Special Needs Car Seats

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Special Needs Car Seats-OH MCD-MM-1444 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 H. References ………………………….. ………………………….. ………………………….. …………………….. 5 Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSpecial Needs Car Seats B. BackgroundSafe transportation for individuals with certain functional needs includes not only the proper restraints but also the correct positioning to secure the person in the vehicle. Currently, the Federal Motor Vehicle Safety Standard (FMVSS) Number 213 regulates the design and performance of restraint systems for persons weighing up to 80 pounds. However, people with special needs greater than 80 pounds may require car seat restraint, and several manufacturers have tested car seats beyond an 80-pound maximum. Once a person has outgrown a standard 5-point harness car seat, options include car seats specially designed for full support of a persons head, neck, and back while supporting up to 115 pounds. Conventional travel vests or specialized medical seating can be used for individuals who require additional trunk support but have stable neck control. Some larger people with certain functional needs , including poor trunk control, can be transported in a special needs belt-positioning booster seat or a conventional belt-positioning booster with trunk support. If the person using the car seat is more than 50 pounds and has significant abnormal tone, contractures, or has significant behaviors, transfer in and out of the vehicle can be very difficult. Car seats come with different weight limits and support systems . Inaddition, cars have different standard restraint systems, seat dimensions, and configurations that can accommodate specific types of cars seats. Not all vehicles come with the standard hardware necessary to secure car seats, especially older vehicles and larger car seats. A trial of the car seat is recommended to find the most appropriate car seat to address the needs of the user and specific restraints, dimensions, and configuration of the vehicle. C. Definitions Booster Seat A seat used for a person during transportation that lifts the person by several inches designed for use with an adult seat belt. Car Safety Seat (CSS) A portable seat for a person weighing under 80 pounds that attaches to an automobile seat and holds the person safely. Child Passenger Safety Technician (CPST) Trained educators in the field of occupant protection knowledgeable in child safety seat installation, best practices, and education. They provide support and guidance to caregivers with child safety seat questions and concerns. Federal Motor Vehicle Safety Standard 213 (FMVSS No. 213 ) Requires child restraint systems (CRSs) to be equipped with attachments that enable the CRS to Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 attach to the vehicle’s restraint anchorage system. The agency added a height provision to make the new standards applicability clear to booster seat manufacturers who choose not to label their restraints with a weight. National Highway Traffic Safety Administration (NHTSA) A division of the U.S. Department of Transportation dedicated to achieving the highest standards of excellence in motor vehicle and highway safety. Neck Loading The dynamic loading of the neck that occurs when the torso is suddenly stopped by the seat belt while the head continues pulling from the neck. Travel Vest Optimizes the existing vehicle seat belt system to protect the person by keeping a low center of gravity and allowing the vehicle seat belt and seat cushion to manage crash forces. D. PolicyI. CareSource considers a special needs car seat medically necessary when ALL the following clinical criteria are met: A. The car seat is a child restraint system that meets National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standard (FMVSS No. 213). B. The car restraint system is not modified or used in a manner other than that specified by the manufacturer, unless the modified restraint system has bee n crash tested and has met all applicable FMVSSs approved by the NHTSA. C. The special needs car seat is the most cost-effective option while still addressing the medical/functional needs of the member. D. The safety and effectiveness of the sp dcial needs car seat has been substantiated by current evidence-based national, state, and peer-reviewed medical guidelines. E. The length or weight limits of a conventional CRS with an internal 5-point harness has been outgrown, and at least one of the following criteria is met . 1. The member has respiratory issues or conditions that require enhanced positioning for safety, including any of the following (not an all-inclusive list): a. hypotonia b. craniofacial abnormalities c. primary airway problems d. cerebral palsy 2. The member has a physical condition (eg, seizure or hypertonicity/spasms) that prevents the independent maintenance of a seated position or requires support to allow a functional position or prevent further disability. 3. The member has gastrointestinal issues, including but not limited to: a. emesis b. gastroesophageal reflux (GERD) c. gastrostomy feeding tube 4. The member uses a spica cast. Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 F. Documentation that the member has been evaluated by a CPST for ALL the following: 1. diagnosis 2. objective and subjective clinical information on ability and impairments 3. reason why commercial car seats are not appropriate 4. member age, height, and weight 5. the size of larger medical car seats may limit space for others traveling with the member or other car seats in the vehicle. Notes need to show that this has been considered when identifying the most appropriate medical car seat or vest restraint. 6. medical equipment, casts, orthoses, and space necessary to transport the member 7. type of vehicle that will transport the member and compatibility of tethering systems in the vehicle II. Where applicable, a trial of the medical car seat should be documented that shows the following:A. The medical car seat can be used safely and as intended to meet the stated goals. B. Education has been provided to the member or the caregiver with demonstrated understanding and safety use. Education should include instruction for quickly extracting the member from the medical car seat in case of an emergency. C. If no trial seat is available documentation should show the following: 1. Caregivers have demonstrated the ability to complete the type of transfer necessary to safely use the type of vehicle restraint requested. 2. The vehicle restraint system in the vehicle used to transport the member is appropriate to secure the car seat based on manufacturer instructions. III. Persons with a tracheostomy tube should not use a CRS with a harness or seat belt that could dislodge the tube. It is strongly recommended that an occupational therapist or passenger safety technician with training and experience in the safe transportation of persons with special needs provide guidance for appropriate equipment selection and use . IV. A special needs car seat will not be considered medical necessary for any of the following: A. The special needs car seat is a more recent advancement in technology when the members current special needs car seat can meet the members basic medical/functional needs. B. The special needs car seat is considered investigational, experimental, or has unproven medical indications for use. Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at Committee.Date Revised 02/28/2024 2/12/202510/08/2025Annual review: editorial changes, updated car seat definition, added D.I.C-D., D.I.E.2, and D.II-III. , and updated references. Approved at Committee. Annual review: updated criteria in D.I.E. and updated references. Approved at Committee. Review . Updated background, a dded CPST documentation , trialing requirements and updated references. Approved at Committee. Date Effective 01/01/2026 Date Archived H. References1. Adams AJ, Johnson MA, Ryan KA, et al. Safe transportation in-spica following surgical treatment of infantile DDH: solutions and threats. JPediatr Orop . 2019;39(7):e488-e493. doi:10.1097/BPO.0000000000001317 2. Angsupaisal M, Maathuis CGB, Hadders-Algra M. Adaptive seating systems in children with severe palsy across International Classification of Functioning, Disability and Health for Children and Young version domains: a systematic review. Dev Med Child Neurol . 2015;57(10):919-930. doi:10.1111/dmcn.12762 3. Car seats and booster seats. National Highway Traffic Safety Administration. Accessed September 29 , 2025. www.nhtsa.gov 4. Car seat safety. National Child Passenger Safety Board. Accessed September 29 , 2025 . www.cpsboard.org 5. Child passenger safety. American Academy of Pediatrics. Accessed September 29 , 2025. www.aap.org 6. Huang PP, Durbin DR. Promoting safety in children with disabilities. UpToDate. Updated March 12, 2025. Accessed September 29 , 2025 . www.uptodate.com 7. Inthachom R, Prasertsukdee S, Ryan SE, et al. Evaluation of the multidimensional effects of adaptive seating interventions for young children with non-ambulatory cerebral palsy. Disabil Rehabil Assist Technol . 2021;16(7):780-788. doi:10.1080/17483107.2020.1731613 Special Needs Car Seats-OH MCD-MM-1444Effective Dat e: 01/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 8. Legare JM, Adam MP, Feldman J, et al. Achondroplasia . GeneReviews; 2023. Revised May 11, 2023. Accessed September 29 , 2025 . www.ncbi.nlm.nih.gov 9. ONeil J, Hoffman B, American Academy of Pediatrics Council on Injury, Violence, and Poison. Transporting children with special health needs. Pediatr . 2019;143(5):e20190724. doi:10.1542/peds.2019-0724 10. Rigby P, Ryan S, Campbell K. Effect of adaptive seating devices on the activity performance of children with cerebral palsy. Arch Phy Med Rehabil . 2009;90(8):1389-1395. doi:10.1016/j.apmr.2009.02.013 11. Ryan SE. Lessons learned from studying the functional impact of adaptive seating interventions for children with cerebral palsy. Dev Med Child Neurol . 2016;58(4):78 – 82. doi:10.1111/dmcn.13046 12. Smith VC, Stewart J. Discharge planning for high-risk newborns. UpToDate. Updated March 23, 2025. Accessed September 29 , 2025 . www.uptodate.com 13. Transportation of Children with Disabilities, OHIO ADMIN CODE 3301-51-10 (2023). 14. Vives-Torres CM, Valdamo M, Jimenez-Octavio JR, et al . Comparison of upper neck loading in young adult and elderly volunteers during low speed frontal impacts . Frontiers Bioeng Biotechnol . 2021;9 :682974 . doi :10.3389/fbioe.2021.682974 Independent med ical review 02/15/2023 ODM Approved 10/ 15/2025

