Special Needs Car Seats

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Special Needs Car Seats-GA MCD-MM-1443 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 08/01/2025The 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 certain 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 supporti ng 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 shows that rear-facing car seats offer greater protection for the head and neck thana 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 possible 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.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. Federal Motor Vehicle Safety Standard 213 (FMVSS No. 213 ) Requires child restraint systems (CRSs) to be equipped with attachments that enable the CRS to Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 attach to the vehicle’s restraint anchorage system. The agency added a height provision to make the new standard’s applicability clear to booster seat manufacturers who choose not to label their restraints with a weight. National Highway Traffic Safety Administration (NHTSA) A division of the U.S. Department of Transportation dedicated to achieving the highest standards of excellence in motor vehicle and highway safety. Neck Loading The dynamic loading of the neck that occurs when the torso is suddenly stopped by the seat belt while the head continues pulling from the neck. Travel Vest Optimizes the existing vehicle seat belt system to protect the 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, includ ing any of the following (not an all-inclusive list): a. hypotonia b. craniofacial abnormalities c. primary airway problems d. cerebral palsy 2. The member has a physical condition (eg, seizure or hypertonicity/spasms) that prevents the independent maintenance of a seated position or requires support to allow a functional position or prevent further disability. 3. The member has gastrointestinal issues, including but not limited to: a. emesis b. gastroesophageal reflux (GERD) c. gastrostomy feeding tube 4. The member uses a spica cast. II. 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 Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 transportation of persons with special needs provide guidance for appropriate equipment selection and use .III. 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 CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at committee.Date Revised 02/28/2024 02/12/2025Annual 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. Date Effective 08/01/2025 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 January 28, 2025 . www.nhtsa.gov 4. Car seat safety. National Child Passenger Safety Board. Accessed January 28, 2025 . www.cpsboard.org 5. Huang PP, Durbin DR. Promoting safety in children with disabilities. UpToDate. Updated January 4, 2024. Accessed January 28, 2025 . www.uptodate.com 6. Inthachom R, Prasertsukdee S, Ryan SE, et al. Evaluation of the multidimensional effects of adaptive seating interventions for young children with non-ambulatory Special Needs Car Seats-GA MCD-MM-1443Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 cerebral palsy. Disabil Rehabil Assist Technol . 2021;16(7):780-788. doi:10.1080/17483107.2020.1731613 7. Legare JM, Adam MP, Feldman J, et al. Achondroplasia . GeneReviews; 2023. Revised May 11, 2023. Accessed January 28, 2025 . www.ncbi.nlm.nih.gov 8. 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 9. 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 10. 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 11. Smith VC, Stewart J. Discharge planning for high-risk newborns. UpToDate. Updated April 10, 2023. Accessed January 28, 2025 . www.uptodate.com 12. 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-3677827 Issue Date 03/01/2023 Approved DCH 04/ 29/2025

Saphenous Vein Ablation, Adhesive Injection

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Saphenous Vein Ablation, Adhesive Injection-GA MCD-MM-1393 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical 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 determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4Saphenous Vein Ablation, Adhesive Injection-GA MCD-MM-1393 Effective Date: 08/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Saphenous Vein Ablation, Adhesive Injection B. Background Varicose veins (varicosities) are dilated, thickened, elongated, and twisted blood vessels that may appear threadlike or as large grape-like clusters under the skin, most often on the legs. Varicose veins are considered a sign of chronic venous insufficiency, a condition characterized by dysfunction of the valves in veins leading to increased blood pressure, blood pooling, and venous reflux in affected areas. Varicose veins may be asymptomatic, or the associated venous insufficiency may cause symptoms such as heaviness, aching, numbness, swelling, and ulceration of the affected limb. In addition, risk is increased for thrombophlebitis, deep vein thrombosis (DVT), and pulmonary embolism. Approximately 25 million adults in the United States are affected by varicose veins. This condition can have a significant impact on patients quality of life (QoL) and increase the health care burden, with an estimated $1 billion incurred annually for treatment in the United States. Conservative therapy includes weight reduction, exercise and prescribed physical activity (walking, treadmill, cycling), periodic leg elevation and compressive therapy with use of surgical grade compression stockings. Non-surgi cal treatment for this condition includes radiofrequency ablation (RFA) and endovenous laser ablation (EVLA). A third, more recent treatment method is Cyanoacrylate adhesive closure (CAC) , a catheter-directed procedure that seals the saphenous vein without the use of tumescent anesthesia. It involves the endovenous delivery of cyanoacrylate adhesive to the vein, inducing a foreign body response resulting in fibrosis and closure. Closure rates for CAC are high without use of post procedure compression, which is unique to this nonthermal method of ablation. C. Definitions Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification The CEAP classification for chronic venous disorders serves as a basis to categorize the clinical presentation of the patient, the underlying etiology, what anatomic veins are affected, and the underlying pathology in those veins. The 7 clinical categories are: o C0 No visible or palpable signs of venous disease o C1 Telangiectasies or reticular veins o C2 Varicose veins; distinguished from reticular veins by a diameter of 3mm or more o C3 Edema o C4 Changes in skin and subcutaneous tissue secondary to CVD C4a Pigmentation or eczema C4b Lipodermatosclerosis or atrophie blanche o C5 Healed venous ulcer Saphenous Vein Ablation, Adhesive Injection-GA MCD-MM-1393 Effective Date: 08/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3o C6 Active venous ulcer Cyanoacrylate adhesive closure (CAC) A nonthermal ablation technique uses a glue delivered into the saphenous vein using a catheter for access that induces a foreign body reaction leading to inflammation and fibrotic occlusion of the vessel. Saphenous veins Either of two main superficial veins of the leg, one larger than the other. These are : o Great saphenous vein (GSV) originating in the foot and passing up the medial side of the leg and through the saphenous opening to join the femoral vein, and the o Small saphenous vein (SSV) originating similarly and passing up the back of the leg to join the popliteal vein at the knee. D. Policy I. CareSource considers Saphenous Vein Ablation with cyanoacrylate adhesive medically necessary when ALL of the following are met: A. Failure of 3 months of conservative treatment, which may include: 1. weight reduction 2. exercise plan and prescribed physical activity (walking, treadmill, cycling) 3. periodic leg elevation 4. compression therapy B. If contraindicated (suspected or proven peripheral arterial disease, venous leg ulceration, superficial thrombophlebitis or severe peripheral neuropathy, etc.) conservative treatment may be waived. C. Documentation in the medical record of CEAP class C2-C6 disease. D. Reflux (> 500 msec), and/or vein diameter 3 mm , and ANY of the following: 1. ulceration secondary to venous stasis 2. significant pain or significant edema associated with saphenous reflux that interferes with activities of daily living (ADLs) 3. hemorrhage or recurrent bleeding associated with ruptured superficial varicosity 4. recurrent episodes of superficial phlebitis 5. refractory dependent edema II. Non-covered /Contraindications A. CEAP clinical classification C0-C1 is cosmetic and not medically necessary . B. Previous administration of sclerotherapy agent

Sacroiliac Joint Procedures

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Sacroiliac Joint Procedures-GA MCD-MM-0215 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assess ment 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 diagnosi s 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, dysfunctio n of a body organ or part, or significant pain and discomfort. These services me et 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 Co verage 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 refe r 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 disord er 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: 08/01/2025The 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 25% 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 treatme nt 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 addition 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 treatment should be provided onl y 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 resulti ng 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 res ults in the peer-reviewed medical literature with limited follow – 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 ma nagement 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 spin al 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 t o complete. Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 08/01/2025The 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-ster oidal 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 inh ibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. 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. Radiofrequency Facet Ablation (RFA) Minimally invasive treatment modalitiy 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 con servative therapies. D. PolicyI. Sacroiliac Joint Injections A. Diagnostic i njections: CareSource considers up to 2 diagnostic sacroiliac joint 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. pain and tenderness located in the sacroiliac joint region 3. positive response to at least one 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 p ast 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 sacroiliac joint 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 pain or deterior ation in function 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 Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 5. no more than 4 injections total (diagnostic and therapeutic) have been administered at the same site in the last 12 monthsC. 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 i ncluded 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 stud ies 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 neces sary. 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 Radiofrequency ablation is considered medically necessary when ALL the following have been met in the last 6 months: 1. The clinical criteria above for failed conservative therapy (I.A.4.a. and I.A. 4.b.) has been met . 2. 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 diagno stic 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 radiofrequency ablation 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 demo nstrating 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: 08/01/2025The 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 stimula tors 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 03/01/202301/31/202401/29/2025Annual 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 Date Effective 08/01/2025 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. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate. Updated May 15, 2024 . Accessed January 5, 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 Sacroiliac Joint Procedures-GA MCD-MM-0215Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 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 January 5, 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. Maas ET, Ostelo RWJG, Niemisto L, et al . Radiofrequency denervation for chronic low back pain. Cochrane Database Syst Rev . 2015;2015(10):CD008572. doi:10.1002/14651858.CD008572.pub2 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 January 5, 202 5. www.painphysicianjournal.com 9. 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 10. Szadek K, Cohen SP, de Andres Ares J, et al. Sacroiliac joint pain. Pain Pract. 2023 ;00:1-20. doi:10.1111/papr.13338 11. Wu L, Tafti D, Varacallo M. Sacroiliac joint injection. StatPearls . StatPearls Publishing; 2023. Updated August 4, 2023. Accessed January 5, 202 5. www.ncbi.nlm.nih.gov Independent Medical Review January 2025GA-MED-P-3677827 Issue Date 02/22/2018 Approved DCH 04/29/2 025

