Medical Policies - DME


Continuous Passive Motion (CPM) Device

Number:DME101.023

Effective Date:07-15-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Continuous Passive Motion (CPM) device may be considered medically necessary for use postoperatively as an adjunct to conventional physical therapy in the following situations ONLY:

Under conditions of low postoperative mobility or inability to comply with rehabilitation exercises following a knee arthroplasty or knee arthroplasty revision. This may include patients with complex regional pain syndrome (reflex sympathetic dystrophy), extensive arthrofibrosis or tendon fibrosis, or physical, mental or behavioral inability to participate in active physical therapy. Use of the CPM device must begin within 48 hours of the surgical procedure (or on discharge from facility following the procedure) and may continue for ONLY up to 21 days postoperatively, OR

For up to 6 weeks during the non-weight bearing rehabilitation period following knee surgery for microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures, and for reconstruction of the anterior cruciate ligament (ACL).

All other uses of a CPM device are considered experimental, investigational and/or unproven, including but not limited to the following:

Postoperative rehabilitation for the following:

1. Shoulder surgery,

2. Total hip replacement (THR),

3. Temporomandibular joint (TMJ) surgery, or

4. Ankle or toe surgery, including bunionectomy;

All surgical procedures on the knee not specified in this policy as being medically necessary;

Prevention of thrombosis following ankle surgery;

Rehabilitation of the shoulder, elbow or hand;

Treatment of osteoarthritis in the shoulder, hip, or any other major joint;

Aiding in the clearance of infection from a septic joint;

Treatment of hemarthrosis in hemophiliac patients;

Treatment of contractures caused by burns, trauma, and Dupuytren's contractures;

Treatment of any other conditions not listed above.

Description:

Physical therapy (PT) of joints following surgery focuses both on passive motion to restore mobility and active exercises to restore strength. While passive motion can be administered by a therapist, continuous passive motion (CPM) devices have also been used. CPM is thought to improve recovery by stimulating the healing of articular tissues and the circulation of synovial fluid; reducing local edema; and preventing adhesions, joint stiffness or contractures, or cartilage degeneration. CPM has been investigated primarily in the knee, particularly after total knee arthroplasty (TKA) or ligamentous or cartilage repair. Acceptance of its use in the knee joint has created interest in CPM use for other weight-bearing joints (i.e., hip, ankle, metatarsals) and non-weight-bearing joints (i.e., shoulder, elbow, metacarpals, interphalangeal joints). Use of CPM in stroke and burn patients is also being explored.

The device used for the knee moves the joint (e.g., flexion/extension), without patient assistance, continuously for extended periods of time (i.e., up to 24 hours/day [h/d]). 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. The ROM is increased by 3 to 5 degrees per day, as tolerated. The speed and ROM can be varied, depending on joint stability. The use of the device may be initiated in the immediate postoperative period and then continued at home for a variable period of time.

NOTE: Meniscal procedures (e.g. meniscus repairs or meniscectomies) do not generally require 6 weeks of non-weight bearing during the rehabilitation period.

Over the past 10 to 20 years, hospital lengths of stay have progressively shortened and, in some cases, surgical repair may be done either as an outpatient or with a length of stay of 1 to 2 days. As a result, there has been a considerable shift in the rehabilitation regimen, moving from an intensive in-hospital program to a less intensive outpatient program. Some providers may want patients to continue CPM in the home setting as a means of duplicating services offered with a longer (7-day) hospital stay.

Regulatory Status

Continuous passive motion devices are considered class I devices by the U.S. Food and Drug Administration (FDA) and are exempt from 510(k) requirements. This classification does not require submission of clinical data on efficacy but only notification to the FDA prior to marketing. FDA product code: BXB.

Rationale:

This policy was originally created in 1990 and has been updated regularly with searches of the MEDLINE database. The most recent literature review was performed through January 25, 2017. Literature review updates have focused on randomized trials of continuous passive motion (CPM) used in the non-acute care hospital or home setting. Most studies identified focused on the use of CPM for the knee. Therefore, the first sections focus on surgical procedures of the knee, followed by CPM for treatment of other joints.

Total Knee Arthroplasty

Early Postoperative In-Hospital Setting

The original policy was based on a 1997 Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessment that concluded CPM met the TEC criteria as an adjunct to physical therapy (PT) in patients undergoing total knee arthroplasty (TKA). (1) Early studies of CPM machines focused on their use in the hospital setting, in which the impact on length of stay was frequently considered a key clinical outcome, and so the TEC Assessment did not specifically examine the point of service or the length of time CPM devices were used. A critical study identified in the TEC Assessment was a randomized controlled trial (RCT) by McInnes et al. (1992) that compared use of CPM initiated in the immediate postoperative period and continued through the 7-day hospital stay to standard rehabilitation alone. (2) At 6 weeks postoperatively, the most salient difference between groups was an increased incidence of arthrofibrosis requiring manipulation in the non-CPM group.

