CMS Issues Permanent HCPCS Code for the PSMA PET Prep Modality Gozellix

The Centers for Medicare and Medicaid Services (CMS) has provided a permanent HCPCS code for the use of the PSMA PET agent Gozellix, a preparation kit for the gallium-68 (⁶⁸Ga) gozetotide injection.

The HCPCS level II code A9616 will go into effect on October 1, 2025, according to Telix Pharmaceuticals, the manufacturer of Gozelliz.

In combination with 68Ga radiolabeling, Gozellix was approved by the Food and Drug Administration (FDA) earlier this year for use in PSMA PET for men with suspected metastatic prostate cancer (PCa) who are eligible for initial definitive therapy. The PSMA PET prep product is also indicated for use in men with suspected biochemical recurrence of PCa.

"Being granted a HCPCS code marks a significant step forward in Telix's mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location,” noted Kevin Richardson, the chief executive officer of precision medicine for Telix Pharmaceuticals. “It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market."