Medical Policy Title: Continuous Passive ARBenefits Approval: 10/12/11

Transcription

1 Medical Policy Title: Continuous Passive ARBenefits Approval: 10/12/11 Motion Device In the Home Setting Effective Date: 01/01/2012 Document: ARB0103 Revision Date: Code(s): E0935 Continuous passive motion exercise device for use on knee only E0936 Continuous passive motion exercise device for use other than knee Public Statement: Administered by: The restoration of joint range of motion following surgery or trauma is dependent upon rehabilitation, and delay in rehabilitation may subsequently result in poor joint function or immobility. Passive motion, a treatment component of joint rehabilitation, may be performed by a physical therapist or accomplished with a continuous passive motion (CPM) device. The device moves the joint (e.g., flexion/extension), without patient assistance, continuously on a 24-hour basis. Scientific evidence supports use of these devices in the immediate post-operative period for patients who have had certain procedures involving the knee. These devices are covered only after these procedures, when the treatment is begun within two days of surgery and is limited to three weeks. Medical Policy Statement: 1) E0935 is covered if initiated within two days of 27407, 27409, 27412, 27415, 27416, 27428, 27429, 27440, 27441, 27442, 27443, 27446, 27447, 27513, 29866, 29867, 29874, 29879, 29885, 29886, 29887, or Coverage is for no more than 19 days. 2) Use of Continuous Passive Motion Devices is considered medically necessary and is covered for: o o o total knee replacement procedures; reconstruction of the anterior cruciate ligament; supracondylar fracture of the femur extending into the knee joint; and Page 1 of 8

2 o intra-articular cartilage repair procedures of the knee (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures). 3) Use of the device must commence within two days following surgery. Coverage is limited to that portion of the three week period following surgery during which the device is used in the patient's home. (There is insufficient evidence to justify coverage of these devices for longer periods of time or for other applications.) Limits: CPM may be used only during the first three weeks after surgery. Background: The restoration of joint range of motion following surgery or trauma is dependent upon rehabilitation, and delay in rehabilitation may subsequently result in poor joint function or immobility. Passive motion, a treatment component of joint rehabilitation, may be performed by a physical therapist or accomplished with a continuous passive motion (CPM) device. To some extent, CPM devices and physical therapists are interchangeable means of delivering passive motion. The preference for one or the other mode of delivery may be determined by considerations related to the organization of services or resource allocation (i.e.., staffing, timing of discharge, patient access to physical therapy). Such use of a continuous passive motion device as a substitute for a physical therapist for delivering passive motion should be distinguished from use of the device as an adjunct to physical therapy, in which the objective is to increase the duration and intensity of passive motion in order to achieve outcomes superior to that achieved by conventional physical therapy programs. Continuous passive motion (CPM) devices are available for synovial joints (hip, knee, ankle, shoulder, elbow, and wrist) following surgery or trauma (including fracture, infection, etc.). The device moves the joint (e.g., flexion/extension), without patient assistance, continuously on a 24-hour basis. The device is held in place across the affected joint by Velcro straps. An electrical power unit is used to set the variable range of motion (ROM) and speed. The initial settings for ROM are based on a patient s level of comfort and other factors that are assessed intraoperatively. These settings are made by a physical therapist or other health professional familiar with these devices. The ROM is increased by 3 5 degrees per day, as tolerated. The speed and range of motion can be varied, depending on joint stability. An emergency stop switch immediately halts the device, if necessary. Continuous Passive Motion Devices have been developed for treatment of a number of Page 2 of 8

