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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Surgery
Policy Number:051
Effective Date: 02/24/2017
Original Policy Date:02/27/2004
Last Review Date:05/12/2020
Date Published to Web: 08/02/2016
Subject:
Artificial Intervertebral Disc: Lumbar Spine

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

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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 leading to disabling symptoms.

PopulationsInterventionsComparatorsOutcomes
Individuals:
    • With lumbar degenerative disc disease
Interventions of interest are:
    • Lumbar artificial intervertebral disc
Comparators of interest are:
    • Conservative therapy
    • Lumbar spinal fusion
Relevant outcomes include:
    • Symptoms
    • Functional outcomes
    • Quality of life
    • Treatment-related morbidity

BACKGROUND

The most frequent cause of back pain requiring surgery, degenerative disc disease is common with age or trauma. Spine imaging, such as magnetic resonance imaging (MRI), computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread but for most people does not cause symptoms. Potential candidates for artificial disc replacement have chronic low back pain attributed to degenerative disc disease, lack of improvement with nonoperative treatment, and none of the contraindications for the procedure, which include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. Patients who require procedures in addition to fusion (eg, laminectomy, decompression) are not candidates for the artificial disc.

When conservative treatment of degenerative disc disease 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 degenerative disc disease and in part due to the success 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 and normal biomechanics of the adjacent vertebrae.

Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include 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, pseudotumor formation).

Regulatory Status

Three artificial lumbar disc devices (activL®, Charité®, ProDisc®-L) have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (Table 1). Production under the name Charité® was stopped in 2010 and the device was withdrawn in 2012

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 Implant Systems), Charité® (DePuy), and ProDisc®-L (Synthes Spine) devices are indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at 1 level. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs.

Table 1. U.S. Food and Drug Administration-Approved Lumbar Artificial Disc Devices

DeviceManufacturerIndicationPMA NumberApproval Date
activLAesculap Implant Systems, LLCThe activL® Artificial Disc (activL) is indicated for reconstruction of the disc at one level (L4-L5 or L5-S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Artificial Disc should have failed at least six months of nonoperative treatment prior to implantation of the device.P12002406/11/2015
ProDisc-LSynthes SpineThe PRODISC®-L Total Disc Replacement is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the PRODISC®-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the PRODISC®-L Total Disc Replacement.P0500108/25/2006
ChariteDepuy Spine, IncThe CHARITE Artificial Disc is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S I. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the CHARITE Artificial Disc should have failed at least six months of conservative treatment prior to implantation of the CHARITE Artificial Disc.P04000610/26/2004
Withdrawn 1/5/2012

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

    • The INMOTION® lumbar artificial disc (DePuy Spine) is a modification of the Charité® 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 approval process and is currently being used under continued access.
    • Kineflex-L™ (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L, scheduled in 2013, but was canceled without explanation.
FDA product code: MJO.

Related Policies

  • Artificial Intervertebral Disc: Cervical Spine (Policy #072 in the Surgery Section)
  • Lumbar Spinal Fusion (Policy #073 in the Surgery Section)

Policy:
(NOTE: Horizon Blue Cross Blue Shield of New Jersey collaborates with eviCore healthcare to conduct Prior Authorization and Medical Necessity Determination for certain Spine Surgery services (the "Program") for members enrolled in Horizon BCBSNJ fully insured products as well as ASO accounts that have elected the Program. The guidelines included in this policy apply to members enrolled in plans that have NOT elected to participate in the Program.

To access guidelines that apply to members enrolled in plans that HAVE elected the Program, please visit

NOTE: For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

1. The use of an FDA-approved lumbar artificial intervertebral disc (e.g., Charité®, ProDisc®-L, activL®) in the treatment of degenerative disc disease (DDD) is considered medically necessary in members who (all criteria must be met):

