MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 12/01/2025 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 ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectDigital Therapy Devices for Treatment of Amblyopia B. Background Amblyopia (ie, "lazy eye") is a neurodevelopmental disorder characterized by diminished visual acuity, usually in 1 eye, that is caused by inadequate visual processing in early childhood. When vision in 1 eye is abnormal, the brain will suppress signals from the weaker eye and rely on information from the stronger eye instead. Amblyopia is defined by the American Academy of Ophthalmology (AAO) as an interocular difference of 2 lines in acuity or acuity 20/30 with the best optical correction. According to the American Academy of Ophthalmology Preferred Practice Pattern guidelines Amblyopia (2024), most children who have moderate amblyopia (20/40 to 20/80) respond to initial treatment consisting of 2 hours of daily patching or weekend atropine. The AAOS Preferred Practice Pattern guidelines (2024) state: Refractive correction with eyeglasses is recommended as the initial step in care of children 0-17 years of age . Additionally, occlusion of the non-amblyopic eye with eye patching or pharmacological treatment with blurring atropine eye drops are each recommended in the guideline as an appropriate choice for amblyopia treatment in children who do not improve with refractive correction alone or who have incomplete resolution of their visual acuity deficit (2024). More recently, digital therapy devices have been developed to treat amblyopia in children with no strabismus or small angle strabismus with some binocularity using therapeutic dichoptic (binocular) visual stimuli. Images are presented using noninvasive, computerized systems such as virtual reality headsets or 3-dimensional glasses; typically, high-contrast images are presented to the amblyopic eye and low-contrast images are presented to the fellow eye. This is a proposed way to help the eyes work together. According to the American Academy of Ophthalmology (2024), Although data from early nonrandomized studies were promising, results from three randomized trials of early software applications failed to demonstrate that game play prescribed 1 hour per day was as good as patching prescribed 2 hours per day or better than placebo game play. Research with this technology is ongoing, which will be used to delineate use of binocular therapy for treatment of amblyopia. Another randomized prospective clinical trial studied a digital therapeutic using a desk-based computer platform, red-blue anaglyph glasses and an eye tracker found at 16 weeks the therapeutic (2.8 lines of improvement to be non-inferior to patching 2 hours per day). C. Definitions Amblyopia Also known as lazy eye, is a developmental disorder of the central nervous system that results from the abnormal processing of visual images, leading Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 to reduced visual acuity (VA) in one or both eyes due to abnormal vision development in infancy and childhood . Convergence Insufficiency Inability to maintain binocular function (keeping the two eyes working together) while working at a near distance. Typically, one eye will turn outward (intermittent exotropia) when focusing on a word or object at near distance. Occlusion Therapy Also called patching, is the mainstay of amblyopia treatment. Patching the unaffected, or good eye provides monocular stimulation to the amblyopic eye, promoting visual development. Occlusion therapy is prescribed to improve vision and as a rule, does not eliminate strabismus. Orthoptic Vision Therapy Eye exercises usually weekly over many months done in the optometrist office. Pharmacologic Penalization Therapy Therapy using eye drops, typically atropine, to blur the vision in the better-seeing eye, thus encouraging the use of the weaker, amblyopic eye. Prescription Digital Therapeutics (PDTs) Software-based therapeutic interventions for the prevention, management, or treatment of medical illnesses or diseases that have been evaluated for safety and efficacy. PDTs are authorized by the US Food and Drug Administration to treat diseases through an approved label and are differentiated from other digital health technologies (traditional health and wellness apps) by the following unique characteristics (Digital Therapeutics Alliance, 2021). Strabismus Misalignment of the eyes. Strabismus is commonly described by the direction of the eye misalignment such as esotropia, exotropia, and hypertropia. D. PolicyI. CareSource considers the following services medically necessary: A. occlusion therapy or pharmacologic penalization therapy for treating amblyopia B. orthoptic therapy or vision therapy for treating convergence insufficiency C. prism adaptation therapy for treating esotropia II. According to Centers for Medicare & Medicaid Services: Early and PeriodicScreening, Diagnostic and Treatment services (EPSDT) does not require coverage of treatments, services, or items that are experimental or investigational. However, requested treatments for children will be reviewed individually to determine the best course of treatment. III. Unproven and Not Medically Necessary A. Orthotic Vision Therapy for treating other conditions not listed above are considered unproven and not medically necessary. B. Prescription Digital Therapeutics for Amblyopia. E. Conditions of Coverage NA Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 F. Related Policies/RulesExperimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/30/2025 New policy. Approved at Committee.Date Revised Date Effective 12/01/2025 Date Archived H. References1. Amblyopia Preferred Practice Pattern 2022-Updated 2024. American Academy of Ophthalmology. December 19, 2022. Accessed July 1, 2025. www.aao.org 2. Birch EE, Kelly KR. Amblyopia and the whole child. Prog Retin Eye Res . 2023;93:101168 doi:10.1016/j.preteyeres.2023.101168 3. Boniquet-Sanchez S, Sabater-Cruz N. Current Management of Amblyopia with New Technologies for Binocular Treatment. Vision (Basel) . 2021;5(2):31. doi:10.3390/vision5020031 4. EPSDT-A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents. Centers for Medicare & Medicaid Services. Accessed July 1, 2025. www.medicaid.gov 5. Levi DM. Rethinking amblyopia 2020. Vision Res . 2020;176:118-129. doi: 10.1016/j.visres.2020.07.014 6. Li T, Qureshi R, Taylor K. Conventional occlusion versus pharmacologic penalization for amblyopia. Cochrane Database Syst Rev . 2019;8(8):CD006460. doi: 10.1002/14651858.CD006460.pub3 7. Meier K, Tarczy-Hornoch K. Recent treatment advances in amblyopia. Annu Rev Vis Sci . 2022; 8:323-343. doi:10.1146/annurev-vision-100720-022550 8. Strul S. Understanding digital treatments for amblyopia. Am Acad Ophthalmol . September 24, 2024. Accessed July 1, 2025. www.aao.org 9. Tsani Z, Ioannopoulos D, Androudi S, et al. Binocular treatment for amblyopia: a systematic review. Int Ophthalmol . 