Medical Policy: 01.01.04
Original Effective Date: December 1993
Reviewed: August 2018
Revised: August 2018
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Continuous passive motion (CPM) devices are used to keep a joint in motion without patient assistance. CPM is being evaluated for treatment and postsurgical rehabilitation of the upper- and lower-limb joints and for a variety of musculoskeletal conditions.
The device moves the joint (e.g., flexion/extension), without patient assistance, continuously for extended periods of time (i.e., up to 24 hours/day). 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 devices may be initiated in the immediate postoperative period and then continued at home for a variable period of time.
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, CPM devices have also been used. Continuous passive motion (CPM) is thought to improve recovery by stimulating the healing of articular tissues and circulation of synovial fluid; reducing local edema; and preventing adhesions, joint stiffness or contractures, or cartilage degeneration. CPM has been most thoroughly investigated in the knee, particularly after total knee arthroplasty (TKA) or ligamentous or cartilage repair, but its acceptance in the knee joint has created interest in extrapolating this experience to 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.
Most research on CPM has been as a postoperative treatment for total knee arthroplasty (TKA). Numerous randomized controlled trials (RCTs) have been performed comparing CPM as an adjunct to physical therapy (PT) for patients undergoing TKA. 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 are considerably different than when the largest body of evidence was collected, making it difficult to apply the available evidence to the present situation.
Based on review of the evidence on total knee replacement that includes several RCTs and a large Cochrane review with a body of evidence extending back to the 1980’s. The systematic reviews identified described limited clinical usefulness for CPM in rehabilitation after knee surgery and described the quality of the evidence as low. The Cochrane review by Harvey et. al. 2014 included 24 RCTs with 1,445 patients and described the effects of CPM on outcomes after total knee replacement such as range of motion, function, pain and quality of life as “not clinically important.”
With respect to reducing deep-venous thrombosis after total knee replacement, the systemic review by He et. al. concluded the evidence is insufficient to determine a benefit from using CPM. This review included 11 RCTs with 808 patients. The results of the meta-analysis showed no evidence that CPM had any effect on preventing venous thrombosis after total knee replacement.
Continuous passive motion (CPM) is also commonly used postoperatively following articular cartilage repair surgery. Unfortunately, the clinical evidence to support the use of CPM is lacking (only 4 clinical studies) and despite the overwhelming abundance of basic science support and the common clinical practice of the use of CPM postoperatively the study results were heterogeneous and were considered low-quality evidence of any benefit from CPM when used after these procedures. Further randomized controlled trials are needed comparing the use of CPM in patients undergoing the same cartilage restoration procedure with patients treated without CPM and only active ROM which would provide high-quality clinical outcome research on which to base postoperative decisions. Also, based on the literature changes in clinical practice have occurred over time which is allowing weight bearing as tolerated immediately following cartilage repair with a gradual increase to full weight bearing at 8 weeks which has been reported to safely improve pain, function, and activity compared to more conservative progression with no increase of complications as of 3 months post operation. Studies also support the need for some degree of compressive loading in addition to joint motion for successful cartilage healing.
The literature suggests that institutional and home use of CPM has minimal benefit alone or when combined with standard PT after TKA, TKA revision or intra-articular cartilage repair. For patients who are unable to participate in standard PT regimens (due to low postoperative mobility or inability to comply with rehabilitation exercises), CPM remains as an alternative PT modality.
For use of CPM in joints other than the knee, there is limited published evidence. In addition, clinical support was limited for these indications. Three small RCTs of CPM post-rotator cuff surgery have been identified in the literature. There is some evidence that use of CPM following rotator cuff repair of the shoulder improves short-term pain and range of motion (ROM); however, this is not high quality evidence, and the small differences in outcomes may not be clinically important. Two of these trials report short-term improvements in ROM for patients undergoing CPM, and 1 reports a short-term reduction in pain. None of the trials report long-term improvements, nor are there any reported benefits in functional status or quality of life. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT regimen post-shoulder surgery such that the optimal comparison for CPM is not clear. Larger RCTs with longer follow-up are required to determine whether CPM following rotator cuff surgery results in clinically meaningful improvements in health outcomes. The available evidence is insufficient to permit conclusions concerning the effect of this technology on health outcomes for all other joints.
