National Medical Policy

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1 National Medical Policy Subject: Policy Number: Continuous Passive Motion (CPM) Devices NMP276 Effective Date*: July 2006 Updated: June 2015 This National Medical Policy is subject to the terms in the IMPORTANT NOTICE at the end of this document For Medicaid Plans: Please refer to the appropriate Medicaid Manuals for coverage guidelines prior to applying Health Net Medical Policies The Centers for Medicare & Medicaid Services (CMS) For Medicare Advantage members please refer to the following for coverage guidelines first: Use Source Reference/Website Link X National Coverage Determination (NCD) Durable Medical Equipment Reference List (280.1) National Coverage Manual Citation Local Coverage Determination (LCD)* Article (Local)* X Other Noridian Medicare. Jurisdiction D. Issue No. 42. March DME Happenings: / /DME+Happenings+Issue+42 +March+2014/19a7b b-4fd3-b554-0a02c14e62bd None Use Health Net Policy Instructions Medicare NCDs and National Coverage Manuals apply to ALL Medicare members in ALL regions. Medicare LCDs and Articles apply to members in specific regions. To access your specific region, select the link provided under Reference/Website and follow the search instructions. Enter the topic and your specific state to find the coverage Continuous Passive Motion (CPM) Devices Jun 15 1

2 determinations for your region. *Note: Health Net must follow local coverage determinations (LCDs) of Medicare Administration Contractors (MACs) located outside their service area when those MACs have exclusive coverage of an item or service. (CMS Manual Chapter 4 Section 90.2) If more than one source is checked, you need to access all sources as, on occasion, an LCD or article contains additional coverage information than contained in the NCD or National Coverage Manual. If there is no NCD, National Coverage Manual or region specific LCD/Article, follow the Health Net Hierarchy of Medical Resources for guidance. Current Policy Statement Health Net, Inc. considers the use of a continuous passive motion (CPM) device to improve range of motion medically necessary in the post-operative rehabilitation period until active physical therapy has been initiated, following any of these surgical procedures: 1. Total knee arthroplasty 2. Anterior cruciate ligament repair/reconstruction 3. During the non-weight-bearing period to promote growth and enhance cartilage healing after articular cartilage grafting procedures (e.g., chondroplasty, microfracture, drilling, abrasion, autologous chondrocyte implantation or surgery for intra-articular cartilage fractures) 4. Surgical release of arthrofibrosis of any joint (e.g. elbow, knee, shoulder) Health Net, Inc. considers the use CPM devices for all other indications, not medically necessary. Note: CPM device should be initiated within 48 hours following surgery and the usual duration of treatment is 7-10 days. There is insufficient evidence to justify use of CPM devices beyond three weeks (21 days). CPM devices are rental items and it is not medically necessary to purchase. Codes Related To This Policy NOTE: The codes listed in this policy are for reference purposes only. Listing of a code in this policy does not imply that the service described by this code is a covered or noncovered health service. Coverage is determined by the benefit documents and medical necessity criteria. This list of codes may not be all inclusive. On October 1, 2015, the ICD-9 code sets used to report medical diagnoses and inpatient procedures will be replaced by ICD-10 code sets. Health Net National Medical Policies will now include the preliminary ICD-10 codes in preparation for this transition. Please note that these may not be the final versions of the codes and that will not be accepted for billing or payment purposes until the October 1, 2015 implementation date. ICD-9 Codes (May not be all inclusive) Rheumatoid arthritis Juvenile rheumatoid arthritis Osteoarthrosis, localized, primary, shoulder Osteoarthrosis, localized, primary, lower leg Continuous Passive Motion (CPM) Devices Jun 15 2

3 Osteoarthrosis, localized, secondary, shoulder region Osteoarthrosis, localized, secondary, lower leg Osteoarthrosis, localized, not specified whether primary or secondary, shoulder region Osteoarthrosis, localized, not specified whether primary or secondary, Lower leg Osteoarthrosis, unspecified whether generalized or localized, shoulder region Osteoarthrosis, unspecified whether generalized or localized, lower leg Internal derangement of knee Old disruption of anterior cruciate ligament Ankylosis of joint, shoulder Ankylosis of joint, upper arm (elbow) Ankylosis of joint, forearm (wrist joint) Ankylosis of joint, lower leg (knee) Adhesive capsulitis of shoulder Complete rupture of rotator cuff Tendon injury V43.61 Total shoulder replacement V43.65 Total knee replacement ICD-10 Codes M M M M M17.0-M17.9 M M M M M M M M M M M M M M M75.00-M75.02 M M Z Z Z M Other specified Rheumatoid arthritis, knee