Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Mechanical Stretching Devices for the Treatment of Joint Stiffness or Contractures

Policy #:05.00.70b

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


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. 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.

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 Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

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

MEDICALLY NECESSARY

DYNAMIC LOW-LOAD PROLONGED STRETCH (LLPS) DEVICES
Dynamic LLPS devices are considered medically necessary and, therefore, covered for the treatment of persistent joint stiffness of the finger, wrist, elbow, or knee for up to four months when one of the following criteria are met:
  • When provided as part of a structured rehabilitative program for persistent joint stiffness to improve range of motion (ROM) in a sub-acute injury or following surgery (ie, more than 3 weeks, but less than 4 months following injury or surgery)
  • When provided in the acute post-operative period following surgery (ie, up to 3 weeks) to improve ROM in a joint previously affected by structural changes of muscle, tendons, ligaments, and skin caused by trauma, injury or disease resulting in persistent joint stiffness
  • When provided for individuals who have not benefited from standard physical therapy modalities because of an inability to exercise the affected joint

Dynamic LLPS devices are considered medically necessary and, therefore, covered for the treatment of persistent joint stiffness of the hallux limitus (ie, degenerative pathology in the first metatarsophalangeal joint or the great toe) following bunionectomy or cheilectomy when provided within two months after surgery.

CUSTOM-FABRICATED DYNAMIC LLPS DEVICES
A custom-fabricated dynamic LLPS device is considered medically necessary and, therefore, covered for an individual who has a documented physical characteristic that requires the use of a custom-fabricated dynamic LLPS device instead of a prefabricated dynamic LLPS device for any of the following conditions (this list is not all-inclusive):
  • Deformity or abnormal limb contour
  • Inability of individual to fit into a standard device so that effectiveness or individual compliance is compromised by poor fit
  • Intolerance of the prefabricated device due to skin breakdown

EXPERIMENTAL/INVESTIGATIONAL

DYNAMIC LLPS DEVICES
All other uses for dynamic LLPS devices including, but not limited to, the following are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature:
  • For the treatment of the shoulder and ankle
  • For the treatment of conditions including, but not limited to, chronic joint stiffness or chronic fixed contractures caused by rheumatoid arthritis, neuromuscular disease, stroke, cerebral palsy, plantar fasciitis, or long-term lack of motion in the joint

STATIC PROGRESSIVE STRETCH (SPS) DEVICES
SPS devices are considered experimental/investigational and, therefore, not covered because the
safety and/or
effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

PATIENT-ACTUATED SERIAL STRETCH (PASS) DEVICES
PASS devices are considered experimental/investigational and, therefore, not covered because the
safety and/or
effectiveness of this service cannot be established by review of the available published peer-reviewed literature.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

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.

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.
Guidelines

Dynamic low-load prolonged-duration stretch (LLPS) devices for the finger, wrist, elbow, knee, or toe should be monitored for improvement or benefit of use. An evaluation should be completed after a four-week period, and, if no improvement is demonstrated, use of the dynamic LLPS device should not be continued.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, dynamic LLPS devices for treatment of persistent joint stiffness are covered as durable medical equipment under the medical benefits of most of the Company’s products when the medical necessity criteria in this medical policy are met.

However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Mechanical stretching devices have been classified by the FDA as Class I medical devices and, therefore, exempt from Premarket Notification procedures.

Description

Joint stiffness or contractures result from structural changes in muscles, tendons, ligaments, and skin, and are often caused by immobilization after trauma, surgery, or disease. In pathological conditions in which joint immobilization is necessary to manage the problem, the connective tissue, which is composed of a network of collagenous and reticular fibers, elastic fibers, fibrin, and ground substance, shortens and thickens, causing reduced range of motion (ROM). Additionally, in the presence of trauma, edema, or impaired circulation, new collagen fibers form in as little as three days, which further restricts motion. The length of the fibers can either increase or decrease, depending, respectively, on the presence or absence of an opposing force. This remodeling, or reorganization, of the connective tissue is well documented through research.

