Final Medicare policy supports transplant surveillance portfolio
CareDx Inc. (NASDAQ:CDNA) shares climbed 20% on Thursday after the company announced that Medicare had finalized its Local Coverage Determination (LCD) covering molecular testing for solid organ transplant rejection.
The finalized policy confirms Medicare coverage for CareDx’s transplant surveillance tests used in kidney, heart and lung transplant patients, providing greater reimbursement certainty for the company’s diagnostic portfolio.
For kidney transplant recipients, the policy maintains coverage for AlloSure Kidney, allowing up to six surveillance tests during the first year after transplant and up to four tests annually in the second and third years. CareDx noted that patients currently receive an average of three to four tests during the first year.
Coverage maintained across heart and lung transplant testing
The final determination also preserves coverage for AlloMap and AlloSure Heart in heart transplant patients, including combined use of both tests when considered medically appropriate. Medicare will cover up to 12 surveillance tests during the first year following transplant and four annual tests during years two and three.
For lung transplant recipients, the policy continues Medicare coverage for AlloSure Lung, providing reimbursement for up to 12 surveillance tests in the first post-transplant year and four tests annually over the following two years.
“The final policy reinforces the role of molecular surveillance in transplant patient management, providing important clarity for patients and clinicians,” commented Dr. Jeffrey Teuteberg, Chief Medical Officer of CareDx.
The proposed coverage policy was first issued on July 17, 2025, followed by a public consultation period that ended on August 31, 2025. The finalized Local Coverage Determination was published on July 16, 2026, and is scheduled to become effective on August 30, 2026.