MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective ProACT Adjustable Continence Therapy-OH MCD-MM-1305 07/01/2026 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.Table of Contents A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 3 E. Conditions of Coverage …………………………………………………………………………………………. 3 F. Related Policies/Rules …………………………………………………………………………………………… 3 G. Review/Revision History ………………………………………………………………………………………… 3 H. References ………………………………………………………………………………………………………….. 4 ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectProACT Adjustable Continence Therapy B. Background Urinary incontinence is a known complication of prostate surgery which can impact quality of life. The incidence of incontinence varies by procedure, but it is transient for most individuals. Incontinence after prostate surgery is a dynamic condition that can greatly improve in the first 1 to 2 years with conservative therapies. Conservative management may include lifestyle modification, pads, compression, catheters, and pelvic floor exercises. An estimated 5% of men whose incontinence fails to resolve undergo an additional procedure for the treatment of incontinence. Surgical management, which is usually deferred for at least 12 months post-prostatectomy, may involve adjustable balloon devices for mild stress incontinence, male slings for mild to moderate stress incontinence, and artificial urinary sphincters for severe stress incontinence. ProACT is a minimally invasive adjustable continence therapy for stress urinary incontinence utilizing a proprietary balloon device. Under fluoroscopic guidance, implantation instruments are advanced via transverse perineal incisions to the area of the bladder neck. The tissue is then dilated to create space for the balloon device. A balloon is inserted bilaterally and inflated with isotonic solution. Titanium ports are placed under the skin to allow for future inflation or deflation of the balloons. While the device has demonstrated efficacy in peer-reviewed medical literature, device migration requiring revision surgery or explantation has also been documented. A shared decision-making approach between physician and patient is recommended. C. Definitions Urinary Incontinence Involuntary leakage of urine, including the following types: o Stress Urinary Incontinence (SUI) Occurs in the absence of a bladder contraction due to inadequate urethral sphincter function, either from mechanical damage to the urethral sphincter or from physiologic effects that limit sphincter function. o Urge Urinary Incontinence (UUI) A sudden and compelling desire to pass urine that is difficult to defer and is accompanied by involuntary leakage, typically associated with bladder outlet obstruction or detrusor overactivity. o Overflow Urinary Incontinence (OUI) Urine is retained in the bladder due to incomplete voiding after an attempt to urinate, potentially caused by bladder outlet obstruction or detrusor underactivity. o Mixed Urinary Incontinence A combination of stress urinary incontinence and urge urinary incontinence, occurring when both the bladder and urinary sphincter have impaired function. ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. CareSource considers ProACT adjustable continence therapy medically necessary when ALL the following clinical criteria are met: A. Member underwent radical prostatectomy or transurethral resection of the prostate at least 12 months prior without radiation therapy. B. Member has documented primary stress urinary incontinence arising from intrinsic sphincter deficiency of at least 12 months duration. C. Member has documentation of conservative therapy failure. D. Member experiences at least 3 incontinence episodes per day. E. Member has positive 24-hour pad weight test (at least 8-gram pad weight increase demonstrated in two 24-hour pad weight tests). II. Limitations/ExclusionsProACT is contraindicated in patients with any of the following: A. urge incontinence B. detrusor instability or over-activity C. residual volume of at least 100ml or at least 25% of the total bladder capacity after voiding D. active systemic or urinary tract infections E. history of bladder stones F. hemophilia or other bleeding disorders G. UI resulting from detrusor instability H. UI resulting from overactive bladder I. reduced bladder compliance J. residual urine volume exceeding 100 cubic centimeters after voiding K. suspected bladder cancer L. radiotherapy within the past 6 months E. Conditions of Coverage N/A F. Related Policies/Rules N/A G. Review/Revision HistoryDATE ACTIONDate Issued 04/13/2022 New PolicyDate Revised 03/29/2023 02/14/2024 02/12/2025 06/04/2025 03/25/2026Annual review: updated references. Approved at Committee. Annual review: editorial changes to document language and updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Review: removed age criteria. Approved at Committee Review: updated references. Approved at Committee. Date Effective 07/01/2026 ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 Date ArchivedH. References1. Angulo JC, Schnburg S, Giamm A, et al. Systematic review and meta-analysis comparing adjustable transobterator male system (ATOMS) and adjustable continence therapy (ProACT) for male stress incontinence. PLoS One . 2019;14(12):e0225762. doi:10.1371/journal.pone.0225762 2. Artificial urinary sphincter: A-0267 (AC). MCG. 29th ed draft. Updated January 25, 2025. Accessed March 5, 2026. www.careweb.careguidelines.com 3. Clemens JQ. Urinary incontinence in men. UpToDate. Updated March 6, 2024. Accessed March 5, 2026. www.uptodate.com 4. Comiter CV, Speed J. Urinary incontinence after prostate treatment. UpToDate. Updated May 16, 2024. Accessed March 5, 2026. www.uptodate.com 5. Finazzi Agr E, Gregori A, Bianchi D, et al. Efficacy and safety of adjustable balloons (ProACT) to treat male stress urinary incontinence after prostate surgery: medium and long-term follow-up data of a national multicentric retrospective study. Neurourol Urodyn . 2019;38(7):1979-1984. doi:10.1002/nau.24103 6. Klock JA, Palacios AR, Leslie SW, et al. Artificial urinary sphincters and adjustable dual-balloon continence therapy in men. Updated November 2, 2023. Accessed March 5, 2026. www.ncbi.nlm.nih.gov 7. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress incontinence: a systematic review and meta-analysis. Neurourol Urodyn . 2019;38(8):2051-2059. doi:10.1002/nau.24135 8. Munier P, Nicolas M, Tricard T, et al. What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling. Nurourol Urodyn . 2020;39(5):1417-1422. doi:10.1002/nau.24355 9. Musco S, Ecclestone H, Hoen L, et al. Efficacy and safety of surgical treatments for neurogenic stress urinary incontinence in adults: a systematic review. Eur Urol Focus . 2022;8(4):1090-1102. doi:10.1016/j.euf.2021.08.007 10. Nash S, Aboseif S, Gilling P, et al. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT. Neurourol Urodyn . 2019;38(1):248-253. doi:10.1002/nau.23838 11. Premarket approval (PMA) P130018: FDA summary of safety and effectiveness data. Food and Drug Administration. November 24, 2015. Accessed March 5, 2026. www.accessdata.fda.gov 12. ProACT: patient brochure. Food and Drug Administration. Accessed March 5, 2026. www.accessdata.fda.gov 13. ProACT: physician instructions for use. Food and Drug Administration. Accessed May 6, 2025. www.accessdata.fda.gov 14. ProACT adjustable continence therapy (Uromedica) for treatment of post-surgical incontinence in men. Hayes. Updated May 24, 2023. Accessed March 5, 2026. www.evidence.hayesinc.com ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 15. ProACT therapy for the treatment of stress urinary incontinence in males (ProACT).National Library of Medicine. Updated May 31, 2018. Accessed May 6, 2025. clinicaltrials.gov 16. Sandhu JS, Bryer B, Comiter C, et al. Incontinence after prostate treatment: AUA/SUFU guideline. JUrol . 2019;202(2):369-378. doi:10/1097/ju.00000000000314 Independent medical review February 2025ODM approved 04/02/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Negative Pressure Wound Therapy-OH MCD-MM-0224 07/01/2026 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.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 ………………………….. ………………………….. ………………………….. ……………………. 5 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The 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 used to treat chronic wounds, such as ulcers related to pressure sores, venous or arterial insufficiency, or neuropathy. There are many causes for pressure ulcers, including diabetes, vascular insufficiencies, and other underlying medical condition s. NPWT involves the controlled application of sub-atmosph eric pressure to the surface ofa wound. 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 th at has demonstrated efficacy 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 inpatient 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-OH MCD-MM-0224Effective Dat e: 07/01/2026The 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 members meeting ALL the following: 1. Member has been on a repositioning regimen with frequency determined by the provider based on the patients activity level and ability to reposition themselves. 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 the member medical record . 3. Members incontinence and moisture issues have been appropriately managed . B. Chronic neuropathic ulcer that meets BOTH of the following criteria: Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 1. A comprehensive diabetic management program has been implemented, including A1C management, medication management, and ongoing diabetic education.2. Foot care has been completed by a medical professional that includes general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies that meet ALL 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 wound 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 flow 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 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 wound 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 exception 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 conditions: A. exposed nerves, blood vessels, or organs in the vicinity of the wound B. uncontrolled soft tissue infection or osteomyelitis C. malignancy present in the wound D. necrotic tissue 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 IV. When applied during surgery, CareSource does not reimburse separately for NPWT. NPWT is covered under the surgery code. 