Based on review of the medical literature the literature reports an improvement in ROM for patients receiving CPM, but these improvements are short term, of small magnitude, and of uncertain clinical significance. No RCTs have reported clinically meaningful improvements in important clinical outcomes such as functional status and/or quality of life compared to those who used CPM in adjunct to physical therapy following TKA, TKA revision or articular cartilage repair surgery.
The literature suggests that institutional and home use of CPM has minimal benefit alone or when combined with standard PT after TKA, TKA revision or intra-articular cartilage repair. For patients who are unable to participate in standard PT regimens (due to low postoperative mobility or inability to comply with rehabilitation exercises), CPM remains as an alternative PT modality.
Two randomized controlled trials (RCTs) (2010 and 2011) of continuous passive motion (CPM) following rotator cuff surgery were identified. These trials reported short-term improvements in range of motion (ROM) for patients undergoing CPM, and one reported a short-term reduction in pain. Neither reported long-term improvements or benefits of functional status. Therefore, the clinical significance of the short-term improvements reported is uncertain. In addition, there is uncertainty about the optimal PT (physical therapy) after shoulder surgery, and so the optimal comparator for CPM is not clear. The available published peer reviewed literature does not support the use of CPM postoperatively following rotator cuff repair.
Dundar et. al. compared continuous passive motion (CPM) with physical therapy (PT) in a randomized trial of 57 patients with adhesive capsulitis (frozen shoulder). CPM or PT was provided for 1 hour a day (5 days/week) for 4 weeks. Pain and function levels were similar in the 2 groups at baseline, with VAS (visual analog) scores for pain ranging from 5.44 (at rest) to 6.34 (with movement). Assessments at baseline, 4, and 12 weeks showed reductions in pain and improvements in 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 (range of motion) or function. This trial provided modest support for the inclusion of CPM in a PT regimen for this patient population.
A randomized controlled trial (RCT) by Ekim et. al. (2016) compared continuous passive motion (CPM) (n=20) with physical therapy (PT) (n=21) for the treatment of adhesive capsulitis in patients who had diabetes. CPM or PT was provided for 1 hour a day (5 days/week) 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 range of motion (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 CPM group, while external and internal rotation improvements were similar across groups.
Continuous passive motion (CPM) is often used in the early post-operative rehabilitation following hip surgery (total hip arthroplasty) or hip arthroscopy. Per review of the peer reviewed medical literature no prospective, controlled data currently exists about whether or not CPM provides a measurable benefit to patients following hip surgery (total hip arthroplasty) or hip arthroscopy. Randomized controlled trials (RCTs) comparing CPM to conventional physical therapy (PT) to include large patient populations with long term follow-up are needed to determine whether the use of CPM for the hip following hip surgery or hip arthroscopy shows clinically meaningful improvements in net health outcomes. The American Academy of Orthopaedic Surgeons (AAOS) guidelines do not mention or indicate the use of CPM in the treatment of osteoarthritis of the hip or as a preventative measure in preventing venous thromboembolic disease in patients undergoing elective hip arthroplasty. The available published peer reviewed literature does not support the use of CPM postoperatively for the hip for any indication.
Postoperative management of open elbow contracture release with continuous passive motion (CPM) was assessed in a matched cohort study by Lindenhovius et. al. Sixteen patients who had used CPM after open contracture release and 16 patients who had not were matched by age, sex, diagnosis, range of motion (ROM) and radiographic appearance. Improvements in ROM did not differ between groups at the early range of 4-10 months and the final range of 11-56 month evaluation. The authors concluded the matched retrospective data did not demonstrate a benefit of CPM in the postoperative management of elbow contracture release.
