NEW YORK — The US Centers for Medicare and Medicaid Services said Friday that Medicare administrative contractors have backed off finalizing a proposed local coverage determination issued a year ago covering noninvasive blood-based surveillance testing for solid organ allograft rejection.
In a statement, CMS said the decision was based on "response to public comments and upon further review of the evidence," and in the coming months, the MACs will issue a new LCD with a chance for the public to comment on the new proposal.
As a result, coverage of blood tests for monitoring organ transplantation rejection when ordered by physicians will not change. Patients with transplanted hearts, lungs, or kidneys who meet Medicare's current LCD criteria can continue to access tests such as CareDx's AlloSure, AlloMap, and HeartCare tests if there are signs or symptoms of transplant rejection and following a physician-assessed pretest, including for surveillance testing, CMS said.
Additionally, the blood-based testing must follow an indeterminate biopsy or be used as a replacement for biopsy as determined to be appropriate by a physician, or it is being used to evaluate the adequacy of immunosuppression.
While the LCD that the MACs are backing away from was proposed in August 2023, the transplantation field began signaling its disapproval of the forthcoming LCD months earlier when Palmetto MolDx updated a reimbursement guidance for molecular tests assessing rejection risk in solid organs. Among other things, the billing article aimed to reimburse only one test per patient encounter, provide new coding to define surveillance and for-cause testing, and redefine acceptable surveillance testing as compliant only for patients enrolled in centers that use surveillance protocols and would otherwise receive such testing.
Also, unless the tests were used in place of a biopsy or to confirm a biopsy result, the test would no longer be reimbursed.
While revisions were made to MolDx's guidance when the updated proposed LCD hit a year ago, some still were troubled by MolDx's plan. CareDx in May 2023 said MolDx's reimbursement guidance caused the firm to miss its first quarter 2023 revenue targets and to withdraw its financial guidance for 2023.
On Friday, the Brisbane, California-based developer of organ transplant tests cheered the new decision by the MACs.
"We appreciate the [CMS] and its local contractors for listening to the voices of thousands of patients and clinicians who tirelessly advocated for access to noninvasive surveillance testing based on its clinical utility in detecting early signs of rejection," CareDx President and CEO John Hanna said in a statement. "We believe their efforts were instrumental in restoring longstanding Medicare coverage."
On Monday, investment bank BTIG upgraded its rating for CareDx to Buy from Neutral and established a price target of $40 per share on the news of the MACs' action. "While we need to wait for the final LCD to get more certainty, our sense is that [CareDx] is likely to increase volumes of surveillance testing over the coming quarters, and in aggregate," BTIG analyst Mark Massaro wrote in a note to investors.