7.01.87 artificial intervertebral disc: lumbar spine · effective date: july 1, 2018 last revised:...

14
MEDICAL POLICY – 7.01.87 Artificial Intervertebral Disc: Lumbar Spine BCBSA Ref. Policy: 7.01.87 Effective Date: July 1, 2018 Last Revised: June 22, 2018 Replaces: N/A RELATED MEDICAL POLICIES: 7.01.108 Artificial Intervertebral Disc: Cervical Spine 7.01.120 Facet Arthroplasty 7.01.542 Lumbar Spinal Fusion 7.01.551 Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy, Laminotomy, Laminectomy Select a hyperlink below to be directed to that section. POLICY CRITERIA | CODING | RELATED INFORMATION EVIDENCE REVIEW | REFERENCES | HISTORY Clicking this icon returns you to the hyperlinks menu above. Introduction The bones of the spine are called vertebrae. Between each of vertebra is a disc, which acts as a shock absorber and prevents the bones from rubbing together. As a person ages, these often become thinner as they lose water and the gel-like substance that’s inside of each disc. This is known as degenerative disc disease. Studies show that most adults over the age of forty have some level of degenerative disc disease. Often, no treatment is needed because the degeneration isn’t severe enough to cause pain in the lower back (lumbar spine). When there is pain, the usual first step is to try nonsurgical treatment, which often works. In cases where it doesn’t work, surgery may be considered. One type of surgery calls for placing an artificial disc between the vertebrae. The goal is to imitate how a natural disc works in the body. There is not enough medical evidence demonstrating the effectiveness of this procedure for the lower back. Artificial disc replacement in the lower back is considered investigational (unproven). Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Upload: lenhi

Post on 14-Sep-2018

215 views

Category:

Documents


0 download

TRANSCRIPT

  • MEDICAL POLICY 7.01.87

    Artificial Intervertebral Disc: Lumbar Spine

    BCBSA Ref. Policy: 7.01.87

    Effective Date: July 1, 2018

    Last Revised: June 22, 2018

    Replaces: N/A

    RELATED MEDICAL POLICIES:

    7.01.108 Artificial Intervertebral Disc: Cervical Spine

    7.01.120 Facet Arthroplasty

    7.01.542 Lumbar Spinal Fusion

    7.01.551 Lumbar Spine Decompression Surgery: Discectomy, Foraminotomy,

    Laminotomy, Laminectomy

    Select a hyperlink below to be directed to that section.

    POLICY CRITERIA | CODING | RELATED INFORMATION

    EVIDENCE REVIEW | REFERENCES | HISTORY

    Clicking this icon returns you to the hyperlinks menu above.

    Introduction

    The bones of the spine are called vertebrae. Between each of vertebra is a disc, which acts as a

    shock absorber and prevents the bones from rubbing together. As a person ages, these often

    become thinner as they lose water and the gel-like substance thats inside of each disc. This is

    known as degenerative disc disease. Studies show that most adults over the age of forty have

    some level of degenerative disc disease. Often, no treatment is needed because the

    degeneration isnt severe enough to cause pain in the lower back (lumbar spine). When there is

    pain, the usual first step is to try nonsurgical treatment, which often works. In cases where it

    doesnt work, surgery may be considered. One type of surgery calls for placing an artificial disc

    between the vertebrae. The goal is to imitate how a natural disc works in the body. There is not

    enough medical evidence demonstrating the effectiveness of this procedure for the lower back.

    Artificial disc replacement in the lower back is considered investigational (unproven).

    Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

    rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

    providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

    be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

    service may be covered.

    https://www.premera.com/medicalpolicies/7.01.108.pdfhttps://www.premera.com/medicalpolicies/7.01.120.pdfhttps://www.premera.com/medicalpolicies/7.01.542.pdfhttps://www.premera.com/medicalpolicies/7.01.551.pdfhttps://www.premera.com/medicalpolicies/7.01.551.pdf

  • Page | 2 of 12

    Policy Coverage Criteria

    Treatment Investigational Artificial intervertebral

    discs lumbar spine

    Artificial intervertebral discs of the lumbar spine are

    considered investigational.

