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Artificial Intervertebral Disc

Policy Number: MP-150

Latest Review Date: May 2022

Category:  Surgery                                                               

 

POLICY:

FDA approved cervical artificial intervertebral disc in adults may be considered medically necessary when:

  1. Cervical degenerative disc disease is from C3-C7; AND
  2. Clinical record documents cervical radiculopathy and/or myelopathy; AND
  3. Patients have failed at least six weeks of conservative therapy,* AND

 

*Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in therapeutic physical medicine modality(ies) and/or manipulations when rendered by an eligible provider (including active exercise).

Simultaneous cervical artificial intervertebral disc implantation at a second contiguous level may be considered medically necessary when the above criteria are met for each disc level, and the device is FDA-approved for 2 levels.

Subsequent cervical artificial intervertebral disc implantation at an adjacent level may be considered medically necessary when all of the following are met:

  1. Criteria 1 to 3 above are met; AND
  2. The device is FDA-approved for 2 levels; AND
  3. The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
  4. Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.

Cervical artificial intervertebral disc is considered investigational for all other indications, including but not limited to the following:

  • In patients with isolated axial neck pain without cervical radiculopathy or myelopathy; OR
  • When requested adjacent to a prior fusion; OR
  • Used as part of a hybrid fusion*: OR
  • When more than two levels are being requested, OR
  • Patient has had a prior surgical procedure at the treated cervical level, OR
  • Anatomical deformity (e.g., ankylosing spondylitis), OR
  • Rheumatoid arthritis or other autoimmune disease, OR
  • Presence of facet arthritis, OR
  • Active Infection, OR
  • Metabolic bone disease (e.g., osteoporosis, osteopenia, osteomalacia), OR
  • Malignancy.

*Hybrid fusion procedure involves the combination of a traditional anterior cervical decompression and fusion (ACDF) and artificial disc replacement.

 

Lumbar artificial intervertebral disc is considered investigational for any indication.

 

Thoracic artificial intervertebral disc is considered investigational for any indication.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Cervical Artificial Disc

Several prosthetic devices are currently available for artificial intervertebral disc arthroplasty (AIDA) of the cervical spine. AIDA is proposed as an alternative to anterior cervical discectomy and fusion (ACDF) for patients with symptomatic cervical degenerative disc disease (DDD).

 

Cervical degenerative disc disease (DDD) is a manifestation of spinal spondylosis that causes deterioration of the intervertebral discs of the cervical spine. Symptoms of cervical DDD include arm pain, weakness, and paresthesias associated with cervical radiculopathy. Disc herniation, osteophytes, kyphosis, or instability that compress the spinal cord can result in myelopathy, which is manifested by subtle changes in gait or balance, and in severe cases leads to weakness in the arms or legs, and numbness of the arms or hands. The prevalence of DDD secondary to cervical spondylosis increases with age. An estimated 60% of individuals older than 40 years have radiographic evidence of cervical DDD. By age 65, some 95% of men and 70% of women have at least one degenerative change evident at radiographic examination. It is estimated that approximately 5 million adults in the United States are disabled to an extent by spine-related disorders, although only a small fraction of those are clear candidates for spinal surgery.

 

Treatment

Cervical degenerative disc disease is initially treated conservatively using noninvasive measures (e.g., rest, heat, ice, analgesics, anti-inflammatory agents, exercise). Surgical intervention may be indicated if symptoms do not improve or resolve after 6 or more weeks, or if they progress. Candidates for surgical intervention have chronic pain or neurologic symptoms secondary to cervical DDD and no contraindications for the procedure.

