† The Horizon BCBSNJ evidence-based, proprietary medical policies evaluate a range of advanced imaging and procedures, including US, CT, MRI, and PET studies

† Horizon BCBSNJ reserves the right to change and update the medical policies. The medical policies undergo a formal review annually. Horizon BCBSNJ’s medical policies are based upon major national and international association and society guidelines and criteria, peer-reviewed literature, major treatises as well as, input from practicing academic and community-based physicians.

† These medical policies are not intended to supersede or replace sound medical judgment, but instead, should facilitate the identification of the most appropriate imaging procedure given the member’s clinical condition. These medical policies are written to cover medical conditions as experienced by the majority of members. However, these medical policies may not be applicable in certain clinical circumstances, and physician judgment can override the medical policies.

† Clinical decisions, including treatment decisions, are the responsibility of the member and his/her provider. Clinicians are expected to use independent medical judgment, which takes into account the clinical circumstances to determine member management decisions.

† Horizon BCBSNJ supports the Choosing Wisely initiative (www.choosingwisely.org) by the American Board of Internal Medicine (ABIM) Foundation and many national physician organizations, to reduce the overuse of diagnostic tests that are low value, no value, or whose risks are greater than the benefits.

Preface-2: Benefits, Coverage Policies, and Eligibility Issues

† Member's contract benefits take precedence over Horizon BCBSNJ medical policies.

Medicare Coverage Policies

† Medicare Advantage Products follow CMS National Coverage Determinations, Local Coverage Determinations and other CMS Guidance (eg, Medicare Benefit Policy Manual, Medicare Learning Network Articles [MLN Matters Articles], Medicare Claims Processing Manual). If CMS does not have a coverage or noncoverage position on a service, Medicare Advantage Products will follow Horizon BCBSNJ Medical Policy.

NCDs available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx
LCDs available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46

DME LCDS available to be accessed at Noridian Healthcare Services, LLC, (DME MAC), Local Coverage Determinations (LCDs) search page: https://www.cms.gov/medicare-coverage-database/indexes/lcd-list.aspx?Cntrctr=389&ContrVer=1&CntrctrSelected=389*1&s=38&DocType=All&bc=AggAAAAAAAAAAA%3d%3d&#ResultsAnchor.

Providers are responsible for reviewing CMS Medicare Coverage Center Guidance and in the event of a conflict between the Medicare Coverage section of the medical policy and the CMS Medicare Coverage Center Guidance, the CMS Medicare Coverage Center Guidance will control.

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP: For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

Investigational and Experimental Studies

† Certain imaging studies described in these medical policies are considered investigational and they are NOT eligible for coverage unless otherwise indicated in the member's/enrollee's plan or coverage document. If the member's contract benefits differ from these medical policies, the member contract prevails. Certain advanced imaging studies, or other procedures, may be considered investigational/experimental if there is a paucity of supporting evidence; if the evidence has not matured to exhibit improved health parameters or; the advanced imaging study/procedure lacks a collective opinion of support.

(NOTE: Also refer to a separate policy on 'Definition of Investigational/Experimental Procedure' - Policy #004 in the Introduction Section.)

† Similar to investigational and experimental studies, clinical trial imaging requests may be considered to determine whether they meet Horizon BCBSNJ approved clinical trials coverage.

† State and federal legislations may need to be considered in the review of advanced imaging requests.

† Horizon BCBSNJ medical policies use an evidence-based approach to determine the most appropriate imaging procedure for each patient, at the most appropriate time in the diagnostic and treatment cycle. Horizon BCBSNJ medical policies direct by:

® Clinical presentation of the patient, not by the studies requested
® Current evaluation (within 60 days), to include the following: a recent detailed history, physical examination, and/or appropriate laboratory studies. The Spine and Musculoskeletal guidelines require x-ray studies from when the current episode of symptoms has started or changed; x-ray imaging does not have to be within the past 60 days.
¡ Advanced imaging should not be ordered prior to clinical evaluation of a patient by the physician treating the individual. This may include referral to Consultant Specialist who will make further treatment decisions.
¡ Other meaningful contact (telephone call, electronic mail or messaging) by an established patient can substitute for a face-to-face clinical evaluation.
¡ An exception can be made if the patient is undergoing a guideline-supported, scheduled follow-up imaging evaluation. These routine surveillance indications are addressed in the applicable guideline sections.

† “Standard” or “conventional” imaging is most often performed in the initial and subsequent evaluations of malignancy. Standard or conventional imaging includes plain film, CT, MRI, or US.

† Often, further advanced imaging is needed when initial imaging, such as ultrasound or CT does not answer the clinical question. Uncertain, indeterminate, inconclusive, or equivocal may describe these situations.