Pharmacogenomics-Gene Testing for Behavioral Health Indications

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – OH MCD-MM-1716 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response. Pharmacokinetics analyzes how drugs move through the body, including absorption, distribution, metabolism, and excretion. In behavioral health medicine, cytochrome P450s (CYPs) a re a common avenue for oxidative metabolism of therapeutic substances, which can be influenced by genetic and environmental factors. CYP genes are polymorphic and affect a significant portion of the populations ability to metabolize chemicals. Members with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound and are , therefore , classified as poor metabolizers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies show potential benefits of genetesting. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited research for a drug class or specific drugs. Most studies are based on small sample sizes and do not perform power calculations or correct for multiple testing scenarios. It is difficult to substantiate conclusions when not accounting for false positives o r false negatives. Additionally, there is a lack of consensus regarding preemptive genotyping efficacy. Two societies publishing guidelines acknowledge that comprehensive guidelines regarding when testing should occur, who should receive testing, and which genes should be tested cannot be offered. The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an internationalorganization whose goal is to reduce the barrier of translating genetic laboratory test results into guided clinical decision support. CPIC guidelines are peer-reviewed, evidence-based and updated as new evidence emerges. The guidelines are indexed in PubMed and endorsed by the American Society of Health-System Pharmacists (ASHP) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Published CPIC guidelines are available for certain drug classes and specific drugs which can lead to customized drug dosing and is presumed to improve time to effective treatment and reduce undertreatment, medication-related adverse events and costs. The guidelines consist of grading levels of evidence for prescription recommendations, which guide physicians on how results can optimize treatment. The strength of recommendations is divided into 4 categories: strong, moderate, optional, and no recommendation. A strong recommendation is backed by high-qualityevidence with desirable effects clearly outweighing undesirable effects. A moderate recommendation recognizes a close or uncertain balance as to whether the evidence is high quality , and desirable effects clearly outweigh the undesirable . In an optional recommendation, the desirable effects are closely balanced with undesirable effects or the evidence is weak or based on extrapolations, and opinions differ as to the need for the recommended course of action. With no recommendation, there is insufficient evidence, confidence, or agreement to provide a recommendation to guide practice. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 In 2018, the American Psychiatric Association (APA) Council of Research Workgroup onBiomarkers and Novel Treatments printed a position statement on pharmacogenomic (PGx) tools for the treatment of depression indicating at present there are insufficient data to support the widespread use of combinatorial pharmacogenetics testing in clinical practice. The Food and Drug Administration (FDA) released a consumer warning, The relationship between DNA variations and the effectiveness of antidepressant medicat ions has never been established. and also cautioned that changes in patient medications based on test results could potentially lead to patient harm. In 2024, Baum, et al., updated the APAs statement upon review of new clinical trials and meta – analyses published from 2017 to 2022 using PGx tools for treatment selection in depression and found addition of these new data do not alter the recommendations of the 2018 report, or the advice of the FDA, that the evidence does not support the use of currently available combinatorial PGx tools for treatment. Additionally in 2019, the International Society of Psychiatric Genetics published the following statement: Pharmacogenetic testing should be viewed as a decision-support tool Evidence to support widespread use of other pharmacogenetic tests at this time is still inconclusive Genetic information for CYP2C19 and CYP2D6 would likely be most beneficial for individuals who have experienced an inad equate response or adverse reaction to a previous antidepressant or antipsychotic trial. Care Source covers items and services with sufficient medical and scientific evidence forthe purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s) but does not cover experimental or investigational testing or products or services with insufficient data to determine net health impact. Insufficient data includes support that the test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinica l utility), performs better than an existing standard of care medical management option, and/or is not generally accepted as standard of care in the evaluation or management of a particular condition. Care Source provides appeal rights to any member or provider acting on behalf of a member who may disagree with denial decisions. Tests should be chosen to maximize the likelihood of identifying mutations in genes of interest for a specific medical reason, contribute to positive alterations in patient management, and minimize the chance of finding variants of uncertain significance. C. Definitions Actionable Use Genotype information may lead to selection of , avoidance of a specific therapy or modification of dosage of a therapy. Change must be based on the FDA label for the drug, an FDA warning or safety concern, or a CPIC level A or B gene-drug interaction. Intended change s in therapy based on the result of a genotyping test not supported by 1 of these sources is not an actionable use. Adherence Consumption of a drug at or near the maximum FDA approved dosage and duration for the medication or documentation that higher doses are not tolerated when less than the FDA-approved maximum. Biomarker A characteristic objectively measured and evaluated as an indicator of biological or pathogenic processes or pharmacologic responses to a specific Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 therapeutic intervention (eg, gene mutations, protein expression, known gene-drug interactions for medications, characteristics of genes ). Biomarker Testing The analysis of tissue, blood, or other biospecimen for the presence of a biomarker . Clinical Utility The likelihood that a test will, by prompting an intervention, result in an improved health outcome. Clinical Validity The accuracy of a test for a given clinical outcome. Consensus Statements Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict-of- interest policy aimed at specific clinical circumstances and based on best available evidence for optimizing outco mes of clinical care. Nationally Recognized Clinical Practice Guidelines Developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure with a conflict-of-interest policy establish ing standards of care informed by a systematic review of evidence and assessment of benefits and risks of alternative care options , includ ing recommendations to optimize patient care. Unbundling HCPCS/CPT codes should be reported only if all services described by the code are performed. Multiple codes should not be reported if a single code exists that describes the services performed. The codes include all services usually performed as part of the procedure as a standard of medical/ surgical practice and should not be separately reported simply because codes exist for the services. D. PolicyI. Biomarker testing that is not addressed by the Ohio Administrative or Revised Code or by the Ohio Department of Medicaid (ODM) in a recently published or updated provider document will follow MCG guidelines. Biomarker testing with uncertain clinical significance in MCG may be considered not covered as there is insufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s). If there are no MCG guidelines available, authorizati on for biomarker testing must be supported by the following scientific and medical evidence (as appropriate) : A. labeled indications for a test approved or cleared by the FDA B. indicated tests for a drug approved by the FDA C. Centers for Medicare and Medicaid Services (CMS) national coverage determinations and/or local coverage determinations by Medicare Administrative Contractors D. nationally recognized clinical practice guidelines and/or consensus statements E. warnings and precautions on FDA-approved drugs II. Any biomarker testing with clinical significance and evidence supported by scientific and medical evidence may be subject to medical necessity review. CareSource usesCPIC guidelines level A or B to determine the appropriateness of testing requests. A. General guidelines for all testing requests Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 The use of pharmacogenomic tests for multi-gene panels to guide therapy decisions may be medically necessary for psychotropic medications when ALL of the following criteria are met: 1. The member is currently or considering taking a drug potentially affected by a known mutation that can be detected by a corresponding test. 2. The drug is to be prescribed for the condition and population consistent with FDA labeling. 3. The test demonstrate s actionability in clinical decision making by CPIC guidelines level A or Band has demonstrated technical and clinical validity. 4. Providers can use results to guide changes in treatment that will improve patient outcome s or directly impact medical care (ie, clinical utility). 5. The ordering provider possesses the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and to prescribe medications for the condition either independently or in an arrangement as required by all applicable state laws. 6. The usefulness of the test is not significantly offset by negative factors, such as expense, clinical risk, or social, or ethical challenges (ie, reasonable use). 7. Requested testing is performed in a CLIA-certified laboratory and has not been previously performed. 8. At least 1 of the following criteria is met: a. Documentation is provided that the requested testing is required to obtain health plan coverage for the medication being considered for treatment. b. An FDA label requires results from a genetic test to effectively or safely use the therapy in question or is listed in the FDA table of known gene – drug interactions. c. Documentation of member adhere nce and fail ure to see expected results from at least 2 prior medications to treat the diagnosed condition. B. Specific testing requests Testing in the following situations may be considered medically necessary and is subject to medical necessity review. To aid in therapy selection and/or dosing for members considered for therapy or in a course of therapy with any of the medications below, testing for following genotype(s) once per lifetime may be considered : 1. CYP2C19 and CYP2D6 t esting for tricyclic antidepressants : a. Amitriptyline b. Imipramine c. Doxepin 2. CYP2C19 and CYP2B6 testing for sert raline, serotonin reuptake inhibitor 3. HLA-A and HLA-B testing for carbamazepine III. Exceptions to this policy or an adverse utilization review determination might be explored via appeal rights , which are p rovide d to any member or provider who requests testing on behalf of the member for any denial of authorization via the provider portal on www .www.caresource.com, fax, or mail by the US P ostal Service. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 IV. CareSource considers the following not medically necessary (not all-inclusive):A. testing or screening 1. in the general population 2. considered non-covered but billed using unlisted procedure codes 3. in the absence of clinical signs or symptoms or for determining a risk for developing a disease or condition 4. not confirming new data for decision making but a known diagnosis 5. without diagnosis-specific indications or ensuring matching tissue specimens B. use of multi-gene panels for genetic polymorphisms, including, but not limited to, pain management, cardiovascular drugs, anthracyclines, or polypharmacy for evaluating drug-metabolizer status C. broad symptom-based panels (eg, comprehensive ataxia panel) when a narrower panel is available and more appropriate based on clinical findings (eg, autosomal dominant ataxia panel) D. more than 1 multigene panel at the same time (should be performed in a tiered fashion with independent justification for each panel requested ) E. genes not identified as having actionable use E. Conditions of CoverageCareSource applies coding edits to medical claims through coding logic software to evaluate accuracy and adherence to accepted national standards. Proper billing and submission guidelines must be followed, including the following: I. Unbundling of codes in a panel may result in payment recovery. Procedures not meeting correct coding standards are not reimbursable, even if medical necessity criteria for the associated test(s) are met. II. Providers must use industry standard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes to the highest level of specificity. III. Services considered to be mutually exclusive, incidental to, or integral to the primary service rendered are not allowed additional payment. IV. Proprietary panel testing requires documentation of medical necessity. V. If a panel was previously performed and an updated, larger panel is being requested, only testing for the medically necessary, previously untested genes will be reimbursable. Therefore, only the most appropriate procedure codes for those additional genes will be considered for reimbursement. F. Related Policies/RulesExperimental or Investigational Items or Services Medical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 10/23/2024 New policy. Converted AD-134 2 to MM with parameters for review of medical necessity. Approved at Committee. Date Revised 10/08 /2025 Annual review. Updated references. Approved at Committee. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Date Effective 01/01/2026Date Archived H. References1. American College of Medical Genetics Board of Directors. Points to consider in the clinical application of genomic sequencing. Genet Med . 2012 Aug;14(8):759-61. doi:10.1038/gim.2012.74 2. Baum M, Widge A, Carpenter L, et al. Pharmacogenomic clinical support tool for the treatment of depression. Am JPsychiatry . 2024;181(7):591-607. doi:10.1176/appi.ajp.20230657 3. Bean LJH, Funke B, Carlston CM, et al. Diagnostic gene sequencing panels: from design to report a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2020;22(3):453-461. doi:10.1038/s41436-019-0666-z 4. Behavioral Health Medication Pharmacogenetics Gene Panels: A-0861. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 5. Beunk L, Nijenhuis M, Soree B, et al. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2D6, CYP3A4 and CYP1A2 and antipsychotics. Eur JHum Genet . 2024;32(3):278-285. doi:10.1038/s41431-023-01347-3 6. Bousman CA, Stevenson JM, Ramsey LB, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes and serotonin reuptake inhibitor antidepressants. Clin Pharmacol Ther . 2023;114(1):51-68. doi:10.1002/cpt.2903 7. Brouwer JMJL, Wardenaar KJ, Nolte IM, et al. Association of CYP2D6 and CYP2C19 metabolizer status with switching and discontinuing antidepressant drugs: an exploratory study. BMC Psych . 2024;24:394-408. doi:10.1186/s12888-024-0576 8. Brown JT, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther . 2019;106(1):94-102. doi:10.1002/cpt.1409 9. Caudle K, Sangkuhl K, Whirl-Carrillo M, et al. Standardizing CYP2D6 genotype to phenotype translation: consensus recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci , 2020;13:116-124. doi:10.1111/cts.12692 10. Chang M, Tybring G, Dahl ML, et al. Impact of cytochrome P450 2C19 polymorphisms on citalopram/escitalopram exposure: a systematic review and meta – analysis. Clin Pharmacokinet . 2014;53(9):801-811. doi:10.1007/s40262-014-0162-1 11. Cicali EJ, Smith DM, Duong BQ, et al. A scoping review of the evidence behind cytochrome p450 2d6 isoenzyme inhibitor classifications. Clin Pharmacol Ther . 2020;108(1):116-125. doi:10.1002/cpt.1768 12. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Accessed September 19, 2025 . www.cdc.gov 13. Clinical Pharmacogenetics Implementation Consortium. Accessed September 19, 2025 . www.cpicpgx.org Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 14. Clinical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents. American Academy of Child & Adolescent Psychiatry; 2020. Accessed September 19, 2025 . www.aacap.org15. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed September 19, 2025 . www.hayesinc.com 16. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Accessed September 19, 2025 . www.hayesinc.com 17. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing for Opioid Treatment for Pain in Adults Selected Single-Gene Variants and Pharmacogenomic Panels. Hayes; 2019. Accessed September 19, 2025 . www.evidenced.hayesinc.com 18. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Hayes; 2020. Accessed September 19, 2025 . www.evidence.hayesinc.com 19. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Accessed September 19, 2025 . www.evidence.hayesinc.com 20. Clinical Utility Evaluation: Pharmacogenomic Testing for Major Depressive Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 21. Clinical Utility Evaluation: Pharmacogenomic Testing for Schizophrenia Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 22. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Accessed September 19, 2025 . www.evidence.hayesinc.com 23. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 24. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Accessed September 19, 2025 . www.genome.gov 25. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 26. Fijal BA, Guo Y, Li SG, et al. CYP2D6 pr edicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial. JClin Pharmcol . 2015;55(10):1167-1174. doi:10.1002/jcph.530 27. Guin D, Hasija Y, Kukreti. Assessment of clinically actionable pharmacogenetic markers to stratify anti-seizure medications. Pharmacogenomics J . 2023;23:149-160. doi:10.1038/s41397-023-00313-y 28. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed September 19, 2025 . www.pubmed.ncbi.nih.gov 29. Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther . 2015;98(2):127-134. doi:10.1002/cpt.147 2 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 30. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants: 2016 update. Clin Pharmacol Ther . 2017;102(1):37-44. doi:10.1002/cpt.597 31. Hicks JK, Swen JJ, Thorn CF, et al. Clinical Pharmacogenetics Implementation Consortium guideline for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther . 2013;93(5):402-408. doi:10.1038/clpt.2013.2 32. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 33. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 34. Jukic MM, Haslemo T, Molden E. Impact of CYP2C19 genotype on escitalopram exposure and therapeutic failure: a retrospective study based on 2087 patients. Am J Psych . 2018;175(5):463-470. doi:10.1176/appi.ajp.2017.17050550 35. Koh A, Pak KC, Choi HY, et al. Quantitative modeling analysis demonstrates the impact of CYP2C19 and CYP2D6 genetic polymorphisms on the pharmacokinetics of amitriptyline and its metabolite, nortriptyline. JClin Pharmacol . 2019;59(4):532-540. doi:10.1002/jcph.1344 36. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Accessed September 19, 2025 . www.uptodate.com 37. Laboratory Requirements, 42 C.F.R. 493 (2024). 38. Lagishetty CV, Deng J, Lesko LJ, et al. How informative are drug-drug interactions of gene-drug interactions? JClin Pharmacol . 2016;56(10):1221-1231. doi:10.1002/jcph.743 39. Leckband SG, Kelso JR, Dunnenberger HM, et al. Clinical Pharmacogenetics Implementation Consortium guidelines for HLA-B genotype and carbamazepine dosing. Clin Pharmacol Ther . 2013;94(3):324-328. doi:10.1038/clpt.2013.103 40. Li D, Pain O, Chiara F, et al. Metabolic activity of CYP2C19 and CYP2D6 on antidepressant response from 13 clinical studies using genotype imputation: a meta – analysis. Transl Psychiatry . 2024;14(1):296. doi:10.1038/s41398-024-02981-1 41. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Accessed September 19, 2025 . www.fda.gov 42. Lu ML, Chen TT, Kuo PH, et al. Effects of adjunctive fluvoxamine on metabolic parameters and psychopathology in clozapine-treated patients with schizophrenia: A 12-week, randomized, double-blind, placebo-controlled study. Schizophr Res . 2018;193:126-133. doi:10.1016/j.schres.2017.06.030 43. McCormack M, Bourgeois S, Farrell JJ, et al. HLA-A*3101 and carbamazepine – induced hypersensitivity reactions in Europeans. NEngl JMed . 2011;364(12):1134 – 1143. doi:10.1056/NEJMoa1013297 44. Medical Code Brief: 0392U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 45. Medical Code Brief: 0411U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 46. Medical Code Brief: 0419U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 47. Medical Code Brief: 0423U-PLA (U Codes). Hayes; 2023. Accessed September 22,2025. www.evidence.hayesinc.com 48. Medical Code Brief: 0434U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 49. Medical Code Brief: 0438U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 50. Medical Code Brief: 0476U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 51. Medical Code Brief: 0477U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 52. Milosavljevic F, Bukvic N, Pavlovic Z, et al. Association of CYP2C19 and CYP2D6 poor and intermediate metabolizer status with antidepressant and antipsychotic exposure: a systematic review and meta-analysis. JAMA Psychiatry . 2021;78(3):270 – 280. doi:10.1001/jamapsychiatry.2020.3643 53. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Accessed September 19, 2025 . www.evidence.hayesinc.com 54. Nahid NA, Johnson JA. CYP2D^ pharmacogenetics and phenoconversion in personalized medicine. Expert Opin Drug Metab Toxicol . 2022;18(11):769-785. doi:10.1080/17425255.2022.2160317 55. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed September 19, 2025 . www.cancer.gov 56. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed September 19, 2025 . www.ncbi.nlm.nih.gov 57. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Accessed September 19, 2025 . www.medicaid.gov 58. Ozeki T, Mushiroda T, Yowang A, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet . 2011;20(5):1034 – 1041. doi:10.1093/hmg/ddq537 59. Patel JN, Morris SA, ,Torres R, et al. Pharmacogenomic insights in psychiatric care: uncovering novel actionability, allele-specific CYP2D6 copy number variation, and phenoconversion in 15,000 patients. Mol Psychiatry . 2024. doi:10.1038/s41380024-0 60. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Accessed September 19, 2025 . www.aacap.org 61. Phillips EJ, Sukasem C, Whirl-Carrillo M, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmaco Ther . 2018. doi:10.1002/cpt.1004 62. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com 63. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed September 19, 2025 . www.evidence.hayesinc.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 64. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed September 19, 2025 . www.evidence.hayesinc.com65. Pritchard D, Patel JN, Stephens LE, et al. Comparison of FDA table of Pharmacogenetic Associations and Clinical Pharmacogenetics Implementation Consortium guidelines. Am JHealth Syst Pharm . 2022;79(12):993-1005. doi:10.1093/ajhp/zxac064 66. Raby B. Personalized medicine. UpToDate. Accessed September 19, 2025 . www.uptodate.com 67. Rehder C, Bean LJH, Bick D, et al. Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4 68. Rosenblat JD, Lee Y, McIntyre RS. Does pharmacogenomic testing improve clinical outcomes for major depressive disorder? a systematic review of clinical trials and cost-effectiveness studies. JClin Psychiatry . 2017;78(6):720-729. doi:10.4088/JCP.15r10583 69. Roy S, LaFramboise WA, Nikiforov YE, et al. Next-generation sequencing informatics: challenges and strategies for implementation in a clinical environment. Arch Pathol Lab Med . 2016;140(9):958-975. doi:10.5858/arpa.2015 – 0507-RA 70. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. Accessed September 19, 2025 . www.rcpsych.ac.uk 71. Saadullah Khani NS, Hudson G, Mills G, et al. A systematic review of pharmacogenetic testing to guide antipsychotic treatment. Nat Mental Health . 2024 ;2(5):616-626. doi:10.1038/s44220-024-00240-2 72. Swen JJ, van der Wouden CH, Manson LE, et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster – randomised crossover implementation study. Lancet . 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4 73. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol . 2013;149(9):1025-1032. doi:10.1001/jamadermatol.2013.4114 74. Tantisira K. Overview of pharmacogenomics. UpToDate. Accessed September 19, 2025 . www.uptodate.com 75. Ter Hark S, Vos CF, Aarnoutse RE, et al. Biomarkers as predictors of treatment response to tricyclic antidepressants in major depressive disorder: a systematic review. JPsych Res . 2022;150:202-213. doi:10.1016/j.jpsychires.2022.03.057 76. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed September 19, 2025 . www.fda.gov 77. Vos CF, Ter Hark SE, Schelleken AFA, et al. Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder: a randomized clinical trial. JAMA Netw Open . 2023;6(5):e2312443. doi:10.1001/jamanetworkopen.2023.12443 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 01/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 78. Wang Q, Sun S, Xie M, et al. Association between the HLA-B alleles and carbamazepine-induced SJS/TEN: a meta-analysis. Epilepsy Res . 2017;135:19-28. doi:10.1016/j.eplepsyres.2017.05.015 79. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 2 9th ed. Accessed September 19, 2025 . www.careweb.careguidelines.com 80. Wu X, Zhang H, Miah MK, et al. Physiologically based pharmacokinetic approach can successfully predict pharmacokinetics of citalopram in different patient populations. JClin Pharmacol . 2020;60(4):477-488. doi:10.1002/jcph.1541 81. Zeier Z, Carpenter L, Kalin N, et al. Clinical implementation of pharmacogenetic decision support tools for antidepressant drug prescribing. Am JPsychiatry . 2018;175(9):873-886. doi:10.1176/appi.ajp.2018.17111282 82. Zubenko G, Sommer B, Cohen B. On the marketing and use of pharmacogenetic tests for psychiatric treatment. JAMA Psychiatry. 2018;75(8):769-770. doi:10.1001/jamapsychiatry.2018.0834 Reviewed by AllMed 09/2024Approved by Ohio Dept of Medicaid 10/10/2025