    Coding

    Code Description

    CPT 0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to

    prepare interspace (other than for decompression), each additional interspace, lumbar

    (List separately in addition to code for primary procedure)

    0164T Removal of total disc arthroplasty (artificial disc), anterior approach, each additional

    interspace, lumbar (List separately in addition to code for primary procedure)

    0165T Revision including replacement of total disc arthroplasty, anterior approach, each

    additional interspace, lumbar (List separately in addition to code for primary

    procedure)

    22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to

    prepare interspace (other than for decompression), single interspace, lumbar

    22862 Revision including replacement of total disc arthroplasty (artificial disc), anterior

    approach, single interspace; lumbar

    22865 Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace;

    lumbar

    Note: CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). HCPCS

    codes, descriptions and materials are copyrighted by Centers for Medicare Services (CMS).

    Related Information

    Artificial intervertebral discs for treating the cervical spine are addressed in a separate medical

    policy (see Related Policies).

  • Page | 3 of 12

    Evidence Review

    Description

    Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is

    proposed as an alternative to spinal fusion in patients with degenerative disc disease that leads

    to disabling symptoms.

    Background

    When conservative treatment of degenerative disc disease (DDD) fails, a common surgical

    approach is spinal fusion. More than 200,000 spinal fusions are performed each year. However,

    outcomes with spinal fusion have been controversial, in part due to the difficulty in determining

    if a patient's back pain is related to DDD, and in part due to the success rate of the procedure

    itself. Also, spinal fusion alters the spine biomechanics, potentially leading to premature disc

    degeneration at adjacent levels, a particular concern for younger patients. During the past 30

    years, various artificial intervertebral discs have been investigated as an alternative approach to

    fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is

    intended to maintain motion at the operative level once the damaged disc has been removed as

    well as the normal biomechanics of the adjacent vertebrae.

    Potential candidates for artificial disc replacement have chronic low back pain attributed to

    DDD, lack of improvement with nonoperative treatment, and have none of the contraindications

    for the procedure. These include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis,

    previous major spine surgery, neurologic symptoms, and other minor contraindications. These

    contraindications make artificial disc replacement suitable for a subset of patients in whom

    fusion is indicated. Patients who require procedures (eg, laminectomy, decompression) in

    addition to fusion are not candidates for the artificial disc.

    Use of a motion-preserving artificial disc increases the potential for a variety of types of implant

    failure, such as device failure (device fracture, dislocation, or wear); bone-implant interface

    failure (subsidence, dislocation-migration, vertebral body fracture); and host response to the

    implant (osteolysis, heterotopic ossification, and pseudotumor formation).

  • Page | 4 of 12

    Summary of Evidence

    For individuals with lumbar degenerative disc disease who receive a lumbar artificial

    intervertebral disc, the evidence includes randomized controlled trials (RCTs) with 5-year

    outcomes and case series with longer-term outcomes. Relevant outcomes are symptoms,

    functional outcomes, quality of life, and treatment-related morbidity. Five-year outcomes for the

    ProDisc-L RCT have provided evidence for the noninferiority of artificial disc replacement. The

    superiority of ProDisc-L with circumferential fusion was achieved at 2 but not at 5 years in this

    unblinded trial. The potential benefits of the artificial disc (eg, faster recovery, reduced adjacent-

    level disc degeneration) have not been demonstrated. Also, considerable uncertainty remains

    whether response rates will continue to decline over longer time periods and if long-term

    complications with these implants will emerge. Although some randomized trials have

    concluded that this technology is noninferior to spinal fusion, outcomes which would make

    noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not

    been established. The evidence is insufficient to determine the effects of the technology on

    health outcomes.

    Ongoing and Unpublished Clinical Trials

    Some currently unpublished trials that might influence this review are listed in Table 1.

    Table 1. Summary of Key Trials

    NCT No. Trial Name Planned

    Enrollment

    Completion

    Date

    Ongoing

    NCT02381574 French Lumbar Total Disk Replacement Observational

    Study (FLTDR Observational Study)

    600 Dec 2020

    NCT: national clinical trial

    https://www.clinicaltrials.gov/ct2/show/NCT02381574?term=NCT02381574&rank=1

  • Page | 5 of 12

    Clinical Input Received from Physician Specialty Societies and Academic

    Medical Centers

    While the various physician specialty societies and academic medical centers may collaborate

    with and make recommendations during this process, through the provision of appropriate

    reviewers, input received does not represent an endorsement or position statement by the

    physician specialty societies or academic medical centers, unless otherwise noted.

