Positron emission tomography (PET) scanning uses positron-emitting radionuclide tracers coupled to organic molecules, such as glucose, ammonia, or water, to produce images. The radionuclide tracers simultaneously emit 2 high-energy photons in opposite directions that can be simultaneously detected (referred to as coincidence detection) by a PET scanner, comprising multiple stationary detectors that encircle the area of interest.
For individuals who have diagnosed breast cancer and inconclusive results from other imaging techniques who receive adjunctive FDG-PET or FDG-PET/CT for staging or restaging, the evidence includes meta-analyses. Relevant outcome is test validity. While studies included in the meta-analyses reported variability in estimates of sensitivity and specificity, FDG-PET or FDG-PET/CT may be helpful in situations in which standard staging results are equivocal or suspicious, particularly in individuals with locally advanced or metastatic disease. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have suspected or diagnosed breast cancer and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes a TEC Assessment, several systematic reviews, and meta-analyses. Relevant outcome is test validity. There is no evidence supporting the use of PET in diagnosing breast cancer. The false-negative rates (5.5% to 8.5%) using PET in individuals with breast cancer can be considered unacceptable, given that breast biopsy can provide more definitive results. Use of PET/CT may be considered for the detection of metastases only when results from other imaging techniques are inconclusive. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who are asymptomatic after completing breast cancer treatment who receive FDG-PET or FDG-PET/CT, there is no evidence. Relevant outcome is test validity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have diagnosed cervical cancer and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes an Agency for Healthcare Research and Quality (AHRQ) report and meta-analyses. Relevant outcome is test validity. Pooled results have shown that PET can be used for staging or restaging and for detecting recurrent disease. Clinical guidelines include PET and CT to inform management decisions that may offer clinical benefit. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have suspected cervical cancer or who are asymptomatic after completing cervical cancer treatment who receive FDG-PET or FDG-PET/CT, there is no evidence. Relevant outcomes are test accuracy and test validity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have diagnosed endometrial cancer in need of staging or restaging information or who are asymptomatic after completing endometrial cancer treatment who receive FDG-PET or FDG-PET/CT, the evidence includes a systematic review and meta-analysis. Relevant outcome is test validity. Pooled estimates from the meta-analysis showed high sensitivities and specificities for FDG-PET/CT in detecting lymph node metastases and endometrial cancer recurrence following treatment. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have diagnosed ovarian cancer and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes an AHRQ systematic review and several meta-analyses. Relevant outcome is test validity. Pooled sensitivities and specificities have supported the use of PET and PET/CT for the detection of recurrent ovarian cancer. Clinical guidelines include PET/CT to inform management decisions that may offer clinical benefit. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have suspected ovarian cancer or who are asymptomatic after completing ovarian cancer treatment who receive FDG-PET or FDG-PET/CT, there is no evidence. Relevant outcome is test validity. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
All policy statements apply to both positron emission tomography (PET) scans and PET plus computed tomography (CT) scans (ie, PET scans with or without PET/CT fusion).
For the clinical situations indicated that may be considered medically necessary, this assumes that the results of the PET scan will influence treatment decisions. If the results will not influence treatment decisions, these situations would be considered not medically necessary.
PET scanning may be considered medically necessary in the staging or restaging of breast cancer for the following application:
Detecting locoregional or distant recurrence or metastasis (except axillary lymph nodes) when suspicion of disease is high and other imaging is inconclusive.
PET scanning is considered investigational in the evaluation of breast cancer for all other applications, including but not limited to the following:
Differential diagnosis in individuals with suspicious breast lesions or an indeterminate or low suspicion finding on mammography
Staging axillary lymph nodes.
Predicting pathologic response to neoadjuvant therapy for locally advanced disease.
PET scanning may be considered medically necessary in the initial staging of individuals with locally advanced cervical cancer.
PET scanning may be considered medically necessary in the evaluation of known or suspected recurrence.
PET scanning is considered medically necessary in the:
Detection of lymph node metastases, and
Assessment of endometrial cancer recurrence.
PET scanning may be considered medically necessary in the evaluation of individuals with signs and/or symptoms of suspected ovarian cancer recurrence (restaging) when standard imaging, including CT scan, is inconclusive.
PET scanning is considered investigational in the initial evaluation of known or suspected ovarian cancer in all situations.
A PET scan involves 3 separate activities: (1) manufacture of the radiopharmaceutical, which may be on site or at a regional center with delivery to the institution performing PET; (2) actual performance of the PET scanner; and (3) interpretation of the results. There are Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes available to code for PET scans.
When the radiopharmaceutical is provided by an outside distribution center, there may be an additional separate charge, or this charge may be passed through and included in the hospital bill. In addition, an extra transportation charge will be likely for radiopharmaceuticals that are not manufactured on site.
The Centers for Medicare & Medicaid Services added 2 new modifiers in 2009 to facilitate the changes in the Medicare national coverage policy for PET. The modifiers are:
PI - Positron emission tomography (PET) or PET/computed tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing, 1 per cancer diagnosis.
PS - Positron emission tomography (PET) or PET/computed tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy.
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CPT |
78811-78816 |
Positron emission tomography (PET) imaging; with/without CT; specific to body area |
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78608-78609 |
Brain imaging, positron emission tomography (PET); by evaluation method |
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ICD-10-PCS |
ICD-10-PCS is for use only on inpatient services. There are a few specific PET ICD-10-PCS codes such as the following: |
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CB32KZZ, CB32YZZ |
Nuclear medicine, respiratory system, positron emission tomographic (PET) imaging, lungs and bronchi, code by radionuclide |
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CB3YYZZ |
Nuclear medicine, respiratory system, positron emission tomographic (PET) imaging, respiratory system |
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HCPCS |
G0235 |
PET imaging, any site not otherwise specified |
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G0252 |
PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (eg, initial staging of axillary lymph nodes). |
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A9552 |
Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries |
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A9597 |
Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified |
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A9598 |
Positron emission tomography radiopharmaceutical, diagnostic, for non-tumor identification, not otherwise classified |
ICD-10-CM |
C50.011-C50.929 |
Malignant neoplasm of breast code range |
C53.0-C53.9 |
Malignant neoplasm of cervix uteri code range |
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C54.1 |
Malignant neoplasm of endometrium |
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C56.0-C56.9 |
Malignant neoplasm of ovary code range |
As with any imaging technique, the medical necessity of positron emission tomography (PET) scanning depends in part on what imaging techniques are used before or after the PET scanning. Due to its expense, PET scanning is typically considered after other techniques, such as computed tomography (CT), magnetic resonance imaging (MRI), or ultrasonography, provide inconclusive or discordant results. If so, the medical necessity of subsequent imaging during the same diagnostic evaluation is unclear. Thus, PET should be considered for the medically necessary indications above only when standard imaging (eg, CT, MRI) is inconclusive or not indicated.
Patient selection criteria for PET scanning may also be complex. Due to the complicated hierarchy of imaging options in individuals with malignancy and complex patient selection criteria, a possible implementation strategy for this policy is its use for retrospective review, possibly focusing on cases with multiple imaging tests, including PET scans.
Use of PET scanning for surveillance as described in the policy statement and policy rationale refers to the use of PET to detect disease in asymptomatic individuals at various intervals. This is not the same as the use of PET for detecting recurrent disease in symptomatic individuals; these applications of PET are considered within tumor-specific categories in the policy statements.
