NEW YORK – The MolDx program on Thursday opened a public comment period for proposed changes on a draft local coverage decision for solid organ transplant molecular testing.
The public comment period runs from Aug. 10 to Sept. 23 and Medicare Administrative Contractor Noridian will hold a public comment meeting on Sept. 18.
In a statement on Friday, CareDx said it "is pleased that MolDX is providing the public with the opportunity to participate in an open and transparent process, as advocated by CareDx and many others across the transplant community."
The Brisbane, California-based company added, however, that although MolDX continues to recognize the value of surveillance testing "in certain scenarios," in the proposed LCD, along with other uses for such tests in the transplant space, "the proposed LCD would change the existing LCD to inappropriately restrict coverage in a manner similar to the restrictions that CareDx believes were impermissibly introduced in the Medicare Billing Article revisions issued on March 2 and May 4, 2023."
The draft text notes that all proposed revisions are made for clarity only and that there is to be "no change in coverage."
Proposed revisions include no longer requiring a physician to hold affiliation with a transplant center and covering molecular testing "in lieu of" surveillance tissue biopsy only as often as a surveillance tissue biopsy would have been covered.
A significant sticking point for organ transplant stakeholders in the previous LCD was the requirement that that only one test per patient encounter would be covered unless a second test was deemed "reasonable and necessary." This, some thought, arbitrarily restricted the testing that a physician could order during a patient encounter.
The new proposed text strikes out the language covering conditions for a second test, stating only that "For a given patient encounter, only one molecular test for assessing allograft status may be performed." The proposed language clarifies that the LCD covers "molecular" tests
The draft LCD states that the changes were MAC initiated, although numerous stakeholders have been voicing complaints, concerns, and requests for clarification following the publishing of the previous billing article.
Billing article changes related to this LCD have caused widespread confusion among transplant stakeholders and significantly impact CareDx's business. The company withdrew full-year financial guidance earlier this year, for instance, while it worked to implement the operational changes needed to comply with all revisions.
"While CareDx welcomes an open process for gaining public feedback on the proposed LCD as required by CMS rules, we are disappointed in the way the coverage policy was changed with two billing articles issued in the six months prior to this proposed LCD," said Reg Seeto, CEO of CareDx. "This has created unnecessary clinician confusion, chaos, and disruption to patient care."