MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – OH MCD-MM-1716 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response. Pharmacokinetics analyzes how drugs move through the body, including absorption, distribution, metabolism, and excretion. In behavioral health medicine, cytochrome P450s (CYPs) a re a common avenue for oxidative metabolism of therapeutic substances, which can be influenced by genetic and environmental factors. CYP genes are polymorphic and affect a significant portion of the populations ability to metabolize chemicals. Members with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound and are , therefore , classified as poor metabolizers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies show potential benefits of genetesting. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited research for a drug class or specific drugs. Most studies are based on small sample sizes and do not perform power calculations or correct for multiple testing scenarios. It is difficult to substantiate conclusions when not accounting for false positives o r false negatives. Additionally, there is a lack of consensus regarding preemptive genotyping efficacy. Two societies publishing guidelines acknowledge that comprehensive guidelines regarding when testing should occur, who should receive testing, and which genes should be tested cannot be offered. The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an internationalorganization whose goal is to reduce the barrier of translating genetic laboratory test results into guided clinical decision support. CPIC guidelines are peer-reviewed, evidence-based and updated as new evidence emerges. The guidelines are indexed in PubMed and endorsed by the American Society of Health-System Pharmacists (ASHP) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Published CPIC guidelines are available for certain drug classes and specific drugs which can lead to customized drug dosing and is presumed to improve time to effective treatment and reduce undertreatment, medication-related adverse events and costs. The guidelines consist of grading levels of evidence for prescription recommendations, which guide physicians on how results can optimize treatment. The strength of recommendations is divided into 4 categories: strong, moderate, optional, and no recommendation. A strong recommendation is backed by high-qualityevidence with desirable effects clearly outweighing undesirable effects. A moderate recommendation recognizes a close or uncertain balance as to whether the evidence is high quality , and desirable effects clearly outweigh the undesirable . In an optional recommendation, the desirable effects are closely balanced with undesirable effects or the evidence is weak or based on extrapolations, and opinions differ as to the need for the recommended course of action. With no recommendation, there is insufficient evidence, confidence, or agreement to provide a recommendation to guide practice. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 In 2018, the American Psychiatric Association (APA) Council of Research Workgroup onBiomarkers and Novel Treatments printed a position statement on pharmacogenomic (PGx) tools for the treatment of depression indicating at present there are insufficient data to support the widespread use of combinatorial pharmacogenetics testing in clinical practice. The Food and Drug Administration (FDA) released a consumer warning, The relationship between DNA variations and the effectiveness of antidepressant medicat ions has never been established. and also cautioned that changes in patient medications based on test results could potentially lead to patient harm. In 2024, Baum, et al., updated the APAs statement upon review of new clinical trials and meta – analyses published from 2017 to 2022 using PGx tools for treatment selection in depression and found addition of these new data do not alter the recommendations of the 2018 report, or the advice of the FDA, that the evidence does not support the use of currently available combinatorial PGx tools for treatment. Additionally in 2019, the International Society of Psychiatric Genetics published the following statement: Pharmacogenetic testing should be viewed as a decision-support tool Evidence to support widespread use of other pharmacogenetic tests at this time is still inconclusive Genetic information for CYP2C19 and CYP2D6 would likely be most beneficial for individuals who have experienced an inad equate response or adverse reaction to a previous antidepressant or antipsychotic trial. Care Source covers items and services with sufficient medical and scientific evidence forthe purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s) but does not cover experimental or investigational testing or products or services with insufficient data to determine net health impact. Insufficient data includes support that the test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinica l utility), performs better than an existing standard of care medical management option, and/or is not generally accepted as standard of care in the evaluation or management of a particular condition. Care Source provides appeal rights to any member or provider acting on behalf of a member who may disagree with denial decisions. Tests should be chosen to maximize the likelihood of identifying mutations in genes of interest for a specific medical reason, contribute to positive alterations in patient management, and minimize the chance of finding variants of uncertain significance. C. Definitions Actionable Use Genotype information may lead to selection of , avoidance of a specific therapy or modification of dosage of a therapy. Change must be based on the FDA label for the drug, an FDA warning or safety concern, or a CPIC level A or B gene-drug interaction. Intended change s in therapy based on the result of a genotyping test not supported by 1 of these sources is not an actionable use. Adherence Consumption of a drug at or near the maximum FDA approved dosage and duration for the medication or documentation that higher doses are not tolerated when less than the FDA-approved maximum. Biomarker A characteristic objectively measured and evaluated as an indicator of biological or pathogenic processes or pharmacologic responses to a specific Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 therapeutic intervention (eg, gene mutations, protein expression, known gene-drug interactions for medications, characteristics of genes ). Biomarker Testing The analysis of tissue, blood, or other biospecimen for the presence of a biomarker . Clinical Utility The likelihood that a test will, by prompting an intervention, result in an improved health outcome. Clinical Validity The accuracy of a test for a given clinical outcome. Consensus Statements Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict-of- interest policy aimed at specific clinical circumstances and based on best available evidence for optimizing outco mes of clinical care. Nationally Recognized Clinical Practice Guidelines Developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure with a conflict-of-interest policy establish ing standards of care informed by a systematic review of evidence and assessment of benefits and risks of alternative care options , includ ing recommendations to optimize patient care. Unbundling HCPCS/CPT codes should be reported only if all services described by the code are performed. Multiple codes should not be reported if a single code exists that describes the services performed. The codes include all services usually performed as part of the procedure as a standard of medical/ surgical practice and should not be separately reported simply because codes exist for the services. D. PolicyI. Biomarker testing that is not addressed by the Ohio Administrative or Revised Code or by the Ohio Department of Medicaid (ODM) in a recently published or updated provider document will follow MCG guidelines. Biomarker testing with uncertain clinical significance in MCG may be considered not covered as there is insufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s). If there are no MCG guidelines available, authorizati on for biomarker testing must be supported by the following scientific and medical evidence (as appropriate) : A. labeled indications for a test approved or cleared by the FDA B. indicated tests for a drug approved by the FDA C. Centers for Medicare and Medicaid Services (CMS) national coverage determinations and/or local coverage determinations by Medicare Administrative Contractors D. nationally recognized clinical practice guidelines and/or consensus statements E. warnings and precautions on FDA-approved drugs II. Any biomarker testing with clinical significance and evidence supported by scientific and medical evidence may be subject to medical necessity review. CareSource usesCPIC guidelines level A or B to determine the appropriateness of testing requests. A. General guidelines for all testing requests Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 The use of pharmacogenomic tests for multi-gene panels to guide therapy decisions may be medically necessary for psychotropic medications when ALL of the following criteria are met: 1. The member is currently or considering taking a drug potentially affected by a known mutation that can be detected by a corresponding test. 2. The drug is to be prescribed for the condition and population consistent with FDA labeling. 