Transplant Advocates Sound Alarm Over Proposed Medicare Test Coverage Policy

WASHINGTON -- Heart transplant patient Eddie Garcia was "feeling like a million bucks" one day in the summer of 2021. He had just gotten back from a 3-mile walk, something he couldn't do prior to his transplant in 2020 -- "There was a time when I couldn't walk down to my mailbox and back without huffing and puffing," Garcia said Tuesday at a press conference at the Cannon House Office Building here.

But then he got a call from his doctor, with the most recent results of a blood test that he had been getting every 3 months for more than a year, to make sure his body wasn't rejecting his transplanted heart. Previously, the test had been negative and the doctor always said he was "good to go," according to Garcia.

But this time, the doctor told him he needed to check into the hospital right away and that he would be there for almost 2 weeks, because despite his apparent vigor, the test had detected that his heart was being rejected. After months of inpatient and outpatient intravenous immunoglobulin (IVIG) treatments, Garcia said he is no longer in rejection.

Test Coverage in Jeopardy, Advocates Say

But now, advocates say, Medicare coverage for blood tests like Garcia's -- tests which run about $3,000 apiece and when used in combination can alert physicians that a transplant is being rejected well before symptoms appear -- is in jeopardy from a new coverage policy that Medicare is considering. Instead, they say, more patients may have to undergo periodic biopsies of their transplanted organs, procedures that would be much more invasive and expensive, and could expose patients to infections and organ damage.

That's what happened to Dave Engeman, an engineer from Fremont, Ohio, who has lived for 8 years with a heart transplant. "I had to have a repair to my tricuspid valve, which was damaged by biopsies," he told MedPage Today.

Under a previous coverage policy that has been in effect since 2017, Medicare covered two types of tests used by transplant surgeons to monitor their patients, explained Albert Hicks III, MD, MPH, section chief for advanced heart failure and transplant at the University of Maryland School of Medicine in Baltimore. One test, the cell-free DNA test, "could predict problems with [the transplanted organ] -- especially if it's in rejection -- weeks or even months ahead of actually showing clinical signs of damage," he told MedPage Today. "And I could have negative biopsies before I actually see something positive. So that [blood test] allows me to treat before there's actual physical damage to the organ."

The other test, a form of gene expression profiling, "tells me if the immune system is revved up," Hicks said. "Gene expression profiling actually looks at markers on the T cell, to see if it's hyper- or under-active. So the combination of those two tests helps me to determine if I'm dealing with a rejection that's mediated by the T cell, rejection that is mediated by the B cell, or damage to the actual heart itself from blockages in the heart."

The Billing Article

On March 31, MolDX -- a Medicare molecular diagnostic testing program administered by Palmetto GBA, a large Medicare administrative contractor -- released an article on the Centers for Medicare & Medicaid Services (CMS) website entitled "Molecular Testing for Solid Organ Allograft Rejection." That article, test advocates say, essentially changed what Medicare would cover, limiting doctors to a single test, and would pay for that test only if it precluded the need for a biopsy -- not if it was done for routine monitoring to make sure the organ wasn't in the early stages of being rejected.

CMS has denied that any changes are being made. "CMS confirms that neither CMS nor the Medicare Administrative Contractors 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 agency said in a September 25 press release.

Not true, said Steven Potter, MD, professor of surgery at Georgetown University School of Medicine here. "It's absolutely a substantive change, a big change," he told MedPage Today. After the article went into effect, "the number of tests ordered around the country plummeted -- roughly 18,000 fewer tests. If this was not a substantive change, why did everyone in the country stop ordering tests? Why were frightened patients calling their transplant providers around the country because the tests they were expecting to receive had been cancelled?"

Moreover, tying the test to the need for a biopsy is problematic because only about 17% of transplant centers utilize surveillance biopsies, he added.

For his part, Hicks noted during the press conference that biopsies -- which run anywhere from $4,000 to $12,000, compared with the molecular test cost of about $3,000 -- "can be very inaccurate. Rejection is not uniform. We could get a sample from a biopsy that didn't show rejection, even when rejection was present."

One reason the new reimbursement rules were published in the form of a billing article -- rather than a local coverage determination (LCD) -- may have been because billing articles, unlike LCDs, don't require a public comment period, Potter said.

Proposed Coverage Determination

In August, after CMS got a lot of criticism for the article, the agency then issued a proposed LCD. In the September press release, CMS said the LCD was issued because "over time, the [Medicare contractors] became aware of improper billing and overutilization of these tests." Asked to respond, a spokesperson for test proponents said in an email that "a leading provider of these tests conducted an independent review and found that actual usage of the tests for use in kidney and heart transplant patients was well within the range of procedures for monitoring these patients and in line with professional medical guidelines."

And although there was a several-month public comment period on the LCD, "the transplant community is concerned their voices have been ignored" as Medicare makes its final decision on whether to approve it, Bill Ryan, president and CEO of the Transplant Life Foundation, said at the press conference. "We're making a public plea to the Biden administration and HHS" to rescind the proposed policy, he said, adding that the community "feels strongly that the process has not been fair."

Sen. Kirsten Gillibrand (D-N.Y.) also spoke at the press conference. "Non-invasive diagnostic testing is essential to be able to conduct the type of monitoring that patients need," she said. "These tests ... promote early detection of organ rejection, which is crucial to making sure that the transplant is a success." Gillibrand is the chief sponsor of the Living Donor Protection Act, which would prohibit insurance carriers from discriminating against living organ donors.

Asked to comment on the issue, a CMS spokesperson quoted from the September press release but did not offer any additional remarks. The spokesperson also did not respond by press time to a question from MedPage Today regarding how much the agency spends on the tests.

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