Historically, the following approaches have been employed to increase joint ROM and soft tissue extensibility (not all-inclusive): 1) manual physical therapy involving passive stretching with progressively greater loads of force; 2) continuous passive motion (CPM); 3) the application of casts at regular intervals; and 4) static splinting. Alternatively, various types of mechanical stretching devices have recently been employed to increase joint ROM within selected joints, including the shoulder, neck, back, finger, wrist, elbow, knee, ankle, and toe. Mechanical stretching devices are designed to permanently elongate the connective tissue. Devices are generally categorized according to their mode of action: 1) dynamic splinting systems that are low-load prolonged-duration stretch (LLPS) devices; 2) static progressive stretch devices (SPS); and 3) patient-actuated serial stretch (PASS) devices. These devices are classified by the US Food and Drug Administration (FDA) as Class I medical devices.

CLASSIFICATION OF MECHANICAL STRETCHING DEVICES

DYNAMIC LOW-LOAD PROLONGED STRETCH (LLPS) DEVICES
The goal of dynamic splinting is to stress scarred or shortened connective tissue with an LLPS to promote non-traumatic, more permanent tissue remodeling. Examples of dynamic splinting system products include Dynasplint Systems® (Dynasplint Systems, Inc., Severna Park, MD), Ultraflex (UltraflexSystems Inc., Pottstown, PA), LMB Pro-glide (LifeTec Inc., Wheeling, Il), and EMPI Advance Dynamic ROM® (Empi, St. Paul, MN). These devices are widely used in the national orthopedic and physical therapy community for selected populations. Dynamic splinting devices, when applied to the following joints, are an effective adjunct to physical therapy received in the clinical setting:
  • Finger
  • Wrist
  • Elbow
  • Knee

Commonly, when dynamic LLPS devices are used continuously for 6-12 hours per day for up to four months consecutively, the result is the permanent elongation of connective tissue and an increase in ROM.

The evidence shows the beneficial effects on health outcomes of dynamic LLPS devices, compared with other types of mechanical stretching devices. Neuhaus et al (2012), in a prospective study, used dynamic splinting during the day and static extension splinting at night after extensor tendon laceration repairs in the fingers and in the thumb (entire thumb). Seventeen individuals with 19 lacerations were included; average time from injury to surgery was 12 days, and follow-up time averaged 96 days. Sixteen individuals achieved good or excellent results by six weeks. Fair results were reported in one individual. No complications were reported. Dynamic splinting systems were compared with controlled passive movement in 192 patients after repair of finger flexor tendon injuries. Total active movement was evaluated as excellent in 87% of those in the dynamic splinting group, while finger movement was evaluated as excellent in 75% of the passive movement group. It was concluded that dynamic splinting systems improved the outcome of the upper extremity, including ROM, grip strength, and function state of the hand, in repairs of the flexor tendons (Kitis 2009). Dynamic splinting systems have also been compared with static splinting in a prospective, randomized controlled study in postoperative individuals after extensor tendon repair. The dynamic splinting group improved when compared with the static group in all areas of total active motion, grip strength, and forceful grip strength (Mowlavi 2005).

Randomized controlled studies, observational studies, case series, and medical community acceptance confirm the benefits of dynamic LLPS devices when used to relieve persistent joint stiffness that can occur after injury or surgery. A retrospective record review was conducted to evaluate the effect of Home Wrist Extension Dynasplint on 133 individuals with distal radius fractures. Improvement in active ROM was demonstrated for all individuals (Berner 2010). Improvement was also noted in 86 patients who underwent a surgical procedure for extension deficits of the knee when Dynasplint Systems® (Dynasplint Systems, Inc., Severna Park, MD) was utilized. At follow-up of 4.6 years, the average extension had increased by 17 degrees (Freiling 2009).

For the dynamic splinting of the toe, a well-designed, randomized and controlled trial involving evaluation of the Dynasplint Metatarsophalangeal System® (MDS) (Dynasplint Systems, Inc., Severna Park, MD) for hallux limitus (ie, loss of motion in the great toe) occurring after either bunionectomy or cheilectomy was reported by John et al (2011). Fifty individuals with limited range of motion of the first metatarsophalangeal (MTP) joint (ie, great toe) within two months after surgery were randomized to treatment or control groups. Duration of the study was eight weeks. In addition to analgesics, orthotics and home stretching exercises, the treatment groups also received treatment with Dynasplint Systems® (Dynasplint Systems, Inc., Severna Park, MD). Results found a significant difference in change in active range of motion in the treatment group versus the control group. A greater difference occurred in individuals treated less than two months following bunionectomy or cheilectomy.

