MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Transcervical Radiofrequency Ablation-OH MCD-MM-1563 02/01/2026 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 ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Transcervical Radiofrequency Ablation-OH MCD-MM-1563Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTranscervical 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 interventions 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 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. D. PolicyI. 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: Transcervical Radiofrequency Ablation-OH MCD-MM-1563Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 A. uterine preservation is desired B. fibroid(s) C. uterine size
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Safety Beds-OH MCD-MM-1457 02/01/2026 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. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Safety Beds-OH MCD-MM-1457 Effective Dat e: 02/01/2026 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 (eg, epilepsy, intracranial injury, hydrocephalus , intellectual d isabilities , autistic spectrum disorder ). The use of these beds increase s patient safety by eliminating falls and preventing injuries and wandering when the patient should be sleeping . Ongoing individ ual 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. Member is not able to safely stay in a regular bed at night and this is creating significant safety risks for the member . C. There should be regular, periodic, and face-to-face (in-person) monitoring while the member is in the safety bed. D. A clinical assessment has been conducted to ensure that less restrictive measures have been tried and are in place . E. The safety bed is to be used for sleep and short naps and not to be used as a restraint , for playtime, for discipline, or as part of a behavior modification program . 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: 02/01/2026 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, standard rail padding , bed rails, bed on the floor,video/audio monitors, removal of safety hazards from the members room (eg, small ingestible items, items that can fall on the child or they can climb and jump off of including unsecured dressers, bookcases, TVs, etc.), child protection devices (eg, locks outside of the reach of the child, alarms, gates, furniture anchors, etc.), treatment plan to help with calming and sleep 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 provider order for the safety bed includes: a. medical necessity for the safety bed b. plan for transitioning away from the safety bed 4. The person-centered service plan is retained and updated. a. Includes a safety bed monitoring plan: 01. defined duration of safety bed use 02. time intervals member will be monitored while inside the safety bed 03. how members personal care needs will be met during safety bed use 04. how medical conditions will be managed during safety bed use 05. safety concerns of potential entrapment and endangerment or injury b. Includes a mental health management plan with member-specific medical/clinical interventions that have been tried to mitigate behaviors, improve quality of sleep and safety when sleeping c. Includes emergency preparedness plan to ensure the safety of the member in case of emergency (eg, natural disaster) as the member is not able to exit the enclosure independently 5. The invoice for the safety bed is retained and submitted along with the prior authorization and reimbursement requests. G. The recommended safety bed is the best bed to meet both the members unique individual clinical needs, and if there are multiple options for this, it is the lowest cost option. II. CareSource considers technology addons and nontechnology accessories as non-medical in nature and therefore not medically necessary. III. 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 CoverageNA F. Related Policies/RulesMedical Necessity Determinations Safety Beds-OH MCD-MM-1457 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at Committee.Date Revised 11/08/2023 11/06/202410/08/2025Annual review. Coverage language refined. Approved at Committee. Annual review: updated background and added documentation requirements . Approved at Committee. Annual review . Added documentation requirements, clinical assessment, and clarification of use. Updated D.I. and references. Added D. II. Approved at Committee. Date Effective 02/01/2026 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 September 29, 2025. www.aafp.org 3. DMEPOS: hospital beds, bed accessories, and pressure-reducing support surfaces , OHIO ADMIN . CODE 5160-10-18 (2024). 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 2/15/2023ODM approved 11/12/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 02/01/2026 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 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 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 Medica l 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNon-Emergency Facility to Facility Transfers B. BackgroundThis policy addresses the necessity of transferring a patient to a second acute care facility (receiving facility) when the individual requires care not available at the original facility. The goal of any transfer is to maintain the optimal health of the patient. This is accomplished by transferring the patient to the nearest facility that provides the highest specialized care needed. Inter-hospital patient transfer is an important aspect of patient care, most often toimprove patient management. During such transfers, there must be continuity of medical care. Key elements include the decision to transfer and communication, pre-transfer stabilization and preparation, choosing the appropriate mode of transfer, personnel accompanying the patient, equipment and monitoring required during the transfer, and documentation and handover of the patient at the receiving facility. Transfer, admission , and subsequent care to the receiving facility is not medicallynecessary when the needed care is available at the originating facility.C. Definitions Non-Emergency A situation for which immediate response is not needed for the provision of medical treatment. Inter-Facility Transfer The transfer of patients between two healthcare facilities. Intra-Facility Transfer The transfer of patients within the same facility. Originating Facility The current facility to which an individual has been admitted for care and from which a transfer is planned. Participating (In-Network) Facility Facility that is contracted with CareSource. Non-Participating (Out-of-Network) Facility Facility that is not contracted with CareSource. Receiving Facility The facility to which a transfer is planned. D. PolicyI. The following non-emergency transfers require a medical necessity review : A. A non-emergency transfer from a participating inpatient facility to a participating inpatient facility that is not within the same healthcare system. B. A non-emergency transfer from a non-participating facility to a participating facility. C. A non-emergency transfer from a non-participating facility to a non-participating facility. II. For non-emergency transfers that require a medical necessity review , the receiving facility submits the medical necessity review request to CareSource . Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 III. Requests for transfers that require a medical necessity review must meet the following criteria: A. Member must be medically stable for transfer AND one or more of the following situations. 1. Member requires transfer to a level of care which is not available at the originating facility . 2. Member requires transfer for a medically necessary diagnostic or therapeutic service which is not available at the originating facility . 3. Member requires transfer for services of a specialist to evaluate, diagnose , or treat their condition when that specialist is not available at the originating facility . 4. Member requires transfer because member has received care at a specific prior institution for a condition not normally managed at the originating facility and return to that prior institution is needed to diagnose, manage, or treat a complication or other acute issue . 5. Member requires transfer to improve the health and welfare of the member (ie, parental bonding) . 6. Transfer to allow a parent who gave birth to remain with the neonate is considered medically necessary when the neonate transfer meets the medically necessary criteria listed above and the parent who gave birth requires continued hospitalization due to birth complications or other medically necessary conditions . IV. The following non-emergency transfers do not require a medical necessity review :A. Inter-facility transfers within the same healthcare system . B. Intra-facility transfers within the same facility . V. Non-emergency (elective) transfers are not a covered service for the following:A. The criteria above have not been met . B. The transfer is for the convenience of the member , the members family, the physician, or the originating facility . E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/15/2023 New policy. Approved at CommitteeDate Revised 02/14/2024 01/15/2025Annual review. No changes. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Non-Emergency Facility to Facility Transfers-OH MCD-MM-1473 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 11/05/2025 Annual review. Replaced prior authorization with medical necessity review. Updated D. III. and references. Approved at Committee.Date Effective 02/01/2026 Date Archived H. References1. Appropriate interhospital patient transfer. American College of Emergency Physicians. January 2022. Accessed October 27, 2025. www.acep.org 2. Discharges and Transfers, 42 C.F.R. 412.4 (2025). 