Neonatal Discharge Criteria

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Neonatal Discharge Criteria-GA MCD-MM-1251 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Neonatal Discharge Criteria-GA MCD-MM-1251Effective Dat e: 08/01/2025The 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 08/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence o f 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 cont rolling 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 fav orable 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. Re view/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 08/01/2025The 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 procedures 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 cond ition, 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 e vents 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 chronic 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 granulat ion 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 sclerosis. 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: 08/01/2025The 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 an d/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 non compliance 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, acetaminophen]). Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered through electrodes placed on the surfa ce 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 endorphins. 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 Chan ge 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 ablati on 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 th e 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 re cord 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: 08/01/2025The 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 ar e 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. Re lated Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/30/2022 New PolicyDate Revised 03/01/2023 01/31/202401/29 /2025Annual 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. Date Effective 08/01/2025 Date Archived Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. References1. Becker S, Hadjipavlou A, Heggeness MH. Ablation of the basivertebral nerve for treatment of back pain: a clinical study. Spine J . 2017;17(2):218-223. doi :10.1016/j.spinee.2016.08.032 2. Evidence-Based Clinical Guidelines for Multidisciplinary Spine Care: Diagnosis and Treatment of Low Back Pain . North American Spine Society ; 2020. Accessed January 2, 2025 . www.spine.org 3. Evolving Evidence Review: Intracept Intraosseous Nerve Ablation System (Relievant Medsystems Inc.) for Treatment of Adults with Low Back Pain. Hayes ; 2023. Reviewed April 17, 2024. Accessed January 2, 202 5. www.evidence.hayesinc.com 4. 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 JSpi ne Surg . 2019;13(2):110-119. doi :10.14444/6015 5. 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 6. Lori o 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 7. McCormick ZL, Curtis T, Cooper A, et al. Low back pain-related he althcare 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 8. Nwosu M, Agyeman WY, Bisht A, et al. The effectiveness of in traosseous basivertebral nerve ablation in the treatment of nonradiating vertebrogenic pain: a systematic review. Cureus . 2023;15(4):e37114. doi:7759/cureus.37114 9. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) evid ence-based clinical guidelines of interventional treatments for low back pain. JPain Res . 2022;15:3728-3832. doi:10.2147/JPR.S386879 10. Sayed D, Naidu RK, Patel KV, et al. Best practice guidelines o n 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 11. Smuck M, Khalil J, Barrette K, et al. Prospective, randomized, m ulticenter 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 12. 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;S 1529-9430(24)01040-4. doi:10.1016/j.spinee.2024.09.016 13. U.S. Food and Drug Administration. 510(k) Premarket Notification: Int racept Intraosseous Nerve Ablation System , 510( k) approval K 222281; 2022. Accessed January 2, 2025 . www.accessdata.fda.gov Intraosseous Basivertebral Nerve Ablation-GA MCD-MM-1303Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 14. U.S. Food and Drug Administration. 510(k) Premarket Notification: RelievantMedsystems RF Generator , 510( k) number: K171143; 20 17. Accessed January 2, 202 5. www.accessdata.fda.gov 15. 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 . 202 0;11(5):761-769. doi:10.1016/j.jcot.2020.06.025 Independent med ical review 2022 GA-MED-P-3677827 Issue Date 03/30/2022 Approved DCH 0 4/29/2025