There is little evidence supporting the effectiveness of dynamic LLPS devices for the rehabilitation of joints other than finger, wrist, elbow, knee, and toe such as, but not limited to, shoulder, neck, back, and ankles. Furthermore, there is insufficient evidence in the published peer-reviewed literature to support the use of dynamic LLPS devices for the treatment of conditions such as, but not limited to, chronic joint stiffness or chronic fixed contractures caused by chronic conditions such as rheumatoid arthritis, neuromuscular disease, cerebral palsy, or plantar fasciitis. Sackley et al (2009) presented a systematic review of randomized trials for the treatment of foot drop and related contractures resulting from neuromuscular disease. Four studies with a total of 152 participants were included in the review. Among the modalities reviewed (physical, orthotic, and surgical treatments), night splinting of the ankle had no significant effect on muscle force or ROM in a trial involving 26 individuals with Charcot-Marie-Tooth disease. According to the authors, more evidence resulting from well-designed trials is needed to determine the appropriate intervention for foot drop in neuromuscular disease. Rose et al (2010) examined six children with cerebral palsy who were treated with dynamic splinting combined with neuromuscular electrical stimulation for wrist or elbow contractures. Wrist ROM improved in one participant treated for a wrist contracture. An increase in passive elbow extension was found in two participants; however, no accompanying change in upper limb function was demonstrated.

STATIC PROGRESSIVE STRETCH DEVICES
Static progressive stretch (SPS) devices apply stress relaxation and low-load stretch using components such as static line, turnbuckles, screws, and gears. These devices are designed to permanently lengthen shortened connective tissue. As the tissues lengthen in response to stress, the individual adjusts the splint to the new length. A typical session lasts 30 minutes and is repeated up to three times daily. Examples of SPS devices include Joint Active Systems® (JAS) splints (Joint Active Systems, Inc., Effington, IL) (JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination). Studies involving SPS devices are case reports limited by lack of randomization, lack of controls, and small sample size (typically 8 to 40 individuals). Additionally, many studies report outcomes from the same set of individuals (Ulrich 2010, Bonutti 2010, McGrath 2009). One study compared static progressive elbow splinting with dynamic splinting and found little difference in elbow extension or flexion between the groups (Lindenhovius 2012). This is the only investigation of the elbow treated with an SPS device, and the study was flawed by a high dropout rate and lack of a control group comparing splints with active, self-assisted stretching exercises. Other studies and literature reviews that compared dynamic and static devices after tendon repair of the hand found similar results for both devices (Riggs 2011) or improved outcomes for dynamic over static splinting (Kitis 2012, Sameem 2011). While Hammond et al (2012) found favorable outcomes with both devices, more tendon ruptures occurred, and more tenolysis procedures were required in the static group. Due to the lack of well-designed, well-conducted studies, conclusions cannot be reached regarding the effect of SPS devices on health outcomes.

In 2014, Ibrahim conducted a randomized, controlled, double-blind study of SPS device efficacy in treating capsulitis of the shoulder. Sixty patients were randomized into two groups: Group 1 received traditional physical therapy plus use of a static progressive stretch device; Group 2 received traditional physical therapy alone. Both groups received 3 traditional physical therapy sessions weekly for 4 weeks. In addition, the experimental group used an SPS (Joint Active Systems) device for 4 weeks. The device was to be worn for one 30-minute session daily for the first week; two 30-minute sessions per day during weeks 2 and 3; and three 30-minute sessions during week 4. The primary outcome was shoulder range of motion, and the secondary outcome was function (measured by the Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire) and pain (measured using a visual analogue scale [VAS]). After 4 weeks there was a significant increase in all ROM scores in the experimental group compared with the control group. The mean increase in active abduction was 76 degrees in group 1 compared with 47 degrees in group 2. Passive abduction increased by 65 degrees in group 1 vs. 37 degrees in group 2. Shoulder external rotation increased by 53 degrees in group 1 vs 30 degrees in group 2. Patients in both groups showed reduced pain at 4 and 12 weeks post-intervention. Patients in both groups showed functional improvement. At 12-month follow-up, significant differences were found between the groups in all outcome measures favoring the experimental group (P<0.001). The authors recognized study limitations. It is unknown whether improvements can be maintained over a longer period of time. Patient activity was not measured or controlled concluding that additional studies are needed to compare SPS and dynamic splinting for treatment of patients with adhesive capsulitis of the shoulder.