    In response to requests, input was received from 1 physician specialty society and 3 academic

    medical centers while this policy was under review in 2008. The 4 reviewers disagreed with the

    policy statement that artificial intervertebral discs for the lumbar spine are investigational.

    After consideration of the clinical input in 2008, it was concluded that due to limitations of the

    randomized controlled trial (described above), combined with the marginal benefit compared

    with fusion, evidence was insufficient to determine whether artificial lumber discs are beneficial

    in the short term. Also, serious questions remain about potential long-term complications with

    these implants.

    Practice Guidelines and Position Statements

    North American Spine Society

    The North American Spine Society (2014) issued coverage recommendations for lumbar artificial

    disc replacement.18 The following recommendation was made:

    Lumbar artificial disc replacement (LADR) is indicated as an alternative to lumbar fusion for

    patients with discogenic low back pain who meet all of the following criteria from the Lumbar

    Fusion Recommendation:

    Advanced single-level disease noted on an MRI (magnetic resonance image) and plain

    radiographs of the lumbar spine at L4-5 or L5-S1, characterized by moderate to severe

    degeneration of the disc with Modic changes (defined as a peridiscal bone signal above and

    below the disc space in question) as compared to other normal or mildly degenerative level

    (characterized by normal plain radiographic appearance and no or mild degeneration on

    MRI)

    Presence of symptoms for at least one year AND that are not responsive to multi-modal

    nonoperative treatment over that period that should include physical therapy/rehabilitation

  • Page | 6 of 12

    program but may also include (but not limited to) pain management, injections, cognitive

    behavior therapy, and active exercise programs

    Absence of active significant psychiatric disorders, such as major depression, requiring

    pharmaceutical treatment

    Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain

    Age 18 to 60 years old (unique to disc replacement, not fusion)

    Absence of significant facet arthropathy at the operative level (unique to disc replacement,

    not fusion)

    Contraindications included multi-level degeneration, facet arthropathy, and hybrid procedures

    (ie, in combination with a spinal fusion or other stabilizing-type procedure).

    American Pain Society

    In 2009, the American Pain Societys practice guidelines concluded there was insufficient

    evidence to adequately evaluate long-term benefits and harms of intervertebral disc

    replacement.19 The guidelines were based on a systematic review commissioned by the Society

    and conducted by the Oregon Evidence-Based Practice Center.20 The rationale for the

    recommendation was that, although artificial disc replacement has been associated with similar

    outcomes compared with fusion, the trial results were only applicable to a narrowly defined

    subset of patients with single-level degenerative disease, and the type of fusion surgery in the

    trials is no longer widely used due to frequent poor outcomes. Also, all trials had been industry-

    funded, and data on long-term (> 2 years) benefits and harms following artificial disc

    replacement were limited.

    National Institute for Health and Care Excellence

    The National Institute for Health and Care Excellence (2009) updated its guidance on safety and

    efficacy of prosthetic intervertebral disc replacement in the lumbar spine with studies reporting

    13-year follow-up, but with most of the evidence from studies with shorter durations of follow-

    up.21 The Institute concluded that evidence was adequate to support the use of this

    procedure.

  • Page | 7 of 12

    Medicare National Coverage

    Effective for services performed on or after August 14, 2007, Centers for Medicare & Medicaid

    Services (CMS) found that LADR (lumbar artificial disc replacement) is not reasonable and

    necessary for the Medicare population older than 60 years of age; therefore, LADR is non-

    covered for Medicare beneficiaries older than 60 years of age.22 For Medicare beneficiaries 60

    years of age and younger, there is no national coverage determination (NCD), leaving such

    determinations to be made by the local contractors.

