POSITRON EMISSION TOMOGRAPHY (PET) & COMBINED PET/CT SCANS
Protocol: RAD023 Effective Date: February 1, 2019
Table of Contents Page COMMERCIAL & MEDICAID COVERAGE RATIONALE ...... 1 BACKGROUND ...... 5 U.S. FOOD AND DRUG ADMINISTRATION (FDA) ...... 6 APPLICABLE CODES ...... 7 REFERENCES ...... 8 PROTOCOL HISTORY/REVISION INFORMATION ...... 8
INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines, to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice.
COMMERCIAL & MEDICAID COVERAGE RATIONALE
PET and PET/CT for Oncology Indications:
PET or PET/CT is not medically necessary for initial treatment strategy for prostate cancer the initial diagnosis of male or female breast cancer the evaluation of axillary nodes in members with a diagnosis of breast cancer the evaluation of regional lymph nodes in members with a diagnosis of melanoma members who have an established diagnosis of a solid tumor but who are asymptomatic with no signs or symptoms of disease and are not currently in treatment.
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 1 of 8
PET or PET/CT may be medically necessary for members with a very strong suspicion of a solid tumor based on standard imaging (must have results of these tests) - one time only initial and subsequent evaluation of members with documented diagnosis of myeloma a member with known diagnosis of malignancy to determine the optimal anatomic site for biopsy or other invasive diagnostic procedure
FDG PET for Cancers Initial Treatment Strategy Subsequent Treatment Strategy Tumor Type (formerly “diagnosis” & (formerly “restaging” & “staging”) “monitoring response to treatment”) Colorectal Cover Cover Esophagus Cover Cover Head and Neck (not thyroid, Cover Cover CNS) Lymphoma Cover Cover Non-small cell lung Cover Cover Ovary Cover Cover Brain Cover Cover Cervix Cover with exceptions * Cover Small cell lung Cover Cover Soft tissue sarcoma Cover Cover Pancreas Cover Cover Testes Cover Cover Prostate Non-cover Cover Thyroid Cover Cover Breast (male and female) Cover with exceptions * Cover Melanoma Cover with exceptions * Cover All other solid tumors Cover Cover Myeloma Cover Cover All other cancers not listed Cover Cover
*Cervix: Non-covered for the initial diagnosis of cervical cancer related to initial anti-tumor treatment strategy. All other indications for initial anti-tumor treatment strategy for cervical cancer are covered.
*Breast: Non-covered for initial diagnosis and/or staging of axillary lymph nodes. Covered for initial staging of metastatic disease. All other indications for initial anti-tumor treatment strategy for breast cancer are covered.
*Melanoma: Non-covered for initial staging of regional lymph nodes. All other indications for initial anti-tumor treatment strategy for melanoma are covered.
Solitary pulmonary nodule by CT Multiple nodules are not covered unless one is significantly larger than the others. Such a lesion should be treated as a solitary nodule A. Solid nodule ≥8mm
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 2 of 8
1. If Negative: Repeat CT Chest with contrast (CPT® 71260) or CT Chest without contrast (CPT® 71250) at 6 months and repeat at 24 months from the first CT Chest 2. If Positive: Qualifies as initial staging PET/CT 3. If Inconclusive: Repeat CT scan or biopsy. PET/CT may not be repeated Brain PET Metabolic Amyvid imaging for dementia is considered to be investigational and/or experimental.
Vizamyl (flutemetamol F18) imaging for Alzheimer's disease is considered investigational and/or experimental.
