National transplant patient and physician groups ask President Joe Biden and HHS Secretary Xavier Becerra to: "Stop private contractors from rolling back Medicare coverage of non-invasive blood tests to detect transplant rejection"

Medicare rollbacks proposed by private contractors to CMS ignore bipartisan congressional letter signed by 14 House members, led by Reps. Anna Eshoo (D-CA) and Dr. Michael Burgess (R-TX)

WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Honor the Gift, a coalition representing organ transplant patients across the nation, along with other allied leaders across the transplant field, held a press conference, calling on President Joseph R. Biden and Health and Human Services (HHS) Secretary Xavier Becerra to stop the current attempt by private contractors to rollback Medicare coverage of safe, non-invasive molecular blood tests that can allow for the early detection of organ rejection.

Medicare coverage for these innovative blood tests became available for transplant patients starting in 2006, with coverage expanding in 2017¹. The alternative for such blood tests is surgical biopsy procedures, which are more expensive, riskier, and burdensome.

However, on March 2, 2023, a private contractor working for the Center for Medicare and Medicaid Services (CMS), called "MolDX," announced, without advance public notice or transplant community comment, a change in Medicare coverage that alarmed transplant patients and clinicians across the nation.

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 rollbacks published by MolDX. See statements from American Society for Transplant Surgeons, American Society of Transplantation, and The International Society for Heart and Lung Transplantation. The American Association of Kidney Patients (AAKP), the nation's largest independent kidney patient organization, has publicly condemned the CMS action as fully contrary to patient-centered medicine.

Rep. Eshoo, who was present at a September 19 House committee hearing reviewing this and other issues, added her own comments: "One contributing factor to the delay is that CMS does not have the resources and expert staff to make nimble coverage decisions. Many of its local coverage decisions are outsourced to Medicare Administrative Contractors who wield significant power over more than a billion Medicare fee-for-service claims each year. These contractors can make a real impact on people's lives. For example, Representative Burgess and I sent a letter to CMS last month raising our concerns about an ill-considered March 2023 billing article from one of these contractors that withdrew Medicare coverage for very important blood tests that help transplant patients stay healthy and keep their new organs. This billing article was issued without allowing for public comment, including comments from the transplant patients who would be impacted. CMS should intervene as soon as possible."

Today's press conference in Washington, D.C. included transplant patients who stated they had been prevented from using these non-invasive molecular blood tests after being denied Medicare coverage in the aftermath of the MolDX unilateral coverage "billing article." Patients participating in the press conference also shared how these blood tests had previously discovered early signs of rejection before irreversible damage could occur. 

CareDx Inc, a leader in the field responsible for providing the molecular tests to evaluate possible rejection indicators, said it believed tens of thousands of transplant patients from across the country were unable to receive these blood test, hundreds who unknowingly may be experiencing early signs of rejection, after MolDX published the coverage "billing article." The company also said that it will take years to quantify the actual long-term impact on patients who have not been tested to detect early signs of rejection. The consequence of delayed detection of rejection will manifest for years. 

One of the transplant patients who participated in the press conference, Margaret Gamble, a kidney-transplant patient in South Carolina, asked: "Why should a policy in place for more than six years to provide Medicare coverage that allows for early detection of rejection through a simple blood test be altered in any way? I fear for my life every day if my kidney is rejected. Why is a private contractor allowed to risk my life in this way?"

Paul T. Conway, a 26-year kidney transplant recipient and Chair of Policy and Global Affairs for AAKP, stated, "This CMS action breaks the national commitment, established under three prior presidential administrations, to increase life-saving organ transplants and to make certain current recipients have access to diagnostics that help maintain their gift of life, avoid the tragedy of organ failure and a return to the transplant waiting list. Secretary Becerra should demonstrate leadership, demand a reversal in CMS actions and begin the process of restoring trust among the patients and families most impacted by this glaring inconsistency in federal transplant policy."

Dr. Eugene DePasquale, a transplant cardiologist, Director of Heart Failure, Transplantation & Medical Circulatory Support at USC, and member of the steering committee that recently updated International Society for Heart and Lung Transplantation medical guidelines to support the routine use of the latest molecular diagnostics technologies in monitoring heart transplant patients, said, "These innovative blood tests to detect organ rejection events before there are symptoms or other indicators are crucial to post-transplant patients. They are far less risky, less expensive, and less traumatic for patients than surgical biopsies to determine rejection risks. In heart transplant patients they have also significantly reduced the need for biopsies. I strongly urge that Medicare stop these cuts. There is no medical evidence that warrants a rollback, quite the contrary – there is significant evidence that supports the use of these blood tests routinely and will hurt patients if no longer covered. We need to address the process fouls made by private contractors to sidestep the medical community and make harmful decisions for patients."

"This was a rushed, ill-conceived decision by private contractors to reverse Medicare coverage in place since broad coverage was established in 2017 and reaffirmed in 2021," said Dr. Reginald Seeto, CEO and president of CareDx, the company providing the blood-based molecular tests for transplant patients. "We are fighting for transplant patients against what we firmly believe is this impermissible change in Medicare coverage ¾ forcing patients to now wait for clinical signs of rejection when it may be too late to prevent irreversible organ damage and even worse, to endure invasive biopsies as a result of rollbacks on surveillance coverage. Private contractors are not operating in the best interests of patients, nor are they incentivized to do so," Dr. Seeto added.

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.

At the press conference today, The Honor the Gift coalition, and allied transplant community advocates called for the immediate rescission by CMS and Secretary Becerra of the MolDX coverage "billing article." They also called for a halt to the purported "reopening" of the Medicare proposed local coverage determination (LCD), considering ratifying the March coverage "billing article." The coalition questioned whether the two meetings held this week by the Medicare coverage organizations were truly public and, thus, satisfying congressional mandates for transparency. 

"The two open meetings held this week were announced on August 10^th, not widely publicized, and MolDX only gave stakeholders two weeks to sign up for oral presentations. Then they indicated that they would not be required to consider comments that address coverage changes– 'only comments pertaining to the changes made for clarity' would be considered, according to the notice of the meetings published in the August federal register. The bottom line is this process has continued to be unfair for the transplant community," said Bill Ryan, president & CEO of Transplant Life Foundation.

References

1. Medicare coverage timeline for molecular diagnostics in transplantation: First gene expression profiling test (GEP) secured coverage in 2006; first donor-derived cell free DNA secured coverage for kidney in 2017, then lung in 2023. First multimodal molecular test including gene expression profiling and donor-derived cell-free DNA secured coverage in 2020 when used together, and in 2023 as a standalone.

CONTACT: Stephanie Wight, 301-512-5583, [email protected]

SOURCE Honor the Gift