Coverage Policies

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

There are four main types of mechanical systems used to treat stiff joints, usually after surgery or in joints with scar tissue. Dynamic splinting can sometimes be shown to be effective, and requires preauthorization. Many other types of splints are not covered because there is insufficient evidence of their effectiveness.

1.     Dynamic splints (e.g. Dynasplint) require pre-authorization.

2.     Flexionators and extensionators (e.g. ERMI Shoulder flexionator, ERMI knee extensionator) are not covered.

3.     Joint Active Systems (JAS) Splints (e.g. JAS Knee, JAS Elbow) are not covered.

4.     Continuous passive motion (CPM) devices are not covered.

Dynamic Splinting Devices:

1. Dynamic splinting devices for the knee, elbow, wrist or finger are considered medically necessary if either of the following two selection criteria is met:
   1. As an adjunct to physical therapy in members with documented signs and symptoms of significant motion stiffness/loss in the sub-acute injury or post-operative period (i.e., at least 3 weeks after injury or surgery); or
   2. In the acute post-operative period for members who have a prior documented history of motion stiffness/loss in a joint and are having additional surgery or procedures done to improve motion to that joint.
2. The prophylactic use of dynamic splinting is considered experimental and investigational in the management of chronic contractures and joint stiffness due to joint trauma, fractures, burns, head and spinal cord injuries, rheumatoid arthritis, multiple sclerosis, muscular dystrophy or cerebral palsy in the absence of surgery to the affected joint. However, if surgery is being performed for a chronic condition, the use of a dynamic splinting system may be considered medically necessary if the member meets the selection criteria stated above. HAYES C
3. Dynamic splinting in the management of joint injuries of the shoulder, ankle, and toe is considered experimental and investigational because there is a lack of scientific evidence regarding its effectiveness for these indications. HAYES C

Flexionators and Extensionators:

The knee/ankle flexionator, the shoulder flexionator, the knee extensionator, and the elbow extensionator are considered experimental and investigational because of a lack of scientific evidence of the effectiveness of these devices. HAYES D

Joint Active Systems (JAS) Splints:

JAS splints (e.g. JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) are considered experimental and investigational because there is insufficient evidence in the peer-reviewed published medical literature concerning their effectiveness. HAYES D

Continuous Passive Motion (CPM) Devices

CPM, as an adjunct to physical therapy, for the knee or other joints in the early postoperative phase, is considered experimental and investigational because there is unproven benefit or insufficient evidence in the peer-reviewed published medical literature concerning effectiveness. HAYES C for knees and shoulders, HAYES D2 for other joints

Codes Used In This BI:

29126                     Apply forearm splint

29131                     Application of finger splint

E0935                     Continuous passive motion device for use on knee only

E0936                     Continuous passive motion device for use other than knee

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

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

E1802                     Dynamic adjustable forearm pronation/supination device, includes

                              soft interface material

E1805                     Dynamic adjustable wrist extension/flexion device, includes

                              soft interface material

E1806                     Static progressive stretch wrist device, extension and/or flexion,

                              with or without range of motion adjustment, includes all

                              components/accessories

E1810                     Dynamic adjustable knee extension/flexion device, includes

                              soft interface material

E1811                     Static progressive stretch knee device, extension and/or flexion,

                              with or without range of motion adjustment, includes all

                              components/accessories

E1812                     Dynamic knee, extension/flexion device with active resistance

                              Control

E1815                     Dynamic adjustable ankle extension/flexion device, includes

                              soft interface material

E1816                     Static progressive stretch ankle device, extension and/or flexion,

                              with or without range of motion adjustment, includes all

                              components/accessories

E1818                     Static progressive stretch forearm pronation/supination device,

                              with or without range of motion adjustment, includes all

                              components/accessories

E1820                     Replacement soft interface material, dynamic adjustable

                              extension/flexion device

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

                              progressive stretch device

E1825                     Dynamic adjustable finger extension/flexion device, includes