I. Primary brain tumor1 [One of the following] A. PET Brain Metabolic Imaging (CPT 78608) is only supported for use in brain tumors of specified histologies such as: 1. Low grade gliomas a. Pilocytic Atrocyoma b. Fibrillary (or Diffuse) Astrocytoma c. Optic Pathway Gliomas d. Pilomyxoid Astrocytoma e. Oligodendroglioma f. Oligoastrocytoma g. Oligodendrocytoma h. Subependymal Giant Cell Astrocytoma (SEGA) i. Ganglioglioma j. Gangliocytoma k. Dysembryoplastic infantile astrocytoma (DIA) l. Dysembryoplastic infantile ganglioglioma (DIG) m. Dysembryoplastic neuroepithelial tumor (DNT) n. Tectal plate gliomas o. Cervicomedullary gliomas p. Pleomorphic xanthoastrocytoma (PXA) q. Any other glial tumor with a WHO grade of I or II 2. High grade gliomas a. Anaplastic astrocytoma b. Glioblastoma multiforme c. Diffuse intrinsic pontine glioma (DIPG, or “brainstem glioma”) d. Gliomatosis cerebri e. Gliosarcoma f. Anaplastic oligodendroglioma g. Anaplastic ganglioglioma h. Anaplastic mixed glioma i. Anaplastic mixed ganglioneuronal tumors j. Any other glial tumor with a WHO grade of III or IV 3. PET Brain Metabolic Imaging (CPT® 78608) is considered investigational/experimental for all other histologies including metastases to the brain.
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 3 of 8
B. PET Brain Metabolic Imaging (CPT® 78608) may be obtained for one of the following: 1. Determine need for biopsy when transformation to high grade glioma is suspected based on clinical symptoms or recent MRI findings 2. Evaluate a brain lesion of indeterminate nature when the PET findings will be used to determine whether biopsy/resection can be safely postponed 3. For High Grade glioma only - Distinguish radiation-induced tumor necrosis from progressive disease within 18 months of completing radiotherapy
II. Movement disorder (MRI) [One of the following] A. Suspected Huntington’s chorea with a non-diagnostic MRI and genetic testing is inconclusive [One of the following] 1. Irregular lurching gait 2. Speech disturbance 3. Positive family history 4. Progressive ataxia of undetermined etiology
III. Seizure (MRI) [All of the following] A. Seizures not responsive to adequate dosage of medications B. Surgery is planned C. MRI does not define a “seizure focus”
PET Myocardial Metabolic 78491 and 78492 are also referred to as a rubidium study stress test. 3D rendering, (CPT® 76376/CPT® 76377), should not be billed in conjunction with PET. Separate codes for such related services as treadmill testing (CPT® 93015-CPT® 93018) and radiopharmaceuticals should be assigned in addition to perfusion PET. These services are paid according to each individual payor. 0482T is an add on code for CPT® 78491 or CPT® 78492 and is considered investigational A. Cardiac PET – Perfusion – Indications (CPT® 78491 and CPT® 78492) Meets all of the criteria for an imaging stress test and additionally any one of the following: 1. Individual is obese (for example BMI>35 kg/m2) or 2. Individual has large breasts or implants B. Equivocal nuclear perfusion (MPI) stress test 1. Routine use in post heart transplant assessment of transplant CAD C. CMS (Medicare) does not cover reporting for wall motion and ejection fraction performed in conjunction with cardiac perfusion PET. There is not a separate CPT® or HCPCS code associated with these specific services. HPN and SHL adhere to the CMS policy, unless explicitly stated in the health plan’s coverage policy.
I. Cardiac PET – Perfusion – Indications (CPT® 78491 and CPT® 78492) A. Performance of quantitation of myocardial blood flow by Cardiac PET is currently non- standardized between different vendor products. B. Absolute quantitation of myocardial blood flow (CPT® 0482T) is considered experimental, investigational and/or unproven (EIU)
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 4 of 8
II. Cardiac PET – Metabolic – Indications (CPT® 78459) A. To determine myocardial viability when a previous study has shown significant left ventricular dysfunction when under consideration for revascularization or B. To identify and monitor response to therapy for established or strongly suspected cardiac sarcoid. This study may be performed in conjunction with a Cardiac PET perfusion examination, single study, CPT® 78491 or MPI SPECT CPT® 78451 For Medicare and Medicaid Service Determination Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. http://www.cms.hhs.gov/mcd/med/search
Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Service’s Website.
