Thursday, June 22, 2023

MolDx Finalizes "Molecular Prognostic and Predictive Classifiers" for Bladder Cancer (L38647)

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


The MolDx LCD has a set of rules for coverage that, one by one, tests may qualify under.  When a test qualifies, I believe its name will be added to the billinlg article.

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.  

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.