Efficacy in the early postoperative period has been cited as a reason to support the continued use of these devices in the non-acute care hospital or home setting following early discharge. CPM after TKA was the subject of a 2003 Cochrane review. (3) Reviewers reported that CPM combined with PT significantly increased active knee flexion and decreased length of stay. However, the analysis suggested that the benefits of CPM in a hospital setting may be small and only short term. (4) This Cochrane review was updated in 2010 and again in 2014. (5, 6) The updated review included 24 RCTs with 1445 participants and examined short-term (<6 weeks), medium-term (6 weeks to 6 months), and long-term (>6 months) effects of CPM. Most included studies examined short-term effects. CPM was applied for 1.5 to 24 hours a day, over 1 to 17 days. A summary of the review’s findings are provided in Table 1.

Table 1. 2014 Cochrane Review Findings on CPM

Finding

QOE

CPM increases passive and active knee flexion range of motion (mean difference, 2°), but the effects were too small to be clinically relevant

Moderate

CPM does not have clinically important short-term effects on pain (-0.4 points on a 10-point scale)

Low

CPM does not have clinically important medium-term effects on function or quality of life

Moderate

CPM may reduce the need for manipulation under anesthesia (25 fewer manipulations per 1000; risk ratio, 0.3)

Very low

CPM reduced the risk of adverse events (13 fewer adverse events per 1000, relative risk, 0.9)

Low

CPM: continuous passive motion; QOE: quality of evidence

A 2014 Cochrane systematic review that included 11 RCTs found no evidence that CPM reduced venous thromboembolism after TKA. (7)

Yashar et al. (1997) randomized 178 patients undergoing TKA to CPM immediately postsurgery or to CPM 1 day postsurgery. (8) A small but statistically significant improvement in flexion was found at the time of discharge among those started on immediate CPM, but this difference did not persist at 4 weeks. MacDonald et al. (2000) reported on a randomized trial comparing immediate postoperative CPM to no CPM on 120 patients after TKA. (9) Patients received a maximum of 24 hours with CPM. There were no differences between treatment groups in ROM, length of stay, or analgesic requirements. In a trial reported by Pope et al. (1997), 53 patients were randomized to 1 of 2 schedules of CPM (both for 48 hours) or to no CPM. (10) The use of CPM was not associated with improved long-term function or ROM. Kumar et al. (1996) randomized 73 patients who had undergone TKA to CPM immediately postsurgery or to a protocol of early passive flexion referred to as the “drop and dangle” technique. (11) Patients assigned to passive flexion were discharged from the hospital 1 day earlier and also had a statistically better extension range of 2.8° at 6 months than the CPM group.

Other RCTs have found that 2 to 4 hours of daily CPM in the hospital after TKA did not improve postoperative outcomes at discharge or follow-up. (12-15) In 1 trial, Bruun-Olsen et al. (2009) randomized 63 patients undergoing TKA to active PT exercises with or without CPM to assess any short-term benefit on pain or function. (12) In both groups, exercises were performed daily for 30 minutes, starting 1 day after surgery and continuing until discharge at 1 week. For the experimental group, CPM was administered for 4 hours on the day of surgery, followed by 6 hours daily in addition to therapist-guided exercises. Blinded assessments at 1 week and 3 months after surgery showed similar results for pain and function in the 2 groups. At 1 week, both groups had visual analog scale (VAS) pain ratings of 40 and flexion scores within 2° of each other. Functional testing at 3 months showed no benefit of adjunctive CPM. The lack of improvement with CPM in these studies might have been attributable to patients mobilizing or commencing flexion immediately following surgery. (14) A 2014 study of 150 patients undergoing TKA found no benefit of CPM when used over a 2-day postoperative hospital stay. (15)

Non-Acute Care Hospital Setting

In a 2014 RCT by Herbold et al., 141 TKA patients were assigned to daily conventional therapy lasting 3 hours or daily CPM for 2 hours throughout their inpatient rehabilitation stay. (16) After an average length of stay of 8 days, there were no significant differences between the CPM and no CPM groups for active ROM, Timed Up and Go test, knee girth, Functional Independence Measure (FIM) scores, ambulation device at discharge, or on the self- reported Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Chen et al. (2000) randomized 51 patients in an inpatient rehabilitation service who had undergone TKA to conventional active PT or to PT plus CPM. (17) Referral to the rehabilitation center was made 5 to 6 days after surgery, and most had received CPM as part of the initial hospitalization. Knee flexion was the principal outcome. No significant difference was noted in passive ROM between the 2 groups, as measured on admission, on the third and seventh days, and at the time of discharge (8 days postadmission). Thus, the use of CPM in the rehabilitation hospital offered no added benefit.