Applied Behavior Analysis for Autism Spectrum Disorder

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 05/10/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standar ds, 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 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 ………………………….. ………………………….. ………………………….. …………. 4 D. Policy ………………………….. ………………………….. ………………………….. ……………….. 4 E. Conditions of Coverage ………………………….. ………………………….. …………………. 14 F. Related Policies/Rules ………………………….. ………………………….. …………………… 16 G. Review/Revision History ………………………….. ………………………….. ………………… 16 H. References ………………………….. ………………………….. ………………………….. ……… 16 Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectApplied Behavior Analysis for Autism Spectrum Disorder B. BackgroundThe Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition, Text Revised (DSM-5-TR) classifies Autism Spectrum Disorder (ASD) as a neurodevelopmental disorder vary ing widely in severity and symptoms, depending on the developmental level and chronological age of the individual . ASD is characterized by specific developmental deficits that affect socialization, communication, academic , and personal functioning. Individuals are typically diagnosed before entering grade school, and symptoms are noticed across multiple contexts, including social reciprocity, nonverbal communicative behaviors, and skills in developing, maintaining , and understanding relationships. Restricted, repetitive patterns of behavior, interests , or activities are also often present. Currently, there is no cure for ASD, nor is there any single treatment for the disorder.The diagnosis may be managed through a combination of therapies, including behavioral, cognitive, pharmacological, and educational interventions with a goal of minimiz ing the severity of ASD symptoms, maximiz ing learning, facilitat ing social integration, and improv ing quality of life for members and families/caregivers. Applied behavior analysis (ABA) , one such therapy, may be provided in centers or at home and provides an evidence-based practice for the treatment of ASD . ABA is based on the science of behavior, which was founded on the premise that understanding behavior functioning, how it is affected by the environment, and how learning to change behavior can improve the human condition. It is a flexible treatment in tha t it should always be adapted to the needs of the individual, teaches skills that areuseful and generalizable, and involves individual, group and family training. Qualified and trained practitioners provide and/or oversee ABA programs and are accountable to state boards for registration, certification, or licensure requirements. Clinical decisions on telehealth service delivery models should be selected based on the individual needs, strengths, preference of service modality, caregiver availability and environmental support available. CareSource follows the Georgia Department of Community Health (DCH) Division of Medicaid and applicable state and federal laws in the provision of ABA services, which are based on a diagnosis from the DSM-5-TR. Severity levels are divided into 2 domainsand are defined as follows:Severity Levels for Autism Spectrum DisorderSeverity Level Social Communication Restricted, Repetitive Behaviors Level 3 Requiring very Severe deficits in verbal & nonverbal social communication skills cause severe impairments in functioning, very limited initiation of social interactions, Inflexibility of behavior, extreme difficulty coping with change, or other restricted/ repetitive behaviors markedly interfere with Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 substantial support and minimal response to social overtures from others. functioning in all spheres. Great distress/difficulty changing focus or action. Level 2 Requiring substantial support Marked deficits in verbal and nonverbal social communication skills, social impairments apparent even with supports in place, limited initiation of social interactions, and reduced or abnormal responses to social overtures from others. Inflexibility of behavior, difficulty coping with change, or other restricted/ repetitive behaviors appear frequently enough to be obvious to the casual observer and interfere with functioning in a variety of contexts. Distress and/or difficulty changing f ocus or action. Level 1 Requiring support Without supports in place, deficits in social communication cause noticeable impairments. Difficulty initiating social interactions and clear examples of atypical or unsuccessful responses to social overtures of others. May appear to have decreased interest in social interactions. Inflexibility of behavior causes significant interference with functioning in one or more contexts. Difficulty switching between activities. Problems of organization and planning hamper independence. Social skills instruction is an important component of management of the diagnosis.Although additional studies are necessary, a 2012 meta-analysis of five randomized trials (196 participants) found evidence that participation in social skills groups improved overall social competence and friendship quality in the short term . A 2020 study demonstrated efficacy of a modified group cognitive behavioral therapy program in children delivered in a community context . A 2021 study demonstrated benefits of group cognitive behavioral treatment in adolescents diagnosed with autism and intellectual disabilities. As children near entry in a public or private school system, research supports the use of group therapy for school readiness and improved social skills. Training must be an integral component of the management of the underlying disorder and include clearly defined goals, teach desired behaviors, provide prompting for natural display of desired behaviors, provide reinforcement of demonstrated behaviors, an d include practice of desired behaviors with goals of generalizability outside the therapeu tic setting (eg, impairments in social-emotional reciprocity, restrictive or obsessional interests, aggressive behaviors). As the child becomes eligible for school-based services (the age varies depending uponthe state), the public school system becomes responsible for the provision of services and education. The services provided are outlined in an individualized education program (IEP), which is reviewed at a minimum of once a year , for children eligible . DCH reiterates that ASD services d o not include education services otherwise available through a program funded under 20 US Code Chapter 3, section 1400 of the Individuals with Disabilities Education Act (IDEA). Congress reauthorized the IDEA in 2004 and most recently amended the IDEA through Public Law 114-95, Every Student Succeeds Act, in December 2015. Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 C. Definitions Applied Behavior Analysis The design, implementation, and evaluation or systematic instructional and environmental modifications by a behavior analyst to produce socially significant improvements in behavior. Behavioral Assessmen t Separate from the initial diagnostic evaluation , the administration of an industry-standard assessment tool for skill acquisition and/or behavior reduction required to substantiate future tre atment services. Caregiver/Family Training Training taught by a therapist to parents/caregivers on how to implement methods utilized in a clinical setting into other environments, such as the home or community, to maximize outcomes furthering generalization of skills, and maximizing and reinforcing methods being taught. Direction Includes, but is not limited to, the QHCP observing implementation of a members protocols with member and providing instructions and corrective feedback as needed and/or demonstrating correct implementation of a new or modified protocol with the member whi le the QHCP observes and provides feedback. Plan of Care (POC ) A document submitted for authorization of treatment services that includes member goals, background, parent/caregiver training and other criteria associated with treatment. Qualified Health Care Professional (QHCP) An individual licensed, certified, or permitted to provide ASD services and enrolled with Georgia Medicaid , including physicians, psychologists, BCBA-D, or a BCBA . Supervisio n The direct clinical review, for the purpose of training or teaching, by a physician, psychiatrist, BCBA-D, or BCBA to promote the development of the practitioners clinical skills and may include, without being limited to, the review of case presentations, audiotapes, videotapes, and direct observation . D. PolicyI. General Guidelines The members treatment record (eg, plans of care, treatment plans, behavior support plans, functional assessments) must be completed by the provider or practitioner, signed by the parent or legal guardian (if minor age) or by the member , if applicable , and submitted to CareSource at the time the provider requests a medical necessity review for behavioral assessment or treatment services. Guardianship documentation must be provided for any member 18 and over, as applicable. A. Medical review must be submitted with appropriate documentation as indicated in this policy and align with the States definition of medical necessity includ ing that treatment is not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results. Along with this policy, CareSource utilizes the following resources for the provision of ABA therapy: 1. Autism Spectrum Disorder Services Manual provided by Georgia Department of Community Health Division of Medicaid 2. MCG Health B. The following providers are authorized to deliver ABA services: Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 1. Licensed physician may supervise BCaBAs and RBTs2. Licensed psychologist may supervise BCaBAs and RBTs 3. Board Certified Behavioral Analyst Doctoral Level (BCBA-D) may supervise BCaBAs, RBTs and other implementing ABA interventions 4. Board Certified Behavior Analyst (BCBA) may supervise BCaBAs and RBTs 5. Board Certified Assistant Behavior Analyst (BCaBA ) must be supervised by a physician, psychologist, or BCBA /BCBA-D but may supervise RBTs and may not be the enrolled QHCP 6. Registered Behavior Technician must be supervised by a BCBA/BCBA-D or BCaBA and may not be the enrolled QHCP C. Eligibility 1. Member is under the age of 21 and must be able to participate in sessions. 2. Behaviors must be exhibited and present as clinically significant health or safety risks to self or others or significantly interfe re with basic selfcare, communication, or social skills . 3. Parent/c aregivers must be able to participate in ABA therapy and have the ability to implement ABA techniques in the home environment. If unwilling or unable, consideration will be given to other modalities of treatment . D. Diagnos tic Evaluation s Evaluations should be comprehensive with multiple informants covering multiple domains and completed prior to requesting a review of medical necessity for behavioral assessment or treatment services . Primary hearing deficits, speech disorder, and heavy metal poisoning must be ruled out as causal reasons for behavior. The following guidelines apply to diagnostic evaluation s: 1. Documentation must be established by a licensed physician . psychologist or other licensed professional as designated by Medical Composite Board . 2. Completion of 1 acceptable evidence-based tool and 1 caregiver tool (a list can be located in the Georgia Autism Spectrum Disorder Services Policies and Procedures Manual ). 3. Results should be submitted in report format with a summary of each individual evaluation instrument, developmental history, and present concerns , include the following information: a. date completed b. minimum of 2 assessment tools , including 1 clinician tool and 1 caregiver tool with a summary of each individual assessment c. any t ests administered with scores d. evaluators name , signature, and credentials E. Diagnostic Reevaluations In certain conditions as outlined in the Georgia Autism Spectrum Disorder Services Policies and Procedures Manual , a diagnostic reevaluation must include, at a minimum, 1 clinician observational assessment (school psychoeducation assessments are not acceptable) that re confirm s the diagnosis : 1. The diagnosis of ASD is provisional. Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 2. No formal neuropsychological evaluation was completed.3. The initial diagnosis is at least 5 years old with no evidence of ongoing assessment and treatment. II. Review of Medical NecessityCareSource considers ABA services , both the behavioral assessment and treatment services, medically necessary when the following criteria are met . Reviews of medical necessity are to be completed separately : A. Behavioral Assessment (BA) Prior Authorization (PA) 1. Authorization may be requested in 3-month increments and completed 1 time during the 6-month treatment authorization period no more than 2 months prior to the effective date of the next treatment authorization . 