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Radioimmunoscintigraphy (RIS) involves the administration of radiolabeled monoclonal antibodies (MAbs), which are directed against specific molecular targets, followed by imaging with an external gamma camera. Indium-111 capromab pendetide (ProstaScint®) is a monoclonal antibody directed against a binding site on prostate-specific antigen (PSA).
Radioimmunoscintigraphy is an imaging modality that uses radiolabeled MAbs to target specific tissue types. MAbs that react with specific cellular antigens are conjugated with a radiolabeled isotope. The labeled antibody-isotope conjugate is then injected into the patient and allowed to localize to the target over a 2- to 7-day period. The patient then undergoes imaging with a nuclear medicine gamma camera, and radioisotope counts are analyzed. Imaging can be performed with planar techniques or by using single-photon emission computed tomography (SPECT).
Indium-111 capromab pendetide (Prostascint®) (also referred to as CYT-356) targets an intracellular binding site on prostate-specific membrane antigen (PSMA) and has been approved by the U.S. Food and Drug Administration (FDA) for use as a “diagnosing imaging agent in newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized after standard diagnostic evaluation, who are at risk for pelvic lymph node metastases and in post-prostatectomy patients with a rising prostate-specific antigen (PSA) and a negative or equivocal standard metastatic evaluation in whom there is a high clinical suspicion of occult metastatic disease.” Other monoclonal antibodies, directed at extracellular PSMA binding sites, are also under development.
POLICYRadioimmunoscintigraphy using indium-111 capromab pendetide (Prostascint®) is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY8/17/2009: Policy added
05/17/2011: Policy reviewed. Policy description and statement unchanged. FEP verbiage added to the Policy Exceptions section.
03/27/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes to policy statement. Removed ICD-9 code 185 from the Code Reference section.
03/11/2014: Policy reviewed; no changes.
02/17/2015: Policy title updated to add "(Monoclonal Antibody Imaging)." Policy description updated. Policy statement unchanged.
09/01/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number added. Policy Guidelines updated to add investigative definition.
SOURCESBlue Cross & Blue Shield Association policy # 6.01.37
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.