National Medical Policy

National Medical Policy Subject: SPECT Scan for Evaluation of Spondylolysis, Spondylolisthesis and Skeletal Disorders Policy Number: NMP67 Effecti...
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National Medical Policy Subject:

SPECT Scan for Evaluation of Spondylolysis, Spondylolisthesis and Skeletal Disorders

Policy Number:


Effective Date*: October 2003 Updated:

January 2016

This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate State's Medicaid manual(s), publication(s), citations(s) and documented guidance for coverage criteria and benefit guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use X

Source National Coverage Determination (NCD)

Reference/Website Link

Single Photon Emission Computed Tomography (SPECT, 220.12)

National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* Other None

Use Health Net Policy

Instructions  Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions.  Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under “Reference/Website” and follow the search instructions. Enter the topic and your specific state to find the coverage determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2)

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 

If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance.

Current Policy Statement Health Net, Inc. considers SPECT scanning medically necessary in any of the following scenarios: 1. 2. 3. 4.

Detection of spondylosis and stress fractures, (eg. Spondylolisthesis can also be due to stress fracture); or Evaluation of bone or skeletal disorders; or Assessment of osteomyelitis, to distinguish bone from soft tissue infection; or To distinguish spinal benign lesions from malignant lesions (eg. SPECT scan will demonstrate a focal area of increased uptake at the site of the lesion & differentiates between a metabolically active or 'hot' lesion and an inactive lesion.)

Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures have been replaced by ICD-10 code sets.

ICD-9 Codes (Not an all-inclusive list) 737 737.1-737.19 738.4 756.11 756.12

Curvature of spine Kyphosis Acquired spondylolisthesis Spondylolysis, lumbosacral region Spondylolisthesis

ICD-10 Codes M4Ø.ØØ M4Ø.2Ø9 M4Ø.299 M40.4-M40.57 M41-M41.9 M42-M42.9 M43 M43.Ø-M43.09 M43.1-M43.19 M43.8-M43.9 M96-M96.5 Q76.2

Postural kyphosis, site unspecified Unspecified kyphosis, site unspecified Other kyphosis, site unspecified Lordosis Scoliosis Spinal osteochondrosis Other deforming dorsopathies Spondylolysis Spondylolisthesis Other deforming dorsopathies Intraoperative and postprocedure complications and disorders of musculoskeletal system, not elsewhere classified Congenital spondylolisthesis

CPT Codes

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78320 78807

Bone and /or joint imaging; tomographic (SPECT) Radiopharmaceutical localization of inflammatory process; tomographic (SPECT)


Scientific Rationale – Update January 2016 Freiermuth et al (2015) performed a prospective randomized placebo-controlled trial to evaluate the value of high-resolution single-photon emission computed tomography (SPECT)/computed tomography (CT) of the lumbar spine prior to any diagnostic infiltration of the medial branches. Patients with suspected zygapophyseal joint-related pain were included in the study. After obtaining a SPECT/CT scan of the lumbar spine a set of infiltrations of the medial branches was done with local anesthetics and placebo on different days. Patients and anesthetists were blinded to the results of SPECT/CT and to the infiltrated agents. In a total of 29 study patients, 7 had positive and 22 negative infiltration tests, and 9 had positive and 20 negative SPECT/CT findings. Sensitivity of SPECT/CT for a positive response after diagnostic infiltration was 0.57 (95% confidence interval [CI] 0.18-0.90); specificity was 0.77 (CI 95% 0.55-0.92); odds ratio was 4.53 (CI 95% 0.75-27.40); and diagnostic accuracy was 0.72. The authors concluded compared with diagnostic infiltrations SPECT/CT scans showed only a moderate sensitivity and specificity and, therefore, may not be recommended as a first line diagnostic tool prior to diagnostic infiltrations.

Scientific Rationale – Update April 2011 The SPECT scan is an established test for spinal disorders and the published studies support its use in detection of spondylolysis and detecting stress/insufficiency fractures. Its use in other conditions are currrently being studied.