Anterior cervical discectomy and fusion (ACDF) has historically been considered the definitive surgical treatment for symptomatic DDD of the cervical spine. The goals of ACDF are to relieve pressure on the spinal nerves (decompression) and to restore spinal column alignment and stability. Resolution of pain and neurologic symptoms may be expected in 80% to 100% of ACDF patients. ACDF involves an anterolateral surgical approach, decompression of the affected spinal level, discectomy, and placement of a PEEK (polyetheretherketone) or titanium interbody cage plus autograft or allograft bone in the prepared intervertebral space to stimulate healing and eventual fusion between the vertebral endplates. A metal anterior cervical plate is attached to the adjoining vertebral bodies to stabilize the fusion site, maintain neck lordosis, and reduce the need for prolonged postoperative brace application that is needed following ACDF without an anterior plate. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies demonstrate similar rates of postoperative fusion (90%-100%) and satisfactory outcomes for single-level, anterior-plated ACDF, using either bone source. Studies have suggested that altered adjacent segment kinematics following fusion may lead to adjacent-level DDD and need for secondary surgery.

Artificial intervertebral disc arthroplasty (AIDA) is proposed as an alternative to ACDF for patients with symptomatic cervical DDD. In AIDA, an artificial disc device is secured in the prepared intervertebral space rather than an interbody cage and/or bone. An anterior plate is not placed to stabilize the adjacent vertebrae, and postsurgical external orthosis is usually not required. It is hypothesized that AIDA will maintain anatomical disk space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels. The potential to reduce the risk of adjacent-level DDD above or below a fusion site has been the major rationale driving device development and use. Disc arthroplasty and ACDF for single-level disease have very similar surgical indications, primarily unremitting pain due to radiculopathy or myelopathy, weakness in the extremities, or paresthesia. However, the chief complaint in AIDA candidates should be radicular or myelopathic symptoms in the absence of significant spondylosis or spondylolisthesis. 

Lumbar Artificial Disc

Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to fusion in patients with degenerative disc disease leading to disabling symptoms.

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, the outcomes of spinal fusion have been controversial over the years, 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 of the procedure itself. In addition, spinal fusion alters the biomechanics of the back, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, a variety of 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 to maintain 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 none of the contraindications for the procedure, which include multilevel disease, spinal stenosis, or 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 in addition to fusion, such as laminectomy and/or decompression, 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. These 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, and pseudotumor formation).

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent literature review was performed through March 7, 2022. 

Summary of Evidence

Cervical Artificial Disc

For individuals who have cervical radicular pain or myelopathy who receive single-level AIDA, the evidence includes randomized controlled trials and meta-analyses of randomized controlled trials. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. At two-year follow-up, trials of all artificial cervical discs met noninferiority criteria compared to ACDF. Mid-term outcomes have been reported on five devices (Prestige ST, ProDisc-C, Bryan, Mobi-C, PCM [Porous Coated Motion]). At four to five years, the trial results have been consistent with the continued noninferiority of AIDA for clinical outcomes and lower cumulative reoperation rates. Seven-year follow-up of the Prestige and ProDisc-C pivotal trials continue to show lower secondary surgery rates, although this is not a consistent finding in other reports. Serious adverse events appear to be uncommon. Heterotopic ossification can occur in a substantial proportion of spinal segments with artificial intervertebral discs but does not appear to lead to a decline in clinical outcomes. The evidence to date shows outcomes that are at least as good as the standard treatment of ACDF. There have been no safety signals with discs approved by the Food and Drug Administration for single-level AIDA. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have cervical radicular pain or myelopathy who receive 2-level AIDA of the cervical spine, the evidence includes RCTs. The relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. FDA approval for the Prestige LP was based on superiority to 2-level ACDF in overall success at 2 years. The increase in overall success rates at 2 years has been maintained for those patients who have reached the 10-year follow-up. At 2- and 4-year follow-ups, the first artificial cervical disc approved for two levels (Mobi-C) was found to be superior to ACDF for NDI scores, NDI success rates, reoperation rates, and overall success composite outcome. At five years, trial results were consistent with the continued superiority of 2-level AIDA for clinical outcomes and lower cumulative reoperation rates. Adjacent-segment degeneration with Mobi-C was found in a significantly lower percentage of patients compared with 2-level ACDF patients. Based on this evidence, it can be concluded that 2-level AIDA with either of these FDA-approved discs is at least as beneficial as the established alternative. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