3. The test demonstrate s actionability in clinical decision making by CPIC guidelines level A or Band has demonstrated technical and clinical validity. 4. Providers can use results to guide changes in treatment that will improve patient outcome s or directly impact medical care (ie, clinical utility). 5. The ordering provider possesses the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and to prescribe medications for the condition either independently or in an arrangement as required by all applicable state laws. 6. The usefulness of the test is not significantly offset by negative factors, such as expense, clinical risk, or social, or ethical challenges (ie, reasonable use). 7. Requested testing is performed in a CLIA-certified laboratory and has not been previously performed. 8. At least 1 of the following criteria is met: a. Documentation is provided that the requested testing is required to obtain health plan coverage for the medication being considered for treatment. b. An FDA label requires results from a genetic test to effectively or safely use the therapy in question or is listed in the FDA table of known gene – drug interactions. c. Documentation of member adhere nce and fail ure to see expected results from at least 2 prior medications to treat the diagnosed condition. B. Specific testing requests Testing in the following situations may be considered medically necessary and is subject to medical necessity review. To aid in therapy selection and/or dosing for members considered for therapy or in a course of therapy with any of the medications below, testing for following genotype(s) once per lifetime may be considered : 1. CYP2C19 and CYP2D6 t esting for tricyclic antidepressants : a. Amitriptyline b. Imipramine c. Doxepin 2. CYP2C19 and CYP2B6 testing for sert raline, serotonin reuptake inhibitor 3. HLA-A and HLA-B testing for carbamazepine III. Exceptions to this policy or an adverse utilization review determination might be explored via appeal rights , which are p rovide d to any member or provider who requests testing on behalf of the member for any denial of authorization via the provider portal on www .www.caresource.com, fax, or mail by the US P ostal Service. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 IV. CareSource considers the following not medically necessary (not all-inclusive):A. testing or screening 1. in the general population 2. considered non-covered but billed using unlisted procedure codes 3. in the absence of clinical signs or symptoms or for determining a risk for developing a disease or condition 4. not confirming new data for decision making but a known diagnosis 5. without diagnosis-specific indications or ensuring matching tissue specimens B. use of multi-gene panels for genetic polymorphisms, including, but not limited to, pain management, cardiovascular drugs, anthracyclines, or polypharmacy for evaluating drug-metabolizer status C. broad symptom-based panels (eg, comprehensive ataxia panel) when a narrower panel is available and more appropriate based on clinical findings (eg, autosomal dominant ataxia panel) D. more than 1 multigene panel at the same time (should be performed in a tiered fashion with independent justification for each panel requested ) E. genes not identified as having actionable use E. Conditions of CoverageCareSource applies coding edits to medical claims through coding logic software to evaluate accuracy and adherence to accepted national standards. Proper billing and submission guidelines must be followed, including the following: I. Unbundling of codes in a panel may result in payment recovery. Procedures not meeting correct coding standards are not reimbursable, even if medical necessity criteria for the associated test(s) are met. II. Providers must use industry standard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes to the highest level of specificity. III. Services considered to be mutually exclusive, incidental to, or integral to the primary service rendered are not allowed additional payment. IV. Proprietary panel testing requires documentation of medical necessity. V. If a panel was previously performed and an updated, larger panel is being requested, only testing for the medically necessary, previously untested genes will be reimbursable. Therefore, only the most appropriate procedure codes for those additional genes will be considered for reimbursement. F. Related Policies/RulesExperimental or Investigational Items or Services Medical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 10/23/2024 New policy. Converted AD-134 2 to MM with parameters for review of medical necessity. Approved at Committee. Date Revised 10/08 /2025 Annual review. Updated references. Approved at Committee. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Date Effective 01/01/2026Date Archived H. References1. American College of Medical Genetics Board of Directors. Points to consider in the clinical application of genomic sequencing. Genet Med . 2012 Aug;14(8):759-61. doi:10.1038/gim.2012.74 2. Baum M, Widge A, Carpenter L, et al. Pharmacogenomic clinical support tool for the treatment of depression. Am JPsychiatry . 2024;181(7):591-607. doi:10.1176/appi.ajp.20230657 3. Bean LJH, Funke B, Carlston CM, et al. Diagnostic gene sequencing panels: from design to report a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2020;22(3):453-461. doi:10.1038/s41436-019-0666-z 4. Behavioral Health Medication Pharmacogenetics Gene Panels: A-0861. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 5. Beunk L, Nijenhuis M, Soree B, et al. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2D6, CYP3A4 and CYP1A2 and antipsychotics. Eur JHum Genet . 2024;32(3):278-285. doi:10.1038/s41431-023-01347-3 6. Bousman CA, Stevenson JM, Ramsey LB, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes and serotonin reuptake inhibitor antidepressants. Clin Pharmacol Ther . 2023;114(1):51-68. doi:10.1002/cpt.2903 7. Brouwer JMJL, Wardenaar KJ, Nolte IM, et al. Association of CYP2D6 and CYP2C19 metabolizer status with switching and discontinuing antidepressant drugs: an exploratory study. BMC Psych . 2024;24:394-408. doi:10.1186/s12888-024-0576 8. Brown JT, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther . 2019;106(1):94-102. doi:10.1002/cpt.1409 9. Caudle K, Sangkuhl K, Whirl-Carrillo M, et al. Standardizing CYP2D6 genotype to phenotype translation: consensus recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci , 2020;13:116-124. doi:10.1111/cts.12692 10. Chang M, Tybring G, Dahl ML, et al. Impact of cytochrome P450 2C19 polymorphisms on citalopram/escitalopram exposure: a systematic review and meta – analysis. Clin Pharmacokinet . 2014;53(9):801-811. doi:10.1007/s40262-014-0162-1 11. Cicali EJ, Smith DM, Duong BQ, et al. A scoping review of the evidence behind cytochrome p450 2d6 isoenzyme inhibitor classifications. Clin Pharmacol Ther . 2020;108(1):116-125. doi:10.1002/cpt.1768 12. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Accessed September 19, 2025 . www.cdc.gov 13. Clinical Pharmacogenetics Implementation Consortium. 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MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 24. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Accessed September 19, 2025 . www.genome.gov 25. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 26. Fijal BA, Guo Y, Li SG, et al. CYP2D6 pr edicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial. JClin Pharmcol . 2015;55(10):1167-1174. doi:10.1002/jcph.530 27. Guin D, Hasija Y, Kukreti. Assessment of clinically actionable pharmacogenetic markers to stratify anti-seizure medications. Pharmacogenomics J . 2023;23:149-160. doi:10.1038/s41397-023-00313-y 28. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed September 19, 2025 . www.pubmed.ncbi.nih.gov 29. Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther . 2015;98(2):127-134. doi:10.1002/cpt.147 2 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 30. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther . 2017;102(1):37-44. doi:10.1002/cpt.597 31. Hicks JK, Swen JJ, Thorn CF, et al. Clinical Pharmacogenetics Implementation Consortium guideline for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther . 2013;93(5):402-408. doi:10.1038/clpt.2013.2 32. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 33. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 34. Jukic MM, Haslemo T, Molden E. Impact of CYP2C19 genotype on escitalopram exposure and therapeutic failure: a retrospective study based on 2087 patients. Am J Psych . 2018;175(5):463-470. doi:10.1176/appi.ajp.2017.17050550 35. Koh A, Pak KC, Choi HY, et al. Quantitative modeling analysis demonstrates the impact of CYP2C19 and CYP2D6 genetic polymorphisms on the pharmacokinetics of amitriptyline and its metabolite, nortriptyline. JClin Pharmacol . 2019;59(4):532-540. doi:10.1002/jcph.1344 36. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Accessed September 19, 2025 . www.uptodate.com 37. Laboratory Requirements, 42 C.F.R. 493 (2024). 38. Lagishetty CV, Deng J, Lesko LJ, et al. How informative are drug-drug interactions of gene-drug interactions? JClin Pharmacol . 2016;56(10):1221-1231. doi:10.1002/jcph.743 39. Leckband SG, Kelso JR, Dunnenberger HM, et al. Clinical Pharmacogenetics Implementation Consortium guidelines for HLA-B genotype and carbamazepine dosing. Clin Pharmacol Ther . 2013;94(3):324-328. doi:10.1038/clpt.2013.103 40. Li D, Pain O, Chiara F, et al. Metabolic activity of CYP2C19 and CYP2D6 on antidepressant response from 13 clinical studies using genotype imputation: a meta – analysis. Transl Psychiatry . 