Dynamic Low-load Prolonged-duration Stretch (LLPS) Devices 
Dynamic low-load prolonged-duration stretch (LLPS) devices for the knee, elbow, wrist or finger (E1800, E1802, E1805, E1810, E1812, E1825) (including but not limited to Dynasplint Systems, LMB Pro-glide, EMPI Advance Ultraflex, and Advanced Biomedics) are considered medically necessary for use on the knee, elbow, wrist or finger in any of the following clinical settings:

1. As an addition to physical therapy in the subacute injury or post-operative period (≥ 3 weeks but ≤ 4 months after injury or operation) in patients with signs and symptoms of persistent joint stiffness or contracture:
   1. For an initial period of up to 4 months; and
   2. If the patient shows improvement after the initial period, thereafter for as long as improvement can continue to be demonstrated; OR
2. In the subacute injury or post-operative period (≥ 3 weeks but ≤ 4 months after injury or operation) in a patient whose limited range of motion poses a meaningful (as judged by the physician) functional limitation, AND who has not responded to other therapy (including physical therapy);
   1. For an initial period of up to 4 months; and 
   2. If the patient shows improvement after the initial period, thereafter for as long as improvement can continue to be demonstrated; OR
3. In the acute post-operative period for patients who have undergone additional surgery to improve the range of motion of a previously affected joint:
   1. For an initial period of up to 4 months; and
   2. If the patient shows improvement after the initial period, thereafter for as long as improvement can continue to be demonstrated; OR
4. For patients unable to benefit from standard physical therapy modalities because of an inability to exercise:
   
   1. For an initial period of up to 4 months; and
   2. If the patient shows improvement after the initial period, thereafter for as long as improvement can continue to be demonstrated.

Replacement of soft interface material (E1820) for dynamic adjustable extension/flexion devices is considered medically necessary.

If there is no significant improvement after four months of use, dynamic (LLPS) devices for the knee, elbow, wrist or finger (E1800, E1802, E1805, E1810, E1812, E1820, E1825) are considered not medically necessary under any circumstance, including but not limited to, for patients unable to benefit from standard physical therapy modalities because of an inability to exercise. Dynamic low-load prolonged-duration stretch (LLPS) devices used for all other conditions are considered not medically necessary.

A participating, preferred, and network provider cannot bill the member for denied services unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement should be maintained in the provider’s records.

Dynamic (LLPS) devices which are specific to the ankle, toe and shoulder (E1815, E1830, E1840) are considered experimental/investigational for all indications including but not limited to the management of chronic joint stiffness or chronic or fixed contractures because there is a lack of scientific evidence regarding its effectiveness for these indications. A participating, preferred, and network provider can bill the member for the denied services.

Bi-directional Static Progressive (SP) Stretch Devices
Bi-directional static progressive (SP) stretch devices (E1801, E1806, E1811, E1816, E1818, E1831, E1841) are considered experimental/investigational. Research on static progressive stretch devices, including but not limited to the Joint Active Systems (JAS Static Progressive Stretch) JAS device is limited to case reports and small uncontrolled studies. A participating, preferred, and network provider can bill the member for the denied services.

Replacement of soft interface material (E1821) for bi-directional static progressive (SP) stretch devices is considered experimental/investigational. A participating, preferred, and network provider can bill the member for the denied services.

Patient-actuated Serial Stretch (PASS) Devices
Patient-actuated serial stretch (PASS) devices (E1399)(e.g., ERMI Knee, MPJ, or Elbow Extensionator® ERMI Knee/Ankle or Shoulder Flexionator®) are considered experimental/investigational. Due to the overall lack of published studies investigating PASS devices, no conclusion can be drawn regarding their efficacy. A participating, preferred, and network provider can bill the member for the denied services.

Description

Dynamic splinting devices are spring-loaded and designed to provide a low load, prolonged stretch (LLPS) to joints that have reduced range of motion secondary to immobilization, surgery, contracture, fracture, dislocation, or a number of additional non-traumatic disorders. Most of these devices are adjustable-tension controlled units that provide a continuous dynamic stretch while patients are asleep or at rest. Standard time of use is continuously for 6-12 hours, which can be at night or can be two three-hour sessions during the day. The objective of stretch therapy is to improve range of motion without compromising the stability and quality of the connective tissue and joint. Currently, dynamic splinting devices are available for, but not limited to, the elbow, wrist, knee, ankle, and toes.

Bi-directional static progressive (SP) stretch devices are used for multiple short treatment sessions per day with the joint angle progressively advanced at each session. SP devices essentially allow the patient to duplicate physical therapy by therapists who apply a new positional stretch multiple times throughout the session. The period of brace utilization is typically 30 minutes, used 2-3 times a day.

Patient-actuated serial stretch (PASS) devices provide a low-to-high level load to the joint using pneumatic or hydraulic systems that are adjusted by the patient. The PASS devices are custom-fitted and are available for the ankle, elbow, knee and shoulder. 

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Farmer SE, Woolam PJ, Patrick JH, Roberts AP, Bromwich W.  Dynamic orthoses in the management of joint contracture. J Bone Joint Surg Br. 2005 Mar;87(3):291-5.

Gaspar PD, Willis FB.  Adhesive capsulitis and dynamic splinting: a controlled, cohort study. BMC Musculoskeletal Disorders. 2009 Sept 7;10:111.

John MM, Willis FB. Dynamic splinting for hallux valgus and hallux varus: a pilot study. The Foot and Ankle Online Journal. 2010 Jan 3;(1):1.

Berner SH, Willis FB. Dynamic splinting in wrist extension following distal radius fractures. J Orthop Surg Res. 2010 Aug 6;5:53.