3 joint, muscle, and tendon problems. There is fairly extensive medical literature on continuous passive motion, but there are few controlled studies available. The effectiveness of continuous passive motion has been determined in randomized controlled trials following total knee replacement, following reconstruction of the anterior cruciate ligament, and following surgical treatment of a supracondylar fracture extending into the knee. Efficacy in the early postoperative period has been cited to support the continued use of these devices in the home setting following early discharge. Although this policy addresses the use of CPM devices in the home, it is notable that a meta-analysis of older studies suggests that the benefits of CPM in a hospital setting may be small and only short term. Two recent randomized controlled trials find that 2 hours of daily CPM in the hospital after total knee replacement does not improve postoperative outcomes at discharge or 1-year follow-up. The lack of improvement with CPM in recent studies may be due to the current practice of permitting patients to mobilize or commence flexion immediately following surgery. Another study compared passive motion versus immobilization following surgical treatment of idiopathic club foot in 38 infants (50 feet). The infants were randomized to CPM (4 hours each day) or casting during days following surgery. Blinded analysis showed improvements in the Dimeglio club foot score (9.7 to 3.1) that were significantly greater than the control group (10.3 to 4.2) through 12 months (97% followup). Between 12 and 18 months this trend reversed, and by 48 months after surgery there was no significant difference between the 2 groups. These recent results provide further support for the current policy statement. CPM is also being studied as a means to aid recovery of motor skills following stroke. One study randomized 35 patients to daily sessions of CPM (25 min) or daily group therapy sessions consisting of self-range motion for post-stroke rehabilitation. All patients also received standard post-stroke therapy for 3.5 hours per day. Following 20 days of therapy, there was a trend for greater shoulder joint stability in the passive motion group (n = 17, p < 0.06) compared with the control group (n=15). No statistically significant differences were found for measures of motor impairment. This study is limited by the small sample size and the short follow-up period; additional studies are needed to determine whether treatment with passive motion over a longer duration could aid in the recovery of motor skills following stroke. Clinical practice guidelines from the French Physical Medicine and Rehabilitation Society conclude that there is not sufficient evidence to recommend substituting CPM for other rehabilitation techniques aimed at early mobilization after TKA. The evidence review found no positive effect of CPM over intermittent early mobilization, at short or long-term follow-up. Dundar et al. compared CPM with physiotherapy in a randomized trial of 57 patients with adhesive capsulitis (frozen shoulder) (Dundar, 2009). CPM or physiotherapy was provided for 1 hour per day (5 days a week) for 4 weeks. Pain and function were similar in the 2 groups at baseline, with visual analog scale (VAS) scores for pain ranging from Page 3 of 8

4 5.44 (at rest) to 6.34 (with movement). Assessments at baseline, 4, and 12 weeks showed improvements in pain and function in both groups. CPM resulted in better pain reduction than physiotherapy (at rest, 47% vs. 25%; with movement, 35% vs. 21%; and at night, 36% vs. 19%, all respectively). There were no differences between groups in range of motion or functional ability. Although this unblinded study provides some support for the inclusion of CPM in a physiotherapy program, additional studies are needed to evaluate CPM when provided at home. Postoperative management of open elbow contracture release with CPM was assessed in a matched cohort study by Lindenhovius et al (Lindenhovius, 2009). Sixteen patients who had used CPM after open contracture release and 16 patients who had not used CPM after surgery were matched for age, gender, diagnosis, range of motion, and radiographic appearance. Chart review was utilized when possible; patients who had insufficient follow-up in the medical record were invited back for follow-up and radiograph. Twenty-three patients (72%) were evaluated by an investigator who was not involved in their care. Improvements in range of motion were not different between the 2 groups for either early (4 10 months) or final (10 56 months) evaluations. Although no controlled clinical studies were identified that compared health outcomes with or without the use of CPM, CPM is used as a part of the rehabilitation protocol for as long as 6 weeks when weight bearing is restricted following autologous chondrocyte implantation (ACI) (Nugent-Derfus, 2007) (Salter, 1989) (Browne, 2005). Basic research supports greater healing of articular cartilage of full-thickness defects that penetrate the subchondral bone than either immobilization or intermittent mobilization (Farr, 2007) (Rosenberger, 2008). Based on expert opinion and the available literature, the coverage statement will be expanded to include coverage for intra-articular cartilage repair procedures of the knee (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures). References: Ark JW, Gelberman RH, Abrahamsson SO, Seiler JG III, Amiel D.(1994) Cellular survival and proliferation in autogenous flexor tendon grafts. J Hand Surg 1994; 19: Arlington R.(1993) Postoperative care of the orthopedic patient. Semin Perioper Nurs 1993; 2: Barr DA, Long L, Kernohan WG, et al.(1994) Continuous passive motion in computer assisted auscultation of the knee. Comput Methods Programs Biomed 1994; 43: Behrman MJ, Bigliani LU.(1993) Distal humeral replacement after failed continuous passive motion in a T-condylar fracture. J Ortho Trauma 1993; 7: Page 4 of 8