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 cov ered 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 willapprove 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. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New policy.Date Revised 11/23/2022 10/11/2023 10/23/202407/30/2025 03/25/2026 Annual review: editorial changes, reference updates. Updated references and clarified coverage criteria in D. IV – VI. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 07/01/2026 Date Archived H. References1. Biancari F, Santoro G, Provenzano F, et al. Negative-pressure wound therapy for prevention of sternal wound infection after adult cardiac surgery: systematic review and meta-analysis. JClin Med . 2022;11(15):4268. doi:10.3390/jcm11154268 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 2. Chen L, Zhang S, Da J, et al. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. 2021;10(10):10830-10839. doi:10.21037/apm-21-2476 3. 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 4. Eriksson E, Liu PY, Schulz GS, et al. Chronic wounds: treatment consensus. Wound Repair Regen .2022;30(2):156-171. doi:10.1111/wrr.12994 5. 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 6. Gestring M. Negative pressure wound therapy. UpToDate. Updated January 30, 2025 . Accessed February 26, 2026 . www.uptodate.com 7. Gould LJ, Alderden J, Aslam R, et al. WHS guidelines for the treatment of pressure ulcers 2023 update. Wound Repair Regen . 2024;32(1):6-33. doi:10.1111/wrr.13130 8. 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 . EClinicalMedicine . 2023;62:102105. doi:10.1016/j.eclinm.2023.102105 9. 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 10. Li P, Li J. Effect of incisional negative pressure therapy and conventional treatment on wound complications after orthopaedic trauma surgery: a meta-analysis of randomized controlled studies. Int Wound J . 2023;20(10):4291-4299. doi:10.1111/iwj.14331 11. Negative pressure wound therapy (vacuum-assisted wound closure): A-0346. MCG, 29 th edition . Updated June 13, 2025 . Accessed February 26, 2026 . careweb.careguidelines.com 12. Negative Pressure Wound Therapy for Closed Surgical Incisions Following Total Knee Arthroplasty. Hayes; 2 023. Reviewed June 30, 2025. Accessed February 26, 2026. www.evidence.hayesinc.com 13. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev . 20 22;6(6):CD009261 . doi:10.1002/14651858.CD009261.pub7 14. 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 15. 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 16. PICO single use negative pressure wound therapy system (Smith & Nephew) for cesarean birth wound care. Hayes ; 2022. Reviewed July 8, 2025 . AccessedFebruary 26, 2026 . evidence.hayesinc.com 17. 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 18. Prevention of surgical site infections after major extremity trauma evidence-based clinical practice guideline . American Academy of Orthopaedic Surgeons. Published March 21, 2022. Accessed February 26, 2026. www.aaos.org 19. Rvsz ES, Altorjay A, Montsk V, et al. Effectiveness of negative pressure wound therapy: minimum five-year follow-up and review of the literature. Jt Dis Relat Surg . 2022;33(1):51-56. doi:10.52312/jdrs.2022.547 20. 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 21. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. Accessed February 26, 2026. www.ncbi.nlm.nih.gov 22. 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 23. 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 4/2020ODM approved 04/06/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Airway Clearance Devices-OH MCD-MM-1578 07/01/2026 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.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectAirway Clearance Devices B. BackgroundHealthy individuals typically produce 10 100 mL of airway secretions daily. The clearance of these secretions from the respiratory tract is accomplished primarily through ciliary action, called the mucociliary escalator and the cough reflex. Secretion retention can occur because of an increased production of secretions due to a number of conditions, including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), mucociliary disorders, neuromuscular disease (NMD), and metabolic disorders that make it more difficult to clear the airway. In patients with a weak cough, retention of these secretions is a major cause of mortality and morbidity. Conventional chest physical therapy has been shown to result in improved respiratory function through the use of percussion and postural drainage. These techniques are usually taught to family members so therapy may be continued at home when needed for chronic disease. However, this highly labor-intensive activity requires the daily intervention of a trained caregiver and may lead to poor compliance with the recommended treatment plan. Airway clearance devices can aid secretion mobilization and expectoration and assist coughing. Educating patients and families on the use of these devices and secretion management are within the scope of practice of respiratory therapists, physical therapists, nurses, and other clinicians. C. Definitions High Frequency Chest Compression Device An inflatable vest connected by tubes to a small air-pulse generator. The air-pulse generator rapidly inflates and deflates the vest, compressing and releasing the chest wall up to 20 times per second. Mechanical Insufflation-Exsufflation Device A device with a facemask that covers the nose and mouth, allowing air to be pumped into the lungs and then rapidly evacuated, facilitating the expulsion of secretions. Oscillation and Lung Expansion (OLE) Device A non-invasive, mechanical airway clearance technique (ACT) that combines continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) to treat lung diseases. D. PolicyI. Mechanical Insufflation-Exsufflation Devices (E0482) A. CareSource considers mechanical in-exsufflation devices medically necessary when all of the following clinical criteria are met: Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 1. There is a presence of neuromuscular or chest wall disease (eg, amyotrophic lateral sclerosis, congenital muscular dystrophies, Duchenne muscular dystrophy, multiple sclerosis, post-poliomyelitis, spinal cord injury, spinal muscle atrophy). 2. The condition causes a significant impairment of chest wall and/or diaphragmatic movement, resulting in an inability to clear retained secretions. 3. The member has an inadequate response or intolerance to chest percussion and postural drainage. 4. Member has no bullous emphysema, pneumomediastinum, or pneumothorax. B. A mechanical insufflation-exsufflation device for any indication not listed above is not covered or reimbursable. II. High Frequency Chest Compression Devices (E0483)A. CareSource considers high frequency chest compression devices medically necessary when any of the following clinical criteria is met: 1. cystic fibrosis when there is failure, intolerance or contraindication to home chest physiotherapy, or it cannot be provided 2. a diagnosis of bronchiectasis which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by a. daily productive cough for at least 6 continuous months or b. frequent (eg, more than 2 per year) exacerbations requiring antibiotic therapy B. Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the absence of a confirmed diagnosis of bronchiectasis do not meet this criterion. C. It is not reasonable and necessary for a member to use both a high frequency chest compression device and a mechanical in-exsufflation device. D. Per Ohio Administrative Code (OAC) 5160-10-08, purchase of a high-frequency chest wall oscillation (HFCWO) device will not be considered: 1. without an initial trial period lasting at least 2 months, excluding any portion that coincides with an inpatient hospital stay 2. Payment for rental may be made during this trial period. E. If use of the HFCWO device is to be continued in a residential setting after the initial trial period, a Certificate of Medical Necessity (CMN) is included that contains 1. an attestation to the effectiveness of the device during the trial period and every previous rental period as exhibited by a decrease in (not all inclusive): a. infections b. hospitalizations and c. antibiotic use 2. if applicable, specification of a change in the duration or frequency of therapy 3. a recommendation either for additional rental or for purchase III. Oscillation and Lung Expansion (OLE) DevicesA. Combination oscillation and lung expansion (OLE) devices for the treatment of respiratory conditions (e.g., the Volara System, BiWaze Clear System, and Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 MetaNeb4 System) as an alternative to conventional chest physical therapy to promote the clearance of respiratory secretions are considered to be of unproven efficacy. OLE devices are not recommended for outpatient use due to insufficient evidence and safety concerns. Requests will be reviewed on a case-by-case basis.B. A review in Clintrials.gov of the Volara device revealed 1 completed pilot study of 20 participants completed on March 19, 2025. Another study of OLE therapy was terminated on Feb.27, 2024 and a third study as of 2025-04-22 is listed as Not Yet Recruiting. C. There is insufficient evidence in the peer-reviewed published medical literature to draw conclusions regarding improvements in health outcomes of these devices compared to established alternatives. E. Conditions of CoverageBased on 2 Class 1 FDA recalls (the most recent being on May 30, 2024) as well as a Hayes 2023 Evidence Analysis Research Brief which detailed the following adverse events: injuries, 5 malfunctions, 2 deaths, Volara is not recommended for outpatient use. F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 01/17/2024 New policy. Approved at Committee.Date Revised 11/20/2024 06/18/2025 11/19/2025 Updated references. Approved at Committee. Updated references. Approved at Committee. Added effectiveness criteria to D.II.E.1, removed D.II.F. Volara section, added section D.III.A-C OLE devices, updated references. Approved at Committee. Date Effective 07/01/2026 Date Archived H. References1. Bach JR. Noninvasive respiratory management of patients with neuromuscular disease. Ann Rehabil Med . 