Special Needs Car Seats

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Special Needs Car Seats-GA MCD-MM-1443 02/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2B. 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 ………………………….. ………………………….. ………………………….. ……………………. 5 Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSpecial Needs Car Seats B. BackgroundThe American Academy of Pediatrics (AAP) states that all children should have access to proper resources for safe transportation, including children with specific functional needs. Safe transportation includes not only the proper restraints, but also the c orrect positioning to secure the child in the vehicle. The AAP notes that a standard car seat provides the best protection for most travel needs. However, additional research is needed for the biomechanics of test dummies representative of children with ce rtain functional needs in crash testing so that such test dummies can be utilized by the National Highway Traffic Safety Administration (NHTSF). Currently, the Federal Motor Vehicle Safety Standard (FMVSS) Number 213 regulates the design and performance of child restraint systems for children weighing up to 80 pounds. However, children greater than 80 pounds may require car seat restraint , andseveral manufacturers have tested their car seats beyond an 80-pound maximum. Once a child has outgrown a standard 5-point harness car seat, options include car seats specially designed for full support of a childs head, neck, and back while supporting up to 115 pounds. Conventional travel vests or specialized medical seating can be used for children who require additional trunk support but have stable neck control. Some older children with certain function al 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. Data has show n that rear-facing car seats offer greater protection for the head and neckthan a front-facing car seat by reducing neck loading in vehicular crashes with a frontal component. Therefore, the AAP encourages use of a rear facing car seat for as long as possi ble for all children, but especially for children diagnosed with a neurological condition (s) , as a forward-facing car seat increases the risk of injury in a crash. Recommendations by the AAP specify that car seats should be placed in the rear seat of the vehicle. However, a child with certain functional needs requiring frequent monitoringmay need to be placed in the front seat when no adult is available to sit in the rear seat with the child. If the child is placed in the front seat, the automatic air bag should be disabled.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 eats. Not all vehicles come with the standard hardware necessary to secure car seats, especially older vehicles a nd larger car seats. A trial of the car seat is recommended to find the most appropriate car Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 small child during transportation that lifts the child 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 attach to the vehicle’s restraint anchorage system. The agency added a height provision to make the new standard’s applicability clear to booster seat manufacture rs 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 child by keeping a low center of gravity and allowing the vehicle seat belt and seat cushion to manage the 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 been 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 special 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 Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 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. 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 . Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 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. 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 02/12/202510/08/2025Annual review: editorial changes, adjustment to car seats definition, added Section D.I.C-D., D.I.E.2, and D.II-III., updated the references. Approved at Committee. Annual review: updated criteria in D.I.E. and references. Approved at Committee. Review. Updated background, added CPST documentation, trialing requirements and updated references. Approved at Committee. Date Effective 02/01/2026 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 Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 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 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. Pediatrics . 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 May 23, 2025. Accessed September 29 , 2025 . www.uptodate.com 13. 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 GA-MED-P-4704650 Issue date 03/01/2023 Approved DCH 11/17/2025

