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A variety of PET radiopharmaceuticals have been investigated; however, only a few have received approval by the U.S. Food and Drug Administration (FDA) for clinical use:

• 18 fluorine (F)-Fluorodeoxyglucose (FDG) for evaluation of glucose metabolism in oncology
• 18F-FDG for evaluation of myocardial hibernation
• 13 Nitrogen (N)-ammonia for evaluation of myocardial blood flow
• 82-rubidium chloride injection (NDA-19-414) was approved in 1989 “for assessing regional myocardial perfusion in the diagnosis and localization of myocardial infarction.
• 18F FDG (NDA 20-306) was approved in 1994 for “the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
• 18F injection (NDA 17-042) was approved in 1972 for “injection as a bone imaging agent to define areas of altered osteogenic activity,” however, the “NDA holder ceased marketing this drug product in 1975.” The FDA determined that this withdrawal was not due to reasons of safety or effectiveness.

The scanners used for PET imaging are somewhat similar to those used for x-ray CT, but PET requires complicated technology and computerized mathematical models of physiologic functions and tracer kinetics for the generation of images.

This policy focuses on the miscellaneous applications of PET scanning.

Oncologic Applications of PET Scanning are addressed in a separate policy.
Cardiac Applications of PET Scanning are addressed in a separate policy.

Important Note: This policy only addresses the use of radiotracers detected with the use of dedicated full-ring PET scanners. Radiotracers such as FDG may be detected using SPECT cameras, a hybrid PET/SPECT procedure that may be referred to as FDG-SPECT or molecular coincidence detection. 

• The assessment of selected patients with epileptic seizures who are candidates for surgery

• Appropriate candidates are:

• Patients with complex partial seizures that have failed to respond to medical therapy and who have been advised to have a resection of a suspected epileptogenic focus located in a region of the brain accessible to surgery
• Conventional techniques for seizure localization must have been tried and provided data that suggested a seizure focus, but were not sufficiently conclusive to permit surgery

• The diagnosis of chronic osteomyelitis

In addition, the purpose of the positron emission tomography (PET) examination should be to avoid subjecting the patient to extended preoperative electroencephalographic recording with implanted electrodes or to help localize and minimize the number of sites for implanted electrodes to reduce the morbidity of that procedure.

The use of PET for all other miscellaneous indications is investigational, including, but not limited to:

CNS diseases

• Autoimmune disorders with CNS manifestations, including:
  • Behçet's syndrome
  • lupus erythematosus
• Cerebrovascular diseases, including:
  • arterial occlusive disease (arteriosclerosis, atherosclerosis)
  • carotid artery disease
  • cerebral aneurysm
  • cerebrovascular malformations (AVM and Moya Moya disease)
  • hemorrhage
  • infarct
  • ischemia
• Degenerative motor neuron diseases, including:
  • amyotrophic lateral sclerosis
  • Friedreich's ataxia
  • olivopontocerebellar atrophy
  • Parkinson's disease
  • progressive supranuclear palsy
  • Shy-Drager syndrome
  • spinocerebellar degeneration
  • Steele-Richardson-Olszewski disease
  • Tourette's syndrome
• Dementias, including:
  • Alzheimer's disease
  • multi-infarct dementia
  • Pick's disease
  • frontotemporal dementia
  • dementia with Lewy-Bodies
  • presenile dementia
• Demyelinating diseases, such as multiple sclerosis
• Developmental, congenital, or inherited disorders, including:
  • adrenoleukodystrophy
  • Down's syndrome
  • Huntington’s chorea
  • kinky-hair disease (Menkes’ syndrome)
  • Sturge-Weber syndrome (encephalofacial angiomatosis) and the phakomatoses
• Miscellaneous
  • chronic fatigue syndrome
  • sick building syndrome
  • post-traumatic stress disorder
• Nutritional or metabolic diseases and disorders, including:
  • acanthocytes
  • hepatic encephalopathy
  • hepatolenticular degeneration
  • metachromatic leukodystrophy
  • mitochondrial disease
  • subacute necrotizing encephalomyelopathy
• Psychiatric diseases and disorders, including:
  • affective disorders
  • depression
  • obsessive-compulsive disorder
  • psychomotor disorders
  • schizophrenia
• Pyogenic infections, including:
  • aspergillosis
  • encephalitis
• Substance abuse, including the CNS effects of alcohol, cocaine, and heroin
• Trauma, including brain injury and carbon monoxide poisoning
• Viral infections, including:
  • acquired immune deficiency syndrome (AIDS)
  • AIDS dementia complex
  • Creutzfeldt-Jakob syndrome
  • progressive multifocal leukoencephalopathy
  • progressive rubella encephalopathy
  • subacute sclerosing panencephalitis
• Mycobacterium infection
• Migraine
• Anorexia nervosa
• Cerebral blood flow in newborns
• Vegetative versus "locked-in" state

Pulmonary diseases

• Adult respiratory distress syndrome
• Diffuse panbronchiolitis
• Emphysema
• Obstructive lung disease
• Pneumonia

Musculoskeletal diseases

• Spondylodiscitis
• Joint replacement follow-up

Other

• Giant cell arteritis
• Vasculitis
• Inflammatory bowel disease
• Sarcoidosis

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.

12/28/2010:  Policy statement updated to add "Vasculitis" as an investigational indication in the "Other" category.

11/04/2011:  Removed the link to the archived medical policy for Single Photon Emission Computed Tomography (SPECT).

04/11/2012:  Added mycobacterium infection and inflammatory bowel disease as investigational indications.

05/13/2013:  Added sarcoidosis as an investigational indication.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document. 

A PET scan essentially involves 3 separate activities:
1. Manufacture of the radiopharmaceutical, which may be manufactured on site or manufactured at a regional delivery center with delivery to the institution performing PET
2. Actual performance of the PET scan, and
3. Interpretation of the results

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, there will likely be an additional transportation charge for radiopharmaceuticals that are not manufactured on site.

Covered Codes        

This is not an all-inclusive list of non-covered procedure codes.

The code(s) listed below and ANY code not listed in the previous section are considered non-covered for this procedure.  

 Non-Covered Codes    

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