Health Equity in Transplantation Coalition Demands to Know Why Expert Physicians' Advice Was Ignored in Medicare Cuts for Life-Saving Blood Tests for Transplant Patients

Report Obtained via Freedom of Information Act Shows Near-Unanimous Support Among Experts of Tests' Importance to Catch Rejection Months in Advance

Comes as Wall Street Journal Editorial Questions Why Private Contractor Resists Freedom of Information Requests; Raises Issue of a Coverup

NEW YORK, April 22, 2024 /PRNewswire/ -- The Health Equity in Transplantation Coalition (HEiTC) and its partners are urging the federal government to address the discrepancy revealed by a Freedom of Information Act (FOIA) request: that the decision by Medicare contractors to limit coverage of blood tests blatantly contradicted the recommendations given by the government's own panel of medical experts. HEiTC's renewed call comes on the heels of a blistering Wall Street Journal editorial condemning the decision of the Medicare contractors to ignore the experts' recommendations. HEiTC continues to demand that Medicare contractors abolish ties to biopsies for coverage of these life-saving tests, which can detect a possible organ transplant rejections months before symptoms start to show.

"I'm incredibly alarmed that this private contractor essentially waved off a majority of doctors, experts on this issue, who made clear that using these tests is critical for monitoring transplant patients for signs of rejection before symptoms present as well as the 'future' of this technology," said Al B. Sure!, Executive Chairman of HEiTC. "Instead of listening to these experts and considering what these tests meant to tens of thousands of transplant recipients, the contractor not only ignored but withheld their expert opinion. In the process, they took away a vital tool for other doctors to monitor an overwhelmingly Black and Brown transplant community, which for the last year has lived with more anxiety than they should. It's never been more important that these cutbacks are reversed and coverage without any tie to a biopsy is restored." 

The new information shows that private Medicare contractors failed to disclose and then ignored the near-unanimous advice of expert physicians – handpicked by the contractors—to evaluate the evidence for non-invasive transplant rejection testing.  There was broad consensus from these expert clinicians that the testing had significant clinical utility including for routine, surveillance testing.

"The science is clear and so is the politics," the Wall Street Journal Editorial Board wrote in a piece published Friday. "Noridian fought the FOIA request because denying coverage your own experts endorse isn't a good look."

The private Medicare contractor heard from expert transplant clinicians in November 2022.  They participated in a public meeting, as well as private polling.  The private polling, which showed strong support for the utility of this transplant testing, was never disclosed to the public. 

Instead, just over three months later, the contractor issued a March 2023 "billing article" that dramatically cutback Medicare coverage on these tests, including for surveillance.

Now, transplant recipients who rely on Medicare can only access these non-invasive tests for routine surveillance in lieu of a painful, time-consuming biopsy. This significantly compromises clinicians' ability to catch rejection before it actually happens.

Doctors Stressed Vital Use of Tests in Surveillance

In November 2022, Noridian, a Medicare Administrative Contractor (MAC) under CMS, queried six physicians on the importance of non-invasive, molecular blood tests for monitoring rejection for kidney patients. 

Noridian was collecting the feedback for itself and MolDX, a program administered by another MAC and led by Dr. Gabriel Bien-Willner, which ultimately made the controversial decision.

According to a summary prepared by Noridian following the meeting, five of the six physicians voted that there was "sufficient evidence for [the tests'] utility" in both the surveillance and for-cause (meaning in response to particular clinical factors) settings.

Five of the six doctors further voted "yes" when asked if they believed there was enough evidence to show the AlloSure and Prospera tests were effective in surveillance, i.e. catching a rejection before it is evident through clinical signs or symptoms. 

This summary and the underlying voting results were never publicly released and only obtained based on a FOIA request. 

On a separate note, last week over two dozen leading transplant clinicians sent a letter to the Centers for Medicare & Medicaid Services (CMS) Administrator, Chiquita Brooks-LaSure, detailing the negative impacts of the Medicare policy change. Clinicians reported a distressing rise in rejection events among organ transplant recipients, an uptick believed to be associated with these restrictions.

MolDX Baffles Medical Community by Blocking Surveillance Abilities

Despite the results of the CAC, MolDX, issued a new billing article tying coverage for these tests to biopsy. In the critical surveillance context, that means they were only covered when they would be replacing a biopsy.  In practice, these new coverage restrictions significantly limited access to the test and undermined a key purpose of the tests - catching rejection early and allowing providers to adjust their care in response. 

The March 2023 decision to tie the test to a biopsy sent shockwaves through the transplant community. Thousands of tests were canceled in the weeks that followed because of the coverage change. Many of those patients have spent more than a year living with anxiety because they now lack access to this critical testing and are unsure if their gift of life is failing them.

Biopsies are not a substitute for this testing.  Beyond their invasive nature and risks, they are burdensome and present challenges especially in rural areas as patients must travel further to have the painful procedure done at a hospital.

The decision also created a double standard in states like South Carolina, where the state's BlueCross BlueShield late last year announced expanded coverage for the tests on heart, lung, and kidney transplants. 

Scaling back coverage will also have longer term financial implications for the healthcare system. Consider the fact that dialysis costs the U.S. government $95,000 annually per patient, whereas kidney transplant maintenance is less than half. Now, add to that the time taken off of work to have the procedure done as well as the recovery time from the pain it causes. 

Fight for Equity Moving Forward

HEiTC, along with its allies, the Honor the Gift Coalition and the American Association of Kidney Patients (AAKP), has spent months sounding the alarm about the impact of these tests, especially for Black, Brown, and rural patients. Some 40% of current transplant recipients are Black, Latino or Hispanic, and they account for a full half of those on the waitlist. MolDX's actions have only furthered an unjust system in which people of color are biologically at a greater risk of organ failure, struggle to get on the donor waitlist, and spend more time there if they're lucky to make it. 

The Coalition has engaged lawmakers on Capitol Hill, including Congressional Black Caucus Chair Steven Horsford, and Vice President Kamala Harris, who met with Al B! earlier this year on the issue. Their advocacy has been covered by MSNBC, Fox News, USA Today, The Hill, and The Grio, but the fight continues. 

In a matter of weeks, CMS will determine whether these cutbacks will remain permanent. That would then take away these tests for thousands of Medicare recipients, who since 2017 relied on this tool to keep track of their health. HEiTC is committed to advocating to CMS that these changes must be reversed and any tie to a biopsy removed. 

Press Contact:
Rachel Noerdlinger
[email protected]

SOURCE Health Equity in Transplantation Coalition