A Posted MolDx LCD Request

 This is a publicly available example, on the CMS website, of a MolDx LCD request.  

The request is for coverage of a Castle melanoma genomic test, to be used when H&E slides of a skin lesion are not diagnostic of either a clearly benign nor malignant lesion.    MolDx had previously covered a Myriad test for this scenario.   Castle asks that the Myriad-specific LCD be broadened to be a "foundational" or I would say "umbrella" LCD, with multiple products.   Note, however, that if there hadn't been a single molecular predicate test, then the otherwise available standard(s) of care would have been the predicate that the new test exceeds.

I've listed some key features below.

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MEDICARE RULES FOR LCD REQUESTS

Before a few years ago, Medicare did not have any rules for LCD requests.  (You just found a medical director's name and sent your request).  Here are the current more formal rules.

1.  MACs must log "LCD Requests" as a specific type of their work functions under their contract.

2.  Further instructions in an online manual, Chapter 13, 13.2.2.

https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/pim83c13.pdf

3.  Request must be in writing and must specify

(a) A benefit category (Diagnostics are category SSA 1861(s)(3) )

(b) Language requested in LCD  ("This LCD covers service X under condition Y" etc)

(c) Justification with evidence, and PDF copies of all evidence.

(d) "Information that addresses relevance, usefulness, clinical health outcomes, or medical benefits"

(e) Fully explain the design, purpose, method, of the service

4.  Requester must be a patient, health professional, or party doing business in the MAC.

CASTLE REQUEST LETTER

MACs are now supposed to post request letters.   However, I've seen at least one that was truncated to only a table of contents.  This is a full request letter, which I think is CMS's intent.   National CMS decisions have always posted request letters in full.

The letter is 9 pages (before bibliography and appendix.)  For example, the letter is not 30 or 60 or 90 pages long.

More about the provenance of this request here:

http://www.discoveriesinhealthpolicy.com/2022/10/moldx-posts-melanoma-dlcd-at-cgs-mac.html

Letter online here:

https://www.cms.gov/medicare-coverage-database/attachments/lcd/39344_6/DecisionDxDiffDxMelanomaZ00BSCoverageRequestFINAL15JAN21.pdf

or  https://drive.google.com/file/d/1iQ1-GnJJTCLImSj0MP8Y8VymLC4WPbW9/view

TIMELINE

The Castle letter describes meetings in October and November 2020.  The PDF seems to be titled as date January 2021.   The LCD revision appeared in draft form in May 2022.   The final version is expected most likely around May 2023.

CMS requires that MACs acknowledge request letters, and log them, within 90 days.  However, CMS does not require requests to be handled in any particular priority, order, or in fact, to ever be acted upon after being logged.

THE LETTER

Page 1 is an overview and summary.   Past meetings are noted.   

Page 2 starts over with general background and a review of the diagnostic pathway (for the "difficult ambiguous biopsy")

Page 2-3 describes alternate methods.  Flow charts for the multi-pathway workflow of a case, are provided.

Page 4 introduces the specific test and how it runs and how it was developed.

Page 4-5 describe the clinical performance and compares, in detail, to laboratory alternatives including FISH.

Page 6 introduces "clinical utility."  They define this as performance in real-world ambiguous cases.   This is very important, because most tests are validated on clear-cut cases.  For example, one has 200 known benign lesions and 200 known malignant lesions, and develop a test that can sort them accurately.   However, the clinical case is to use AMBIGUOUS lesions.   So this is a separate, later study, to study the performance in AMBIGUOUS lesions which are the whole point of the test.  Castle styles this as "Clinical utility."  

Page 7 shows that for an existing 23 gene test, the test should reduce unnecessary re excisions (intrusive wide excisions) by 63%.  The new Castle 35 gene test should reduce these by 76%.

Page 7:  Describes why this reduction in extra surgery is a "health outcome improvement."  
Page 8 summarizes the key points in a two-column format (issue on the left, answer on the right).

Page 9 concludes with a final summary and leads into the bibliography.  

Page 10-12 is bibliography.  39 references.

Page 13 is a logical summary of reasons and rationale why the test is medically necessary again in two column format.

Page 14 is a gene list of the test.

I've attached my own redline copy with highlights I felt were pivotal.  A clean copy would be at the links above.