CMS defends change in payment language for coverage of transplant test
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Key takeaways:
- Transplant advocates said a language change in Medicare payment policy would limit availability of a test used to detect a failing allograft.
- CMS said the tests have been costly and overused.
Citing overuse and high costs, CMS is defending a change in coverage for a blood test used by specialists to help determine whether a transplanted organ may be failing.
The agency released a statement supporting the changes in payment coverage of molecular diagnostic tests for organ allograft rejection by the Palmetto Medicare Administrative Contractor (MAC) but said that the modifications to the payment policy did not “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 is one of 12 MACs that make Medicare payments for Part A and Part B services provided by hospitals, nursing homes, hospice programs, along with physicians and dialysis providers. Palmetto covers Alabama, Georgia, Tennessee, North Carolina, South Carolina, Virgina and West Virginia.
MACs assist CMS in making payments but also have jurisdiction in determining local coverage based on the organization’s interpretation of Medicare policy. Medicare coverage of molecular diagnostic tests includes a blood test used by physicians to help determine if a transplanted organ is failing.
Protests from community
Patient advocacy groups, transplant organizations and legislators have protested the language change, saying it would limit access to the tests and jeopardize the health of the transplanted organ.
The American Society of Transplant Surgeons, the International Society for Heart and Lung Transplantation and the American Society of Transplantation have written letters to the Palmetto MAC questioning the change and explaining why the test was important as an alternative compared with using a biopsy to determine a potential allograft failure.
“Transplant professionals have been using molecular diagnostic testing, most commonly to monitor heart and kidney recipients, as a noninvasive method to assess for allograft injury or rejection,” Deepali Kumar, MD, MSc, FRCPC, FAST, American Society of Transplantation president, said in an email to Gabriel A. Bien-Willner, MD, PhD,
medical director of Palmetto GBA. “We were surprised to see the rapidity with which the recent change was announced with limited notice and without any call for public comment or request for data. Changes in reimbursement directly impact the way these tests can be used for patient care. We believe that these changes have the potential to significantly restrict physician’s judgment in considering the best testing option for their patients and their individual circumstances.”
Fourteen members of Congress also sent a letter to CMS Administrator Chiquita Brooks-LaSure asking that coverage of the tests be restored and saying the decision by the Palmetto MAC may harm transplant patients in poor communities that have “less access to specialized transplant centers, making noninvasive diagnostic tests even more critical for their ongoing post-transplant care.”
Honor the Gift, a coalition representing organ transplant patients, held a press conference on Sept. 21 calling on the Biden administration and HHS to “stop the current attempt by private contractors to rollback Medicare coverage of safe, noninvasive molecular blood tests that can allow for the early detection of organ rejection,” according to a press release from the coalition.
Eugene C. DePasquale, MD, a transplant cardiologist and director of Heart Failure, Transplantation & Medical Circulatory Support at the University of Southern California, said in the release, “These innovative blood tests to detect organ rejection events before there are symptoms or other indicators are crucial to post-transplant patients. They are far less risky, less expensive and less traumatic for patients than surgical biopsies to determine rejection risks.
“In heart transplant patients, they have also significantly reduced the need for biopsies. I strongly urge that Medicare stop these cuts.”
Costly test
CMS said the change was made after the Palmetto MAC “became aware of improper billing and overutilization” of the tests but “patients with transplanted hearts, lungs or kidneys who meet the coverage criteria for these tests, as laid out in the Local Coverage Determination (LCD), can continue to access these tests in place of a more invasive biopsy,” CMS said in the statement.
The Palmetto MAC issued revised billing instructions to providers on March 31, and billing and coding articles provided additional educational content “to help providers, suppliers and other interested parties better understand the intent of the existing LCD criteria language,” CMS said.
The agency said it covers the test because a biopsy is an invasive procedure and includes risks for patients; the Palmetto policy covers tests that “can potentially negate the need for a biopsy by providing clinicians with actionable information that can be used to help optimize immunosuppressive therapy,” CMS said in the statement. “This means the test can be used instead of a biopsy when clinically appropriate and meeting the reasonable and necessary guidelines laid out by the MACs. This LCD coverage criteria was developed based on the available evidence and a rigorous public comment process.”
References:
CMS statement on current status of blood tests for organ transplant rejection. https://www.cms.gov/newsroom/press-releases/cms-statement-current-status-blood-tests-organ-transplant-rejection. Published Sept. 25, 2023. Accessed Oct. 2, 2023.
Letter from the American Society of Transplantation. April 5, 2023. https://www.myast.org/sites/default/files/2023.04.05%20AST%20MolDX%20Inquiry.pdf. Published April 5, 2023. Accessed Sept. 29, 2023.
National transplant patient, physician groups to Biden, HHS Sec. Becerra: Stop private contractors from rolling back Medicare coverage of noninvasive blood tests to detect transplant rejection. https://www.honorthegift.org/news/national-transplant-patient-physician-groups-to-pres-biden-hhs-sec-becerra-stop-private-contractors-from-rolling-back-medicare-coverage-of-non-invasive-blood-tests-to-detect-transplant-rejection. Published Sept. 21, 2023. Accessed Oct. 2, 2023.