2024;14(1):296. doi:10.1038/s41398-024-02981-1 41. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Accessed September 19, 2025 . www.fda.gov 42. Lu ML, Chen TT, Kuo PH, et al. Effects of adjunctive fluvoxamine on metabolic parameters and psychopathology in clozapine-treated patients with schizophrenia: A 12-week, randomized, double-blind, placebo-controlled study. Schizophr Res . 2018;193:126-133. doi:10.1016/j.schres.2017.06.030 43. McCormack M, Bourgeois S, Farrell JJ, et al. HLA-A*3101 and carbamazepine – induced hypersensitivity reactions in Europeans. NEngl JMed . 2011;364(12):1134 – 1143. doi:10.1056/NEJMoa1013297 44. Medical Code Brief: 0392U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 45. Medical Code Brief: 0411U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 46. Medical Code Brief: 0419U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 47. Medical Code Brief: 0423U-PLA (U Codes). Hayes; 2023. Accessed September 22,2025. www.evidence.hayesinc.com 48. Medical Code Brief: 0434U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 49. Medical Code Brief: 0438U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 50. Medical Code Brief: 0476U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 51. Medical Code Brief: 0477U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 52. Milosavljevic F, Bukvic N, Pavlovic Z, et al. Association of CYP2C19 and CYP2D6 poor and intermediate metabolizer status with antidepressant and antipsychotic exposure: a systematic review and meta-analysis. JAMA Psychiatry . 2021;78(3):270 – 280. doi:10.1001/jamapsychiatry.2020.3643 53. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Accessed September 19, 2025 . www.evidence.hayesinc.com 54. Nahid NA, Johnson JA. CYP2D^ pharmacogenetics and phenoconversion in personalized medicine. Expert Opin Drug Metab Toxicol . 2022;18(11):769-785. doi:10.1080/17425255.2022.2160317 55. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed September 19, 2025 . www.cancer.gov 56. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed September 19, 2025 . www.ncbi.nlm.nih.gov 57. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Accessed September 19, 2025 . www.medicaid.gov 58. Ozeki T, Mushiroda T, Yowang A, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet . 2011;20(5):1034 – 1041. doi:10.1093/hmg/ddq537 59. Patel JN, Morris SA, ,Torres R, et al. Pharmacogenomic insights in psychiatric care: uncovering novel actionability, allele-specific CYP2D6 copy number variation, and phenoconversion in 15,000 patients. Mol Psychiatry . 2024. doi:10.1038/s41380024-0 60. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Accessed September 19, 2025 . www.aacap.org 61. Phillips EJ, Sukasem C, Whirl-Carrillo M, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmaco Ther . 2018. doi:10.1002/cpt.1004 62. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com 63. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed September 19, 2025 . www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 64. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com65. Pritchard D, Patel JN, Stephens LE, et al. Comparison of FDA table of Pharmacogenetic Associations and Clinical Pharmacogenetics Implementation Consortium guidelines. Am JHealth Syst Pharm . 2022;79(12):993-1005. doi:10.1093/ajhp/zxac064 66. Raby B. Personalized medicine. UpToDate. Accessed September 19, 2025 . www.uptodate.com 67. Rehder C, Bean LJH, Bick D, et al. Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4 68. Rosenblat JD, Lee Y, McIntyre RS. Does pharmacogenomic testing improve clinical outcomes for major depressive disorder? a systematic review of clinical trials and cost-effectiveness studies. JClin Psychiatry . 2017;78(6):720-729. doi:10.4088/JCP.15r10583 69. Roy S, LaFramboise WA, Nikiforov YE, et al. Next-generation sequencing informatics: challenges and strategies for implementation in a clinical environment. Arch Pathol Lab Med . 2016;140(9):958-975. doi:10.5858/arpa.2015 – 0507-RA 70. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. Accessed September 19, 2025 . www.rcpsych.ac.uk 71. Saadullah Khani NS, Hudson G, Mills G, et al. A systematic review of pharmacogenetic testing to guide antipsychotic treatment. Nat Mental Health . 2024 ;2(5):616-626. doi:10.1038/s44220-024-00240-2 72. Swen JJ, van der Wouden CH, Manson LE, et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster – randomised crossover implementation study. Lancet . 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4 73. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol . 2013;149(9):1025-1032. doi:10.1001/jamadermatol.2013.4114 74. Tantisira K. Overview of pharmacogenomics. UpToDate. Accessed September 19, 2025 . www.uptodate.com 75. Ter Hark S, Vos CF, Aarnoutse RE, et al. Biomarkers as predictors of treatment response to tricyclic antidepressants in major depressive disorder: a systematic review. JPsych Res . 2022;150:202-213. doi:10.1016/j.jpsychires.2022.03.057 76. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed September 19, 2025 . www.fda.gov 77. Vos CF, Ter Hark SE, Schelleken AFA, et al. Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder: a randomized clinical trial. JAMA Netw Open . 2023;6(5):e2312443. doi:10.1001/jamanetworkopen.2023.12443 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 78. Wang Q, Sun S, Xie M, et al. Association between the HLA-B alleles and carbamazepine-induced SJS/TEN: a meta-analysis. Epilepsy Res . 2017;135:19-28. doi:10.1016/j.eplepsyres.2017.05.015 79. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 80. Wu X, Zhang H, Miah MK, et al. Physiologically based pharmacokinetic approach can successfully predict pharmacokinetics of citalopram in different patient populations. JClin Pharmacol . 2020;60(4):477-488. doi:10.1002/jcph.1541 81. Zeier Z, Carpenter L, Kalin N, et al. Clinical implementation of pharmacogenetic decision support tools for antidepressant drug prescribing. Am JPsychiatry . 2018;175(9):873-886. doi:10.1176/appi.ajp.2018.17111282 82. Zubenko G, Sommer B, Cohen B. On the marketing and use of pharmacogenetic tests for psychiatric treatment. JAMA Psychiatry. 2018;75(8):769-770. doi:10.1001/jamapsychiatry.2018.0834 Reviewed by AllMed 09/2024Approved by Ohio Dept of Medicaid 10/10/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-OH MCD-MM-0798 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Policies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 5 Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectClinical Trial Coverage B. Background Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials evaluate new or emerging devices, treatments, and procedures. They may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol or action plan for conducting the trial. The protocol or action plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical trials are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested or non-standard treatments to standard currently accepted treatments. Clinical trials are intended to improve clinicians knowledge about a treatment and to improve clinical outcomes for future patients. Clinical trials generally proceed through four phases: a. Phase I the study treatment is given to a small group of people who are healthy or have the disease/condition for the first time to evaluate its safety and determine a safe dosage range b. Phase II the study treatment is given to a large group of people who have the disease/condition to see if it is effective and to identify side effects c. Phase III the study treatment is given usually to large groups of people who have the disease/condition to confirm its effectiveness, monitor adverse reactions, compare it to commonly used treatments and collect information that will allow the treatment to be used safely d. Phase IV studies performed after the treatment has been marketed to collect information about its effects in various populations of people who have the disease/condition and to identify side effects associated with long-term use. NOTE: Experimental, investigational, and unproven treatment, procedures and all related services are not a covered service by Medicaid.C. Definitions Clinical Trial is a Phase I, II, III, or IV research study that does ONE of the following for the treatment of cancer or a life-threatening disease: o tests how to administer a health care service o tests responses to a health care service o compares effectiveness of a health care service o studies new uses of a health care service AND Is approved and funded by ONE of the following: Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o a cooperative group of research facilities that has an established peer review program that is approved by a National Institutes of Health Institute or center and assures an unbiased review of standards of care with qualified individuals who do not have an interest in the review outcome o National Institutes of Health (NIH) o The Centers for Disease Control and Prevention (CDC) o The Agency for Health Care Research and Quality (AHRQ) o The Centers for Medicare and Medicaid services (CMS) o a cooperative group or center of NIH, CDC, AHRQ, DOD, VA, or CMS o The United States Department of Veterans Affairs (VA) o The United States Department of Defense (DOD) o The Food and Drug Administration (FDA) o The United States Department of Energy o The institutional review board of an institution located