2024;44(1):362. doi:10.1007/s10792-024-03259-7 10. Yeritsyan A, Surve AV, Ayinde B, et al. Efficacy of amblyopia treatments in children up to seven years old: a systematic review. Cureus . 2024;16(3): e56705. doi:10.7759/cureus.56705 Approved by ODM on 09/02/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nursing Facility Level of Care-OH MCD-MM-1218 11/01/2025 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 ………………………………………………………………………………………..11 F. Related Policies/Rules ………………………………………………………………………………………….11 G. Review/Revision History ……………………………………………………………………………………….11 H. References …………………………………………………………………………………………………………12 Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNursing Facility Level of Care B. Background Nursing facilities (NFs) provide professional skilled and non-skilled services that facilitate member recovery and stability. Nursing facility care should be considered when a member no longer requires acute care services but continues to need healthcare services that can only be managed in the recovery facility environment. When primarily rehabilitation services are needed, health professionals working in acute care hospitals should recognize members' needs for rehabilitation care and facilitate transition to appropriate rehabilitation care settings. C. Definitions Assistance Per the Ohio Administrative Code (OAC) is the hands-on provision of help in the initiation and/or completion of a task. Hands-on help is generally considered to be any aid in which the caregiver makes direct, physical contact with members to provide assistance with tasks, rather than just supervision or cueing. Intermediate Level of Care (ILOC) A level of care for members whose needs are less than skilled level of care, but more than the protective level of care, and are stable. These members also do not meet the criteria for the ICF-IID-based level of care. The member has a need for a minimum of one of the following: o Assistance with a minimum of 2 activities of daily living o Assistance with a minimum of 1 ADL and medication administration o A minimum of 1skilled nursing service or skilled rehabilitation service o 24-hour support in order to prevent harm due to a cognitive impairment as diagnosed by a physician or other licensed health professional acting within their scope of practice. Intermediate Care Facilities for Individuals with Intellectual Disability (ICF/IID) A place where someone with a disability can choose to live and get the services that help them live their lives with staff and aides who work at the facility 24 hours a day . Level of Care (LOC) The level of services and supports required by an individual to manage medical conditions and/or activities of daily living (ADL) and instrumental activities of daily living (IADL) needs. The criteria for NF based level of care includes an individual requiring assistance with mobility, bathing, grooming, toileting, dressing, and eating. The two levels of care in Ohio that qualify an individual to receive nursing facility-based care are Intermediate LOC and Skilled LOC Long-Term Services and Supports (LTSS) Encompasses an array of medical and personal care services for people who struggle with self-care due to aging, physical, cognitive, or mental conditions or disabilities. People commonly receive LTSS services for months or even years, which is the reason LTSS are sometimes referred to as long-term care. It includes cost-effective, person-centered home and case managed community-based alternatives to institutional care. LTSS include, but are not limited to: o nursing facility care Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o adult daycare programs o home health aide services o personal care services o transportation o assistance provided by a family caregiver Nursing Facility (NF) Institutions that provide nursing and medical care to members who no longer require care in an acute setting, but do require licensed nursing services, rehabilitation services, or other health-related services that must be performed by a skilled, licensed professional on a daily basis that cannot be provided in the home. The nursing facility-based level of care includes both the intermediate and skilled levels of care. Ohio Administrative Code (OAC) The rules adopted by the agencies of the state of Ohio. State agencies adopt rules to carry out the policies and intent of laws passed by the General Assembly. The rules are collected and published in the OAC. Clinical Care Reviewer (CCR) A clinical professional who reviews clinical information, applies criteria, and evaluates the care needs of a member who needs inpatient or outpatient services that require a prior authorization. Preadmission Screening/Resident Review (PASRR) A federal requirement to help ensure that individuals are not inappropriately placed in nursing homes for care. PASRR requirements must be completed prior to an individual being admitted to a Medicaid certified nursing facility. Evidence of PASRR requirements being met must be provided to CareSource at the time of the request for authorization. Protective Level of Care Care provided primarily to assist a member in meeting the instrumental activities of daily living but not requiring nursing facility based care . Protective care can reasonably and safely be provided by non-licensed caregivers in a community setting. Skilled Level of Care Skilled level of care is when: o The member's LTSS needs exceed the criteria for the protective level of care, the intermediate level of care, or the ICF-MR-based level of care. o The member requires either 1 skilled nursing service no less than 7 days a week or one skilled rehabilitation service no less than 5 days a week, or o The member has an unstable medical condition. Skilled Nursing Services Tasks that must be provided by a registered nurse directly or by a licensed practical nurse at the direction of a registered nurse. Skilled Rehabilitation Services Specific tasks that must be provided directly by a licensed or other appropriately certified technical or professional health care personnel. D. PolicyI. CareSource will review all Ohio Medicaid Nursing Facility requests (for admission and continued stays) for skilled and intermediate level of care using OAC 5160-3-08, Criteria for nursing facility-based level of care for an adult and OAC 5160-1-01, Medical Necessity. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 II. Preadmission Screening and Resident Review Requirements CareSource requires evidence that Preadmission Screening and Resident Review requirements have been met prior to the members admission to a NF as part of the prior authorization and level of care review processes in accordance with OAC 5160-3-14 process and timeframes for a level of care determination for nursing facility-based level of care programs, OAC 5160-3-15.1 Preadmission screening requirements for individuals seeking admission to nursing facilities, and OAC 5160-3-15.2 Resident Review requirements for individuals residing in nursing facilities. III. Skilled Level of Care CriteriaCareSource considers skilled care in a nursing facility medically necessary when the following factors have been met: A. Member must have an unstable medical condition as defined in OAC 5160-3- 05(B)(40) in that clinical signs and symptoms are present in an individual and a physician has determined that: 1. The individual's signs and symptoms are outside of the normal range for that individual. 