Fraction Flow Reserve from Computer Tomography (FFRct)

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Fraction Flow Reserve from Computer Tomography (FFRct)- OH MCD-MM-1046 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 …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Fraction Flow Reserve from Computer Tomography (FFRct)-OH MCD-MM-1046Effective Date: 01/01/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectFraction 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 the blood pressure to determine adequate blood flow or blockage during an invasive coronary angiography. A noninvasive alternative for stable symptomatic members with CAD is Heartflow Fraction Flow Reserve from Computer Tomography (FFRct), in which a digital 3-D model 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 mathematically-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 and qualitative analysis of previously acquired computed tomography. D. PolicyI. Prior authorization is required. II. Prior authorization must include the following:A. a prescription B. documentation supporting a clinically stable symptomatic member with coronary artery disease. For example, a member with stable angina pectoris would be a candidate for this procedure, whereas a member with unstable angina would not be a candidate for this procedure. III. Procedure limitations The safety and effectiveness of FFRct has not been evaluated for the following populations: A. suspicion of acute coronary syndrome (where acute myocardial infarction or unstable angina has not been ruled out) B. recent prior myocardial infarction within 30 days C. complex congenital heart disease D. prior coronary artery bypass graft (CABG) surgery E. patients with a Body Mass Index >35 F. patients who require emergent procedures or have any evidence of ongoing Fraction Flow Reserve from Computer Tomography (FFRct)-OH MCD-MM-1046Effective Date: 01/01/2026 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure

Clinical Trial Coverage

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

Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental

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

Peroral Endoscopic Myotomy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Peroral Endoscopic Myotomy-OH MCD-MM-1245 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 ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 Peroral Endoscopic Myotomy-OH MCD-MM-1245Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeroral Endoscopic Myotomy B. BackgroundAchalasia (ie, failure to relax) is a rare esophageal disorder that affects about 1 in every 100,000 people. A major symptom of achalasia is usually difficulty with swallowing. Most people are diagnosed between the ages of 25 and 60 years. Achalasia occurs when nerves in the esophagus become damaged. As a result, the esophagus becomes paralyzed and dilated over ti me and eventually loses the ability to squeeze food down into the stomach. Although the condition cannot be cured, the symptoms can usually be con trolled with treatment. Treatments for achalasia include oral medications, dilation or stretching of the esophagus, surgery (open and laparoscopic), endoscopic surgery, and injection of muscle-relaxing medicines (botulinum toxin) directly into the esophagus. Peroral endoscopic myotomy (POEM) is a procedure developed in Japan performed withthe patient under general anesthesia. POEM differs from traditional laparoscopic surgery , which involves the complete division of both the longitudinal and circular lower esophageal muscle layers . Studies suggest that POEM can achieve results comparable to or better than those of pneumatic dilation and surgical myotomy with similar safety. However, POEM is a new procedure, and knowledge of long-term outcome s are limited. POEM is a form of natural orifice transluminal endoscopic surgery. The procedure is performed perorally without any incisions in the chest or abdomen. The advantage of this approach is to reduce procedure-related pain and return patients to regular activit iessooner than surgeries requiring external incisions.C. Definitions Achalasia A rare disorder making it difficult for food and liquid to pass from the swallowing tube connecting the mouth and stomach. Nerve cells in the esophagus degenerate. As a result, the lower end of the esophagus , the lower esophageal sphincter (LES) , fails to open to allow food into the stomach, leading to complications (eg, coughing, choking, aspiration pneumonia, ulceration, and weight loss ). There are 3 different achalasia types : o Type I Minimal esophageal pressurization , this type is associated with the incomplete relaxation of the LES, a lack of mobility in terms of contraction and relaxation, and a small amount of pressure built up in the esophagus. o Type II Indicated by esophageal compression , this type is more severe with more massive compression in the esophagus, often caused by the failure to relax and the build-up of pressure in the esophagus, typically from food. o Type III With spasms that result in sudden, abnormal squeezing of the esophagus and the LES , this type is the most severe and can also elicit the most serious symptoms (eg, chest pains that may mimic those of a heart attack and spasms that can wake a person from sleep ). Peroral Endoscopic Myotomy-OH MCD-MM-1245Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Eckardt Symptom Score The grading system most frequently used for the evaluation of symptoms, stages, and efficacy of achalasia treatment. It attributes points (0 to 3 points) for 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), with scores ranging from 0 to 12 . Gastroesophageal Reflux Disease (GERD) A chronic disorder that occurs when stomach bile or acid flows into the esophagus and irritates the lining. Laparoscopic Heller Myotomy (LHM) A minimally invasive surgical procedure used to treat achalasia. Pneumatic Balloon Dilation (PD) An endoscopic therapy for achalasia. An air – filled cylinder-shaped balloon disrupts the muscle fibers of the lower esophageal sphincter, which is too tight in patients with achalasia. D. PolicyI. CareSource considers the POEM procedure medically necessary whe n ALL the following clinical criteria are met: A. The member h as a diagnosis of primary achalasia, types I, II, or III . B. POEM is proposed after the member has tried and failed conventional therapy, including pneumatic dilation or is not a surgical candidate for Heller myotomy . C. Eckardt symptom score is greater than or equal to 3. D. There is no history of previous open surgery of the stomach or esophagus. II. Members 18 years or younger should be reviewed for medical necessity.III. POEM for any other indication is considered experimental, investigational , and unproven. IV. Contraindications for this procedure are as follows :A. severe erosive esophagitis B. significant coagulation disorders C. liver cirrhosis with portal hypertension D. severe pulmonary disease E. esophageal malignancy F. prior therapy that may compromise the integrity of the esophageal mucosa or lead to submucosal fibrosis, including recent esophageal surgery, radiation, endoscopic mucosal resection, or radiofrequency ablation V. Previous therapies for achalasia (eg, PD, botulinum toxin injection, or LHM ) are not contraindications to POEM. VI. Members receiving POEM should be made aware there is a high risk in develop ingGERD and will need to be advised of management considerations prior to undergoing the procedure. Peroral Endoscopic Myotomy-OH MCD-MM-1245Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 03/30/2022 New policyDate Revised 02/15/2023 02/14/2024 12/18/202408/13/2025 Age 18 years or younger removed as hard limit per ODM. Annual review: deleted POEM definition, changed reflux esophagitis in Section D.V. to GERD to match LCD ; updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Annual revew: updated references. Approved at Committee. Date Effective 12/01/2025 Date Archived H. References1. Aiolfi A, Bona D, Riva CG, et al. Systematic review and bayesian network meta – analysis comparing laparoscopic Heller myotomy, pneumatic dilatation, and peroral endoscopic myotomy for esophageal achalasia. JLaparoendosc Adv Surg Tech A . 2020;30(2):147-155. doi:10.1089/lap.2019.0432 2. Familiari P, de Andreis FB, Landi R, et al. Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomized controlled trial. Gut . 2023;72(8):1442-1450. doi:10.1136/gutjnl-2021-325579 3. Health technology assessment: p eroral endoscopic myotomy for treatment of esophageal achalasia . Hayes; 2019. Accessed December 5, 2024. www.evidence.hayes.inc.com 4. Huang Z, Cui Y, Li Y, et al. Peroral endoscopic myotomy for patients with achalasia with previous Heller myotomy: a systematic review and meta-analysis. Gastrintest Endosc . 2021;93(1):47-56.e5. doi:10.1016/j.gie.2020.05.056 5. Khashab MA, Vela MF, Thosani N, et al . ASGE guideline on th e management of achalasia. Gastrointest Endosc . 2020;91(2):213-227 . doi:10.1016/j.gie.2019.04.231 6. Khashab MA, Kumbhari V, Tieu AH , et al. Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic Heller myotomy. Saudi JGastroenterol . 2017;23(2):91-96. doi:10.4103/1319-3767.203360 7. Kohn GP, Dirks RC, Ansari MT, et al. SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia. Surg Endosc . 2021;35(5):1931-1948. doi:10.1007/s00464-020-08282-0 8. Meng F, Li P, Wang Y, et al . Peroral endoscopic myotomy compared with pneumatic dilation for newly diagnosed achalasia. Surg Endosc . 2017;31(11):4665-4672. doi:10.1007/s00464-017-5530-0 Peroral Endoscopic Myotomy-OH MCD-MM-1245Effective Dat e: 12/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 9. Patel DA, Lappas BM, Vaezi MF . An overview of achalasia and its subtypes.Gastroenter ol Hepatol . 2017 ;13(7): 411-421. Accessed December 5, 2024 . www.ncbi.nlm.nih.gov 10. Schneider AM, Louie BE, Warren HF, et al . A matched comparison of per oral endoscopic myotomy to laparoscopic Heller myotomy in the treatment of achalasia. J Gastrointest Surg . 2016;20(11):1789-17 96. doi:10.1007/s11605-016-3232-x 11. Spechler SJ. Achalasia: overview of the management of treatment. UpToDate. Accessed August 1, 2025. www.uptodate.com 12. Tan S, Zhong C, Ren Y, et al. Efficacy and safety of peroral endoscopic myotomy in achalasia patients with failed previous intervention: a systematic review and meta – analysis. Gut Liver . 2021;15(2):153-167. doi:10.5009/gnl19234 13. Vaezi MF, Pandolfino JE, Yadlapati RH, et al. ACG clinical guidelines: diagnosis and management of achalasia: diagnosis and management. Am JGastroenterol . 2020;115(9):1393-1411. doi:10.14309/ajg.0000000000000731 14. Vespa E, Pellegatta G, Chandrasekar VT, et al. Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis. Endoscopy . 2023;55(2):167-175. doi:10.1055/a-1894-0147 15. Yang D, Bechara R, Dunst CM, et al. AGA clinical practice update on advances in per-oral endoscopic myotomy (POEM) and remaining questions what have we learned in the past decade: expert review. Gastroenterology . 2024;167(7):1483 – 1490. doi:10.1053/j.gastro.2024.08.038 Independent med ical review March 2022 Ohio Dept of Medicaid approved 08/21/2025

