Medical Policy


Subject:Positron Emission Tomography (PET) and PET/CT Fusion
Policy #:  RAD.00002Current Effective Date:  07/09/2008
Status:ReviewedLast Review Date:  05/15/2008

Description/Scope

Positron Emission Tomography (PET) is an imaging modality that produces an image of the body's soft structures, including metabolic and/or chemical information. The CT scan produces an image of body structures, including bone and tissue. The PET/CT fusion combines the two images to show both hard structures, such as bone, and soft structures, such as growing tissue or tumors. This document addresses the use of PET scans and PET/CT fusion.

Note:  For information related to the use of PET scans using gamma cameras, please see RAD.00040 PET Scanning Using Gamma Cameras.

Policy Statement

Medically Necessary: 

Positron emission tomography (PET) is considered medically necessary for the following conditions when the results of the test can reasonably be expected to influence the clinical management of the patient.   

Neurologic Applications:
Identification or localization of seizure foci in patients who are surgical candidates for neurosurgical treatment of intractable epilepsy.    

Cardiac Applications:

  1. To assess myocardial viability in those with severe left ventricular dysfunction to determine candidacy for a cardiac surgery procedure including CABG, PTCA and transplantation.  
  2. To assess myocardial perfusion performed at rest or with pharmaceutical stress in the diagnosis of coronary artery disease. PET Scanning is used to diagnose and/or determine the severity of coronary artery disease when any of the following are present:
    1. Unavailable or inconclusive SPECT Scan; or
    2. Body habitus or other conditions for which SPECT may have attenuation problems, (e.g., obesity, large breasts, left mastectomy, breast implant, chest wall deformity, left pleural or pericardial effusion, circulatory problems in inferior-septal areas of the heart) or other technical difficulty (extensive prior myocardial infarction); or
    3. Conditions for which angiography may be technically challenging, (e.g., low to intermediate probability of coronary artery disease, borderline stenosis) or associated with high risk for morbidity (allergy to contrast medium, poor arterial access, renal dysfunction for which angiography increases the likelihood of renal failure).

Oncologic Applications:
PET scans with or without PET/CT fusion are considered medically necessary for the following oncologic indications:

  1. To evaluate head and neck cancer (excluding thyroid and CNS cancers) in the following clinical situations:
    1. Identifying an unknown primary cancer suspected to be head and neck cancer in patients presenting with disease metastatic to the cervical lymph nodes;
    2. In patients with known head and neck cancer, as a technique of staging and restaging the cervical lymph nodes and for assessing resectability of the tumor;
    3. For detecting residual/recurrent head and neck cancer in patients being followed after treatment.
      (Note: When used for restaging in head and neck cancer, PET scan is generally recommended 2 to 6 months after the completion of chemo-radiation treatment or 1 to 2 months after surgery OR when recurrence is suspected by biochemical findings or conventional imaging.) 
  2. To detect recurrence of thyroid carcinoma for staging or restaging in patients with negative I131 scanning results but elevated serum thyroglobulin concentrations;
  3. For diagnosis, staging and restaging of medullary thyroid carcinoma;
  4. To differentiate radiation necrosis from recurrent tumor for an intracranial lesion visible on CT or MRI in a patient who has been previously treated for a brain tumor, or to stage or assess response to treatment;  
  5. For the evaluation of suspicious pulmonary nodule(s), for patients in whom curative intent treatment is contemplated;
  6. As a staging technique in patients with known non-small cell (NSCLC) and small cell lung cancer; 
    Note: In NSCLC, PET scan is also indicated for restaging.  In this setting PET scan is generally recommended 2 to 6 months after the completion of chemo-radiation treatment or 1 to 2 months after surgery OR when recurrence is suspected by biochemical findings or conventional imaging.  When used for restaging non-small cell lung cancer, it should be used to determine one of the following: 
    1. Differentiation between persistent or recurrent tumor AND fibrosis in those with residual chest X-Ray findings; OR
    2. Selection of a biopsy site for confirmation of suspected recurrence; OR
    3. Determination of actual extent of recurrence (locoregional and distant).
  7. For assessing spread of malignant melanoma beyond the lymph nodes (extranodal) at initial staging or for restaging during follow-up treatment.  PET Scanning may be the sole imaging technique in melanoma;  
  8. For staging or restaging lymphoma (Hodgkin's and non-Hodgkin's) and for detection of residual/recurrent disease vs. post-treatment fibrosis;
  9. For localization of recurrent ovarian cancer with rising CA-125 levels and negative or equivocal CT imaging;
  10. For restaging disease in patients with a history of testicular cancer and post-treatment signs or symptoms suggestive of residual or recurrent disease, (e.g., elevated alpha-fetoprotein [AFP], placental alkaline phosphatase [PLAP], hCG, LDH) and negative or equivocal CT imaging;
  11. For staging or restaging of confirmed esophageal cancer when PET is used as an adjunctive method of assessment, when conventional radiographic and endoscopic techniques are negative, inconclusive, or non-diagnostic;
    (Note: When used for restaging esophageal cancer, PET may provide more accurate diagnosis of regional and distant recurrences than other imaging. PET for perianastomotic recurrence may not be as accurate as other diagnostic techniques.)   
  12. Colorectal cancer:
    1. To detect and assess resectability of hepatic or extrahepatic metastases of colorectal cancer;
    2. For staging or restaging to detect recurrence of colorectal cancer in patients with rising CEA levels or in patients who present with signs and symptoms of recurrence;
    3. To assess scarring vs. local bowel recurrence in patients with previously resected colorectal cancer.
  13. To differentiate between malignant and benign pancreatic lesions;
  14. Cervical Cancer for staging or restaging;
  15. Breast cancer:
    1. To evaluate the presence of metastases in high risk patients (grade 2B or greater) where standard imaging is inconclusive;
    2. For staging or restaging when progressive disease is suspected on the basis of rising markers when standard imaging is inconclusive; 
      (Note: When used for restaging, PET is most useful to determine the actual extent of recurrence or differentiate between metastatic and benign plexopathy.)    
    1. For monitoring tumor response in those patients in whom PET scans have been established as the only technique to follow disease.
  16. Musculoskeletal Neoplasms:
    1. For differentiation of benign versus malignant primary musculoskeletal tumors and differentiation of biological aggressiveness;
    2. For staging and detection for recurrent disease in individuals with known musculoskeletal sarcoma and assessment of tumor viability after chemotherapy before planned limb amputation.
  17. Carcinoma of unknown primary presenting with metastatic disease outside the cervical lymph nodes when all of the following criteria are met:
    1. Local or regional treatment for a single site of metastatic disease is being considered;
    2. PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment;
    3. Standard work-up for occult primary tumor is negative;
    4. Tumor is limited to a single site of disease;
  18. For other malignancies where major surgery or curative local high dose radiation is being recommended and a PET scan may identify the presence of metastatic disease that will change the management of the patient;
  19. For initial diagnosis and ongoing assessment for response to chemotherapy in pediatric patients with neuroblastoma.

