Coverage Policy Manual
Policy #: 2018011
Category: Radiology
Initiated: March 2018
Last Review: December 2023
  PET or PET/CT for Penile, Vaginal, and Vulvar Cancer
Description:
Note:  This policy is intended for those members with contracts that do not have requirements for prior approval for imaging procedures through an independent imaging review organization.
 
Positron Emission Tomography (PET) imaging uses radiotracers that can reveal both anatomical and physiological information. The glucose analog, 2-[fluorine-18]-Fluoro-2-deoxy-D-glucose (FDG) is useful in cancer imaging because it has been found that tumor cells show increased utilization of glucose compared to non-malignant tissue and is the most common radiotracer that is utilized. For certain malignancies PET scans have been shown to be more accurate than other non-invasive tests in detecting malignant disease. However, as with all diagnostic tests, PET scans do not detect cancer 100% of the time that cancer is present (a false negative test), nor do all positive PET scans represent the presence of malignant disease (a false positive test). A false negative test may occur because a critical volume of malignant cells is necessary for a PET scan to be positive. PET scans may be false positive in the presence of inflammation or granulomatous disease.
 
For individuals who have suspected or diagnosed penile cancer and in need of staging or restaging information who receive 18F-FDG-PET or 18F-PET/CT, the evidence includes a systematic review and a meta-analysis. Relevant outcomes are test accuracy and test validity. The evidence have shown that PET had a low sensitivity, and no comparisons were made with other modalities. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
For individuals who are asymptomatic after completing penile cancer treatment who receive 18F-FDG-PET or 18F-FDG-PET/CT, there is no evidence. Relevant outcomes are test accuracy and test validity. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
Definitions
 
Screening – testing in the absence of an established or clinically suspected diagnosis
 
Diagnosis - testing based on a reasonable clinical suspicion of a particular condition or disorder
 
Diagnostic Workup – initial staging of documented malignancy
 
Management – testing to direct therapy of an established condition, which may include preoperative or postoperative imaging, or imaging performed to evaluate the response to nonsurgical intervention. In oncologic imaging, management applies to patients with measurable disease and to imaging performed before or after planned treatment intervention, therapy response, restaging or clinically suspected recurrence.
 
Surveillance – periodic assessment following completion of therapy. In oncologic imaging, surveillance applies to asymptomatic patients in remission and/or without measurable disease
 
Cannot be performed or is nondiagnostic – applies when the test:
    • Is positive or indeterminate for clinically significant pathology when the information provided about the abnormality by the test is not sufficient to direct subsequent management
    • Is negative when the negative likelihood ratio of the test is both insufficient to confidently exclude the absence of suspected disease and unable to direct subsequent management. This typically applies in scenarios with moderate to high clinical pretest probability with negative testing or low pretest probability with clear evidence for net benefit
    • Has been previously nondiagnostic because of a persistent clinical factor (e.g., body habitus, immobility) that is very likely to make retesting nondiagnostic as well Cannot be performed due to a medical contraindication (e.g., contrast nephrotoxicity, allergy, or in highly radiation sensitive populations such as pediatrics and pregnancy) or reasonable unavailability related to lack of local expertise or service availability
Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
Policy/
Coverage:
EFFECTIVE MARCH 13, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with penile, vaginal, and vulvar cancers meets member benefit certificate primary coverage criteria of effectiveness for improving health outcomes for:
Diagnostic Workup:
As clinically indicated in EITHER of the following scenarios:
        • Standard imaging cannot be performed or is nondiagnostic for metastatic disease
        • Staging of penile cancer when pelvic lymph nodes are enlarged on CT or MRI and needle biopsy is not technically feasible  
Management:
Indicated in ANY of the following scenarios:
        • Radiation planning for preoperative or definitive treatment only
        • Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
        • Restaging of local recurrence when pelvic exenteration surgery is planned
 
For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with penile, vaginal, and vulvar cancers does not meet benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
    • Surveillance*
 
For contracts without primary coverage criteria, PET/CT for patients with for patients with Penile, Vaginal, and Vulvar Cancers is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
    • Surveillance*
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
*For all fully insured contracts, all self-funded church-sponsored health plans and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
 
 
Effective Prior to MARCH 13, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with penile, vaginal, and vulvar cancers meets member benefit certificate primary coverage criteria of effectiveness for improving health outcomes for:
 
Diagnostic Workup  
As clinically indicated in EITHER of the following scenarios:  
    • Standard imaging studies are equivocal or nondiagnostic for metastatic disease;
    • Staging of penile cancer when pelvic lymph nodes are enlarged on CT or MRI and needle biopsy is not technically feasible.
 
Management  
As clinically indicated in ANY of the following scenarios:  
    • Radiation planning for preoperative or definitive treatment only;
    • Standard imaging studies are equivocal or nondiagnostic for recurrent or progressive disease;
    • Restaging of local recurrence when pelvic exenteration surgery is planned.
 