Safety Beds

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Safety Beds-GA MCD-MM-1456 02/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Safety Beds-GA MCD-MM-1456 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectSafety Beds B. BackgroundHealthy sleep requires adequate duration, appropriate timing, good quality, regularity, and the absence of sleep disturbances. The American Academy of Sleep Medicine has issued recommendations for sleep needs by age. An individuals bedtime environment is an important consideration, with factors such as the bed and mattress affecting the quality and duration of sleep. A safety bed is an enclosed bed, typically fitted with a mesh canopy, padded walls, and/or a specially designed mattress. A safety bed may be necessary to ensure thesafety of an individual with a variety of medical or behavioral health diagnoses , (eg,epilepsy, intracranial injury, hydrocephalus , intellectual disabilities , autistic spectrum disorder ). The use of these beds increases patient safety by eliminating falls and preventing injuries and wandering when the patient should be sleeping . Ongoing indivi dual evaluation and monitoring is recommended for appropriate use and prescribing. C. Definitions Crib Canopy A cover that attaches to the top of a crib that prevents a toddler from climbing out of the crib or, in some cases, pets from climbing into the crib. Hospital Bed A bed used for individuals that can be adjusted to raise the head end, foot end, or middle, as required. The overall bed height is also adjustable. Physical Therapy (PT) Exercises, massages, and other treatments generally under the supervision of a trained provider based on physical stimuli (eg, heat, cold, electrical currents, ultrasound) to relieve pain, improve mobility, strengthen weakened muscles, and often includes an educational component showing the patient how they can improve their own health. Also known as physiotherapy. Occupational Therapy (OT) Service that promotes quality of life through participation in meaningful occupations. OT practitioners are skilled in physical and psychological evaluation with a focus on psychological wellbeing. Safety Bed A bed to prevent individuals from leaving the bed at night without supervision, preventing injuries, falls, and wandering, and can be institutional, adaptive, enclosed bed system , net bed, or special needs beds. Standard Bed A fixed height bed that is typically sold as furniture and consists of a frame, box spring, and mattress. D. PolicyI. CareSource considers a safety bed medically necessary when ALL the following criteria are met : A. Member has a behavioral health or medical diagnosis that may lead to safety concerns. The provider treating the specific condition must have a face-to-face encounter with the member and order the safety bed within 10 months of the encounter. Safety Beds-GA MCD-MM-1456 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.B. The safety bed has been approved by the FDA and otherwise considered to be safe and effective for in-home use to treat the condition for which it is prescribed.C. Member requires a safety bed that prevent s the member from leaving the bed at night without a supervisor. D. There should be regular, periodic , and face-to-face (in-person) monitoring while the member is in the safety bed. E. An in-home assessment has been conducted to ensure that less restrictive measures have been tried and are in place. F. The safety bed is to be used for sleep and short naps and not to be used as a restraint , for playtime, for discipline, or as part of a behavior modification program. G. The member is mobile and at risk of entanglement in a standard hospital bed or traveling outside of the home. H. The request is not based on physical or environmental issues, such as hunger, thirst, pain, restlessness, use of restroom, changes in caregivers or routines, etc. I. For members with severe behavioral disorders, there is a plan for behavioral management. J. Documentation submitted to CareSource for review must show that the member meets the above criteria, and: 1. Bed alarms, door alarms, standard rail padding , bed rails, bed on the floor, video/audio monitors, removal of safety hazards from the members room (eg, small ingestible items, items that can fall on the child or they can climb and jump off of including unsecured dressers, bookcases, TVs, etc.), child protection devices (eg, locks outside of the reach of the child, alarms, gates, furniture anchors, etc.), treatment plan to help with calming and sleep failed to meet the medical needs of the member. 2. The safety bed is for the benefit of the member and not for any caregiver, family member, or provider. 3. The provider order for the safety bed is included and has a monitoring plan describing: a. medical necessity for the safety bed b. plan for transitioning away from the safety bed c. when the bed will be used d. how member will be monitored e. how members needs will be met while in the safety bed f. how medical conditions will be managed while bed in use 4. PT/OT evaluation that specifically outlines safety, cognitive, behavioral, and boundary concerns underlying the need for the safety bed. The evaluation should also include how the safety bed was chosen over other options. 5. The person-centered service plan is retained and updated. a. Includes a mental health management plan with member-specific medical/clinical interventions that have been tried to mitigate behaviors, improve quality of sleep and safety when sleeping b. Includes emergency preparedness plan to ensure the safety of the member in case of emergency (eg, natural disaster) as the member is not able to exit the enclosure independently Safety Beds-GA MCD-MM-1456 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6. The invoice with signed/dated proof of delivery for the safety bed is retained and submitted along with the prior authorization and reimbursement requests. L. The safety bed is the lowest cost alternative that addresses the members health condition. II. CareSource considers technology addons as non-medical in nature and therefore not medically necessary. III. LimitationsA. Safety beds are not covered for use as infant cribs or as a convenience item. B. Safety beds are not covered for members over 21 years of age. C. Safety beds submitted under a miscellaneous code are not covered. D. Safety beds may only be replaced once per 3 years with evidence that the member has grown significantly. E. Conditions of CoverageN/A F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policyDate Revised 11/08/2023 05/08/202411/06/202410/08/2025Annual review. C overage language refined. Approved at committee. Annual review: adjusted title, revised background and definitions, condensed coverage criteria, removed sections D.I. and D.IV., and updated references. Approved at Committee. Annual review: updated background and added documentation requirements. Annual review. Added documentation requirements, in – home assessment, and clarification of use. Updated D.I. and references. Added D. II and III. Approved at Committee. Date Effective 02/01/2026 Date Archived H. References1. Caggiari G, Talesa GR, Toro G, et al. What type of mattress should be chosen to avoid back pain and improve sleep quality? review of the literature. JOrthop Traumatol . 2021;22(1):51. doi:10.1186/s10195-021-00616-5 2. DeGeorge KC, Neltner CE, Neltner BT. Prevention of unintentional childhood injury. Am Fam Physician . 2020;102(7):411-417. Accessed September 10 , 202 5. www.aafp.org Safety Beds-GA MCD-MM-1456 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3. In Brief: Physical Therapy. Institute for Quality and Efficiency in Health Care(IQWiG); 2006 . Updated March 19, 2024. Accessed September 10, 2025. www.ncbi.nlm.nih.gov 4. Janssen S, Grabanski JL. Occupational Therapy in Long Term Care. StatPearls; (2023). Updated February 28, 2023. Accessed September 10, 2025. www.ncbi.nlm.nih.gov 5. Policies and Procedures for Durable Medical Equipment Services , Part II . Georgia Dep t of Community Health. Revised July 1, 2025. Accessed September 10, 2025. www. mmis. georgia.gov 6. Paruthi S, Brooks LJ, DAmbrosio C, et al. Recommended amount of sleep for pediatric populations: a consensus statement of the American Academy of Sleep Medicine. JClin Sleep Med . 2016; 2(6):785-786. doi:10.5664/jcsm.5866 7. Sherburne E, Snethen JA, Kelber S. Safety profile of children in an enclosure bed. Clin Nurse Spec . 2017;31(1):36-44. doi:10.1097/NUR.0000000000000261 Independent med ical review 2/15/2023 GA-MED-P-4704650 Issue date 03/01/2023 Approved DCH 11/17/2025

