Note: It is only approved for limited purposes:
1) To detect suspected metastases in unfavorable risk patients who are potentially curable with RT or RP . In this regard, it can be used as bone scans/CT are used in such patients to rule out futility of such treatment.
2) To detect sites of suspected recurrence in patients who have already had RT or RP and may be good candidates for salvage therapy.
Since the Ga-68-PSMA PET scan for these purposes has already been available (for about $3000) for these purposes at UCLA and UCSF, this is not a big change. Sometimes Medicare allows reimbursement on diagnostics that have been FDA approved, but sometimes it doesn't. CMS will have to review. Other insurance companies may or may not reimburse for it - always get pre-authorization.
So far, approval is limited to those two institutions only (similar to the way Mayo was only approved for C-11 Choline PET scans), but other institutions may continue to offer it in clinical trials.
No word yet on DCFPyL and other novel PSMA-based ligands.