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CLINICAL POLICY Total Clinical Policy: Total Knee Arthroplasty Reference Number: PA.CP.MP.OR.1002 Coding Implications Effective Date: 04/01/2020 Revision Log Last Review Date: NEW POLICY

See Important Reminder at the end of this policy for important regulatory and legal information.

Common Name: Total

Description: Total knee arthroplasty, or surgical replacement of the knee with an artificial prosthesis, is a reconstructive procedure that has improved the management of those diseases of the knee joint that have responded poorly to other more conservative medical therapies.

Device Capture: Product Line + Devices

I. Criteria for Inclusion: A. Total knee arthroplasty using FDA approved devices is considered medically necessary for any of the following indications: 1. Advanced degenerative joint disease as indicated by ALL of the following: a. , post-traumatic , osteonecrosis, or confirmed by standing x-rays with documentation of all of the following: i. Significant (at least moderate-to-severe) joint destruction ii. Descriptive criteria including at least two of the following: • Subchondral cysts • Subchondral sclerosis • Joint space narrowing • Joint subluxation • Osteophyte formation b. Symptoms correlate with knee pathology, supported by physical exam findings (e.g. antalgic gait, pain or limitation with range of motion, crepitus, joint effusion, swelling) c. Presence of significant pain or disability that interferes with ability to perform daily activities that has failed to improve with at least 3 months of conservative treatment, including all of the following, unless contraindicated: i. Analgesics or anti-inflammatory medications ii. Muscle strengthening and flexibility exercises, instructed by medical professional, in preparation for post-operative interval and recovery iii. Activity modification iv. Weight reduction as appropriate; • For BMI 30 to 35, medical record must document weight discussion • For BMI 35 to 40, medical record must document plan for weight loss • BMI greater than 40 is a contraindication for total knee replacement, unless significant weight loss is clearly documented

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v. Use of an assistive device (optional) vi. Therapeutic knee injections (optional) 2. Failure of previous proximal tibial , distal femoral osteotomy, or unicompartmental knee arthroplasty 3. Posttraumatic knee joint destruction 4. Distal femur fracture repair in elderly patient with osteoporosis 5. Limb salvage for malignancy 6. Hemophilic arthropath B. Knee arthrodesis is considered medically necessary for any of the following indications: 1. As a salvage procedure for failed total knee arthroplasty 2. Reconstruction after tumor resection 3. Posttraumatic arthritis not amenable to traditional total knee arthroplasty 4. Painful after infection or trauma 5. Loss of extensor mechanism 6. Persistent/chronic joint infection

II. Criteria for Exclusion: A. In persons with any of the following contraindications, total knee replacement is considered not medically necessary: 1. Infection of the knee joint, skin, and/or systemic bacteremia that is active or persistent 2. Neurological disorder or disease that is rapidly progressing 3. Allergy or history of allergy to implant material used (e.g. cobalt, chromium, alumina) that has not been evaluated by an allergist or immunologist 4. Current smoker within 2 months 5. Simultaneous bilateral TKA is considered not medically necessary for persons over 70 years of age or ASA 3-4. B. Bicompartmental (or bi-unicompartmental) knee arthroplasty is considered not medically necessary. C. Knee arthrodesis is considered not medically necessary if any of the following are present: 1. Active infection 2. or degeneration or hip fusion in the same limb 3. Contralateral knee arthrodesis or amputation D. Patients unable or unwilling to cooperate with postoperative rehabilitation. E. For persons with significant co-morbidities or complications, the medical record must contain documentation of the risk/benefit of total knee replacement.

III. Device Considerations A. Only implants with FDA approval are considered to be medically appropriate B. Cruciate-retaining implants may be appropriate for a patient whose posterior cruciate ligament is healthy enough to continue stabilizing the knee joint. C. A mobile-bearing (rotating platform) prosthetic may be considered medically appropriate for younger, more active, and/or obese patients D. In patients who are osteoporotic and/or over 75 years old, cemented fixation is recommended E. Antibiotic impregnated cement, when appropriate, should be used for any

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patients that are considered to be immunocompromised F. Gender specific prosthetics have not proven superior to standard prosthetic devices, and requests for these products will be sent to medical review