in Ohio that has a multiple project assurance contract approved by the National Institutes of Health Office for Protection from Research Risks as provided in 45 CFR 46.103 o a research entity that meets eligibility criteria for a support grant from a National Institutes of Health center o a qualified non-governmental research entity in guidelines issued by the NIH for center support grants AND o is conducted in a facility where the personnel have training, and expertise required to provide type of care required in the study AND o has a written protocol for the clinical trial AND o designed to have a therapeutic intent. Routine Care Cost The cost of medically necessary items and services related to the care method which is under evaluation in the clinical trial. Life-threatening Disease or Condition Any disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Category A (Experimental) Device Per Centers for Medicare and Medicaid Services a device for which absolute risk of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. Category B (Non-experimental/investigational) Device Per Centers for Medicare and Medicaid Services a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type. Experimental/investigational/unproven Any procedure, treatment, service, supply, or product that meets one or more of the following: o Is subject to Institutional Review Board review or approval. o Effectiveness on health outcomes is unproven based on clinical evidence in peer-reviewed medical literature. Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 o Cannot be legally marketed in the United States without final approval from appropriate government regulatory or licensing body. ICD-10-CM Code Z00.6 A billable ICD code used to specify a diagnosis of encounter for examination for normal comparison and control in clinical research program. The Z00.6 diagnosis code reports that the service involved "examination of participant in clinical trial." The Z00.6 diagnosis code must be used for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be conventional care for the patient absent the trial. D. Policy I. Prior authorization is required for ICD-10-CM Code Z00.6. II. Informed consent approved by an IRB accredited Association for the Accreditation ofHuman Research Protection Programs (AAHRPP) must be obtained from the member before enrolling in a clinical trial. III. CareSource will cover routine care costs for a member enrolled in a clinical trial asdescribed in this policy when A. The same routine care costs would be typically covered for a member who is not enrolled in the clinical trial AND B. All items and services are medically necessary AND C. All items and services are a covered benefit. IV. CareSource will cover routine care costs for member in a clinical trial where the itemor service is A. Required for the administration and provision of the item or service such as the staffing and equipment need to implant the device OR B. For the clinically appropriate monitoring of the effects of the item or service OR C. For the prevention, diagnosis, or treatment of complications from item or service provided in the clinical trial. V. CareSource will NOT cover the following items as they are not considered routine care costs typically covered by a member who is not enrolled in the clinical trial A. Item or service being evaluated. B. Item or service that is only utilized for data collection and analysis and not related to the direct clinical management of member. C. Item or service reimbursed or provided for free from another source including the research sponsor. D. Item or service only utilized to determine if individual is eligible to participate in clinical trial. E. Clinical trials designed to only test toxicity or disease pathology. F. Treatment that is not standard of care to support or administer the item or service in the clinical trial. Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 G. Transportation, housing, food or expenses for the member or family members/companions associated with travel to or from facility providing the clinical trial. H. Experimental/investigational/unproven procedure, treatment, service, supply, device, or product. VI. All applicable plan limitations for coverage for out-or-network providers will apply toroutine care costs in a clinical trial.VII. All applicable utilization management guidelines (including prior authorizations) willapply to routine care for members in a clinical trial.E. Conditions of CoverageN/A F. Related Policies/Rules Experimental or Investigational Item or ServiceG. Review/Revision HistoryDATE ACTIONDate Issued 05/19/2015 New PolicyDate Revised 05/19/2015 05/17/2016 07/10/2019 11/01/2019 10/28/2020 10/27/202108/31/202208/30/202309/05/202409/10/2025 No changes Changed title from Clinical Trials. Changed from AD-0002. Removed all other state requirements. Added specific criteria. Added PA requirement. Updated references. Per SIU expanded definition Z00.6, Encounter for examination for normal comparison and control in clinical research program No changes; updated references Changed title to Clinical Trial Coverage. Updated references. No other changes. Updated references. Approved at Committee. Updated references. Approved at Committee. Added Experimental or Investigational Item or Service to Sec. F. Updated references. Approved at Committee . Date Effective 01/01/2026 Date Archived H. References1. Associations for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed August 1, 2025. www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed August 1, 2025. www.ecfr.gov 3. Medicare and Medicaid Services Medicare Learning Network (2015). MLN Matters. Medicare Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies. Accessed August 1, 2025. www.cms.gov Clinical Trial Coverage-OH MCD-MM-0798Effective Date: 01/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 4. National Coverage Determination for Routine Costs in Clinical Trials (310.1).Accessed August 1, 2025. www.cms.gov 5. Denial of Coverage to Cancer Clinical Trial Participant, O HIO R EV . C ODE ANN 3923.80 (2009). 6. Non-Covered Services, O HIO ADMIN . C ODE 5160-1-61 (2022). Accessed August 1, 2025. www.codes.ohio.gov 7. Patient Protection and Affordable Care Act. (2010, March 23). Accessed August 1, 2025. www.govinfo.gov. 8. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). Accessed August 1, 2025. www.govinfo.gov Approved ODM on 09/18/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 12/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject . .2 B. Background 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …….. 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ……. 3 H. References ………………………….. ………………………….. ………………………….. ……………………… 4 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.2 A. SubjectPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental B. BackgroundPositive airway pressure (PAP) devices u tilize a machine with a mask or other apparatus that fits over the nose and/or mouth to provide positive pressure , keep ing airways open. Continuous positive airway pressure , or CPAP , is used to treat sleep-related breathing disorders , including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bi – level or two-level positive airway pressure , or BiPAP , is used to treat lung disorders , such as chronic obstructive pulmonary disease ( COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP devices can provide better sleep quality, reduc e or eliminat e snoring, and less en daytime sleepiness. PAP devices should always be used according to the physicians order , as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome . C. Definitions Adherence Use of the PAP device as prescribed by the ordering physician, defined as utilization for 4 or more hours per night for 70% of the nights during the most recent consecutive 30-day period during the first initial usage. Bi-Level Positive Airway Pressure (BiPAP) Device A device that uses mild bi-level or two levels of air pressure to keep airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep airways open. Positive Airway Pressure (PAP) Device A device that uses air pressure to keep airways open , including both continuous positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices. D. PolicyI. PAP devices addressed in this policy are as follows: A. E0601 CPAP, continuous pressure capability, used with noninvasive nasal or face mask. This item is a rent to purchase. B. E0470 BiPAP, Bi-level pressure capability, without backup rate feature, used with noninvasive nasal or face mask. This item is a rent to purchase. C. E0471 BiPAP, Bi-level pressure capability, with backup rate feature, used with noninvasive nasal or face mask. This item is a rental only. D. E0472 BiPAP, Bi-level pressure capability, with backup rate feature, used with invasive tracheostomy tube. This item is a rental only. II. PAP devices CPAP (E0601) and BiPAP (E0470):A. Initial prior authorization review: PAP devices CPAP (E0601) and BiPAP (E0470): 1. During the first 3 months rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device, CareSource considers the device Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.3 medically necessary when Ohio Administrative Code (OAC) clinical criteria are met. B. Continued rent to purchase period 1. For months 4-10 rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device documentation confirming adherence (see above definition) must be submitted. Note: CPAP (E0601) and BiPAP (E0470) machines are a 