MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Tumor Treatment Field Devices for Glioblastoma Multiforme – OH MCD-MM-1224 03/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 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 Tumor Treatment Field Devices for Glioblastoma Multiform e (GBM) B. Background Glioblastoma m ultiforme is the most common central nervous system malignancy of the brain in adults with an average onset age between 55 to 60 years. The incidence rate between 2010 and 2014 was 29.2 per 100,000 in adults , and 5.81 per 100,000 in children. Management of the disease follows a combined-modality approach, including adjuvant postoperative radiation therapy and adjuvant chemotherapy following initial sur gery. Surgery remains the mainstay of treatment in order to remove as much tumor as possible whi le preserving surrounding brain tissue required for normal brain function. Despite tumor debulking measures, glioblastoma tumors infiltrate surrounding tissues creating little success for removal of the entire tumor (AANS, 2020). Glioblastoma has a high rate of recurrence and poor overall survival rate even with optimum therapy treatment s. Most patients live 1-2 years after initial diagnosis. Tumor treating field devices (TTF) are a novel method of cancer treatment involving emitting alternating electric fields to disrupt the rapid cell divi sion exhibited by cancer cells. This treatment first became available in 2011 to treat recurrent glioblastoma. TTF is considered safe with no systemic toxicity observed and only mild to moderate side effects (reported in 1-2% of patients) involving the skin beneath transducer arrays . Patients are required to wear the device at least 18 hours a day for effectiveness and minimum treatment duration is 4 weeks. Randomized clinical trial results suggest the device improves overall survival when combined with monthly temozolomide in patients with newly diagnosed glioblastoma in the post radiation setting. C. Definitions Glioblastoma Multiforme (GBM) A lso referred to as a grade IV astrocytoma, is a fast-growing and aggressive brain tumor. It invades the nearby brain tissue, but generally does not spread to distant organs. Medically Necessary Services which are necessary for the diagnosis or treatment of disease, illness, and injury, and meet accepted guidelines of medical practice. A medically necessary service must be related to the illness or injury for which it is performed regarding type, intensity, and duration of service and setting of treatment. Tumor Treatment Fields (TTF) Mild electrical fields that vibrate through the skin of the scalp and disturb cancer cells ability to divide, possibly slowing tumor growth and spread. Kar nofsky Performance Status (KPS) An index that classifies the functional impairment of patients. . This can be used to compare the effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 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.3Response Assessment in Neuro-Oncology (RANO) A working group established to improve the assessment of tumor response and selection of end points, specifically in the context of clinical trials . D. Policy I. Tumor treatment field devices for glioblastoma multiforme are considered medically necessary when ALL of the following criteria have been met: A. The member has a new diagnosis of GBM ( grade IV astrocytoma). B. The member is age 22 years or older . C. The member has received initial treatment with surgery when reasonable. D. TTF therapy is initiated within 7 weeks from the last dose of chemotherapy or radiotherapy . E. The member has a Karnofsky Performance Scale (KPS) index of at least 6 0. F. TTF treatment will be used for an average of 18 hours per day. II. Continued coverage (beyond first 3 months of therapy) for newly diagnosed GBM and documentation of clinical benefit demonstrates ALL of the following: A. in-person clinical re-evaluation by treating practitioner B. obj ective evidence of adherence to therapy, reviewed by treating practitioner C. m aintain KPS of at least 60 D. if KPS is unavailable, then no evidence of progression by Response Assessment in Neuro-Oncology (RANO) criteria III. The following is a list of contraindications for TTF treatment (not all inclusive): A. cardiac pacemaker or implantable defibrillator B. deep brain, spinal cord, or vagus nerve stimulator C. major skull defect (eg, missing section of calvarium) D. metal within brain (eg, aneurysm clip, bullet fragment) E. programmable ventriculoperitoneal shunt F. pregnancy G. known sensitivity to conductive hydrogels (eg, gels used on electrocardiogram ) H. ECG stickers or transcutaneous electrical nerve stimulation (TENS) electrodes IV. CareSource considers TTF therapy for GBM only. Treatment of any other tumors is not medically necessary and experimental/investigational. V. The use of enhanced treatment planning software (Novotal) is non-covered because CareSource considers it to be e xperimental/investigational for ALL indications. E. Conditions of Coverage N/A F. Related Polic ies/Rules N/A Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 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.4G. Review/Revision HistoryDATE ACTIONDate Issued 09/29/2021 New Policy.Date Revised 07/06/2022 11/8/ /2023 11/06/2024 Updated references. No changes. Archived Jan.202 3. Added Section II (Continued coverage) . Approved at Committee. Removed PA language from policy. Updated references. Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. Alternating Electric Field Therapy ACG: A-0930 (AC). 2024 . Accessed October 22, 2024 . www.careweb. careguidelines.com 2. Batchelor T. Initial treatment and prognosis of IDH-wildtype glioblastoma in adults. UpToDate. Updated August 7, 2024. Accessed October 22, 2024 . www.uptodate.com 3. Burri SH, Gondi V, Brown PD, Mehta MP. The evolving role of tumor treating fields in managing glioblastoma: guide for oncologists. Am JClin Oncol . 2018;41(2):191-196. doi:10.1097/COC.0000000000000395 4. Chukwueke UN, Wen PY. Use of the Response Assessment in Neuro-Oncology (RANO) criteria in clinical trials and clinical practice. CNS Oncol. 2019;8(1):CNS28. doi:10.2217/cns-2018-0007 5. Fernandes C, Costa A, Osrio L, et al. Current standards of care in glioblastoma therapy . In: De Vleeschouwer S, ed. Glioblastoma. Codon Publications; 2 017. Accessed October 22, 2024. www.ncbi.nih.gov 6. Glioblastoma multiforme. American Association of Neurological Surgeons . Accessed October 22, 2024 . www.aans.org 7. Health Technology Assessment: Tumor Treatment Fields (Optune) for Treatment of Glioblastoma. Hayes; 2019. Reviewed January 5, 2023. Accessed October 22, 2024 . www.hayesinc.com 8. Kanderi T, Gupta V. Glioblastoma Multiforme. In: StatPearls. Treasure Island (FL): StatPearls Publishing; 2022. Accessed October 22, 2024 . 9. Karnofsky Performance Status Scale definitions rating criteria. National Palliative Care Research Center . Accessed October 22, 2024. www.npcrc.org 10. OPTUNE (NovoTTF-100A System) Patient Information and Operation Manual . Food and Drug Administration. Document QSD-QR-33 Accessed October 22, 2024 . www.accessdata.fda.gov 11. Wen PY, Chang SM, Van den Bent MJ, et al Response assessment in neuro- oncology clinical trials. JClin Oncol. 2017;35(21):2439-2449. doi:10.1200/JCO.2017.72.7511 ODM Approved 11/21/2024 Tumor Treatment Field Devices for Glioblastoma Multiforme-OH MCD-MM-1224 Effective Date: 03/01/2025 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.5I nde pendent med ica l r e view November 2020
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Transcervical Radiofrequency Ablation-OH MCD-MM-1563 03/01/2025 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 ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3Transcervical Radiofrequency Ablation-OH MCD-MM-1563 Effective Date: 03/01/2025 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 Transcervical Radiofrequency Ablation B. Background Uterine leiomyomas (fibroids) are the most common solid benign tumors of the uterus, estimated to occur in up to 70% of women by menopause. Uterine fibroids are associated with heavy menstrual bleeding, dysmenorrhea, pelvic pain, quality of life , and difficulty in achieving pregnancy. The combined effect of the direct costs attributable to fibroid diagnosis and treatment, plus the indirect costs due to work absenteeism and loss of productivity, are responsible for a significant economic burden of $34 billion annually in the United States. Hysterectomy and myomectomy are the most commonly performed surgical i nterventions for the treatment of uterine fibroids. Hysterectomy involves removal of the uterus (and generally, the cervix), with or without ovarian conservation. Myomectomy is an operation in which individual fibroids are removed, retaining the uterus and the potential for pregnancy. In recent years, leiomyoma ablation techniques have emerged as less invasive alternatives. Transcervical uterine ablation of leiomyomas combines reusable intrauterine ultrasound with a single-use intrauterine radiofrequency ablation (RFA) handpiece and needle electrode to facilitate targeted thermal ablation of symptomatic uterine leiomyomas. This creates coagulative necrosis within the treated leiomyoma. The Sonata system (Gynesonics Inc.) is a minimally invasive, uterine-sparing, ultrasound-guided system for performing transcervical RFA of fibroids in the outpatient setting. It integrates intrauterine ultrasound imaging with a radiofrequency treatment device to provide a uterus-conserving, transcervical incisionless treatment for a range of leiomyoma types and sizes. Sonata has received clearance by the FDA and has CE marking for use in the European Union. C. Definitions Leiomyomas also called uterine fibroids , are an extremely common benign neoplasm in women of reproductive age. They are composed of smooth muscle cells and fibroblasts. Myomectomy a surgical procedure to remove uterine fibroids while preserving the uterus . Radiofrequency Ablation a minimally invasive technique that shrinks the size of tumors by using heat to destroy tissue. Transcervical Radiofrequency Ablation-OH MCD-MM-1563 Effective Date: 03/01/2025 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.3D. Policy I. Transcervical ultrasound guided radiofrequency ablation (Sonata) is considered medically necessary as an alternative to myomectomy or hysterectomy for treating symptomatic uterine fibroid(s) when all the following criteria are met: A. u terine preservation is desired B. f ibroid(s) C. u terine size
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Safety Beds-OH MCD-MM-1457 03/01/2025 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-OH MCD-MM-1457 Effective Dat e: 03/01/2025 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 d isabilities , and autistic spectrum disorder . The use of these beds increase s 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 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 called i nstitutional, adaptive, enclosure bed, 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 required to prevent the member from leaving the bed at night without a supervis or. C. There should be r egular, 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. Documentation submitted to CareSource for review must show that the member meets the above criteria, and : Safety Beds-OH MCD-MM-1457 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.1. Bed alarms, door alarms, and standard rail padding failed to meet the medical needs of the member. 2. The safety bed is for the benefit of the member and not for any caregiver, family member, or provider. 3. The physician order for the safety bed is included. 4. The person-centered service pla n includes the use of a safety bed . 5. The invoice for the safety bed is retained and submitted along with the prior authorization and reimbursement requests . II. For members with specific medical needs, such as special positioning or IV poles, refer to Ohio Administrative Code 5160-10-18 for hospital beds, bed accessories,and pressure-reducing support surfaces. E. Conditions of CoverageN/A F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 03/01/2023 New policy. Approved at Committee.Date Revised 11/08/2023 11/0 6/2024Annual review. Coverage language refined. Approved at Committee. Annua l review: updated background and added documentation requirements . Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. Caggiari G, Talesa GR, Toro G, et al. What type of mattress should be chosen to avoid back pain and improve sleep quality? Review of the literature. JOrthop Traumatol . 2021;22(1):51. doi:10.1186/s10195-021-00616-5 2. DeGeorge KC, Neltner CE, Neltner BT. Prevention of unintentional childhood injury. Am Fam Physician . 2020;102(7):411-417. Accessed October 25, 2024. www.aafp.org 3. DMEPOS: hospital beds, bed accessories, and pressure-reducing support surfaces , OHIO ADMIN . CODE 5160-10-18 (2018). 4. Paruthi S, Brooks LJ, DAmbrosio C, et al. Recommended amount of sleep for pediatric populations: a consensus statement of the American Academy of Sleep Medicine. JClin Sleep Med . 2016; 2(6) :785-786. doi:10.5664/jcsm.5866 5. Services and Supplies Never Covered , OHIO ADMIN . CODE 4123-6-07 (2021). 6. 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 2/15/2023Safety Beds-OH MCD-MM-1457 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.Approved ODM 11/21/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Hypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea-OH MCD-MM-1253 03/01/2025 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 ………………………….. ………………………….. ………………………….. …… 5 H. References ………………………….. ………………………….. ………………………….. …………………….. 5 Hypoglossal Nerve Stimulation for the Treatment ofObstructive Sleep Apnea-OH MCD-MM-1253Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectHypoglossal Nerve Stimulation for the Treatment of Obstructive Sleep Apnea B. BackgroundObstructive Sleep Apnea (OSA) is a chronic disorder characterized by recurrent repisodes of upper airway obstruction during sleep. Th e untreated disruption of airflow caused by OSA is associated with multiple comorbidities , such as nocturnal hypoxemia, cardiac arrhythmia, hypertension, an increased risk of cardiovascular disease , cessation of breathing, loud snoring, and daytime sleepiness. Continuous positive airway pressure (CPAP) therapy, which delivers oxygen in a continuous stream independent of whether the patient is inhaling or exhaling a breath, has been the mainstay therapy for treat ment of OSA. However, despite its efficacy and manufacturers redesigns to make the devices more comfortable, a large percentage of patients are unable to tolerate CPAP therapy , and adherence is low. As a result, alternative treatment strategies are necessary . The hypoglossal nerve is the twelfth cranial nerve and innervates all the extrinsic and intrinsic muscles of the tongue, except for the palatoglossus , which is innervated by thevagus nerve. It is a nerve with a solely motor function. The nerve arises from the hypoglossal nucleus in the brain stem as a number of small rootlets, passes through the hypoglossal canal and down through the neck, and eventual ly passes up again over the tongue muscles it supplies into the tongue. There are two hypoglossal nerves i n the body: one on the left and one on the right. The hypoglossal nerve stimulator ( HGNS ) is an implanted medical device that works toreduce the occurrence of OSA by electrically stimulating the hypoglossal nerve to the tongue. A surgeon implants the system containing a neurostimulator subcutaneously in the patients upper right chest, with one lead attached to the patients hypoglossal nerve (cranial nerve XII) at the base of the tongue . The lead in the chest consists of a pressure sensor that detects breathing. Information about respiration rate is rela yed to the device, which stimulates the hypoglossal nerve in the tongue. When stimulated, the tongue moves forward, opening the airway. The patient can operate the device by remote control, which the patient activates before going to sleep. The device turn s on after 20 minutes to