2. Review must be requested by the enrolled QHCP . 3. The BA is c onducted by a n independent practitioner who also develop s a treatment plan before services are provided . Comprehensive BAs are not to exceed 8 hours every 6 months unless additional justification is provided. 4. The BA will assess the following: a. sk ill acquisition, which may include: 01. Verbal Behavior Milestones and Assessments Placement Program (VB-MAPP) 02. Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) 03. Assessment of Functional Living Skills (AFLS) 04. Promoting the Emergence of Advanced Knowledge Generalization (PEAK) 05. other direct s kills assessment b. maladaptive behavior, which may include: 01. functional behavioral assessment s 02. traditional functional analyses 03. Interview-Informed Synthesized Contingency Analysis (IISCAs) / Practical Functional Assessment (PFA) 5. Summarized re sults will be used to develop interventions in the form of a plan of care (POC) , a required document for treatment service authorization that must be signed by the parent , guardian , or member (if 18 and over ) and submitted to CareSource at the time of the review request 6. With appropriate consent, behavior analysts s hould conduct record reviews of available data when receiving members from other facilities; however, BAs and treatment plans must be developed by the current provider. a. A behavior analyst should not submit BAs and treatment plans that are the work product of another behavior analyst to obtain a PA. b. If a member transfers to another provider within the same company during a period covered under an active PA, the behavior analyst receiving the transferred member must review and attest that the treatment plan has been approved and signed by the parent, guardian or member, as applicable . Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 7. Medical necessity review documentation should include the following , as applicable : a. diagnostic evaluation b. Letter of Medical Necessity (LMN) c. individualized Family Service Plan d. Individual Education Plan (IEP) e. previous hospitalization or out-of-home placement documents f. Medicaid Cover Page (see Georgia Autism Spectrum Disorder Services Policies and Procedures M anual ) g. any other clinical documentation needed to support the plan of care as supported by best practices (eg, behavioral, psychological or medical history, evidence of previous therapies with results, history of symptom intensity that demonstrates how the members ability to function in various setting is impacted) B. Treatment Services Prior Authorization (PA) 1. Authorization may be requested in 6-month increments . 2. Documentation should include the following , as applicable : a. diagnostic evaluation b. Letter of Medical Necessity (LMN) c. descriptive results of the BA conducted/dated no more than 2 months prior to the treatment services PA effective date d. proposed Plan of Care (POC) signed by the parent, guardian or member, as applicable e. updated data collected during previous treatment authorizations if not initial request f. individualized Family Service Plan g. Individual Education Plan (IEP) h. previous hospitalization or out-of-home placement documents i. progress notes , if requested by CareSource j. Medicaid Cover Page (see Georgia Autism Spectrum Disorder Services Policies and Procedures Manual ) k. any other clinical documentation needed to support the POC as supported by best practices 3. Medical necessary will determine approved hours per week (eg, typically 10 – 30 hours) but should be c ommensurate with skill deficit or behavioral excesses as identified in the BA. 4. Active parent/caregiver participation and involvement is required to increase behavior improvement in behaviors identified as causing limitations or deficits in functional skills . C. Follow-up service medical necessity reviews following the initial treatment PA must include the following: 1. a summary of previous goals and progress 2. results of a recent BA within the previous 2 month s, including any graphs and current measurements 3. individualized goals for the member and parent/ caregivers as described in Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 the practice guidelines for treatment of ASD developed by the Behavior Analyst Certification Board (BACB)III. Plan of Care (POC)The POC must be submitted for review , be signed by the parent/caregiver and authoriz e treatment services and must comply the following: A. It should include a clear connection between the results of the BA to specific goals developed for the member. B. Goals should highlight areas in need of remediation, focusing on functional skills related to core deficits of ASD. C. Baseline data, current progress data, measurement , graphs and mastery criteria should be included and address core deficits as described in the practice guidelines for treatment set forth by the BACB . D. Treatment must 1. demonstrate that interventions are not custodial or maintenance-oriented in nature 2. include coordination across all providers, supports, and resources, particularly that applicable community resources have been identified and engaged 3. include c riteria and specific behavioral goals and interventions for lesser intensity of care and discharge 4. identify parent, guardian, and/or caregiver involvement in prioritizing target behaviors and training in behavioral techniques to provide additional supportive interventions 5. provide evidence/support for reasonable expectation that the member can benefit from services provided IV. Parent/Caregiver TrainingTraining will evolve as goals are met. Parent/caregiver(s) must actively work on at least 1 unmet goal with the provider documenting and tracking 2-4 goals. The plan of care must include documentation of the following: A. understanding /agreement to comply with the requirements of treatment B. how the parent/caregiver (s) will be trained in skills g eneraliza ble to the home and other environments , how the treatment goas are addressed when providers are not present, and overall skill abilities C. methods by which the parent/caregiver (s) will demonstrate trained skills (presence during sessions is not sufficient for a goal or method of training ) D. barriers to parent involvement and how those are being addressed ( eg, parents having the skills to assist with generalization of skills developed by the member) E. training and time involvement, including any materials or meetings occurring on a routine basis V. Discontinuation of ABA TherapyTitration and/or discontinuation of ABA therapy should occur when the following conditions are met (not an all-inclusive list): Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 A. Treatment ceases to produce significant meaningful progress or maximum benefit has been reached . B. Member behavior does not demonstrate meaningful progress for two successive 6-month authorization periods as demonstrated via standardized assessments. C. ABA therapy is making symptoms, behaviors or impairments worse. D. Symptoms have stabilized allowing member transition to a less intensive type of treatment or level of care to manage symptoms. E. Parent/caregiver(s) have refused treatment recommendations, are unable to participate in the treatment program and/or do not follow through on treatment recommendations to an extent that compromises the effectiveness of the services for member progress. VI. Documentation RequirementsThe State of Georgia and DCH enacts regulations and establishes guidelines related to requirements for documentation expectations for client records. Each dated entry in the record is to be maintained for a t least 5 years after the last date of service or not less than the length of time required by other regulations if longer , including those outlined by Centers for Medicare and Medicaid Services (CMS) and Health Insurance Portability and Accountability Act (HIPAA) . All written, electronic and other record s will be stored and disposed of in a manner that ensure s confidentiality. DCH outlines the following minimum standards for records, including: A. complete medical file with sufficient information to validate the diagnosis and establish the basis for treatment , including, at a minimum, the following: 1. member name or other information related to identification ( eg, social security number, medicaid identification number, date of birth) 2. date and time of admission 3. admitting, and then, verified diagnosis 4. name, address, telephone number of emergency contact 5. appropriate authorizations and consents for procedures and treatment 6. medical necessity of the service(s) being provided 7. results of any testing and/or assessments, including previous testing 8. records or reports from previous or current providers 9. documented correlation between assessed need and care plan 10. documentation of treatment that supports billing and clear evidence that the services billed are the services provided 11. financial and insurance information 12. pertinent medical information with physician, nursing, other practitioner, and case management progress notes 13. any treatment and medication orders 14. date and time o f discharge or death and/or condition on discharge B. plan of care that includes clear and specific coordination with all providers involved in treatment with individualized expectations and the following: 1. individualized expectations 2. prescribed services 3. service frequency Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 4. scope and duration of treatment5. measurable goals to be achieved C. progress notes that are legible, detailed, complete, signed and dated, including 1. signatures must be legible, original , and belonging to the person creating the signature 2. if illegible, the name should be printed as well as signed 3. signatures must be dated the actual date signed 4. rubber stamps are not acceptable but electronic signatures are acceptable in certain circumstances (see Part I Policies and Procedures for Medicaid/Peachcare for Kids , Section 106, General Conditions of Participation) D. corrections should be made by striking one line through the error, writing the correction, and including the initials of the person making the correction along with the date the correction is made (whiteout or any such product is unacceptable) E. back-dated records are not allowed, as records should be documented in real – time VII. Codes of ConductCodes of conduct to protect members by establishing, disseminating, and managing professional standards. Additionally, the State of Georgia mandates requirements for providers to comply with and train in standards and ethics . The ethics code written by the BACB includes the following standards (not all-inclusive): A. Family oversight must occur by/with the BCBA or BCaBA. An RBT may be present during a family training session to provide assistance with interventions, but the training or supervision of interventions cannot be completed by the RBT. B. Providers will create a contract for consent to services ( eg, Declaration of Professional Practices and Procedures) at the onset of services that defines and documents, in writing, the professional role with relevant parties. C. Appropriate effort will be made to involve members and stakeholders in treatment, including selecting goals, designing assessments and interventions, and conducting continual progress monitoring. D. Providers will identify and address environmental conditions ( eg, behavior of others, hazards to client or staff) that may interfere with service delivery, including the identification of effective modifications to interventions and appropriate documentation of conditions, actions taken, and eventual outcomes. E. Continuity of services will be facilitated to avoid interruption or disruption of services for members, including documentation of actions taken and eventual outcomes. F. Providers will address any possible circumstances when relevant stakeholders are not complying with the behavior-change intervention(s) despite documented and appropriate efforts to address barriers to treatment. Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 VIII. Supervision ExpectationsThe State of Georgia and DCH enacts guidelines with requirements for supervision and documentation. The QHCP must supervise non-enrolled practitioners under the enrolled provider identification number of the QHCP and/or facility. However, supervision must be performed in acco rdance with the supervision guidelines of the BACB. Supervision is not separately reimbursable as it is build into the direct service code rates. Time reported and billed MUST be face-to-face time with the patient. QHCP billing of protoc ol modification is not appropriate in instances when documentation supports only supervision or services being performed at a time when the member is not present. If there are any discrepancies with supervision documentation, the associated claims are subject to recoupment. At a minimum, supervision must include the following and records maintained by the supervisor and supervisee to be submitted for auditing upon r equest: A. GA DCH requirements (at a minimum): 1. duration and type of supervision session 2. brief summary of pertinent activity for each session B. The BACB outlines the following minimum provisions for supervision documentation: 1. RBTs must document the following during supervision (not all-inclusive): a. days and times behavior-analytic services were provided b. dates and duration of supervision c. supervision format (individual, group) d. dates of direct observation e. names of supervisors providing supervision f. noncertified RBT supervisor form, if applicable g. proof of supervisors relationship to the client h. additional documentation in the event of discrepant records (session notes) 2. Supervisors must document the following for any supervision hours conducted (not an all-inclusive list): a. date with start and stop times b. fieldwork type c. supervision type (group, individual) d. activity category (restricted or unrestricted) e. summary of supervision activity, including 01. discussion of activities completed during independent hours and any feedback provided 02. progress toward individual member goals 03. outcome of supervision, including any modification to treatment interventions or plans of care 04. collaboration of care among providers f. dated signatures of supervisor and supervisee, including credentials 3. Observations must include the following (at a minimum): a. date with start and stop times b. fieldwork type Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 c. setting name d. supervisor name e. activity category (restricted or unrestricted) C. QHCPs are required to follow DCH guidance regarding delegation of work, including the following: 1. QHCP s are responsible for all delegated work performed by any supervisee. 2. QHCPs will not delegate professional responsibilities to a person not qualified to provide those services. Responsibilities, even with appropriate levels of supervision, must be within the supervisees scopes of practice. 3. QHCP must have education completion and training on supervision rules, professional ethics, standards of practice, and certification guidelines. 4. QHCPs are responsible for determining competency of supervisee and will provide specific instructions regarding limits of the supervisees role. 5. Any QHCP contracts for independent contractors must maintain compliance with DCH policies, including Medicaid enrollment requirements. D. The BACB publishe s ethical codes related to supervision includ ing 1. Behavior analysts are knowledgeable about and comply with all applicable supervisory requirements (eg, BACB rules, licensure requirements, funder and organization policies), including those related to supervision modalities and structure (eg, in person, vi deo conference, individual, group). 2. Behavior analysts supervise and train others only within an individual ly identified scope of competence. 3. Behavior analysts take on only the number of supervisees that allows effective supervision and training. When a threshold volume for providing effective supervision has been met , document ation of self-assessment and communicat ion of results to employer(s) and relevant parties must occur. 4. Behavior analysts are accountable for supervisory practices and professional activities (eg, client services, supervision, training, research activity, public statements) of supervisees occurring as part of th at re lationship. 5. Behavior analysts ensure that documentation and the documentation of supervisees or trainees is accurate and complete. 6. Behavior analysts deliver supervision and training in compliance with applicable requirements (eg, BACB rules, licensure requirements, funder and organization policies) and design and implement supervision and training procedures that are evidence based, focus on positive reinforcement, and are individualized for each supervisee and circumstances. 7. Behavior analysts actively engage in continual evaluation of supervisory practices using feedback from others and client and supervisee outcomes. Self-evaluations are documented and timely adjustments made to supervisory and training practices as indicated. IX . Special Provisions Related to RBTsA. Current Standards for RBTs1. RBT services must be supervised by a qualified RBT supervisor (BCBA,BCBA-D, or BCaBA) . RBTs may not be the enrolled QHCP and must obtain Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 ongoing supervision for a minimum of 5% of the hours spent providing ABAservices per month. Additionally, the BACB publishes information regarding the structure o f supervision and parameters for group and individual supervision in the RBT Handbook . 2. An RBT certified by the BACB may provide ABA under the supervision of an independent practitioner if enrolled in the Medicaid program and affiliated with the organization under which the provider is employed or contracted. If the independent practitioner leaves the affiliated organization and no longer provides supervision, the RBT may not continue to provide services under that independent practitioner. Additionally, if the RBT leaves the affiliated organization and no longer receives mandated supervision, the RBT may not continue to provide services to the member. 3. RBTs must use appropriate modifiers that indicate qualifications of staff delivering services. B. Upcoming RBT Changes from the Behavior Analyst Certification Board 1. Effective January 1, 2026 : In the interest of consumer protection, the BACB Board of Directors approved a recommendation that RBT supervisors must hold BCBA or BCaBA certification. Noncertified supervisors will not be allowed to provide BACB-required supervision to RBTs. During th is transition, RBT Requirements Coordinators who currently attest to the qualifications of noncertified supervisors should make preparations to ensure continuity of care for clients. 2. Effective January 1, 2026 : New rules regarding eligibility for and maintenance of certification for RBTs were adopted by the BACB Board of Directors and can be located in the BACB Newsletter: December 2023 at www.bacb.com. X. Telehealth GuidanceThe provision of ABA services is allowed via telehealth per GA DCH. Part II Policies and Procedures for Autism Spectrum Disorder Services publishes applicable codes, modifiers and allowable provider types. Additionally, Part II Policies and Procedures for Telehealth Guidance provides information for telehealth billing requirements , which is only billable if the provider is in GA or within 50 miles of the GA border when services are rendered. Providers utilizing telehealth for the delivery of services must make decisions that are consistent with best, currently available evidence and clinical consensus. Clinical rationale must consider assessed needs, strengths, preferences, and availableresources of members and caregivers. The same professional ethics governing in-person care must be followed and limitations considered, including interstate licensure challenges, state regulatory issues, member or caregiver discomfort with technology, technology limitations, and cultural acceptance of virtual visits. Providers must identify protocols for clinical appropriateness (eg, risk assessment, safety planning, patient/caregiver characteristics), ensure the rapeutic benefit for recipients, and ensure provider competence of delivering care via telehealth modalities. Peer Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 reviewed studies and other best evidence literature provides guidance on appropriate screeners and questionnaires for use in the determination of appropriateness of telehealth services for particular clients.XI. ExclusionsAB A is not covered in the following circumstances: A. rehabilitative services (eg, community psychiatric supportive treatment, therapeutic behavioral service, and psychosocial rehabilitation service ) for the provision of ABA B. reimbursement is not permitted under any of the following situations: 1. any services not documented in the treatment plan 2. behavioral methods or mode s considered experimental 3. education al-related services or activities described under Individuals with Disabilities Education Improvement Act of 2004, 20 U.S.C. 1400 (IDEA) , amended through Public Law 114-95, the Every Student Succeeds Act 4. vocational services in nature or those available through program s funded under Section 110 of the Rehabilitation Act of 1973 5. component s of adult day care programs C. treatment solely for the benefit of the family, caregiver or therapist D. treatment solely focused on recreational or educational outcomes E. goals focused on academic targets ( eg, treatment should address autistic symptoms impeding deficits in the home environment, such as reduction of frequency of self-stimulatory behavior to follow through with toilet training or completing a mathematic sorting task) F. treatment un expected to cause measurable , functional improvement or improvement is not documented G. duplicative therapy services addressing the same behavioral goals using the same techniques as the treatment plan, including services under an IEP H. services provided by family or household members I. care primarily custodial in nature and not requiring trained/professional ABA staff J. shadow ing , para-professional, or companion services in any setting K. personal training or life coaching L. services more costly than an alternative service (s) , which are as likely to produce equivalent diagnostic or therapeutic results for the member M. program s or service s performed in nonconventional settings , even if performed by a licensed provider, including spas/resorts , vocational or recreational settings , Outward Bound , and wilderness camp or ranch programs E. Conditions of CoverageI. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis, subsequent medical review audits, recovery of overpayments identified, and provider prepay review. II. When a member has other insurance, Medicaid is always the payer of last resort. CareSource will not pay more than the Medicaid rate totals for service. The p rimaryApplied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 payer must provide evidence of determinations for consideration of Medicaid coverage for services. III. CareSource reserves the right to request supervision documentation.A. Level 4 and 5 practitioners work under the supervision of higher-level practitioners. Providers are required to bill at the appropriate practitioner level and service code for the service rendered. To enroll as a Medicaid provider, the provider must either physically be located in Georgia or located within 50 miles of the Georgia border. B. Adaptive behavior treatment with protocol modification administered by an authorized provider type (ie, physician, psychiatrist, psychologist, BCBA-D, BCBA) with 1 client for the first 30 minutes utilizes patient face-to-face time. Additional 30-minute increments requirement authorization in accordance with medical necessity. IV. Providers a gree to bill Medicaid for only those services rendered by the provider or by a QHP under the provider s direct supervision . Under no circumstances may a provider bill for services rendered by another practitioner who is enrolled or eligible to enroll as a provider. All services are to be billed with modifiers specific for practitioner level and service delivery setting/modality , as follows: Practioner Level Legend Physician, Psychiatrist U1 Level 1 Psychologist, BCBA-D U2 Level 2 BCBA U3 Level 3 BCaBA U4 Level 4 RBT U5 Level 5 V. Providers a gree to bill the procedure code(s) which best describes the servicerendered and not to bill under separate procedure codes for services included under a single procedure code. Coding of both diagnoses and procedures is required for all claims and must be to the highest level. VI. Providers cannot submit multiple dates of service on a single claim line. Each claim line must be specific to a single date of service and the units provided on that single date of service.VII. Both codes and modifiers can be found in the Georgia Autism Spectrum DisorderServices Policies and Procedures Manual. The maximum daily units per procedure code as mandated by CMS and published by the State of GA is as follows: Procedure Code Max Units Per Day 97151 32 97152 16 97153 32 97154 18 Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 97155 2497156 16 97157 16 97158 16 0362T 16 0373T 32 F. Related Policies/RulesI. Health Insurance Po rtability and Accountability Act (HIPAA) of 1996 II. Diagnostic, screening, preventive, and rehabilitative services, 42 C .F.R. 440.130(c) (2023) III. Definitions, 42 U.S.C. 1396d (2019) G. Review/Revision HistoryDATE ACTIONDate Issued 11/29/2017Date Revised 04/19/2018 04/01/202004/28/202112/01/202104/27/202204/12/2023 03/13/2024 04/24/202407/31 /202409/25/202403/12/2025Addition of qualified healthcare profession re: final diagnosis criteria . Section III. Diagnosis Updated policy. Annual review. Updated medical necessity criteria, exclusions, discontinuation criteria, and added in language from GAMMIS. Clarified documents referenced. Title change Removed telehealth exclusion Changed assessment from 3 to 5 years; removed Appendix G; added note D.2.k. Updated definitions. Reorganized. Approved at Committee. Annual review. Expanded background. Added sections VII-X. Added sections VII X & MUE information to Cond of Coverage section. Updated H. Approved at Committee. Added II.A.5. GAMMIS update 4/1/24. Approved at Committee. Added direction (GAMMIS update 7/1/24), D.III.E., VIII.D., IX.A.1.a. – b., X., E.III.A-C., updated references. Approved at Committe e. Out of cycle review. Added documentation submission prior to claim submission. Out of cycle review. Removed parent guardian signature on daily progress notes prior to claims submission. Approved by Committee. Date Effective 05/10/2025 Date Archived H. References1. 