Thursday, August 22, 2019

Very Brief Blog: MolDx Releases Bonanza of New Proposed LCDs

On August 21, 2019, MolDx released a bonanza of new LCDs for public review and comment.   See further below where I put a ZIP file of all 13 LCDs in the cloud for downloading.

How to find the LCDs directly:
  • Start on the PalmettoGBA MAC Policy Page, here.
  • Click on "Proposed LCD Status Report"
  • This takes you to a web page with several dozen proposed or recently completed LCDs.
  • I suggest clicking on the column header, "Comment Period Start Date" and setting the View Items Per Page to 100.
  • While it looks like there are 19 new LCDs of all types, there are specifically about 13 that are MolDx molecular LCDs.
    • Note in particular there are two interacting LCDs on pharmacogenomics, both DL35633 and DL38294.
Here's a short tally:
  1. DL38255, AlloSure cfDNA Testing (Heart, Kidney)
  2. DL35633, Combinatorial Pharmacogenomics
  3. DL38292, Decipher Prostate, Favorable Intermediate Risk
  4. DL37725, DecisionDx Melanoma
  5. DL38240, Molecular Erythrocyte Typing
  6. DL38258, "Molecular Microscope" [transplant], Heart
  7. DL37701, Oncotype DX AR V7, Prostate
  8. DL38294, PGx Test [non combinatorial]
  9. DL38238, "Razor 14 Gene Lung Cancer Assay"
  10. DL38274, Repeat Germline Testing
  11. DL38242, SelectMDX, Prostate
  12. DL38290, Signatera Minimum Residual Disease, Colon Cancer
  13. DL38260, Allograft Kidney Biopsy Tissue: Genomic Tests for Rejection
Cloud Zip File for You

Saving readers a huge amount of clicking and pecking, I put all 13 LCDs in a public Zip file in the cloud, HERE.

What It Means

It will take time to assess all of these.  A few early take home lessons:
  • In psychiatric gene panel testing, both Myriad GeneSight and Althea NeuroIDGenetix are covered.   
    • It appears restrictions on psychiatrist ordering are continued (coverage for GeneSight, NeuroIDGenetix, when ordered by a psychiatrist.)
    • In contrast, United Healthcare will newly cover this type of testing ordered by any provider (here).
    • The FDA-based kerfuffle about PGx testing (here) occurred well after these LCDs were locked down.
    • While it's unclear if FDA could/would actually require Myriad to strip drug recommendations out of GeneSight and report only CYP* genotypes, if FDA did that, the test wouldn't really continue to be the test as studied in trials (with red/green/yellow bins and guidance.)
  • Revised CareDx AlloSure LCD covers both kidney and heart testing using the donor organ cfDNA model..
  • Natera Signatera LCD covers serial use of MRD monitoring in colorectal cancer.  
    • This is a big deal for molecular diagnostics in clinical oncology.
    • Interestingly, Natera stock hadn't really moved by late morning eastern time, suggesting either the market had already incorporated this news in past weeks or a market inefficiency.
    • The Natera stock did pop around 5%, but not until after lunch Eastern Time - given LCD watchers a several hour window to use the buying opportunity.  
      • It doesn't take millisecond fiber optics.(*)
    •   (By 10:15 Myriad hadn't moved significantly either).
Note that since January 2019, all changes in LCDs must go into a public comment process, therefore, even relatively small expansions in coverage trigger a new draft LCD.  For example, I can't tell what the update is to DL38292, I'm pretty sure I've seen this LCD title before.

The LCD authors, particularly in PGx LCDs, place a lot of weight on trial population > 65, and a lot of adverse weight on any changes in analysis plan relative to original study design.  They will look up your 5-year-old entry and read it with a magnifying glass.


These LCDs will go through the several MolDx MACs (Noridian, etc) for public comment.  There will be a public open meeting for Palmetto JM on October 7, 2019, which will trigger a 45 day public comment period October 7-November 21. 

It usually takes at least several months after the close of public comment for MolDx to post final LCDs, which in turn, have a 45 day period before they are effective.  Therefore, expected typical effective dates could easily begin in February or March 2020, although MolDx could (hypothetically) move somewhat faster.

Timelines for LCDs

Generally, these LCDs would have been under review at MolDx by April or May 2019.  They would have been finalized in June or early July.  They would have been reviewed by CMS for up to 21 days in July 2019.   They would be completely locked down several weeks before the August 22 posting.   Considering public comment at multiple MACs, the final effective dates are very likely to go out into 1Q2020 or even 2Q2020

Add these up, and the total timeline from meetings and presentations and dossiers, to final active LCDs, approaches a full year.

Fun Facts

The LCDs average 12 pages long (12.3 ±  SD 4.3) with a range of 9pp to 24 pp. There are 160 pages of draft LCDs here.

In the Signatera policy, it is noted that "a series of assays comprises a single test."  Similarly, in article A56322 for ClonoSEQ, a series of assays comprise a single test.

In the Signatera policy, there is also language that defines certain postsurgical patients as "not known to be with cancer."   This relates to the CMS NGS NCD 90.2, which governs NGS testing in patient "with cancer" and provides rules about possible LCD NGS coverage in advanced (stage 3,4) versus non advanced cancer. 

Presumably, by analogy between CRC and breast cancer, a patient with Stage 1 or 2 personal history of breast cancer and post lumpectomy, would not be a patient "known to be with cancer" at the time of BRCA testing.   This would mean a Stage 1/2 breast cancer patient could get NGS testing, postsurgically, since she is "not known to be with cancer," but if she was known to be with cancer post lumpectomy, it would not be local cancer, it would be advanced, and therefore she could also get NGS testing.  (Whew).


*Natera.  Stock popped at least +4% several hours after the LCD news was released.  That's circa $100M of market cap.  You would not have needed nanosecond fiber optic cables to catch that particular wave.

For more about trading responses on Day 1, here.

Natera, 8/22/2019

For an August 27 article at MedTechDive on how payers are reacting to an earlier favorable psychiatry PGx policy from United Healthcare, here.