Scientific Rationale – Updated August 2007 The role of SPECT of the spine has changed in recent years with the wide availability of MRI and especially contrast-enhanced MRI. Bone scanning with SPECT of the spine has been accepted as extremely sensitive in detecting incipient spondylolysis and stress/insufficiency fractures (Manaster, et al., 2005). SPECT is especially important in children and adolescents, by noting a pars defect that may not be detected by conventional imaging. Because of the sensitivity of SPECT scans, 80% of all fractures show an abnormality 24 hours post injury and 95% at 72 hours. In addition, the SPECT scan is able to differentiate between osseous and soft tissue injury as well. A normal scan generally excludes the diagnosis of stress/insufficiency fracture, and the patient may return to normal activity, when immobilization would have been the appropriate treatment. Per the (SNM) Society of Nuclear Medicine (2006), SPECT and CT are proven diagnostic procedures. The integration of these two procedures into a single device has resulted in the development of this technology. An SNM procedure guideline states that indications for SPECT/CT include imaging of skeletal disorders and tumors. Recent studies have evaluated the ability of bone scans, with the addition of singlephoton emission computed tomography (SPECT), to assist in the following types of issues that could be related to back problems:

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To distinguish benign spinal lesions from malignant lesions. SPECT scan differs from bone scan because it provides a three-dimensional image that enables physicians to locate the lesion more precisely. Lesions that affect the pedicles are a strong indicator of malignancy, while lesions of the facets are likely to be benign. Lesions of the vertebral body or spinous process are just as likely to be benign as malignant and, therefore, offer little diagnostic evidence. The SPECT scan will demonstrate a focal area of increased uptake at the site of the lesion and is therefore also able to differentiate between a metabolically active or 'hot' lesion and an inactive lesion.


The limited sensitivity of plain x-rays and the difficulty in attributing symptomatology to a lesion seen on plain x-rays has led to the increasing use of Single Photon Emission Computerized Tomography (SPECT) scanning. SPECT scanning has been shown to be more sensitive for identifying pars lesions than plain radiography in a number of studies. The SPECT scan will demonstrate a focal area of increased uptake at the site of the lesion and is therefore also able to differentiate between a metabolically active or 'hot' lesion and an inactive lesion.


Assists in identifying a stress fracture at an early enough stage to prevent completion of the fracture. (e.g. stress fractures in the spine - spondylolysis).


Assessment of osteomyelitis, to distinguish bone from soft tissue infection.

National Guideline Clearinghouse (2004) Single photon emission computed tomographic (SPECT, also known as SPET) images may be obtained by reconstruction of a number of planar images taken at different angles. Computed tomography (CT) scanners have been combined with some single-photon cameras that have SPECT capability in order to provide attenuation correction capability as well as localizing information. Use of combined SPECT/CT scanners is likely to increase in the future. The Centers for Medicare and Medicaid Services (CMS) have a NCD for single photon emission computed tomography (SPECT) (Manual Section Number 220.12) effective 10/1/2002. It states: “SPECT acquires information on the concentration of radionuclides introduced into the patient’s body”. It is useful in the diagnosis of several clinical conditions, including all of the following scenarios relating to the skeletal system: 

Stress fracture;


Infection (e.g., discitis); and

Tumor (e.g., osteoid osteoma)

Evidence in the published peer-reviewed scientific literature, textbooks, and current clinical practice demonstrate that nuclear imaging including single-photon emission computed tomography (SPECT) is a proven and well-established imaging modality. Specific clinical applications depend on the specific radiopharmaceutical. Nuclear imaging including SPECT may be utilized when other imaging studies are inconclusive

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or contraindicated. This policy is specific to SPECT scanning Scan for the evaluation of spondylolysis, spondylolisthesis and skeletal disorders.

