Thursday, June 29, 2023

MolDx Finalizes Bladder Cancer Biomarker LCD L38576

MolDx has finalized a bladder cancer biomarker LCD ("Prognostic and Predictive Classifiers" that it proposed in July 2022.  The LCD will be effective August 5, 2023.

The LCD was "MAC initiated."

  • As a MolDx LCD, the LCD covers only DNA/RNA biomarkers.   (In this application, other types of biomarkers may ahve the same indications, but are NOT covered in this LCD).
  • The LCD was "MAC initiated" per its Tracking Sheet.
  • See the draft LCD here. DL38576.
  • See the final LCD here.  L38576.
  • See the "responses to comments" here. A59408.
  • See the Billing Article here
  • The LCD is about 2000 words (w/ Bibliography).  See a draft to final "redline" here.
    • The revisions are minor.
    • Text asking the lab to notify "indications" to the physician, is revised.
    • If NGS is used, conditions in NCD 90.2 must be fulfilled ("advanced cancer," etc.)
    • While several test brands are "covered," only 1 may be used  prior to therapy unless the 2nd is different genomic content and medically necessary in addition to the first.
    • The LCD adds a statement that NCCN "recommends molecular/genomic testing for Stages IVA, IVB," and "possibly IIIB."  
    • In addition the the guidance to Stage IV, the NCCN also is quoted as, "recommends that molecular testing be conducted early."
  • The billing article includes codes 81445 (5-50 genes in tumor), 0016M ("Decipher Bladder", a gene expression test), and 81479 (other genomic test).
Other Topics

  • LCDs vs Articles?
    • A current lengthy article at Genomeweb has multiple stakeholders discussing the ground between LCDs and Articles (here).  
    • Here, similarly, the LCD gives generalistic statements in its concluding section ("Numerous prior Medicare decisions consider the Fryback and Thornbury evidence hierarchy...For patients with bladder cancer, an array of treatment possibilities exist...Diagnostic tests are expected to change physician management."  
    • From these "concluding statements," MolDx discerns, crafts and periodically updates a billing article that covers and non covers various tests without further public discussion or public comment on their evidence.  
  • CGP? 
    • This LCD discusses CGP (Ross et al. 2016, 295 genes, 90% of cases actionable), and the LCD cites CGP genes like PIK3CA and ERBB2 and FGFR2.  
    • But bladder cancer CGP is also covered under rules found in the LCD for Comprehensive Genomic Profiling (e.g. L38158).   
    • And an FDA-approved bladder cancer test like Foundation Medicine would be covered not under this LCD, but under  rules at NCD 90.2, leading the reader to a third overlapping CMS document. 
  • Recurrence? 
    • MolDx has a different LCD (see A58376) that covers the Signatera bladder cancer recurrence test.
  • Other "biomarkers"?  
    • This LCD discusses "prognostic predictive" bladder cancer biomarkers but as a MolDx branded LCD, it covers only DNA/RNA testing.  
      • Some similar recurrence or prognostic indications are covered in an independent document at Noridian, See L36680 "Bladder tumor biomarkers" which certainly sounds by its title like an overlapping LCD.  
      • Unless you're up on your "MolDxology" and understand the quarter to quarter negotiations between Noridian and MolDx, you might not understand the different territory of the two bladder cancer biomarker LCDs and co-existing sets of rules, L38576/L36680.  Neither bladder cancer biomarker LCD points the reader to the other, as if they exist in unrelated universes.
  • Use of NCCN.
    • Recently, Novitas published an oncology NCD that relies heavily on external references sources like NCCN.   (See my blog here, but I understand there's a lot of stormy stakeholder pushback.)   MolDx also points heavily to external guidance in its pharmacogenetics LCD and its hereditary germline cancer syndrome LCD.  Here, for the bladder cancer LCD, in the Q&A A59408, MolDx makes this comment re NCCN.
      • While we acknowledge the NCCN Biomarker Compendium and find it a great resource the MolDx program performs an independent technical assessment to determine Analytical validity, Clinical validity and Clinical utility. 
      • We use the published literature and review it to determine the above criteria and do not rely exclusively on one source.
    • In contrast, the MolDx LCD L39017 inherited cancer syndrome LCD adopts this coverage rule, "The test includes the genetic content with definitive or well established guidelines."