minimize disrupting the patients sleep onset . T he device must be manually turned off via remote when the patient wakes. C. Definitions Apnea-Hypopnea Index (AHI) The number of respiratory events (apneas, hypopneas) divided by the number of hours of sleep documented during a PSG or other sleep study. Drug Induced Sleep Endoscopy (DISE) A diagnostic tool to assess the upper airway of snorers and OSA patients in conditions that mimic natural sleep. Due to documented inconsistency in determining if complete concentric collapse (CCC) is present, the inserting provider shall be certified by the FDA-approved manufacturers second opinion service of validation via video clip submissions of at least 80% Hypoglossal Nerve Stimulation for the Treatment ofObstructive Sleep Apnea-OH MCD-MM-1253Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 agreement in at least 15 consecutive studies. Inserting providers shall have documentation to submit to this contractor if requested. Hypoglossal Nerve The twelfth cranial nerve that stimulates all the extrinsic and intrinsic muscles of the tongue, except for the palatoglossus, which is stimulated by the vagus nerve . Obstructive Sleep Apnea (OSA) A disease characterized by recurrent episodes of upper airway obstruction during sleep . Polysomnography (PSG) The gold standard lab test used to diagnose obstructive sleep apnea. D. PolicyI. CareSource considers HGNS for the treatment of moderate to severe OSA medically necessary when ALL the following clinical criteria are met: A. A pulmonary specialist, internal medicine provider , or sleep medicine specialist verifies the member is eligible for treatment . B. If the member has a cardiac condition, this requires clearance from a cardiologist . C. The member is 18 years of age or older . D. Body mass index (BMI) is less than 35 kg/m2 . E. An in-lab (eg, PSG) or home sleep study has been performed no more than 24 months before the first consultation of the HGNS implant, and there has not been a change of body weight by 10% or more from the time of the diagnostic sleep study . F. Member has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total AHI ). G. AHI is 15 to 65 events per hour . H. Member has documentation that demonstrates bilevel positive airway pressure (BiPAP) or CPAP failure: 1. defined as AHI greater than 15 despite BiPAP or CPAP usage 2. BiPAP or CPAP intolerance (defined as less than 4 hours per night, 5 nights per week or the BiPAP or CPAP has been returned) 3. shared decision making that the patient was intolerant of BiPAP or CPAP in consultation with a sleep expert I. Complete concentric collapse at the soft palate level is absent on a DISE procedure . J. There are no other anatomical findings that would compromise performance of device (eg, tonsil size 3 or 4 per standardized tonsillar hypertrophy grading scale). II. CareSource considers the following not medically necessary and , therefore, not covered : A. HGNS is considered not medically reasonable and necessary for all other indications . Hypoglossal Nerve Stimulation for the Treatment ofObstructive Sleep Apnea-OH MCD-MM-1253Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 B. Non-FDA-approved HGNS is considered not medically reasonable and necessary for the treatment of adult OSA due to insufficient evidence of safety and efficacy . C. HGNS is considered not medically reasonable and necessary when ANY of the following contraindications are present : 1. members with central and mixed apneas that make up more than one-quarter of the total AHI 2. members with an implantable device could experience unintended interaction with the HGNS implant system 3. BMI equal to or greater than 35 4. neuromuscular disease 5. hypoglossal-nerve palsy 6. severe restrictive or obstructive pulmonary disease 7. moderate-to-severe pulmonary arterial hypertension 8. severe valvular heart disease 9. New York Heart Association Class III or IV heart failure 10. recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months) 11. persistent uncontrolled hypertension despite medication use 12. an active, serious mental illness that reduces the ability to carry out Activities of Daily Living (ADLs) and interfere s with the ability to operate the H GNS and report problems to the attending provider 13. coexisting non-respiratory sleep disorders that would confound functional sleep assessment 14. member s who are, or who plan to become pregnant 15. members requir ing Magnetic Resonance Imaging (MRI) with Inspire model 3024 16. members requir ing MRI with Inspire model 3028, can undergo MRI on the head and extremities if certain conditions and precautions are met (refer to the manufacturer guidelines for this model and future model s for more information ) 17. members unable or without the necessary assistance to operate the sleep remote 18. members with any condition or procedure that has compromised neurological control of the upper airway E. Conditions of CoverageN/A F. Related Policies/RulesN/A Hypoglossal Nerve Stimulation for the Treatment ofObstructive Sleep Apnea-OH MCD-MM-1253Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 G. Review/Revision HistoryDATE ACTIONDate Issued 02/16/2022 New PolicyDate Revised 02/15/2023 02/14/2024 12/04/2024Lowered age to 18 to make less restrictive. Added BiPAP .Annual review : editorial changes to policy document, added definitions, and updated references . Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. Baptista PM, Costantino A, Moffa A, et al. Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: patient selection and new perspectives. Nat Sci Sleep . 2020;12:151-159. doi:10.2147/NSS.S221542 2. Chang JL, Goldberg AN, Alt JA, et al. International consensus statement on obstructive sleep apnea. Int Forum Allergy R hinol . 2023;13(7):1061-1482. doi:10.1002/alr.23079 3. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO): indications for metabolic and bariatric surgery. Obes Surg . 202 3;33 (1): 3-14 . doi:10.1007/s11695-022-06332-1 4. Gottlieb DJ, Punjabi NM. Diagnosis and management of obstructive sleep apnea: a review. JAMA . 2020;323(14):1389-1400. doi:10.1001/jama.2020.3514 5. Kim DH, Kim SW, Han JS, et al. Hypoglossal nerve stimulation effects on obstructive sleep apnea over time: a systematic review and meta-analysis. Otolaryngol Head Neck Surg . 2024;170(3):736-746. doi:10.1002/ohn.617 6. Mashaqi S, Patel SI, Combs D, et al. The hypoglossal nerve stimulation as a novel therapy for treating obstructive sleep apnea a literature review. Int JEnviron Res Public Health . 2021;18(4):1642. doi:10.3390/ijerph18041642 7. Olson MD, Junna MR. Hypoglossal nerve stimulation therapy for the treatment of obstructive sleep apnea. Neurotherapeutics . 2021;18(1):91-99. doi:10.1007/s13311 – 021-01012-x 8. Position statement: hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA) . American Academy of Otolaryngology-Head and Neck Surgery (AAO – HNS). Revised April 22, 2021. Accessed November 12, 2024. www.entnet.org 9. Schwartz AR, Jacobowitz O, Eisele DW, et al. Targeted hypoglossal nerve stimulation for patients with obstructive sleep apnea: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg . 2023;149(6):512-520. doi:10.1001/jamaoto.2023.0161 10. Suurna M. Hypoglossal nerve stimulation for adult patients with obstructive sleep apnea. UpToDate. Updated May 28, 2024. Accessed November 12, 2024 . www.uptodate.com Hypoglossal Nerve Stimulation for the Treatment ofObstructive Sleep Apnea-OH MCD-MM-1253Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 11. Tietjens JR, Claman D, Kezirian EJ, et al. Obstructive sleep apnea in cardiovascular disease: a review of the literature and proposed multidisciplinary clinical management strategy. JAm Heart Assoc . 2019;8(1):e010440. doi:10.1161/JAHA.118.010440 12. Yeghiazarians Y, Jneid H, Tietjens JR, et al. Obstructive sleep apnea and cardiovascular disease: a scientific statement from the American Heart Association. Circulation . 2021;144(3):e56-e67. doi:10.1161/CIR.0000000000000988 Independent med ical review February 2022ODM Approved 12/12/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 03/01/2025 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 wit hout which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a bo dy organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………….. ………………………….. ………………………….. ……………………. 2 B. Background ………………………….. ………………………….. ………………………….. ……………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………… 4 D. Policy ………………………….. ………………………….. ………………………….. ………………………. 5 E. Conditions Of Coverage ………………………….. ………………………….. ………………………… 13 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. 15 G. Review/Revision History ………………………….. ………………………….. ……………………….. 15 H. References ………………………….. ………………………….. ………………………….. …………….. 15 Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectApplied Behavior Analysis Therapy 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 var ies 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 acr oss 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, th ere 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 the member and fami ly/caregiver (s). Applied behavior analysis (ABA), one such therapy, may be provided in centers or at home and provi des an evidence-ba se d 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 each 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 Ohio Administrative Code (OAC) and Ohio Department of Medicaid (ODM) guidelines in the provision of ABA services, based on a diagnosis from the DSM-5-TR . Severity levels are divided into 2 domains, social communication and restricted, repetitive behaviors: Severity Levels for Autism Spectrum DisorderSeverity Level Social Communication Restricted, repetitive behaviors Level 3 Requiring very substantial support Severe deficits in verbal & nonverbal social communication skills cause severe impa irments in functioning, very limited initiation of social interactions, Inflexibility of behavior, extreme difficulty coping with change, or other restricted/ repetitive behaviors markedly interfere with functioning in all spheres. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 and minimal response to social overtures from others. 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 overtur es 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 in clude clearly defined goals, teach desired behaviors, provide prompting for natural display of desired behaviors, provide reinforcement of demonstrated behaviors, and 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. ASD services do not include education services otherwise available through a program funded under 20 US Code Chapter 3, section 1400 of the Individuals with Disabilities Ed ucation 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-OH MCD-MM-0028 Effective Dat e: 03/01/2025 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 (ABA ) The design, implementation, and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvement in human behavior, including the use of direct observation, measurement, and functional analysis of the relationship between environment and behavior. Caregiver/Family Trainin g Therapist teaches parents/caregivers to implement methods utilized in a clinical setting i nto other environments, such as the home or community, to maximize member outcomes by furthering the generalization of skills and reinforcing methods being taught to the member in other sessions. Functional Assessment The determination of underlying function or purpose of behavior to develop an effective treatment plan, including a variety of systematic, information gathering techniques regarding factors influencing behavior occurrence (eg, antecedents, consequences, s etting events and motivating operations), such as interview, indirect assessment, direct observation, descriptive assessment, experimental analysis, and systematic manipulation of environmental variables to demonstrate a relationship between an event and t argeted behavior. Independent Practitioner All ABA services must be provided by a provider/practitioner compliant with Ohio Revised Code 4783.02 with approved supervision, as applicable , including the following (not an all-inclusive list): o Board Certified Assistant Behavior Analyst (BCaBA) o Certified Ohio Behavioral Analyst (COBA) or Board-Certified Behavior Analyst (BCBA) o Board Certified Behavior Analyst – Doctoral (BCBA-D) o Registered Behavior Technician (RBT) Medically Unlikely Edit (MUE) Maximum units of service for 1 Current Procedural Terminology (CPT) code a provider can report for 1 member on 1 date of service. Standardized Diagnostic Assessment Tool s Direct assessment, e vidence – based tools designed to assist with identification of symptoms and criteria for a diagnosis or disorder. SMART Goal s Goals that are specific (S) , measurable (M) , attainable (A) , relevant (R) , and time-bound (T) . Supervisio n Directing, guiding, training , and assessing individuals who provide behavior-analytic services with responsibilities in accordance with the board from which the practitioner received a license. o BCaBAs ervices must be supervised by a COBA/ BCBA, BCBA-D, or a licensed psychologist who has tested in ABA and is certified by the American Board of Professional Psychology in Behavioral and Cognitive Psychology . Treatment Plan A written document describing presenting behavior problem(s) and behavioral goals and interventions selected to alter behavior based on information gathered from in-person assessments, review of records from other professionals, direct observation, and clinical interview data, including an estimate of the length of time and/or number of sessions anticipated to achieve goals and specific statements about the measurement of progress toward achieving goals. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 D. PolicyI. General Guidelines A. Medical necessity review is required for all ABA services initially with a baseline and then, again, every 6 months. Medical review must be submitted with appropriate documentation as indicated in this policy and align with the States definition of medical necessity that includes 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. B. ABA therapy should begin early in life, ideally by the age of 2, typically lasting up to 3 to 4 years and is subject to the members response to treatment. C. Members under the age of 21 will be assessed. Treatment goals and intensity will be based on individual needs and progress in treatment with a focus on remediation of symptoms. D. The members treatment record (eg, plans of care, treatment plans, behavior support plans, functional assessments, daily service notes, progress notes) must be completed by the provider or practitioner and submitted to CareSource prior to claim submission. Claims will not be accepted without accompanying treatment documentation . II. Initia tion of ABA ServicesA. Documentation: CareSource must receive documentation that confirms the following medical criteria: 1. definitive, primary diagnosis of ASD made by one of the following practitioner s upon evaluation : a. child and adolescent psychiatrist b. psychologist c. child neurologist d. developmental pediatrician 2. standardized diagnostic assessment tools that are considered multidisciplinary evaluations, including a. Autism Diagnostic Observation Schedule (ADOS) b. Autism Diagnostic Interview Revised (ADI-R) c. Childhood Autism Rating Scale, 2 nd edit. (CARS-2) 3. written documentation ( eg, provider letter ) that d escri bes DSM clinical symptoms present within the past year requir ing treatment if the submitted diagnostic evaluation was completed more than 24 months from date of request B. Initial Behavior Assessment: Before services are provided, an initial behavior identification assessment will be performed by a fully credentialed BCBA with state licensure, if available, and devel op a treatment plan. Generally, b ehavioral assessments are not to exceed 6-10 hours every 6 months , unless additional justification is provided. C. Initial Treatment Plan: An initial ABA treatment plan individualized to the caregiver/family needs, values, priorities and circumstances for member goals Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 and parent/caregiver training will be developed by the member, family/caregiver,and provider and m ust include the following: 1. biopsychosocial information, including, but not limited to: a. current family structure b. medication history, including dosage and prescribing physician c. medical history d. school placement and hours in school per week, including homeschool instruction and any individualized education plans (IEP) e. history of ABA services, including service dates and progress notes f. all behavioral health diagn oses and services, including any hospitalizations g. other services member is receiving (eg, speech therapy [ST] , occupational therapy [OT], physical therapy [PT]) , including evidence of coordination with other disciplines involved in the assessment h. caregiver proficiency and involvement in treatment i. any major life changes 2. rationale for ABA services (eg, how ABA addresses current areas of need ), including the following : a. history with symptom intensity and symptom duration, including how symptoms affect the members ability to function in various settings b. evidence of previous therapy ( eg, outcomes from previous ABA treatment, ST, OT, PT) and how result s influence proposed treatment c. type, duration, frequency for services 3. goals related to core deficits ( eg, communication problems, relationship development, social and problem behaviors) must includ e the following: a. outcome driven , performance-based, and individualized measures focused on targeted symptoms, behaviors, and functional impairments b. based on the direct behavioral assessment and a standardized developmental and functional skills assessment/curriculum ( eg, Verbal Behavior Milestones Assessment and Placement Program [VB-MAPP ], Assessment of Basic Language and Learning Skills [ABLLS-R]). c. a description of treatment activities and documentation of active participation by member and caregiver/family in the implementation of treatment OR documentation detailing barriers to family/ caregiver participation and how those barriers are being actively addressed d. SMART goals that define how improvement will be noted, frequency of treatment (number of hours per week), and duration of treatment 4. Behavioral Intervention Plan and/or a Plan of Care (POC) 5. requested number of ABA hours per week based on the members specific needs , not on a general program structure , as evidenced by all of the following: a. Treatment is provided at the lowest level of intensity appropriate to the members clinical needs and goals with the number of hours requested reflecting the actual number of hours intended to be provided . Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 b. A d etailed description of problems, goals and interventions support the requested intensity of treatment . 6. a plan to modify the intensity and duration of treatment over time based on the members progress, including an individualized discharge plan specific to treatment needs 7. coordination with other behavioral health and medical providers III. Continuation of ABARequests for continuation of ABA services are to be submitted every 6 months, and documentation must meet EITHER of the following criteria: A. A d efinitive diagnosis of ASD persists , and m ember continues to demonstrate ASD symptoms that will benefit from treatment in at least two settings . B. A t reatment plan as noted in D. II. C., including the following: 1. an updated progress report with assessment scores that note improvement and member response to treatment from baseline targeted symptoms, behaviors, and functional impairments using the same modes of measurement utilized for baseline measurements 2. a plan to transition services in intensity over time C. Parent/caregiver(s) are involved and making progress in development of behavioral interventions. OR D. When requesting continuation with inadequate progress on targeted symptoms or behaviors or no demonstrable progress within a 6-month period, an assessment of the reasons for lack of progress should be documented and provided. Treatment interventions should be modified to achieve adequate progress. Documentation should include 1. change in possible treatment techniques 2. increased parent/caregiver training 3. increased time and/or frequency working on specific targets 4. identification and resolution of barriers to treatment efficacy 5. any newly identified co-existing disorders and possible treatment 6. modified or removed goals and interventions IV. Discontinuation of ABA TherapyTitration or discontinuation of ABA therapy should occur when any of the following conditions are met (not an all-inclusive list): 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 worsens symptoms, behaviors or impairments. D. Symptoms stabilize allowing member to transition to less intensive treatment or level of care. E. Parents/caregivers have refused treatment recommendations, are unable to participate in the treatment program, and/or do not follow through on treatment Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 recommendations to an extent that compromises the effectiveness of the services for member progress.V. Parent/ Caregiver TrainingTraining will evolve as goals are met . Parent/caregiver should be actively working on at least 1 unmet goal . ABA services must include documentation of the following: A. understand ing and agree ment to comply with the requirements of treatment B. how the parents/caregivers will be trained in skills that can be generalized to the home and other environments C. methods by which the parents/caregivers will demonstrate trained skills D. barriers to parent involvement and plans to address (eg, are treatment goals addressed when treatment professionals are not present , overall skill abilities ) E. time involvement, including materials or meetings occurring on a routine basis VI. TelehealthParent/caregiver training and supervision may be provided by telehealth . 1:1 ABA services may be provided via telehealth in instances deemed medically necessary with supporting documentation that provides a plan for the provision of service delivery. 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 available resou rces 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, technolog y limitations, and cultural acceptance of virtual visits. Providers must identify protocols for clinical appropriateness (eg, risk assessment, safety planning, patient/caregiver characteristics), ensure therapeutic benefit for recipients, and ensure provid er competence of delivering care via telehealth modalities. Peer 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 pa rticular clients. VII. Documentation RequirementsThe State of Ohio enacts code related to requirements for documentation expectations for client records maintained for third party billing. Each dated entry in the professional record is maintained for a period of not less than 7 years after the last date of service or not less than the length of time required by other regulations if longer. Records documenting services rendered to minors must be retained for not less than 2 years after the minor reaches the age of majority or for 7 years after the last da te of service, whichever is longer. All written, electronic and other records will be stored and disposed of in such a manner as to ensure confidentiality . All must be legible . Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 A. Minimum documentation requirements for ABA client records include the following: 1. presenting problem, including any relevant diagnosis and any recommendation for ABA services rendered by a licensed professional 2. date(s) and purpose of each service contact (eg, service note) 3. fee arrangement 4. treatment plan and functional assessment on which behavior plan is based 5. data collected to ascertain efficacy of ABA and any subsequent modifications of the plan 6. notation and results of formal contacts with other providers 7. authorizations, if any, by the client for release of records or information B. Minimum documentation requirements for for all service s rendered include 1. name of provider organization clearly visible on the record 2. members name on each page (ie, legal name) with date of birth or unique identifier 3. start and stop times of the session , including any pauses in services (must indicate time paused and time resumed) 4. date and location of rendered service and date of note creation if different from date of rendered service 5. type/code of service provided 6. provider rendering the service with appropriate credentials and dated signature 7. dated signature of parent/guardian or member, depending on member age 8. identification of others present, including the relationship to the member and number of individuals participating in group sessions 9. interventions occurring during the session that directly relate to the POC and client response to interventions 10. any needed modifications to treatment or items requiring follow up from previous sessions , including any addendums to the record VIII. Codes of ConductCodes of conduct exist to meet credentialing needs of professionals but also function to protect members by establishing, disseminating, and managing professional standards. Ohio mandates that providers of ABA services understand and follow codes of conduct supporting the profession. CareSource supports professional standards established by licensing and credentialing bodies, and therefore, encourages professional compliance to any and all standards across disciplines for the protection of members and famil ies. The ethics code written by the Behavior Analyst Certificat ion Board 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. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 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. IX. Supervision ExpectationsThe State of Ohio enacts code for supervision requirements and documentation expectations for providers within the profession . The BACB provides guidelines for supervision requirements and documentation expectations for providers within the profession. If there are discrepancies with supervision documentation, the associated claims are subject to recoupment. A. At a minimum, supervision must include the following activities : 1. consultation with the supervisee(s) prior to initiation of the treatment plan 2. training regarding implementation of the treatment plan, data collection regarding effectiveness, and measurement of client progress 3. consultation with the supervisee(s) prior to modification of the treatment plan 4. periodic direct observation of each supervisee implementing assessment and treatment procedures with clients, including performance evaluation and additional instruction as necessary B. Record Maintenance Supervision records will be maintained by certified Ohio behavior analysts for a period of 5 years , BCBAs /RBTs for 7 years , following the termination of supervision, which include the following documents , at a minimum: 1. supervision plans for each client treatment plan 2. dates of training on treatment plans, procedures, and interventions 3. supervision provided when treatment plans are reviewed or modified C. General supervision documentation records must include the following information (not an all-inclusive list) : 1. date and start/stop time s of supervision session 2. names, credentials and/or relationship of individuals present at each session 3. type of supervision (general or direct) 4. purpose of supervision, including any collaborati on of care among providers 5. outcome of supervision, including any modification to treatment inventions or plans of care, including the following information: a. review of services provided b. review of data forming basis of a continued treatment plan Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 c. review of client progress, including results of tools noting progress6. name and credentials of the supervisor (if documenting for billing purposes, the supervisors National Provider Identifier), included dated signature 7. dated signature of supervisee, including credentials D. 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. fie ldwork 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 c. setting name d. supervisor name e. activity category (restricted or unrestricted) E. CareSource supports BACB published ethical codes related to supervision for the provision of services to clients, including, but not limited to 1. Behavior analysts (BA) are knowledgeable about and comply with all applicable supervisory requirements, funder and organization policies), including those related to supervision modalities and structure. 2. BAs supervise and train others only within an individual identified scope of competence. 3. BAs take on only the number of supervisees allowing effective supervision and training. When a threshold volume for providing effective Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 supervision has been met, documentation of this self-assessment and communication of results to employer(s) and relevant parties must occur. 4. BAs are accountable for supervisory practices and professional activities (eg, client services, supervision, training, research activity, public statements) of supervisees occurring as part of that relationship. 5. BAs ensure that documentation, and the documentation of supervisees or trainees, is accurate and complete. 6. BAs 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 p ositive reinforcement, and are individualized for each supervisee and circumstances. 7. BAs 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. X. Special Provisions Related to RBTsA. Current Standards for RBTs 1. RBT services must be supervised by a qualified RBT supervisor. RBTs must obtain ongoing supervision for a minimum of 5% of the hours spent providing ABA services per month. Additionally, the BACB publishes information regarding the structure of supervision and parameters for group and individual supervision in the RBT Handbook. 2. An RBT who is 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 super vision, the RBT may not continue to provide services to the member. 3. RBTs must use appropriate modifiers that indicate qualifications of staff delivering services , if appropriate. 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 this 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 e ligibility for and maintenance of certification for RBTs were adopted by the BACB Board of Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 Directors and can be located in the BACB Newsletter: December 2023 at www.bacb.com. XI. ExclusionsA. reimbursement for the following services or activities is not permitted: 1. any services not documented in the treatment pla n 2. behavioral methods or modes considered experimental 3. education-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. components of adult day care programs B. treatment solely for the benefit of the family, caregiver , or therapist C. treatment focused on recreational or educational outcomes D. treatment worsening symptoms or prompting member regression E. treatment for sy mptoms and behaviors not part of core symptoms of ASD ( eg, impulsivity due to ADHD, reading difficulties due to learning disabilities, excessive worry due to an anxiety disorder) F. goals focused on academic targets ( eg, treatment should address autistic symptoms impeding deficits in the home environment , such as reduc tion of frequency of self-stimulatory behavior to follow through with toilet training or complet ing a mathematic sorting task) G. treatment unexpected to cause measurable , functional improvement or improvement is not documented H. duplicative t herapy services addressing the same behavioral goals using the same techniques as the treatment plan, including services under an IEP I. services provided by family or household members J. care primarily custodial in nature and not requir ing trained/professional ABA staff K. shadowing, para-professional, or companion services in any setting L. personal training or life coaching M. services more costly than an alternative service(s), which are as likely to produce equivalent diagnostic or therapeutic results for the member N. any program or service performed in nonconventional settings, even if performed by a licensed provider ( eg, spas/resorts, vocational or recreational settings, Outward Bound, 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 prepayment review. Program Integrity will be engaged for an annual review of data. II. When a member has other insurance, Medicaid is always the pay er of last resort.CareSource will not pay more than the Medicaid rate totals for service. Primary payer Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 must provide evidence of determinations for consideration of Medicaid coverage for services.III. CareSource reserves the right to request supervision documentation, particularly related to telehealth services.IV. 