Digital Therapy Devices for Treatment of Amblyopia

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

Transcranial Magnetic Stimulation for Treatment of Depression

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Transcranial Magnetic Stimulation for Treatment of Depression – OH MCD-MM-0233 11/01/2025 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTranscranial Magnetic Stimulation for Treatment of Depression B. BackgroundTranscranial magnetic stimulation (TMS) was originally introduced in 1985 as a noninvasive treatment modality for treatment-resistant Major Depressive Disorder (MDD) . Brief , repetitive pulses of magnetic energy are sent to the scalp via a large electromagnetic coil , generating a low level of electrical stimulation. These magnetic fields pass through the sk ull and induce electric al currents that depolarize neurons in a focal area of the surface cortex. The magnetic field generated by this type of stimulation is very small and cannot be felt by the patient but is strong enough to flow into the brain without inducing seizures or creating a need for anesthesia. TMS is generally an outpatient procedure with conscious patients and sessions tha t varybetween 30 to 40 minutes. Treatment can be delivered as a single pulse or as a series of pulses. Despite variability in the number of pulses delivered per session and the number of sessions per patient, research indicates that typical courses of TMS consist of treatment up to 5 days a week for up to 6 weeks. A tapering schedule is used to end treatment. C. Definitions Acute (Index) Course of Treatment The initial series of treatment given to relieve acute symptoms of MDD . Adequate Trial Taking a drug at least 4 weeks at or near the maximum dose for the specific medicat ion as approved by the F ood and Drug Administration (F DA) or documentation exists that higher doses were not tolerated when the dose is less than the FDA approved maximum. Continuation TMS Treatment beginning after the acute/index course lasting up to 6 months and designed to prevent the worsening of symptoms and continue d treatment for a depressive episode that has not yet remitted. Depression Rating Scale Standardized s cales for national use that reliably assess the range of symptoms most commonly observed in adults with MDD, including type and magnitude. Listed below are examples of commonly used scales : OBeck Depression Inventory (BDI) o Geriatric Depression Scale (GDS) o Hamilton Depression Rating Scale (HAM-D) o Patient Health Questionnaire-9 (PHQ-9) o Quick Inventory of Depressive Symptomatology (QIDS) Maintenance TMS Regularly scheduled TMS sessions on a weekly, biweekly, or monthly basis used to prevent relapse of depressive symptoms. Medication Side Effects Unexpected effects that cause significant distress, inhibit daily function, have the potential to worsen health, or are life threatening. Remission The absence of significant signs or symptoms of a n MDD episode during the previous 2 months. Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. A review of medical necessity is required for initial or continuation courses of TMS . II. Initial (acute/index) treatment is considered medically necessary when ALL the following criteria are met: A. Member is 18 years of age or older. B. Member has a confirmed diagnosis of major depressive disorder , single or recurrent , with a current severe episode as evidenced by a recent score on a standardized depression rating scale and at least 1 of the following: 1. Need for treatment , as indicated by 1 of the following: a. resistance to treatment with documented adherence as evidenced by a lack of a clinically significant response during a current or previous depressive episode and 2 or more classes of an tidepressant agents at or near maximum effective dose and duration approved by the FDA b. inability to tolerate pharmacotherapy evidenced by 2 antidepressants with documented side effects 2. Continuation of acute course of treatment, as indicated by a. continuation of symptoms 30 days after index (acute) course of treatment b. previous positive response to index (acute) course of treatment evidenced by a reduction of 50% in a depression severity rating scale as compared to baseline C. None of the following conditions or contraindications are present: 1. epilepsy , history of seizure or other neurologic disease that may lower seizure threshold (eg, cerebrovascular accident, severe head trauma, increased intracranial pressure) 2. acute or chronic psychotic symptoms or disorders (eg, schizophrenia, schizophreniform, or schizoaffective disorder) 3. cochlear implant s or deep brain stimulator s 4. current use of substances that may significantly lower seizure threshold (eg , alcohol or stimulants ) 5. metallic hardware or implanted magnetic-sensitive medical device s (eg, implanted cardioverter-defibrillator s, pacemaker s, metal aneurysm clips or coils) at a distance within the electromagnetic field of the discharging coil (eg, less than or equal to 30 cm to the discharging coil). III. Maintenance treatment with TMS is not considered medically necessary . T here is not sufficient evidence in peer reviewed literature to assess net benefit versus harm for patients. IV. Additional criteriaA. TMS must be administered by an FDA cleared device for the treatment of MDD in a safe and effective manner according to the manufacturers user manual and specified stimulation parameters. Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 B. A treatment course should not exceed 5 days a week for 6 weeks (total of 30sessions), followed by a 3-week taper of 3 treatments in 1 week, 2 treatments the next week , and 1 treatment in the last week. C. TMS can be ordered by and performed under direction of a neurologist, licensed psychiatrist, or psychiatric nurse practitioner who has examined the member , reviewed the record when it is within the scope of practice , and has experience in administering TMS therapy within the scope of practice . E. Conditions of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 07/12/2018Date Revised 11/11/2020 10/28/2021 08/31/2022 01/19/2023 07/19/2023 06/19 /2024 06/04 /2025 Removed a definition, added neurologist. Revised and expanded definitions. Added Section II and IV. Updated background , d efinitions , & criteria (MCG 26 th ed). Updated title for clarity. Annual review. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Annual review. Deleted III (repeat of D.II.B .2) and updated references. Approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised. American Psychiatric Association; 2022. 2. Holtzheimer PE. Unipolar major depression: administering transcranial magnetic stimulation (TMS). UptoDate. Updated January 22, 2025 . Accessed May 3 0, 202 5. www.uptodate.com 3. Holtzheimer PE. Unipolar depression in adults: indications, efficacy, and safety of transcranial magnetic stimulation (TMS). UptoDate. Updated January 22, 2025 . Accessed May 3 0, 202 5. www.uptodate.com 4. Jarrett R, Vittengl J. Unipolar depression in adults: continuation and maintenance treatment. UptoDate. Updated October 3, 2024 . Accessed May 3 0, 202 5. www.uptodate.com 5. National Institute of Mental Health. Brain Stimulation Therapies . National Institutes of Health; 2023. NIH publication 0925-0648. Accessed May 3 0, 202 5. www.nimh .nih.gov Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 6. Perera T, George MS, 5rammar G, et al. The Clinical TMS Society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimul . 2016;9(3):336-346. doi:10.1016/j.brs.2016.03.010 7. Thase M, Connolly R. Unipolar depression in adults: choosing treatment for resistant depression. UptoDate. Updated November 2, 2023. Accessed May 3 0, 202 5. www.uptodate.com 8. Transcranial magnetic stimulation: B-801-T. MCG Health, 28 th edit. Updated March 14, 2024. Accessed May 3 0, 202 5. www.careweb.careguidelines.com Approved by Ohio Department of Medicaid 08/12/ 2025