Lumbar Artificial Disc

For individuals who have lumbar degenerative disc disease who receive a lumbar artificial intervertebral disc, the evidence includes randomized controlled trials (RCTs) of artificial discs versus fusion 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 compared to spinal fusion. 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 (e.g., 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 long-term complications with these implants will emerge. Although some randomized trials have concluded that this technology is noninferior to spinal fusion, outcomes that would make noninferiority sufficient to demonstrate the clinical benefit of the artificial lumbar disc have not been established. No RCTs compared ActivL to spinal fusion or conservative care. RCTs were limited by a lack of blinding, insufficient followup to evaluate potential harms, and lack of comparison to the criterion standard for treatment of DDD. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

North American Spine Society (NASS)

The 2015 guidelines from the North American Spine Society state that:

“Cervical artificial disc replacement (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following diagnoses with qualifying criteria, when appropriate:

  1. Radiculopathy related to nerve root compression from one or 2-level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or nonoperative management.
  2. Myelopathy or myeloradiculopathy related to central spinal stenosis from one or 2-level degenerative disc disease from C3-4 to C6-7 with or without neck pain.”

The North American Spine Society (2019) issued coverage recommendations for lumbar artificial disc replacement. The following recommendation was made:

Lumbar Artificial Disc Replacement is indicated for patients with discogenic low back pain who meet ALL of the following criteria

  1. Symptomatic single level lumbar disc disease at L3-L4, L4-L5 or L5-S1 level
  2. Presence of symptoms for at least 6 months or greater and that are not responsive to multi-modal nonoperative treatment over that period that should include a physical therapy/rehabilitation program but may also include (but not limited to) pain management, injections, cognitive behavior therapy, and active exercise programs
  3. Any underlying psychiatric disorder, such as depression, should be diagnosed and the management optimized prior to surgical intervention
  4. Primary complaint of axial pain, with a possible secondary complaint of lower extremity pain

Lumbar Disc Arthroplasty is NOT indicated in ANY of the following scenarios:

  1. Any case that does not fulfill ALL of the above criteria
  2. Presence of symptomatic degenerative disk disease at more than one level
  3. Presence of spinal instability with spondylolisthesis greater than Grade I
  4. Chronic radiculopathy (unremitting pain with predominance of leg pain symptoms greater than back pain symptoms extending over a period of at least one year)
  5. Osteopenia as evidenced by a DEXA bone mineral density T-score less than or equal to -1.0
  6. Poorly managed psychiatric disorder
  7. Significant facet arthropathy at the index level 8. 
  8. Age greater than 60 years or less than 18 years
  9. Presence of infection or tumor

 

National Institute for Health and Care Excellence (NICE)

The United Kingdom’s National Institute for Health and Care Excellence (NICE) issued guidance on the artificial cervical disc in 2010. NICE concluded that:

“Current evidence on the efficacy of prosthetic intervertebral disc replacement in the cervical spine shows that this procedure is as least as efficacious as fusion in the short term and may result in a reduced need for revision surgery in the long term. The evidence raises no particular safety issues that are not already known in relation to fusion procedures. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

This procedure should only be carried out in specialist units where surgery of the cervical spine is undertaken regularly.

NICE encourages further research into prosthetic intervertebral disc replacement in the cervical spine. Research outcomes should include long-term data on preservation of mobility, occurrence of adjacent segment disease and the avoidance of revision surgery.”

The National Institute for Health and Care Excellence (2009) updated its guidance on the 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.” The Institute concluded that evidence was “adequate to support the use of this procedure.”

American Association of Neurological Surgeons

The 2009 guidelines from the American Association of Neurological Surgeons address anterior cervical discectomy and anterior cervical discectomy and fusion for the treatment of cervical degenerative radiculopathy and cervical spondylotic myelopathy. These guidelines do not address the artificial cervical disc.