In 2012, a retrospective comparative study by the same group as the RCT by Herbold et al. evaluated the use of CPM in 61 matched pairs of patients admitted to a rehabilitation hospital. (18) Outcomes following use of CPM were compared with those from a cohort of 61 inpatients who also had poor initial ROM, defined as less than 75° of active knee flexion at the time of admission, and matched for postoperative day at admission, age, length of stay, and Health Insurance Prospective Payment System (HIPPS) code. Use of CPM (2 hours/day [h/d]) was determined primarily by the referring physician and used in 29% of the pool of 633 patients who had poor initial ROM. Average length of stay was 7.85 days. There were no significant differences in outcomes at discharge, including knee flexion or extension, discharge to the community, need for home care services, need for an assistive device, or functional scores on the HIPPS.

Home Setting

A study by Worland et al. (1998) compared the use of CPM with active PT in the home setting. At discharge, they randomized 80 patients undergoing TKA to home CPM (3 h/d for 10 days) or to active PT. (19) Most studies have examined CPM as an adjunct to active PT, while this study proposed CPM as an alternative to PT. At 2 weeks, knee flexion was similar in both groups, but a flexion contracture was noted in 1 patient in the CPM group. At 6 months, no differences were found in knee scores or knee flexion.

In another RCT published in 2008, 60 patients with limited flexion ROM (<80°) at the time of hospital discharge were assigned to standard PT alone or PT plus CPM in the home (4 h/d) until assessment on postoperative day 17. (20) Blinded assessment showed a trend for increased ROM for the CPM group (e.g., 89° vs 84°, respectively, p=0.07), with no differences in function between groups, as measured by the Knee Society Score (function subscore 43 vs 40, respectively) and the WOMAC difficulty score (49 vs 45, respectively). No differences were observed between groups in ROM or function at the 6-week or 3- month assessment. In addition, no differences were observed for the secondary outcome measures (perceived effect, medication use, satisfaction with treatment, adherence) at either of the assessment times.

Section Summary: Total Knee Arthroplasty

Numerous RCTs have compared CPM as adjunctive therapy to PT for patients undergoing TKA. Most trials used CPM in the inpatient setting and are less relevant to today’s practice patterns of shorter hospital stays followed by outpatient rehabilitation. Some of these trials have reported an improvement in ROM for patients receiving CPM, but these improvements were short term, of small magnitude, and of uncertain clinical significance. The RCTs that specifically evaluated CPM in the non-acute care hospital setting or home setting did not show improved outcomes with CPM.

Intra-Articular Cartilage Repair of the Knee

Although no RCTs were identified comparing health outcomes with or without the use of CPM, CPM is routinely used as part of the rehabilitation protocol for as long as 6 weeks when weight bearing is restricted following autologous chondrocyte implantation (ACI). (21-23) Basic research supports the use of CPM to obtain greater healing of articular cartilage of full-thickness defects that penetrate the subchondral bone compared with either immobilization or intermittent mobilization. (24, 25)

In 2010, Fazalare et al. published a systematic review of CPM after knee cartilage defect surgery. (26) Reviewers found that CPM had been used following ACI, microfracture, and osteochondral autografts in numerous studies in the previous 5 years. Four level III (cohort) studies with 262 patients were identified that compared CPM with no CPM; no RCTs were identified. Procedures in these 4 studies included microfracture, periosteal transplant of the patella, and high tibial osteotomy with diagnostic arthroscopy or abrasion arthroplasty. CPM regimens ranged from 6 days to 8 weeks. Heterogeneity in the studies and outdated surgical techniques limited conclusions drawn from these trials. Clinical outcomes did not permit a definitive conclusion of efficacy of CPM. However, reviewers cited several studies in which other outcomes (e.g., histologic outcomes on follow-up biopsies) did favor CPM.

Another systematic review, by Howard et al. (2010), evaluated CPM and other postoperative practices after knee cartilage repair. (27) Reviewers cited several basic science studies using animal models that appear to support CPM. They identified 2 clinical studies, both of which were retrospective nonrandomized comparative studies. In 1 study (N=43), there were no differences between groups in clinical or functional outcomes at an average follow-up of 4.2 years. In the other study (N=77), patients in the CPM group (n=46) had greater improvement in grading of the cartilage lesion compared to patients who did not have access to CPM (n=31).

Other Musculoskeletal Conditions Requiring PT

Intra-Articular Knee Fractures

Hill et al. (2014) randomized 40 patients with intra-articular fractures of either the proximal part of the tibia or the distal end of the femur to standardized PT with or without CPM for 48 hours postoperatively. (28) At the 48-hour assessment, the CPM group had significantly greater knee flexion (43°difference, p<0.005). However, 6 of 20 patients were unable to tolerate CPM, and there was no benefit to adding 48 hours of CPM when assessed at any of the follow-up visits (2, 6, 12, 24 weeks).

