Spinal Fusion*

Medical Policy: 07.01.49 
Original Effective Date: March 2010 
Reviewed:  
Revised: May 2011 

Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

Description: 

Spinal arthrodesis, or the invention of fusion, was used to treat the instability and deformity due to tuberculosis, scoliosis, and traumatic injury. Surgical implants for the spine were developed later attempting to improve the rate of fusion and hasten patients’ recovery post surgery. In the USA in 2005, low back pain was the most common cause of disability in persons younger than 45 years old, causing the greatest loss of productivity of any medical condition, second only to the common cold. It is estimated between 8-56% of the USA population experiences low back pain every year, with the lifetime incidence rate between 65%-80%. Spinal fusion surgery is rapidly increasing in the USA. Between 1996 and 2001 national survey data indicated the annual number of spinal fusion operations rose by 77%. Factors leading to this increase are: an increased aging population, technical advances in spinal instrumentation, biologics to promote bony fusion including bone-graft substitutes and supplements such as bone morphogenetic proteins, new spinal-fixation devices, computer-guided and minimally invasive surgical techniques. During this same time, hip replacement and knee arthroplasty procedures increased only 13-14%.

Spinal fusion is a surgical procedure used to treat neck or back pain caused by degenerative lumbar spondylolisthesis (an acquired anterior displacement of a vertebrae over the vertebrae lying under or below, coupled with degenerative changes, with no associated disruption or defect in the vertebral ring), spinal nerve compression from trauma injury, or degenerative disc disease (DDD). Spondylolisthesis may occur with or without stenosis. Degenerative lumbar spinal stenosis is an imaging finding which may or may not accompany clinical findings of buttock or lower extremity pain, occurring with or without back pain, and is related to a diminished available space for the neural and vascular elements of the spine. Abnormal curvatures of the spine found in scoliosis or kyphosis, and vertebral instability due to tumors or infections may also be surgically  treated with spinal fusion. The goal of spinal fusion is to provide relief from pain or nerve damage caused by spinal instability by permanently immobilizing certain vertebra in the spine.  Improving spinal stability should result in absence of motion between two or more segments of vertebra and relief of pain when excessive movement  (instability) is the cause.

The cervical and lumbar vertebrae are the most mobile segments of the spinal column and the sites where spinal fusion is most commonly performed. Either minimally invasive* or open surgical procedures may be done. Two or more vertebrae are joined by the growth of new bone (graft) during fusion.  A bone graft is placed between the vertebrae to stimulate the growth of new bone and fuse the vertebra. The graft can be placed on each side of the vertebrae, but it is usually placed between the bodies of adjacent vertebra resulting in interbody fusion. Bone is removed most commonly from the patient’s iliac crest (pelvis). Harvesting the patient’s bone and implanting it at another site is known as “autografting.”  When sufficient autograft bone is not available, surgeons may use synthetic bone growth and bone graft products for spinal fusion. Different approaches used to place the bone graft include: anterior, posterior, posterolateral, transforaminal, intertransverse, or circumferential (360⁰ approach) fusion.

* Minimally invasive techniques have been developed in an attempt to decrease healing time, blood loss and hospital length of stay.  Minimally invasive techniques currently under investigation include: Axial Lumbar Interbody Fusion (AxiaLIF^® and AxiaLIF II^®) Interlaminar Lumbar Instrumented Fusion (ILIF ™)  and Extreme Lateral Interbody Fusion (XLIF^®)

The AxiaLIF^® (Axial Lumbar Interbody Fusion) and AxiaLIF^® II Level Systems were developed by TranS1^® and consist of techniques and surgical instruments for creating a pre-sacral access route to perform percutaneous fusion of the L5 - S1 or L4 – S1 vertebral bodies under fluoroscopic guidance.FDA premarket notification [510(k)] summaries are noted June 14, 2005 for TranS1^® AxiaLIF^® System, and April 28, 2008 for TranS1^® AxiaLIF^® II System. The AxiaLIF^® systems are indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. They are not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Their usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L4-S1 in conjunction with legally marketed facet or pedicle screw systems.