    The national coverage determination (NCD) was revised in September 2007 to reflect a change

    from noncoverage for a specific implant (the Charit), to noncoverage for the LADR procedure

    for the Medicare population older than 60 years of age.23 CMS provided this explanation:

    The original NCD for LADR was focused on a specific lumbar artificial disc implant

    (Charit) because it was the only one with FDA approval at that time. In the original

    decision memorandum for LADR, CMS stated that when another lumbar artificial disc

    received FDA approval CMS would reconsider the policy. Subsequently, another lumbar

    artificial disc, ProDisc-L, received FDA approval, which initiated the reconsideration of

    the NCD on LADR. After reviewing the evidence, CMS is convinced that indications for

    the procedure of LADR exclude the populations older than age 60; therefore, the

    revised NCD addresses the procedure of LADR rather than LADR with a specific

    manufacturers implant. 24

    Regulatory Status

    Three artificial lumbar disc devices (activL, Charit, ProDisc-L) have been approved by the

    U.S. Food and Drug Administration (FDA) through the premarket approval process. Because the

    long-term safety and effectiveness of these devices were not known when approved, approval

    was contingent on completion of postmarketing studies. The activL (Aesculap Impant Systems)

    Charit (DePuy), and ProDisc-L (Synthes Spine) devices are indicated for spinal arthroplasty

    in skeletally mature patients with degenerative disc disease (DDD) at 1 level. DDD is defined as

    discogenic back pain with degeneration of the disc confirmed by patient history and

    radiographs. Production under the name Charit was stopped in 2010.

    A number of other artificial lumbar discs are in development or available only outside of the

    United States:

  • Page | 8 of 12

    The INMOTION lumbar artificial disc (DePuy Spine) is a modification of the Charit

    device with a change in name under the same premarket approval. The INMOTION is not

    currently marketed in the United States.

    The Maverick artificial disc (Medtronic) is not marketed in the United States due to patent

    infringement litigation.

    The metal-on-metal FlexiCore artificial disc (Stryker Spine) has completed the

    investigational device exemption trial as part of the FDA process of approval and is currently

    being used under continued access. (Artificial intervertebral discs for treating the cervical

    spine are considered in a separate policy, see Related Policies.)

    Kineflex-L (Spinal Motion) is a 3-piece modular metal-on-metal implant. An FDA advisory

    committee meeting on the Kineflex-L, scheduled for July 2013, was cancelled without

    explanation.

    FDA product code: MJO

    References

    1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial vertebral disc replacement. TEC

    Assessments. 2005;Volume 20:Tab 1.

    2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial lumbar disc replacement. TEC

    Assessments. 2007;Volume 22:Tab 2.

    3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Artificial lumbar disc arthroplasty. TEC Assessments.

    2013;Volume 28:Tab 7.

    4. U.S. Food and Drug Administration. Draft: PRODISC-L Total Disc Replacement package insert. 2005;

    https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010c.pdf. Accessed June 2018.

    5. U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data: PRODISC-L Total Disc Replacement. 2006;

    https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf. Accessed June 2018.

    6. Zigler J, Delamarter R, Spivak JM, et al. Results of the prospective, randomized, multicenter Food and Drug Administration

    investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment

    of 1-level degenerative disc disease. Spine (Phila Pa 1976). May 15 2007;32(11):1155-1162; discussion 1163. PMID 17495770

    7. Zigler JE, Delamarter RB. Five-year results of the prospective, randomized, multicenter, Food and Drug Administration

    investigational device exemption study of the ProDisc-L total disc replacement versus circumferential arthrodesis for the

    treatment of single-level degenerative disc disease. J Neurosurg Spine. Dec 2012;17(6):493-501. PMID 23082846

    8. Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated

    using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. Dec 2012;17(6):504-511.

    PMID 23082849

    https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010c.pdfhttps://www.accessdata.fda.gov/cdrh_docs/pdf5/P050010b.pdf

  • Page | 9 of 12

    9. Hellum C, Johnsen LG, Storheim K, et al. Surgery with disc prosthesis versus rehabilitation in patients with low back pain and

    degenerative disc: two year follow-up of randomised study. BMJ. May 19 2011;342:d2786. PMID 21596740

    10. Hellum C, Berg L, Gjertsen O, et al. Adjacent level degeneration and facet arthropathy after disc prosthesis surgery or

    rehabilitation in patients with chronic low back pain and degenerative disc: second report of a randomized study. Spine (Phila

    Pa 1976). Dec 1 2012;37(25):2063-2073. PMID 22706091

    11. Furunes H, Storheim K, Brox JI, et al. Total disc replacement versus multidisciplinary rehabilitation in patients with chronic low

    back pain and degenerative discs: 8-year follow-up of a randomized controlled multicenter trial. Spine J. Oct 2017;17(10):1480-

    1488. PMID 28583869

    12. Delamarter R, Zigler JE, Balderston RA, et al. Prospective, randomized, multicenter Food and Drug Administration investigational

    device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of

    two-level lumbar degenerative disc disease: results at twenty-four months. J Bone Joint Surg Am. Apr 20 2011;93(8):705-715.