Other Applications:
PET scans with or without PET/CT fusion are considered medically necessary to diagnose chronic osteomyelitis of the central skeleton.

Investigational and Not Medically Necessary: 

PET scans with or without PET/CT fusion are considered investigational and not medically necessary when used as a screening tool for cancer or for routine surveillance of asymptomatic patients.

All other uses of PET scans with or without PET/CT fusion, other than as set forth above, are considered investigational and not medically necessary including, but not limited to, the following:

  1. Malignancies that do not meet the Oncologic Applications in the medically necessary section above;
  2. Adult respiratory distress syndrome;
  3. Alzheimer's disease and other dementias (e.g., multi-infarct dementia, fronto-temporal dementia);
  4. Anorexia nervosa;
  5. Autoimmune disorders with CNS manifestations (e.g., systemic lupus erythematosus, Bechet's syndrome);
  6. The use of PET Scans for asymptomatic individuals without cardiac risk factors or as a screening test for the population as a whole;
  7. Cardiomyopathy;
  8. Cerebral blood flow in newborns;
  9. Cerebrovascular disease (e.g., carotid artery disease, aneurysms, arteriovascular malformations, ischemic cerebrovascular disease or assessment of arterial vasospasm subsequent to subarachnoid hemorrhage);
  10. Parkinson's disease;
  11. Degenerative peripheral motor diseases (e.g., amyotrophic lateral sclerosis);
  12. Demyelinating diseases (e.g., multiple sclerosis);
  13. Developmental, congenital, or inherited disorders (e.g., attention deficit disorders, Down's syndrome, Huntington's chorea);
  14. Emphysema;
  15. Epilepsy and convulsive disorders for all indications not listed above as medically necessary;
  16. Migraine;
  17. Motor neuron diseases, degenerative;
  18. Other musculoskeletal disorders other than those considered medically necessary above;
  19. Nutritional or metabolic diseases and disorders (e.g., hepatic encephalopathy, leukodystrophy);
  20. Obstructive lung disease;
  21. Panbronchiolitis, diffuse;
  22. Pancreatic disease, for all other pancreatic conditions not listed as medically necessary above;
  23. Pneumonia;
  24. Psychiatric diseases and disorders (e.g., bipolar disorder, depression, obsessive compulsive disorders, schizophrenia);
  25. Pyogenic infections (e.g., aspergillosis, encephalitis);
  26. Substance abuse (e.g., CNS effects of alcohol, cocaine or heroin);
  27. Thyroid disease, for all other thyroid conditions not listed as medically necessary above;
  28. Trauma, including brain injury and CO (carbon monoxide) poisoning;
  29. Vegetative vs. "locked-in" state;
  30. Viral infections (e.g., HIV infections, Creutzfeldt-Jakob disease, progressive multifocal leukoencephalopathy, subacute sclerosing panencephalitis);
  31. Other miscellaneous disorders including chronic fatigue syndrome, "sick building" syndrome.
Rationale

For the indications listed as medically necessary, there is sufficient evidence in the medical literature to support the use of PET in identifying or localizing anatomic or physiologic lesions, providing information that may aid in deciding the parameters of medical and surgical treatment. This includes the use of PET for localizing seizure foci in selected patients for whom neurosurgical treatment of epilepsy is contemplated.  The most appropriate candidates are those with complex partial seizures who have failed to respond to medical therapy.  In addition, a PET scan may eliminate the need for extended preoperative EEG recordings with implanted electrodes.

