CMS Withdraws Proposed Coverage Policy, Ensures Continued Access to Critical Post-Transplant Non-Invasive Monitoring

Decision Follows Transplant Community Advocacy; Honor the Gift Coalition to Remain Focused on Future Policy Developments that Impact Transplant Patients

WASHINGTON, Aug. 22, 2024 /PRNewswire/ -- The Honor the Gift Coalition is pleased to share that the Centers for Medicare and Medicaid Services (CMS) has issued a statement that it intends to retire a proposed draft coverage policy that would have restricted coverage of surveillance monitoring. The statement recognizes the importance of early detection of rejection and reaffirms coverage for post-transplant surveillance without a tie to biopsy.

The statement also notes that another Local Coverage Determination (LCD) is forthcoming. We will continue to advocate tirelessly to ensure that patient access to these essential diagnostic tools is maintained and expanded as future policies are developed.

These non-invasive tests, including donor-derived cell-free DNA (dd-cfDNA) and gene expression profiling (GEP) are vital tools for earlier detection of organ transplant injury and rejection. Non-invasive blood tests are a significant innovation in the post-transplant space, offering a less-invasive alternative to traditional biopsies to monitor early signs of rejection, which can be burdensome, painful, and even harmful to patients.

The CMS announcement follows a fifteen-month campaign spearheaded by the transplant patient and clinician communities and supported by congressional leaders to advocate for the importance of patient access to these non-invasive tests. The campaign was initiated in the wake of significant restrictions on non-invasive tests improperly imposed through a billing article by its private Medicare contractor. The billing article limited Medicare coverage of these tests for surveillance to situations in which an invasive biopsy would otherwise be performed, effectively restricting coverage of surveillance testing for community nephrologists since they do not perform biopsies. Honor the Gift believes CMS has now reversed these restrictions and restored prior longstanding coverage.

Honor the Gift, a coalition of 16 transplant patient advocacy organizations and allies dedicated to fighting for greater access and coverage to post-transplant care, responded on behalf of the transplant community following the release of the March 2023 billing article, mobilizing thousands to act. Honor the Gift Founding Member and Co-Leader Bill Ryan, President and CEO of the Transplant Life Foundation, reflects, "After learning of the coverage reductions for non-invasive tests, I was deeply concerned, but hopeful that bringing together authentic patient voices with lived experiences in transplant would be the most effective force to restore coverage. Honor the Gift assembled to answer the call, and I am incredibly proud of all we have accomplished over the past year."

"It is inspiring what we have been able to accomplish in a relatively short time frame thanks to the dedication of impacted patients, clinicians, and countless other advocates who understood what was at stake," shared Melissa McQueen, Co-Founder and Executive Director of Transplant Families.

Honor the Gift's work was recognized in many significant milestones that sounded the alarm and raised awareness about coverage rollbacks, including thousands of messages sent from transplant patients to their members of Congress, two congressional letters of inquiry to CMS, led by Representatives Anna Eshoo (D-CA-16) and Michael Burgess, M.D. (R-TX-26), and two media events and several placements across outlets like The Wall Street Journal, STAT News, USA Today, MedPage Today, and The Hill. Leading transplant medical associations also strongly condemned the rollbacks in statements sent to CMS from the American Society for Transplant Surgeons (ASTS), the American Society of Transplantation (AST), and the International Society for Heart and Lung Transplantation (ISHLT).

Last December, in partnership with its allies at the Health Equity in Transplantation Coalition (HEiTC), Honor the Gift was proud to organize a rally and press conference on Capitol Hill with more than 150 transplant advocates who met with over 100 congressional offices as part of the Coalition's Action Day. This day of advocacy was particularly pivotal in engaging congressional leaders to join the effort to shed light on how critical organ transplant monitoring is for advancing health equity, as Black and Brown Americans are more likely to experience rejection after receiving a transplant.

"In a significant victory for the transplant community, CMS announced that it will not finalize a proposed local coverage determination (LCD), which would have further imposed coverage restrictions for post-transplant blood tests. Last year, a Medicare contractor introduced new coverage restriction for non-invasive diagnostics for organ recipients," said Congresswoman Eshoo, Ranking Member of the House Energy and Commerce Health Subcommittee. "I wrote two letters to the CMS Administrator urging her to reverse that decision. Organ transplant patients depend on these blood tests to know whether their transplant is successful. They offer a less painful and less harmful alternative to biopsies. I am very pleased that CMS changed course and will continue to cover such tests. This is a win for patients."

"Being a physician for over 30 years, I understand the importance of listening to the concerns and requests of your patients and doing what is best for their wellbeing," said Congressman Burgess, M.D., Co-Chair of the GOP Doctors Caucus. "The Centers for Medicare and Medicaid Services announcement to restore coverage for post-transplant blood tests for organ damage demonstrates their commitment to ensuring doctors are able to detect early signs of treatment rejection in their patients."

Recent actions taken by the community included an April 2024 letter signed by more than 24 leading transplant clinicians to CMS raising concern for the recent decline in testing. Steven Potter, MD, Professor of Surgery at Georgetown University School of Medicine, Immediate Past Chair of the ASTS Legislative and Regulatory Committee, letter co-signer, and outspoken Honor the Gift ally on this issue relayed, "There has been a staggering 50 percent reduction in ordering of these vital tests since the restrictions on testing were put in place. Transplant clinicians are worried that patients are at elevated risk of rejection without ready access to this critical monitoring tool. This announcement will again allow clinicians the coverage clarity they need to act in the best interest of their patients when it comes to sustaining organ health. However, patient and clinician concerns will only fully be addressed when testing volumes have risen back up to meet the needs of the patients we serve."

Despite this serious and unfortunate setback in patient care, Honor the Gift is optimistic that this announcement signals a commitment to support the permanency of comprehensive coverage and an environment that promotes further innovation. This aligns with our country's goals to increase the rate of transplant success and support the prevailing standard of care for transplant monitoring. The Honor the Gift coalition will keep up its momentum, ensuring that patients retain access to non-invasive testing. Our efforts will include ongoing advocacy with lawmakers, clinicians, and patients to secure long-term coverage in the forthcoming LCD.  

"We've reached a positive inflection point in our efforts to promote expanded and improved post-transplant care, but our work is not done. We are focused on achieving a new LCD that will meet the needs of our patient community. We are also supporting patients, particularly those from underserved communities, to help them understand their options for organ surveillance and feel empowered to talk to their doctor about non-invasive testing as part of their transplant journey", shared Lorrinda Gray-Davis, Founding Member and Co-Lead of Honor the Gift and President of Transplant Recipients International Organization (TRIO).

Media Contact: Stephanie Wight: (301) 512-5583

References:

1. Organ Donation Statistics. Health Resources and Services Administration. (March 2023.) https://www.organdonor.gov/learn/organ-donation-statistics.
2. 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. 
3. 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/. 
4. 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.

SOURCE Honor the Gift