    PMID 21398574

    13. Garcia R, Jr., Yue JJ, Blumenthal S, et al. Lumbar total disc replacement for discogenic low back pain: two-year outcomes of the

    activL multicenter randomized controlled IDE clinical trial. Spine (Phila Pa 1976). Dec 2015;40(24):1873-1881. PMID 26630435

    14. Schoenfeld AJ. Commentary on an article by Rick Delamarter, MD, et al.: "Prospective, randomized, multicenter Food and Drug

    Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential

    arthrodesis for the treatment of two-level degenerative lumbar disc disease. Results at twenty-four months". J Bone Joint Surg

    Am. Apr 20 2011;93(8):e41. PMID 21398573

    15. Siepe CJ, Heider F, Wiechert K, et al. Mid- to long-term results of total lumbar disc replacement: a prospective analysis with 5-

    to 10-year follow-up. Spine J. Aug 1 2014;14(8):1417-1431. PMID 24448028

    16. Laugesen LA, Paulsen RT, Carreon L, et al. Patient-reported Outcomes and Revision Rates at a Mean Follow-up of 10 Years After

    Lumbar Total Disc Replacement. Spine (Phila Pa 1976). Nov 1 2017;42(21):1657-1663. PMID 28368983

    17. Tropiano P, Huang RC, Girardi FP, et al. Lumbar total disc replacement. Seven to eleven-year follow-up. J Bone Joint Surg Am.

    Mar 2005;87(3):490-496. PMID 15741612

    18. North American Spine Society (NASS). NASS coverage policy recommendations: Lumbar Artificial Disc Replacement. 2014;

    https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx. Accessed

    June 2018.

    19. Chou R, Loeser JD, Owens DK, et al. Interventional therapies, surgery, and interdisciplinary rehabilitation for low back pain: an

    evidence-based clinical practice guideline from the American Pain Society. Spine (Phila Pa 1976). May 1 2009;34(10):1066-1077.

    PMID 19363457

    20. Chou R, Baisden J, Carragee EJ, et al. Surgery for low back pain: a review of the evidence for an American Pain Society Clinical

    Practice Guideline. Spine (Phila Pa 1976). May 1 2009;34(10):1094-1109. PMID 19363455

    21. National Institute for Health and Care Excellence (NICE). Prosthetic intervertebral disc replacement in the lumbar spine [IPG306].

    2009; https://www.nice.org.uk/guidance/IPG306. Accessed June 2018.

    22. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) for LUMBAR ARTIFICIAL DISC

    Replacement (LADR) (150.10). 2007; https://www.cms.gov/medicare-coverage-database/details/ncd-

    details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&KeyWordLookU

    p=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&. Accessed June 2018.

    23. Centers for Medicare & Medicaid Services. CMS Manual System: Change request 5727. 2007 September 11

    https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R75NCD.pdf. Accessed March 13, 2018.

    24. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network Matters. 2007;

    http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5727.pdf. Accessed June 2018.

    https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspxhttps://www.nice.org.uk/guidance/IPG306https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&KeyWordLookUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&KeyWordLookUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=lumbar+artificial+disc&KeyWordLookUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5727.pdf

  • Page | 10 of 12

    History

    Date Comments 08/12/03 Add to Surgery Section - New policy. Hold for notification, effective date December 15,

    2003.

    01/01/04 Replace policy - CPT code updates only.

    05/10/05 Replace policy - Policy updated with February 2005 TEC Assessment; references added;

    policy statement unchanged.

    04/21/06 Codes Updated - No other changes

    07/11/06 Replace policy - Policy updated with Medicare noncoverage decision; policy statement

    unchanged; reference added.

    09/12/06 Replace policy - Updated Description and Benefit Application sections to include

    information on FDA approval of ProDisk L. No other changes.

    01/26/07 Codes Updated - No other changes.

    02/26/07 Update Codes - No other changes.

    03/13/07 Replace policy - Title expanded for clarification with the addition of Lumbar Spine;

    cross reference added.

