Coverage Policy Manual
Policy #: 2018012
Category: Radiology
Initiated: March 2018
Last Review: December 2023
  PET or PET/CT for Bone 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.
 
In the United States PET/CT is usually done by a dedicated scanner that allows both forms of imaging on a single table but it can also be done with fusion or registration.
 
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.
 
Related Policies:  See PET scanning policies for specific indications.
Policy/
Coverage:
EFFECTIVE April 14, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Bone Cancer meets member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
 
Diagnostic Workup:
Indicated in ANY of the following scenarios (all tumor types):
        • Initial work-up of Ewing sarcoma and osteosarcoma if curative treatment planned
        • Standard imaging* cannot be performed or is nondiagnostic or metastatic disease
        • Standard imaging* suggests a resectable solitary metastasis
        • Baseline study prior to neoadjuvant chemotherapy
Management:
Indicated in EITHER of the following scenarios:
        • Following completion of neoadjuvant chemotherapy
        • Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
 
For fully-insured contracts subject to Act 583 of 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 Bone Cancer does not meet member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
    • Surveillance*
For contracts without primary coverage criteria, PET/CT for patients with Bone Sarcoma 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 fully-insured contracts subject to Act 583 of 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 MARCH 13, 2022 to April 13, 2024
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Bone Sarcoma meets member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
 
Diagnostic Workup:
Indicated in ANY of the following scenarios (all tumor types):
        • Initial work-up of Ewing sarcoma and osteosarcoma if curative treatment planned
        • Standard imaging** cannot be performed or is nondiagnostic or metastatic disease
        • Standard imaging** suggests a resectable solitary metastasis
        • Baseline study prior to neoadjuvant chemotherapy
 
Management:
        • Indicated following completion of neoadjuvant 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 Bone Sarcoma does not meet member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
    • Surveillance*
 
For contracts without primary coverage criteria, PET/CT for patients with Bone Sarcoma 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 Bone Cancer meets member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
 
Diagnostic Workup:  
Indicated in ANY of the following scenarios (all tumor types):
        • Initial work-up of Ewing sarcoma and osteosarcoma if curative treatment planned; or
        • Standard imaging cannot be performed or is nondiagnostic or metastatic disease; or
        • Standard imaging suggests a resectable solitary metastasis; or
        • Baseline study prior to neoadjuvant chemotherapy
Treatment Management:
        • Indicated following completion of neoadjuvant chemotherapy
 
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 Bone Cancer 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 Bone Cancer is considered investigational:  
    • for screening and surveillance
    • for any other indication not specifically listed as covered above  
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
 
PET scanning in the staging or restaging of Ewing sarcoma and osteosarcoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scanning in the staging of chondrosarcoma 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 the staging of chondrosarcoma is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
A literature review was performed with a search of the MEDLINE database through February 2018. The key literature is summarized below.
 
BONE CANCER AND 18F-FDG-PET AND 18F-FDG-PET/CT
A systematic review and meta-analysis (35 studies, total N=2171 patients) by Liu et al (2015) evaluated fluorine 18 fludeoxyglucose PET (18F-FDG-PET) and 18F-PET with/CT (18F-PET/CT) in the diagnosis, staging, and recurrence assessment of bone sarcoma (Liu, 2015). Most selected studies used PET/CT (n=29). Meta-analyses showed high sensitivity (96%; 95% confidence interval [CI], 93% to 98%) and specificity (79%; 95% CI, 63% to 90%) of 18F-FDG-PET and –PET/CT to differentiate primary bone sarcomas from benign lesions. For pooled results for detecting recurrence, sensitivity was 92% (95% CI, 85% to 97%) and specificity was 93% (95% CI, 88% to 96%). For pooled results for detecting distant metastases, sensitivity was 90% (95% CI, 86% to 93%) and specificity was 85% (95% CI, 81% to 87%). Subgroup analysis by specific metastatic site revealed that PET alone was less effective in detecting lung metastases than other metastatic sites (sensitivity, 71%; 95% CI, 52% to 86%; specificity, 92%; 95% CI, 87% to 96%).
 
A systematic review (13 studies, total N=342 patients) and meta-analysis (5 studies, n=279 patients) by Treglia et al examined the diagnostic accuracy of 18F-FDG-PET and -PET/CT in Ewing sarcoma (Treglia, 2012). The meta-analysis showed high estimates of sensitivity and specificity for 18F-FDG-PET and -PET/CT (pooled sensitivity, 96%; pooled specificity, 92%).
 
In a prospective study by Völker et al of 46 pediatric patients with sarcoma (Ewing sarcoma, osteosarcoma, rhabdomyosarcoma), PET was compared with conventional imaging techniques (ultrasound, CT, MRI, bone scintigraphy) (Volker, 2007). The study showed that PET was as effective as conventional imaging in detecting primary tumors, and PET was superior to conventional imaging in detecting lymph node and bone involvement. However, CT was more reliable in detecting lung metastases. The most thorough assessment of cancer involvement used both PET and conventional tests and resulted in important changes in therapy decisions.
 