Pharmacogenomics-Gene Testing for Behavioral Health Indications

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – GA MCD-MM-1712 02/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response . Pharmacokinetics analyzes how drug s move through the body, including absorption, distribution, metabolism, and excretion. In behavioral health medicine, cytochrome P450s (CYPs) are 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. Individuals with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound and are , therefore , classified as poor metabolize rs, 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 a small sample si ze and d o not perform a power calculation or correct for multiple testing scenarios. It is difficult to substantiate conclusion s when not accounting for false positive s or false negatives . Additionally, there is a lack of con sensus regarding preemptive genotyping efficacy. T wo societies publish ing 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 international organization whose goal is to reduce the barrier of translating genetic laboratory test results into guided clinical decision support. CPIC guidelines are peer-reviewed,ev idence-based, and updated as new evidence emerges. The guidelines are indexed inPubMed 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 opt imize treatment. The strength of recommendations is divided into 4 categories: strong, moderate, optionaland no recommendation. A strong recommendation is backed by high-quality evidence ,and the desirable effects clearly outweigh the undesirable effects. A moderate recommendation recognizes a close or uncertain balance as to whether the evidence is high quality , and the 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 evidence, confidence, or agreement to provide a recommendation to guide clinical practice.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 medications 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: Pharmac ogenetic 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 inadequate response or adverse reaction to a previous antidepressant or antipsychotic trial . CareSource 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 (cl inical utility), performs better than an existing standard of care medical management option, and/or is not generally accepted as standard of care in the evaluation or management of a particular condition. CareSource provides appeal rights to any member or provider acting on behalf of a member who may disagree with denial decisions. Tests should be chosen to maximize the likelihood of identifying mutations in genes of interest for a spe cific 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. Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 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 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 and with a conflict-of-interest policy aimed at specific clinical circumstances and based on the best available evidence for optimizi ng outcomes of clinical care. Nationally Recognized Clinical Practice Guidelines Developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure and 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 th e 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 GA Dept of Community Health (DCH) in a recently published or updated GA Medicaid Management Information System (GAMMIS ) manual or GA DCH policy and procedure 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 ar e no MCG guidelines available, authorization for biomarker testing must be supported by the following scientific and medical evidence (as appropriate) : A. labeled indications for a test approved or cleared by the FDA B. indicated tests for a drug approved by the FDA C. Centers for Medicare and Medicaid Services (CMS) national coverage determinations and/or local coverage determinations by Medicare Administrative Contractors D. nationally recognized clinical practice guidelines and/or consensus statements E. warnings and precautions on FDA-approved drugs Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 II. Any biomarker testing with clinical significance and evidence supported by scientific and medical evidence may be subject to medical necessity review. CareSource usesCPIC guidelines level A or B to determine the appropriateness of testing requests. Guidelines may be located at www.cpicpgx.org/guidelines. A. General guidelines for all testing requests 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 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 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.caresource.com, fax, or mail by the US Postal Service. IV. CareSource considers the following not medically necessary (not all-inclusive):A. testing or screening 1. in the general population 2. considered n on-covered but billed using unlisted procedure code s 3. in the absence of clinical signs and 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: 1. 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. 2. Providers must use industry standard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes to the highest level of specificity. 3. Services considered to be mutually exclusive, incidental to, or integral to the primary service rendered are not allowed additional payment. 4. Proprietary panel testing requires documentation of medical necessity. 5. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 G. Review/Revision HistoryDATE ACTIONDate Issued 08/28/2024 New policy. Converted AD-1345 to MM with parameters for review of medical necessity. Approved at Committee. Date Revised 10/08/2025 Annual review. Updated references. Approved at Committee. Date Effective 02/01/2026 Date 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. Biomarker Testing for Medicaid Recipients , GA. CODE ANN . 49-4-159.3 (2023). 7. 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 8. 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 9. 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 10. 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. https://doi.org/10.1111/cts.12692 11. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 12. 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 13. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Accessed September 19, 2025. www.cdc.gov 14. Clinical Pharmacogenetics Implementation Consortium. Accessed September 19, 2025. www.cpicpgx.org 15. Clinical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents. American Academy of Child & Adolescent Psychiatry; 2020. Accessed September 19 , 202 5. www.aacap.org 16. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed September 19 , 202 5. www.hayesinc.com 17. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Accessed September 19 , 202 5. www.hayesinc.com 18. 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 , 202 5. www.evidenced.hayesinc.com 19. 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 20. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Accessed September 19 , 202 5. www.evidence.hayesinc.com 21. Clinical Utility Evaluation: Pharmacogenomic Testing for Major Depressive Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 22. Clinical Utility Evaluation: Pharmacogenomic Testing for Schizophrenia Disorder. Hayes; 2025. Accessed September 22, 2025. www.evidence.hayesinc.com 23. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Accessed September 19 , 202 5. www.evidence.hayesinc.com 24. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 2 9th ed. Accessed September 19 , 202 5. www. careweb.careguidelines.com 25. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Accessed September 19 , 202 5. www.genome.gov 26. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 27. 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 28. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 29. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. JAHIMA . 2016;87(1):56-59. Accessed September 19 , 202 5. www.pubmed.ncbi.nih.gov 30. 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 31. 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 32. 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 33. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 34. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 2 9th ed. Accessed September 19 , 202 5. www.careweb.careguidelines.com 35. 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 36. 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 37. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Accessed September 19 , 202 5. www.uptodate.com 38. Laboratory Requirements, 42 C.F.R. 493 (2024). 39. 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 40. 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 41. 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 42. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Accessed September 19, 2025 . www.fda.gov 43. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 44. 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 45. Medical Code Brief: 0392U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 46. Medical Code Brief: 0411U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 47. Medical Code Brief: 0419U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 48. Medical Code Brief: 0423U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 49. Medical Code Brief: 0434U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 50. Medical Code Brief: 0438U-PLA (U Codes). Hayes; 2023. Accessed September 22, 2025. www.evidence.hayesinc.com 51. Medical Code Brief: 0476U-PLA (U Codes). Hayes; 2024. Accessed September 22, 2025. www.evidence.hayesinc.com 52. 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 , 202 5. www.careweb.careguidelines.com 53. 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 54. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Accessed September 19 , 202 5. www.evidence.hayesinc.com 55. 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 56. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed September 19 , 202 5. www.cancer.gov 57. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed September 19 , 202 5. www.ncbi.nlm.nih.gov 58. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Accessed September 19 , 202 5. www.medicaid.gov 59. 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 60. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 61. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Accessed September 19 , 202 5. www.aacap.org62. 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 63. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed September 19 , 202 5. www.evidence.hayesinc.com 64. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed September 19 , 202 5. www.evidence.hayesinc.com 65. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed September 19 , 202 5. www.evidence.hayesinc.com 66. 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. 67. Raby B. Personalized medicine. UpToDate. Accessed September 19 , 202 5. www.uptodate.com 68. 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 69. 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 70. 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 71. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. 72. Saadullah Khani NS, Hudson G, Mills G, et al. A systematic review of pharmacogenetic testing to guide antipsychotic treatment. Nat Mental Health . 2024 (2) :616-626. doi:10.1038/s44220-024-00240-2 73. 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 74. 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 75. Tantisira K. Overview of pharmacogenomics. UpToDate. Accessed September 19, 2025. www.uptodate.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 02/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 76. 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.2022.03.05777. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed September 19 , 202 5. www.fda.gov 78. 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 79. 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 80. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 2 9th ed. Accessed September 19 , 202 5. www.careweb.careguidelines.com 81. 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 82. 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 83. 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 09/2024GA-MED-P-4704650 Issue date 08/28/2024 Approved DCH 11/17/2025

Clinical Trial Coverage

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-GA MCD-MM-0799 02/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. 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-GA MCD-MM-0799Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. 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 treatments, 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: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 Clinical Trial Coverage-GA MCD-MM-0799Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 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 is 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 – is defined as 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 o Cannot be legally marketed in the United States without final approval from appropriate government regulatory or licensing body. Clinical Trial Coverage-GA MCD-MM-0799Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 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 as described in this policy when A. The same routine care costs would be typically covered for a member who is NOT enrolled in the clinical trial AND B. All items and services are medically necessary AND C. All items and services are a covered benefit. IV. CareSource will cover routine care costs for member in a clinical trial where the 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. 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. G. Transportation, housing, food or expenses for the member or family members/companions associated with travel to or from facility providing the clinical trial. Clinical Trial Coverage-GA MCD-MM-0799Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 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 05/19/2015Date Revised 05/17/2016 07/10/2019 11/01/2019 10/28/2020 10/27/2021 08/31/2022 08/30/2023 09/11/2024 09/10/2025 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 02/01/2026 Date Archived H. References1. Association for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed July 29, 2025. www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed July 29, 2025. www.ecfr.gov 3. Eligibility Criteria, GA. CODE ANN. 31-52-4 (2023). Accessed July 29, 2025. www.law.justia.com 4. Medicare and Medicaid Services Medicare Learning Network (2015). MLN Matters. Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies. Accessed July 29, 2025. www.cms.gov Clinical Trial Coverage-GA MCD-MM-0799Effective Date: 02/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 5. National Coverage Determination for Routine Costs in Clinical Trials (310.1).Accessed July 29, 2025. www.cms.gov 6. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). GA-MED-P-4499700 Issue Date 05/19/2015 Approved DCH 11/17/2025