    04/10/07 Cross Reference Update - No other changes.

    08/14/07 Replace policy - Policy updated with 2007 TEC Assessment; new reference added.

    Policy statement unchanged.

    02/12/08 Replace policy - Policy updated with literature review; no change in policy statement.

    References added.

    01/13/09 Replace policy - Policy updated with literature search; no change to the policy

    statement. Rationale section extensively revised references and codes added.

    12/08/09 Replace policy - Policy updated with literature search; no change to the policy

    statement. References added.

    09/14/10 Cross Reference Update - No other changes.

    12/14/10 Replace policy - Policy updated with literature search through August 2010. References

    have been added and reordered; the policy statement remains unchanged.

    12/16/11 Replace policy Policy updated with literature search through August 2011; Rationale

    section revised; references 11 and 14 added and references reordered; policy

    statement unchanged.

    11/27/12 Replace policy - Rationale section revised based on literature review through June

    2012. References 12, 14,19,20,23 29 added; others renumbered. Policy statement

    unchanged.

  • Page | 11 of 12

    Date Comments 01/10/13 Coding update. CPT code 22586, effective 1/1/13, added to policy.

    04/17/13 Update Related Policies Add 7.01.542.

    09/30/13 Update Related Policies. Change title to 7.01.120.

    12/09/13 Replace policy. Rationale section updated. Added references 8,9,11,12,13,23,31,32. No

    change to policy statement. CPT codes 63030 and 63035 removed from policy; these

    do not apply.

    03/25/14 Replace policy. Policy updated with literature search through October, 2013.

    References 12, 16, 17 and 24 added; others renumbered/removed. Policy statement

    unchanged. ICD-9 diagnosis and ICD-10-CM codes removed from the policy; these are

    not utilized in adjudication.

    08/12/14 Update Related Policies. Change title to 7.01.542.

    01/08/15 Update Related Policies. Add 7.01.551.

    06/09/15 Coding update. ICD-10-PCS codes added to support remediation efforts.

    08/11/15 Annual Review. Policy updated with literature review through November 25, 2014;

    references 15, 27-28, and 37 added; policy statement unchanged.

    07/01/16 Annual Review, approved June 14, 2016. Policy updated with literature review through

    February 9, 2016; references 16, 22, 27, 32, and 39-40 added. Removed CPT code

    22586. Policy statement unchanged.

    10/28/16 Coding update. Removed ICD-10 codes from coding section.

    07/01/17 Annual Review, approved June 6, 2017. Policy moved into new format. Policy updated

    with literature review through February 23, 2017; reference 4 added. Discussion of

    artificial discs not available in the United States was removed. Policy statement

    unchanged.

    07/01/18 Annual Review, approved June 22, 2018. Policy updated with literature review through

    February 2018; references 9-11 and 16 added. Policy statement unchanged.

    Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

    Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

    local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

    and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

    booklet or contact a member service representative to determine coverage for a specific medical service or supply.

    CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). 2018 Premera

    All Rights Reserved.

    Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

    determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

    the limits and conditions of the member benefit plan. Members and their providers should consult the member

  • Page | 12 of 12

    benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

    applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

  • 037338 (07-2016)

    Discrimination is Against the Law Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. Premera: Provides free aids and services to people with disabilities to communicate

    effectively with us, such as: Qualified sign language interpreters Written information in other formats (large print, audio, accessible

    electronic formats, other formats) Provides free language services to people whose primary language is not

    English, such as: Qualified interpreters Information written in other languages

    If you need these services, contact the Civil Rights Coordinator. If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email [email protected] You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html. Getting Help in Other Languages This Notice has Important Information. This notice may have important information about your application or coverage through Premera Blue Cross. There may be key dates in this notice. You may need to take action by certain deadlines to keep your health coverage or help with costs. You have the right to get this information and help in your language at no cost. Call 800-722-1471 (TTY: 800-842-5357). (Amharic): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357)

    :(Arabic) .

