In August, we reported on the decision by the Centers for Medicare & Medicaid Services (CMS) to not pursue
a proposed Medicare policy that would have restricted coverage of a blood test used to monitor for transplant rejection. In this report, we follow up on what has happened since.
Some transplant patient advocacy groups have a message for transplant patients who are also Medicare beneficiaries: yes, Medicare is continuing to cover an expensive molecular blood test to monitor for 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 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 in an interview in December 2023. "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 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 large Medicare administrative contractor -- released an article on the CMS website entitled, "Molecular Testing for Solid Organ Allograft Rejection," which, according to test advocates, essentially changed what Medicare would cover, limiting doctors to a single test, and noting that the contractor 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.
In August 2023, after CMS was heavily criticized for the article, the agency issued a proposed local coverage determination (LCD) laying out the criteria for coverage of the tests. In a Sept. 25, 2023 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."
CMS denied that any changes were being made. "CMS confirms 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 agency said in the September press release.
Advocates Push Back
CMS's assertion 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 substantive change, a big change," he told MedPage Today in an interview last December following an event in Washington organized by testing advocates. 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.
This August, the agency walked back the proposed LCD, noting that the MACs "have carefully considered all the feedback received from interested parties" regarding the proposed LCD, CMS said in a statement on August 16.
"In response to public comments and upon 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 the public has additional opportunities to comment on the policy, the MACs intend to issue a new LCD in the coming months."
Volume Remains Low
Since then, however, testing volume has not gone back up, a fact that has concerned some testing advocates. "While CMS can issue statements and conduct a government process, what matters to us ... and people like me -- 27 years out on a transplant -- is whether or not utilization rates are restored" to what they were before, said Paul Conway, chair of policy and global affairs at the American Association of Kidney Patients, during an online interview at which a public relations person was present. "Until they go back, everything is not OK."
"We think the CMS administrator, in her last 6 weeks, should take action and demonstrate serious commitment to patients and give a clear message to providers and MACs that these tests should be accessed as frequently 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 are not happy with where this is."
Potter is also concerned. "If testing volumes haven't returned to baseline, then essentially, although patients legally have access to the test, they're not getting tested because of ambiguity in that regard -- they don't really have access," he said in a phone interview. "That's thousands of patients around the country ... We'd like to see that improved. I think some of the onus is on the transplant community to try to spread the word and get on the job of getting their testing volumes back up."
"The main thing CMS could do is to not issue press releases or try to educate the public," Potter added. "Instead, it would be nice for them to issue a crystal-clear LCD that removes linkage to tissue biopsy for non-invasive blood testing, and overtly supports using the test for cause and for surveillance. That would be the number one thing they could do."
Bill Ryan, president and CEO of the Transplant Life Foundation, said that although he would like to see a new LCD, he wasn't too concerned that one hadn't been issued yet. "Those involved understood that it wouldn't be issued until 2025," he said in a phone interview. "I thought they were going to wait first and foremost to see what happened in the political arena at the end of 2024."
CMS isn't going to do anything to let people know the tests are being covered, he noted. "They take a very benign attitude about letting people know that they can get these tests done. It's going to have 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. They need to really ramp it back up again, so that when [CMS officials] do have to make a decision on the LCD, there's some market movement that makes them believe the tests are viable and should be continued."
Asked when a new LCD might be coming, a CMS spokesperson said in an email that "because of the importance of identifying solid organ allograft rejection early, the MolDX partner MACs are carefully reviewing clinical evidence about these tests. To promote additional opportunities for public comment on the policy, the MolDX partner MACs intend to issue a new proposed LCD. When posted, the new proposed LCD will be available for review in the Medicare Coverage Database." No specific timing was offered.
https://www.medpagetoday.com/publichealthpolicy/medicare/113561
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