MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Medical Interventions for Gender Dysphoria-OH MCD-MM-0034 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 ……………………………………………………………………………………… 4 F. Related Policies/Rules ……………………………………………………………………………………….. 4 G. Review/Revision History …………………………………………………………………………………….. 4 H. References ………………………………………………………………………………………………………. 4 02/07/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 Medical Interventions for Gender Dysphoria-OH MCD-MM-0034 Effective Date: 02/07/2026A.SubjectMedical Interventions for Gender DysphoriaB.BackgroundState Medicaid programs have a responsibility to ensure that payments are consistent with efficiency, economy, and quality of care under Section 1902(a)(30)(A) of the Social Security Act. Section 1902(a)(19) requires that states provide such safeguards as may be necessary to ensure that covered care and services are provided in a manner consistent with the best interests of recipients. Agencies have a basic obligation to ensure the quality of Medicaid-covered care and that such care is provided in a manner consistent with the best interest of beneficiaries.Federal matching funds may not be claimed for any sterilization procedure performed on an individual under age 21, 42 C.F.R 441.253(a). Specifically, federal financial participation is unavailable for any procedure, treatment or operation done for the purpose of permanently rendering an individual incapable of reproducing, 42 C.F.R. 441.251. Additionally, 42 C.F.R. 441.255(a) prohibits financial federal participation for any hysterectomy performed solely for sterilization. All sterilization procedures must also meet the consent and waiting-period requirements set forth in 42 C.F.R. 441.252.254.C.Definitions Cross-Sex Hormone Testosterone, estrogen, or progesterone given to a minor individual in an amount greater than would normally be produced endogenously in a healthy individual of the minor individual’s age and sex. Early Periodic Screening, Diagnosis and Treatment (EPSDT) Program A comprehensive preventive health program for individuals under age 21 that requires coverage of any service necessary to correct or ameliorate defects, physical and mental illnesses and conditions discovered by screening. 42 C.F.R. 441.50 et seq. Gender Dysphoria Affective and/or cognitive discontent accompanying incongruence between experienced or expressed gender and assigned gender, lasting at least 6 months and meeting diagnostic criteria listed in the DSM-5-TR. Gender Reassignment Surgery Any surgery performed for the purpose of assisting an individual with gender transition that seeks to surgically alter or remove healthy physical or anatomical characteristics or features that are typical for the individual’s biological sex, in order to instill or create physiological or anatomical characteristics that resemble a sex different from the individual’s birth sex, including genital or non-genital gender reassignment surgery. Gender-Related Condition Any condition where an individual feels an incongruence between the individual’s gender identity and biological sex, including gender dysphoria. Gender Transition Services Any medical or surgical service (including physician services, inpatient and outpatient hospital services, or prescription drugs or hormones) provided for the purpose of assisting an individual with gender transition The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 that seeks to alter or remove physical or anatomical characteristics or features that are typical for the individuals biological sex, or to instill or create physiological or anatomical characteristics that resemble a sex different from the individuals birth sex, including medical services that provide puberty blocking drugs, cross-sex hormones, or other mechanisms to promote the development of feminizing or masculinizing features in the opposite sex, or genital or non-genital gender reassignment surgery. Minor Any member under the age of 18. Puberty-Blocking Drugs Gonadotropin-releasing hormone analogs or other synthetic drugs used to stop luteinizing hormone and follicle stimulating hormone secretion, synthetic antiandrogen drugs used to block the androgen receptor or any drug to delay or suppress normal puberty. D. Policy I. CareSource complies with state and federal regulations for the coverage of medically necessary services. Medically necessary services are health care services needed to diagnose or treat that meet the accepted standards of medicine. 42 C.F.R. 440.230. All requests are reviewed on a case-by-case basis, including any applicable requests under the Early Periodic Screening, Diagnosis and Treatment (EPSDT) program. II. For any member under the age of 18, Ohio Revised Code 3129.06 prohibits coverage of gender transition services, subject to certain exceptions as follows: A. mental health services provided for a gender-related condition B. treatment, including surgery or prescribing drugs or hormones, to a minor who 1. was born with a medically verifiable disorder of sex development 2. received a diagnosis of a disorder of sexual development 3. needs treatment for any infection, injury, disease, or disorder that has been caused or exacerbated by the performance of gender transition services III. Any member 18 to 20 years of age, as per 42 CFR 441.56 and 42 U.S.C. 1396d(r), will be reviewed for medical necessity as required by the EPSDT program (ie, Ohio Healthchek). CareSource will cover medically necessary care if deemed essential by a healthcare provider, including gender-related care. IV. For any member 21 years of age or older, Ohio Administrative Code 5160-2-03 establishes that gender transformation services are not covered services (eg, clitoroplasty, intersex surgery, vaginectomy, penectomy, mastectomy, breast augmentation). V. All behavioral health services for gender dysphoria will be subject to the same utilization management and cost-sharing requirements as other behavioral and medical benefits in compliance with Mental Health Parity and Addiction Equity Act. 42 U.S.C. 300gg-26; 45 C.F.R. Part 146. Medical Interventions for Gender