Novitas' LCD for genomic testing in oncology has made news several times.
- Summer 2023
- Novitas released a final version that was greatly different than the 2022 proposal.
- Stakeholders got CMS to cancel that, and Novitas had to reissue the LCD as a "new" proposal for public comment.
- Summer 2024
- Novitas announces that new final version would be delayed.
- January 2025
- Novitas releases the new final version, with almost exactly the same non-coverage test list as 2023.
- On January 27, 2025, Interpace Diagnostics issues a press release that the Novitas LCD is delayed again, until April, to allow the Trump Administration to review the data for an Interpace test.
More Weirdness
You're excused if you don't think anything could get more atypical. In this blog, I look at the actual final LCD (albeit, on hold).
First, the title changed. The draft LCD was L39367, "Genetic Testing for Oncology."
The final LCD has a different title - "Genetic Testing in Oncology - Specific Tests."
Second, Novitas defines "genetic" to be any form of DNA or RNA test. (I think more often, genetic focuses on germline, genomic to broader applications.)
Novitas says, it is not appropriate to use the term "genomic."
Use of the term, "genomic," in PubMed (1.9M results):
Third, while the LCD has some very broad definitional sections (see "Structure," below), the only "coverage statements" are about 11 brand-name special tests (of which only one, Urovysion, which is FDA-approved, is covered).
Fourth, this means, you'll look in vain for any explicit text about whether Novitas covers tumor CGP, or when, or covers liquid biopsy CGP, or when, or MDR testing, or when.
Fifth, the LCD references two billing/coding articles.
A59123 seems more specific to the LCD (its title, says, "Specific Tests.")
A58918 is "billing and coding, molecular pathology and genetic testing." A58918 has a banner, "Not an LCD Reference Article." Although, A58918 references several LCDs in its official "associated documents" section, and, A58918 is referenced by, L39367.
A58918 references Novitas LCD L34519 for "molecular pathology procedures."
But that LCD is from 2021 (and mostly 2015), so you'll look in vain for any text about modern developments like LBx, MRD, etc.
Structure of LCD
The HTML document is not paginated, these are pages from my version, to give you a general idea.
- Page 1
- Coverage Indications, Limitations, Medical Necessity [header]
- History/Background
- A page of general remarks about molecular testing and its "complexity and rapidly expanding knowledge."
- Page 2-4
- Definitions
- Of note, definition of treating physician (related to who can order a test.)
- Genetic defined as any DNA RNA test.
- "Genomic" not to be used.
- Some topics like MRD and TMB are defined, but not otherwised used again.
- Page 4
- Covered Indications
- This section says Urovysion (FDA) is selectively covered.
- Page 5
- Limitations
- A few general limitations then a list of non covered branded tests, of which I don't think any are FDA approved. These non covered tests are #4-#12.
- Page 6
- Provider qualifications - only treating MD can order.
- See my May 2024 blog about MolDx's important article, A59741. Writing, "Pathologists may order molecular diagnostic services..." within certain guardrails.
- Page 6-14
- Summary of Evidence [each named test discussed in turn.]
- Page 14-34
- Analysis of Evidence [Rationale]
- Page 34-65
- Bibliography (n=470)
Half the LCD, by volume, is bibliography.
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Recall a September 2024 announcement by Novitas that (while it has few LCDs on the 100s of PLA codes), it reserved the right to require full medical records documentations from patients whenever a PLA code is ordered.