BlueCross and BlueShield of Montana Medical Policy/Codes
Radioimmunoscintigraphy (RIS) Imaging (Monoclonal Antibody Imaging)
Chapter: Radiology
Current Effective Date: November 26, 2013
Original Effective Date: August 10, 2011
Publish Date: November 26, 2013
Revised Dates: April 6, 2012; October 29, 2013
Description

Monoclonal antibodies are desirable for many research, diagnostic, and therapeutic purposes because of their defined nature and specificity.  These antibodies (sometimes abbreviated as MoABs, or MAbs) are artificially mass-produced in the laboratory by fusing a myeloma cell from a mouse’s own immune cells (B cells) which make a specific antibody.  The cell that results from this fusion is called a hybridoma.  Proper names for the various monoclonal antibodies identify their species source; those ending in –ximab are chimeric antibodies, and those ending in –zumab are either humanized or fully human.  MAbs are approved as biologics by the U.S. Food and Drug Administration (FDA). 

Monoclonal Antibodies for Diagnostic Purposes

The search for techniques with greater sensitivity for detecting small, subclinical tumor deposits and improved specificity for distinguishing between malignant and benign masses has led to the development of techniques for linking radioactive labels to tumor-specific antibodies.  Monoclonal antibody (MAb) imaging, also known as radioimmunoscintigraphy (RIS) or immunoscintigraphy has been proposed as an imaging method to target certain cancer cells. (1, 2)

Satumomab Pendetide (OncoScint)

OncoScint® CR/OV: Indium-111 satumomab pendetide was the first labeled monoclonal antibody to be approved by the FDA for tumor imaging.  It detects a protein that is found at high levels on the surface of most ovarian and colorectal cancers.  Satumomab pendetide is manufactured by Cytogen Corporation (Princeton, N.J.) under the trade name OncoScint® CR/OV.  In OncoScint CR/OV, the monoclonal antibody satumomab pendetide has been chemically modified so that it can bind to radioactive indium-111.  The diagnostic imaging agent is licensed for use in patients with known ovarian or colorectal cancer in whom recurrent or metastatic disease is suspected.  In patients with recurrent ovarian cancer, it may provide earlier diagnosis of small-tumor deposits in the abdominal cavity; conventional tests often miss these masses.  Diagnostic testing with the new imaging product does not replace but is best used in conjunction with computed tomography (CT) scans and other standard tests.  Coupling OncoScint with CT enables identification of about 80% of tumors; accuracy is lower when the antibody is used alone.  OncoScint's accuracy for ovarian cancer is less than for colon cancer.  In cases where it is difficult to diagnose recurrence, this test is sometimes used to help clarify the clinical picture.  It is not effective as a screening test for ovarian or colorectal cancer. 

TC 99m-arcitumomab (CEA Scan)

CEA-Scan® is an anti-carcinoembryonic antigen (CEA) Mab antibody fragment labeled with technetium-99m pertechnetate (99mTc).  This antigen is increased in a variety of carcinomas, particularly of the gastrointestinal tract, and is used as a tumor marker for cancers of the colon and rectum.  The purpose for its use is to enhance pre-operative determination of resectability.  It has a short (13 +/- 4 hours) biological half-life, rapid blood clearance, and minimal liver metabolism.  CEA-Scan has the advantages of less nonspecific localization and more rapid clearance from the body.  It is FDA-approved specifically to determine the presence, location and extent of metastatic disease in primary/recurrent colorectal cancer.

Indium In-111 pentetreotide (OctreoScan)

Indium In-111 pentetreotide (OctreoScan®) is a DTPA conjugate of octreotide, which is a long-acting analog of the human hormone, somatostatin.  Indium In-111 pentetreotide binds to somatostatin receptors on cell surfaces throughout the body.

Capromab Pentetide (ProstaScint)

ProstaScint®: Capromab pendetide labeled with the radioisotope indium 111 is a monoclonal antibody that recognizes prostate-specific membrane antigen (PSMA), a substance found only in normal and cancerous prostate cells.  When the combination of ProstaScint and Indium is injected into a patient's bloodstream, the antibody attaches itself to sites of PSMA.  The patient can then be photographed or scanned with a gamma camera to view, or image, the areas that have large amounts of the antibody.