    • are skeletally mature;
    • have degenerative disc disease (DDD) at one level in the lumbar spine at either L4-L5 or L5-S1 for the Charité® and activL®; L-3-L4, L4-L5, or L5-S1 for the ProDisc®-L;
    • have degenerative disc disease (DDD) confirmed by member history and radiographic studies (i.e., MR imaging and provocative discography);
    • have no more than 3 mm of spondylolisthesis at the involved level for Charité® or no more than Grade I spondylolisthesis for ProDisc®-L, and activL®;
    • have had no relief from pain after at least six months of conservative/non-operative treatment (e.g., physical therapy, facet joint injections, epidural steroids, ultrasound, manipulation, anti-inflammatory medications, analgesic medications, muscle relaxants, lumbosacral stabilization therapy); and
    • do not have a contraindication to disc arthroplasty including, but not limited to, any of the following:
        - active systemic infection or infection localized to the site of implantation,
        - osteoporosis,
        - osteopenia,
        - bony lumbar stenosis,
        - allergy or sensitivity to implant materials (e.g., cobalt, chromium, titanium, polyethylene),
        - isolated radicular compression syndromes, especially to disc herniation, or
        - pars defect
        - involved vertebral endplate that is dimensionally smaller than 34.5 mm in the medial-lateral and/or 27 mm in the anterial-posterior directions (for ProDisc®-L), and involved vertebral endplate that is dimensionally smaller than 31 mm in the medical-lateral and/or 26 mm in the anterior-posterior directions (for activL®)
        - clinically compromised vertebral bodies at the affected level due to current or past trauma (for ProDisc®-L, and activL®).
    [INFORMATIONAL NOTE: The above-mentioned criteria are based on the FDA-approved indications for the Charité®, ProDisc®-L, and activL® and the study protocols used in the multi-center clinical trials that served as the basis for the FDA approval.]
    2. The off-label use of Charité®, ProDisc®-L, or activL® including, but not limited to, any of the following is considered investigational:
      • use at more than one level
      • use at a spinal level(s) other than L4-L5 or L5-S1 for Charité® and activL®, or other than L3-L4, L4-L5, or L5-S1 for ProDisc®-L
      • use in members with prior thoracic or lumbar spinal fusion.
      3. The use of any non-FDA-approved lumbar artificial intervertebral disc (e.g., FlexiCore, Maverick, Kineflex-L, INMOTION) for spinal arthroplasty is considered investigational.


      Medicare Coverage:
      Per NCD 150.10, lumbar artificial disc replacement (LADR) is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR is non-covered for Medicare beneficiaries over 60 years of age. CMS left the determination of coverage regarding LADR for Medicare beneficiaries under 60 years of age to the local Medicare Administrative Contractors.

      Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination on lumbar artificial disc replacement (LADR) for individuals 60 years of age or younger. Individual consideration will be given to Medicare Advantage members 60 years of age and under to determine if LADR is reasonable and necessary under the circumstances.

      For additional information, refer to National Coverage Determination (NCD) for Lumbar Artificial Disc Replacement (LADR) (150.10). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.


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

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


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      Horizon BCBSNJ Medical Policy Development Process:

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

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      Index:
      Artificial Intervertebral Disc: Lumbar Spine
      Lumbar Total Disc Arthroplasty
      Total Disc Replacement with Artificial Intervertebral Disc
      ProDisc Device, Artificial Intervertebral Disc
      SB Charite Device, Artificial Intervertebral Disc
      Spine Arthroplasty
      Charite Artificial Disc
      FlexiCore
      Kineflex-L
      Maverick
      ProDisc -L
      INMOTION Lumbar Artificial Disc
      Maverick Artificial Disc
      Activ-L

      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 March 9, 2020.

      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 March 9, 2020.

      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

      9. 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

      10. 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

      11. 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

      12. 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

      13. 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

      14. 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

      15. Yue JJ, Garcia R, Blumenthal S et al. Five-year Results of a Randomized Controlled Trial for Lumbar Artificial Discs in Single-level Degenerative Disc Disease. Spine. 2019 Dec;44(24). PMID 31404055

      16. 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

      17. 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

      18. 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

      19. North American Spine Society (NASS). NASS coverage policy recommendations: Lumbar Artificial Disc Replacement. 2019; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations. Accessed March 9, 2020.

      20. 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

      21. 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

      22. 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 March 9, 2020.

      23. 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&KeyWordLo okUp=Title&KeyWordSearchType=And&id=170&bc=gAAAABAAAAAA&. Accessed March 9, 2020.

      24. 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 9, 2020.

      25. Centers for Medicare & Medicaid Services (CMS). Medicare Learning Network Matters. 2007; http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM5727.pdf. Accessed March 9, 2020.


      Codes:
      (The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

      CPT*
        22857
        22862
        22865
        0163T
        0164T
        0165T
      HCPCS

      * CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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

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

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