Unspecified juvenile rheumatoid arthritis, knee Osteoarthritis of knee Primary osteoarthritis, shoulder Derangement of meniscus due to old tear or injury Other spontaneous disruption of anterior cruciate ligament of knee Ankylosis, shoulder Ankylosis, elbow Ankylosis, wrist Ankylosis, knee Adhesive capsulitis of shoulder Rotator cuff tear or rupture,not specifid as traumatic Presence of artificial shoulder joint Presence of artificial knee joint CPT Codes N/A HCPCS Codes E0935 Continuous passive motion exercise device for use on knee only E0936 Continuous passive motion exercise device for use other than knee Scientific Rationale Update June 2015 Harvey et al. (2014) completed a Cochrane Database System Review that included randomized controlled trials, to assess the benefits and harms of CPM and standard postoperative care versus similar postoperative care, with or without additional knee exercises, in people with knee arthroplasty. This review is an update of a 2003 and 2010 version of the same review. There were two groups: one was called the Continuous Passive Motion (CPM) Devices Jun 15 3

4 experimental group and they received CPM, and both the experimental and control groups received similar postoperative care and therapy following total knee arthroplasty in people with arthritis. Two review authors independently selected trials for inclusion, extracted data and assessed risk of bias. The primary outcomes of interest were active knee flexion ROM, pain, quality of life, function, participants' global assessment of treatment effectiveness, incidence of manipulation under anaesthesia and adverse events. The secondary outcomes were passive knee flexion ROM, active knee extension ROM, passive knee extension ROM, length of hospital stay, swelling and quadriceps strength. The authors estimated effects for continuous data as mean differences or standardised mean differences (SMD), and effects for dichotomous data as risk ratios; all with 95% confidence intervals (CI). If appropriate, meta-analyses were done using random-effects models. The authors identified 684 papers from the electronic searches after removal of duplicates and retrieved the full reports of 62 potentially eligible trials. Twenty-four RCTs of 1445 participants met the inclusion criteria; four of these trials were new to this update. There was moderate-quality evidence to indicate that CPM does not have clinically important short-term effects on active knee flexion ROM: mean knee flexion was 78 degrees in the control group, CPM increased active knee flexion ROM by 2 degrees (95% CI 0 to 5) or absolute improvement of 2% (95% CI 0% to 4%). The mediumand long-term effects are similar although the quality of evidence is lower. There was low-quality evidence to indicate that CPM does not have clinically important shortterm effects on pain: mean pain was 3 points in the control group, CPM reduced pain by 0.4 points on a 10-point scale (95% CI -0.8 to 0.1) or absolute reduction of -4% (95% CI -8% to 1%).There was moderate-quality evidence to indicate that CPM does not have clinically important medium-term effects on function: mean function in the control group was 56 points, CPM decreased function by 1.6 points (95% CI -6.1 to 2.0) on a 100-point scale or absolute reduction of -2% (95% CI -5% to 2%). The SMD was -0.1 standard deviations (SD) (95% CI -0.3 to 0.1).There was moderatequality evidence to indicate that CPM does not have clinically important mediumterm effects on quality of life: mean quality of life was 40 points in the control group, CPM improved quality of life by 1 point on a 100-point scale (95% CI -3 to 4) or absolute improvement of 1% (95% CI -3% to 4%).There was very low-quality evidence to indicate that CPM reduces the risk of manipulation under anaesthesia; risk of manipulation in the control group was 7.2%, risk of manipulation in the experimental group was 1.6%, CPM decreased the risk of manipulation by 25 fewer manipulations per 1000 (95% CI 9 to 64) or absolute risk reduction of -4% (95% CI -8% to 0%). The risk ratio was 0.3 (95% CI 0.1 to 0.9).There was low-quality evidence to indicate that CPM reduces the risk of adverse events; risk of adverse events in the control group was 16.3%, risk of adverse events in the experimental group was 17.9%, CPM decreased the risk of adverse event by 150 fewer adverse events per 1000 (95% CI 103 to 216) or absolute risk reduction of -1% (95% CI - 5% to 3%). The risk ratio was 0.9 (95% CI 0.6 to 1.3). The estimates for risk of manipulation and adverse events are very imprecise and the estimate for the risk of adverse events does not distinguish between a clinically important increase and decrease in risk. There was insufficient evidence to determine the effect of CPM on participants' global assessment of treatment effectiveness. CPM does not have clinically important effects on active knee flexion ROM, pain, function or quality of life to justify its routine use. It may reduce the risk of manipulation under anaesthesia and risk of developing adverse events although the quality of evidence supporting these findings are very low and low, respectively. The effects of CPM on other outcomes are unclear. Scientific Rationale Update June 2013 Continuous Passive Motion (CPM) Devices Jun 15 4

