Medicare’s Bureaucracy vs. Doctors

Originally published in the Wall Street Journal.

The government ignored its own medical experts on transplant tests.

We’ve told you about the organ transplant patients whose Medicare coverage was restricted for blood tests that pick up early signs of organ rejection. It turns out the decision to limit the tests contradicted the recommendations of the government’s own panel of medical experts.

That news comes from a Freedom of Information Act (FOIA) request by CareDx, one of the companies that produces the blood tests. Noridian, a Medicare administrative contractor that covers California, fought the FOIA and had to be sued to comply. No wonder: The documents show government contractors ignored the advice of their own handpicked expert clinicians who supported the use of the tests.

The controversy began in 2023 when MolDX, a program run by Medicare contractor Palmetto GBA, reduced its coverage for molecular diagnostic tests that can detect early signs of rejection of kidney, liver, heart and lung transplants. While Medicare initially covered the tests for routine monitoring of post-transplant organ health, a 2023 coverage decision said the tests could only be used in lieu of biopsies.

The tie to biopsies was a dumb metric because the tests were designed to be used before symptoms of organ rejection (like fever) are detected and thereby protect patients from organ damage. MolDx claimed it had clarified existing policy, but the shift was government healthcare rationing to stop what it considered overutilization of a new technology. The blood tests cost less than biopsies but can be used more frequently.

The rollback certainly wasn’t based on outcomes. Polling results from the transplant clinicians released through the FOIA show broad agreement that the tests most commonly used by doctors are a valuable tool for medical surveillance. Asked if there is sufficient evidence on the clinical context in which the blood tests could be used for kidney patients, five of six clinicians said the “evidence clearly indicates for-cause and surveillance use” for the most commonly used blood test. Five of the six also said the tests have proven clinically beneficial for surveillance.

All six clinicians agreed that use of the test for kidney monitoring would preclude the need for biopsies in patients without symptoms of rejection. Instead of subjecting patients to repeated biopsies that are uncomfortable and can damage an organ over time, the government’s panel of clinical experts said the blood tests were a valuable diagnostic tool.

That also happens to be what Medicare contractors said about the blood tests before the 2023 rationing took hold. When MolDx established coverage for Allosure for kidney patients, it approved coverage for routine surveillance after transplants. After MolDx suggested tying coverage to biopsies in a 2020 draft coverage policy, it backtracked after public comments. MolDx noted in 2021 its policy was “not intended to rescind coverage for tests used for low-risk patients using such tests for surveillance.”

The science is clear and so is the politics. Noridian fought the FOIA request because denying coverage your own experts endorse isn’t a good look. Mr. Biden’s Centers for Medicare and Medicaid Services has evaded questions about the coverage changes and claims patients can still access the blood tests “when medically appropriate.” Transplant patients would disagree, and this is the future of American medicine when government rations care.