Dysphoria-OH MCD-MM-0034 Effective Date: 02/07/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 Dates Action Date Issued 05/18/2017 Date Revised 05/29/2019 09/02/2020 07/07/2021 05/19/2022 06/21/2023 07/17/2024 07/02/2025 Updated evidence, changed policy # (MM-0080), removed pharmacy info, added addtl requirements for surgery, specifics on hair removal, items not covered & types of surgery for medical necessary review. Updated definitions, removed research & codes, added references, changed letter recommendation requirement, changed title. Removed endocrinologist rule, added psych NP & safety info. Annual review. Updated definitions. Added PCP to hormone therapy requirement. Removed conception counseling for genital surgery. Removed breast augmentation from the exclusion list. Annual review. Updated background, definitions, reference list. Approved at Committee. Annual review. Top changed to chest, bottom to genital. Updated background & definitions. Combined letter info. Updated references. Approved at Committee. Rewrote background to comply with 2025 CMS letter. Revised all sections re: compliance with regulations. Approved at Committee. Date Effective Date Archived H. References 1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR). Arlington, VA; 2022. 2. Conditions and Limitations. OHIO ADMIN. CODE 5160-2-03 (2022). 3. Definitions. 42 U.S.C. 1396d(r) (2024). 4. Gender Transition Services for Minors. OHIO REV. CODE Chapter 3129 (2024). 5. Healthchek: Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Covered Services. OHIO ADMIN. CODE 5160-1-14 (2017). 6. Medicaid Medical Necessity: Definitions and Principles. OHIO ADMIN. CODE 5160-1-01 (2022). 7. Puberty Blockers, Cross-sex Hormones, and Surgery Related to Gender Dysphoria. Centers for Medicare and Medicaid Services; April 11, 2025. Accessed June 11, 2025. www.cms.gov. 8. Required Activities. 42 C.F.R. 441.56 (1984). Approved by Ohio Department of Medicaid 10/24/2025. Medical Interventions for Gender Dysphoria-OH MCD-MM-0034 Effective Date: 02/07/2026E.Conditions Of CoverageNAF.Related Policies/RulesMedical Necessity DeterminationsG.Review/Revision History02/07/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Epidural Steroid Injections-OH MCD-MM-0007 03/01/2026 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 ………………………….. ………………………….. ……………….. 6 H. References ………………………….. ………………………….. ………………………….. ……… 6 Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectEpidural Steroid Injections B. BackgroundNearly 84% of adults experience back pain during their lifetime. Long-term outcomes are largely favorable for most patients, but a small percentage of patients symptoms are persistent . Persistent p ain is categorized as subacute when lasting between 4 and 12 weeks and chronic when persisting for at least 3 months. Comprehensive pain management care plan s are most effective in managing a patientschronic pain. These plans focus on a person-centered approach and incorporate conservative treatment with other modalities . These m ultidisciplinary treatments include promoting patient self-management and aim to reduce the impact of pain on a patient’s daily life, even if the pain cannot be relieved completely. In addition to conservative therapy, additional treatment options may include nonpharmacologic or pharmacologic tre atments, nonsurgical interventions, and surgical interventions. Interventional procedures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services. Epidural steroid injections (ESIs) are a nonsurgical, minimally-invasive intervention for chronic back pain. ESIs may be administered through the translaminar approach (via the interlaminar space in the spine), the transforaminal approach (through the neuroforamen dorsal to the nerve root), or the caudal approach (through the sacral hiatus at the sacr al canal ). There is conflicting evidence on the efficacy of ESIs and a lack of consensus on frequency and number of epidural steroid injections from professional organizations. However, clinical experience suggests that some patients obtain more significan t relief, making it reasonable to offer a trial of steroid injections when conservative management has failed. Imaging studies of the symptomatic region may be performed to evaluate suspected specific causes of spinal pain (eg, herniated disc, spinal stenosis, degenerative vertebral disease, rule out fracture or tumor). However, evidence does not support the routin e useof imaging or other diagnostic tests in patients with nonspecific back pain. Diagnostic imaging and testing are only recommended when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination. C. Definitions Conservative Therapy A multimoda l plan of care including both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, including physical therapy, occupational therapy, a physician supervised home exercise program (HEP), and/or chiropractic care. Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete the HEP due to a stated physical reason (ie, increased pain, inability to physical ly per form exercises). Patient inconvenience or noncompliance without explanation does not consistute an inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, acupuncture, TENS u se , and/or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphi ns. Its use, frequency, duration, and start dates must be documented in the medical record to be considered part of conservative therapy during the period of prior authorization request. Epidural Steroid I njection Administration of steroids via a needle inserted in the space between the ligamentum flavum and the dura and adm inistered by translaminar, tranforaminal , or caudal approach es . Injections are intended to cause a short-term reduction in pain in the affected region. D. PolicyI. Epidural steroid injections for labor and delivery in childbirth or post-surgical pain do not require medical necessity review . II. Initial (Diagnostic) InjectionCareSource considers an initial (diagnostic) epidural steroid injection (maximum of 2injections) medically necessary for the management of chronic back pain when ALL the following