Skin Substitutes

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Skin Substitutes-OH MCD-MM-1398 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 ………………………………………………………………………………………… 5 F. Related Policies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 6 Skin Substitutes-OH MCD-MM-1398Effective 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. SubjectSkin Substitutes B. Background Wounds are disruptions of the skins structural and functional integrity and normally transition through distinct phases until the skins structure and function are restored, including hemostasis, inflammation, cellular migration and proliferation, and remodeling. Chronic wounds can result in loss of function, wound recurrence, and significant morbidity. Pressure ulcers, diabetic foot ulcers, and venous leg ulcers are the three categories that comprise the majority of chronic wounds. Skin substitutes are a heterogeneous group of biologics, synthetics, or biosynthetic materials. When determining if the use of a skin substitute is appropriate, the clinician evaluates the material being used and its properties. Individual wounds have a specific microenvironment. Various manufacturers may utilize differing processes in the development of skin substitutes but generally seed selected cells onto a matrix. The matrices subsequently receive proteins and growth factors necessary to divide and develop into the desired tissue. Skin substitutes provide coverage for open wounds, both deep thermal and full-thickness wounds. Skin substitutes have the function and composition of skin or have the potential for autologous regenerative healing when applied to a wound. Uses span acute or chronic wounds, burns, or reconstruction, such as release of contractures secondary to severe burns. The most common classification system utilized to determine the type of skin substitute that would be appropriate for a particular wound is the Kumar Classification system, in which Class I includes temporary impervious dressing material, Class II includes single-layer durable skin substitutes, and Class III includes composite skin substitutes that replace both dermal and epidermal layers. C. Definitions Ankle-Brachial Index A comparison of the blood pressure measured at the ankle with blood pressure measured at the arm with lower numbers indicating narrowing or blockage of the arteries in the legs. Autologous Derived from the same individual, such as an individual serving as both donor and recipient. Cellular and Tissue-Based Products (CTPs) Wound dressings or coverings that contain or consist of cells and/or tissue to promote wound healing. They are often used as alternatives to skin grafts for chronic wounds, burns, and ulcers. Chronic Wounds Wounds that have not progressed along the normal healing process, generally after a 4-week duration. Chronic Venous Ulcers A wound that takes longer than usual to heal and often occurs on the legs or ankles when oxygen-poor blood flow is impaired and pools, creating pressure in the veins. Skin Substitutes-OH MCD-MM-1398Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Diabetic Foot Ulcers An open sore or wound located on the foot occurring in approximately 15% of patients with diabetes. Pressure Ulcers Injuries to skin and underlying tissue resulting from prolonged pressure on the skin, including bedsores that most often develop on skin covering bony areas of the body, such as heels, ankles, hips, and tailbone. Tissue Engineering The practice of combining scaffolds, cells, and biologically active molecules into functional tissues to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs. D. PolicyI. CareSource considers the use of skin substitute products medically necessary under ANY of the following circumstances: A. The presence of a chronic, non-infected diabetic foot ulcer (DFU) having failed to achieve at least 50% ulcer area reduction with documented standard of care (SOC) treatment) for a minimum of 4 weeks with documented compliance. Treatment of diabetic foot ulcer as indicated by all of the following: 1. when adequate circulation to the affected extremity is present as indicated by ONE of the following: a. palpable pedal b. ankle-brachial index (ABI) between 0.7 and 1.2 c. dorsum transcutaneous oxygen test (TcPO2) 30 mm Hg within the last 60 days d. triphasic or biphasic Doppler arterial waveforms at the ankle of affected leg 2. appropriate glycemic control 3. no wound infection. 4. no response to conventional therapy, including all of the following: a. offloading (pressure relief) b. appropriate dressings to facilitate healing c. debridement as needed B. The presence of a chronic, non-infected venous insufficiency ulcers having failed to respond to documented SOC treatment for a minimum of 4 weeks with documented compliance. Treatment of venous insufficiency ulcers when ALL of the following criteria are met: 1. noninvasive duplex ultrasound documenting chronic venous disease 2. adequate perfusion of involved limb 3. appropriate surgical venous interventions 4. concurrent conventional wound care 5. concurrent glycemic management if patient is also diabetic 6. duration greater than 6 weeks 7. partial-thickness or full-thickness ulcer due to venous insufficiency 8. no allergy to bovine products 9. no response to conventional therapy, including all of the following: a. compression therapy b. surgical intervention for UVD (if applicable) Skin Substitutes-OH MCD-MM-1398Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 c. dressings to maintain moist wound environment (eg, saline-moistened dressings, negative pressure wound therapy) d. sharp debridement 10. no wound infection C. Treatment of burn wounds when ONE of the following criteria are met: 1. a temporary wound covering for excised full-thickness and deep partial- thickness burn wounds in individuals who require such a covering prior to autograft placement 2. treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting D. Repair of scar contractures when more conservative therapeutic options have failed when used in conjunction with a breast reconstruction procedure. E. Pressure redistribution support surfaces for pressure ulcers II. Documentation RequirementsA. Standard of Care treatment documentation includes: 1. Comprehensive patient assessment (history, exam, vascular assessment) and diagnostic tests as indicated as part of the implemented treatment plan 2. Assessment of Type 1 or 2 diabetes for DFU patients including management history and any comorbidities (eg. vascular disease, neuropathy, osteomyelitis), current blood glucose levels (A1c) and assessment of off-loading devices and footwear. 3. Assessment of clinical history for venous insufficiency ulcer patients including a. prior ulcers b. body mass index c. history of pulmonary embolism or superficial/deep venous thrombosis d. number of pregnancies and physical inactivity e. physical exam f. evaluation of venous reflux, perforator incompetence, and venous thrombosis g. the use of any compression garments B. Treatment Plan documentation Includes ALL of the following: 1. debridement as appropriate to a clean granular base 2. documented evidence of offloading for DFUs 3. documented evidence of sustained compression dressings for venous insufficiency ulcers 4. infection control with removal of foreign body or focus of infection 5. management of exudate with maintenance of a moist environment 6. documentation of smoking history, counseling on the effects of smoking on wound healing 7. treatment for smoking cessation and current status III. Non-Covered or Medically Necessary Skin Substitutes-OH MCD-MM-1398Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 A. New Quarterly skin substitutes or Q-codes that have not been used outside clinical trials B. Greater than 3 applications of a skin substitute graft/CTP over 12 weeks if volume has not decreased by at least 50% C. Repeat applications of skin substitute graft/CTP when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, no measurable change from baseline, and no sign of significant improvement or indication that significant improvement is likely (such as granulation, epithelialization, or progress towards closure) D. Application of skin substitute graft/CTP in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, ischemia E. Use of surgical preparation services (eg. debridement), in conjunction with routine, simple or repeat skin replacement therapy with a skin substitute graft/CTP F. All liquid or gel skin substitute products or CTPs for ulcer care G. Placement of skin substitute graft/CTP on infected, ischemic, or necrotic wound bed H. Skin substitute products that are not on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational. I. Life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. NOTE: A list of approved skin substitutes may be found on the ODM Provider-Administered Pharmaceuticals fee schedule. (see reference below) E. Conditions of CoverageNA F. Related Policies/Rules Breast Reconstruction Surgery Experimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 02/15/2023 New Policy.Date Revised 02/14/2024 02/12/202507/02/2025Updated references. Approved at Committee. Added I. A. 1-4. Added II. B. Life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. Added new requirements for Sec. I.A, Band E. Added new Sec. II-Documentation Requirements Added extra non-covered items to Sec. III. Added E&I to Related Policies/Rules. Updated referencesSkin Substitutes-OH MCD-MM-1398Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Date Effective 11/01/2025 Date Archived H. References1. Ankle-brachial index. Mayo Clinic. Accessed June 3, 2025. www.mayoclinic.org 2. Bedsores (pressure ulcers). Mayo Clinic. Accessed June 3, 2025. www.mayoclinic.org 3. Hart CE, Loewen-Rodriguez A, Lessem J. Dermagraft: use in the treatment of chronic wounds. Adv Wound Care . 2012;1(3):138-141. doi:10.1089/wound.2011.0282 4. Immunizations, injections and infusions (including trigger-point injections), skin substitutes, and provider-administered pharmaceuticals, Ohio Admin. Code 5160-4-12 (2022). 5. James CV, Murray Q, Park SY, et al. Venous leg ulcers: potential algorithms of care. Wounds . 2022;34(12):288-296. doi:10.25270/wnds/21160 6. Porcine skin and gradient pressure dressings. Centers for Medicare & Medicaid Services. Accessed January 3, 2025. www.cms.gov 7. Provider-Administered Pharmaceuticals fee schedule. Ohio Dept of Medicaid. Updated April 1, 2025. ProviderAdminDrugTable.xlsx Accessed June 11, 2025. www.medicaid.ohio.gov 8. Research Protocol: Skin Substitutes for Treating Chronic Wounds . Effective Health Care Program, Agency for Healthcare Research and Quality; 2018. Reviewed January 2020. Accessed June 3, 2025. www.effectivehealthcare.ahrq.gov 9. Shahrokhi S. Skin substitutes. UpToDate. Updated May 8, 2023. Accessed June 3, 2025. www.uptodate.com 10. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer: A-0326. MCG Health. 28th ed. Accessed June 3, 2025. www.careweb.careguidelines.com 11. Tissue engineering and regenerative medicine. National Institute of Biomedical Imaging and Bioengineering. Accessed January 3, 2025. www.nibib.nih.gov 12. Venous ulcers. Cleveland Clinic. Reviewed May 26, 2022. Accessed June 3, 2025. www.myclevelandclinic.org 13. What is a diabetic foot ulcer? American Podiatric Medical Association. Accessed June 3, 2025. www.apma.org Approved by ODM on 07/09/2025 Independent medical review 01/19/2023