202 5 NCCI MUE Edits-Practitioner Services . Centers for Medicare and Medicaid Services. Updated January 1, 2025 . Accessed February 26, 2025 . www.cms.gov 2. Anglim M, Conway EV, Barry M, et al. An initial examination of the psychometric properties of the Diagnostic Instrument for Social and Communication Disorders Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 (DISCO-11) in a clinical sample of children with a diagnosis of autism spectrum disorder. Ir JPsychol Med . 2022;39(3):251-260. doi:10.1017/ipm.2020.100 3. Applied Behavior Analysis: B-806-T. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 4. Augustyn M. Autism spectrum disorder in children and adolescents: evaluation and diagnosis. UptoDate. Updated May 16, 2022. Accessed February 26, 2025 . www.uptodate.com 5. Augustyn M. Autism spectrum disorder (ASD) in children and adolescents: terminology, epidemiology, and pathogenesis. UptoDate. Updated January 24, 2024. Accessed February 26, 2025 . www.uptodate.com 6. Augustyn M, Von Hahn E. Autism spectrum disorder in children and and adolescents: clinical features. UptoDate. Updated May 17, 2023. Accessed February 26, 2025 . www.uptodate.com 7. Autism spectrum disorder. American Academy of Pediatrics. Updated April 5, 2023. Accessed February 26, 2025 . www.aap.org 8. Autism Spectrum Disorder In Young Children: Screening . U SPreventive Services Task Force; 2016. Accessed February 26, 2025 . www.uspreventiveservicestaskforce.org 9. Autism Spectrum Disorders: M-7075. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 10. Autism Spectrum Disorders: B-012-HC. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 11. Autism Spectrum Disorders, Adult, Inpatient Care: B-012-IP. MCG. 28th ed. Updated March 14 , 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 12. Autism Spectrum Disorders, Child or Adolescent: B-019-IP. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 13. Autism Spectrum Disorders, Intensive Outpatient Program: B-012-IOP. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 14. Autism Spectrum Disorders, Outpatient Care: B-012-AOP. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 15. Autism Spectrum Disorders, Partial Hospitalization Program: B-012-PHP. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 16. Autism Spectrum Disorders, Residential Care: B-012-RES. MCG. 28th ed. Updated March 14, 2024 . Accessed February 26, 2025 . www.careweb.careguidelines.com 17. BACB Newsletter . Behavior Analyst Certfication Board; September 2023. Accessed February 26, 2025 . www.bacb.com 18. BACB Newsletter: Introducing the 2026 RBT Examination and Certification Requirements . Behavior Analyst Certification Board; December 2023. Accessed February 26, 2025 . www.bacb.com 19. Bak M, Plavnick J, Dueas A, et al. The use of automated data collection in applied behavior analytic research: a systematic review. Behavior Analysis: Res Practice. 2021;21(4), 376 405. https://doi.org/10.1037/bar0000228 Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 20. Bearss K, Burrell T, Challa S, et al. Feasibility of parent training via telehealth for children with autism spectrum disorder and disruptive behavior: a demonstration pilot. JAutism Dev Dis . 2018;48:1020-3. doi: 10.1007/s10803-017-3363-221. Blakeley-Smith A, Meyer A, Boles R, et al. Group cognitive behavioral treatment for anxiety in autistic adolescents with intellectual disability: a pilot and feasibility study. JApp Res Intell Disab. 2021;34(3):777-788. doi:10.111/jar.12854 22. Board Certified Behavior Analyst Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed February 26, 2025 . www.bacb.com 23. Board Certified Assistant Behavior Analyst Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed February 26, 2025 . www.bacb.com 24. Buckley A, Hirtz D, Oskoui M, et al.; Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Practice guideline: treatment for insomnia and disrupted sleep behavior in cihldre n and adolescents with autism spectrum disorder. Neurology . 2020;94(9):392-404. doi:org/10.1212/WNL0000000000009033 25. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems: part I, common clinical challenges of patients with mental health or behavioral emergencies. Pediatr. 2016;138(3):e20161570. doi:org/10.1542/peds.2016-1570 26. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems: part II, recognition of clinically challenging mental health related conditions presenting with medical or uncertain symptoms. Pediatr. 2016;138(3):e20161573. doi:org/10.1542/peds.2016-1573 27. Coverage for Autism, GA. CODE ANN . 33-24-59.10 (2023). 28. Crockett, JL, Fleming RK, Doepke K, et al. Parent training: acquisition and generalization of discrete trials teaching skills with parents of children with autism. Res Dev Disabilities . 2007; 28 (1):23-36. doi.org/10.1016/j.ridd.2005.10.003 29. Declaration of Purpose, GA. CODE ANN . 37-2-1 (2023). 30. Dubreucq J, Haesebaert F, Plasse J, et al. A systematic review and meta-analysis of social skills training for adults with autism spectrum disorder. JAutism Dev Disorders. 2022;52(4):1598-1609. doi:10.1007/s10803-021-05058 31. Ellison K, Guidry J, Picou P, et al. Telehealth and autism prior to and in the age of COVID-10: a systematic and critical review of the last decade. Clin Child Family Psych Rev . 2021;24:599-630. doi:10.1007/s10567-021-00358-0 32. Ethics Code for Behavior Analysts. Behavior Analyst Certification Board; 2020. Updated January 1, 202 2. Accessed February 26, 2025 . www. bacb.com 33. Evidence analysis research brief: intensive behavioral intervention for treatment of Autism Spectrum Disorder. Hayes; 2024. Accessed February 24, 2025. www.evidence.hayesinc.com Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.19 34. Gates JA, Kang E, Lerner MD. Efficacy of group social skills interventions for youth with autism spectrum disorder: a systematic review and meta-analysis. Clin PsychRev . 2017;52:164-81. doi:10.1016/j.cpr.2017.01.006 35. Gilmore R, Ziviani J, Chatfield MD, et al. Social skills group training in adolescents with disabilities: a systematic review. Res Dev Disab . 2022;125:online. doi:10.1016/j.ridd.2022 .104218 36. Gonzlez MC, Vsquez M, Hernndez-Chvez M. Autism spectrum disorder: clinical diagnosis and ADOS Test. Rev Chil Pediatr . 2019;90(5):485-491. doi:10.32641/rchped.v90i5.872 37. Health tech nology assessment: comparative effectiveness review of intensive behavioral intervention for treatment of autism spectrum disorder. Hayes; 2019. Updated February 10, 2022. Accessed February 26, 2025 . www.evidence.hayesinc.com 38. Hyman S, Levy S, Myers S; Council on Children with Disabilities. Developmental and behavioral pediatrics: identification, evaluation, and management of children with autism spectrum disorder. Pediatr. 2020;145(1):e20193447. doi:org/10.1542/peds.2019-3447 39. Information on autism spectrum disorder for healthcare providers. Centers for Disease Control and Prevention (CDC). Updated December 6, 2022. Accessed February 26, 2025 . www.cdc.gov 40. Kreyenbuhl J, Buchanan RW, Dickerson FB ; Schizophrenia Patient Outcomes Research Team (PORT). The Schizophrenia Patient Outcomes Research Team (PORT): updated treatment recommendations. Schizophrenia Bull . 2010;36(1):94 – 103. doi: 10.1093/schbul/sbp130 41. Lebersfeld JB, Swanson M, Clesi CD, et al. Systematic review and meta-analysis of the clinical utility of the ADOS-2 and the ADI-R in diagnosing autism spectrum disorders in children. JAutism Dev Disord . 2021;51(11):4101-4114. doi:10.1007/s10803-020-04839-z 42. Lefort-Besnard J, Vogeley K, Schilbach L, et al. Patterns of autism symptoms: hidden structure in the ADOS and ADI-R instruments. Transl Psychiatry . 2020;10(1):257. doi:10.1038/s41398-020-00946-8 43. Lim N, Russell-George A. Home-based early behavioral interventions for young children with autism spectrum disorder. Clin Psychol . 2022;29(4):415-416. doi:org/10.1037/cps0000117 44. Marino F, Chila P, Failla C, et al. Tele-assisted behavioral intervention for families with children with autism spectrum disorders: a randomized control trial. Brain Sci . 2020;10(9):649. doi:10.3390/brainsci10090649 45. Medica re Claims Processing Manual. Centers for Medicare and Medicaid Services; Publication # 100-04. Updated October, 2024. Accessed February 26, 2025 . www.cms.gov 46. MeiMei L, Zenghui M. A systematic review of telehealth screening, assessment, and diagnosis of autism spectrum disorder. Child Adol Psychiatry Mental Health. 2022;16(79):1-15. doi: 10.1186/s13034-022-00514-6 Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.20 47. Moody CT, Laugeson EA. Social skills training in autism spectrum disorder across the lifespan. Child Adol Psychiatric Clinics NAmer 2020;29(2):359-371. doi :10.1016/j.chc.2019.11.001 48. Policies a nd Procedures for Autism Spectrum Disorder Services, Part II . Georgia Dept. of Community Health, Division of Medicaid. Revised January 1, 2025 . Accessed February 26, 2025 . www.mmis.georgia.gov 49. Practice of Applied Behavior Analysis, GA. CODE ANN . 43-7A-1 to 11 (2023) . 50. Registered Behavior Technician Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed February 26, 2025 . www.bacb.com 51. Sneed L, Little S, Akin-Little A. Evaluating the effectiveness of two models of applied behavior analysis in a community-based setting for children with autism spectrum disorder. Behav Anal: Res Pract . 2023;23(4):238-253. doi:org/10.1037/bar0000277 52. Solish A, Klemencic N, Ritzema A , et al. Effectiveness of a modified group cognitive behavioral therapy program for anxiety in children with ASD delivered in a community context. Molecular Autism 2020; 11 (34 ):1-11. doi.10.1186/s13229020003416 53. Unholz-Bowden E, McComas J, McMaster K, et al. Caregiver training via telehealth on behavioral procedures: a systematic review. JBeh Educ . 2020;29:246-281. doi:10.1007/s10864-020-09381-7 54. Volkmar F, Siegel M, Woodbury-Smith M, et al.; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. JAm Acad Child Adolesc Psychiatry . 2014;53(2):237-57. doi: 10.1016/j.jaac.2013.10.013 55. Weissm an L. Autism spectrum disorders in children and adolescents: behavioral and educational interventions . UptoDate. Updated October 22, 2024 . Accessed February 26, 2025 . www.uptodate.com 56. Weissman L. Autism spectrum disorder in children and adolescents: overview of management. UptoDate. Updated September 8, 2023. Accessed February 26, 2025 . www.uptodate.com 57. Weissman L. Autism spectrum disorder in children and adolescents: pharmacologic interventions. UptoDate. Updated October 8 , 2024 . Accessed February 26, 2025 . www.uptodate.com 58. Weissman L. Autism spectrum disorder in children and adolescents: screening tools. UptoDate. Updated January 24, 2024. Accessed February 26, 2025 . www.uptodate.com 59. Weissman L. Autism spectrum disorder in children and adolescents: surveillance and screening in primary care. UptoDate. Updated November 25, 2024 . Accessed February 26, 2025 . www.uptodate.com 60. Weissman L, Harris H. Autism spectrum disorder in children and adolescents: complementa ry and alternative therapies. UptoDate. Updated June 20, 2022. Accessed February 26, 2025 . www.uptodate.com 61. Wergeland J, Posserud M, Fjermestad K, et al. Early behavioral interventions for children and adolescents with autism spectrum disorder in routine clinical care: a Applied Behavior Analysis for Autism Spectrum Disorder-GA MCD-MM-0212 Effective Dat e: 05/10 /2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.21 systematic review and metaanalysis. Clin Psychol . 2022;29(4):400-414. doi:org/10.1037/cps0000106 62. Witwer A, Walton K, Held M. Taking an evidence-based child-and family-centered perspective on early autism intervention. Clin Psychol . 2022;29(4):420-422. doi:org/10.1037/cps0000122 GA-MED-P-3325183 Issue Date 11/29/2017 Approved DCH 03/0 6/2025