2017;41(4):519-538. doi:10.5535/arm.2017.41.4.519 2. Basavaraj A, Choate R, Addrizzo-Harris D, et al. Airway clearance techniques in bronchiectasis: analysis from the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest . 2020;158(4):1376-1384. doi: 10.1016/j.chest.2020.06.050 3. Chatwin M, Wakeman RH. Mechanical insufflation-exsufflation: considerations for improving clinical practice. JClin Med . 2023;12(7):2626. doi:10.3390/jcm12072626 Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 4. DMEPOS: High-Frequency Chest Wall Oscillation (HFCWO) Devices, O HIO ADMIN .C ODE 5160-10-08 (2024). 5. Evidence Analysis Research Brief. Volara (Hillrom) for Respiratory Therapy. Updated August 2023. Accessed January 29, 2026. www.evidence.hayesinc.com 6. Ferreira de Camillis ML, Savi A, Goulart Rosa R, et al. Effects of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU subjects. Respir Care . 2018;63(12):1471-1477. doi:10.4187/respcare.06253 7. Finder JD, Birnkrant D, Carl J, et al. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am JRespir Crit Care Med. 2004;170(4):456-465. doi:10.1164/rccm.200307-885ST 8. High Frequency Chest Compression Device: A-0356 (AC). MCG Health. 29th ed. 2024. Updated June 13, 2025. Accessed October 24, 2025. www.careweb.careguidelines.com 9. Main E, Rand S. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev . 2023;5(5):CD002011. Published 2023 May 5. doi:10.1002/14651858.CD002011.pub3 10. Mechanical Insufflation-Exsufflation Device: A-0884 (AC). MCG Health. 29th ed. 2025. Updated June 13, 2025. Accessed October 24, 2025. www.careweb.careguidelines.com 11. Raywood E, Shannon H, Filipow N, et al. Quantity and quality of airway clearance in children and young people with cystic fibrosis. JCyst Fibros . 2023;22(2):344-351. doi: 10.1016/j.jcf.2022.09.008 12. Strickland SL, Rubin BK, Drescher GS, et al. AARC clinical practice guideline: effectiveness of nonpharmacologic airway clearance therapies in hospitalized patients. Respir Care . 2013;58(12):2187-2193. doi:10.4187/respcare.02925 Approved by ODM on 3/20/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Mechanical Stretching Devices-OH MCD-MM-1225 06/01/2026 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.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMechanical Stretching Devices B. Background Mechanical stretching devices are intended to restore range of motion (ROM) for joint stiffness or contracture by stretching joints. These devices provide passive stretching to an adjustable degree for a selected duration for multiple sessions. A variety of mechanical stretching devices are available for extension or flexion of the shoulder, elbow, wrist, fingers, knee, ankle, and toes. These devices can provide stretching for longer periods than a physical therapist and are generally used as adjunct treatment to physical therapy and/or exercise. Mechanical Stretching Devices (also known as dynamic splinting systems) include: Low-load prolonged duration stretch devices (LLPS) Static progressive stretch (SPS) splint devices Patient actuated serial stretch (PASS) devices C. Definitions Low-Load Prolonged Duration Stretch Devices (LLPS) These devices permit resisted active and passive motion (elastic traction) within a limited range. LLPS devices maintain a set level of tension by means of incorporated rubber bands or springs. Patient Actuated Serial Stretch (PASS) Devices These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). This type of device itself does not exert a stress on the tissue unless the joint angle is set at the maximum ROM. Static Progressive Stretch Devices (SPS) These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). D. Policy I. CareSource considers dynamic splinting devices medically necessary durable medical equipment (DME) as an adjunct treatment to physical therapy, massage, and/or exercise for an existing joint contracture when the following clinical criteria is met: A. medically necessary only for the following joints: knee, elbow, wrist, finger, ankle and toe B. after 3 weeks of exercise, physical therapy and skilled therapy in the initial subacute injury or post-operative period in members with: 1. signs and symptoms of persistent joint stiffness or contracture 2. limited range of motion that poses a meaningful functional limitation as judged by a physician C. documentation showing compliance with wear and compliance with any additional activity and exercise recommended by medical professional Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. may be used for an initial period of 4 weeks, a subsequent 4-week period with reevaluation, and then up to 4 months based on continued improvement. E. documentation to show objective ROM and functional improvement II. In the acute post-operative period for members who have undergone additional surgery to improve the range of motion of a previously affected joint, CareSource considers use of an LLPS device medically necessary for: A. an initial 4-week period B. an additional 4-week period, if improvement was noted after the initial 4 weeks, for up to 4 months. III. Non-Covered ServicesA. CareSource considers the use of dynamic splinting experimental and investigational for the following indications, including but not limited to: 1. adhesive capsulitis 2. carpal tunnel syndrome 3. cerebral palsy 4. foot drop associated with neuromuscular diseases 5. hallux valgus 6. head and spinal cord injuries 7. improvement of outcomes following botulinum toxin injection for treatment of limb spasticity 8. injuries of the ankle and shoulder 9. multiple sclerosis 10. muscular dystrophy 11. plantar fasciitis 12. rheumatoid arthritis 13. stroke 14. trismus B. CareSource considers the following devices experimental and investigational due to insufficient scientific evidence of efficacy: 1. patient Actuated Serial Stretch (PASS) devices (for example, ERMI Knee Extensionater and ERMI Shoulder Extensionater) 2. static Progressive Stretch devices (SPS) (for example, Joint Active Systems (JAS) splints (for example, JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) E. Conditions of CoverageAll claims for LLPS are subject to post-payment review by CareSource. F. Related Policies/Rules NA Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision History DATE ACTIONDate Issued 11/09/2023 New PolicyDate Revised 02/15/2023 06/07/2023 05/22/2024 03/12/2025 03/11/2026 e-voted addition of ankle and toe to policy to match fee schedule and MCG. Annual review. Added examples of PASS and SPS devices. Annual review. Updated references. Approved at Committee. Updated references. Approved at Committee. Added compliance documentation requirements to Sec.I. C. and ROM and improvement documentation to I. E. Updated references. Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther . 2013;30(8):763-770. doi:10.1007/s12325-013-0052-1 2. Dynamic Joint Extension and Flexion Devices: ACG A-0882. MCG. 29th ed. 2025. Accessed February 3, 2026. www.careweb.careguidelines.com 3. Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution predictors of contracture resolution. J Hand Ther . doi:10.1016/j.jht.2011.03.001 4. Harvey LA, Katalinic OM, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database of Systematic Reviews . 2017;1(1):CD007455. doi:10.1002/14651858.CD007455.pub3 5. Karjalainen TV, Lusa V, Page MJ, O'Connor D, Massy-Westropp N, Peters SE. Splinting for carpal tunnel syndrome. Cochrane Database Syst Rev. 2023;2(2):CD010003. doi:10.1002/14651858.CD010003.pub2 6. Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Hayes; 2022. Accessed February 3, 2026. www.hayesinc.com 7. Zatarain LA, Smith DK, Deng J, et al. A randomized feasibility trial to evaluate use of the jaw dynasplint to prevent trismus in patients with head and neck cancer receiving primary or adjuvant radiation-based therapy. Integr Cancer Ther . 2018. 17(3):960- 967. doi:10.1177/1534735418784363. Independent medical review 12/21Approved by ODM 03/17/2026
MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 06/01/2026Policy 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 Contents A. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 06/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTranscranial Magnetic Stimulation for Treatment of Depression B. BackgroundTranscranial magnetic stimulation (TMS) was originally introduced in 1985 as a noninvasive treatment modality for treatment-resistant Major Depressive Disorder (MDD) . Brief , repetitive pulses of magnetic energy are sent to the scalp via a large electromagnetic coil , generating a low level of electrical stimulation. These magnetic fields pass through the sk ull and induce electric al currents that depolarize neurons in a focal area of the surface cortex. The magnetic field generated by this type of stimulation is very small and cannot be felt by the patient but is strong enough to flow into the brain without inducing seizures or creating a need for anesthesia. TMS is generally an outpatient procedure with conscious patients and sessions tha t varybetween 30 to 40 minutes. Treatment can be delivered as a single pulse or as a series of pulses. Despite variability in the number of pulses delivered per session and the number of sessions per patient, research indicates that typical courses of TMS consist of treatment up to 5 days a week for up to 6 weeks. A tapering schedule is used to end treatment. C. Definitions Acute (Index) Course of Treatment The initial series of treatment given to relieve acute symptoms of MDD . Adequate Trial Taking a drug at least 4 weeks at or near the maximum dose for the specific medication as approved by the F ood and Drug Administration (FDA) or documentation exists that higher doses were not tolerated when the dose is less than the FDA approved maximum. Continuation TMS Treatment beginning after the acute/index course lasting up to 6 months and designed to prevent the worsening of symptoms and continue d treatment for a depressive episode that has not yet remitted. Depression Rating Scale Standardized scales for national use that reliably assess the range of symptoms most commonly observed in adults with MDD, including type and magnitude. Listed below are examples of commonly used scales : OBeck Depression Inventory (BDI) o Geriatric Depression Scale (GDS) o Hamilton Depression Rating Scale (HAM-D) o Patient Health Questionnaire-9 (PHQ-9) o Quick Inventory of Depressive Symptomatology (QIDS) Maintenance TMS Regularly scheduled TMS sessions on a weekly, biweekly, or monthly basis used to prevent relapse of depressive symptoms. Medication Side Effects Unexpected effects that cause significant distress, inhibit daily function, have the potential to worsen health, or are life threatening. Remission The absence of significant signs or symptoms of a n MDD episode during the previous 2 months. Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 06/01/2026 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 D. PolicyI. A review of medical necessity is required for initial or continuation courses of TMS .II. Initial (acute/index) treatment is considered medically necessary when ALL the following criteria are met:A. Member is 18 years of age or older .B. Member has a confirmed diagnosis of major depressive disorder , single or recurrent , with a current severe episode as evidenced by a recent score on a standardized depression rating scale and at least 1 of the following :1. Need for treatment , as indicated by 1 of the following:a. r esistance to treatment with documented adherence as evidenced by a lack of a clinically significant response during a current or previous depressive episode and 2 or more classes of an tidepressant agents at or near maximum effective dose and duration approved by the FDAb. i nability to tolerate pharmacotherapy evidenced by 2 antidepressants with documented side effects2. Continuation of acute course of treatment, as indicated by a. c ontinuation of symptoms 30 days after index (acute) course of treatment b. p revious positive response to index (acute) course of treatment evidenced by a reduction of 50% in a depression severity rating scale as compared to baselineC . None of the following conditions or contraindications are present :1. epilepsy , history of seizure or other neurologic disease or disorder that may lower seizure threshold (eg, cerebrovascular accident, severe head trauma,increased intracranial pressure) or a family history of epilepsy (parent, sibling,child)2 . acute or chronic psychotic symptoms or disorders (eg, schizophrenia,schizophreniform, or schizoaffective disorder)3. bipolar disorder4. cochlear implant s or deep brain stimulator s5. current use of substances that may significantly lower seizure threshold (eg ,alcohol or stimulants ) or recent discontinuation of alcohol, benzodiazepines ,or anticonvulsants; sleep deprivation ; active illicit substance abuse6. metallic hardware or implanted magnetic-sensitive medical device s (eg,implanted cardioverter-defibrillator s , pacemaker s , metal aneurysm clips or coils , intracardiac lines, medication pumps ) or other metal fragments at a distance within the electromagnetic field of the discharging coil (eg, less than or equal to 30 cm to the discharging coil)7. unstable medical disorders (eg, recent heart attack, severe uncontrolled hypertension)8 . tattoos in the head or neck with ferromagnetic-containing inkI II . Maintenance treatment with TMS is not considered medically necessary . There is not sufficient evidence in peer reviewed literature to assess net benefit versus harm for patients. Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 06/01/2026 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. 4 I V. Additional criteriaA. TMS must be administered by an FDA cleared device for the treatment of MDD in a safe and effective manner according to the manufacturers user manual and specified stimulation parameters.B. A treatment course should not exceed 5 days a week for 6 weeks (total of 30sessions), followed by a 3-week taper of 3 treatments in 1 week, 2 treatments the next week , and 1 treatment in the last week.C. TMS can be ordered by and performed under direction of a neurologist, licensed psychiatrist, or psychiatric nurse practitioner who has examined the member,reviewed the record when it is within the scope of practice, and has experience in administering TMS therapy within the scope of practice.E. Conditions of CoverageNAF. Related Policies/RulesMedical Necessity DeterminationsG. Review/Revision HistoryDATE ACTION Date Issued 07/12/2018 Date Revised 11/11/2020 10/28/2021 08/31/2022 01/19/2023 07/19/2023 06/19 /2024 06/04 /2025 03/11/2026 Removed a definition, added neurologist. Revised and expanded definitions. Added Section II and IV. Updated background , d efinitions , & criteria (MCG 26 th ed). Updated title for clarity. Annual review. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Annual review. Deleted III (repeat of D.II.B.2) and updated references. Approved at Committee. Annual review, updated Section II.C. Updated reference s . Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. American Psychiatric Association. Diagnostic and Statistical Manual of MentalDisorders, Fifth Edition, Text Revised. American Psychiatric Association; 2022.2. Holtzheimer PE. Unipolar major depression: administering transcranial magnetic stimulation (TMS). UptoDate. Updated July 21, 2025 . Accessed February 6, 2026 .www.uptodate.com3. Holtzheimer PE. Unipolar depression in adults: indications, efficacy, and safety of transcranial magnetic stimulation (TMS). UptoDate. Updated July 21, 2025 .Accessed February 6, 2026 . www.uptodate.com Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 06/01/2026 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. 5 4. Jarrett R, Vittengl J. Major depressive disorder in adults : Continuation and maintenance treatment. UptoDate. Updated October 3, 2024 . Accessed February 6,2026 . www.uptodate.com5. National Institute of Mental Health. Brain Stimulation Therapies . National Institutes ofHealth; 2023. NIH publication 0925-0648. Accessed February 6, 2026 .www.nimh.nih.gov6. Perera T, George MS, Grammar G, et al. The Clinical TMS Society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimul . 2016;9(3):336-346. doi:10.1016/j.brs.2016.03.0107. Thase M, Connolly R. Treatment-resistant unipolar major depression (major depressive disorder) in adults. UpToDate. Updated November 17, 2025 . AccessedFebruary 6, 2026 . www.uptodate.com8. Transcranial magnetic stimulation: B-801-T. MCG Health, 2 9 th edit. Updated June13, 2025 . Accessed February 6, 2026 . www.careweb.careguidelines.comApproved by Ohio Department of Medicaid 03/17/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Genetic Testing and Counseling-OH MCD-MM-0003 06/01/2026 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.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Polices/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectGenetic Testing and Counseling B. BackgroundAdvancements in technology have contributed to the rapid expansion of identified genetic variations . Some of these variations have been identified as disease-causing, while others are considered common variants with no clinical impact . With the ev er- expanding number of genetic tests available , it can be clinically difficult to determine the most appropriate tests for a particular patient. When clinically appropriate, genetic testing may provide diagnostic and/or actionable therapeutic results which can impact a patients outcome. Due to the complexity of genetic tests and th eir results , consultation with m edical genetics professionals and counselors may be required to assist members. According to the National Society of Genetic Counselors of the United States, genetic counseling is meant to integrate the following goals: 1) interpretation of family and medical histories to assess the chance of disease occurrence or recurrence; 2) education about the natural history of the condition, inheritance pattern, testing,management, prevention, support resources, and research; 3) counseling to promote informed choices in view of risk assessment, family goals, ethical and religious values; and 4) support to encourage the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence of that disorder. Genetic counselors are healthcare professionals trained to provide this care ; however , access issues may require other healthcare professionals to assume this role. Genetic counseling , whether provided by a certified genetic counselor or other qualified healthcare professional, is an integral component of genetic testing that is informative and supportive to memb ers, both before and after they undergo testing. C. Definitions Genetic Screening Th e process of testing a population for a genetic disease to identify a subgroup of people who either have the disease or the potential to pass it to offspring. Genetic Testing A medical test that identifies changes in genes, chromosomes, or proteins to confirm or rule out a suspected genetic condition , either hereditary or acquired. Human Leukocyte Antigen (HLA) Typing A test used to match patients and donors for bone marrow or cord blood transplants. Inherited Genetic Variant A type of DNA sequence change passed from parent to offspring (ie, germline). Precision Medicine A field of medicine that selects pharmacotherapies based on the patients genetics. Somatic Gene Variant A type of DNA sequence change that is not inherited from a parent but acquired during a persons life. Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. Prior authorization may be required for genetic testing . This includes both somatic and germline genetic testing. II. CareSource will review for medical neces sity using published MCG criteria whenavailable and the Medical Necessity Determinations administrative policy . This policy does not apply to requests that have MCG guidelines with clear genetic counseling requirements/recommendations. III. Proprietary panel testing requires evidence-based documentation per the MedicalNecessity Determinations administrative policy. Individual genetic tests may be requested separately based on the Medical Necessity Determinations administrati ve policy for panels not meeting medical necessity requirements. IV. Genetic counseling is required for all germline genetic testing , as indicated by ALLthe following: A. Counseling is provided by a healthcare professional with education and training in genetic issues relevant to the genetic tests under consideration . B. Counseling is provided to enable members informed decision making concerning proposed testing (eg, purpose of testing, management that may be informed by result, heritable nature informed by 3-generation family history, range of possible results, potentia l benefits and risks of testing (eg, psychological, social, economic). V. Somatic genetic testing (eg, cancer testing) does not require genetic counseling described above. VI. Human leukocyte antigen (H LA ) typing is not part of the genetic testing policy and do es not require pre-authorization. VII. W hile most inherited genetic testing is only necessary on ce in a lifetime, CareSource recognizes that a germline genetic test could be appropriately repeated in extraordinary circumstances due to changes in technology. This situation will be considered with the proper medical necessity documentation. E. Conditions of CoverageNAF. Related Polices/RulesMedical Necessity Determinations Cystic Fibrosis Testing Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 02/24/2015 New PolicyDate Revised 06/05/2019 09/03/2020 07/07/2021 05/25/2022 05/10 /202304/10/202407/03/2024 04/23 /202503/11 /2026Revised title, removed MCG table, condensed background Reviewed, updated referencesAnnual review: updated definitions, background, and references, re-organized criteria Annual review: updated background, definitions, and references , rephrased genetic counseling process. Approved at Committee. Review: updated references, approved at Committee Review: clarified genetic counseling requirements, added language regarding MCG. Approved at Committee Review: updated references, approved at Committee. Review: updated references, approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Ambulatory care : genetic medicine. MCG Health . 