Anterior Cruciate Ligament Repair

This literature review did not identify any RCTs of CPM in the home setting after repair of the anterior cruciate ligament (ACL). However, the studies of CPM after ACL repair in the immediate postoperative period may be relevant to the non-acute care hospital or home setting for patients discharged following a shorter hospital stay. The 1997 TEC Assessment concluded that CPM as an adjunct to conventional PT in the immediate postoperative period after ACL repair offered no demonstrable advantage over conventional PT alone. (1) In a 2008 systematic review of ACL reconstruction rehabilitation, Wright et al. (2008) discussed 6 RCTs on CPM published before 1996; no RCTs published after the 1997 TEC Assessment were identified. (29) Reviewers found no substantial advantage for CPM use and concluded that CPM for ACL rehabilitation could not be justified. Wright et al. also noted that most current ACL rehabilitation protocols initiate early motion within the first postoperative week.

Rotator Cuff Repair

In 2011, Du Plessis et al. published a systematic review of CPM following rotator cuff repair. (30) Three RCTs were included, though meta-analysis could not be conducted due to heterogeneity across trials. Two of the RCTs, by Lastayo et al. and Raab et al. are discussed below. (31, 32) The third trial was a German-language report that found a significant reduction of 12 days in the time to reach 90° abduction compared with the PT control group, with no significant difference in pain between the 2 groups.

The trial conducted by Lastayo et al. (1998) randomized 31 patients undergoing rotator cuff repair to a 4-week home program of CPM (average, 3 h/d) or to manual passive elevation and rotation exercises. (31) No significant difference in outcomes was observed between the 2 approaches. Previously, Raab et al. (1996) had randomized 26 patients to postoperative PT alone or to PT plus CPM. (32) Patients were evaluated with preoperative and 3-month postoperative shoulder scores that included pain, function, muscle strength, and ROM. A statistically significant improvement was found in the subscore of ROM for those receiving CPM, although there was no significant improvement in overall shoulder score between groups. Both of these RCTs were likely underpowered to show differences on important clinical outcomes.

In 2010, Garofalo et al. reported on a randomized trial assessing the effects of CPM after rotator cuff repair. (33) During weeks 1 to 4 postsurgery, all 100 patients underwent passive self-assisted ROM exercise, with half of the patients also receiving CPM for four 30-minute sessions per day. The physical therapist?supervised exercises included pendulum movements and progressive passive abduction, forward flexion, and external rotation. When patients were not exercising, the shoulder was immobilized in a sling brace. From weeks 5 to 28 postsurgery, all patients underwent the same PT protocol. ROM and VAS ratings for pain were measured at 2.5, 6, and 12 months by an independent examiner. Between groups, VAS ratings were slightly better for patients who received CPM at 2.5-month follow-up (7.5 vs 9.1), but not at the 6-month (0.5 vs 0.6) or 12-month (0.2 vs 0.2) assessments, all respectively. ROM was significantly better in the group receiving CPM versus those who did not at 2.5-month follow-up (eg, forward flexion, 133.0° vs 120.7°) and 6 months (158.1° vs 151.7°), but not at 12 months (165.2° vs 158.0°), all respectively.

Subsection Summary: Rotator Cuff Repair

Three RCTs of CPM following rotator cuff surgery were identified in the English-language literature. Two of these trials reported short-term improvements in ROM for patients undergoing CPM, and 1 reported a short-term reduction in pain. None reported long-term improvements or benefits in functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen after shoulder surgery, and so the optimal comparator for CPM is not clear.

Hip Osteoarthritis

One pilot study examined the use of CPM in patients with hip osteoarthritis in the absence of surgical intervention. (34) In this uncontrolled study, CPM was used for 1.2 to 7.6 hours daily during the 12-week trial. While improvements were noted in patients’ pain assessments, a controlled trial is needed to validate this treatment effect, particularly compared with a program of regular walking.

Adhesive Capsulitis of the Shoulder

Dundar et al. (2009) compared CPM with PT in a randomized trial of 57 patients with adhesive capsulitis (frozen shoulder). (35) CPM or PT was provided for 1 hour a day (5 d/wk) for 4 weeks. Pain and function levels were similar in the 2 groups at baseline, with VAS scores for pain ranging from 5.44 (at rest) to 6.34 (with movement). Assessments at baseline, 4, and 12 weeks showed improvements in pain and function levels for both groups. However, CPM resulted in greater pain reduction than PT (at rest, 47% vs 25%; with movement, 35% vs 21%; at night, 36% vs 19%, all respectively). There were no differences between groups in ROM or function. This study provided modest support for the inclusion of CPM in a PT regimen for this patient population.

An RCT published in 2016 compared CPM (n=20) with PT (n=21) for the treatment of adhesive capsulitis in patients with diabetes. (36) CPM or PT was provided for 1 hour a day (5 d/wk) for 4 weeks. All patients received electrotherapy and, after the 4-week initial treatment phase, were instructed to continue with an 8-week at-home exercise program. Outcome measures were pain (at rest, in motion, at night) and ROM (active and passive). Pain decreased significantly in both treatment groups, though patients in the CPM group reported a larger improvement in pain scores than those in the PT group. ROM improved significantly in both treatment groups as well. Patients in the CPM group reported larger improvements in abduction and flexion measures than patients in the PT group, while external and internal rotation improvements were similar across groups.

