MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – OH MCD-MM-1716 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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: 02/01/2025 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. Those with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound. Individuals are therefore classified as poor metabolizers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies continue to show potential benefits of gene testing. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited available research for a drug class or specif ic drugs. Moststudies 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 or false negatives. Additionally, th ere 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 o ffered. 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, which 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: 02/01/2025 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 indiv iduals who have experienced an inadequate response or adverse reaction to a previous antidepressant or antipsychotic trial. CareSource covers items and services with sufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s) but does not cover experimental or investigational te sting orproducts 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 (cl inical 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. CareSource 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 mana gement, 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: 02/01/2025 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 avail able, authorization 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. Guidelines may be located at www.cpicpgx.org/guidelines. A. General guidelines for all testing requests Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 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: 02/01/2025 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 w ill 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Date Effective 02/01/2025Date 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. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. 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. Reviewed January 16, 2024. Accessed October 7 , 2024. www.cdc.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 13. Clinical Pharmacogenetics Implementation Consortium. Accessed October 7 , 2024. www.cpicpgx.org 14. Clinical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents. American Academy of Child & Adolescent Psychiatry; 2020. Accessed October 7 , 2024. www.aacap.org 15. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed October 7 , 2024. www.hayesinc.com 16. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Updated May 23, 2021. Accessed October 7 , 2024. www.hayesinc.com 17. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing for Opioid Treatment for Pain in Adults Selected Single-Gene Variants and Pharmacogenomic Panels. Hayes; 2019. Updated October 26, 2022. Accessed October 7 , 2024. www.evidenced.hayesinc.com 18. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Hayes; 2020. Updated June 30, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 19. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Updated February 27, 2024. Accessed October 7 , 2024. www.evidence.hayesinc.com 20. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Updated December 1, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 21. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www. careweb.careguidelines.com 22. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Updated August 24, 2020. Accessed October 7 , 2024. www.genome.gov 23. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 24. 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 25. 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 26. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed October 7 , 2024. www.pubmed.ncbi.nih.gov 27. 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 28. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 tricyclic antidepressants: 2016 update. Clin Pharmacol Ther . 2017;102(1):37-44. doi:10.1002/cpt.597 29. 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 30. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 31. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 32. 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 33. 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 34. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated October 7, 2022. Accessed October 7 , 2024. www.uptodate.com 35. Laboratory Requirements, 42 C.F.R. 493 (2024). 36. 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 37. 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 38. 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 39. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Updated December 21, 2023. Accessed October 7 , 2024. www.fda.gov 40. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Medicare Coverage Database. LCD ID L35025. Revised May 4, 2023. Accessed October 7 , 2024. www.cms.gov 41. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Centers for Medicaid and Medicare Services; 2017. LCD ID L36807. Revised April 27, 2023. Accessed October 7 , 2024. www.cms.gov 42. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38294. Revised August 24, 2023. Accessed October 7 , 2024. www.cms.gov 43. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38435. Revised August 24, 2023. Accessed October 7 , 2024. www.cms.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 44. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38274. Revised April 25, 2024. Accessed October 7 ,2024. www.cms.gov 45. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38429 . Revised April 25, 2024. Accessed October 7 , 2024. www.cms.gov 46. 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 47. 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 48. Medical Code Brief: 0345U-PLA (U Codes). Hayes; 2022. Accessed October 7 , 2024. www.evidence.hayeinc.com 49. Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 50. 