WSJ Critiques MOLDX vs BCBS (Feb 22 2024) 

https://www.wsj.com/articles/medicare-kidney-transplant-blood-tests-moldx-palmetto-bluecross-blueshield-b514102e?mod=hp_opin_pos_6#cxrecs_s

The BCBS policy is very, very easy to read

https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external/external-policies/transplant-rejection-testing/

It is hard to tell that the surveillance testing is NOT covered from the Medicare policy

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38582&ver=7

BCBS TEXT

For single-kidney transplant recipients who are 18 years of age or older and who are at least 14 days post-transplant, the use of donor-derived cell-free DNA tests (e.g., AlloSure Kidney) to assess the probability of allograft rejection is considered MEDICALLY NECESSARY at the following frequency:

Once per month for individuals who are 1 – 4 months post-transplant.

Every 3 months for individuals who are greater than 6 months post-transplant.

BUT

For kidney transplant recipients with stable renal function, the use of peripheral blood microarray-based genomic tests that analyze gene expression profiles to rule out kidney transplant rejection (e.g., TruGraf) is considered NOT MEDICALLY NECESSARY.

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MOLDX TEXT

Molecular diagnostic tests that assess a transplanted allograft for rejection status are covered when ALL of the following criteria are met:

• The test must provide information about at least on of the two following clinical status determinations:
  • AR status
  • Cellular or Anibody-mediated rejection (ACR or AMR) status
• The tintended 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 in a patient for whom information from a tissue biopsy would be used to make a management decision regarding immunosuppression, OR
  • As a rule-out test for AR in validated populations of patients with clinical suspicion of rejection with a non-invasive or minimally invasive test to make a clinical decision regarding obtaining a biopsy, OR
  • For further evaluation of allograft status for the probability of allograft rejection after a physician-assessed pretest, OR
  • To assess rejection status in patients that have received a biopsy, but the biopsy results are inconclusive or limited by insufficient material.
• The test demonstrates analytical validity (AV), including an analytical and clinical validation for any given measured analytes, and has demonstrated equivalence or superiority for sensitivity or specificity (depending on intended use) of detecting allograft rejection to other already-accepted tests for the same intended use measuring the same or directly comparable analytes.
• Clinical validity (CV) of any analytes (or expression profiles) measured must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population. The degree of validity must be similar or superior to established and covered tests (see associated coverage Articles). If conducted with concordance to tissue histologic evaluation the Banff Classification for renal allografts or other accepted criteria (if existing) for other organs must be used.
• The test is being used in a patient who is part of the population in which the test was analytically validated and has demonstrated CV.
• For a given patient encounter, only one molecular test for assessing allograft status may be performed UNLESS a second test, meeting all the criteria established herein, is reasonable and necessary as an adjunct to the first test.
• For minimally or non-invasive tests, the benefit to risk profile of the molecular test is considered by the ordering clinician to be more favorable than the benefit to risk profile of a tissue biopsy, or a tissue biopsy cannot be obtained. For example, this may be the case if a biopsy is considered medically contraindicated in a patient.
• The test successfully completes a Technical Assessment that will ensure that AV, CV, and clincal utility criteria are set tin this policy are met to establish the test as REasonable and Necessary.