IV. Surgical Considerations A. Pre-Operative Considerations: 1. Preoperative care planning needs may include: a. Routine preoperative evaluation. b. Preoperative treatment, procedures, and stabilization, including: i. Iron supplementation and erythropoietin ii. Ruling out sources of infection, including dental and lower urinary tract infections iii. Dental prophylaxis as indicated iv. Patient education c. Preoperative discharge planning as appropriate. B. Intra-Operative Considerations: 1. Epidural anesthesia 2. Antibacterial wipes 3. Antibacterial nasal swab 4. Periarticular local anesthetic infiltration 5. Peripheral nerve blockade 6. Neuraxial anesthesia 7. Per AAOS guidelines, TurningPoint cannot recommend utilization of tourniquets as studies have not shown any improvement in outcomes or lessening of complications C. Post-Operative & Inpatient Considerations: 1. Diagnostic test scheduling and completion, including: a. Limb x-ray postoperatively b. Lower extremity Doppler study 2. Treatment and procedure scheduling and completion, including: a. IV antibiotics b. DVT prophylaxis c. Tranexamic acid administration d. Transfusion e. Pain management f. Per AAOS guidelines, TurningPoint cannot recommend using cryotherapy devices, drains, or continuous passive motion (CPM) post operatively as studies have not shown that they improve functionality or outcomes nor decrease complications. 3. Consultation, assessment, and other services scheduling and completion, including: a. Physical therapy b. Occupational therapy c. Gait training 4. Monitoring patient's status for deterioration and comorbid conditions; key items include: a. Neurovascular status D. Discharge Planning & Considerations 1. Assessment of needs and planning for care, including: Page 3 of 10

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a. Develop treatment plan (involving multiple providers as needed). b. Evaluate and address preadmission functioning as needed. c. Evaluate and address patient or caregiver preferences as indicated. d. Identify skilled services needed at next level of care, with specific attention to: i. Medication management, adherence instruction, and side effects assessment ii. Neurovascular status assessment iii. Pain management iv. Wound or dressing management e. Evaluate and address psychosocial status issues as indicated. 2. Early identification of anticipated discharge destination; options include: a. Home, considerations include: i. Access to follow-up care ii. Home safety assessment. iii. Self-care ability, if appropriate. b. Caregiver need, ability, and availability c. Post-acute skilled care or custodial care, as indicated. 3. Transition of care plan complete, which may include: a. Patient and caregiver education complete. b. Medication reconciliation completion includes: i. Compare patient's discharge list of medications (prescribed and over-the- counter) against physician's admission or transfer orders. ii. Assess each medication for correlation to disease state or medical condition. iii. Report medication discrepancies to prescribing physician, attending physician, and primary care provider, and ensure accurate medication order is identified. iv. Provide reconciled medication list to all treating providers. v. Confirm that patient, family, or caregiver can acquire medication. vi. See Medication Reconciliation Tool for further information. vii. Educate patient, family, and caregiver. • Provide complete medication list to patient, family, or caregiver. • Confirm that patient, family, or caregiver understands importance of presenting personal medication list to all providers at each care transition, including all physician appointments. • Confirm that patient, family, or caregiver understands reason, dosage, and timing of medication (eg, use "teach-back" techniques). c. Plan communicated to patient, caregiver, and all members of care team, including: i. Inpatient care and service providers ii. Primary care provider iii. All post-discharge care and service providers d. Post-discharge appointment plans made as needed, which may include: i. Primary care provider ii. Anticoagulation monitoring iii. Orthopedic surgeon iv. Rehabilitation therapy services v. Specialists for management of comorbid conditions e. Post-discharge testing and procedure plans made, which may include: i. Laboratory testing Page 4 of 10

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f. Referrals made for assistance or support, which may include: i. Financial, for follow-up care, medication, and transportation ii. Community services iii. Smoking cessation counseling or treatment g. Medical equipment and supplies coordinated which may include: i. Ambulation devices (eg, cane, crutches, walker) ii. Antiembolic or compression stockings iii. Syringes and needles for subcutaneous injections iv. Wound care supplies

