Medical Policy: 01.01.16
Original Effective Date: March 2009
Reviewed: January 2021
Revised: January 2021
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy 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 will be reviewed regularly and be updated as scientific and medical literature becomes available.
Mechanical stretching devices are generally proposed as an adjunct treatment to PT and/or exercise. Mechanical stretching devices differ from continuous passive motion devices in that they are nonmotorized and include the following types: low-load prolonged-duration stretch (LLPS) devices, patient-actuated serial stretch (PASS) devices and static progressive stretch (SPS) devices. Mechanical stretching devices are generally proposed as an adjunct treatment to physical therapy (PT) and/or exercise. Physical Therapy (PT)/Occupational Therapy (OT) procedures and stretching devices have been developed to increase ROM without damaging the affected joint or its related muscles, tendons, and connective tissue.
Treatment of joint stiffness/contractures may include physical therapy, manipulation under anesthesia, arthroscopic or open lysis of adhesions, or revision surgery. Conservative treatment typically consists of postoperative physical therapy with pressure stretching techniques and home exercises. When rehabilitation has failed, serial casting, static braces, or dynamic splints that provide low-load prolonged stretch may be used if appropriate and proven. Dynamic splints use spring loading or elastic bands to provide low-intensity tension (less than that exerted by a physical therapist) and are designed to be worn over relatively long periods (ie, 6-8 hours or overnight). The efficacy of a stretching regimen to permanently remodel tissue is considered to be a function of the intensity, length of the session, number of sessions per day, and number of days per week that stretching is performed.
Several types of dynamic splinting devices are available:
LLPS devices permit active and passive motion with elastic traction within a limited range. The devices maintain a set level of tension by incorporated springs. Examples of low-load, prolonged-duration stretch (LLPS) devices include:
SP stretch devices hold the joint in a set position, while allowing manual modification of the joint angle, and may allow active motion without resistance. The device does not exert stress on the tissue unless the angle is set to the joint’s limitation. This type of device allows a limited range of passive or active motion, but the motion is free and does not provide elastic traction. Available static progressive (SP) stretch devices include:
PASS devices provide a low-to high-level load to the joint using pneumatic (Extensionators [ERMI} or hydraulic (Flexionators [ERMI}) systems that are adjusted by the patient. PASS devices are custom-fitted and are available for the ankle, elbow, knee, and shoulder. A customized treatment protocol and training in use of the device are provided to the patient. Available patient-actuated serial stretch (PASS) devices include:
Jaw stretch devices are devices that open the jaw to stretch the oro-facial tissues and mobilize the temporomandibular joint (TMJ). It is used primarily to prevent and treat trismus and scarring or fibrosis from radiation therapy, surgery, and trauma. Brands include:
The use of low-load prolonged stretch (LLPS) splinting devices are proven for improvement of range of motion after surgery or injury when physical therapy alone has not been effective. The use is limited to joints of the knee, elbow, toe, finger, and wrist. Use in other joints has not been proven at this time. Use prophylactically has not been proven at this time. Success in use with chronic or long-term fixed contractures has not been proven at this time.
The U.S. Food and Drug Administration (FDA) has determined that devices classified as “Exerciser, Non-Measuring” are considered Class I devices and exempt range of motion 510(k) requirements. This classification does not require submission of clinical data on efficacy, only notification to the FDA prior to marketing.
This Policy addresses mechanical stretching devices including:
Low-load prolonged stretch (LLPS) will be considered medically necessary for those with contractures of the following joints, caused by injury or joint stiffness (not due to the indications found in the investigational list) of the following joints:
There is no evidence that prolonged use of dynamic splinting devices past four months has been any more effective in long-term outcomes.
Dynamic splinting devices (dynamic (low-load prolonged stretch [LLPS]) devices are considered investigational for use with joints other than knee, elbow, toe, finger, and wrist.
Dynamic splinting devices (dynamic (low-load prolonged stretch [LLPS]) devices which are specific to the ankle and shoulder are considered investigational for all indications including but not limited to the management of chronic joint stiffness or chronic fixed contractures due to trauma, fractures, burns, head and spinal cord injury, rheumatoid arthritis, multiple sclerosis, muscular dystrophy, or cerebral palsy. Based on peer reviewed literature there is lack of scientific evidence regarding the safety and effectiveness of dynamic splinting for these indications.
The use of dynamic splinting devices are not appropriate and are unproven in the pediatric population. Dynamic splinting devices are investigational for pediatrics, those patients under 18 years of age.
The use of dynamic splinting devices are not appropriate and unproven in the use of chronic conditions including, but not limited to: contractures from chronic conditions, arthritis. Prophylactic use of dynamic splinting is investigational in the management of chronic contractures.
Dynamic splinting is considered investigational for the following indications (this is not an all-inclusive list):
Based on peer reviewed literature there is lack of scientific evidence regarding the safety and effectiveness of dynamic splinting for these indications and therefore, is considered investigational.
Bi-directional static progressive stretch (SPS) devices including JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) are considered investigational for all indications.
Clinical evidence is not sufficient to demonstrate that use of static progressive or patient actuated devices is a safe or effective treatment option. Studies are limited to small sample sizes. Based on peer review literature clinical evidence is not sufficient to demonstrate that the use of a static progressive stretch device improves long-term patient outcomes. Evidence is limited to primarily short-term outcomes and lack of comparison to other treatment modalities and therefore is considered investigational for all indications.
Patient-actuated serial stretch (PASS) (including but not limited to ERMI Flexonaters and Extensonators) devices are considered investigational for all indications.
Based on peer reviewed literature, there is lack of published studies investigating PASS devices, no conclusion can be drawn regarding their efficacy. Therefore, patient-actuated serial stretch (PASS) devices are considered investigational for all indications.
Use of jaw stretch devices (e.g. TheraBite, OraStretch) is considered investigational
Based on peer reviewed literature, there is lack of published studies investigating jaw stretch devices. No conclusion can be drawn regarding their efficacy.
Use of the SaeboMas (e.g. SaeboFlex, SaeboReach) support system is considered investigational.
Based on peer reviewed literature, there is lack of published studies investigating the SaeboMas support system for patients. No conclusion can be drawn regarding the efficacy.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.