BACKGROUND
Positron emission tomography (PET) is an imaging technique that provides data on biochemical and physiological activity. To measure such activity, a positron-emitting radionuclide is incorporated into an organic molecule or compound to form the appropriate radiotracer. After administering the radiotracer, its concentration in tissues and organs is imaged by a PET scanner and constructed into a three-dimensional image by a computer. By comparing the radiotracer concentration in target areas with that expected or imaged in normal tissue, it is possible to determine whether the imaged function is normal or abnormal. The value of PET for oncologic imaging primarily is based on the increased rate in malignant tissue of some metabolic processes, particularly glucose metabolism, which can be measured by PET with the radiotracer fluorine-18-labeled fluorodeoxyglucose (18F-FDG). 18F-FDG PET has been found effective for evaluating numerous cancer types and, since metabolic changes occur in tumors prior to apparent morphologic changes, often detects tumors not found by CT, allowing earlier treatment. However, 18F-FDG accumulates not only in malignant lesions but also to varying degrees at sites of other pathology, such as areas of inflammation or infection; sites where physiologic glucose activity is high, such as areas of muscular activity, in the digestive tract, or near large vascular structures; and, during excretion of 18F-FDG, in urinary collecting systems. Moreover, PET does not provide anatomic detail, which impedes its ability to localize and classify sites of increased 18F-FDG activity. (Antioch 2004)
Positron emission tomography (PET) is a three-dimensional (3-D) noninvasive nuclear imaging technique for detection of normal and abnormal function of living tissue. In contrast with traditional diagnostic techniques, such as x-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI) and ultrasonography (US), which produce images of the body's anatomy, PET produces images of the body's basic biochemistry or function. The use of PET imaging in cancer patients is based on the premise that metabolic processes and blood flow in tumors typically differ from those of normal adjacent tissue and the radiolabeled sugars or other tracers injected during a PET procedure become concentrated within the cancer cells.
PET may be approved in a patient with known diagnosis of malignancy to determine optimal anatomic site for biopsy or other invasive diagnostic procedure for staging and restaging. It may be used if standard diagnostic imaging work up (US, CT, MRI) is inconclusive or may replace conventional
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 5 of 8
imaging when conventional imaging will be inadequate for accurate staging and clinical management will depend upon the stage of disease.
Routine monitoring of tumor response during treatment (when no change in therapy is planned) is not an approved indication. Restaging after completion of therapy to detect residual disease, recurrence, and extent of recurrence is a valid indication.
Requests for suspected recurrence should include changes in the clinical status of the patient leading to the suspicion that includes new symptoms and elevated tumor markers or other laboratory changes.
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Several combined positron emission tomography-computed tomography (PET-CT) scanners are FDA- approved and commercially available. These include the GE Discovery ST, the GE Discovery LS, the GE Discovery VI (formerly known as the POSiTRACE PET-CT system), and the GE MOBILE Discovery systems, all manufactured by General Electric Medical Systems (Milwaukee, WI); the LSO PET/CT HiRez 64 system, the ECAT PET/CT, and the ECAT LSO PET/CT series, manufactured by CTI PET Systems Inc (Knoxville, TN); the Gemini 16 system, manufactured by Phillips Medical Systems (Cleveland, OH); and the Sceptre P3 system (Hitachi Medical Systems America, Twinsburg, OH). For most of these systems, FDA data regarding indications for use were relatively general, stating that the PET-CT system was indicated for use in head and whole-body Positron emission tomography (PET) for attenuation correction and localization of emission activity in patient anatomy by means of integrating PET and CT images and for use as stand-alone head and whole-body diagnostic computed tomography (CT). More specific indications were listed only for two systems and included evaluation and diagnosis of cancer, cardiovascular disease, and brain dysfunction as well as radiotherapy planning for the GE Discovery LS system and only "oncology" for the GE Discovery VI system. A few PET-CT systems previously approved by the FDA were recalled by the manufacturer, CTI PET Systems, due to an occasional malfunction that prevented the operator from stopping bed motion. These include the biograph and biograph LSO systems distributed by Siemens Medical Solutions (Knoxville, TN) and the ECAT REVEAL system distributed by CTI between October 31, 2000 and June 24, 2003.