† Requests for many Healthcare Common Procedure Coding System (HCPCS) codes, including nonspecific codes such as S8042 [Magnetic resonance imaging (MRI), low-field], should be redirected to a more appropriate and specific CPT^® code. Exceptions are noted in the applicable guidelines

Imaging – Contrast Media

† Contrast is the second important component, along with the advanced imaging modality (refer to specific guideline contrast section)

® If, during the performance of a non-contrast imaging study, there is the need to use contrast in order to evaluate a possible abnormality, then that is appropriate.¹

† Most orthopedic and dental implants are not magnetic. These include hip and knee replacements; plates, screws, and rods used to treat fractures; and cavity fillings. Yet, all of these metal implants can distort the MRI image if near the part of the body being scanned.

® Other implants, however, may have contraindications to MRI. These include:
¡ Pacemakers
¡ ICD or heart valves
¡ Metal implants in the brain
¡ Metal implants in the eyes or ears
¡ Infusion catheters and bullets or shrapnel.
® CT can therefore be an alternative study to MRI in these scenarios.

† CT can be performed without contrast, with contrast, or without and with contrast depending on the clinical indication and body part.

† CT without contrast maybe appropriate if clinical criteria are met AND:

® Patient has elevated BUN and/or creatinine
® Renal insufficiency
® Allergies to iodinated CT contrast
® Thyroid disease which could be treated with I-131
® Diabetics
® Very elderly

† Both contrast CT and MRI may be considered to have the same risk profile with renal failure (GFR <30 mL/min).

† The use of CT contrast should proceed with caution in pregnant and breast feeding patients. There is a theoretical risk of contrast to the fetal and infant thyroid. The procedure can be performed if the specific need for that procedure outweighs risk to the fetus. Breast feeding patients may pump and discard breast milk for 12-24 hours after the contrast injection.

Magnetic Resonance Imaging (MRI):

† MR imaging may be utilized through these guidelines either as the primary advanced imaging modality, or when further definition is needed based on CT imaging.

† MRI imaging may be preferred in patients with renal failure, and in patients allergic to intravenous CT contrast.

® Both contrast CT and MRI may be considered to have the same risk profile with renal failure (GFR <30 mL/min).
® Gadolinium can cause Nephrogenic Systemic Fibrosis (NSF). The greater the number exposure of gadolinium in patients with a low GFR (especially if on dialysis), the greater the chance of NSF.
® Multiple studies have demonstrated potential for gadolinium deposition following the use of gadolinium-based contrast agents (GBCAs) for MRI studies.^3,4,5,6,7 The U.S. Food and Drug Administration (FDA) has noted that there is currently no evidence to suggest that gadolinium retention in the brain is harmful and restricting gadolinium-based contrast agents (GBCAs) use is not warranted at this time. It has been recommended that GBCA use should be limited to circumstances in which additional information provided by the contrast agent is necessary and the necessity of repetitive MRIs with GBCAs should be assessed.⁸

® Clinical criteria are met for MRI AND there is a contraindication to having an MRI (pacemaker, ICD, insulin pump, neurostimulator, etc.)
® Caution should be taken in the use of gadolinium in patients with renal failure
® The use of gadolinium contrast agents is contraindicated during pregnancy unless the specific need for that procedure outweighs risk to the fetus.
® MRI can be performed for non ferromagnetic body metals, although some imaging facilities will consider it contraindicated if recent surgery, regardless of the metal type

Overutilization of Advanced Imaging:

† A number of recent reports describe over-utilization in all areas of advanced imaging, which may include:

® High level testing without consideration of lesser invasive, lesser cost and low technology options
® Excessive radiation and costs with unnecessary testing
® Defensive medical practice
® CT without and with contrast (so called “double contrast studies) requests, which have few current indications.
® MRI requested in place of CT to avoid radiation without considering the primary indication for imaging
® Adult CT settings and protocols used for smaller people and children
® Unnecessarily imaging procedures when the same or similar studies have already been conducted.

® The results of initial diagnostic tests or radiologic studies to narrow the differential diagnosis should be obtained prior to performing further tests or radiologic studies.
® The clinical history should include a potential indication such as a known or suspected abnormality involving the body part for which the imaging study is being requested. These potential indications are addressed in greater detail within the applicable guidelines.
® The results of the requested imaging procedures should be expected to have an impact on patient management or treatment decisions.
® Repeat imaging studies are not generally necessary unless there is evidence of disease progression, recurrence of disease, and/or the repeat imaging will affect a patient’s clinical management.

For this condition imaging is medically necessary based on the following criteria:

† Whole body CT or LifeScan (CT of Brain, Chest, Abdomen, and Pelvis) for screening of asymptomatic patients is considered investigational. The performance of whole body screening CT examinations in healthy patients does not meet any of the current validity criteria for screening studies and there is no clear documentation of benefit versus radiation risk.

