MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Tumor Treatment Field Devices for Glioblastoma Multiforme – OH MCD-MM-1224 03/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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 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 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 ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Tumor Treatment Field Devices for Glioblastoma Multiform e (GBM) B. Background Glioblastoma m ultiforme is the most common central nervous system malignancy of the brain in adults with an average onset age between 55 to 60 years. The incidence rate between 2010 and 2014 was 29.2 per 100,000 in adults , and 5.81 per 100,000 in children. Management of the disease follows a combined-modality approach, including adjuvant postoperative radiation therapy and adjuvant chemotherapy following initial sur gery. Surgery remains the mainstay of treatment in order to remove as much tumor as possible whi le preserving surrounding brain tissue required for normal brain function. Despite tumor debulking measures, glioblastoma tumors infiltrate surrounding tissues creating little success for removal of the entire tumor (AANS, 2020). Glioblastoma has a high rate of recurrence and poor overall survival rate even with optimum therapy treatment s. Most patients live 1-2 years after initial diagnosis. Tumor treating field devices (TTF) are a novel method of cancer treatment involving emitting alternating electric fields to disrupt the rapid cell divi sion exhibited by cancer cells. This treatment first became available in 2011 to treat recurrent glioblastoma. TTF is considered safe with no systemic toxicity observed and only mild to moderate side effects (reported in 1-2% of patients) involving the skin beneath transducer arrays . Patients are required to wear the device at least 18 hours a day for effectiveness and minimum treatment duration is 4 weeks. Randomized clinical trial results suggest the device improves overall survival when combined with monthly temozolomide in patients with newly diagnosed glioblastoma in the post radiation setting. C. Definitions Glioblastoma Multiforme (GBM) A lso referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue, but generally does not spread to distant organs. Medically Necessary Services which are necessary for the diagnosis or treatment of disease, illness, and injury, and meet accepted guidelines of medical practice. A medically necessary service must be related to the illness or injury for which it is performed regarding type, intensity, and duration of service and setting of treatment. Tumor Treatment Fields (TTF) Mild electrical fields that vibrate through the skin of the scalp and disturb cancer cells ability to divide, possibly slowing tumor growth and spread. Kar nofsky Performance Status (KPS) An index that classifies the functional impairment of patients. . This can be used to compare the effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3Response Assessment in Neuro-Oncology (RANO) A working group established to improve the assessment of tumor response and selection of end points, specifically in the context of clinical trials . D. Policy I. Tumor treatment field devices for glioblastoma multiforme are considered medically necessary when ALL of the following criteria have been met: A. The member has a new diagnosis of GBM ( grade IV astrocytoma). B. The member is age 22 years or older . C. The member has received initial treatment with surgery when reasonable. D. TTF therapy is initiated within 7 weeks from the last dose of chemotherapy or radiotherapy . E. The member has a Karnofsky Performance Scale (KPS) index of at least 6 0. F. TTF treatment will be used for an average of 18 hours per day. II. Continued coverage (beyond first 3 months of therapy) for newly diagnosed GBM and documentation of clinical benefit demonstrates ALL of the following: A. in-person clinical re-evaluation by treating practitioner B. obj ective evidence of adherence to therapy, reviewed by treating practitioner C. m aintain KPS of at least 60 D. if KPS is unavailable, then no evidence of progression by Response Assessment in Neuro-Oncology (RANO) criteria III. The following is a list of contraindications for TTF treatment (not all inclusive): A. cardiac pacemaker or implantable defibrillator B. deep brain, spinal cord, or vagus nerve stimulator C. major skull defect (eg, missing section of calvarium) D. metal within brain (eg, aneurysm clip, bullet fragment) E. programmable ventriculoperitoneal shunt F. pregnancy G. known sensitivity to conductive hydrogels (eg, gels used on electrocardiogram ) H. ECG stickers or transcutaneous electrical nerve stimulation (TENS) electrodes IV. CareSource considers TTF therapy for GBM only. Treatment of any other tumors is not medically necessary and experimental/investigational. V. The use of enhanced treatment planning software (Novotal) is non-covered because CareSource considers it to be e xperimental/investigational for ALL indications. E. Conditions of Coverage N/A F. Related Polic ies/Rules N/A Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.4G. Review/Revision HistoryDATE ACTIONDate Issued 09/29/2021 New Policy.Date Revised 07/06/2022 11/8/ /2023 11/06/2024 Updated references. No changes. Archived Jan.202 3. Added Section II (Continued coverage) . Approved at Committee. Removed PA language from policy. Updated references. Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. Alternating Electric Field Therapy ACG: A-0930 (AC). 2024 . Accessed October 22, 2024 . www.careweb. careguidelines.com 2. Batchelor T. Initial treatment and prognosis of IDH-wildtype glioblastoma in adults. UpToDate. Updated August 7, 2024. Accessed October 22, 2024 . www.uptodate.com 3. Burri SH, Gondi V, Brown PD, Mehta MP. The evolving role of tumor treating fields in managing glioblastoma: guide for oncologists. Am JClin Oncol . 2018;41(2):191-196. doi:10.1097/COC.0000000000000395 4. Chukwueke UN, Wen PY. Use of the Response Assessment in Neuro-Oncology (RANO) criteria in clinical trials and clinical practice. CNS Oncol. 2019;8(1):CNS28. doi:10.2217/cns-2018-0007 5. Fernandes C, Costa A, Osrio L, et al. Current standards of care in glioblastoma therapy . In: De Vleeschouwer S, ed. Glioblastoma. Codon Publications; 2 017. Accessed October 22, 2024. www.ncbi.nih.gov 6. Glioblastoma multiforme. American Association of Neurological Surgeons . Accessed October 22, 2024 . www.aans.org 7. Health Technology Assessment: Tumor Treatment Fields (Optune) for Treatment of Glioblastoma. Hayes; 2019. Reviewed January 5, 2023. Accessed October 22, 2024 . www.hayesinc.com 8. Kanderi T, Gupta V. Glioblastoma Multiforme. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2022. Accessed October 22, 2024 . 9. Karnofsky Performance Status Scale definitions rating criteria. National Palliative Care Research Center . Accessed October 22, 2024. www.npcrc.org 10. OPTUNE (NovoTTF-100A System) Patient Information and Operation Manual . Food and Drug Administration. Document QSD-QR-33 Accessed October 22, 2024 . www.accessdata.fda.gov 11. Wen PY, Chang SM, Van den Bent MJ, et al Response assessment in neuro- oncology clinical trials. JClin Oncol. 2017;35(21):2439-2449. doi:10.1200/JCO.2017.72.7511 ODM Approved 11/21/2024 Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.5I nde pendent med ica l r e view November 2020
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Transcervical Radiofrequency Ablation-OH MCD-MM-1563 03/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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 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 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 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 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 …………………………………………………………………………………………………………. 3Transcervical Radiofrequency Ablation-OH MCD-MM-1563 Effective Date: 03/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Transcervical Radiofrequency Ablation B. Background Uterine leiomyomas (fibroids) are the most common solid benign tumors of the uterus, estimated to occur in up to 70% of women by menopause. Uterine fibroids are associated with heavy menstrual bleeding, dysmenorrhea, pelvic pain, quality of life , and difficulty in achieving pregnancy. The combined effect of the direct costs attributable to fibroid diagnosis and treatment, plus the indirect costs due to work absenteeism and loss of productivity, are responsible for a significant economic burden of $34 billion annually in the United States. Hysterectomy and myomectomy are the most commonly performed surgical i nterventions for the treatment of uterine fibroids. Hysterectomy involves removal of the uterus (and generally, the cervix), with or without ovarian conservation. Myomectomy is an operation in which individual fibroids are removed, retaining the uterus and the potential for pregnancy. In recent years, leiomyoma ablation techniques have emerged as less invasive alternatives. Transcervical uterine ablation of leiomyomas combines reusable intrauterine ultrasound with a single-use intrauterine radiofrequency ablation (RFA) handpiece and needle electrode to facilitate targeted thermal ablation of symptomatic uterine leiomyomas. This creates coagulative necrosis within the treated leiomyoma. The Sonata system (Gynesonics Inc.) is a minimally invasive, uterine-sparing, ultrasound-guided system for performing transcervical RFA of fibroids in the outpatient setting. It integrates intrauterine ultrasound imaging with a radiofrequency treatment device to provide a uterus-conserving, transcervical incisionless treatment for a range of leiomyoma types and sizes. Sonata has received clearance by the FDA and has CE marking for use in the European Union. C. Definitions Leiomyomas also called uterine fibroids , are an extremely common benign neoplasm in women of reproductive age. They are composed of smooth muscle cells and fibroblasts. Myomectomy a surgical procedure to remove uterine fibroids while preserving the uterus . Radiofrequency Ablation a minimally invasive technique that shrinks the size of tumors by using heat to destroy tissue. Transcervical Radiofrequency Ablation-OH MCD-MM-1563 Effective Date: 03/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3D. Policy I. Transcervical ultrasound guided radiofrequency ablation (Sonata) is considered medically necessary as an alternative to myomectomy or hysterectomy for treating symptomatic uterine fibroid(s) when all the following criteria are met: A. u terine preservation is desired B. f ibroid(s) C. u terine size
