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:
- 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.
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SOURCE Honor the Gift