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Patients Bear the Brunt of CMS Restrictions Introduced Over a Year Ago that Limit Access to Rejection Monitoring Blood Tests Unless Tied to an Invasive Biopsy

26 Doctors Pen Letter to CMS Administrator Brooks-LaSure Urging Immediate Restoration of Coverage for Blood Test that Catches Early Signs of Rejection

WASHINGTON, April 16, 2024 /PRNewswire/ -- The Honor the Gift Coalition, representing organ transplant patients across the nation, raises the alarm after over two dozen leading transplant clinicians sent a letter to the Centers for Medicare & Medicaid Services (CMS) Administrator, Chiquita Brooks-LaSure, detailing the negative impacts of Medicare policy changes made by a private contractor, MolDX, in March 2023. Most detrimentally, the changes hinder expert transplant doctors from using non-invasive post-transplant blood tests for surveillance unless an invasive biopsy would otherwise have been performed, eliminating a key benefit of the tool, and removing surveillance testing altogether for community nephrologists who don't perform biopsies. Clinicians are now reporting a distressing rise in rejection events among organ transplant recipients, an uptick believed to be associated with these restrictions.

The tests, including donor-derived cell-free DNA (dd-cfDNA) and gene expression profiling (GEP), have been pivotal in early detection of organ rejection, enabling swift interventions to help extend the life of transplanted organs. The billing restriction is directly counter to long-standing coverage, mounting clinical evidence, and clear guidance from the transplant community about the importance of these tests for monitoring organ health.

"While CMS and MolDX repeatedly asserted that there had been no change in coverage policy, CMS recently admitted there was a staggering 50% reduction in the ordering of these vital tests that catch early signs of transplant rejection following the imposition of the new restrictions. A year after the restrictions, we fear that many patients are now actively facing organ rejection, or are at increased risk, due to these policy constraints," said Steven Potter, MD, Professor of Surgery at Georgetown University School of Medicine. "This not only affects patient well-being but also runs counter to the shared national goal of enhancing the success rate of organ transplantation. Now more than ever, transplant providers should be empowered to order these essential tests for patients without being hamstrung by a policy that ties their hands."

Layal Abdel Rahman, MD, Medical Director of the kidney transplant program at the Transplant Institute of Florida, shared the devastating impact on her patients: "Prior to the billing change, my center was giving donor-derived cell-free DNA tests every three months to all kidney transplant patients as a part of their ongoing care. Once the restrictive guidance came out, we stopped using the tests for surveillance, and could only use them if patients were experiencing symptoms. That has backfired—we currently have three patients in severe rejection, which is very unusual for our center. If we had continued giving the tests regularly, we would have detected the rejections earlier, while there was still time to intervene."

Further, as the nation works to expand access to transplants, there is a pressing need to engage community nephrologists in long-term, post-transplant care, a practice impeded by the current changes. Community nephrologists, who are now restricted from ordering non-invasive testing methods for surveillance since they do not perform biopsies, are significantly disadvantaged by these changes. Independence from biopsy for transplant surveillance is vital because it offers early detection of potential rejection episodes and more personalized and targeted management strategies, in addition to being a safer, less invasive, and cost-effective method. These limits on non-invasive testing jeopardize the survival of transplant recipients and their transplanted organs.

Additionally, The American Association of Kidney Patients (AAKP), the nation's largest kidney patient organization, recently released a special report exposing an alarming new disparity for kidney transplant patients caused by MolDx and Medicare. BlueCross BlueShield of South Carolina, the parent entity of MolDX, extended comprehensive access to these same critical blood tests for its private insurance beneficiaries with organ transplants, while its MolDx subsidiary, responsible for issuing Medicare coverage decisions, did the exact opposite. This new disparity between private and public transplant healthcare coverage is unjust and leaves many vulnerable patients trapped in a dangerous coverage gap.

Transplant clinicians, with the strong support of a growing coalition of allies including the Honor the Gift coalition, the Health Equity in Transplantation Coalition (HEiTC) and AAKP, implore CMS to immediately engage transplant care providers and patient advocates to devise policies that better protect the long-term health of transplant recipients and their life-saving organ transplants. Their united concerns are escalating in advance of a pending CMS decision on a draft Local Coverage Determination (LCD), which could formalize the restrictions imposed in March of 2023 —restrictions that transplant clinicians across the nation believe will be detrimental to patient care.

Lawmakers from both sides of the aisle have weighed in. In August, a bipartisan letter signed by 14 members of the House of Representatives led by Reps. Anna Eschoo (D-CA) and Dr. Michael Burgess (R-TX), expressing concerns about the March rollbacks was sent to CMS and earlier this year, Congressional Black Caucus Chair Steven Horsford also raised this issue in a letter to CMS and the Department of Health and Human Services.

The coalition remains hopeful that CMS will align its policies with the on-the-ground realities of patient needs and the expertise of transplant professionals.

Stephanie Wight

(301) 512-5583

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SOURCE Honor the Gift