Coverage Policy Manual
Policy #: 2001040
Category: Radiology
Initiated: December 1999
Last Review: January 2024
  PET or PET/CT for Testicular Germ Cell Cancer
Description:
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.
 
The sensitivity of PET with FDG in detecting disease averages only 56% in the studies thus far reported, is not able to identify mature teratomas, and has been shown to have no apparent benefit in post-chemotherapy evaluation of residual masses in bulky seminoma.
 
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
 
Seminoma
 
FDG-PET/CT for patients with Testicular Seminoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for patients for:
Diagnostic Workup:   
      • Indicated when standard imaging cannot be performed or is nondiagnostic for metastatic disease
Management:
Indicated in EITHER of the following scenarios:
      • Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
      • Residual mass greater than 3 cm and normal tumor markers after completion of chemotherapy
 
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 Testicular Seminoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any other indication not listed as covered above including but not limited to:
    • Surveillance*
 
For contracts without primary coverage criteria, PET/CT for patients with Testicular Seminoma is 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.
 
Nonseminoma
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Testicular Nonseminoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any indication.
 
For contracts without primary coverage criteria, PET/CT for patients with Testicular Nonseminoma is considered investigational for any indication. 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
 
Seminoma
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Testicular Seminoma meets member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
Diagnostic Workup:   
        • When standard imaging cannot be performed or is nondiagnostic for metastatic disease
Treatment Management:  
Indicated in EITHER of the following scenarios:
        • Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
        • Residual mass greater than 3 cm and with normal tumor markers
 
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 Testicular Seminoma does not meet member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:  
    • for screening and surveillance*
    • for 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 Testicular Seminoma is considered investigational:  
    • for screening and surveillance
    • for any other indication not specifically listed as covered above  
Investigational services are Plan exclusions.
 
 
Nonseminoma
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Testicular Nonseminoma does not meet member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for any indication.
 
*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 Testicular Nonseminoma is considered investigational for any indication. Investigational services are Plan exclusions.
  
Notes:  
Standard or conventional imaging refers to imaging that does not require a PET/CT.
CT/MRI is usually considered first-line imaging.  
 
 
Effective Prior to August 2021
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) scanning meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for men with testicular germ cell cancer following initial surgical removal of the tumor as a guide to additional therapy decisions in patients with pure seminoma.
 
PET is covered for restaging if tumor marker(s) (e.g., hCG or alpha-fetoprotein) is elevated.
 
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 scanning for men with testicular germ cell cancer for any reason other than those specifically addressed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness, including but not limited to:
  • for initial staging, staging of asymptomatic males with normal tumor marker,  
  • to monitor response to chemotherapy, or
  • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence  
 
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.
 
PET scanning should not be done for staging or re-staging of tumors that are known not to be 18FDG-avid. (Juweid ME, Cheson BD. NEJM, 2006;354:496-507)
Rationale:
2014 Update
 
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
 
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement.  
 
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.
 
2022 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
GCTs are staged using the American Joint Committee on Cancer TNM system. CT abdomen and pelvis with contrast is primarily used to evaluate the retroperitoneal lymph nodes. (2) A CT Chest with contrast is indicated if the abdominal/pelvic CT or chest x-ray shows evidence of metastatic disease. In direct comparisons, MRI has not shown an advantage over CT for accuracy of staging. (3, 4) Per NCCN, PET scans should not be used routinely to stage testicular GCTs. In a prospective study, CT imaging showed sensitivity, specificity, positive predictive value, and negative predictive value of 41%, 95%, 87%, and 67% compared with PET/CT 66%, 98%,95%, and 78%, respectively. The poor negative predictive value of PET limits its usefulness in initial staging. (5) In another prospective trial in which high risk stage I NSGCT was imaged with PET, only 23 of 110 patients were found to have PET avid disease, and 33 of 88 PET-negative patients had disease relapse. (6)
 
MANAGEMENT
PET/CT has higher positive and negative predictive values for identifying residual viable seminomatous tumors compared to CT, especially in the setting of a radiographically persistent mass and normal tumor markers. In the prospective multicenter SEMPET trial, patients with seminoma, negative tumor markers, and at least a 1 cm residual mass following completion of chemotherapy were imaged with PET and CT of the abdomen and pelvis. When compared to CT, PET had superior sensitivity and specificity (80% and 100% vs 74% and 70%) as well as positive predictive value and negative predictive value (100% and 96% vs 37% and 92%).7 Accuracy is improved and falsenegative results decreased when PET/CT is used to evaluate residual masses at least 3 cm in size. (8) In patients with NSGCT and residual mass > 1 cm after primary chemotherapy, retroperitoneal lymph node dissection or surgical resection of the residual mass should be strongly considered as opposed to continued radiographic surveillance. PET has limited ability to differentiate residual non-seminomatous tumor from radiation necrosis and fibrosis. In a prospective German multicenter trial, PET used for detection of residual NSGCT after chemotherapy only had an accuracy of 56% (compared to CT scan 55% and serum tumor markers 56%). (9) Guidelines are in accordance with the National Comprehensive Cancer Network (NCCN) Guidelines for Testicular Cancer. (10)
 