Peroral Endoscopic Myotomy

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Peroral Endoscopic Myotomy-GA MCD-MM-1306 02/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 Peroral Endoscopic Myotomy-GA MCD-MM-1306Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeroral Endoscopic Myotom y B. BackgroundAchalasia (ie, failure to relax) is a rare esophageal disorder that affects about 1 in every 100,000 people and is usually associated with difficulty 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 time and eventually loses the ability to squee ze food down into the stomach. Although the condition cannot be cured, the symptoms can usually be controlled with treatment. Treatments for achalasia include oral medications, dilation or stretching of the esophagus, surgery (open and laparoscopic), endos copic surgery, and injection of muscle-relaxing medicines (botulinum toxin) directly into the esophagus. Peroral endoscopic myotomy (POEM) is a procedure developed in Japan that isperformed with the patient under general anesthesia. Studies suggest that POEM can achieve results comparable to or even better than those of pneumatic balloon dilation and laparoscopic Heller myotomy with similar safety. However, POEM is a newer procedure, and long-term outcome data is 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 activi tiessooner 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. In achalasia, 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 three different achalasia types, referred to as Type I, Type II, and Type III. o Type I Characterized by minimal esophageal pressurization , this type is characterized by 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 W ith 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 severe symptoms (eg, severe chest pains that may mimic those of a heart attack and spasms severe enough to wake a person from sleep ). Peroral Endoscopic Myotomy-GA MCD-MM-1306Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 four symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss) with scores rangi ng 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 to be medically necessary whe n all the following clinical criteria is met: A. The m ember has a diagnosis of primary achalasia, types I, II, or III . B. POEM is being 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 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 include :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-GA MCD-MM-1306Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 02/15/2023 New policyDate Revised 02/14/2024 12/18/202408/13/2025Annual review: title has been altered to remove the acronym, editorial changes to policy document language, deleted POEM definition, lowered Eckardt symptom score criteria to 3 to match LCD, changed reflux esophagitis in Section D.V. to GERD to match LCD , and updated references. Approved at Committee. Annual review: updated age requirement and references. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 02/01/2026 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: peroral endoscopic myotomy for treatment of esophageal achalasia. Hayes; 2019. Reviewed March 7, 2023. Accessed December 5, 2024. www.evidence.hayesinc.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 the 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 Peroral Endoscopic Myotomy-GA MCD-MM-1306Effective Dat e: 02/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 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 9. Patel DA, Lappas BM, Vaezi MF. An overview of achalasia and its subtypes. Gastroenterol 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):1789-1796. doi:10.1007/s11605-016-3232-x 11. Spechler SJ. Achalasia: overview of the management of treatment . UpToDate. Updated July 3 0, 202 5. 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 2022GA-MED-P-4390704 Issue date 02/15/2023 Approved DCH 11/21/2025

Speech Therapy and Language Disorder Rehabilitation

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Speech Therapy and Language Disorder Rehabilitation-GA MCD-MM-0714 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 …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polices/Rules …………………………………………………………………………………………… 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Speech Therapy and Language Disorder Rehabilitation-GA MCD-MM-0714 Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectOutpatient Speech Therapy and Language Disorder Rehabilitation B. Background Speech language pathology services include the diagnosis and treatment of speech and language disorders. These services are provided by speech-language-pathologists within the scope of practices. Speech language pathologists diagnose and treat swallowing disorders (dysphagia) and communication disabilities. Speech, language, and swallowing disorders can be a result of a variety causes, such as hearing loss, autism, developmental delay, Parkinsons disease, a cleft palate, stroke or brain injury. C. Definitions Speech-Language Pathology (SLP) A field in which a clinician specializes in the evaluation and treatment of disorders, cognition, swallowing, voice, and communication disorders. Clinicians are referred to as speech language pathologists, speech and language therapists, or speech therapists. Receptive Language The ability to understand what is being said, this can involve the understanding the meaning of words and sentences of what is being spoken. Expressive Language The ability to put thoughts into words and sentences that make sense to others. Language Disorder Disorders that involve the processing of linguistic information, which can involve both receptive and expressive language. D. Policy CareSource requires outpatient speech language pathology services to meet medical necessity criteria. I. Speech language services documentation must include the following: A. An expectation that the patients condition will: 1. improve significantly within 60 days after the evaluation 2. or the services must be for the establishment of a safe and effective maintenance program. B. An order or referral by the referring physician to the SLP, including specific testing in areas of concern. C. SLP documentation of the screening or evaluation, including evidence of a face- to-face assessment supporting medical necessity for speech therapy. II. Per MCG criteria: developmental language disorder rehabilitation may be indicated for 1 or more of the following: A. Initial therapy when ALL of the following are present 1. Diagnosed medical condition as indicated by 1 or more of the following: a. Autism Spectrum Disorder b. central nervous system infection (eg, herpes encephalitis) c. Cerebral palsy d. child abuse or neglect Speech Therapy and Language Disorder Rehabilitation-GA MCD-MM-0714 Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 e. developmental language disorder (specific language impairment) f. Dyslexia g. Epilepsy or other seizure disorder h. Fetal Alcohol Syndrome i. genetic syndrome, with associated language disorder j. hearing disorders (eg, auditory processing disorder and hearing loss) k. Inborn error of metabolism (eg, phenylketonuria galactosemia) l. intellectual or developmental disability m. language based learning disabilities n. premature birth or low birth weight o. receptive-expressive language impairment (also referred to as mixed receptive-expressive language impairment) 2. Impairment of function (clinically significant) relative to the developmental normative data, as indicated by 1 or more of the following: a. decreased ability to recall specific content of information read or heard b. decreased oral and written language comprehension, processing and expression c. decreased preliteracy of literacy skills d. decreased sentence or utterance length and complexity e. decreased social communication skills f. difficulty organizing, planning and formulation content or oral and written expressive language g. difficulty with syntax and grammar in oral and written language h. pragmatic deficits i. decreased receptive OR expressive language 3. Recent change in language status as indicated by 1 or more of the following: a. change of symptoms or function in patient with previous chronic or stable pediatric or development language disorder b. recent diagnosis of medical condition or language delay/disorder B. Extended therapy when ALL of the following are present: 1. Functional progress has been made during initial therapy, or patient requires maintenance therapy plan to prevent further deterioration or preserve existing function. 2. Generalization and carryover of targeted skills into natural environment is occurring. 3. Goals of therapy are not yet met. 4. Patient is actively participating in treatment sessions. E. Conditions of Coverage N/A F. Related Polices/Rules N/A Speech Therapy and Language Disorder Rehabilitation-GA MCD-MM-0714 Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 07/10/2020 New PolicyDate Revised 05/26/2021 07/06/2022 07/19/202307/17/202407/02/2025 Removed language with PA limits on 2-and under. Bolded 2.8 Decreased receptive OR expressive language. Removed Covid red box; updated references; title Highlighted slight change in MCG from 25 th to 26 th ed. Updated references. Approved at Committee. Updated references. Approved at Committee Updated references. Approved at Committee Date Effective 11/01/2025 Date Archived H. References1. Introduction to Medicaid . Accessed June 5, 2025. www.asha.org 2. Understanding Language Disorders . Accessed June 5, 2025. www.understood.org 3. Developmental Language Disorders Rehabilitation ACG: A-0561 (AC). MCG, 28 th ed. Updated 2024. Accessed June 5, 2025. www.careweb.careguidelines.com 4. Georgia Department of Community Health. CIS/CISS Provider Manual (2024). Accessed June 5, 2025. www.georgia.gov Independent medical review 06/2019 GA-MED-P-4186818 Issue Date 07/10/2020 Approved DCH 08/06/2025

