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
Medicare provides coverage for two important blood tests to monitor organ transplant patients for early signs of rejection. Cell-free DNA tests and gene expression profiling tests help to detect the issue before the transplanted organ shows any damage. Recent changes and uncertainty in coverage policies have sparked concern among transplant patients, providers and advocacy groups (1✔ ✔Trusted Source
Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule
).
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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.
Together these tests provide a comprehensive diagnostic approach, with costs reaching up to $3,000 each.
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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.
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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.
Advocates argue that Medicare needs to clearly state that these tests are covered for routine monitoring, not just as a substitute for 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.
Medicare is expected to release updated rules in 2025. Until then, advocacy groups have recommended that patients and doctors use these tests when needed.
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