Scientific Rationale - Initial The spine consists of a series of vertebrae that provide support for the spinal cord. Each vertebra consists of an anterior vertebral body, a posterior bony ring with two superior facets and two inferior facets that articulate with the adjoining vertebrae. These articulations form the posterior facet joints that provide stability to the spine. In spondylolysis, a stress fracture develops in the pars interarticularis (which literally means the "piece between the articulations") and is commonly referred to as a "pars defect." A pars defect can be unilateral or bilateral, and although the defect can be found at any level, the 5th lumbar vertebra is most commonly affected. Spondylolysis can be caused by a congenital defect in the spine (spina bifida occulta), acute trauma to the back, chronic overextension of the back while performing certain sports and activities, degenerative conditions of the spine, and (rarely) cerebral palsy. Although spondylolysis has several origins, the most common is in highly competitive adolescent athletes who participate in sports that require intense levels of training and performance in which the spine is repeatedly bent backwards (i.e. gymnastics, football, weight lifting and karate). Initial treatment for spondylolysis is conservative and includes rest, back bracing and/or physical therapy. Epidural steroid injections may also help alleviate inflammation and ease pain. In most cases, activities can be resumed gradually with few complications or recurrence. Stretching and strengthening exercises for the back and abdominal muscles can help prevent future stress fractures. X-rays may be taken every few months to monitor the healing process. In cases of bilateral spondylolysis, the posterior articulations no longer provide posterior stability, and anterior slipping of the L5 vertebra over the sacrum can occur. This slipping is called spondylolisthesis. Pain usually spreads across the lower back, and may feel like a muscle strain. Spondylolisthesis can cause spasms that stiffen the back and tighten the hamstring muscles, resulting in changes to posture and gait. If the slippage is significant, it may begin to compress the nerves and narrow the spinal canal. Individuals may eventually experience pain that radiates down one or both legs. If conservative treatment such as rest, back bracing and/or physical therapy fail to alleviate the symptoms of spondylolisthesis, surgical fusion may become necessary. Diagnosis of a pars fracture is usually made from an x-ray of the lumbar spine taken from an angled or oblique view. Often the oblique views are best for revealing the defects in the pars interarticularis. In viewing the film, the radiologist can trace around the vertebral body and bony ring on the X-ray film. The outline normally forms an image that looks like a small dog. When a crack is present however, the dog will appear to have a collar around its neck. This is referred to as the "Scotty dog" sign, and it confirms a diagnosis of spondylolysis. Small defects in the bone or a recent stress fracture may not show up on X-ray. A bone scan, CT scan or MRI may be needed before treatment begins to rule out any other contributing conditions. SPECT (Single Photon Emission Computed Tomography) is a three dimensional imaging technique which reflects the distribution of radiotracer in the body. It is

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designed to reflect the level of physiologic activity within organs or organ system, but it can also provide structural information. Bone scanning with SPECT has been shown to detect some lesions related to stress fractures in the spine, such as pars defects, however it has not yet been shown in the peer-reviewed literature to be equally effective as standard diagnostics (x-rays, bone scan, CT or MRI). There is a need for large patient study populations, and comparisons with conventional diagnostic methods, in order to determine what role SPECT will eventually have in the diagnosis of spondylolysis.

Review History October 2003 June 2005 July 2006 August 2007

February 2009 April 2011 January 2012 January 2013 January 2014 January 2015 January 2016

Medical Advisory Council Medical Advisory Council – no revisions Update – no revisions Revision to consider SPECT scans medically necessary in detection of spondylosis and stress fractures, evaluation of bone or skeletal disorders, assessment of osteomyelitis, to distinguish bone from soft tissue infection & to distinguish spinal benign lesions from malignant lesions. Update – no revisions Update. Added revised Medicare table with link to NCD. Update - no revisions. Update – no revisions. Codes updated. Update – no revisions. Codes updated. Update – no revisions. Codes updated. Update – no revisions.

This policy is based on the following evidence-based guideline: 1. National Guideline Clearinghouse. Procedure guideline for general imaging. Society of Nuclear Medicine. Procedure guideline for general imaging. Version 3.0. Reston (VA): Society of Nuclear Medicine; 2004 May 30. 10 p.

References – Update January 2016 1.

2. 3.