Skin Substitutes

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Skin Substitutes-GA MCD-MM-1399 10/01/2025 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-GA MCD-MM-1399Effective Date: 10/01/2025The 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-GA MCD-MM-1399Effective Date: 10/01/2025The 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-GA MCD-MM-1399Effective Date: 10/01/2025The 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 supports 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-GA MCD-MM-1399Effective Date: 10/01/2025The 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 an 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 (eg, 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. 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 02/12/2025 07/02/2025Updated 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. Review: added new requirements for D.I.A, B, and E, added D.II, Non-Covered items to D.III, and Experimental or Investigational Item or Service to Related Policies/Rules. Updated references. Approved at Committee. Date Effective 10/01/2025 Skin Substitutes-GA MCD-MM-1399Effective Date: 10/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Date ArchivedH. References1. Ankle-brachial index. Mayo Clinic. Accessed January 3, 2025. www.mayoclinic.org 2. Bedsores (pressure ulcers). Mayo Clinic. Accessed January 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. 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 5. Porcine skin and gradient pressure dressings. Centers for Medicare & Medicaid Services. Accessed January 3, 2025. www.cms.gov 6. Research Protocol: Skin Substitutes for Treating Chronic Wounds . Effective Health Care Program, Agency for Healthcare Research and Quality; 2018. Reviewed January 2020. Accessed January 3, 2025. www.effectivehealthcare.ahrq.gov 7. Shahrokhi S. Skin substitutes. UpToDate. Updated August 2, 2023. Accessed January 03,2025. www.uptodate.com 8. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer: A-0326. MCG Health. 28th ed. Accessed August 3, 2025. www.careweb.careguidelines.com 9. Tissue engineering and regenerative medicine. National Institute of Biomedical Imaging and Bioengineering. Accessed August 3, 2025. www.nibib.nih.gov 10. Venous ulcers. Cleveland Clinic. Reviewed May 26, 2022. Accessed August 3, 2025. www.myclevelandclinic.org 11. What is a diabetic foot ulcer? American Podiatric Medical Association. Accessed January 3, 2025. www.apma.org GA-MED- MED-P-4186818 02/14/2024 Issue date Approved DCH 8/06/2025Independent medical review 01/19/2023

Radiofrequency and Microwave Ablation of Tumors

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Radiofrequency and Microwave Ablation of Tumors-GA MCD-MM-1350 10/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 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-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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 orchemo embolization, 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 microwave ablation, which are types of thermos-ablation, 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 alternativ e definitivetreatment. This procedure can be done percutaneously, using minimally invasive surgical techniques, or during open surgery, and involves placement of one more probe s directly into the t umors location, where microwave energy can be directly applied, causing des truction of the tumor and limited s urrounding tissues. Microwave ablation does not spare vessels. Radiofrequency and Microwave Ablation of Tumors-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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. Microwave 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-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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 (eg, ultrasound) or hysteroscopy 3. patient desires uterine conservation or is not a surgical 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 Review: updated references, approved at Committee Radiofrequency and Microwave Ablation of Tumors-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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 indications for Barrett and thyroid nodules, updated references, approved at Committee.Date Effective 10/01/2025 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]. Published April 27, 2016 . Accessed May 9, 2025. www.nice.org Radiofrequency and Microwave Ablation of Tumors-GA MCD-MM-1350Effective Dat e: 10/01/2025The 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]. Published 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 ]. Published February 2, 2022 . 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). 28th ed. MCG Health; 2024. Updated March 14, 2024. Accessed August 7, 2024. www.careweb.guidelines.com 18. Wang N, Xu J, Wang G, et al. Safety and efficacy of microwave 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 2022GA-MED-P-4186818 Issue Date 10/12/2022 Approved DCH 08/06/2025