In 2015, Veltman reported a systematic review of the literature to evaluate evidence for the best non-operative treatment for post-traumatic elbow stiffness in adults. Eight studies with 232 elbows were included. The SPS device was used in 4 studies (160 elbows), and dynamic splinting was used in 3 studies (72 elbows). Only 1 randomized, controlled trial was included in the Veltman study. Treatment protocols varied greatly between the groups, including length of time the orthoses were used. The authors indicated the need for large prospective randomized studies of SPS vs dynamic splinting focusing on duration of splint use per day, patient satisfaction, and other outcome factors that have not been studied.

PATIENT-ACTUATED SERIAL STRETCH DEVICES
Patient-actuated serial stretch (PASS) devices allow resisted active and passive motion within a limited range. PASS devices provide a low-level to high-level load to the joint, using pneumatic or hydraulic systems that can be manually adjusted by the individual. Examples of PASS devices include the ERMI Knee Extensionater®, ERMI Elbow Extensionater®, ERMI Knee/Ankle Flexionater®, and the ERMI Shoulder Flexionater® (ERMI, Inc., Atlanta, GA). According to a retrospective medical review evaluating the efficacy of a high-intensity stretch device, although gains in passive knee extension were made, researchers were unable to determine whether the gains corresponded to improvement in clinical functional outcomes (Dempsey 2010). Other studies involving PASS devices have small sample sizes and are uncontrolled; therefore, there is insufficient evidence in the published peer-reviewed literature to determine the safety and effectiveness of the use of PASS devices for the treatment of joint stiffness or contractures.

STRETCH MODALITIES ON THE TREATMENT AND PREVENTION OF CONTRACTURES
Katalinic et al (2010) reviewed the effect of stretch modalities, including those that are self administered and therapist administered, splinting, and casting on the treatment and prevention of contractures in 35 studies with 1391 participants, and concluded that stretch has no clinically important effect on joint mobility in neurological or non-neurological conditions.

PREFABRICATED OR CUSTOM-FABRICATED MECHANICAL STRETCHING DEVICES

A prefabricated device is manufactured in quantity without a specific individual in mind. A prefabricated device may be trimmed, bent, molded (with or without heat), or otherwise modified (eg, custom-fitted) for use by a specific individual. A device that is assembled from prefabricated components is considered prefabricated.

A custom-fabricated device is made for a specific individual. The process of making a custom-fabricated device starts with basic materials, including, but not limited to: plastic, metal, leather, or cloth in the form of sheets, bars, etc. Custom-fabricated devices entail substantial work, including cutting, bending, molding, and sewing, and may also incorporate some prefabricated components. The construction of a custom-fabricated device involves more effort than merely trimming, bending, or making other modifications to a substantially prefabricated item.

The peer-reviewed literature does not show advantages of custom-fabricated dynamic LLPS devices, except for the following indications:
  • Deformity or abnormal limb contour
  • Inability of individual to fit into a standard device so that effectiveness or individual compliance is compromised by poor fit
  • Intolerance of the standard device secondary to skin breakdown

References


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Berner SH, Willis FB. Dynamic splinting in wrist extension following distal radius fractures. J Orthop Surg Res. 2010;6:53.

Bonutti PM, McGrath MS, Ulrich SD, et al. Static progressive stretch for the treatment of knee stiffness. Knee. 2008;15:272-6.

Bonutti PM, Marulanda GA, McGrath MS, et al. Static progressive stretch improves range of motion in arthrofibrosis following total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2010;19:194-9.

Bonutti PM, Windau JE, Ables BA, et al. Static progressive stretch to reestablish elbow range of motion. Clin Orthop Relat Res. 1994;303:128-34.

Branch TP, Karsch RE, Mills TJ, et al. Mechanical therapy for loss of knee flexion. Am J Orthop. 2003;32:195-200.

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ClinicalTrials.gov. Ankle equinus contracture treated with dynamic splinting. [Clinical Trials.gov Web site]. 07/10/13. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01238484?term=dynasplint&rank=7. Accessed February 11, 2019.

ClinicalTrials.gov. Hallux limitus treated with dynamic splinting: A randomized controlled trial. [Clinical Trials.gov Web site]. 04/27/2012. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00717691?term=%23NCT00717691&rank=1. Accessed February 11, 2019.

