This article has been amended to correct a typo. Cell-free DNA tests have gained coverage, not cfRNA tests.
NEW YORK – Blue Cross Blue Shield of Florida, also known as Florida Blue, will cover donor-derived cell-free DNA-based transplant rejection tests, as stated in a recent medical coverage guideline.
The policy covers tests such as Natera's Prospera Heart and Prospera Kidney, CareDx's AlloMap and AlloSure, and Viracor's TRAC assays, when they meet the insurer's definition of medical necessity.
For kidney transplant, Florida Blue defines medical necessity as when a member is at least 18 years old, at least 14 days post-transplant, testing takes place at least once a month for members who are one to six months post-transplant, and every three months for those over six months post-transplant.
For heart transplants, medical necessity is met when a member is at least 18 years old, at least 29 days post-transplant, testing takes place at least once a month for members who are one to 12 months post-transplant, and every three months for those over 12 months post-transplant.
"We are thrilled with this new policy, which increases access to Prospera for commercially insured transplant patients and adds to the existing Medicare coverage in heart, kidney, and lung," Bernie Tobin, general manager of organ health at Natera, said in a statement.
The decision comes shortly after the Centers for Medicare and Medicaid Services issued a statement clarifying recent changes that had been made to solid organ transplant test coverage, which had caused confusion and concern across the transplant space.
Last year, Natera gained Medicare coverage for its Prospera Lung transplant rejection test.