The Centers for Medicare and Medicaid Services (CMS) Proposed Policy The department announced it would provide further clarification on Medicare coverage for the types of blood tests that organ transplant patients often undergo to monitor for rejection.
“Medicare Administrative Contractors (MACs) have carefully considered all feedback received from stakeholders regarding the proposed Community Coverage Decision (LCD) for MolDX: a molecular test for solid organ transplant rejection,” CMS said. It said in a statement It was announced last Friday: “In response to public comments and after further consideration of the evidence, the MAC will not finalise the proposed LCD issued on 10 August 2023. Given the importance of early identification of solid organ transplant rejection and to ensure further opportunities for the public to comment on the policy, the MAC intends to issue a new LCD in the coming months.”
Asked exactly when the new LCDs will be available, a CMS spokesperson did not respond and referred to a statement.
Under previous coverage policies, in place since 2017, Medicare covered two types of tests that transplant surgeons use to monitor patients, Albert Hicks III, MD, MPH, chief of the division of severe heart failure and transplantation at the University of Maryland School of Medicine in Baltimore, explained at a press conference on the issue last December.
One test, cell-free DNA testing, is [the transplanted organ] In particular, in the case of rejection, this can occur weeks or even months before actual clinical signs of damage appear. Medpage Today“And it's possible for a biopsy to come back negative before it actually comes back positive. [blood test] It can be treated before any actual physical damage occurs to the organs.”
The other test is a type of gene expression profiling that “tells us whether the immune system is activated,” Hicks says. “Gene expression profiling looks at markers on the T cells to see if they're over-activated or under-activated. So the combination of these two tests can help us determine whether it's T-cell mediated rejection, B-cell mediated rejection, or even damage to the heart itself due to a blockage in the heart.”
However, on March 31, 2023, MolDX, a Medicare molecular diagnostic testing program run by Palmetto GBA, a large Medicare administrative contractor, The article was published The test is listed on the CMS website under the title “Molecular Test for Solid Organ Transplant Rejection.” Testing advocates say the billing provision essentially changes Medicare coverage, limiting doctors to a one-time test, and that Medicare would only pay for the test if it eliminates the need for a biopsy, not if it's done for routine monitoring to make sure the organ isn't in the early stages of rejection.
The provision had an immediate effect, said Stephen Potter, MD, of Georgetown University School of Medicine in Washington, D.C., in a phone interview. “When the bill was issued, testing dropped precipitously. In the nine months after it was issued, testing dropped by 18,000,” he said, meaning testing was cut by about half.
In August, CMS announced that after receiving a lot of criticism for the article, Issued the proposed LCDThe document's preamble states that Medicare “will provide limited coverage for molecular diagnostic tests used in the evaluation and management of patients receiving solid organ transplants. These tests, along with standard clinical evaluations, aid in decision-making in the evaluation of organ damage due to adverse organ rejection (AR). These tests, ordered by a licensed physician considering the diagnosis of AR, can help rule out this condition when evaluating the need for and results of a diagnostic biopsy.”
CMS said it issued the LCD because “over time, [Medicare contractors] “We found improper billing and overutilization of these tests.” But Potter, who is also former chair of the American Society of Transplant Surgeons' Legislative and Regulatory Committee, said the LCDs didn't actually reveal anything to providers or patients.
after that, Press Release September 2023But the agency denied that anything had changed regarding coverage. “CMS confirms that neither CMS nor MAC have made any changes that would affect patients' ability to receive covered blood tests used to monitor organ transplant rejection when ordered by a physician in medically appropriate circumstances,” the agency said. “Heart, lung, and kidney transplant patients who meet the coverage criteria for these tests will continue to be able to receive these tests in lieu of more invasive biopsies.”
After all that confusion, the withdrawal of the LCD proposal is “a victory and really encouraging that CMS has listened to patients and transplant professionals and reversed the restrictions on access to care,” Potter said. “But there's still a lot of work to be done.”
“First, to let patients and healthcare providers know that access has been restored so they can order appropriate patient testing,” he said, “and secondly, a new LCD has been published with a new public comment period, so it's important that the community speaks up and stays focused on this issue.”
Rep. Anna Eshoo (D-Calif.), ranking member of the House Energy, Commerce and Health Committee, called the decision a “big win.”
“Organ transplant patients rely on these blood tests to know if their transplant was successful,” she says. stated in a press release“It's a less painful and harmful alternative to a biopsy, and we're thrilled that CMS has changed course and will continue to cover these tests. This is a win for patients.”
