In August we reported on decision by the Centers for Medicare & Medicaid Services (CMS) not to proceed a proposed Medicare policy that would have limited coverage of a blood test used to monitor transplant rejection. In this report, we follow up on what has happened since then.
Some transplant patient groups have a message for transplant patients who are also Medicare recipients: yes, Medicare continues to cover an expensive molecular blood test to monitor transplant rejection — at least for now.
Under a coverage policy that has been in effect since 2017, Medicare covered two types of tests used by transplant surgeons to monitor their patients, according to Albert Hicks III, MD, MPH, section chief of advanced heart failure and transplantation at the University of Maryland School of Medicine in Baltimore .
One test, the cell-free DNA test, “can predict problems with (the transplanted organ) — especially if it’s in rejection — weeks or even months before it actually shows clinical signs of damage,” he told MedPage today in an interview in December 2023. “It (the blood test) allows me to treat before there is real physical damage to the organ.”
The second test, a form of gene expression profiling, “tells me if the immune system is raised,” Hicks said. “Gene expression profiling actually looks at markers on the T cell, to see if it’s hyper- or underactive. So the combination of these two tests helps me determine if I’m dealing with a T-cell-mediated rejection of the B cell, or damage to the heart itself from blockages in the heart.” The tests can cost as much as $3,000 each.
Change in test coverage
On March 31, 2023, MolDX—a Medicare molecular diagnostic testing program administered by Palmetto GBA, a major Medicare administrative contractor— released an article on the CMS website titled “Molecular Testing for Solid Organ Allograft Rejection,” which, according to test advocates, substantially changed what Medicare would cover, limiting physicians to a single test and noting that the contractor would pay for that test only if it ruled out the need for a biopsy – not if it was done for routine monitoring to ensure the organ was not in the early stages of rejection.
In August 2023, after CMS was heavily criticized for the article, the agency came issued a proposed local coverage determination (LCD) determine the criteria for coverage of the tests. In a September 25, 2023 press releaseCMS said the LCD was issued because “over time (Medicare contractors) became aware of improper billing and overuse of these tests.”
Asked to respond, a spokesman for test proponents said in an email that “a leading supplier of these tests conducted an independent review and found that the actual use of the tests for use in kidney and heart transplant patients was well within the procedures for monitoring these patients and in line with professional medical guidelines.”
CMS denied any changes were made. “CMS confirms that neither CMS nor Medicare Administrative Contractors (MACs) have made changes that affect patients’ ability to obtain blood tests used to monitor organ transplant rejection when ordered by their physicians under medically appropriate circumstances,” the agency said in the report. Press release in September.
Advocate Push Back
CMS’ claim that no changes were made is not true, said Steven Potter, MD, professor of surgery at Georgetown University School of Medicine in Washington, D.C. “It’s absolutely a significant change, a big change,” he told MedPage today in an interview last December an event in Washington organized by testing advocates. After the article went into effect, “the number of tests ordered around the country dropped—about 18,000 fewer tests. If this wasn’t a significant change, why did everyone in the country stop ordering tests? Why were scared patients calling their transplant providers around the the country because the tests they expected to get had been canceled?”
Also, linking the test to the need for a biopsy is problematic because only about 17% of transplant centers use surveillance biopsies, he added.
In August, the agency went back the proposed LCD, noting that the MACs have “carefully considered all feedback from stakeholders” regarding the proposed LCD, CMS said in a statement on August 16.
“In response to public comments and after further review of the evidence, the MACs are not finalizing the proposed LCD issued on August 10, 2023,” the statement continued. “Due to the importance of identifying solid organ allograft rejection early and to ensure that the public has further opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months.”
The volume remains low
Since then, however, the volume of testing has not increased, a fact that has concerned some testing advocates. “While CMS can issue statements and do a government process, what’s important to us … and people like me — 27 years post-transplant — is whether or not utilization rates are restored” to what they were before, said Paul Conway, president of policy and global issues at the American Association of Kidney Patients, during an online interview where a PR person was present. “Until they go back, everything is not OK.”
“We think the CMS administrator, in his last 6 weeks, should take action and show a serious commitment to patients and send a clear message to providers and MACs that these tests should be accessed as often as possible and not hide behind press releases .” he continued. “We hold the CMS administrator and HHS fully accountable for disruptions in transplant care. … They need to speak up; that’s what we expect. We’re not happy with where this is.”
Potter is worried too. “If the test volumes haven’t returned to baseline, then basically they’re not testing, even if patients legally have access to the test, because of ambiguity in that regard — they don’t really have access,” he said in a telephone interview. “There are thousands of patients around the country … We’d like to see that improve. I think part of the responsibility is on the transplant community to try to spread the word and get their test volumes back up.”
“The most important thing CMS can do is not issue press releases or try to educate the public,” Potter added. “Instead, it would be nice for them to release a crystal clear LCD that removes the link to tissue biopsy for non-invasive blood testing, and openly supports the use of the test for causation and monitoring. That would be the most they could do.”
Bill Ryan, president and CEO of the Transplant Life Foundation, said that while he would like to see a new LCD screen, he wasn’t too concerned that one hadn’t been issued yet. “Those involved understood that it would not be issued until 2025,” he said in a telephone interview. “I thought they would first of all wait to see what happened in the political arena at the end of 2024.”
CMS won’t do anything to let people know the tests are covered, he noted. “They have a very benign attitude about letting people know they can get these tests done. It has to be the medical profession, backed by the companies that designed and produced the tests. I have encouraged the companies to be very aggressive in letting their patients know , or letting the transplant centers know that these tests are now available and will be paid for on the LCD, there is some market movement that makes them believe the tests are feasible and should continue.”
When asked when a new LCD screen might arrive, a CMS spokesperson said in an email that “due to the importance of identifying solid organ allograft rejection early, MolDX partner MAC is carefully reviewing the clinical evidence on these tests. For to promote additional opportunities for public comment on the policy, MolDX Partners’ MAC intends to issue a new proposed LCD.When published, the new proposed LCD will be available for review in Medicare Coverage Database.” No specific time was offered.
