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Positron emission tomography (PET) images biochemical and physiologic functions by measuring concentrations of radioactive chemicals that are partially metabolized in the body region of interest. Radiopharmaceuticals used for PET are generated in a cyclotron or nuclear generator and introduced into the body by intravenous injection or by respiration.
A variety of PET radiopharmaceuticals have been investigated; however, only a few have received marketing approval by the U.S. Food and Drug Administration (FDA) for clinical use. The scanners used for PET imaging are somewhat similar to those used for radiograph computed tomography (CT), but PET requires complicated technology and computerized mathematical models of physiologic functions and tracer kinetics for the generation of images.
The 1997 FDA Modernization Act established FDA authority over the safety and effectiveness of locally manufactured radiotracers and developed streamlined regulations for good manufacturing practices with which each PET facility must comply.
The following radiotracers have been approved by FDA:
In September 2005, FDA issued a draft rule and draft guidance on current good manufacturing practice (CGMP) for PET drug products. The final CGMP regulation for the production of PET drugs was issued on December 9, 2009, and took effect on December 12, 2011. More detailed information is available online.
Alternative radiotracers to FDG in identifying Alzheimer disease are under investigation. In particular, there is interest in amyloid PET tracers (see Beta Amyloid Imaging with Positron Emission Tomography (PET) for Alzheimer’s Disease medical policy).
This policy focuses on the miscellaneous applications of PET scanning.
Important Note: This policy only addresses the use of radiotracers detected with the use of dedicated full-ring PET scanners. Radiotracers such as fluorodeoxyglucose (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 use of SPECT cameras for PET radiotracers presents unique issues of diagnostic performance and is not considered in this policy.
POLICYPositron emission tomography (PET) using 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) may be considered medically necessary in:
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:
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 Nervous/Mental Conditions, 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 Medically Necessary, “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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
POLICY HISTORY11/19/2009: 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."
SOURCESBlue Cross Blue Shield Association policy # 6.01.06
CODE REFERENCEThis 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:
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.
Brain imaging, positron emission tomography (PET); metabolic evaluation
Brain imaging, positron emission tomography (PET); perfusion evaluation
Unlisted musculoskeletal procedure, diagnostic nuclear medicine
Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries
PET imaging, any site, not otherwise specified
Cerebral scan (other radioisotope scan)
C030BZZ, C030KZZ, C030MZZ, C030YZZ
Positron Emission Tomographic (PET) Imaging of Brain
Bone scan (other radioisotope scan)
PET Scan of Whole Body
345.00, 345.01, 345.10, 345.11, 345.2, 345.3, 345.40, 345.41, 345.50, 345.51, 345.60, 345.61, 345.70, 345.71, 345.80, 345.81, 345.90, 345.91
Epilepsy and recurrent seizures (code range)
G40.011, G40.019, G40.111, G40.119, G40.211, G40.219
Epilepsy, partial, intractable (code ranges)
730.10, 730.11, 730.12, 730.13, 730.14, 730.15, 730.16, 736.17, 730.18, 730.19
Chronic osteomyelitis (code range)
M86.30 - M86.469, M86.48 - M86.569, M86.60 - M86.69, M86.8X0 - M86.8X9
Chronic osteomyelitis (code ranges)