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Safety Beds-OH MCD-MM-1457 03/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. …………….. 2 B. Background ………………………….. ………………………….. ………………………….. ………………………….. ……… 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………….. ………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. ……………….. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ………………… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …………………. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ………………. 3 H. References ………………………….. ………………………….. ………………………….. ………………………….. ………. 3 Safety Beds-OH MCD-MM-1457 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectSafety Beds B. BackgroundHealthy sleep requires adequate duration, appropriate timing, good quality, regularity, and the absence of sleep disturbances. The American Academy of Sleep Medicine has issued recommendations for sleep needs by age. An individuals bedtime environment is an important consideration, with factors such as the bed and mattress affecting the quality and duration of sleep. A safety bed is an enclosed bed, typically fitted with a mesh canopy, padded walls,and/or a specially designed mattress. A safety bed may be necessary to ensure the safety of an individual with a variety of medical or behavioral health diagnoses , such as epilepsy, intracranial injury, hydrocephalus , intellectual d isabilities , and autistic spectrum disorder . The use of these beds increase s patient safety by eliminating falls and preventing injuries and wandering . In addition, safety beds might assist with treatments for other symptoms, such as aggression, impulsivity, noncompliance, or elopement behaviors. Ongoing individual evaluation and monitoring is recommended for appropriate use and prescribing. C. Definitions Crib Canopy A cover that attaches to the top of a crib that prevent s a toddler from climbing out of the crib or, i n some cases, pets from climbing into the crib. Hospital Bed A bed that can be adjusted to raise the head end, foot end, or middle , as required . The overall bed height is also adjustable. Safety Bed A bed to prevent individuals from leaving the bed at night without supervision , preventing injuries, falls, and wandering , and can be called i nstitutional, adaptive, enclosure bed, enclosed bed system , net bed, or special needs beds . Standard Bed A fixed height bed that is typically sold as furniture and consists of a frame, box spring, and mattress. D. PolicyI. CareSource considers a safety bed medically necessary when ALL the following criteria are met: A. Member has a behavioral health or medical diagnosis that may lead to safety concerns . B. A safety bed is required to prevent the member from leaving the bed at night without a supervis or. C. There should be r egular, periodic , and face-to-face (in-person) monitoring while the member is in the safety bed. D. The safety bed is not used as a restraint . E. The safety bed is the lowest cost alternative that addresses the members health condition. F. Documentation submitted to CareSource for review must show that the member meets the above criteria, and : Safety Beds-OH MCD-MM-1457 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.1. Bed alarms, door alarms, and standard rail padding failed to meet the medical needs of the member. 2. The safety bed is for the benefit of the member and not for any caregiver, family member, or provider. 3. The physician order for the safety bed is included. 4. The person-centered service pla n includes the use of a safety bed . 5. The invoice for the safety bed is retained and submitted along with the prior authorization and reimbursement requests . II. For members with specific medical needs, such as special positioning or IV poles, refer to Ohio Administrative Code 5160-10-18 for hospital beds, bed accessories,and pressure-reducing support surfaces. E. Conditions of CoverageN/A F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at Committee.Date Revised 11/08/2023 11/0 6/2024Annual review. Coverage language refined. Approved at Committee. Annua l review: updated background and added documentation requirements . Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. Caggiari G, Talesa GR, Toro G, et al. What type of mattress should be chosen to avoid back pain and improve sleep quality? Review of the literature. JOrthop Traumatol . 2021;22(1):51. doi:10.1186/s10195-021-00616-5 2. DeGeorge KC, Neltner CE, Neltner BT. Prevention of unintentional childhood injury. Am Fam Physician . 2020;102(7):411-417. Accessed October 25, 2024. www.aafp.org 3. DMEPOS: hospital beds, bed accessories, and pressure-reducing support surfaces , OHIO ADMIN . CODE 5160-10-18 (2018). 4. Paruthi S, Brooks LJ, DAmbrosio C, et al. Recommended amount of sleep for pediatric populations: a consensus statement of the American Academy of Sleep Medicine. JClin Sleep Med . 