Sacroiliac Joint Procedures

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Sacroiliac Joint Procedures-GA MCD-MM-0215 04/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Polices/Rules ………………………….. ………………………….. ………………………….. ……… 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectSacroiliac Joint Procedures B. BackgroundNearly 84% of adults experience back pain during their lifetime. Long-term outcomes are largely favorable for most patients, but a small percentage of patients symptoms are persistent. Persistent pain is categorized as subacute when lasting between four and twelve weeks , and chronic when persisting for at least three months. Up to 10% to 30 % of patients with persistent low back pain may have a component ofpain related to sacroiliac joints (SIJ) . Comprehensive pain management care plans are most effective in managing patients chronic pain. These plans focus on a person – centered approach and incorporate conservative treatment with other modalities. These multidisciplinary treatments include promoting patient self-management and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved completely. In addit ion to conservative therapy, additional treatment options may include nonpharmacologic or pharmacologic treatments, nonsurgical interventions, and surgical interventions. Interventional procedures for the management of pain unresponsive to conservative tre atment should be provided only by physicians qualified to deliver these health services. Sacroiliac joint injections using local anesthetic and/or corticosteroid medication have been shown to be effective for diagnostic purposes but provide limited short-term relief from pain resulting from SI Jdysfunction. Long-term use has not been adequately studied to establish standards of care. Radiofrequency ablation (RFA) is another treatment method, which uses heat to destroy nerves. RFA for the treatment of low back pain has inconsistent results in the peer-reviewed medical literature with limited fol low – up. However, clinical experience suggests that some patients obtain more significant relief from these procedures, making it reasonable to offer SIJ injections and/or RFA when conservative management has failed. C. Definitions Conservative Therapy A multimodal plan of care includ ing both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen supporting muscle groups and target key spinal structures, including physical therapy, occupational therapy, and/or physician supervised home exercise program (HEP) . HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete the HEP due to a stated physical reason (ie, increased pain, inability to physically perform exercises). Patient inconvenience or noncompliance without explanation does not constitute an inability to complete. Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices , TENS use , and/ or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphin s. Its use, frequency, duration, and sta rt dates must be documented in the medical record to be considered part of conservative therapy during the period of prior authorization request. Functional Disability Acquired difficulty in performing basic everyday tasks or more complex tasks needed for independent living. Radiofrequency Facet Ablation (RFA) Minimally invasive treatment modality that percutaneous ly introduc es an electrode under fluoroscopic guidance to thermocoagulate medial branches of the dorsal spinal nerves. Sacroiliac Joint (SIJ) Injections Corticosteroid and local anesthetic therapeutic injections into the SIJ to treat pain that hasnt responded to conservative therapies. D. PolicyI. Sacroiliac Joint Injections A. Diagnostic i njections: CareSource considers up to 2 diagnostic SIJ injection s for the treatment of chronic low back pain medically necessary when ALL the following criteria are met : 1. somatic or nonradicular low back and/or lower extremity pain experienced for at least 3 months 2. severe pain (ie. at least a 6 out of 10 on pain scale) and tenderness located in the SIJ region that cause functional disability 3. positive response to at least 3 SIJ pain provocation test (eg, distraction, compression, thigh thrust, Gaenslens, Patricks test/FABER test, sacral thrust) 4. failure of conservative therapy, as evidenced by ALL the following: a. document ation in the medical record of at least 6 weeks of active conservative therapy ( as defined above ) within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance b. documentation in the medical record of at least 6 weeks of inactive conservative therapy ( as defined above ) within the past 6 months 5. if a second diagnostic injection is requested , at least 1 week has passed since the initial injection B. Therapeutic injections: CareSource considers therapeutic SIJ injections medically necessary when ALL the following criteria are met: 1. most recent SIJ injection le d to at least a 75% pain relief and functional improvement 2. member experiences return of severe pain or deterioration in function Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 3. injection is used in conjunction with conservative therapy (as defined above)4. injection is repeated at a frequen cy of no greater than every 2 months 5. no more than 4 injections total (diagnostic and therapeutic) have been administered at the same site in the last 12 months C. Exclusions/Limitations 1. Codes 64451 and 27096 may not be billed together (on the same date for the same side of the body). Only one code will be reimbursed . 