3. Heaton JK. EMS Inter-Facility Transport. In: StatPearls . StatPearls Publishing; 2025. 4. Kulshrestha A, Singh J. Inter-hospital and intra-hospital patient transfer: recent concepts. Indian JAnaesth . 2016;60(7):451-457. doi:10.4103/0019-5049.186012 5. Obstetric Care Consensus Number 9. Levels of Maternal Care. American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM); 2025. Accessed October 27, 2025. www.acog.org Independent med ical review 02/21/2023ODM approved 11/12/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 02/01/2026 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 …………………………………………………………………………………………………………. 3Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMyoelectric 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 Ohio Administrative Code (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 deternined 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 trials 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-1560Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Orthosis 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, butis not limited to, the following: A. MyoPro B. MyoPro 2E. Conditions of CoverageNA F. Related Policies/Rules Experimental and Investigational Item or Service G. Review/Revision History DATES ACTIONDate Issued 10/25/2023 New Policy. Approved at Committee.Date Revised 10/23/2024 10/22/2025 Updated references. Approved at Committee. Updated references. Approved at Committee. Date Effective 02/01/2025 Date Archived H. References1. DMEPOS Fee Schedule: CY 2024 Update. MLN Matters MM13463. January 1, 2024. Accessed February 18, 2026. www.cms.gov 2. Evolving Evidence Review: MyoPro Orthosis (Myomo Inc.) for Upper Extremity Paralysis/Paresis After Stroke. Hayes, Inc. Updated Apr 4, 2025. Accessed September 22, 2025. evidence.hayesinc.com Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 3. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . C ODE 5160-1-01 (2022). 4. Premarket Notification 510(k) Summary K062631. US Food and Drug Administration. April 12, 2007. Accessed September 22, 2025. 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. J Rehabil Assist Technol Eng . 2020;7:1-11. doi:10.1177/2055668320921067 7. Richards LG, Sethi A, Paluselli M, Cramer SC. Use of myoelectric orthosis after stroke or traumatic brain injury: a systematic review. Top Stroke Rehabil. Published online September 22, 2025. doi:10.1080/10749357.2025.2553591 ODM Approved 10/28/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Inhaled Nitric Oxide-OH MCD-MM-1053 02/01/202 6 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 ………………………….. ………………………….. ………………………….. ………………………. 7 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 7 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …….. 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ………. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. ……. 8 H. References ………………………….. ………………………….. ………………………….. ……………………… 9 Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectInhaled Nitric Oxide (iNO) B. BackgroundInhaled Nitric oxide (iNO ) is a lipophilic gas that is naturally produced in numerous cells in the body and is readily absorbed across pulmonary membranes in the ventilated lung after inhalation. In the body, nitric oxide is involved in oxygen transport to the tissues, the transmission of nerve impulses, and other physiological activities. When administered via inhalation, it is a potent endogenous vasodilator that induces relaxation of vascular and bronchial smooth muscle, vasodilation of blood vessels, and can increase the partia l pressure of arterial oxygen. iNO was initially approved by the U.S. Food and Drug Administration (FDA) in 1999. A complete nitric oxide delivery system is comprised of a nitric oxide administration apparatus, a nitric oxide gas analyzer, and a nitrogen d ioxide gas analyzer. Additional warnings and precautions were added in 2013, including rebound hypertension following abrupt discontinuation, hypoxia from methemoglobinemia, and airway injury from nitrous dioxide. Dilation of pulmonary vessels in well-ventilated lung areas redistributes blood flow awayfrom lung areas where ventilation/perfusion ratios are poor. iNO has been used in conjunction with ventilator support as a treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN), in infants who are at term or near-term (greater than 34 weeks gestation) to improve oxygenation,and to decrease the need for extracorporeal membrane oxygenation (ECMO). Respiratory failure is a clinical state that is defined either by the inability to rid the bodyof carbon dioxide or establish an adequate blood oxygen level. Acute respiratory failure is the most common clinical problem seen in term, near-term (born at 34 or more weeks of gestation), and pre-term (less than 34 weeks of gestation) infants admitted to neonatal intensive care units. Acute respiratory failure is frequently associated with meconium aspiration syndrome, sepsis, pulmonary hypoplasia, and/or prima ry pulmonary hypertension of the newborn. Management of infants with respiratory failure includes administration of high concentrations of oxygen, hyperventilation, high-frequency ventilation, neuromuscularblockade, antenatal steroids for the prevention of respiratory distress syndrome, use of po st-natal steroids to decrease inflammation, as well as iNO therapy.Clinical studies have shown that iNO is a selective pulmonary vasodilator without significant effects on the systemic circulation. There is scientific evidence that iNO therapy improves oxygenation and ventilation, reduces the need for extracorporealmembrane oxygenation (ECMO), and lowers the incidences of chronic lung disease and death among infants with respiratory failure. Moreover, the literature indicates that iNO does not appear to increase the incidence of adverse neurodevelopmental, behavioral, Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 or medical sequelae in these high-risk neonates. Infants with congenital diaphragmatic hernia (CDH) have not been shown to benefit from iNO therapy. Clark, et al (2000) concluded iNO does not lead to reduced ECMO use and Putnam, et al (2016) concluded iNO use in CDH may be associated with increased mortality. In preterm infants, the most common cause of acute respiratory failure is respiratory distress syndrome as a result of surfactant deficiency. According to the available literature, treatment of preterm infants usually entails exogenous surfactant administr ation. A systematic review of the evidence (Barrington and Finer, 2003)concluded: “The currently published evidence from randomized trials does not support the use of inhaled nitric oxide in preterm infants with hypoxic respiratory failure.” Carey, et al (2018) also concluded, Off-label prescription of iNO is not associated with reduced in-hospital mortality among premature infants with respiratory distress syndrome (RDS). In an Agency for Healthcare Research and Qualitys assessment on Inhaled Nitric Oxidein Preterm Infants , Allen, et al (2010) systematically reviewed the evidence on the use of iNO in preterm infants born at or before 34 weeks gestation age who receive respiratory support. They searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Studies (CENTRAL) and PsycInfo in June 2010. They also searched the proceedings of the 2009 and 2010 Pediatric Academic Societies Meeting and ClinicalTrials.gov. They identified additional studies from reference lists of eligible articles and relevant reviews, as well as from technical experts. Questions were developed in collaboration with technical experts, including the chair of the upcoming National Institutes of Health Office of Medical Applications of Research Consensus Development Conference. These researchers limited their review to randomized controlled trials (RCTs) for the question of survival or occurrence of bronchopulmonary dysplasia (BPD), and for the question on short-term risks. All study designs were considered for long-term pulmonary or neurodevelopmental outcomes, and for questions about whether outcomes varied by subpopula tion or by intervention characteristics. Two investigators independently screened search results and abstracted data from eligible articles. These investigators identified a total of 14 RCTs, reported in 23 articles, and 8 observational studies. Chronic Lu ng Disease (CLD) or BPD studies have shown that there is insufficient evidence to support iNO for the treatment of CLD or BPD. Mortality rates in the neonatal intensive care unit (NICU) did not differ for infants treatedwith iNO versus those not treated with iNO (RR 0.97 (95 % CI: 0.82 to 1.15)). Broncho-pulmonary dysplasia at 36 weeks for iNO and control groups also did not differ (RR 0.93 (0.86, 1.003) for survivors). A small difference was found between iNO and control infants in the composite outcome of death or BPD (RR 0.93 (0.87, 0.99)). There was inconsistent evidence about the risk of brain injury from individual RCTs, bu t meta – analyses showed no difference between iNO and control groups. These researchers found no evidence of differences in other short-term risks. There was no evidence to suggest a difference in the incidence of cerebral palsy (RR 1.36 (0.88, 2.10)), Inhaled Nitric Oxide-OH MCD-MM-1053Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 neurodevelopmental impairment (RR 0.91 (0.77, 1.12)), or cognitive impairment (RR 0.72 (0.35, 1.45)). Evidence was limited on whether the effect of iNO varies by subpopulation or by characteristics of the therapy (timing, dose and duration, mode of deliver y, or concurrent therapies). The authors concluded that there