The XLIF^® and ILIF ™ systems were developed by NuVasive, Inc.(San Diego, CA). The XLIF^® system utilizes an endoscopic lateral approach that passes through the retroperitoneal fat and psoas muscle to treat patients with degenerative disc disease with instability, recurrent disc herniation, degenerative spondylolisthesis (less than or equal to grade 2), degenerative scoliosis, pseudoarthrosis, discitis, vertebral osteomyelitis (without active infection), total disc replacement revision, post-laminectomy instability, or junctional disease.  XLIF^® is contraindicated for L5-S1, lumbar deformities with greater than 30 degrees rotation, degenerative spondylolisthesis greater than grade 3, bilateral retroperitoneal scarring, or the need for direct posterior decompression through the same approach.  Interlaminar Lumbar Instrumented Fusion (ILIF ™) is a neural decompression which uses 1. An allograft interspinous spacer (ExtenSure® H2) to maintain segmental distraction and 2. A spinous process fixation plate (Affix™) to maintain stability for eventual segmental fusion.

Non-surgical management therapies, include, but are not limited to:

• program of supervised physical therapy including but not limited to: back education (adapting body mechanics), cognitive behavioral therapy (relieve pain by improving coping and adaptive skills), manual therapy, exercise instruction, including but not limited to: aerobic conditioning by walking or use of stationary bike, stretching and strengthening with isometric and progressive resistance exercises, or minimal weight bearing exercise such as aquatic-based activity
• cessation of inciting sports or activities
• weight reduction
• chiropractic manipulation
• analgesic agents, including but not limited to, nonsteroidal anti-inflammatory drugs; acetaminophen; in rare cases based on severity, opioids may be used
• epidural injections
• limited course of cervical traction

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Prior Approval: 

Prior approval is recommended for Iowa and South Dakota providers only. Submit a prior approval now. 

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Policy: 

CERVICAL

Cervical spinal fusion may be considered medically necessary in patients with verifiable cervical spinal instability as a result of:

• spinal fracture or dislocations from trauma, OR
• pseudoarthrosis (non-union) from prior fusion

Cervical spinal fusion may be considered medically necessary in patients with verifiable cervical spinal instability in patients meeting ALL of the following:

• Patient history, current symptoms, and physical exam findings indicative of damage, injury  or compression to the spinal cord (myelopathy) or a nerve root(s) (radiculopathy) consistent with the spinal level (s) for the proposed procedure.

AND ARE CORRELATED WITH

• Radiographic evidence of spinal cord compression or cervical nerve root compression, AND
• Clinically significant functional limitations resulting in diminished quality of life and impaired, age-appropriate activities of daily living, AND
• Failure of  a reasonable trial of non-surgical management

Cervical spinal fusion may be considered medically necessary in patients that are at risk of spinal instability subsequent to spinal surgery for one of the following:

• spinal tumor, OR
• spinal infection/abscess

Cervical spinal fusion may be considered medically necessary in patients that are at risk of spinal instability subsequent to spinal decompression surgery in patients meeting ALL of the following:

• Patient history, current symptoms, and physical exam findings indicative of damage, injury  or compression to the spinal cord (myelopathy) or a nerve root(s) (radiculopathy) consistent with the spinal level (s) for the proposed procedure.

AND ARE CORRELATED WITH

• Radiographic evidence of spinal cord compression or cervical nerve root compression, AND
• Clinically significant functional limitations resulting in diminished quality of life and impaired, age-appropriate activities of daily living, AND
• Failure of  a reasonable trial of non-surgical management

LUMBAR

Lumbar spinal fusion may be considered medically necessary in patients with verifiable lumbar spinal instability as a result of:

• spinal fracture or dislocations from trauma, OR
• pseudoarthrosis (non-union) from prior fusion

Lumbar spinal fusion may be considered medically necessary in patients with verifiable lumbar spinal instability in patients meeting ALL of the following:

• Patient history, current symptoms, and physical exam findings indicative of damage or injury to the spinal nerve root(s) (radiculopathy) or Cauda Equina (Cauda Equina Syndrome) or unremitting neurogenic claudication.
  

