White Paper: Cervical Disc Replacement: When is the Mobi-C Cervical Disc Medically Necessary?

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1 White Paper: Cervical Disc Replacement: When is the Mobi-C Cervical Disc Medically Necessary? For Health Plans, Medical Management Organizations and TPAs Cervical Disc Disease: An Overview The cervical spine is made up of the rst seven vertebrae (C1 through C7) in the spine, which are responsible for the normal function and mobility of the neck. It starts just below the skull and ends at the top of the thoracic spine. The rst two vertebral bodies in the cervical spine, C1 (atlas) and C2 (axis), are highly specialized and designed for rotation; they form a unique set of articulations that provide a high degree of mobility for the skull. C3 to C7 are more classic vertebrae, with a body, pedicles, laminae, spinous processes, and facet joint. Unlike the rest of the spine, the segments in the cervical spine contain openings in each vertebral body for arteries to carry blood to the brain. Cervical disc degeneration is a common cause of neck pain. However, it is much less common than disc degeneration in the lumbar spine because the neck is generally subjected to less torque and force. There are a number of degenerative diseases of the cervical spine, including disc herniation, radiculopathy, facet joint pathologies, cervical spondylotic myelopathy, and osteophytes (bone spurs). Cervical disc replacement has become an increasingly viable alternative to spinal fusion for select patients as longer-term data and improved technology continue to emerge. A herniated disc develops when the nucleus of the intervertebral disc pushes out from the center of the disc, placing pressure on the spinal cord or nerve root. Symptoms may include neck pain, arm pain/radiculopathy (compression of the nerve root), and myelopathy (compression of the spinal cord). Cervical radiculopathy occurs when a spinal nerve root is irritated and/or compressed by either a herniated disc or an osteophyte, or both. Symptoms of radiculopathy may include pain or tingling in extremities, muscle weakness, re!ex loss, and neurapraxia (temporary loss of function). Cervical spondylotic myelopathy results from spinal cord compression due to narrowing of the spinal canal. It can be caused by either congenital conditions or gradual degenerative changes (spondylosis) that result in the growth of osteophytes, which may compress the spinal cord. Symptoms may include loss of ne motor control of the hands, motor weakness in the upper and/or lower extremities, gait/walking di"culties, pain in the neck and/or shoulder area, sensory changes in the lower extremities, and upper and lower motor neuron ndings (for example, bowel and bladder dysfunction). There are a number of non-surgical treatment options for cervical disc disease, including pharmacologic treatment, partial rest, and physical therapy. A variety of medications may be used to relieve symptoms, including non-steroidal anti-in!ammatory drugs (NSAIDs), steroids (a short course on a tapering dose), non-narcotic analgesics, and narcotic analgesics (short term). AllMed Healthcare Management Inc. 1

2 Surgery can be considered only after an adequate trial of conservative treatment has failed. Patients with soft disc herniations can be considered to undergo advanced cervical discectomy (ACD), and anterior cervical discectomy with interbody fusion (ACDF) can be considered for patients with advanced spondylosis. ACDF involves removing the problem disc entirely and replacing it with a piece of bone, either from the patient s hip or a human cadaver. A metal plate with screws and/or a cervical collar may also be used to help hold the bone in place and allow this segment of the neck to fuse together. Although ACDF is the most common surgical intervention, there are a number of potential complications associated with the procedure. Bone grafts may be associated with both acute and potentially long-term pain from the donor site, or the bone graft may fail to heal, resulting in a non-union, which may require another fusion operation. While sterile bank bone (cadaver bone) is more convenient, it has a lower percentage rate of healing. Adjacent-segment degeneration is another potential complication that occurs when the levels of the spine above and below the fused segment wear out and become symptomatic because they are forced to absorb more load (since there is no longer any intervening motion shock absorption). Cervical Intervertebral Disc Prostheses The goals of arti cial cervical disc surgery are to remove the diseased disc, restore normal disc height, and decrease discogenic neck pain and associated arm pain or weakness. Surgery should also aim to preserve motion in the a#ected vertebral segment and improve patient function. Anterior cervical discectomy and arti cial disc replacement, which uses an anterior approach to the spine, involves removing the diseased intervertebral disc (discectomy) and performing a surgical decompression of the spinal cord and spinal nerve roots. An arti cial disc is then positioned in the space that results from the discectomy and decompression. There are a number of cervical intervertebral disc prostheses approved by the United States Food and Drug Administration (FDA). Single-level cervical disc replacement devices include the Prestige ST Cervical Disc, PRODISC-C Total Disc Replacement, BRYAN Cervical Disc, SECURE-C Arti cial Cervical Disc, and Mobi-C Cervical Disc. The Mobi-C Cervical Disc is the only device approved for two-level cervical disc replacement. According to the general indications for cervical intervertebral disc prostheses, patients should be skeletally mature, have only one or two symptomatic disc levels (C3 through C7), and have radiculopathy or neurologic de cit that has failed six weeks of conservative therapy. General contraindications for the devices include infection (especially in the spine and/or surrounding area), osteoporosis or osteopenia, trauma or other anatomic deformity, biomechanical instability, and allergies or sensitivity to implant material. Potential complications of arti cial disc replacement include neck/arm pain, swallowing di"culties, speech di"culties, and infection. Despite these risks, there are also potential advantages of arti cial cervical disc replacement over ACDF. Arti cial disc replacement may maintain normal neck motion and reduce degeneration of adjacent segments of the cervical spine. It also eliminates the need for a bone graft. Early postoperative neck motion and faster return to normal activity are also possible. 2

