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 diagnosed brain tumors and in need of staging or restaging information or who have suspected brain tumor who receive FDG-PET, 18F fluoro-ethyl-tyrosine PET, or carbon 11 (11C) methionine PET, the evidence includes several systematic reviews and meta-analyses. Relevant outcome is test validity. Pooled analyses have shown that PET or PET/CT can be effective in distinguishing brain tumors from normal tissue. Indirect comparisons between the radiotracers 11C-methionine and FDG have shown that 11C-methionine may have better diagnostic performance. Clinical guidelines include PET 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 brain cancer treatment who receive FDG-PET, 18F fluoro-ethyl-tyrosine-PET, or 11C-methionine PET, the evidence includes systematic reviews and meta-analyses. Relevant outcome is test validity. Pooled analyses did not support the use of PET for surveillance of brain cancer following treatment. 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 stage I or II melanoma and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes a TEC Assessment. Relevant outcome is test validity. Evidence has shown PET and PET/CT are not as beneficial as the reference standard (sentinel node biopsy) for assessing regional lymph nodes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have diagnosed advanced melanoma (stage III or IV) and in need of staging or restaging information who receive FDG-PET or FDG-PET/CT, the evidence includes a TEC Assessment and a meta-analysis. Relevant outcome is test validity. Evidence has shown PET and PET/CT can detect systemic metastases in individuals with advanced melanoma. Clinical guidelines include PET/CT for staging or restaging stage III or IV disease and for surveillance. 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 melanoma treatment who receive FDG-PET or FDG-PET/CT, the evidence includes retrospective and observational studies. Relevant outcome is test validity. At the discretion of the physician, imaging surveillance can be considered every 3 to 12 months. Because recurrences usually occur within 3 years, screening asymptomatic individuals beyond 3 to 5 years is not recommended. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with cancer of unknown primary and single-site metastatic disease who receive FDG-PET or FDG-PET/CT, the evidence includes a TEC Assessment. Relevant outcome is test validity. Studies reviewed in the assessment showed that PET identified previously undetected metastases confirmed by biopsy. Additionally, PET can contribute to the management of individuals with cancer of unknown primary. 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.
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 brain cancer.
PET scanning may be considered medically necessary as a technique for assessing extranodal spread of malignant melanoma at initial staging or at restaging during follow-up treatment for advanced disease (stage III or IV).
PET scanning is considered investigational in managing stage 0, I, or II melanoma.
PET scanning is considered investigational as a technique to detect regional lymph node metastases in individuals with clinically localized melanoma who are candidates to undergo sentinel node biopsy.
PET scanning may be considered medically necessary in individuals with a cancer of unknown primary who meet ALL of the following criteria:
In individuals with a single site of disease outside the cervical lymph nodes, and
Individual is considering local or regional treatment for a single site of metastatic disease, and
After a negative workup for an occult primary tumor, and
PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment.
PET scanning is considered investigational for other indications in individuals with a cancer of unknown primary, including, but not limited to the following:
As part of the initial workup of a cancer of unknown primary, and
As part of the workup of individuals with multiple sites of disease.
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 |
G0219 |
PET imaging whole body; melanoma for noncovered indications |
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G0235 |
PET imaging, any site not otherwise specified |
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A9515 |
Choline C-11 injection, diagnostic, per study dose up to 20 millicuries |
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A9552 |
Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries |
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A9580 |
Sodium fluoride F-18, diagnostic, per study dose, up to 30 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 |
C43.0-C43.9 |
Malignant melanoma of skin code range |
C71.0-C71.9 |
Malignant neoplasm of brain code range |
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C80.0-C80.1 |
Malignant neoplasm without specification of site (unknown primary) |
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.