AND ARE CORRELATED WITH

• Radiographic evidence of lumbar root compression or Cauda Equina injury., AND
• Clinically significant functional limitations resulting in diminished quality of life and impaired, age-appropriate ac^tivities of daily living, AND
• Failure of  a reasonable trial of non-surgical management

Lumbar spinal fusion may be considered medically necessary in patients that are at risk of spinal instability subsequent to spinal surgery for one of the following:

• spinal tumor, OR
• spinal infection/abscess, OR
• herniated lumbar disc , third occurrence or greater (with 2 previous herniated lumbar disc surgeries) at same lumbar vertebral level

Lumbar spinal fusion may be considered medically necessary in patients that are at risk of spinal instability subsequent to spinal decompression surgery patients meeting ALL of the following:

• Patient history, current symptoms, and physical exam findings indicative of damage or injury to the spinal nerve root(s) (radiculopathy) or Cauda Equina (Cauda Equina Syndrome) or unremitting neurogenic claudication.

AND ARE CORRELATED WITH

• Radiographic evidence of lumbar root compression or Cauda Equina injury., AND
• Clinically significant functional limitations resulting in diminished quality of life and impaired, age-appropriate ac^tivities of daily living, AND
• Failure of  a reasonable trial of non-surgical management

Severe Single Level Degenerative Disc Disease

• Back pain without true radiculopathy for 6 months to a year, AND
• Confirmatory MRI with or without myelography within the past 6 months which demonstrates severe single level disc pathology, AND
• Failed participation in a program of active supervised rehabilitative exercise consisting of core stabilization exercises, AND
• A positive discogram for concordant pain at the proposed single level to be fused with at least one normal control level documented

Extreme Lateral Interbody Fusion (XLIF ^®)

• meet the lumbar spinal fusion criteria listed above, and
• are absent of any of the following contraindications:
  • L5 to S1 pathology
  • Lumbar deformities with greater than 30 degrees rotation
  • degenerative spondylolisthesis less than or equal to grade 2
  • bilateral retroperitoneal scarring
  • the need for direct posterior decompression through the same approach

Axial lumbar interbody fusion (AxiaLIF^®or AxiaLIF II^®) or Interlaminar Lumbar Instrumented Fusion (ILIF ™) is considered investigational based on the lack of published scientific literature.

Lumbar spinal fusion with initial laminectomy/discectomy related to unilateral compression of a lumbar nerve root is considered not medically necessary. 

Relative contraindications require additional consideration prior to surgery because of potential risk for poor outcomes:

• current smoking
• severe physical deconditioning
• disability for one year or longer prior to consideration of fusion
• absence of evidence of functional recovery for at least 6 months after most recent spine surgery
• severe medical problems/comorbid conditions – cardiopulmonary disease, diabetes, kidney disease, and poor nutritional status
• severe psychological problems, including, but not limited to:  depression, history of drug or alcohol abuse, personality disorder, or major psychiatric illness
• osteoporosis
• Body mass index (BMI) > 50 kg/m²

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Procedure Codes and Billing Guidelines: 

• To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
• 22533 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
• 22534 Arthrodesis, lateral extracavitary technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic or lumbar, each additional vertebral segment (List separately in addition to code for primary procedure)
• 22548 Arthrodesis, anterior transoral or extraoral technique, clivus-C1-C2 (atlas-axis), with or without excision of odontoid process
• 22551 Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2
• 22552 Arthrodesis, anterior interbody, including disc space preparation, discectomy, osteophytectomy and decompression of spinal cord and/or nerve roots; cervical below C2, each additional interspace (List separately in addition to code for separate procedure)  
• 22554 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); cervical below C2
• 22556 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); thoracic
• 22558 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar
• 22585 Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); each additional interspace (List separately in addition to code for primary procedure)
• 22590 Arthrodesis, posterior technique, craniocervical (occiput-C2)
• 22595 Arthrodesis, posterior technique, atlas-axis (C1-C2)
• 22600 Arthrodesis, posterior or posterolateral technique, single level; cervical below C2 segment
• 22612 Arthrodesis, posterior or posterolateral technique, single level; lumbar (with or without lateral transverse technique)
• 22614 Arthrodesis, posterior or posterolateral technique, single level; each additional vertebral segment (List separately in addition to code for primary procedure)
• 22630 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; lumbar
• 22632 Arthrodesis, posterior interbody technique, including laminectomy and/or discectomy to prepare interspace (other than for decompression), single interspace; each additional interspace (List separately in addition to code for primary procedure)
• 0195T Arthrodesis, pre-sacral interbody technique, including instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; single interspace
• 0196T Arthrodesis, pre-sacral interbody technique, including instrumentation, imaging (when performed), and discectomy to prepare interspace, lumbar; each additional interspace (List separately in addition to code for primary procedure)
• 22633 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; lumbar
• 22634 Arthrodesis, combined posterior or posterolateral technique with posterior interbody technique including laminectomy and/or discectomy sufficient to prepare interspace (other than for decompression), single interspace and segment; each additional interspace and segment (List separately in addition to code for primary procedure)              