Radiofrequency and Microwave Ablation of Tumors

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349 11/01/2025 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 Contents A. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 6 Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectRadiofrequency and Microwave Ablation of Tumors B. BackgroundRadiofrequency ablation of a tumor involves the delivery of high frequency alternating current to induce thermal injury of target ed tissue. Evidence for the use of radiofrequency ablation is constantly evolving based on the type of tumor and its location. Hepatocellular carcinoma is the most common type of primary liver cancer. For most patients, treatment with curative intent is not possible. Treatment options include surgical excision, hepatic artery infusion chemotherapy, trans-arterial bland orchemoemb olization, selective interstitial radiotherapy (Yttrium 90 microspheres),percutaneous ethanol injection, cryoablation, and thermo-ablation. Liver transplantation for curative intent may be appropriate for some patients. Radiofrequency ablation and microwa ve ablation, which are types of thermoablation, have proven to be effective local therapy techniques with similar results to other treatment options for smaller tumors. Liver metastases are a common manifestation of many primary cancers. The number, location, size, and patients general health influence the choice of treatment for liver metastases. Surgical resection with curative intent is ideal, however this applies to aminority of patients. Non-surgical ablative techniques may be used for both curative and palliative intent, includ ing systemic chemotherapy , targeted therapy, immunotherapy , external beam radiotherapy, cryoablation, thermo-ablation, arterial embolization techniques, and selective internal radiation therapy. Lung cancer is one of the most common types of cancer, with symptoms often not appearing until advanced disease, causing poor prognosis. Common treatments for primary or metastatic cancer in the lung includes surgery, chemotherapy, radiotherapy, photodynam ic therapy, thermal ablation, immunotherapy, and biological therapy.Treatment selection is based on type, size, position and stage of cancer, and the patients overall health.Microwave ablation (MWA) uses microwave energy to cause thermal coagulation and tissue necrosis at a specific location. When a tumor is not amenable to resection or a patient is ineligible for surgery, MWA may be an appropriate alternative definitive treat ment. This procedure can be done percutaneously, using minimally invasivesurgical techniques, or during open surgery, and involves placement of one or more probes directly into the tumors location, where microwave energy can be directly applied, causing destruction of the tumor and limited surrounding tissues. Microwave ablation does not spare vessels. Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 C. Definitions Tumor Ablation Direct application of energy to eradicate or destroy focal tumors. The method of ablation is dependent on the characteristics of the lesion and risk mitigation. o Microwave Ablation (MWA) Delivery of high-frequency microwave energy to rapidly agitate water molecules in the target tissue; the energy is converted to heat, which causes tissue necrosis. o Radiofrequency Ablation (RFA) Delivery of radio waves to generate heat and induce tissue destruction in the targeted area. D. PolicyI. Microwave ablation for tumor treatment using an FDA-approved device is considered medically necessary when ANY (either A or B) of the following indications are met: A. Member has primary or metastatic hepatic (liver) tumor and ALL the following: 1. The tumor is unresectable due to location of lesion(s) OR the member has comorbid condition (s) that are contraindicative to surgery . 2. The t umor is at most 5cm in size or there are no more than 3 nodules, all of which are no more than 3cm in size . 3. Microwave ablation may be used alone or in conjunction with open or minimally invasive resection of other liver tumors. Curative resection of all disease must be the stated goal of therapy . or B. Member has primary or metastatic lung tumor and ALL the following: 1. The tumor is unresectable due to location of lesion(s) or the member has comorbid condition(s) that are contraindicative to surgery . 2. Single tumor is no more than 3cm in size. II. Microwave ablation is not covered for any other indication, including (but not limited to), the following:A. Microwave ablation for any other tumor type is considered experimental and investigational due to a lack of clinical evidence on its efficacy . B. Microw ave ablation for tumors larger than 5cm or more than 3 nodules larger than 3cm is considered experimental and investigational due to a lack of clinical evidence on its efficacy compared to other treatment modalities. III. Radiofrequency ablation for tumor treatment is considered medically necessary forANY of the following indications : A. Barrett esophagus with dysplasia B. bone metastases C. hepatocellular carcinoma with ALL the following: 1. Child-Pugh class A or Bliver function (score of 9 or less) 2. surgical evaluation indicates at least one of the following: a. patient is a candidate for surgical resection following radiofrequency ablation Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 b. patient is a candidate for transplant following bridge therapy by radiofrequency ablation c. patient is not a surgical candidate (or elects against surgery) d. patient is not a transplant candidate 3. tumor has all the following: a. location amenable to percutaneous, minimally invasive or open surgical ablation b. margins accessible to ablation c. not in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other intra-abdominal organs) d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 4. no portal hypertension D. kidney tumor with ALL the following: 1. clinical stage T1 renal lesion 2. patient is not candidate for or elects against active surveillance 3. patient is not a surgical candidate (or elects against surgery) 4. tumor is not a renal angiomyolipoma E. liver metastases from colorectal carcinoma with ALL the following: 1. patient is not an ideal surgical candidate (or elects against surgery) 2. tumor has all the following: a. location amenable to percutaneous or surgical ablation b. margins accessible to ablation c. no t in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other int ra-abdominal organs) d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 3. no extrahepatic disease F. lung cancer (non-small cell [NSCLC ]) with ALL the following: 1. patient is not a surgical candidate (or elects against surgery) 2. tumor with ALL the following: a. less than 3cm in diameter b. node negative (stage I) c. not in close proximity to major pulmonary vessels or esophagus G. osteoid osteoma H. soft tissue sarcoma with at least ONE of the following: 1. gastrointestinal stromal tumor with limited progressive disease (ie, appearance of new lesion, increase in tumor size) 2. soft tissue sarcoma of extremity, superficial trunk, or head/neck, as indicated by both : a. synchronous stage IV disease b. need for treatment of tumor bulk limited to single organ that is amenable to local therapy, or palliation of disseminated metastases I. thyroid cancer with at least ONE of the following: Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 1. differentiated thyroid carcinoma (eg, follicular, papillary) with at least ONE of the following: a. distant metastasis or persistent disease not amenable to treatment with radioactive iodine b. recurrent disease following treatment of locoregional disease 2. medullary carcinoma with at least ONE of the following: a. palliative treatment of symptomatic metastases or progressive disease needed b. Patient asymptomatic, with at least ONE of the following: 01. disease metastasis 02. persistent disease following treatment of locoregional disease 03. recurrent disease following treatment of locoregional disease J. thyroid nodules, with ALL the following: 1. compressive symptoms from nodules (eg, cough, dysphagia, foreign body sensation, pain, voice changes) 2. patient not a surgical candidate (or elects against surgery) K. uterine leiomyomas with ALL the following: 1. laparoscopic ultrasound-guided procedure planned 2. leiomyomas documented by imaging study (e g, ultrasound) or hysteroscopy) 3. patient desires uterine conservation or is not a s urgical candidate 4. patient is premenopausal 5. persistent symptoms (3 months or greater in duration) directly attributed to presence of leiomyomas, as indicated by at least ONE of the following: a. abnormal uterine bleeding unresponsive to conservative management (eg, hormonal therapy) b. bowel dysfunction c. dyspareunia d. infertility e. iron deficiency anemia f. pelvic pain or pressure g. urinary dysfunction 6. testing has ruled out other potential ca uses of symptoms E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 10/12/2022Date Revised 09/27 /2023 08/28/2024 Annual review: updated references. Approved at Committee. Revew: updated references, approved at Committee Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 06/18 /2025 Review: added Barrett and thyroid nodule indications,updated references, approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. Abdalla M, Collings AT, Dirks R, et al. Surgical approach to microwave and radiofrequency liver ablation for hepatocellular carcinoma and colorectal liver metastases less than 5cm: a systematic review and meta-analysis. Surg Endosc. 2023;37(5):3340-3353. doi:10.1007/s00464-022-09815-5 2. Chung SR, Suh CH, Baek JH, et al. Safety of radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: a systematic review and meta – analysis. Int JHyperthermia . 2017;33:920-930. doi:10.1080/02656736.2017.1337936 3. Cui R, Yu J, Kuang M, et al. Microwave ablation versus other interventions for hepatocellular carcinoma: a systematic review and meta-analysis. JCancer Res Ther . 2020;16(2):379-386. doi:10.4103/jcrt.JCRT_403_19 4. Curley SA, Stuart KE, Schwartz JM, et al. Localized hepatocellular carcinoma: liver – directed therapies for nonsurgical candidates who are eligible for local ablation. UpToDate. Updated April 23, 2025 . Accessed May 19, 2025 . www.uptodate.com 5. Dupuy DE. Image-guided ablation of lung tumors. UpToDate. Updated November 6, 2023. Accessed May 19, 2025 . www.uptodate.com 6. Genshaft SJ, Suh RD, Abtin F, et al. Society of Interventional Radiology quality improvement standards on percutaneous ablation of non-small cell lung cancer and metastatic disease to the lungs. JVasc Interv Radiol . 2021;32:1242.e1-1242.e10. doi:10.1016/j.jvir.2021.04.027 7. Glassberg MB, Ghosh S, Clymer JW, et al. Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic review and meta-analysis. World JSurg Oncol . 2019;17(1):98. doi:10.1186/s12957-019-1632-6 8. Han Y, Yan X, Zhi W, et al. Long-term outcome following microwave ablation of lung metastases from colorectal cancer. Front Oncol . 2022;12:943715. doi:10/3389/fonc.2022.943715 9. Matsui Y, Tomita K, Uka M, et al. Up-to-date evidence on image-guided thermal ablation for metastatic lung tumors: a review. Jpn JRadiol . 2022. ;40(10):1024-1034. doi:10/1007/s11603-022-01302-0. 10. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Hepato cellular Carcinoma . Version 1.2025 . Issued March 20, 2025 . Accessed May 9, 2025 . www.nccn.org 11. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer . Version 3.2025 . Issued January 14, 2025. Accessed May 9, 2025 . www.nccn.org 12. National Institute for Health and Care Excellence. Microwave ablation for treating liver metastases [IPG553]. April 27, 2016 . Accessed May 9, 2025 . www.nice.org Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 13. National Institute for Health and Care Excellence. Microwave ablation of hepatocellular carcinoma [IPG214]. March 28, 2007 . Accessed May 9, 2025. www.nice.org 14. National Institute for Health and Care Excellence. Microwave ablation for primary or metastatic cancer in the lung [IPG 716 ]. February 2, 20 22 . Accessed May 9, 2025 . www.nice.org 15. Nelson DB, Tam AL, Mitchell KG, et al. Local recurrence after microwave ablation of lung malignancies: a systematic review. Ann Thorac Surg . 2019;107(6):1876-1883. doi:10.1016-j.athoracsur.2018.10.049 16. Palussiere J, Chomy F, Savina M, et al. Radiofrequency ablation of stage IA non – small cell lung cancer in patients ineligible for surgery: results of a prospective multicenter phase II trial. JCardiothorac Surg . 2018;13(1):91. doi:10/1186/s13019 – 018-0773-y 17. Radiofrequency Ablation of Tumor : ACG : A-0718 (AC) . 29th ed. MCG H ealth ; 2025. Updated January 25, 2025 . Accessed May 9, 2025 . www.careweb.guidelines.com 18. Wang N, Xu J, Wang G, et al. Safety and efficacy of micro wave ablation for lung cancer adjacent to the interlobar fissure. Thorac Cancer . 2022 ;13(18):2557-2565 . doi:10.1111/1759-7714.14589 19. Wu X, Uhlig J, Blasberg JD, et al. Microwave ablation versus stereotactic body radiotherapy for stage I non-small cell lung cancer: a cost-effectiveness analysis. J Vasc Interv Radiol . 2022;33(8):964-971.e2. doi:10.1016/j.jvir.2022.04.019 Independent med ical review September 2022Approved ODM 07/21/2025

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