2 9th ed. Accessed January 30, 2026 . www.careweb.careguidelines.com 2. Cohen SA, Bradbury A, Henderson V, et al. Genetic counseling and testing in a community setting: quality, access, and efficiency. Am Soc Clin Oncol Educ Book . 2019;e34-e44. doi:10.1200/EDBK_238937 3. Crooke A, Jacobs C, Newton-John T, et al. Genetic counseling and testing practices for late-onset neurodegenerative disease: a systematic review. JNeurol. 2022;269(2):676-692. doi:10.1007/s00415-021-10461-5 4. Nowaczyk MJM. Genetic testing. UpToDate. Updated July 10, 2025 . Accessed January 30, 2026. www.uptodate.com 5. Mundy J, Davies HL, Radu M, et al. Research priorities in psychiatric genetic counselling: how to talk to children and adolescents about genetics and psychiatric disorders. Eur JHum Genet . 2023;31(3):262-264. doi:10.1038/s41431-022-01253-0 6. National Center for Biotechnology Information (NCBI). Genetic Testing Registry (GTR) National Library of Medicine. Accessed January 30, 2026 . www.ncbi.nlm.nih.gov 7. National Human Genome Research Institute. Coverage and Reimbursement of Genetic Tests. National Institutes of Health. Updated February 6, 2024 . Accessed January 30, 2026 . www.genome.gov 8. National Human Genome Research Institute. Regulation of Genetic Tests. National Institutes of Health. Updated February 19, 2024 . Accessed January 30, 2026 . www.genome.gov Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 9. Raby BA, Kohlmann W. Genetic counseling: family history interpretation and risk assessment. UpToDate. Updated April 9 , 2024. Accessed January 30, 2026 .www.uptodate.com 10. Sarata AK. Genetic Testing: Background and Policy Issues . Congressional Research Service Report ; 2015 . RL33832. Accessed January 30, 2026 . www.sgp.fas.org 11. Senter L, Austin JC, Carey M, et al. Advancing the genetic counseling profession through research: identification of priorities by the National Society of Genetic Counselors research task force. JGenet Couns. 2020;29(6):884-887. doi:10.1002/jgc4.1330 12. White S, Jacobs C, Phillips J. Mainstreaming genetics and genomics: a systematic review of the barriers and facilitators for nurses and physicians in secondary and tertiary care. Genet Med. 2020;22(7):1149-1155. doi:10.1038/s41436-020-0785-6 Approved by ODM 03/17/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Standing Frames-OH MCD-MM-1331 06/01/2026 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.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 ………………………….. ………………………….. ………………………….. ……………………. 5 Standing Frames-OH MCD-MM-1331Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectStanding Frames B. BackgroundSupported standing is a common, adjunctive therapeutic practice in which patients with neuromuscular conditions are enabled to assume an upright position. Homebased standing programs are commonly recommended for adults and children who cannot stand and/or walk independently and are usually part of a postural management program, which plays a role in preventing contracture, deformity, pain, and asymmetry. Standing frames (also known as standers) might include prone, supine, vertical, multi – positional , and sit-to-stand types. Standing frames are durable medical equipment (DME) that secure an individual in astanding position . These devices provide no mobility, but research has shown medical benefits supporting use, including an enhanced ability to perform tasks, maintained or improved joint range of motion, muscle spasticity and bone density , and an enhanced ability to perform activities of daily living. In recent studies, some adults and children report a decrease in pain, suppository use , decubitus ulcers, urinary tract infections (UTI), and clinical depression, while reporting an increase in improved bowel function , breathing, circulation , and muscle tone. Psychological benefits have also been documented and include improved socialization, patient satisfaction and quality of life due to improved interacti on with others. Additionalbenefits for some patients can include enhanced independence, improved vocational activities, and increased recreational activities with peers and others, which have been reported to instill a heightened sense of confidence and equality and improved self – esteem in children and adults. Acceptance by others and a sense of integration is perceived to be higher among standing frame users. No adverse events or effects have been frequently reported or documented in literature, but some contraindications have been widely discussed. Additionally, many patients do not report pain with use of standing frames. With the added benefit of the enhance mentof functional recovery with early physical rehabilitation, many providers are adding supported standing as a practice in postural management after consideration of contraindications is examined by a medical professional .C. Definitions Activities of Daily Living (ADLs) Fundamental skills required to independently care for oneself Durable Medical Equipment (DME or DMEPOS ) A collective term for a covered durable medical equipment item, prosthetic device, orthotic device, or medical supply item furnished by an eligible provider to an eligible recipient Home Medical Equipment Equipment that can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury and is appropriate for use in the home. Postural Management A multi-disciplinary approach incorporating a comprehensive schedule of daily and night-time positions, equipment, and physical Standing Frames-OH MCD-MM-1331Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 activity to help maintain or improve body structures and function and increase activity and participation. Technologically Sophisticated Medical Equipment (TSME) Prescribed by an authorized health care professional and requir ing individualized adjustment or regular maintenance by a home medical equipment services provider to maintain a recipients health care condition or the effectiveness of the equipment. Standers are considered TSME. D. PolicyI. CareSource will review medical necessity requests for non-powered standing frames on a case-by-case basis once ALL the following information is submitted for review: A. New Equipment 1. stander information, including ALL the following details: a. manufacturer b. model number c. type of stander d. part number, if applicable and if available e. an itemized list of any additional and accessories with individual prices, if not included with the basic stander or if applicable 2. a face-to-face evaluation with a qualified professional, such as an occupational therapist or a physical therapist, that includes ALL the following: a. recommendation of a postural management program that includes supported standing b. type of stander recommended (eg, prone, supine, vertical, multi – positional, sit-to-stand) c. goals of the postural management program including the goals of the type of stander requested d. specific dosing of the requested stander for the goals to be met e. a documented trial with the type of stander requested demonstrating the recipient can tolerate the recommended dose 3. a prescription following a face-to-face encounter addressing the same medical condition for which the stander is prescribed with a medical professional who has a relationship with the member and documented in the medical record , valid for 1 year, unless a different length of time is specified, and must include ALL the following: a. dated signature of 1 of the following appropriately Ohio-licensed and/or certified medical professionals: 01. physician (MD or DO) 02. advanced practice registered nurse (APRN) with a relevant specialty 03. physician assistant (PA) b. specific recipient diagnosis ( -es) documenting a neuromuscular condition (eg, multiple sclerosis, cerebral palsy, spinal cord injury, stroke) or documented developmental delay impairing the recipients ability to stand independently 4. documentation showing that the member or parent/guardian received training in the use of the requested type of stander , which can be completed during a scheduled therapy session for the member, if applicable Standing Frames-OH MCD-MM-1331Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 5. documentation showing the member or parent/guardian demonstrated safe use of the requested type of stander in the home setting (eg, documentation from physical therapy or other therapy sessions documenting trials of use suffice) 6. documentation that device use can be reasonably expected to provide therapeutic benefits or enable the member to perform certain tasks unable to perform otherwise due to the diagnosis, such as but not limited to 1 or more of the following: a. aids in the prevention of atrophy in the trunk and leg muscles b. improves strength and/or circulation to the trunk and lower extremities c. prevents formation of decubitus ulcers with changeable positions d. helps maintain bone and/or skin integrity e. reduces swelling in the lower extremities f. improves range of motion and/or aids normal skeletal development g. improves function of kidneys, bladder, and/or bowels h. decreases muscle spasms i. strengthens cardiovascular system and builds