CMS Drops Controversial Proposal for Blood Tests After Organ Transplant

The Centers for Medicare & Medicaid Services (CMS) dropped a proposed policy to further delineate Medicare coverage for the types of blood tests that organ recipients often get to monitor for rejection, the agency announced.

“The Medicare Administrative Contractors (MACs) have carefully considered all the feedback received from interested parties regarding the MolDX: Molecular Testing for Solid Organ Allograft Rejection proposed local coverage determination (LCD),” CMS said in a statement last Friday. “In response to public comments and upon further review of the evidence, the MACs are not finalizing the proposed LCD issued on August 10, 2023. Due to the importance of identifying solid organ allograft rejection early and to ensure the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months.”

Asked exactly when the new LCD might be forthcoming, a CMS spokesperson did not answer but instead referred back to the statement.

Under a previous coverage policy that has been in effect since 2017, Medicare covered two types of tests used by transplant surgeons to monitor their patients, explained Albert Hicks III, MD, MPH, section chief for advanced heart failure and transplant at the University of Maryland School of Medicine in Baltimore, at a press conference on the issue last December.

One test, the cell-free DNA test, “could predict problems with [the transplanted organ] — especially if it’s in rejection — weeks or even months ahead of actually showing clinical signs of damage,” he told MedPage Today. “And I could have negative biopsies before I actually see something positive. So that [blood test] allows me to treat before there’s actual physical damage to the organ.”

The other test, a form of gene expression profiling, “tells me if the immune system is revved up,” Hicks said. “Gene expression profiling actually looks at markers on the T cell, to see if it’s hyper- or under-active. So the combination of those two tests helps me to determine if I’m dealing with a rejection that’s mediated by the T cell, rejection that is mediated by the B cell, or damage to the actual heart itself from blockages in the heart.”

But on March 31, 2023, MolDX — a Medicare molecular diagnostic testing program administered by Palmetto GBA, a large Medicare administrative contractor — released an article on the CMS website entitled “Molecular Testing for Solid Organ Allograft Rejection.” That billing article, test advocates said, essentially changed what Medicare would cover, limiting doctors to a single test; Medicare would pay for that test only if it precluded the need for a biopsy — not if it was done for routine monitoring to make sure the organ wasn’t in the early stages of being rejected.

The article had immediate effect, Steven Potter, MD, of Georgetown University School of Medicine in Washington, D.C., said in a phone interview. “Testing volume dropped precipitously when the billing article was issued; there were 18,000 fewer tests over the 9-month span following the article,” meaning that testing volume dropped by about half, he said.

In August, after CMS got a lot of criticism for the article, the agency then issued a proposed LCD. The introduction to the document noted that Medicare “will provide limited coverage for molecular diagnostic tests used in the evaluation and management of patients who have undergone solid organ transplantation. These tests can inform decision-making along with standard clinical assessments in their evaluation of organ injury for active rejection (AR). These tests may be ordered by qualified physicians considering the diagnosis of AR, helping to rule in or out this condition when assessing the need for or results of a diagnostic biopsy.”

CMS said the LCD was issued because “over time, the [Medicare contractors] became aware of improper billing and overutilization of these tests.” The LCD, however, didn’t really clarify anything for providers or patients, according to Potter, who is also immediate past chair of the American Society of Transplant Surgeons Legislative and Regulatory Committee.

Then, in a September 2023 press release, the agency denied that anything had changed regarding coverage. “CMS confirms that neither CMS nor the MACs have made changes that affect patients’ ability to have blood tests used to monitor for organ transplantation rejection covered when ordered by their physicians in medically appropriate circumstances,” the agency said. “Patients with transplanted hearts, lungs, or kidneys who meet the coverage criteria for these tests … can continue to access these tests in place of a more invasive biopsy.”

After all of that confusion, the withdrawal of the proposed LCD “is a win and really encouraging to see that CMS listened to the voice of patients and transplant professionals and rolling back limitation on access to care,” Potter said. “But we’ve still got a lot of work to do.”

“First, educate patients and providers that access has been restored so they can then order tests for patients as appropriate,” he said. “And the second thing is, there’s another LCD coming out and another public comment period, and so it’s important that the community has its voice heard and stays focused on this issue.”

Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy & Commerce Health Subcommittee, called the decision a “significant victory.”

“Organ transplant patients depend on these blood tests to know whether their transplant is successful,” she said in a press release. “They offer a less painful and less harmful alternative to biopsies. I am very pleased that CMS changed course and will continue to cover such tests. This is a win for patients.”

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