Temporomandibular Disorders – Nonsurgical Treatment

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418 12/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 I. References ………………………….. ………………………….. ………………………….. ……………………. 5 Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTemporomandibular Disorders – Nonsurgical Treatment B. BackgroundTemporomandibular disorder (TMD) refers to a group of conditions involving the orofacial region divided into those affecting the masticatory muscles and those affecting the temporomandibular joint (TMJ). Although the precise etiology of TMD is unclear, it is believed to be multifactorial. Temporomandibular disorders are often divided into 2 main categories: articular disorders and masticatory muscle disorders. These disorders are believed to be the result of either macro or micro trauma affecting the joint and/or the associated facial musculature. The diagnosis of TMD is largely based on a clinical examination and patient symptom ssurvey. Symptoms attributed to TMD are varied and may include clicking sounds in the jaw, headaches, closing or locking of the jaw due to muscle spasms (trismus) , a displaced disc, tinnitus, bruxism and associated pain in the ears, neck, arm, or spine. Imaging of the temporomandibular joints and associated structures may be necessary to establish the presence or absence of pathology, establish prognosis, stage dis ease for a ppropriate treatment , and assess response to therapy. Treatment options vary depending on symptoms. Options include nonsurgical or surgical treatment. There is evidence that support s most patients improve with a combination ofnoninvasive therapies, patient education, self-care, cognitive behavior therapy,pharmacotherapy, physical therapy, and the use of occlusal devices. When symptoms are not resolved through noninvasive therapy, ref erral to an oral and maxillofacial surgeon is indicated. In a prospective controlled study, Hall et al . (2005) compared the out comes of 4 surgical treatments (arthroscopy, condylotomy, discectomy , and disc repositioning) used for the treatment of TMD and concluded all 4 procedures were followed by marked improvements. While surgical procedures follow MCG clinical criteria, this policy discusses nonsurgical treatment guidelines. Medically necessary services that could be performed by a qualified healthcare provider, including a dentist, are covered if performance of those services is within the scope of the dentist’s license, according to state law. Therapy of TMD varies considera blyaccording to training, discipline, and experience of the clinician.C. Definitions Arthrography A type of imaging used to evaluate and diagnose unexplained pain and joint conditions. Articular Disorder TMJ disorders, including ankylosis, congenital or developmental disorders, disc derangement disorders, fractures, inflammatory disorders, osteoarthritis, and joint dislocation. Bruxism Clenching or grinding of the teeth. Masticatory Muscle Disorder TMJ disorders, including myofascial pain, myofibrotic contracture, myospasm, and neoplasia. Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Physical Therapy Therapy as defined in this policy may include repetitive active or passive jaw exercises, thermal modalities (hot/cold packs), joint manipulation, vapor coolant spray, stretch technique, and electro-galvanic simulation. Temporomandibular Joint (TMJ) The connecting hinge mechanism between the base of the skull (temporal bone) and the lower jaw (mandible). Tinnitus Ringing or other noises in one or both ears. Trismus Locking of the jaw due to muscle spasms. D. PolicyI. Clinical Information Documentation Requirements CareSource considers non-surgical treatment of TMD medically necessary when ALL the following clinical documentation criteria are included: A. comprehensive clinical office notes identifying ALL the following: 1. diagnosis of a well-defined physical and/or physiological abnormality (eg, congenital abnormality, functional or skeletal impairments) resulting in a medical condition that has required or will require TMD treatment 2. notation that the documented physical and/or physiological abnormality has resulted in a functional deficit or impairment 3. notation that the functional deficit or impairment is recurrent or persistent in nature 4. notation regarding the degree to which the abnormality is causing impairment 5. documentation of prior medical and surgical treatment B. applicable TMD radiological films and/or reports , such as AP radiograph, panoramic radiograph, CT scans and/or MRI C. completion and results of blood tests and laboratory studies as applicable if systemic illness is suspected D. completion and results of a psychological evaluation, if applicable E. treating clinicians plan of care, including treatment objectives and expected outcome for the improvement of the functional deficit II. Diagnostic ProceduresCareSource considers the following modalities medically necessary for diagnostic testing for TMD: A. examination , including physical and psychological evaluation (as applicable) B. imaging that may include the following: 1. radiologic examination ( ie, contrast studies), but not standard dental radiographic images 2. temporomandibular joint ultrasound 3. CT/MRI scan for presurgical exam based on CareSources vendor management requirements , which prior authorization review by CareSources imaging management vendor and are subject to vendor review criteria . 4. Laboratory studies and blood tests may be performed if systemic illness is suspected to be the cause of the temporomandibular disorder , which may require prior authorization review by CareSources laboratory vendor and are subject to vendor review criteria . Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 5. Joint arthrography may be considered when patient history and physical examination findings indicate joint trauma and/or suspected pathology and confirmation of the suspected structures involved is needed and cannot be made from standard imaging . III. Nonsurgical TreatmentCareSource considers appliance therapy , such as an occlusal orthotic device, physical therapy, masticatory muscle and temporomandibular joint injections, and trigger point injections , as medically necessary when significant clinical symptoms and signs are present, including at least 2 or more of the following: A. extra-articular pain related to muscles of the head and neck region, such as earaches, headaches, masticatory, or cervical myalgias B. painful chewing (not dental pathology related) C. restricted range of motion, manifested by 1 of the following: 1. interincisal opening of less than 35 mm (greatest distance between front upper teeth and lower front teeth when mouth is wide open) 2. lateral excursive movement (side to side movement) of less than 35 mm 3. protrusive excursive movement (front to back motion) of less than 4 mm 4. deviation on opening of greater than 5 mm; AND symptoms are not resolved by conservative treatment, such as removal of precipitating activities (ie, gum chewing, eating hard candies), pharmacological treatment (such as anti-inflammatory or analgesic medications), or change of textural diet change Note: Physical therapy of necessary frequency and duration may be limited to a multiple modality benefit when more than 1 therapeutic treatment is renderedon the same date of service.IV. ExclusionsCareSource considers the following experimental and investigational for diagnosis and the nonsurgical treatment of TMD due to insufficient evidence of efficacy and , therefore , are not a covered benefit (not an all-inclusive list ): A. standard dental radiographic procedures B. hydrotherapy (immersion therapy, whirlpool baths) C. iontophoresis D. orthodontic/bite adjustment services and orthodontic fixed appliances E. biofeedback Note: It will be determined during the Plans prior authorization process if the nonsurgical treatment of TMD is considered medically necessary for the requested indication (and must be related to a specific medical condition). E. State-Specific InformationNA Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 F. Conditions of Coverage NA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 01/18/2023 New policyDate Revised 12/13/2023 12/04/2024 09/10 /2025Updated references. Approved at Committee.Annual review. Updated references. Approved at Committee. Annual r eview. Title amended , replaced TMJD/TMJ with TMD , removed references to surgical procedures , updated references. Change physician to provider where applicable. Approved at Committee. Date Effective 12/01/2025 Date Archived I. References1. Alam MK, Rashid ME, Akhter K, Abdelghani A, Babkair HA, Sghaireen MG. Surgical vs. non-surgical management of temporomandibular joint disorders: clinical outcomes. JPharm Bioallied Sci . 2024;16(Suppl 1):S678-S680. doi:10.4103/jpbs.jpbs_938_23 2. Alowaimer HA, Al Shutwi SS, Alsaegh MK, et al. Comparative efficacy of non – invasive therapies in temporomandibular joint dysfunction: a systematic review. Cureus . 2024;16(3):e56713. Published 2024 Mar 22. doi:10.7759/cureus.56713 3. American Society of Temporomandibular Joint Surgeons. Guidelines for diagnosis and management of disorders involving the temporomandibular joint and related musculoskeletal structures. Cranio. 2016;21(1):68-76. doi:10.1080/08869634.2003.11746234 4. Gauer RL, Semidey MJ. Diagnosis and treatment of temporomandibular disorders. Am Fam Physician . 2015;91(6):378-386. Accessed July 24 , 202 5. www.aafp.org 5. Maini K, Dua A. Temporomandibular Syndrome. [Updated 2023 Jan 30]. StatPearls Publishing; 2025 Jan -. Accessed July 24, 2025. www.ncbi.nlm.nih.gov/books/NBK551612/ 6. Schiffman E, Ohrbach R. Executive summary of the diagnostic criteria for temporomandibular disorders for clinical and research applications. JAm Dent Assoc . 2016;147(6):438-445. doi:10.1016/j.adaj.2016.01.007 7. Science Policy: Temporomandibular Joint Disorders (TMD) . American Association for Dental, Oral and Craniofacial Research; 2021. Accessed July 24 , 202 5. www.aadocr.org Temporomandibular Disorders – Nonsurgical Treatment-MP-MM-1418Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 8. Temporomandibular Joint Arthroscopy: A-0492. MCG Health. 29th ed. AccessedSeptember 4, 202 5. www.mcg.com 9. Temporomandibular Joint Modified Condylotomy: A-0521 . MCG Health. 2 9th ed. Accessed September 4, 202 5. www.mcg.com 10. Temporomandibular Joint Arthrotomy: A-0522. MCG Health. 29th ed. Accessed September 4, 202 5. www.mcg.com 11. Temporomandibular Joint Arthroplasty: A-0523. MCG Health. 2 9th ed. Accessed September 4, 202 5. www.mcg.com Independent med ical review 12/03/2021