Noninvasive Home Mechanical Ventilation

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 8 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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. SubjectNoninvasive Home Mechanical Ventilation B. BackgroundThis document outlines the medical necessity criteria for a noninvasive home ventilator for a patient with stable, chronic respiratory failure. This device does not treat the underlying cause of respiratory failure but functions as supportive therapy, which may include reducing symptoms, improving quality of life, or sustaining or extending life. It may be used intermittently during the day and/or during sleep. A noninvasive home ventilator will not be reimbursed as such when its sole purpose is to function as a respiratory assistance device, including continuous positive airway pressure (CPAP), auto-titrating PAP, and bilevel airway pressure (BiPAP).C. Definitions Apnea-Hypopnea Index (AHI) The combined average number of apneas and hypopneas that occur per hour of sleep to determine the severity of obstructive sleep apnea (OSA) . Apnea-Hypopnea Index (AHI)Adult AHI Pediatric AHIMild OSA 5-14 1-4.9Moderate OSA 15 – 30 5-9.9 Severe OSA > 30 > 10 Bi-level Positive Airway Pressure (B iPAP) Device A device that uses mild bi-level or 2 levels of air pressure to keep breathing airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep breathing airways open. Home Mechanical Ventilation (HMV) A device used in the home setting for patients with chronic respiratory failure that delivers respiratory assistance via an invasive (ie, tracheostomy) or noninvasive (ie, nose/mouth mask, mouthpiece , nasal prongs) interface. These devices possess more advanced features than a CPAP/BiPAP machine, which include monitoring, rate control, safety, and backup power features. The ventilator can custom control a ll phases of the breathing cycle . D. PolicyI. CareSource utilizes Georgia Department of Community Health (GA DCH) and MCG Health criteria to determine medical necessity for noninvasive HMV (E0466) . An initial approval for HMV is valid for a maximum of 3 months. A new medical necessity determination thereafter is required every 6 months for continued rental use. Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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 II. Initial Rental of HMV Medical necessity for the initial coverage of noninvasive HMV is based on the following conditions in II – IV being met . A patient must have 1 of the following qualifying diagnoses: A. Congenital central hypoventilation syndrome B. Chronic lung disease of infancy (eg, bronchopulmonary dysplasia) unable to maintain acceptable pH and PCO 2 without ventilator support C. Chronic obstructive pulmonary disease (COPD) and 1 OR MORE of the following: 1. Chronic hypercapnia with PaCO 2 of 50 mm Hg (6.7 kPa) to less than 52 mm Hg (6.9 kPa) and at least 1 of the following: a. Arterial oxygen saturation 88% for 5 consecutive minutes during nocturnal oximetry while on at least 2 liters of oxygen per minute . b. Invasive or noninvasive ventilation for acute exacerbation required during 2 or more hospitalizations per year . 2. Chronic hypercapnia with PaCO 2 of 52 mm Hg (6.9 kPa) or greater 3. Palliative care for end-stage disease and advance directive states no desire for intubation D. Neuromuscular disorder accompanied by chronic respiratory failure , as indicated by the following: Documentation of respiratory failure, as indicated by ONE OR MORE : 1. Arterial O2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry 2. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) 3. Forced vital capacity less than 50% of predicted 4. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure 5. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower 6. Maximum sniff nasal inspiratory pressure less than 40 cm H 2O (3923 Pa) 7. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: a. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . b. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater) . E. Obesity hypoventilation syndrome , as indicated by ALL of the following: 1. BMI > 30 2. CPAP unsuccessful or not appropriate , as indicated by ONE OR MORE of the following: Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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 a. Comorbid sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer ). b. Intolerance of CPAP pressures necessary to correct obstructive sleep apnea (OSA) component (ie, difficulty exhaling against fixed airway pressure) c. Lack of resolution of hypercarbia, nocturnal desaturation, and OSA despite 3 months of CPAP use d. Titration study demonstrates OSA despite CPAP 15 cm H 2O (1471 Pa) that is responsive to BiPAP 3. Daytime hypercapnia with PaCO 2 greater than 45 mm Hg (6.0 kPa) without other etiology (eg, kyphoscoliosis, lung parenchymal disease, myopathy, severe hypothyroidism) 4. Sleep-disordered breathing or hypoventilation on polysomnography, as indicated by ONE OR MORE of the following: a. Apnea-hypopnea index of 5 or greater b. Increase in PaCO 2 during sleep by more than 10 mm Hg (1.3 kPa) above value while awake c. Significant oxygen desaturation (eg, less than 90%) not explained by obstructive apneas or hypopneas 5. TSH level does not demonstrate hypothyroidism F. OSA in child or adolescent and ONE OR MORE of the following: 1. Mild OSA (ie, apnea-hypopnea index from 1 to 5) and ONE OR MORE of the following: a. achondroplasia b. behavioral problems c. cardiovascular disease (eg, elevated blood pressure, pulmonary hypertension) d. Chiari malformation e. craniofacial abnormalities f. Down Syndrome g. excessive daytime sleepiness h. impaired cognition i. inattention or hyperactivity j. mucopolysaccharidoses k. neuromuscular disorders l. Prader-Willi syndrome 2. Moderate or severe OSA (ie, apnea-hypopnea index greater than 5) 3. Residual apnea-hypo pnea index greater than 5 in pediatric patient after adenotonsillectomy G. Restrictive disorder of chest wall , as indicated by ALL of the following: 1. Appropriate chest wall disorder as indicated by ONE OR MORE of the following: Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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 a. asphyxiating thoracic dystrophy b. kyphoscoliosis c. other chest wall disorder accompanied by chronic respiratory failure (eg, ankylosing spondylitis, fibrothorax, post-tuberculous chest wall deformity) 2. Documentation of respiratory failure as indicated by ONE OR MORE of the following : a. Arterial O 2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry b. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) c. Forced vital capacity less than 50% of predicted d. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure e. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower f. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: 01. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . 02. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater ). III. Respiratory status is STABLE , as indicated by ALL of the following:A. Airway interface is safe with a n oninvasive interface with acceptable fit . B. Airway pressure requirement appropriate, as indicated by ONE OR MORE of the following: 1. BiPAP expiratory positive airway pressure requirement is to 10 cm H 2O (981 Pa). 2. CPAP pressure requirement in child is 15 cm H 2O (1471 Pa). 3. Ventilator positive end-expiratory pressure requirement is 10 cm H 2O (981 Pa). C. Oxygen requirement does not exceed FiO 2 of 40%. D. Settings are stable on chosen device. E. No continuous invasive monitoring is required. IV. A BiPAP or CPAP device must NOT be clinically appropriate as indicated by ONEOR MORE of the following. A. Chronic respiratory insufficiency fails to improve with simple BiPAP device. B. Infant or child does not meet the minimum body weight requirement for CPAP device. Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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 C. Infant or child is not appropriate for simple BiPAP device due to setting or performance requirements, as indicated by ONE OR MORE of the following:1. Breath rates delivered by device not appropriate for patient . 2. Compatible ventilator circuits not appropriate for patient (eg, circuit compliance, compressed volume, dead space) . 3. Inspiratory flows delivered by device not appropriate for patient . 4. Patient does not meet ventilator minimum body weight requirements. 5. Pressure range (eg, expiratory pressure, inspiratory pressure) not appropriate for patient . 6. Tidal volume range delivered by device not appropriate for patient. 