2. The individual's signs and symptoms require extensive monitoring and ongoing evaluation of the individual's status and care, and there are supporting diagnostic or ancillary testing reports that justify the need for frequent monitoring or adjustment of the treatment regimen. 3. Changes in the individual's medical condition are uncontrollable or unpredictable and may require immediate interventions. 4. A licensed health care professional must provide ongoing assessments and evaluations of the individual that will result in adjustments to the treatment regimen as medically necessary. B. The member requires skilled nursing services or skilled rehabilitation services, ie, services that must be performed by or under the supervision of professional or technical personnel, that are ordered by a physician. C. The daily skilled services can be provided only on an inpatient basis in a NF. D. The services delivered are reasonable and necessary for the treatment of a members illness or injury,(ie, are consistent with the nature and severity of the individuals illness or injury), the individuals particular medical needs, and accepted standards of medical practice. E. The member requires a minimum of one of the following: 1. 1 skilled nursing service daily (or more frequently) 7 days per week 2. 1 skilled rehabilitation service daily, at least 5 days per week F. The request meets the requirements of OAC 5160-1-01 Conditions of Medical Necessity. G. There is a therapeutic plan to provide ALL of the following: 1. Case management and evaluation to meet member needs, achieve treatment goals, and ensure medical safety 2. Observation and assessment of member's changing condition to evaluate the need for treatment modification or for additional procedures until condition is stabilized Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Member education to teach member self-maintenance or to teach caregiver member care. H. When they are not safe to perform at a lower level of care, examples of direct skilled nursing services or skilled rehabilitation services include, but are not limited to: Daily nursing treatments are needed for one or more of the following: 1. Intravenous (IV) infusion, IV injection, or intramuscular injection 2. Insulin regimen establishment in presence of unstable blood sugar reading 3. Tube feeding (eg, gastrostomy tubes, jejunostomy tubes percutaneous endoscopic gastrostomy (PEG) tubes, nasogastric tubes) required because member needs feeding to supply at least 26% of daily calories and at least 501 mL of daily fluids 4. Nasopharyngeal or tracheostomy suctioning and suprapubic catheter irrigation 5. Pain management for infusion of pain medications 6. Wound care that requires dressing changes with prescription medication or clean technique and treatment for: 01. Burns 02. Foot infections or wounds 03. Open lesions 04. Surgical wound complications 05. Treatment with any stage III or IV pressure injury 06. Treatment with 2 or more wounds, including venous ulcers, arterial ulcers, or stage II pressure injuries 07. Widespread skin disorder treatments 7. Heat treatments that require nurse observation to evaluate response 8. Oxygen administration, starting or managing changes, including ventilator 9. Member care training and assistance for 1 or more of the following: 01. Exercise program (eg, range of motion, pulmonary, cardiac) 02. Preventing complications and the start or revision of the member's maintenance therapy plan 03. Safe performance of ADL (eg, dressing, communicating, eating) 04. Splint, brace, cast, prosthesis, or orthosis management 05. Urinary or bowel toileting program 10. Pain management for infusion of pain medications I. Rehabilitation therapy treatments (PT, OT, or SLP) are needed for 1 or more of the following: 1. Ongoing assessment of rehabilitation needs and potential (eg, range of motion, strength, balance) 2. Supervision of therapeutic exercises or activities to ensure member safety and treatment effectiveness 3. Gait evaluation and training 4. Preventing complications and the start or revision of the member's maintenance therapy plan 5. Therapy modalities that require PT or OT observation to evaluate response Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 6. Restoration of speech or swallowing with services of speech-language pathologist 7. Prosthetic evaluation and training. III. Intermediate Level of Care CriteriaFor members needing assistance that cannot safely be performed at a lower level of care or the resources to provide the needed care and services in a home or community-based setting are not available, the Intermediate Level of Care (ILOC) is a lower cost alternative that effectively addresses and treats the medical problem, as described in OAC 5160-1-01, Medicaid medical necessity: definitions and principles. Criteria include, but are not limited to: A. The individual's needs for long-term services and supports (LTSS) exceed the criteria for the protective level of care. B. The individuals LTSS needs are less than the criteria for the skilled level of care. C. Individual requires assistance (not necessarily a licensed professional) with the completion of a minimum of two activities of daily living (ADL) as outlined below: 1. Assistance with mobility in at least one of the following components: a. bed mobility b. locomotion c. transfer 2. Assistance with bathing 3. Assistance with grooming in ALL of the following components: a. oral hygiene b. hair care c. nail care 4. Assistance with toileting in at least one of the following components: a. Using a commode, bedpan, or urinal b. Changing incontinence supplies or feminine hygiene products c. Cleansing self d. Managing an ostomy or catheter 5. Assistance with dressing in at least one of the following components: a. Putting on and taking off items of clothing or prosthesis b. Fastening and unfastening an item of clothing or prosthesis 6. Assistance with eating D. Assistance with the completion of a minimum of 1 ADL and assistance with medication administration (ADLs listed in III C 1-6), which is required due to 1. Medication administration is required due to members inability to safely self- manage medications. Reasons may include but are not limited to: a. Does not know current medications b. Lacks insight into reasons medications are prescribed c. Lacks ability to take medications as ordered due to cognitive impairment E. Need for 24 hour support in order to prevent harm due to a cognitive impairment. Examples may include: 1. Member