Cigna / ASH Medical Coverage Policies

Cigna / ASH Medical Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document may differ significantly from the standard benefit plans upon which these Cigna / ASH Medical Coverage Policies are based. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Cigna / ASH Medical Coverage Policy. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Determinations in each specific instance may require consideration of:

1. the terms of the applicable benefit plan document in effect on the date of service
2. any applicable laws/regulations
3. any relevant collateral source materials including Cigna-ASH Medical Coverage Policies and
4. the specific facts of the particular situation

Cigna / ASH Medical Coverage Policies relate exclusively to the administration of health benefit plans. Cigna / ASH Medical Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. Some information in these Coverage Policies may not apply to all benefit plans administered by Cigna. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make benefit determinations. References to standard benefit plan language and benefit determinations do not apply to those clients.

GUIDELINES

Medically Necessary Cervical

Use of cervical mechanical traction is considered medically necessary in the clinic setting for patients who meet all of the following criteria:

• Failure of other evidence-based therapeutic procedures to resolve symptoms after 3 weeks
• Only used in combination with other evidence-based treatments including therapeutic exercise. The therapeutic exercise(s) should not cause aggravation or peripheralization of symptoms.
• Patient has cervical radiculopathy diagnosis with at least 3 of the following findings:
  • Patient reported peripheralization with lower cervical spine (C4-7) mobility testing;
  • Positive shoulder abduction test;
  • Age > or =55;
  • Positive upper limb tension test A
  • Positive neck distraction test

Cervical mechanical traction is considered experimental, investigational, or unproven for the treatment of other conditions or when the above criteria are not met.

Lumbar

Use of lumbar mechanical traction is considered medically necessary in the clinic setting for patients who meet all of the following criteria:

• Failure of other evidence-based therapeutic procedures to resolve symptoms after 3 weeks
• Only used in combination with other evidence-based treatments including therapeutic exercise with extension movements. The therapeutic exercise(s) should not cause aggravation or peripheralization of symptoms.
• Patient has sciatica or signs of nerve root compression and either peripheralization with extension movements or a positive crossed straight leg raise test.

Lumbar mechanical traction is considered experimental, investigational, or unproven for treatment of other conditions or when the above criteria are not met. These guidelines are NOT relevant to axial or spinal decompression therapy.

Note:

Mechanical traction using a table with moving roller(s) against the spine or paraspinal tissue (e.g., Spinalator) is considered a type of passive mobilization modality (often referred to as “intersegmental traction”) that may have limited value in reducing spinal stiffness and muscle tension and is only appropriate as preparatory or adjunctive to spinal manipulative procedures. It should not be used as a stand-alone therapy. It should only be used for a short duration (1-2 weeks) to facilitate manipulations and to transition into an active therapy program.

Experimental, Investigational, Unproven

Nonsurgical axial/spinal decompression therapy is considered to be experimental, investigational, or unproven for the treatment of neck, low back and related disorders. This includes any motorized mechanical traction device that is promoted as providing “decompression therapy” e.g., VAX-D, IDD Therapy® [Intervertebral Differential Dynamics Therapy], DRS, DRX, DRX-2000, DRX-3000, DRX-5000, DRX-9000, Accu-SPINA™, Lordex Power Traction device, Mettler Traction Device [MTD 4000], Tru Trac 401, Integrity Spinal Care System Alpha-SPINA System, Dynatron DX2, Dynapro™ DX2, Spinerx LDM, or any other device that claims to create spinal decompression. Mechanical traction applied to the thoracic spine is considered experimental, investigational, or unproven for treatment of thoracic conditions or other spinal conditions other than those outlined in this guideline. Mechanical traction applied to other spinal conditions other than those outlined in this guideline is considered experimental, investigational, or unproven.

DESCRIPTION

Traction as a treatment option for low back pain and sciatica has existed for many years. Its use has progressed from continuous static traction to intermittent motorized traction. Traditional mechanical traction is a therapeutic method used to relieve pain by stretching and separating the vertebrae to help to relieve direct nerve pressure and stress on the vertebral discs. Cervical traction is a common nonsurgical treatment for a herniated disc in the neck that relieves pain by opening up the cervical foramen to reduce pressure on compressed nerve roots exiting the spinal canal. Traction can either be applied manually or by spinal traction devices. This guideline focuses on various mechanical traction devices that provide continuous or intermittent forces to the spine.

It has been proposed that cervical traction results in an expansion of the intervertebral spaces, an increase joint mobility, and a stretching muscles and ligaments adjacent to the vertebral bodies, which will improve clinical outcomes in those with neck pain. After 2 minutes of sustained traction, the intervertebral spaces begin to widen. Forces between 20 and 50 pounds are frequently used to achieve intervertebral separation. Continuous

Axial/Spinal Decompression Therapy/Mechanical Traction (Provided in a Clinic Setting) (CPG 275)

or static traction can be applied in a steady amount for specific time periods. Intermittent or cyclical traction involves traction being applied and released multiple times during one treatment session. Duration of cervical traction can range from a few minutes to 20 to 30 minutes, one to three times weekly. Traction is used for treatment of low back pain (LBP) as well and it is provided in combination with other treatment modalities, as is cervical traction. Lumbar traction uses a harness (with Velcro strapping) that is put around the lower rib cage and around the iliac crest. Duration and level of force exerted through this harness can be varied in a continuous or intermittent mode. The exact mechanism through which traction might be effective is still unclear.