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with penile, vaginal, and vulvar cancers does not meet benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:  
    • Screening and surveillance*;
    • Any other indication not specifically listed as covered above .
 
*For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
For members with contracts without primary coverage criteria, PET/CT for patients with penile, vaginal, and vulvar cancers is considered investigational for:  
    • Screening and surveillance*;
    • Any other indication not specifically listed as covered above.
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective March 2018 to May 2021
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scanning in all aspects of managing penile cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, PET scanning in all aspects of managing penile cancer is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Rationale:
This evidence review was originally created in April 2000 and has been updated regularly with searches of the MEDLINE database. It has been informed by multiple evaluations of positron emission tomography (PET), including TEC Assessments, other systematic reviews, meta-analyses, decision analyses, and cost-effectiveness analyses. The most recent literature update was performed through March 23, 2017.
 
Assessment of a diagnostic technology typically focuses on 3 categories of evidence: (1) its technical performance (test-retest reliability or interrater reliability); (2) diagnostic accuracy (sensitivity, specificity, and positive and negative predictive value) in relevant populations of patients; and (3) demonstration that the diagnostic information has clinical utility (ie, it can be used to improve patient outcomes).
 
The majority of evidence on the use of PET scanning in oncology focuses on diagnostic accuracy (sensitivity, specificity). There are few rigorous studies assessing the impact of PET on clinical outcomes. A few of the studies that have reported on changes in staging and/or treatment that result from the PET scan do not evaluate whether these changes result in an improvement in the net health outcome. Clinical guidelines help to outline the indications for which clinical utility is supported.
 
PENILE CANCER AND 18F-FDG-PET AND 18F-FDG-PET/CT
A systematic review with meta-analysis of PET has focused on staging inguinal lymph nodes among patients with penile squamous cell carcinoma. No comparisons were made with other imaging modalities.
 
The 2012 report found that PET had low sensitivity, and reviewers concluded that PET is not suited for routine clinical use in this setting (Sadeghi, 2012).
 
SUMMARY OF EVIDENCE
For individuals who have suspected or diagnosed penile cancer and in need of staging or restaging information who receive 18F-FDG-PET or 18F-PET/CT, the evidence includes a systematic review and a meta-analysis. Relevant outcomes are test accuracy and test validity. The evidence have shown that PET had a low sensitivity, and no comparisons were made with other modalities. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
For individuals who are asymptomatic after completing penile cancer treatment who receive 18F-FDG-PET or 18F-FDG-PET/CT, there is no evidence. Relevant outcomes are test accuracy and test validity. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through February 2020.  There was no new information identified that would prompt a change in the coverage statement.   
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
December 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
Vaginal, vulvar, and penile cancers are staged using the American Joint Committee on Cancer TNM system.
 
In a retrospective study, MRI performed prior to surgery for vulvar cancer had a local staging accuracy of 83% and an overall staging accuracy of 69.4%, which increased to 75%-85% when combined with CT.2 Comparable findings regarding the utility of MRI for the diagnosis, local staging, and spread of disease of vaginal cancer have been reported  in 2 small studies.3, 4 There is a lack of high-quality prospective studies evaluating PET/CT for staging vaginal and vulvar cancer. Cohn et al. found that PET/CT had sensitivity of 80%, specificity of 90%, and negative predictive value of 80% in identifying lymph node metastases; thus, PET/CT does not obviate the need for surgical staging.5 In the largest study (N = 50) comparing PET and conventional imaging data for vulvar and vaginal cancer, FDG PET/CT detected nodes suspicious for metastases in 35% of patients, as compared to MRI and CT, 13% and 7%, respectively. Distant metastases were seen in an additional 4% when compared to conventional CT, and overall resultant change in management occurred in 36% of cases. 6 In a small prospective study (N =23) of patients with vaginal cancer, PET detected lymph node involvement in 35% of patients compared to 17% for CT alone.7
 
The NCCN recommends sentinel lymph node detection in patients with T1 or T2 and clinically lymph node-negative vulvar cancer. The use of sentinel lymph node detection has been shown to decrease extent and morbidity of surgery without compromise to outcome. Patients with higher stage disease may require full lymph node dissections. (8)
 
For penile cancer, imaging is not indicated for low-risk disease (Tis,Ta, T1a). Distant metastatic disease is rare and occurs in less than 4% of cases without bulky disease. (7, 9) For intermediate to high risk (T1b, T2 or greater) and/or palpable inguinal lymph nodes, chest imaging should be performed in addition to CT abdomen and pelvis with contrast. Preoperative CT has a reported sensitivity of 95% and a specificity of 82%. In a study of 10 patients, MRI with lymphotropic nanoparticles had a sensitivity, specificity, positive predictive value, and negative predictive value of 100%, 97%, 81%, and 100%, respectively. (10) There is insufficient data to support the routine use of PET/CT for staging of penile cancer. In a comparative study, the sensitivity of PET was 80% compared to 100% in MRI and specificities were equivalent. (11) Another trial looking at 13 patients confirmed these findings.12 In a meta-analysis of 7 studies, PET had a pooled sensitivity and specificity of 80.9% and 92.4%. Sensitivity was 96.4% when inguinal lymph nodes were detected clinically but fell to 56.5% when nodes were clinically negative. (13)
 