resides in a locked dementia unit 2. Negative results of mini mental status exam Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 F. Direct skilled rehabilitation services less than 5 days per week G. Wound care that cannot be done in the community (wounds less than stage III).NOTE: Members already enrolled in NF services, in particular those requiring intermediate care, should be individually assessed for medical necessity. CareSource supports lower cost alternatives that effectively address the problem. For example, home health or family caregivers, are viable and medically appropriate options. IV. Documentation to Support Nursing Facility-Based Care DeterminationsA. The CareSource prior authorization form or the ODM Nursing Facility Request Form will be accepted for submission of requests. B. PASRR Documentation. One of the following is required at the time of the initial request for nursing facility services: 1. PASRR Level I screen and preadmission screen (PAS) or resident review (RR) results 2. PASRR Level II evaluation and results, if indicated 3. Hospital Exemption Notice (for stays expected to be less than 30 days). Note: For stays in which the hospital exemption notice was submitted at the time of the initial request and the stay is expected to or exceeds 30 days, the PASRR Level I or II, determined by indications of serious mental illness and/or developmental disabilities or related conditions for the member, and resident review results are required to be submitted to CareSource. C. The members medical record must document all the following: 1. The history and physical exam pertinent to the members care including the response or changes in behavior to previously administered skilled services 2. The skilled services provided 3. The plan for future care based on the rationale of prior results 4. A detailed rationale that explains the need for the skilled service in light of the members overall medical condition and experiences 5. The complexity of the service to be performed 6. A decline in physical function compared to the prior level of function (PLOF) 7. Inability to safely ambulate household distance (50 feet) 8. The member requires minimum assist to perform mobility-related activities of daily living (MRADLs) 9. The need for active assistance (hands-on vs. supervision) 10. The documentation in the members medical record must be accurate and avoid vague or subjective descriptions of the members care that would not be sufficient to indicate the need for skilled care 11. Updated clinical evaluation to support on-going concurrent review 12. The services promote the documented therapeutic goals 13. Minimum Data Set (MDS) documentation of cognitive, mood, functional performance, DME use, and/or nutritional status 14. Complete discharge planning assessment and ongoing changes to the plan Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 NOTE: The treatment goal cannot be modified retrospectively.V. Bed-Hold Days A. In accordance with OAC 5160-3-16.4, CareSource will provide payment to a NF provider to reserve a bed for not more than 30 days in any calendar year when: 1. A member is authorized by CareSource for the nursing facility stay at either the skilled or intermediate level of care. 2. A member is not discharged from the NF. 3. A member, who is a resident of the NF, is temporarily absent from the NF due to a hospitalization, therapeutic leave, or visitation with friends or relatives and has the intent and ability to return to the same NF. B. Bed-hold days do not require prior authorization. VI. Non-covered services in a NFClinical documentation that does not support the medical necessity requirements outlined in OAC 5160-1-01 that meets, at a minimum, the ILOC criteria for the following services: A. Repetitious exercises to improve gait, or to maintain strength and endurance and assistive walking can be appropriately provided by supportive personnel. B. When the performance of a maintenance program does not require the skills of a therapist because it could safely and effectively be accomplished by the member or with the assistance of non-therapists, including unskilled caregivers. C. General exercises to promote overall fitness and flexibility and activities to provide diversion or general motivation or the supervision of taught exercises. D. Lack of a competent person to provide a nonskilled service regardless of the importance of the service to the member, does not make it a skilled service when a nurse provides the service. E. Protective LOC services. F. Services not expected to produce the desired outcome. VII. Transitioning from a Nursing FacilityA. Evaluation 1. As part of the discharge planning process and in conjunction with the nursing facility staff, CareSource Case Management (CM) may evaluate a member receiving nursing facility care and services for potential for referral to home and community-based services and/or other state and local resources to assist members in receiving needed services in the least restrictive environment. 2. In compliance with OAC 5160-1-01, members will be reassessed. When the member no longer meets the medical necessity criteria for skilled or intermediate nursing facility care, CareSource will evaluate for discharge to the community (ie, home with needed services and supports). 3. In compliance with OAC 5160-1-01, if the member no longer meets the skilled level of care, or intermediate level of care, CareSource will evaluate for Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 discharge to an appropriate community setting that will meet the members care needs.4. After an initial evaluation period, the UM clinical care reviewer must evaluate the members progress. This initial evaluation may be followed by case management. These reports will include clinical review from the members care team including documentation from facility discharge planning staff. 5. CareSource may perform a re-evaluation of members to identify any changes that require modification of the treatment plan and incorporate these into discharge planning. B. Discharge Planning 1. CareSource expects discharge planning for all members admitted to a nursing facility to begin immediately upon admission. Discharge planning should not be delayed until the member is stable for discharge as this frequently leads to unnecessary delays in a discharge and unnecessary lengthening of the members facility stay. Discharge planning includes: 1. Treatment plan development involving providers engaged in members care 2. Evaluation of members premorbid functioning compared to current state 3. Member and caregiver preferences and abilities 4. Evaluation for services at next level of care as appropriate for member's continued needs 5. Housing 6. Evaluation of psychosocial status and needs 7. Coordination of follow up appointments, planned or scheduled 8. Transportation 9. Coordination of prescription medications and treatments to be available to member upon discharge 10. Home care services, if applicable 11. Referrals made for assistance and support including to state and local programs and/or community-based organizations 12. Medical equipment and supplies coordinated 13. Transition plan communicated to all members of member's care team 2. CareSource Utilization Management (UM) and Case Management (CM) will work, either in-person or via telephonic outreach, with the Nursing Facility to ensure a safe and timely discharge for our members. This collaboration should start within 3 days of the members admission to the NF. 3. The NF must develop and share with CareSource UM during each review a post-discharge plan of care to address the anticipated needs of a member for discharge to a private residence, to another NF, or to another type of residential facility such as a group home, medical respite facility, sober living home, or an intermediate care facility for individuals with intellectual disabilities. 