Elbow Contracture

Postoperative management of open elbow contracture release with CPM was assessed in a matched cohort study by Lindenhovius et al. (2009). (37) Sixteen patients who had used CPM after open contracture release and 16 patients who had not were matched by age, sex, diagnosis, ROM, and radiographic appearance. Improvements in ROM did not differ between groups at the early (range, 4-10 months) and the final (range, 11-56 months) evaluations.

Hand Repair

The 1997 TEC Assessment reviewed a multicenter study of CPM in patients who had undergone flexor tendon repair, and found the data inadequate to permit scientific conclusions about CPM application. (1)

Ring et al. (1998) conducted a randomized trial that examined the role of CPM in patients undergoing silicone interposition arthroplasty of the metacarpophalangeal joints secondary to rheumatoid arthritis. (38) Patients were randomized to a 6-week protocol of CPM (10 hands [40 joints]) or to a standard dynamic splint protocol (15 hands [60 joints]). The trial did not show better outcomes in the CPM group.

A retrospective chart review (2008) compared 15 patients who had received CPM after tenolysis with 21 who did not. (39) Patients who received CPM improved total active motion by 40° (range, 137°-177°), while patients who did not improved total active motion by 32° (range, 152°-184°); however, this difference was not statistically significant.

Foot Repair

One study (2005) compared CPM and immobilization following surgical treatment of idiopathic club foot in 37 infants (50 feet). (40) The infants were randomized to CPM (4 h/d) or to casting during days 10 to 42 following surgery. Blinded analysis showed improvements in the Dimeglio Clubfoot Score with CPM (from 9.7 to 3.1) that were significantly greater than those in the control group (from 10.3 to 4.2) through 12 months (97% follow-up). Between 12 and 18 months, this trend reversed and by 48 months postsurgery, there was no significant difference between groups. Another study by the same group reported low compliance with this treatment. (41)

Back Pain

An RCT by Gavish et al. (2015) evaluated a CPM device for treatment of chronic low back pain in 36 patients. (42) Although patients treated with the device appeared to have improved outcomes on a numeric rating scale of back pain compared to waiting-list controls, the trial had significant methodologic problems. Patients who received other treatments were excluded, a large number of subjects dropped out, and control patients did not receive any conservative management.

Stroke

CPM has been studied as a means to aid recovery of motor skills following stroke. One study (2005) randomized 35 patients to daily sessions of CPM (25 minutes) or to daily group therapy sessions consisting of self-directed ROM for poststroke rehabilitation. (43) All patients also received standard poststroke therapy for 3.5 hours a day. After 20 days of therapy, there was a trend for greater shoulder joint stability in the CPM 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 had a small sample size and short follow-up period.

Summary of Evidence

For individuals who have total knee arthroplasty (TKA) who receive continuous passive motion (CPM) in the home setting, the evidence includes randomized clinical trials (RCTs), case series, and systematic reviews. Relevant outcomes are symptoms and functional outcomes. Early trials generally used CPM in the inpatient setting and are less relevant to today’s practice patterns of short hospital stays followed by outpatient rehabilitation. Current postoperative rehabilitation protocols differ considerably from when the largest body of evidence was collected, making it difficult to apply available evidence to the present situation. For use of CPM after TKA, recent studies have suggested that institutional and home use of CPM has no benefit compared to standard physical therapy (PT). There were no studies evaluating CPM in patients who could not perform standard PT. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have intra-articular cartilage repair of the knee who receive CPM in the home setting, the evidence includes nonrandomized studies, case series, and studies with nonclinical outcomes (e.g., histology), and systematic reviews of these studies. Relevant outcomes are symptoms and functional outcomes. Systematic reviews of CPM for this indication have cited studies reporting better histologic outcomes in patients following CPM. A few studies have reported clinical outcomes, but inadequacies of these studies do not permit conclusions on efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have musculoskeletal conditions other than TKA or knee cartilage repair requiring PT who receive CPM in the home setting, the evidence includes RCTs for some conditions and case series for others. Relevant outcomes are symptoms and functional outcomes. Three small RCTs of CPM after rotator cuff surgery showed some evidence that CPM after this shoulder surgery improved short-term pain and range of motion (ROM); however, the trials were not high quality, and the small differences in outcomes may not be clinically important. Two trials reported short-term improvements in ROM for patients undergoing CPM, and 1 reported a short-term reduction in pain. None reported long-term improvements, and there are no reported benefits in functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen following shoulder surgery such that the optimal treatment comparator for CPM is unclear. Two small RCTs compared CPM with conventional PT for treatment of adhesive capsulitis. One of the trials focused on diabetic patients with adhesive capsulitis. Both reported comparable improvements in ROM and functional ability between treatment groups. For other musculoskeletal conditions, RCTs do not exist; case series either did not show efficacy of CPM or had important methodologic flaws. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have had a stroke requiring PT who receive CPM in the home setting, the evidence includes 1 small RCT. Relevant outcomes are symptoms and functional outcomes. This trial reported a trend toward improved shoulder joint stability, but no statistical difference between CPM plus PT compared to PT alone. The trial was small and treatment lasted only 20 days. The evidence is insufficient to determine the effects of the technology on health outcomes.