American Pain Society

In 2009, the American Pain Society’s (APS) practice guidelines provided a recommendation of “insufficient evidence” to adequately evaluate long-term benefits and harms of vertebral disc replacement. The guideline was based on a systematic review commissioned by APS and conducted by the Oregon Evidence-Based Practice Center. The rationale for the recommendation was that although artificial disc replacement has been associated with similar outcomes compared to 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. In addition, all trials had been industry-funded, and data on long-term (beyond 2 years) benefits and harms following artificial disc replacement were limited.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Degenerative disc disease, spinal fusion, artificial intervertebral disc arthroplasty (AIDA), total disc replacement, spinal arthroplasty, SB Charite III, ProDisc, Maverick™, Prestige ST Cervical Disc, Bryan Cervical Disc, ProDisc-L, ProDisc-C, PCM Cervical disc, Mobi-C, Secure-C, activ-L™ (Aesculap), INMOTION® lumbar artificial disc, Prestige LP, CDA, cervical disc arthroplasty, Simplify

APPROVED BY GOVERNING BODIES:

Cervical Artificial Disc

The Prestige® ST Cervical Disc (Medtronic) received U.S. Food and Drug Administration (FDA) premarket application (PMA) approval as a Class III device on July 16, 2007. The Prestige ST Cervical Disc is composed of stainless steel and is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy. The device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should be present, with at least 1 of the following items producing symptomatic nerve root and/or spinal cord compression as documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurologic deficit) and radiographic studies (e.g., computed tomography [CT], magnetic resonance imaging [MRI], x-rays): herniated disc and/or osteophyte formation. FDA has required the Prestige disc manufacturer to conduct a 7-year post-approval clinical study of the safety and function of the device and a 5-year enhanced surveillance study of the disc to more fully characterize adverse events in a broader patient population.

In 2014, the Prestige® LP artificial cervical disc (Medtronic Sofamor Danek) was approved by FDA through the PMA process. The Prestige® LP differs from the original Prestige cervical disc in terms of material and fixation. The LP implant is composed of a proprietary titanium-ceramic composite and has 2 rails that press-fit into holes created during the surgical procedure. In 2016, the Prestige® LP was approved by FDA for 2 adjacent levels. A postapproval study will follow the investigational device exemption (IDE) patients who received the Prestige® LP at 2 contiguous levels for 10 years. Medtronic will also submit to FDA adverse events, device failures, and complaint analysis for 10 years. This includes subsequent surgeries, heterotopic ossification, device malfunction, and other serious device-related complications.

Another disc arthroplasty product, the ProDisc-C® (Synthes Spine), was approved by the FDA through the premarket approval process in 2007. As with the Prestige ST Cervical Disc, the FDA approval of ProDisc-C was made conditional on the 7 year follow-up of the 209 subjects included in the non-inferiority trial, 7 year follow-up of 99 continued-access subjects, and a 5 year enhanced surveillance study to characterize more fully adverse events when the device is used under general conditions of use. The ProDisc-C Vivo is currently marketed by Centinal Spine.

 

More recently, continued FDA approval requires the completion of 2 postapproval studies. One study provides extended follow-up of the premarket pivotal cohort out to 7 years. The second study provides 10 year enhanced surveillance of adverse event data. Continued approval is contingent on the submission of annual reports, which include the number of devices sold, heterotopic ossification, device malfunction, device removal, other serious device-related complications, and analysis of all explanted discs.

 

Cervical Disc Prostheses Approved for use in the United States

Prosthesis

Manufacturer

Characteristics

FDA Approval

Year

Prestige® ST

Medtronic

Stainless Steel

P060018

2007

ProDisc-C®

Centinal Spine

Two metal (cobalt-chromium alloy) endplates and a polyethylene insert

P070001

2007

Bryan® Cervical Disc

Medtronic Sofamor Danek

2 titanium-alloy shells encasing a polyurethane nucleus

P060023

2009

PCM [porous-coated motion] Cervical Disc®

NuVasive

PCM® is a semi-constrained device consisting of two metal (cobalt-chromium alloy) endplates and a polyethylene insert.