Recently, there has been increased interest in the use of PET scans in Alzheimer's disease (AD) generated, in part, by the availability of pharmacologic agents to treat Alzheimer's, increased public awareness and increased availability of PET scans.  PET scans have been suggested for use in the differentiation of AD from certain other dementias, such as fronto-temporal dementia (FTD). However, even those advocating the use of PET scans in this setting acknowledge the lack of direct evidence and that this position is based on consensus reports and expert opinion, rather than direct evidence.  Additionally, there is a lack of studies that specifically look at the incremental benefit of PET over standard clinical evaluation alone, which is accurate in up to 90% of cases. Finally, there is no evidence in the peer reviewed literature to indicate that the use of PET scans contributes to improved outcomes in any group with dementia. 

There also is relatively little evidence to support the use of PET in predicting the future progression of dementia, as the predictive models for the rate of cognitive decline have not been validated in subjects outside the studies, which tended to have small sample sizes or significant loss to follow-up. The evidence supporting these conclusions includes systematic reviews and cohort studies.

As noted in the 2003 American College of Cardiology /American Heart Association/American Society of Nuclear Cardiology Guidelines for the Clinical Use of Cardiac Radionuclide Imaging, cardiac applications of PET scanning include assessment of myocardial viability and as an adjunct in diagnosing coronary artery disease in selected patients.  Myocardial viability studies are useful to identify those with significant left ventricular dysfunction who may be candidates for transplantation, as opposed to those who may benefit from revascularization. With regard to the use of PET in coronary artery disease, this guideline indicates that PET and SPECT scanning share many indications but does not make definitive statements, as to their relative value.  It also notes that, at this time, there is not a robust database of head to head comparison of these two techniques.  Thus, PET is often used when other diagnostic procedures or modalities are inconclusive or cannot be performed, (e.g., SPECT, angiography).  

The evidence shows that PET may be used for select oncologic applications in diagnosis, initial staging (determining the extent of disease after diagnosis), restaging (determining the extent of disease after surgery or a course of treatment) and monitoring tumor response to treatment. However, the efficacy of PET and the sensitivity and specificity of the technology does vary with the type of tumor and, thus, the use of PET is only supported for specific indications. The medical necessity of PET scanning for oncologic applications depends, in part, on what imaging techniques are used either before or after PET scanning. PET scanning is typically considered after other techniques, such as computed tomography (CT), magnetic resonance imaging (MRI), or ultrasonography, provide inconclusive or discordant results. 

A review and meta-analysis of the literature on diagnostic imaging was conducted to evaluate diagnostic imaging modalities for evaluation of chronic osteomyelitis.  The diagnostic imaging techniques that were reviewed for the assessment of chronic osteomyelitis were radiography, computed tomography, magnetic resonance imaging (MRI), leukocyte scintigraphy, bone scintigraphy, gallium scintigraphy, fluorodeoxyglucose positron emission tomography and combined techniques, such as combined bone and leukocyte scintigraphy and combined bone and gallium scintigraphy.  A total of twenty-three clinical studies were included in the review.  Pooled sensitivity demonstrated that fluorodeoxyglucose positron emission tomography was the most sensitive technique with a sensitivity of 96% (95% confidence interval, 88% to 99%), compared with 82% (95% confidence interval, 70% to 89%) for bone scintigraphy; 61% (95% confidence interval, 43% to 76%) for leukocyte scintigraphy; 78% (95% confidence interval, 72% to 83%) for combined bone and leukocyte scintigraphy; and 84% (95% confidence interval, 69% to 92%) for magnetic resonance imaging.  Pooled specificity demonstrated that bone scintigraphy had the lowest specificity with 25% compared with 60% for MRI; 77% for leukocyte scintigraphy; 84% for combined bone and leukocyte scintigraphy; and 91% for fluorodeoxyglucose positron emission tomography.  The sensitivity of leukocyte scintigraphy in detecting chronic osteomyelitis in the peripheral skeleton was 84% compared with 21% for its detection in the axial skeleton.  The specificity of leukocyte scintigraphy in the axial skeleton was 60% compared with 80% for the peripheral skeleton.  The authors concluded that while leukocyte scintigraphy has appropriate diagnostic accuracy in detecting chronic osteomyelitis of the peripheral skeleton, fluorodeoxyglucose positron emission tomography is superior for detecting chronic osteomyelitis in the axial (central) skeleton (Termaat, 2005).

For the conditions and indications listed as investigational, there has not, as of yet, been adequate evidence in the medical literature to support the use of PET. In most circumstances, there has not been sufficient numbers of well-conducted clinical trials evaluating the efficacy and utility of PET in either diagnosing or guiding the treatment of such conditions.  Finally, PET has not been shown to be effective as a screening modality for asymptomatic individuals for any condition.

The fusion of PET and CT imaging into a single system has been widely reported to offer physicians improved diagnostic capabilities, especially in the field of oncology. While the results from a majority of the published studies on PET/CT fusion are preliminary and have focused on assessing technical feasibility and potential clinical applications, it can already be stated that this diagnostic tool improves upon imaging by using PET alone, because it synthesizes both structural and metabolic information. Early studies suggest that this additional information may help alter treatment decisions. From a practical perspective, there is now a movement toward utilizing PET/CT imaging for any oncologic indication where PET scanning would be indicated, i.e., for the diagnosis, staging, and monitoring of treatment for a number of different malignancies. Specifically, several small studies have suggested that PET/CT fusion has improved diagnostic ability over PET alone in lung cancer, lymphoma, malignant melanoma, and a variety of gastrointestinal, gynecological and head and neck malignancies. PET/CT fusion may be considered medically necessary for any oncologic indication where PET scanning is considered medically necessary.