clinical criteria are met: A. Pain is located in either the cervical, thoracic, or lumbar spine and is predominantly radiating or shooting in nature . B. Pain is causing functional disability . C. Signs or symptoms are consistent with radiculopathy, as indicated by at least 1 of the following: 1. diminished or absent deep tendon reflexes 2. paresthesia, numbness, sensory change, or weakness in dermatomal distribution 3. positive femoral nerve stretch test 4. positive Spurling test 5. positive straight leg raising test D. Conservative therapy has failed to alleviate symptoms, as evidenced by ALL the following: 1. documentation in the medical record of at least 6 weeks of active conservative therapy ( see definition above ) within the past 6 months OR Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 inability to complete active conservative therapy due to contraindication, increased pain, or intolerance2. documen tation in the medical record of at least 6 weeks of inactive conservative therapy ( see definition above ) within the past 6 months E. Imaging (eg, x-ray, CT, MRI), if performed, demonstrates that there are no conditions present that would preclude the safety of the performance of the procedure. III. Subsequent (Therapeutic) InjectionsCareSource considers therapeutic epidural steroid injections medically necessary when ALL the following criteria are met: A. The diagnostic or last therapeutic injection for current episode of pain provided significant functional pain relief as measured by a significant decrease in pain level (as demonstrated on a qualitative pain scale) , decrease in pain medications, and/or increase in physical function . B. The member continues to have ongoing pain or documented functional disability . C. At least 3 weeks have passed since the prior injection in order to reach pharmacodynamic effect . D. No more than 3 procedures in a 12-week period of time per region are considered medically necessary. E. The member continues to engage in conservative therapy (see definition above). IV. Limitations and ExclusionsA. In general, most individuals should not require more than 6 total epidural injections in 12 months. Additional injections may be considered on a case by case basis when the individual has multiple treatment sites.B. For interlaminar or caudal epidural injections , no more than 1 epidural injection per treatment date should be performed . C. For t ransforaminal epidurals or selective nerve root blocks (SNRBs) , no more than 2 vertebral levels per treatment date, whether unilateral or bilateral, should be performed . D. Real-time image guidance and any injection of contrast are inclusive components of epidural injections and are not compensated for separately or unbu ndled for coverage. E. Conscious sedation, if required for co-morbidities or patient/physician preference, may be provided without a medical necessity review but services will be considered part of the procedure and are not eligible for additional reimbursement if administered by a second provider. F. Monitored anesthesia is considered not medically necessary . G. Patients with indwelling implanted spinal cord stimulators or pain pumps must have a device interrogation report and an interpretation submitted with medical records, and included in the prior authorization request for p ropos ed interventional pain injections. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. Clinical evaluations and care of candidate patients for epidural injections should also address, at t he discretion of the physician and according to prevailing standards of medical care: 1. no acute spinal cord compression 2. selected body imaging evaluation s to evaluate the area of pain, particularly for acute pain, or to evaluate escal ations in chronic baseline pain 3. appropriate imaging to rule out red flag conditions may be indicated if potential issues of trauma, osteomyelitis or malignancy , or other diagnoses are a concern I. Contraindications include any of the following: 1. pain related to cancer etiology 2. local or systemic infection 3. cauda equina syndrome 4. spinal trauma (eg, hematoma, hemorrhage, mass, ischemia) 5. coagulopathy V. Inconclusive or Non-Supportive EvidenceA. Evidence reported in the medical literature is inconclusive as to the use of epidural injections for long term relief or treatment of chronic pain. Long-term continuation (epidural injections beyond 1 year) may be subject to medical necessity review. B. For both cervical and lumbar transforaminal (TF) ESIs, using particulate steroid is associated with a rare risk of catastrophic neurovascular complications such as stroke or death. Cervical transforaminal injections are risky because arterial supply may be densely concentrated in and around the interver tebral foramen. TF ESIs can be performed without contrast in patients with documented contraindication to its use. In these circumstances , particulate steroids are contraindicated and only the preservative fr ee, particulate fre e steroids which are available should be used. C. Cervical transforaminal ESIs have sparse literature for cervical radicular pain, and , if performed , should be performed by injecting contrast medium under real – time fluoroscopy and/or digital subtraction angiography (DSA) in a frontal plane, before injecting any substance potentially hazardous to the patient. Particulate steroids should not be used for cervical TF injections as per the contraindication established by the FDA warning. E. Conditions of CoverageNA F. Related Policies/RulesNA Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 G. Review/Revision HistoryDATES ACTIONDate Issued 01/27/2015 New PolicyDate Revised 03/06/2019 05/13/202004/28/202103/ 16 /2022 11/03/202203/15 /202301/31/202401/15/202512/03 /2025Annual Update: Removed start and end dates. Addition of PA clarification and documentation requirements.Annual Update : Updated language around benefit limits. Annual Update: Removed PA language. Annual Review. Updated formatting and references, consolidated background and evidence , separated indic ations into initial and subsequent injections, frequency restrictions, and limitations/exclusions, added contraindications. Removed anti-platelet therapy contraindication Annual review: reorganized criteria, simplified conservative therapy, added provocation tests . Approved at Committee. Annual review: updated references and formatting. Approved at Committee. Review: removed US limitation, updated references, approved at Committee. Review: Updated references. Approved at Committee . Date Effective 03/01/2026 Date Archived H. References1. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated April 29 , 202 5. Accessed November 18, 202 5. www.uptodate.com 2. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 3. Chou R, Hashimoto R, Friedly J, et al. Epidural corticosteroid injections for radiculopathy and spinal stenosis: a systematic review and meta-analysis. Ann Intern Med . 2015;163(5):373-381. doi:10.7326/M15-0934 4. Conger A, Cushman DM, Speckman RA, et al. The effectiveness of fluroscopically guided cervical transforaminal epidural steroid injection for the treatment of radicular pain; a systematic review and meta-analysis. Pain Med. 2020;21(1):41-54. doi:410.1093/pm/pnz127 5. Dydyk AM, Hu Y, Stretanski MF, et al. Cervical Epidural Injection. In: StatPearls [Internet]. Updated June 2, 2025. Accessed November 18, 2025. www.ncbi.nlm.nih.gov 6. Fromm MK, Liu SH, Carr C, et al. Factors associated with improved outcomes after lumbar transforaminal epidural steroid injections for radicular pain: a systematic review. NASSJ . 2025; 21:100592 . doi :10.1016/j.xnsj.2025.100592 Epidural Steroid Injections-OH MCD-MM-0007Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 7. Goel A, Singh S, Shukla NK, et al . Efficacy of caudal epidural steroid injections in chronic low backache patients. JPharm Bioallied Sci. 2023;15(Suppl 1):S669-S672. doi:10.4103/jpbs.jpbs_89_23 8. Helm S, Harmon PC, Noe C, et al. Transforaminal epidural steroid injections: a systematic review and meta-analysis of efficacy and safety. Pain Phys ician . 2021;24:S209-S232. Accessed November 18 , 202 5. www.painphysicianjournal.com 9. Manchikanti L, Benyamin RM, Falco FJ, et al. Do epidural injections provide short – and long-term relief for lumbar disc herniation? A systematic review. Clin Orthop Relat Res. 2015;473(6):1940-1956. doi:10.1007/s11999-014-3490-4 10. Manchikanti L, Knezevic NN, Boswell MV, et al. Epidural injections for lumbar radiculopathy and spinal stenosis: a comparative systematic review and meta – analysis. Pain Physician. 2016;19(3):E365-410. Accessed November 18 , 202 5. www.painphysicianjournal.com 11. Manchikanti L, Knezevic NN, Navani A, et al. Epidural interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) comprehensive evidence-based guidelines. Pain Physician. 2021;24(S1): S27-S208. Accessed November 18 , 202 5. www.painphysicianjournal.com 12. Oliveira CB, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections for lumbosacral radicular pain. Cochrane Database Syst Rev. 2020;4(4):CD013577. doi: 10.1002/14651858.CD013577 13. Qassem A, Wilt TJ, McLean RM et al. Noninvasive treatments for acute, subacute and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Inter n Med . 2017 ;166(7):514-530 . doi:10.7326/M16-2367 14. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3729-3832. doi:10.2147/JPR.S386879 15. Taskaynatan MA, Tezel K, Yavuz F, et al. The effectiveness of transforaminal epidural steroid injection in patients with radicular low back pain due to lumbar disc herniation two years after treatment. JBack Musculoskelet Rehabil. 2015;28(3):447 – 451. doi:10.3233/BMR-140539 16. Verheijen EJA, Bonke CA, Amorij EMJ, et al . Epidural steroid compared to placebo injection for sciatica: a systematic review and meta-analysis. Euro Spine J . 2021;30:3255-3264. doi:10.1007/s00586-021-06854-9 17. Woo JH, Park HS. Cervical transforaminal epidural block using low-dose local anesthetic: a prospective, randomized, double-blind study. Pain Med. 2015;16(1):61 – 67. doi:10.1111/pme.12582 18. Yang S, Kim W, Kong HH, et al. Epidural steroid injection versus conservative treatment for patients with lumbosacral radicular pain: a meta-analysis of randomized controlled trials. Med. 2020;99(30):e21283. doi:10/1097/MD. 0000000000021283 Approved by ODM 12/10 /2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Home Health Services-OH MCD-MM-1243 03/01/2026 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 8 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectHome Health Services B. BackgroundHome health services are skilled and supportive care services provided in the members home to meet skilled care needs and associated activities of daily living (ADLs) to allow the member to safely stay in the home. Home health services incorporate a wide variety of skilled healthcare and supportive services provided by licensed and unlicensed professionals. These services are designed to meet the needs of members with acute, chronic, and terminal illnesses or disabilities, who without this support might ot herwise require services in an acute care or residential facility. These guidelines identify clinical information that CareSource uses to determine medicalnecessity for home health services. These guidelines are based on generally accepted standards of practice, review of medical literature, as well as federal and state policies and laws applicable to Medicaid programs.Providers should consult Chapter 5160-12 of the Ohio Administrative Code for detailsabout coverage, limitations, service conditions, and prior-authorization requirements.C. Definitions HealthChek Program The Ohio-administered version of the early and periodic screening, diagnosis, and treatment (EPSDT) program, which is a federally mandated program of comprehensive preventive health services available to Medicaid-eligible individuals from birth through age twenty years and administered by the County Department of Job and Family Services (CDJFS). Home Health Agency A person or government entity, other than a nursing home, residential care facility, or hospice care program, that has the primary function of providing any of the following services to a patient at a