P100012

2013

SECURE®-C

Globus Medical

Semi-constrained device with two metal (cobalt-chromium molybdenum alloy) endplates and a polyethylene insert.

P100003

2012

Mobi-C®

Zimmer Biomet (previously LDR Spine)

Semi-constrained device with metal (cobalt-chromium alloy) endplates and a polyethylene insert. Approved for both 1 and 2- levels

P110002/P110009

2013

Prestige LP™

Medtronic Sofamor Danek

Titanium-ceramic composite with a metal-on-metal bearing. Approved for both 1- and 2-levels

P090029

2014/2016

M6®-C

Orthofix (previously Spinal Kinetics)

Ultra-high molecular weight polyethylene weaved fiber creating a matrix (artificial annulus) within a sheath and titanium alloy endplates

P170036

2019

Simplify® Cervical Artificial Disc

NuVasive (previously Simplify Medical)

PEEK endplates and a mobile ceramic core. MRI compatible

P200022

2020

Lumbar Artificial Disc

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. 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, 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 (DDD) at 1 level. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs. The activL device is approved for use at 1 level. Initial approval for ProDiscL was also limited to patients with disease at 1 level. In April 2020, the ProDiscL indication was expanded to include patients with disease at up to 2 consecutive levels.

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

Device

Manufacturer

Indication

PMA Number

Approval Date

 

activL

 

Aesculap Implant Systems, LLC

The 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.

 

P120024

 

06/11/2015

 

ProdiscL

 

Synthes Spine

The 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.

 

P050010

 

8/25/2006

 

Charite

 

Depuy Spine, Inc

The 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.

 

P040006

 

10/26/2004

 

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 cancelled without explanation.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING:

CPT:

0095T

Removal of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical (list separately in addition to code for primary procedure)

0098T

Revision including replacement of total disc cervical arthroplasty, (artificial disc), anterior approach; each additional interspace, cervical (list separately in addition to code for primary procedure)

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, (artificial disc), anterior approach, each additional interspace, lumbar (list separately in addition to code for primary procedure)

0719T Posterior vertebral joint replacement, including bilateral facetectomy, laminectomy, and radical discectomy, including imaging guidance, lumbar spine, single segment (Efffective 07/01/22)

22856

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical

22857

Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace; lumbar

22858

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (List separately in addition to code for primary procedure)

22860 Total disc arthroplasty, anterior approach, including discectomy; second lumbar interspace (Effective 01/01/23)

22861

Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical

22862

                        ; lumbar

22864

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

22865

Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), single interspace, lumbar

22899

Unlisted procedure, spine

PREVIOUS CODING:

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) (deleted effective 12/31/22)

REFERENCES:

  1. Bae HW, Kim KD, Nunley PD, et al. Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine (Phila Pa 1976). Jun 01 2015; 40(11): 759-66.
  2. Burkus JK, Haid RW, Traynelis VC, et al. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. Sep 2010; 13(3): 308-18.
  3. Burkus JK, Traynelis VC, Haid RW, et al. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. Oct 2014; 21(4): 516-28.
  4. Chen J, Wang X, Bai W, et al. Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis. Eur Spine J. Apr 2012; 21(4): 674-80.
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  7. Coric D, Kim PK, Clemente JD, et al. Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site. J Neurosurg Spine. Jan 2013; 18(1): 36-42.
  8. Davis RJ, Kim KD, Hisey MS, et al. Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial: clinical article. J Neurosurg Spine. Nov 2013; 19(5): 532-45.
  9. Davis RJ, Nunley PD, Kim KD, et al. Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results. J Neurosurg Spine. Jan 2015; 22(1): 15-25.
  10. Delamarter RB, Murrey D, Janssen ME, et al. Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS J. 2010; 4(4): 122-8.
  11. Delamarter RB, Zigler J. Five-year reoperation rates, cervical total disc replacement versus fusion, results of a prospective randomized clinical trial. Spine (Phila Pa 1976). Apr 20 2013; 38(9): 711-7.
  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): 705-15.
  13. Deng Y, Li G, Liu H, et al. Mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement compared with anterior cervical discectomy and fusion: a meta-analysis of prospective randomized clinical trials. J Orthop Surg Res. Oct 12 2020; 15(1): 468.
  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.
  15. Garcia R, 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): 1873-81.
  16. Gornet MF, Burkus JK, Shaffrey ME, et al. Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. J Neurosurg Spine. Nov 2015; 23(5): 558-573.
  17. Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. Jun 21 2019: 1-11.
  18. Heller JG, Sasso RC, Papadopoulos SM, et al. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). Jan 15 2009; 34(2): 101-7.
  19. 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 01 2012; 37(25): 2063-73.
  20. 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.
  21. Hisey MS, Bae HW, Davis R, et al. Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. Int J Spine Surg. 2014; 8.
  22. Hisey MS, Bae HW, Davis RJ, et al. Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up. J Spinal Disord Tech. May 2015; 28(4): E237-43.
  23. Hisey MS, Zigler JE, Jackson R, et al. Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up. Int J Spine Surg. 2016; 10: 10.
  24. Hu Y, Lv G, Ren S, et al. Mid- to Long-Term Outcomes of Cervical Disc Arthroplasty versus Anterior Cervical Discectomy and Fusion for Treatment of Symptomatic Cervical Disc Disease: A Systematic Review and Meta-Analysis of Eight Prospective Randomized Controlled Trials. PLoS One. 2016; 11(2): e0149312.
  25. Huppert J, Beaurain J, Steib JP, et al. Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J. Sep 2011; 20(9): 1417-26.
  26. Janssen ME, Zigler JE, Spivak JM, et al. ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study. J Bone Joint Surg Am. Nov 04 2015; 97(21): 1738-47.
  27. Latka D, Kozlowska K, Miekisiak G, et al. Safety and efficacy of cervical disc arthroplasty in preventing the adjacent segment disease: a meta-analysis of mid- to long-term outcomes in prospective, randomized, controlled multicenter studies. Ther Clin Risk Manag. 2019; 15: 531-539.
  28. Lavelle WF, Riew KD, Levi AD, et al. Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial. Spine (Phila Pa 1976). May 01 2019; 44(9): 601-608.
  29. 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 01 2017; 42(21): 1657-1663.  
  30. MacDowall A, Skeppholm M, Lindhagen L, et al. Artificial disc replacement versus fusion in patients with cervical degenerative disc disease with radiculopathy: 5-year outcomes from the National Swedish Spine Register. J Neurosurg Spine. Nov 02 2018; 30(2): 159-167.
  31. Mummaneni PV, Burkus JK, Haid RW, et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. Mar 2007; 6(3): 198-209.
  32. Murrey D, Janssen M, Delamarter R, et al. Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J. Apr 2009; 9(4): 275-86.
  33. National Institute for Health and Care Excellence (NICE). Prosthetic intervertebral disc replacement in the cervical spine [IPG341]. 2010; https://www.nice.org.uk/guidance/ipg341.  
  34. 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.  