Freiermuth D, Kretzschmar M, Bilecen D, et al. Correlation of (99m) Tc-DPD SPECT/CT Scan Findings and Diagnostic Blockades of Lumbar Medial Branches in Patients with Unspecific Low Back Pain in a Randomized-Controlled Trial. Pain Med. 2015 Oct;16(10):1916-22. Hudyana H, Maes A, Vandenberghe T, et al. Accuracy of bone SPECT/CT for identifying hardware loosening in patients who underwent lumbar fusion with pedicle screws. Eur J Nucl Med Mol Imaging. 2015 Aug 13. Lee I, Budiawan H, Moon JY, et al. The value of SPECT/CT in localizing pain site and prediction of treatment response in patients with chronic low back pain. J Korean Med Sci. 2014 Dec;29(12):1711-6.

References Update – January 2015 1. 2.

Heller GV. Attenuation artifact in SPECT radionuclide myocardial perfusion imaging. UpToDate. Updated November 2014. Sumer J, Schmidt D, Ritt P, et al. Spect/CT in patients with lower back pain after lumbar fusion surgery. Nucl Med Commun. 2013 Oct;34(10):964-70.

References Update – January 2014 1.

Davis PC, Wippold FJ II, Cornelius RS, et al. Expert Panel on Neurologic Imaging. ACR Appropriateness Criteria head trauma. American College of Radiology

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(ACR); 2012. Available at: sion+Computed+Tomography

References Update – January 2013 1. 2.

Firestein: Kelley's Textbook of Rheumatology, 9th ed. Other Imaging Modalities. 2012 Saunders, An Imprint of Elsevier. Metz LN. Infectious, inflammatory, and metabolic diseases affecting the athlete's spine. Clin Sports Med 31 (2012) 535–567.

References Update – January 2012 1.

Nigrovik PA. Back pain in children and adolescents: Overview of causes. UpToDate. February 15, 2011.

References Update – August 2007 1. Society of Nuclear Medicine (SNM) procedure guideline for SPECT/CT Imaging. May 2006. Available at: 2. Manaster BJ, Grossman JW, Dalinka MK, et al. Expert Panel on Musculoskeletal Imaging. Stress/insufficiency fracture, including sacrum, excluding other vertebrae. American College of Radiology (ACR); 2005. 3. Medicare CMS. NCD for Single Photon Emission Computed Tomography (SPECT). Manual Section (220.12). Publication Number 100-3. Manual Section Number 220.12. Version Number 1. 10/1/2002.

References – Initial 1. Anderson K, Sarwark JF, Conway JJ, Logue ES, Schafer MF. Quantitative assessment with SPECT imaging of stress injuries of the pars interarticularis and response to bracing. Pediatr Orthop. 2000 Jan-Feb;20(1):28-33. 2. Bellah RD, Summerville DA, Treves ST, Micheli LJ. Low-back pain in adolescent athletes: detection of stress injury to the pars interarticularis with SPECT. Radiology. 1991 Aug;180(2):509-12. 3. Blanda J, Bethem D, Moats W, Lew M. Defects of pars interarticularis in athletes: a protocol for nonoperative treatment. J Spinal Disord. 1993 Oct;6(5):406-11. 4. Blanda J, Bethem D, Moats W, Lew M. Defects of pars interarticularis in athletes: a protocol for nonoperative treatment. J Spinal Disord. 1993 Oct;6(5):406-11. 5. Bodner RJ, Heyman S, Drummond DS, Gregg JR. The use of single photon emission computed tomography (SPECT) in the diagnosis of low-back pain in young patients. Spine. 1988 Oct;13(10):1155-60. 6. Connolly LP, d'Hemecourt PA, Connolly SA, Drubach LA, Micheli LJ, Treves ST. Skeletal scintigraphy of young patients with low-back pain and a lumbosacral transitional vertebra. J Nucl Med. 2003 Jun;44(6):909-14. 7. d'Hemecourt PA, Zurakowski D, Kriemler S, Micheli LJ. Spondylolysis: returning the athlete to sports participation with brace treatment. Orthopedics. 2002 Jun;25(6):653-7. 8. Dutton JA, Hughes SP, Peters AM. SPECT in the management of patients with back pain and spondylolysis. Clin Nucl Med. 2000 Feb;25(2):93-6. 9. Gates GF. SPECT bone scanning of the spine. Semin Nucl Med. 1998 Jan;28(1):78-94. 10. Halvorsen TM, Nilsson S, Nakstad PH. [Stress fractures. Spondylolysis and spondylolisthesis of the lumbar vertebrae among young athletes with back pain] Tidsskr Nor Laegeforen. 1996 Jun 30;116(17):1999-2001.