5 Herbold et al (2012) examined the use of CPM as an adjunct to physical therapy after total knee replacement (TKR) in patients who were transferred to an inpatient rehabilitation facility (IRF) and to compare the effectiveness of CPM on active range of motion (AROM), functional tasks, destination after discharge, the need for home care services, and the ambulation device at discharge. Patients admitted to a rehabilitation setting after total knee replacement surgery with an initial AROM for knee flexion of less than 75 at admission to the IRF were included in the study. From this initial population, a matched sample of 61 patient pairs was included in the analysis (61 who used the CPM and 61 who did not receive the adjunct therapy). Participants used CPM for 2 hours per day as an adjunct to the 3 hours of physical and occupational therapy customary in an IRF. Primary outcomes were discharge active knee flexion ROM and flexion gain. Secondary outcomes were motor, cognitive, and total Functional Independence Measure scores; discharge ambulation device; destination after discharge; and the need for home care services after the inpatient stay. The outcome variables of 61 matched pairs of CPM users and non- CPM users were reported. No statistically significant differences were found in any of the outcome variables that were compared in this matched case design, including AROM knee, flexion gain, discharge to the community, need for home care services after discharge, and discharge with cane/no device. No significant difference was found in all functional scores as measured by the Functional Independence Measure scale. Investigators concluded for this population, we determined at one facility that less than 30% are provided with a CPM as an adjunct to physical therapy. Using a matched cohort design, we compared CPM use with non-cpm use and determined that the application of CPM may not significantly influence ROM gain. Scientific Rationale Continuous passive motion (CPM) device is a motorized device that moves a joint through a prescribed range of motion for an extended period of time. The use of CPM devices are based on the theory that passive motion early in the healing process can provide movement of the synovial fluid and thus promote lubrication of the joint, stimulate the healing of articular tissues, prevent adhesions and joint stiffness, and reduce edema, without interfering with the healing of incisions or wounds over the moving joint. The goal of CPM devices is to maintain or restore range of motion (ROM) to the joint. The benefits of CPM are recognized although quantifying its value has been difficult. There is some evidence that use of CPM improves short- and midterm ROM of joints, avoiding a potentially painful physical therapy regimen to regain lost ROM. However, there continues to be conflicting findings regarding its effectiveness. CPM is often used to improve range of motion without patient assistance following total knee replacement, ligament reconstruction, tendon repair, joint manipulation under anesthesia, arthroscopic debridement of adhesions, stabilized intra-articular fracture, and articular cartilage regeneration techniques. Generally, CPM is initiated within 24 to 48 hours following surgery. Physical therapy following joint surgery or trauma focuses on restoration of mobility and active exercises to restore strength. Once the patient is participating in active PT, CPM is no longer medically necessary. The majority of the published literature relates to the use of CPM in patients who have undergone a total knee replacement/arthroplasty. Limited published literature exsists for use of CPM following surgery of the articular tissues of the shoulder, elbow, or hand or CPM following ACL repair. The Cochrane Collaboration completed a systematic review regarding the effectiveness of continuous passive motion (CPM) after knee arthroplasty. This review of 14 studies (952 participants) found significant improvements in active knee flexion and analgesic use two weeks post- Continuous Passive Motion (CPM) Devices Jun 15 5