Background/Overview

Description of Disease
One of the major applications of PET is for the detection and evaluation of various malignancies. The National Cancer Institute estimates that approximately 8.9 million Americans with a history of cancer were alive in January 1999. Some of these individuals were cancer-free, while others still had evidence of cancer and may have been undergoing treatment. Approximately 1.4 million new cancer cases are diagnosed annually.  In addition, this imaging technique is used in cardiology and in the localization of seizure focus for those with intractable epilepsy under consideration for neurosurgical resection.   

Description of Technology
A PET scan (Positron Emission Tomography) is a highly specialized imaging technique that produces three-dimensional colored images to provide information about the body's chemistry. Unlike computed tomography (CT) or magnetic resonance imaging (MRI) scans, which look at anatomy or body form, PET studies metabolic activity or body function. The principle behind PET is that the utilization of substances, such as glucose, may differ between various tissue types or within different parts of an organ. Changes in the differential utilization of certain substances may occur in the presence of certain disease conditions, and patterns found on imaging are correlated with clinical implications.      

PET scans can be done on an outpatient basis; however, some hospital inpatients may undergo a PET examination, if indicated. The procedure may be expected to last from 30 minutes to 2 hours, depending on the specific type of PET examination. Generally, a PET scan procedure follows this process:

  1. A small amount of radioactive material (called a tracer) is combined with a chemical, (such as glucose), and this mixture is generally injected into a vein but, on occasion, may be inhaled. The tracer emits tiny positively charged particles (positrons) that produce signals. The chemical substance and radioactive tracer chosen for the test vary according to the organ being evaluated.  A period of equilibration occurs and then images are taken. 
  2. A camera records the tracer's signals, as it travels through the body and collects in organs. A computer then converts the signals into three-dimensional images of the examined organ. The three-dimensional views can be produced from any angle and provide a clear view of an abnormality. For example, glucose or sugar, (which the body uses to produce energy), combined with a radioisotope, will show where glucose is being used in the brain, the heart muscle, or a growing tumor. Rapidly multiplying cancer cells need more sugar fuel, and, therefore, take up more of the sugar than other tissues, which show up as hot spots on the scan. When these images are combined or fused-with a patient's CT or MRI scans, physicians have the most complete picture possible of the disease.

Proposed Benefits
PET scans are purported to be useful in a variety of conditions where variations in physiologic function can be detected. Major applications of PET include neurologic, (such as seizure foci detection); cardiac, (such as coronary artery disease evaluation and assessment of myocardial viability); and oncologic (tumor evaluation). The results of the scan may be used to help diagnose, localize, or evaluate the status of certain disease states, so that more informed treatment decisions may be made.

Possible Risks
There is always a slight risk of damage to cells or tissue from being exposed to any radiation, including the low level of radiation released by the radioactive tracer used for a PET scan. However, the risk of damage from the tracer is usually very low compared with the potential benefits of the test. Most of the tracer will be eliminated from the body within 6 to 24 hours. Allergic reactions to the tracer are very rare.

PET/CT fusion refers to the imaging technique that combines the functional information from Positron Emission Tomography with the anatomical information from Computed Tomography into one set of images. The PET and CT images are either "fused" by a software package that superimposes two digital images together or are processed simultaneously by combined PET/CT scanners. In either case, PET/CT fusion has been purported to allow for earlier and more accurate detection and staging of a number of malignancies. 

Definitions

Autoimmune disorder: a condition or disease where the body's natural immune function attacks a part of the body

CEA levels: carcinoembryonic antigen; a protein found in the blood of patients suffering from colon cancer and other diseases that is otherwise typically found in fetal tissue

Computed tomography (CT): a special imaging technique that uses a computer to combine multiple X-ray images into a 2 dimensional cross-sectional image of the inside of the body

Demyelinating: a characteristic of some nervous system conditions where there is loss of the insulating cover (myelin sheath) that surrounds nerve cells

Endoscopic: a medical or surgical procedure that uses an endoscope, a thin, flexible device, which allows visualization and manipulation of areas of concern usually inaccessible without surgery

Extrahepatic: disease that is outside of, or unrelated to, the liver

Extranodal: a term used to describe the extent and site of cancer that has spread beyond the lymph nodes

Intracranial lesion: any type of abnormality in structure or function inside the skull

Lymphoma: a malignant cancer occurring in the lymph system

Medically refractory: a disease or condition that does not yield to treatment with medications

Melanoma: a form of malignant skin cancer

Metastases: cancer that started from cancer cells from another part of the body; for example: cancer that starts in the breast can spread to the lymph nodes and then be spread throughout the body

Musculoskeletal neoplasms: heterogeneous malignant tumors of the skeletal system and soft tissues

Myocardial viability: a measure of the functional condition of heart muscle centering on its ability to work properly

Neoplastic: referring to new and abnormal growth of tissue, which may be benign or malignant

Lymph node: small round anatomical structures that are part of the lymphatic system, which drains fluid from various organs or anatomical areas; cancer cells from nearby organs may collect in these nodes

Panbronchiolitis: a condition where the small air passages of the lungs become inflamed causing severe coughing and phlegm production

Positron emission tomography (PET): an imaging technique that measures the concentration of chemicals injected into the body, and provides images of the chemical function of body parts of interest

Radiation necrosis: an area of dead cells that result from complications of therapy or surgery using high-energy radiation techniques

Resectability: the quality of a tumor or other tissue that allows it to be safely removed in whole or part by surgery

Resection: surgical removal of a portion or all of an organ or other body structure