Skin Substitutes

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Skin Substitutes-MP-MM-1414 12/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Policies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 6 Skin Substitutes-MP-MM-1414Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSkin Substitutes B. Background Wounds are disruptions of the skins structural and functional integrity and normally transition through distinct phases until the skins structure and function are restored, including hemostasis, inflammation, cellular migration and proliferation, and remodeling. Chronic wounds can result in loss of function, wound recurrence, and significant morbidity. Pressure ulcers, diabetic foot ulcers, and venous leg ulcers are the three categories that comprise the majority of chronic wounds. Skin substitutes are a heterogeneous group of biologics, synthetics, or biosynthetic materials. When determining if the use of a skin substitute is appropriate, the clinician evaluates the material being used and its properties. Individual wounds have a specific microenvironment. Various manufacturers may utilize differing processes in the development of skin substitutes but generally seed selected cells onto a matrix. The matrices subsequently receive proteins and growth factors necessary to divide and develop into the desired tissue. Skin substitutes provide coverage for open wounds, both deep thermal and full-thickness wounds. Skin substitutes have the function and composition of skin or have the potential for autologous regenerative healing when applied to a wound. Uses span acute or chronic wounds, burns, or reconstruction, such as release of contractures secondary to severe burns. The most common classification system utilized to determine the type of skin substitute that would be appropriate for a particular wound is the Kumar Classification system, in which Class I includes temporary impervious dressing material, Class II includes single-layer durable skin substitutes, and Class III includes composite skin substitutes that replace both dermal and epidermal layers. C. Definitions Ankle-Brachial Index A comparison of the blood pressure measured at the ankle with blood pressure measured at the arm with lower numbers indicating narrowing or blockage of the arteries in the legs. Autologous Derived from the same individual, such as an individual serving as both donor and recipient. Cellular and Tissue-Based Products (CTPs) Wound dressings or coverings that contain or consist of cells and/or tissue to promote wound healing. They are often used as alternatives to skin grafts for chronic wounds, burns, and ulcers. Chronic Wounds Wounds that have not progressed along the normal healing process, generally after a 4-week duration. Skin Substitutes-MP-MM-1414Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Chronic Venous Ulcers A wound that takes longer than usual to heal and often occurs on the legs or ankles when oxygen-poor blood flow is impaired and pools, creating pressure in the veins. Diabetic Foot Ulcers An open sore or wound located on the foot occurring in approximately 15% of patients with diabetes. Pressure Ulcers Injuries to skin and underlying tissue resulting from prolonged pressure on the skin, including bedsores that most often develop on skin covering bony areas of the body, such as heels, ankles, hips, and tailbone. Tissue Engineering The practice of combining scaffolds, cells, and biologically active molecules into functional tissues to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs. D. PolicyI. CareSource considers the use of skin substitute products medically necessary under ANY of the following circumstances: A. The presence of a chronic, non-infected diabetic foot ulcer (DFU) having failed to achieve at least 50% ulcer area reduction with documented standard of care (SOC) treatment) for a minimum of 4 weeks with documented compliance. Treatment of DFU as indicated by all of the following: 1. when adequate circulation to the affected extremity is present as indicated by ONE of the following: a. palpable pedal b. ankle-brachial index (ABI) between 0.7 and 1.2 c. dorsum transcutaneous oxygen test (TcPO2) 30 mm Hg within the last 60 days d. triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg 2. appropriate glycemic control 3. no wound infection. 4. no response to conventional therapy, including all of the following: a. offloading (pressure relief) b. appropriate dressings to facilitate healing c. debridement as needed B. The presence of a chronic, non-infected venous insufficiency ulcers having failed to respond to documented SOC treatment for a minimum of 4 weeks with documented compliance. Treatment of venous insufficiency ulcers when ALL of the following criteria are met: 1. noninvasive duplex ultrasound documenting chronic venous disease 2. adequate perfusion of involved limb 3. appropriate surgical venous interventions 4. concurrent conventional wound care 5. concurrent glycemic management if patient is also diabetic 6. duration greater than 6 weeks 7. partial-thickness or full-thickness ulcer due to venous insufficiency 8. no allergy to bovine products Skin Substitutes-MP-MM-1414Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 9. no response to conventional therapy, including all of the following:a. compression therapy b. surgical intervention for UVD (if applicable) c. dressings to maintain moist wound environment (eg, saline-moistened dressings, negative pressure wound therapy) d. sharp debridement 10. no wound infection C. Treatment of burn wounds when ONE of the following criteria are met: 1. a temporary wound covering for excised full-thickness and deep partial- thickness burn wounds in individuals who require such a covering prior to autograft placement 2. treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting D. Repair of scar contractures when more conservative therapeutic options have failed when used in conjunction with a breast reconstruction procedure. E. Pressure redistribution support surfaces for pressure ulcers II. Documentation RequirementsA. Standard of Care treatment documentation includes: 1. Comprehensive patient assessment (history, exam, vascular assessment) and diagnostic tests as indicated as part of the implemented treatment plan 2. Assessment of Type 1 or 2 diabetes for DFU patients including management history and any comorbidities (eg. vascular disease, neuropathy, osteomyelitis), current blood glucose levels (A1c) and assessment of off-loading devices and footwear. 3. Assessment of clinical history for venous insufficiency ulcer patients including a. prior ulcers b. body mass index c. history of pulmonary embolism or superficial/deep venous thrombosis d. number of pregnancies and physical inactivity e. physical exam f. evaluation of venous reflux, perforator incompetence, and venous thrombosis g. the use of any compression garments B. Treatment Plan documentation Includes ALL of the following: 1. debridement as appropriate to a clean granular base 2. documented evidence of offloading for DFUs 3. documented evidence of sustained compression dressings for venous insufficiency ulcers 4. infection control with removal of foreign body or focus of infection 5. management of exudate with maintenance of a moist environment 6. documentation of smoking history, counseling on the effects of smoking on wound healing 7. treatment for smoking cessation and current status III. Non-Covered or Medically NecessarySkin Substitutes-MP-MM-1414Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 A. New Quarterly skin substitutes or Q-codes that have not been used outside clinical trials B. Greater than 3 applications of a skin substitute graft/CTP over 12 weeks if volume has not decreased by at least 50% C. Repeat applications of skin substitute graft/CTP when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, no measurable change from baseline, and no sign of significant improvement or indication that significant improvement is likely (such as granulation, epithelialization, or progress towards closure). D. Application of skin substitute graft/CTP in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (eg, active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, ischemia E. Use of surgical preparation services (eg, debridement), in conjunction with routine, simple or repeat skin replacement therapy with a skin substitute graft/CTP F. All liquid or gel skin substitute products or CTPs for ulcer care G. Placement of skin substitute graft/CTP on infected, ischemic, or necrotic wound bed H. Skin substitute products that are not on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational. I. Life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. E. Conditions of CoverageNA F. Related Policies/Rules Breast Reconstruction Surgery Experimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 02/15/2023 New Policy.Date Revised 02/14/2024 02/12/2025 08/27/2025Updated references. Approved at Committee. Added I. A. 1-4. Added II. B. Life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. Added new requirements for D.I.A, B, and E, added D.II, Documentation Requirements. Added more Non-Covered items to D.III, and Related Policies/Rules. Updated references. Approved at Committee. Date Effective 12/01/2025 Date Archived Skin Substitutes-MP-MM-1414Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 H. References 1. Ankle-brachial index. Mayo Clinic. Accessed January 3, 2025. www.mayoclinic.org 2. Bedsores (pressure ulcers). Mayo Clinic. Accessed July 14, 2025. www.mayoclinic.org 3. Hart CE, Loewen-Rodriguez A, Lessem J. Dermagraft: use in the treatment of chronic wounds. Adv Wound Care . 2012;1(3):138-141. doi:10.1089/wound.2011.0282 4. James CV, Murray Q, Park SY, et al. Venous leg ulcers: potential algorithms of care. Wounds . 2022;34(12):288-296. doi:10.25270/wnds/21160 5. Porcine skin and gradient pressure dressings. Centers for Medicare & Medicaid Services. Accessed July 14, 2025. www.cms.gov 6. Research Protocol: Skin Substitutes for Treating Chronic Wounds . Effective Health Care Program, Agency for Healthcare Research and Quality; 2018. Reviewed January 2020. Accessed July 14, 2025. www.effectivehealthcare.ahrq.gov 7. Shahrokhi S. Skin substitutes. UpToDate. Updated August 2, 2023. Accessed July 14, 2025. www.uptodate.com 8. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer: A-0326. MCG Health. 28th ed. Accessed July 14, 2025. www.careweb.careguidelines.com 9. Tissue engineering and regenerative medicine. National Institute of Biomedical Imaging and Bioengineering. Accessed July 14, 2025. Venous ulcers. Cleveland Clinic. Reviewed May 26, 2022. Accessed July 14, 2025. www.myclevelandclinic.org 10. What is a diabetic foot ulcer? American Podiatric Medical Association. Accessed July 14, 2025. www.apma.org Independent medical review 01/19/2023

