Pentixapharm Applauds CMS Reimbursement Enhancement for Radiopharmaceuticals

Pentixapharm Holding AG has expressed approval for the recent decision by the U.S. Centers for Medicare & Medicaid Services (CMS) to enhance reimbursement for specialized diagnostic radiopharmaceuticals. This policy change allows for separate payments beyond the transitional pass-through period, significantly affecting future reimbursement for Pentixapharm’s Ga68-PentixaFor. This diagnostic tool, intended for detecting primary aldosteronism (PA), is set to begin a Phase III clinical trial in the U.S. next year, with potential market authorization by 2028.

The CMS's previous policy covered high-cost diagnostics during a limited pass-through payment period, which then reverted to standard bundles. The new policy provides ongoing separate payments, influencing how hospitals adopt innovative technologies. As Medicare and Medicaid cover over 140 million Americans, this decision could lead private insurers to adopt similar reimbursement strategies, thus broadening access to advanced diagnostics.