6 operatively with the use of continuous passive motion and physiotherapy compared to physiotherapy alone. In addition, length of hospital stay and need for knee manipulations were significantly decreased in the continuous passive motion group. Outcome measures of interest were: active and passive knee range of motion (ROM) length of hospital stay, pain, swelling and quadriceps strength. The rehabilitation process following surgery of the anterior cruciate ligament (ACL) generally involves intense therapy. The use of continuous passive motion (CPM) following ACL reconstruction has become common in the acute post operative period followed by active physical therapy. CPM can be used to establish 0-30 of motion immediately postoperatively and progress to 60 of knee flexion by the morning following the operation. There is some evidence that suggests that CPM gives a slight advantage in the rehabilitation after the ACL replacement. One small published study found that the flexion-extension in the CPM group as compared to active motion only, was significantly greater at the time of discharge, but this difference was practically eliminated in 6 months after the operation. No other significant difference were noted between the two groups. Rehabilitation is a key element of successful treatment of cartilage defects with cell transplantation. Cartilaginous regeneration is enhanced by CPM, although the mechanisms by which CPM stimulate chondrogenesis are unknown. CPM exercises and physiotherapy are usually initiated soon after surgery, during the non-weight bearing period, to promote growth and enhance cartilage healing. CPM devices are not usually necessary during the weight bearing phase of recovery. A Cochrane review in 2004, examined evidence from randomized controlled trials, the optimal rehabilitation strategy after surgery, for flexor tendon injuries in the hand. Six trials, including three reported only in abstracts, with a total of 464 participants were included. One trial compared continuous passive motion (CPM) with controlled intermittent passive motion (CIPM) and found a significant difference in mean active motion favoring CPM. Another trial compared a shortened passive flexion/active extension program with a normal passive flexion/active extension mobilization program, and reported (without data) a significant reduction in absence from work of 2.1 weeks in favor of the shortened program. The remaining trials compared active flexion with rubber band traction, early controlled active mobilization with early controlled passive mobilization and dynamic splintage versus static splintage. No trials found significant differences in overall functioning or complication rate. The author concluded that there was insufficient evidence from randomized controlled trials to define the best mobilization strategy. Review History July 2006 July 2010 June 2011 June 2012 June 2013 June 2014 June 2015 Medical Advisory Council, initial approval Update Added Medicare criteria for CPM based on NCD for Durable Medical Equipment Reference List. No change for commercial members. Update no revisions Update no revisions Uppdate no revisions. Code updates. Update no revisions. Code updates. Update no revisions. Code updates. This policy is based on the following evidence-based guidelines: Continuous Passive Motion (CPM) Devices Jun 15 6

7 1. National Guideline Clearinghouse. Work Loss Data Institute. Knee & leg (acute & chronic). Corpus Christi (TX): Work Loss Data Institute; Hayes Medical Technology Directory. Mechanical Stretching Devices and Continuous Passive Motion for Joints of the Extremities. July Accessed June Hayes Medical Technology Directory. Continuous Passive Motion for the Treatment of Joint Contractures of the Extremities. Mar Updated March References Update June Boese CK, Weis M, Phillips T, et al. The efficacy of continuous passive motion after total knee arthroplasty: a comparison of three protocol. J Arthroplasty Jun;29(6): doi: /j.arth Epub 2013 Dec Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev Feb 6;2:CD 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;95(7): doi: /j.apmr Epub 2014 Mar 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;96(14):e118. [Epub ahead of print] References Update June Karnes JM, Harris JD, Griesser MJ, et al. Continuous passive motion following cartilage surgery: does a common protocol exist? Phys Sports med Nov;41(4): doi: /psm References Update June 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;4(10): Zhu Y, Nakamura M, Horiuchi T, et al. New wearable walking-type continuous passive motion device for postsurgery walking rehabilitation. Proc Inst Mech Eng H Mar 19. References Update June He ML, Xiao ZM, Lei M, et al. Continuous passive motion for preventing venous thromboembolism after total knee arthroplasty. Cochrane Database Syst Rev Jan 18;1:CD References Update June Alkire MR, Swank ML. Use of inpatient continuous passive motion versus no CPM in computer-assisted total knee arthroplasty. Orthop Nurs Jan- Feb;29(1): 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;25(4): Ersözlü S, Sahin O, Ozgür AF, Tuncay IC. The effects of two different continuous passive motion protocols on knee range of motion after total knee arthroplasty: Continuous Passive Motion (CPM) Devices Jun 15 7

