New rules from CMS are affecting access to molecular diagnostic testing — a blood test a patient who has received an organ transplant can use at home to track how their body is adjusting to the new organ.
The test can provide early signals if the body begins to reject the transplant, at which point physicians can take a biopsy and then decide how to proceed, USA Today reported Dec. 6.
The agency made revisions to the rule March 31, affecting how the tests are paid for and limiting what CMS has described as "overuse." The new language in the rule makes the tests accessible only in person, rather than at home, creating a barrier that patients, physicians and groups such as the American Society of Transplantation and American Society of Transplant Surgeons have pushed to have reversed.
Members of Congress also have registered concerns on the matter.
However, in a Sept. 25 statement, CMS asserted that it and its contractors have not impaired or limited patient access.
"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 statement read. "Patients with transplanted hearts, lungs or kidneys who meet the coverage criteria for these tests, as laid out in the Local Coverage Determination, can continue to access these tests in place of a more invasive biopsy."
But taking time off to access the tests in person is also a barrier for some patients, according to USA Today.
In their letter, members of Congress noted that they "remain very concerned that CMS has allowed the March 2023 billing article to remain in effect because we believe it is out of step with widely accepted evidence and is a departure from precedent …" and are urging CMS to "consider the potential harm to transplant patients, particularly under-resourced populations."