Thursday, May 4, 2017

MolDX Issues New Draft LCDs for June 2017

On May 4, 2017, MolDx issued six new draft LCDs.

To access, go to the MolDx website here and click on "Draft LCD Status Report."  When you get to the resulting table, click on "comment period start date" to sort for the new June LCDs.

Topics include:
  • DL37264, EndoPredict Breast Cancer Gene Expression
  • DL37266, AlloSure Donor Derived Cell Free DNA Test
  • DL37330, Foodborne GI Panels Detected by Multiplex nucleic acid amplification tests (NAAT)
  • DL37258, Respiratory Viral Test Panels by NAAT
  • DL37260, Prometheus IBD-SGI Diagnostic Policy
  • DL37262, Oncotype DX Prostate for Men with Favorable Intermediate Risk for Prostate Cancer
Comment periods open June 5 (when Palmetto holds its public comment session) and close July 20.

PDFs filed in one cloud Zip file, here.

Very brief summaries are below.  For full details, see each LCD.
  • Endopredict, recently licensed in the US by Myriad, is covered in ER positive, Her2 negative breast cancer (0-3 nodes).
  • Allosure looks at cfDNA leaked by transplanted kidneys under immune attack; it is covered with ongoing clinical trial and outcome requirements.*  Stock price rose +40%.  
    • For an August 2017 press release on CareDx Allosure transplant test data, here.
  • The Oncotype DX prostate policy extends defined coverage into intermediate risk populations.
  • GI organism panel tests get detailed rules for limited coverage.  A number of test brands are cited (Hologic, BD, Nanosphere, Luminex, Biofire).
  • The respiratory panel LCD "is a non coverage policy for multiplex PCR respiratory panels." Luminex, eSensor, and Biofire panels are cited.
  • The Prometheus IBD sgi test policy is non-coverage.
Myriad has reported that Endopredict "significantly outperforms the first generation test," here.

CareDx's stock price opened Thursday at 87 cents, rising as high as $1.65 before closing at $1.20, +40%.   Market cap at close of day was $26M, suggesting about a $10M rise in market cap for the day.


* Based on changes in the past six months, the LCDs do not describe "coverage with data development" or "coverage with evidence development" (here) but MolDx LCDs may state that certain published studies with certain clinical outcome parameters will be expected - as in the AlloSure policy.


LCDs have a minimum comment period of 45 days.  There is no minimum or maximum time for additional contractor review after a comment period.  LCDs become effecdtive after a final version is posted plus another 45 day notice period.  Online manual here.

MACs "shall" hold an open public meeting for comments, and shall hold these before their CAC meeting, and shall allow interested parties including providers and manufacturers, to make presentations.  I thought that the LCDs must be posted some period (10 or 20 days) prior to the meeting, but I don't find that enumerated in the manual (  It would be perverse, say, to require registration 7 days in advance but announce LCDs 1 day in advance - but I don't see a written rule about this in the current manual.