Monoclonal Antibody Imaging for Prostate Cancer
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This policy governs coverage of radioimmunoscintigraphy (monoclonal antibody imaging) for prostate cancer, including indium-111 capromab pendetide (ProstaScint®), for Blue Cross Blue Shield of North Carolina members and affected providers.
No material clinical or coverage changes in this revision.
Coverage Determination
Not covered — investigational
Covered when ALL of the following are met:
BCBSNC does not provide coverage for investigational services or procedures.
Radioimmunoscintigraphy (monoclonal antibody imaging) using indium-111 capromab pendetide (ProstaScint®) is considered investigational for all applications.
No indications are listed as covered for monoclonal antibody imaging for prostate cancer; coverage is not applicable.
Applicable Service Codes
Provider Billing and Documentation Actions
Step therapy — none specified
No step-therapy requirements or sequential treatment prerequisites are specified in this policy.
Medical record request
BCBSNC may request medical records to determine medical necessity. Letters of support or explanation can be submitted but are not sufficient unless they include all information needed for a medical necessity determination.
- BCBSNC may request medical records for determination of medical necessity
- Letters of support/explanation are often useful but are insufficient unless they include all information needed to make a medical necessity determination
Investigational — potential claim denial
Monoclonal antibody imaging (radioimmunoscintigraphy) for prostate cancer is considered investigational for all applications; claims may be denied because BCBSNC does not provide coverage for investigational services.
- Policy statement: Monoclonal antibody imaging for prostate cancer is considered investigational for all applications
- BCBSNC does not provide coverage for investigational services or procedures
Background
Radioimmunoscintigraphy (RIS) is an imaging technique in which a radiolabeled monoclonal antibody is administered and, after a period to allow localization (typically days), imaged with a gamma camera (planar or SPECT). Indium-111 capromab pendetide (ProstaScint®) is a monoclonal antibody that targets a PSMA-related intracellular binding site and has been evaluated for diagnostic imaging in prostate cancer. The policy notes modest sensitivity and moderate-to-high specificity for certain staging applications but concludes that evidence is insufficient to demonstrate improved management or outcomes; consequently, RIS with this agent is considered investigational.
Key Definitions
Policy Revision History
Policy for monoclonal antibody imaging separated out and policy statement established that radioimmunoscintigraphy using indium-111 capromab pendetide (ProstaScint®) is considered investigational; notification given and policy effective 2011-08-30.
Policy became effective.
Specialty Matched Consultant Advisory Panel review; description section revised and policy guidelines updated with references; no change to policy intent.
Reference added to the policy.
Specialty Matched Consultant Advisory Panel review; no change to policy.
Reference added to the policy.
Specialty Matched Consultant Advisory Panel review; no change to policy.
Reference added to the policy.
Specialty Matched Consultant Advisory Panel review; no change to policy.
Specialty Matched Consultant Advisory Panel review; no change to policy.
Reference added and policy guidelines updated; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; policy guidelines updated and reference added; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; reference added; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; reference added; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; reference added; no change to policy statement.
Specialty Matched Consultant Advisory Panel review; no change to policy statement.
Most recent Specialty Matched Consultant Advisory Panel and Medical Director review; policy status noted as current with last review March 2026.
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