Honor the Gift disputes CMS' claim that there is no change in Medicare coverage of blood tests for monitoring rejection in transplant patients

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Sep 27, 2023, 08:00 ET

Medicare rollbacks proposed by private contractors fail to comprehend the effect on patients and physicians

WASHINGTON, Sept. 27, 2023 /PRNewswire/ -- Honor the Gift, a coalition representing organ transplant patients across the nation, along with other allied leaders across the transplant field, respond to the Centers for Medicare & Medicaid Services' (CMS) press release stating that "neither CMS nor the Medicare Administrative Contractors (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 Honor the Gift coalition finds this statement inaccurate and contradicted by patients and physicians nationwide. The changes announced on March 2, 2023, have alarmed transplant patients and clinicians across the nation, followed by an apparent decline in physician ordering of these vital blood tests¹. See recent Wall Street Journal editorials here and here.

On March 2, 2023, one of the Medicare coverage private contractors, or "MACs," MolDX, unexpectedly published, without public notice or public participation, a coverage article stating that it was "clarifying existing coverage" and said that Medicare would cover blood tests for "surveillance" only if the patient would otherwise receive a biopsy. The Honor the Gift coalition and allies dispute this assertion – this is not a "clarification" but a change in coverage policy.

Since 2017 and reaffirmed in 2021, the MACs publicly endorsed "surveillance" testing, that is using non-invasive blood tests when symptoms were not apparent or serious enough to justify the riskier and more expensive biopsies as an option. For example, in 2017, the MACs affirmed broad coverage for surveillance testing not tied to a biopsy, stating, "Since a biopsy is not frequently performed for surveillance due to its invasive nature, the use of [the molecular diagnostic test] may be performed at a frequency established for other non-invasive tests such as viral testing and donor-specific antibody testing¹." In 2021, the MACs expressly stated that they had added testing language "not tying its need to a biopsy"¹.

As a result of the MolDX coverage article issued on March 2^nd, the following statements show the effect on clinical practice and how transplant patients and physicians were forced to cancel their blood tests.

Patients whose tests were canceled included Margaret Gamble and Evan Dame. Margaret Gamble, 2x kidney transplant recipient, said, "Since the Medicare coverage guidance came out in March 2023, I haven't received my regular donor-derived cell-free DNA test – and this has left me in the dark about the health of my donated kidney. Losing my sister's kidney was devastating and necessitated that I go on dialysis for a year, at a cost that exceeded a hundred thousand dollars. There is no way a cost benefit analysis has been done in making the decision that has taken this surveillance tool from transplant patients."  

"The recent and discreet cutbacks to Medicare coverage saw the discontinuation of the phlebotomy service at my transplant center in George Washington University Hospital that was providing me with regular non-invasive molecular diagnostic blood tests to monitor my donated kidney," added Evan Dame, a kidney transplant recipient, "This has left me with an unsettling uncertainty about the status of my kidney health, forcing me to wait for overt symptoms before seeking an invasive biopsy." 

Clinicians have also shared they have stopped ordering the tests. Dr. Keith Melancon, Chief of the Division of Transplant Surgery at George Washington School of Medicine, said, "Before the Medicare coverage guidance, my center was giving kidney recipients seven surveillance tests in the first year following their transplant and then three to four tests per year in the following years. But after the change, we drastically cut down on the number of surveillance tests to just two in the first year and none in the following years, to match the number of surveillance biopsies we had been conducting before the coverage change."

Dr. Vasil Peev, Associate Professor of Medicine, Transplant Nephrologist, and Medical Director of the Living Donor Program at RUSH University Medical Center, added, "I read the billing article, coverage was changed, and I canceled tests for Medicare patients. I am disappointed with the new billing article that was released, as we are not able to provide the same level of care for kidney transplant recipients, which will lead to worse post-transplant outcomes and premature return of transplant recipients to dialysis."

That announcement – through what is called a coverage "billing article" – led to a bipartisan letter by 14 House Republicans and Democrats, led by Reps Michael Burgess, MD (R-TX) and Anna Eshoo (D-CA), who expressed broad congressional concerns to CMS about allowing a private contractor to effect a rollback of Medicare coverage potentially creating additional risks and anxiety for tens of thousands of transplant patients. Leading transplant medical associations also wrote to CMS strongly condemning the March Medicare rollbacks published by MolDX, agreeing that the Billing Article "dramatically and substantively change[s] the LCD by limiting access to these critical tests," especially impacts "patients in rural areas, and will negatively impact health equity," "significantly restricts physician's judgment in considering the best testing option for their patients and their individual circumstances," and "has the potential to both harm patients and increase costs to [CMS], without affording beneficiaries and stakeholders the statutorily required public comment period." See statements from the American Society for Transplant Surgeons, the American Society of Transplantation, and The International Society for Heart and Lung Transplantation. Furthermore, the American Association of Kidney Patients (AAKP), the largest independent kidney patient organization in the nation, has openly criticized the CMS action as being at odds with consensus national kidney priorities and patient-centered care.

Last week, the Wall Street Journal published an editorial critical of the policy change, especially the non-transparent process used by a contractor outside the government. Additionally, the Wall Street Journal published another editorial yesterday on the heels of CMS's statement, critical of this policy change as a cost-cutting move.

CMS in its statement says it is "committed to ensuring transplant patients with Medicare can access the coverage, care, and services they need" – Honor the Gift is committed to advocating for patients to ensure this happens. The concerns raised by patients, clinicians, and Congress emphasize the need for continued dialogue to restore longstanding Medicare coverage. Honor the Gift invites CMS and the MACs to engage in constructive discussions. The collective goal should be to create a policy that recognizes the value of non-invasive monitoring, prioritizes patients' health, and ensures the longevity of transplanted organs.