                              soft interface material

E1830                     Dynamic adjustable toe extension/flexion device, includes

                              soft interface material

E1831                     Static progressive stretch toe device, extension and/or flexion,

                              with or without range of motion adjustment, includes all

                              components/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/accessories

Dynamic Splinting Systems:

• Dynamic splinting systems are spring-loaded, adjustable devices designed to provide low-load prolonged stretch while patients are asleep or at rest. Dynamic splinting units (for both extension as well as flexion) are available for elbow, wrist, fingers, knee, ankle, and toes. These units are being marketed for the treatment of joint stiffness due to immobilization or limited range of motion (ROM) as a consequence of fractures, dislocations, tendon and ligament repairs, joint arthroplasties, total knee replacements, burns, rheumatoid arthritis, hemophilia, tendon releases, head trauma, spinal cord injuries, cerebral palsy, multiple sclerosis, and other traumatic and non-traumatic disorders.
• Dynamic splinting is commonly used in the post-operative period for the prevention or treatment of motion stiffness/loss in the knee, elbow, wrist, or finger. It is not generally used in other joints such as the hip, ankle, or foot.
• Product names commonly encountered on the market for dynamic splinting include: Dynasplint™, Ultraflex™, LMB Pro-glide™, and EMPI Advance™.

Flexionators and Extensionators:

• The shoulder flexionator (ERMI Shoulder Flexionater®) is designed to isolate and treat decreased glenohumeral abduction and external rotation. The device is intended to addresses the needs of patients with excessive scar tissue. This customizable device has biomechanically and anatomically located pads to focus treatment on the glenohumeral joint, without stressing the other shoulder joints. Once customized, the shoulder flexionator can be used by the patient at home without assistance to perform serial stretching exercises, alternately stretching and relaxing the scar tissue surrounding the glenohumeral joint. The device has three sections, the main frame, arm unit, and pump unit. The shoulder flexionator was listed with the FDA in 2001, and is Class I exempt.
• The knee/ankle flexionator (ERMI Knee/Ankle Flexionater®) is a self-contained device that facilitates recovery from decreased range of motion of the knee and/or ankle joints. The knee flexionator is designed to address the needs of patients with artrofibrosis (excessive scar tissue within and around a joint). The knee/ankle flexionator is a variable load/variable position device that uses a hydraulic pump and quick-release mechanism to allow patients to perform dynamic stretching exercises in the home without assistance, alternately stretching and relaxing the scar tissue surrounding affected joints.
• The knee extensionator (ERMI Knee Extensionater®) and elbow extensionator (ERMI Shoulder Extensionater®) provide serial stretching, using a patient-controlled pneumatic device that can deliver variable loads to the affected joint. The manufacturer claims that the knee and shoulder extensionators are the only devices on the market that can “consistently stretch scar tissue, without causing vascular re-injury and thereby significantly reduce the need for additional surgery” (ERMI, 2002).
• There are no controlled published peer-reviewed studies on the effectiveness of the knee/ankle flexionator, the shoulder flexionator, the knee extensionator, or the elbow extensionator. There is insufficient scientific evidence to support the manufacturer`s claims that these home-based stretching devices can consistently stretch scar tissues without causing vascular re-injury and thus significantly reduce the need for additional surgery (e.g., surgery for artrofibrosis after knee surgery). Furthermore, there is a lack of published data to support the claim that these devices can reduce the need for surgery manipulation under anesthesia. Therefore, extensionator and flexionator devices are considered experimental and investigational.

Joint Active Systems (JAS) Splints:

• JAS splints (e.g., JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) (Joint Active Systems, Effingham, IL) use static progressive stretch. Typically, the patient sets the device angle at the beginning of the session, and every several minutes the angle is increased. Unlike the flexionator, the joint is not allowed to recover during the stretch period. According to the manufacturer, JAS systems are designed to simulate manual therapy. The manufacturer claims that JAS devices eliminate the risk of joint compression, provide soft tissue distraction, and “achieve permanent soft tissue lengthening in a short amount of time.”
• Published reports of the effectiveness of JAS splints are limited to case reports and small uncontrolled case series. There are no prospective randomized studies demonstrating that the addition of the use of JAS devices to the physical therapy management of patients with joint injury or surgery significantly improves patient`s clinical outcomes. Thus, JAS splints are considered experimental and investigational.