2. Image guidance and/or injection of contrast is included in sacroiliac injection procedures and may not be billed separately. 3. If neural blockade is applied for different regions or different sides, injections are performed at least one week apart . 4. Pain management literature highlighting controlled studies of SI Jpain management has not demonstrated injections of the SI Jto be effective as a long-term management modality. Long-term continuation may be subject to medical necessity review. 5. Monitored anesthesia and conscious sedation are not medically necessary. 6. The use of SI Jinjections for the treatment of pain as a result of Herpes Zoster is considered not medically necessary due to insufficient evidence demonstrating efficacy in the peer-reviewed published literature. II. Radiofrequency Ablation of the SI JA. Initial radiofrequency ablation of the SI J 1. Radiofrequency ablation is considered medically necessary when ALL the following have been met in the last 6 months: a. The clinical criteria above for failed conservative therapy (I.A.4.a. and I.A. 4.b.) has been met . b. One diagnostic injection per joint to evaluate pain and attain therapeutic effect has been performed with a reported 75% or greater reduction in pain after injection. B. Repeat radiofrequency ablation of the SI J 1. Conservative therapy and diagnostic injections are not required if there has been a reduction in pain for at least 12 months or more from the initial RFA within the last 36 months. 2. When there has not been a repeat RFA in the last 36 months, a diagnostic injection is required. 3. A maximum of 1 RFA for SI Jpain per side per 12 months is considered medically necessary. C. Exclusions/Limitations 1. The use of cooled RFA for SI J-mediated low back pain is considered not medically necessary due to insufficient evidence demonstrating efficacy in the peer-reviewed published literature. 2. Pain management literature highlighting controlled studies of SI Jpain management has not demonstrated the effectiveness of RFA as a long-term management modality. Long-term continuation may be subject to medical necessity review. Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 III. Spinal Cord Stimulators/Pain PumpsMembers with indwelling implanted spinal cord stimulators or pain pumps should have a device interrogation report submitted with medical records for a prior authorization request for proposed interventional pain injections. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. E. Conditions of CoverageNA F. Related Polices/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 02/22/2018 New PolicyDate Revised 08/01/2019 05/13/202004/28/202104/06/2022 03/01/202301/31/202401/29/202512/17 /2025Annual Update: Addition of PA clarification and documentation requirements. Revision of injection frequency. Annual Update: Added cli nical criteria for coverage of radiofrequency ablation of the SI Joint . Added coding information. Annual Update : Removed PA language. Annual Review: Updated references and background, re – organized criteria by procedure and initial vs repeat procedure Annual review: restructured conservative management and clinical criteria, added provocation tests . Approved at Committee Annual review: updated formatting and references, approved at Committee Review: updated references, approved at Committee Review: added pain level criteria, increased number of provocation test positives and updated references. Approved at Committee. Date Effective 04/01/2026 Date Archived H. References1. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic ther apies for low back pain: a systematic rev iew for an American College of Physicians clinical practice guideline . Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 2. Chou R, Cohen SP . Subacute and chronic low back pain: nonsurgical interventional Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 treatment. UpToDate. Updated April 29 , 202 5. Accessed November 24 , 202 5. www.uptodate.com 3. Cine HS, Uysal E, Demirkol M, et al . Under what conditions is the intra-articular steroid injection superior to nonsteroidal anti-inflammatory drugs for treating sacroiliac joint pain? Eur Rev Med Pharmacol Sci . 