Based on a review by Viveen et.al. (2017) to date there have been no prospective randomized trials comparing rehabilitation protocols after surgery release of stiff elbow. Based upon current scientific literature, there is no clear preference for one of the treatments over the other (CPM or PT) regarding the increase of ROM after surgery. CPM in elbow surgery may be redundant as well as in other joints, the use of CPM as a post treatment seems ineffective and unnecessary.
There is a scarcity of peer reviewed evidence on the use of continuous passive motion (CPM) postoperatively for the wrist and ankle. Randomized controlled trials (RCTs) comparing the use of CPM to physical therapy (PT) to improve range of motion are needed to determine whether the use of CPM provides clinically meaningful improvements in net health outcomes. The available published peer reviewed literature does not support the use of CPM postoperatively.
Based on review of the peer reviewed medical literature, there is limited publised high quality evidence for use of continuous passive motion (CPM) in joints other than the knee including but not limited to the hip, ankle, shoulder, elbow, wrist. The evidence includes a few randomized controlled trials (RCTs) for some conditions and case series for others. Based on review of the literature, there may be some evidence that use of CPM may improve short term pain and range of motion (ROM), however these improvements are short term, of small magnitude, and of uncertain clinical significance. Larger randomized controlled trials (RCTs) comparing the use of CPM to physical therapy (PT) to include longer follow-up are required to determine whether the use of CPM in joints other than the knee shows clinically meaningful improvements in net health outcomes. The available published peer reviewed literature does not support the use of CPM postoperatively.
In 2011, the American Academy of Orthopaedic Surgeons issued an evidence based clinical practice guideline on preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty, this guideline does not mention or indicate the use of continuous passive motion (CPM) postoperatively.
In 2013, the American Academy of Orthopaedic Surgeons issued an evidence based clinical practice guideline for optimizing the management of rotator cuff problems, this guideline does not mention or indicate the use of continuous passive motion (CPM) postoperatively.
In 2015, the American Academy of Orthopedic Surgeons issued an evidence based clinical practice guideline for the surgical management of osteoarthritis of the knee which states: "Continuous Passive Motion: Strong evidence supports that CPM after knee arthroplasty (KA) does not improve outcomes. Strength of recommendations: Strong Evidence."
In 2017, the American Academy of Orthopaedic Surgeons evidence based clinical practice guideline on the management of osteoarthritis of the hip does not mention or indicate the use of continuous passive motion postoperatively. The guideline states the following: “moderate evidence supports the use of post-operative physical therapy because it could improve early function to a greater extent than no physical therapy management for patients with symptomatic osteoarthritis of the hip who have undergone total hip arthroplasty.”
CPM devices are considered class I devices by the FDA and are exempt from 510(k) requirements. This classification does not require submission of clinical data regarding efficacy but only notification of the FDA before marketing.
Not applicable
If the CPM device is determined to be medically necessary, the CPM is payable only as rental equipment for 30 days following surgery.
Use of continuous passive motion (CPM) device in the home setting may be considered medically necessary in the below situations as an alternative to physical therapy when the patient has low postoperative mobility or inability to comply with rehabilitation exercises (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):
Note: The literature suggests that institutional and home use of continuous passive motion (CPM) has minimal benefit alone or when combined with standard physical therapy (PT) after total knee arthroplasty (TKA), TKA revision or intra-articular cartilage repair. For patients who are unable to participate in standard PT regimens (due to low post-operative mobility or inability to comply with rehabilitation exercises), CPM remains as an alternative PT modality.
All other uses for continuous passive motion (CPM) device in the home setting for any condition of the knee other than described above is considered not medically necessary.
Duplicate rehabilitative therapy is considered not medically necessary. When individuals are receiving physical therapy the therapist should provide different treatments and not duplicate the same treatment (i.e. CPM provides ROM (range of motion) and physical therapy protocols also typically provide ROM treatment/services).
Continuous Passive Motion (CPM) device in the home setting for any joint other than the knee including but not limited to the hip, ankle, shoulder, elbow and wrist is considered not medically necessary, because the available published peer reviewed literature does not support the use of CPM postoperatively.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.