5 Biyani A, Reddy NS, Chaudhury J, et al.(1995) The results of surgical management of displaced tibial plateau fractures in the elderly. Injury 1995; 26: Browne JE, Anderson AF, Arciero R et al.(2005) Clinical outcome of autologous chondrocyte implantation at 5 years in US subjects. Clin Orthop Relat Res 2005; (436): Colwell CW, Morris BA.(1992) The influence of continuous passive motion on the results of total knee arthroplasty. Clin Orthop 1992; 276: Connor JC, Berk DM, Hotz MW.(1995) Effects of continuous passive motion following Austin bunionectomy. J Am Pod Med Assoc 1995; 85: Connor JC, Berk DM.(1994) Continuous passive motion as an alternative treatment for iatrogenic hallux limitus. J Foot Ankle Surg 1994; 33: DeCarlo MS, Shelbourne KD, McCarroll JR, et al.(1992) Traditional versus accelerated rehabilitation following ACL reconstruction: a one-year follow-up. JOSPT 1992; 15: Dent JA.(1993) Continuous passive motion in hand rehabilitation. Prosthet Orthot Int 1993; 17: Dirette D, Hinojosa J.(1994) Effects of continuous passive motion on the edematous hands of two persons with flaccid hemiplegia. Am J Occup Ther 1994; 48: Dundar U, Toktas H, Cakir T et al.(2009) Continuous passive motion provides good pain control in patients with adhesive capsulitis. Int J Rehabil Res 2009; 32(3): Ebraheim NA, DeTroye RJ, Saddemi SR.(1993) Results of Judet quadricepsplasty. J Ortho Trauma 1993; 7: Engstrom B, Sperber A, Wredmark T.(1995) Continuous passive motion in rehabilitation after anterior cruciate ligament reconstruction. Knee Surg Sprts Trauma Arthroscopy 1995; 3: Farr J.(2007) Autologous chondrocyte implantation improves patellofemoral cartilage treatment outcomes. Clin Orthop Relat Res 2007; 463: Gebhard JS, Kabo JM, Meals RA.(1993) Passive motion: the dose effects on joint stiffness, muscle mass, bone density, and regional swelling. A study in an experimental model following intra-articular injury. J Bone Jt Surg 1993; 75: Jansen CM, Windau JE, Bonutti PM, et al.(1996) Treatment of a knee contracture using a knee orthosis incorporating stress-relaxation techniques. Phys Ther 1996; 76:182- Page 5 of 8

6 186. Jordan LR, Siegel JL, Olivo JL.(1995) Early flexion routine. An alternative method of continuous passive motion. Clin Orthop 1995; 315: Kay RM, Eckardt JJ.(1994) Total elbow allograft for twice-failed total elbow arthroplasty. A case report. Clin Orthop 1994; 303: Kearney LM, Brown KK.(1994) The therapist s management of intra-articular fractures. Hand Clin 1994; 10: Keppler P, Holz U, Thielemann FW, et al.(1994) Locked posterior dislocation of the shoulder; treatment using rotational osteotomy of the humerus. J Ortho Trauma 1994; 8: Kim HK, Kerr RG, Cruz TF, et al.(1995) Effects of continuous passive motion and immobilization on synovitis and cartilage degradation in antigen induced arthritis. J Rheum 1995; 22: Kim JM, Moon MS.(1995) Squatting following total knee arthroplasty. Clin Orthop 1995; 313: Kirby JJ.(1994) The Kirby Connector. J Hand Ther 1994; 7:197. Kreder HJ, Moran M, Keeley FW, et al.(1994) Biologic resurfacing of a major joint defect with cryopreserved allogeneic periosteum under the influence of continuous passive motion in a rabbit model. Clin Orthop 1994; 300: LaStayo P, Jaffe R.(1994) Assessment and management of shoulder stiffness: a biomechanical approach. J Hand Ther 1994; 7: Lemke RR, Van Sickels JJ.(1993) Electromyographic evaluation of continuous passive motion versus manual rehabilitation of the temporomandibular joint. Oral Maxillofac Surg 1993; 51: Lindenhovius AL, van de Luijtgaarden K, Ring D et al.(2009) Open elbow contracture release: postoperative management with and without continuous passive motion. J Hand Surg Am 2009; 34(5): Llinas A, McKellop HA, Marshall GJ, et al.(1993) Healing and remodeling of articular incongruities in a rabbit fracture model. J Bone Jt Surg 1993; 75: McCarthy MR, Yates CK, Anderson MA, et al.(1993) The effects of immediate continuous passive motion on pain during the inflammatory phase of soft tissue healing following anterior cruciate ligament reconstruction. J Ortho Sports Phys Ther 1993; 17: Page 6 of 8