It has been suggested that spinal elongation, through decreasing lordosis and increasing intervertebral space, inhibits pain (nociceptive) impulses, improves mobility, decreases mechanical stress, reduces muscle spasm or spinal nerve root compression (due to osteophytes), releases luxation of a disc or capsule from the zygapophyseal joint, and releases adhesions around the zygapophyseal joint and the annulus fibrosus. So far, the proposed mechanisms have not been supported by sufficient empirical information. According to CPT, mechanical traction is described as the force used to create a degree of tension of soft tissues and/or to allow for separation between joint surfaces. The degree of traction is controlled through the amount of force (pounds) allowed, duration (time), and angle of pull (degrees) using mechanical means. Terms often used in describing pelvic (lumbar)/cervical traction are intermittent or static (describing the length of time traction is applied).

GENERAL BACKGROUND

The most recent form of intermittent motorized traction is commonly referred to as axial/spinal decompression therapy. Developers and manufacturers of the equipment along with clinicians often consider it to be a unique form of traction. Proponents of nonsurgical axial/spinal decompression therapy claim it to be a safe and effective alternative to surgical interventions. Companies demonstrate intense marketing programs and claim high success rates.

Axial/spinal decompression therapy is intended to create negative pressure within the spine so that as the spinal column is elongated, pressure is taken off the nerve root(s), and herniated disc material may be pulled back into place. Axial/spinal decompression therapy is generally performed using a specially designed computerized mechanical table that separates in the middle. Depending on the type of table being used, a patient is strapped in a prone or supine position to the lower part of the table using a pelvic harness and may hold handgrips at the top of the table. The table is then mechanically separated in the middle creating a distractive force to relieve pressure within the spine that may be causing pain.

The amount of distractive force is tailored for each patient and usually lasts about 60 seconds. Depending on the device utilized, static, intermittent, or cycled distractive force may be applied. Typical treatment protocols include 20 sessions, each lasting 30 to 40 minutes. The process of distraction and relaxation is fully computerized using a programmable logic controller and is monitored by a licensed health care practitioner. The American Medical Association (AMA), Food and Drug Administration (FDA), and Centers for Medicare & Medicaid Services (CMS) all consider axial/spinal decompression therapy to be a form of traction. However, this therapy involves a special table and protocol that isn’t the same as conventional or traditional traction with claims of spinal decompression. The tables utilized for axial/spinal decompression therapy are classified by the FDA as powered traction equipment.

Examples of axial/spinal decompression therapy tables (and their manufacturers) include:

• VAX-D Table (VAX-D Manufacturing, Palm Harbor, FL)
• Decompression, Reduction, Stabilization (DRS) System (North American Medical Corporation, Atlanta, GA)
• DRX 2000 and DRX 9000 (Axiom Worldwide, Tampa, FL)
• Spina System (North American Medical Corporation, Atlanta, GA)

Two popular units will be described here. Due to the number of available products, it would be impractical to provide information on all of them. VAX-D: The manufacturer suggests that use of the VAX-D table applies distractive forces in a gradual, progressive fashion through extension of the lower end of the table.

The level of tension is preset on a control panel and can be increased, allowing for various decompression phases and a rest phase. Various decompression phases allow alternating cycles of distraction and relaxation. Typically, a treatment cycle consists of 15 cycles of tension and relaxation. The patient lies prone on the VAX-D table. The table is split, allowing the table to slowly extend, thus decreasing load bearing in the intervertebral discs and/or intervertebral joint spaces. The VAX-D manufacturer claims specific parameters of their system make the device inherently safe. These safety features include the use of air pressure as the energy source; the ramp characteristics employed in applying the distraction tensions; the release rate of the distraction and relaxation cycles; the cycle periodicity; the upper limits on the distraction tensions; the positioning of the patient and the means of fixing the upper body; and the ability of the patient to release the handgrips if the distraction tension causes pain or discomfort. Information regarding the range and incidence of adverse effects that occur during VAX-D therapy is limited. Complications reported with VAX-D include:

• The development of a sharp burning, radiating pain during therapy;
• Stress to the shoulder girdle and rotator cuff muscles; and
• Overstretching of the soft tissue of the back.

Axial/Spinal Decompression Therapy/Mechanical Traction (Provided in a Clinic Setting) (CPG 275)

Decompression, Reduction, Stabilization (DRS) System: Manufacturers recommend the DRS System for treatment of low back pain. This device uses a bed that is split into two cushions. The patient can step onto a foot pad, have a pelvic and chest harness attached, after which the patient and bed are lowered to a horizontal position. Distraction tension is applied by the pelvic harness while the patient’s upper body is secured to the locked upper cushion via the chest harness. The DRS System is marketed for the treatment of low back pain associated with herniated and degenerated discs. According to the manufacturer, the DRS System applies pressures on the disc in a graduated manner, which bypasses the inherent neurological mechanisms that lead to firing of stretch receptors in the paravertebral structures. This decreased resistance to the distractive forces allows a reduction in intradiscal pressures, which promotes retraction of herniated disc material and facilitates influx of oxygen, proline, and other substrates.

The research evidence concerning nonsurgical axial/spinal decompression therapy is lacking and of low quality. Any estimate of treatment effect is uncertain, as is the clarity of risk, benefit and burden to the patient. There are significant burdens placed upon health plan members due to high out-of-pocket costs, time spent receiving the intervention, and the unsubstantiated/misleading marketing about the alleged proven effectiveness and safety of nonsurgical axial/spinal decompression therapy. These burdens have been recognized as significant by some professional licensing boards and state justice departments.