2023;27(21):10539-10546. doi:10.26355/eurrev_202311_34331 4. Jamjoom AM, Saeedi RJ, Jamjoom AB. Placebo effect of sham spine procedures in chronic low back pain: a systematic review. JPain Res . 2021;14:3057-3065. doi:10.2147/JPR.S317697 5. Janapala RN, Knezevic E, Knezevic NN, et al. Systematic review and meta-analysis of effectiveness of therapeutic sacroilic joint injections. Pain Phys ician . 2023;26:E413-E435. Accessed November 24 , 2025 . www.painphysicianjournal.com 6. Lee DW, Pritzlaff S, Jung MJ, et al. Latest evidence-based application for radiofrequ en cy neurotomy (LEARN): best practice guidelines from the American Society of Pain and Neuroscience (ASPN). JPain Res. 2021;14:2807-2831. doi:10.2147/JPR.S235665 7. Liu Y, Suvithayasiri S, Kim JS. Comparative efficacy of clinical interventions for sacroiliac joint pain: systematic review and network meta-analysis with preliminary design of treatment algorithm. Neurospine . 2023 Sep;20(3):997 – 1010. doi: 10.14245/ns.2346586.293. 8. Manchikanti L, Kaye AD, Soin A, et al. Comprehensive evidence-based guidelines for facet joint interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) guidelines facet joint inerventions 2020 guidelines. Pain Phys. 2020;23(3S):S1-S127. Accessed November 24 , 202 5. www.painphysicianjournal.com 9. Sacroiliac Joint Injection: A-1048 (AC). MCG. 29 th ed. Updated June 23, 2025. Accessed December 1, 2025. www.careweb.careguidelines.com 10. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3728-3832. doi:10.2147/JPR.S386879 11. Szadek K, Cohen SP, de Andres Ares J, et al. Sacroiliac joint pain. Pain Pract. 2023 ;00:1-20. doi:10.1111/papr.13338 12. Wu L, Tafti D, Varacallo M. Sacroiliac joint injection. StatPearls . StatPearls Publishing; 2023. Updated August 4, 2023. Accessed November 24 , 202 5. www.ncbi.nlm.nih.gov Independent Medical Review January 2025GA-MED-P-3677827 Issue Date 02/22/2018 Approved DCH 01/02/2026

Neonatal Discharge Criteria

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Neonatal Discharge Criteria-GA MCD-MM-1251 04/01/2026 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 Neonatal Discharge Criteria-GA MCD-MM-1251Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNeonatal Discharge Criteria B. BackgroundInfants who require neonatal admission remain at increased risk for morbidity and mortality following discharge. These infants require comprehensive discharge planning to ensure a smooth transition from the neonatal intensive care unit (NICU) and to reduce morbidity and mortality after discharge. Despite the inability to predict the exact timing of a NICU discharge, discharge planning should begin at NICU admission in an effort to avoid overwhelming parents and hospitalstaff. This planning will aid in minimizing discharge delays and will promote safe and healthy discharges to home.Discharge may be appropriate when the establishment of physiologic competencies, including , but not limited to, thermoregulation, feeding, respiratory control, and stabilityregardless of weight or corrected gestational age, have been achieved.C. Definitions Acceptable Bilirubin Level Defined per American Academy of Pediatrics (AAP) guidelines . Bilirubin Blood test to measure liver function. Car Seat Test Eligibility An infant tolerance test for sitting usually occurring 36.4 Caxillary while clothed in an open bed/ crib . D. PolicyI. CareSource considers neonatal discharge medically appropriate for non-technology dependent infants when ALL of the following clinical criteria are met: A. Thermoregu lation Stability 1. Infant demonstrates the ability to maintain normal body temperature while clothed in an open crib. Up to 48 hours of stable body temperature is typically adequate for infants born

Intraosseous Basivertebral Nerve Ablation

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303 04/01/2026 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 ………………………….. ………………………….. ………………………….. ……………………. 5 Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectIntraosseous Basivertebral Nerve Ablation B. BackgroundInterventional procedures for management of acute and chronic pain are part of a comprehensive pain management care plan that incorporates active conservative treatment in a multimodality approach. Multidisciplinary treatments include promoting patient self-management and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved completely. Interventional proced ures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services. Chronic low back pain (CLBP) is a common disabling condition, estimated to afflict 80%of adults at some point. Degenerative disc disease (DDD) is an important cause ofCLBP. While discs are avascular with limited nerve distribution, vertebral endplates have the potential to trigger a cascade of