Friday, May 21, 2021

MOLDX: New LCDs and LCD Proposals - May 2021

CMS runs a database of national and local coverage decisions, which includes a "What's New" weekly update report for LCDs and Articles from MACs.   This website lists both newly completed LCDs and newly proposed ones.  Here.

I noted a flurry of MOLDX activity.  Note that MolDx LCDs and articles appear at four different MACs (Palmetto, Noridian, CGS, WPS) and each has its own timing.   For example, at one MAC a proposed LCD might appear two weeks later, so at that MAC its comment period runs two weeks later as well.

Here's a What's New listing, and I also put all the items into one Zip file in the cloud here.

  • DL37725 - Melanoma Risk Stratification Molecular Testing.
  • DL38966 - NGS LDTs for Inherited Cancer Syndromes.
  • DL38988 - Multiplex NAAT Panels for Infectious Disease Testing
  • DL38985 - Biomarkers to Risk-Stratify Patients for Prostate Cancer
  • L38671 - Molecular Testing for Organ Allograft Rejection
    • Here.
    • A58170, Billing and Coding for same, here.\
    • Existing Allosure LCD L38255 has simultaneously been scheduled for Retirement on 6/5/2021.  Here.
  • L38645 - Phenotypic Biomarkers for Circulating Tumor Cells
    • Here.
    • A58185, Billing and Coding for same, here.
    • A58782, Response to Comments for same, here.

General Comment

Overall, these policies represent umbrella policies (sometimes called foundational LCDs) that outline general criteria for a class of coverage.   

Tech Assessments Move from LCD Body to Private Documents.  Previous LCDs provided detailed tech assessments of particular tests, so you could tell (for example) exactly what the MolDx review required in domains like sensitivity, specificity, PPV, limit of detection, and so on..   Notably, now those evaluations go inside of internal technology assessments and are not publicly visible in the LCD body, or elsewhere.  

Covered Tests May or May Not be Named in Billing Article.  In addition, covered tests may appear in the billing article, or may not appear there.   (The billing article may only say that covered tests not otherwise named, should be submitted as 81479 unlisted code + Z code).  The point is: This makes it difficult for Medicare patients, their physicians, or other labs to know which tests are in fact covered, or, based on what performance.

If Covered Tests Aren't Named, and, TA is Not Published, The, How the Heck Do You Show You Are Equivalent to Covered Tests?   For a new entrant, difficult to know what the acceptable technical criteria for the covered tests for that LCD were, criteria that shall be met or exceeded, if the covered test is not named in the coding article and if its TA performance is private, not in the body of the LCD as before.   In order to write a dossier showing a new test is similar to a covered test.   Showing an incoming new test is similar to a prior covered test is the whole point (the raison d'etre) of these policies. 

Unlisted Codes - Limited Value for Public Health Researchers. 
While unlisted code use + Z codes are a key feature of MolDx claims processing, this does make it difficult for public health stakeholders and researchers to know year by year what tests for what purposes are being covered by Medicare; all the claims for different disorders and conditions aggregate under payments for code 81479.  Among many others, groups that use CPT utilization to understand Medicare trends include Katherine Phillips' group at UCSF (e.g. here) or Peter Neumann's group at Tufts (e.g. here).  You can count, study, and assess which Medicare patients got a tumor panel test if coded as 81455 or a PLA code, but not when coded as 8179 unlisted code.   (Unlisted codes also circumvent the PAMA rate setting process entirely.)

In More Detail

Please note, I am only summarizing highlights of coverage here and readers must see the full LCD (or draft LCD) for details.  TA = Tech Assessment (elaborate paperwork and spreadsheets submitted to MolDx).  

DL37725- Melanoma Risk Stratification
   The patient has a personal history of melanoma, AND T1b/T1a, AND evaluated for therapy, AND non-metastatic, AND has >5% chance of coming to sentinel node biopsy, AND as a tumor consistent with requirements for a particular test.   The test must be evaluated by technical assessment (TA) to have utility beyond conventional risk factors and performance similar or better than covered similar tests.

