Natera's Prospera wins Medicare coverage for 6 annual kidney tests

Natera's Prospera portfolio secured expanded Medicare surveillance coverage, doubling allowable kidney tests in years 2-3 to 4 per year, effective Aug. 30.

The Centers for Medicare & Medicaid Services, through its MolDx program, finalized local coverage determination L40060 for molecular testing of solid organ allograft rejection, strengthening reimbursement for Natera Inc.'s Prospera portfolio in the surveillance setting. The policy covers 6 tests in year one for kidney transplant patients and 4 per year in years two and three, up from the 2 per year the July 2025 draft had proposed across all indications. Heart transplant surveillance received 12 tests in year one and 4 per year in years two and three, while lung transplant testing — now including both bilateral and single lung — mirrors the heart schedule.

"This new policy provides strong support for molecular testing in surveillance, thereby enabling clinicians to respond to rejection and help prevent irreversible damage to donor organs," Matt Mega, senior vice president of market access at Natera, said.

The final determination improves substantially on the draft policy released in July 2025, which had limited kidney surveillance to 4 tests in year one and only 2 per year in years two and three across all organ types. Major medical societies — including the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society of Heart & Lung Transplantation — submitted comments supporting expanded test frequency. For-cause coverage, used when rejection is already suspected, remains unchanged under the new policy.

The expanded reimbursement framework directly benefits Natera's competitive position in the $2 billion-plus transplant diagnostics market, where it competes with CareDx Inc. and Insight Molecular Diagnostics Inc. CareDx shares jumped on the news, while iMDx — whose GraftAssure portfolio also received favorable treatment in a separate but related MolDx policy — highlighted that the final rule removed the testing ceiling for years four and beyond, provided clinical utility is demonstrated. iMDx's GraftAssureCore test carries a Medicare reimbursement rate of $2,753 per result.

What the expanded coverage means for transplant centers

For hospitals and transplant centers evaluating whether to bring dd-cfDNA testing in-house, the higher allowable testing frequency strengthens the economic case. Natera's Prospera, a send-out test processed at the company's CLIA-certified laboratories in Austin, Texas, and San Carlos, California, now has clearer reimbursement parameters for long-term surveillance. The policy covers kidney, heart, and lung transplantation — the three highest-volume solid organ transplant categories in the U.S., where more than 40,000 transplants are performed annually.

The competitive landscape is shifting as both Natera and iMDx pursue different strategies. Natera operates a centralized lab model, while iMDx is seeking FDA marketing authorization for its GraftAssureDx kit, which would allow transplant center laboratories to run tests locally and bill Medicare at the same rate. iMDx has described the strategy as a potential paradigm shift from centralized reference labs to hospital-based testing, though its kit remains under FDA review.

Natera shares, which trade on the Nasdaq, have not yet reacted to the news in after-hours trading. The company's Prospera test is supported by more than 400 peer-reviewed publications, according to Natera. The final LCD takes effect Aug. 30, giving transplant centers roughly six weeks to adjust their testing protocols and billing practices.

This article is for informational purposes only and does not constitute investment advice.