ProstaScint is FDA-approved as an imaging agent for use in newly diagnosed patients with biopsy-proven prostate cancer that standard diagnostic evaluation indicates is clinically localized and who are at high risk for pelvic lymph node metastases, as well as in post prostatectomy patients with rising PSA levels and negative or equivocal standard metastatic evaluations in whom there is a high clinical suspicion of occult metastatic disease. 

Imciromab Pentetate (MyoScint®)

Myoscint™: Indium-111In-imciromab pentetate is FDA-approved for use as a cardiac imaging agent to detect the presence and/or identify the location of myocardial injury in patients with suspected myocardial infarction.  Specific for myocardial necrosis, the agent binds irreversibly to exposed myosin filaments of damaged myosites.  The antibody targets the heavy chain of human cardiac myosin.  The anticipated use of Myoscint™ is in situations where electrocardiography and cardiac enzymes are nondiagnostic.

I-131 meta-Iodobenzylguanidine (MIBG)

MIBG is a compound that is actively accumulated in neuroendocrine tumors and thyroid tumors, which express the noradrenaline transporter.  The FDA approved I-131 MIBG as an adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytoma and neuroblastoma.  MIBG has also been used for detection of other neural crest tumors. Adrenomedullary imaging can also be performed with I-123 MIBG.  Furthermore, I-123 MIBG scintigraphy is also used for characterization of the cardiac nervous system.  Cardiac I-123 MIBG imaging, which reflects cardiac adrenergic nerve activity, may provide prognostic information on patients with congestive heart failure.  It is also used in the diagnosis of other cardiac diseases such as cardiomyopathy and idiopathic ventricular fibrillation.

Iobenguane I-123 injection (AdreView®)

The FDA approved iobenguane I-123 injection (AdreView) for the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.  Iobenguane accumulates in adrenergically innervated tissues as well as tumors derived from the neural crest.  The uptake of iobenguane I-123 by metabolically active neuroblastoma or pheochromocytoma allows scintigraphic visualization of these tumors.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coverage

Radioimmunoscintigraphy (RIS) imaging using satumomab pendetide (CYT-103, OncoScint® CR/OV) or Tc 99m-arcitumomab (IMMU-4, CEA-4Scan) as the monoclonal antibody may be considered medically necessary in patients with known or suspected recurrent colorectal carcinoma under the following conditions:

  • In patients with an elevated carcinoembryonic antigen (CEA) level, who have no evidence of disease with other imaging modalities (i.e., CT scan), in whom a second-look laparotomy is under consideration, OR
  • In patients with an isolated, potentially resectable recurrence identified with conventional imaging modalities (i.e., CT), for whom the detection of additional occult lesions would alter the surgical plan. 

Radioimmunoscintigraphy (RIS) imaging using satumomab pendetide (CYT-103, OncoScint® CR/OV) as the monoclonal antibody may be considered medically necessary for detection of occult recurrent ovarian cancer in patients with suspected recurrence suggested by elevated tumor markers, when no other imaging or physical examination technique can locate the suspected disease.

Radioimmunoscintigraphy (RIS) imaging using indium-111 pentetreotide (Octreoscan®) as the monoclonal antibody may be considered medically necessary in patients for the localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.  These tumors typically arise in the pancreas or adrenal gland (e.g., pheochromocytoma).

Radioimmunoscintigraphy (RIS) imaging using  indium-111 capromab pendetide (Prostascint®) may be considered medically necessary for use in either:

  • Newly diagnosed patients with biopsy-proven prostate cancer, thought to be clinically localized  after standard diagnostic evaluation, who are at high risk for pelvic lymph node metastases;
  • patients previously treated for prostate cancer (e.g., radiation therapy, surgery) with detectable or rising prostate-specific antigen (PSA) levels and negative or equivocal standard metastatic evaluations in whom there is a high clinical suspicion of occult metastatic disease.

Radioimmunoscintigraphy (RIS) imaging using Imciromab Pentetate (MyoScint®) may be considered medically necessary for detecting myocardial injury where standard electrocardiogram (EKG) and cardiac enzyme studies are nondiagnostic.

Radioimmunoscintigraphy (RIS) imaging using I-131 meta-Iodobenzylguanidine (MIBG) may be considered medically necessary for localizing or confirming any of the following conditions:

  • Adrenal medulla hyperplasia,
  • Carcinoid tumors,
  • Neuroblastoma,
  • Paraganglioma,
  • Pheochromocytoma, or
  • Thyroid carcinoma.