Applied Behavior Analysis for Autism Spectrum Disorder

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 12/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 8 G. Review /Revision History ………………………….. ………………………….. ………………………….. ….. 9 H. References ………………………….. ………………………….. ………………………….. ……………………. 9 Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectApplied Behavior Analysis for Autism Spectrum Disorder B. BackgroundThe Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revised (DSM – 5-TR) classifies Autism Spectrum Disorder (ASD) as a neurodevelopmental disorder varying widely in severity and symptoms depending on the members developmental level and chronological age. ASD is characterized by specific developmental deficits affecting socialization, communication, academic and personal functioning. Diagnoses typically occur before entering grade school, and symptoms are noticed across multiple contexts (eg, social reciprocity, nonverbal communic ative behaviors, skills in developing, maintaining and understanding relationships). Restricted, repetitive patterns of behavior, interests or activities are also often present. There is no cure for ASD, nor is there any single treatment. The diagnosis may be managed through a combination of therapies (eg, behavioral, cognitive, pharmacologic, educational) to minimize the severity of symptoms, maximize learning, facilitate social integration andimprove quality of life. Applied behavior analysis (ABA), one such therapy, may be provided in centers or at home and provides an evidence-based practice for the treatment of ASD.ABA is based on the science of behavior and the premise that understanding behavior functioning, how it is affected by the environment and how learning to change behavior can improve the human condition. It is a flexible treatment that should be adapted to the needsof each member, teaches skills that are useful and generalizable and involves individual, group and family training. Qualified and trained practitioners provide and/or oversee ABA programs and are accountable to state boards for registration, ce rtification or licensure requirements. Clinical decisions on telehealth service delivery models should be selected based on the individual needs, strengths, preference of service modality, caregiver availability and environmental support available. CareSource follows state law and guidelines in the provision of ABA services, which are based on a diagnosis from the DSM-5-TR. Severity levels are divided into 2 domains, socialcommunication and restricted, repetitive behaviors, and are defined as follow s:Severity Levels for Autism Spectrum Disorder Severity Level Social Communication Restricted, Repetitive Behaviors Level 3 Requiring very substantial support Severe deficits in verbal & nonverbal social communication skills cause severe impairments in functioning, very limited initiation of social interactions, and minimal response to social overtures from others. Inflexibility of behavior, extreme difficulty coping with change, or other restricted/ repetitive behaviors markedly interfere with functioning in all spheres. Great distress/difficulty changing focus or action. Level 2 Requiring substantial support Marked deficits in verbal and nonverbal social communication skills, social impairments apparent even with supports in place, limited initiation of Inflexibility of behavior, difficulty coping with change, or other restricted/ repetitive behaviors appear frequently enough to be obvious to the casual Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 social interactions, and reduced or abnormal responses to social overtures from others. observer and interfere with functioning in a variety of contexts. Distress and/or difficulty changing focus or action. Level 1 Requiring support Without supports in place, deficits in social communication cause noticeable impairments. Difficulty initiating social interactions and clear examples of atypical or unsuccessful responses to social overtures of others. May appear to have decreased interest in social interactions. Inflexibility of behavior causes significant interference with functioning in one or more contexts. Difficulty switching between activities. Problems of organization and planning hamper independence. Social skills instruction is an important component of management of the diagnosis.A 2012 meta-analysis of 5 randomized trials (196 participants) found evidence that participation in social skills groups improved overall social competence and friendship quality in the short term. A 2020 study demonstrated efficacy of a modified group cog nitive behavioral therapy program in children delivered in a community context. A 2021 study demonstrated benefits of group cognitive behavioral treatment in adolescents diagnosed with autism and intellectual disabilities. As children near entry into vario us school programs, research supports group therapy for school readiness and improved social skills. Training must include clearly defined goals, teach desired behaviors, provide prompting desired behaviors, provide reinforcement of demonstrated behaviors and include practicing desired behaviors with goals of generalizability outside the therapeutic setting (eg, impairments in social-emotional reciprocity, restrictive or obsessional interests, aggressive behaviors). As the child becomes eligible for school-based services, the public school system becomesresponsible for the provision of services and education. Services provided are outlined in an individualized education program (IEP). ASD services do not include educ ation services otherwise available through a program funded under 20 US Code Chapter 3, section 1400 of the Individuals with Disabilities Education Act (IDEA). Congress reauthorized the IDEA in 2004 and most recently amended the IDEA through Public Law 114-95, Every Student Succeeds Act, in December 2015. C. Definitions Applied Behavior Analysis (ABA ) Design, implementation and evaluation of environmental modifications using behavioral stimuli and consequences to produce significant improvements in behavior, including direct observation, measurement and functional analysis of the relationship between en vironment and behavior. Caregiver/Family Trainin g Training taught by a therapist to parent/caregiver (s) on the implement ation of methods utilized in a clinical setting into other environments, such as the home or community, to maximize outcomes furthering generalization of skills and maximizing and reinforcing methods being taught. Independent Practitioner Behavior Analyst Certification Board (BACB) -certified behavior professional or paraprofessional supervised appropriately according to Wisconsin Insurance Regulation 3.36 must provide services. Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 SMART Goals Goals that are specific (S), measurable (M), attainable (A), relevant(R), and time-bound (T). Standardized Diagnostic Assessment Tool s Direct assessment, evidence-based tools that assist with identification of symptoms and criteria for a diagnosis . Supervisio n Directing, guiding, training, and assessing individuals who provide behavior-analytic services with responsibilities in accordance with the Board from which the practitioner received a license. o Services delivered by a BCaBA must be supervised by a BCBA, BCBA-D, or a licensed psychologist who tested in ABA and is certified by the American Board of Professional Psychology in Behavioral and Cognitive Psychology. A BCaBA must be enrolled in the Marketplace program and affiliated with the organization under which the provider is employed or contracted. D. PolicyI. General Guidelines A. Members and providers must adhere to the Plans Evidence of Coverage document and schedule of benefits . B. Medical necessity review is required for all ABA services initially with a baseline and then, again, every 6 months. Appropriate documentation, as indicated in this policy, mu st be submitted for review . T reatment should not be more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results. C. ABA therapy should begin early in life, ideally by the age of 2, typically lasting 3 to 4 years and is subject to the members response to treatment. D. Treatment goals and intensity will be based on individual needs and progress in treatment with a focus on remediation of symptoms. II. Initiation of ABA ServicesA. CareSource must receive documentation that confirms the following medical criteria: 1. definitive , primary diagnosis of ASD made by 1 of the following upon evaluation independent of the ABA provider and with a relationship with the member: a. child and adolescent psychiatrist b. clinical psychologist c. child neurologist d. developmental pediatrician 2. standardized diagnostic assessment tools used as part of a referral for services (eg, Autism Diagnostic Observation Schedule [ADOS ], Autism Diagnostic Interview Revised [ADI-R], Childhood Autism Rating Scale, 2 nd edition [CARS-2]) 3. description of clinical symptoms (eg, provider letter) present within the past year that require treatment if the diagnostic evaluation was completed more than 24 months from the date of the request B. A licensed ABA practitioner will perform a behavior al assessment (BA) and develop a treatment plan before services are provided. Generally, BAs are not to exceed 8 hours every 6 months unless additional justification is provided. The BA should not be older than 2 months when requesting an authorization for treatment services. Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 C. An initial ABA treatment plan individualized to the caregiver/family needs, values,priorities and circumstances for member goals and parent/caregiver training will be developed by the member, family/caregiver and provider , signed by the parent/caregiver and must include the following : 1. biopsychosocial information, including, but not limited to the following : a. current family structure b. medication history, including dosage and prescribing physician c. medical history d. school placement and hours in school per week, including homeschool instruction and any applicable individualized education plans (IEP) e. history of ABA services, including service dates (duration), type of therapy received, results, and progress notes (W hen previous ABA therapy info rmation is unknown, documentation must be provided regarding why the information is inaccessible and how or if this will affect treatment. ) f. all behavioral health diagnoses and services, including any hospitalizations g. other services the member is receiving or has receiv ed (eg, speech therapy [ST ], occupational therapy [OT ], physical therapy [PT ]), including evidence of coordination with other disciplines involved in the assessment h. caregiver proficiency and involvement in treatment i. any major life changes 2. rationale for services and how ABA addresses current areas of need, including a. a history with symptom intensity and symptom duration, as well as how the symptoms affect the members ability to function in various settings b. evidence of previous therapy ( eg, outcomes from previous ABA treatment, ST, OT, PT) and how results influence proposed treatment c. type, duration, and frequency for services 3. goals related to core deficits ( eg, communication problems, relationship development, social and problem behaviors) and including the following: a. outcome driven, performance-based, and individualized focused on targeted symptoms, behaviors, and functional impairments b. based on the direct behavioral assessment and a standardized developmental and functional skills assessment/curriculum ( eg, Verbal Behavior Milestones Assessment and Placement Program [VB-MAPP], Assessment of Basic Language and Learning Skills [ABLLS-R]). c. a description of treatment activities and documentation of active participation by caregiver/family in the implementation of the treatment program OR documentation detailing barriers to family/ caregiver participation and how those barriers are being actively addressed d. SMART goals that define how improvement will be noted, frequency of treatment (number of hours per week) and duration of treatment 4. a hypothesis for maintaining function for targeted behaviors for deceleration (maladaptive) and functionally equivalent replacement behaviors (FERBS) for those identified deceleration behavior 5. Behavioral Intervention Plan and/or a Plan of Care (POC) requested number of ABA hours per week based on the members specific needs , n ot on a general program structure , as evidenced by all the following: Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 a. Treatment is provided at the lowest level of intensity appropriate to the members clinical needs and goals with the number of hours requested reflecting the actual number of hours intended to be provided. b. A d etailed description of problems, goals and interventions support the requested intensity of treatment . 6. a plan to modify the intensity and duration of treatment over time based on the members progress, including a discharge plan specific to treatment needs 7. coordination with other behavioral health and medical providers D. Authorization for Initial Course of Treatment 1. Once the diagnostic evaluation is authorized and completed, the treatment plan signed by the parent /guardian or member if 18 or older (see above) must be submitted for approval . Any guardianship documentation must also be submitted, if applicable, for any member 18 or older. 2. In addition to the submitted treatment plan, the treating BCBA must include a. any b aseline measurements , graphs and current measurements b. progress reports , particularly documentation of rationale for any adjustment of hours per week upon regular treatment revie w 3. Individualized p arent/ caregiver training, including documented plans for the training and parent/caregiver ability and willingness to learn and use therapy techniques in the home must be included . 4. School transition plans that include the following: a. attendance at school , if age appropriate b. plans to transition to school , if not currently attending c. plans to attend school without additional ABA therapy outside the school setting 5. Documentation that a licensed or certified behavior analyst will be providing ABA services . III. Continuation of AB ARequests for continuation of ABA services are to be submitted every 6 months, and documentation must meet EITHER of the following criteria: A. A definitive diagnosis of ASD persists, and the member continues to demonstrate ASD symptoms that will benefit from treatment in at least 2 settings. B. A treatment plan as noted in D. II. C., including the following: 1. an updated progress report with assessment scores that note improvement and member response to treatment from baseline targeted symptoms, behaviors and functional impairments using the same modes of measurement utilized for baseline measurements 2. a plan to transition services in intensity over time 3. utilization of prior approved hours C. Parent/caregiver(s) are involved and making progress in development of behavioral interventions. OR D. When requesting continuation with inadequate progress on targeted symptoms or behaviors or no demonstrable progress within a 6-month period, an assessment of the reasons for lack of progress should be documented and provided. Treatment Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 interventions should be modified to achieve adequate progress. Documentation should include1. change in possible treatment techniques 2. increased parent/caregiver training 3. increased time and/or frequency working on specific targets 4. identification and resolution of barriers to treatment efficacy 5. any newly identified co-existing disorders and possible treatment 6. modified or removed goals and interventions IV. Discontinuation of ABA TherapyTitration and/or discontinuation of ABA therapy should occur when the following conditions are met (not an all-inclusive list): A. Treatment ceases to produce significant meaningful progress or maximum benefit has been reached. B. Member behavior does not demonstrate meaningful progress for 2 successive 6 – month authorization periods demonstrated via standardized assessments. C. ABA therapy worsens symptoms, behaviors or impairments. D. Symptoms stabilize , allowing the member to transition to less intensive treatment or level of care. E. Parents/caregivers refused treatment recommendations, are unable to participate in the treatment program, and/or do not follow through on treatment recommendations to an extent that compromises the efficacy of services for member progress. V. Parent/ Caregiver TrainingTraining will evolve as goals are met. Parent/caregiver must be actively working on at least 1-3 unmet goal (s) . ABA services must include documentation of the following: A. understand ing/ agree ment to comply with the requirements of treatment B. how the parent/caregiver (s) will be trained in skills that can be generalized to the home and other environments C. methods by which parent/caregiver (s) will demonstrate trained skills D. barriers to parent involvement and plans to address ( eg, are treatment goals addressed when professionals are not present, overall skill abilities) E. time involvement, including any materials or meetings occurring on a routine basis VI. TelehealthTelehealth services may be provided whe n appropriate in instances deemed medically necessary with supporting documentation that provides a plan for the provision of service delivery. Providers utilizing telehealth must make decisions consistent with best, currently available evidence and clinical consensus. Clinical rationale must consider assessed needs, strengths, preferences, and available resources of members /caregivers. Thesame professional ethics governing in-person care must be followed and limitations considered (eg, interstate licensure challenges, state regulatory issues, member/ caregiver discomfort with technology, technology limitations, cultural acceptance of virtual visi ts). Providers must identify protocols for appropriateness (eg, risk assessment, Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 safety planning, patient/caregiver characteristics), ensure therapeutic benefit for recipients and ensure provider competence. Peer reviewed studies and other best evidence literature provides guidance on appropriate screeners and questionnaires for use in the determination of appropriateness of telehealth services for particular clients.VII . ExclusionsA. reimbursement for the following services or activities is not permitted: 1. any services not documented in the treatment plan 2. behavioral methods or modes considered experimental 3. education-related services or activities described under Individuals with Disabilities Education Improvement Act of 2004, 20 U.S.C. 1400 (IDEA) , amended through Public Law 114-95, the Every Student Succeeds Act 4. vocational services in nature or those available through programs funded under Section 110 of the Rehabilitation Act of 1973 5. components of adult day care programs 6. services for members receiving other duplicative therapy services B. treatment solely for the benefit of the family, caregiver, or therapist or for symptoms/behaviors not part of core symptoms of ASD C. treatment worsening symptoms , prompti ng member regression or unexpected to cause improvement D. more than 1 program manager or lead behavioral therapist or more than 1 agency or organization providing ABA for a member at any 1 time E. services provided by family or household members or custodial care not requiring trained ABA staff F. shadowing, para-professional, or companion services in any setting G. services more costly than alternative service(s) likely to produce equivalent diagnostic or therapeutic results H. any program or service performed in nonconventional settings, even if performed by a licensed provider ( eg, spas/resorts, vocational or recreational settings, Outward Bound, wilderness, camp or ranch programs) E. Conditions of CoverageI. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis, subsequent medical review audits, recovery of overpayments identified, and provider prepayment review. II. CareSource reserves the right to request supervision documentation , particularly related to telehealth services. F. Related Policies/RulesApplied Behavior Analysis Payment policy Medical Necessity Determinations Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 G. Review /Revision HistoryDate ActionDate Issued 08/14/2024 New policy. Approved at Committee.Date Revised 09/25/2024 08/27 /2025Out of cycle review. Added D.I.E., VII.B, E.III. Updated references. Approved at Committee.Annual review. Split payment information into separate PY policy. Updated references. Approved at Committee. Date Effective 12/01/2025 Date Archived H. References1. Anglim M, Conway EV, Barry M, et al. An initial examination of the psychometric properties of the Diagnostic Instrument for Social and Communication Disorders (DISCO-11) in a clinical sample of children with a diagnosis of autism spectrum disorder. Ir JPsychol Med . 2022;39(3):251-260. doi:10.1017/ipm.2020.100 2. Applied Behavior Analysis : B-806-T. MCG , 29th ed. Updated June 13, 2025 . Accessed August 18, 2025 . www.careweb.careguidelines.com 3. Augustyn M. Autism spectrum disorder in children and adolescents: evaluation and diagnosis. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 4. Augustyn M. Autism spectrum disorder (ASD) in children and adolescents: terminology, epidemiology, and pathogenesis. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 5. Augustyn M, Von Hahn E. Autism spectrum disorder in children and adolescents: clinical features. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 6. Autism spectrum disorder. American Academy of Pediatrics. Accessed August 18, 2025 . www.aap.org 7. Autism Spectrum Disorder in Young Children: Screening . US Preventive Services Task Force; 2016. Accessed August 18, 2025 . www.uspreventiveservicestaskforce.org 8. Autism spectrum disorders : M-7075. MCG Health, 29th ed. Updated June 13, 2025 . Accessed August 18, 2025 . www.careweb.careguidelines.com 9. Autism Spectrum Diso rders : B-012-HC. MCG , 29th ed. Updated June 13, 2025 . Accessed August 18, 2025 . www.careweb.careguidelines.com 10. Autism Spectrum Disorders, Outpatient Care : B-012-AOP. MCG , 29th ed. Updated June 13, 2025 . Accessed August 18, 2025 . www.careweb.careguidelines.com 11. Bak M, Plavnick J, Dueas A, et al. The use of automated data collection in applied behavior analytic research: a systematic review. Behav Anal: Res Practice. 2021;21(4), 376 405. doi :10.1037/bar0000228 12. Bearss K, Burrell T, Challa S, et al. Feasibility of parent training via telehealth for children with autism spectrum disorder and disruptive behavior: a demonstration pilot. J Autism Dev Dis . 2018;48:1020-3. doi:10.1007/s10803-017-3363-2 13. Blakeley-Smith A, Meyer A, Boles R, et al. Group cognitive behavioral treatment for anxiety in autistic adolescents with intellectual disability: a pilot and feasibility study. J App Res Intell Disab. 2021;34(3):777-788. doi:10.111/jar.12854 14. Board Certified Behavior Analyst Handbook . Behavior Analyst Certification Board. Accessed August 18, 2025 . www.bacb.com Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 15. Board Certified Assistant Behavior Analyst Handbook . Behavior Analyst CertificationBoard. Accessed August 18, 2025 . www.bacb.com 16. Buckley A, Hirtz D, Oskoui M, et al; Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Practice guideline: treatment for insomnia and disrupted sleep behavior in children and adolescents with autism spectrum disorder. Neurology . 2020;94(9):392-404. doi:10.1212/WNL0000000000009033 17. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , I: common clinical challenges of patients with mental health or behavioral emergencies. Pediatr. 2016;138(3):e20161570. doi10.1542/peds.2016-1570 18. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , II: recognition of clinically challenging mental health related conditions presenting with medical or uncertain symptoms. Pediatr. 2016;138(3):e20161573. doi:10.1542/peds.2016-1573 19. Crockett, JL, Fleming RK, Doepke K, et al. Parent training: acquisition and generalization of discrete trials teaching skills with parents of children with autism. Res Dev Disabilities . 2007; 28 (1):23-36. doi :10.1016/j.ridd.2005.10.003 20. Definitions, 42 U.S.C. 1396d (2019). 21. Dubreucq J, Haesebaert F, Plasse J, et al. A systematic review and meta-analysis of social skills training for adults with autism spectrum disorder. JAutism Dev Disorders. 2022;52(4):1598-1609. doi:10.1007/s10803-021-05058 22. Ellison K, Guidry J, Picou P, et al. Telehealth and autism prior to and in the age of COVID-10: a systematic and critical review of the last decade. Clin Child Family Psych Rev . 2021;24:599-630. doi:10.1007/s10567-021-00358-0 23. Ethics Code for Behavior Analysts. Behavior Analyst Certification Board; 2020. Updated January 1, 2023. Accessed August 18, 2025 . www.bacb.com 24. Evidence analysis research brief: applied behavior analysis training via telehealth for caregivers of children wi th Autism Spectrum Disorder . Hayes; 2022. Accessed August 18, 2025 . www.evidence.hayesinc.com 25. Evidence analysis research brief: direct-to-patient applied behavior analysis telehealth for children wi th Autism Spectrum Disorder . Hayes; 2022. Accessed August 18, 2025 . www.evidence.hayesinc.com 26. Gates JA, Kang E, Lerner MD. Efficacy of group social skills interventions for youth with autism spectrum disorder: a systematic review and meta-analysis. Clin Psych Rev . 2017;52:164-81. doi:10.1016/j.cpr.2017.01.006 27. Georgia Marketplace Evidence of Coverage . CareSource; 2025. www.caresource.com 28. Gilmore R, Ziviani J, Chatfield MD, et al. Social skills group training in adolescents with disabilities: a systematic review. Res Dev Disab . 2022;125:online. doi:10.1016/j.ridd.2022.104218 Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 29. Gonzlez MC, Vsquez M, Hernndez-Chvez M. Autism spectrum disorder: clinical diagnosis and ADOS Test. Rev Chil Pediatr . 2019;90(5):485-491. doi:10.32641/rchped.v90i5.872 30. Health technology assessment: comparative effectiveness review of intensive behavioral intervention for treatment of Autism Spectrum Disorder . Hayes; 2019. Updated February 10, 2022. Accessed August 18, 2025 . www.evidence.hayesinc.com 31. Hyman S, Levy S, Myers S; Council on Children with Disabilities. Developmental and behavioral pediatrics: identification, evaluation, and management of children with autism spectrum disorder. Pediatr. 2020;145(1):e20193447. doi:10.1542/peds.2019-3447 32. Indiana Marketplace Evidence of Coverage . CareSource; 2025. www.caresource.com 33. Information on autism spectrum disorder for healthcare providers. Centers for Disease Control and Prevention. Updated December 6, 2022. Accessed August 18, 2025 . www.cdc.gov 34. Kreyenbuhl J, Buchanan RW, Dickerson FB; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations. Schizophrenia Bull. 2010;36(1):94-103. doi:10.1093/schbul/sbp130 35. Lebersfeld JB, Swanson M, Clesi CD, et al. Systematic review and meta-analysis of the clinical utility of the ADOS-2 and the ADI-R in diagnosing autism spectrum disorders in children. JAutism Dev Disord . 2021;51(11):4101-4114. doi:10.1007/s1083-020-04839-z 36. Lefort-Besnard J, Vogeley K, Schilbach L, et al. Patterns of autism symptoms: hidden structure in the ADOS and ADI-R instruments. Transl Psychiatry . 2020;10(1):257. doi:10.1038/s41398-020-00946-8 37. Lim N, Russell-George A. Home-based early behavioral interventions for young children with autism spectrum disorder. Clin Psychol . 2022;29(4):415-416. doi:10.1037/cps0 0117 38. Marino F, Chila P, Failla C, et al. Tele-assisted behavioral intervention for families with children with autism spectrum disorders: a randomized control trial. Brain Sci . 2020;10(9):649. doi:10.3390/brainsci10090649 39. MeiMei L, Zenghui M. A systematic review of telehealth screening, assessment, and diagnosis of autism spectrum disorder. Child Adol Psych Men tl Health . 2022;16(79):1 – 15. doi:10.1186/s13034-022-00514-6 40. Moody CT, Laugeson EA. Social skills training in autism spectrum disorder across the lifespan. Child Adol Psych Clinics NAmer 2020;29(2):359-371. doi:10.1016/j.chc.2019. 1 41. Ohio Marketplace Evidence of Coverage . CareSource; 2025. www.caresource.com 42. Registered Behavior Technician Handbook . Behavior Analyst Certification Board. Accessed August 18, 2025 . www.bacb.com 43. Sneed L, Little S, Akin-Little A. Evaluating the effectiveness of two models of applied behavior analysis in a community-based setting for children with autism spectrum disorder. Behav Anal: Res Pract . 2023;23(4):238-253. doi:10.1037/bar0000277 44. Solish A, Klemencic N, Ritzema A, et al. Effectiveness of a modified group cognitive behavioral therapy program for anxiety in children with ASD delivered in a community context. Molecular Autism 2020;11(34):1-11. doi.10.1186/s13229020003416 45. Unholz-Bowden E, McComas J, McMaster K, et al. Caregiver training via telehealth on behavioral procedures: a systematic review. JBeh Educ . 2020;29:246-281. doi:10.1007/s10864-020-09381-7 Applied Behavior Analysis for Autism Spectrum Disorder-MP-MM-1329 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 46. Volkmar F, Siegel M, Woodbury-Smith M, et al; American Academy of Child andAdolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. JAm Acad Child Adolesc Psychiatry . 2014;53(2):237-57. doi:10.1016/j.jaac.2013.10.013 47. Weissman L. Autism spectrum disorders in children and adolescents: behavioral and educational interventions . Up ToDate. Accessed August 18, 2025 . www.uptodate.com 48. Weissman L. Autism spectrum disorder in children and adolescents: overview of management. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 49. Weissman L. Autism spectrum disorder in children and adolescents: pharmacologic interventions. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 50. Weissman L. Autism spectrum disorder in children and adolescents: screening tools. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 51. Weissman L. Autism spectrum disorder in children and adolescents: surveillance and screening in primary care. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 52. Weissman L, Harris H. Autism spectrum disorder in children and adolescents: complementary and alternative therapies. Up ToDate. Accessed August 18, 2025 . www.uptodate.com 53. West Virginia Marketplace Evidence of Coverage . CareSource; 2025. www.caresource.com 54. Wergeland J, Posserud M, Fjermestad K, et al. Early behavioral interventions for children and adolescents with autism spectrum disorder in routine clinical care: a systematic review and metanalysis . Clin Psychol . 2022;29(4):400-414. doi:10.1037/cps0000106 55. Witwer A, Walton K, Held M. Taking an evidence-based child-and family-centered perspective on early autism intervention. Clin Psychol . 2022;29(4):420-422. doi:10.1037/cps0000122

Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-MP-MM-1323 11/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 2 E. State-Specific Information ………………………….. ………………………….. ………………………….. …. 3 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. …… 3 I. References ………………………….. ………………………….. ………………………….. …………………….. 3 Positive Airway Pressure Devices for Pulmonary DisordersContinued Rental-MP-MM-1323Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental B. BackgroundPositive airway pressure (PAP) devices u tilize a machine with a mask or other apparatus that fits over the nose and/or mouth to provide positive pressure , keep ing airways open. Continuous positive airway pressure , or CPAP , is used to treat sleep-related breathing disorders , including sleep apnea. It also may be used to treat preterm infants with underdeveloped lungs. Bi-level or two-level positive airway pressure , or BiPAP , is used to treat lung disorders , such as chronic obstructive pulmonary disease (COPD). While CPAP delivers a single pressure, BiPA Pdelivers positive pressure both on inhalation and exhalation. PAP devices can provide better sleep quality, reduc e or eliminat e snoring, and less en daytime sleepiness. PAP devices should always be used according to the physicians order , as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome . C. Definitions Adherence Use of the PAP device as prescribed by the ordering physician, defined as utilization for 4 or more hours per night for 70% of the nights during the most recent consecutive 30-day period during the first initial usage. Bi-Level Positive Airway Pressure (BiPAP) Device A device that uses mild bi – level or 2 levels of air pressure to keep airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep airways open. Positive Airway Pressure (PAP) Device A device that uses air pressure to keep airways open , including both continuous positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices. D. PolicyI. PAP devices addressed in this policy include the following: A. E0601 CPAP, continuous pressure capability, used with noninvasive nasal or face mask. B. E0470 BiPAP, Bi-level pressure capability, without backup rate feature, used with noninvasive nasal or face mask. C. E0471 BiPAP, Bi-level pressure capability, with backup rate feature, used with noninvasive nasal or face mask. D. E0472 BiPAP, Bi-level pressure capability, with backup rate feature, used with invasive tracheostomy tube. II. CareSource uses MCG Health clinical criteria to determine medical necessity for PAP devices, CPAP (E0601) and BiPAP (E0470) :A. During the first 3 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 4-13 rental, CareSource considers the device medically necessary whe n d ocumentation confirming adherence (see above definition) is submitted. Positive Airway Pressure Devices for Pulmonary DisordersContinued Rental-MP-MM-1323Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 III. PAP devices BiPAP (E0471) and BiPAP (E0472) CareSource uses MCG Health clinical criteria to determine medical necessity. A. During the first 6 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 7-12 rental, CareSource considers the device medically necessary when documentation confirming adherence (see above definition) is submitted. C. Documentation confirming adherence must be submitted annually with the prior authorization request. CareSource considers the device medically necessary when BOTH the following are met: 1. The MCG Health clinical criteria are met. 2. Documentation confirming adherence (see above definition) is submitted. E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesNoninvasive Home Mechanical Ventilation H. Review/Revision HistoryDATE ACTIONDate Issued 05/25/2022 New policyDate Revised 06/07/2023 05/22/2024 08/28/202408/13 /2025Annual review. Updated references. Approved at Committee. Annual review. Removed supply chain disclaimer. Updated references. Approved at Committee. Annual review. Updated title. Revised D. II. and III. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Date Effective 11/01/2025 Date Archived I. References1. Bi-level Positive Airway Pressure (BPAP) Device: ACG A-0994. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1 , 202 5. www.careweb.careguidelines.com 2. Continuous Positive Airway Pressure (CPAP) Device: ACG A-0431. MCG Health. 29th ed. Updated March 14, 2024. Accessed August 1 , 2025 . www.careweb.careguidelines.com 3. CPAP. National Heart, Lung, and Blood Institute. Updated March 24, 2022. Accessed August 1 , 2025 . www.nhlbi.nih.gov 4. LCD Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) . Centers for Medicare and Medicaid. Updated January 1, 2024. Accessed August 1 , 2025. www.cms.gov Positive Airway Pressure Devices for Pulmonary DisordersContinued Rental-MP-MM-1323Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 5. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JClin Sleep Med . 2019;15(02):335-343. doi:10.5664/jcsm.7640This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC.

Peroral Endoscopic Myotomy

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Peroral Endoscopic Myotomy-MP-MM-1308 11/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. …. 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 H. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 I. References ………………………….. ………………………….. ………………………….. …………………….. 4 Peroral Endoscopic Myotomy-MP-MM-1308Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeroral Endoscopic Myotomy B. BackgroundAchalasia (ie, failure to relax) is a rare esophageal disorder that affects about 1 in every 100,000 people and is usually associated with difficulty swallowing. Most people are diagnosed between the ages of 25 and 60 years. Achalasia occurs when nerves in the esophagus become damaged. As a result, the esophagus becomes paralyzed and dilated over time and eventually loses the ability to squee ze food down into the stomach. Although the condition cannot be cured, the symptoms can usually be controlled with treatment. Treatments for achalasia include oral medica tions, dilation or stretching of the esophagus, surgery (open and laparoscopic), endoscopic surgery, and injection of muscle-relaxing medicines (botulinum toxin) directly into the esophagus. Peroral endoscopic myotomy (POEM) is a procedure developed in Japan that isperformed with the patient under general anesthesia. Studies suggest that POEM can achieve results comparable to or even better than those of pneumatic balloon dilation and laparoscopic Heller myotomy with similar safety. However, POEM is a newer procedure, and long-term outcome data is limited. POEM is a form of natural orifice transluminal endoscopic surgery. The procedure is performed perorally, without any incisions in the chest or abdomen. The advantage of this approach is to reduce procedure-related pain and return patients to regular activi tiessooner than surgeries requiring external incisions.C. Definitions Achalasia A rare disorder making it difficult for food and liquid to pass from the swallowing tube connecting the mouth and stomach. In achalasia, nerve cells in the esophagus degenerate. As a result, the lower end of the esophagus, the lower esophageal sphincter (LES ), fails to open to allow food into the stomach, leading to complications (e.g., coughing, choking, aspiration pneumonia, ulceration, and weight loss ). There are 3 different achalasia types :. o Type I Characterized by minimal esophageal pressurization , this type is associated with incomplete relaxation of the LES, a lack of mobility in terms of contraction and relaxation, and a small amount of pressure built up in the esophagus. o Type II Indicated by esophageal compression , this type is more severe with a more massive compression in the esophagus, often caused by the failure to relax and the build-up of pressure in the esophagus, typically from food. o Type III W ith spasms that result in sudden, abnormal squeezing of the esophagus and the LES , this type is the most severe and can also elicit the most serious symptoms (e.g., chest pains that may mimic those of a heart attack and spasms that can wake a person from sleep ). Peroral Endoscopic Myotomy-MP-MM-1308Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Eckardt Symptom Score The grading system most frequently used for the evaluation of symptoms, stages, and efficacy of achalasia treatment. It attributes points (0 to 3 points) for four symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), with scores ranging from 0 to 12 . Gastroesophageal Reflux Disease (GERD) A chronic disorder that occurs when stomach bile or acid flows into the esophagus and irritates the lining. Laparoscopic Heller Myotomy (LHM) A minimally invasive, surgical procedure used to treat achalasia. Pneumatic Balloon Dilation (PD) An endoscopic therapy for achalasia. An air – filled cylinder-shaped balloon disrupts the muscle fibers of the lower esophageal sphincter, which is too tight in patients with achalasia. D. PolicyI. CareSource considers the POEM procedure to be medically necessary when all the following clinical criteria is met: A. The member h as a diagnosis of primary achalasia, types I, II, or III . B. POEM is being proposed after the member has tried and failed conventional therapy, including pneumatic dilation or is not a surgical candidate for Heller myotomy . C. Eckardt symptom score is greater than or equal to 3. D. There is no history of previous open surgery of the stomach or esophagus. II. Members 18 or younger should be reviewed for medical necessity.III. POEM for any other indication is considered experimental, investigational , and unproven. IV. Contraindications for this procedure are as follows :A. severe erosive esophagitis B. significant coagulation disorders C. liver cirrhosis with portal hypertension D. severe pulmonary disease E. esophageal malignancy F. prior therapy that may compromise the integrity of the esophageal mucosa or lead to submucosal fibrosis, including recent esophageal surgery, radiation, endoscopic mucosal resection, or radiofrequency ablation. V. Previous therapies for achalasia (eg, PD, botulinum toxin injection, or LHM ) are not contraindications to POEM. VI. Members receiving POEM should be made aware there is a high risk in developing GERD and will need to be advised of management considerations prior to undergoing the procedure. Peroral Endoscopic Myotomy-MP-MM-1308Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 02/15/2023Date Revised 02/14/2024 12/18/202408/13/2025Annual review: title has been altered to remove the acronym, editorial changes to policy document language, deleted POEM definition, lowered Eckardt symptom score criteria to 3 to match other lines of business (LOBs), changed reflux esophagitis in Section D.V. to GERD to match other LOBs, and updated references. Approved at Committee. Annual review: updated age requirement and references. Approved at Committee. Annual review: updated references. Approved at Committee Date Effective 11/01/2025 Date Archived I. References1. Aiolfi A, Bona D, Riva CG, et al. Systematic review and bayesian network meta – analysis comparing laparoscopic Heller myotomy, pneumatic dilatation, and peroral endoscopic myotomy for esophageal achalasia. JLaparoendosc Adv Surg Tech A . 2020;30(2):147-155. doi:10.1089/lap.2019.0432 2. Familiari P, de Andreis FB, Landi R, et al. Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomized controlled trial. Gut . 2023;72(8):1442-1450. doi:10.1136/gutjnl-2021-325579 3. Health technology assessment: peroral endoscopic myotomy for treatment of esophageal achalasia. Hayes; 2019. Reviewed March 7, 2023. Accessed August 1, 2025 . www.evidence.hayesinc.com 4. Khashab MA, Vela MF, Thosani N, et al. ASGE guideline on the management of achalasia. Gastrointest Endosc . 2020;91(2):213-227 . doi:10.1016/j.gie.2019.04.231 5. Khashab MA, Kumbhari V, Tieu AH, et al. Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic Heller myotomy. Saudi JGastroenterol . 2017;23(2):91-96. doi:10.4103/1319-3767.203360 6. Kohn GP, Dirks RC, Ansari MT, et al. SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia. Surg Endosc . 2021;35(5):1931-1948. doi:10.1007/s00464-020-08282-0 Peroral Endoscopic Myotomy-MP-MM-1308Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 7. Meng F, Li P, Wang Y, et al. Peroral endoscopic myotomy compared with pneumatic dilation for newly diagnosed achalasia. Surg Endosc . 2017;31(11):4665-4672. doi:10.1007/s00464-017-5530-0 8. Patel DA, Lappas BM, Vaezi MF. An overview of achalasia and its subtypes. Gastroenterol Hepatol . 2017;13(7):411-421. Accessed August 1, 2025 . www.ncbi.nlm.nih.gov 9. Schneider AM, Louie BE, Warren HF, et al. A matched comparison of per oral endoscopic myotomy to laparoscopic Heller myotomy in the treatment of achalasia. J Gastrointest Surg . 2016;20(11):1789-1796. doi:10.1007/s11605-016-3232-x 10. Spechler SJ. Achalasia: ov erview of the management of treatment . UpToDate. Updated July 3 0, 202 5. Accessed August 1, 2025 . www.uptodate.com 11. Tan S, Zhong C, Ren Y, et al. Efficacy and safety of peroral endoscopic myotomy in achalasia patients with failed previous intervention: a systematic review and meta – analysis. Gut Liver . 2021;15(2):153-167. doi:10.5009/gnl19234 12. Vaezi MF, Pandolfino JE, Yadlapati RH, et al. ACG clinical guidelines: diagnosis and management of achalasia: diagnosis and management. Am JGastroenterol . 2020;115(9):1393-1411. doi:10.14309/ajg.0000000000000731 13. Vespa E, Pellegatta G, Chandrasekar VT, et al. Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis. Endoscopy . 2023;55(2):167-175. doi:10.1055/a-1894-0147 14. Yang D, Bechara R, Dunst CM, et al. AGA clinical practice update on advances in per-oral endoscopic myotomy (POEM) a nd remaining questions what have we learned in the past decade: expert review. Gastroenterology . 2024;167(7):1483 – 1490. doi:10.1053/j.gastro.2024.08.038 Independent med ical review March 2022

