Summary. Since about 2012, the MolDx program has operating under a master LCD called "Molecular Diagnostic Tests." One function of the LCD was to allow MolDx to treat certain tests that were not yet reviewed or covered, as "non-covered." The LCD quirkily defined "molecular diagnostic tests" as assays of DNA, RNA, proteins, or metabolites. We just discovered newly-released edit changes. MolDx appears to be walking back from asserting coverage or control of proteomic/metabolomic testing.
Medicare's documentation cited at links throughout this article, but also available in a cloud zip file here.
MolDx dates back to 2011/2012 (white paper here, ACLA letter here) and operates under a "master LCD" that defines its scope, and a couple dozen individual LCDs for specific tests or clinical use cases.
Molecular diagnostic tests are defined in the LCD as being, "any test that involves the detection or identification of nucleic acid(s) (DNA/RNA), proteins, chromosomes, enzymes, cancer chemotherapy sensitivity and/or other metabolite(s). The test may or may not include multiple components. A MDT may consist of a single mutation analysis/identification, and/or may or may not rely upon an algorithm or other form of data evaluation/derivation." (quote-unquote).
What's New: Test Types Abruptly Deleted from Master MolDx LCD
Here's what's new. Go to the master coding article for MolDx tests, A56853 (here). Scroll down to Revision History. In Revision R7, released February 5, 2021, but effective January 1, we count that 32 specific test codes are DELETED from control by the LCD. (MolDx also deletes several unlisted codes, e.g. 84999).
It looks like proteomic and metabolomic codes, which had previously been actively listed (hence requiring active deletion) are being deleted. See table:
|Click to enlarge / Deleted from Control of Master LCD for MolDx
Some Quirks We've Found
MoLDx is an important but quirky program, and I've counted 4 quirks triggered by the article updates.
1. Mismatch of LCD Text and Its Coding Article
The LCD text defines Molecular Diagnostic Tests as including DNA, RNA, proteomics, or metabolomics, but the corresponding article exempts all but DNA and RNA tests from its domain. So the LCD and coding article seem out of sync.
2. Palmetto Rules, Out of Sync with Other MACs in MolDx Program
The corresponding Noridian LCD/Article (L35160, A57526) haven't been revised for a year, so they are currently out of sync with the Palmetto MolDx documents.
3. MolDx Palmetto "DEX" Website Lists Tests as "Non-covered by MolDx" that MolDx Defines as Outside Its Scope
I realize that's a mouthful.
MolDx appears to be defining non-DNA, non-RNA tests as outside of its scope. OK.
However, if you go to the official Palmetto- and MolDx-branded and Medicare-branded Diagnostics Exchange website, it's clear that some of the tests deleted from scope above, are concurrently listed as "non covered by Medicare Palmetto MolDx" on the DEX website.
Potentially, Medicare Advantage plans could view the Palmetto- and MolDx- and Medicare-branded DEX website as a coverage decision source, see a test there being directly named as non-covered by MolDx Medicare, and non-cover it under Medicare Advantage. This seems hard to square with the test being outside MolDx Medicare scope of review per A56853. (For example, ineligible for a MolDx LCD to reverse the MolDx non coverage.) I'm not sure what next steps for such a company would be. Let's say they have code 80101, and it's a proteomic MAAA test, and it's deleted from eligibility for review by Palmetto-Medicare-MolDx, but it's listed on DEX as non-covered by Palmetto-Medicare-MolDx. Seems like that would be a Catch-22 which could annoy someone significantly.
Below is an actual example of a test that is publicly listed by "Palmetto MolDx Medicare" as not covered, on the DEX website, but the very same test is also excluded from the MolDx scope and tech assessment and LCD review process by "Palmetto MolDx Medicare." Ouch.
4. Article Appears to Define MolDx Scope, but Variance Occurs
Article A56853 says that its code lists define the codes that apply under MolDx ("This addition and deletion is due to coding that is applicable to the MolDX program," quote-unquote.)
However, MolDx has recent and active LCDs in infectious disease (e.g. LCD L37315 governing code 87631 per article A57340), and has even held a 2021 advisory panel on infectious disease (here). But, like proteomic codes, DNA RNA infectious disease tests appear to not be codes that MolDx views as active under MolDx per the MDT LCD and its code-list article.
I think at the end of the day, MolDx is helping us understand that it focuses on DNA RNA tests, while reserving the right to contribute its staff expertise to other MACs in the MolDx consortium on other types of tests.