CMS ends plans to limit use of test for evaluating transplant graft health
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Key takeaways:
- Patient advocacy groups and legislators pressed the agency to reverse its initial decision.
- CMS is now dropping a plan to limit use of a noninvasive test for determining the health of a transplanted organ.
After protests from transplant patient advocacy groups and legislators for more than a year, CMS has agreed to drop a proposal that would have limited access to a noninvasive test used to determine the health of a transplanted organ.
“Organ transplant patients depend on these blood tests to know whether their transplant is successful,” Rep. Anna Eshoo, D-Calif., said in a press release. “They offer a less painful and less harmful alternative to biopsies. I am pleased that CMS changed course and will continue to cover such tests. This is a win for patients."
The coverage change was originally proposed in August 2023 by Medicare Administrative Contractor (MAC) Noridian Healthcare Solutions, which processes Medicare payments for health care providers in California, Hawaii, Nevada, American Samoa, Guam and Northern Mariana Islands. The proposed change would have required clinicians to perform a biopsy first to determine if a kidney may be rejecting before the MACs would pay for use of the noninvasive test, called the MolDx: Molecular Testing for Solid Organ Allograft Rejection (CareDx Inc.)
“The [MACs] have carefully considered all the feedback received from interested parties regarding the proposed local coverage determination (LCD),” according to a press release from CMS. “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.
“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,” according to the release.
“Patients with transplanted hearts, lungs, or kidneys who meet Medicare’s existing local coverage criteria can continue to access these blood tests, including after an indeterminate biopsy; as a replacement for a biopsy when deemed clinically appropriate by the patient’s qualified physician and for evaluation of the adequacy of immunosuppression,” according to a CMS release. As the payment change was only a proposal, coverage for the blood tests has not changed.
CMS originally defended the proposed policy change when issued last August, indicating the MAC “became aware of improper billing and overutilization” of the tests but said patients with transplanted hearts, lungs or kidneys “who meet the coverage criteria for these tests, as laid out in the [LCD], can continue to access these tests in place of a more invasive biopsy,” according to the CMS release.
Honor the Gift, a coalition of 16 transplant patient advocacy organizations and supporters, said coverage of the noninvasive tests for surveillance was key because community nephrologists do not perform biopsies.
Eshoo and Rep. Michael Burgess, MD, R-Texas, sent letters to CMS along with other legislators urging the agency to drop the proposal. “Being a physician for over 30 years, I understand the importance of listening to the concerns and requests of your patients and doing what is best for their well-being,” Burgess, co-chair of the GOP Doctors Caucus, said in a press release issued by Honor the Gift. “The [CMS] announcement to restore coverage for post-transplant blood tests for organ damage demonstrates their commitment to ensuring doctors are able to detect early signs of treatment rejection in their patients.”
Leading transplant medical associations including the American Society for Transplant Surgeons, the American Society of Transplantation, and the International Society for Heart and Lung Transplantation also sent letters to CMS asking the agency to drop the proposal.
Reference:
CMS withdraws proposed coverage policy, ensures continued access to critical post-transplant non-invasive monitoring. https://www.honorthegift.org/news/cms-withdraws-proposed-coverage-policy-ensures-continued-access-to-critical-post-transplant-non-invasive-monitoring. Published Aug. 22, 2024. Accessed Aug. 26, 2024.
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