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Evan Dame lives in near-constant fear his body will reject his transplanted kidney.
For a time, a simple blood test from the comfort of the 39-year-old’s Maryland home just outside of Washington would assuage that fear. He’d get the test every two to three months at 6 a.m., just before he started work as a facilities manager.
Managing those fears became far more difficult in March, when federal changes regarding how to pay for the screenings meant the at-home tests were no longer available to Dame. The tests are still available, just with the added inconvenience of an hourlong trip to a clinic. That meant having to take off from work – an option not available to everyone who needs the screenings. With the change, it’s harder to tell if or when Dame’s body will reject his new organ. Without early intervention, he could land back in dialysis, or worse.
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“It’s always a risk,” he told USA TODAY. “For them to take away a test that can detect it early on, and possibly treat it and stop it, it just blows me away.”
In March, when the change was made, the federal Centers for Medicare and Medicaid Services, or CMS, said medical providers overuse these tests, resulting in additional bills.
Medical experts and patient advocates told USA TODAY the Medicare change has a chilling effect across the health care industry, causing people like Dame, who has private insurance, to also lose out on the simple blood tests. Those limits, they say, put transplant patients at immediate risk, particularly low-income people and people of color who face existing barriers to access to care. In the long run, they fear lack of adequate testing will lead to more failed organs.
Tuesday, a bipartisan group of lawmakers, along with advocates for doctors and patients, planned to call on the Biden administration to reverse the change, especially as President Joe Biden recently signed a law in September to streamline a lengthy waitlist of more than 100,000 people waiting for organ transplants. Future transplant recipients will need testing to make sure their organs remain healthy.
“In an era where we are promoting organ transplantation, the confidence that comes with getting an organ transplant is knowing that your transplant team has the tools to help you maintain it,” said Paul Conway, a 59-year-old patient advocate who has lived with a transplanted kidney for 26 years. “Taking those off the table and restricting those with no evidence does not serve the patient.”
Agency says no change on patient access, but doctors disagree
CMS said in a statement that Medicare administrative contractors learned of improper billing and over-utilizing molecular tests, which is what Dame could receive at home. In March, CMS updated billing and coding to limit where and who can administer the tests for the MolDX molecular testing program, administered by Palmetto GBA. An updated local coverage determination for the testing program also has language to restrict these tests.
But neither CMS nor its contractors, the statement said, “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.”
Palmetto, which is part of BlueCross BlueShield of South Carolina, referred to CMS’ statement.
The American Society of Transplant Surgeons and the American Society of Transplantation, both medical professional associations, have urged CMS and its Medicare billing contractor, Palmetto GBA, to reverse course.
Transplant surgeons told USA TODAY the change makes it more difficult to have successful, long-term outcomes for patients. The change, they say, favors biopsies. While established practice, biopsies are invasive and potentially dangerous to collect organ tissue samples that may not give a complete picture of organ rejection until it’s too late.
“We want to have the blood test to pick it up on a screening, and then the biopsy to kind of decide what we need to do about it,” Dr. David Mulligan, a professor of transplant surgery at Yale School of Medicine, told USA TODAY. “This new policy takes that away. That’s a pretty scary piece that we want to make sure is not going forward.”
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The goal of testing is to see how the body responds to the new organ and ensure the body doesn’t reject it, which is costly and can be deadly.
Molecular DNA tests have made several technological leaps in recent years to use blood samples to see if the body rejects a transplanted organ. This includes detecting the organ donor’s DNA in the recipient’s body, or trying to gauge how a recipient’s white blood cell genes might attack the new organ. There’s evidence that combining the tests gives better indicators to detect issues earlier, especially with kidney and heart transplants.
In 2021, research from the University of Pittsburgh suggested molecular tests may not be as cost-effective compared to annual biopsies in expanding life. However many transplant surgeons said this is short-sighted. It doesn’t fully account for the risks and costs of biopsies. Patients, meanwhile, must travel farther distances for routine tests, or put them off.
“By saying that the test itself is expensive, it’s not looking at the larger picture,” said Dr. Kiran Kaur Khush, a professor of cardiovascular medicine at Stanford Medicine who specializes in heart transplantation. The molecular tests can improve outcomes for patients to live longer with their transplanted organs, and they’re less likely to have complications that can land them in the hospital, she said. “All of these, in the long term, will result in significant cost savings to the system,” she said.
Change ‘out of step’ with evidence, precedence, bipartisan lawmakers say
There is bipartisan opposition to the CMS decision, with 14 members from the U.S. House of Representatives writing to oppose the change in August. In October, Reps. Dr. Michael Burgess, R-Texas, and Anna Eshoo, D-Calif., questioned the agency’s position that access to non-invasive blood testing remains unchanged, which is in contrast to what patients and doctors have said.
“We remain very concerned that CMS has allowed the March 2023 billing article to remain in effect because we believe it is out of step with widely accepted evidence and is a departure from precedent,” Burgess and Eshoo wrote to CMS Administrator Chiquita Brooks-LaSure.
The Rev. Al Sharpton, a civil rights leader, and former House Speaker Newt Gingrich, a conservative politician, are among others who oppose the measure. Sharpton recently formed a coalition with R&B singer Al B. Sure!, a liver transplant recipient, to highlight inequities for Black and Latino communities with organ transplants. Along with lawmakers, they planned to speak Tuesday on Capitol Hill.
Black and Latino people remain overrepresented among those in need of an organ transplant, yet they and other people of color comprise a smaller share of those who get a transplant, according to federal data.
“I understand the private sector may want to deal with this from a business model,” Sharpton told USA TODAY. “This is a human rights model, as far as I’m concerned.”
The point of the tests is to provide more comfortable, less invasive monitoring for better long-term health, said Dr. John Friedewald, a professor of medicine and surgery at Northwestern University Feinberg School of Medicine. Limiting access leads to shorter survival of the transplanted organ and, ultimately, the person, he said.
“We want to make sure that everyone has equal access to these important tests to maintain the health of their transplant and themselves,” he said.
Eduardo Cuevas covers health and breaking news for USA TODAY. He can be reached at EMCuevas1@usatoday.com.
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