DL38966 - NGS Tests for Inherited Cancer

Note that this is an NCD, 90.2, that covers FDA approved NGS tests for both advanced cancer tumor testing and FDA approved NGS tests for inherited risk testing.   If not FDA approved, such tests fall  under LCDs.

Test is covered if it has completed a TA, and has the "minimum genes or variants" for its intended use and clinical decision making.  Genes and variants will change with evolving literature.  Remarks on non-duplicative germline testing.  Do not use NGS panel to confirm a variant that can be confirmed with a specific test.  Legacy tests not covered by TA yet must have TA by the effective date of this policy (likely 6-12 months in the future, it is a new draft policy).

This is actually a pretty radically different (postmodernist?) approach to an LCD.   At both Medicare and commercial payers, including current MolDx, there are careful lists of rules for when BRCA testing is covered (maybe 6-10 rules), when Lynch testing is covered, and so on.  Here, there is just an umbrella statement that for whatever diseases at risk, appropriate testing or panels are covered, having completed a TA.   

One point I am sure to hear from lab clients is, this sort of floating general statement without any specific facts is very hard for Medicare Advantages plans to implement, as they work to conform to regulations requiring MA plans to match Medicare coverage rules.   

It's also impossible for physicians and patients to read the LCD, as written, and know which genes are covered for which patients.   Or for public health experts to compare published policies of different payers and compare them in a table to this one.
Quite similarly, Novitas recently released a draft LCD that infectious disease panels are covered 'when they are timely and likely to influence care" - full stop.  Again, very hard as a rule that Medicare Advantage plans must copy and audit to. (DL38916).  And hard for labs to educate physicians in advance what is covered or not covered by their MAC.

DL38988 - NAAT Panels for Infectious Disease

Note that MolDx held an advisory public meeting on this topic in January 2021.

The critiera for this LCD are much longer than other LCDs and the full text should be read.  In addition to the link above for DL38988, I've cut and pasted the current draft text in a separate blog here.  Panels > 5 are covered in certain circumstances.   This LCD will replace current and quite narrow LCDs for respiratory and GI testing which have been protested by groups like IDSA and AMP.

DL39095 = Risk Stratification of Possible Prostate Cancer Patients

MolDx had previously had a number of separate LCDs for tests to handle ambiguous PSA levels and, if possible, avoid biopsy.  This consolidates coverage, when finalized in the future.  This only attempts to stratify patients who are being considered for a biopsy in the future.  Tests include 4KSCORE, ExoDX, EPI, and others.

Separately from this, MolDx also covers molecular tests to determine, post biopsy, if a prostatectomy is better than watchful waiting.


L38671 - Molecular Testing for Allograft Rejection

Covers both circulating DNA tests (e.g. Allosure) and expression tests to determine management of transplant patients.  "Intended use of the test must be: To assist in the evaluation of adequacy of immunosuppression, wherein a non-invasive or minimally invasive test can be used in lieu of a tissue biopsy..."

This umbrella policy will supercede L38255, Allosure and Equivalent Tests, which is being retired shortly, here.  CareDx was up 3% in morning trading (market cap +$115M), perhaps on information that the new replacement LCD held no surprises when finally published.  NASDAQ as a whole was up only +0.2%.

L38645 - Biomarkers in CTCs

Covers e.g. Her2 testing in CTCs rather than biopsy.  See Comments document; there were a large number of supportive comments.  Covered tests include Biocept HER2 and androgen receptor ARV7 tests (coding article A58185).

At a recent California Clinical Lab Association meeting, MolDx leadership noted that in the future, they planned to issue technical assessment templates specific to each foundational LCD, when required.  For example, if there is an future LCD for "ABC" clinical category, they will issue an excel spreadsheet or similar templates for how to submit a technical assessment of your test in ABC clinical category.  This should speed the review process and increase the uniformity of decisions.