The NCCN recommends sentinel lymph node detection for clinically lymph node-negative penile cancer. The use of sentinel lymph node detection has been shown to decrease extent and morbidity of surgery without compromise to outcome. Patients with higher stage disease may require full lymph node dissections. (14)
SURVEILLANCE
As most recurrences of vulvar and vaginal cancer are local, surveillance imaging is not indicated. In concordance with both National Comprehensive Cancer Network and Society of Gynecologic Oncology guidelines, imaging should only be performed when recurrence is suspected based on symptoms or exam findings. (8, 15) For penile cancer, surveillance with CT may be performed for N2/3 disease, but is not indicated beyond 2 years. (14)
 
Current References
    1. Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2021. CA Cancer J Clin. 2021;71(1):7-33. PMID: 33433946
    2. Kataoka MY, Sala E, Baldwin P, et al. The accuracy of magnetic resonance imaging in staging of vulvar cancer: a retrospective multi-centre study. Gynecol Oncol. 2010;117(1):82-7. PMID: 20092880
    3. Chang YC, Hricak H, Thurnher S, et al. Vagina: evaluation with MR imaging. Part II. Neoplasms. Radiology. 1988;169(1):175-9. PMID: 3420257
    4. Taylor MB, Dugar N, Davidson SE, et al. Magnetic resonance imaging of primary vaginal carcinoma. Clin Radiol. 2007;62(6):549-55. PMID: 17467392
    5. Cohn DE, Dehdashti F, Gibb RK, et al. Prospective evaluation of positron emission tomography for the detection of groin node metastases from vulvar cancer. Gynecol Oncol. 2002;85(1):179-84. PMID: 11925141
    6. Robertson NL, Hricak H, Sonoda Y, et al. The impact of FDG-PET/CT in the management of patients with vulvar and vaginal cancer. Gynecol Oncol. 2016;140(3):420-4. PMID: 26790773
    7. Lamoreaux WT, Grigsby PW, Dehdashti F, et al. FDG-PET evaluation of vaginal carcinoma. Int J Radiat Oncol Biol Phys. 2005;62(3):733-7. PMID: 15936553
    8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Vulvar Cancer (Squamous Cell Carcinoma) (Version 2.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    9. Ornellas AA, Kinchin EW, Nobrega BL, et al. Surgical treatment of invasive squamous cell carcinoma of the penis: Brazilian National Cancer Institute long-term experience. J Surg Oncol. 2008;97(6):487-95. PMID: 18425779
    10. Tabatabaei S, Harisinghani M, McDougal WS. Regional lymph node staging using lymphotropic nanoparticle enhanced magnetic resonance imaging with ferumoxtran -10 in patients with penile cancer. J Urol. 2005;174(3):923-7; discussion 7. PMID: 16093989
    11. Mueller-Lisse UG, Scher B, Scherr MK, et al. Functional imaging in penile cancer: PET/computed tomography, MRI, and sentinel lymph node biopsy. Curr Opin Urol. 2008;18(1):105-10. PMID: 18090498
    12. Scher B, Seitz M, Reiser M, et al. 18F-FDG PET/CT for staging of penile cancer. J Nucl Med. 2005;46(9):1460-5. PMID: 16157528
    13. Sadeghi R, Gholami H, Zakavi SR, et al. Accuracy of 18F-FDG PET/CT for diagnosing inguinal lymph node involvement in penile squamous cell carcinoma: systematic review and meta-analysis of the literature. Clin Nucl Med. 2012;37(5):436-41. PMID: 22475891
    14. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Penile Cancer (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    15. Salani R, Khanna N, Frimer M, et al. An update on post-treatment surveillance and diagnosis of recurrence in women with gynecologic malignancies: Society of Gynecologic Oncology (SGO) recommendations. Gynecol Oncol. 2017;146(1):3-10. PMID: 28372871
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
 
NCCN Guidelines for Gastric Cancer for Vulvar Cancer and for Penile Cancer Version 2022 were reviewed.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
78811Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck)
78812Positron emission tomography (PET) imaging; skull base to mid thigh
78813Positron emission tomography (PET) imaging; whole body
78814Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck)
78815Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid thigh
78816Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body
References: National Comprehensive Cancer Network,(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Penile Cancer (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

National Comprehensive Cancer Network,(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Vulvar Cancer (Squamous Cell Carcinoma) (Version 2.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

Sadeghi R, Gholami H, Zakavi SR, et al.(2012) Accuracy of 18F-FDG PET/CT for diagnosing inguinal lymph node involvement in penile squamous cell carcinoma: systematic review and meta-analysis of the literature. Clin Nucl Med. May 2012;37(5):436-441. PMID 22475891
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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