4. Upon request, the discharge plan must be shared with CareSource CM. C. Discharge Criteria Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 Once skilled nursing services (ie, wound care, IV or IV antibiotics treatment) and/or rehabilitation have been completed for safe transfer to lower level of care OR the member is no longer demonstrating significant functional gains and does not meet criteria for intermediate or skilled level of care, the following criteria must be completed prior to discharge: 1. Medication regimen has been established and reconciliation completed. 2. Medical status is stable for member's condition and manageable at lower level of care. 3. Any inserted or implanted device discontinued, or functioning normally and manageable at lower level of care. 4. Medical equipment and supplies are available at next level of care and safe use has been demonstrated. 5. Wound(s) or dressing changes are manageable at a lower level of care. 6. Skilled services (as needed) and logistical requirements can be met at a lower level of care. 7. Transition plans and education are understood by the member and/or the caregiver. D. MCO Initiated Nursing Facility Disenrollment Process 1. Requests for member disenrollment from managed care to fee for service Medicaid due to a need for extended nursing facility care must be submitted to the Ohio Department of Medicaid by CareSource. Approval of disenrollment requests are made at the discretion of ODM. 2. To be eligible for a request for disenrollment from managed care to be submitted to ODM, the member must meet all of the following criteria: a. Be enrolled in a Medicaid category identified by the Ohio Department of Medicaid as eligible for disenrollment. b. Be authorized by CareSource for the NF stay and have a continuous stay in the nursing facility for no less than the month of admission and two complete consecutive months thereafter. c. The members discharge plan documents that nursing facility discharge is not expected in the foreseeable future and the member has a need for long-term nursing facility care. d. The member has not used hospice services during the period outlined in (D)(2)(b). e. In addition, when a member meets criteria outlined in D.2 a, c, and d, the following scenarios are considered: i. If a member is admitted to a nursing facility while enrolled with another MCO and changes to CareSource, CareSource will align the disenrollment request to the disenrollment table dates. ii. If the admission date to the nursing facility is greater than three months prior to enrollment with CareSource, CareSource will submit the disenrollment request during the initial enrollment month to disenroll the member the last calendar date of the month prior to the initial enrollment. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 iii. If a member is admitted to a nursing facility prior to being enrolled withCareSource and was admitted under fee-for-service Medicaid, CareSource will submit a disenrollment request during the initial enrollment month to disenroll the member the last calendar date f the month prior to initial enrollment. If the disenrollment request is not submitted in the initial month, the member will be disenrolled as of the last calendar date of the submission month. 3. When the member is identified as eligible for potential disenrollment as outlined in step D 2, CareSource will submit the request for disenrollment to ODM. NOTE : Modified Adjusted Gross Income (MAGI) Medicaid members in the Adult Extension (MAGI Group 8) category may not be disenrolled. 4. Requests for disenrollment will be submitted in the format specified by ODM. The disenrollment table lists the earliest disenrollment date if all criteria is met. See disenrollment table below: Month of Nursing Facility AdmissionNext Two Consecutive Months Earliest Disenrollment Date January February & March March 31 February March & April April 30 March April & May May 31 April May & June June 30 May June & July July 31 June July & August August 31 July August & September September 30 August September & October October 31 September October & November November 30 October November & December December 31 November Dec. & Jan. (next CY) January 31 (next CY) December January & February (next CY) Last Day of February (next CY) E. Conditions of CoverageNA F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 09/01/2021 New PolicyNursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 Date Revised 05/11/2022 08/09/2022 05/10/2023 07/16/2024 07/30/2025Updated references; no changes E-voted adding new section V. on Bed-Hold days Changed Member Care Coordinator (PCC) to Clinical Care Reviewer (CCR). Added Preadmission Screening and Resident Review requirements to align with Provider Agreement. Added sections IV. A and Bto align with Provider Agreement and reporting requirements. Updated references. Approved at Committee. Updated section IV.B.3 documentation for the Hospital Exemption Notice. Added to section V. Bed-hold Days criteria. Checked with Legal on current contract. Updated references. Approved at Committee. Changed MCP to MCO to align language to the current provider agreement; Added disenrollment language from the new contract. Date Effective 11/01/2025 Date Archived H. References1. ASPE. An Overview of Long-Term Services and Supports and Medicaid: Final report. May 8, 2018. Accessed July 7, 2025. www.hhs.gov 2. CareSource Desk Reference. Nursing Facility Disenrollment Process. July 1, 2019. Accessed June 2, 2025. www.CareSource.com 3. CareSource Procedure. Utilization Management-Level of Care. 2023. Accessed June 12, 2025. www.CareSource.com 4. CG-GRFAC (RFC) General Recovery Facility Comparison Tool. MCG Guidelines. 28th ed. 2024. Accessed June 12, 2025. www.careweb.careguidelines.com 5. CMS. Long Term Services & Supports. 2016. June 2, 2025. www.cms.gov 6. Criteria for Nursing Facility-Based Level of Care, O HIO ADMIN . C ODE 5160-3-08 (2025). 7. Criteria for the protective level of care. O HIO ADMIN . C ODE 5160-3-06 (2025). 