Restaging: to determine a disease's response to a completed therapy

Revascularization: a medical or surgical procedure that re-establishes blood supply to a part of the body

Seizure focus: the area of the brain from which a seizure originates

Serum thyroglobulin: a blood borne protein that is produced by the thyroid gland; elevated blood concentrations of this protein are commonly seen in patients with thyroid cancer

Staging: initial determination of the phase or severity of a disease based on a classification of established symptomatic criteria

Coding

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Brain PET imaging, nonspecific 

When services may be Medically Necessary when criteria are met:

CPT

 

78608

Brain imaging, positron emission tomography (PET); metabolic evaluation

78609

Brain imaging, positron emission tomography (PET); perfusion evaluation

 

 

ICD-9 Diagnosis

 

191.0-192.1

Malignant neoplasm of brain, cranial nerves, cerebral meninges

198.3

Secondary malignant neoplasm of brain and spinal cord

237.5

Neoplasm of uncertain behavior of brain and spinal cord

239.6

Neoplasm of unspecified nature, brain

345.00-345.91

Epilepsy

V10.85

Personal history of malignant neoplasm of brain

When services are Investigational and Not Medically Necessary:
For the procedure and diagnostic codes listed above, when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational and not medically necessary.

Myocardial PET imaging 

When services may be Medically Necessary when criteria are met:

CPT

 

78459

Myocardial imaging, positron emission tomography (PET), metabolic evaluation

78491

Myocardial imaging, positron emission tomography (PET), perfusion; single study at rest or stress

78492

Myocardial imaging, positron emission tomography (PET), perfusion; multiple studies at rest and/or stress

 

 

ICD-9 Diagnosis

 

410.00-414.9

Ischemic heart disease

428.0-429.9

Heart failure

786.50-786.51

Chest pain

786.59

Chest pain, other

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above, when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational and not medically necessary.

Miscellaneous PET imaging, nonspecific 

When services may be Medically Necessary when criteria are met:

CPT

 

78811

Positron emission tomography (PET) imaging; limited area (e.g., chest, head/neck)

78812

Positron emission tomography (PET) imaging; skull base to mid-thigh

78813

Positron emission tomography (PET) imaging; whole body

78814

Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (e.g., chest, head/neck)

78815

Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh

78816

Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body

 

 

HCPCS

 

G0235

PET imaging, any site, not otherwise specified

 

Revenue Code

 

0404

Positron emission tomography

 

 

ICD-9 Diagnosis

 

140.0-208.9

Malignant neoplasms

211.6-211.7

Benign neoplasm of pancreas, islets of Langerhans

212.3

Benign neoplasm of bronchus and lung

213.0-215.9

Benign neoplasm

230.0-230.1

Carcinoma in situ of lip, oral cavity and pharynx, esophagus

230.9

Carcinoma in situ of other digestive organs (pancreas)

231.0

Carcinoma in situ of larynx

231.2

Carcinoma in situ of bronchus and lung

232.0-232.4

Carcinoma in situ of skin; lip, eyelid, ear, face, neck

233.0

Carcinoma in situ of breast

233.39

Carcinoma in situ of other female genital organ (ovary)

233.6

Carcinoma in situ of male genital organs (testis)

234.0

Carcinoma in situ of eye

234.8

Carcinoma in situ, other specified site (thyroid)

235.2

Carcinoma in situ, stomach, intestines, and rectum

235.5

Neoplasm of uncertain behavior, other digestive organs (pancreas)

235.7

Neoplasm of uncertain behavior of trachea, bronchus and lung

237.5

Neoplasm of uncertain behavior of brain and spinal cord

238.0

Neoplasm of uncertain behavior of bone and articular cartilage

238.1

Neoplasm of uncertain behavior of connective and other soft tissue

239.0

Neoplasms of unspecified nature, digestive system

239.2

Neoplasms of uncertain nature; bone, soft tissue and skin

239.6

Neoplasms of unspecified nature, brain

518.89

Other diseases of lung not elsewhere classified (solitary pulmonary nodule)

577.2

Cyst and pseudocyst of pancreas

730.10-730.11

Chronic osteomyelitis, site unspecified, shoulder region

730.15

Chronic osteomyelitis, pelvic region and thigh

730.18-730.19

Chronic osteomyelitis, other specified sites, multiple sites

751.7

Anomalies of pancreas (congenital pancreatic cyst)

793.1

Nonspecific abnormal findings on radiological and other exam of lung

V10.01-V10.02

Personal history of malignant neoplasm of tongue, oral cavity and pharynx

V10.21-V10.22

Personal history of malignant neoplasm of larynx, nasal cavities, middle ear, and accessory sinuses

V10.43

Personal history of malignant neoplasm of ovary

V10.47

Personal history of malignant neoplasm of testis

V10.82

Personal history of malignant neoplasm of skin (melanoma)

V10.84-V10.85

Personal history of malignant neoplasm of eye, brain

V10.87

Personal history of malignant neoplasm of thyroid

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis codes listed above, when criteria are not met, for all other diagnoses not listed; or when the code describes a procedure indicated in the Policy section as investigational and not medically necessary.