Negative Pressure Wound Therapy

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Negative Pressure Wound Therapy-MP-MM-1386 01/01/2025 KY inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. …. 5 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 5 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 5 H. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 I. References ………………………….. ………………………….. ………………………….. …………………….. 5 Negative Pressure Wound Therapy-MP-MM-1386Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNegative Pressure Wound Therapy B. BackgroundNegative pressure wound therapy (NPWT), also known as vacuum-assisted wound closure, is a type of wound therapy that is used to treat chronic wounds , such as ulcers related to pressure sores, venous or arterial insufficiency , or neuropathy. There are many causes for pressure ulcer s, such as diabetes, vascular insufficiencies, or an underlying medical condition. NPWT involves the controlled application of sub atmospheric pressure to the surface of awound. This type of therapy utilizes an electrical pump, connected to a specialized dressing that then removes debris and exudate from the wound and drains into a collection canister. NPWT is a noninvasive type of therapy that has been shown to be effective in accelerat ing wound healing for chronic wounds. To provide a more conducive environment for wound healing, the NPWT method utilizes a semipermeable dressing that always remains moist and warm. This therapy can be done in the home or in an outpatient treatment facility. NPWT typically does not require in-patient monitoring.C. Definitions Arterial Insufficiency Ulcer A type of ulcer that develops due to the lack of delivery of oxygen-rich blood to the tissue which causes the tissue to begin to deteriorate and develop into an open wound. Deep Tissue Pressure Injury A type of injury resulting from a serious pressure ulcer that has advanced with additional necrosis of underlying soft tissue that may or may not be visible. Dehisced Wounds A wound that has ruptured along the wound margin typically due to infection. Eschar Black or brown, thick, leathery feeling dead tissue covering an ulcer. Measurable improvement Measurable changes in wound healing, including drainage , inflammation , swelling , pain , and/or tenderness , wound dimensions , surface measurements , granulation tissue , necrotic tissue/slough , tunneling , or undermining . Neuropathic Ulcer A type of ulcer that occurs due to lack of sensation secondary to neuropathy which causes skin and underlying tissue to begin to breakdown causing ulcers further complicated by infection. Pressure Ulcer A type of ulcer that develops due to an extended amount of time when there is compression of the soft tissue overlying bony prominences and an outside object causing tissue necrosis. Slough Avascular (dead) soft tissue found in higher stage ulcers. Tunneling Channels of tissue deterioration that extend from the wound to the subcutaneous tissue typically in one direction. Negative Pressure Wound Therapy-MP-MM-1386Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Undermining Subcutaneous tissue deterioration around the margin of a wound and may occur in any direction . Venous Insufficiency Ulcer A type of ulcer that occurs due to the lack of properly functioning venous valves, which causes the veins to increase in size. Pressure Ulcer StagingStage 1 A localized area of skin that is intact with non-blanchable erythema. Changes in sensation, temperature , or firmness of the skin may be present prior to visual alterations of the skin. If discoloration is purple or maroon, this may indicate a deep tissue injury. Stage 2 A surface area of skin that has partial-thickness loss of skin with exposed dermis. May initially present as a serum-filled blister that has ruptured. The wound bed will be moist, red/pink , and the skin should be viable. There should be no evidence of visible adipose (fatty) tissue, eschar, slough , or granulation. Stage 3 A surface area of skin that has full-thickness loss of skin with visible adipose (fat) tissue and granulation. The wound edges are often rolled (epibole), and there may be visible eschar and slough. Undermining and tunneling may occur in the wound. At this stage, there should be no fascia, muscle, tendon ligament, cartilage , and/or bones exposed. Stage 4 A surface area of skin that has full-thickness loss of skin. At this stage, there will be fascia, muscle, tendon, ligament, cartilage or bone that is visible or directly palpable. The wound edges will be rolled (epibole), and there is typically visible eschar and slough. Undermining and tunneling occur often in the wound. Unstageable Inability to fully assess the extent of the tissue damage due to eschar or slough obscuring visibility, but there is observable full-thickness skin and tissue loss that is unstageable. D. PolicyI. CareSource considers NPWT medically necessary when the following clinical criteria are met : A. Stage III or IV pressure ulcer (see staging criteria above) in individuals who meet ALL of the following: 1. Member has been on an every 2-hour turning and repositioning regimen . 2. Pressure relief techniques and/or pressure-reducing surfaces have been ordered (eg, foam overlay mattress, egg crate foam mattress , or low-air-loss devices) and documented ongoing compliance is in member medical record. 3. Members incontinence and moisture issues have been appropriately managed. B. Chronic neuropathic ulcer that meets BOTH of the following criteria: 1. A comprehensive diabetic management program has been implemented , including A1C management, medication management , and ongoing diabetic education . Negative Pressure Wound Therapy-MP-MM-1386Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 2. Foot care has been done by a medical professional that include s general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies, that meet the following criteria: 1. Compression garments/dressing/bandages are being applied consistently per physician orders in documented venous insufficiency plan of care for at least 30 days . 2. Ambulation and leg elevation have been ordered and documented ongoing compliance is in the member medical record . D. Member has any of the following: 1. high-risk open fracture 2. dehisced w ound 3. post sternotomy wound complication or infection (mediastinitis) 4. surgically created wound with complications resulting in a need for accelerated granulation therapy that cannot be achieved by other treatment modalities , such as topical wound treatment . 5. open non-healing amputation site in diabetic 6. delayed healing or non-healing of skin graft which is likely due to irregularly contoured or inadequate blood flo w from the graft bed II. CareSource members may be eligible for the continuation of NPWT treatment when documentation by a licensed medical professional includes ALL of the following criteria: A. A licensed medical professional has directly performed the dressing change and is monitoring and controlling the members underlying medical conditions . B. The w ound has progressive and measurable improvement. 1. If no measurable degree of improvement in wound healing has occurred from month to month, the approval for the NPWT will be discontinued. 2. An e xception to measurable improvement is when a wound has been debrided within the last approval period . Documentation of debridement must accompany the request for continuation of NPWT. Before and after images are preferred. C. If abnormal, provisions have been made to the members nutritional status . III. CareSource does not consider NPWT medically necessary for non-healing wounds or ulcers under any of the following medical conditions: A. exposed nerves, blood vessels , or organs in the vicinity of the wound B. uncontrolled soft tissue i nfection or osteomyelitis C. malignancy present in the wound D. necrotic tissue is present in the wound with eschar and has not been debrided E. open fistula present to an organ or body cavity within the vicinity of the wound F. active bleeding IV. When applied during surgery, CareSource does not reimburse separately for NPWT. NPWT is covered under the surgery code.Negative Pressure Wound Therapy-MP-MM-1386Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 V. The coverage provided for NPWT by the global surgical package is not intended to deny billing for NPWT in outpatient services. When a patient is discharged from the hospital with wounds that are still in need of NPWT treatment, outpatient wound care is covered when it meets medical necessity. VI. Initial approval for NPWT in the outpatient setting will be for a month. After the initial month, continued approval will be based on the medical necessity guidelines in this policy. Continued approval will be made in 1-month increments. CareSource willap prove the following allowances for supplies:A. Fifteen dressing kits per wound per month . Additional dressing kits may be requested with documentation that the wound size requires more than one kit. B. Ten canister sets per month . Additional canister sets can be requested if there is documentation showing greater than 90 ml drainage exudate per day. C. Initial approval includes NPWT equipment and supplies that are used upon discharge from an in-patient setting. E. State-Specific InformationN/A F. Conditions of CoverageN/A G. Related Policies/RulesN/A H. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New PolicyDate Revised 02/02/2022 11/30/2022 10/11/2023 10/23/2024Updated background and references , updated Sec II. E.Updated references. Editorial changes. Annual review. Updated references and clarified coverage criteria in D. IV-VI . Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 01/01/2025 Date Archived I. References1. De Pellegrin L, Feltri P, Filardo G, et al. Effects of negative pressure wound therapy with instillation and dwell time (NPWTi-d) versus NPWT or standard of care in orthoplastic surgery: a systematic review and meta-analysis . Int Wound J . 2023;20(6):2402-2413. doi:10.1111/iwj.14072 2. Gao J, Wang Y, Song J, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis. JAdv Nurs . 2021;77(10):3980 – 3990. doi:10.1111/jan.14876 Negative Pressure Wound Therapy-MP-MM-1386Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 3. Gestring M. Negative pressure wound therapy. UpToDate. Updated November 1 7,202 3. Accessed August 23, 2024 . www.uptodate.com 4. Groenen H, Jalalzadeh H, Buis DR, et al. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis . 2023;62:102105. doi:10.1016/j.eclinm.2023.102105 5. Kim PJ, Attinger CE, Constantine T, et al . Negative pressure wound therapy with instillation : international consensus guidelines update . Int Wound J . 2020;17(1):174 – 186. doi:10.1111/iwj.13254 6. Negative pressure wound therapy (vacuum-assisted wound closure): A-0346. MCG Health. 28 th ed. Updated March 14, 2024. Accessed August 23, 2024. www.careweb.careguidelines.com 7. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev . 2022;6(6):CD009261. doi:10.1002/14651858.CD009261.pub7 8. Orlov A, Gefen A. The potential of a canister-based single-use negative-pressure wound therapy system delivering a greater and continuous absolute pressure level to facilitate better surgical wound care. Int Wound J . 2022;19(6):1471-1493. doi:10.1111/iwj.13744 9. Pedrazzi NE, Naiken S, La Scala G. Negative pressure wound therapy in pediatric burn patients: a systematic review. Adv Wound Care (New Rochelle) . 2021;10(5):270-280. doi:10.1089/wound.2019.1089 10. PICO single use negative pressure wound therapy system (Smith & Nephew) for cesarean birth wound care. Hayes; 2022. Reviewed July 10, 2024 . Accessed August 23, 2024 . www.evidence.hayesinc.com 11. Poteet SJ, Schulz SA, Povoski SP, et al. Negative pressure wound therapy: device design, indications, and the evidence supporting its use. Expert Rev Med Devices . 2021;18(2):151-160. doi:10.1080/17434440.2021.1882301 12. Revesz ES, Altorjay A, Montsko V, et al. Effectiveness of negative pressure wound therapy: minimum five-year follow-up and review of the literature . JDis Relat Surg . 2022;33(1):51-56. doi:10.52312/jdrs.2022.547 13. Shi J, Gao Y, Tian J, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Sys Rev . 2023;5(5):CD011334. doi:10.1002/14651858.CD011334.pub3 14. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. www.ncbi.nlm.nih.gov 15. Tian Y, Li K, Zeng L. A systematic review with meta-analysis on prophylactic negative pressure wound therapy versus standard dressing for obese women after caesarean section. Nurs Open . 2023;10(9):5999-6013. doi:10.1002/nop2.1912 16. Xie W, Dai L, Qi Y, et al. Negative pressure wound therapy compared with conventional wound dressings for closed incisions in orthopaedic trauma surgery: A meta-analysis . Int Wound J . 2022;19(6):1319-1328. doi:10.1111/iwj.13726 Independent med ical review 4/2020