10-month rent to purchase. III. PAP devices BiPAP (E0471) and BiPAP (E0472) CareSource uses MCG Health and /orOAC clinical criteria to determine medical necessity A. During the first 6 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 7-12 rental, CareSource considers the device medically necessary when documentation confirming adherence (see above definition) is submitted . C. Documentation confirming adherence must be submitted annually with the prior authorization request. CareSource considers the device medically necessary when BOTH the following are met: 1. The MCG Health clinical criteria are met. 2. Documentation confirming adherence (see above definition) is submitted. E. Conditions of CoverageNA F. Related Policies/RulesNoninvasive Home Mechanical Ventilation G. Review/Revision HistoryDATE ACTIONDate Issued 06/10/2020 New policyDate Revised 03/31/2021 Revised medical necessity criteria language. Added definitions. Clarified types of PAP devices.05/11/2022 No changes. Updated references. Approved at PGC.03/15/2023 Added Ohio Administrative Code language. Updated02/28/202408/28/202408/13/2025 references. Approved at Committee.Annual review. Removed MCG from initial review and supply chain statement. Updated references. Approved at Committee. Revised D. II. and III. Updated references. Approved at Committee. Annual review. Updated F. and references. Approved at Committee. Date Effective 12/01/2025 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.4 Date ArchivedH. References1. Bi-level Positive Airway Pressure (BPAP) Device: ACG A-0994. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1 , 2025 . www.careweb.careguidelines.com 2. Continuous Positive Airway Pressure (CPAP) Device: ACG A-0431. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1, 2025 . www.careweb.careguidelines.com 3. CPAP. National Heart, Lung, and Blood Institute. Updated March 24, 2022. Accessed August 1, 2025 . www.nhlbi.nih.gov 4. DMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). 5. LCD Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) . Centers for Medicare and Medicaid. Updated January 1, 2024. Accessed August 1, 2025 . www.cms.gov 6. Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers, OHIO ADMIN . CODE 5160-10-1. Accessed August 1, 2025 . www.codes.ohio.gov 7. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JClin Sleep Med . 2019;15(02):335-343. doi:10.5664/jcsm.7640 This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. Approved by ODM 08/21/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 12/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectDigital Therapy Devices for Treatment of Amblyopia B. Background Amblyopia (ie, "lazy eye") is a neurodevelopmental disorder characterized by diminished visual acuity, usually in 1 eye, that is caused by inadequate visual processing in early childhood. When vision in 1 eye is abnormal, the brain will suppress signals from the weaker eye and rely on information from the stronger eye instead. Amblyopia is defined by the American Academy of Ophthalmology (AAO) as an interocular difference of 2 lines in acuity or acuity 20/30 with the best optical correction. According to the American Academy of Ophthalmology Preferred Practice Pattern guidelines Amblyopia (2024), most children who have moderate amblyopia (20/40 to 20/80) respond to initial treatment consisting of 2 hours of daily patching or weekend atropine. The AAOS Preferred Practice Pattern guidelines (2024) state: Refractive correction with eyeglasses is recommended as the initial step in care of children 0-17 years of age . Additionally, occlusion of the non-amblyopic eye with eye patching or pharmacological treatment with blurring atropine eye drops are each recommended in the guideline as an appropriate choice for amblyopia treatment in children who do not improve with refractive correction alone or who have incomplete resolution of their visual acuity deficit (2024). More recently, digital therapy devices have been developed to treat amblyopia in children with no strabismus or small angle strabismus with some binocularity using therapeutic dichoptic (binocular) visual stimuli. Images are presented using noninvasive, computerized systems such as virtual reality headsets or 3-dimensional glasses; typically, high-contrast images are presented to the amblyopic eye and low-contrast images are presented to the fellow eye. This is a proposed way to help the eyes work together. According to the American Academy of Ophthalmology (2024), Although data from early nonrandomized studies were promising, results from three randomized trials of early software applications failed to demonstrate that game play prescribed 1 hour per day was as good as patching prescribed 2 hours per day or better than placebo game play. Research with this technology is ongoing, which will be used to delineate use of binocular therapy for treatment of amblyopia. Another randomized prospective clinical trial studied a digital therapeutic using a desk-based computer platform, red-blue anaglyph glasses and an eye tracker found at 16 weeks the therapeutic (2.8 lines of improvement to be non-inferior to patching 2 hours per day). C. Definitions Amblyopia Also known as lazy eye, is a developmental disorder of the central nervous system that results from the abnormal processing of visual images, leading Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 to reduced visual acuity (VA) in one or both eyes due to abnormal vision development in infancy and childhood . Convergence Insufficiency Inability to maintain binocular function (keeping the two eyes working together) while working at a near distance. Typically, one eye will turn outward (intermittent exotropia) when focusing on a word or object at near distance. Occlusion Therapy Also called patching, is the mainstay of amblyopia treatment. Patching the unaffected, or good eye provides monocular stimulation to the amblyopic eye, promoting visual development. Occlusion therapy is prescribed to improve vision and as a rule, does not eliminate strabismus. Orthoptic Vision Therapy Eye exercises usually weekly over many months done in the optometrist office. Pharmacologic Penalization Therapy Therapy using eye drops, typically atropine, to blur the vision in the better-seeing eye, thus encouraging the use of the weaker, amblyopic eye. Prescription Digital Therapeutics (PDTs) Software-based therapeutic interventions for the prevention, management, or treatment of medical illnesses or diseases that have been evaluated for safety and efficacy. PDTs are authorized by the US Food and Drug Administration to treat diseases through an approved label and are differentiated from other digital health technologies (traditional health and wellness apps) by the following unique characteristics (Digital Therapeutics Alliance, 2021). Strabismus Misalignment of the eyes. Strabismus is commonly described by the direction of the eye misalignment such as esotropia, exotropia, and hypertropia. D. PolicyI. CareSource considers the following services medically necessary: A. occlusion therapy or pharmacologic penalization therapy for treating amblyopia B. orthoptic therapy or vision therapy for treating convergence insufficiency C. prism adaptation therapy for treating esotropia II. According to Centers for Medicare & Medicaid Services: Early and PeriodicScreening, Diagnostic and Treatment services (EPSDT) does not require coverage of treatments, services, or items that are experimental or investigational. However, requested treatments for children will be reviewed individually to determine the best course of treatment. III. Unproven and Not Medically Necessary A. Orthotic Vision Therapy for treating other conditions not listed above are considered unproven and not medically necessary. B. Prescription Digital Therapeutics for Amblyopia. E. Conditions of Coverage NA Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 F. Related Policies/RulesExperimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/30/2025 New policy. Approved at Committee.Date Revised Date Effective 12/01/2025 Date Archived H. References1. Amblyopia Preferred Practice Pattern 2022-Updated 2024. American Academy of Ophthalmology. December 19, 2022. Accessed July 1, 2025. www.aao.org 2. Birch EE, Kelly KR. Amblyopia and the whole child. Prog Retin Eye Res . 2023;93:101168 doi:10.1016/j.preteyeres.2023.101168 3. Boniquet-Sanchez S, Sabater-Cruz N. Current Management of Amblyopia with New Technologies for Binocular Treatment. Vision (Basel) . 2021;5(2):31. doi:10.3390/vision5020031 4. EPSDT-A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents. Centers for Medicare & Medicaid Services. Accessed July 1, 2025. www.medicaid.gov 5. Levi DM. Rethinking amblyopia 2020. Vision Res . 2020;176:118-129. doi: 10.1016/j.visres.2020.07.014 6. Li T, Qureshi R, Taylor K. Conventional occlusion versus pharmacologic penalization for amblyopia. Cochrane Database Syst Rev . 2019;8(8):CD006460. doi: 10.1002/14651858.CD006460.pub3 7. Meier K, Tarczy-Hornoch K. Recent treatment advances in amblyopia. Annu Rev Vis Sci . 2022; 8:323-343. doi:10.1146/annurev-vision-100720-022550 8. Strul S. Understanding digital treatments for amblyopia. Am Acad Ophthalmol . September 24, 2024. Accessed July 1, 2025. www.aao.org 9. Tsani Z, Ioannopoulos D, Androudi S, et al. Binocular treatment for amblyopia: a systematic review. Int Ophthalmol . 2024;44(1):362. doi:10.1007/s10792-024-03259-7 10. Yeritsyan A, Surve AV, Ayinde B, et al. Efficacy of amblyopia treatments in children up to seven years old: a systematic review. Cureus . 2024;16(3): e56705. doi:10.7759/cureus.56705 Approved by ODM on 09/02/2025
