HEADER: CMS Proposes rules that M.A, grant coverage only on LCD text alone. I comment that other sources - like MolDx DEX REGISTRY - list cumulative approved use cases, and must supplement the static LCD text.
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As I noted in a prior blog, CMS has rulemaking underway, comments due January 26, on Medicare Advantage plans. CMS wants to ensure M.A. plans match fee-for-service coverage. However, along the way, CMS states that M.A. plans must track ONLY the CLEAR TEXT of LCDs - not associated articles or other sources.
For me, this raises a challenge for Foundational LCDs at MolDx, some of which have not been revised since 2021 or earlier. Yes coverage constantly evolves - as we see from regular press releases from companies getting expanded test coverage or expanded use cases. The reader of the LCD will find only general statements, such as "Tests must be validated in appropriate populations and pass a MolDx technology assessment." You can read such words, from 2021, over and over again, but you won't suddenly know exactly which tests MolDx covers this month, and for whom, and when.
I submitted a comment letter to CMS explaning that ofr modern MAC coverage, sources outside the "plain text" of the LCD may be necessary.
More background here including CMS comment box link:
https://www.discoveriesinhealthpolicy.com/2025/01/follow-up-blog-why-comment-on-new.html
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PUBLIC COMMENT
January 22, 2025
I am commenting as a pathologist and full-time Medicare policy expert. Stakeholders appreciate CMS's effort to clarify the use of internal coverage criteria under §422.101.
I am concerned that the proposed language at §422.101(b)(6)(i)(A) and related text (e.g., 99457 col. 3 and 99458 col. 1) may severely misalign with the practical realities of Medicare coverage policies, particularly for the Molecular Diagnostic Services (MolDx) program.
- MolDx LCDs frequently provide only general guidance for coverage. For example, transplant test LCD L38671 includes broad statements such as, "Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population."
The company NATERA announced new expanded coverage for its
lung transplant rejection test. This
falls under the vague or umbrella policy L38671. FN3.
The new coverage cannot be gleaned from the original, vague, LCD text from
2021. That text only assumed that
future tests would be covered when “clinically validated” and passing a “tech
assessment.”
The company GUARDANT announced new expanded coverage for its colon cancer
relapse test. This falls under the vague
or umbrella policy L38814. FN4. However, the particular use case for a particular test and indication cannot be
determined only from the original 2021 LCD text, which just promises that
future tests will be covered when the MAC validates them.
SUMMARY
Requiring Medicare Advantage (M.A.) plans to rely solely on
explicit LCD text, as proposed, risks confusion and misinterpretation. For
instance, the generic language in MolDx LCDs—e.g., “clinical validity
must be established”—cannot alone guide readers at M.A. plans to determine
which tests are covered, for whom, or under what conditions. Without reference
to supplemental resources, MA plans would struggle to align with the dynamic nature
of MolDx policies.
FN1
https://www.discoveriesinhealthpolicy.com/2025/01/follow-up-blog-why-comment-on-new.html
FN2
https://www.discoveriesinhealthpolicy.com/2025/01/decibio-reports-on-mrd-coverage.html
FN3
FN4
https://finance.yahoo.com/news/guardant-health-receives-medicare-coverage-130500233.html
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Thank you! Your comment has been submitted to Regulations.gov for review by the the Centers For Medicare & Medicaid Services.
Comment Tracking Number: m68-9gtr-mt4a