8 a prospective analysis. Acta Orthop Traumatol Turc Nov-Dec;43(5): Fazalare JA, Griesser MJ, Siston RA, Flanigan DC. The use of continuous passive motion following knee cartilage defect surgery: a systematic review. Orthopedics Dec 1;33(12): 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;94 Suppl 1:S Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev Mar 17;(3):CD Podwika M, Łepski M, Woźniak W. Rehabilitation after operative treatment with hip joint preservation in adults--own experience. Chir Narzadow Ruchu Ortop Pol Jul-Aug;75(4): References Update July Centers for Medicare and Medicaid Services. NCD for Durable Medical Equipment Reference List. Effective May References 1. Alfredson H, Lorentzon R. Superior results with continuous passive motion compared to active motion after periosteal transplantation. A retrospective study of human patella cartilage defect treatment. Knee Surg Sports Traumatol Arthrosc. 1999;7(4): Bennett LA, Brearley SC, Hart JA, et al. A comparison of 2 continuous passive motion protocols after total knee arthroplasty: a controlled and randomized study. J Arthroplasty Feb;20(2): Brosseau L, Milne S, Wells G, et al. Efficacy of continuous passive motion following total knee arthroplasty: a metaanalysis. J Rheumatol Nov;31(11): Bruns J, Steinhagen J. Transplantation of chondrogenic tissue in the treatment of lesions of the articular cartilage.orthopade Jan;28(1): 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;86(2): Deszczynski J, Slynarski K. Rehabilitation after cell transplantation for cartilage defects. Transplant Proc Jan-Feb;38(1): Friemert B, Bach C, Schwarz W, et al. Benefits of active motion for joint position sense. Knee Surg Sports Traumatol Arthrosc Nov 23;: Kirschner P. CPM--Continuous Passive Motion: treatment of injured or operated knee-joints using passive movement. A meta-analysis of current literature. Unfallchirurg Apr;107(4): 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 Feb Lenssen AF, Crijns YH, Waltje EM, et al. Effectiveness of prolonged use of continuous passive motion (CPM) as an adjunct to physiotherapy following total knee arthroplasty: design of a randomized controlled trial [ISRCTN ]. BMC Musculoskelet Disord Feb 23;7: Lynch D, Ferraro M, Krol J, et al. Continuous passive motion improves shoulder joint integrity following stroke. Clin Rehabil Sep;19(6): Continuous Passive Motion (CPM) Devices Jun 15 8

9 12. Michael JW, Konig DP, Imhoff AB, et al. Efficiency of a postoperative treatment after rotator cuff repair with a continuous passive motion device (CPM) Orthop Ihre Grenzgeb Jul-Aug;143(4): Milne S, Brosseau L, Robinson V, Continuous passive motion following total knee arthroplasty. Cochrane Database Syst Rev. 2003;(2) 14. Mukherjee N, Saris DB, Schultz FM, et al. The enhancement of periosteal chondrogenesis in organ culture by dynamic fluid pressure. J Orthop Res Jul;19(4): Erratum in: J Orthop Res 2001 Nov;19(6): Naylor J, Harmer A, Fransen M, et al. Status of physiotherapy rehabilitation after total knee replacement in Australia. Physiother Res Int Mar;11(1): Ring D, Simmons BP, Hayes M. Continuous passive motion following metacarpophalangeal joint arthroplasty. J Hand Surg [Am] May;23(3): Souryal T, Adams K, Anterior Cruciate Ligament Injury. emedicine. Updated September 14, Accessed June Available at: Thien TB, Becker JH, Theis JC. Rehabilitation after surgery for flexor tendon injuries in the hand. Cochrane Database Syst Rev Oct 18;(4) 19. Zeifang F, Carstens C, Schneider S, et al. Continuous passive motion versus immobilization in a cast after surgical treatment of idiopathic club foot in infants: a prospective, blinded, randomized, clinical study. J Bone Joint Surg Br Dec;87(12): Important Notice General Purpose. Health Net's National Medical Policies (the "Policies") are developed to assist Health Net in administering plan benefits and determining whether a particular procedure, drug, service or supply is medically necessary. The Policies are based upon a review of the available clinical information including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the drug or device, evidence-based guidelines of governmental bodies, and evidence-based guidelines and positions of select national health professional organizations. Coverage determinations are made on a case-by-case basis and are subject to all of the terms, conditions, limitations, and exclusions of the member's contract, including medical necessity requirements. Health Net may use the Policies to determine whether under the facts and circumstances of a particular case, the proposed procedure, drug, service or supply is medically necessary. The conclusion that a procedure, drug, service or supply is medically necessary does not constitute coverage. The member's contract defines which procedure, drug, service or supply is covered, excluded, limited, or subject to dollar caps. The policy provides for clearly written, reasonable and current criteria that have been approved by Health Net s National Medical Advisory Council (MAC). The clinical criteria and medical policies provide guidelines for determining the medical necessity criteria for specific procedures, equipment, and services. In order to be eligible, all services must be medically necessary and otherwise defined in the member's benefits contract as described this "Important Notice" disclaimer. In all cases, final benefit determinations are based on the applicable contract language. To