was a 7% reduction in the risk of the composite outcome of death or BPD at 36 weeks PMA for infants treated with iNO compared to controls, but no reduction in death or BPD alone. They stated that further studies are needed to explore subgroups of infants and to ass ess long-term outcomes including function in childhood. There is currently no evidence to support the use of iNO in preterm infants with respiratory failure outside the context of rigorously conducted RCTs. To provide health care professionals, families, and the general public with a responsible assessment of currently available data regarding the benefits and risks of iNO in premature infants, the Eunice Kennedy Shriver National Institute of Child Health andHuman Development, the National Heart, Lung, and Blood Institute, and the Office of Medical Applications of Research of the National Institutes of Health (Cole, et al, 2011) convened a consensus-development conference. Findings from a substantial body of experimental work in developing animals and other model systems suggest that iNO may enhance lung growth and reduce lung inflammation independently of its effects on blood vessel resistance. Although this work demonstrates biological plausibility and the results of RCTs in term and near-term infants were positive, combined evidence from the 14 RCTs of iNO treatment in premature infants of gestation of 34 weeks or less shows equivocal effects on pulmonary outcomes, survival, and neurodevelopmental outcomes. A National Institutes of Health Consensus Development Conference for inhaled nitricoxygen in premature infants (Cole, et al, 2010) recommended the following:1. Taken as a whole, the available evidence does not support use of iNO in early routine, early rescue, or later rescue regimens in the care of premature infants
Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Durable Medical Equipment Repairs-OH MCD-MM-1579 02/01/2026 Policy Type MEDICAL 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 …………………………………………………………………………………………………………… 3 Durable Medical Equipment Repairs-OH MCD-MM-1579 Effective Date: 02/0 1/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectDurable Medical Equipment RepairsB. Background Durable medical equipment (DME) is equipment that serves a medical purpose, helps complete activities of daily living (ADLS), can withstand repeated use, and is primarily used in the home. DME includes items, such as wheelchairs, hospital beds, continuous positive airway pressure (CPAP), walkers, oxygen tanks, etc. DME is dispensed when medical necessity is established to meet the needs of the members medical condition. DME is likely to last 3 years or more but may require maintenance, service, or repair periodically. When service is required, the DME provider may request authorization to perform the required maintenance, service, or repair to restore the DME item to working order. C. Definitions Durable Medical Equipment (DME) 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. Healthcare Common Procedure Coding System (HCPCS) A numeric and alphanumeric code set maintained and distributed by the Centers for Medicare and Medicaid Services for the uniform designation of certain medical procedures and related services. Repair The repairs, including the replacement of essential accessories, such as hoses, tubes, mouth pieces, etc., for necessary DME are covered when required to make the item/device serviceable. Replacement Replacement of DME is for the same or similar type of equipment, which is beyond its reasonable useful life span and has become irreparable. D. Policy I. A review of medical necessity is required for all DME repairs. II. If the DME item was not originally approved by CareSource, medical necessity must be established before any repair is authorized. III. Providers should submit ODM form 01904 and must include the following: A. specification of the item, including manufacturer, model, and serial number, if applicable B. date on which the item was originally purchased or dispensed or, if the date is not known, the approximate age of the item C. any warranty period and the type of warranty (manufacturer or dealer) D. a full description of the wear, damage, or malfunction E. a full description of the repair F. a description, with dates, of previous repairs (both major and minor) Durable Medical Equipment Repairs-OH MCD-MM-1579 Effective Date: 02/0 1/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 G. a complete itemization of parts H. an estimate of labor time needed (Labor should be billed with K0739 for 15-minute increments, 4 units = 60 minutes of labor.) IV. During the medical necessity review A. Providers should advise CareSource when, in a professional opinion, replacement of an item would be more cost-effective than repair. B. CareSource may consider whether the purchase of a new piece of equipment may be more cost-effective than continued repair. CareSource will not reimburse a repair that exceeds the cost of a replacement item. C. Multiple repairs requested within a short time span may suggest deliberate or malicious damage or destruction. In these cases, repair may be denied. V. Separate payment will not be made for the following items or services: A. temporary replacement ("loaner") equipment provided while an individual's own equipment is being repaired B. repair of an item if within the preceding 12 months Medicaid payment was made for the repair of a duplicate or conflicting item currently in the individual's possession C. repair of an item that is no longer deemed to be medically necessary D. maintenance and repair of DME during a rental period VI. CareSource considers a replacement part as a new equipment purchase and modifier NU should be used instead of modifier RB.E. Conditions of Coverage NA F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 02/14/2024 New policy. Approved at Committee.Date Revised 01/15/2025 11/05/2025Annual review. Updated references and medical necessity lanaguge. Approved at Committee. Periodic review. Added D.VD. Updated references. Approved at Committee. Date Effective 02/01/2026 Date Archived H. References1. DMEPOS: Repair, O HIO ADMIN . C ODE 5160-10-02 (2024).Durable Medical Equipment Repairs-OH MCD-MM-1579 Effective Date: 02/0 1/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 2. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . C ODE 5160-10-01 (2024). 3. DMEPOS: Wheelchairs, OHIO ADMIN . C ODE 5160-10-16 (2021). 4. Definitions, O HIO REV . C ODE 4752.01 (2018). 5. Definitions, 42 U.S.C. 1395x (2025). ODM approved 11/12/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Special Needs Car Seats-OH MCD-MM-1444 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.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 Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSpecial Needs Car Seats B. BackgroundSafe transportation for individuals with certain functional needs includes not only the proper restraints but also the correct positioning to secure the person in the vehicle. Currently, the Federal Motor Vehicle Safety Standard (FMVSS) Number 213 regulates the design and performance of restraint systems for persons weighing up to 80 pounds. However, people with special needs greater than 80 pounds may require car seat restraint, and several manufacturers have tested car seats beyond an 80-pound maximum. Once a person has outgrown a standard 5-point harness car seat, options include car seats specially designed for full support of a persons head, neck, and back while supporting up to 115 pounds. Conventional travel vests or specialized medical seating can be used for individuals who require additional trunk support but have stable neck control. Some larger people with certain functional needs , including poor trunk control, can be transported in a special needs belt-positioning booster seat or a conventional belt-positioning booster with trunk support. If the person using the car seat is more than 50 pounds and has significant abnormal tone, contractures, or has significant behaviors, transfer in and out of the vehicle can be very difficult. Car seats come with different weight limits and support systems . Inaddition, cars have different standard restraint systems, seat dimensions, and configurations that can accommodate specific types of cars seats. Not all vehicles come with the standard hardware necessary to secure car seats, especially older vehicles and larger car seats. A trial of the car seat is recommended to find the most appropriate car seat to address the needs of the user and specific restraints, dimensions, and configuration of the vehicle. C. Definitions Booster Seat A seat used for a person during transportation that lifts the person by several inches designed for use with an adult seat belt. Car Safety Seat (CSS) A portable seat for a person weighing under 80 pounds that attaches to an automobile seat and holds the person safely. Child Passenger Safety Technician (CPST) Trained educators in the field of occupant protection knowledgeable in child safety seat installation, best practices, and education. They provide support and guidance to caregivers with child safety seat questions and concerns. Federal Motor Vehicle Safety Standard 213 (FMVSS No. 213 ) Requires child restraint systems (CRSs) to be equipped with attachments that enable the CRS to Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 attach to the vehicle’s restraint anchorage system. The agency added a height provision to make the new standards applicability clear to booster seat manufacturers who choose not to label their restraints with a weight. National Highway Traffic Safety Administration (NHTSA) A division of the U.S. Department of Transportation dedicated to achieving the highest standards of excellence in motor vehicle and highway safety. Neck Loading The dynamic loading of the neck that occurs when the torso is suddenly stopped by the seat belt while the head continues pulling from the neck. Travel Vest Optimizes the existing vehicle seat belt system to protect the person by keeping a low center of gravity and allowing the vehicle seat belt and seat cushion to manage crash forces. D. PolicyI. CareSource considers a special needs car seat medically necessary when ALL the following clinical criteria are met: A. The car seat is a child restraint system that meets National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standard (FMVSS No. 213). B. The car restraint system is not modified or used in a manner other than that specified by the manufacturer, unless the modified restraint system has bee n crash tested and has met all applicable FMVSSs approved by the NHTSA. C. The special needs car seat is the most cost-effective option while still addressing the medical/functional needs of the member. D. The safety and effectiveness of the sp dcial needs car seat has been substantiated by current evidence-based national, state, and peer-reviewed medical guidelines. E. The length or weight limits of a conventional CRS with an internal 5-point harness has been outgrown, and at least one of the following criteria is met . 