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Selected References: 

• Deyo RA, Nachemson A, Mirza Sk. Spinal-fusion surgery – the case for restraint. N Engl J Med. 2004;350(7):722-726.
• Resnick DK, Choudhri TF, Dailey AT, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 1: Introduction and methodology. J Neurosurg Spine. 2005;2(6):637-638.
• Resnick DK, Choudhri TF, Dailey AT, et al; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: Assessment of functional outcome. J Neurosurg Spine. 2005;2(6):639-646.
• Resnick DK, Choudhri TF, Dailey AT, et al; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8: Lumbar fusion for disc herniation and radiculopathy. J Neurosurg Spine. 2005;2(6):673-678.
• Resnick DK, Choudhri TF, Dailey AT, et al; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: Fusion in patients with stenosis and spondylolisthesis. J Neurosurg Spine. 2005;(6):679-685.
• Resnick DK, Choudhri TF, Dailey AT, et al; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 10. Fusion following decompression in patients with stenosis without spondylolisthesis. J Neurosurg Spine. 2005;2(6): 686-691.
• Resnick DK, Choudhri TF, Dailey AT, et al; American Association of Neurological Surgeons/Congress of Neurological Surgeons. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 14: brace therapy as an adjunct to or substitute for lumbar fusion. J Neurosurg Spine 2005 Jun;2(6):716-24.
• Carette S, Fehlings MG. Clinical practice. Cervical radiculopathy. N. Engl J Med. 2005 Jul 28;353(4):392-9.
• ECRI Institute. Guidelines for Spinal Fusion. Plymouth Meeting (PA): ECRI Institute; 2005 November 21. 10p. [ECRI hotline response]. Also available: http://www.ecri.org.
• Wang MC, Chan L, Maiman DJ, Kreuter W, Deyo RA. Complications and mortality associated with cervical spine surgery for degenerative disease in the United States. Spine (PhilaPa 1976). 2007 Feb 1;32(3):342-7.
• ECRI Institute. Spinal Fusion and Discography for Chronic Low Back Pain and Uncomplicated Lumbar Degenerative Disc Disease. Plymouth Meeting (PA): ECRI Institute; 2007 Oct 19. 211 p. [ECRI Health Technology Assessment (HTA) Program]. Also available: http://www.ecri.org.
• Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Assessment Program. Artificial Lumbar Disc Replacement. Vol. 22, No. 2. June 2007.
• Chou R, Huffman LH; American Pan Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Inten Med. 2007 Oct 2;147(7):492-504.
• North American Spine Society (NASS). Diagnosis and Treatment of Degenerative Lumbar Spinal Stenosis. Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Burr Ridge, IL:NASS; 2007. URL, <http://www.spine.org/Documents/NASSCG_Stenosis.pdf>, accessed August 10, 2009.
• Garrison KR, Donnel S, Ryder J, Shemilt I, Mugford M, Harvey I, et al. Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review. Health Technol Assess 2007; 11(30).
• Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N. Engl J Med. 2007 May 31;356(22):2257-70.
• Weinstein JN, Tosteson TD, Lurie JD, Tostson AN, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N. Engl J Med. 2008 Feb 21;358(8):794-810.
• McCormick, P. Lumbar Spine Disease: Considerations for Obese Patients. AANS Neurosurgeon 2008;17(2):14-15. URL, <http://www.aans.org/bulletin/pdfs/Vol%2017_2_08.pdf>,accessed August 10, 2009.
• North American Spine Society (NASS). Diagnosis and Treatment of Degenerative Lumbar Spondylosisthesis. Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care. Burr Ridge, IL:NASS; 2008. URL, <http://www.spine.org/Documents/Spondylolisthesis_Clinical_Guideline.pdf>, accessed August 10, 2009. 
• Hu SS, Tribus CB, Diab M, Ghanayem AJ. Spondylolisthesis and spondylolysis. J Bone Joint Surg Am. 2008 Mar;90(3):656-71.
• Manchikanti L, Boswell MV, Singh V, et al. Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2009 Jul-Aug;12(4):699-802.
• Blue Cross Blue Shield Association Medical Policy Reference Manual (MPRM), 7.01.115 Axial (Percutaneous) Lumbar Interbody Fusion. 2011.
• Shen FH, Samartzis D, Dip EB et al. Minimally invasive techniques for lumbar interbody fusion. Orthop Clin N Am 2007; 38:373-86.
• U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification [510(K)] Summary. TranS1^® AxiaLIF^® Fixation System. Available at http://www.fda.gov/cdrh/pdf7/K073514.pdf.
• U.S. Food and Drug Administration Center for Devices and Radiological Health. Premarket Notification [510(K)] Summary. TranS1^® AxiaLIF^® II System. Available at http://www.fda.gov/cdrh/pdf7/K073643.pdf.
• ECRI Institute.  Minimally invasive spinal fusion surgery using extreme lateral interbody fusion or axial lumbar interbody fusion for back pain. Plymouth Meeting (PA): ECRI Institute; 2009 Oct 14. 6p. [ECRI hotline response] Updated Mar 2010. Also available: http://www.ecri.org
• Youssef JA, McAfee PC, Patty CA et al. Minimally invasive sugery: lateral approach interbody fusion. Spine 2010; 35 (26S): S302-S311.
• Oliveira L, Marchi L, Coutinho E, et al. A radiographic assessment of the ability of the extreme lateral interbody fusion procedure to indirectly decompress the neural elements. Spine 2010; 35 (26S): S331-S337.
• Deluzio KJ, Lucio JC, Rogers, WB. Value and cost in less invasive spinal fusion surgery: lessons from a community hospital. SAS Journal 2010:37-40 doi: 10.1016/j.esas.2010.03.004.

