Hundreds of transplant patients, physicians, and health equity advocates join Honor the Gift rally on Capitol Hill to implore President Biden and HHS Secretary Becerra to immediately restore Medicare coverage of critical blood tests that detect organ transplant rejection

Bipartisan leaders unite: Representative Don Bacon, Senator Kirsten Gillibrand, and former Speaker of the House Newt Gingrich express grave concern over private contractors rolling back transplant blood test coverage after CMS denies any changes and notable decline in patient testing  

Reverend Al Sharpton and Al B. Sure! of the Health Equity in Transplantation Coalition and Paul T. Conway of the American Association of Kidney Patients join transplant advocates to fight Medicare rollbacks to non-invasive blood tests that monitor organ health

WASHINGTON, Dec. 5, 2023 /PRNewswire/ -- Congressman Don Bacon (R-NE-02), Senator Kirsten Gillibrand (D-NY), co-sponsors of the Living Donor Protection Act, Newt Gingrich, former Speaker of the House, Reverend Al Sharpton, civil rights and social justice leader, and Al B. Sure!, universally celebrated recording artist and liver transplant recipient, joined the Honor the Gift coalition and the American Association of Kidney Patient's (AAKP) Chair of Policy and Global Affairs Paul T. Conway, and other leaders in the field for a press conference on Capitol Hill, calling on the Centers for Medicare & Medicaid Services (CMS), Health and Human Services (HHS) Secretary Xavier Becerra, and President Joe Biden to stop the current attempt by private contractors to rollback Medicare coverage for innovative molecular blood tests for transplant patients.

Transplant patient advocates today made a public plea to the Biden Administration, fearful that their voices have been ignored. The press conference was held at 2:00 pm at the Cannon Caucus room on Capitol Hill.

The critical tests at issue help detect organ transplant rejection early and reduce the need for invasive biopsies. For example, many transplant patients receive these sequential blood tests post-transplant to monitor their transplanted organ. The results of each blood test can provide a potential early warning of organ transplant rejection and injury before other indicators.

"These innovative molecular tests are an indispensable tool in post-transplant care, aimed at reducing the number of recipients who lose their organs and return to the waitlist. There are over 100,000 patients waiting for a new organ and these policy changes have the potential to increase the nationwide organ shortage," said Bill Ryan, President, and CEO of the Transplant Life Foundation and a founding member of the Honor the Gift coalition. "The transplant community is outraged by the Medicare rollbacks made in March and the subsequent restrictions proposed in the latest coverage guidance, as they limit doctors' ability to effectively monitor their patients' health using these vital tests."

In March 2023 private contractors, including Palmetto GBA and its MolDX program and Noridian, announced significant new coverage restrictions that have sharply impacted access to this important testing for thousands of Medicare beneficiary patients. Especially troubling is that some of these patients who have not received testing may unknowingly be suffering from asymptomatic organ transplant rejection.

Among other restrictions, Medicare will now only cover the blood test for the surveillance of organ health if the doctor would have otherwise performed an invasive biopsy. This means patients may have to depend on invasive biopsies or wait until their body shows signs of rejection, which is often too late to intervene. Yet, CMS said in a recent statement 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 and its allies, such as AAKP and the American Society of Transplant Surgeons (ASTS), find this statement inaccurate and contradicted by patients and physicians. 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 tests.

"CMS' rogue contractor alleges `overutilization of these tests', but an increase in utilization is a natural part of the innovation life cycle. As a brother of two immunocompromised siblings and an in-law living with transplants, I'm thankful that a positive outcome of the pandemic was the accelerated adoption of these tests?many of which can be done from home. A hospital treating patients with COVID-19 is the last place I wanted my siblings to be," said Newt Gingrich, former Speaker of the House, who recently published an op-ed about Medicare gaslighting patients. "Rolling back coverage of this surveillance test can have deadly consequences and the Administration needs to stop letting this private company put their profits over patient health."

Today, transplant patients and clinician groups are making two simple requests of President Biden and HHS Secretary Becerra: 1) Cancel or "rescind" the March policy changes, and 2) STOP all ongoing attempts to change Medicare coverage from the 2021 policy, which did not tie Medicare coverage of surveillance/routine molecular blood tests to biopsies. 

Representative Don Bacon, who previously signed a bipartisan letter to CMS about this issue shared: "By eliminating monitoring and testing post-transplant, the risk for organ rejection increases significantly. It is disappointing that private contractors have made the decision to restrict coverage and implement restrictions that impact patient's lives."

Reverend Al Sharpton, who has a life-long history of defending the rights of the poor and underserved communities as founder of one of the nation's largest civil rights organizations, put it simply: "Black, Hispanic, Latino, and underserved communities were given a lifeline with these non-invasive tests. That was taken away in March 2023, when a private company decided Medicare would no longer cover this life-saving measure for transplant recipients, who overwhelmingly come from these communities. It's time we reverse this decision and allow transplant recipients to have access to more and better tools ? not less." 

