Since 2017, Medicare has covered critical blood tests for transplant monitoring. These tests detect organ rejection early, sometimes weeks before symptoms appear, but recent policy confusion has caused major concerns.
- Cell-free DNA tests and gene expression profiling tests help to monitor organ transplant patients for early signs of rejection
- In March 2023, Medicare proposed limiting coverage of the tests
- Clear guidelines and better communication are needed to ensure all transplant patients get the care they deserve
Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule
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Due to Medicare policy confusion, 18,000 fewer blood tests were conducted across the U.S. in 2023, leaving many transplant patients without critical monitoring. #transplantcare #Medicarepolicy #medindia’





Medicare Coverage of Critical Tests for Transplant Monitoring
Since 2017, Medicare has covered cell-free DNA tests and gene expression profiling for transplant monitoring. The purpose of these tests is:- The cell-free DNA test detects early signs of organ rejection, sometimes weeks before symptoms appear.
- Gene expression profiling examines immune system activity to identify the type of rejection or damage.
Proposed Policy Changes and Their Effect on Test Utilization
In March 2023, Medicare proposed limiting coverage of the tests. The proposal stated:Medicare will pay only for one test instead of both. The test will be covered if it replaces a biopsy, not for routine checkups. This caused a lot of concern because most transplant centres don’t routinely conduct biopsies.
As a result, many doctors stopped recommending these blood tests leading to 18,000 fewer tests being done nationwide. Patients and doctors were confused about whether the tests were covered.
Ongoing Confusion and the Need for Clearer Medicare Guidelines
After criticism from doctors, patients, and advocacy groups, Medicare reversed the proposed changes in August 2023. However, the number of tests has not returned to previous levels.- Patients and doctors are still unsure if Medicare will pay for these tests.
- Fewer recommended tests denote that some patients are not getting the necessary monitoring.
- Tying test coverage to biopsy necessity is problematic, as fewer than 20% of transplant centers routinely perform biopsies.
Doctors and advocacy groups want Medicare to:
- Issue clear guidelines so everyone knows the tests are covered.
- Remove confusing statements that link the tests to biopsies.
- Work with transplant centres and test makers to let patients know these tests are still available.
Blood tests are a critical tool for keeping transplant patients healthy. However, confusion around Medicare’s policies has made it harder for patients to access them. Clear guidelines and better communication are needed to ensure all transplant patients get the care they deserve.
Reference:
- Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule - (https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-proposed-rule)
Source-Medindia