place of residence used as the patients home: o skilled nursing care o physical therapy o speech-language pathology o occupational therapy o medical social services o home health aide services, which means any of the following services provided by an employee of a home health agency: hands-on bathing or assistance with a tub bath or shower assistance with dressing, ambulation, and toileting catheter care but not insertion meal preparation and feeding Home Health Aide Services Services that use the skills of and are performed by a home health aide employed or contracted by the Medicare Certified Home Health Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Agency (MCHHA) providing the service. Home health aide services include, but are not limited to, the following:o bathing, dressing, grooming, hygiene, including shaving, skin care, foot care, ear care, hair, nail and oral care, that are needed to facilitate care or prevent deterioration of the individual’s health, and including changing bed linens of an incontinent or immobile individual o feeding, assistance with elimination including administering enemas (unless the skills of a home health nurse are required), routine catheter care, routine colostomy care, assistance with ambulation, changing position in bed, and assistance with transfers o assisting with activities such as routine maintenance exercises and passive range of motion as specified in the plan of care. These activities are directly supportive of skilled therapy services but do not require the skills of a therapist to be safely and effectively performed. The plan of care is developed by either a licensed therapist or a licensed registered nurse within their scope of practice o performing routine care of prosthetic and orthotic devices Home Health Nursing Services Services that require the skills of and are performed by a registered nurse or a licensed practical nurse at the direction of a registered nurse. The nurse performing the home health service must possess a current, valid, and unrestricted license with the Ohio Board of Nursing and must be employed or contracted by an MCHHA that has an active Medicaid provider agreement. A service is not considered a nursing service merely because it is performed by a licensed nurse. o Home health nursing services include, but are not limited to, the following: IV insertion, removal, or discontinuation IV medication administration programming of a pump to deliver medications including, but not limited to, epidural, subcutaneous IV (except routine doses of insulin through a programmed pump) insertion or initiation of infusion therapies central line dressing changes blood product administration o Home health nursing services do not include a visit when the sole purpose is for the supervision of the home health aide. Medical Necessity Must meet ALL of the following conditions: o meets generally accepted standards of medical practice o clinically appropriate in its type, frequency, extent, duration, and delivery setting o appropriate to the adverse health condition for which it is provided and is expected to produce the desired outcome o is the lowest cost alternative that effectively addresses and treats the medical problem o provides unique, essential, and appropriate information if it is used for diagnostic purposes o not provided primarily for the economic benefit of the provider nor for the convenience of the provider or anyone else other than the recipient Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 Skilled Therapies A collective term encompassing physical therapy, occupational therapy, speech-language pathology, and audiology. D. PolicyI. Home health services, including home health aide and home health nursing, are provided to any CareSource Ohio Medicaid member when considered medically necessary. II. Duplicative services are not covered.A. There must be documentation of all other therapies/services the member is receiving, when relevant to home health services. B. If the member is receiving other assistance (eg, meal delivery program, family caregiver, additional supportive services), this information and the hours involved must be provided to adequately evaluate medical necessity of home health services. C. The care provided must be appropriate to the member. Guidelines are provided (see Table below) to assist in determining the amount of care a member requires. III. Home Health Services for Individuals Age d 21 Years and OlderA. Routine home health services are considered medically necessary for individuals age d 21 years and older when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services or within 30 days following the start of home health services . 3. There is a written plan of treatment, as evidenced by one of the following: the Ohio Department of Medicaid (ODM) 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services OR the individual’s plan of care if all of the data elements specified for home health services on the ODM 07137 are included . 4. At the time of billing, the plan of care /treatment plan contains the signature, credentials , and the date of the signature of the qualifying treating physician, advanced practice registered nurse , or physician assistant . 5. The home health services will be provided by a MCHHA . 6. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for private duty nursing (PDN) , which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 14 hours combined per week of home health nursing and home health aide services Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 NOTE: additional hours of care may be considered based upon medical necessity . B. Following discharge from an inpatient hospital stay, home health services are considered medically necessary for individuals age 21 years and older when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . 3. There is a written plan of treatment as evidenced by the ODM 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services . 4. The individual is discharged from a covered inpatient hospital stay of at least 3 days, with the discharge date recorded on form ODM 07137 . 