19 Del. Admin. Code § 1342-F-6.0

Current through Register Vol. 27, No. 12, June 1, 2024

Section 1342-F-6.0 - THERAPEUTIC PROCEDURES - OPERATIVE

All operative interventions should be based on a positive correlation with clinical findings, the natural history of the disease, the clinical course, and diagnostic tests. A comprehensive assimilation of these factors should have led to a specific diagnosis with positive identification of the pathologic condition(s). It is imperative for the clinician to rule out non-physiologic modifiers of pain presentation, or non-operative conditions mimicking radiculopathy or instability (peripheral compressive neuropathy, chronic soft tissue injuries, and psychological conditions), prior to consideration of elective surgical intervention. Early intervention may be required in acute incapacitating pain or in the presence of severe or progressive neurological deficits. Patients who are not candidates for or refuse surgical treatment should be treated with non-operative therapy as indicated.

Operative treatment is indicated when the natural history of surgically treated lesions is better than the natural history for non-operatively treated lesions. All patients being considered for surgical intervention should first undergo a comprehensive neuromusculoskeletal examination to identify mechanical pain generators that may respond to non-surgical techniques, or may be refractory to surgical intervention.

In situations requiring the possible need for reoperation, and spinal fusions or total disc replacements over two levels, a second opinion may be necessary. Interdisciplinary interventions should be strongly considered post-operatively in patients not making functional progress within expected time

6.1General Recommendations -If cervical fusion is being considered, it is recommended that the injured worker be encouraged to quit or decrease smoking for at least two weeks prior to surgery and during the time of healing. Because smokers have a higher risk of non-union and higher post-operative costs, it is recommended that insurers cover a smoking cessation program peri-operatively.

6.2General Indications for Surgery - Operative intervention should be considered and a consultation obtained when improvement of symptoms has plateaued and the residual symptoms of pain and functional disability are unacceptable at the end of six weeks of treatment, or at the end of longer duration of non-operative intervention for debilitated patients with complex problems. Choice of hardware instrumentation is based on anatomy, the patient's pathology, and surgeon's experience and preference.

6.3Specific Indications include:

6.3.1For Patients with Myelopathy: immediate surgical evaluation and treatment is indicated.

6.3.2For Patients with Cervical Radiculopathy:

6.3.2.1 Early intervention may be required for acute incapacitating pain or in the presence of severe or progressive neurological deficits.

6.3.2.2 Persistent or recurrent arm pain with functional limitations, unresponsive to conservative treatment after six weeks; or

6.3.2.3 Progressive functional neurological deficit; or

6.3.2.4 Static neurological deficit associated with significant radicular pain; and

6.3.2.5 Confirmatory imaging studies consistent with clinical findings.

6.3.3For Patients with Persistent Non-radicular Cervical Pain: in the absence of a radiculopathy, it is recommended that a decisive commitment to surgical or nonsurgical interventions be made by 4 months following injury. The effectiveness of three-level cervical fusion for non-radicular pain has not been established. In patients with non-radicular cervical pain for whom fusion is being considered, required pre-operative indications include all of the following:

6.3.3.1 In general, if the program of non-operative treatment fails, operative treatment is indicated when:

6.3.3.1.1 Improvement of the symptoms has plateaued, and the residual symptoms of pain and functional disability are unacceptable at the end of 6 to 12 weeks of active treatment, or at the end of longer duration of non-operative programs for debilitated patients with complex problems; and/or

6.3.3.1.2 Frequent recurrences of symptoms cause functional limitations even if a non-operative active treatment program provides satisfactory relief of symptoms, and restoration of function on each recurrence.

6.3.3.2 Pain generators are adequately defined and treated; and

6.3.3.3 Physical medicine and manual therapy interventions are completed

6.3.3.4 X-ray, MRI, or CT/discography demonstrating disc pathology or spinal instability.

6.3.3.5 Spine pathology is limited to two levels.

6.4Surgical Procedures include:

6.4.1Cervical Discectomy with or without Fusion:

6.4.1.1Description - Procedure to relieve pressure on one or more nerve roots or spinal cord. It may be performed with or without the use of a microscope.

6.4.1.2Surgical Indications - Radiculopathy from ruptured disc or spondylosis, spinal instability, or patients with non-radicular neck pain meeting fusion criteria. Discectomy alone from a posterior approach may be considered in patients with pure radicular symptoms from their herniated disc and who have sufficiently large foramen that disc space collapse is unlikely to further compromise the nerve root. Failure rates increase with disease at more than two levels.

6.4.1.3Operative Treatment - Cervical plating may be used to prevent graft dislodgment and facilitate fusion. It has the added advantage of eliminating the need for postoperative bracing and allowing faster functional recovery.

Recombinant Human Bone Morphogenetic Protein (rhBMP-2) is a member of a family of cytokines capable of inducing bone formation. It is produced from genetically modified cell lines using molecular cloning techniques. Use of rhBMP-2 in the cervical spine may carry a risk of swelling and ectopic bone formation which can encroach on neurovascular structures and on the esophagus. As of the date of adoption the FDA has not approved its use in the cervical spine. At the time of this guideline, cervical application of rhBMP-2 is investigational and remains outside the purview of the guidelines. Prior authorization is required.

6.4.1.4Post-Operative Therapy - Cervical bracing may be used. Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program, with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate and encouraged to expedite a return to higher function. Active treatment, which patients should have had prior to surgery, will frequently require a repeat of the sessions previously ordered. The goals of the therapy program should include instruction in a long-term home-based exercise program.