Radioimmunoscintigraphy (RIS) imaging using iobenguane I-123 injection (AdreView®) may be considered medically necessary for the detection of primary or metastatic pheochromocytoma or neuroblastoma as an adjunct to other diagnostic tests.

Radioimmunoscintigraphy (RIS) imaging using any monoclonal antibody, for diagnostic indications other than those identified above is considered experimental, investigational and unproven

Technetium (99m Tc) fanolesomab (NeutroSpec) and Nofetumomab Merpentan (Verluma) are monoclonal antibody products no longer marketed in the United States and therefore are considered experimental, investigational and unproven for all indications.

Rationale

Satumomab Pendetide (OncoScint, CYT-103)

A retrospective study was performed to determine the diagnostic value of OncoScint CR/OV immunoscintigraphy in patients with suspected recurrence of carcinoma of the colon or ovary (Pinkas et al., 1999). (3)  Surgical and histopathological findings of 31 patients were compared to scintigraphic exams.  The combined sensitivity and accuracy of immunoscintigraphy was significantly higher than that of cross sectional radiological imaging in detecting extra-hepatic disease.  OncoScint scintigraphy is a sensitive method for detecting local recurrence and extra-hepatic metastases in colorectal and ovarian carcinoma.  A multi-center clinical trial was conducted on 103 colorectal cancer patients (Doerr et al., 1991). (4) 111In-CYT-103 immunoscintigraphic findings were consistent with the pathologic diagnoses for 70% of patients with colorectal cancer and 90% of disease-free patients.  Antibody imaging contributed to surgical decision-making by detecting occult disease (12% of patients) and confirming localized, potentially resectable disease without regional or metastatic spread.  The researchers conclude that 111In-CYT-103 is a useful diagnostic tool for presurgical evaluation of colorectal cancer patients.  In another multi-center clinical trial, 111In-CYT-103 immunoscintigraphy correctly identified surgically confirmed tumor in 68% of 103 patients with ovarian adenocarcinoma (Surwit et al., 1993). (5)  Overall sensitivity of 111In-CYT-103 immunoscintigraphy was greater than that of CT imaging.  The authors conclude that the results of this trial support 111In-CYT-103 immunoscintigraphy as a valuable addition to the presurgical evaluation of patients with suspected persistent or recurrent ovarian cancer.

TC 99m-arcitumomab (CEA Scan)

Comparison studies with CT scan have shown that this agent provides a 40% increase (66% vs. 47%) in detection of patients with respectable disease, a 143% increase (47% vs. 19%) in detection of patients with non-resectable disease, a 60% decrease (23% vs. 59%) in the false-negative (FN) rate, and a positive-predictive value of 97%.

Indium-111 pentetreotide (Octreoscan®)

OctreoScan® was studied in nine unblinded clinical studies in a total of 365 patients.  Of these patients, 174 were male and 191 were female.  Eligible patients had a demonstrated or high clinical suspicion of a neuroendocrine tumor.  The most common tumors were carcinoids (132 of 309 evaluable patients).  Scintigraphic results were compared to results of conventional localization procedures (CT, ultrasound, MRI, angiography, surgery and/or biopsy).  OctreoScan® results were consistent with the final diagnosis (success) in 267 of 309 evaluable patients (86.4%).  Compared with carcinoids and gastrinomas, lower success rates were noted for localization of insulinomas, neuroblastomas, pituitary adenomas and medullary thyroid carcinomas.  OctreoScan® success was observed in 27 of 32 patients (84.4%) with clinically nonfunctioning neuroendocrine tumors (i.e., no symptom of a clinical syndrome mediated by abnormally elevated hormones).  OctreoScan® localized previously unidentified tumors in 57/204 patients.  In 55/195 patients, indium In-111 pentetreotide uptake occurred in lesions not thought to have somatostatin receptors.  In a small subgroup of 39 patients who had tissue confirmation, the sensitivity rate for OctreoScan® scintigraphy was 85.7%; for CT/MRI the rate was 68%.  The specificity rate for OctreoScan® scintigraphy was 50%, the rate for CT/MRI was 12%.  Overall, including all tumor types with or without the presence of somatostatin receptors, there were 3/508 false positives and 104/508 false negatives.  Of the 309 patients, 87 had received octreotide for therapeutic purposes within 72 hours of OctreoScan® administration. These patients had an overall 95% success rate. (6)

Capromab Pentetide (ProstaScint)

In one of the original studies, ProstaScint imaging was performed in 152 patients undergoing radical prostatectomy to evaluate pelvic lymph node status.  The results of these ProstaScint scans were compared to the lymph node pathology obtained from pelvic lymphoadenectomy PLND.  This study reported that ProstaScint was approximately 70% accurate.  Of note, this study revealed that 14 of 25 men (56%) with negative lymph nodes on pathology but positive ProstaScint scans experienced PSA progression following radical prostatectomy.  This suggested that the true accuracy of ProstaScint imaging may actually be higher than reported.