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nursing Facility Level of Care-OH MCD-MM-1218 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………..11 F. Related Policies/Rules ………………………………………………………………………………………….11 G. Review/Revision History ……………………………………………………………………………………….11 H. References …………………………………………………………………………………………………………12 Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNursing Facility Level of Care B. Background Nursing facilities (NFs) provide professional skilled and non-skilled services that facilitate member recovery and stability. Nursing facility care should be considered when a member no longer requires acute care services but continues to need healthcare services that can only be managed in the recovery facility environment. When primarily rehabilitation services are needed, health professionals working in acute care hospitals should recognize members' needs for rehabilitation care and facilitate transition to appropriate rehabilitation care settings. C. Definitions Assistance Per the Ohio Administrative Code (OAC) is the hands-on provision of help in the initiation and/or completion of a task. Hands-on help is generally considered to be any aid in which the caregiver makes direct, physical contact with members to provide assistance with tasks, rather than just supervision or cueing. Intermediate Level of Care (ILOC) A level of care for members whose needs are less than skilled level of care, but more than the protective level of care, and are stable. These members also do not meet the criteria for the ICF-IID-based level of care. The member has a need for a minimum of one of the following: o Assistance with a minimum of 2 activities of daily living o Assistance with a minimum of 1 ADL and medication administration o A minimum of 1skilled nursing service or skilled rehabilitation service o 24-hour support in order to prevent harm due to a cognitive impairment as diagnosed by a physician or other licensed health professional acting within their scope of practice. Intermediate Care Facilities for Individuals with Intellectual Disability (ICF/IID) A place where someone with a disability can choose to live and get the services that help them live their lives with staff and aides who work at the facility 24 hours a day . Level of Care (LOC) The level of services and supports required by an individual to manage medical conditions and/or activities of daily living (ADL) and instrumental activities of daily living (IADL) needs. The criteria for NF based level of care includes an individual requiring assistance with mobility, bathing, grooming, toileting, dressing, and eating. The two levels of care in Ohio that qualify an individual to receive nursing facility-based care are Intermediate LOC and Skilled LOC Long-Term Services and Supports (LTSS) Encompasses an array of medical and personal care services for people who struggle with self-care due to aging, physical, cognitive, or mental conditions or disabilities. People commonly receive LTSS services for months or even years, which is the reason LTSS are sometimes referred to as long-term care. It includes cost-effective, person-centered home and case managed community-based alternatives to institutional care. LTSS include, but are not limited to: o nursing facility care Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o adult daycare programs o home health aide services o personal care services o transportation o assistance provided by a family caregiver Nursing Facility (NF) Institutions that provide nursing and medical care to members who no longer require care in an acute setting, but do require licensed nursing services, rehabilitation services, or other health-related services that must be performed by a skilled, licensed professional on a daily basis that cannot be provided in the home. The nursing facility-based level of care includes both the intermediate and skilled levels of care. Ohio Administrative Code (OAC) The rules adopted by the agencies of the state of Ohio. State agencies adopt rules to carry out the policies and intent of laws passed by the General Assembly. The rules are collected and published in the OAC. Clinical Care Reviewer (CCR) A clinical professional who reviews clinical information, applies criteria, and evaluates the care needs of a member who needs inpatient or outpatient services that require a prior authorization. Preadmission Screening/Resident Review (PASRR) A federal requirement to help ensure that individuals are not inappropriately placed in nursing homes for care. PASRR requirements must be completed prior to an individual being admitted to a Medicaid certified nursing facility. Evidence of PASRR requirements being met must be provided to CareSource at the time of the request for authorization. Protective Level of Care Care provided primarily to assist a member in meeting the instrumental activities of daily living but not requiring nursing facility based care . Protective care can reasonably and safely be provided by non-licensed caregivers in a community setting. Skilled Level of Care Skilled level of care is when: o The member's LTSS needs exceed the criteria for the protective level of care, the intermediate level of care, or the ICF-MR-based level of care. o The member requires either 1 skilled nursing service no less than 7 days a week or one skilled rehabilitation service no less than 5 days a week, or o The member has an unstable medical condition. Skilled Nursing Services Tasks that must be provided by a registered nurse directly or by a licensed practical nurse at the direction of a registered nurse. Skilled Rehabilitation Services Specific tasks that must be provided directly by a licensed or other appropriately certified technical or professional health care personnel. D. PolicyI. CareSource will review all Ohio Medicaid Nursing Facility requests (for admission and continued stays) for skilled and intermediate level of care using OAC 5160-3-08, Criteria for nursing facility-based level of care for an adult and OAC 5160-1-01, Medical Necessity. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 II. Preadmission Screening and Resident Review Requirements CareSource requires evidence that Preadmission Screening and Resident Review requirements have been met prior to the members admission to a NF as part of the prior authorization and level of care review processes in accordance with OAC 5160-3-14 process and timeframes for a level of care determination for nursing facility-based level of care programs, OAC 5160-3-15.1 Preadmission screening requirements for individuals seeking admission to nursing facilities, and OAC 5160-3-15.2 Resident Review requirements for individuals residing in nursing facilities. III. Skilled Level of Care CriteriaCareSource considers skilled care in a nursing facility medically necessary when the following factors have been met: A. Member must have an unstable medical condition as defined in OAC 5160-3- 05(B)(40) in that clinical signs and symptoms are present in an individual and a physician has determined that: 1. The individual's signs and symptoms are outside of the normal range for that individual. 2. The individual's signs and symptoms require extensive monitoring and ongoing evaluation of the individual's status and care, and there are supporting diagnostic or ancillary testing reports that justify the need for frequent monitoring or adjustment of the treatment regimen. 3. Changes in the individual's medical condition are uncontrollable or unpredictable and may require immediate interventions. 4. A licensed health care professional must provide ongoing assessments and evaluations of the individual that will result in adjustments to the treatment regimen as medically necessary. B. The member requires skilled nursing services or skilled rehabilitation services, ie, services that must be performed by or under the supervision of professional or technical personnel, that are ordered by a physician. C. The daily skilled services can be provided only on an inpatient basis in a NF. D. The services delivered are reasonable and necessary for the treatment of a members illness or injury,(ie, are consistent with the nature and severity of the individuals illness or injury), the individuals particular medical needs, and accepted standards of medical practice. E. The member requires a minimum of one of the following: 1. 1 skilled nursing service daily (or more frequently) 7 days per week 2. 