Positron emission tomography (PET) scans are based on the use of positron-emitting radionuclide tracers coupled to organic molecules, such as glucose, ammonia, or water. 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.
The utility of PET scanning for the diagnosis, staging and restaging, and surveillance of malignancies varies by type of cancer. In general, PET scanning can distinguish benign from malignant masses in certain circumstances and improve the accuracy of staging by detecting additional disease not detected by other imaging modalities. Therefore, PET scanning for diagnosis and staging of malignancies can be considered medically necessary when specific criteria are met for specific cancers, as outlined in the policy statements. For follow-up, after initial diagnosis and staging have been performed, there are a few situations in which PET can improve detection of recurrence, and lead to changes in management that improve the net health outcome. The use of PET for interim scanning to assess early response is addressed in policy 6.01.51.
For individuals who have suspected or diagnosed bone sarcoma and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes systematic reviews and meta-analyses. Relevant outcome is test validity. Pooled analyses have shown that PET or PET/CT can effectively diagnose and stage bone sarcoma, including chondrosarcoma. Use of PET or PET/CT has high sensitivities and specificities in detecting metastases in bone and lymph nodes; however, the tests have low sensitivity in detecting lung metastases. 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 are asymptomatic after completing bone sarcoma 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 soft tissue sarcoma and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes an AHRQ review and a systematic review using PET for assessing response to imatinib. Relevant outcome is test validity. The review reported that PET had low diagnostic accuracy and there was a lack of studies comparing PET with alternative diagnostic modalities. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with diagnosed soft tissue sarcoma and in need of rapid reading of response to imatinib treatment who receive FDG-PET or FDG-PET/CT, the evidence includes a systematic review. Relevant outcome is test validity. The review concluded that PET/CT can be used to monitor treatment response to imatinib, which can lead to individually adapted treatment strategies. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have suspected soft tissue sarcoma or who are asymptomatic after completing soft tissue sarcoma treatment who receive FDG-PET or FDG-PET/CT, the evidence includes a systematic review. Relevant outcome is test validity. The review concluded that there was insufficient evidence on the use of PET for the detection of locoregional recurrence. 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.
PET scanning may be considered medically necessary in the staging or restaging of Ewing sarcoma and osteosarcoma.
PET scanning is considered investigational in the staging of chondrosarcoma.
PET scanning is considered investigational in evaluation of soft tissue sarcoma, including but not limited to the following applications:
Distinguishing between benign lesions and malignant soft tissue sarcoma,
Distinguishing between low-grade and high-grade soft tissue sarcoma,
Detecting locoregional recurrence, and
Detecting distant metastasis.
PET scanning is considered medically necessary for evaluating response to imatinib and other treatments for gastrointestinal stromal tumors.
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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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 |
C40.0-C41.9 |
Malignant neoplasms of bone and articular cartilage code range |
C49.0-C49.9 |
Soft Tissue Sarcoma 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. 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.