endurance j. prevents or decreases muscle contractures and/or progressive scoliosis k. improves social interaction and psychological well-being l. increases performance of activities of daily living (ADLs) 7. no contraindications to supported standing, such as but not limited to a. healing fracture or severe osteoporosis precluding weight bearing of any kind b. significant hip or knee flexion or ankle plantarflexion contractures in which stretch or pressure prevents standing c. compromised cardiovascular or respiratory systems requiring frequent monitoring of circulation and function while in stander d. significant inflexible skeletal deformities e. lack of standing tolerance (ie, cannot maintain a standing position due to little or no residual strength in the hips, legs, and lower extremities) f. postural hypotension 8. CareSource reserves the right to request the following: a. proof of delivery b. documentation of routine maintenance, adjustments, readjustments, or repairs c. annual review of continued need by a qualified provider B. Replacement of a non-powered standing frame is considered medically necessary after 5 years when both of the following criteria have been met: 1. medical necessity criteria above are met 2. device is out of warranty or not functioning properly and cannot be refurbished or adequately repaired II. The following items or services are not covered or separately reimbursable:A. electric, motorized, or powered standing frames B. items or services covered under manufacturer or dealer warranty C. DME items that duplicate or conflict with another item currently in the recipients possession Standing Frames-OH MCD-MM-1331Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 D. replacement items or previously approved equipment that have been damaged because of perceived misuse, abuse, or negligenceE. Conditions of CoverageAdditional instructions regarding reimbursement of DME items may be located in OAC 5160-10-01. CareSource reserves the right to request additional information if medical necessity is not adequately documented.F. Related Policies/Rules Medical Necessity Determinations Durable Medical Equipment (DME) Modifiers G. Review/Revision HistoryDATE ACTIONDate Issued 08/31/2022 New policy.Date Revised 07/19/2023 07/17/202405/07/202502/11/2025Annual review. Updated formatting to AMA style. Updated references. Approved at Committee.Annual review. Updated prescription validity to 1 year. Added face to face encounter with provider. Updated references. Approved at Committee. Annual review: references updated. Approved at Committee. Periodic review. Added requirement for evaluation with qualified professional and added type of stander to trial, training, and demonstrated safe use in the home. Updated references. Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Capati V, Covert SY, Paleg G. Stander use for an adolescent with cerebral palsy at GMFCS level with hip and knee contractures. Assist Technol . 2020;32(6):335-341. doi:10.1080/10400435.2019.1579268 2. Definitions , OHIO REV . CODE ANN . 4752.01 (20 18 ). 3. Durable Medical Equipment, Prosthesis, Orthoses, and Supplies (DMEPOS): General Provisions , OHIO ADMIN . CODE 5160-10-01 (202 4). 4. Edemekong PF, Bomgaars DL, Sukumaran S, et al . Activities of Daily Li ving. In: StatPearls. Updated May 4, 2025 . 5. Ferrarello F, Deluca G, Pizzi A, et al. Passive standing as an adjunct rehabilitation intervention after stroke: a randomized controlled trial. Arch Physiother . 2015;5(2). doi:10.1186/s40945-015-0002-05 6. Goodwin J, Lecouturier J, Basu A, et al . Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess . 2018;22(50):1-232. doi:10.3310/hta22500 7. Ibitoye MO, Hamzaid NA, Ahmed YK. Effectiveness of FES-supported leg exercise for promotion of paralysed lower limb muscle and bone health a systematic review. Biomed Tech (Berl) . 2023;68(4):329-350. doi:10.1515/bmt-2021-0195 Standing Frames-OH MCD-MM-1331Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 8. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrs M, et al . Standing programs to promote hip flexibility in children with spastic diplegic cerebral pal sy. Pediatr Phys Ther . 2015;27(3):243-249. doi:10.1097/PEP.000000 00 00000150 9. Martinsson C, Himmelmann K. Abducted standing in children with cerebral palsy: effects on hip development after 7 years . Pediatr Phys Ther . 2021;33(2):101-107. doi:10.1097/PEP.0000000000000789 10. Masselink, CE, Detterbeck A, LaBerge NB, et al. RESNA and CTF position on the application of supported standing devices: Current state of the literature. Assist Technol . 2024;37(4):257-274. doi: 10.1080/10400435.2024.2411560 11. Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil . 2012;26(12):1059-1077. doi:10.1177/0269215512443373 12. ODA Provider Certification: Home Medical Equipment and Supplies , OHIO ADMIN . CODE 173-39-02.7 (2022). 13. Paleg G, Livingstone R. Evidence-informed clinical perspectives on postural management for hip health in children and adults with non-ambulant cerebral palsy. J Pediatr Rehabil Med . 2022;15(1):39-48. doi:10.3233/PRM-220002 14. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord . 2015;16:358. doi:10.1186/s12891-015-0813-x 15. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther . 2013;25(3):232-247. doi:10.1097/PEP.0b013e318299d5e7 16. Pedlow K, McDonough S, Lennon S, et al. Assisted standing for Duchenne muscular dystrophy . Cochrane Database Syst Rev . 2019;10(10):CD011550. doi:10.1002/14651858. CS011550.pub2 17. Standing frame : A-0996. MCG . 29th ed ition. Accessed January 7, 2026 . www.careweb.careguidelines.com 18. Synnot A, Chau M, Pitt V, et al . Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev . 2017;11(11):CD008929. doi:10.1002/14651858.CD008929.pub2 Independent med ical review 08/2022Approved by ODM 03/06/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Adaptive Seating for Special Needs-OH MCD-MM-1718 06/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and ap plying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between t he Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectAdaptive Seating for Special Needs B. BackgroundCerebral palsy, developmental delays, Down Syndrome , and other health conditions may compromise an individuals ability to maintain a sitting posture , muscle tone, and movement . Depending on the severity and type of health condition, individuals may require support for the head, trunk, pelvis, and legs limit ing the ability to interact with others, eat, dress, work, and play. In addition, stability and strength for mobility or transfers may be lacking . There are many types of adaptive seating with different support systems. There is not one device that will meet the needs of all users. Some are requested as alternate positioning outside of a wheelchair. Some are used more for lounging. Others provide toimprove participation in functional activity, peer and family interactions and play.Adaptive seating systems (AdSS) may be used by individuals to achieve and hold an upright sitting position, enabling individuals to engage with others and conduct activitiesof daily living. AdSS can be individualized to meet the unique needs of the person with accessories that allow the seats to tilt, adjust seat height, increase posture support, transfers, and grant limited mobility in the local environment.C. Definitions Adaptive Desks Generally considered furniture and used to support physical and educational needs in a school setting. Adaptive Seating Systems (AdSSs) Equipment designed to improve safety, efficiency of movement , and optimize positioning while promoting active participation in daily activities . There are 2 types o Activity Chairs Seats that o ptimiz e positioning (eg, adaptive chairs, special needs chairs, pediatric positioning chairs, sitters, and therapy chairs ). o High-Low Chairs Height adjustable seats that secure the individual at the midline with adjustable trunk support, shoulder straps, and hip belts. Adaptive Strollers Strollers with increased seating and positioning options than a basic stroller . D. PolicyI. Adaptive Seating Systems (AdSS) and Accessories A. Adaptive Seating Systems CareSource considers AdSS medically necessary when ALL the following medical and clinical criteria are met: 1. A prescription valid for 1 year is written by any of the following providers with an established relationship with the member and appropriate certifications or training after documenting a completed face-to-face encounter: a. physician Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 b. advanced practice registered nurse c. physician assistant 2. member cannot safely sit in conventional seating due to a medical condition, modifications to the members current seating equipment cannot meet their needs, and at least 1 of the following medical criteria must be met : a. significant head and/or trunk instability or weakness with decreased motor control b. requires external support to maintain an upright position and proper body alignment due to medical condition c. has no functional protective or righting reaction d. must be in an upright supported position for safe and effective feeding and would otherwise have to be held by the caregiver for feeding e. severe seizure activity f. orthopedic condition resulting in significant bony fragility or significant fracture 3. A physical therap ist (PT) or occupational therapist (OT) experienced in an appropriate specialty and independent from the equipment vendor completed an evaluation and documented that the member can benefit from and safely use the item requested. a. A trial of the equipment must be completed to ensure member can safely use the requested seat and the goals of the seat can be achieved. b. Caregiver education on the use of the equipment must be completed with demonstrated safe use. c. Improvement of function due to the equipment must be documented. d. Other equipment used by the member needs to be listed as part of the evaluation (ie, wheelchairs, standers, gait trainers, other seating ). 