7. Ventilator inspiratory trigger delay (ie, airway pressure rise time) not appropriate for patient . 8. Ventilator inspiratory trigger sensitivity not appropriate for patient . D. The following setting or functionality is required by the patient and is not available with simple BiPAP device: 1. Alarms required by patient are not available on the device . 2. Daytime ventilation using mouthpiece is required . 3. Pressure range delivered by device is not appropriate for patient . 4. Patient requires volume-assured pressure support or volume control mode (eg, obesity hypoventilation syndrome). E. Ventilated patient requires cough assistance via volume ventilator’s breath stacking capability. F. Ventilation is required 24 hours per day. V. HMV Continued UseFor HMV continued use beyond the initial 3-month determination, medical necessity must be reestablished every 6 months thereafter . The following is to be provided for continued use: A. Re-evaluation by the treating medical professional must be completed no earlier than 61 days after initiating therapy. B. Documentation of the persistence of the disease process for which HMV has been prescribed. C. Medical records must document that the patient is compliant with and benefitting from HMV. D. At least 30 consecutive days of device data, beginning after 31 days of initiation, demonstrating that the patient is utilizing the device an average of 6 hours per 24-hour period. NOTE: Failure of the patient to consistently use HMV for an average of 6 hours per 24-hour period would demonstrate non-compliant utilization of the device for its intended purpose and expectation of benefit, which would constitute a denial in continued coverage as not reasonable and necessary . E. Additional information as requested. VI. In accordance with GA DCH policy, DME 1112.10 , for each claim, the provider cannot legitimately receive payment until necessary supporting documents have Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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 been obtained and placed in the providers files. These documents include the following items: A. A detailed written order including the type of equipment ordered, the length of need, and the qualifying diagnosis from D. II. B. A copy of the patient s history and physical examination from the ordering physician. C. The patient was an inpatient for at least 14 consecutive days prior to home ventilation. D. The patient is dependent on a ventilator for life support for at least 6 hours per day. E. The home ventilator replaces the need for inpatient respiratory care services that would be reimbursed by Medicaid. F. The patient has adequate support services or caregiver which would allow sufficient use of the ventilator in the home. 1. A checklist documenting the patient s environment from the vendor. 2. A comprehensive list of all items required for the patient to use the home ventilator (ie, back-up unit, suction equipment, and supplies). 3. The patient receives services under the direction of a pulmonary physician who is familiar with the technical and medical components of home ventilator support and has determined that in-home care is safe and feasible for the patient . G. Practitioner order and chart notes , which support the determination of medical necessity , including ventilator settings . VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary. A certified respiratory technician (RT) is responsible for equipment set up, training/education on the proper usage of the equipment, and monthly visits to the home. VIII. ExclusionsA. Any application for HMV (E0466) not meeting the criteria above will be denied as being not medically necessary, including but not limited to when its sole purpose is to function as a respiratory assistance device, including CPAP, auto-titrating PAP, BiPAP /BPAP , average volume assured pressure support (AVAPS) with or without auto EPAP (A E), or intelligent volume assured pressure support (iVAPS). B. The HMV rental (E0466) includes all associated supplies that are required for appropriate use of the device and are not separately reimbursed. Servicing, repairs, and labor are included in the monthly rental fee and may not be submitted for separate reimbu rsement.E. Conditions of CoverageI. Claims for ventilators being utilized to provi de CPAP or BiPAP therapy for conditions described above and are submitted with HCPCS code E0466, will be denied as not being reasonable and necessary. If a HMV is dispensed to a patient for CPAP or Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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.8 BiPAP therapy, the claim must be coded in accordance with CareSource policy,Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental , and Georgia Department of Community Health policy, DME 1112.3 . All requirements in D. I. -V. of this policy must be satisfied for HMV to be considered medically necessary. II. CareSource may verify the use of equipment through post-payment review andrequest additional supporting medical record documentation. If the use of a more appropriate code or piece of equipment is warranted, CareSource may request recoupment.F. Related Policies/RulesGA DCH DME 1112.10 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental Overpayment Recovery G. Review/Revision HistoryDATE ACTIONDate Issued 09/11/2024 Approved at CommitteeDate Revised 05/21/2025 07/30/2025 Annual review-added E. II. Approved at Committee Revision D.VIII. Exclusions updated. Approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi: 10.1513/AnnalsATS.201810-657CME 2. Dudgeon D. Assessment and management of dyspnea in palliative care. UpToDate. Updated April 5, 2025 . Accessed May 5, 2025 . www.uptodate.com 3. Ferrell BR, Twaddle ML, Melnick A, et al. National Consensus Project clinical practice guidelines for quality palliative care guidelines, 4th edit. JPalliative Med . 2018;21(12): 1684-1689. doi:10.1089/jpm.2018.04311684 4. Freedman N. Treatment of obstructive sleep apnea: choosing the best positive airway pressure device. Sleep Med Clin . 2020;15(2):205-218. doi:10.1016/j.jsmc.2020.02.007 5. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated February 5, 2025 . Accessed May 5, 2025 . www.uptodate.com 6. Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive summary: optimal NIV Medicare access promotion: a technical expert panel report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest . 2021;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074 Noninvasive Home Mechanical Ventilation-GA MCD-MM-1700Effective 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.9 7. Hansen-Flaschen J, Ackrivo J. Practical guide to management of long-term noninvasive ventilation for adults with chronic neuromuscular disease. Resp Care . 2023;68(8):1123-1157. doi:10.4187/respcare.10349 8. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes of ventilatory support. UpToDate. Updated November 13 , 2024. Accessed April 16, 2025 . www.uptodate.com 9. Home Ventilator (Invasive or Noninvasive Interface): ACG A-0893. MCG Health . 2 8th ed. Accessed May 5, 202 5. www.careweb.careguidelines.com 10. Khan A, Frazer-Green L, Amin R, et al. Respiratory management of patients with neuromuscular weakness: an American College of Chest Physicians clinical practice guideline and expert panel report. Chest . 2023;164(2):394-413. doi:10.1016/j.chest.2023.03.011 11. Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Updated October 9, 202 4. Accessed May 5, 2025 . www.uptodate.com 12. Macrea M, Oczkowski S, Rochwerg B, et al. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease: an official American Thoracic Society clinical practice guideline. Am JResp Crit Care Med . 2020;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST 13. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated March 4, 2024. Accessed May 5, 2025 . www.uptodate.com 14. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 10.1177/0194599818801757 15. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasive ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev . 2021;8:CD002878. doi:10.1002/14651858.CD002878.pub3 16. Respiratory services: 1254 ventilators. Policies and Procedures for Durable Medical Equipment Services . Georgia Dept of Community Health; 202 5. Accessed May 5, 2025 . mmis.georgia.gov 17. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinical practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.01766 18. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest . 2020;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007 Independent Medical Review 05/08/24GA-MED-P-4284804 Issue date 09/11/2024 Approved DCH 08/19/2025