    Premera Blue Cross. . . . (TTY: 800-842-5357) 1471-722-800

    (Chinese): Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357)

    Oromoo (Cushite): Beeksisni kun odeeffannoo barbaachisaa qaba. Beeksisti kun sagantaa yookan karaa Premera Blue Cross tiin tajaajila keessan ilaalchisee odeeffannoo barbaachisaa qabaachuu dandaa. Guyyaawwan murteessaa taan beeksisa kana keessatti ilaalaa. Tarii kaffaltiidhaan deeggaramuuf yookan tajaajila fayyaa keessaniif guyyaa dhumaa irratti wanti raawwattan jiraachuu dandaa. Kaffaltii irraa bilisa haala taeen afaan keessaniin odeeffannoo argachuu fi deeggarsa argachuuf mirga ni qabaattu. Lakkoofsa bilbilaa 800-722-1471 (TTY: 800-842-5357) tii bilbilaa. Franais (French): Cet avis a d'importantes informations. Cet avis peut avoir d'importantes informations sur votre demande ou la couverture par l'intermdiaire de Premera Blue Cross. Le prsent avis peut contenir des dates cls. Vous devrez peut-tre prendre des mesures par certains dlais pour maintenir votre couverture de sant ou d'aide avec les cots. Vous avez le droit d'obtenir cette information et de laide dans votre langue aucun cot. Appelez le 800-722-1471 (TTY: 800-842-5357). Kreyl ayisyen (Creole): Avi sila a gen Enfmasyon Enptan ladann. Avi sila a kapab genyen enfmasyon enptan konsnan aplikasyon w lan oswa konsnan kouvti asirans lan atrav Premera Blue Cross. Kapab genyen dat ki enptan nan avi sila a. Ou ka gen pou pran kk aksyon avan sten dat limit pou ka kenbe kouvti asirans sante w la oswa pou yo ka ede w avk depans yo. Se dwa w pou resevwa enfmasyon sa a ak asistans nan lang ou pale a, san ou pa gen pou peye pou sa. Rele nan 800-722-1471 (TTY: 800-842-5357). Deutsche (German): Diese Benachrichtigung enthlt wichtige Informationen. Diese Benachrichtigung enthlt unter Umstnden wichtige Informationen bezglich Ihres Antrags auf Krankenversicherungsschutz durch Premera Blue Cross. Suchen Sie nach eventuellen wichtigen Terminen in dieser Benachrichtigung. Sie knnten bis zu bestimmten Stichtagen handeln mssen, um Ihren Krankenversicherungsschutz oder Hilfe mit den Kosten zu behalten. Sie haben das Recht, kostenlose Hilfe und Informationen in Ihrer Sprache zu erhalten. Rufen Sie an unter 800-722-1471 (TTY: 800-842-5357). Hmoob (Hmong): Tsab ntawv tshaj xo no muaj cov ntshiab lus tseem ceeb. Tej zaum tsab ntawv tshaj xo no muaj cov ntsiab lus tseem ceeb txog koj daim ntawv thov kev pab los yog koj qhov kev pab cuam los ntawm Premera Blue Cross. Tej zaum muaj cov hnub tseem ceeb uas sau rau hauv daim ntawv no. Tej zaum koj kuj yuav tau ua qee yam uas peb kom koj ua tsis pub dhau cov caij nyoog uas teev tseg rau hauv daim ntawv no mas koj thiaj yuav tau txais kev pab cuam kho mob los yog kev pab them tej nqi kho mob ntawd. Koj muaj cai kom lawv muab cov ntshiab lus no uas tau muab sau ua koj hom lus pub dawb rau koj. Hu rau 800-722-1471 (TTY: 800-842-5357). Iloko (Ilocano): Daytoy a Pakdaar ket naglaon iti Napateg nga Impormasion. Daytoy a pakdaar mabalin nga adda ket naglaon iti napateg nga impormasion maipanggep iti apliksayonyo wenno coverage babaen iti Premera Blue Cross. Daytoy ket mabalin dagiti importante a petsa iti daytoy a pakdaar. Mabalin nga adda rumbeng nga aramidenyo nga addang sakbay dagiti partikular a naituding nga aldaw tapno mapagtalinaedyo ti coverage ti salun-atyo wenno tulong kadagiti gastos. Adda karbenganyo a mangala iti daytoy nga impormasion ken tulong iti bukodyo a pagsasao nga awan ti bayadanyo. Tumawag iti numero nga 800-722-1471 (TTY: 800-842-5357). Italiano (Italian): Questo avviso contiene informazioni importanti. Questo avviso pu contenere informazioni importanti sulla tua domanda o copertura attraverso Premera Blue Cross. Potrebbero esserci date chiave in questo avviso. Potrebbe essere necessario un tuo intervento entro una scadenza determinata per consentirti di mantenere la tua copertura o sovvenzione. Hai il diritto di ottenere queste informazioni e assistenza nella tua lingua gratuitamente. Chiama 800-722-1471 (TTY: 800-842-5357).