Current NCCN guidelines for bone cancer state that PET and CT may be considered for (NCCN, 2017):  
 
    • Workup of patients with chordoma, Ewing sarcoma, or osteosarcoma,
    • Restaging in patients with Ewing sarcoma or osteosarcoma, and
    • Surveillance of patients with Ewing sarcoma or osteosarcoma (category 2B).
 
Evidence for the use of 18F-FDG-PET and 18F-PET/CT for the diagnosis and for the staging and restaging of bone cancer consists of systematic reviews and meta-analyses of many studies. Pooled analyses have shown that PET is effective in staging of bone cancer. PET has also shown high sensitivities and specificities in detecting metastases in bone and lymph nodes, but low sensitivity in detecting lung metastases. The evidence supports the use of 18F-FDG-PET and 18F-PET/CT for the diagnosis and staging and restaging of bone cancer but does not support their use for surveillance.
 
 
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. The key identified literature is summarized below.
 
Bone Sarcoma
 
A meta-analysis (12 studies, N=375) by Zhang et al evaluated FDG-PET and FDG-PET/CT in the diagnosis and staging of chondrosarcoma, a common type of bone sarcoma (Zhang, 2020). Six studies used PET/CT, 5 studies used PET, and 1 study utilized both. For differentiating between chondrosarcoma and benign lesions, the pooled sensitivity and specificity of FDG-PET were 84% (95% CI, 46% to 97%) and 82% (95% CI, 55% to 94%), respectively. The sensitivity and specificity for FDG-PET/CT were also found to be high at 94% (95% CI, 86% to 97%) and 89% (95% CI, 82% to 93%), respectively. There was substantial heterogeneity for sensitivity (I2, 86.90%; 95% CI, 76.8% to 97.0%) and specificity (I2, 70.32%; 95% CI, 42.57 to 98.07%) among studies. Most included studies were retrospective (75%) and included small sample sizes (n=7 to 95), potentially introducing bias and variability.
 
December 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
Sarcomas are staged using the American Joint Committee on Cancer TNM system. Imaging of the primary tumor is important to assess resectability and local invasion. CT or MRI may be done as part of initial workup. However, MRI is often preferred for imaging the primary tumor due to superior resolution of tumor versus surrounding muscle and neurovascular bundles, and for delineating disease involving the pelvis. (2-7) In a large prospective trial comparing CT and MRI imaging in both soft tissue sarcomas and bone cancer, the accuracy of local staging was not statistically different between the 2 modalities. (8)
 
Imaging of the lungs is critical, as this is the most common site of metastases. Additional imaging recommendations for soft tissue sarcoma vary by subtype. Multiple studies have shown a correlation between FDG uptake and tumor grade, which is a strong indicator of prognosis. However, the evidence has not shown that PET significantly impacts staging or management. (9,10)
 
For Ewing sarcoma and osteosarcoma, NCCN recommends whole body PET/CT and/or bone scan as part of initial workup (level of evidence category 2A). (11) A meta-analysis showed a pooled sensitivity of 96% and pooled specificity of 92% for staging and restaging Ewing sarcoma when PET was combined with conventional imaging. (12) In another meta-analysis of 42 trials, PET had a pooled sensitivity and specificity of 96% and 79% for differentiating primary bone sarcomas from benign lesions, 92% and 93% for detecting recurrence, and 90% and 85% for detecting distant metastasis, respectively. (13)
 
MANAGEMENT
PET has been shown to be a useful adjunct in assessing treatment response to neoadjuvant therapy, as well as an indicator of prognosis. (11-13) A review and meta-analysis of 11 studies confirmed the prognostic value of PET response to overall survival in soft tissue and bone sarcoma. (14,15)
 
SURVEILLANCE
Imaging of the primary site for soft tissue sarcoma is based on the risk of recurrence and the accessibility of the primary cancer site. (14) Particularly for younger patients where the radiation risks from multiple CT examinations might cause some concern, the follow up can be performed with MRI of the abdomen and pelvis supplemented with CT thorax.
 