SURVEILLANCE
Seminomas tend to recur within the first 14 months and nonseminomas within the first 2 years. (11) These guidelines are in accordance with the NCCN Guidelines for Testicular Cancer and European Society for Medical Oncology guidelines. (12)
 
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. Leibovitch L, Foster RS, Kopecky KK, et al. Improved accuracy of computerized tomography based clinical staging in low stage nonseminomatous germ cell cancer using size criteria of retroperitoneal lymph nodes. J Urol.1995;154(5):1759-63. PMID: 7563341
    3. Ellis JH, Bies JR, Kopecky KK, et al. Comparison of NMR and CT imaging in the evaluation of metastatic retroperitoneal lymphadenopathy from testicular carcinoma. J Comput Assist Tomogr. 1984;8(4):709-19. PMID:6539790
    4. Hogeboom WR, Hoekstra HJ, Mooyaart EL, et al. The role of magnetic resonance imaging and computed tomography in the treatment evaluation of retroperitoneal lymph-node metastases of non-seminomatous testicular tumors. Eur J Radiol. 1991;13(1):31-6. PMID: 1716204
    5. de Wit M, Brenner W, Hartmann M, et al. [18F]-FDG-PET in clinical stage I/II non-seminomatous germ cell tumours: results of the German multicentre trial. Ann Oncol. 2008;19(9):1619-23. PMID: 18453520
    6. Huddart RA, O'Doherty MJ, Padhani A, et al. 18fluorodeoxyglucose positron emission tomography intheprediction of relapse in patients with high-risk, clinical stage I nonseminomatous germ cell tumors: preliminary report of MRC Trial TE22--the NCRI Testis Tumour Clinical Study Group. J Clin Oncol.2007;25(21):3090-5.PMID: 17634488
    7. De Santis M, Becherer A, Bokemeyer C, et al. 2-18fluoro-deoxy-D-glucose positron emission tomography is a reliable predictor for viable tumor in post chemotherapy seminoma: an update of the prospective multicentric SEMPET trial. J Clin Oncol. 2004;22(6):1034-9. PMID: 15020605
    8. Treglia G, Sadeghi R, Annunziata S, et al. Diagnostic performance of fluorine-18-fluorodeoxyglucose positron emission tomography in the post chemotherapy management of patients with seminoma: systematic review and meta-analysis. Biomed Res Int. 2014;2014(Article ID 852681):[11 p.]. PMID: 24963486
    9. Oechsle K, Hartmann M, Brenner W, et al. [18F] fluorodeoxyglucose positron emission tomography in nonseminomatous germ cell tumors after chemotherapy: the German multicenter positron emission tomography study group. J Clin Oncol. 2008;26(36):5930-5. PMID: 19018083
    10. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Testicular Cancer (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    11. Kollmannsberger C, Tandstad T, Bedard PL, et al. Patterns of relapse in patients with clinical stage I testicularcancer managed with active surveillance. J Clin Oncol. 2015;33(1):51-7. PMID: 25135991
    12. Oldenburg J, Fossa SD, Nuver J, et al. Testicular seminoma and non -seminoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24 Suppl 6:vi125-32. PMID: 24078656
 
2023 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 Testicular Cancer (Version 2.2022) was reviewed and notes that, “PET has no role in assessing treatment response and residual masses following chemotherapy in patients with nonseminoma.”
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
 
NCCN Guidelines for Testicular Cancer (Version 1.2023) was reviewed and notes that, “PET has no role in assessing treatment response and residual masses following chemotherapy in patients with nonseminoma.”
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: Albers P, Bender H, Yilmaz H, et al.(1999) Positron emission tomography in the clinical staging of patients with stage I and II testicular germ cell tumors. Urology 1999; 53:808-811.

Cremerius U, Effert PJ, Adam G, et al.(1998) FDG PET for detection and therapy control of metastatic germ cell tumor. J Nucl Med 1998; 39:815-822.

Ganjoo KN, Chan RJ, Sharma M, et al.(1999) Positron emission tomography scans in the evaluation of postchemotherapy residual masses in patients with seminoma. J Clin Oncol 1999; 17:3457-3460.

Hain SF, O’Doherty MJ, Timothy AR, et al.(2000) Fluorodeoxyglucose PET in the initial staging of germ cell tumors. Eur J Nucl Med 2000; 27:590-594.

Hain SF, O’Doherty MJ, Timothy AR, et al.(2000) Fluorodeoxyglucose positron emission tomography in the evaluation of germ cell tumors at relapse. Br J Cancer 2000; 83:863-869.

Hoh CK, Seltzer MA, Franklin J, et al.(1998) Positron emission tomography in urological oncology. J Urol 1998; 159:347-356.

Juweid ME, Cheson BD.(2006) Positron Emission Tomography and assessment of cancer therapy. NEJM 2006; 354:496-507.

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

Nuutinen JM, Leskinen S, Elomaa I, et al.(1997) Detection of residual tumors in post chemotherapy testicular cancer by FDG-PET. Eur J Cancer 1997; 33:1234-1241.

Sugawara Y, Zasadny KR, Grossman HB, et al.(1999) Germ cell tumor: differentiation of viable tumor, mature teratoma, and necrotic tissue with FDG PET and kinetic modeling. Radiology 1999; 211:249-256.
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.
CPT Codes Copyright © 2024 American Medical Association.