Back in July 2022, the MolDx MACs put out draft LCDs on prognostic and/or predictie classifieres for bladder cancer.
The final LCD isout, effective August 5, 2023.
- Find L38647 Final, here
Note that recent coverage for Signatera Bladder MRD was added not to a bladder LCD, but rather to a general MRD LCD. And CGP tests seem to be covered under the general CGP LCD, where all the bladder codes C67* are payable for CGP.
Read the whole LCD - it's not long - but some key rules summarize as:
- Bene actively managed for bladder cancer.
- Bene matches the test population of the selected assay.
- Patient is either a candidate for multiple treatments [test will help] or patient is a candidate for therapies and test will predict resposen per a national concensus guideline.
- [I think you can separately get a CGP test via CGP LCD rules, subcategory bladder cancer]
- If NGS is used, follow special rules in NCD 90.2 (patient has advanced cancer and plans are being made).
- The test has AV CV and if an algorithm, it's validated.
- Test has demonstrated CV CU - and completes a MolDx TA - and only 1 test allowed unless add'l rules are met.
But Wait There's More
Scroll down for a Billing Article A58181 and a draft LCD Q&A A59452. Billing, one branded test is mentioned 0016M, Decipher Bladder. [Not to be confused with the better known Decipher Prostate tests].
Cloud Redline
I've put a redline of the draft / final online in the cloud, quite a few edits.
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| comparing and redlining goes on |
Mixed Methods
There are multiple tests for handling bladder cancer, FISH (UroVision), proteomics, cytology, cystoscopy. This MOLDX LCD I would expect carves down to only DNA RNA tests, rather than discuss the condition and its Medicare coverage options in one coordinated way.