  35. North American Spine Society. NASS coverage policy recommendations: Cervical artificial disc replacement. 2015; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx.  .
  36. North American Spine Society (NASS). NASS coverage policy recommendations: Lumbar Artificial Disc Replacement. 2019; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.  
  37. Nunley PD, Cavanaugh DA, Kerr EJ, et al. Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years-Prevalence, Progression, Clinical Implications, and Risk Factors. Int J Spine Surg. Jun 2018; 12(3): 352-361.
  38. Phillips FM, Coric D, Sasso R, et al. Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study. Spine J. Feb 2021; 21(2): 239-252.
  39. Phillips FM, Geisler FH, Gilder KM, et al. Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion. Spine (Phila Pa 1976). May 15 2015; 40(10): 674-83.
  40. Phillips FM, Lee JY, Geisler FH, et al. A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. 2-year results from the US FDA IDE clinical trial. Spine (Phila Pa 1976). Jul 01 2013; 38(15): E907-18.
  41. Radcliff K, Coric D, Albert T. Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. Aug 2016; 25(2): 213-24.
  42. Radcliff K, Davis RJ, Hisey MS, et al. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(C) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017; 11: 31.
  43. Radcliff K, Zigler J, Braxton E, et al. Final Long-Term Reporting from a Randomized Controlled IDE Trial for Lumbar Artificial Discs in Single-Level Degenerative Disc Disease: 7-Year Results. Int J Spine Surg. Aug 2021; 15(4): 612-632.
  44. Sasso RC, Anderson PA, Riew KD, et al. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. Sep 21 2011; 93(18): 1684-92.
  45. 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.
  46. Schroeder GD, Vaccaro AR, Divi SN, et al. 2021 Position Statement From the International Society for the Advancement of Spine Surgery on Cervical and Lumbar Disc Replacement. Int J Spine Surg. Feb 2021; 15(1): 37-46.
  47. 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 01 2014; 14(8): 1417-31.
  48. Staub LP, Ryser C, Roder C, et al. Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials. Spine J. Feb 2016; 16(2): 136-45.
  49. 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): 490-6.  
  50. U.S. Food and Drug Administration (FDA). Report of United States Clinical Study Results (G010188) -- Prestige LP Cervical Disc System. 2014; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090029
  51. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED): Mobi-C. 2013; https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110002b.pdf.
  52. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED): SECURE-C. 2012; https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100003b.pdf. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: M6-C Artificial Cervical Disc. 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170036.
  53. U.S. Food and Drug Administration. Summary of Safety and Effectiveness: Prestige LP Cervical Disc. PMA Number P090029/S003. 2016; https://www.accessdata.fda.gov/cdrh_docs/pdf9/p090029s003b.pdf.
  54. U.S. Food and Drug Administration (FDA) Summary of Safety and Effectiveness: Simplify Cervical Artificial Disc. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200022B.pdf. 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.
  55. 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.
  56. U.S. Food & Drug Administration. The prodisc L Total Disc Replacement P050010/S020. April 10, 2020. https://www.fda.gov/medical-devices/recently-approved-devices/prodisc-l-total-disc-replacement-p050010s020.
  57. Vaccaro A, Beutler W, Peppelman W, et al. Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study. Spine (Phila Pa 1976). Dec 15 2013; 38(26): 2227-39.
  58. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. Sep 1991; 14(7): 409-15.
  59. 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 (Phila Pa 1976). Dec 15 2019; 44(24): 1685-1696.
  60. Zhai S, Li A, Li X, et al. Total disc replacement compared with fusion for cervical degenerative disc disease: A systematic review of overlapping meta-analyses. Medicine (Baltimore). May 2020; 99(19): e20143.
  61. Zhang HX, Shao YD, Chen Y, et al. A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion. Int Orthop. Dec 2014; 38(12): 2533-41.
  62. 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.
  63. 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): 1155-62; discussion 1163.
  64. Zigler JE, Delamarter R, Murrey D, et al. ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration U.S. Food & Drug Administration. study. Spine (Phila Pa 1976). Feb 01 2013; 38(3): 203-9.
  65. 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): 504-11.