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11. Hanly JG, Barnes DC, Mitchell MJ, MacMillan L, Docherty P. Single photon emission computed tomography in the diagnosis of inflammatory spondyloarthropathies. J Rheumatol. 1993 Dec;20(12):2062-8. 12. Harvey CJ, Richenberg JL, Saifuddin A, Wolman RL. The radiological investigation of lumbar spondylolysis. Clin Radiol. 1998 Oct;53(10):723-8. 13. Hasler C, Dick W. [Spondylolysis and spondylolisthesis during growth] Orthopade. 2002 Jan;31(1):78-87. 14. Itoh K, Hashimoto T, Shigenobu K, Yamane S, Tamaki N. Bone SPET of symptomatic lumbar spondylolysis. Med Commun. 1996 May;17(5):389-96. 15. Morita T, Ikata T, Katoh S, Miyake R. Lumbar spondylolysis in children and adolescents. J Bone Joint Surg Br. 1995 Jul;77(4):620-5. 16. Nyska M, Constantini N, Cale-Benzoor M, Back Z, Kahn G, Mann G. Spondylolysis as a cause of low back pain in swimmers. Int J Sports Med. 2000 Jul;21(5):3759. 17. Ralston S, Weir M. Suspecting lumbar spondylolysis in adolescent low back pain. Clin Pediatr (Phila). 1998 May;37(5):287-93. 18. Ryan PJ, Gibson T, Fogelman I. Spinal bone SPECT in chronic symptomatic ankylosing spondylitis. Clin Nucl Med. 1997 Dec;22(12):821-4. 19. Saifuddin A, Burnett SJ. The value of lumbar spine MRI in the assessment of the pars interarticularis. Clin Radiol. 1997 Sep;52(9):666-71. 20. Sarikaya I, Sarikaya A, Holder LE. The role of single photon emission computed tomography in bone imaging. Semin Nucl Med. 2001 Jan;31(1):3-16. 21. Spieth ME, Schmitz SL. Fractured osteophyte demonstrated on SPECT and computed tomography. Clin Nucl Med. 2003 Aug;28(8):663-5. 22. Stabler A, Paulus R, Steinborn M, Bosch R, Matzko M, Reiser M. [Spondylolysis in the developmental stage: diagnostic contribution of MRI] Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr. 2000 Jan;172(1):33-7. 23. Standaert CJ, Herring SA, Halpern B, King O. Spondylolysis. Phys Med Rehabil Clin N Am. 2000 Nov;11(4):785-803. 24. Standaert CJ. New strategies in the management of low back injuries in gymnasts. Curr Sports Med Rep. 2002 Oct;1(5):293-300. 25. Sys J, Michielsen J, Bracke P, Martens M, Verstreken J. Nonoperative treatment of active spondylolysis in elite athletes with normal X-ray findings: literature review and results of conservative treatment. Eur Spine J. 2001 Dec;10(6):498-504. 26. Congeni J, McCulloch J, Swanson K. Lumbar spondylolysis. A study of natural progression in athletes. Am J Sports Med. 1997 Mar-Apr;25(2):248-53. 27. Weir MR, Smith DS. Stress reaction of the pars interarticularis leading to spondylolysis. A cause of adolescent low back pain. J Adolesc Health Care. 1989 Nov;10(6):573-7. Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net’s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific

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procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member’s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. states, prior notice or website posting is required before an amendment is deemed effective.

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