degenerative events if there is a loss of integrity. Vertebral endplates are a thin interface between bone marrow and discs and contain neural elements. Breakdown of the endplate is believed to cause v ertebrogenic c hronic low back pain , a type of chronic low back pain . Endplate degeneration can be observed on MRI through Modic changes (MC). Histologically, in MC type I (MC I) lesions, the endplate is disrupted as fibrous tissuereplaces bone marrow, causing the disc-bone interface to be filled with vascularized granulation tissue. MC I represents bone marrow edema and inflammation. In MC t ype II (MC II) lesions, there is demonstration of fatty marrow replacement in addition to MC type I findings. MC II represents conversion of hematopoietic marrow into fatty, yellow bone marrow. MC type III (MC III) lesions are related to subchondral bone scle rosis. Analysis of Modic lesion s shows that MC I is characterized by high bone turnover, MC II is characterized by decreased bone turnover, and MC III are stable. Radiofrequency ablation is a minimally invasive, percutaneous treatment which uses heat to ablate the nerve pathway that conducts the pain signal. The goal of RFA is to interrupt the pain pathway without causing excessive sensory loss, motor dysfunction, o r other complications. Intracept is an RFA system designed to ablate the basivertebral nerve of the vertebral endplate. C. Definitions Chronic Low Back Pain Persistent pain in the lumbar region lasting for more than 12 weeks. Conservative Therapy A mult imodality plan of care including both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, including physical therapy, occupational therapy, and/or physician supervised home exercise program (HEP). Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete the HEP due to a stated physical reason (ie, increased pain, inability to physical ly perform exercises). Patient inconvenience or noncompliance without explanation does not constitute an inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, TENS unit, and/or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminoph en]). Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorp hins. Its use, frequency, duration, and start dates must be documented in the medical record to be considered part of conservative therapy during the period of prior authorization request. Modic Changes Vertebral bone marrow signal intensity changes that are observable on MRI and are commonly associated with degenerative disc disease. o Modic Change Type I Characterized by hypo-and hyper-intense signal intensities on T1-and T2-weighted spin-echo (T1W1 and T2W1), respectively. o Modic Change Type II Characterized by hyper-intense signal intensities on both T1W1 and T2W1. o Modic Change Type III Characterized by hypo-intense signal intensities on both T1W1 and T2W1. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial or lateral branches of the dorsal spinal nerves. D. PolicyI. CareSource considers intraosseous basivertebral nerve ablation medically necessary when ALL the following clinical criteria is met: A. member has a diagnosis and documentation of chronic low back pain of at least 6 months duration B. failure of conservative therapy, as evidenced by ALL the following: 1. documentation in the medical record of at least 6 weeks of active conservative therapy (see definition above) within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance 2. documentation in the medical record of at least 6 weeks of inactive conservative therapy (see definition above) within the past 6 months C. MRI demonstrates Type I or Type II modic changes at one or more vertebra l endplates from level L3 to S1 , as demonstrated by 1. hypointense T1-weighted signal and hyperintense T2-weighted signal (ie, bone marrow edema and inflammation) , or Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 2. hyperintense T1-weighted signal and hyperintense T2-weighted signal (ie,bone marrow ischemia) D. device is FDA-approved (eg, Intracept System) E. member does not have any of the following contraindications: 1. severe cardiac or pulmonary compromise 2. member has a targeted ablation zone less than 10mm from a sensitive structure not intended to be ablated (including vertebral foramen) 3. active systemic infection or localized infection in the area to be treated 4. member is currently pregnant 5. skeletal immaturity 6. implantable pulse generator (eg, pacemaker, defibrillator) or other electronic implant 7. scoliosis 8. spinal instability II. Repeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary, as it has not been adequately studied in the peer-reviewed medical literature. III. Monitored anesthesia and conscious sedation during intraosseous basivertebral nerve ablation are considered not medically necessary and will therefore not be reimbursed.IV. Coverage is limited to the above criteria. Intraosseous basivertebral nerve ablation is considered not medically necessary for all other indications.E. Conditions of Coverage NA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/30/2022 New PolicyDate Revised 03/01/2023 01/31/202401/29/202512/17/2025 Annual review: restructured conservative therapy, added HEP and TENS definitions. Approved at Committee. Annual review: updated references, approved at Committee. Review: updated references, approved at Committee. Review: updated references. Approved at Committee. Date Effective 04/01/2026 Date Archived Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. References1. Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain . North American Spine Society ; 2020. Accessed December 2, 2025. www.spine.org 2. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Euro Spine J . 2018;27:1146-1156. doi:10.1007/s00586-018-5496-1 3. Fischgrund JS, Rhyne A, Franke J, et al. Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 2-year results from a prospective randomized double-blind sham-controlled multicenter study. Int JSpine Surg . 2019;13(2):110-119. doi :10.14444/6015 4. Fischgrund JS, Rhyne A, Macadaeg K, et al. Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham – controlled multi-cent er study. Eur Spine J. 2020;29:1925-1934. doi:10.1007/s00586 – 020-06448-x 5. Health Technology Assessment: Intracept Intraosseous Nerve Ablation System (Relievant Medsystems Inc.) for Treatment of Adults with Low Back Pain. Hayes ; 2025. Reviewed November 20, 2025. Accessed December 2, 2025. www.evidence.hayesinc.com 6. Khalil JG, Smuck M, Koreckij T, et al. A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J . 2019:1620-1632. doi:10.1016/j.spinee.2019.05.598 7. Lorio M, Clerk-Lamalice O, Beall DP, et al . ISASS guideline : intraosseous ablation of the basivertebral nerve for the relief of chronic low back pain. Int JSpine Surg . 2020;14(1):18-25. doi:10.14444/7002 8. Lorio M, Clerk-Lamalice O, Rivera M, et al. ISASS policy statement 2022: literature review of intraosseous basivertebral nerve ablation. Int JSpine Surg . 2022;16(6):1084-1094. doi:10.14444/8362 9. McCormick ZL, Curtis T, Cooper A, et al. Low back pain-related healthcare utilization following intrasosseous basivertebral nerve radiofrequency ablation: a pooled analysis from three prospective clinical trials. Pain Med . 2024;25:20-32. doi:10.1093/pm/pnad114 10. Nwosu M, Agyeman WY, Bisht A, et al. The effectiveness of intraosseous basivertebral nerve ablation in the treatment of nonradiating vertebrogenic pain: a systematic review. Cureus . 2023;15(4):e37114. doi:7759/cureus.37114 11. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3728-3832. doi:10.2147/JPR.S386879 12. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines on the diagnosis and treatment of vertebrogenic pain and basivertebral nerve ablation from the American Society of Pain and Neuroscience. JPain Res . 2022;15:2801-2819. doi:10.2147/JPR.S378544 Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 13. Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month result. Reg Anesth Pain Med. 2021;46:683-693. doi:10.1136/rapm-2020-102259 14. Smuck M, McCormick, ZL, Gilligan C, et al. A cost-effectiveness analysis of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2024;S1529-9430(24)01040-4. doi:10.1016/j.spinee.2024.09.016 15. U.S. Food and Drug Administration. 510(k) Premarket Notification: Intracept Intraosseous Nerve Ablation System , 510( k) approval K 222281; 2022. Accessed December 2, 2025. www.accessdata.fda.gov 16. U.S. Food and Drug Administration. 510(k) Premarket Notification: Relievant Medsystems RF Generator , 510( k) number: K171143; 201 7. Accessed December 2, 2025. www.accessdata.fda.gov 17. Viswanathan VK, Shetty AP, Rajasekaran S. Modic changes : an evidence-based, narrative review on its pathophysiology, clinical significance and role in chronic low back pain. JClin Orthop Trauma . 2020;11(5):761-769. doi:10.1016/j.jcot.2020.06.025 Independent med ical review 2022 GA-MED-P-4932752 Issue Date 03/30/2022 Approved DCH 01/02/2026

Epidural Steroid Injections