POLICY HISTORY:

Medical Policy Group, February 2004 (2)

Medical Policy Administration Committee, March 2004

Available for comment March 22-May 5, 2004

Medical Policy Group, January 2006 (1)

Medical Policy Group, June 2006

Medical Policy Group, August 2006 (1)

Medical Policy Administration Committee, August 2006

Medical Policy Group, September 2006 (2)

Medical Policy Group, April 2007

Medical Policy Group, July 2007 (1)

Medical Policy Administration Committee, August 2007

Medical Policy Group, October 2007 (1)

Medical Policy Group, March 2008

Medical Policy Group, May 2008

Medical Policy Group, August 2008 (3)

Medical Policy Group, June 2009 (3)

Medical Policy Administration Committee, July 2009

Medical Policy Group, October 2009 (1)

Medical Policy Group, October 2010 (1): Updated description, Key Points, no policy statement coverage change

Medical Policy Panel, October 2010

Medical Policy Group, January 2011 (2)

Medical Policy Group, November 2011 (2): Updated Description, Key Points & References

Medical Policy Group, October 2013 (2): Removed ICD-9 Procedure codes; Removed references related to Medical Policy Reference Manual; no change to policy statement.

Medical Policy Panel, October 2013

Medical Policy Panel, November 2013

Medical Policy Group, December 2013 (2):  Updated Policy Statement with limited coverage for cervical artificial disc.  Key Points, Approved by Governing Bodies, Key Words and References updated to reflect information found in latest literature search.  Invalid web references deleted.  Coding section corrected

Medical Policy Administration Committee, December 2013 and March 2014

Available for comment March 5 through April 16, 2014

Medical Policy Group, May 2014 (4): Updated Key Points and References No changes to the policy statement at this time.

Medical Policy Group, November 2014: 2015 Annual Coding update; Added CPT 22858 and 0375T to current coding. Moved 0092T to previous coding

Medical Policy Panel, July 2015

Medical Policy Group, July 2015 (2): Updates to Key Points, Approved by Governing Bodies, and References, policy statement updated to include additional criteria and contraindications for cervical intervertebral disc; no change to intent of policy statement.

Medical Policy Group, November 2015 (2): Definition of hybrid fusion added to policy section; no change in policy statement.

Medical Policy Group, November 2015 (2): Added clarifying statement to policy section on investigational listing “for any additional levels being requested,” no change to intent of policy statement.

Medical Policy Panel, September 2016

Medical Policy Group, September 2016 (7): Policy statement revised with criteria update to include simultaneous cervical artificial intervertebral disc implantation at a second contiguous level; subsequent cervical artificial intervertebral disc implantation at an adjacent level; and more than two levels as being investigational. Updated Key Points, Approved by Governing Bodies and References.

Medical Policy Administration Committee, October 2016

Available for comment October 14 through November 30, 2016

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (7): Updates to Description, Key Points, and References. Policy statement- removed “degenerative joint disease” and added thoracic artificial intervertebral disc as being investigational.

Medical Policy Administration Committee, May 2017

Available for comment May 16 through June 29, 2017

Medical Policy Panel, April 2018

Medical Policy Group, June 2018 (7): 2018 Updates to Key Points and References. Removed Policy statement from 2014 and Previous Coding Section. No changes to intent of Policy Statement.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (7): 2019 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Group, December 2019:  2020 Annual Coding Update. Moved CPT code 0357T from Current coding section.  Created Previous coding section to include code 0375T

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (7): 2020 Updates to Key Points, Approved by Governing Bodies, and References. Added Key Words: CDA, cervical disc arthroplasty, Simplify.

Deleted previous policy statements prior to May 15, 2017. No change in Policy Statement.

Medical Policy Panel, April 2021

Medical Policy Group, May 2021 (7): Updates to Key Points, Approved by Governing Bodies, and References. Policy section updated to remove “not medically necessary” statements. No change in intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (7): Updates to Key Points, Approved by Governing Bodies, and References. No change in Policy Statement. Removed Previous Coding section. CPT 0375T was deleted effective 12/31/19.

Medical Policy Group, June 2022: 2022 Quarterly Coding Update. Added CPT codes 0719T to the Current coding section.

Medical Policy Group, November 2022: 2023 Annual Coding Update- Added CPT code 22860 to the Current coding section. Moved CPT code 0163T to the Previous Coding section.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.