Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Cervical Traction Devices for In-home Use
Policy #:MA05.009

This policy is applicable to the Company’s Medicare Advantage products only. Policies that are applicable to the Company’s commercial products are accessible via a separate commercial policy database.


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.


This Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's Evidence of Coverage.

MEDICALLY NECESSARY

Cervical traction applied using a mechanical device (E0860) in the home setting is considered medically necessary and, therefore, covered when all of the following criteria are met:
  • The individual has a musculoskeletal or neurologic impairment requiring cervical traction equipment.
  • The appropriate use of an in-home home cervical traction device has been demonstrated to the individual who has tolerated the selected device.
  • The traction device will require the individual to be non-ambulatory during the period of use.

Cervical traction applied using a pneumatic device (E0849, E0855) in the home setting is considered medically necessary and, therefore, covered when all of the above criteria for the mechanical device are met and at least one of the following criteria is met:
  • The treating professional provider orders more than 20 pounds of cervical traction.
  • The individual has been diagnosed with and treated for a condition that may worsen with the use of mechanical traction, such as, but not limited to, the following:
    • Temporomandibular joint (TMJ) dysfunction
    • Distortion of the lower jaw or neck anatomy (eg, radical neck dissection) such that a mechanical cervical traction device is unable to be utilized

NOT MEDICALLY NECESSARY

Cervical traction applied via attachment to a headboard (E0840) or a free-standing frame (E0850) has no proven clinical advantage compared to cervical traction applied via an over-the-door mechanism. Therefore, cervical traction devices represented by E0840 or E0850 are considered not medically necessary and, therefore, not covered.

Inflatable cervical traction devices (E0856) are considered not medically necessary and, therefore, not covered because the device does not require the individual to be non-ambulatory during the period of use.

FACE-TO-FACE REQUIREMENTS

As a condition for payment, a professional provider must have a face-to-face examination with the individual for whom the item is ordered that meets all of the following requirements:
  • The treating professional provider must have an in-person examination with the individual within the six (6) months prior to the date of the written order prior to delivery.
  • This examination must document that the individual was evaluated and/or treated for a condition that supports the need for the item(s) of DME ordered.

A new face-to-face examination is required each time a new prescription for one of the specified items is ordered. A new prescription is required:
  • For all claims for purchases or initial rentals
  • When there is a change in the prescription for the accessory, supply, drug, etc.
  • If periodic prescription renewal required per medical policy
  • When an item is replaced
  • When there is a change in the supplier
  • When required by state law

In this policy the specified items are:
E0849 TRACTION EQUIPMENT, CERVICAL, FREE-STANDING STAND/FRAME, PNEUMATIC, APPLYING TRACTION FORCE TO OTHER THAN MANDIBLE
E0855 CERVICAL TRACTION EQUIPMENT NOT REQUIRING ADDITIONAL STAND OR FRAME

REQUIRED DOCUMENTATION

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports. This policy is consistent with Medicare's documentation requirements, including the following required documentation:

PRESCRIPTION (ORDER) REQUIREMENTS
Before submitting a claim to the Company, the supplier must have on file a timely, appropriate, and complete order for each item billed that is signed and dated by the professional provider who is treating the member. Requesting a provider to sign a retrospective order at the time of an audit or after an audit for submission as an original order, reorder, or updated order will not satisfy the requirement to maintain a timely professional provider order on file.

PROOF OF DELIVERY
Medical record documentation must include a contemporaneously prepared delivery confirmation or member’s receipt of supplies and equipment. The medical record documentation must include a copy of delivery confirmation if delivered by a commercial carrier and a signed copy of delivery confirmation by member/caregiver if delivered by the DME supplier/provider. All documentation is to be prepared contemporaneous with delivery and be available to the Company upon request.

CONSUMABLE SUPPLIES
The durable medical equipment (DME) supplier must monitor the quantity of accessories and supplies an individual is actually using. Contacting the individual regarding replenishment of supplies should not be done earlier than approximately seven days prior to the delivery/shipping date. Dated documentation of this contact with the individual is required in the individual’s medical record. Delivery of the supplies should not be done earlier than approximately five days before the individual would exhaust their on-hand supply.

Documentation of a face to face encounter, between the treating professional provider and the individual meeting the above requirements, including an assessment of the individual’s clinical condition supporting the need for the prescribed DME item(s) must be provided to and kept on file by the DME supplier.

If required documentation is not available on file to support a claim at the time of an audit or record request, the durable medical equipment (DME) supplier may be required to reimburse the Company for overpayments.
Policy Guidelines

The cervical traction devices described in this policy are appropriate for use in the home because they do not require supervision by a trained professional after initial set-up and instruction. These in-home devices are not to be confused with traction units, which are designed specifically for facility use and require attendance by a trained professional.

This policy is consistent with Medicare's coverage determination. The Company's reimbursement methodology may differ from Medicare.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable Evidence of Coverage, in-home cervical traction is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in the policy are met. However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA has approved several types of in-home cervical traction devices and considers them to be Class I devices, which are exempt from premarket notification procedures.

Description

Acute neck pain is a relatively common disorder. Neck pain may be a result of, but is not limited to: sprains or strains of cervical tissues, poor posture, cervical spondylosis (degeneration of the spinal column), or cervical disc herniations with radiculopathy (pain, numbness, or weakness radiating from the spine). The pain is typically self-limiting and usually resolves spontaneously after a period of rest without sequelae. Some individuals may experience persistent pain that can be associated with numbness, tingling, muscle weakness, and loss of reflexes. Treatment for such pain may be medical or surgical and usually depends on the source of the pain.