Because the value of a diagnostic imaging modality is measured in its potential impact on patient management and health outcomes, it is noteworthy that ProstaScint was found to be the best single predictor of positive lymph nodes in a study population at high risk for nodal metastasis.   Gleason score, PSA, and ProstaScint results were all fairly good predictive factors when considered separately, but only ProstaScint demonstrated statistically significant, independent evidence for lymph node metastases if used alone.  ProstaScint imaging detected lymph node lesions that were not identified by other diagnostic tests and were confirmed to be malignant in 38 patients in addition to revealing malignancy in 12 patients in areas outside the field of surgery.

In a multi-center study comparing ProstaScint imaging to PLND in 51 prostate carcinoma patients at high risk for lymph node metastases, ProstaScint surpassed the combined diagnostic performance of CT, MRI and US with an overall accuracy of 81%.  Additional data from this study provided evidence of the potential beneficial impact of ProstaScint imaging on health outcomes.  Two patients were found to have histologically proven “skip metastases” near the level of the aortic bifurcation, which is outside the conventional location of standard pelvic exploration.  Both patients had had previous pelvic lymph node dissections that were pathologically negative, but ProstaScint scans that were abnormal.  The investigators noted that because patients who have skip metastases and negative pelvic lymph nodes have been found to later develop distant metastases, ProstaScint imaging was instrumental in detecting metastatic disease early and prompting further investigation.

A study was conducted to evaluate the role of radioimmunoscintigraphy (RIS) directed against prostate-specific membrane antigen (PSMA) in influencing decision-making about radiotherapy (RT) following radical retropubic prostatectomy (RRP) (Jani et al., 2004).(7)   The study evaluated RT treatment decisions based on knowledge gained from radioimmunoscintigraphy and compared them with those made before the radioimmunoscintigraphy.  Knowledge of radioimmunoscintigraphy results led to withdrawal of the decision to offer RT for four of 54 patients (7.4%) and changes to the general treatment volume for six of 54 patients (11.1%).  In total, radioimmunoscintigraphy altered the RT decision in 10 of 54 patients (18.5%).

In 2007, the National Comprehensive Cancer Network (NCCN) updated their Prostate Cancer Clinical Practice Guideline (v.2.2007) to include ProstaScint scan as an option under ‘Salvage Workup and Primary Salvage Therapy, Postsurgery Patients’ and under ‘Postradiation Recurrence’ (NCCN, 2007).  On the NCCN’s patient information site, the NCCN states that “the advantage of this test is that it has the potential to detect spread of prostate cancer to bone, lymph nodes, and other organs and can distinguish prostate cancer from other cancers and benign disorders.  The disadvantage is the lack of specificity, meaning that it often suggests spread when there is none.  The ProstaScint scan is usually not used to stage the cancer before initial treatment.  It may prove to be more useful after treatment, in cases where it is thought that the cancer has come back (recurred).  Although mostly retrospective studies, evidence in the published, peer-reviewed scientific literature indicates that the use of ProstaScint® (Indium-111 labeled capromab pendetide) may aid in the diagnosis of prostate cancer. (11, 12, 13)

Imciromab Pentetate (MyoScint®)

MyoScint is highly specific (specificity of 97%), since normal myocytes do not take up MyoScint, and heavy chain myosin is not found free in the circulation.  Thus the FAB fragments localize to sites of necrotic myocardium.  The extent of cardiac uptake correlates with prognosis (e.g., risk of subsequent cardiac death), and sensitivity ranges from 84% acutely to 72% at two months post myocardial infarction.  The agent can be injected immediately after the onset of chest pain.  It may have diagnostic value when the EKG and cardiac enzyme studies are equivocal.

Summary

Monoclonal antibodies, though more commonly used in immunotherapy than in diagnosis, have been shown to be effective when used in scintigraphy to aid in detecting and diagnosing numerous cancers.  Clinical trials and research will continue to expand both the number of monoclonal antibodies used as imaging agents and their potential indications for use.