Current References
    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30. PMID: 31912902
    2. Aisen AM, Martel W, Braunstein EM, et al. MRI and CT evaluation of primary bone and soft-tissue tumors. AJR Am J Roentgenol. 1986;146(4):749-56. PMID: 3485348
    3. Demas BE, Heelan RT, Lane J, et al. Soft-tissue sarcomas of the extremities: comparison of MR and CT in determining the extent of disease. AJR Am J Roentgenol. 1988;150(3):615-20. PMID: 3257620
    4. Manaster BJ. Soft-tissue masses: optimal imaging protocol and reporting. AJR Am J Roentgenol. 2013;201(3):505-14. PMID: 23971442
    5. Sundaram M, McGuire MH, Herbold DR. Magnetic resonance imaging of soft tissue masses: an evaluation of fifty-three histologically proven tumors. Magn Reson Imaging. 1988;6(3):237-48. PMID: 3398729
    6. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastrointestinal Stromal Tumors (GISTs) (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    8. Panicek DM, Gatsonis C, Rosenthal DI, et al. CT and MR imaging in the local staging of primary malignant musculoskeletal neoplasms: report of the Radiology Diagnostic Oncology Group. Radiology. 1997;202(1):237-46. PMID: 8988217
    9. Schuetze SM. Utility of positron emission tomography in sarcomas. Curr Opin Oncol. 2006;18(4):369-73. PMID: 16721133
    10. Eary JF, O'Sullivan F, Powitan Y, et al. Sarcoma tumor FDG uptake measured by PET and patient outcome: a retrospective analysis. Eur J Nucl Med Mol Imaging. 2002;29(9):1149-54. PMID: 12192559
    11. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bone Cancer (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    12. Treglia G, Salsano M, Stefanelli A, et al. Diagnostic accuracy of 18F-FDG-PET and PET/CT in patients with Ewing sarcoma family tumours: a systematic review and a meta-analysis. Skeletal Radiol. 2012;41(3):249-56. PMID: 22072239
    13. Liu F, Zhang Q, Zhu D, et al. Performance of positron emission tomography and positron emission tomography/computed tomography using fluorine-18-fluorodeoxyglucose for the diagnosis, staging, and recurrence assessment of bone sarcoma: a systematic review and meta-analysis.[Erratum appears in Medicine (Baltimore). 2016 Jan;95(2):e187a Note: Liu, Fengxia [Added]]. Medicine (Baltimore). 2015;94(36):e1462. PMID: 26356700
    14. Li YJ, Dai YL, Cheng YS, et al. Positron emission tomography (18)F-fluorodeoxyglucose uptake and prognosis in patients with bone and soft tissue sarcoma: a meta-analysis. Eur J Surg Oncol. 2016;42(8):1103-14. PMID: 27189833
    15. Chen L, Wu X, Ma X, et al. Prognostic value of 18F-FDG PET-CT-based functional parameters in patients with soft tissue sarcoma: a meta-analysis. Medicine (Baltimore). 2017;96(6):e5913. PMID: 28178131
    16. Patel SR, Zagars GK, Pisters PW. The follow-up of adult soft-tissue sarcomas. Semin Oncol. 2003;30(3):413-6. PMID: 12870143
 
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 Bone Cancer, Version 2.2022 were reviewed with no change from Version 2021 with regard to PET applications in Bone Cancer.
 
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
A9580Sodium fluoride f 18, diagnostic, per study dose, up to 30 millicuries
References: Liu F, Zhang Q, Zhu D, et al.(2015) Performance of positron emission tomography and positron emission tomography/computed tomography using fluorine-18-fluorodeoxyglucose for the diagnosis, staging, and recurrence assessment of bone sarcoma: a systematic review and meta-analysis. Medicine (Baltimore). Sep 2015;94(36):e1462. PMID 26356700 tomography/computed tomography using fluorine-18-fluorodeoxyglucose for the diagnosis, staging, and recurrence assessment of bone sarcoma: a systematic review and meta-analysis. Performance of positron emission tomography and positron emission tomography/computed tomography using fluorine-18-fluorodeoxyglucose for the diagnosis, staging, and recurrence assessment of bone sarcoma: a systematic review and meta-analysis.

National Comprehensive Cancer Network (NCCN).(2017) NCCN Clinical Practice Guidelines in Oncology: Bone Cancer. Version 2.2017. https://www.nccn.org/professionals/physician_gls/pdf/bone.pdf. Accessed April 17, 2017.

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

Treglia G, Salsano M, Stefanelli A, et al.(2012) Diagnostic accuracy of (1)(8)F-FDG-PET and PET/CT in patients with Ewing sarcoma family tumours: a systematic review and a meta-analysis. Skeletal Radiol. Mar 2012;41(3):249-256. PMID 22072239

Völker T, Denecke T, Steffen I, et al.(2007) Positron emission tomography for staging of pediatric sarcoma patients: results of a prospective multicenter trial. J Clin Oncol. Dec 1 2007;25(34):5435-5441. PMID 18048826

Zhang Q, Xi Y, Li D, et al.(2020) The utility of 18 F-FDG PET and PET/CT in the diagnosis and staging of chondrosarcoma: a meta-analysis. J Orthop Surg Res. Jun 22 2020; 15(1): 229. PMID 32571371
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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