mp-242 - Medical Policies - Alabama
Continuous Passive Motion in the Home Setting
Policy Number: MP-242
Latest Review Date: March 2022
Category: Durable Medical Equipment
Continuous passive motion (CPM) devices may be considered medically necessary for the following surgeries, provided the device is initiated within 48 hours following the surgery:
- Total knee arthroplasty (TKA)
- Knee ligament reconstructive surgery
- Open reduction and internal fixation for tibial plateau fracture
- Manipulation and osteotomy around the knee, distal femur, or proximal tibia
- Autologous chondrocyte transplant (ACT)
- Open reduction internal fixation of an osteochondral fracture
Following total knee arthroplasty (TKA), continuous passive motion (CPM) in the home setting should be limited to a 17 day period following discharge from the hospital after surgery while patients are immobile or unable to bear weight.
Following articular cartilage repair procedures of the knee, CPM in the home setting should be limited to a six week period following discharge from the hospital after surgery during non-weight-bearing rehabilitation.
Use of the device for longer than the period specified above must be reviewed for medical necessity.
Use of continuous passive motion (CPM) devices for conditions/surgeries other than those listed above, including but not limited to, shoulder, elbow, hip, ankle, and wrist, is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
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.
Physical Therapy (PT) of points 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. 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 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) as well as 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 h/d). An electrical power unit is used to set the variable 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° 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.
Over time, 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. Therefore, some providers may want patients to continue CPM in the home as a means of duplicating the services offered with a longer (7-day) hospital stay.
The focus of the current review is to examine the literature on the use of CPM in the home setting as it is currently being prescribed postoperatively. Relevant comparisons are treatment outcomes of CPM when used alone or with physical therapy, compared with physical therapy alone.
The most recent literature update was performed through December 20, 2021.
SUMMARY OF EVIDENCE:
For individuals who have total knee arthroplasty who receive CPM in the home setting, the evidence includes RCTs, case series, and systematic reviews. The 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 with standard PT. There were no studies evaluating CPM in patients who could not perform standard PT.
For individuals who have 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. The 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.
For individuals who have musculoskeletal conditions other than total knee arthroplasty or knee cartilage repair requiring who receive continuous passive motion 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 continuous passive motion after rotator cuff surgery showed some evidence that continuous passive motion after this shoulder surgery improved short-term pain and range of motion; 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 range of motion for patients undergoing continuous passive motion, and one 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 continuous passive motion is unclear. Two small RCTs compared continuous passive motion with conventional PT for treatment of adhesive capsulitis. One of the trials focused on diabetic patients with adhesive capsulitis. Both reported comparable improvements in range of motion and functional ability between treatment groups. For other musculoskeletal conditions, RCTs do not exist; case series either did not show efficacy of continuous passive motion or had important methodologic flaws. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals who have had a stroke requiring PT who receive CPM in the home setting, the evidence includes a small RCT. The 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 and PT alone. The trial was small and treatment lasted only 20 days. The evidence is insufficient to determine that the technology results in an improvement in net health outcomes.
PRACTICE GUIDELINES AND POSITION STATEMENTS:
American Academy of Orthopaedic Surgeons
The American Academy of Orthopaedic Surgeons (AAOS) published evidence based guidelines on surgical management of osteoarthritis of the knee in 2015. The AAOS identified 2 high quality studies and 5 moderate quality studies that evaluated the use of CPM. In one of the high quality studies, CPM was utilized 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”.
U.S. Preventive Services Task Force Recommendations
Continuous passive motion (CPM), total knee arthroplasty (TKA), rotator cuff repair (RCR), arthrofibrosis of the elbow, elbow arthroplasty, adhesive capsulitis, frozen shoulder
APPROVED BY GOVERNING BODIES:
CPM devices are considered Class I devices by 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.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.
Continuous passive motion exercise device for use on knee only
Continuous passive motion exercise device for use other than knee
- American Academy of Orthopaedic Surgeons. Surgical management of osteoarthritis of the knee. Evidence-based clinical practice guideline. 2015; //www.aaos.org/uploadedFiles/PreProduction/Quality/Guidelines_and_Reviews/guidelines/SMOAK%20CPG_4.22.2016.pdf. Accessed July 8, 2016.
- 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 2014; 29(6):1158-62.
- 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.
- Ekim AA, Inal EE, Gonullu E, et al. Continuous passive motion in adhesive capsulitis patients with diabetes mellitus: Arandomized controlled trial. J Back Musculoskelet Rehabil. Nov 21 2016; 29(4): 779-786.
- Fazalare JA, Griesser MJ, Siston RA et al. The use of continuous passive motion following knee cartilage defect surgery: a systematic review. Orthopedics 2010; 33(12):878.
- 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.
- 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.
- Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev 2010; (3):CD004260.
- Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev 2014; 2:CD004260.
- 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.
- 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 2014.
- 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 2012; 4(10):719-25.
- 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.
- 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.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- Karnes JM, Harris JD, Griesser MJ et al. Continuous passive motion following cartilage surgery: does a common protocol exist? Phys Sportsmed 2013; 41(4):53-63.
- Phillips BB. Arthroscopy of upper extremity. Canale: Campbell’s Operative Orthopaedics, 10th ed. Mosby Inc.
Medical Policy Group, December 2006 (2)
Medical Policy Administration Committee, January 2007
Available for comment December 29, 2006-February 12, 2007
Medical Policy Group, March 2007 (2)
Medical Policy Administration Committee, March 2007
Available for comment March 23-May 7, 2007
Medical Policy Group, October 2008 (2)
Medical Policy Administration Committee, November 2008
Available for comment November 20, 2008-January 5, 2009
Medical Policy Panel, December 2009
Medical Policy Group, May 2010 (2)
Medical Policy Administration Committee May 2010
Available for comment May 26-July 9, 2010
Medical Policy Panel, July 2014Medical Policy Group, July 2014 (5): Policy updated with literature review through June 2, 2014; Key points and references added; Policy statements unchanged.
Medical Policy Panel, July 2015
Medical Policy Group, July 2015 (6): Updates to Description, Key Points, Approved by Governing Bodies and References; no change to policy statement.
Medical Policy Group, November 2015 (6): Change to policy statement-Removing coverage for shoulder and elbow indications and adding criteria regarding coverage period of up to 17 days after total knee arthroplasty surgery and up to 6 weeks after other specified knee surgeries.
Medical Policy Administration Committee December 2015
Available for comment November 24, 2015 through January 7, 2016
Medical Policy Panel, July 2016
Medical Policy Group, July 2016 (6): Updates to Title, Description of Procedure, Key Points, Summary, Practice Guidelines and Position Statements and References. No change to policy intent.
Medical Policy Panel, March 2017
Medical Policy Group, April 2017 (6): Updates to Description, Key Points and Practice Guidelines. No change to policy statement.
Medical Policy Panel, May 2017
Medical Policy Group, July 2017 (6): The word “intra-” removed from the second bullet point of the first policy statement. Policy statements otherwise unchanged.
Medical Policy Panel, March 2018
Medical Policy Group, March 2018 (6): Updates to Key Points and References.
Medical Policy Panel, March 2019
Medical Policy Group, April 2019 (6): Updates to Key Points. No change to policy statement.
Medical Policy Panel, March 2020
Medical Policy Group, March 2020 (6): Updates to Key Points.
Medical Policy Panel, March 2021
Medical Policy Group, March 2021 (6): Updates to Key Points and References. Policy statement updated to remove "not medically necessary", no change to policy intent.
Medical Policy Panel, March 2022
Medical Policy Group, March 2022 (6): Updates to Key Points, Key Words and References.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.