2012 Update

A search of peer reviewed literature conducted through December 2012 identified the following scientific information specific to RIS imaging. Other than what’s addressed below, no additional scientific information or publications were found that would alter the current coverage position of this medical policy for RIS imaging (4)

OncoScint for Ovarian Cancer

In regards to ovarian cancer, serum CA-125 levels have been shown to be useful in predicting the presence of ovarian cancer, but negative titers do not preclude malignancy. In clinical trials, OncoScint has a sensitivity of 70 % versus 44 % for CT, and a specificity of 55 % (79 % for CT) in patients with ovarian cancer. Carcinomatosis was detectable by antibody imaging in 71 % of patients, but in only 45 % by CT.

ProstaScint for Prostate Cancer

In Version 1:2011 of the National Comprehensive Cancer Network (NCCN) Guidelines for prostate cancer ProstaScint was removed as a recommendation in the workup of a patient with recurrence after prostatectomy and with a recurrence after RT. No rationale listed. (14)   In Version 1:2013 no mention or comments were found in the guidelines when searching for the term ProstaScint. (15)

I-131 meta-Iodobenzylguanidine (MIBG)

According to the NCI PDQ Database, CT and MRI scans are about equally sensitive (98 to 100 %) for pheochromocytoma, while MIBG scanning has a sensitivity of only 80 %.  However, MIBG scanning has a specificity of 100 %, compared to specificity of 70 % for CT and MRI.  Thus, I-131 MIBG imaging provides a method for confirming that a tumor is a pheochromocytoma and rules out metastatic disease. Currently, I-131 MIBG is approved as an adjunctive diagnostic agent in the localization of primary or metastatic pheochromocytoma and neuroblastoma.  According to the National Cancer Institute’s PDQ Database, for staging of neuroblastoma,  bone should be assessed by MIBG scan (applicable to all sites of disease) and by technetium-99 scan if the results of the MIBG imaging are negative or unavailable.(16) 

Iobenguane I-123 injection (AdreView®)

The safety and effectiveness of iobenguane I-123 were assessed in a single-arm clinical study of patients with known or suspected neuroblastoma or pheochromocytoma.  Diagnostic effectiveness was determined for 211 patients by comparison of focal increased radionuclide uptake on planar scintigraphy at 24 ± 6 hours post-administration of iobenguane I-123 injection against the definitive diagnosis (standard of truth).  The standard of truth was a diagnosis of presence or absence of pheochromocytoma in 127 patients and neuroblastoma in 84 patients.  The diagnosis was determined by histopathology or, when histopathology was unavailable, a composite of imaging, plasma/urine catecholamine and/or catecholamine metabolite measurements and clinical follow-up.  In the detection of either neuroblastoma or pheochromocytoma, the iobenguane I-123's sensitivity and specificity were determined independently based upon results of 3 image-readers who were fully masked to clinical information.  The sensitivity ranged from 77 % to 80 % and the specificity ranged from 69 % to 77 %.  Performance characteristics were similar between the groups of patients who had either a pheochromocytoma or neuroblastoma truth standard. (17, 18)

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

Rationale for Benefit Administration
 
ICD-9 Codes

185, V10.46, 153.0 - 153.9, 154.0 - 154.8, 183.0, V10.05, V10.06, V10.43, 170.0 - 170.9, 171.0 - 171.9, 193, 194, 226, V10.87, 157.0 - 157.9, 192.0, 192.1, 193, 194.0, 194.3, 194.6, 194.5, 194.6, 201.00 - 201.98, 209.00 - 209.30, 209.40 - 209.69, 211.1, 211.6, 211.7, 225.2, 225.4, 227.0,  227.3, 227.5, 227.6,  235.2, 235.5, 235.7,  237.0, 237.2, 237.3, 237.4, 237.6, 255.8, 259.2

