Leading Patient Advocacy Groups Launch Honor the Gift Campaign to Oppose Medicare Restrictions to Post-Transplant Diagnostic Testing

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May 15, 2023, 10:00 ET

Recent restrictions could lead to greater reliance on invasive, costly tissue biopsies and potentially impact the early detection of organ transplant rejection

WASHINGTON, May 15, 2023 /PRNewswire/ -- Leading transplant advocacy groups announced today the re-activation of the Honor the Gift campaign, a coalition dedicated to advocating for greater access and coverage to ensure the long-term health of transplant patients. The reinvigorated campaign, which originally contributed to the successful passage of the Immuno Bill, will take on the latest challenge following Medicare's recent restriction of non-invasive diagnostic tests for solid organ allograft injury. Additionally, the coalition will focus on state and federal policies to protect and expand access to innovative tests that are vital to post-transplant patient's health.

Organ transplantation is a crucial treatment for end-stage organ failure, but organs are among the scarcest medical resource, with over 100,000 people on waiting lists in the U.S., and an average of 17 who die each day waiting for an organ.¹ To compound the problem, it is estimated that within the first year post-transplant, 1 in 3 lung transplants will fail, and within 5 years, 1 in 3 heart, and 1 in 5 kidney will fail, respectively^2,3,4. To improve early detection of organ rejection and prolong the life of transplants, post-transplant surveillance is essential.

Non-invasive diagnostic blood tests like donor-derived cell free-DNA (dd-cfDNA) and gene expression profiling (GEP) have been adopted across major transplant centers as the standard of care to monitor a patient's transplanted organ health and immune status. These tests provide important information that helps clinicians assess early signs of declining health in transplanted organs and intervene earlier to preserve the transplanted organ's function and help avoid irreversible organ damage. Additionally, the tests may help reduce or avoid the need for traditional, burdensome tissue biopsy.

The Honor the Gift campaign will focus first and foremost on restoring Medicare coverage following the March 2023 release of a billing article that restricts coverage of non-invasive post-transplant diagnostic tests like dd-cfDNA and GEP. A recent survey of transplant patients found that 95% believe reduced coverage for non-invasive tests would negatively impact their post-transplant care.

Additionally, state legislation is actively being considered to mandate insurance coverage for biomarker tests, including dd-cfDNA and GEP. Support for this state-level movement will be another focus of the campaign as it works to ensure that transplant patients are at the center of expanded coverage policies.

"I am seriously concerned that reductions in Medicare coverage for non-invasive tests will negatively impact care for an already vulnerable population and disproportionately impact transplant recipients in under-resourced communities," said Bill Ryan, President, and CEO of the Transplant Life Foundation. "I am proud to be part of the Honor the Gift campaign to advocate for continued coverage. Honoring the gift of a donated organ means successfully monitoring the long-term health of the transplanted organ and intervening early when there are signs of injury or rejection."

"Unfortunately, coverage policies are lagging behind innovative advancements in transplant care including non-invasive testing, and when these tests aren't covered broadly by Medicare and private insurers, post-transplant care suffers," shared Lorrinda Gray-Davis, transplant recipient and President of the Transplant Recipients International Organization (TRIO). "Honor the Gift will give a much-needed voice to promoting the policies that ensure doctors have the choice to use non-invasive tests when they are medically necessary, and patients can depend on these tests being covered."

The Honor the Gift campaign was established in 2019 as a national, patient-centered coalition which successfully advocated for the passage of legislation to extend Medicare's immunosuppressive medication coverage for post-transplant patients—legislation that had languished with inaction for over 20 years. The coalition grew to include 32 organizations who worked to successfully pass the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2020 ("Immuno Bill"). This law now provides thousands of transplant patients with the assurance of lifelong coverage for their essential immunosuppressive medicines.

"The Immuno Bill was a huge victory to improve the long-term survival of transplants for all patients, especially those in under-resourced communities, many of whom had to go back on dialysis after their immunosuppressive coverage ran out," said Dr. Keith Melancon, a transplant surgeon at George Washington University Hospital. "Now, we must continue the fight towards optimal post-transplant care, so that we are extending the life of precious organs with the tools that we know improve long-term health."

The revitalized campaign is led by several of the original coalition members including the Alport Syndrome Foundation, Ava's Heart, the HeartBrothers Foundation™, Heartfelt Help Foundation, the Lung Transplant Foundation, The Mended Hearts, Inc., the National Kidney Donation Organization (NKDO), the Texas Kidney Foundation, Transplant Families, the Transplant Life Foundation, Transplant Recipients International Organization (TRIO), and The YNOTT? Foundation, with support from CareDx. In this phase of the campaign, Honor the Gift currently has 12 members and welcomes additional members who share its mission of advocating for coverage of the care that post-transplant patients need to live healthy lives.

For questions about the campaign or membership, please contact [email protected].

References:

Organ Donation Statistics. Health Resources and Services Administration. (March 2023.) https://www.organdonor.gov/learn/organ-donation-statistics.
Yusen, Roger D et al. "The Registry of the International Society for Heart and Lung Transplantation: Thirty-second Official Adult Lung and Heart-Lung Transplantation Report--2015; Focus Theme: Early Graft Failure." The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation vol. 34,10 (2015): 1264-77. doi:10.1016/j.healun.2015.08.014.
Wilhelm, Markus J. "Long-term outcome following heart transplantation: current perspective." Journal of thoracic disease vol. 7,3 (2015): 549-51. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4387387/.
Sussell, Jesse et al. "The economic burden of kidney graft failure in the United States." American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons vol. 20,5 (2020): 1323-1333. doi:10.1111/ajt.15750.