Safety Beds

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Safety Beds-GA MCD-MM-1456 04/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 3 Safety Beds-GA MCD-MM-1456 Effective Dat e: 04/01/2025 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 the safety of an individual with a variety of medical or behavioral health diagnoses , such as epilepsy, intracranial injury, hydrocephalus , intellectual disabilities , and autistic spectrum disorder . The use of these beds increases patient safety by eliminating falls and preventing injuries and wandering . In addition, safety beds might assist with treatments for other symptoms, such as aggression, impulsivity, noncompliance, or elopement behaviors. Ongoing individual 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 prevent s a toddler from climbing out of the crib or, i n 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. 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. B. A safety bed is require d to prevent the member from leaving the bed at night without a supervis or. C. There should be regular, periodic , and face-to-face (in-person) monitoring while the member is in the safety bed. D. The safety bed is not used as a restraint. E. The safety bed is the lowest cost alternative that addresses the members health condition. F. The member is mobile and at risk of entanglement in a standard hospital bed or traveling outside of the home. G. The least costly alternatives have been tried and failed. Safety Beds-GA MCD-MM-1456 Effective Dat e: 04/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.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, and standard rail padding failed to meet the safety and 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 physician order for the safety bed is included. 4. The person-centered service plan is retained and updated. 5. The invoice for the safety bed is retained and submitted along with the prior authorization and reimbursement requests. 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 05/08/202411/0 6/2024Annual 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. Date Effective 04/01/2025 Date Archived H. References6. 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 7. DeGeorge KC, Neltner CE, Neltner BT. Prevention of unintentional childhood injury. Am Fam Physician . 2020;102(7):411-417. Accessed October 25, 2024 . www.aafp.org 8. Policies and Procedures for Durable Medical Equipment Services , Part II . Georgia Dep t of Community Health. Revised October 1, 2024 . Accessed October 28 , 2024 . www. mmis. georgia.gov Safety Beds-GA MCD-MM-1456 Effective Dat e: 04/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9. Paruthi S, Brooks LJ, DAmbrosio C, et al. Recommended amount of sleep for pediatric populations: a consensus statement of the American Academy of SleepMedicine. JClin Sleep Med . 2016; 2(6):785-786. doi:10.5664/jcsm.5866 10. 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 2/15/2023GA-MED-P-3459100 Issue date 03/01/2023 Approved DCH 12 /30 /2024

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 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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: 01 /01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response . Pharmacokinetics analyzes how 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. Those with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound. Individuals are therefore classified as poor metaboliz ers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies continue to show potential benefitsof gene testing. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited available research for a drug class or specific drugs. Most studies are base d on a small sample size and did 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 consensus regarding preemptive genotyping efficacy. Two 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, which is presumed to improve time to effective treatment and reduce undertreatment, medication-related adverse events, and costs. The guidelines consist of grading levels of evidence for prescription recommendations, which guide physicians on how results can optimize treatment. The strength of recommendations is divided into four categories: strong, moderate, optional, and no recommendation. A strong recommendation is backed by high-qualityevidence 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: 01 /01/2025 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 o nBiomarkers and Novel Treatments printed a position statement on pharmacogenomi c (PGx) tools for the treatment of depression indicating at present there are insufficien t data to support the widespread use of combinatorial pharmacogenetics testing in clinica l practice. The Food and Drug Administration (FDA) released a consumer warning, Th e relationship between DNA variations and the effectiveness of antidepressan t medica tions has never been established. and also cautioned that changes in patien t 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 met a- analyse s published from 2017 to 2022 using PGx tools for treatment selection i n depression and found addition of these new data do not alter the recommendations o f the 2018 report, or the advice of the FDA, that the evidence does not support the use o f currently available combinatorial PGx tools for treatment. Additionally in 2019, th e International Society of Psychiatric Genetics published the following statement : Pharmacogenetic testing should be viewed as a decisio n-support tool Evidence t o support widespread use of other pharmacogenetic tests at this time is still inconclusive Genetic information for CYP2C19 and CYP2D6 would likely be most beneficial fo r indi viduals who have experienced an inadequate response or adverse reaction to a previous antidepressant or antipsychotic tria l. CareSource covers items and services with sufficient medical and scientific evidence fo rthe purposes of diagnosis, treatment, appropriate management, or ongoing monitoring o f disease(s) or condition(s) but does not cover experimental or investigational t esting o r products or services with insufficient data to determine net health impact. Insufficien t data includes support that the test accurately assesses the outcome of interes t (analytical and clinical validity), significantly improves health outcomes (c linical utility) , performs better than an existing standard of care medical management option, and/or i s not generally accepted as standard of care in the evaluation or management of a particular condition. CareSource provides appeal rights to any member o r provider actin g on behalf of a member who may disagree with denial decisions. Tests should be chose n to maximize the likelihood of identifying mutations in genes of interest for a specifi c medical reason, contribute to positive alterations in patient man agement, and minimiz e the chance of finding variants of uncertain significanc e. 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: 01 /01/2025 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 ne ar 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 optimizing 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: 01 /01/2025 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 uses CPIC 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 therapy or in a course of therapy with any of the medications below, testing for following genotype(s) once per lifetime may be considered : 1. CYP2C19 and CYP2D6 t esting for tricyclic antidepressants : a. Amitriptyline b. Imipramine c. Doxepin 2. CYP2C19 and CYP2B6 testing for sert raline, serotonin reuptake inhibitor 3. HLA-A and HLA-B testing for carbamazepine Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 01 /01/2025 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 clin ical signs and symptoms or for determini ng 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 spe cim ens 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: 01 /01/2025 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 Date Effective 01/01/2025 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. 28th ed. Updated February 1, 2024. Accessed August 19 , 2024. www.careweb.careguidelines.com 5. Beunk L, Nijenhuis M, Soree B, et al. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2D6, CYP3A4 and CYP1A2 and antipsychotics. Eur JHum Genet . 2024;32(3):278-285. doi:10.1038/s41431-023-01347-3 6. 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: 01 /01/2025 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. Reviewed January 16, 2024. Accessed August 19 , 2024. www.cdc.gov 14. Clinical Pharmacogenetics Implementation Consortium. Accessed August 19, 2024. 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 August 19 , 2024. www.aacap.org 16. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed August 19 , 2024. www.hayesinc.com 17. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Updated May 23, 2021. Accessed August 19 , 2024. 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. Updated October 26, 2022. Accessed August 19 , 2024. www.evidenced.hayesinc.com 19. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Hayes; 2020. Updated June 30, 2023. Accessed August 19 , 2024. www.evidence.hayesinc.com 20. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Updated February 27, 2024. Accessed August 19 , 2024. www.evidence.hayesinc.com 21. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Updated December 1, 2023. Accessed August 19 , 2024. www.evidence.hayesinc.com 22. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 28th ed. Updated February 1, 2024. Accessed August 19 , 2024. www. careweb.careguidelines.com 23. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Updated August 24, 2020. Accessed August 19 , 2024. www.genome.gov 24. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 25. 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 26. 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 27. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed August 19 , 2024. www.pubmed.ncbi.nih.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 01 /01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 28. 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 29. 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 30. 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 31. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 32. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 28th ed. Updated February 1, 2024. Accessed August 19 , 2024. www.careweb.careguidelines.com 33. 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 34. 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 35. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated October 7, 2022. Accessed August 19 , 2024. www.uptodate.com 36. Laboratory Requirements, 42 C.F.R. 493 (2024). 37. 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 38. 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 39. 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 40. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Updated December 21, 2023. Accessed August 19 , 2024. www.fda.gov 41. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Medicare Coverage Database. LCD ID L35025. Revised May 4, 2023. Accessed August 19, 2024. www.cms.gov 42. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Centers for Medicaid and Medicare Services; 2017. LCD ID L36807. Revised April 27, 2023. Accessed August 19, 2024. www.cms.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 01 /01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 43. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38294. Revised August 24, 2023. Accessed August 19, 2024. www.cms.gov44. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38435. Revised August 24, 2023. Accessed August 19, 2024. www.cms.gov 45. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38274. Revised April 25, 2024. Accessed August 19, 2024. www.cms.gov 46. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38429 . Revised April 25, 2024. Accessed August 19, 2024. www.cms.gov 47. 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 48. 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 49. Medical Code Brief: 0345U-PLA (U Codes). Hayes; 2022. Accessed August 19 , 2024. www.evidence.hayeinc.com 50. Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 28th ed. Updated February 1, 2024. Accessed August 19 , 2024. www.careweb.careguidelines.com 51. 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 52. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Updated November 13, 2023. Accessed August 19 , 2024. www.evidence.hayesinc.com 53. 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 54. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed August 19 , 2024. www.cancer.gov 55. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed August 19 , 2024. www.ncbi.nlm.nih.gov 56. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Updated January 1, 2024. Accessed August 19 , 2024. www.medicaid.gov 57. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 01 /01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 58. 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 59. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Updated December 2019. Accessed August 19 , 2024. www.aacap.org 60. 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 61. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed August 19 , 2024. www.evidence.hayesinc.com 62. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed August 19 , 2024. www.evidence.hayesinc.com 63. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed August 19 , 2024. www.evidence.hayesinc.com 64. 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. 65. Raby B. Personalized medicine. UpToDate. Updated September 06, 2023. Accessed August 19 , 2024. www.uptodate.com 66. 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 67. 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 68. 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 69. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. 70. 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 71. 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 72. 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 Pharmacogenomics-Gene Testing for Behavioral Health Indications-GA MCD-MM-1712 Effective Dat e: 01 /01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 73. Tantisira K. Overview of pharmacogenomics. UpToDate. Updated July 05, 2024.74. Ter Hark S, Vos CF, Aarnoutse RE, et al. Biomarkers as predictors of treatment response to tricyclic antidepressants in major depressive disorder: a systematic review. JPsych Res . 2022;150:202-213. doi:10.1016/j.jpsychires.2022.03.057 75. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed August 19 , 2024. www.fda.gov 76. 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 77. 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 78. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 28th ed. Updated February 1, 2024. Accessed August 19 , 2024. www.careweb.careguidelines.com 79. 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 80. 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 81. 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-3303157 Issue date 08/28/2024 Approved DCH 10/15/2024

