Miscellaneous (Noncardiac, Nononcologic) Applications of Fluorine 18 Fluorodeoxyglucose Positron Emission Tomography

POLICY NUMBER

A.6.01.06

DESCRIPTION

Positron emission tomography (PET) images biochemical and physiologic functions by measuring concentrations of radioactive chemicals that have been partially metabolized in a particular region of the body. Radiopharmaceuticals used for PET are generated in a cyclotron (nuclear generator) and introduced into the body by intravenous injection or respiration.

Positron Emission Tomography

Positron emission tomography (PET) scans couple positron-emitting radionuclide tracers to other molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit two high-energy photons in opposite directions that can be simultaneously detected (referred to as "coincidence detection") by a PET scanner, which comprises multiple stationary detectors that encircle the region of interest.

A variety of tracers are used for PET scanning, including oxygen 15, nitrogen 13, carbon 11, and fluorine 18. The radiotracer most commonly used in oncology imaging has been fluorine 18, coupled with fluorodeoxyglucose (FDG), which has a metabolism related to glucose metabolism. While FDG has traditionally been used in cancer imaging, it potentially has many other applications.

Following the U.S. Food and Drug Administration's (FDA) approval of the Penn-PET in 1989, a number of PET scan platforms have been cleared by the FDA through the 510(k) process. These systems are intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease, and organ function for the evaluation of diseases, and disorders such as, but not limited to, cardiovascular disease, neurologic disorders, and cancer. The images produced by the system can aid in radiotherapy treatment planning and interventional radiology procedures.

PET radiopharmaceuticals have been evaluated and approved as drugs by the FDA for use as diagnostic imaging agents. These radiopharmaceuticals are approved for specific conditions.

In December 2009, the FDA issued guidance for Current Good Manufacturing Practices for PET drug manufacturers and, in August 2011, issued similar Current Good Manufacturing Practices guidance for small businesses compounding radiopharmaceuticals. An additional final guidance document, issued in December 2012, required all PET drug manufacturers and compounders to operate under an approved new drug application (NDA) or abbreviated NDA, or investigational new drug application, by December 12, 2015.

In 1994, the FDG radiotracer was originally approved by the U.S. Food and Drug Administration (FDA) through the new drug application (NDA 20-306) process. The original indication was for “the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.” Added indications in 2000 were for “Assessment of glucose metabolism to assist in the evaluation of malignancy…” and “Assessment of patients with coronary artery disease and left ventricular dysfunction….”

Multiple manufacturers have approved NDAs for FDG.

This policy does not cover the use of fluorine 18 fluorodeoxyglucose positron emission tomography (FDG-PET) for diagnosis or evaluation of Alzheimer's disease or other dementias. See related medical policy Selected Positron Emission Tomography Technologies for Evaluation of Alzheimer Disease for Alzheimer’s disease indications for FDG. This policy also does not cover oncologic or cardiovascular uses of FDG-PET. See related medical policies Oncologic Applications of PET Scanning and Interim PET Scanning in Oncology to Detect Early Response During Treatment for oncologic indications and Cardiac Applications of PET Scanning for cardiac indications for FDG.

POLICY

Positron emission tomography (PET) using 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) may be considered medically necessary in:

1. The assessment of select individuals with epileptic seizures who are candidates for surgery

   • Appropriate candidates are:

     • Individuals with complex partial seizures who have failed to respond to medical therapy and have been advised to have a resection of a suspected epileptogenic focus located in a region of the brain accessible to surgery.

     • Conventional noninvasive techniques for seizure localization must have been tried and provided data that suggested a seizure focus, but were not sufficiently conclusive to permit surgery.

2. The diagnosis of chronic osteomyelitis.

In addition, the purpose of the positron emission tomography (PET) examination should be to avoid subjecting the individual 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 FDG-PET for all other miscellaneous indications is investigational, including, but not limited to:

Central Nervous System (CNS) Diseases

• Autoimmune disorders with CNS manifestations, including:

  • Behçet syndrome

  • lupus erythematosus

• Cerebrovascular diseases, including:

  • arterial occlusive disease (arteriosclerosis, atherosclerosis)

  • carotid artery disease

  • cerebral aneurysm

  • cerebrovascular malformations (arteriovenous malformation and Moya-Moya disease)