Clinical Input Received From Physician Specialty Societies and Academic Medical Centers

2016 Input

The Blue Cross Blue Shield Association (BCBSA), requested and received input from 2 physician specialty societies and 1 academic medical center while this policy was under review in 2016 on the use of continuous passive motion (CPM) after knee intra-articular repair procedures. Input agreed that CPM is considered medically necessary as an adjunct to physical therapy during the non-weight-bearing rehabilitation period following intra-articular cartilage repair procedures of the knee. One reviewer referred to the 2015 American Academy of Orthopaedic Surgery guidelines on the surgical management of osteoarthritis of the knee, which concluded that there was strong evidence that CPM after knee arthroplasty does not improve outcomes.

2010 Input

In 2010, the Blue Cross Blue Shield Association (BCBSA) requested and received clinical input from various physician specialty societies and academic medical centers. Overall, clinical input supported the use of continuous passive motion (CPM) under conditions of low postoperative mobility or inability to comply with rehabilitation exercises following a TKA or TKA revision or during the non-weight-bearing rehabilitation period following intra-articular cartilage repair procedures of the knee. Support was limited for use of CPM in joints other than the knee, or in situations/conditions other than those described in this policy.

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (AAOS) published evidence-based guidelines on the surgical management of osteoarthritis of the knee in 2015. (44) AAOS identified 2 high-quality studies and 5 moderate-quality studies that evaluated the use of continuous passive motion (CPM). In 1 high-quality study, CPM was used for about 2 weeks after discharge. AAOS concluded that “the combined results provide strong evidence that the surgical outcomes for those who used continuous passive motion are not better than for those who did not use continuous passive motion.”

French Physical Medicine and Rehabilitation Society

Clinical practice guidelines from the French Physical Medicine and Rehabilitation Society, published in 2007, concluded that evidence is not sufficient to recommend substituting CPM for other rehabilitation techniques aimed at early mobilization after total knee arthroplasty. (45) The evidence review did not find a positive effect of CPM over intermittent early mobilization, at short- or long-term follow-up.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

None

HCPCS Codes

E0935, E0936, E1399

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Continuous Passive Motion as an Adjunct to Physical Therapy for Joint Rehabilitation. Chicago, Illinois; TEC Assessments. 1997; Volume 12:Tab 20.

2. McInnes J, Larson MG, Daltroy LH, et al. A controlled evaluation of continuous passive motion in patients undergoing total knee arthroplasty. JAMA. Sep 16 1992; 268(11):1423-1428. PMID 1512910

3. Milne S, Brosseau L, Robinson V, et al. Continuous passive motion following total knee arthroplasty. Cochrane Database Syst Rev. 2003(2):CD004260. PMID 12804511

4. Brosseau L, Milne S, Wells G, et al. Efficacy of continuous passive motion following total knee arthroplasty: a metaanalysis. J Rheumatol. Nov 2004; 31(11):2251-2264. PMID 15517640

5. Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2010(3):CD004260. PMID 20238330

6. Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2014; 2:CD004260. PMID 24500904

7. He ML, Xiao ZM, Lei M, et al. Continuous passive motion for preventing venous thromboembolism after total knee arthroplasty. Cochrane Database Syst Rev. 2014; 7:CD008207. PMID 25069620

8. Yashar AA, Venn-Watson E, Welsh T, et al. Continuous passive motion with accelerated flexion after total knee arthroplasty. Clin Orthop Relat Res. Dec 1997(345):38-43. PMID 9418619

9. MacDonald SJ, Bourne RB, Rorabeck CH, et al. Prospective randomized clinical trial of continuous passive motion after total knee arthroplasty. Clin Orthop Relat Res. Nov 2000(380):30-35. PMID 11064970

10. Pope RO, Corcoran S, McCaul K, et al. Continuous passive motion after primary total knee arthroplasty. Does it offer any benefits? J Bone Joint Surg Br. Nov 1997; 79(6):914-917. PMID 9393903

11. Kumar PJ, McPherson EJ, Dorr LD, et al. Rehabilitation after total knee arthroplasty: a comparison of 2 rehabilitation techniques. Clin Orthop Relat Res. Oct 1996(331):93-101. PMID 8895624