Personal Emergency Response Systems

MEDICAL POLICY STATEMENT Marketplace Policy Name & Number Date Effective Personal Emergency Response Systems-MP-MM-1425 11/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West VirginiaTable of Contents Table of Contents ………………………….. ………………………….. ………………………….. ………………….. 1 A. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 2 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 G. Related Polic i es/Rules ………………………….. ………………………….. ………………………….. …….. 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 I. References ………………………….. ………………………….. ………………………….. ……………………. 3 Personal Emergency Response Systems-MP-MM-1425Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPersonal Emergency Response System s B. BackgroundPersonal Emergency Response Systems (PERS) are devices with an integrated service that can secure help in the event of an emergency. Currently available PERS allow for communication between the user and responders with additional services and alarms incorporated into the device depending on the sophistication of the device. Trained personnel at a remote monitoring station respond to a members alarm signal via the individual s PERS equipment. PERS can provide safety , assist in medication adherence, and allow for independent living when part of the physicians prescribed plan of treatment . C. Definitions Personal Emergency Response System (PERS) Includes telecommunications equipment, a central monitoring station, and a medium for two-way, hands-free communication between the individual and the station. This does not include remot e video monitoring of the individual in the home or systems that only connect to emergency service personnel. D. PolicyI. The use of a PERS in a members home may be medically necessary when ALL the following criteria are met: A. Documentation by the members provider of ALL of the following : 1. specific clinical diagnoses and/or physical-functional limitations which serve as an indication for a PERS 2. how t he PERS specifically will improve member safety and facilitate continued residence in the home setting B. The member retains an appropriate mobile or landline phone system that will support the PERS device . C. To be eligible for PERS service, the member is assessed by CareSource Case Management to be: 1. frail and functionally impaired 2. living alone or with another functionally impaired person 3. willing to arrange for private line telephone service , if private line is not currently in place OR willing to sign a form saying that they have accepted a wireless cellular device as an alternative 4. mentally and physically able to use the equipment appropriately E. State-Specific InformationN/A Personal Emergency Response Systems-MP-MM-1425 Effective Dat e: 11/01/2025 The MEDICAL Po l i c y St a t e m e nt d e t ai l e d a bo v e h a s r ecei v e d due c on si d e ra t i o n a s d e f i n e d i n the MEDICAL Po li c y St a t e m e nt Po li c y a nd i s a pp r o v e d. 3 F. Conditions of Coverage NAG. Related Polic i es/Rules NAH. Review/Revision HistoryDATE ACTION Date Issued 02/01/2023 New Policy Date Revised 01/31/2024 12/18/2024 08/13/2025 Annual review: minor adjustment to background and definitions, and updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 11/01/2025 Date Archived I. References1. Agboola S, Goals S, Fischer N, et al. Healthcare utilization in older patients using personal emergency response systems: an analysis of electronic health records and medical alert data. BMC Health Serv Res . 2017;17(1):282. doi:10.1186/s12913-017-2196-12. Andrew NE, Wang Y, Teo K, et al. Exploring patterns of personal alarm system use and impacts on outcomes. Australas JAgeing . 2021;40(3):252-260. doi:10.1111/ajag.129413. Bat-Erdene BO, Saver JL. Automatic acute stroke symptom detection and emergency medical systems alerting by mobile health technologies: a review. JStroke Cerebrovasc Disc. 2021;30(7):105826. doi:10.1016/j.jstrokecerebrovasdis.2021.1058264. Casabona E, Riva-Rovedda F, Castello A, et al. Factors associated with falls in community-dwelling older adults: a subgroup analysis from a telemergency service.Geriatrics (Basel) . 2024;9(3):69. doi:10.3390/geriatrics90300695. Colaianni S . Best medical alert systems of 2025 . National Council on Aging. UpdatedAugust 4, 2025 . Accessed August 4, 2025 . www.ncoa.org6. Evidence Review: New Technologies: Epilepsies in Children, Young People andAdults: Diagnosis and Management. National Institute for Health and CareExcellence (NICE); 2022. Accessed August 4, 2025 . www.p ubmed.ncbi.nlm.nih.gov7. Falls and fractures in older adults: causes and prevention. National Institute onAging. Reviewed September 12, 2022. Accessed August 4, 2025 . www.nia.nih.gov8. Golas SB, Nikola-Simons M, Palacholla R, et al. Predictive analytics and tailored interventions improve clinical outcomes in older adults: a randomized controlled trial.NPJ Digit Med. 2021;4(1):97. doi:10.1038/s41746-021-00463-y Personal Emergency Response Systems-MP-MM-1425Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 9. Jacobs JA, Hastu RR, Cooley V, et al. Congestive heart failure management at home use of personal emergency response systems (PERS). Prof Case Manag . 2022;27(6):306-312. doi:10.1097/NCM.0000000000000607 10. Jehu DA, Davis JC, Falck RS, et al. Risk factors for recurrent falls in older adults: a systematic review with meta-analysis. Maturitas. 2021;144:23-28. doi:10.1016/j.maturitas.2020.10.021 11. Lachal F, Tchalla AE, Cardinaud N, et al. Effectiveness of light paths coupled with personal emergency response systems in preventing functional decline among the elderly. SAGE Open Med . 2016;4 :1-8. doi:10.1177/2050312116665764 12. Stokke R. The personal emergency response system as a technology innovation in primary health care services: an integrative review. JMed Internet Res . 2016;18(7):e187. doi:10.2196/jmir.5727

Myoelectric Lower Extremity Prosthetic Technology

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Myoelectric Lower Extremity Prosthetic Technology-MP-MM-1327 11/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage …………………………………………………………………………………………. 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Myoelectric Lower Extremity Prosthetic Technology-MP-MM-1327Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMyoelectric Lower Extremity Prosthetic Technology B. Background The policy addresses the computerized limb prosthesis that is a nonstandard, external prosthetic device incorporating a microprocessor for movement control. These devices are equipped with a sensor that detects when the knee is in full extension and adjusts the swing phase automatically, permitting a more natural walking pattern of varying speeds. C. Definitions Myoelectric Lower Extremity Prosthetic Technology Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing phase only, includes electronic sensor(s), any type. Classification Level Rehabilitation potential as described by Centers for Medicare & Medicaid Services: Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility a. The individual does not have sufficient cognitive ability to safely use a prosthesis with or without assistance. b. The individual requires assistance from equipment or caregiver in order to transfer and use of a prosthesis does not improve mobility or independence with transfers. c. The individual is wheelchair dependent for mobility and use of a prosthesis does not improve transfer abilities. d. The individual is bedridden and has no need or capacity to ambulate or transfer. Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence, typical of the limited and unlimited household ambulator. a. The individual has sufficient cognitive ability to safely use a prosthesis with or without an assistive device and/or the assistance/supervision of one person. b. The individual is capable of safe but limited ambulation within the home with or without an assistive device and/or with or without the assistance/supervision of one person. c. The individual requires the use of a wheelchair for most activities outside of their residence. d. The individual is not capable of most of the functional activities designated in Level 2. Level 2: Has the ability or potential for ambulation with the ability to transverse low level environmental barriers such as curbs, stairs or uneven surfaces. This level is typical of the a. The individual can ambulate with or without an assistive device (which may include one or two handrails) and/or with or without the assistance/supervision of one person: i. Perform the level 1 tasks designated above ii. Ambulate on a flat, smooth surface iii. Negotiate a curb iv. Access public or private transportation v. Negotiate 1-2 stairs Myoelectric Lower Extremity Prosthetic Technology-MP-MM-1327Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 limited community ambulator.vi. Negotiate a ramp built to ADA specifications b. The individual may require a wheelchair for distances that are beyond the perimeters of the yard/driveway, apartment building, etc. c. The individual is only able to increase his/her generally observed speed of walking for short distances or with great effort. d. The individual is generally not capable of accomplishing most of the tasks at Level 3 (or does so infrequently with great effort). Level 3: Has the ability or potential for ambulation with variable cadence, typical of the community ambulator who has the ability to transverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. a. With or without an assistive device (which may include one or two hand rails), the individual is independently capable (ie requires no personal assistance or supervision) of performing the Level 2 tasks above and can i. Walk on terrain that varies in texture and level (eggrass, gravel, uneven concrete) ii. Negotiate 3-7 consecutive stairs iii. Walk up/down ramps built to ADA specifications iv. Open and close doors v. Ambulate through a crowded area (eg, grocery store, big box store, restaurant) vi. Cross a controlled intersection within his/her community within the time limit provided (varies by location) vii. Access public or private transportation viii. Perform dual ambulation tasks (eg, carry an item or meaningfully converse while ambulating) b. The individual does not perform the activities of Level 4. Level 4: Has the ability or potential for prosthetic ambulation that exceeds the basic ambulation skills, exhibiting high impact, stress or energy levels typical of the prosthetic demands of the child, active adult, or athlete. With or without an assistive device (which may include one or two hand rails), this individual is independently capable (ie, requires no personal assistance or supervision) of performing high impact domestic, vocational or recreational activities such as: a. Running b. Repetitive stair climbing c. Climbing of steep hills d. Being a caregiver for another individual e. Home maintenance (eg, repairs, cleaning) NOTE: Consideration is given to bilateral amputees who often cannot be strictlybound by the Classification Levels.Myoelectric Lower Extremity Prosthetic Technology-MP-MM-1327Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 D. PolicyI. CareSource considers myoelectric lower limb prosthetic technology medically necessary when the following criteria are met: A. The member is 18 years of age or older. B. Has a lower extremity prosthesis(s). C. Documentation submitted supports medical necessity and includes the following: 1. A written order/prescription from a treating practitioner for the additional technology. 2. Sufficient documentation of the rehabilitation potential including, but not limited to, clear documentation supporting the expected potential classification level that is K3 or above. 3. Member exhibits ALL the following characteristics: a. emotionally readiness b. ability and willingness to participate in training c. ability to care for the technology d. physically ability to use the equipment e. adequate cardiovascular and pulmonary reserve for ambulation at faster than normal walking speed NOTE: Documentation for Durable Medical Equipment, Prosthetics, Orthotics,and Supplies is followed. E. Conditions of CoverageN/A F. Related Policies/Rules Medical Record Documentation Standards for Practitioners G. Review/Revision History DATE ACTIONDate Issued 07/20/2022 New PolicyDate Revised 07/19/2023 08/28/2024 07/30/2025 Updated references. Approved at Committee Updated references. Approved at Committee Updated references. Approved at Committee Date Effective 11/01/2025 Date Archived H. References1. Centers for Medicare & Medicaid Services Health Technology Assessment. Lower Limb Prosthetic Workgroup Consensus Document . September 2017. Accessed June 30, 2025. www.cms.gov 2. Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items and services having special DME review considerations. Medicare Program Integrity Manual . US Centers for Medicare and Medicaid Services; 2025. Accessed June 30, 2025. www.cms.gov Myoelectric Lower Extremity Prosthetic Technology-MP-MM-1327Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Liu W, Fleming A, Lee IC, et al. Direct myoelectric control modifies lower limb functional connectivity: a case study. Annu Int Conf IEEE Eng Med Biol Soc . 2021;2021:6573-6576. doi:10.1109/EMBC46164.2021.9630844 4. Lower limb prosethesis: A-0487 (AC). MCG Health. 28th ed. Accessed June 30, 2025. www.careweb.careguidelines.com 5. Schulte RV, Prinsen EC, Buurke JH, et al. Adaptive lower limb pattern recognition for multi-day control. Sensors (Basel) . 2022;22(17):6351. doi:10.3390/s22176351 Independent medical review May 2021