1 skilled rehabilitation service daily, at least 5 days per week F. The request meets the requirements of OAC 5160-1-01 Conditions of Medical Necessity. G. There is a therapeutic plan to provide ALL of the following: 1. Case management and evaluation to meet member needs, achieve treatment goals, and ensure medical safety 2. Observation and assessment of member's changing condition to evaluate the need for treatment modification or for additional procedures until condition is stabilized Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Member education to teach member self-maintenance or to teach caregiver member care. H. When they are not safe to perform at a lower level of care, examples of direct skilled nursing services or skilled rehabilitation services include, but are not limited to: Daily nursing treatments are needed for one or more of the following: 1. Intravenous (IV) infusion, IV injection, or intramuscular injection 2. Insulin regimen establishment in presence of unstable blood sugar reading 3. Tube feeding (eg, gastrostomy tubes, jejunostomy tubes percutaneous endoscopic gastrostomy (PEG) tubes, nasogastric tubes) required because member needs feeding to supply at least 26% of daily calories and at least 501 mL of daily fluids 4. Nasopharyngeal or tracheostomy suctioning and suprapubic catheter irrigation 5. Pain management for infusion of pain medications 6. Wound care that requires dressing changes with prescription medication or clean technique and treatment for: 01. Burns 02. Foot infections or wounds 03. Open lesions 04. Surgical wound complications 05. Treatment with any stage III or IV pressure injury 06. Treatment with 2 or more wounds, including venous ulcers, arterial ulcers, or stage II pressure injuries 07. Widespread skin disorder treatments 7. Heat treatments that require nurse observation to evaluate response 8. Oxygen administration, starting or managing changes, including ventilator 9. Member care training and assistance for 1 or more of the following: 01. Exercise program (eg, range of motion, pulmonary, cardiac) 02. Preventing complications and the start or revision of the member's maintenance therapy plan 03. Safe performance of ADL (eg, dressing, communicating, eating) 04. Splint, brace, cast, prosthesis, or orthosis management 05. Urinary or bowel toileting program 10. Pain management for infusion of pain medications I. Rehabilitation therapy treatments (PT, OT, or SLP) are needed for 1 or more of the following: 1. Ongoing assessment of rehabilitation needs and potential (eg, range of motion, strength, balance) 2. Supervision of therapeutic exercises or activities to ensure member safety and treatment effectiveness 3. Gait evaluation and training 4. Preventing complications and the start or revision of the member's maintenance therapy plan 5. Therapy modalities that require PT or OT observation to evaluate response Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 6. Restoration of speech or swallowing with services of speech-language pathologist 7. Prosthetic evaluation and training. III. Intermediate Level of Care CriteriaFor members needing assistance that cannot safely be performed at a lower level of care or the resources to provide the needed care and services in a home or community-based setting are not available, the Intermediate Level of Care (ILOC) is a lower cost alternative that effectively addresses and treats the medical problem, as described in OAC 5160-1-01, Medicaid medical necessity: definitions and principles. Criteria include, but are not limited to: A. The individual's needs for long-term services and supports (LTSS) exceed the criteria for the protective level of care. B. The individuals LTSS needs are less than the criteria for the skilled level of care. C. Individual requires assistance (not necessarily a licensed professional) with the completion of a minimum of two activities of daily living (ADL) as outlined below: 1. Assistance with mobility in at least one of the following components: a. bed mobility b. locomotion c. transfer 2. Assistance with bathing 3. Assistance with grooming in ALL of the following components: a. oral hygiene b. hair care c. nail care 4. Assistance with toileting in at least one of the following components: a. Using a commode, bedpan, or urinal b. Changing incontinence supplies or feminine hygiene products c. Cleansing self d. Managing an ostomy or catheter 5. Assistance with dressing in at least one of the following components: a. Putting on and taking off items of clothing or prosthesis b. Fastening and unfastening an item of clothing or prosthesis 6. Assistance with eating D. Assistance with the completion of a minimum of 1 ADL and assistance with medication administration (ADLs listed in III C 1-6), which is required due to 1. Medication administration is required due to members inability to safely self- manage medications. Reasons may include but are not limited to: a. Does not know current medications b. Lacks insight into reasons medications are prescribed c. Lacks ability to take medications as ordered due to cognitive impairment E. Need for 24 hour support in order to prevent harm due to a cognitive impairment. Examples may include: 1. Member resides in a locked dementia unit 2. Negative results of mini mental status exam Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 F. Direct skilled rehabilitation services less than 5 days per week G. Wound care that cannot be done in the community (wounds less than stage III).NOTE: Members already enrolled in NF services, in particular those requiring intermediate care, should be individually assessed for medical necessity. CareSource supports lower cost alternatives that effectively address the problem. For example, home health or family caregivers, are viable and medically appropriate options. IV. Documentation to Support Nursing Facility-Based Care DeterminationsA. The CareSource prior authorization form or the ODM Nursing Facility Request Form will be accepted for submission of requests. B. PASRR Documentation. One of the following is required at the time of the initial request for nursing facility services: 1. PASRR Level I screen and preadmission screen (PAS) or resident review (RR) results 2. PASRR Level II evaluation and results, if indicated 3. Hospital Exemption Notice (for stays expected to be less than 30 days). Note: For stays in which the hospital exemption notice was submitted at the time of the initial request and the stay is expected to or exceeds 30 days, the PASRR Level I or II, determined by indications of serious mental illness and/or developmental disabilities or related conditions for the member, and resident review results are required to be submitted to CareSource. C. The members medical record must document all the following: 1. The history and physical exam pertinent to the members care including the response or changes in behavior to previously administered skilled services 2. The skilled services provided 3. The plan for future care based on the rationale of prior results 4. A detailed rationale that explains the need for the skilled service in light of the members overall medical condition and experiences 5. The complexity of the service to be performed 6. A decline in physical function compared to the prior level of function (PLOF) 7. Inability to safely ambulate household distance (50 feet) 8. The member requires minimum assist to perform mobility-related activities of daily living (MRADLs) 9. The need for active assistance (hands-on vs. supervision) 10. The documentation in the members medical record must be accurate and avoid vague or subjective descriptions of the members care that would not be sufficient to indicate the need for skilled care 11. Updated clinical evaluation to support on-going concurrent review 12. The services promote the documented therapeutic goals 13. Minimum Data Set (MDS) documentation of cognitive, mood, functional performance, DME use, and/or nutritional status 14. Complete discharge planning assessment and ongoing changes to the plan Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 NOTE: The treatment goal cannot be modified retrospectively.V. Bed-Hold Days A. In accordance with OAC 5160-3-16.4, CareSource will provide payment to a NF provider to reserve a bed for not more than 30 days in any calendar year when: 1. A member is authorized by CareSource for the nursing facility stay at either the skilled or intermediate level of care. 2. A member is not discharged from the NF. 3. A member, who is a resident of the NF, is temporarily absent from the NF due to a hospitalization, therapeutic leave, or visitation with friends or relatives and has the intent and ability to return to the same NF. B. Bed-hold days do not require prior authorization. VI. Non-covered services in a NFClinical documentation that does not support the medical necessity requirements outlined in OAC 5160-1-01 that meets, at a minimum, the ILOC criteria for the following services: A. Repetitious exercises to improve gait, or to maintain strength and endurance and assistive walking can be appropriately provided by supportive personnel. B. When the performance of a maintenance program does not require the skills of a therapist because it could safely and effectively be accomplished by the member or with the assistance of non-therapists, including unskilled caregivers. C. General exercises to promote overall fitness and flexibility and activities to provide diversion or general motivation or the supervision of taught exercises. D. Lack of a competent person to provide a nonskilled service regardless of the importance of the service to the member, does not make it a skilled service when a nurse provides the service. E. Protective LOC services. F. Services not expected to produce the desired outcome. VII. Transitioning from a Nursing FacilityA. Evaluation 1. As part of the discharge planning process and in conjunction with the nursing facility staff, CareSource Case Management (CM) may evaluate a member receiving nursing facility care and services for potential for referral to home and community-based services and/or other state and local resources to assist members in receiving needed services in the least restrictive environment. 2. In compliance with OAC 5160-1-01, members will be reassessed. When the member no longer meets the medical necessity criteria for skilled or intermediate nursing facility care, CareSource will evaluate for discharge to the community (ie, home with needed services and supports). 