Myoelectric Lower Extremity Prosthetic Technology

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Myoelectric Lower Extremity Prosthetic Technology-GA MCD-MM-1222 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 ContentsA. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage …………………………………………………………………………………………. 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Myoelectric Lower Extremity Prosthetic Technology-GA MCD-MM-1222Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMyoelectric Lower Extremity Prosthetic Technology B. Background The policy addresses the computerized limb prosthesis that is a nonstandard, external prosthetic device incorporating a microprocessor for movement control. These devices are equipped with a sensor that detects when the knee is in full extension and adjusts the swing phase automatically, permitting a more natural walking pattern of varying speeds. C. Definitions Myoelectric Lower Extremity Prosthetic Technology Addition to lower extremity prosthesis, endoskeletal knee-shin system, microprocessor control feature, swing phase only, includes electronic sensor(s), any type. Classification Level Rehabilitation potential as described by Centers for Medicare & Medicaid Services: Level 0: Does not have the ability or potential to ambulate or transfer safely with or without assistance and a prosthesis does not enhance their quality of life or mobility a. The individual does not have sufficient cognitive ability to safely use a prosthesis with or without assistance. b. The individual requires assistance from equipment or caregiver in order to transfer and use of a prosthesis does not improve mobility or independence with transfers. c. The individual is wheelchair dependent for mobility and use of a prosthesis does not improve transfer abilities. d. The individual is bedridden and has no need or capacity to ambulate or transfer. Level 1: Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence, typical of the limited and unlimited household ambulator. a. The individual has sufficient cognitive ability to safely use a prosthesis with or without an assistive device and/or the assistance/supervision of one person. b. The individual is capable of safe but limited ambulation within the home with or without an assistive device and/or with or without the assistance/supervision of one person. c. The individual requires the use of a wheelchair for most activities outside of their residence. d. The individual is not capable of most of the functional activities designated in Level 2. Level 2: Has the ability or potential for ambulation with the ability to transverse low level environmental barriers such as curbs, stairs or uneven surfaces. This level is typical of the a. The individual can ambulate with or without an assistive device (which may include one or two handrails) and/or with or without the assistance/supervision of one person: i. Perform the level 1 tasks designated above ii. Ambulate on a flat, smooth surface iii. Negotiate a curb iv. Access public or private transportation v. Negotiate 1-2 stairs vi. Negotiate a ramp built to ADA specifications Myoelectric Lower Extremity Prosthetic Technology-GA MCD-MM-1222Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 limited community ambulator.b. The individual may require a wheelchair for distances that are beyond the perimeters of the yard/driveway, apartment building, etc. c. The individual is only able to increase his/her generally observed speed of walking for short distances or with great effort. d. The individual is generally not capable of accomplishing most of the tasks at Level 3 (or does so infrequently with great effort). Level 3: Has the ability or potential for ambulation with variable cadence, typical of the community ambulator who has the ability to transverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion. a. With or without an assistive device (which may include one or two hand rails), the individual is independently capable (i.e. requires no personal assistance or supervision) of performing the Level 2 tasks above and can i. Walk on terrain that varies in texture and level (eg, grass, gravel, uneven concrete) ii. Negotiate 3-7 consecutive stairs iii. Walk up/down ramps built to ADA specifications iv. Open and close doors v. Ambulate through a crowded area (eg, grocery store, big box store, restaurant) vi. Cross a controlled intersection within his/her community within the time limit provided (varies by location) vii. Access public or private transportation viii. Perform dual ambulation tasks (eg, carry an item or meaningfully converse while ambulating) b. The individual does not perform the activities of Level 4. Level 4: Has the ability or potential for prosthetic ambulation that exceeds the basic ambulation skills, exhibiting high impact, stress or energy levels typical of the prosthetic demands of the child, active adult, or athlete. With or without an assistive device (which may include one or two hand rails), this individual is independently capable (i.e. requires no personal assistance or supervision) of performing high impact domestic, vocational or recreational activities such as: a. Running b. Repetitive stair climbing c. Climbing of steep hills d. Being a caregiver for another individual e. Home maintenance (eg, repairs, cleaning) NOTE: Consideration is given to bilateral amputees who often cannot be strictlybound by the Classification Levels.Myoelectric Lower Extremity Prosthetic Technology-GA MCD-MM-1222Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 D. PolicyI. CareSource considers myoelectric lower limb prosthetic technology medically necessary when the following criteria are met: A. The member is 18 years of age or older. B. Has a lower extremity prosthesis(s). C. Documentation submitted supports medical necessity and includes the following: 1. A written order/prescription from a treating practitioner for the additional technology. 2. Sufficient documentation of the rehabilitation potential including, but not limited to, clear documentation supporting the expected potential classification level that is K3 or above. 3. Member exhibits the following characteristics: a. emotionally readiness b. ability and willingness to participate in training c. ability to care for the technology d. physically ability to use the equipment e. adequate cardiovascular and pulmonary reserve for ambulation at faster than normal walking speed NOTE: Documentation for Durable Medical Equipment, Prosthetics, Orthotics,and Supplies is followed. E. Conditions of CoverageN/A F. Related Policies/Rules Medical Record Documentation Standards for Practitioners G. Review/Revision History DATE ACTIONDate Issued 07/21/2022 New PolicyDate Revised 07/19/2023 08/28/2024 07/30/2025 Updated references. Approved at Committee Updated references. Approved at Committee Updated references. Approved at Committee Date Effective 11/01/2025 Date Archived H. References1. Centers for Medicare & Medicare Services Health Technology Assessment. Lower Limb Prosthetic Workgroup Consensus Document . September 2017. Accessed June 30, 2025. www.cms.gov 2. Durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items and services having special DME review considerations. Medicare Program Integrity Myoelectric Lower Extremity Prosthetic Technology-GA MCD-MM-1222Effective Date: 11/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 Manual . US Centers for Medicare and Medicaid Services; 2025. Accessed June 30,2025. www.cms.gov 3. Liu W, Fleming A, Lee IC, Huang HH. Direct myoelectric control modifies lower limb functional connectivity: a case study. Annu Int Conf IEEE Eng Med Biol Soc . 2021;2021:6573-6576. doi:10.1109/EMBC46164.2021.9630844 4. Lower limb prosethesis: A-0487 (AC). MCG Health. 28th ed. Accessed June 30, 2025. www.careweb.careguidelines.com 5. Schulte RV, Prinsen EC, Buurke JH, et al. Adaptive lower limb pattern recognition for multi-day control. Sensors (Basel) . 2022;22(17):6351. doi:10.3390/s22176351 Independent medical review May 2021 GA-MED-P-4284804 Issue Date 07/21/2022 Approved DCH 08/19/2025

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