Radiofrequency and Microwave Ablation of Tumors

Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Radiofrequency and Microwave Ablation of Tumors-MP – MM-1351 10/01/2025 Kentucky inactive as of 1/1/2026 Policy Type MEDICAL This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 3 D. Policy ………………………………………………………………………………………………………………….. 3 E. State-Specific Information ………………………………………………………………………………………. 5 F. Conditions of Coverage ………………………………………………………………………………………….. 5 G. Related Policies/Rules ……………………………………………………………………………………………. 5 H. Review/Revision History …………………………………………………………………………………………. 5 I. References …………………………………………………………………………………………………………… 6 Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectRadiofrequency and Microwave Ablation of TumorsB. Background Radiofrequency ablation of a tumor involves the delivery of high frequency alternating current to induce thermal injury of targeted tissue. Evidence for the use of radiofrequency ablation is constantly evolving based on the type of tumor and its location. Hepatocellular carcinoma is the most common type of primary liver cancer. For most patients, treatment with curative intent is not possible. Treatment options include surgical excision, hepatic artery infusion chemotherapy, trans-arterial bland or chemoembolization, selective interstitial radiotherapy (Yttrium 90 microspheres), percutaneous ethanol injection, cryoablation, and thermo-ablation. Liver transplantation for curative intent may be appropriate for some patients. Radiofrequency ablation and microwave ablation, which are types of thermos-ablation, have proven to be effective local therapy techniques with similar results to other treatment options for smaller tumors. Liver metastases are a common manifestation of many primary cancers. The number, location, size, and patients general health influence the choice of treatment for liver metastases. Surgical resection with curative intent is ideal, however this applies to a minority of patients. Non-surgical ablative techniques may be used for both curative and palliative intent; this includes systemic chemotherapy, targeted therapy, immunotherapy, external beam radiotherapy, cryoablation, thermo-ablation, arterial embolization techniques, and selective internal radiation therapy. Lung cancer is one of the most common types of cancer, with symptoms often not appearing until advanced disease, causing poor prognosis. Common treatments for primary or metastatic cancer in the lung includes surgery, chemotherapy, radiotherapy, photodynamic therapy, thermal ablation, immunotherapy, and biological therapy. Treatment selection is based on type, size, position and stage of cancer, and the patients overall health. Microwave ablation (MWA) uses microwave energy to cause thermal coagulation and tissue necrosis at a specific location. When a tumor is not amenable to resection or a patient is ineligible for surgery, MWA may be an appropriate alternative definitive treatment. This procedure can be done percutaneously, using minimally invasive surgical techniques, or during open surgery, and involves placement of one more probes directly into the tumors location, where microwave energy can be directly applied, causing destruction of the tumor and limited surrounding tissues. Microwave ablation does not spare vessels. Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 C. Definitions Tumor Ablation direct application of energy to eradicate or destroy focal tumors. The method of ablation is dependent on the characteristics of the lesion and risk mitigation. o Microwave Ablation (MWA) delivery of high-frequency microwave energy to rapidly agitate water molecules in the target tissue; the energy is converted to heat, which causes tissue necrosis. o Radiofrequency Ablation (RFA) delivery of radio waves to generate heat and induce tissue destruction in the targeted area.D. Policy I. Microwave ablation for tumor treatment using an FDA-approved device is considered medically necessary when ANY (either A or B) of the following indications are met: A. Member has primary or metastatic hepatic (liver) tumor and ALL the following: 1. The tumor is unresectable due to location of lesion(s) OR the member has comorbid condition(s) that are contraindicative to surgery. 2. The tumor is at most 5cm in size OR there are no more than 3 nodules, all of which are no more than 3cm in size. 3. Microwave ablation may be used alone or in conjunction with open or minimally invasive resection of other liver tumors. Curative resection of all disease must be the stated goal of therapy. or B. Member has primary or metastatic lung tumor and ALL the following: 1. The tumor is unresectable due to location of lesion(s) OR the member has comorbid condition(s) that are contraindicative to surgery. 2. Single tumor is no more than 3cm in size. II. Microwave ablation is not covered for any other indication, including (but not limited to), the following: A. Microwave ablation for any other tumor type is considered experimental and investigational due to a lack of clinical evidence on its efficacy. B. Microwave ablation for tumors larger than 5cm or more than 3 nodules larger than 3cm is considered experimental and investigational due to a lack of clinical evidence on its efficacy compared to other treatment modalities. III. Radiofrequency ablation for tumor treatment is considered medically necessary for ANY of the following indications: A. Barrett esophagus with dysplasia B. bone metastases C. hepatocellular carcinoma with ALL the following: 1. Child-Pugh class A or Bliver function (score of 9 or less) 2. surgical evaluation indicates at least one of the following: a. patient is a candidate for surgical resection following radiofrequency ablation Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 b. patient is a candidate for transplant following bridge therapy by radiofrequency ablation c. patient is not a surgical candidate (or elects against surgery) d. patient is not a transplant candidate 3. tumor has all the following: a. location amenable to percutaneous, minimally invasive or open surgical ablation b. margins accessible to ablation c. not in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other intra-abdominal organs) d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 4. no portal hypertension D. kidney tumor with ALL the following: 1. clinical stage T1 renal lesion 2. patient is not candidate for or elects against active surveillance 3. patient is not a surgical candidate (or elects against surgery) 4. tumor is not a renal angiomyolipoma E. liver metastases from colorectal carcinoma with ALL the following: 1. patient is not an ideal surgical candidate (or elects against surgery) 2. tumor has all the following: a. location amenable to percutaneous or surgical ablation b. margins accessible to ablation c. not in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other intra-abdominal organs)d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 3. no extrahepatic disease F. lung cancer (non-small cell [NSCLC]) with ALL the following: 1. patient is not a surgical candidate (or elects against surgery) 2. tumor with ALL the following: a. less than 3cm in diameter b. node negative (stage I) c. not in close proximity to major pulmonary vessels or esophagus G. osteoid osteoma H. soft tissue sarcoma with at least ONE of the following: 1. gastrointestinal stromal tumor with limited progressive disease (ie, appearance of new lesion, increase in tumor size) 2. soft tissue sarcoma of extremity, superficial trunk, or head/neck, as indicated by both: a. synchronous stage IV disease b. need for treatment of tumor bulk limited to single organ that is amenable to local therapy, or palliation of disseminated metastases I. thyroid cancer with at least ONE of the following: 1. differentiated thyroid carcinoma (eg, follicular, papillary) with at least ONE of the following:Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 a. distant metastasis or persistent disease not amenable to treatment with radioactive iodine b. recurrent disease following treatment of locoregional disease 2. medullary carcinoma with at least ONE of the following: a. palliative treatment of symptomatic metastases or progressive disease needed b. Patient asymptomatic, with at least ONE of the following: 01. disease metastasis 02. persistent disease following treatment of locoregional disease 03. recurrent disease following treatment of locoregional disease J. thyroid nodules, with ALL the following: 1. compressive symptoms from nodules (eg, cough, dysphagia, foreign body sensation, pain, voice changes) 2. patient not a surgical candidate (or elects against surgery) K. uterine leiomyomas with ALL the following: 1. laparoscopic ultrasound-guided procedure planned 2. leiomyomas documented by imaging study (eg, ultrasound or hysteroscopy) 3. patient desires uterine conservation or is not a surgical candidate 4. patient is premenopausal 5. persistent symptoms (3 months or greater in duration) directly attributed to presence of leiomyomas, as indicated by at least ONE of the following: a. abnormal uterine bleeding unresponsive to conservative management (eg, hormonal therapy) b. bowel dysfunction c. dyspareunia d. infertility e. iron deficiency anemia f. pelvic pain or pressure g. urinary dysfunction 6. testing has ruled out other potential causes of symptomsE. State-Specific Information NA F. Conditions of Coverage NA G. Related Policies/Rules NA H. Review/Revision History DATE ACTION Date Issued 10/12/2022 Date Revised 09/27/2023 08/28/2024 Annual review: updated references, approved at Committee Review: updated references, approved at Committee. Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 6 06/18/2025 Review: added indications for Barrett and thyroid nodules,updated references, approved at Committee. Date Effective 10/01/2025 Date Archived I. References 1. Abdalla M, Collings AT, Dirks R, et al. Surgical approach to microwave and radiofrequency liver ablation for hepatocellular carcinoma and colorectal liver metastases less than 5cm: a systematic review and meta-analysis. Surg Endosc. 2023;37(5):3340-3353. doi:10.1007/s00464-022-09815-5. 2. Chung SR, Suh CH, Baek JH, et al. Safety of radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: a systematic review and meta-analysis. Int JHyperthermia 2017;33:920-930. doi:10.1080/02656736.2017.1337936 3. Cui R, Yu J, Kuang M, et al. Microwave ablation versus other interventions for hepatocellular carcinoma: a systematic review and meta-analysis. JCancer Res Ther . 2020;16(2):379-386. doi:10.4103/jcrt.JCRT_403_19 4. Curley SA, Stuart KE, Schwartz JM, et al. Localized hepatocellular carcinoma: liver-directed therapies for nonsurgical candidates who are eligible for local ablation. UpToDate. Updated April 23, 2025. Accessed May 19, 2025. www.uptodate.com 5. Dupuy DE. Image-guided ablation of lung tumors. UpToDate. Updated November 6, 2023. Accessed May 19, 2025. www.uptodate.com 6. Genshaft SJ, Suh RD, Abtin F, et al. Society of Interventional Radiology quality improvement standards on percutaneous ablation of non-small cell lung cancer and metastatic disease to the lungs. JVasc Interv Radiol. 2021;32:1242.e1-1242.e10. doi:10.1016/j.jvir.2021.04.027 7. Glassberg MB, Ghosh S, Clymer JW, et al. Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. World JSurg Oncol . 2019;17(1):98. doi:10.1186/s12957-019-1632-6 8. Han Y, Yan X, Zhi W, et al. Long-term outcome following microwave ablation of lung metastases from colorectal cancer. Front Oncol. 2022;12:943715. doi:10/3389/fonc.2022.943715. 9. Matsui Y, Tomita K, Uka M, et al. Up-to-date evidence on image-guided thermal ablation for metastatic lung tumors: a review. Jpn JRadiol . 2022;40(10):1024-1034. doi:10/1007/s11603-022-01302-0. 10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Hepatocellular Carcinoma. Version 1.2025. Issued March 20, 2025. Accessed May 9, 2025. www.nccn.org 11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 3.2025. Issued January 14, 2025. Accessed May 9, 2025. www.nccn.org 12. National Institute for Health and Care Excellence. Microwave ablation for primary or metastatic cancer in the lung [IPG716]. Published February 2, 2022. Accessed May 9, 2025. www.nice.org Radiofrequency and Microwave Ablation of Tumors-MP-MM-1351 Effective Date: 10/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 7 13. National Institute for Health and Care Excellence. Microwave ablation for treating liver metastases [IPG553]. Published April 27, 2016. Accessed May 9, 2025. www.nice.org 14. National Institute for Health and Care Excellence. Microwave ablation of hepatocellular carcinoma [IPG214]. Published March 28, 2007. Accessed May 9, 2025. www.nice.org 15. Nelson DB, Tam AL, Mitchell KG, et al. Local recurrence after microwave ablation of lung malignancies: A Systematic Review. Ann Thorac Surg . 2019;107(6):1876-1883. doi:10.1016-j.athoracsur.2018.10.049 16. Palussiere J, Chomy F, Savina M, et al. Radiofrequency ablation of stage IA non-small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial. JCardiothorac Surg . 2018;13(1):91. doi:10/1186/s13019-018-0773-y 17. Radiofrequency Ablation of Tumor. ACG: A-0718 (AC). 29th ed. MCD Health; 2025. Updated January 25, 2025. Accessed May 9, 2025. www.careweb.guidelines.com 18. Wang N, Xu J, Wang G, et al. Safety and efficacy of microwave ablation for lung cancer adjacent to the interlobar fissure. Thorac Cancer . 2022;13(18):2557-2565. doi:10.1111/1759-7714.14589 19. Wu X, Uhlig J, Blasberg JD, et al. Microwave ablation versus stereotactic body radiotherapy for stage I non-small cell lung cancer: a cost-effectiveness analysis. JVasc Interv Radiol . 2022;33(8):964-971.e2. doi:10.1016/j.jvir.2022.04.019 Independent medical review September 2022