V. Length of Stay Considerations A. Goal length of stay: Ambulatory or inpatient up to 2 days B. Facility type criteria 1. Ambulatory: Selected patients may be able to be treated on ambulatory basis a. Patient must not have any significant comorbidities b. Patient has adequate support at home to support them during recovery c. Patient is under the age of 75 2. Inpatient: may be more appropriate for patients with the following a. Bilateral knee replacement b. Age over 75 c. Uncontrolled diabetes mellitus, defined as hemoglobin A1c greater than 7.0% 2 d. Body mass index (BMI) greater than 30 kg/m e. A known bleeding disorder f. American Society of Anesthesiologist (ASA) scores greater than II g. Poorly controlled cardiac or pulmonary comorbidities h. History of chronic opioid consumption i. Functional neurologic impairments j. Chronic or end-stage renal disease k. Reduced pre-operative cognitive capacity l. Severe mobility disorders m. Voiding difficulties or pre-operative use of urologic medications 3. Extended stay beyond goal length may be needed for: a. Deep venous thrombosis or pulmonary embolism: Anticipate anticoagulation as indicated and local external measures b. Surgical complications: May require acute inpatient care or reoperation c. Acute arterial thrombosis: Anticipate thrombectomy and possible bypass d. Extensor mechanism rupture: Requires surgical repair e. Infected knee joint or operative site: Anticipate antibiotics, cultures, and monitoring of hemodynamic stability f. Fat embolism: Anticipate hemodynamic and ventilatory support and possible steroids g. Bilateral knee replacements: Transition patient to recovery facility when stable if ambulation goals are not achieved h. Periprosthetic fractures: May require protected weight-bearing, cast or brace immobilization, surgical fixation, or revision arthroplasty i. Active comorbidities (eg, heart failure, renal failure, anemia) j. Older patient: Patient 75 years or older may require longer acute hospital care Page 5 of 10

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VI. Coding A. CPT 27445 Arthroplasty, knee, hinge prosthesis (eg, Walldius type) Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella 27447 resurfacing (total knee arthroplasty) 27580 Arthrodesis, knee, any technique 27599 Unlisted procedure, femur or knee

B. HCPCS L8699 Prosthetic implant, not otherwise specified C1763 Connective tissue, non-human (includes synthetic) C1776 Joint device (Implantable)

C. ICD-10 Procedure No ICD-10 Procedure codes

D. ICD-10 Diagnosis All associated ICD-10 Diagnosis codes

References

1. American College of Subcommittee on Osteoarthritis Guidelines. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. Arthritis Rheum. 2000;43(9):1905-1915. 2. American Academy of Orthopedic Surgeons. (2013). Treatment of osteoarthritis of the knee. Retrieved from http://www.aaos.org/research/guidelines/TreatmentofOsteoarthritisoftheKneeGuidel ine.pdf 3. Medical Advisory Secretariat (2005). Total knee replacement: An evidence-based analysis. Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3382388/pdf/ohtas-05-51.pdf 4. Ries, M. D. (2012). Primary arthroplasty for management of osteoporotic fractures about the knee. Current Osteoporosis Reports, (4), 322. 5. Biau, D., Faure, F., Katsahian, S., Jeanrot, C., Tomeno, B., & Anract, P. (2006). Survival of total knee replacement with a megaprosthesis after bone tumor resection. Journal Of Bone & Joint Surgery, American Volume, 88-A(6), 1285-1293. 6. Cerciello, S., Vasso, M., Maffulli, N., Neyret, P., Corona, K., & Panni, A. (2014). Total knee arthroplasty after high tibial osteotomy. Orthopedics, 37(3), 191-198. 7. Aggarwal, V. K., Goyal, N., Deirmengian, G., Rangavajulla, A., Parvizi, J., & Austin, M. S. (2014). Revision total knee arthroplasty in the young patient: Is there trouble on the horizon?. Journal Of Bone & Joint Surgery, American Volume, 96(7), 536-542. 8. Milliman Care Guidelines 18th edition. (2014). Knee arthroplasty 9. Anthem. (2014). Bicompartmental knee arthroplasty. Retrieved from http://www.anthem.com/medicalpolicies/policies/mp_pw_b0941 02.htm 10. Palumbo, B. T., & Scott, R. D. (2014). Diagnosis and indications for

