The transitional pass-through payment reimbursement code for the FDA-approved PSMA PET agent for prostate cancer detection will be effective as of October 1, according to the Centers for Medicare and Medicare Services (CMS).
The Centers for Medicare and Medicaid Services (CMS) has reportedly issued a pass-through payment reimbursement code for flotufolastat F 18 (POSLUMA, Blue Earth Diagnostics).
Set to go into effect on October 1, 2023, the reimbursement code may facilitate increased access for Medicare beneficiaries to the prostate-specific membrane antigen (PSMA) positron emission tomography (PET) agent for prostate cancer imaging.
Approved by the Food and Drug Administration (FDA) in May 2023, POSLUMA is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer and suspected metastasis who are candidates for initial definitive treatment, as well as cases involving suspected prostate cancer recurrence for men with elevated prostate-specific antigen (PSA) levels.
“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,” said David E. Gauden, D.Phil., the chief executive officer of Blue Earth Diagnostics. “POSLUMA provides physicians with high-quality diagnostic information based on its diagnostic performance even at low PSA levels, high-affinity PSMA binding and potential for low urinary bladder activity.”
In a recent interview at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference, Philip Kuo, M.D., Ph.D., FACR, noted phase 3 findings from the SPOTLIGHT and LIGHTHOUSE trials that showed in 96 percent of a 712-patient cohort, the use of POSLUMA enabled clinicians to clearly distinguish between urinary activity and disease uptake with prostate cancer.
“In the vast majority of the cases, urinary activity (with flotufolastat F 18) is low enough in the ureters and bladder that we think it will not potentially affect your ability to detect disease in the pelvis,” noted Dr. Kuo, a professor of medical imaging, biomedical engineering, and medicine at the University of Arizona College of Medicine.