Drug Testing

MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Drug Testing-IN MP-MM-0130 10/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 7 F. Related Polices /R ules ………………………….. ………………………….. ………………………….. ……… 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectDrug Testing B. BackgroundDrug testing is part of medical care during multiple phases for members with substance use disorder (SUD) or those at risk for abuse/misuse or diversion of drugs. The testing process assists providers in member care and serves a variety of purposes, inclu ding enhancing patient care, reducing health risk, justifying continued therapy, and providing rationale for changing or altering treatment. The assessment process, including initial drug testing, aids providers in individualizing treatment plans for membe rs. Drug testing may help determine if a member is adhering to prescription medication, reveal nonprescribed drugs or illicit drugs, and/or provide evidence to suggest diversion. Providers requesting drug testing should have proficiency in drug test interpreta tion andan understanding of tests that need ordered. Urine drug testing (UDT) is the most common method for monitoring drug use, presumptive and confirmatory testing, also referred to as toxicology testing. Presumptive testing identifies the use or non-use of a drug or class of drugs and aremore commonly routine due to speed of testing, accuracy, and accessibility in a wide variety of settings. Definitive tests are more specific, can refine test results, and allow for the detection of specific drugs or metabolites of interest. Definitive testing may be needed when presumptive results are not sufficient to guide clinical care, but definitive testing must be clinically meaningful with documentation that support s the specific necessity of each definitive assay performed. Ethical use of drug testing requires a testing panel and frequency justified by the clinical condition and the ordering providers need for information. C. Definitions Aberrant Behavior Behaviors indicating medication/drug abuse or misuse (ie, losing prescriptions, early refill requests, multiple prescribers for controlled substances on the states Prescription Drug Monitoring Program). Chronic Opioid Therapy The use of opioids to treat chronic pain at intervals longer than 3 months or past the time of normal tissue healing. Definitive (Confirmatory/Quantitative) Test A test determining the amount of a substance per unit volume or unit weight of specific drugs or metabolites. Presumptive (Qualitative) Test Testing of a substance or mixture to determine the presence or absence of a drug or drug class. Relapse A person with addiction issues returns to use after a period of sobriety. Residential Treatment Services Health care services that can include individual and group psychotherapy, family counseling, nursing services, and pharmacological therapy with 24-hour support. Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. Medical Necessity Review and Quantity Limitations A. CareSource will review medical necessity on a case-by-case basis . Presumptive testing should be the initial test considered. Higher number drug panels are rarely indicated for routine UDT as lower number panels are sufficient for modifying treatment plans in most cases. B. CareSource will cover up to 30 presumptive and 12 definitive UDT per member per calendar year before a review of medical necessity is required. 1. Appropriate clinical documentation must be included with request s and should provide clear evidence for the level of testing requested, including a. phase of treatment ( eg, assessment, early recovery, stabilization, maintenance) and current level of care (ASAM level) b. member drug(s) of choice c. days since last drug test with unexpected results d. current prescribed drugs , including over-the-counter drugs and illicit drugs with unexpected results in recent tests e. member s current , active symptoms that led to the request f. provider actions taken on recent unexpected test results and member response to that action g. clinical documentation showing member contesting the result of an unexpected presumptive test h. results of any pill counts performed by treatment team 2. A review of medical necessity i s not required in an emergency department (ED) setting. Confirmatory testing is rarely needed in this setting. UDT utilization will be monitored by CareSource. Blood drug testing is considered medically necessary when in an ED setting. C. If needed, the licensed practitioner operating with in an applicable scope of practice must obtain the medical necessity review. D. Each CPT code is counted as 1 test. E. In determining medical necessity for additional tests, current clinical information will be considered . A review of medical records will be performed to determine the appropriateness of the initial drug tests ordered within a calendar yea r. F. Confirmatory Testing Confirmatory testing s hould not routinely be utilized as the first choice for UDT. Medical necessity criteria for confirmatory testing are met when 1 of the following is documented in the medical record : 1. Member reports taking medication as prescribed, but p resumptive testing was negative for prescription medications . The provider was expecting a positive result for prescribed medication . 2. Member disputes the following presumptive test results: a. positive results for prescription drug with abuse potential that was not prescribed by provider b. positive results for an illegal drug Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 3. A specific substance or metabolite needs identified that cannot be identified by a presumptive testing (eg, semi-synthetic or synthetic opioids , particular benzodiazepines ). II. Documentation RequirementsA. Drug Test Order Copies of test results without the providers order are not sufficient documentation of medical necessity to support a claim. Orders must include, at a minimum, all the following: 1. type of test to be performed (presumptive or confirmatory) 2. all medications currently prescribed to the member 3. drug and drug class to be tested 4. clinical indication 5. signature and date of qualified provider 6. must specifically match the number, level and complexity of testing components performed B. Provider Documentation in the Member Medical Record A panel of drugs may be performed as part of an initial assessment to develop a monitoring plan but should only be conducted based on an individualized treatment plan noting the need for confirmatory test with greater than 14 drug tests, which are rarely i ndicated for routine UDT. Provider s must maintain a complete, legible medical record for the member and include the following: 1. complete member name and identification on each page of record 2. identification of the provider responsible for providing member care 3. appropriate indication for UDT 4. how the UDT result will guide the plan of treatment 5. CPT code that accurately describes the service(s) performed C. Laboratory Documentation Documentation maintained must include the following: 1. physicians order for testing 2. test results 3. all records pertinent to billing III. Clinical IndicationsTesting should be completed randomly within a specific time frame to produce a sample and analytes tested based on the members drug(s) of choice. Periodically, drugs commonly used or regionally prevalent may be rotated into the testing schedule. The rationale is not meant to include all drugs all the time, rather the drugs most likely to be present in the member to assist clinical care regarding specific treatment. Providers should understand windows of detection time to determin e frequency of testing, know detection windows for drugs, and be aware of the potential for cross-reactivity when using presumptive tests. Testing does not have to be associated with an office visit. Providers and laboratories will ensure specimen integrity appropriate for the stability of the drug being tested. Diluted, substituted or adulterated urine samples will alter a Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 test result. If tampering is suspected, the sample should be discarded , and w hen possible, the member should remain at the provider facility until a new specimen is obtained and can be tested. A. Drug testing in addiction treatment 1. UDT frequency is more frequent early in treatment or when tapering and expected to decrease as a member stabilizes. 2. Prior to initiation or in the early recovery phase and including members who have relapsed: a. Obtain history , as well as a medical and psychological assessment. b. Review approximate time frame of drug detected in urine. c. Identify questions to answer , as well as treatment plan ning options based on potential UDT results. d. Obtain an individualized baseline UDT based on members unique clinical presentation, prescribed medications, members self-reported drugs of choice, and regional drug trends. e. Discuss results with member. f. Agree on plan of care , including treatment interventions and goals. g. This phase includes members that have relapsed. 3. Maintenance phase : Test a t least once per month. 4. Intensive outpatient : Test a t least weekly. 5. Substance use disorder residential treatment program : Test a t least monthly. 6. Stable recovery : Drug testing may be done less frequently . 7. Members taking long-acting naltrexone : Test at least monthly. B. Drug testing in an opioid treatment program (OTP) 1. Maintenance treatment : federal regulations governing OTP require initial toxicology plus 8 random UDT screens per year per member . 2. Short-term detoxification treatment requires 1 initial UDT per member . 3. Long-term detoxification treatment includes an initial and monthly random UDT (s) per member . C. Drug testing by advanced practice registered nurse (APRN) 1. Prescribing naltrexone to treat OUD : Complete UDT or serum medication levels at least every 3 months for the first year and then at least every 6 months thereafter . 2. Prescribing buprenorphine products : Complete UDT or serum medication levels at least twice per quarter for the first year of treatment and once per quarter thereafter. D. Chronic pain management 1. Prior to or upon initiation of treatment a. Complete an assessment for risk of substance abuse using a validated risk assessment screening tool (eg, Screener and Opioid Assessment for Patient with Pain-Revisited [SOAPP-R], Opioid Risk Tool [ORT ]). b. Review the State prescription drug monitoring program data (PDMP) . c. Obtain baseline UDT screening and discuss results with the member. d. Agree on plan of care , including treatment goals , and provide education on risks and benefits with strategies to mitigate risks. Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 e. Combine evidence-based non-pharmacologic and non-opioid pharmacologic therapy , as necessary. 2. Ongoing monitoring of treatment determined by level of risk for ab use a. Low risk : UDT once a year . b. Moderate risk : UDT twice a year . c. High risk : UDT up to 4 times a year . d. UDT when a member shows aberrant drug-related behavior . e. Review PDMP data every 1-3 months . f. Evalu ate benefits and risks of treatment at least every 3 months . E. Unexpected results 1. Discuss any possible member aberrant behavior. 2. Potential reasons for unexpected results may include the following : a. nonadherence (either recently or not at all) b. member utilizing drug amount below detection threshold c. substance cannot be identified by the type of test performed d. lab error s, adulterated specimens and/or cross-reactivity e. member absorbs, excretes, and/or metabolizes at different rate f. not members urine sample or diluted urine from water loading g. diversion 3. Potential interventions for unexpected results are dependent on assessment and may include the following : a. Evaluate and discuss factors contributing to relapse. b. Minimize tampering opportunities during collection of sample. c. Monitor pill counts and/or review PDMP. d. Adjust dosage and/or collaborat e/consult with specialist. e. Change the level of care , intensity of treatment , or plan of treatment ( ie, addition of behavioral therapy or community supports). f. Attend to psychosocial barriers (eg, transportation, finances) to encourage a c hange in lifestyle (eg, housing, support system ). g. Address co-occurring medical or behavioral needs. h. Obtain a confirmatory UDT. IV. Testing that is considered not medically necessary for presumptive and/or confirmatory testing, includes , but is not limited to , the following: A. Testing that is not individualized , including , but not limited to : 1. reflexive testing , routine, standard and/or preprinted orders 2. requesting all tests from a machine solely because a result may be positive 3. large, arbitrary panels , universal testing , or orders for Conduct additional testing as needed . B. Testing required by third parties , including , but not limited to : 1. court-ordered for other medico-legal purpose s (eg, c hild custody ) 2. pre-employment or random testing that is a requirement of employment 3. physicians health programs (eg, recovery programs for physicians, dentists, veterinarians, pharmacists, or others ) 4. school entry , testing for athletics , and/or military service testing Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 5. residential treatment facility, partial hospital, or sober living testing as a condition to remain in that community 6. testing with a primary pay source (eg, county, state or federal agency ) 7. marriage license or other administrative purpose testing 8. forensic testing 9. routine physical and/or medical examination conditions C. Blood drug testing when completed outside the ED. D. Hair, saliva, or other body fluid testing for controlled substance monitoring. E. Any type of drug testing not addressed in this policy or without documentation of medical necessity. F. Routine use of definitive t esting following a negative presumptive resul t or p rior to discussing results of presumptive test with member. E. Conditions of CoverageI. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis, subsequent medical review audits, recovery of overpayments identified, and provider prepay review. II. CareSource may require documentation of FDA-approved complexity level for instrumented equipment, and/or Clinical Laboratory Improvement Amendments (CLIA) Certificate of Registration, compliance, or accreditation as a high complexity lab. F. Related Polices /R ulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 12/13/2017Date Revised 08/01/2019 01/01/202009/02/202009/01/2021 08/31/2022 08/02/2023 07/17/ 2024 06/18/2025Updated clinical indications, quantity limits, and prior authorization requirements .Removed quantity limits and authorization requirements. Updated D. III. & D. IV. Reformatted. Removed related reimbursement policy. Updated references. Annual review. No changes. Annual review. Updated references. Approved at Committee. Annual review. Updated background and references. Approved at Committee. Annual review. Updated references. Approved at Committee. Date Effective 10/01/2025 Date Archived Drug Testing-IN MP-MM-0130Effective Dat e: 10/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 H. References1. Agnoli AL, Howe R, Magnan E, et al . Urine drug testing among patients prescribed long-term opioid therapy: patient and clinician factors. JAm Board Fam Med . 2023;36(4):537-541. doi:10.3122/jabfm.2022.220360R1 2. Andersson HW, Wenaas M, Nordfjrn T. Relapse after inpatient substance use treatment: a prospective cohort study among users of illicit substances. Addict Behav . 2019;90:222-228. doi:10.1016/j.addbeh.2018.11.008 3. Chang YP, Raynor T. Factors associated with relapse in individuals with Opioid Use Disorder receiving suboxone in rural areas. JAddict Nurs . 2021;32(1):20-26. doi:10.1097/JAN.0000000000000381 4. CLIA program and Medicare laboratory services. Centers for Medicare and Medicaid Services . Updated May 5, 2025 . Accessed June 2, 2025 . www.cms.gov 5. Clinical Drug Testing in Primary Care . Technical Assistance Publication 32. HHS Publication No. 12-4668. Substance Abuse and Mental Health Services Administration; 2012. Accessed June 2, 2025. www.samhsa.gov 6. Federal Guidelines for Opioid Treatment Programs . Substance Abuse and Mental Health Services Administration. Updated October 11, 2024. Accessed June 2, 2025. www.samhsa.gov 7. Indiana Marketplace Evidence of Coverage . CareSource; 2025. Accessed June 2, 2025. www.caresource.com 8. Information about medications for Opioid Use Disorder (MOUD). US Food and Drug Administration. Updated December 26, 2024. Accessed June 2, 2025. www.fda.gov 9. Jaffe A, Molnar S, Williams N, et al. Review and recommendations for drug testing in substance use treatment contexts. JReward Defic Syndr Addict Sci . 2016;2(1):28 – 45. doi:10.17756/jrdsas.2016-0 10. Jarvis M, Williams J, Hurford M, et al. Appropriate use of drug testing in clinical addiction medicine. JAddict Med . 2017;11(3):163-173. doi:10.1097/ADM.000000323 11. Lu T, Fox A, Stein M. Primary care management of adults with Opioid Use Disorder. UpToDate. Updated February 29, 2024. Accessed June 2, 2025. www.uptodate.com 12. Medicat ion Assisted Treatment for Opioid Use Disorders. 42 C.F.R. 8.1-655 (202 4). 13. Public policy statement on drug testing as a component of addiction treatment and monitoring programs and in other clinical settings. American Society of Addiction Medicine. Accessed June 2, 2025. www.asam.org 14. Rosano TG, Wood M, Hooten WM, et al. Application and clinical value of definitive drug monitoring in pain management and addiction medicine. Pain Med . 20228;23(4):821-833. doi:10.1093/pm/pnab303 15. Rzetelny A, Zeller B, Miller N, et al . Counselors’ clinical use of definitive drug testing results in their work with substance-use clients: a qualitative study . Int JMent Health Addict . 2016;14:64-80. doi:10.1007/s11469-015-9569-7 16. Warrington JS, Warrington GS, Francis-Fath S, et al. Urinary Buprenorphine, Norbuprenorphine and Naloxone concentrations and ratios: review and potential clinical implications. JAddict Med . 2020;14(6):e344-e349. doi:10.1097/ADM.0000000000000676

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