced cancer and for which the test is on-label and PMA approved by
the FDA.
Medicare defines all other
current and future uses of NGS testing in oncology as not medically reasonable
and necessary. However, NGS
technologies that are (A) PMA tests used off label or (B) 510(k) cleared tests,
can be used under a Coverage with Evidence Development paradigm. If a diagnostic test is not PMA or 510(k),
coverage is available only in NCI-sponsored trials.
The wide-ranging proposal would
provide automated coverage for PMA NGS tests in patients with the on-label
cancers. However, it would open a very
wide chasm between PMA-approved and other tests that are equally genetically
accurate.
The NCD reflects a bold vision to
push Medicare fee-for-service system, where most cancer care is provided, into
a learning healthcare system, but the intensity of C.E.D as proposed may be
unworkable.
There may be a host of unintended
consequences of the draft language, which have taken time to discover.
· * BRCA risk
testing in Medicare patients is always in women with a personal history of
cancer, and normally done by NGS testing, but there is no germline PMA level
risk test for BRCA in breast cancer patients.[i]
· * If a test like the Oncotype DX test were converted
to a faster, more accurate NGS format, it would lose LCD coverage because it
would carry a complementary diagnostic and not PMA claim.
· * The volume
of patients diverted immediately in March into either FMI CDx testing or
C.E.D. testing could swamp either system during 1H2018.
Stakeholders should comment
carefully and with intensive and accurate citation to existing literature or
other quantitative arguments. One
option for CMS is to close the final decision with coverage for PMA on-label
testing, but initiate a multi-stakeholder dialog in 1H2018 (ACS, ASCO, AAMC,
NIH, FDA, AHRQ, and others) to craft a more realistic way to bootstrap Medicare
oncology into a learning healthcare system.
Some Unintended Consequences?
1. Covered Tests for Advanced-Cancer Patients.
2. Non-Covered Tests for Advanced-Cancer
Patients.
3. Financial Scope of the NCD
4. Explosion of Population Covered NGS Test
Panels with First PMA “MSI” Approval
5. Immediate Non-coverage of Risk Testing and Evolving
Complementary Diagnostics
6. Puzzling Scope: Leukemia/Lymphoma?
7. Scope:
Liquid Biopsy Tests
8. Dilemmas in Interpretation of “Advanced”
Cancer
9. Redundant Government Coverage of NCI-Funded Testing
10. New Liabilities for Hospitals?
11. Implementation Chaos?
12. The View from VOI?