6.4.1.5Intervertebral Biomechanical Device(s) and Use of Code 22851

Code 22851 describes the application of an intervertebral biomechanical device to a vertebral defect or interspace. Code 22851 should be listed in conjunction with a primary procedure without the use of modifier 51. The use of 22851 is limited to one instance per single interspace or single vertebral defect regardless of the number of devices applied and infers additional qualifying training, experience, sizing, and/or use of special surgical appliances to insert the biomechanical device. Qualifying devices include manufactured synthetic or allograft biomechanical devices, or methyl methacrylate constructs, and are not dependant on a specific manufacturer, shape, or material of which it is constructed. Qualifying devices are machine cut to specific dimensions for precise application to an intervertebral defect. (For example, the use of code 22851 would be appropriate during a cervical arthrodesis (22554) when applying a synthetic alloy cage, a threaded bone dowel, or a machine cut hexahedron cortical, cancellous, or cortico cancellous allograft biomechanical device. Surgeons utilizing generic non-machined bony allografts or autografts are referred to code sets 20930-20931, 20936-20938respectively.)

6.4.2Cervical Corpectomy

6.4.2.1Description - Removal of a portion or the entire vertebral body from the front of the spine. May also include removal of the adjacent discs. Usually involves fusion.

6.4.2.2Surgical Indications - Single or two-level spinal stenosis, spondylolisthesis, or severe kyphosis, with cord compression.

6.4.2.3Operative Treatment - Neural decompression, fusion with instrumentation, or halo vest placement to maintain cervical position. Hemicorpectomy may be done when only a portion of the vertebral body needs to be resected. Allografts may be used for single bone graft fusion; however, autografts are generally preferable for multi-level fusions unless a large strut graft is required.

6.4.2.4Post-Operative Therapy - Dependent upon number of vertebral bodies involved, healing time may be longer than discectomy. Halo vest care is required. Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening is appropriate for most patients once the cervical spine is deemed stable and without complication. The goals of the therapy program should include instruction in a long-term home-based exercise program.

6.4.3Cervical Laminectomy with or without Foraminotomy or Fusion

6.4.3.1Description - Surgical removal of the posterior portion of a vertebrae in order to gain access to the spinal cord or nerve roots.

6.4.3.2Surgical Indications - Neural compression.

6.4.3.3Operative Treatment - Laminotomy, partial discectomy, and nerve root decompression.

6.4.3.4Post-Operative Therapy - Cervical bracing may be appropriate (usually 6 to 12 weeks with fusion). Home programs with instruction in ADLs, sitting, posture, and a daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate for most patients once the cervical spine is deemed stable and without complication. The goals of the therapy program should include instruction in a long-term home-based exercise program

6.4.4Cervical Laminoplasty

6.4.4.1Description - Technique that increases anterior or posterior dimensions of the spinal canal while leaving posterior elements partially intact. It may be performed with or without the use of a microscope.

6.4.4.2 Surgical Indications - Multi-level disease: cervical spinal stenosis or spondylitic myelopathy. Not indicated in cervical kyphosis.

6.4.4.3Operative Treatment - Posterior approach, with or without instrumentation.

6.4.4.4Post-Operative Therapy - May include 4 to 12 weeks of cervical bracing. Home programs with instruction in ADLs, sitting, posture, and daily walking program should be an early part of the rehabilitation process. Referral to a formal rehabilitation program with emphasis on cervical, scapular, and thoracic strengthening and restoration of ROM is appropriate once the cervical spine is stable and without complication. Active treatment which patients should have had prior to surgery will frequently require a repeat of the sessions previously ordered. The goals of the therapy program should include instruction in a long-term, home-based exercise program.

6.4.5Artificial Cervical Disc Replacement

6.4.5.1Description - involves the insertion of a prosthetic device into an intervertebral space from which a degenerated disc has been removed, sparing only the peripheral annulus. The endplates are positioned under intraoperative fluoroscopic guidance for optimal placement in the sagittal and frontal planes. The prosthetic device is designed to distribute the mechanical load of the vertebrae in a physiologic manner and maintain range of motion.

6.4.5.2General Selection Criteria - for cervical disc replacement includes symptomatic degenerative disc disease. The patient must also meet fusion surgery criteria, and if the patient is not a candidate for fusion, a disc replacement procedure should not be considered. Additionally, the patient should be able to comply with pre-and post-surgery protocol.

6.4.5.3The Theoretical Advantage - of total disc arthroplasty is that it preserves range of motion and physiologic loading of the disc. This could be an advantage for adults who are physically active. Studies do not demonstrate a long-term advantage of measured function or pain over comparison groups undergoing fusion. The longevity of this prosthetic device has not yet been determined. Significant technical training and experience is required to perform this procedure successfully. Surgeons must be well-versed in anterior spinal techniques and should have attended appropriate training courses, or have undergone training during a fellowship. Mentoring and proctoring of procedures is highly recommended.

6.5External Spinal Stimulators Post Fusion

6.5.1 The following criteria are established for the medically accepted standard of care when determining applicability for the use of an external spinal stimulator:

6.5.1.1 Patient has had a previously failed spinal fusion, and/or

6.5.1.2 Patient is scheduled for revision or repair of pseudoarthrosis, and/or

6.5.1.3 The patient smokes greater than a pack of cigarettes per day and is scheduled for spinal fusion

6.5.1.4 The external spinal stimulator is approved for use in primary spinal fusions, if medical co morbidities increase the likelihood of non-union

6.5.1.5 The patient is metabolically in poor health, with other medical co morbidities such as diabetes, Rheumatoid arthritis, lupus or other illnesses requiring oral steroids or cytotoxic medications.

6.5.2 Precertification is required for use of the external spinal stimulator if the planned use falls outside the above indications.

19 Del. Admin. Code § 1342-F-6.0

12 DE Reg. 1515 (06/01/09)
17 DE Reg. 322 (9/1/2013) (Final)