5. The individual has a comparable level of care as evidenced by either: enrollment in a home and community-based services (HCBS) waiver OR a medical condition that temporarily meets the criteria for an institutional level of care . 6. The individual requires home health nursing, or a combination of PDN , home health nursing, or waiver nursing and/or skilled therapy services at least 1 per week . 7. The home health services will be provided by a MCHHA . 8. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for PDN , which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 28 hours combined per week of home health nursing and home health aide services for up to 60 consecutive days from the date of discharge from an inpatient hospital stay Note: additional hours of care may be considered based upon medical necessity. IV. Routine Home Health Services for Individuals Under Age 21 YearsA. Routine home health services are considered medically necessary for individuals under age 21 years when ALL of the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . 3. There is a written plan of treatment, as evidenced by one of the following: the ODM 07137 Certificate of Medical Necessity for Home Health Services and Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Private Duty Nursing Services OR the individual s plan of care if all of the data elements specified for home health services on the ODM 07137 are included . 4. At the time of billing, the plan of care contains the signature, credentials , and the date of the signature of the qualifying treating physician, advanced practice registered nurse or physician assistant . 5. The home health services will be provided by a MCHHA . 6. The services are provided on a part-time or intermittent basis as follows: a. Total Hours Per Visit: 4 hours (individuals who require more than 4 hours of care per visit may qualify for PDN , which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 14 hours combined per week of home health nursing and home health aide services d. A member may qualify for increased home health services when ALL the following criteria are met: 01. The services are required for treatment in accordance with the Healthchek program (EPSDT) . 02. The member has a comparable level of care as evidenced by either enrollment in a HCBS waiver or a level of care evaluated initially and annually by ODM or its designee for an individual not enrolled in an HCBS waiver . 03. The member needs home health nursing or a combination of PDN, home health nursing, waiver nursing, and skilled therapies at least once per week . 04. The member needs more than, as ordered by the treating clinician, 8 hours per day of any home health service, or a combined total of 14 hours per week of home health aide and home health nursing. B. Following discharge from an inpatient hospital stay, home health services are considered medically necessary for individuals under age 21 years when ALL the following criteria are met: 1. There has been a face-to-face encounter between the individual and a qualifying treating physician, advanced practice registered nurse, or physician assistant . 2. The face-to-face encounter occurred within 90 days prior to the start of home health services, or within 30 days following the start of home health services . 3. There is a written plan of treatment as evidenced by the ODM 07137 Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services . 4. The home health services will be provided by a MCHHA . 5. The individual is discharged from a covered inpatient hospital stay of at least 3 days , with the discharge date recorded on form ODM 07137 . 6. The services are provided on a part-time or intermittent basis as follows: Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 a. Total Hours Per Visit: 4 hours (individuals who require more than 4hours of care per visit may qualify for PDN , which is outside the scope of this policy) b. Total Hours Per Day: 8 hours combined per day of home health nursing, home health aide, and skilled therapies c. Total Hours Per Week: 28 hours combined per week of home health nursing and home health aide services for up to 60 consecutive days from the date of discharge from an inpatient hospital stay d. A member may qualify for increased home health services when ALL the following criteria are met: 01. The services are required for treatment in accordance with the Healthchek program (EPSDT) . 02. The individual has a comparable level of care as evidenced by either: enrollment in a HCBS waiver OR a medical condition that temporarily meets the criteria for an institutional level of care . 03. The individual requires home health nursing, or a combination of PDN , home health nursing, or waiver nursing and/or skilled therapy services at least 1 per week . 04. The member needs more than, as ordered by the treating clinician, a combined total of 28 hours per week of home health nursing and home health aide for up to 60 days. V. Incidental services may be included during a home health visit, as long as the services do not substantially extend the time of the visit. A. Incidental services are necessary household tasks that must be performed by someone to maintain a home and can include light chores, laundry, light house cleaning, preparation of meals, and taking out the trash. B. The main purpose of a home health aide visit cannot be solely to provide these incidental services since the services are not health related services. C. Incidental services are to be performed only for the individual and not for other people in the individuals place of residence. VI. Home health services do NOT include any of the following :A. a visit when the sole purpose is for the supervision of the home health aide B. patient assessment services C. patient consultation services D. transporting the member to grocery stores, pharmacies, banks, etc. E. homemaker services (eg, shopping, laundry, cleaning, meal preparation) F. chores (eg, running errands, picking up prescriptions) G. sitter or companion services (eg, activity planning, escorting member to events) H. respite care VII. General guidelines for care based on the Aide