When services are also Investigational and Not Medically Necessary:

HCPCS

 

G0219

PET imaging whole body; melanoma for noncovered indications

G0252

PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes)

 

 

ICD-9 Diagnosis

 

 

All diagnoses

 

References

Peer Reviewed Publications:

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  4. Antoch G, Beyer T et al. PET/CT or CT/PET? A radiologist's perspective. Electromedica. 2003; 71(1):64-69.
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  7. Berberat P, Friess H, et al. Diagnosis and staging of pancreatic cancer by positron emission tomography. World J Surg. 1999; 23(9):882-887.
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  13. Bristow RE, et al. Clinically occult recurrent ovarian cancer: patient selection for secondary cytoreductive surgery using combined PET/CT. Gynecol Oncol. 2003 Sep; 90(3):519-528.
  14. Brucher BL. Neoadjuvant therapy of esophageal squamous cell carcinoma: response evaluation by positron emission tomography. Ann Surg. 2001; 233(3):300-309.
  15. Burcombe RJ, et al. Evaluation of good clinical response to neoadjuvant chemotherapy in primary breast cancer using F-18 flurodeoxyglucose positron emission tomography. Eur J Cancer. 2002: 38:375-379.
  16. Caputo FM, Buquicchio GL.  Esophageal cancer staging:  the role of radiology. Rays. 2005; 30(4):309-314.
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  18. Chang CH, Shiau YC, Shen YY, et al.  Differentiating solitary pulmonary metastases in patients with renal cell carcinomas by 18F-Fluoro-2-Deoxyglucose positron emission tomography – a preliminary report.  Urologia Int. 2003; 71:306-309.
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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Balk E, Lau J. Report for the Agency for Healthcare Research and Quality. Systematic Review of Positron Emission Tomography for Follow-up of Treated Thyroid Cancer. April 2002.
  2. Blue Cross Blue Shield Association. FDG positron emission tomography for evaluating breast cancer. TEC Assessment, 2001; 16(5).
  3. Blue Cross Blue Shield Association. FDG PET to manage patients with occult primary carcinoma and metastasis outside the head and neck. TEC Assessment, 2002; 17(14).
  4. Blue Cross Blue Shield Association. FDG positron emission tomography for evaluating esophageal cancer. TEC Assessment, 2002; 16(21).
  5. Blue Cross and Blue Shield Association. FDG positron emission tomography in head and neck cancer. TEC Assessment, 2000; 15(4).
  6. Blue Cross and Blue Shield Association. FDG positron emission tomography in colorectal cancer. TEC Assessment, 2000; 14(25).
  7. Blue Cross and Blue Shield Association. FDG positron emission tomography in lymphoma. TEC Assessment, 2000; 14(26).
  8. Blue Cross and Blue Shield Association. FDG positron emission tomography in melanoma. TEC Assessment, 2000; 14(27).
  9. Blue Cross and Blue Shield Association. FDG positron emission tomography in pancreatic cancer. TEC Assessment, 2000; 14(28).
  10. Blue Cross and Blue Shield Association. FDG PET to manage patients with an occult primary carcinoma and metastasis outside the cervical lymph nodes. TEC Assessment. 2003; 17(14).
  11. Blue Cross and Blue Shield Association. FDG positron emission tomography for evaluating breast cancer. TEC Assessment. 2003; 18(14).
  12. Canadian Coordinating Office for Health Technology Assessment (CCOHTA). PET scanner update. Health Technology Update. Ottawa, ON: CCOHTA; Fall 2005.
  13. Centers for Medicare and Medicaid Services.  National Coverage Determination for PET (FDG) for All Other Cancer Indications Not Previously Specified. NCD #220.6.15. Effective January 28, 2005. Available at:   http://www.cms.hhs.gov. Accessed on April 7, 2008. 
  14. Centers for Medicare and Medicaid Services.  National Coverage Determination for PET (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers. NCD #220.6.14.  Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  15. Centers for Medicare and Medicaid Services.  National Coverage Determination for NCD for PET (FDG) for Breast Cancer. NCD #220.6.10. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  16. Centers for Medicare and Medicaid Services.  National Coverage Determination for PET (FDG) for Colorectal Cancer. NCD #220.6.4. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  17. Centers for Medicare and Medicaid Services. National Coverage Determination PET (FDG) for Dementia and Neurodegenerative Diseases. NCD #220.6.13. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  18. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Esophageal Cancer. NCD #220.6.3. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  19. Centers for Medicare and Medicaid Services.  National Coverage Determination for PET (FDG) for Head and Neck Cancers. NCD #220.6.7. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  20. Centers for Medicare and Medicaid Services.  National Coverage Determination for PET (FDG) for Lung Cancer. NCD #220.6.2. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  21. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Lymphoma. NCD #220.6.5. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  22. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Melanoma. NCD #220.6.6. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  23. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Myocardial Viability. NCD #220.6.8. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  24. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Refractory Seizures. NCD #220.6.9. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  25. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Soft Tissue Sarcoma. NCD #220.6.12. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  26. Centers for Medicare and Medicaid Services. National Coverage Determination for PET (FDG) for Thyroid Cancer. NCD #220.6.11. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  27. Centers for Medicare and Medicaid Services. National Coverage Determination for PET for Perfusion of the Heart. NCD #220.6.1. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  28. Centers for Medicare and Medicaid Services. National Coverage Determination for PET Scans. NCD #220.6. Effective January 28, 2005. Available at: http://www.cms.hhs.gov. Accessed on April 7, 2008.
  29. Centers for Medicare & Medicaid Services (CMS). Proposed decision memo for positron emission tomography (FDG) for infection and inflammation (CAG-00382N). December 20, 2007. Phurrough SE, Jacques L, Caplan S, Feinglass SR. CMS: Baltimore, MD. Available at: https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=207.  Accessed on April 7, 2008.
  30. Feldman MD. Positron emission tomography (PET) for the evaluation of Alzheimer's disease/dementia. Technology Assessment. San Francisco, CA: California Technology Assessment Forum; February 11, 2004. Available at: http://ctaf.org/  Accessed on April 7, 2008.
  31. Hayes Inc.  Hayes Medical Technology Brief. (18F-FDG) Positron Emission Tomography for assessing myocardial viability.  Archived: September 15, 2005.
  32. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for liver cancer. Lansdale, PA: Hayes, Inc; February 2001.  Search updated May 2, 2007. Archived: 2008.
  33. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for malignant melanoma. Lansdale, PA: Hayes, Inc; August 2000.  Search updated December 11, 2005. Archived: 2007.
  34. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for malignant lymphoma. Lansdale, PA: Hayes, Inc; August 2000. Search updated December 29, 2005. Archived: 2007.
  35. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for colorectal cancer.. Lansdale, PA: Hayes, Inc; January 2001. Search updated October 3, 2006. Archived: 2007.
  36. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for cardiac applications. Lansdale, PA: Hayes, Inc; May 2003. Search updated April 4, 2007.
