Coding Code Description

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).

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

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).

For individuals withlumbar 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.

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

*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  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).

Effective for services performed from May 16, 2006 through August 13, 2007, the Centers for Medicare & Medicaid Services (CMS) made the decision that lumbar artificial disc replacement (LADR) with the ChariteTM lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age. See Pub. 100-03, Medicare National Coverage Determinations Manual, section 150.10, for more information about the non-covered determination.

Effective for services performed on or after August 14, 2007, CMS made the decision that LADR with any lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age, (i.e., on or after a beneficiary’s 61st birthday).

For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination for LADR, leaving such determinations to continue to be made by the local contractors.

Carrier Billing Requirements

Effective for services performed on or after January 1, 2007 through August 13, 2007, for Medicare beneficiaries over 60 years of age, LADR with the ChariteTM lumbar artificial disc, carriers shall deny claims submitted with the following codes:

• 22857 Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, single interspace; and

• 0163T Total disc arthroplasty (artificial disc), anterior approach, including discectomy to prepare interspace (other than for decompression), lumbar, each additional interspace.