Latest Review Date: December 2024

Category: Durable Medical Equipment (DME)                                                                    

POLICY:

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 investigational.

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:

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. Mechanical stretching devices are generally proposed as an adjunct treatment to PT and/or exercise.

LLPS devices, also referred to as dynamic splinting, permit active and passive motion with elastic traction within a limited range and maintain a set level of tension by means of incorporated springs. Examples of LLPS devices include, but may not be limited to, Advance Dynamic ROM, Dynasplint, EMPI Advance Dynamic ROM, Proglide Advance Dynamic ROM, LMB Pro-Glide, SaeboFlex, SaeboReach, Stat-A-Dyne and Ultraflex.

Jaw mobility mechanical stretching devices are suggested for use in the treatment of temporomandibular joint (TMJ) disorders, trismus or other conditions in which jaw movement is limited. Examples of this type of mechanical stretching device include, but may not be limited to, TheraBite Jaw Motion Rehabilitation System, Dynasplint Trismus System or Orastretch.

KEY POINTS:

This evidence review was created with searches of the PubMed database. The most recent literature update was performed through December 10, 2024.

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. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

The use of low-load prolonged stretch (LLPS) splinting devices in joints other than those mentioned above and prophylactic use has not been proven at this time. Effectiveness with chronic or long-term fixed contractures has not been proven at this time. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

KEY WORDS:

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™, active resistance control

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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts:Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING:

HCPCS:

REFERENCES:

1. Aspinall SK, Bamber ZA, Hignett SM, et al. Medical stretching devices are effective in the treatment of knee arthrofibrosis: A systematic review. J Orthop Translat. 2021;27:119-131.
2. 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.
3. Canale & Beaty:  Campbell’s Operative Orthopedics, 11th edition, Mosby 2007.
4. Finger E and Willis FB.  Dynamic Splinting for Knee Flexion Contracture Following Total Knee Arthroplasty:  A Case Report.  Cases Journal 2008; I: 421.
5. 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.
6. Hayes Directory. (2013, February 20). Mechanical stretching devices and continuous passive motion for joints of the extremities. Retrieved from http://www.hayesinc.com. 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.
7. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
8. Kalish SR and Willis FB.  Hallux Limitus and Dynamic Splinting:  A Retrospective Series.  The Foot and Ankle Online Journal 2009, Vol. 2, No. 4.
9. 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.
10. 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.
11. 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.
12. Lundequan P and Willis FB.  Dynamic splinting home therapy for toe walking:  A case report.  Cases Journal 2009; 2: 188.
13. 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.
14. 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.
15. 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.
16. Ring D, et al.  Hinged elbow external fixation for severe elbow contracture.  Am Journal Bone Joint Surgery, June 2005; 87(6): 1293-1296.
17. Roos E, et al.  Foot orthoses for the treatment of plantar fasciitis.  Foot Ankle International, August 2006; 27(8): 606-611.
18. Sheridan L, Lopez A, et al.  Plantar Fasciopathy treated with dynamic splinting.  Journal of the American Podiatric Medical Association 2010; 100(3):161-165.
19. Stubblefield MD et al. A preliminary report on the efficacy of a dynamic jaw opening device (dynasplint trismus system) as part of the multimodal treatment of trismus in patients with head and neck cancer. Arch Phys Med Rehabil. 2010;91(8): 1278-1282.
20. 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.
21. 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.
22. 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.
23. Verdugo RJ, Salinas RA, Castillo JL and Cea JG.  Surgical versus non-surgical treatment for carpal tunnel syndrome.  Cochrane Database Syst Rev 2008; CD001552.

POLICY HISTORY:

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.

Medical Policy Group, December 2022 (6): Updates to Description, Key Points and References.

Medical Policy Group, December 2023 (6): Updates to Key Points and Benefit Application.

Medical Policy Group, November 2024 (6) 2025 Annual Coding Update. Added HCPCS E1803, E1804, E1807, E1808, E1813, E1814, E1822, E1823, E1826, E1827, E1828, E1829 to Current Coding section.

Medical Policy Group, December 2024 (6): Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Key Points and Key Words. 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.