Al B. Sure!, a liver transplant recipient, and Executive Chairman of newly formed Health Equity in Transplantation Coalition, added: "I am saddened by the impact this is having on underserved communities who are disproportionately impacted by organ failure. Black, Hispanic and Latino Americans represent 40 percent of transplants in the U.S. ? well above the 32 percent of the general U.S. population. It makes no sense to take away Medicare coverage for these underserved transplant recipients who can take these modern blood tests at home. Rather than tying Medicare to an invasive biopsy that might require expensive travel, time off work for their patient and caregiver, and surgery in a hospital."

U.S. Senator Kirsten Gillibrand (D-NY) said: "Every organ that goes to a patient in need is a precious gift that we should protect vigilantly. The organ shortage in our country is a crisis?every day 17 people die waiting for an organ. If we don't prioritize policies to ensure access to transplants and optimal post-transplant care, we are failing patients. In addition to protecting patients' access to care, it is important to ensure that we are removing barriers for living organ donors. I am proud to have introduced by bipartisan Living Donor Protection Act, which would ensure that individuals who are willing to save someone's life through organ donation can do so without worrying that they'll face harsh repercussions, like insurance discrimination or job loss."

Transplantation is a lifesaving treatment for patients experiencing end-stage organ failure. Unfortunately, in the five years following a transplant, 50 percent of lung transplants and 33 percent of heart transplants fail. And for kidney transplant patients, about half of all deceased-donor transplanted kidneys will fail within 10 years. These outcomes are most commonly due to rejection by the recipient's immune system ? a lifelong concern that recipients manage by taking immunosuppressive medications that increase the risk of infection and cancer. By ensuring consistent access to post-transplant surveillance diagnostic testing, healthcare providers can promptly identify and address organ rejection and personalize immunosuppression drug levels, potentially reducing the recurrence of patients on the organ waitlist and increasing patients' quality of life. For Medicare the yearly cost to care for a kidney transplant patient is less than half the cost of caring for a patient on dialysis.

"When the coverage changes were issued in March, the lack of clarity around what providers should do created a 'chilling effect,' that led many to cancel surveillance tests for fear of noncompliance," said Steven Potter, MD, Professor of Surgery at Georgetown University School of Medicine. "For example, once the Medicare coverage guidance was made, I know some kidney transplant centers went from doing seven surveillance tests in the first-year post-transplant and three to four tests per year in the following years, to only doing two in the first year and none in the following years." 

Eddie Garcia, a heart transplant patient based in San Jose, CA shared his personal journey during the press conference: "As a transplant recipient, I am appalled that the government would restrict access to critical blood tests that literally saved my life. A year after my transplant, I was feeling great but the diagnostic blood test I received for surveillance alerted my care team that I had early signs of organ rejection. Thankfully, my doctors were able to quickly intervene and there was minimal damage to my heart. Under the proposed coverage changes, I would not have had access to the test that detected rejection for me in 2021 and most likely not be here today." 

In August and September, private contractors allowed for a public comment process on a proposed coverage determination, which includes the same limitations as the March billing change. The process gave minimal time to provide feedback and the private contractor 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. During the open comment period, MACs heard from deeply concerned physicians and patients who have not received their regularly schedule tests and fear for their lives. Now, as Medicare reviews the comment and determines the final decision on coverage, the transplant community is fearful their voices have been ignored and are making a public plea to the Administration.  

Paul T. Conway, a 26-year kidney transplant recipient and Chair of Policy and Global Affairs for AAKP, stated, "This reckless CMS policy change in access to organ transplant surveillance blood tests exemplifies Government Determinants of Health ? instances when federal health agencies knowingly take actions that disrupt and negatively impact Americans that they have a duty to serve. Health and Human Services Secretary Becerra should immediately intervene, demonstrate compassionate leadership, and restore access to these critical blood tests to the same levels that existed in 2021. Anything short of renewed access, without new CMS-imposed barriers, undermines the bipartisan national effort to reduce the organ waiting list by preventing avoidable organ rejections and the need for re-transplantation. AAKP is working closely with allies to win this fight and protect people whose transplants and lives have been placed in jeopardy by an unaccountable CMS contractor." Since 2017, AAKP has conducted the largest, non-partisan voter registration program in the kidney community, KidneyVoterstm.

Alexander Johnson, President of Patient and Testing Services at CareDx, a leader in the field providing the molecular transplant tests, said, "Medicare beneficiaries have lost critical access to post-transplant care. These innovative tests can give doctors indications of organ rejection months earlier than older methods, which gives them more time to intervene. Organ rejection is often non-reversable once it starts and patients have no time to waste; time is tissue. The time is now to rollback these cuts."

Many leading voices have spoken out on this issue since March. Additionally, letters have poured in, including from leading national professional transplant medical associations ? the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society for Heart and Lung Transplantation. The issue has also gained national attention in Wall Street Journal editorials published on September 10, 22, and 26, calling out this decision and the need for further transparency.

SOURCE Honor the Gift