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 51. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Updated November 13, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 52. 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 53. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed October 7 , 2024. www.cancer.gov 54. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed October 7 , 2024. www.ncbi.nlm.nih.gov 55. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Updated January 1, 2024. Accessed October 7 , 2024. www.medicaid.gov 56. 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 57. 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 58. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Updated December 2019. Accessed October 7 , 2024. www.aacap.org Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 59. Phillips EJ, Sukasem C, Whirl-Carrillo M, et al. Clinical PharmacogeneticsImplementation Consortium Guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmaco Ther . 2018. doi:10.1002/cpt.1004 60. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed October 7 , 2024. www.evidence.hayesinc.com 61. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed October 7 , 2024. www.evidence.hayesinc.com 62. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed October 7 , 2024. www.evidence.hayesinc.com 63. 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 64. Raby B. Personalized medicine. UpToDate. Updated September 06, 2023. Accessed October 7 , 2024. www.uptodate.com 65. 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 66. 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 67. 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 68. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. Accessed October 7, 2024. www.rcpsych.ac.uk 69. 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 70. 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 71. 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 72. Tantisira K. Overview of pharmacogenomics. UpToDate. Updated July 05, 2024. Accessed October 7, 2024. www.uptodate.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 73. 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.2022.03.05774. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed October 7 , 2024. www.fda.gov 75. 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 76. 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 77. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 78. 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 79. 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 80. 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 11/14/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Myoelectric Upper Extremity Orthosis B. Background Experimental or Investigational items or services are not covered. An upper limb myoelectric orthosis is a robotic assisted brace. It is proposed that the device self-initiates movement using the members own muscle signals. Upper limb myoelectric orthoses are considered experimental and investigational due to insufficient evidence of efficacy. These devices should not be confused with prosthetic devices, which are intended to replace or compensate for a missing limb or other body part. The intent of this policy is to address requests that require medical necessity review in accordance with OAC 5160-1-01 . C. Definitions Experimental or Investigational Items or Services Medical, surgical, diagnostic, psychiatric, substance use disorders treatment or other health care services, technologies, equipment, supplies, treatments, procedures, therapies, biologics, drugs, or devices (each a Health Care Item or Service) that, at the time CareSource has made a determination regarding coverage in a particular case, are: o Not approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use o Not identified in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use, or o Determined by the FDA to be contraindicated for the specific use o Subject to review and approval by any institutional review board or other body serving a similar function for the proposed use, and such final approval has not been granted o The subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight o Provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service , or supply o Provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply as experimental or investigational, or otherwise indicate that the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation NOTE: Devices that are FDA approved under the Humanitarian Use Device exemption are not considered to be experimental or investigational. Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3Orthosis A brace, sling, or splint often made from thermoplastics, casting, and metal. Upper Limb Myoelectric Orthosis Device that combines a standard upper limb orthotic device with microprocessors, muscle sensor, and an electric motor of a myoelectric device. D. Policy I. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. The use of myoelectric upper extremity orthotic devices is considered investigational and not medically necessary for all indications including, but not limited to, restoration of function to arms and hands paralyzed or weakened by cerebrovascular accident , brachial plexus injury, cerebral palsy, or any other neurological or neuromuscular disease or injury. III. Myoelectric upper limb and hand orthotic devices are not covered. This includes, but is not limited to, the following: A. MyoPro B. MyoPro 2 E. Conditions of Coverage NA F. Related Policies/Rules Experimental, Investigational and Other Non-Covered Service G. Review/Revision History DATES ACTIONDate Issued 10/25/2023 New Policy . Approved at Committee.Date Revised 10/23/2024 Updated references. Approved at Committ ee Date Effective 02/01/2025 Date Archived H. References1. Evolving Evidence Review: MyoPro Orthosis (Myomo Inc.) for Upper Extremity Paralysis/Paresis After Stroke. Hayes; 2023. Accessed September 30, 2024. www.hayesinc.com 2. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . CODE 5160-1-01 (2022). Accessed September 30, 2024. www.codes.ohio.gov Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.43. Medicare coverage of items and services in category a and b investigational device exemption (IDE) s tudies. US Centers for Medicare and Medicaid Services. January 1, 2015. MLN Matters MM8921. Accessed September 30, 2024. www.cms.gov 4. Premarket Notification 510(k) Summary K062631. US Food and Drug Administration. April 12, 2007. Accessed September 30, 2024. www.fda.gov 5. Jensen EF, Raunsbk J, Lund JN, et al . Development and simulation of a passive upper extremity orthosis for amyoplasia. JRehabil Assist Technol Eng. 2018;5. doi:10.1177/2055668318761525 6. Pundik S, McCabe J, Kesner S, et al . Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. JRehabil Assist Technol Eng. 2020;7: 1-11. doi:10.1177/2055668320921067 ODM Approved 11/ 14/202 4
MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Fraction Flow Reserve from computer tomography (FFRct) – OH MCD-MM-1046 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines.Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A.Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Fraction Flow Reserve from computer tomography ( FFRct)-OH MCD-M M-1046 Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.2A. Subject Fraction Flow Reserve from Computer Tomography (FFRct) B.Background Heart disease, with coronary artery disease (CAD) being the most common, is the leading cause of death for men and women. The traditional test in management of coronary artery stenosis is a procedure where the fractional flow reserve measures t he bl ood pressure to determine adequate blood flow or blockage during an invasiv e c oronary angiography.A noninvasive alternative for stable symptomatic members with CAD is HeartflowFraction Flow Reserve from Computer Tomography (FFR ct), in which a digital 3-D m odel of the heart arteries is created to assist in determining restricted blood flow.Heartflow FFRct is intended to be used in conjunction with clinical history, symptoms,diagnostic test, and the clinicians professional judgement. C.Definitions FFRct A mathematical ly-derived quantity, computed from simulated pressure,velocity and blood flow information that was obtained from a 3D computer model derived from a coronary CT image.Heartflow FFRct Post-processing software for the clinical quantitative a nd qual itative analysis of previously acquired computed tomography. D. Policy I.Prior authorization is required.I I. Prior authorization must include the following:A. a prescriptionB. documentation supporting a clinically stable symptomatic member with coronary artery disease . For example, a member with stable angina pectoris would be a c andidate for this procedure; whereas a member with unstable angina would not be a candidate for this procedure.II I. Procedure limitationsThe safety and effectiveness of FFRct has not been evaluated for the followi ng popul ations:A. suspicion of acute coronary syndrome (where acute myocardial infarction or unstable angina have not been ruled out)B. recent prior myocardial infarction within 30 daysC. complex congenital heart diseaseD. prior coronary artery bypass graft (CABG) surgeryE. patients with a Body Mass Index >35F. patients who require emergent procedures or have any evidence of ongoing Fraction Flow Reserve from computer tomography (FFRct)-OH MCD-MM-1046Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-OH MCD-MM-0798 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Polic ies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 5 Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Clinical 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 t hat 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-0798 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3o 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 A ny 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-0798 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.4o 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 of Human 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 as described 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 item or 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-0798 Effective Date: 01/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.5G. 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 to routine care costs in a clinical trial. VII. All applicable utilization management guidelines (including prior authorizations) will apply to routine care for members in a clinical trial. E. Conditions of Coverage N/A F. Related Polic ies/Rules G. Review/Revision HistoryDATE ACTIONDate Issued 05/19/2015Date Revised 05/19/2015 05/17/2016 07/10/2019 11/01/2019 10/28/2020 10/27/2021 08/31/2022 08/30/2023 09/ 05 /2024 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 .Date Effective 01/01/2025Date Archived H. References1. Associations for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed August 14, 2024 . www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed August 14, 2024. www.ecfr.gov 3. Local Coverage Article. Clinical Trials-Medical Policy Article (A52430). Accessed August 14, 2024 . www.cms.gov 4. 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 14, 2024. www.cms.gov Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.65. National Coverage Determination for Routine Costs in Clinical Trials (310.1). Accessed August 14, 2024. www.cms.gov 6. Denial of Coverage to Cancer Clinical Trial Participant, O HIO REV . CODE ANN 3923.80 (2009). Accessed August 14, 2024. www.codes.ohio.gov 7. Non-Covered Serv ices, O HIO ADMIN . CODE 5160-1 -61 (2022). Patient Protection and Affordable Care Act. (2010, March 23). Accessed August 14, 2024. www.govinfo.gov. 8. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). Accessed August 13, 2024 . www.govinfo.gov A pproved ODM on 09/19/2024
© Copyright CareSource 2025. All rights reserved.
System Details