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.V. CareSource complies with the Centers for Medicare and Medicaid Services (CMS)medically unlikely edit (MUE) table. If CMS updates the MUE list, the update will take precedence over this policy. The following applies to ABA CPTs: CPT Max imum Unit s Allowed 97151 32 97152 16 97153 32 97154 18 97155 24 97156 16 97157 16 97158 16 0362T 16 0373T 32 VI. Treatment codes are based on daily total units of service in 15-minute increments. A unit of time is att ained when the mid-point is passed. The following are time interval examples: Unit (s) Number of Minutes 1 unit >8-22 minutes 2 units >23 – 37 minutes 3 units >38 – 52 minutes 4 units >53 – 67 minutes 5 units >68 – 82 minutes 6 units >83 – 97 minutes 7 units >98 – 112 minutes 8 units >113 – 127 minutes VII. ODM allows Mental Health Community Behavioral Health Centers (CBHCs), provider type 84, to render and be reimbursed for ABA services using the service code H0036-Community Psychiatric Supportive Treatment (CPST). CareSource strongly encourages CBHCs to use ABA CPT codes outlined above for billing purposes but does accept H0036 when submitted by an appropriately certified CBHC. Expectations of this policy apply to all ABA services , whether billed using ABA CPTcodes or H0036. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 F. Related Policies/RulesI. CareSource Documents A. Coordination of Benefits B. Medical Necessity Determinations II. Other Sources A. Privileged Communications, OHIO REV . CODE 2317.02 (2017). B. Definitions, 42 U.S.C. 1396d (2019). G. Review/Revision HistoryDATE ACTIONDate Issued 10/04/2018Date Revised 01/27/2020 01/25/202108/04/202103/30/202201/04/202304/ 12 /202303/13 /202409/25/202410/23/2024Added program attributes, definitions of provider types and ABA ; title change ; clarified PAd services ; changed NP to healthcare provider trained in ASD ; added IV , willingness to participate , description of p oc, ages ; clarified provider requirements ; added ASD diagnosis, home school /IEP, doc requirements, type of ASD treatment program with PA ; revised continuation of A BA therapy requirements . Added AFLS, ESDM and PEAK-DT assessments & section on ABA transition to school , revised discontinuation criteria & exclusions; removed PA checklist. Clarified telehealt h, moved doc requirements to Medical Records Doc for Practitioners ; re moved transition to school section ; updated school section & RBT supervision ; u pdated definitions & ABA criteria. Removed PA language. III.B.1. Primary diagnosis by a qualified practitioner. Added to section 5. F.02: Removed old section M. to sec. DIII 5.g. added ABA services must include parent/family training . Edited Sec. V. Removed VII. A E-voted ODM changes Sec. B. 1 and 2 Consolidated information into Sec. IV. Initial ABA Treatment Plan. Added Sec. V.J. Pare nt/Caregiver Involvement. Updated references. Reorganized policy & updated definitions. Removed 1:1 telehealth ABA exclusion. Removed I under Exclusions . Annual review. Added VII-X. Merged AD policy info to Cond of Coverage section. Updated H. Approved at Committee. Out of cycle review. Adde d backgroun d, D.I.D, IX.E., E.IV. Updated references. Approved at Committee . Out of cycle review. Removed parent signature as requirement per ODM. Approved at Committee. Date Effective 03/01/2025 Date Archived H. References1. 2024 Q2 NCCI MUE Edits-Practitioner Services . Centers for Medicare and Medicaid Services. Updated March 1, 2024. Accessed September 16 , 2024. www.cms.gov 2. Additional Medicaid Waiver Components for Home and Community-Based Services, OHIO REV . CODE 5166.20 (2016). 3. 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-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 (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 4. Applied Behavior Analysis: B-806-T. MCG. 2 8th ed. Updated March 14 , 202 4. Accessed September 16 , 2024. www.careweb.careguidelines.com 5. Augustyn M. Autism spectrum disorder in children an d adolescents: evaluation and diagnosis. Up ToDate. Updated May 16, 2022. Accessed September 16, 2024 . www.uptodate.com 6. Augustyn M. Autism spectrum disorder (ASD) in children and adolescents: terminology, epidemiology, and pathogenesis. Up ToDate. Updated January 24, 2024. Accessed September 16, 2024 . www.uptodate.com 7. Augustyn M, Von Hahn E. Autism spectrum disorder in children and and adolescents: clinical features. Up ToDate. Updated May 17, 2023. Accessed September 16, 2024 . www.uptodate.com 8. Autism spectrum disorder. American Academy of Pediatrics . Updated April 5, 2023. Accessed September 16, 2024 . www.aap.org 9. Autism spectrum disorder in young children: screening. U.S. Preventive Services Task Force; 2016. Accessed September 16 , 2024. www.uspreventiveservicestaskforce.org 10. Autism Spectrum Disorders: M-7075. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 11. Autism Spectrum Disorders: B-012-HC. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 12. Autism Spectrum Disorders, Adult, Inpatient Care: B-012-IP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 13. Autism Spectrum Disorders, Child or Adolescent: B-019-IP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 14. Autism Spectrum Disorders, Intensive Outpatient Program: B-012-IOP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 15. Autism Spectrum Disorders, Outpatient Care: B-012-AOP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 16. Autism Spectrum Disorders, Partial Hospitalization Program: B-012-PHP. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 17. Autism Spectrum Disorders, Residential Care: B-012-RES. MCG. 28th ed. Updated March 14, 2024 . Accessed September 16 , 2024. www.careweb.careguidelines.com 18. BACB Newsletter . Behavior Analyst Certfication Board; September 2023. Accessed September 16, 2024 . www.bacb.com 19. BACB Newsletter: Introducing the 2026 RBT Examination and Certification Requirements . Behavior Analyst Certification Board; December 2023. Accessed September 16, 2024 . www.bacb.com 20. 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-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 21. Board Certified Behavior Analyst Handbook . Behavior Analyst Certification Board.Updated December 2023. Accessed September 16 , 2024. www.bacb.com 22. Board Certified Assistant Behavior Analyst Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed September 16 , 2024. www.bacb.com 23. 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 an d disrupted sleep behavior in children and adolescents with autism spectrum disorder. Neurology . 2020;94(9):392-404. doi:10.1212/WNL0000000000009033 24. Certified Ohio behavior analyst supervision. State of Ohio Board of Psychology. Accessed September 16, 2024 . www.psychology.ohio.gov 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 , I: common clinical challenges of patients with mental health or behavioral emergencies. Pediatr. 2016;138(3):e20161570. doi: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 , II: recognition of clinically challenging mental health related conditions presenting with medical or uncertain symptoms. Pediatr. 2016;138(3):e20161573. doi:10.1542/peds.2016-1573 27. Coverage for Autism Spectrum Disorder, OHIO REV . CODE 1751.84 (2021). 28. Crockett, JL, Fleming RK, Doepke K, et al. Parent training: acquisition and gene ralization of discrete trials teaching skills with parents of children with autism. Res Dev Disabilities . 2007; 28 (1):23-36. doi :10.1016/j.ridd.2005.10.003 29. Ethics Code for Behavior Analysts . Behavior Analyst Certification Board; 2020. Updated January 1, 2023. Accessed September 16 , 2024. www.bacb.com 30. Evidence Analysis Research Brief: Applied Behavior Analysis Training Via Telehealth for Caregivers of Children with Autism Spectrum Disorder . Hayes; 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 31. Evidence Analysis Research Brief: Direct-To-Patient Applied Behavior Analysis Telehealth for Children with Autism Spectrum Disorder . Hayes; 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 32. 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 33. Health Technology Assessment: Comparative Effectiveness Review of Intensive Behavioral Intervention for Treatment of Autism Spectrum Disorder . Hayes; 2019. Updated February 10, 2022. Accessed September 16 , 2024. www.evidence.hayesinc.com 34. Hyman S, Levy S, Myers S ; Council on Children with Disabilities. Developmental and behavioral pediatrics : identification, evaluation, and management of children with Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 autism spectrum disorder . Pediatr . 2020 ;145(1) :e20193447 . d oi:10.1542/peds.2019-3447 35. Information on autism spectrum disorder for healthcare providers. Centers for Disease Control and Prevention (CDC). Updated December 6, 2022. Accessed September 16 , 2024. www.cdc.gov 36. 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 37. 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 38. Lim N, Russell-George A. Home-based early behavioral interventions for young children with autism spectrum disorder. Clin Psycho l. 2022;29(4):415-416. doi:10.1037/cps0000117 39. Registered Behavior Technician Handbook . Behavior Analyst Certification Board. Updated December 2023. Accessed September 16 , 2024. www.bacb.com 40. Medicare Claims Processing Manual. Centers for Medicare and Medicaid Services; 2024. Publication # 100-04 . Accessed September 16 , 2024. www.cms.gov 41. 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:10.1037/bar0000277 42. Society guideline links: autism spectrum disorder. Up ToDate. Accessed September 16 , 2024. www.uptodate.com 43. Standards for Telehealth Services, OHIO REV . CODE 4743.09 (2023). 44. State Board of Psychology-Certified Ohio Behavior Analysts, OHIO ADMIN . CODE 4783-1 to 11 (2023). 45. 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 46. Weissman L. Autism spectrum disorders in children and adolescents: behavioral and educational interventions . Up ToDate. Updated December 4, 2023. Access ed September 16 , 2024. www.uptodate.com 47. Weissman L. Autism spectrum disorder in children and adolescents: overview of management. Up ToDate. Updated September 8, 2023. Accessed September 16 , 2024. www.uptodate.com 48. Weissman L. Autism spectrum disorder in children and adolescents: pharmacologic interventions. Up ToDate. Updated May 30, 2024 . Accessed September 16 , 2024. www.uptodate.com 49. Weissman L. Autism spectrum disorder in children and adolescents: screening tools. Up ToDate. Updated January 24, 2024. Accessed September 16 , 2024. www.uptodate.com Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 03/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.19 50. Weissman L. Autism spectrum disorder in children and adolescents: surveillance and screening in primary care. Up ToDate. Updated May 5, 2022. Accessed September16 , 2024. www.uptodate.com 51. Weissman L, Harris H. Autism spectrum disorder in children and adolescents: complementary and alternative therapies. Up ToDate. Updated June 20, 2022. Accessed September 16 , 2024. www.uptodate.com 52. Wergeland J, Posserud M, Fjermestad K, et al. Early behavioral interventions for children and adolescents with autism spectrum disorder in routine clinical care: a systematic review and metaanalysis. Clin Psycho l. 2022;29(4):400-414. doi:10.1037/cps0000106 53. 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:10.1037/cps0000122 Approved by Ohio Department of Medicaid 11/21/ 2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Airway Clearance Devices-OH MCD-MM-1578 03/01/2025 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 …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4Airway Clearance Devices-OH MCD-MM-1578 Effective Date: 03/01/2025 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 Airway Clearance Devices B. Background Healthy individuals typically produce 10 100 mL of airway secretions daily. The clearance of these secretions from the respiratory tract is accomplished primarily through ciliary action, called the mucociliary escalator and the cough reflex. Secretion retention can occur because of an increased production of secretions due to a number of conditions, including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), mucociliary disorders, neuromuscular disease (NMD) and metabolic disorders that make it more difficult to clear the airway . In patients with a weak cough, retention of these s ecretions is a major cause of mortality and morbidity . Conventional chest physical therapy has been shown to result in improved respiratory function through the use of percussion and postural drainage. These techniques are usually taught to family members so therapy may be continued at home when needed for chronic disease. However, t his highly labor-intensive activity requires the daily intervention of a trained caregiver and may lead to poor compliance with the recommended treatment plan. Airway clearance devices can aid secretion mobilization and expectoration and assist coughing. Educating patients and families on the use of these devices and secretion management are within the scope of practice of respiratory therapists , physical therapists, nurses, and other clinicians. C. Definitions High Frequency Chest Compression Device A n inflatable vest connected by tubes to a small air-pulse generator. The air-pulse generator rapidly inflates and deflates the vest, compressing and releasing the chest wall up to 20 times per second. Mechanical insufflation-exsufflation device A device with a facemask that covers the nose and mouth, allowing air to be pumped into the lungs and then rapidly evacuated, facilitating the expulsion of secretions. D. Policy I. Mechanical Insufflation-Exsufflation Devices (E0482) A. CareSource considers mechanical in-exsufflation devices medically necessary when all of the following clinical criteria are met: 1. There is a presence of n euromuscular or chest wall disease (eg, amyotrophic lateral sclerosis, congenital muscular dystrophies, Duchenne muscular dystrophy, multiple sclerosis, post-poliomyelitis, spinal cord injury, spinal muscle atrophy) . Airway Clearance Devices-OH MCD-MM-1578 Effective Date: 03/01/2025 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.32. The condition caus es a significant impairment of chest wall and/or diaphragmatic movement, result ing in an inability to clear retained secretions. 3. The member has an inadequate response or intolerance to chest percussion and postural drainage . 4. Member has no bullous emphysema, pneumomediastinum, or pneumothorax . B. A mechanical insufflation-exsufflation device for any indication not listed above is not covered or reimbursable. II. High Frequency Chest Compression Devices (E0483) A. CareSource considers hi gh frequency chest compression device s medically necessary when any of the following clinical criteria is met: 1. cystic fibrosis when there is failure, intolerance or contraindication to home chest physiotherapy , or it cannot be provided 2. a diagnosis of bronchiectasis which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by a. daily productive cough for at least 6 continuous months or b. frequent ( eg, more than 2 per year) exacerbations requiring antibiotic therapy B. Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the absence of a confirmed diagnosis of bronchiectasis do not meet this criterion. C. It is not reasonable and necessary for a member to use both a high frequency chest compression device and a mechanical in-exsufflation device. D. Per Ohio Administrative Code (OAC) 5160-10-08, purchase of a high-frequency chest wall oscillation (HFCWO) device will not be considered: 1. without an initial trial period lasting at least 2 months, excluding any portion that coincides with an inpatient hospital stay 2. Payment for rental may be made during this trial period. E. If use of the HFCWO device is to be continued in a residential setting after the initial trial period, a Certificate of Medical Necessity (CMN) is included that contains 1. an attestation to the effectiveness of the device during the trial period and every previous rental period 2. if applicable, specification of a change in the duration or frequency of therapy 3. a recommendation either for additional rental or for purchase F. The Volara device is not approved for outpatient use. E. Conditions of Coverage NA F. Related Policies/Rules NA Airway Clearance Devices-OH MCD-MM-1578 Effective Date: 03/01/2025 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.4G. Review/Revision History DATE ACTIONDate Issued 01/17/2024 New policy. Approved at Committee.Date Revised 11/20/2024 Updated references. Approved at Committee, Date Effective 03/01/2025 Date Archived H. References1. Bach JR. Noninvasive r espiratory management of p atients with neuromuscular d isease. Ann Rehabil Med. 2017;41(4):519-538. doi:10.5535/arm.2017.41.4.519 2. Basavaraj A, Choate R, Addrizzo-Harris D, et al. Airway clearance techniques in b ronchiectasis: analysis from the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest. 2020;158(4):1376-1384. doi:10.1016/j.chest.2020.06.050 3. Chatwin M, Wakeman RH. Mechanical insufflation-exsufflation: considerations for improving clinical practice. JClin Med . 2023;12(7):2626. doi:10.3390/jcm12072626 4. DMEPOS: High-Frequency Chest Wall Oscillation (HFCWO) Devices, O HIO ADMIN . CODE 5160-10-08 (2024). 5. Ferreira de Camillis ML, Savi A, Goulart Rosa R, et al. Effects of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU subjects. Respir Care . 2018;63(12):1471-1477. doi:10.4187/respcare.06253 6. Finder JD, Birnkrant D, Carl J, et al. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am JRespir Crit Care Med. 2004;170(4):456-465. doi:10.1164/rccm.200307-885ST 7. High Frequency Chest Compression Device : A-0356 (AC). MCG Health. 2 8th ed. 2024 . Updated March 14, 2024. Accessed November 1, 2024. www.careweb.careguidelines.com 8. Local Coverage Determination: High Frequency Chest Wall Oscillation Devices. Medicare Coverage Database; 2022 . L3378. Accessed November 1, 2024. www.cms.gov 9. Local Coverage Determination: Mechanical In-exsufflation Devices. Medicare Coverage Database; 2020. L33795 . Accessed November 1, 2024 . www.cms.gov 10. Mechanical Insufflation-Exsufflation Device: A-0884 (AC) . MCG Health. 2 8th ed. 2024 . Accessed November 1, 2024 . www.careweb.careguidelines.com 11. Raywood E, Shannon H, Filipow N, et al. Quantity and quality of airway clearance in children and young people with cystic fibrosis. JCyst Fibros. 2023;22(2):344-351. doi:10.1016/j.jcf.2022.09.008 12. Strickland SL, Rubin BK, Drescher GS, et al. AARC clinical practice guideline: effectiveness of nonpharmacologic airway clearance therapies in hospitalized patients. Respir Care . 2013;58(12):2187-2193. doi:10.4187/respcare.02925 Approved by ODM on 12/12/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-Gene Testing for Behavioral Health Indications – OH MCD-MM-1716 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPharmacogenomics-Gene Testing for Behavioral Health Indications B. BackgroundPharmacogenomics is the study of how genetic variation affects drug response. Pharmacokinetics analyzes how drugs move through the body, including absorption, distribution, metabolism, and excretion. In behavioral health medicine, cytochrome P450s (CYPs) a re a common avenue for oxidative metabolism of therapeutic substances, which can be influenced by genetic and environmental factors. CYP genes are polymorphic and affect a significant portion of the populations ability to metabolize chemicals. Those with functional changes in CYP genes may have absent, diminished, or excessive metabolism of a drug compound. Individuals are therefore classified as poor metabolizers, extensive (normal) metabolizers, and ultra-rapid metabolizers. The role of pharmacogenetics is promising as studies continue to show potential benefits of gene testing. Clinical research, however, is unable to adequately replicate studies and findings, and there is limited available research for a drug class or specif ic drugs. Moststudies are based on small sample sizes and do not perform power calculations or correct for multiple testing scenarios. It is difficult to substantiate conclusions when not accounting for false positives or false negatives. Additionally, th ere is a lack of consensus regarding preemptive genotyping efficacy. Two societies publishing guidelines acknowledge that comprehensive guidelines regarding when testing should occur, who should receive testing, and which genes should be tested cannot be o ffered. The Clinical Pharmacogenetics Implementation Consortium (CPIC) is an internationalorganization whose goal is to reduce the barrier of translating genetic laboratory test results into guided clinical decision support. CPIC guidelines are peer-reviewed, evidence-based and updated as new evidence emerges. The guidelines are indexed in PubMed and endorsed by the American Society of Health-System Pharmacists (ASHP) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Published CPIC guidelines are available for certain drug classes and specific drugs which can lead to customized drug dosing, which is presumed to improve time to effective treatment and reduce undertreatment, medication-related adverse events, and costs. The guidelines consist of grading levels of evidence for prescription recommendations, which guide physicians on how results can optimize treatment. The strength of recommendations is divided into 4 categories: strong, moderate, optional, and no recommendation. A strong recommendation is backed by high-qualityevidence with desirable effects clearly outweighing undesirable effects. A moderate recommendation recognizes a close or uncertain balance as to whether the evidence is high quality and desirable effects clearly outweigh the undesirable. In an optional recommendation, the desirable effects are closely balanced with undesirable effects or the evidence is weak or based on extrapolations, and opinions differ as to the need for the recommended course of action. With no recommendation, there is insufficient evidence, confidence, or agreement to provide a recommendation to guide practice. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 In 2018, the American Psychiatric Association (APA) Council of Research Workgroup onBiomarkers and Novel Treatments printed a position statement on pharmacogenomic (PGx) tools for the treatment of depression indicating at present there are insufficient data to support the widespread use of combinatorial pharmacogenetics testing in clinical practice. The Food and Drug Administration (FDA) released a consumer warning, The relationship between DNA variations and the effectiveness of antidepressant medicat ions has never been established. and also cautioned that changes in patient medications based on test results could potentially lead to patient harm. In 2024, Baum, et al., updated the APAs statement upon review of new clinical trials and meta – analyses published from 2017 to 2022 using PGx tools for treatment selection in depression and found addition of these new data do not alter the recommendations of the 2018 report, or the advice of the FDA, that the evidence does not support the use of currently available combinatorial PGx tools for treatment. Additionally in 2019, the International Society of Psychiatric Genetics published the following statement: Pharmacogenetic testing should be viewed as a decision-support tool Evidence to support widespread use of other pharmacogenetic tests at this time is still inconclusive Genetic information for CYP2C19 and CYP2D6 would likely be most beneficial for indiv iduals who have experienced an inadequate response or adverse reaction to a previous antidepressant or antipsychotic trial. CareSource covers items and services with sufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s) but does not cover experimental or investigational te sting orproducts or services with insufficient data to determine net health impact. Insufficient data includes support that the test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (cl inical utility),performs better than an existing standard of care medical management option, and/or is not generally accepted as standard of care in the evaluation or management of a particular condition. CareSource provides appeal rights to any member or provider acting on behalf of a member who may disagree with denial decisions. Tests should be chosen to maximize the likelihood of identifying mutations in genes of interest for a specific medical reason, contribute to positive alterations in patient mana gement, and minimize the chance of finding variants of uncertain significance. C. Definitions Actionable Use Genotype information may lead to selection of , avoidance of a specific therapy or modification of dosage of a therapy. Change must be based on the FDA label for the drug, an FDA warning or safety concern, or a CPIC level A or B gene-drug interaction. Intended change s in therapy based on the result of a genotyping test not supported by 1 of these sources is not an actionable use. Adherence Consumption of a drug at or near the maximum FDA approved dosage and duration for the medication or documentation that higher doses are not tolerated when less than the FDA-approved maximum. Biomarker A characteristic objectively measured and evaluated as an indicator of biological or pathogenic processes or pharmacologic responses to a specific Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 therapeutic intervention (eg, gene mutations, protein expression, known gene-drug interactions for medications, characteristics of genes ). Biomarker Testing The analysis of tissue, blood, or other biospecimen for the presence of a biomarker . Clinical Utility The likelihood that a test will, by prompting an intervention, result in an improved health outcome. Clinical Validity The accuracy of a test for a given clinical outcome. Consensus Statements Developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure with a conflict-of- interest policy aimed at specific clinical circumstances and based on best available evidence for optimizing outco mes of clinical care. Nationally Recognized Clinical Practice Guidelines Developed by independent organizations or medical professional societies utilizing a transparent methodology and reporting structure with a conflict-of-interest policy establish ing standards of care informed by a systematic review of evidence and assessment of benefits and risks of alternative care options , includ ing recommendations to optimize patient care. Unbundling HCPCS/CPT codes should be reported only if all services described by the code are performed. Multiple codes should not be reported if a single code exists that describes the services performed. The codes include all services usually performed as part of the procedure as a standard of medical/ surgical practice and should not be separately reported simply because codes exist for the services. D. PolicyI. Biomarker testing that is not addressed by the Ohio Administrative or Revised Code or by the Ohio Department of Medicaid (ODM) in a recently published or updated provider document will follow MCG guidelines. Biomarker testing with uncertain clinical significance in MCG may be considered not covered as there is insufficient medical and scientific evidence for the purposes of diagnosis, treatment, appropriate management, or ongoing monitoring of disease(s) or condition(s). If there are no MCG guidelines avail able, authorization for biomarker testing must be supported by the following scientific and medical evidence (as appropriate) : A. labeled indications for a test approved or cleared by the FDA B. indicated tests for a drug approved by the FDA C. Centers for Medicare and Medicaid Services (CMS) national coverage determinations and/or local coverage determinations by Medicare Administrative Contractors D. nationally recognized clinical practice guidelines and/or consensus statements E. warnings and precautions on FDA-approved drugs II. Any biomarker testing with clinical significance and evidence supported by scientific and medical evidence may be subject to medical necessity review. CareSource usesCPIC guidelines level A or B to determine the appropriateness of testing requests. Guidelines may be located at www.cpicpgx.org/guidelines. A. General guidelines for all testing requests Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 The use of pharmacogenomic tests for multi-gene panels to guide therapy decisions may be medically necessary for psychotropic medications when ALL of the following criteria are met: 1. The member is currently or considering taking a drug potentially affected by a known mutation that can be detected by a corresponding test. 2. The drug is to be prescribed for the condition and population consistent with FDA labeling. 3. The test demonstrate s actionability in clinical decision making by CPIC guidelines level A or Band has demonstrated technical and clinical validity. 4. Providers can use results to guide changes in treatment that will improve patient outcome s or directly impact medical care (ie, clinical utility). 5. The ordering provider possesses the licensure, qualifications, and necessary experience/training to both diagnose the condition being treated and to prescribe medications for the condition either independently or in an arrangement as required by all applicable state laws. 6. The usefulness of the test is not significantly offset by negative factors, such as expense, clinical risk, or social, or ethical challenges (ie, reasonable use). 7. Requested testing is performed in a CLIA-certified laboratory and has not been previously performed. 8. At least 1 of the following criteria is met: a. Documentation is provided that the requested testing is required to obtain health plan coverage for the medication being considered for treatment. b. An FDA label requires results from a genetic test to effectively or safely use the therapy in question or is listed in the FDA table of known gene – drug interactions. c. Documentation of member adhere nce and fail ure to see expected results from at least 2 prior medications to treat the diagnosed condition. B. Specific testing requests Testing in the following situations may be considered medically necessary and is subject to medical necessity review. To aid in therapy selection and/or dosing for members considered for therapy or in a course of therapy with any of the medications below, testing for following genotype(s) once per lifetime may be considered : 1. CYP2C19 and CYP2D6 t esting for tricyclic antidepressants : a. Amitriptyline b. Imipramine c. Doxepin 2. CYP2C19 and CYP2B6 testing for sert raline, serotonin reuptake inhibitor 3. HLA-A and HLA-B testing for carbamazepine III. Exceptions to this policy or an adverse utilization review determination might be explored via appeal rights , which are p rovide d to any member or provider who requests testing on behalf of the member for any denial of authorization via the provider portal on www .www.caresource.com, fax, or mail by the US P ostal Service. Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 IV. CareSource considers the following not medically necessary (not all-inclusive):A. testing or screening 1. in the general population 2. considered non-covered but billed using unlisted procedure codes 3. in the absence of clinical signs or symptoms or for determining a risk for developing a disease or condition 4. not confirming new data for decision making but a known diagnosis 5. without diagnosis-specific indications or ensuring matching tissue specimens B. use of multi-gene panels for genetic polymorphisms, including, but not limited to, pain management, cardiovascular drugs, anthracyclines, or polypharmacy for evaluating drug-metabolizer status C. broad symptom-based panels (eg, comprehensive ataxia panel) when a narrower panel is available and more appropriate based on clinical findings (eg, autosomal dominant ataxia panel) D. more than 1 multigene panel at the same time (should be performed in a tiered fashion with independent justification for each panel requested ) E. genes not identified as having actionable use E. Conditions of CoverageCareSource applies coding edits to medical claims through coding logic software to evaluate accuracy and adherence to accepted national standards. Proper billing and submission guidelines must be followed, including the following: I. Unbundling of codes in a panel may result in payment recovery. Procedures not meeting correct coding standards are not reimbursable, even if medical necessity criteria for the associated test(s) are met. II. Providers must use industry standard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes to the highest level of specificity. III. Services considered to be mutually exclusive, incidental to, or integral to the primary service rendered are not allowed additional payment. IV. Proprietary panel testing requires documentation of medical necessity. V. If a panel was previously performed and an updated, larger panel is being requested, only testing for the medically necessary, previously untested genes will be reimbursable. Therefore, only the most appropriate procedure codes for those additional genes w ill be considered for reimbursement. F. Related Policies/RulesExperimental or Investigational Items or Services Medical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 10/23/2024 New policy. Converted AD-134 2 to MM with parameters for review of medical necessity. Approved at Committee. Date Revised Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Date Effective 02/01/2025Date Archived H. References1. American College of Medical Genetics Board of Directors. Points to consider in the clinical application of genomic sequencing. Genet Med . 2012 Aug;14(8):759-61. doi:10.1038/gim.2012.74 2. Baum M, Widge A, Carpenter L, et al. Pharmacogenomic clinical support tool for the treatment of depression. Am JPsychiatry . 2024;181(7):591-607. doi:10.1176/appi.ajp.20230657 3. Bean LJH, Funke B, Carlston CM, et al. Diagnostic gene sequencing panels: from design to report a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2020;22(3):453-461. doi:10.1038/s41436-019-0666-z 4. Behavioral Health Medication Pharmacogenetics Gene Panels: A-0861. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 5. Beunk L, Nijenhuis M, Soree B, et al. Dutch Pharmacogenetics Working Group (DPWG) guideline for the gene-drug interaction between CYP2D6, CYP3A4 and CYP1A2 and antipsychotics. Eur JHum Genet . 2024;32(3):278-285. doi:10.1038/s41431-023-01347-3 6. Bousman CA, Stevenson JM, Ramsey LB, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6, CYP2C19, CYP2B6, SLC6A4, and HTR2A genotypes and serotonin reuptake inhibitor antidepressants. Clin Pharmacol Ther . 2023;114(1):51-68. doi:10.1002/cpt.2903 7. Brouwer JMJL, Wardenaar KJ, Nolte IM, et al. Association of CYP2D6 and CYP2C19 metabolizer status with switching and discontinuing antidepressant drugs: an exploratory study. BMC Psych . 2024;24:394-408. doi:10.1186/s12888-024-0576 8. Brown JT, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium Guideline for Cytochrome P450 (CYP)2D6 Genotype and Atomoxetine Therapy. Clin Pharmacol Ther . 2019;106(1):94-102. doi:10.1002/cpt.1409 9. Caudle K, Sangkuhl K, Whirl-Carrillo M, et al. Standardizing CYP2D6 genotype to phenotype translation: consensus recommendations from the Clinical Pharmacogenetics Implementation Consortium and Dutch Pharmacogenetics Working Group. Clin Transl Sci , 2020;13:116-124. doi :10.1111/cts.12692 10. Chang M, Tybring G, Dahl ML, et al. Impact of cytochrome P450 2C19 polymorphisms on citalopram/escitalopram exposure: a systematic review and meta – analysis. Clin Pharmacokinet . 2014;53(9):801-811. doi:10.1007/s40262-014-0162-1 11. Cicali EJ, Smith DM, Duong BQ, et al. A scoping review of the evidence behind cytochrome p450 2d6 isoenzyme inhibitor classifications. Clin Pharmacol Ther . 2020;108(1):116-125. doi:10.1002/cpt.1768 12. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Reviewed January 16, 2024. Accessed October 7 , 2024. www.cdc.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 13. Clinical Pharmacogenetics Implementation Consortium. Accessed October 7 , 2024. www.cpicpgx.org 14. Clinical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents. American Academy of Child & Adolescent Psychiatry; 2020. Accessed October 7 , 2024. www.aacap.org 15. Clinical Utility Evaluation: MTHRF Genetic Testing for Nondevelopmental Psychiatric Disorders. Hayes; 2023. Accessed October 7 , 2024. www.hayesinc.com 16. Clinical Utility Evaluation: MTHRF Pharmacogenetic Genotyping for Altering Drug Treatment. Hayes; 2017. Updated May 23, 2021. Accessed October 7 , 2024. www.hayesinc.com 17. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing for Opioid Treatment for Pain in Adults Selected Single-Gene Variants and Pharmacogenomic Panels. Hayes; 2019. Updated October 26, 2022. Accessed October 7 , 2024. www.evidenced.hayesinc.com 18. Clinical Utility Evaluation: Pharmacogenetic and Pharmacogenomic Testing to Improve Outcomes Related to Opioid Use Disorder. Hayes; 2020. Updated June 30, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 19. Clinical Utility Evaluation: Pharmacogenomic Testing for Attention – Deficit/Hyperactivity Disorder. Hayes; 2022. Updated February 27, 2024. Accessed October 7 , 2024. www.evidence.hayesinc.com 20. Clinical Utility Evaluation: Pharmacogenomic Testing of Selected Mental Health Conditions. Hayes; 2021. Updated December 1, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 21. Cytochrome P450 Pharmacogenetics Gene Tests and Gene Panels: A-0775. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www. careweb.careguidelines.com 22. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Updated August 24, 2020. Accessed October 7 , 2024. www.genome.gov 23. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions , 42 C.F.R. 410.32 (2023). 24. Fijal BA, Guo Y, Li SG, et al. CYP2D6 pr edicted metabolizer status and safety in adult patients with attention-deficit hyperactivity disorder participating in a large placebo-controlled atomoxetine maintenance of response clinical trial. JClin Pharmcol . 2015;55(10):1167-1174. doi:10.1002/jcph.530 25. Guin D, Hasija Y, Kukreti. Assessment of clinically actionable pharmacogenetic markers to stratify anti-seizure medications. Pharmacogenomics J . 2023;23:149-160. doi:10.1038/s41397-023-00313-y 26. Hefti E, Blanco JG. Documenting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed October 7 , 2024. www.pubmed.ncbi.nih.gov 27. Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther . 2015;98(2):127-134. doi:10.1002/cpt.147 2 28. Hicks JK, Sangkuhl K, Swen JJ, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 tricyclic antidepressants: 2016 update. Clin Pharmacol Ther . 2017;102(1):37-44. doi:10.1002/cpt.597 29. Hicks JK, Swen JJ, Thorn CF, et al. Clinical Pharmacogenetics Implementation Consortium guideline for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic antidepressants. Clin Pharmacol Ther . 2013;93(5):402-408. doi:10.1038/clpt.2013.2 30. Hippman C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 31. Hyperhomocysteinemia MTHRF Gene: A-0629. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 32. Jukic MM, Haslemo T, Molden E. Impact of CYP2C19 genotype on escitalopram exposure and therapeutic failure: a retrospective study based on 2087 patients. Am J Psych . 2018;175(5):463-470. doi:10.1176/appi.ajp.2017.17050550 33. Koh A, Pak KC, Choi HY, et al. Quantitative modeling analysis demonstrates the impact of CYP2C19 and CYP2D6 genetic polymorphisms on the pharmacokinetics of amitriptyline and its metabolite, nortriptyline. JClin Pharmacol . 2019;59(4):532-540. doi:10.1002/jcph.1344 34. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated October 7, 2022. Accessed October 7 , 2024. www.uptodate.com 35. Laboratory Requirements, 42 C.F.R. 493 (2024). 36. Lagishetty CV, Deng J, Lesko LJ, et al. How informative are drug-drug interactions of gene-drug interactions? JClin Pharmacol . 2016;56(10):1221-1231. doi:10.1002/jcph.743 37. Leckband SG, Kelso JR, Dunnenberger HM, et al. Clinical Pharmacogenetics Implementation Consortium guidelines for HLA-B genotype and carbamazepine dosing. Clin Pharmacol Ther . 2013;94(3):324-328. doi:10.1038/clpt.2013.103 38. Li D, Pain O, Chiara F, et al. Metabolic activity of CYP2C19 and CYP2D6 on antidepressant response from 13 clinical studies using genotype imputation: a meta – analysis. Transl Psychiatry . 2024;14(1):296. doi:10.1038/s41398-024-02981-1 39. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration. Updated December 21, 2023. Accessed October 7 , 2024. www.fda.gov 40. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Medicare Coverage Database. LCD ID L35025. Revised May 4, 2023. Accessed October 7 , 2024. www.cms.gov 41. Local Coverage Determination: MolDx Molecular Diagnostic Tests (MDT). Centers for Medicaid and Medicare Services; 2017. LCD ID L36807. Revised April 27, 2023. Accessed October 7 , 2024. www.cms.gov 42. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38294. Revised August 24, 2023. Accessed October 7 , 2024. www.cms.gov 43. Local Coverage Determination: MolDX Pharmacogenomics Testing. Medicare Coverage Database; 2020. LCD ID L38435. Revised August 24, 2023. Accessed October 7 , 2024. www.cms.gov Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 44. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38274. Revised April 25, 2024. Accessed October 7 ,2024. www.cms.gov 45. Local Coverage Determination: MolDx Repeat Germline Testing. Medicare Coverage Database; 2020. LCD ID L38429 . Revised April 25, 2024. Accessed October 7 , 2024. www.cms.gov 46. Lu ML, Chen TT, Kuo PH, et al. Effects of adjunctive fluvoxamine on metabolic parameters and psychopathology in clozapine-treated patients with schizophrenia: A 12-week, randomized, double-blind, placebo-controlled study. Schizophr Res . 2018;193:126-133. doi:10.1016/j.schres.2017.06.030 47. McCormack M, Bourgeois S, Farrell JJ, et al. HLA-A*3101 and carbamazepine – induced hypersensitivity reactions in Europeans. NEngl JMed . 2011;364(12):1134 – 1143. doi:10.1056/NEJMoa1013297 48. Medical Code Brief: 0345U-PLA (U Codes). Hayes; 2022. Accessed October 7 , 2024. www.evidence.hayeinc.com 49. Methotrexate Pharmacogenetics-MTHFR Gene: A-1009. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 50. Milosavljevic F, Bukvic N, Pavlovic Z, et al. Association of CYP2C19 and CYP2D6 poor and intermediate metabolizer status with antidepressant and antipsychotic exposure: a systematic review and meta-analysis. JAMA Psychiatry . 2021;78(3):270 – 280. doi:10.1001/jamapsychiatry.2020.3643 51. Molecular Test Assessment: GeneSight Psychotropic (Assurex Health Inc/Myriad Neuroscience). Hayes; 2021. Updated November 13, 2023. Accessed October 7 , 2024. www.evidence.hayesinc.com 52. Nahid NA, Johnson JA. CYP2D^ pharmacogenetics and phenoconversion in personalized medicine. Expert Opin Drug Metab Toxicol . 2022;18(11):769-785. doi:10.1080/17425255.2022.2160317 53. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. National Institute of Health. Accessed October 7 , 2024. www.cancer.gov 54. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed October 7 , 2024. www.ncbi.nlm.nih.gov 55. National Correct Coding Initiative Policy Manual For Medicaid Services . Centers for Medicaid and Medicare Services. Updated January 1, 2024. Accessed October 7 , 2024. www.medicaid.gov 56. Ozeki T, Mushiroda T, Yowang A, et al. Genome-wide association study identifies HLA-A*3101 allele as a genetic risk factor for carbamazepine-induced cutaneous adverse drug reactions in Japanese population. Hum Mol Genet . 2011;20(5):1034 – 1041. doi:10.1093/hmg/ddq537 57. Patel JN, Morris SA, ,Torres R, et al. Pharmacogenomic insights in psychiatric care: uncovering novel actionability, allele-specific CYP2D6 copy number variation, and phenoconversion in 15,000 patients. Mol Psychiatry . 2024. doi:10.1038/s41380024-0 58. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Updated December 2019. Accessed October 7 , 2024. www.aacap.org Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 59. Phillips EJ, Sukasem C, Whirl-Carrillo M, et al. Clinical PharmacogeneticsImplementation Consortium Guideline for HLA genotype and use of carbamazepine and oxcarbazepine: 2017 update. Clin Pharmaco Ther . 2018. doi:10.1002/cpt.1004 60. Precision Medicine Research Brief: Genecept Assay (Genomind). Hayes; 2016. Accessed October 7 , 2024. www.evidence.hayesinc.com 61. Precision Medicine Research Brief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed October 7 , 2024. www.evidence.hayesinc.com 62. Precision Medicine Research Brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed October 7 , 2024. www.evidence.hayesinc.com 63. Pritchard D, Patel JN, Stephens LE, et al. Comparison of FDA table of Pharmacogenetic Associations and Clinical Pharmacogenetics Implementation Consortium guidelines. Am JHealth Syst Pharm . 2022;79(12):993-1005. doi:10.1093/ajhp/zxac064 64. Raby B. Personalized medicine. UpToDate. Updated September 06, 2023. Accessed October 7 , 2024. www.uptodate.com 65. Rehder C, Bean LJH, Bick D, et al. Next-generation sequencing for constitutional variants in the clinical laboratory, 2021 revision: a technical standard of the American College of Medical Genetics and Genomics (ACMG). Genet Med . 2021;23(8):1399-1415. doi:10.1038/s41436-021-01139-4 66. Rosenblat JD, Lee Y, McIntyre RS. Does pharmacogenomic testing improve clinical outcomes for major depressive disorder? a systematic review of clinical trials and cost-effectiveness studies. JClin Psychiatry . 2017;78(6):720-729. doi:10.4088/JCP.15r10583 67. Roy S, LaFramboise WA, Nikiforov YE, et al. Next-generation sequencing informatics: challenges and strategies for implementation in a clinical environment. Arch Pathol Lab Med . 2016;140(9):958-975. doi:10.5858/arpa.2015 – 0507-RA 68. Royal College of Psychiatrists. College Report CR237: The Role of Genetic Testing in Mental Health Settings . Royal College of Psychatrists; 2023. Accessed October 7, 2024. www.rcpsych.ac.uk 69. Saadullah Khani NS, Hudson G, Mills G, et al. A systematic review of pharmacogenetic testing to guide antipsychotic treatment. Nat Mental Health . 2024 ;2(5):616-626. doi:10.1038/s44220-024-00240-2 70. Swen JJ, van der Wouden CH, Manson LE, et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster – randomised crossover implementation study. Lancet . 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4 71. Tangamornsuksan W, Chaiyakunapruk N, Somkrua R, et al. Relationship between the HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis: a systematic review and meta-analysis. JAMA Dermatol . 2013;149(9):1025-1032. doi:10.1001/jamadermatol.2013.4114 72. Tantisira K. Overview of pharmacogenomics. UpToDate. Updated July 05, 2024. Accessed October 7, 2024. www.uptodate.com Pharmacogenomics-Gene Testing for Behavioral Health Indications-OH MCD-MM-1716 Effective Dat e: 02/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 73. Ter Hark S, Vos CF, Aarnoutse RE, et al. Biomarkers as predictors of treatment response to tricyclic antidepressants in major depressive disorder: a systematic review. JPsych Res . 2022;150:202-213. doi:10.1016/j.jpsychires.2022.03.05774. US Food and Drug Administration. Warning letter: MARC-CMS 577422. 