4. Any person-centered service plans for the member, when applicable, must list use of AdSS. 5. A complete description of the item requested, including a. manufacturer b. model of style c. size d. all bundled components e. any accessories or not-included components f. any itemization of all charges B. Accessories 1. Accessories are considered medically necessary when providing additional functional support than that offered by a chair alone and any of the following criteria are met : a. cannot maintain head control in an upright position b. unable to perform a functional weight shift requiring relief to prevent pressure injuries c. needs additional trunk support that is not provided by the chair alone d. changes in muscle tone affecting body tilt or needs additional support for proper digestion or avoidance of severe gastroesophageal reflux Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 e. needed for independent movement in and out of the chair or repositioning the chair to complete daily activitiesII. Exclusions and LimitationsA. AdSS does not include ANY of the following: 1. adaptive desks (except for members under 21 will be reviewed on a case by case basis for EPSDT) 2. any items not meeting the medical necessity criteria in this policy B. Duplicative equipment is excluded. Equipment with the same function as an existing AdSS will not be reviewed for medical necessity. C. AdSS must be the lowest cost alternative that addresses the members health condition. D. AdSS is for the benefit of the member and not for any caregiver, family member, or provider convenience. E. Conditions of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 01/15 /202 5 New policy. Approved at Committee.Date Revised 01 /28 /202 6 Annual review. Update d background, D.I.A.3. II, exclusions and references. Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Angsupaisal M, Maathuis CGB, Hadders-Algra M. Adaptive seating systems in children with severe cerebral palsy across International Classification of Functioning, Disability, and Health for children and youth version domains: a systematic review. Dev Med Child Neurol . 2015;57(10):919-930. doi:10.1111/dmcn.12762 2. Barkoudah E, Whitaker A. Cerebral palsy: treatment of spasticity, dystonia, and associated orthopedic issues. UpToDate. Updated July 15, 2025 . Accessed January 14 , 202 6. www.uptodate.com 3. Hale LW, Martin C. Autism spectrum disorder in children and adolescents: behavioral and educational interventions. UpToDate. Updated June 19, 2025 . Accessed January 14 , 202 6. www.uptodate.com 4. Inthachom R, Prasertsukdee S, Ryan SE, et al. Evaluation of the multidimensional effects of adaptive seating interventions for young children with non-ambulatory cerebral palsy. Disabil Rehabil Assist Technol . 2021;16(7):780-788. doi:10.1080/17483107.2020.1731613 Adaptive Seating for Special Needs-OH MCD-MM-1718Effective Dat e: 06/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 5. Khan I, Leventhal BL. Developmental Delay . StatPearls Publishing; 2023. AccessedJanuary 14 , 202 6. www.ncbi.nlm.nih.gov 6. Lyman J. Complex rehabilitation fact sheet. Cerebral Palsy Foundation. Accessed January 14 , 202 6. cpresource.org 7. Paleg G, Livingstone R, Rodby-Bousquet E, et al. Care Pathways central hypotonia. American Academy of Cerebral Palsy and Developmental Medicine. Accessed January 14 , 202 6. www.aacpdm.org 8. Provider recommendations for FY 2024 budget medical care advisory committee meeting June 2022. National Council for Assistive & Rehab Technology. Accessed January 14 , 202 6. www.ncart.us 9. Ryan SE. Lessons learned from studying the functional impact of adaptive seating interventions for children with cerebral palsy. Dev Med Child Neurol . 2016;58 (Suppl 4):78-82. doi:10.1111/dmcn.13046 10. Saihinoglu D, Coskun G, Bek N. Effects of different seating equipment on postural control and upper extremity function in children with cerebral palsy. Prosthet Orthot Int . 2017;41(1):85-94. doi:10.1177/0309364616637490 Independent medical review December 2024ODM approved 03 /06 /202 6
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333 06/01/2026 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.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Summary of Evidence ………………………….. ………………………….. ………………………….. ……… 2 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 I. References ………………………….. ………………………….. ………………………….. ……………………. 3 Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 06/01/20262A. SubjectPeripheral Nerve Stimulators for Treatment of Pain B. BackgroundThe role of targeting and treating peripheral nerves as sources of pain when conservative therapy has failed is being more extensively explored than in previous years. Neuromodulation of peripheral nerves to treat refractory pain is one such area of interest. The neuromodulation of peripheral nerves to reduce pain is commonly known as peripheral nerve stimulation (PNS), peripheral nerve field stimulation (PNFS), and percutaneous-eletrical nerve field stimulation (PENFS). It has been developed as a minimally invasive pain management modality intended to manage acute and chronic pain. The proposed mechanism of action, referred to as the gate control theory, involves a method by which stimulation of large-diameter sensory neurons reduces transmission ofpainful stimuli from small nociceptive fibers to the brain. The stimulation system is placed adjacent to the nerve, a process commonly known as remote selective targeting. The lead is connected to a small, wearable stimulator. Depending on the device, the wearer may be able to adjust the level of stimulation using Bluetooth technology. C. DefinitionsAcute Pain Pain lasting 4 weeks or less. Chronic Pain A distressing feeling often caused by intense or damaging stimuli (pain) lasting more than 3 months, which is considered beyond normal healing time. Sub-Acute Pain Pain lasting between 4 and 12 weeks. D. PolicyI. Peripheral nerve stimulat ion for pain management is considered experimental and investigational due to limited evidence published in peer-reviewed medical literature to support its long-term safety and efficacy . Examples of PNS devices include, but are not limited to: A. IB-Stim (NeurAxis) B. Moventis PNS C. Nalu Neurostimulation System D. Nerivio E. SPRINT PNS System F. StimQ PNS System G. StimRouter Neuromodulation System E. Summary of EvidenceWest et al. (2024) published the findings of a 2-year multicenter ana lysis of 126 patients to aid in determining the long-term effectiveness of PNS and if there was an impact to opioid consumption with PNS treatment. The study found no changes in opioid consumption after 24 months and due to the substantial loss to follow-up, the long-term effectiveness of PNS could not be determined. Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 06/01/20263Chogle et al. (2024) conducted a multicenter, prospective open-label study for children ages 8-18 who underwent PENFS. 371 participants were enrolled and 292 had sufficient data on at least one of the three outcome surveys. Outcomes were assessed at baseline , weekly until the last visit, and follow-up time points. After 3 weeks, there was significant loss of participation (76/290) , which inc reased through the 12-month follow-up period (12/290). The study concluded that the significant loss of participation in extended follow-up made it difficult to understand the long-term suitability of PENFS. Goree et al . (2024) conducted a multicenter, rando mized, double-blind, placebo-controlled trial for treating chronic, persistent postoperative pain after total knee arthroplasty for end-stage knee osteoarthritis with percutaneous peripheral nerve stimulation . PNS provides great pain relief and reduced opioid use within the first two weeks after surgery and this study aimed to determine if pain management could continue for persistent, chronic pain. 29 p atients underwent treatment with the device for 8 weeks and continued follow up at 3, 6, 9, and 12 months. 27 patients underwent placebo treatment with follow up at the same intervals. A greater propor tion of patients in the PNS group versus the placebo group had 50% reduction in pain relief through weeks 5-8. Pro spective follow-up is on going to determine long term results. F. Conditions of CoverageN/A G. Related Policies/RulesMedical Necessity Determinations Experimental and /or Investigational Item or Service H. Review/Revision HistoryDATE ACTIONDate Issued 10/01/2022Date Revised 07/29/2022 02/15/202301/17/202406/05/2024 05/07/2025 01/28/2025 Converted from administrative policy (AD-1201) to medical policy. Annual review. Updated definitions. Annual review : references updated ; approved at Committee. Revised Background, added D. III. A. Approved at Committee Annual review-references updated, approved at Committee. Annual review, added Nerivio to D. III. Section E., Summary of Evidence, added. Approved at Committee Date Effective 06/01/2026 Date Archived I. References1. Abd-Elsayed A, Keith MK, Cao NN, Fiala KJ, Martens JM. Temporary peripheral nerve stimulation as treatment for chronic pain. Pain Ther . 2023;12(6):1415-1426. doi:10.1007/s40122-023-00557-3 Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 06/01/202642. Albright-Trainer B, Phan T, Trainer RJ, et al. Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial. Pain Manage . 2022;12(3):357-369. doi:10.2217/pmt-2021-0087 3. Char S, Jin MY, Francio VT, et al. Implantable peripheral nerve stimulation for peripheral neuropathic pain: a systematic review of prospective studies. Biomed . 2022;10(10)2606. doi:10.3390/biomedicines10102606 4. Chogle A, El-Chammas K, Santucci N, et al. A multicenter registry study on percutaneous electrical nerve field stimulation for pediatric disorders of gut-brain. J Pediatr Gastroenterol Nutr . 2024;78(4):817-826. doi:10.1002/jpn3.12174 5. DSouza RS, Jin MY, Abd-Elsayed A. Peripheral nerve stimulation for low back pain: a systematic review. Curr Pain Headache Rep . 2023;27:117-128. doi:10.1007/s11916-023-01109-2 6. Dorfman L, El-Chammas K, Graham K, et al. Repeat round of auricular percutaneous electrical nerve field stimulation for pediatric disorders of gut brain interaction. JPediatr Gastroenterol Nutr . 2025;(81)(2):234-245. doi:10.1002/jpn3.70109 7. Evidence Analysis Research Brief: Peripheral Nerve Stimulation for the Treatment of Superior Cluneal Neuralgia. Hayes; 2024. Accessed January 21, 2026 . www.evidence.hayesinc.com 8. Evolving Evidence Review: IB-Stim (NeurAxis) for Treatment of Pain Associated with Irritable Bowel Syndrome in Adolescents. Hayes; 2022. Reviewed July 28, 2025 . Accessed January 21, 2026 . www.evidence.hayesinc.com 9. Evolving Evidence Review: Nerivio (Theranica Bio-Electronics LTD.) for Treatment of Acute Migraine Episodes in Adults. Hayes ; 2025. Accessed December 10, 2025. www.evidence.hayesinc.com 10. Evolving Evidence Review: SPRINT PNS System (SPR Therapeutics) for Chronic Pain. Hayes; 2021. Updated February 27, 2025 . Accessed January 21, 2026 . www.evidence.hayesinc.com 11. Goree JH, Grant SA, Dickerson DM, et al. Randomized placebo-controlled trial of 60 – day percutaneous peripheral nerve stimulation treatment indicates re lief of persistent postoperative pain and improved function after knee replacement. Neuromodulation . 