Nonsurgical treatments aimed at relieving pain and restoring motion can include education on how to improve posture and ergonomics, oral medications, soft cervical collars, physical therapy, and cervical traction. Cervical traction is commonly performed to relieve muscle spasms in the neck and shoulders, and to relieve the pain of pinched nerves in the neck. It can be administered by various techniques ranging from supine mechanical motorized or pneumatic traction, to seated traction using over-the-door pulleys with attached weights. Cervical traction equipment is used for individuals with orthopedic impairments who require traction that prevents ambulation during the period of use.

A mechanical cervical traction unit is a device that is used to apply a therapeutic pulling force (static or intermittent) to the cervical spine. Aside from pulleys and weights, these units generally consist of a traction cord, spreader bar, heavy-duty pulley arm, door bracket, and head halter. In general, over-the-door traction is limited to providing less than 20 pounds of traction.

There are several pneumatic in-home cervical traction devices on the market, including the Pronex® pneumatic cervical traction device (Empi, St. Paul, MN) and the Saunders® Hometrac device (Empi, St. Paul, MN). According to the manufacturer's literature, these devices are used in the supine position and utilize individual-controlled air inflation to provide adjustable traction comparable to the forces provided by a physical therapist in the outpatient setting. The Pronex® device cradles the individual's head and neck on two cushions. One cushion supports the occiput, and the other rests against the upper trapezius. When the individual inflates the device, the bellow expands and lifts the head upward. The Saunders® Hometrac device involves resting the individual's head on a padded track. The occiput is supported by a cushion, and the forehead is held in place by a strap. When the device is pumped with air, the track expands to lift the head upward, providing up to 50 pounds of adjustable traction.

Some cervical traction devices can be used with ambulation, such as the Pneu-trac® Traction Collar (Trulife, Jackson, MI). According to the manufacturer, the collar's pressure can be inflated by the individual to fit diagnosis and tolerance. The flexible cervical collar is composed of a tubular, air-inflatable bladder that is secured to the collar. The bladder is filled with air, under pressure from a manually operated air pump, to inflate the bladder so that it presses downwardly against the shoulder region of the individual and continuously around the lower neck region. This expands the height of the collar, applying upward force around the base of the chin, and the left and right mandibular and occipital region of the individual. The collar allows a controlled and uniform amount of traction force to encircle the cervical region of the individual. The goal of the cervical collar is to control the amount of static traction around the neck while allowing the individual to be ambulatory.

Clinical Biomechanics of Posture® (CBP®), formerly known as Chiropractic Biophysics®, are techniques involving full spine and pelvis corrective and rehabilitative procedures. The focus of the correction is on the abnormal curvature of the spine. The technique uses cervical traction combined with spinal manipulation to improve the appearance of an abnormal-looking spine, while using radiograph studies to compare the spinal structure before and after the treatment. The goal of CBP is to relieve cervical pain, with the main focus on optimal posture and spinal alignment and correction.
References

Centers for Medicare & Medicaid Services (CMS). MLN Matters. Detailed written orders and face-to-face encounters. [CMS Web site]. 07/01/2013. Available at:
http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM8304.pdf. Accessed May 3, 2019.

Chiropractic Biophysics Online. [Chiropractic Biophysics Web site]. 2009. Available at: http://www.idealspine.com/. Accessed May 3, 2019.

Harrison DE, Harrison DD, Betz JJ, et al. Increasing the cervical lordosis with chiropractic biophysics seated combined extension-compression and transverse load cervical traction with cervical manipulation: nonrandomized clinical control trial (abstract). J Manipulative Physiol Ther. 2005;26(3):214. Available at: http://www.jmptonline.org/article/S0161-4754(05)00044-8/fulltext. Accessed May 3, 2019.

Noridian Healthcare Solutions. Local Coverage Article (A52476). Cervical Traction Devices. [Noridian Web site]. Original 10/01/2015. (Revised:01/01/2019). Available at: https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52476&ver=20&DocType=All&bc=AACAAAAAAAAA&. Accessed May 3, 2019.

Noridian Healthcare Solutions. Local Coverage Determination (L33823). Cervical Traction Devices.[Noridian Web site]. Original 10/01/2015. (Revised: 01/01/2017). Available at:
https://med.noridianmedicare.com/documents/2230703/7218263/Cervical+Traction+Devices/0aa6a314-c877-48f9-92d1-1ae1bda5c98a. Accessed May 3, 2019.

Trulife. Pneu-trac® Traction Collar. [Trulife Web site]. Available at: https://trulife.com/product/pneu-trac-traction-collar. Accessed May 3, 2019.



Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

MEDICALLY NECESSARY


E0849 Traction equipment, cervical, free-standing stand/frame, pneumatic, applying traction force to other than mandible

E0855 Cervical traction equipment not requiring additional stand or frame

E0860 Traction equipment, overdoor, cervical


NOT MEDICALLY NECESSARY

E0840 Traction frame, attached to headboard, cervical traction

E0850 Traction stand, freestanding, cervical traction

E0856 Cervical traction device, with inflatable air bladder(s)



Revenue Code Number(s)

N/A

Coding and Billing Requirements






Policy History

MA05.009
06/05/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on cervical traction for in-home use.


MA05.009
03/14/2018The policy has been reviewed and reissued to communicate the Company’s continuing position on cervical traction for in-home use.
02/15/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on cervical traction for in-home use.
03/16/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on cervical traction for in-home use.
01/07/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on cervical traction for in-home use.
01/01/2015This is a new policy.





Version Effective Date: 01/01/2015
Version Issued Date: 01/01/2015
Version Reissued Date: 06/05/2019