1. The member has respiratory issues or conditions that require enhanced positioning for safety, including any of the following (not an all-inclusive list): a. hypotonia b. craniofacial abnormalities c. primary airway problems d. cerebral palsy 2. The member has a physical condition (eg, seizure or hypertonicity/spasms) that prevents the independent maintenance of a seated position or requires support to allow a functional position or prevent further disability. 3. The member has gastrointestinal issues, including but not limited to: a. emesis b. gastroesophageal reflux (GERD) c. gastrostomy feeding tube 4. The member uses a spica cast. Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 F. Documentation that the member has been evaluated by a CPST for ALL the following: 1. diagnosis 2. objective and subjective clinical information on ability and impairments 3. reason why commercial car seats are not appropriate 4. member age, height, and weight 5. the size of larger medical car seats may limit space for others traveling with the member or other car seats in the vehicle. Notes need to show that this has been considered when identifying the most appropriate medical car seat or vest restraint. 6. medical equipment, casts, orthoses, and space necessary to transport the member 7. type of vehicle that will transport the member and compatibility of tethering systems in the vehicle II. Where applicable, a trial of the medical car seat should be documented that shows the following:A. The medical car seat can be used safely and as intended to meet the stated goals. B. Education has been provided to the member or the caregiver with demonstrated understanding and safety use. Education should include instruction for quickly extracting the member from the medical car seat in case of an emergency. C. If no trial seat is available documentation should show the following: 1. Caregivers have demonstrated the ability to complete the type of transfer necessary to safely use the type of vehicle restraint requested. 2. The vehicle restraint system in the vehicle used to transport the member is appropriate to secure the car seat based on manufacturer instructions. III. Persons with a tracheostomy tube should not use a CRS with a harness or seat belt that could dislodge the tube. It is strongly recommended that an occupational therapist or passenger safety technician with training and experience in the safe transportation of persons with special needs provide guidance for appropriate equipment selection and use . IV. A special needs car seat will not be considered medical necessary for any of the following: A. The special needs car seat is a more recent advancement in technology when the members current special needs car seat can meet the members basic medical/functional needs. B. The special needs car seat is considered investigational, experimental, or has unproven medical indications for use. Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at Committee.Date Revised 02/28/2024 2/12/202510/08/2025Annual review: editorial changes, updated car seat definition, added D.I.C-D., D.I.E.2, and D.II-III. , and updated references. Approved at Committee. Annual review: updated criteria in D.I.E. and updated references. Approved at Committee. Review . Updated background, a dded CPST documentation , trialing requirements and updated references. Approved at Committee. Date Effective 01/01/2026 Date Archived H. References1. Adams AJ, Johnson MA, Ryan KA, et al. Safe transportation in-spica following surgical treatment of infantile DDH: solutions and threats. JPediatr Orop . 2019;39(7):e488-e493. doi:10.1097/BPO.0000000000001317 2. Angsupaisal M, Maathuis CGB, Hadders-Algra M. Adaptive seating systems in children with severe palsy across International Classification of Functioning, Disability and Health for Children and Young version domains: a systematic review. Dev Med Child Neurol . 2015;57(10):919-930. doi:10.1111/dmcn.12762 3. Car seats and booster seats. National Highway Traffic Safety Administration. Accessed September 29 , 2025. www.nhtsa.gov 4. Car seat safety. National Child Passenger Safety Board. Accessed September 29 , 2025 . www.cpsboard.org 5. Child passenger safety. American Academy of Pediatrics. Accessed September 29 , 2025. www.aap.org 6. Huang PP, Durbin DR. Promoting safety in children with disabilities. UpToDate. Updated March 12, 2025. Accessed September 29 , 2025 . www.uptodate.com 7. 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 Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 8. Legare JM, Adam MP, Feldman J, et al. Achondroplasia . GeneReviews; 2023. Revised May 11, 2023. Accessed September 29 , 2025 . www.ncbi.nlm.nih.gov 9. ONeil J, Hoffman B, American Academy of Pediatrics Council on Injury, Violence, and Poison. Transporting children with special health needs. Pediatr . 2019;143(5):e20190724. doi:10.1542/peds.2019-0724 10. Rigby P, Ryan S, Campbell K. Effect of adaptive seating devices on the activity performance of children with cerebral palsy. Arch Phy Med Rehabil . 2009;90(8):1389-1395. doi:10.1016/j.apmr.2009.02.013 11. Ryan SE. Lessons learned from studying the functional impact of adaptive seating interventions for children with cerebral palsy. Dev Med Child Neurol . 2016;58(4):78 – 82. doi:10.1111/dmcn.13046 12. Smith VC, Stewart J. Discharge planning for high-risk newborns. UpToDate. Updated March 23, 2025. Accessed September 29 , 2025 . www.uptodate.com 13. Transportation of Children with Disabilities, OHIO ADMIN CODE 3301-51-10 (2023). 14. Vives-Torres CM, Valdamo M, Jimenez-Octavio JR, et al . Comparison of upper neck loading in young adult and elderly volunteers during low speed frontal impacts . Frontiers Bioeng Biotechnol . 2021;9 :682974 . doi :10.3389/fbioe.2021.682974 Independent med ical review 02/15/2023 ODM Approved 10/ 15/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – OH MCD-MM-1716 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response. Pharmacokinetics analyzes how drugs move through the body, including absorption, distribution, metabolism, and excretion. In behavioral health medicine, cytochrome P450s (CYPs) a re a common avenue for oxidative metabolism of therapeutic substances, which can be influenced by genetic and environmental factors. CYP genes are polymorphic and affect a significant portion of the populations ability to metabolize chemicals. Members with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound and are , therefore , classified as poor metabolizers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies show potential benefits of genetesting. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited research for a drug class or specific drugs. Most studies are based on small sample sizes and do not perform power calculations or correct for multiple testing scenarios. It is difficult to substantiate conclusions when not accounting for false positives o r false negatives. Additionally, there is a lack of consensus regarding preemptive genotyping efficacy. Two societies publishing guidelines acknowledge that comprehensive guidelines regarding when testing should occur, who should receive testing, and which genes should be tested cannot be offered. The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an internationalorganization whose goal is to reduce the barrier of translating genetic laboratory test results into guided clinical decision support. CPIC guidelines are peer-reviewed, evidence-based and updated as new evidence emerges. The guidelines are indexed in PubMed and endorsed by the American Society of Health-System Pharmacists (ASHP) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Published CPIC guidelines are available for certain drug classes and specific drugs which can lead to customized drug dosing and is presumed to improve time to effective treatment and reduce undertreatment, medication-related adverse events and costs. The guidelines consist of grading levels of evidence for prescription recommendations, which guide physicians on how results can optimize treatment. The strength of recommendations is divided into 4 categories: strong, moderate, optional, and no recommendation. A strong recommendation is backed by high-qualityevidence with desirable effects clearly outweighing undesirable effects. A moderate recommendation recognizes a close or uncertain balance as to whether the evidence is high quality , and desirable effects clearly outweigh the undesirable . In an optional recommendation, the desirable effects are closely balanced with undesirable effects or the evidence is weak or based on extrapolations, and opinions differ as to the need for the recommended course of action. With no recommendation, there is insufficient evidence, confidence, or agreement to provide a recommendation to guide practice. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 In 2018, the American Psychiatric Association (APA) Council of Research Workgroup onBiomarkers and Novel Treatments printed a position statement on pharmacogenomic (PGx) tools for the treatment of depression indicating at present there are insufficient data to support the widespread use of combinatorial pharmacogenetics testing in clinical practice. The Food and Drug Administration (FDA) released a consumer warning, The relationship between DNA variations and the effectiveness of antidepressant medicat ions has never been established. and also cautioned that changes in patient medications based on test results could potentially lead to patient harm. In 2024, Baum, et al., updated the APAs statement upon review of new clinical trials and meta – analyses published from 2017 to 2022 using PGx tools for treatment selection in depression and found addition of these new data do not alter the recommendations of the 2018 report, or the advice of the FDA, that the evidence does not support the use of currently available combinatorial PGx tools for treatment. Additionally in 2019, the International Society of Psychiatric Genetics published the following statement: Pharmacogenetic testing should be viewed as a decision-support tool Evidence to support widespread use of other pharmacogenetic tests at this time is still inconclusive Genetic information for CYP2C19 and CYP2D6 would likely be most beneficial for individuals who have experienced an inad equate response or adverse reaction to a previous antidepressant or antipsychotic trial. Care Source covers items and services with sufficient medical and scientific evidence forthe purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s) but does not cover experimental or investigational testing or products or services with insufficient data to determine net health impact. Insufficient data includes support that the test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinica l utility), performs better than an existing standard of care medical management option, and/or is not generally accepted as standard of care in the evaluation or management of a particular condition. Care Source provides appeal rights to any member or provider acting on behalf of a member who may disagree with denial decisions. Tests should be chosen to maximize the likelihood of identifying mutations in genes of interest for a specific medical reason, contribute to positive alterations in patient management, and minimize the chance of finding variants of uncertain significance. C. Definitions Actionable Use Genotype information may lead to selection of , avoidance of a specific therapy or modification of dosage of a therapy. Change must be based on the FDA label for the drug, an FDA warning or safety concern, or a CPIC level A or B gene-drug interaction. Intended change s in therapy based on the result of a genotyping test not supported by 1 of these sources is not an actionable use. Adherence Consumption of a drug at or near the maximum FDA approved dosage and duration for the medication or documentation that higher doses are not tolerated when less than the FDA-approved maximum. Biomarker A characteristic objectively measured and evaluated as an indicator of biological or pathogenic processes or pharmacologic responses to a specific Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 therapeutic intervention (eg, gene mutations, protein expression, known gene-drug interactions for medications, characteristics of genes ). Biomarker Testing The analysis of tissue, blood, or other biospecimen for the presence of a biomarker . Clinical Utility The likelihood that a test will, by prompting an intervention, result in an improved health outcome. Clinical Validity The accuracy of a test for a given clinical outcome. Consensus Statements Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict-of- interest policy aimed at specific clinical circumstances and based on best available evidence for optimizing outco mes of clinical care. Nationally Recognized Clinical Practice Guidelines Developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure with a conflict-of-interest policy establish ing standards of care informed by a systematic review of evidence and assessment of benefits and risks of alternative care options , includ ing recommendations to optimize patient care. Unbundling HCPCS/CPT codes should be reported only if all services described by the code are performed. Multiple codes should not be reported if a single code exists that describes the services performed. The codes include all services usually performed as part of the procedure as a standard of medical/ surgical practice and should not be separately reported simply because codes exist for the services. D. PolicyI. Biomarker testing that is not addressed by the Ohio Administrative or Revised Code or by the Ohio Department of Medicaid (ODM) in a recently published or updated provider document will follow MCG guidelines. Biomarker testing with uncertain clinical significance in MCG may be considered not covered as there is insufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s). If there are no MCG guidelines available, authorizati on for biomarker testing must be supported by the following scientific and medical evidence (as appropriate) : A. labeled indications for a test approved or cleared by the FDA B. indicated tests for a drug approved by the FDA C. Centers for Medicare and Medicaid Services (CMS) national coverage determinations and/or local coverage determinations by Medicare Administrative Contractors D. nationally recognized clinical practice guidelines and/or consensus statements E. warnings and precautions on FDA-approved drugs II. Any biomarker testing with clinical significance and evidence supported by scientific and medical evidence may be subject to medical necessity review. CareSource usesCPIC guidelines level A or B to determine the appropriateness of testing requests. A. General guidelines for all testing requests Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 The use of pharmacogenomic tests for multi-gene panels to guide therapy decisions may be medically necessary for psychotropic medications when ALL of the following criteria are met: 1. The member is currently or considering taking a drug potentially affected by a known mutation that can be detected by a corresponding test. 2. The drug is to be prescribed for the condition and population consistent with FDA labeling. 3. The test demonstrate s actionability in clinical decision making by CPIC guidelines level A or Band has demonstrated technical and clinical validity. 4. Providers can use results to guide changes in treatment that will improve patient outcome s or directly impact medical care (ie, clinical utility). 5. The ordering provider possesses the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and to prescribe medications for the condition either independently or in an arrangement as required by all applicable state laws. 6. The usefulness of the test is not significantly offset by negative factors, such as expense, clinical risk, or social, or ethical challenges (ie, reasonable use). 7. Requested testing is performed in a CLIA-certified laboratory and has not been previously performed. 8. At least 1 of the following criteria is met: a. Documentation is provided that the requested testing is required to obtain health plan coverage for the medication being considered for treatment. b. An FDA label requires results from a genetic test to effectively or safely use the therapy in question or is listed in the FDA table of known gene – drug interactions. c. Documentation of member adhere nce and fail ure to see expected results from at least 2 prior medications to treat the diagnosed condition. B. Specific testing requests Testing in the following situations may be considered medically necessary and is subject to medical necessity review. To aid in therapy selection and/or dosing for members considered for therapy or in a course of therapy with any of the medications below, testing for following genotype(s) once per lifetime may be considered : 1. CYP2C19 and CYP2D6 t esting for tricyclic antidepressants : a. Amitriptyline b. Imipramine c. Doxepin 2. CYP2C19 and CYP2B6 testing for sert raline, serotonin reuptake inhibitor 3. HLA-A and HLA-B testing for carbamazepine III. Exceptions to this policy or an adverse utilization review determination might be explored via appeal rights , which are p rovide d to any member or provider who requests testing on behalf of the member for any denial of authorization via the provider portal on www .www.caresource.com, fax, or mail by the US P ostal Service. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 IV. CareSource considers the following not medically necessary (not all-inclusive):A. testing or screening 1. in the general population 2. considered non-covered but billed using unlisted procedure codes 3. in the absence of clinical signs or symptoms or for determining a risk for developing a disease or condition 4. not confirming new data for decision making but a known diagnosis 5. without diagnosis-specific indications or ensuring matching tissue specimens B. use of multi-gene panels for genetic polymorphisms, including, but not limited to, pain management, cardiovascular drugs, anthracyclines, or polypharmacy for evaluating drug-metabolizer status C. broad symptom-based panels (eg, comprehensive ataxia panel) when a narrower panel is available and more appropriate based on clinical findings (eg, autosomal dominant ataxia panel) D. more than 1 multigene panel at the same time (should be performed in a tiered fashion with independent justification for each panel requested ) E. genes not identified as having actionable use E. Conditions of CoverageCareSource applies coding edits to medical claims through coding logic software to evaluate accuracy and adherence to accepted national standards. Proper billing and submission guidelines must be followed, including the following: I. Unbundling of codes in a panel may result in payment recovery. Procedures not meeting correct coding standards are not reimbursable, even if medical necessity criteria for the associated test(s) are met. II. Providers must use industry standard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes to the highest level of specificity. III. Services considered to be mutually exclusive, incidental to, or integral to the primary service rendered are not allowed additional payment. IV. Proprietary panel testing requires documentation of medical necessity. V. If a panel was previously performed and an updated, larger panel is being requested, only testing for the medically necessary, previously untested genes will be reimbursable. Therefore, only the most appropriate procedure codes for those additional genes will be considered for reimbursement. F. Related Policies/RulesExperimental or Investigational Items or Services Medical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 10/23/2024 New policy. Converted AD-134 2 to MM with parameters for review of medical necessity. Approved at Committee. Date Revised 10/08 /2025 Annual review. Updated references. Approved at Committee. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Date Effective 01/01/2026Date Archived H. References1. American College of Medical Genetics Board of Directors. Points to consider in the clinical application of genomic sequencing. Genet Med . 2012 Aug;14(8):759-61. doi:10.1038/gim.2012.74 2. Baum M, Widge A, Carpenter L, et al. Pharmacogenomic clinical support tool for the treatment of depression. Am JPsychiatry . 2024;181(7):591-607. doi:10.1176/appi.ajp.20230657 3. Bean LJH, Funke B, Carlston CM, et al. Diagnostic gene sequencing panels: from design to report a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2020;22(3):453-461. doi:10.1038/s41436-019-0666-z 4. Behavioral Health Medication Pharmacogenetics Gene Panels: A-0861. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 5. Beunk L, Nijenhuis M, Soree B, et al. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2D6, CYP3A4 and CYP1A2 and antipsychotics. Eur JHum Genet . 2024;32(3):278-285. doi:10.1038/s41431-023-01347-3 6. Bousman CA, Stevenson JM, Ramsey LB, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes and serotonin reuptake inhibitor antidepressants. Clin Pharmacol Ther . 2023;114(1):51-68. doi:10.1002/cpt.2903 7. Brouwer JMJL, Wardenaar KJ, Nolte IM, et al. Association of CYP2D6 and CYP2C19 metabolizer status with switching and discontinuing antidepressant drugs: an exploratory study. BMC Psych . 2024;24:394-408. doi:10.1186/s12888-024-0576 8. Brown JT, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther . 2019;106(1):94-102. doi:10.1002/cpt.1409 9. Caudle K, Sangkuhl K, Whirl-Carrillo M, et al. Standardizing CYP2D6 genotype to phenotype translation: consensus recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci , 2020;13:116-124. doi:10.1111/cts.12692 10. Chang M, Tybring G, Dahl ML, et al. Impact of cytochrome P450 2C19 polymorphisms on citalopram/escitalopram exposure: a systematic review and meta – analysis. Clin Pharmacokinet . 2014;53(9):801-811. doi:10.1007/s40262-014-0162-1 11. Cicali EJ, Smith DM, Duong BQ, et al. A scoping review of the evidence behind cytochrome p450 2d6 isoenzyme inhibitor classifications. Clin Pharmacol Ther . 2020;108(1):116-125. doi:10.1002/cpt.1768 12. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Accessed September 19, 2025 . www.cdc.gov 13. Clinical Pharmacogenetics Implementation Consortium. Accessed September 19, 2025 . www.cpicpgx.org Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 14. Clinical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents. American Academy of Child & Adolescent Psychiatry; 2020. Accessed September 19, 2025 . www.aacap.org15. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed September 19, 2025 . www.hayesinc.com 16. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Accessed September 19, 2025 . www.hayesinc.com 17. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing for Opioid Treatment for Pain in Adults Selected Single-Gene Variants and Pharmacogenomic Panels. Hayes; 2019. Accessed September 19, 2025 . www.evidenced.hayesinc.com 18. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Hayes; 2020. Accessed September 19, 2025 . www.evidence.hayesinc.com 19. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Accessed September 19, 2025 . www.evidence.hayesinc.com 20. Clinical Utility Evaluation: Pharmacogenomic Testing for Major Depressive Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 21. Clinical Utility Evaluation: Pharmacogenomic Testing for Schizophrenia Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 22. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Accessed September 19, 2025 . www.evidence.hayesinc.com 23. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 24. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Accessed September 19, 2025 . www.genome.gov 25. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 26. Fijal BA, Guo Y, Li SG, et al. CYP2D6 pr edicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial. JClin Pharmcol . 2015;55(10):1167-1174. doi:10.1002/jcph.530 27. Guin D, Hasija Y, Kukreti. Assessment of clinically actionable pharmacogenetic markers to stratify anti-seizure medications. Pharmacogenomics J . 2023;23:149-160. doi:10.1038/s41397-023-00313-y 28. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed September 19, 2025 . www.pubmed.ncbi.nih.gov 29. Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther . 2015;98(2):127-134. doi:10.1002/cpt.147 2 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 30. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther . 2017;102(1):37-44. doi:10.1002/cpt.597 31. Hicks JK, Swen JJ, Thorn CF, et al. Clinical Pharmacogenetics Implementation Consortium guideline for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther . 2013;93(5):402-408. doi:10.1038/clpt.2013.2 32. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 33. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 34. Jukic MM, Haslemo T, Molden E. Impact of CYP2C19 genotype on escitalopram exposure and therapeutic failure: a retrospective study based on 2087 patients. Am J Psych . 2018;175(5):463-470. doi:10.1176/appi.ajp.2017.17050550 35. Koh A, Pak KC, Choi HY, et al. Quantitative modeling analysis demonstrates the impact of CYP2C19 and CYP2D6 genetic polymorphisms on the pharmacokinetics of amitriptyline and its metabolite, nortriptyline. JClin Pharmacol . 2019;59(4):532-540. doi:10.1002/jcph.1344 36. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Accessed September 19, 2025 . www.uptodate.com 37. Laboratory Requirements, 42 C.F.R. 493 (2024). 38. Lagishetty CV, Deng J, Lesko LJ, et al. How informative are drug-drug interactions of gene-drug interactions? JClin Pharmacol . 2016;56(10):1221-1231. doi:10.1002/jcph.743 39. Leckband SG, Kelso JR, Dunnenberger HM, et al. Clinical Pharmacogenetics Implementation Consortium guidelines for HLA-B genotype and carbamazepine dosing. Clin Pharmacol Ther . 2013;94(3):324-328. doi:10.1038/clpt.2013.103 40. Li D, Pain O, Chiara F, et al. Metabolic activity of CYP2C19 and CYP2D6 on antidepressant response from 13 clinical studies using genotype imputation: a meta – analysis. Transl Psychiatry . 2024;14(1):296. doi:10.1038/s41398-024-02981-1 41. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Accessed September 19, 2025 . www.fda.gov 42. Lu ML, Chen TT, Kuo PH, et al. Effects of adjunctive fluvoxamine on metabolic parameters and psychopathology in clozapine-treated patients with schizophrenia: A 12-week, randomized, double-blind, placebo-controlled study. Schizophr Res . 2018;193:126-133. doi:10.1016/j.schres.2017.06.030 43. McCormack M, Bourgeois S, Farrell JJ, et al. HLA-A*3101 and carbamazepine – induced hypersensitivity reactions in Europeans. NEngl JMed . 2011;364(12):1134 – 1143. doi:10.1056/NEJMoa1013297 44. Medical Code Brief: 0392U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 45. Medical Code Brief: 0411U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 46. Medical Code Brief: 0419U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 47. Medical Code Brief: 0423U-PLA (U Codes). Hayes; 2023. Accessed September 22,2025. www.evidence.hayesinc.com 48. Medical Code Brief: 0434U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 49. Medical Code Brief: 0438U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 50. Medical Code Brief: 0476U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 51. Medical Code Brief: 0477U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 52. Milosavljevic F, Bukvic N, Pavlovic Z, et al. Association of CYP2C19 and CYP2D6 poor and intermediate metabolizer status with antidepressant and antipsychotic exposure: a systematic review and meta-analysis. JAMA Psychiatry . 2021;78(3):270 – 280. doi:10.1001/jamapsychiatry.2020.3643 53. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Accessed September 19, 2025 . www.evidence.hayesinc.com 54. Nahid NA, Johnson JA. CYP2D^ pharmacogenetics and phenoconversion in personalized medicine. Expert Opin Drug Metab Toxicol . 