7 McCarty WL Jr, Darnell MW.(1993) Rehabilitation of the temporomandibular joint through the application of motion. Cranio 1993; 11: McInnes J, Larson MG, Daltroy LH, et al.(1992) A controlled evaluation of continuous passive motion in patients undergoing total knee arthroplasty. JAMA 1992; 268: Nadler SF, Malanga GA, Zimmerman JR.(1993) Continuous passive motion in the rehabilitation setting. A retrospective study. Am J Phys Med Rehab 1993; 72: Noyes FR, Mangine RE, Barber SD.(1992) The early treatment of motion complications after reconstruction of the anterior cruciate ligament. Clin Orthop 1992; 277: Nugent-Derfus GE, Takara T, O'Neill J K et al.(2007) Continuous passive motion applied to whole joints stimulates chondrocyte biosynthesis of PRG4. Osteoarthritis Cartilage 2007; 15(5): Ostermann PA, Neumann K, Ekkernkamp A, et al.(1994) Long term results of unicondylar fractures of the femur. J Ortho Trauma 1994; 8: Richard R, Staley M, Miller SF.(1994) The effect of extremity range of motion on vital signs of critically ill patients and patients with burns: a pilot study. J Burn Care Rehab 1994; 15: Rosen MA, Jackson DW, Atwell EA.(1992) The efficacy of continuous passive motion in the rehabilitation of anterior cruciate ligament reconstructions. Am J Sports Med 1992; 20: Rosenberger RE, Gomoll AH, Bryant T et al.(2008) Repair of large chondral defects of the knee with autologous chondrocyte implantation in patients 45 years or older. Am J Sports Med 2008; 36(12): Ruesch PD, Holdener H, Ciaramitaro M, et al.(1994) A prospective study of surgically treated acetabular fractures. Clin Orthop 1994; 305: Salter RB.(1989) The biologic concept of continuous passive motion of synovial joints. The first 18 years of basic research and its clinical application. Clin Orthop Relat Res 1989; (242): Salter RB.(1994) The physiologic basis of continuous passive motion for articular cartilage healing and regeneration. Hand Clin 1994; 10: Sampson SP, Badalamente MA, Hurst LC, et al.(1992) The use of a passive motion machine in the postoperative rehabilitation of Dupuytren's disease. J Hand Surg; A: Page 7 of 8

8 Schenck RR.(1994) Combining movement and traction for intra-articular fractures of the phalanges. The dynamic traction method. Hand Clin 1994; 10: Silfverskiold KL, May EJ, Tornvall AH.(1993) Tendon excursions after flexor tendon repair in zone II: Results with a new controlled-motion program. J Hand Surg 1993; 18: Silfverskiold KL, May EJ.(1993) Gap formation after flexor tendon repair in zone II. Results with a new controlled motion program. Scand J Plast Reconstr Surg Hand Surg 1993; 27: Smith H, Greenhouse BB, Palmer GM.(1995) Reflex sympathetic dystrophy. J Hand Surg 1995; 20: Smith PJ, Douglass JB.(1995) The use of an orthodontic appliance to stabilize a temporomandibular joint continuous passive motion machine. J Oral Maxillofac Surg 1995; 53: Ververeli PA, Sutton DC, Hearn SL, et al.(1995) Continuous passive motion after total knee arthroplasty. Analysis of cost and benefits. Clin Orthop 1995; 321: Williams JM, Moran M, Thonar EJ, et al.(1994) Continuous passive motion stimulates repair of rabbit knee articular cartilage after matrix proteoglycan loss. Clin Orthop 1994; 304: Witherow GE, Bollen SR, Pinczewski LA.(1993) The use of continuous passive motion after arthroscopically assisted anterior cruciate ligament reconstruction: help or hindrance. Knee Surg Sprts Trauma Arthroscopy 1993; 1: Application to Products This policy applies to ARBenefits. Consult ARBenefits Summary Plan Description (SPD) for additional information. Last modified by: Date: Page 8 of 8