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treatment of unicompartmental arthritis. Clinics In Sports Medicine, 33(1), 11-21. 11. Plate, J.F., Mofidi, A., Mannava, S., Lorentzen, C.M., Smith, B.P., Seyler, T.M., Mctighe, T., & Jinnah, R.H. (2012). Unicompartmental knee arthroplasty: past, present, future. Retrieved from http://www.jisrf.org/pdfs/unicompartmental-knee- arthroplasty-past-present-future.pdf 12. Falck-Ytter Y, et al. Prevention of VTE in patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):e278S-325S. DOI: 10.1378/chest.11-2404. 13. Husted H, Troelsen A, Otte KS, Kristensen BB, Holm G, Kehlet H. Fast-track surgery for bilateral total knee replacement. Journal of Bone and Joint Surgery. British Volume 2011;93(3):351-6. DOI: 10.1302/0301-620X.93B3.25296 14. Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. Journal of Bone and Joint Surgery. British Volume 2011;93(12):1577-85. DOI: 10.1302/0301- 620X.93B12.26989. 15. Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. Journal of Bone and Joint Surgery. American Volume 2012;94(13):1153-9. DOI: 10.2106/JBJS.K.00873. 16. Imaging after total knee arthroplasty. ACR Appropriateness Criteria [Internet] American College of Radiology (ACR). 2011 Accessed at: http://www.acr.org. [created 1995; accessed 2013 Oct 10] 17. Nader A, Kendall MC, Wixson RL, Chung B, Polakow LM, McCarthy RJ. A randomized trial of epidural analgesia followed by continuous femoral analgesia compared with oral opioid analgesia on short- and long-term functional recovery after total knee replacement. Pain Medicine 2012;13(7):937-47. DOI: 10.1111/j.1526-4637.2012.01409.x. 18. Labraca NS, Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Sanchez-Joya Mdel M, Moreno-Lorenzo C. Benefits of starting rehabilitation within 24 hours of primary total knee arthroplasty: randomized clinical trial. Clinical Rehabilitation 2011;25(6):557-66. DOI: 10.1177/0269215510393759. 19. Chen AF, Stewart MK, Heyl AE, Klatt BA. Effect of immediate postoperative physical therapy on length of stay for total joint arthroplasty patients. Journal of Arthroplasty 2012;27(6):851-6. DOI: 10.1016/j.arth.2012.01.011. 20. Parker RJ. Evidence-based practice: caring for a patient undergoing total knee arthroplasty. Orthopaedic Nursing 2011 Jan-Feb;30(1):4-8; quiz 9-10. DOI: 10.1097/NOR.0b013e3182057451. 21. Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. Journal of Bone and Joint Surgery. British Volume 2011;93(12):1577-85. DOI: 10.1302/0301- 620X.93B12.26989. 22. Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. Journal of Bone and Joint Surgery. American Volume 2012;94(13):1153-9. DOI: 10.2106/JBJS.K.00873. 23. Imaging after total knee arthroplasty. ACR Appropriateness Criteria [Internet] American College of Radiology (ACR). 2011 Accessed at: http://www.acr.org. 24. Nader A, Kendall MC, Wixson RL, Chung B, Polakow LM, McCarthy RJ. A Page 7 of 10

