mp-346 - Medical Policies - Alabama
Stretching and Splinting Devices for the Treatment of Joint Stiffness and Contractures
Policy Number: MP-346
Latest Review Date: January 2022
Dynamic low-load prolonged-duration stretch (LLPS) devices for use on the ankle, knee, elbow, wrist, finger or jaw may be considered medically necessary for a period of up to 4 months in the following clinical setting:
- As a treatment for loss of motion from a contracture as part of a formal rehabilitation program or when a formal rehabilitative program is not feasible or has failed to provide benefit.
Only one device is covered per affected area, i.e., separate devices for flexion and extension for the same area are considered not medically necessary.
The use of dynamic LLPS devices for any other joint or condition including, but not limited to toe, foot, shoulder and forearm disorders, chronic joint stiffness, chronic or fixed contractures, rheumatoid arthritis or plantar fasciitis are considered investigational.
Dynamic low-load prolonged-duration stretch (LLPS) devices are non-covered when used as a part of post-operative care.
The use of dynamic, extension/flexion devices with active resistance control are considered investigational.
The use of carpal tunnel dynamic splinting as a non-surgical rehabilitative modality for the treatment of carpal tunnel syndrome is considered investigational.
For Bi-directional static progressive (SP) stretch devices and patient-actuated serial stretch (PASS) devices, please refer to Medical Policy 578-Patient-actuated End Range Motion Stretching Devices.
DESCRIPTION OF PROCEDURE OR SERVICE:
Joint stiffness or contractures may be caused by immobilization following an injury, disease, or surgery. A joint contracture is characterized by persistently reduced range of motion (ROM) as a result of structural changes in muscles, tendons, ligaments, and skin. This decrease in joint mobility occurs when elastic connective tissue is replaced with inelastic fibrous material, resulting in tissue that is resistant to stretching. Other causes of joint contractures include spasticity secondary to nerve damage, such as stroke or spinal cord injury and muscle weakness due to muscle, tendon, or ligament disease including paralysis.
Stretching devices are intended to stretch joints that have reduced range of motion secondary to immobilization, surgery, contracture, fracture, dislocation, or a number of additional non-traumatic disorders. These devices are intended to replace or reduce the number of physical therapist-directed sessions by providing frequent and controlled joint mobilization in a hospital or in a patient’s home. The goal is to cause permanent elongation of the connective tissue in order to increase range of motion. Mechanical stretching devices are not motorized and may be prefabricated or custom fabricated.
Dynamic low-load prolonged-duration stretch (LLPS) devices allow resisted active and passive motion (elastic traction) within a restricted range. LLPS devices sustain a set level of tension using integrated springs. Examples of LLPS devices include but are not limited to: Dynasplint System®, Dynasplint® Trismus System, EMPI Advance Dynamic ROM®, and LMB Pro-Glide™.
Low-load prolonged-duration stretch (LLPS) device/dynamic stretch device (HCPCS codes E1800, E1802, E1805, E1810, E1812, E1815, E1825, E1830, E1840)
Jaw Stretch Devices:
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:
- TheraBite® Jaw Motion Rehabilitation System™
- OraStretch™ Press Jaw Motion Rehab
Jaw stretch device (HCPCS codes E1700, E1701, E1702)
Literature review through January 2022.
SUMMARY OF EVIDENCE:
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 jaw, ankle, knee, elbow, 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.
Joint stiffness, contracture, dynamic low-load prolonged-duration stretch (LLPS) devices, plantar fasciitis, Dynasplint System, Dynasplint Trismus System, EMPI Advance Dynamic ROM, LMB Pro-Glide,TheraBite®, OraStretch™
APPROVED BY GOVERNING BODIES:
Mechanical stretching devices are classified by the FDA as Class 1 medical devices. Class 1 devices have the least amount of regulatory control; manufacturers of these devices are exempt from premarket notification procedures and are not required to provide safety and effectiveness data prior to marketing. Numerous mechanical stretch devices have been developed and are generally categorized as static progressive (SP) stretch devices, low-load, prolonged-duration stretch (LLPS) devices, and patient-actuated serial stretch (PASS) devices.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Jaw motion rehabilitation system
Replacement cushions for jaw motion rehabilitation system, pkg. of 6
Replacement measuring scales for jaw motion rehabilitation system, pkg. of 200
Dynamic adjustable elbow extension/flexion device, includes soft interface material
Dynamic adjustable forearm pronation/supination device, includes soft interface material
Dynamic adjustable wrist extension / flexion device, includes soft interface material
Dynamic adjustable knee extension / flexion device, includes soft interface material
Dynamic knee, extension/flexion device with active resistance control
Dynamic adjustable ankle extension/flexion device, includes soft interface material
Replacement soft interface material, dynamic adjustable extension/flexion device
Dynamic adjustable finger extension/flexion device, includes soft interface material
Dynamic adjustable toe extension/flexion device, includes soft interface material
Dynamic adjustable shoulder flexion / abduction / rotation device, includes soft interface material
- Berlet GC, et al. A prospective trial of night splinting in the treatment of recalcitrant plantar fasciitis: the ankle dorsiflexion Dynasplint. Orthopedics, November 2002; 25(11): 1273-1275.