Norms ToolTask Type General Guideline Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 Mobility (bed, transfer, locomotion)5min/ADL inside and 15min outside. Positioning Q2 hr Bathing 30 min/day includes prep/clean up; transfers Grooming 15 min/day includes all hair care, oral care, nails general hygiene care Medication 5 min/dose time regardless of number of medications Toileting Bladder : 10 min/2 hr awake; 2x/night; add 5 min if incontinent. Bowel: 10 min/BM, add 10 min if incontinent Dressing 15 min/day; plus 5 min/device (prosthetic) Eating 30 min/meal with 3 meals and 2 snacks per day Linen Changes 30 min/week E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 1/19/2022 New policy.Date Revised 06/16/2022 02/01/202301/17 /202401/15 /202512/03 /2025Out-of-cycle update: split criteria III.A.3 and IV.A.3 so latter states at time of billing. Annual review: updated references, clarified hours of care based on medical necessity . Annual review: updated references and formatting. Approved at Committee. Review: updated references. Approved at Committee. Review: updated acronyms and references. Approved at Committee. Date Effective 03/01/2026 Date Archived H. References1. Administrative procedures for comprehensive health care for children in placement, OHIO ADMIN . CODE 51 80:2-42-66 (20 24 ). 2. Definitions, OHIO ADMIN . CODE 3701-19-01 (2020). 3. Definitions, OHIO ADMIN . CODE 3701-60-01 (20 23 ). 4. Home Health and Private Duty Nursing: visit policy, OHIO ADMIN . CODE 5160-12-04 (2021). 5. Home Health Services: provision requirements, coverage and service specification, OHIO ADMIN . CODE 5160-12-01 (2021). Home Health Services-OH MCD-MM-1243Effective Dat e: 03/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 6. Managed Care: covered services, OHIO ADMIN . CODE 5160-26-03 (2022).7. Medicare Certified Home Health Agencies: qualification and requirements, OHIO ADMIN . CODE 5160-12-03 (2015). 8. Payment For Home Health Nursing Services and Home Health Aide Services , OHIO ADMIN . CODE 4123-6-38 (2022). 9. Payment For Nursing and Caregiver Services Provided by Persons Other Than Home Health Agency Employees, OHIO ADMIN . CODE 4123-6-38.1 (2022). 10. Reimbursement: exceptions, OHIO ADMIN . CODE 5160-12-07 (2015). 11. Reimbursement: home health services, OHIO ADMIN . CODE 5160-12-05 (202 4). Approved by ODM on 12/10 /202 5
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Tumor Treatment Field Device Therapy-OH MCD-MM-1224 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 ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Tumor Treatment Field Device Therapy-OH MCD-MM-1224Effective 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. SubjectTumor Treatment Field Device Therapy B. BackgroundGlioblastoma multiforme is the most common central nervous system malignancy of the brain accounting for 47.7% of all cases. Median age of diagnosis is 64 years, and it is more common in men as compared to women. Management of the disease follows a combined-modality approach, including adjuvant postoperative radiation therapy and adjuvant chemotherapy following initial surgery. Surgery remains the mainstay of treatment in order to remove as much tumor as possible while preserving surrounding brain tissue required for normal brain function. Despite tumor debulking measures, glioblastoma tumors infiltrate surrounding tissues creating little success for removal of the entire tumor (AANS, 2020). Glioblastoma has a high rate of recurrence and poor overall survival rate even with optimum therapy treatments, with approximately 40% survival in the first year post diagnosis and 17% in the second year. Lung cancer is the leading cause of cancer-related mortality in the United States. The 5-year relative survival rate from 2014 to 2020 for patients with lung cancer was 27%. The 5-year relative survival rate varies markedly for patients diagnosed at local stage (64%), regional stage (36%), or distant stage (9%). Non-Small Cell Lung Cancer (NSCLC) is any type of epithelial lung cancer other than small cell lung cancer (SCLC). The most common types of NSCLC are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma, but there are several other types that occur less frequently, and all types can occur in unusual histological variants. Although NSCLCs are associated with cigarette smoke, adenocarcinomas may be found in patients who never smoked. Tumor treating field devices (TTF) are a novel method of cancer treatment involving emitting alternating electric fields to disrupt the rapid cell division exhibited by cancer cells. This treatment first became available in 2011 to treat recurrent glioblastoma. TTF is considered safe with no systemic toxicity observed and only mild to moderate side effects (reported in 1-2% of patients) involving the skin beneath transducer arrays. Patients are required to wear the device at least 18 hours a day for effectiveness and minimum treatment duration is 4 weeks. Randomized clinical trial results suggest the device improves overall survival when combined with monthly temozolomide in patients with newly diagnosed glioblastoma in the post radiation setting. C. Definitions Glioblastoma Multiforme (GBM) Also referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue but generally does not spread to distant organs. Karnofsky Performance Status (KPS) An index that classifies the functional impairment of patients. This can be used to compare the effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Tumor Treatment Field Device Therapy-OH MCD-MM-1224Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Medically Necessary Services which are necessary for the diagnosis or treatment of disease, illness, and injury, and meet accepted guidelines of medical practice. A medically necessary service must be related to the illness or injury for which it is performed regarding type, intensity, and duration of service and setting of treatment. Non-Small Cell Lung Cancer (NSCLC) A group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. The three main types of non-small cell lung cancer are adenocarcinoma (most common), squamous cell carcinoma, and