The MolDx program issued a number of LCDs for review in May 2021, and on May 19, 2022, three were released in final form. This set of LCDs will be effective July 2, 2022.
The three topics are:
- MOLDX: Melanoma Risk Stratification Molecular Testing - L37725 here.
- MOLDX: Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer - L38985 here.
- MOLDX: LDTs for Inherited Cancer Syndromes in Patients with Cancer - L38966 here.
LCD numbers vary in different MolDx jurisdictions (e.g. Noridian). For each of the above LCDs, you must also scroll to the bottom of the LCD to find the associated billing & coding article. In addition, each LCD links to a Q&A from the public comment period.
I've put all the LCDs, the associated billing and Q&A articles, and also a Word REDLINE of the final version, in a cloud zip file. Find it here:
Some highlights of the LCDs:
L37725 Melanoma Stratification
This LCD is several years old, focused on a Castle melanoma test for risk for lymph node biopsy. It was released in May 2021 with an unusual paragraph highlighting some debates in the dermatology literature about the use cases for this testing, and a solicitation of public comment. The final LCD had no significant changes, but includes a 57 page public Q&A document. The LCD is an umbrella that can cover similar tests, such as the Skyline Merlin test. (Which is covered, at $3200, in the separate DEX registry here.)
The LCD is 14 pages long with 49 references. A redline version shows several paragraphs added to the discussion but few other changes.
L38985 Prostate Stratification
This LCD is 12 pages with 63 references, and the public Q&A document is 23 pages. The LCD lists two use cases, to inform the decision to biopsy at all (e.g. what to do with a PSA of 5) and tests that are performed when a prostate biopsy is negative but there is a high suspicion of a false negative.
Note what is not included. The Opko 4KScore test fits the first use case (the PSA of 5) but it's not a molecular test, so it doesn't fall under MolDx. Veracyte/Decipher and Oncotype Prostate and other tests are used after a cancerous biopsy (or resection), and therefore are downstream of the use cases covered by this LCD. There are 11 rules (e.g. "test is ordered by...a urologist or oncologist.")
The billing article A58700 lists two tests "which are performed in the post biopsy setting," a urine test Progensa and the Confirm MDx FFPE test.
A redline review shows that this was the most-extensively-altered LCD between draft and final.
L38966 Cancer Hereditary Genetics
This LCD is only 7 pages long but has 43 references. Much of the decisional material is delegated to the billing article (A58652 17pp). The Q&A A59058 ran 24 pages long.
Historically Medicare has basically covered risk testing as BRCA testing (and related genes) after a diagnosis of cancer with increased family risk, or Lynch syndrome testing in colorectal cancer patients. This foundational or umbrella LCD is pretty generic - patients must have "a cancer diagnosis, a clinical indication for testing, a risk factor for germline inherited cancer," and "not tested for the same content." MolDx lists the required variants to test in associated online forms (see the MolDx website tech assessment template section) and "the test has well established guideline based evidence." This allows a lot of opportunity for expansion as guidelines change.
Hereditary cancer genetics falls under some controls added in 2019 to NCD 90.2, NGS cancer tests (whether of tumor or germline).
The structure of the billing article is simple, listing a single block of pertinent codes (e.g. the codes for HBOC like 81432 and the codes for LYNCH like 81435) and then listing a very long range of cancer ICD10 codes.
Note that while the LCD points to "well established guidelines" neither the LCD nor the billing article enumerates any particular objective risk factors that have always been found in BRCA LCDs, such as a particular constellation of risk factors, number of relatives with which cancer, etc, which would allow BRCA coverage. In contrast, the prostate LCD lists 11 highly granular and meticulously redlined and specific rules for test coverage, about as perplexing to work through as as crossword puzzle. Turn to BRCA and Lynch testing, and the rules evaporate in this version of a BRCA/Lynch LCD except for a call out to "well established guidelines."
The LCD for hereditary cancer syndromes requires a personal history of cancer and LCDs usually pair that with a family history of cancer. To my eye, a very close reading of NCD 90.2 does not require a family history of cancer, since the named and allowable risk factors cited in the NCD can be as generic as "aging" instead of as particular as a "high family incidence."
In principal, you might think the LCD would apply coverage to any type of inherited disorder with strong guidelines (e.g. why not cardiology genes ) but note that the title of the LCD is for cancer syndromes only.