3 Mobi-C Cervical Disc: Indications and Contraindications The Mobi-C Cervical Disc prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurologic de cit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions con rmed by radiographic imaging (CT, MRI, x-rays): herniated nucleus pulposus, spondylosis (de ned by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Mobi-C Cervical Disc prosthesis is implanted using an anterior approach. Patients should have failed at least six weeks of conservative treatment or demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation of the Mobi-C Cervical Disc prosthesis. Contraindications to the Mobi-C Cervical Disc include: An active whole body (systemic) infection, such as pneumonia; An infection at the surgery site, such as a skin rash or infected cut; A known allergy to cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements; Damaged cervical vertebrae from an accident (trauma) at the level of the surgery; An unhealthy shape (deformity) of the cervical vertebrae at the level of the surgery; A cervical spine that shows an unhealthy amount of extra movement (instability); Low bone mineral density, such as osteoporosis or osteopenia (de ned as a DEXA bone mineral density T-score less than -1.5); and Severe disease or degeneration in the joints in the back of the cervical vertebrae (facet joints). Guidelines and Recommendations for Treating Cervical Disc Disease In 2009, the International Society for the Advancement of Spine Surgery (ISASS) published a position statement in favor of cervical disc arthroplasty when performed according to the indications outlined in the FDA approvals. More recently, in 2014, ISASS published a policy statement supporting the safety and e"cacy of cervical disc arthroplasty as an alternative to ACDF for individuals with one- or two-level cervical radiculopathy or myelopathy. According to coverage policy recommendations developed by the North American Spine Society in 2014, cervical arti - cial disc replacement may be indicated for the following diagnoses with qualifying criteria, when appropriate: Radiculopathy related to single-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 non-operative management; and Myelopathy or myeloradiculopathy related to single-level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that is severe enough to warrant surgical intervention. 3

4 Determining Medical Necessity for Treatment of Cervical Disc Disease Most health plans cover cervical arti cial disc prostheses for patients with degenerative cervical disc disease when very speci c conditions are met. Sample language may include the following: Cervical arti cial total disc replacement of FDA-approved prosthesis for degenerative cervical disc disease with symptomatic intractable radiculopathy and/or myelopathy is proven and medically necessary in a skeletally mature individual when at least one of the following criteria are met: o o Herniated disc; or Osteophyte formation; and Both of the following: o Documented patient history of neck and/or arm pain and/or a functional/neurological de cit associated with the cervical level to be treated; o Failed at least six weeks of non-operative treatment prior to implantation (only applicable for elective surgery; emergent surgery, or does not require prior non-operative treatment); Cervical arti cial disc replacement is proven and medically necessary for the treatment of symptomatic contiguous two-level degenerative disc disease in skeletally mature patients when used according to FDA-labeled indications (Note: not all cervical arti cial discs have FDA labeling for contiguous two-level degenerative disc disease. Only cervical arti cial discs FDA labeled for contiguous two-level disease are proven and medically necessary for this indication.); or Cervical arti cial disc replacement at one level combined with cervical spinal fusion surgery at another level (adjacent or non-adjacent) performed at the same surgical setting is unproven and not medically necessary. This is commonly referred to as a hybrid surgery. There is insu"cient published clinical evidence in peerreviewed medical literature demonstrating the safety and e"cacy of combination cervical spine surgery at multiple adjacent or non-adjacent levels. The Role of External Independent Review in Determining Medical Necessity for Cervical Intervertebral Disc Prostheses Practice guidelines are continually changing to re!ect advances in understanding of the use of cervical arti cial disc prostheses for degenerative cervical disc disease, which may complicate the process of establishing evidence-based criteria for practice guidelines and reimbursement for new procedures and treatments. An independent medical review, which is normally used by healthcare payers, looks at whether a speci c procedure was medically necessary. The specialty match that an independent review organization (IRO) provides is especially important as new technologies for arti cial disc replacement continue to emerge. The board-certi ed physician specialists who work with IROs keep up to date with the latest medical research literature and the latest standard of care. By staying on top of continually evolving technology and treatments as they are studied more extensively and potentially accepted into clinical guidelines, physicians who review cases for IROs work to ensure that patients receive the safest and most e#ective care possible. Independent medical reviews also avoid con!icts of interest, which can relate to economics, lack of specialists to review cases, or having the same doctor who denied a case review an appeal. 4

5 Conclusions Cervical disc replacement has become an increasingly viable alternative to spinal fusion for select patients as longerterm data and improved technology continue to emerge. The Mobi-C Cervical Disc is currently the only cervical intervertebral disc prosthesis that has been approved by the FDA to treat more than one level of the cervical spine. As technologies and indications evolve, it is essential for healthcare plans to position themselves to be able to make timely updates to their coverage criteria and medical policies in order to optimize care and treatment outcomes. 5

6 Bibliography 1. International Society for the Advancement of Spine Surgery. Position Statement: Cervical Total Disc Arthroplasty North American Spine Society. Cervical Arti cial Disc Replacement. De ning Appropriate Coverage Positions About AllMed AllMed Healthcare Management provides physician review outsourcing solutions to leading health plans, medical management organizations, TPAs and integrated health systems, nationwide. AllMed o#ers MedReview (SM), MedCert (SM), and Medical Director sta"ng services that cover initial pre-authorizations and both internal and external appeals, drawing on a panel of over 400 board-certi ed specialists in all areas of medicine. Services are deployed through PeerPoint, AllMed s state-of-the-art medical review portal. For more information on how AllMed can help your organization improve the quality and integrity of healthcare, contact us today at or visit us at 621 SW Alder St., Suite 740 Portland, OR

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