Preface-4.2: Whole Body MR Imaging

For this condition imaging is medically necessary based on the following criteria:

† Whole body MRI (WBMRI) is, with the exception of Li-Fraumeni syndrome discussed below, generally not supported by Horizon BCBSNJ at this time due to lack of standardization in imaging technique and lack of evidence that WBMRI improves patient outcome for any individual disease state.

® While WBMRI has the benefit of whole body imaging and lack of radiation exposure, substantial variation still exists in the number of images, type of sequences (STIR vs. diffusion weighting, for example), and contrast agent(s) used.

® There are no established CPT^® or HCPCS codes for reporting WBMRI.
® WBMRI is at present only reportable using CPT^® 76498. All other methods of reporting whole body MRI are inappropriate, including:
¡ Separate diagnostic MRI codes for multiple individual body parts
¡ MRI Bone Marrow Supply (CPT^® 77084)

® Cancer screening:
¡ Annual WBMRI is recommended for cancer screening in patients with Li-Fraumeni Syndrome. Otherwise, WBMRI has not been shown to improve outcomes for cancer screening. See Pediatric Oncology Imaging Policy (Policy #166 in the Radiology Section); PEDONC-2.2: Li-Fraumeni Syndrome (LFS) for additional information
® Cancer staging and restaging
¡ While the feasibility of WBMRI has been established, data remain conflicting on whether WBMRI is of equivalent diagnostic accuracy compared with standard imaging modalities such as CT, scintigraphy, and PET imaging. Evidence has not been published establishing WBMRI as a standard evaluation for any type of cancer.
® Autoimmune disease
¡ WBMRI has been shown to increase the number of detected lesions in chronic multifocal osteomyelitis and other inflammatory arthridities, but no improvement in outcomes from the use of WBMRI has yet been shown. See Pediatric Musculoskeletal Imaging Policy (Policy # 164 in the Radiology Section); PEDMS-10.2: Chronic Recurrent Multifocal Osteomyelitis for additional information.

† PET-MRI is considered investigational at this time due to lack of standardization in imaging technique and lack of evidence that PET-MRI improves patient outcome for any individual disease state.

References
1. Villani A, Tabori U, Schiffman J, et al, Biochemical and imaging surveillance in germline TP53 mutation carriers with Li-Fraumeni syndrome: a prospective observational study, Lancet Oncol 2011;12:559-567.
2. Siegel MJ, Acharyya S, Hoffer FA et al, Whole-Body MR Imaging for Staging of Malignant Tumors in Pediatric Patients: Results of the American College of Radiology Imaging Network 6660 Trial, Radiology 2013;266:599-609.
3. Antoch G, Vogt FM, Freudenberg LS, et al, Whole-Body Dual-Modality PET/CT and Whole-Body MRI for Tumor Staging in Oncology, JAMA 2003;290:3199-3206.
4. Lauenstein TC and Semelka RC, Emerging Techniques: Whole-Body Screening and Staging With MRI, J Magn Reson Imaging 2006;24:489-498.
5. Khanna G, Sato TP, and Ferguson P, Imaging of Chronic Recurrent Multifocal Osteomyelitis, Radiographics 2009;29:1159-1177.
6. Ferguson PJ and Sandu M, Current Understanding of the Pathogenesis and Management of Chronic Recurrent Multifocal Osteomyelitis, Curr Rheumatol Rep 2012;14:130-141.
7. National Comprehensive Cancer Network (NCCN) Guidelines Version 3.2019. – January 18, 2019, Genetic/Familial High Risk Assessment: Breast and Ovarian, available at: https://www.nccn.org/professionals/physician_gls/pdf/genetics_screening.pdf. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Genetic/Familial High Risk Assessment: Breast and Ovarian V3.2019. – January 18, 2019 ©. 2019 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines™ and illustrations herein may not be reproduced in any form for any purpose without the express written permission of the NCCN. To view the most recent and complete version of the NCCN Guidelines™, go online to NCCN.org.


Preface-5: References

† Complete reference citations for the journal articles are embedded within the body of the guidelines and/or may be found on the Reference pages at the end of some guideline sections.

† The website addresses for certain references are included in the body of the guidelines but are not hyperlinked to the actual website.

† The website address for the American College of Radiology (ACR) Appropriateness Criteria^® is http://www.acr.org.


Preface-6: Trademarks

CPT^® (Current Procedural Terminology) is a registered trademark of the American Medical Association (AMA). CPT^® five digit codes, nomenclature, and other data are copyright 2020 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in the CPT^® book. AMA does not directly or indirectly practice medicine or dispense medical services. AMA assumes no liability for the data contained herein or not contained herein.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
General Guideline for Advanced Imaging Studies

References:

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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