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 head and neck cancer in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes several systematic reviews and meta-analyses. Relevant outcome is test validity. In individuals with head and neck cancers, PET and PET/CT are better able to detect local and metastatic disease compared with other imaging techniques. Evidence has also shown that FDG-PET/CT may be useful in predicting response to therapy. Two meta-analyses calculated the ability of FDG-PET or PET/CT to detect the residual or recurrent disease during various stages of treatment and another meta-analysis calculated the ability of positive PET or PET/CT results to predict overall survival and event-free survival. 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 head and neck 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 suspected or diagnosed neuroendocrine tumors and in need of staging or restaging information or who are asymptomatic after completing neuroendocrine tumor treatment who receive FDG-PET or FDG-PET/CT, the evidence includes 2 meta-analyses. Relevant outcome is test validity. The evidence did not compare PET or PET/CT with other modalities and, therefore, did not provide comparative effectiveness information. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have suspected or diagnosed neuroendocrine tumors and in need of staging or restaging information who receive gallium 68 (68Ga) or copper 64 (64Cu) PET or PET/CT , the evidence includes several systematic reviews with meta-analyses and prospective, comparative studies. Relevant outcome is test validity. The meta-analyses showed relatively high sensitivities and specificities using 68Ga-PET/CT as the radiotracer compared with other imaging techniques in the diagnosis and staging of neuroendocrine tumors. A study comparing the diagnostic performance between 64Cu PET/CT and 68Ga-PET/CT reported an increase in detection of lesions with 64Cu PET/CT. Current guidelines recommend using somatostatin receptor PET tracers, 68Ga-dotatate, 68Ga-dotatoc, or 64Cu-dotatate, to assess receptor status and presence of distant 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 neuroendocrine tumors and in need of staging or restaging information who receive gallium 68 (68Ga) or copper 64 (64Cu) PET or PET/CT , the evidence includes several systematic reviews with meta-analyses and prospective, comparative studies. Relevant outcome is test validity. The meta-analyses showed relatively high sensitivities and specificities using 68Ga-PET/CT as the radiotracer compared with other imaging techniques in the diagnosis and staging of neuroendocrine tumors. A study comparing the diagnostic performance between 64Cu PET/CT and 68Ga-PET/CT reported an increase in detection of lesions with 64Cu PET/CT. Current guidelines recommend using somatostatin receptor PET tracers, 68Ga-dotatate, 68Ga-dotatoc, or 64Cu-dotatate, to assess receptor status and presence of distant disease. 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 neuroendocrine tumor treatment who receive68Ga or 64Cu PET or 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 with diagnosed thyroid cancer 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 detect recurrent differentiated thyroid 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 thyroid cancer or who are asymptomatic after completing thyroid 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.
PET scanning may be considered medically necessary in the evaluation of head and neck cancer in the
Initial diagnosis of suspected cancer,
Initial staging of disease, and restaging of residual or recurrent disease during follow-up, and
Evaluation of response to treatment.
PET scanning with gallium 68 and copper 64 may be considered medically necessary as a technique for staging neuroendocrine tumors either during initial staging or for restaging at follow-up.
PET scanning with other radiotracers is considered investigational in all aspects of managing neuroendocrine tumors.
PET scanning may be considered medically necessary in the restaging of individuals with differentiated thyroid cancer when thyroglobulin levels are elevated and whole-body iodine-131 imaging is negative.
PET scanning is considered investigational in the evaluation of known or suspected differentiated or poorly differentiated thyroid cancer in all other situations.
PET scanning is considered investigational when used as a surveillance tool for individuals with cancer or with a history of cancer. A scan is considered surveillance if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in individuals without objective signs or symptoms suggestive of cancer recurrence (see Policy Guidelines section).
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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A9587 |
Gallium ga-68, dotatate, diagnostic, 0.1 millicurie |
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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 |
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C9067 |
Gallium ga-68, dotatoc, diagnostic, 0.01 mci |
ICD-10-CM |
C73 |
Malignant neoplasm of thyroid gland |
C7A.00-C7B.8 |
Malignant neuroendocrine tumors |
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C76.0 |
Malignant neoplasm of head, face and neck NOS |
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.
