Wednesday, January 22, 2025

My Public Comment on Proposed Medicare Advantage Rule: Coverage Isn't LCD Text Only Any More

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

 Contract Year 2026 Policy and Technical Changes to Medicare Advantage Program, CMS 4208-P

 Section U, Internal Coverage Criteria

 Commenter:  Bruce Quinn MD, Los Angeles, CA

 Brief summary of comment:

 CMS is concerned that Medicare Advantage (M.A.) plans do not provide coverage at least equal to Part B under LCDs, NCDs, or regulations.    CMS directs M.A. plans to look only to the “PLAIN TEXT” of the LCD itself, and not attached articles or other MAC information sources.   

 With regard to some modern LCDs, this is a fatal error.    For one example, the MOLDX program, which handles the lion’s share of CMS genomic tests, issues “foundational LCDs” that are broadly worded and rarely revised.   The LCD makes generalistic statements, such as “covered tests must be clinically validated and pass a MolDx tech assessment.”   For years thereafter, substantial and important coverage changes are only updated by adjunct documents, and the original (vague) LCD is unchanging.   Therefore, adjunct documents are absolutely essential to interpreting the aging original  LCD text.

 Comment on Section U, Internal Coverage Criteria (§422.101):

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." 

 In practice, actual coverage details are continuously updated in supplemental resources like the Palmetto DEX™ Diagnostics Exchange registry, which MolDx explicitly refers to as the authoritative source for test-specific coverage determinations [FN1].  See also illustration at end of  this letter.

 While CMS assumes LCDs undergo rigorous review and provide clarity and specificity, foundational MolDx LCDs such as L38671 (genomic transplant rejection tests) and L38814 (minimal residual disease testing) remain intentionally broad.

 MolDx directs stakeholders to supplemental resources, including LCD articles and the DEX registry, to operationalize coverage determinations.  (Its DEX REGISTRY is a separate online copyrighted database not mirrored by CMS.)   

 These external resources are integral to understanding and applying coverage policy under the so-called “plain text” (vague) of the LCD. [FN1, FN2, FN3, FN4].

 Example 1 (January 2025)

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.”

 Example 2 (January 2025)

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.

 I urge CMS to explicitly acknowledge the role of supplemental resources like the DEX registry in operationalizing coverage policies. Prohibiting M.A. plans from referencing these essential tools would undermine the intent and functionality of the MolDx program, and reverse the intentions of CMS's new rulemaking.  Given that MolDx publicly and deliberately directs stakeholders to these resources as the main record of its evolving coverage decisions [FN1], CMS should revise the proposed language to accommodate their use.


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

https://www.natera.com/company/news/natera-announces-medicare-coverage-for-prospera-in-single-lung-transplant-recipients/

FN4

https://finance.yahoo.com/news/guardant-health-receives-medicare-coverage-130500233.html

 

COMMENT BOX - https://www.federalregister.gov/documents/2024/12/10/2024-27939/medicare-and-medicaid-programs-contract-year-2026-policy-and-technical-changes-to-the-medicare  

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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