3. In compliance with OAC 5160-1-01, if the member no longer meets the skilled level of care, or intermediate level of care, CareSource will evaluate for Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 discharge to an appropriate community setting that will meet the members care needs.4. After an initial evaluation period, the UM clinical care reviewer must evaluate the members progress. This initial evaluation may be followed by case management. These reports will include clinical review from the members care team including documentation from facility discharge planning staff. 5. CareSource may perform a re-evaluation of members to identify any changes that require modification of the treatment plan and incorporate these into discharge planning. B. Discharge Planning 1. CareSource expects discharge planning for all members admitted to a nursing facility to begin immediately upon admission. Discharge planning should not be delayed until the member is stable for discharge as this frequently leads to unnecessary delays in a discharge and unnecessary lengthening of the members facility stay. Discharge planning includes: 1. Treatment plan development involving providers engaged in members care 2. Evaluation of members premorbid functioning compared to current state 3. Member and caregiver preferences and abilities 4. Evaluation for services at next level of care as appropriate for member's continued needs 5. Housing 6. Evaluation of psychosocial status and needs 7. Coordination of follow up appointments, planned or scheduled 8. Transportation 9. Coordination of prescription medications and treatments to be available to member upon discharge 10. Home care services, if applicable 11. Referrals made for assistance and support including to state and local programs and/or community-based organizations 12. Medical equipment and supplies coordinated 13. Transition plan communicated to all members of member's care team 2. CareSource Utilization Management (UM) and Case Management (CM) will work, either in-person or via telephonic outreach, with the Nursing Facility to ensure a safe and timely discharge for our members. This collaboration should start within 3 days of the members admission to the NF. 3. The NF must develop and share with CareSource UM during each review a post-discharge plan of care to address the anticipated needs of a member for discharge to a private residence, to another NF, or to another type of residential facility such as a group home, medical respite facility, sober living home, or an intermediate care facility for individuals with intellectual disabilities. 4. Upon request, the discharge plan must be shared with CareSource CM. C. Discharge Criteria Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 Once skilled nursing services (ie, wound care, IV or IV antibiotics treatment) and/or rehabilitation have been completed for safe transfer to lower level of care OR the member is no longer demonstrating significant functional gains and does not meet criteria for intermediate or skilled level of care, the following criteria must be completed prior to discharge: 1. Medication regimen has been established and reconciliation completed. 2. Medical status is stable for member's condition and manageable at lower level of care. 3. Any inserted or implanted device discontinued, or functioning normally and manageable at lower level of care. 4. Medical equipment and supplies are available at next level of care and safe use has been demonstrated. 5. Wound(s) or dressing changes are manageable at a lower level of care. 6. Skilled services (as needed) and logistical requirements can be met at a lower level of care. 7. Transition plans and education are understood by the member and/or the caregiver. D. MCO Initiated Nursing Facility Disenrollment Process 1. Requests for member disenrollment from managed care to fee for service Medicaid due to a need for extended nursing facility care must be submitted to the Ohio Department of Medicaid by CareSource. Approval of disenrollment requests are made at the discretion of ODM. 2. To be eligible for a request for disenrollment from managed care to be submitted to ODM, the member must meet all of the following criteria: a. Be enrolled in a Medicaid category identified by the Ohio Department of Medicaid as eligible for disenrollment. b. Be authorized by CareSource for the NF stay and have a continuous stay in the nursing facility for no less than the month of admission and two complete consecutive months thereafter. c. The members discharge plan documents that nursing facility discharge is not expected in the foreseeable future and the member has a need for long-term nursing facility care. d. The member has not used hospice services during the period outlined in (D)(2)(b). e. In addition, when a member meets criteria outlined in D.2 a, c, and d, the following scenarios are considered: i. If a member is admitted to a nursing facility while enrolled with another MCO and changes to CareSource, CareSource will align the disenrollment request to the disenrollment table dates. ii. If the admission date to the nursing facility is greater than three months prior to enrollment with CareSource, CareSource will submit the disenrollment request during the initial enrollment month to disenroll the member the last calendar date of the month prior to the initial enrollment. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 iii. If a member is admitted to a nursing facility prior to being enrolled withCareSource and was admitted under fee-for-service Medicaid, CareSource will submit a disenrollment request during the initial enrollment month to disenroll the member the last calendar date f the month prior to initial enrollment. If the disenrollment request is not submitted in the initial month, the member will be disenrolled as of the last calendar date of the submission month. 3. When the member is identified as eligible for potential disenrollment as outlined in step D 2, CareSource will submit the request for disenrollment to ODM. NOTE : Modified Adjusted Gross Income (MAGI) Medicaid members in the Adult Extension (MAGI Group 8) category may not be disenrolled. 4. Requests for disenrollment will be submitted in the format specified by ODM. The disenrollment table lists the earliest disenrollment date if all criteria is met. See disenrollment table below: Month of Nursing Facility AdmissionNext Two Consecutive Months Earliest Disenrollment Date January February & March March 31 February March & April April 30 March April & May May 31 April May & June June 30 May June & July July 31 June July & August August 31 July August & September September 30 August September & October October 31 September October & November November 30 October November & December December 31 November Dec. & Jan. (next CY) January 31 (next CY) December January & February (next CY) Last Day of February (next CY) E. Conditions of CoverageNA F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 09/01/2021 New PolicyNursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 Date Revised 05/11/2022 08/09/2022 05/10/2023 07/16/2024 07/30/2025Updated references; no changes E-voted adding new section V. on Bed-Hold days Changed Member Care Coordinator (PCC) to Clinical Care Reviewer (CCR). Added Preadmission Screening and Resident Review requirements to align with Provider Agreement. Added sections IV. A and Bto align with Provider Agreement and reporting requirements. Updated references. Approved at Committee. Updated section IV.B.3 documentation for the Hospital Exemption Notice. Added to section V. Bed-hold Days criteria. Checked with Legal on current contract. Updated references. Approved at Committee. Changed MCP to MCO to align language to the current provider agreement; Added disenrollment language from the new contract. Date Effective 11/01/2025 Date Archived H. References1. ASPE. An Overview of Long-Term Services and Supports and Medicaid: Final report. May 8, 2018. Accessed July 7, 2025. www.hhs.gov 2. CareSource Desk Reference. Nursing Facility Disenrollment Process. July 1, 2019. Accessed June 2, 2025. www.CareSource.com 3. CareSource Procedure. Utilization Management-Level of Care. 2023. Accessed June 12, 2025. www.CareSource.com 4. CG-GRFAC (RFC) General Recovery Facility Comparison Tool. MCG Guidelines. 28th ed. 2024. Accessed June 12, 2025. www.careweb.careguidelines.com 5. CMS. Long Term Services & Supports. 2016. June 2, 2025. www.cms.gov 6. Criteria for Nursing Facility-Based Level of Care, O HIO ADMIN . C ODE 5160-3-08 (2025). 7. Criteria for the protective level of care. O HIO ADMIN . C ODE 5160-3-06 (2025). 8. Level of Care Definitions, O HIO ADMIN . C ODE 5160-3-05 (2025). 9. Managed Care: Termination of Enrollment, O HIO ADMIN . C ODE 5160-26-02.1 (2023). 10. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . C ODE 5160-1-01 (2022). 11. Nursing Facilities (NFs): Covered Days and Bed-Hold Days, O HIO ADMIN . C ODE 5160-3-16.4 (2017). 12. Nursing Home and Residential Care Facility Definitions, O HIO R EV . C ODE 3721.01 (2023). 13. ODM. Nursing Facility Request Form. Accessed June 12, 2025. www.medicaid.ohio.gov 14. Process and timeframes for a level of care determination for nursing facility-based level of care programs. O HIO ADMIN . C ODE 5160-3-14 (2025). 15. Skilled Nursing, O HIO R EV . C ODE 3721.011 (2023). ODM approved 08/13/2025
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