The only PET radiotracers that have received FDA approval are 18-F-fluorodeoxyglucose (18F-FDG) for diagnosing seizure disorders, rubidium-82 (82Rb) for myocardial perfusion imaging, and fluorine- 18-labeled (18F)-sodium fluoride for bone imaging. However, the manufacturer of 18F-sodium fluoride stopped producing the drug and no other 18F-sodium fluoride product has received approval. Despite this, the FDA has completed reviews on the use of some PET radiotracers for specific indications and has established that, when produced under conditions specified in an approved application and injected at an approved dose, the following PET radiopharmaceuticals can be found safe and effective: 18F-FDG (approved dose, 10 mCi for adults) for evaluating malignancy in patients with known or suspected abnormalities found with other imaging techniques or patients with an existing diagnosis of cancer. 18F-FDG (approved dose, 10 mCi for adults) in combination with myocardial perfusion imaging for identifying myocardial hibernation in patients with coronary artery disease and left ventricular dysfunction.
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 6 of 8
13 Nitrogen-13-ammonia ( NH3; approved dose, 10 mCi for adults) for assessing myocardial perfusion under rest or pharmacological stress conditions in patients with suspected or existing coronary artery disease. 18F-sodium fluoride (approved dose, 2.0 mCi/mL) as a bone imaging agent to define areas of altered osteogenic activity.
APPLICABLE CODES
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non- covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Coverage Determination Guidelines may apply.
CPT® Code Description Myocardial imaging, positron emission tomography (PET), metabolic 78459 evaluation Myocardial imaging; positron emission tomography (PET), perfusion; single 78491 study at rest or stress Myocardial imaging; positron emission tomography (PET), perfusion; 78492 multiple studies at rest and/or stress 78608 Brain imaging, positron emission tomography (PET); metabolic evaluation 78609 Brain imaging, positron emission tomography (PET); perfusion evaluation Positron emission tomography (PET) imaging; limited area (e.g., chest, 78811 head/neck) 78812 Positron emission tomography (PET) imaging; skull base to mid-thigh 78813 Positron emission tomography (PET) imaging; whole body Positron emission tomography (PET) with concurrently acquired computed 78814 tomography (CT) for attenuation correction and anatomical localization imaging; limited area (e.g., chest, head/neck) Positron emission tomography (PET) with concurrently acquired computed 78815 tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh Positron emission tomography (PET) with concurrently acquired computed 78816 tomography (CT) for attenuation correction and anatomical localization imaging; whole body CPT® is a registered trademark of the American Medical Association.
HCPCS Code Description A9552 Flurodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries G0219 Pet imaging whole body; melanoma for non-covered indications G0235 PET imaging, any site, not otherwise specified
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 7 of 8
PET imaging, full and partial-ring PET scanners only, for initial diagnosis of G0252 breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes), not covered by Medicare Fluorine-18 fluorodeoxyglucose (f-18 fdg) imaging using dual-head S8085 coincidence detection system (non-dedicated pet scan)
REFERENCES
Antoch G, Freudenberg LS, Beyer T, et al. To enhance or not to enhance? F-18-FDG and CT contrast agents in dual-modality F-18-FDG PET/CT. J Nucl Med. 2004; 45(Suppl 1):56S-65S.
UnitedHealthcare Physician Guidelines: Current, Evidence-based Recommendations Regarding Imaging, Effective June 22, 2018. Accessed October 2018.
PROTOCOL HISTORY/REVISION INFORMATION
Date Action/Description 01/24/2019 11/29/2018 10/26/2017 08/25/2016 08/27/2015 Corporate Medical Affairs Committee 06/26/2014 03/22/2012 03/24/2011 09/23/2010 03/19/2010
The foregoing Health Plan of Nevada/Sierra Health & Life Healthcare Operations protocol has been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee.
Positron Emission Tomography (PET) & Combined PET/CT Scans Page 8 of 8