2022;18(11):769-785. doi:10.1080/17425255.2022.2160317 55. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed September 19, 2025 . www.cancer.gov 56. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed September 19, 2025 . www.ncbi.nlm.nih.gov 57. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Accessed September 19, 2025 . www.medicaid.gov 58. Ozeki T, Mushiroda T, Yowang A, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet . 2011;20(5):1034 – 1041. doi:10.1093/hmg/ddq537 59. Patel JN, Morris SA, ,Torres R, et al. Pharmacogenomic insights in psychiatric care: uncovering novel actionability, allele-specific CYP2D6 copy number variation, and phenoconversion in 15,000 patients. Mol Psychiatry . 2024. doi:10.1038/s41380024-0 60. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Accessed September 19, 2025 . www.aacap.org 61. Phillips EJ, Sukasem C, Whirl-Carrillo M, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmaco Ther . 2018. doi:10.1002/cpt.1004 62. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com 63. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed September 19, 2025 . www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 64. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com65. Pritchard D, Patel JN, Stephens LE, et al. Comparison of FDA table of Pharmacogenetic Associations and Clinical Pharmacogenetics Implementation Consortium guidelines. Am JHealth Syst Pharm . 2022;79(12):993-1005. doi:10.1093/ajhp/zxac064 66. Raby B. Personalized medicine. UpToDate. Accessed September 19, 2025 . www.uptodate.com 67. Rehder C, Bean LJH, Bick D, et al. Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4 68. Rosenblat JD, Lee Y, McIntyre RS. Does pharmacogenomic testing improve clinical outcomes for major depressive disorder? a systematic review of clinical trials and cost-effectiveness studies. JClin Psychiatry . 2017;78(6):720-729. doi:10.4088/JCP.15r10583 69. Roy S, LaFramboise WA, Nikiforov YE, et al. Next-generation sequencing informatics: challenges and strategies for implementation in a clinical environment. Arch Pathol Lab Med . 2016;140(9):958-975. doi:10.5858/arpa.2015 – 0507-RA 70. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. Accessed September 19, 2025 . www.rcpsych.ac.uk 71. Saadullah Khani NS, Hudson G, Mills G, et al. A systematic review of pharmacogenetic testing to guide antipsychotic treatment. Nat Mental Health . 2024 ;2(5):616-626. doi:10.1038/s44220-024-00240-2 72. Swen JJ, van der Wouden CH, Manson LE, et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster – randomised crossover implementation study. Lancet . 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4 73. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol . 2013;149(9):1025-1032. doi:10.1001/jamadermatol.2013.4114 74. Tantisira K. Overview of pharmacogenomics. UpToDate. Accessed September 19, 2025 . www.uptodate.com 75. Ter Hark S, Vos CF, Aarnoutse RE, et al. Biomarkers as predictors of treatment response to tricyclic antidepressants in major depressive disorder: a systematic review. JPsych Res . 2022;150:202-213. doi:10.1016/j.jpsychires.2022.03.057 76. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed September 19, 2025 . www.fda.gov 77. Vos CF, Ter Hark SE, Schelleken AFA, et al. Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder: a randomized clinical trial. JAMA Netw Open . 2023;6(5):e2312443. doi:10.1001/jamanetworkopen.2023.12443 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 78. Wang Q, Sun S, Xie M, et al. Association between the HLA-B alleles and carbamazepine-induced SJS/TEN: a meta-analysis. Epilepsy Res . 2017;135:19-28. doi:10.1016/j.eplepsyres.2017.05.015 79. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 80. Wu X, Zhang H, Miah MK, et al. Physiologically based pharmacokinetic approach can successfully predict pharmacokinetics of citalopram in different patient populations. JClin Pharmacol . 2020;60(4):477-488. doi:10.1002/jcph.1541 81. Zeier Z, Carpenter L, Kalin N, et al. Clinical implementation of pharmacogenetic decision support tools for antidepressant drug prescribing. Am JPsychiatry . 2018;175(9):873-886. doi:10.1176/appi.ajp.2018.17111282 82. Zubenko G, Sommer B, Cohen B. On the marketing and use of pharmacogenetic tests for psychiatric treatment. JAMA Psychiatry. 2018;75(8):769-770. doi:10.1001/jamapsychiatry.2018.0834 Reviewed by AllMed 09/2024Approved by Ohio Dept of Medicaid 10/10/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-OH MCD-MM-0798 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Policies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 5 Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectClinical Trial Coverage B. Background Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials evaluate new or emerging devices, treatments, and procedures. They may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol or action plan for conducting the trial. The protocol or action plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical trials are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested or non-standard treatments to standard currently accepted treatments. Clinical trials are intended to improve clinicians knowledge about a treatment and to improve clinical outcomes for future patients. Clinical trials generally proceed through four phases: a. Phase I the study treatment is given to a small group of people who are healthy or have the disease/condition for the first time to evaluate its safety and determine a safe dosage range b. Phase II the study treatment is given to a large group of people who have the disease/condition to see if it is effective and to identify side effects c. Phase III the study treatment is given usually to large groups of people who have the disease/condition to confirm its effectiveness, monitor adverse reactions, compare it to commonly used treatments and collect information that will allow the treatment to be used safely d. Phase IV studies performed after the treatment has been marketed to collect information about its effects in various populations of people who have the disease/condition and to identify side effects associated with long-term use. NOTE: Experimental, investigational, and unproven treatment, procedures and all related services are not a covered service by Medicaid.C. Definitions Clinical Trial is a Phase I, II, III, or IV research study that does ONE of the following for the treatment of cancer or a life-threatening disease: o tests how to administer a health care service o tests responses to a health care service o compares effectiveness of a health care service o studies new uses of a health care service AND Is approved and funded by ONE of the following: Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o a cooperative group of research facilities that has an established peer review program that is approved by a National Institutes of Health Institute or center and assures an unbiased review of standards of care with qualified individuals who do not have an interest in the review outcome o National Institutes of Health (NIH) o The Centers for Disease Control and Prevention (CDC) o The Agency for Health Care Research and Quality (AHRQ) o The Centers for Medicare and Medicaid services (CMS) o a cooperative group or center of NIH, CDC, AHRQ, DOD, VA, or CMS o The United States Department of Veterans Affairs (VA) o The United States Department of Defense (DOD) o The Food and Drug Administration (FDA) o The United States Department of Energy o The institutional review board of an institution located in Ohio that has a multiple project assurance contract approved by the National Institutes of Health Office for Protection from Research Risks as provided in 45 CFR 46.103 o a research entity that meets eligibility criteria for a support grant from a National Institutes of Health center o a qualified non-governmental research entity in guidelines issued by the NIH for center support grants AND o is conducted in a facility where the personnel have training, and expertise required to provide type of care required in the study AND o has a written protocol for the clinical trial AND o designed to have a therapeutic intent. Routine Care Cost The cost of medically necessary items and services related to the care method which is under evaluation in the clinical trial. Life-threatening Disease or Condition Any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Category A (Experimental) Device Per Centers for Medicare and Medicaid Services a device for which absolute risk of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. Category B (Non-experimental/investigational) Device Per Centers for Medicare and Medicaid Services a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type. Experimental/investigational/unproven Any procedure, treatment, service, supply, or product that meets one or more of the following: o Is subject to Institutional Review Board review or approval. o Effectiveness on health outcomes is unproven based on clinical evidence in peer-reviewed medical literature. Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 o Cannot be legally marketed in the United States without final approval from appropriate government regulatory or licensing body. ICD-10-CM Code Z00.6 A billable ICD code used to specify a diagnosis of encounter for examination for normal comparison and control in clinical research program. The Z00.6 diagnosis code reports that the service involved "examination of participant in clinical trial." The Z00.6 diagnosis code must be used for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be conventional care for the patient absent the trial. D. Policy I. Prior authorization is required for ICD-10-CM Code Z00.6. II. Informed consent approved by an IRB accredited Association for the Accreditation ofHuman Research Protection Programs (AAHRPP) must be obtained from the member before enrolling in a clinical trial. III. CareSource will cover routine care costs for a member enrolled in a clinical trial asdescribed in this policy when A. The same routine care costs would be typically covered for a member who is not enrolled in the clinical trial AND B. All items and services are medically necessary AND C. All items and services are a covered benefit. IV. CareSource will cover routine care costs for member in a clinical trial where the itemor service is A. Required for the administration and provision of the item or service such as the staffing and equipment need to implant the device OR B. For the clinically appropriate monitoring of the effects of the item or service OR C. For the prevention, diagnosis, or treatment of complications from item or service provided in the clinical trial. V. CareSource will NOT cover the following items as they are not considered routine care costs typically covered by a member who is not enrolled in the clinical trial A. Item or service being evaluated. B. Item or service that is only utilized for data collection and analysis and not related to the direct clinical management of member. C. Item or service reimbursed or provided for free from another source including the research sponsor. D. Item or service only utilized to determine if individual is eligible to participate in clinical trial. E. Clinical trials designed to only test toxicity or disease pathology. F. Treatment that is not standard of care to support or administer the item or service in the clinical trial. Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 G. Transportation, housing, food or expenses for the member or family members/companions associated with travel to or from facility providing the clinical trial. H. Experimental/investigational/unproven procedure, treatment, service, supply, device, or product. VI. All applicable plan limitations for coverage for out-or-network providers will apply toroutine care costs in a clinical trial.VII. All applicable utilization management guidelines (including prior authorizations) willapply to routine care for members in a clinical trial.E. Conditions of CoverageN/A F. Related Policies/Rules Experimental or Investigational Item or ServiceG. Review/Revision HistoryDATE ACTIONDate Issued 05/19/2015 New PolicyDate Revised 05/19/2015 05/17/2016 07/10/2019 11/01/2019 10/28/2020 10/27/202108/31/202208/30/202309/05/202409/10/2025 No changes Changed title from Clinical Trials. Changed from AD-0002. Removed all other state requirements. Added specific criteria. Added PA requirement. Updated references. Per SIU expanded definition Z00.6, Encounter for examination for normal comparison and control in clinical research program No changes; updated references Changed title to Clinical Trial Coverage. Updated references. No other changes. Updated references. Approved at Committee. Updated references. Approved at Committee. Added Experimental or Investigational Item or Service to Sec. F. Updated references. Approved at Committee . Date Effective 01/01/2026 Date Archived H. References1. Associations for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed August 1, 2025. www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed August 1, 2025. www.ecfr.gov 3. Medicare and Medicaid Services Medicare Learning Network (2015). MLN Matters. Medicare Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies. Accessed August 1, 2025. www.cms.gov Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 4. National Coverage Determination for Routine Costs in Clinical Trials (310.1).Accessed August 1, 2025. www.cms.gov 5. Denial of Coverage to Cancer Clinical Trial Participant, O HIO R EV . C ODE ANN 3923.80 (2009). 6. Non-Covered Services, O HIO ADMIN . C ODE 5160-1-61 (2022). Accessed August 1, 2025. www.codes.ohio.gov 7. Patient Protection and Affordable Care Act. (2010, March 23). Accessed August 1, 2025. www.govinfo.gov. 8. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). Accessed August 1, 2025. www.govinfo.gov Approved ODM on 09/18/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 12/01/2025 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 ………………………….. ………………………….. ………………………….. ……………………… 4 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.2 A. SubjectPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental B. BackgroundPositive airway pressure (PAP) devices u tilize a machine with a mask or other apparatus that fits over the nose and/or mouth to provide positive pressure , keep ing airways open. Continuous positive airway pressure , or CPAP , is used to treat sleep-related breathing disorders , including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bi – level or two-level positive airway pressure , or BiPAP , is used to treat lung disorders , such as chronic obstructive pulmonary disease ( COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP devices can provide better sleep quality, reduc e or eliminat e snoring, and less en daytime sleepiness. PAP devices should always be used according to the physicians order , as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome . C. Definitions Adherence Use of the PAP device as prescribed by the ordering physician, defined as utilization for 4 or more hours per night for 70% of the nights during the most recent consecutive 30-day period during the first initial usage. Bi-Level Positive Airway Pressure (BiPAP) Device A device that uses mild bi-level or two levels of air pressure to keep airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep airways open. Positive Airway Pressure (PAP) Device A device that uses air pressure to keep airways open , including both continuous positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices. D. PolicyI. PAP devices addressed in this policy are as follows: A. E0601 CPAP, continuous pressure capability, used with noninvasive nasal or face mask. This item is a rent to purchase. B. E0470 BiPAP, Bi-level pressure capability, without backup rate feature, used with noninvasive nasal or face mask. This item is a rent to purchase. C. E0471 BiPAP, Bi-level pressure capability, with backup rate feature, used with noninvasive nasal or face mask. This item is a rental only. D. E0472 BiPAP, Bi-level pressure capability, with backup rate feature, used with invasive tracheostomy tube. This item is a rental only. II. PAP devices CPAP (E0601) and BiPAP (E0470):A. Initial prior authorization review: PAP devices CPAP (E0601) and BiPAP (E0470): 1. During the first 3 months rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device, CareSource considers the device Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.3 medically necessary when Ohio Administrative Code (OAC) clinical criteria are met. B. Continued rent to purchase period 1. For months 4-10 rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device documentation confirming adherence (see above definition) must be submitted. Note: CPAP (E0601) and BiPAP (E0470) machines are a 10-month rent to purchase. III. PAP devices BiPAP (E0471) and BiPAP (E0472) CareSource uses MCG Health and /orOAC clinical criteria to determine medical necessity A. During the first 6 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 7-12 rental, CareSource considers the device medically necessary when documentation confirming adherence (see above definition) is submitted . C. Documentation confirming adherence must be submitted annually with the prior authorization request. CareSource considers the device medically necessary when BOTH the following are met: 1. The MCG Health clinical criteria are met. 2. Documentation confirming adherence (see above definition) is submitted. E. Conditions of CoverageNA F. Related Policies/RulesNoninvasive Home Mechanical Ventilation G. Review/Revision HistoryDATE ACTIONDate Issued 06/10/2020 New policyDate Revised 03/31/2021 Revised medical necessity criteria language. Added definitions. Clarified types of PAP devices.05/11/2022 No changes. Updated references. Approved at PGC.03/15/2023 Added Ohio Administrative Code language. Updated02/28/202408/28/202408/13/2025 references. Approved at Committee.Annual review. Removed MCG from initial review and supply chain statement. Updated references. Approved at Committee. Revised D. II. and III. Updated references. Approved at Committee. Annual review. Updated F. and references. Approved at Committee. Date Effective 12/01/2025 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.4 Date ArchivedH. References1. Bi-level Positive Airway Pressure (BPAP) Device: ACG A-0994. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1 , 2025 . www.careweb.careguidelines.com 2. Continuous Positive Airway Pressure (CPAP) Device: ACG A-0431. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1, 2025 . www.careweb.careguidelines.com 3. CPAP. National Heart, Lung, and Blood Institute. Updated March 24, 2022. Accessed August 1, 2025 . www.nhlbi.nih.gov 4. DMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). 5. LCD Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) . Centers for Medicare and Medicaid. Updated January 1, 2024. Accessed August 1, 2025 . www.cms.gov 6. Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers, OHIO ADMIN . CODE 5160-10-1. Accessed August 1, 2025 . www.codes.ohio.gov 7. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JClin Sleep Med . 2019;15(02):335-343. doi:10.5664/jcsm.7640 This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. Approved by ODM 08/21/2025
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