12. Bruun-Olsen V, Heiberg KE, Mengshoel AM. Continuous passive motion as an adjunct to active exercises in early rehabilitation following total knee arthroplasty - a randomized controlled trial. Disabil Rehabil. 2009; 31(4):277-283. PMID 18608367

13. Denis M, Moffet H, Caron F, et al. Effectiveness of continuous passive motion and conventional physical therapy after total knee arthroplasty: a randomized clinical trial. Phys Ther. Feb 2006; 86(2):174-185. PMID 16445331

14. Leach W, Reid J, Murphy F. Continuous passive motion following total knee replacement: a prospective randomized trial with follow-up to 1 year. Knee Surg Sports Traumatol Arthrosc. Oct 2006; 14(10):922-926. PMID 16489477

15. Boese CK, Weis M, Phillips T, et al. The efficacy of continuous passive motion after total knee arthroplasty: a comparison of three protocols. J Arthroplasty. Jun 2014; 29(6):1158-1162. PMID 24412145

16. Herbold JA, Bonistall K, Blackburn M, et al. Randomized controlled trial of the effectiveness of continuous passive motion after total knee replacement. Arch Phys Med Rehabil. Jul 2014; 95(7):1240-1245. PMID 24685389

17. Chen B, Zimmerman JR, Soulen L, et al. Continuous passive motion after total knee arthroplasty: a prospective study. Am J Phys Med Rehabil. Sep-Oct 2000; 79(5):421-426. PMID 10994883

18. Herbold JA, Bonistall K, Blackburn M. Effectiveness of continuous passive motion in an inpatient rehabilitation hospital after total knee replacement: a matched cohort study. PM R. Oct 2012; 4(10):719-725. PMID 22959052

19. Worland RL, Arredondo J, Angles F, et al. Home continuous passive motion machine versus professional physical therapy following total knee replacement. J Arthroplasty. Oct 1998; 13(7):784-787. PMID 9802665

20. Lenssen TA, van Steyn MJ, Crijns YH, et al. Effectiveness of prolonged use of continuous passive motion (CPM), as an adjunct to physiotherapy, after total knee arthroplasty. BMC Musculoskelet Disord. 2008; 9:60. PMID 18442423

21. Browne JE, Anderson AF, Arciero R, et al. Clinical outcome of autologous chondrocyte implantation at 5 years in US subjects. Clin Orthop Relat Res. Jul 2005(436):237-245. PMID 15995447

22. Farr J. Autologous chondrocyte implantation improves patellofemoral cartilage treatment outcomes. Clin Orthop Relat Res. Oct 2007; 463:187-194. PMID 17960681

23. Rosenberger RE, Gomoll AH, Bryant T, et al. Repair of large chondral defects of the knee with autologous chondrocyte implantation in patients 45 years or older. Am J Sports Med. Dec 2008; 36(12):2336-2344. PMID 18725654

24. Nugent-Derfus GE, Takara T, O'Neill J K, et al. Continuous passive motion applied to whole joints stimulates chondrocyte biosynthesis of PRG4. Osteoarthritis Cartilage. May 2007; 15(5):566-574. PMID 17157538

25. Salter RB. 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. May 1989(242):12-25. PMID 2650945

26. Fazalare JA, Griesser MJ, Siston RA, et al. The use of continuous passive motion following knee cartilage defect surgery: a systematic review. Orthopedics. Dec 2010; 33(12):878. PMID 21162503

27. Howard JS, Mattacola CG, Romine SE, et al. Continuous passive motion, early weight bearing, and active motion following knee articular cartilage repair: evidence for clinical practice. Cartilage. Oct 2010; 1(4):276-286. PMID 26069559

28. Hill AD, Palmer MJ, Tanner SL, et al. Use of continuous passive motion in the postoperative treatment of intra- articular knee fractures. J Bone Joint Surg Am. Jul 16 2014; 96(14):e118. PMID 25031380

29. Wright RW, Preston E, Fleming BC, et al. A systematic review of anterior cruciate ligament reconstruction rehabilitation: part I: continuous passive motion, early weight bearing, postoperative bracing, and home-based rehabilitation. J Knee Surg. Jul 2008; 21(3):217-224. PMID 18686484

30. Du Plessis M, Eksteen E, Jenneker A, et al. The effectiveness of continuous passive motion on range of motion, pain and muscle strength following rotator cuff repair: a systematic review. Clin Rehabil. Apr 2011; 25(4):291-302. PMID 20943710

31. Lastayo PC, Wright T, Jaffe R, et al. Continuous passive motion after repair of the rotator cuff. A prospective outcome study. J Bone Joint Surg Am. Jul 1998; 80(7):1002-1011. PMID 9698005

32. Raab MG, Rzeszutko D, O'Connor W, et al. Early results of continuous passive motion after rotator cuff repair: a prospective, randomized, blinded, controlled study. Am J Orthop (Belle Mead NJ). Mar 1996; 25(3):214-220. PMID 8775698