  • hemorrhage

  • infarct

  • ischemia

• Degenerative motor neuron diseases, including:

  • amyotrophic lateral sclerosis

  • Friedreich ataxia

  • olivopontocerebellar atrophy

  • Parkinson disease

  • progressive supranuclear palsy

  • Shy-Drager syndrome

  • spinocerebellar degeneration

  • Steele-Richardson-Olszewski syndrome

  • Tourette syndrome

• Demyelinating diseases, such as multiple sclerosis

• Developmental, congenital, or inherited disorders, including:

  • adrenoleukodystrophy

  • Down syndrome

  • Huntington chorea

  • kinky-hair disease (Menkes disease)

  • 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:

  • acanthocytosis

  • 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:

  • HIV/acquired immune deficiency syndrome (AIDS)

  • AIDS dementia complex

  • Creutzfeldt-Jakob disease

  • progressive multifocal leukoencephalopathy

  • progressive rubella encephalopathy

  • subacute sclerosing panencephalitis

• Mycobacterium infection

• Migraine

• Anorexia nervosa

• Assessment ofcerebral blood flow in newborns

  • Vegetative versus locked-in syndrome

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

• Vascular prosthetic graft infection

• Inflammatory bowel disease

• Sarcoidosis

• Fever of unknown origin

• Inflammation of unknown origin.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/19/2009: Policy added as a result of the decision to separate the Positron Emission Tomography (PET) medical policy into application specific policies, this one addressing miscellaneous applications only. Upon creation of this separate policy, miscellaneous applications have been revised as outlined: The Policy Description Section revised for a clearer understanding of PET, Policy Statement Section revised to add the diagnosing chronic osteomyelitis as medically necessary, added a guideline for epileptic candidates for surgery, added CNS diseases, Pulmonary diseases, Musculoskeletal diseases and Giant cell arteritis to investigational implications, Policy Coding Section updated to include Covered Codes specific to epilepsy, seizures, and chronic osteomyelitis applications for PET, and added non-Covered Codes Table.

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.

03/17/2014: Policy reviewed; no changes.

03/30/2015: Policy title updated to add "(Noncardiac, Nononcologic)." Policy description updated regarding PET radiopharmaceuticals. Investigational indications for CNS diseases updated to change "acanthocytes" to "acanthocytosis" and "cerebral blood flow in newborns" to "assessment of cerebral blood flow in newborns." Added vascular prosthetic graft infection, fever of unknown origin, and inflammation of unknown origin as investigational indications. Policy guidelines updated to define medically necessary and investigative.

09/01/2015: Code Reference section updated for ICD-10.

11/16/2015: Policy description updated regarding radiotracers and regulations for good manufacturing practices. The following investigational indications were updated: "Steele-Richardson-Olszewski disease" changed to "Steele-Richardson-Olszewski syndrome;" "Menkes' syndrome" changed to "Menkes disease;" and "Vegetative versus 'locked-in' state" changed to "Vegetative versus 'locked-in' syndrome."

05/31/2016: Policy number A.6.01.06 added.

11/29/2016: Policy title updated to add "Fluorodeoxyglucose F 18." Policy description updated regarding epilepsy, suspected chronic osteomyelitis, suspected alzheimer disease, and large vessel vasculitis. Investigational policy statement updated to add "FDG."

12/30/2016: Code Reference section updated to add new 2017 HCPCS code A9598.

10/13/2017: Policy title updated to change "Applications of Fluorodeoxyglucose F 18" to "Applications of Fluorine 18 Fluorodeoxyglucose." Policy description updated regarding devices. Policy statements unchanged.

10/03/2018: Policy reviewed; no changes.

10/21/2019: Policy description revised to remove information regarding epilepsy, suspected chronic osteomyelitis, suspected alzheimer disease, and large vessel vasculitis. Medically necessary policy statement updated to change "conventional techniques" to "conventional noninvasive techniques."

10/13/2020: Policy reviewed; no changes.

10/24/2022: Policy description updated regarding related medical policies. Policy section updated to change "patients" to "individuals," remove the dementia criteria from the investigational statement, and add HIV as investigational. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

11/15/2023: Policy reviewed; no changes.

01/10/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 6.01.06

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy. 

The code(s) listed below are ONLY medically necessary 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 PET2. Actual performance of the PET scan, and3. 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

Investigational Codes

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