1. HAYES Inc. Mechanical Stretching Devices and Continuous Passive Motion for Joints of the Extremities; published July 7, 2005.
2. HAYES Inc. Continuous Passive Motion for the Treatment of Joint Contractures of the Extremities; published March 1, 2013
3. McClure PW, Blackburn LG, Dusold C. The use of splints in the treatment of joint stiffness: Biologic rationale and an algorithm for making clinical decisions. Phys Ther. 1994; 74(12):1101-1107.
4. Hepburn GR, Crivelli KJ. Use of elbow Dynasplint for reduction of elbow flexion contractures: A case study. J Orthop Sports Phys Ther. 1984; 5(5):269-274.
5. Mackay-Lyons M. Low-load, prolonged stretch in treatment of elbow flexion contractures secondary to head trauma: A case report. Phys Ther. 1989; 69(4):292-296.
6. Hepburn GR. Case studies: Contracture and stiff joint management with Dynasplint. J Orthop Sports Phys Ther. 1987; 8:498-504.
7. Steffen TM, Mollinger LA. Low-load, prolonged stretch in the treatment of knee flexion contractures in nursing home residents. Phys Ther. 1995; 75(10):886-897.
8. Chow JA, Dovelle S, Thomes LJ, et al. A comparison of results of extensor tendon repair followed by early controlled mobilization versus static immobilization. J Hand Surg. 1989; 14(1):18-20.
9. Browne EZ Jr, Ribik CA. Early dynamic splinting for extensor tendon injuries. J Hand Surg [Am]. 1989; 14(1):72-76.
10. Kerr CD, Burczak JR. Dynamic traction after extensor tendon repair in zone 6, 7, and 8: A retrospective study. J Hand Surg [Br]. 1989; 14(1):21-25.
11. Blair WF, Steyers CM. Extensor tendon injuries. Orthop Clin North Am. 1992; 23(1):141-148.
12. Center for Medicare and Medicaid Services (CMS). Payment and coding determinations for new durable medical equipment. CMS Public Meeting Agenda. Baltimore, MD: CMS; June 17, 2002. Available at: http://www.hcfa.gov/medicare/jun2dme.pdf. Accessed July 25, 2002.
13. ERMI, Inc. Insurance Provider Information Folder. Decatur, GA: ERMI; 2002.
14. Bonutti PM, Windau JE, Ables BA, et al. Static progressive stretch to reestablish elbow range of motion. Clin Orthop. 1994; 303:128-134.
15. Jansen CM, Windau JE, Bonutti PM, et al. Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther. 1996; 76(2):182-186.
16. Cohen EJ. Adjunctive therapy devices: Restoring ROM outside of the clinic. Phys Ther Magazine. 1995 Mar: 10-13.
17. Joint Active Systems, Inc. JAS OnLine [website]. Effingham, IL: Joint Active Systems; 2002. Available at: http://www.jointactivesystems.com/
18. Branch TP, Karsch RE, Mills TJ, Palmer MT. Mechanical therapy for loss of knee flexion. Am J Orthop. 2003; 32(4):195-200.
19. Egan M, Brosseau L, Farmer M, et al. Splints and orthosis for treating rheumatoid arthritis (Cochrane Review). In: The Cochrane Library, Issue 3, 2003. Oxford, UK: Update Software.
20. Howard JS, Mattacola CG, Romine SE and Latterman C. Continuous Passive Motion, Early Weight Bearing and Active Motion following Knee Articular Cartilage Repair. Cartilage. 2010; 1(4): 276-286.
21. Hayes Inc. Review of Reviews: Continuous Passive Motion for Knee Indications. Published March 15, 2018.