- Berner SH, Willis FB and Martinez J. Treating carpal tunnel syndrome with dynamic splinting: A randomized, controlled trial. The Journal of Medicine, December 2008, Vol. 1, Issue 1.
- Bolitho DG. Hand, tendon lacerations: Flexors. June 2006, www.emedicine.medscape.com/article/1286303-print.
- Branch TP, et al. Mechanical therapy for loss of knee flexion. American Journal of Orthopedics, April 2003; 32(4): 195-200.
- Bruner S, et al. Dynamic splinting after extensor tendon repair in zones V to VII. Br Journal of Hand Surgery, June 2003; 28(3): 224-227.
- Canale & Beaty: Campbell’s Operative Orthopedics, 11th edition, Mosby 2007.
- Cetin A, et al. Rehabilitation of flexor tendon injuries by use of a combined regimen of modified Kleinert and modified Duran techniques. American Journal Physical Medicine Rehabilitation, October 2001; 80(10): 721-728.
- Chester DL, et al. A prospective, controlled, randomized trial comparing early active extension with passive extension using a dynamic splint in the rehabilitation of repaired extensor tendons. Br Journal of Hand Surgery, June 2002; 27(3): 283-288.
- Crawford F, et al. Interventions for treating plantar heel pain. Cochrane Database System Review 2003; (3): CD000416.
- Crosby CA, et al. Early protected motion after extensor tendon repair. American Journal Hand Surgery, September 1999; 24(5): 1061-1070.
- Egan M, et al. Splints/orthoses in the treatment of rheumatoid arthritis. Cochrane Database System Review 2003(1): CD004018.
- Farmer SE, et al. Dynamic orthoses in the management of joint contracture. British Journal Bone Joint Surgery, March 2005; 87(3): 291-295.
- Finger E and Willis FB. Dynamic Splinting for Knee Flexion Contracture Following Total Knee Arthroplasty: A Case Report. Cases Journal 2008; I: 421.
- Frontera: Essentials of Physical Medicine and Rehabilitation, 1st edition, Hanley and Belfus, Inc. 2002.
- Furia JP, Willis FB, Shanmugam R, Curran SA. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther. 2013;30(8):763-770.
- Germann G, et al. Early dynamic motion versus post-operative immobilization in patients with extensor indicis proprius transfer to restore thumb extension: A prospective randomized study. Journal Hand Surgery, November 2001; 26(6): 1111-1115.
- Gerritsen AA, Korthals-de Bos IB, Laboyrie PM, et al. Splinting for carpal tunnel syndrome: A randomized controlled trial. JAMA 2002; 288: 1245.
- Harvey L, et al. Does stretching induce lasting increases in joint ROM? A systematic review. Physiotherapy Res Int 2002; 7(1): 1-13.
- Hayes Directory. (2013, February 20). Mechanical stretching devices and continuous passive motion for joints of the extremities. Retrieved from http://www.hayesinc.com. Accessed January 07, 2020.
- Henrichs J, et al. Shoulder impingement syndrome. Primary Care, December 2004; 31(4): 789-805.
- Hewitt B, et al. Flexion vs. extension: A comparison of post-operative total knee arthroplasty mobilization regimens. Knee, December 2001; 8(4): 305-309.
- John MM, Willis FB and Portillo A. Dynamic Splinting for Runner’s Toe. A Case Report with Gait Analysis. Journal of the American Podiatric Medical Association, July/August 2009, Vol. 99, No. 4, pp. 367-370.
- Kalish SR and Willis FB. Hallux Limitus and Dynamic Splinting: A Retrospective Series. The Foot and Ankle Online Journal 2009, Vol. 2, No. 4.
- Khandwala AR, et al. A comparison of dynamic extension splinting and controlled active mobilization of complete divisions of extensor tendons in zones 5 and 6. Br Journal of Hand Surgery, April 2000; 25(2): 140-146.
- Khandwala AR, et al. Immediate repair and early mobilization of the extensor pollicis longus tendon in zones 1 to 4. Journal Hand Surgery, June 2004; 29(3): 250-258.
- Lai JM, Jones M and Willis FB. Efficacy of Dynamic Splinting on Plantar-Flexion Tone and Contracture Seen in CVA and TBI Patients: A Controlled Cross-Over Study. Proceedings of the 16th European Congress of Physical and Rehabilitation Medicine 2008; 106-109.