  37. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for neurologic applications. Lansdale, PA: Hayes, Inc; July 1997. Archived: 2006.
  38. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for non-central nervous system head and neck tumors. Lansdale, PA: Hayes, Inc; June 2001. Search updated January 31, 2006. Archived: 2007.
  39. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for assessing myocardial metabolism. Lansdale, PA: Hayes, Inc; June 2005. Search updated July 31, 2007.
  40. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for malignant lymphoma. Lansdale, PA: Hayes, Inc; August 2000. Search updated December 29, 2005. Archived: 2007.
  41. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for prostate cancer. Lansdale, PA: Hayes, Inc; September 2001. Search updated October 4, 2006. Archived: 2007.
  42. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for testicular cancer. Lansdale, PA: Hayes, Inc; February 2002. Search updated December 26, 2007. Archived: 2008.
  43. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for central nervous system tumor. Lansdale, PA: Hayes, Inc; June 2001. Search updated October 4, 2006. Archived: 2007.
  44. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for lung cancer. Lansdale, PA: Hayes, Inc; August 2002. Search updated July 3, 2007.
  45. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for bone cancer. Lansdale, PA: Hayes, Inc; January 2002. Search updated April 12, 2007. Archived: 2008.
  46. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for soft tissue sarcoma. Lansdale, PA: Hayes, Inc; January 2002. Search updated March 22, 2007. Archived: 2008.
  47. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for epilepsy. Lansdale, PA: Hayes, Inc; March 2003. Search updated January 15, 2008.
  48. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for breast cancer. Lansdale, PA: Hayes, Inc: April 2003.  Search updated January 10, 2008.
  49. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for esophageal cancer. Lansdale, PA: Hayes, Inc: April 2001.  Search updated October 8, 2006. Archived: 2007.
  50. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for other malignancies. Lansdale, PA: Hayes, Inc: May 2002.  Search updated April 19, 2007. Archived: 2008.
  51. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for ovarian cancer. Lansdale, PA: Hayes, Inc: September 2001. Search updated October 25, 2006.  Archived: 2007.
  52. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for pancreatic cancer. Lansdale, PA: Hayes, Inc; February 2001. Search updated October 22, 2006.  Archived: 2007.
  53. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for thyroid cancer. Lansdale, PA: Hayes, Inc: March 2003.  Search updated January 17, 2008.
  54. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for Alzheimer's Disease. Lansdale, PA: Hayes, Inc: August 25, 2007.
  55. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for Parkinson's Disease. Lansdale, PA: Hayes, Inc: January 2004. Search updated March 4, 2008.
  56. Hayes Inc. Hayes Medical Technology Directory. Positron emission tomography (PET) for Huntington's Disease. Lansdale, PA: Hayes, Inc: February 2004. Search updated April 12, 2007.
  57. Hayes Inc.  Medical Technology Directory.  Positron emission tomography (PET) for stroke.  Lansdale, PA: Hayes, Inc.  March 2005.  Search updated March 26,, 2008.
  58. Hayes Inc. Medical Technology Directory.  Combined positron emission tomography-computed tomography (PET-CT).  Lansdale, PA: Hayes, Inc.  December 2004.  Search updated January 4, 2008.
  59. Hillner BE, Siegel BA, Liu D, et al. Impact of positron emission tomography/computed tomography and positron emission tomography alone on expected management of patients with cancer: Initial results from the National Oncologic PET Registry. J Clin Oncol. 2008; 26(13):1-8.  Epub ahead of print: March 24, 2008. Available at:  http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2007.14.5631. Accessed on April 7, 2008.
  60. Institute for Clinical Evaluative Sciences (ICES). Health Technology Assessment of Positron Emission Tomography (PET) in Oncology. A Systemic Review. Toronto, ON; ICES; April, 2004. Available at:  http://www.ices.on.ca/file/Pet_report_Apr_2004[1].pdf.  Accessed on April 7, 2008.
  61. Ioannidis JP, Lau J. Report for the Agency for Healthcare Research and Quality. FDG-PET for the diagnosis and management of soft tissue sarcoma. April 2002.
  62. Klocke FJ, Baird MG, Baterman TM, et al.  ACC/AHA/ASNC Guidelines for the clinical use of cardiac radionuclide imaging:  A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.  ACC/AHA/ASNC Committee to revise the 1995 Guidelines for the clinical use of radionuclide imaging; 2003.  Available at:  http://www.acc.org/  Accessed on April 7, 2008.
  63. Matchar DB, Kulasingam SL, McCrory DC, et al. Use of positron emission tomography and other neuroimaging techniques in the diagnosis and management of Alzheimer's disease and dementia. Report for the Agency for Healthcare Quality and Research. December 14, 2001. Available at: http://www.cms.hhs.gov.  Accessed on April 7, 2008.
  64. Matchar DB, Kulasingam SL, Havrilesky L.  Agency for Healthcare Research and Quality (AHRQ) Technology Assessment:  Positron emission testing for six cancers (brain, cervical, small cell lung, ovarian, pancreatic and testicular).  Rockville, MD: February 2004.
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  68. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology.  V.1.2008: Cervical Cancer.  Available at: http://www.nccn.org/professionals/physician_gls/PDF/cervical.pdf.  Accessed on April 7, 2008.
  69. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. V.1.2008: Prostate Cancer.  Available at: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf. Accessed on April 7, 2008.
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  73. U.S. Department of Health and Human Services.  Agency for Healthcare Research and Quality. Technology Assessment: Use of Positron Emission Tomography and other neuroimaging techniques in the diagnosis and management of Alzheimer's disease and dementia.  December 14, 2001.  Available at: http://www.cms.hhs.gov/coverage/download/id64.pdf?origin=globalsearch&page=/mcd/viewtechassess.asp&id=64&where=  Accessed on April 7, 2008.
  74. U.S. Department of Health and Human Services.  Agency for Healthcare Research and Quality. Technology Assessment: FDG Positron Emission Tomography for evaluating Breast Cancer.  May 2001.  Available at: http://www.cms.hhs.gov/coverage/download/id71.pdf.  Accessed on April 7, 2008.
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  76. U.S. Department of Health and Human Services.  Agency for Healthcare Research and Quality. Technology Assessment: Positron Emission Testing for six cancers (brain, cervical, small cell lung, ovarian, pancreatic and testicular).  February 12, 2004. Available at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?id=92.  Accessed on April 7, 2008.
  77. U.S. Department of Health and Human Services.  Agency for Healthcare Research and Quality. Technology Assessment: FDG-PET for the diagnosis and management of soft tissue sarcoma.  April 5, 2002. Available at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?id=69.  Accessed on April 7, 2008.
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Web Sites for Additional Information
  1. American College of Radiology. RadiologyInfo: Positron Emission Tomography (PET). Last reviewed: May 1, 2003.  Available at: http://www.radiologyinfo.org/ Accessed on April 7, 2008.
  2. National Institutes of Health (NIH).  University of Pennsylvania.  FDG-PET Imaging in Complicated Diabetic Foot.  NCT00194298.  Available at:  http://www.clinicaltrials.gov/ct/shor/NCT00194298?order=1.  Accessed on April 7, 2008.
Policy History