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randomized trial of epidural analgesia followed by continuous femoral analgesia compared with oral opioid analgesia on short- and long-term functional recovery after total knee replacement. Pain Medicine 2012;13(7):937-47. DOI: 10.1111/j.1526-4637.2012.01409.x. 25. Labraca NS, Castro-Sanchez AM, Mataran-Penarrocha GA, Arroyo-Morales M, Sanchez-Joya Mdel M, Moreno-Lorenzo C. Benefits of starting rehabilitation within 24 hours of primary total knee arthroplasty: randomized clinical trial. Clinical Rehabilitation 2011;25(6):557-66. DOI: 10.1177/0269215510393759. 26. Chen AF, Stewart MK, Heyl AE, Klatt BA. Effect of immediate postoperative physical therapy on length of stay for total joint arthroplasty patients. Journal of Arthroplasty 2012;27(6):851-6. DOI: 10.1016/j.arth.2012.01.011. 27. Parker RJ. Evidence-based practice: caring for a patient undergoing total knee arthroplasty. Orthopaedic Nursing 2011 Jan-Feb;30(1):4-8; quiz 9-10. DOI: 10.1097/NOR.0b013e3182057451. 28. Garabekyan T, Oliashirazi A, Winters K. The value of immediate preoperative vascular examination in an at-risk patient for total knee arthroplasty. Orthopedics 2011;34(1):52. DOI: 10.3928/01477447-20101123-23. 29. Mihalko WM. Arthroplasty of the knee. In: Canale ST, Beaty JH, editors. Campbell's Operative Orthopaedics. 12th ed. Philadelphia, PA: Elsevier Mosby; 2013:376-444. 30. American Academy of Orthopaedic Surgeons. (2015). Surgical management of osteoarthritis of the knee. Retrieved from http://www.aaos.org/uploadedFiles/PreProduction/Quality/Guidelines_and_Review s/SMOAK% 20CPG 12.4.15.pdf 31. Winemaker M, Petruccelli D, Kabali C, de Beer J. Not all total patients are created equal: preoperative factors and length of stay in hospital. Canadian Journal Of Surgery [serial online]. June 2015;58(3):160-166. 32. Maradit Kremers H, Kremers W, Berry D, Lewallen D. Social and Behavioral Factors in Total Knee and Hip Arthroplasty. Journal Of Arthroplasty [serial online]. October 2015;30(10):1852-1854 33. Nwachukwu B, Gurary E, Katz J, et al. Effect of smoking and soft tissue release on risk of revision after total knee arthroplasty: a case-control study. BMC Musculoskeletal Disorders [serial online]. September 10, 2015;16(1):1-6. 34. Krause A, Sayeed Z, El-Othmani M, Pallekonda V, Mihalko W, Saleh K. Outpatient Total Knee Arthroplasty: Are We There Yet? (Part 1). Orthopedic Clinics Of North America [serial online]. 2018;49(1):1-6. 35. MacDonald JH, Agarwal S, Lorei MP, Johanson NA, Freiberg AA. Knee arthrodesis. J Am Acad Orthop Surg. 2006 Mar;14(3):154-63. 36. Wood JH, Conway JD. Advanced concepts in knee arthrodesis. World Journal of Orthopedics. 2015;6(2):202-210. doi:10.5312/wjo.v6.i2.202. 37. Rodriguez-Merchan EC. Knee Fusion or Above-The-Knee Amputation after Failed Two-Stage Reimplantation Total Knee Arthroplasty. Archives of Bone and Joint Surgery. 2015;3(4):241-243. 38. Kunutsor SK, Whitehouse MR, Blom AW, Beswick AD, INFORM Team. Patient- Related Risk Factors for Periprosthetic Joint Infection after Total Joint Arthroplasty: A Systematic Review and Meta-Analysis. PLoS One. 2016;11(3):e0150866. 39. Lim CT, Goodman SB, Huddleston JI 3rd, Harris AHS, Bhowmick S, Maloney WJ, Amanatullah DF. Smoking is associated with earlier time to revision of total knee Page 8 of 10

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arthroplasty. Knee. 2017 Oct;24(5): 1182-1186. doi: 10.1016/j.knee.2017.05.014. 40. Singh JA. Smoking and outcomes after knee and hip arthroplasty: a systematic review. J Rheumatol. 2011;38(9):1824-34.

Regulatory Data Policy Number/Name: PA.CP.MP.OR.1002 Total Knee Replacement Initial Approval and Effective Date: 09/23/14 Reviewed Dates: 09/23/14, 02/26/16; 8/2/2016; 2/17/2017; 12/5/2017; 6/20/2018; 2/11/2019 All Approval Dates: 09/23/14; 02/26/16; 2/17/2017; 12/5/2017; 6/20/2018; 2/15/2019 Approval Authority: Utilization Management Committee Business Owner: Utilization Management Applicable lines of business: All Board approval, if appropriate: N/A Approval Signature: On file

URAC Standards:

State Requirements: CMS/Federal Requirements: Corresponding policies:

Reviews, Revisions, and Approvals Date Approval Date • New Policy created. 03/20 6/23/2020 • Policy administered by Turning Point Healthcare Solutions

Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by PA Health & Wellness, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, Page 9 of 10

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contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.

Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Note: For Medicare members, to ensure consistency with the Medicare National Coverage Determinations (NCD) and Local Coverage Determinations (LCD), all applicable NCDs, LCDs, and Medicare Coverage Articles should be reviewed prior to applying the criteria set forth in this clinical policy. Refer to the CMS website at http://www.cms.gov for additional information.

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