Novitas LCD for Oncology - Specific Tests - Is Finally "FINALED"

Completeing a several-year saga, the Novitas LCD for oncology testing "specific tests" is finally "finalized" - and effective as of today, April 24, 2025.

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39365&ver=131&stateRegion=all&contractorNumber=all&proposedStatus=F&sortBy=noticeStart&bc=11

The take-home lesson is, it took Novitas three years (spring 2022-spring 2025, about 36 months) to non-cover several LDT tests, which could have been done, A to Z, in about six months.

Interpace to nix its Pancragen testing now.

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The LCD was released in January 2025 as "final,' but put "on hold" for the "Trump Administration to review" according to a press release by one company involved.

The LCD was started as a proposal in 2022, finalized in 2023.  But CMS put the radically-changed LCD on hold, and it entered a new comment period in summer 2023.   That versiin should have been "finalized" in summer 2024, but Novitas issued a delay notice.   One source commented that besides the LCD appeals, court actions had been filed along the way.

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The LCD has some quirks.  First, it states that the term "genomic" shall not be used, because it is too confusing.  It uses the word "genetic" to describe any kind of DNA-RNA test.   

The LCD was proposed as a broad LCD with many topics, and extensive references to outside sources (like NCCN) for coverage and non-coverage.   The final LCD is vastly restricted in scope and basically reviews about 7 named proprietary (branded) tests, many of which you've likely never heard of, and almost none of which are covered.  (The scope was narrowed by excluding some tests initially reviewed negatively, but not finalized because they weren't offered by labs in the Novitas region).

The authors write, for example, "Based on these factors, there is insufficient evidence to determine the clinical utility for DecisionDx-SCC."  (This test appears to be non-covered also under MolDx LCD L39583.)  However, the corresponding code is listed as an ADLT status (0315U) by CMS, part of which status requires a determination of coverage.

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UROVYSION (FDA FISH test) - Covered as listed.

NOT COVERED

• CxBladder
• Thyroseq CRC
• Pancragen
• Decision Dx SCC Castle
• Colvera
• PancreaSEQ