ICD-10 Codes
C61,  Z45.46,  C72YYZZ, C75YYZZ, CT6YYZZ, CW1ZYZZ 
Procedural Codes: 78800, 78801, 78802, 78803, 78804, A4641, A4642, A9507, A9508, A9568, A9572, A9582, Q9969
References
  1. BCBSA TEC Assessments:  1997, Tabs 17 and 18, Radioimmunoscintigraphy for Prostate Cancer and Lung Cancer.
  2. BCBSA TEC Assessments:  Volume 9, No. 5, March 1994, Monoclonal Antibody Imaging.
  3. Pinkas, L., Robins, P.D, et al.   Clinical experience with radiolabelled monoclonal antibodies in the detection of colorectal and ovarian carcinoma recurrence and review of the literature.  Nucl Med Commun (1999 Aug) 20(8):689-96.
  4. Doerr, RJ, Abdel-Nabi, H., et al, Radiolabeled antibody imaging in the management of colorectal cancer. Results of a multicenter clinical study. Ann Surg. 1991 August; 214(2): 118–124.
  5. Surwit, E.A., Childers, J.M. et al, Clinical assessment of 111In-CYT-103 immunoscintigraphy in ovarian cancer.  Gynecol Oncol (1993 Mar) 48(3):285-92.
  6. Octreoscan- indium in -111 pentetreotide Mallinckrodt Inc. http://medlibrary.org  .Last accessed January 2013
  7. Jani, AB, Blend, MJ., et al.  Influence of Radioimmunoscintigraphy on Postprostatectomy Radiotherapy Treatment Decision Making.  Journal of Nuclear Medicine (2004 April) Vol. 45 No. 4:571-78.
  8. Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) Using Technetium-99m Nofetumomab Merpentan (Verluma).  BCBSA Medical Policy Reference Manual, (November 2004) Radiology 6.01.05.
  9. Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) Using In-111 Satumomab Pendetide (OncoScint) or Tc-99m Arcitumomab (IMMU-4, CEA-Scan).  BCBSA Medical Policy Reference Manual, (February 2004) Radiology 6.01.36.
  10. Obradovic, v. artiko, V., et al.  Radioimmunoscintigraphy of colorectal carcinomas with three different radiopharmaceuticals.  Neoplasma (2006) 53 (5):444-9.
  11. Nagda SN, Mohideen N, Lo SS et al. Long-term follow-up of 111In-capromab pendetide (ProstaScint) scan as pretreatment assessment in patients who undergo salvage radiotherapy for rising prostate-specific antigen after radical prostatectomy for prostate cancer. Int J Radiat Oncol Biol Phys (2007) 67(3):834-40.
  12. Ashesh, B., Jani, MD, et al.  The Role of Indium-111 Radioimmunoscintigraphy in Post-Radical Retropubic Prostatectomy Management of Prostate Cancer Patients.  Clinical Medicine & Research (2007) Volume 5, Number 2:123-31.
  13. Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) with Indium-111 Capromab Perndetide (Prostascint) for Prostate Cancer.  BCBSA Medical Policy Reference Manual, Radiology (February 2012) 6.01.37.
  14. Prostate Cancer. V.1.2011. National Comprehensive Cancer Network. 2011. Available online at: http://www.nccn.org . Last accessed January 2013.
  15. Prostate Cancer. V.1.2013. National Comprehensive Cancer Network. 2013. Available online at: http://www.nccn.org . Last accessed January 2013.
  16. National Cancer Institute (NCI).  Pheochromocytoma (PDQ): Treatment Information for Health Professionals: Bethesda, MD: NCI; updated December 18, 2003. Available at: http://www.nci.nih.gov . Accessed January 2013.
  17. U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER). FDA approves Iobenguane I 123 for the detection of primary or metastatic pheochromocytoma or neuroblastoma. Rockville, MD: FDA; September 30, 2008. Available at: http://www.fda.gov . Accessed January 2013.
  18. GE Healthcare. AdreView (iobenguane I 123 injection) for intravenous use. Prescribing Information. Arlington Heights, IL: GE Healthcare; revised September 2008. Available at: http://www.fda.gov . Accessed January 2013.
History
June 2011 New Policy: codes 78800, 78801, 78803 already set as investigational.
April 2012 Policy updated with literature review. Rationale section re-written, references revised/renumbered. No change to policy statement.
November 2013 Policy formatting and language revised.  Title changed from "Radioimmunoscintigraphy Imaging (Monoclonal Antibody Imaging) with Indium-111 Capromab Pendetide (Prostascint®) for Prostate Cancer" to "Radioimmunoscintigraphy (RIS) Imaging (Monoclonal Antibody Imaging".  Policy statement changed from investigational to possibly medically necessary.  Added HCPCs codes A4641, A4642, A9508, A9568, A9572, A9582, and Q9969.
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Radioimmunoscintigraphy (RIS) Imaging (Monoclonal Antibody Imaging)