33. Garofalo R, Conti M, Notarnicola A, et al. Effects of one-month continuous passive motion after arthroscopic rotator cuff repair: results at 1-year follow-up of a prospective randomized study. Musculoskelet Surg. May 2010; 94 Suppl 1:S79-83. PMID 20383685

34. Simkin PA, de Lateur BJ, Alquist AD, et al. Continuous passive motion for osteoarthritis of the hip: a pilot study. J Rheumatol. Sep 1999; 26(9):1987-1991. PMID 10493681

35. Dundar U, Toktas H, Cakir T, et al. Continuous passive motion provides good pain control in patients with adhesive capsulitis. Int J Rehabil Res. Sep 2009; 32(3):193-198. PMID 19011582

36. Ekim AA, Inal EE, Gonullu E, et al. Continuous passive motion in adhesive capsulitis patients with diabetes mellitus: A randomized controlled trial. J Back Musculoskelet Rehabil. Nov 21 2016; 29(4):779-786. PMID 27002662

37. Lindenhovius AL, van de Luijtgaarden K, Ring D, et al. Open elbow contracture release: postoperative management with and without continuous passive motion. J Hand Surg Am. May-Jun 2009; 34(5):858-865. PMID 19362791

38. Ring D, Simmons BP, Hayes M. Continuous passive motion following metacarpophalangeal joint arthroplasty. J Hand Surg Am. May 1998; 23(3):505-511. PMID 9620192

39. Schwartz DA, Chafetz R. Continuous passive motion after tenolysis in hand therapy patients: a retrospective study. J Hand Ther. Jul-Sep 2008; 21(3):261-266; quiz 267. PMID 18652971

40. Zeifang F, Carstens C, Schneider S, et al. Continuous passive motion versus immobilisation in a cast after surgical treatment of idiopathic club foot in infants: a prospective, blinded, randomised, clinical study. J Bone Joint Surg Br. Dec 2005; 87(12):1663-1665. PMID 16326882

41. Kasten P, Geiger F, Zeifang F, et al. Compliance with continuous passive movement is low after surgical treatment of idiopathic club foot in infants: a prospective, double-blinded clinical study. J Bone Joint Surg Br. Mar 2007; 89(3):375-377. PMID 17356153

42. Gavish L, Barzilay Y, Koren C, et al. Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study. Physiotherapy. Mar 2015; 101(1):75-81. PMID 25280603

43. Lynch D, Ferraro M, Krol J, et al. Continuous passive motion improves shoulder joint integrity following stroke. Clin Rehabil. Sep 2005; 19(6):594-599. PMID 16180594

44. American Academy of Orthopaedic Surgeons. Surgical management of osteoarthritis of the knee. Evidence-based clinical practice guideline. 2015; Available at: <http://www.aaos.org> (accessed February 14, 2017).

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46. Center for Medicare and Medicaid. National Coverage Decision (NCD) for Durable Medical Equipment Reference List (280.1). 2005; Available at: <https://www.cms.gov> (accessed February 14, 2017).

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Policy History:

Date Reason
7/15/2018 Reviewed. No changes.
11/15/2017 Document updated with literature review. Coverage has changed for the second bullet under the Continuous Passive Motion (CPM) device may be considered medically necessary for use postoperatively as an adjunct to conventional physical therapy in the following situations ONLY statement and reflects the following: For up to 6 weeks during the non-weight bearing rehabilitation period following knee surgery for microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures, and for reconstruction of the anterior cruciate ligament (ACL).
7/15/2016 Document updated with literature review. Coverage unchanged.
8/15/2015 Reviewed. No changes.
12/1/2014 Document updated with literature review. The following changes were made to the first bullet listed under the conditions considered medically necessary in the coverage section: Total knee arthroplasty (TKA) or TKA revision changed to knee arthroplasty or knee arthroplasty revision. The following clarification was made to the example section listed in the coverage section: From (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures, reconstruction of the anterior cruciate ligament [ACL]). To: (e.g., microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures), and for reconstruction of the anterior cruciate ligament (ACL).
1/1/2012 Document updated with literature review. The following changes were made: 1) Following intra-articular cartilage repair procedures of the knee, CPM may be allowed for up to six (6) weeks during non-weight-bearing rehabilitation; 2) “This document is no longer scheduled for routine literature review and update.” was removed.
4/15/2009 Revised/updated entire document
2/15/2008 Revised/updated entire document. This policy is no longer scheduled for routine literature review and update.
3/15/2006 Revised/updated entire document
4/1/2002 Revised/updated entire document
3/1/1998 Revised/updated entire document
5/1/1996 Revised/updated entire document
3/1/1996 Revised/updated entire document
10/1/1994 Revised/updated entire document
7/1/1992 Revised/updated entire document
9/1/1990 New Medical Document

Archived Document(s):

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