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Epidural Steroid Injections-GA MCD-MM-0217 04/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………… 2 B. Background ………………………….. ………………………….. ………………………….. …….. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………. 2 D. Policy ………………………….. ………………………….. ………………………….. …………….. 3 E. Conditions of Coverage ………………………….. ………………………….. …………………. 5 F. Related Policies/Rules ………………………….. ………………………….. ………………….. 5 G. Review/Revision History ………………………….. ………………………….. ……………….. 5 H. References ………………………….. ………………………….. ………………………….. ……… 6 Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectEpidural Steroid Injections B. BackgroundNearly 84% of adults experience back pain during their lifetime. Long term outcomes are largely favorable for most patients, but a small percentage of patients symptoms are persistent. Persistent pain is categorized as subacute when lasting between 4 and 12 weeks and chronic when persisting for at least 3 months. Comprehensive pain management care plan s are most effective in managing a patientschronic pain. These plans focus on a person-centered approach and incorporate conservative treatment with other modalities . These m ultidisciplinary treatments include promoting patient self-management and aim to reduce the impact of pain on a patient’s daily life, even if the pain cannot be relieved completely. In addition to conservative therapy, additional treatment options may include nonpharmacologic or pharmacologic treatments, nonsurgical interventions, and surgical interventions. Interventional procedures for the management o f pain unresponsive to conservative treatment should be provided only by physicians qualified to deliver these health services . Epidural steroid injections (ESIs) are a nonsurgical, minimally-invasive intervention for chronic back pain. ESIs may be administered through the translaminar approach (via the interlaminar space in the spine), the transforaminal approach (through the neuroforamen dorsal to the nerve root), or the caudal approach (through the sacral hiatus at the sacra l canal ). There is conflicting evidence on the efficacy of ESIs and a lack of consensus on frequency and number of epidural steroid injections from professional organizations. However, clinical experience suggests that some patients obtain more significant relief, making it reasonable to offer a trial of steroid injections when conservative management has failed. Imaging studies of the symptomatic region may be performed to evaluate suspectedspecific causes of spinal pain ( eg, herniated disc, spinal stenosis, degenerative vertebral disease , rul e out fracture or tumor). However, e vidence does not support the routine use of imaging or other diagnostic tests in patients with nonspecific back pain. Diagnostic imaging and testing are only recommended when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination. C. Definitions Conservative Therapy A multimodal plan of care includ ing both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, including physical therapy, occupational therapy , and/ or a physician supervised home exercise program (HEP) . Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete the HEP due to a stated physical reason (ie, increased pain, inability to physi cally perform exercises). Patient inconvenience or noncompliance without explanation does not constitue an inability to complete. o Inactive Conservative Therapies Passive activites by the patient that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, TENS u se, and /or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphi ns. Its use, frequency, duration, and start dates must be documented in the medical record to be considered part of conservative therapy during the period of prior authorization request. Epidural Steroid I njections Administration of steroids via a needle inserted in the space between the ligamentum flavum and the dura and admistered by translaminar, tranforaminal , or caudal approach es . Injections are intended to cause a short-term reduction in pain in the affected region. D. PolicyI. Epidural steroid injections for labor and delivery in childbirth or post-surgical pain do not require medical necessity review . II. Initial (Diagnostic) InjectionA. CareSource considers an initial (diagnostic) epidural steroid injection (maximum of 2 injections) medically necessary for the management of chronic back pain when ALL the following clinical criteria are met : 1. Pain is located in either the cervical, thoracic, or lumbar spine and is predominantly radiating or shooting in nature . 2. Pain is causing functional disability (at least a 6 on a scale of 0 to 10). 3. Signs or symptoms are consistent with radiculopathy, as indicated by at least 1 of the following: a. diminished or absent deep tendon reflexes b. parasthesias, numbness, sensory change, or weakness in dermatomal distribution c. positive femoral nerve stretch test d. positive Spurling test e. positive straight leg raising test 4. Conservative therapy has failed to alleviate symptoms, as evidenced by ALL the following: a. documentation in the medical record of at least 6 weeks of active conservative therapy (see definition above) within the past 6 months OR Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 inability to complete active conservative therapy due to contraindication, increased pain, or intolerance b. documentation in the medical record of at least 6 weeks of inactive conservative therapy (see definition