Clinicaltrials.gov. Plantar fasciitis treated with Dynamic Splinting. [Clinical Trials.gov Web site] 4/27/12. Available at:
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ClinicalTrials.gov. Dynamic splinting for patients with adhesive capsulitis (DS-SDH). Available at: https://clinicaltrials.gov/show/NCT00873158. Accessed February 11, 2019.

Costa CR, McElroy MJ, Johnson AJ, et al. Use of a static progressive stretch orthosis to treat post-traumatic ankle stiffness. BMC Res Notes. 2012;5:348.

Dempsey AL, Branch TP, Mills T, et al. High-intensity mechanical therapy for loss of knee extension for worker’s compensation and non-compensation patients. Sports Med Arthrosc Rehabil Ther Technol. 2010;2:26. {Epub ahead of print}

Doornberg JN, Ring D, Jupiter JB. Static progressive splinting for posttraumatic elbow stiffness. J Orthop Trauma. 2006;20:400-4.

Dynasplint® Systems, Inc.. Stretch beyond your expectations. [Dynasplint® Systems, Inc. Web site]. 2010. Available at: http://www.dynasplint.com/. Accessed February 11, 2019.

Empi®. Dynamic splinting. [Empi Web site]. Available at: http://www.djoglobal.com/. Accessed November 9, 2017.

Freiling D, Lobenhoffer P. The surgical treatment of chronic extension deficits of the knee. Oper Orthop Traumatol. 2009;21:545-56.

Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther. 2013;30:763-770.

Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution. J Hand Ther. 2011;24(3):195-205.

Hammond K, Starr H, Katz D, et al. Effect of aftercare with extensor tendon repair: a systematic review of the literature. J Surg Orthop Adv. 2012;21(4):246-252.

Ibrahim M, Donatelli R, Hellman M, et al. Efficacy of a static progressive stretch device as an adjunct to physical therapy in treating adhesive capsulitis of the shoulder: a prospective, randomized study. Physiotherapy. 2014 Sep;100:228-234.

Ibrahim MI, Johnson AJ, Pivec R, et al. Treatment of adhesive capsulitis of the shoulder with a static progressive stretch device: a prospective, randomized study. J Long Term Eff Med Implants. 2012;22:281-291.

Ibrahim MI, Johnson AJ, Pivec R, et al. Treatment of adhesive capsulitis of the shoulder with a static progressive stretch device: a prospective, randomized study. J Long Term Eff Med Implants. 2012;22:281-291.

John MM, Kalish S, Perns SV, et al. Dynamic splinting for postoperative hallux limitus: A randomized controlled trial. J Am Podiatr Med Assoc. 2011;101(4):285-288.

Katalinic OM, Harvey LA, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database Syst Rev. 2010;9:CD007455.

Kitis A, Ozcan RH, Bagdatli D, et al. Comparison of static and dynamic splinting regimens for extensor tendon repairs in zones V to VII. J Plast Surg Hand Surg. 2012;46(3-4):267-271.

Kitis PT, Buker N, Kara IG. Comparison of two methods of controlled mobilisation of repaired flexor tendons in zone. Scand J Plast Reconstr Surg Hand Surg. 2009;43:160-5.

Larson D, Jerosch-Herold C. Clinical effectiveness of post-operative splinting after surgical release of Dupuytren’s contracture: a systematic review. BMC Musculoskelet Disord. 2008;21:104.

Life Tec Inc.. Specializing in products for orthopedics, rehabilitation, and fitness. [Life Tec, Inc. Web site]. 1983. Available at: http://lifetecinc.com/. Accessed February 11, 2019.

Lindenhovius ALC, Doornberg JN, Brouwer KM, et al. A prospective randomized controlled trial of dynamic versus static progressive elbow splinting for posttraumatic elbow stiffness. J Bone Joint Surg Am. 2012;94(8):694-700.

Lucado AM, Li Z. Static progressive splinting to improve wrist stiffness after distal radius fracture: a prospective, case series study. Physiother Theory Pract. 2009;25:297-309.

McGrath MS, Ulrich SD, Bonutti PM, et al. Static progressive splinting for restoration of rotational motion of the forearm. J Hand Ther. 2009;22:3-8.

Mowlavi A, Burns M, Brown RE. Dynamic versus static splinting of simple zone V and zone VI extensor tendon repairs: a prospective, randomized controlled study. Plast Reconstr Surg. 2005;115:482-7.

Neuhaus V, Wong G, Russo KE, et al. Dynamic splinting with early motion following zone IV/V and TI to TIII extensor tendon repair. J Hand Surg Am. 2012; 37(5):933-937.