  • (Japanese): Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357) (Korean): . Premera Blue Cross . . . . 800-722-1471 (TTY: 800-842-5357) . (Lao): . Premera Blue Cross. . . . 800-722-1471 (TTY: 800-842-5357). (Khmer):

    Premera Blue Cross

    800-722-1471 (TTY: 800-842-5357) (Punjabi): . Premera Blue Cross . . , , 800-722-1471 (TTY: 800-842-5357).

    :(Farsi) .

    . Premera Blue Cross .

    . .

    )800-842-5357 TTY( 800-722-1471 .

    Polskie (Polish): To ogoszenie moe zawiera wane informacje. To ogoszenie moe zawiera wane informacje odnonie Pastwa wniosku lub zakresu wiadcze poprzez Premera Blue Cross. Prosimy zwrcic uwag na kluczowe daty, ktre mog by zawarte w tym ogoszeniu aby nie przekroczy terminw w przypadku utrzymania polisy ubezpieczeniowej lub pomocy zwizanej z kosztami. Macie Pastwo prawo do bezpatnej informacji we wasnym jzyku. Zadzwocie pod 800-722-1471 (TTY: 800-842-5357). Portugus (Portuguese): Este aviso contm informaes importantes. Este aviso poder conter informaes importantes a respeito de sua aplicao ou cobertura por meio do Premera Blue Cross. Podero existir datas importantes neste aviso. Talvez seja necessrio que voc tome providncias dentro de determinados prazos para manter sua cobertura de sade ou ajuda de custos. Voc tem o direito de obter esta informao e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

    Romn (Romanian): Prezenta notificare conine informaii importante. Aceast notificare poate conine informaii importante privind cererea sau acoperirea asigurrii dumneavoastre de sntate prin Premera Blue Cross. Pot exista date cheie n aceast notificare. Este posibil s fie nevoie s acionai pn la anumite termene limit pentru a v menine acoperirea asigurrii de sntate sau asistena privitoare la costuri. Avei dreptul de a obine gratuit aceste informaii i ajutor n limba dumneavoastr. Sunai la 800-722-1471 (TTY: 800-842-5357). P (Russian): . Premera Blue Cross. . , , . . 800-722-1471 (TTY: 800-842-5357). Faasamoa (Samoan): Atonu ua iai i lenei faasilasilaga ni faamatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei faasilasilaga o se fesoasoani e faamatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Faamolemole, ia e iloilo faalelei i aso faapitoa oloo iai i lenei faasilasilaga taua. Masalo o lea iai ni feau e tatau ona e faia ao lei aulia le aso ua taua i lenei faasilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo oloo e iai i ai. Oloo iai iate oe le aia tatau e maua atu i lenei faasilasilaga ma lenei famatalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357). Espaol (Spanish): Este Aviso contiene informacin importante. Es posible que este aviso contenga informacin importante acerca de su solicitud o cobertura a travs de Premera Blue Cross. Es posible que haya fechas clave en este aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura mdica o ayuda con los costos. Usted tiene derecho a recibir esta informacin y ayuda en su idioma sin costo alguno. Llame al 800-722-1471 (TTY: 800-842-5357). Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357). (Thai): Premera Blue Cross 800-722-1471 (TTY: 800-842-5357) (Ukrainian): . Premera Blue Cross. , . , , . . 800-722-1471 (TTY: 800-842-5357). Ting Vit (Vietnamese): Thng bo ny cung cp thng tin quan trng. Thng bo ny c thng tin quan trng v n xin tham gia hoc hp ng bo him ca qu v qua chng trnh Premera Blue Cross. Xin xem ngy quan trng trong thng bo ny. Qu v c th phi thc hin theo thng bo ng trong thi hn duy tr bo him sc khe hoc c tr gip thm v chi ph. Qu v c quyn c bit thng tin ny v c tr gip bng ngn ng ca mnh min ph. Xin gi s 800-722-1471 (TTY: 800-842-5357).