• Carrino JA, Lurie JD, Tosteson AN, Carragee EJ et al. Lumbar Spine: Reliability of MR

  Imaging Findings1. Radiology: Volume 250: Number 1—January 2009

• Katz JN. Lumbar disc disorders and lowback pain: socioeconomic factors and consequences.

• Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D, Ross JS. Magnetic resonance imaging of the lumbar spine in people without back pain. N Engl J Med 1994;331(2):69-73

• Weishaupt D, Zanetti M, Hodler J, Boos N. MR imaging of the lumbar spine: prevalence

  of intervertebral disk extrusion and sequestration, nerve root compression, end plate

  abnormalities, and osteoarthritis of the facet joints in asymptomatic volunteers. Radiology

  1998;209(3):661–666.

• Stadnik TW, Lee RR, Coen HL, Neirynck EC, Buisseret TS, Osteaux MJ. Annular tears and disk herniation: prevalence and contrast enhancement on MR images in the absence of low back pain or sciatica. Radiology 1998; 206(1):49–55.

• Boden SD, Davis DO, Dina TS, Patronas NJ, Wiesel SW. Abnormal magnetic-resonance

  scans of the lumbar spine in asymptomatic subjects: a prospective investigation. J Bone

  Joint Surg Am 1990;72(3):403–408.

• Carragee EJ, Paragioudakis SJ, Khurana S. 2000 Volvo Award winner in clinical studies:

  lumbar high-intensity zone and discography in subjects without low back problems. Spine

  2000;25(23):2987–2992.

• Chung CB, Vande Berg BC, Tavernier T, et al. End plate marrow changes in the

  asymptomatic lumbosacral spine: frequency, distribution and correlation with age and degenerative changes. Skeletal Radiol 2004; 33(7):399–404.

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Policy History: 

Date                      Reason                               Action

May 2011             Interim review                    Policy revised

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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.