above) within the past 6 months 5. Imaging (eg, x-ray, CT, MRI), if performed, demonstrates that there are no conditions present that would preclude the safety of the performance of the procedure. III. Subsequent (Therapeutic) InjectionsCareSource considered therapeutic epidural steroid injections medically necessary when ALL the following criteria are met: A. The diagnostic or last therapeutic injection for current episode of pain provided significant functional pain relief of at least 50% as measured by a significant decrease in pain level, decrease in pain medications, and/or increase in physical function. B. The member continues to have ongoing pain or documented functional disability (at least a 6 on a scale of 0 to 10) . C. At least 3 weeks have passed since the prior injection in order to reach pharmacodynamic effect . D. No more than 3 procedures in a 12-week period of time per region are considered medically necessary . E. The member continues to engage in conservative therapy (see definition above) . IV. Limitations and ExclusionsA. The maximum number of all epidural injections a member can receive in 12 months is 6, regardless of the number of levels involved. B. For interlaminar or caudal epidural injections , no more than 1 epidural injection per treatment date should be performed . C. For transforaminal epidurals or selective nerve root blocks (SNRBs) , no more than 2 vertebral levels per treatment date, whether unilateral or bilateral, should be performed. D. Real-time image guidance and any injection of contrast are inclusive components of epidural injections and are not compensat ed for separately or unbundled for coverage. E. Conscious sedation, if required for co-morbidities or patient/physician preference, may be provided without a medical necessity review but services will be considered part of the procedure and are not eligible for additional reimbursement if administered by a second provider. F. Monitored anesthesia is not considered medically necessary . G. Patients with indwelling implanted spinal cord stimulators or pain pumps must have a device interrogation report and an interpretation submitted with medical records, and included in the prior authorization request for propo sed interventional pain injections. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. Clinical evaluations and care of candidate patients for epidural injections should also address, at t he discretion of the physician and according to prevailing standards of medical care: 1. no acute spinal cord compression 2. selected body imaging evaluation s to evaluate the area of pain, particularly for acute pain, or to evaluate escal ations in chronic baseline pain 3. appropriate imaging to rule out red flag conditions may be indicated if potential issues of trauma, osteomyelitis or malignancy , or other diagnoses are a concern I. Contraindications include any of the following: 1. pain related to cancer etiology 2. local or systemic infection 3. cauda equina syndrome 4. spinal trauma (eg, hematoma, hemorrhage, mass, ischemia) 5. coagulopathy V. Inconclusive or Non-Supportive EvidenceA. Evidence reported in the medical literature is inconclusive as to the use of epidural injections for long term relief or treatment of chronic pain. Long-term continuation (epidural injections beyond 1 year) may be subject to medical necessity review. B. For both cervical and lumbar transforaminal (TF) ESIs, using particulate steroid is associated with a rare risk of catastrophic neurovascular complications such as stroke or death. Cervical transforaminal injections are risky because arterial supply may be densely concentrated in and around the intervert ebral foramen. TF ESIs can be performed without contrast in patients with documented contraindication to its use. In these circumstances , particulate steroids are contraindicated and only the preservative fr ee, particulate fre e steroids which are available should be used. C. Cervical transforaminal ESIs have sparse literature for cervical radicular pain, and , if performed , should be performed by injecting contrast medium under real – time fluoroscopy and/or digital subtraction angiography (DSA) in a frontal plane, before injecting any substance potentially hazardous to the patient. Particulate steroids should not be used for cervical TF injections as per the contraindication established by the FDA warning. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision History DATES ACTION Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Date Issued 02/22/2018 New PolicyDate Revised 03/06/2019 05/13/202004/28/202103/16/202211/03/202203/15 /2023 01/31/202401/15 /202412/03 /2025Annual Update: Removed chiropractic care as a conservative therapy option.Annual Update: No policy criteria revisions. Only formatting and restructuring of policy information. Annual Update: Removed PA language. Reorganization of clinical criteria, but no content changes. Annual Review: updated formatting and references, consolidated background and evidence, separated indications into initial and subsequent injections, frequency restrictions, and limitations/exclusions . Added contraindications Removed anti-platelet therapy as contraindication Annual review: reorganized criteria, simplified conservative therapy, added provocation tests, added pain scale to diagnostic injection criteria . Approved at Committee. Annual review: updated references and formatting, approved at Committee. Review: removed US limitation, updated references, approved at Committee. Review: Updated references. Approved at Committee. Date Effective 04/01/2026 Date Archived H. References1. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated April 29, 202 5. Accessed November 18, 202 5. www.uptodate.com 2. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 3. Chou R, Hashimoto R, Friedly J, et al. Epidural corticosteroid injections for radiculopathy and spinal stenosis: a systematic review and meta-analysis. Ann Intern Med . 2015;163(5):373-381. doi:10.7326/M15-0934 4. Conger A, Cushman DM, Speckman RA, et al. The effectiveness of fluroscopically guided cervical transforaminal epidural steroid injection for the treatment of radicular pain; a systematic review and meta-analysis. Pain Med. 2020;21(1):41-54. doi:410.1093/pm/pnz127 5. Dydyk AM, Hu Y, Stretanski MF, et al. Cervical Epidural Injection. In: StatPearls [Internet]. Updated June 2, 2025. Accessed November 18, 2025. www.ncbi.nlm.nih.gov 6. Fromm MK, Liu SH, Carr C, et al. Factors associated with improved outcomes after lumbar transforaminal epidural steroid injections for radicular pain: a systematic review. NASSJ . 2025; 21:100592 . doi :10.1016/j.xnsj.2025.100592 Epidural Steroid Injections-GA MCD-MM-0217Effective Dat e: 04/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 7. Goel A, Singh S, Shukla NK, et al. Efficacy of caudal epidural steroid injections in chronic low backache patients. JPharm Bioallied Sci. 2023;15(Supple 1):S669-S672. doi:10.4103/jpbs.jpbs_89_23 8. Helm S, Harmon PC, Noe C, et al. Transforaminal epidural steroid injections: a systematic review and meta-analysis of efficacy and safety. Pain Phys ician . 2021;24:S209-S232. Accessed November 18 , 202 5. www.painphysicianjournal.com 9. Manchikanti L, Benyamin RM, Falco FJ, et al. Do epidural injections provide short – and long-term relief for lumbar disc herniation? A systematic review. Clin Orthop Relat Res. 2015;473(6):1940-1956. doi:10.1007/s11999-014-3490-4 10. Manchikanti L, Knezevic NN, Boswell MV, et al. Epidural injections for lumbar radiculopathy and spinal stenosis: a comparative systematic review and meta – analysis. Pain Physician. 2016;19(3):E365-410. Accessed December 18 , 2024. www.painphysicianjournal.com 11. Manchikanti L, Knezevic NN, Navani A, et al. Epidural interventions in the management of chronic spinal pain: American Society of Interventional Pain Physicians (ASIPP) comprehensive evidence-based guidelines. Pain Physician. 2021;24(S1): S27-S208. Accessed December 18 , 2024. www.painphysicianjournal.com 12. Oliveira CB, Maher CG, Ferreira ML, et al. Epidural corticosteroid injections for lumbosacral radicular pain. Cochrane Database Syst Rev. 2020;4(4):CD013577. doi: 10.1002/14651858.CD013577 13. Qassem A, Wilt TJ, McLean RM, et al . Noninvasive treatments for acute, subacute and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med . 2017 ;166(7):514-530 . doi:10.7326/M16-2367 14. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evidence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3729-3832. doi:10.2147/JPR.S386879 15. Taskaynatan MA, Tezel K, Yavuz F, et al. The effectiveness of transforaminal epidural steroid injection in patients with radicular low back pain due to lumbar disc herniation two years after treatment. JBack Musculoskelet Rehabil. 2015;28(3):447 – 451. doi:10.3233/BMR-140539 16. Verheijen EJA, Bonke CA, Amorij EMJ, et al . Epidural steroid compared to placebo injection for sciatica: a systematic review and meta-analysis. Euro Spine J . 2021;30:3255-3264. doi:10.1007/s00586-021-06854-9 17. Woo JH, Park HS. Cervical transforaminal epidural block using low-dose local anesthetic: a prospective, randomized, double-blind study. Pain Med. 2015;16(1):61 – 67. doi:10.1111/pme.12582 18. Yang S, Kim W, Kong HH, et al. Epidural steroid injection versus conservative treatment for patients with lumbosacral radicular pain: a meta-analysis of randomized controlled trials. Med. 2020;99(30):e21283. doi:10/1097/MD. 0000000000021283 GA-MED-P-4932752 Issue Date 02/22/2018 Approved DCH 01/02/2026

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

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