Positron Emission Tomography (Pet) & Combined Pet/Ct Scans
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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