2019. Accessed October 7 , 2024. www.fda.gov 75. Vos CF, Ter Hark SE, Schelleken AFA, et al. Effectiveness of genotype-specific tricyclic antidepressant dosing in patients with major depressive disorder: a randomized clinical trial. JAMA Netw Open . 2023;6(5):e2312443. doi:10.1001/jamanetworkopen.2023.12443 76. Wang Q, Sun S, Xie M, et al. Association between the HLA-B alleles and carbamazepine-induced SJS/TEN: a meta-analysis. Epilepsy Res . 2017;135:19-28. doi:10.1016/j.eplepsyres.2017.05.015 77. Warfarin Pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 Genes: A-0587. MCG Health. 28th ed. Updated March 14 , 2024. Accessed October 7 , 2024. www.careweb.careguidelines.com 78. Wu X, Zhang H, Miah MK, et al. Physiologically based pharmacokinetic approach can successfully predict pharmacokinetics of citalopram in different patient populations. JClin Pharmacol . 2020;60(4):477-488. doi:10.1002/jcph.1541 79. Zeier Z, Carpenter L, Kalin N, et al. Clinical implementation of pharmacogenetic decision support tools for antidepressant drug prescribing. Am JPsychiatry . 2018;175(9):873-886. doi:10.1176/appi.ajp.2018.17111282 80. Zubenko G, Sommer B, Cohen B. On the marketing and use of pharmacogenetic tests for psychiatric treatment. JAMA Psychiatry. 2018;75(8):769-770. doi:10.1001/jamapsychiatry.2018.0834 Reviewed by AllMed 09/2024Approved by Ohio Dept of Medicaid 11/14/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pediatric Asthma-OH MCD-MM-1710 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPediatric Asthma B. BackgroundAsthma is the most common chronic childhood disease – an estimated 5 million children in the United States have asthma with a disproportionate number living in poverty. Asthma is an immune-mediated, inflammatory disease, which is characterized by chronic, intermittent, and reversible lower airway obstruction caused by smooth muscle constriction and airway narrowing in response to an environmental trigger. In children, res piratory viral infections are the most common trigger of asthma exacerbation (eg, rhinovirus, influenza, and respiratory syncytial virus). In general, children are more susceptible to disease and complications , and whencombined with developmental issues makes treating asthma in children a difficult process with age-specific recommendations . For example, traditional pulmonary function testing is difficult to perform in children under 5 years of age, and physical signs of overt respiratory distress are often less prominent in older children and teens compared with infants and younger children. In addition, medication adherence and education , su ch as inhaled corticosteroids , are challenging . These issues in pediatric asthma treatment elevate the difficulty of inpatient admission during acute asthmatic distress . C. Definitions Acute Decompensation A clinical symptom of new or worsening signs and symptoms of heart failure. Hemodynamic Instability An abnormality of the heart, blood vessels, or other organs resulting in cardiac arrest, obstructive shock, or persistent hypotension . Hypoperfusion A supply of O 2 that does not adequately address the needs of cells. Failure of O 2 use leads to anaerobic metabolism which is the source of several detectable products and byproducts. Hypotension Decrease in systemic blood pressure below accepted low values. Inotropic/Inotropes Medications that increase cardiac contractility, which improves cardiac output ( amount of blood pumped by the heart per minute ), aiding in maintaining mean arterial pressure and perfusion to the body. Ipratropium A bronchodilator medication that dilates the airways of the lungs. Used to treat bronchospasms associated with asthma exacerbations. Metabolic Acidosis A disturbance in the homeostasis of blood plasma leading to an increase in hydrogen ion concentration in blood plasma. Peak Expiratory Flow Rate (Peak Flow) Maximal flow rate that can be achieved during forceful expiration following full inspiration. Short-Acting Beta A gonist First-line medications for acute treatment in asthma symptoms and exacerbations. Vasopressors Medications that increase vasoconstriction, which leads to increased systemic vascular resistance (SVR). Increasing SVR leads to increased mean arterial pressure and increased perfusion to organs. Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Vital Sign Objective measurement of essential physiological functions ( eg,temperature, heart rate, respiratory rate, blood pressure) of a living organism. Wheez e A high pitched or coarse whistling sound heard in the respiratory airway when one breathes that is a result of a disease-caused airway obstruction . D. PolicyI. CareSource considers inpatient treatment for asthma in members younger than 18 years medically necessary when 1 or more of the following clinical criteria is met: A. Hemodynamic instability, as indicated by 1 or more of the following: 1. Vital sign abnormality not readily corrected by appropriate treatment, indicated by 1 or more of the following: a. hypotension that persists despite appropriate treatment (eg, volume repletion, treatment of underlying cause) b. orthostatic hypotension that persists despite appropriate treatment (eg, volume repletion) 2. Hypotension that is severe, as indicated by 1 or more of the following: a. lactate of 2.0 mmol/L (18 mg/dL) or more secondary to hypotension (ie, hypoperfusion) b. metabolic acidosis (arterial or venous pH less than 7.35) not otherwise explained c. mean arterial pressure less than 65 mm Hg d. IV inotropic or vasopressor medication required to maintain adequate blood pressure or perfusion B. Altered mental status agitation (that is not developmentally appropriate), drowsy, or confused ; C. Ventilatory assistance needed; D. Peak expiratory flow rate less than 25% of predicted or personal best before treatment; E. Peak expiratory flow rate less than 40% of predicted or personal best after treatment; F. Room air oxygen saturation less than 92% at the admitting facility at least 1 hour after completion of initial recommended treatment (ie, 3 doses of a short-acting beta agonist (SABA) with ipratropium for moderate to severe exacerbations administered every 20-30 minutes for 3 doses or continuous ly for 1 hour and administration of systemic steroids . G. Capillary, venous, or arterial pCO 2 greater than or equal to 42, if a previous elevated pCO 2 baseline has not been established. For members with an elevated pCO 2 at baseline, an elevation of 2 mm Hg or greater above baseline. H. Clinical finding (eg, moderate wheeze, breathlessness, head bobbing, nasal flaring, feeding difficulties, inability to maintain oral hydration, retractions, prolonged expiration) that persists despite observation care (eg, beta-agonist response not sustain ed for at least 4 hours); I. Peak expiratory flow rate between 40% and 60% of predicted or personal best despite observation care; Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 J. Radiographic evidence of complication requiring inpatient treatment (eg, tension pneumothorax);K. No baseline peak flow provided, or patient unable to perform peak flow , and ALL of the following: 1. Finding indicative of a moderate to severe asthma exacerbation, as indicated by 1 or more of the following: a. at least moderate wheeze (eg, wheeze during inspiration and expiration) b. vital sign abnormality sustained despite appropriate treatment as indicated by 1 or more of the following: 01. abnormal heart rate as defined as: (1). 180/min (for ages 3 yrs) (2). 150/min (for ages > 3 to 12 yrs) (3). 120/min (for ages > 12 yrs) c. at least moderate degree of use of accessory muscles (eg, suprasternal or scalene retractions) d. unable to speak in full sentences (as appropriate for age and development) e. moderate or severe prolongation of expiration f. silent chest (absent or markedly diminished breath sounds) g. feeding difficulties 2. Inadequate response to therapy, as indicated by 1 or more of the following : a. deterioration of symptoms despite bronchodilator therapy b. lack of significant improvement after 1 hour of bronchodilator therapy c. current presentation represents a recurrence within 48 hours of last asthma exacerbation (eg, emergency department or hospitalization) L. Change in clinical status requiring escalation of treatment, as indicated by 1 or more of the following: 1. subsequent administration of magnesium sulfate outside of emergency department 2. initiate or increase O 2 3. increased frequency in bronchodilator therapy 4. acute decompensation (eg, hospital-based rapid response system activated for timely clinical evaluation) requiring consideration of higher level of care E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 09/25 /2024 New policy. Approved at Committee.Date Revised Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 Date Effective 02/01/2025Date Archived H. References1. 202 4 GINA Report, Global Strategy for Asthma Management and Prevention. Global Initiative for Asthma; 202 4. Updated 202 4. Accessed August 19, 2024 . ginasthma.org 2. Abebe MM, Arefayne NR, Temesgen MM, et al. Incidence and predictive factors associated with hemodynamic instability among adult surgical patients in the post – anesthesia care unit, 2021: a prospective follow up study. Ann Med Surg (Lond) . 2022;74:103321. doi:10.1016/j.amsu.2022.103321 3. Asthma. Centers for Disease Control & Prevention. Accessed August 19, 2024 . www.cdc.gov 4. Asthma, pediatric: P-60 (ISC). MCG Health, 28 th ed. Updated March 14, 2024. Accessed August 19, 2024 . www.careweb.careguidelines.com 5. Bacharier LB, Guilbert TW, Jartti T, et al. Which wheezing preschoolers should be treated for asthma. JAllergy Clin Immunol Pract . 20231;9(7):2611-2618. doi:10.1016/j.jaip.2021.02.045 6. Bhakta NR, Bime C, Kaminsky DA, et al. Race and ethnicity in pulmonary function test interpretation: an official American Thoracic Society statement. Am JRespir Crit Care Med . 2023;207(8):978-995. doi:10.1164/rccm.202302-0310ST 7. Burger M, Schaller DJ. Metabolic Acidosis . StatPearls Publishing; 2023. Accessed August 1, 2024. www.ncbi.nlm.nih.gov 8. Chen X, Han P, Kong Y, et al. The relationship between changes in peak expiratory flow and asthma exacerbations in asthmatic children. BMC Pedatr . 2024;24(1):284. doi:10.1186/s12887-024-04754-7 9. Cloutier MM, Baptist AP, Blake KV, et al. 2020 Focused updates to the Asthma Management Guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. JAllergy Clin Immunol . 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003 10. Craig S, Powell CVE, Nixon GM, et al. Treatment patterns and frequency of key outcomes in acute severe asthma in children: a Paediatric Research in Emergency Departments International Collaborative (PREDICT) multicentre cohort study. BMJ Open Respir Res. 2 022;9(1):e001137. doi:10.1136/bmjresp-2021-001137 11. Devonshire AL, Kumar R. Pediatric asthma: principles and treatment. Allergy Asthma Proc . 2019;40(6):389-392. doi:10.2500/aap.2019.40.4254 12. DeVrieze BW, Modi P, Giwa AO. Peak Flow Rate Measurement . StatPearls Publishing; 2023. Accessed August 1, 2024. www.ncbi.nlm.nih.gov 13. Edwards LR, Borger J. Pediatric Bronchospasm . StatPearls Publishing; 2023. www.ncbi.nlm.nih.gov 14. Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC). 2020 Focused updates to the Asthma Management Guidelines: a report from the National Asthma Education and Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 Prevention Program Coordinating Committee Expert Panel Working Group. JAllergyClin Immunol . 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003 15. Hartert T. An overview of asthma management in children and adults. UpToDate. Updated June 14, 2024. Accessed August 19, 2024 . www.uptodate.com 16. Hsu E, Bajaj T. Beta2-Agonists . StatPearls Publishing; 2023. Updated June 20, 2023. Accessed August 16, 2024. www.ncbi.nlm.nih.gov 17. Kaufman J, Marino M, Lucas J, et al. Racial and ethnic disparities in acute care use for pediatric asthma. Ann Fam Med . 2022;20(2):116-122. doi:10.1370/afm.2771 18. Levy ML, Bacharier LB, Bateman E, et al. Key recommendations for primary care from the 2022 Global Initiative for Asthma (GINA) update. NPJ Prim Care Respir Med . 2023;33(1):7. doi:10.1038/s41533-023-00330-1 19. Martin J, Townshend J, Brodlie M. Diagnosis and management of asthma in children. BMJ Paediatr Open . 2022;6(1):e001277. doi:10.1136/bmjpo-2021-001277 20. Medical Review Asthma. InterQual. Accessed July 30, 2024. prod.cue4.com 21. Meyer TE. Approach to diagnosis and evaluation of acute decompensated heart failure in adults. UpToDate. Updated May 9, 2023. Accessed August 19, 2024 . www.uptodate.com 22. Miller AG, Haynes KE, Gates RM, et al. Initial modified pulmonary index score predicts hospital length of stay for asthma subjects admitted to the pediatric intensive care unit. Respir Care . 2020;65(9):1227-1232. doi:10.4187/respcare.07396 23. National Asthma Education and Prevention Program. Expert panel 24. Patel P, Saab H, Aboeed A. Ipratropium . StatPearls Publishing; 2024. Updated February 19, 2024. Accessed August 16, 2024. www.ncbi.nlm.nih.gov 25. Patel PH, Mirabile VS, Sharma S. Wheezing . StatPearls Publishing; 2023. Accessed July 31, 2024. www.ncbi.nlm.nih.gov 26. Patel SJ, Teach SJ. Asthma. Pediatr Rev . 2019;40(11):549-567. doi:10.1542/pir.2018-0282 27. Sapra A, Malik A, Bhandari P. Vital Sign Assessment . StatPearls Publishing; 2023. Updated May 1, 2023. Accessed August 16, 2024. www.ncbi.nlm.nih.gov 28. Savona S, Rajpal S. 2019 ESC guidelines for the diagnosis and management of acute PE. American College of Cardiology. Accessed August 1, 2024. www.acc.org 29. Scarfone RJ. Acute asthma exacerbations in children younger than 12 years: emergency department management. UpToDate. Updated November 16, 2022. Accessed August 19, 2024 . www.uptodate.com 30. Sharma S, Hashmi MF, Bhattacharya PT. Hypotension . StatPearls Publishing; 2023. Accessed August 1, 2024. www.ncbi.nlm.nih.gov 31. VanValkinburgh D, Kerndt CC, Hashmi MF. Inotropes and Vasopressors . StatPearls Publishing; 2023. Updated February 19, 2023. Accessed August 16, 2024. www.ncbi.nlm.nih.gov 32. Vyas DA, Eisenstein LG, Jones DS. Hidden in plain sight reconsidering the use of race correction in clinical algorithms. NEngl JMed . 2020;383(9):874-882. doi:10.1056/NEJMms2004740 Approved ODM 10/ 31/2024Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 Independent medical review 09/2024
MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Negative Pressure Wound Therapy-OH MCD-MM-0224 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical 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 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 ContentsTable of Contents ………………………….. ………………………….. ………………………….. ………………….. 1A. 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectNegative Pressure Wound Therapy B. BackgroundNegative pressure wound therapy (NPWT), also known as vacuum-assisted wound closure, is a type of wound therapy that is used to treat chronic wounds , such as ulcers related to pressure sores, venous or arterial insufficiency , or neuropathy. There are many causes for pressure ulcers , such as diabetes, vascular insufficiencies, or an underlying medical condition. NPWT involves the controlled application of subatmosph eric pressure to the surface of awound. This type of therapy utilizes an electrical pump connected to a specialized dressing that then removes debris and exudate from the wound and drains into a collection canister. NPWT is a noninvasive type of therapy th at has been shown to be effective in accelerat ing wound healing for chronic wounds . To provide a more conducive environment for wound healing, the NPWT method utilizes a semipermeable dressing that always remains moist and warm . This therapy can bedone in the home or in an outpatient treatment facility. NPWT typically does not require in-patient monitoring.C. Definitions Arterial Insufficiency Ulcer A type of ulcer that develops due to the lack of delivery of oxygen-rich blood to the tissue which causes the tissue to begin to deteriorate and develop into an open wound. Deep Tissue Pressure Injury A type of injury resulting from a serious pressure ulcer that has advanced with additional necrosis of underlying soft tissue that may or may not be visible. Dehisced Wounds A wound that has ruptured along the wound margin typically due to infection. Eschar Black or brown, thick, leathery feeling dead tissue covering an ulcer. Measurable Improvement Measurable changes in wound healing, including drainage , inflammation , swelling , pain and/or tenderness , wound dimensions , surface measurements , granulation tissue , necrotic tissue/slough , tunneling , or undermining . Neuropathic Ulcer A type of ulcer that occurs due to lack of sensation secondary to neuropathy which causes skin and underlying tissue to begin to breakdown causing ulcers further complicated by infection. Pressure Ulcer A type of ulcer that develops due to an extended amount of time when there is compression of the soft tissue overlying bony prominences and an outside object causing tissue necrosis. Slough Avascular (dead) soft tissue found in higher stage ulcers. Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved. Tunneling Channels of tissue deterioration that extend from the wound to the subcutaneous tissue typically in one direction. Undermining Subcutaneous tissue deterioration around the margin of a wound and may occur in any direction . Venous Insufficiency Ulcer A type of ulcer that occurs due to the lack of properly functioning venous valves, which causes the veins to increase in size. Pressure Ulcer StagingStage 1 A localized area of skin that is intact with non-blanchable erythema.Changes in sensation, temperature , or firmness of the skin may be present prior to visual alterations of the skin. If discoloration is purple or maroon, this may indicate a deep tissue injury. Stage 2 A surface area of skin that has partial-thickness loss of skin with exposed dermis. May initially present as a serum-filled blister that has ruptured. The wound bed will be moist, red/pink , and the skin should be viable. There should be no evidence of visible adipose (fatty) tissue, eschar, slough , or granulation. Stage 3 A surface area of skin that has full-thickness loss of skin with visible adipose (fat) tissue and granulation. The wound edges are often rolled (epibole), and there may be visible eschar and slough. Undermining and tunneling may occur in the wound. At this stage, there should be no fascia, muscle, tendon ligament, cartilage , and/or bones exposed. Stage 4 A surface area of skin that has full-thickness loss of skin. At this stage, there will be fascia, muscle, tendon, ligament, cartilage , or bone that is visible or directly palpable. The wound edges will be rolled (epibole), and there is typically visible eschar and slough. Undermining and tunneling occur often in the wound. Unstageable Inability to fully assess the extent of the tissue damage due to eschar or slough obscuring visibility, but there is observable full-thickness skin and tissue loss that is unstageable. D. PolicyI. CareSource considers NPWT medically necessary when the following clinical criteria are met : A. Stage III or IV pressure ulcer (see staging criteria above) in individuals who meet ALL of the following: 1. Member has been on a repositioning regimen with frequency determined by the provider based on the patients activity level and ability to reposition themselves. 2. Pressure relief techniques and/or pressure-reducing surfaces have been ordered (eg, foam overlay mattress, egg crate foam mattress, or low-air-loss devices) and documented ongoing compliance is in the member medical record . 3. Members incontinence and moisture issues have been appropriately managed . Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.B. Chronic neuropathic ulcer that meets BOTH of the following criteria:1. A comprehensive diabetic management program has been implemented , including A1C management, medication management, and ongoing diabetic education . 2. Foot care has been done by a medical professional t hat include s general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies, that meet the following criteria: 1. Compression garments/dressing/bandages are being applied consistently per physician orders in documented venous insufficiency plan of care for at least 30 days . 2. Ambulation and leg elevation have been ordered and documented ongoing compliance is in the member medical record . D. Member has any of the following: 1. high-risk open fracture 2. dehisced wound 3. post sternotomy wound complication or infection (mediastinitis) 4. surgically created wound with complications resulting in a need for accelerated granulation therapy that cannot be achieved by other treatment modalities , such as topical wound treatment 5. open non-healing amputation site in diabetic 6. delayed healing or non-healing of skin graft which is likely due to irregularly contoured or inadequate blood flood from the graft bed II. CareSource members may be eligible for the continuation of NPWT treatment when documentation by a licensed medical professional includes ALL of the following criteria: A. A licensed medical professional has directly performed the dressing change and is monitoring and controlling the members underlying medical conditions . B. The w ound has progressive and measurable improvement. 1. If no measurable degree of improvement in wound healing has occurred from month to month, the approval for the NPWT will be discontinued . 2. An e xception to measurable improvement is when a wound has been debrided within the last approval period . Documentation of debridement must accompany the request for continuation of NPWT. Before and after images are preferred. C. If abnormal, provisions have been made to the member s nutritional status . III. CareSource does not consider NPWT medically necessary for non-healing wounds or ulcers under any of the following conditions: A. exposed nerves, blood vessels , or organs in the vicinity of the wound B. uncontrolled soft tissue infection or osteomyelitis C. malignancy present in the wound D. necrotic tissue present in the wound with eschar and has not been debrided E. open fistula present to an organ or body cavity within the vicinity of the wound F. active bleeding Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.IV. W hen applied during surgery , CareSource does not reimburse separately for NPWT . NPWT is covered under the surgery code. V. The coverage provided for NPWT by the global surgical package is not intended to deny billing for NPWT in outpatient services. When a patient is discharged from the hospital with wounds that are still in need of NPWT treatment, outpatient wound care is cov ered when it meets medical necessity.VI. Initial approval for NPWT in the outpatient setting will be for a month . After the initialmonth , continued approval will be based on the medical necessity guidelines in this policy. Continued approval will be made in 1-month increments . CareSource will approve the following allowances for supplies: A. Fifteen dressing kits per wound per month . Additional dressing kits may be requested with documentation that the wound size requires more than one kit. B. Ten canister sets per month . Additional canister sets can be requested if there is documentation showing greater than 90 ml drainage exudate per day. C. Initial approval includes NPWT equipment and supplies that are used upon discharge from an in-patient setting. E. Conditions of CoverageN/A F. Related Polices/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New PolicyDate Revised 11/23/2022 10/11/202310/23/2024 Annual review: editorial changes, reference updates. Updated references and clarified coverage criteria in D. IV – VI. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 02/01/2025 Date Archived H. References1. Biancari F, Santoro G, Provenzano F, et al. Negative-pressure wound therapy for prevention of sternal wound infection after adult cardiac surgery: systematic review and meta-analysis. JClin Med . 2022;11(15):4268. doi:10.3390/jcm11154268 2. Chen L, Zhang S, Da J, et al. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. 2021;10(10):10830-10839. doi:10.21037/apm-21-2476 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3. De Pellegrin L, Feltri P, Filardo G, et al. Effects of negative pressure wound therapy with instillation and dwell time (NPWTi-d) versus NPWT or standard of care in orthoplastic surgery: a systematic review and meta-analysis. Int Wound J . 2023;20(6):2402-2413. doi:10.1111/iwj.14072 4. Definitions Home Medical Equipment , OHIO ADMIN CODE 4729-11-1-01 (2022). 5. Gao J, Wang Y, Song J, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis. JAdv Nurs . 2021;77(10):3980 – 3990. doi:10.1111/jan.14876 6. Gestring M. Negative pressure wound therapy. UpToDate. Updated November 1 7, 202 3. Accessed August 27, 2024 . www.uptodate.com 7. Groenen H, Jalalzadeh H, Buis DR, et al. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis . EClinicalMedicine . 2023;62:102105. doi:10.1016/j.eclinm.2023.102105 8. Kim PJ, Attinger CE, Constantine T, et al . Negative pressure wound therapy with instillation : international consensus guidelines update . Int Wound J . 2020;17(1):174 – 186. doi:10.1111/iwj.13254 9. Li P, Li J. Effect of incisional negative pressure therapy and conventional treatment on wound complications after orthopaedic trauma surgery: a meta-analysis of randomized controlled studies. Int Wound J . 2023;20(10):4291-4299. doi:10.1111/iwj.14331 10. Negative pressure wound therapy (vacuum-assisted wound closure): A-0346. MCG, 28 th ed. Updated March 14, 2024. Accessed August 27, 2024. careweb.careguidelines.com 11. Norman G, Goh EL , Dumville JC , et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochra ne Database Syst Rev . 20 22; 6(6):CD009261 . doi:10.1002/14651858.CD009261.pub7 12. Orlov A, Gefen A. The potential of a canister-based single-use negative-pressure wound therapy system delivering a greater and continuous absolute pressure level to facilitate better surgical wound care. Int Wound J . 2022;19(6):1471-1493. doi:10.1111/iwj.13744 13. Pedrazzi NE, Naiken S, La Scala G. Negative pressure wound therapy in pediatric burn patients: a systematic review. Adv Wound Care (New Rochelle) . 2021;10(5):270-280. doi:10.1089/wound.2019.1089 14. PICO single use negative pressure wound therapy system (Smith & Nephew) for cesarean birth wound care. Hayes ; 2022. Reviewed July 10, 2024 . Accessed August 27, 2024 . evidence.hayesinc.com 15. Poteet SJ, Schulz SA, Povoski SP, et al. Negative pressure wound therapy: device design, indications, and the evidence supporting its use. Expert Rev Med Devices . 2021;18(2):151-160. doi:10.1080/17434440.2021.1882301 16. Rvsz ES, Altorjay A, Montsk V, et al. Effectiveness of negative pressure wound therapy: minimum five-year follow-up and review of the literature. Jt Dis Relat Surg . 2022;33(1):51-56. doi:10.52312/jdrs.2022.547 17. Shi J, Gao Y, Tian J, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Sys Rev . 2023;5(5):CD011334. doi:10.1002/14651858.CD011334.pub3 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. www.ncbi.nlm.nih.gov19. Tian Y, Li K, Zeng L. A systematic review with meta-analysis on prophylactic negative pressure wound therapy versus standard dressing for obese women after caesarean section. Nurs Open . 2023;10(9):5999-6013. doi:10.1002/nop2.1912 20. Xie W, Dai L, Qi Y, et al. Negative pressure wound therapy compared with conventional wound dressings for closed incisions in orthopaedic trauma surgery: A meta-analysis . Int Wound J . 2022;19(6):1319-1328. doi:10.1111/iwj.13726 Independent med ical review 4/2020Approved ODM 10/31/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Myoelectric Upper Extremity Orthosis B. Background Experimental or Investigational items or services are not covered. An upper limb myoelectric orthosis is a robotic assisted brace. It is proposed that the device self-initiates movement using the members own muscle signals. Upper limb myoelectric orthoses are considered experimental and investigational due to insufficient evidence of efficacy. These devices should not be confused with prosthetic devices, which are intended to replace or compensate for a missing limb or other body part. The intent of this policy is to address requests that require medical necessity review in accordance with OAC 5160-1-01 . C. Definitions Experimental or Investigational Items or Services Medical, surgical, diagnostic, psychiatric, substance use disorders treatment or other health care services, technologies, equipment, supplies, treatments, procedures, therapies, biologics, drugs, or devices (each a Health Care Item or Service) that, at the time CareSource has made a determination regarding coverage in a particular case, are: o Not approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use o Not identified in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use, or o Determined by the FDA to be contraindicated for the specific use o Subject to review and approval by any institutional review board or other body serving a similar function for the proposed use, and such final approval has not been granted o The subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight o Provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service , or supply o Provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply as experimental or investigational, or otherwise indicate that the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation NOTE: Devices that are FDA approved under the Humanitarian Use Device exemption are not considered to be experimental or investigational. Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3Orthosis A brace, sling, or splint often made from thermoplastics, casting, and metal. Upper Limb Myoelectric Orthosis Device that combines a standard upper limb orthotic device with microprocessors, muscle sensor, and an electric motor of a myoelectric device. D. Policy I. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. The use of myoelectric upper extremity orthotic devices is considered investigational and not medically necessary for all indications including, but not limited to, restoration of function to arms and hands paralyzed or weakened by cerebrovascular accident , brachial plexus injury, cerebral palsy, or any other neurological or neuromuscular disease or injury. III. Myoelectric upper limb and hand orthotic devices are not covered. This includes, but is not limited to, the following: A. MyoPro B. MyoPro 2 E. Conditions of Coverage NA F. Related Policies/Rules Experimental, Investigational and Other Non-Covered Service G. Review/Revision History DATES ACTIONDate Issued 10/25/2023 New Policy . Approved at Committee.Date Revised 10/23/2024 Updated references. Approved at Committ ee Date Effective 02/01/2025 Date Archived H. References1. Evolving Evidence Review: MyoPro Orthosis (Myomo Inc.) for Upper Extremity Paralysis/Paresis After Stroke. Hayes; 2023. Accessed September 30, 2024. www.hayesinc.com 2. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . CODE 5160-1-01 (2022). Accessed September 30, 2024. www.codes.ohio.gov Myoelectric Upper Extremity Orthosis-OH MCD-MM-1560 Effective Date: 02/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.43. Medicare coverage of items and services in category a and b investigational device exemption (IDE) s tudies. US Centers for Medicare and Medicaid Services. January 1, 2015. MLN Matters MM8921. Accessed September 30, 2024. www.cms.gov 4. Premarket Notification 510(k) Summary K062631. US Food and Drug Administration. April 12, 2007. Accessed September 30, 2024. www.fda.gov 5. Jensen EF, Raunsbk J, Lund JN, et al . Development and simulation of a passive upper extremity orthosis for amyoplasia. JRehabil Assist Technol Eng. 2018;5. doi:10.1177/2055668318761525 6. Pundik S, McCabe J, Kesner S, et al . Use of a myoelectric upper limb orthosis for rehabilitation of the upper limb in traumatic brain injury: A case report. JRehabil Assist Technol Eng. 2020;7: 1-11. doi:10.1177/2055668320921067 ODM Approved 11/ 14/202 4
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