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CMS Clarifies Billing Article Revisions for Organ Transplant Rejection Testing

NEW YORK – The Centers for Medicare and Medicaid Services (CMS) issued a statement on Thursday to clarify recent changes made to solid organ transplant test coverage and to allay public concern that billing article changes made last year would deny some patients access to coverage in certain cases.

CMS explained in its statement that the billing article changes implemented in March of last year were intended to reduce overutilization and clarified that transplant rejection tests "remain available to patients when medically necessary and ordered by a physician" and when billed in accordance with the local coverage determination (LCD).

That clarification might allow physicians greater freedom in determining which tests to order, particularly in the case of surveillance testing.

The earlier revised LCD limited reimbursement to one test per patient encounter, provided new coding to define surveillance and for-cause testing, redefined acceptable surveillance testing as compliant only for patients enrolled in centers that utilize surveillance protocols and would otherwise receive such testing, and eliminated reimbursement of for-cause tests unless used in place of a biopsy or to confirm biopsy results.

The changes sowed confusion and concern among stakeholders across the transplant space, with many worrying that equitable access to testing would be restricted as a consequence.

Particularly with respect to surveillance coverage, the previous revisions suggested that such tests would only be covered in the case of transplant centers that also performed surveillance biopsies, effectively eliminating community nephrology coverage, where biopsies are not done.

The earlier revisions also limited multimodality testing, which had a particularly strong impact on CareDx, as that company's business focuses entirely on organ transplant, compared to more diversified competitors such as Natera. The multimodality test limitations restricted access to CareDx's HeartCare product, contributing to weakened financial results over the past year.

The newly revised article specifically lists the tests it covers, which comprise AlloMap, AlloSure, and HeartCare, from CareDx; Natera's Prospera; NephroSant's QSant; Transplant Genomics' TruGraf; Eurofins' Viracor TRAC; and Oncocyte's VitaGraft/Allaro Kidney.

The article now states that these tests "have completed a MolDx technical assessment and are deemed compliant with policy. However, the tests must be billed in accordance with the specific required indications/coverage criteria outlined in the policy."