CMS grants transitional pass-through payment status for prostate cancer PET imaging agent

The Centers for Medicare & Medicaid Services has granted transitional pass-through payment status for a key PET imaging agent, the product’s developer announced Tuesday.

Blue Earth Diagnostics, a Bracco company, said the designation applies to Posluma, its prostate-specific membrane antigen-targeted radiopharmaceutical. CMS typically grants pass-through status to allow Medicare beneficiaries broader access to new and innovative drugs.

Beginning on Oct. 1, the agency will provide separate payment for the diagnostic radiopharmaceutical, along with reimbursing for the PET/CT scan itself, when used in hospital outpatient settings.

“We are very pleased that CMS has granted pass-through status for Posluma, as it increases patient access to our innovative product to inform patient management,” David E. Gauden, CEO of Oxford, England-based Blue Earth Diagnostics, said in a Sept. 26 announcement.

The U.S. Food and Drug Administration first approved the positron emission tomography agent in May. Posluma is indicated for imaging of PSMA-positive lesions in men with prostate cancer suspected to have metastasized.

The announcement comes as radiology providers have witnessed growing demand for the modality after the FDA approved the first commercially available PSMA PET agent two years ago. Experts marked the decision as a significant milestone in medicine, with the Cleveland Clinic labeling PSMA PET as one of the top 10 medical innovations to watch in 2022. A report from IMV released in March also charted 46% year-over-year growth in PET prostate scan volumes, climbing 3 percentage points to account for 9% of the overall procedure mix by study type.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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