- Larson D and Jerosch-Herold C. Clinical Effectiveness of Post-Operative Splinting After Surgical Release of Dupuytren’s Contracture: A Systematic Review. BMC Musculoskeletal Disorders 2008; 9: 104.
- Lindenhovius AL, 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.
- Lundequan P and Willis FB. Dynamic splinting home therapy for toe walking: A case report. Cases Journal 2009; 2: 188.
- Martin JE, et al. Mechanical treatment of plantar fasciitis. A prospective study. Journal American Podiatry Medical Association, February 2001; 91(2): 55-62.
- McPoil TG, et al. Heel Pain – Plantar Fasciitis: clinical practice guidelines linked to the international classification of functioning, disability, and health from the Orthopedic section of the American Physical Therapy Association. J. Orthop. Sports Phys. Ther. 2008; 38(4):A1-A18.
- Mowlavi A, et al. Dynamic versus static splinting of simple zone V and zone VI extensor tendon repairs: A prospective, randomized, controlled study. Plastic Reconstructive Surgery, February 2005; 115(2): 482-487.
- Plaass C, Karch A, Koch A, et al. Short term results of dynamic splinting for hallux valgus - A prospective randomized study. Foot Ankle Surg. 2020;26(2):146-150.
- Porter D, et al. The effects of duration and frequency of Achilles tendon stretching on dorsiflexion and outcome in painful heel syndrome: a randomized, blinded, control study. Foot Ankle Int. July 2002; 23(7):619-624.
- Ring D, et al. Hinged elbow external fixation for severe elbow contracture. Am Journal Bone Joint Surgery, June 2005; 87(6): 1293-1296.
- Roos E, et al. Foot orthoses for the treatment of plantar fasciitis. Foot Ankle International, August 2006; 27(8): 606-611.
- Sheridan L, Lopez A, et al. Plantar Fasciopathy treated with dynamic splinting. Journal of the American Podiatric Medical Association 2010; 100(3):161-165.
- Steffan TM, et al. Low-load, prolonged stretch in the treatment of knee flexion contractures in nursing home residents. Physical Therapy, October 1995; 75(10): 886-895.
- Thomas JL, et al. The diagnosis and treatment of heel pain: a clinical practice guideline – revision 2010. The Journal of Food and Ankle Surgery 2010; 49:S1-S19.
- U.S. Food and Drug Administration (FDA): Centers for Devices and Radiologic Health. www.accessdata.fda.gov/scripts/cdrh/cfdocs/search/search.cfm?db=CFR&id-890.3475.
- Veltman ES, Doornberg JN, Eygendaal D, et al. Static progressive versus dynamic splinting for posttraumatic elbow stiffness: A systematic review of 232 patients. Arch Orthop Trauma Surg. 2015;135(5):613-617.
- Verdugo RJ, Salinas RA, Castillo JL and Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. Cochrane Database Syst Rev 2008; CD001552.
- Yasukawa A, et al. Efficacy for maintenance of elbow range of motion of two types of orthotic devices: A case series. Journal of Prosthetics and Orthotics 2003, Vol. 15, No. 2, pp. 72-77.
Medical Policy Group, January 2009 (3)
Medical Policy Administration Committee, July 2009
Medical Policy Group, September 2009 (3)
Medical Policy Administration Committee, October 2009
Available for comment October 3-November 17, 2009
Medical Policy Group, December 2009 (3)
Medical Policy Group, December 2010 – Add CPT Code effective Jan 1, 2011
Medical Policy Group, April 2011 – Added Key Points, Key Word, and References
Medical Policy Group, February 2012 (3): Added new devices in Policy Section.
Medical Policy Administration Committee, February 2012
Medical Policy Group, May 2013: Effective 05/1/2013: Active Policy but no longer scheduled for regular literature reviews and updates.
Medical Policy Group, September 2013 (2): Added new Key Word ‘FlexPro Knee Flexor’
Medical Policy Group, August 2014 (5): Added References; no change to policy statement.
Medical Policy Group, January 2015 (6): Removed information on bi-directional static progressive (SP) stretch devices and Patient-actuated serial stretch (PASS) devices – these devices are addressed in Medical Policy 578.
Medical Policy Group, January 2020 (6): Updates to Description, Key Points, Key Words (Dynasplint System, Dynasplint Trismus System, EMPI Advance Dynamic ROM, and LMB Pro-Glide) and References. No change to policy intent.
Medical Policy Group, January 2021 (6): Updates to Key Points and References. No change to policy intent.
Medical Policy Group, January 2022 (6): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.Updates to Description, Key Words (TheraBite®, OraStretch™) and Key Points. Policy statement updated to remove “not medically necessary,” no change to policy intent.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.