Clinical Trial Coverage

MEDICAL POLICY STATEMENTGeorgia Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-GA MCD-MM-0799 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Polic ies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 5 Clinical Trial Coverage-GA MCD-MM-0799 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Clinical Trial Coverage B. Background Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose , or treat a disease. Clinical trials evaluate new or emerging devices, treatments, and procedures. They may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol or action plan for conducting the trial. The protocol or action plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical trials are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested , or non-standard treatments to standard currently accepted treatments. Clinical trials are intended to improve clinicians knowledge about a treatment and to improve clinical outcomes for future patients . Clinical trials generally proceed through four phases: a. Phase I the study treatment is given to a small group of people who are healthy or have the disease/condition for the first time to evaluate its safety and determine a safe dosage range; b. Phase II the study treatment is given to a large group of people who have the disease/condition to see if it is effective and to identify side effects; c. Phase III the study treatment is given usually to large groups of people who have the disease/condition to confirm its effectiveness, monitor adverse reactions, compare it to commonly used treatments and collect information that will allow the treatment to be used safely; d. Phase IV studies performed after the treatment has been marketed to collect information about its effects in various populations of people who have the disease/condition and to identify side effects associated with long-term use. NOTE: Experimental, investigational, and unproven treatment s, procedures , and all related services are not a covered service by Medicaid. C. Definitions Clinical Trial is a Phase I, II, III, or IV research study That does ONE of the following for the treatment of cancer or a life-threatening disease: o tests how to administer a health care service o tests responses to a health care service o compares effectiveness of a health care service o studies new uses of a health care service AND Is approved and funded by ONE of the following: Clinical Trial Coverage-GA MCD-MM-0799 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3o A cooperative group of research facilities that has an established peer review program that is approved by a National Institutes of Health Institute or center and assures an unbiased review of standards of care with qualified individuals who do not have an interest in the review outcome o National Institutes of Health (NIH) o The Centers for Disease Control and Prevention (CDC) o The Agency for Health Care Research and Quality (AHRQ) o The Centers for Medicare and Medicaid services (CMS) o A cooperative group or center of NIH, CDC, AHRQ, DOD, VA, or CMS o The United States Department of Veterans Affairs (VA) o The United States Department of Defense (DOD) o The Food and Drug Administration 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 Clinical Trial Coverage-GA MCD-MM-0799 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.4o Cannot be legally marketed in the United States without final approval from appropriate government regulatory or licensing body. ICD-10-CM Code Z00.6 a billable ICD code used to specify a diagnosis of encounter for examination for normal comparison and control in clinical research program. The Z00.6 diagnosis code reports that the service involved "examination of participant in clinical trial". The Z00.6 diagnosis code must be used for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be conventional care for the patient absent the trial. D. Policy I. Prior Authorization is required for ICD-10-CM Code Z00.6. II. Informed consent approved by an IRB accredited Association for the Accreditation of Human Research Protection Programs (AAHRPP) must be obtained from the member before enrolling in a clinical trial. III. CareSource will cover routine care costs for a member enrolled in a clinical trial as described in this policy when A. The same routine care costs would be typically covered for a member who is NOT enrolled in the clinical trial . B. All items and services are medically necessary . C. All items and services are a covered benefit . IV. CareSource will cover routine care costs for member in a clinical trial where the item or service is A. Required for the administration and provision of the item or service such as the staffing and equipment need to implant the device . 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. Clinical Trial Coverage-GA MCD-MM-0799 Effective Date: 01/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.5G. Transportation, housing, food or expenses for the member or family members/companions associated with travel to or from facility providing the clinical trial. H. Experimental/investigational/unproven procedure, treatment, service, supply, device, or product . VI. All applicable plan limitations for coverage for out-or-network providers will apply to routine care costs in a clinical trial. VII. All applicable utilization management guidelines (including prior authorizations) will apply to routine care for members in a clinical trial. E. Conditions of Coverage N/A F. Related Polic ies/Rules N/AG. 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 Changed title from Clinical Trials. Changed from AD-0002. Removed all other state requirements. Added specific criteria. Added PA requirement. Updated references. Per SIU expanded definition Z00.6, Encounter for examination for normal comparison and control in clinical research program No changes; updated references Changed title to Clinical Trial Coverage. Updated references. No other changes. Updated references. Approved at Committee. Updated references. Approved at Committee Date Effective 01/01/2025 Date Archived H. References 1. Association for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed August 14, 2024. www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed August 7, 2023 . www.ecfr.gov 3. Local Coverage Article. Clinical Trials-Medical Policy Article (A52430). Accessed August 14, 2024 . www.cms.gov 4. Medicare and Medicaid Services Medicare Learning Network (2015). MLN Matters. Medicare Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies. Accessed August 7, 2023 . www.cms.gov 5. National Coverage Determination for Routine Costs in Clinical Trials (310.1). Accessed August 14, 2024. www.cms.gov Clinical Trial Coverage-GA MCD-MM-0799 Effective Date: 01/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.66. Eligibility Criteria, G A. CODE ANN . 31-52-4 (2023). Accessed August 14, 2024. www.law.justia.com 7. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). Accessed August 14, 2024 . www.govinfo.gov GA-MED-P-3303157 Issue Date 05/19/2015 Approved DCH 10/15 /2024

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