large cell carcinoma. Response Assessment in Neuro-Oncology (RANO) A working group established to improve the assessment of tumor response and selection of end points, specifically in the context of clinical trials. Tumor Treatment Fields (TTF) Mild electrical fields that vibrate through the skin of the scalp and disturb cancer cells ability to divide, possibly slowing tumor growth and spread. D. Policy I. Tumor treatment field devices are considered medically necessary for the following: A. Glioblastoma multiforme 1. Initial treatment is considered medically necessary when ALL of the following criteria have been met: a. The member has a new diagnosis of GBM (grade IV astrocytoma). b. The member is age 22 years or older. c. The member has received initial treatment with surgery when reasonable. d. TTF therapy is initiated within 7 weeks from the last dose of chemotherapy or radiotherapy. e. The member has a Karnofsky Performance Scale (KPS) index of at least 60. f. TTF treatment will be used for an average of 18 hours per day. 2. Continued coverage (beyond first 3 months of therapy) for newly diagnosed GBM and documentation of clinical benefit demonstrates ALL of the following: a. in-person clinical re-evaluation by treating practitioner b. objective evidence of adherence to therapy, reviewed by treating practitioner c. maintain KPS of at least 60 d. if KPS is unavailable, then no evidence of progression by Response Assessment in Neuro-Oncology (RANO) criteria B. Non-Small Cell Lung Cancer (NSCLC) Treatment is considered medically necessary when ALL of the following criteria have been met: 1. NSCLC metastatic disease with progression on or after platinum-based therapy Tumor Treatment Field Device Therapy-OH MCD-MM-1224Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 2. TTF therapy is administered in combination with atezolizumab, nivolumab,pembrolizumab, or docetaxel II. The following is a list of contraindications for TTF treatment (not all inclusive):A. cardiac pacemaker or implantable defibrillator B. deep brain, spinal cord, or vagus nerve stimulator C. major skull defect (eg, missing section of calvarium) D. metal within brain (eg, aneurysm clip, bullet fragment) E. programmable ventriculoperitoneal shunt F. pregnancy G. known sensitivity to conductive hydrogels (eg, gels used on electrocardiogram) H. ECG stickers or transcutaneous electrical nerve stimulation (TENS) electrodes III. CareSource considers TTF therapy for GBM and NSCLC only. Treatment of any other tumors is not medically necessary and experimental/investigational. IV. The use of enhanced treatment planning software (Novotal) is non-covered becauseCareSource considers it to be experimental/investigational for ALL indications. E. Conditions of CoverageN/A F. Related Policies/Rules N/A G. Review/Revision History DATE ACTIONDate Issued 09/29/2021 New Policy.Date Revised 07/06/2022 11/8//2023 11/06/2024 11/05/2025 Updated references. No changes. Archived Jan.2023. Added Section II (Continued coverage) . Approved at Committee. Removed PA language from policy. Updated references. Approved at Committee. Changed title to Tumor Treatment Field Device Therapy. Added background on non-small cell lung cancer and definition. Added Sec. I.B. to describe medical necessity criteria for NSCLC. Added NSCLC to sec. III. Updated references. Approved at Committee. Date Effective 02/01/2026 Date Archived H. References1. Alternating Electric Field Therapy ACG: A-0930 (AC). 2025. Accessed September26, 2025. www.careweb.careguidelines.com Tumor Treatment Field Device Therapy-OH MCD-MM-1224Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 2. Batchelor T. Initial treatment and prognosis of IDH-wildtype glioblastoma in adults.UpToDate. Updated August 7, 2024. Accessed September 30, 2025. www.uptodate.com 3. Burri SH, Gondi V, Brown PD, Mehta MP. The evolving role of tumor treating fields in managing glioblastoma: guide for oncologists. Am JClin Oncol . 2018;41(2):191-196. doi:10.1097/COC.0000000000000395 4. Chukwueke UN, Wen PY. Use of the Response Assessment in Neuro-Oncology (RANO) criteria in clinical trials and clinical practice. CNS Oncol . 2019;8(1):CNS28. doi:10.2217/cns-2018-0007 5. Fernandes C, Costa A, Osrio L, et al. Current standards of care in glioblastoma therapy. In: De Vleeschouwer S, ed. Glioblastoma . Codon Publications; 2017. Accessed September 26, 2025. www.ncbi.nih.gov 6. Glioblastoma multiforme. American Association of Neurological Surgeons. Accessed September 26, 2025. www.aans.org 7. Health Technology Assessment: Tumor Treatment Fields (Optune) for Treatment of Glioblastoma. Hayes; 2019. Reviewed January 5, 2023. Accessed September 26, 2025. www.evidence.hayesinc.com 8. Kanderi T, Gupta V. Glioblastoma Multiforme. In: StatPearls . Treasure Island (FL): StatPearls Publishing; 2022. Accessed September 30, 2025. 9. Karnofsky Performance Status Scale definitions rating criteria. National Palliative Care Research Center. Accessed September 30, 2025. www.npcrc.org 10. Katiyar V, De Jesus O. Tumor Treatment Fields in Oncology. In: StatPearls. Treasure Island (FL): StatPearls Publishing; August 23, 2023. Accessed September 30, 2025 11. Leal T, et al. Tumor Treating Fields therapy with standard systemic therapy versus standard systemic therapy alone in metastatic non-small-cell lung cancer following progression on or after platinum-based therapy (LUNAR): a randomised, open-label, pivotal phase 3 study. Lancet Oncology 2023;24(9):1002-1017. DOI: 10.1016/S1470-2045(23)00344-3. 12. Non-Small Cell Lung Cancer. NIH, National Cancer Institute. Accessed September 30, 2025. www.cancer.org 13. OPTUNE (NovoTTF-100A System) Patient Information and Operation Manual . Food and Drug Administration. Document QSD-QR-33 Accessed September 30, 2025. www.accessdata.fda.gov 14. Wen PY, Chang SM, Van den Bent MJ, et al Response assessment in neuro- oncology clinical trials. JClin Oncol . 2017;35(21):2439-2449. doi:10.1200/JCO.2017.72.7511 ODM Approved 11/12/2025 Independent medical review November 2020
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
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