Papotto BA, Mills T. Treatment of severe flexion deficits following total knee arthroplasty. Orthop Nurs. 2012;31(1):29-34.

Postans N, Wright P, Bromwich W, et al. The combined effect of Dynamic splinting and Neuromuscular electrical stimulation in reducing wrist and elbow contractures in six children with Cerebral palsy. Prosthet Orthot Int. 2010;34:10-19.

Riggs JM, Lynden AS, Chung KC, et al. Static versus dynamic splinting for proximal interphalangeal joint pyrocarbon implant arthroplasty: a comparison of current and historical cohorts. J Hand Ther. 2011;24(3):231-238.

Rose KJ, Burns J, Wheeler DM, et al. Interventions for increasing ankle range of motion in patients with neuromuscular disease. Cochrane Database Syst Rev. 2010;2:CD006973.

Sackley C, Disler PB, Turner-Stokes L, et al. Rehabilitation interventions for foot drop in neuromuscular disease. Cochrane Database Syst Rev. 2009;8:CD003908.

Sameem M, Wood T, Ignacy T, et al. A systematic review of rehabilitation protocols after surgical repair of the extensor tendons in zones V-VIII of the hand. J Hand Ther. 2011;24(4):365-372.

Sharma NK, Loudon JK. Static progressive stretch brace as a treatment of pain and functional limitations associated with plantar fasciitis: a pilot study. Foot Ankle Spec. 2010;3:117-24.

Sheridan L, Lopez A, Perez A, et al. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010;100:161-5.

Steffen TM, Mollinger LA. Low-load prolonged stretch in the treatment of knee flexion contractures in nursing home residents. Phys Ther. 1995;75:886-95.

Stephenson JJ, Quimbo RA, Gu T. Knee-attributable medical costs and risk of re-surgery among patients utilizing non-surgical treatment options for knee arthrofibrosis in a managed care population. Curr Med Res Opin. 2010;6:1109-18.

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Ulrich SD, Bonutti PM, Sevler TM, et al. Restoring range of motion via stress relaxation and static progressive stretch in posttraumatic elbow contractures. J Shoulder Elbow Surg. 2010;19:196-201.

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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

E1800 Dynamic adjustable elbow extension/flexion device, includes soft interface material

E1802 Dynamic adjustable forearm pronation/supination device, includes soft interface material

E1805 Dynamic adjustable wrist extension/flexion device, includes soft interface material

E1810 Dynamic adjustable knee extension/flexion device, includes soft interface material

E1812 Dynamic knee, extension/flexion device with active resistance control

E1820 Replacement soft interface material, dynamic adjustable extension/flexion device

E1825 Dynamic adjustable finger extension/flexion device, includes soft interface material

E1830 Dynamic adjustable toe extension/flexion device, includes soft interface material


EXPERIMENTAL/INVESTIGATIONAL

E1801 Static progressive stretch elbow device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories

E1806 Static progressive stretch wrist device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories

E1811 Static progressive stretch knee device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories

E1815 Dynamic adjustable ankle extension/flexion device, includes soft interface material

E1816 Static progressive stretch ankle device, flexion and/or extension, with or without range of motion adjustment, includes all components and accessories

E1818 Static progressive stretch forearm pronation/supination device, with or without range of motion adjustment, includes all components and accessories

E1821 Replacement soft interface material/cuffs for bi-directional static progressive stretch device

E1831 Static progressive stretch toe device, extension and/or flexion, with or without range of motion adjustment, includes all components and accessories

E1840 Dynamic adjustable shoulder flexion/abduction/rotation device, includes soft interface material

E1841 Static progressive stretch shoulder device, with or without range of motion adjustment, includes all components and accessories

THE FOLLOWING CODE IS USED TO REPRESENT PATIENT-ACTUATED SERIAL STRETCH (PASS) DEVICES:

E1399 Durable medical equipment, miscellaneous


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References

Related Documents


Policy History

05.00.70b
03/27/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Mechanical Stretching Devices for the Treatment of Joint Stiffness or Contractures.
08/15/2018This policy has been reissued in accordance with the Company's annual review process.
12/06/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on Mechanical Stretching Devices for the Treatment of Joint Stiffness or Contractures.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 08/26/2016
Version Issued Date: 08/26/2016
Version Reissued Date: 03/27/2019

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