2016; 2(6) :785-786. doi:10.5664/jcsm.5866 5. Services and Supplies Never Covered , OHIO ADMIN . CODE 4123-6-07 (2021). 6. Sherburne E, Snethen JA, Kelber S. Safety profile of children in an enclosure bed. Clin Nurse Spec . 2017;31(1):36-44. doi:10.1097/NUR.0000000000000261 Independent med ical review 2/15/2023Safety Beds-OH MCD-MM-1457 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.Approved ODM 11/21/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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 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 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 ContentsA. 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 …………………………………………………………………………………………………………. 3 Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Myoelectric Upper Extremity Orthosis B. Background Experimental or Investigational items or services are not covered. An upper limb myoelectric orthosis is a robotic assisted brace. It is proposed that the device self-initiates movement using the members own muscle signals. Upper limb myoelectric orthoses are considered experimental and investigational due to insufficient evidence of efficacy. These devices should not be confused with prosthetic devices, which are intended to replace or compensate for a missing limb or other body part. The intent of this policy is to address requests that require medical necessity review in accordance with OAC 5160-1-01 . C. Definitions Experimental or Investigational Items or Services Medical, surgical, diagnostic, psychiatric, substance use disorders treatment or other health care services, technologies, equipment, supplies, treatments, procedures, therapies, biologics, drugs, or devices (each a Health Care Item or Service) that, at the time CareSource has made a determination regarding coverage in a particular case, are: o Not approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use o Not identified in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use, or o Determined by the FDA to be contraindicated for the specific use o Subject to review and approval by any institutional review board or other body serving a similar function for the proposed use, and such final approval has not been granted o The subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight o Provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service , or supply o Provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply as experimental or investigational, or otherwise indicate that the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation NOTE: Devices that are FDA approved under the Humanitarian Use Device exemption are not considered to be experimental or investigational. Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3Orthosis A brace, sling, or splint often made from thermoplastics, casting, and metal. Upper Limb Myoelectric Orthosis Device that combines a standard upper limb orthotic device with microprocessors, muscle sensor, and an electric motor of a myoelectric device. D. Policy I. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. The use of myoelectric upper extremity orthotic devices is considered investigational and not medically necessary for all indications including, but not limited to, restoration of function to arms and hands paralyzed or weakened by cerebrovascular accident , brachial plexus injury, cerebral palsy, or any other neurological or neuromuscular disease or injury. III. Myoelectric upper limb and hand orthotic devices are not covered. This includes, but is not limited to, the following: A. MyoPro B. MyoPro 2 E. Conditions of Coverage NA F. Related Policies/Rules Experimental, Investigational and Other Non-Covered Service G. Review/Revision History DATES ACTIONDate Issued 10/25/2023 New Policy . Approved at Committee.Date Revised 10/23/2024 Updated references. Approved at Committ ee Date Effective 02/01/2025 Date Archived H. References1. Evolving Evidence Review: MyoPro Orthosis (Myomo Inc.) for Upper Extremity Paralysis/Paresis After Stroke. Hayes; 2023. Accessed September 30, 2024. www.hayesinc.com 2. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . CODE 5160-1-01 (2022). Accessed September 30, 2024. www.codes.ohio.gov Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.43. Medicare coverage of items and services in category a and b investigational device exemption (IDE) s tudies. US Centers for Medicare and Medicaid Services. January 1, 2015. MLN Matters MM8921. Accessed September 30, 2024. www.cms.gov 4. Premarket Notification 510(k) Summary K062631. US Food and Drug Administration. April 12, 2007. Accessed September 30, 2024. www.fda.gov 5. Jensen EF, Raunsbk J, Lund JN, et al . Development and simulation of a passive upper extremity orthosis for amyoplasia. JRehabil Assist Technol Eng. 2018;5. doi:10.1177/2055668318761525 6. Pundik S, McCabe J, Kesner S, et al . Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. JRehabil Assist Technol Eng. 2020;7: 1-11. doi:10.1177/2055668320921067 ODM Approved 11/ 14/202 4
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