the extent there are any conflicts between medical policy guidelines and applicable contract language, the contract language prevails. Medical policy is not intended to override the policy that defines the member s benefits, nor is it intended to dictate to providers how to practice medicine. Policy Effective Date and Defined Terms. The date of posting is not the effective date of the Policy. The Policy is effective as of the date determined by Health Net. All policies are subject to applicable legal and regulatory mandates and requirements for prior notification. If there is a discrepancy between the policy effective date and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. * In some states, prior notice or posting on the website is required before a policy is deemed effective. For information regarding the effective dates of Policies, contact your provider representative. The Policies do not include definitions. All terms are defined by Health Net. For information regarding the definitions of terms used in the Policies, contact your provider representative. Policy Amendment without Notice. Health Net reserves the right to amend the Policies without notice to providers or Members. In some states, prior notice or website posting is required before an amendment is deemed effective. Continuous Passive Motion (CPM) Devices Jun 15 9

10 No Medical Advice. The Policies do not constitute medical advice. Health Net does not provide or recommend treatment to members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. No Authorization or Guarantee of Coverage. The Policies do not constitute authorization or guarantee of coverage of particular procedure, drug, service or supply. Members and providers should refer to the Member contract to determine if exclusions, limitations, and dollar caps apply to a particular procedure, drug, service or supply. Policy Limitation: Member s Contract Controls Coverage Determinations. Statutory Notice to Members: The materials provided to you are guidelines used by this plan to authorize, modify, or deny care for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract. The determination of coverage for a particular procedure, drug, service or supply is not based upon the Policies, but rather is subject to the facts of the individual clinical case, terms and conditions of the member s contract, and requirements of applicable laws and regulations. The contract language contains specific terms and conditions, including pre-existing conditions, limitations, exclusions, benefit maximums, eligibility, and other relevant terms and conditions of coverage. In the event the Member s contract (also known as the benefit contract, coverage document, or evidence of coverage) conflicts with the Policies, the Member s contract shall govern. The Policies do not replace or amend the Member s contract. Policy Limitation: Legal and Regulatory Mandates and Requirements The determinations of coverage for a particular procedure, drug, service or supply is subject to applicable legal and regulatory mandates and requirements. If there is a discrepancy between the Policies and legal mandates and regulatory requirements, the requirements of law and regulation shall govern. Reconstructive Surgery CA Health and Safety Code requires health care service plans to cover reconstructive surgery. Reconstructive surgery means surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function or (2) To create a normal appearance, to the extent possible. Reconstructive surgery does not mean cosmetic surgery," which is surgery performed to alter or reshape normal structures of the body in order to improve appearance. Requests for reconstructive surgery may be denied, if the proposed procedure offers only a minimal improvement in the appearance of the enrollee, in accordance with the standard of care as practiced by physicians specializing in reconstructive surgery. Reconstructive Surgery after Mastectomy California Health and Safety Code requires treatment for breast cancer to cover prosthetic devices or reconstructive surgery to restore and achieve symmetry for the patient incident to a mastectomy. Coverage for prosthetic devices and reconstructive surgery shall be subject to the co-payment, or deductible and coinsurance conditions, that are applicable to the mastectomy and all other terms and conditions applicable to other benefits. "Mastectomy" means the removal of all or part of the breast for medically necessary reasons, as determined by a licensed physician and surgeon. Policy Limitations: Medicare and Medicaid Policies specifically developed to assist Health Net in administering Medicare or Medicaid plan benefits and determining coverage for a particular procedure, drug, service or supply for Medicare or Medicaid members shall not be construed to apply to any other Health Net plans and members. The Policies shall not be interpreted to limit the benefits afforded Medicare and Medicaid members by law and regulation. Continuous Passive Motion (CPM) Devices Jun 15 10