2024; 27:847-861. doi:10.1016/j.neurom.2024.03.001 12. Hatheway J, Hersel A, Song J, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial. Reg Anesth Pain Med . 2024;0:1-7. doi:10.1136/rapm-2023-105264 13. Health Technology Assessment: Percutaneous Peripheral Nerve Stimulation for Treatment of Chronic Pain. Hayes; 2022. Reviewed May 30 , 202 5. Accessed January 21, 2026 . www.evidence.hayesinc.com 14. Health Technology Assessment: Peripheral Nerve Field Stimulation for Treatment of Chronic Low Back Pain. Hayes; 2021. Reviewed April 17, 2024. Accessed January 21, 2026 . www.evidence.hayesinc.com 15. Helm S, Shirsat N, Calodney A, et al. Peripheral nerve stimulation for chronic pain: a systematic review of effectiveness and safety. Pain Ther . 2021;10(2):985-1002. doi:10.1007/s40122-021-00306-4 16. Huntoon MA, Slavin KV, Hagedorn JM, et al. A retrospective review of real-world outcomes following 60-day peripheral nerve stimulation for the treatment of chronic Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 06/01/20265pain. Pain Physician . 2023;26(3):273-281. Accessed January 21, 2026 .www.painphysicianjournal.com 17. Kaye AD, Ridgell S, Alpaugh ES, et al. Peripheral nerve stimulation: a review of techniques and clinical efficacy. Pain Ther . 2021;10(2):961-972. doi:10.1007/s40122 – 021-00298-1 18. Li AH, Gulati A, Leong MS, et al. Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain. an international cross-sectional survey of implanters. Pain Pract . 2022;22(5):508-515. doi:10.1111/papr.13105 19. Luna D, Hettie G, Pirrotta L, et al. Real-world long-term outcomes of peripheral nerve stimulation: a prospective observational study. Pain Manag . 2025 ;15(1):37-44. doi:10.1080/17581869.2025.2451605 20. McCullough M, Kenney D, Curtin C, et al. Peripheral nerve stimulation for saphenous neuralgia. Reg Anesth Pain Med . 2024;49(6):455-460. doi:10.1136/rapm-2023 – 104538 21. Smith BJ, Twohey EE, Dean KP, DSouza RS. Peripheral nerve stimulation for the treatment of postamputation pain: a systematic review. Am JPhys Med Rehabil . 2023;102(9):846-854. doi:10.1097/PHM.0000000000002237 22. Strand N, DSouza RS, Hagedorn JM. Evidence-based clinical guidelines from the American Society of Pain and Neuroscience for the use of implantable peripheral nerve stimulation in the treatment of chronic pain. JPain Res . 2022;15:2483-2504. doi:10.2147/JPR.S362204 23. Vangeison CT, Bintrim DJ, Saha AK, et al. The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Pain Manag . 2023;13(4):213 – 218. doi:10.2217/pmt-2023-0025 24. West T, Hussain N, Bhatia A, et al. Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis. Reg Anesth Pain Med . 2024. doi:10.1136/rapm-2024-105704 25. Xu J, Sun Z, Wu J, et al. Peripheral nerve stimulation in pain management: a systematic review. Pain Physician . 2021;24(2):E131-E152. Accessed January 21, 2026 . www.painphysicianjournal.com Approved by ODM on 02/25/2026
MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Metabolic, Bariatric and Revision Surgery-OH MCD-MM-1061 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. Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 4 Metabolic, Bariatric and Revision Surgery-OH MCD-MM-1061Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMetabolic, Bariatric and Revision Surgery B. Background Obesity continues to be a major health threat in the United States affecting an increasingly larger proportion of adults and children. The Centers for Disease Control and Prevention (CDC) estimates that over 40.3% of adults in the United States older than the age of 20 are obese (2021-2023). Obesity in adults aged 40 to 59 is higher (46.4%) than those under aged 40 (35.5%). The primary goals in achieving optimal health outcomes for CareSource members are to provide noninvasive approaches to reduce or prevent obesity by promoting healthy life-styles that will improve long-term outcomes. For individuals not able to manage serve obesity though non-surgical interventions, metabolic and bariatric surgery options may be an effective intervention. Revision procedures are typically done because of complications from or a failure of the initial surgical procedure. Complications may include surgical or anatomical complications, as well as nutritional or metabolic complications. A failure of the initial bariatric surgery may result in an inadequate weight loss or a weight regain. C. Definitions Revisional Bariatric Surgery (RBS) surgery to address those patients whose original operation was unsuccessful in achieving satisfactory weight loss goals, or in whom complications from the original operation have occurred. Inadequate Weight Loss Less than 50% expected weight loss and/or weight remains greater than 40% over ideal body weight (normal body weight BMI parameter = 18.5-24.9). D. Policy I. CareSource reviews medical necessity for the initial bariatric surgery using MCG criteria. II. CareSource considers surgical revision of a bariatric surgery procedure a covered service when medically necessary. III. Inadequate weight loss due only to non-compliance with dietary, behavior, or exercise recommendations is not a medically necessary indication for a revision procedure. III. A revision procedure is medically necessary when all of the following criteria are met and documented in the medical record: A. surgery/procedure selected is a proven procedure and not considered experimental/investigational and Metabolic, Bariatric and Revision Surgery-OH MCD-MM-1061Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 B. a technical failure or major complication has occurred from the initial procedure that cannot be managed medically. Technical failure and major complication examples include the following: 1. persistent pain and recurrent bleeding occur 2. chronic stenosis remains after multiple dilations 3. faulty component or malfunction that cannot be repaired 4. candy cane roux syndrome 5. complications that cannot be corrected with band manipulation, adjustments or replacement including band slippage and port leakage or a. obstruction confirmed by imaging studies. NOTE: Stretching of a stomach pouch formed by a previous bariatric surgery due to overeating is not considered a complication and therefore is not considered an indication for revision . IV. In the absence of a technical failure or major complication, individuals with weight loss failure 2 years following the initial bariatric surgery procedure must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. V. CareSource does not consider endoscopic bariatric and metabolic therapies such as Intragastric balloon (IGB) , endoscopic sleeve gastroplasty (ESG), or aspiration therapy (AT) to be weight loss surgery. Individuals with weight loss failure from prior endoscopic therapies must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. E. Conditions of CoverageN/A F. Related Policies/Rules Medical Necessity Determinations Experimental and Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/22/2020 New policy Separated out from adolescent and adult policiesDate Revised 06/23/2021 06/22/202206/21/2023PA language replaced by medical necessity criteria. PA enforced by inclusion on the PA list. Updated references. Re-wording of section IV re: medical necessity for revision bariatric surgery. Sec. V. Added IGB, ESG and AT non-coverage. Updated references. Annual review; no changes, Updated references, Approved at committee. Metabolic, Bariatric and Revision Surgery-OH MCD-MM-1061Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 06/19/202402/26/202502/25/2026Added definition of Revisional bariatric surgery (RBS). Updated references. Approved at Committee. Updated references. Approved at Committee. Changed title. Added extra background and section I regarding initial procedure medical necessity criteria. Updated references. Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Chen S, Chiang J, Ghanem O, et al. Decision-making Considerations in Revisional Bariatric Surgery. Surg Laparosc Endosc Percutan Tech. 2024;34(4):400-406. doi:10.1097/SLE.0000000000001296 2. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federal for the Surgery of Obesity and Metabolic Disorders (IFSO): indications for metabolic and bariatric surgery. Surg Obes Relat Dis. 2022;18(12):1345-1356. Accessed January 14, 2026. www.soard.org 3. Ellsmere J. Bariatric operations: late complications with subacute presentations. Updated July 18, 2023. Accessed January 17, 2026. www.uptodate.com 4. Evolving Evidence Review. Apollo ESG System (Apollo Endosurgery Inc.) for Endoscopic Sleeve Gastroplasty. September 11, 2024. Accessed January16, 2026. www.hayesinc.com. 5. Federal Drug Administration. Updated Sept. 15, 2023. Weight-Loss and Weight- Management Devices. Accessed January 16, 2026. www.fda.gov 6. Gastric Restrictive Procedure with Gastric Bypass (S-512). MCG. 29th ed. 2025. Accessed January 14, 2026. www.careweb.careguidelines.com 7. Intragastric Balloons for Treatment of Obesity. Hayes Technology Review Mar 16, 2022. Accessed January 14, 2026. www.hayesinc.com 8. Mechanick J, Apovian C, Brethauer S, et al. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures 2019 update: cosponsored by American Association of Clinical Endocrinologist/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Obesity. 2020;28(4):683-839. doi:10.1002/oby.22719 9. Mirkin K, Alli VV, Rogers AM. Revisional Bariatric Surgery. Surg Clin North Am. 2021;101(2):213-222. doi:10.1016/j.suc.2020.12.008 10. Salas-Parra RD, Smolkin C, Choksi S, Pryor AD. Bariatric Surgery: Current Trends and Newer Surgeries. Gastrointest Endosc Clin NAm. 2024;34(4):609-626. doi:10.1016/j.giec.2024.06.005 11. Yung-Chieh, Y, Huang, C, Tai, C. Psychiatric aspects of bariatric surgery. Current Opinion in Psychiatry. 2014;27(5):374-379. doi:10.1097/YCO.0000000000000085. Independent medical review 7/2020 Metabolic, Bariatric and Revision Surgery-OH MCD-MM-1061 Effective Date: 06/01/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 Approved by ODM 03/03/202 6
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