Status

Date

Action

 

Reviewed

05/15/2008

Medical Policy & Technology Assessment Committee (MPTAC) review.

 

Reviewed

05/14/2008

Hematology/Oncology Subcommittee review.  No change to criteria.  References were updated.

 

Reviewed

01/01/2008

Updated coding section with 01/01/2008 CPT changes.  The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary."  This change was approved at the November 29, 2007 MPTAC meeting.

 

Reviewed

10/01/2007

Updated coding section with 10/01/2007 ICD-9 changes.

 

Revised

05/17/2007

MPTAC review.  Policy criteria were expanded to add chronic osteomyelitis of the central skeleton and pediatric neuroblastoma to the medically necessary indications.  Rationale, References and coding were updated.

 

Revised

05/16/2007

Hematology/Oncology Subcommittee review.  Coding updated; removed CPT 78810 deleted 12/31/2004 and HCPCS codes deleted 03/31/2005.

 

Revised

06/08/2006

MPTAC review.  Revisions made to the medical necessity criteria to broaden and clarify the criteria under each indication. Revisions were based on recently published literature, including the Juweid/Cheson article in the NEJM 2006.  References were also updated with this and other articles and AHRQ/other technology assessment reports information.

 

Reviewed

12/01/2005

MPTAC review. 

 

Revised

11/30/2005

Hematology/Oncology Subcommittee review.  Merged RAD.00039 PET/CT fusion into this policy.  Clarified use in breast cancer.

 

 

11/21/2005

Added references for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).

 

Revised

04/28/2005

MPTAC review.  Revision based on Policy Harmonization: Pre-merger Anthem and Pre-merger WellPoint.

Updated coding: Added HCPCS codes G0210, G0212, G0213, G0216, G0219, G0220, G0226, G0228, G0252, G0336

 

Pre-merger Organizations

Last Review Date

Policy Number

Title

Anthem

07/27/2004

RAD.00002

Positron Emission Tomography

WellPoint Health Networks, Inc.

12/02/2004

4.01.10

Positron Emission Tomography (PET) Scans

 

09/23/2004

Clinical Guideline

Positron Emission Tomography (PET) for Cardiac Applications

 

09/23/2004

Clinical Guideline

Positron Emission Tomography (PET) for Neurologic Applications

 

12/02/2004

Clinical Guideline

Positron Emission Tomography (PET) for Oncologic Applications