Friday, October 23, 2020

MolDx (And Noridian) Finalize Prostate Cancer Tissue Prognostics LCD

Since May 2020, MOLDX watchers have often been perplexed by the new discrepancies between system-wide MolDx LCDs (in four MACs) and unique maneuvers of the western Noridian MAC which differ from final MOLDX decisions elsewhere.  See for example here.  

By late September, I felt confident enough to call a pattern (here).  

  • Noridian was declining to finalize LCDs from MOLDX that it felt were too specific to a single product. (In some cases, Noridian declined to finalize such an LCD even if MOLDX changed the headline title of the LCD).   
  • Noridian does go along with MOLDX, verbatim, when an LCD is clearly designed in a holistic way to cover a whole domain of test types.

Prostate LCD Finalized, From Specific to General

A good example is the finalization of last year's draft LCD DL38341.  The original title was, "MolDX: Decipher® Biopsy Prostate Cancer Classifier Assay for Men with Favorable Intermediate Risk Disease (DL38341)."   Note that there are at least three covered prostate cancer tissue risk classifiers - Myriad, Oncotype, and Decipher - but there are multiple context (biopsy tissue pre surgery, postsurgical resection tissue, before and after various definitive or invasive therapies).

DL3841 has now been finalized, even in Noridian, as " Prostate Cancer Genomic Classifier Assay for Men with Localized Disease (L38341)."  It comes with a Response to Comments document A58511.  It comes with a Billing and Coding article A57236.   I've made a redline comparing the text of DRAFT versus FINAL.

  • I've put the whole set in one zip file in the cloud, here.
    • See upper right hand "down" arrow to download zip.

The coverage article appears to provide equal coverage for 81541 and 81542, which are Myriad Prolaris and Decipher Bioscience, Decipher Test.  81541 is $3873 while 81542 has been in the 2020 gapfill process, recently given a price of $3159 (new, subject to appeal).  

Oncotype Prostate, 0047U, is not listed in the coding article A57236.  (Current fee schedule $3873).