8. Level of Care Definitions, O HIO ADMIN . C ODE 5160-3-05 (2025). 9. Managed Care: Termination of Enrollment, O HIO ADMIN . C ODE 5160-26-02.1 (2023). 10. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . C ODE 5160-1-01 (2022). 11. Nursing Facilities (NFs): Covered Days and Bed-Hold Days, O HIO ADMIN . C ODE 5160-3-16.4 (2017). 12. Nursing Home and Residential Care Facility Definitions, O HIO R EV . C ODE 3721.01 (2023). 13. ODM. Nursing Facility Request Form. Accessed June 12, 2025. www.medicaid.ohio.gov 14. Process and timeframes for a level of care determination for nursing facility-based level of care programs. O HIO ADMIN . C ODE 5160-3-14 (2025). 15. Skilled Nursing, O HIO R EV . C ODE 3721.011 (2023). ODM approved 08/13/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588 09/01/2025 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 ………………………….. ………………………….. ………………………….. …… 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNoninvasive Home Mechanical Ventilation B. BackgroundThis document outlines the medical necessity criteria for a noninvasive home ventilator for a member with stable, chronic respiratory failure. This device does not treat the underlying cause of respiratory failure but functions as supportive therapy, which may include reducing symptoms, improving quality of life, or sustaining or extending life. It may be used intermittently during the day and/or during sleep. A noninvasive home ventilator will not be reimbursed as such when its sole purpose is to function as a respiratory assistance device, including continuous positive airway pressure (CPAP), auto-titrating PAP, and bilevel airway pressure (BiPAP).C. Definitions Apnea-Hypopnea Index (AHI) The combined average number of apneas and hypopneas that occur per hour of sleep to determine the severity of obstructive sleep apnea (OSA) . Apnea-Hypopnea Index (AHI) Adult AHI Pediatric AHIMild OSA 5-14 1-4.9Moderate OSA 15 – 30 5-9.9 Severe OSA > 30 > 10 Bi-level Positive Airway Pressure (B iPAP) Device A device that uses mild bi – level or 2 levels of air pressure to keep breathing airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep breathing airways open. Home Mechanical Ventilation (HMV) A device used in the home setting for patients with chronic respiratory failure that delivers respiratory assistance via an invasive (ie, tracheostomy) or noninvasive (ie, nose/mouth mask, mouthpiece , nasal prongs) interface. These devices possess more advanced features than a CPAP/BiPAP machine, which include monitoring, rate control, safety, and backup power features. The ventilator can custom control a ll phases of the breathing cycle . D. PolicyI. CareSource utilizes Ohio Administrative Code and MCG Health criteria to determine medical necessity for noninvasive HMV (E0466) . An initial approval for HMV is valid for a maximum of 3 months. A new medical necessity determination thereafter is required every 6 months for continued rental use. II. Initial Rental of HMVMedical necessity for the initial coverage of noninvasive HMV is based upon the following conditions in II – IV being met : Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 A. Congenital central hypoventilation syndromeB. Chronic lung disease of infancy (eg, bronchopulmonary dysplasia), and patient unable to maintain acceptable pH and PCO 2 without ventilator support C. Chronic obstructive pulmonary disease (COPD) and ONE OR MORE of the following: 1. Chronic hypercapnia with PaCO 2 of 50 mm Hg (6.7 kPa) to less than 52 mm Hg (6.9 kPa) and at least ONE of the following: a. Arterial oxygen saturation 88% for 5 consecutive minutes during nocturnal oximetry while on at least 2 liters of oxygen per minute . b. Invasive or noninvasive ventilation for acute exacerbation required during 2 or more hospitalizations per year . 2. Chronic hypercapnia with PaCO 2 of 52 mm Hg (6.9 kPa) or greater 3. Palliative care for end-stage disease and advance directive states no desire for intubation D. Neuromuscular disorder accompanied by chronic respiratory failure , as indicated by the following: Documentation of respiratory failure, as indicated by ONE OR MORE : 1. Arterial O2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry 2. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) 3. Forced vital capacity less than 50% of predicted 4. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure 5. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower 6. Maximum sniff nasal inspiratory pressure less than 40 cm H 2O (3923 Pa) 7. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: a. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . b. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater) . E. Obesity hypoventilation syndrome , as indicated by ALL of the following: 1. BMI > 30 2. CPAP unsuccessful or not appropriate , as indicated by ONE OR MORE of the following: a. Comorbid sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer ) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 b. Intolerance of CPAP pressures necessary to correct obstructive sleep apnea (OSA) component (ie, difficulty exhaling against fixed airway pressure) c. Lack of resolution of hypercarbia, nocturnal desaturation, and OSA despite 3 months of CPAP use d. Titration study demonstrates OSA despite CPAP 15 cm H 2O (1471 Pa) that is responsive to BiPAP 3. Daytime hypercapnia with PaCO 2 greater than 45 mm Hg (6.0 kPa) without other etiology (eg, kyphoscoliosis, lung parenchymal disease, myopathy, severe hypothyroidism) 4. Sleep-disordered breathing or hypoventilation on polysomnography, as indicated by ONE OR MORE of the following: a. Apnea-hypopnea index of 5 or greater b. Increase in PaCO 2 during sleep by more than 10 mm Hg (1.3 kPa) above value while awake c. Significant oxygen desaturation (eg, less than 90%) not explained by obstructive apneas or hypopneas 5. TSH level does not demonstrate hypothyroidism F. OSA in child or adolescent and ONE OR MORE of the following: 1. Mild OSA (ie, apnea-hypopnea index from 1 to 5) and ONE OR MORE of the following: a. achondroplasia b. behavioral problems c. cardiovascular disease (eg, elevated blood pressure, pulmonary hypertension) d. Chiari malformation e. craniofacial abnormalities f. Down Syndrome g. excessive daytime sleepiness h. impaired cognition i. inattention or hyperactivity j. mucopolysaccharidoses k. neuromuscular disorders l. Prader-Willi syndrome 2. Moderate or severe OSA (ie, apnea-hypopnea index greater than 5) 3. Residual apnea-hypo pnea index greater than 5 in pediatric patient after adenotonsillectomy G. Restrictive disorder of chest wall , as indicated by ALL of the following: 1. Appropriate chest wall disorder as indicated by ONE OR MORE of the following: a. asphyxiating thoracic dystrophy b. kyphoscoliosis c. other chest wall disorder accompanied by chronic respiratory failure (eg, ankylosing spondylitis, fibrothorax, post-tuberculous chest wall deformity) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 2. Documentation of respiratory failure as indicated by ONE OR MORE of the following : a. Arterial O 2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry b. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) c. Forced vital capacity less than 50% of predicted d. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure e. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower f. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: 01. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . 02. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater ). III. Respiratory status is STABLE , as indicated by ALL of the following:A. Airway interface is safe with a n oninvasive interface with acceptable fit . B. Airway pressure requirement appropriate, as indicated by ONE OR MORE of the following: 1. BiPAP expiratory positive airway pressure requirement is to 10 cm H 2O (981 Pa). 2. CPAP pressure requirement in child is 15 cm H 2O (1471 Pa). 3. Ventilator positive end-expiratory pressure requirement is 10 cm H 2O (981 Pa). C. Oxygen requirement does not exceed FiO 2 of 40%. D. Settings are stable on chosen device. E. No continuous invasive monitoring is required. IV. A BiPAP or CPAP device must not be clinically appropriate as indicated by ONE ORMORE of the following. A. Chronic respiratory insufficiency fails to improve with simple BiPAP device. B. Infant or child does not meet the minimum body weight requirement for CPAP device. C. Infant or child is not appropriate for simple BiPAP device due to setting or performance requirements, as indicated by ONE OR MORE of the following: 1. Breath rates delivered by device not appropriate for patient . 2. Compatible ventilator circuits not appropriate for patient (eg, circuit compliance, compressed volume, dead space) . Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 3. Inspiratory flows delivered by device not appropriate for patient .4. Patient does not meet ventilator minimum body weight requirements. 5. Pressure range (eg, expiratory pressure, inspiratory pressure) not appropriate for patient . 6. Tidal volume range delivered by device not appropriate for patient . 7. Ventilator inspiratory trigger delay (ie, airway pressure rise time) not appropriate for patient . 8. Ventilator inspiratory trigger sensitivity not appropriate for patient . D. The following setting or functionality is required by the member and is not available with simple BiPAP device: 1. Alarms required by member are not available on the device . 2. Daytime ventilation using mouthpiece is required . 3. Pressure range delivered by device is not appropriate for member . 4. Member requires volume-assured pressure support or volume control mode (eg, obesity hypoventilation syndrome). E. Ventilated patient requires cough assistance via volume ventilator’s breath stacking capability. F. Ventilation is required 24 hours per day. V. HMV Continued UseFor HMV continued use beyond the initial 3-month determination, medical necessity must be reestablished every 6 months thereafter . The following is to be provided for continued use: A. Re-evaluation by the treating medical professional must be completed no earlier than 61 days after initiating therapy. B. Documentation of the persistence of the disease process for which HMV has been prescribed. C. Medical records must document that the member is compliant with and benefitting from HMV. D. At least 30 consecutive days of device data, beginning after 31 days of initiation, demonstrating that the member is utilizing the device an average of 4 hours per 24-hour period. NOTE: Failure of the member to consistently use HMV for an average of 4 hours per 24-hour period would demonstrate non-compliant utilization of the device for its intended purpose and expectation of benefit, which would constitute a denial in continued coverage as not reasonable and necessary . E. Additional information as requested. VI. In accordance with Rule 5160-10-01 for each claim, the provider cannot legitimately receive payment until necessary supporting documents have been obtained and placed in the providers files. These documents include the prescription and the following items: A. A completed CMN form: ODM 01902 . Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 B. Practitioner order and chart notes , which support the determination of medical necessity , including ventilator settings . VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.VIII. ExclusionsAny application for a noninvasive home ventilator (E0466) not meeting the criteria above will be denied as being not medically necessary, including but not limited to when its sole purpose is to function as a respiratory assistance device, including settings of CPAP, auto-titrating PAP, Bilevel positive airway pressure (BiPAP, BPAP), average volume assured pressure support (AVAPS) with or without auto EPAP (AE), or intelligent volume assured pressure support (iVAPS). E. Conditions of CoverageI. Claims for ventilators being utilized to provi de CPAP or BiPAP therapy for conditions described above and are submitted with HCPCS code E0466, will be denied as not being reasonable and necessary. If a HMV is dispensed to a Member for CPAP or BiPAP therapy, the claim must be coded in accordance with CareSource policy, Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental . All requirements in D. I. -V. of this policy must be satisfied for HMV to be considered medically necessary. II. CareSource may verify the use of the equipment through post-payment audit andrequest additional supporting medical record documentation. If the use of a more appropriate code or piece of equipment is warranted, CareSource may request recoupment.F. Related Policies/RulesDMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental Overpayment Recovery G. Review/Revision HistoryDATE ACTIONDate Issued 05/22/2024 New Policy, Approved at CommitteeDate Revised 06/04/2025 Annual review: Added E.II. , Updated Exclusions to include AVAPS, EPAP, iVAPS; Approved at Committee Date Effective 09/01/2025 Date Archived Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 H. References 1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi: 10.1513/AnnalsATS.201810-657CME 2. DMEPOS: Ventilators, OHIO ADMIN . CODE 5160-10-22 (2021). 3. Dudgeon D. Assessment and management of dyspnea in palliative care. UpToDate. Updated April 04, 2025 . Accessed April 16, 2025 . www.uptodate.com 4. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (2024). 5. Ferrell BR, Twaddle ML, Melnick A, et al. National Consensus Project clinical practice guidelines for quality palliative care guidelines, 4th edition. JPalliative Med . 2018;21(12): 1684-1689. doi:10.1089/jpm.2018.04311684 6. Freedman N. Treatment of obstructive sleep apnea: choosing the best positive airway pressure device. Sleep Med Clin . 2020;15(2):205-218. doi:10.1016/j.jsmc.2020.02.007 7. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated February 5, 2025 . Accessed April 16, 2025 . www.uptodate.com 8. Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive summary: optimal NIV Medicare access promotion: a technical expert panel report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest . 2021;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074 9. Hansen-Flaschen J, Ackrivo J. Practical guide to management of long-term noninvasive ventilation for adults with chronic neuromuscular disease. Resp Care . 2023;68(8):1123-1157. doi:10.4187/respcare.10349 10. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes of ventilatory support. UpToDate. Updated November 13, 2024 . Accessed April 16, 2025 . www.uptodate.com 11. Home Ventilator (Invasive or Noninvasive Interface ): ACG A-0893. MCG Health . 2 8th ed. Accessed May 16 , 2024. www.careweb.careguidelines.com 12. Khan A, Frazer-Green L, Amin R, et al. Respiratory management of patients with neuromuscular weakness: an American College of Chest Physicians clinical practice guideline and expert panel report. Chest . 2023;164(2):394-413. doi:10.1016/j.chest.2023.03.011 13. Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate . Updated October 9, 202 4. Accessed April 16, 2025 . www.uptodate.com 14. Macrea M, Oczkowski S, Rochwerg B, et al. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease: an official American Thoracic Society clinical practice guideline. Am JResp Crit Care Med . 2020;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST 15. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated March 4, 2024. Accessed April 16, 2025 . www.uptodate.com Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588 Effective Dat e: 09/01/2025 The MEDICAL Po l i c y St a t e m e nt d e t ai l e d a bo v e h a s r ecei v e d due c on si d e ra t i o n a s d e f i n e d i n the MEDICAL Po li c y St a t e m e nt Po li c y a nd i s a pp r o v e d. 9 16. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 1 0.1177/019459981880175717. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasive ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev .2021;8:CD002878. doi:10.1002/14651858.CD002878.pub318. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinical practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.0176619. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest .2020 ;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007I nd e pe n de nt Med i ca l Re v iew 05/08/24 Approved by ODM 06/10/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Penile Implants in the Treatment of Erectile Dysfunction B. Background Erectile dysfunction (ED) is the consistent or recurrent inability to acquire or sustain an erection, and the most common sexual problem affecting males. Surveys suggest 5-10% of men between the age s of 20 to 30 are a ffected, and that number increas es to 35-40 % of men aged 70 or older . The National Institutes of Health (NIH) estimates that up to 30 million men experience erectile dysfunction. Various treatment modalities exist for ED. One treatment option is a surgical penile implant (also called a penile prosthesis) . A penile implant is indicated when there is a clear medical cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments. A basic penile prosthesis consists of a pair of bendable, silicone rods that are surgically implanted within the erection chambers of the penis. Identification of the underlying etiology is an important first step. This includes ruling out the adverse effects of medication(s), identifying, and treating risk factors. C. Definitions Erectile Dysfunction The consistent or recurrent inability to acquire or sustain an erection. Neurogenic Impotence Nervous system issues affecting the ability to maintain or have an erection . Vascular Impotence Restricted or d ecreased blood flow to the penis causing impotence . D. Policy I. Medication is the f irst line of treatment for ED , including A. oral phosphodiesterase type 5 inhibitors B. intra-urethral alprostadil C. intracavernous vasoactive drug injections Ohio Medicaid does not cover m edications including oral, injectable, and transdermal varieties for the treatment of erectile dysfunction. II. External penile pumps or vacuum constr iction devices (VCD) are the s econd line of treatment after first line therapy has failed. III. Ohio Medicaid does not cover e xternal penile pumps and vacuum constr iction d evices . Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3IV. Internal penile prosthetic implants are covered in extraordinary circumstances . They are consi dered medically necessary when ALL of the following conditions are met: A. First and second line therapy have been documented as ineffective , or there is a compelling, well documented reason to proceed with surgery without a failed trial of first and second-line therapies. B. Absence of active alcohol or substance use disorder as documented in the medical record. C. Absence of drug induced impotence related to ALL of the following: 1. anabolic steroid use 2. anticholinergics 3. antidepressants 4. antipsychotics or central nervous system depressants D. Neurogenic impotence due to ONE of the following: 1. diabetes 2. fractured pelvis 3. m ajor surgery of the pelvis, retroperitoneum, radical prostatectomy, or colorectal surgery 4. m ultiple sclerosis 5. spina bifida 6. spinal cord injury/disease 7. syringomy elia OR E. Vascular impotence due to ONE of the following: 1. hypertension 2. intrapenile arterial disease 3. penile fracture 4. Peyronies disease 5. smoking 6. status post cavernosal infection 7. impotence due to radiation therapy to the pelvis or retroperitoneum V. Internal penile prosthetic implant removal is considered medically necessary when ANY of the following occur: A. infection B. mechanical failure C. urinary obstruction D. intractable pain E. Conditions of Coverage N/A F. Related Polic ies/Rules N/A Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4G. Review/Revision History DATE ACTIONDate Issued 07/26/2016Date Revised 05/13/2020 05/11/2022 05/10/2023 05/08/2024 06/18/2025Updated References, Updated Background information, condensed medical criteria. Added penile implant information to Background; updated references. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee.Date Effective 09/01/2025 Date Archived H. References1. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. JUrology. 2018;200:633-641. doi:10.1016/j.juro.2018.05.004 2. Khera M. Treatment of male sexual dysfunction. UpToDate. Updated October 24, 2023. Accessed June 3, 2025. www.uptodate.com 3. Lazarou S. Surgical treatment of erectile dysfunction. UpToDate. Updated November 14, 2023. Accessed June 3, 2025. www.uptodate.com 4. Pharmacy Services: Covered Drugs and Associated Limitations, O HIO ADMIN . CODE 5160-9- 03(B)(3) (2024). 5. Urologic Surgery or Procedure GRG: SG-US. MCG Health. 28th ed. Updated February 1, 2024. Accessed June 3, 2025. www.careweb.careguidelines.com Inde pendent med ica l rev iew 05/2020Approved by ODM on 6/23/2025 .
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