Thursday, March 28, 2019

MolDx Releases New LCDs, May 2019

MolDx has released a host of new LCDs, to be discussed at a May 6, 2019 open meeting (for the Palmetto MAC).   The LCDs will, over a future period of weeks, be introduced in each of the several MACs around the U.S. who participate in MolDx consensus policies.  For Palmetto itself, the 45-day comment periods run May 6-June 20.  May 6 is a public comment meeting in Columbia, SC.

See All LCDs in ZIP File in Cloud:  HERE

DL38043:  G360 Liquid Biopsy in Solid Tumors

Re-release of Guardant G360 LCD but now expanded from lung cancer to broader coverage in solid tumors, with notes the test use must ALSO be consistent with the CMS NCD 90.2 for use of NGS tests in advanced cancers.
DL38045: General LCD for NGS in Solid Tumors
This is a general LCD about next gen sequencing in cancer regarding when it will be viewed as compliant, or non-compliant, with NGS NCD 90.2, as well as local implementation rules.  This particular policy is stated to be only concerning solid tumors, not hematologic cancers, ctDNA, or germline testing.   It doesn't say those other areas are outside the NCD, it simply says they are outside this particular LCD's discussion of the NCD. 
LDT NGS tumor panels are covered *after* completing a MolDx technical assessment (the LCD refers to the MolDx website for details).  For example, if I read this correctly, the Sloan Kettering IMPACT gene panel test under MolDx would have the same coverage as the FMI F1 CDx test under the FDA-approval-oriented parallel review NCD.  Assuming only that IMPACT or a similar test passed the in-house tech assessment by the MolDx team.  I believe that the LCD won't list test names, but that a MolDx article would need to list test names so that Medicare Advantage plans could implement corresponding coverage.    
The only CPT code listed for NGS testing is 81479, not 81445/81455. 
DL38047: General LCD for NGS in Myeloid Cancers
This is a general LCD about the use of NGS LDT tests (non-FDA-approved tests) for actual or suspected myeloid malignancies.  This appears to be a "class" LCD, provided general rules, but requiring that any particular test ALSO successfully pass a MolDx test specific technology assessment.  
Leukemias had some difficulty under the CMS NCD which allowed payment only for advanced cancers that must be "recurrent, refractor, relapsed, or stage 3/4."   To resolve this, the LCD explicitly declares AML, MDS, MPN as "refractory or metastatic cancers" by definition.  Gene panel testing is also covered where a myeloid malignancy is "suspected," with cytopenia over six months and "other possible causes have been reasonably excluded."

DL38041: Natera Prospera Test for dd-cfDNA in Renal Rejection

Provides coverage for the Natera Prospera test for donor-derived cell free DNA (dd-cfDNA) in management of renal graft rejection.

Noridian LCD L37358 covers the CareDx AlloSure test for cfDNA.

DL38039:  TruGraf Gene Expression for Renal Rejection

Provides coverage for the TruGraf Blood Gene Expression Test (Transplant Genomics, Inc), which uses gene expression to identify renal graft rejection. (Last year, MolDx covered a different type of renal rejection test, from CareDx, which picks up donor graft DNA in patient blood).

DL38029, DL38035: Decipher Prostate - Intermediate Risk

Decipher Biopsy Prostate Classifier to be covered for men with intermediate risk disease.  This helps determine next clinical steps after an intermediate-risk biopsy.

Assay covered with separate criteria in two separate LCDs (!) - one for patients with "unfavorable" versus one for patients with "favorable" intermediate-risk biopsy.

DL38051: DermTech Pigmented Lesion Assay PLA

The DermTech Pigmented Lesion Assay (PLA) assess RNA expression in patient skin for atypical lesions to determine the need for a melanoma biopsy in a atypical lesion.

DL38037: InterAct Drug Interaction

Although not billed as a "MolDx" LCD, an interesting additional LCD does NOT provide coverage for separately coded and billed drug interaction testing.  See on the InterACT Rx software system which is paired with a blood assay for interacting (including non-Rx) substances.  See Aegis website here.

That totals nine different new LCDs.


Coverage of the Guardant LCD at Genomeweb, here.  The NCD provides LBx coverage for patients with a solid tumor which could require a drug with a genetic biomarker on the G360 panel.  Note, though, that larotrectinib is approved in any solid cancer with an NTRK mutation.

For a recent blog on the overall structure and clarity of MolDx LCDs, here.
One thing I noted in that blog, is fixed already.   I was concerned that MolDx LCDs ended, as required by CMS, with an "Analysis of Evidence" but previously MolDx limited this to a few words, like "Quality Moderate, Weight Low."  Nothing else.  That's not "analysis."  
These new LCDs now end with a one or two paragraph analytic discussion of the quality and meaning of the evidence vis-a-vis the coverage decision.  I think this is a big improvement.  My only remaining wish is that they'd provide a short description of what the heck they mean by their three terms, "Quality, Weight, Strength" and how each term specifically differs from another.  When can evidence have "high weight, low strength" for example.
LCDs Timed with PLA Codes

Two LCDs are timed with new April 2019 AMA PLA codes.  These are PLA Pigmented Lesion Assay, Dermtech (PLA 0089U), and MyPath Melanoma, Myriad (PLA0090U).

Formatting of Indication: One Place or Two?

In DL38029, DL38035, Decipher Prostate Biopsy Assay,  the LCDs open with a short description of general coverage (e.g. "to inform  treatment decisions...for men with unfavorable intermediate risk prostate cancer."   Detailed coverage criteria with multiple bullet points and "AND" logic statements appear at the end of the LCD body.

In contrast, the DL38051 PLA melanoma assay has a brief coverage description at the beginning immediately followed immediately by detailed coverage criteria.

LCD Data

The LCDs average 11 pages (included coding lists or boilerplate) and 23 citations, citation range 7-39.

Three Renal Transplant Tests - Indications

The two new, and one prior, molecular renal graft tests are compared in the table below:


Administrative Details: Open Meeting, Columbia, May 6

(Read the fine print at bottom of LCDs.)