Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 12/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject . .2 B. Background 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …….. 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ……. 3 H. References ………………………….. ………………………….. ………………………….. ……………………… 4 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.2 A. SubjectPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental B. BackgroundPositive airway pressure (PAP) devices u tilize a machine with a mask or other apparatus that fits over the nose and/or mouth to provide positive pressure , keep ing airways open. Continuous positive airway pressure , or CPAP , is used to treat sleep-related breathing disorders , including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bi – level or two-level positive airway pressure , or BiPAP , is used to treat lung disorders , such as chronic obstructive pulmonary disease ( COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP devices can provide better sleep quality, reduc e or eliminat e snoring, and less en daytime sleepiness. PAP devices should always be used according to the physicians order , as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome . C. Definitions Adherence Use of the PAP device as prescribed by the ordering physician, defined as utilization for 4 or more hours per night for 70% of the nights during the most recent consecutive 30-day period during the first initial usage. Bi-Level Positive Airway Pressure (BiPAP) Device A device that uses mild bi-level or two levels of air pressure to keep airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep airways open. Positive Airway Pressure (PAP) Device A device that uses air pressure to keep airways open , including both continuous positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices. D. PolicyI. PAP devices addressed in this policy are as follows: A. E0601 CPAP, continuous pressure capability, used with noninvasive nasal or face mask. This item is a rent to purchase. B. E0470 BiPAP, Bi-level pressure capability, without backup rate feature, used with noninvasive nasal or face mask. This item is a rent to purchase. C. E0471 BiPAP, Bi-level pressure capability, with backup rate feature, used with noninvasive nasal or face mask. This item is a rental only. D. E0472 BiPAP, Bi-level pressure capability, with backup rate feature, used with invasive tracheostomy tube. This item is a rental only. II. PAP devices CPAP (E0601) and BiPAP (E0470):A. Initial prior authorization review: PAP devices CPAP (E0601) and BiPAP (E0470): 1. During the first 3 months rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device, CareSource considers the device Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.3 medically necessary when Ohio Administrative Code (OAC) clinical criteria are met. B. Continued rent to purchase period 1. For months 4-10 rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device documentation confirming adherence (see above definition) must be submitted. Note: CPAP (E0601) and BiPAP (E0470) machines are a 10-month rent to purchase. III. PAP devices BiPAP (E0471) and BiPAP (E0472) CareSource uses MCG Health and /orOAC clinical criteria to determine medical necessity A. During the first 6 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 7-12 rental, CareSource considers the device medically necessary when documentation confirming adherence (see above definition) is submitted . C. Documentation confirming adherence must be submitted annually with the prior authorization request. CareSource considers the device medically necessary when BOTH the following are met: 1. The MCG Health clinical criteria are met. 2. Documentation confirming adherence (see above definition) is submitted. E. Conditions of CoverageNA F. Related Policies/RulesNoninvasive Home Mechanical Ventilation G. Review/Revision HistoryDATE ACTIONDate Issued 06/10/2020 New policyDate Revised 03/31/2021 Revised medical necessity criteria language. Added definitions. Clarified types of PAP devices.05/11/2022 No changes. Updated references. Approved at PGC.03/15/2023 Added Ohio Administrative Code language. Updated02/28/202408/28/202408/13/2025 references. Approved at Committee.Annual review. Removed MCG from initial review and supply chain statement. Updated references. Approved at Committee. Revised D. II. and III. Updated references. Approved at Committee. Annual review. Updated F. and references. Approved at Committee. Date Effective 12/01/2025 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 12/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.4 Date ArchivedH. References1. Bi-level Positive Airway Pressure (BPAP) Device: ACG A-0994. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1 , 2025 . www.careweb.careguidelines.com 2. Continuous Positive Airway Pressure (CPAP) Device: ACG A-0431. MCG Health. 2 9th ed. Updated March 14, 2024. Accessed August 1, 2025 . www.careweb.careguidelines.com 3. CPAP. National Heart, Lung, and Blood Institute. Updated March 24, 2022. Accessed August 1, 2025 . www.nhlbi.nih.gov 4. DMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). 5. LCD Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) . Centers for Medicare and Medicaid. Updated January 1, 2024. Accessed August 1, 2025 . www.cms.gov 6. Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers, OHIO ADMIN . CODE 5160-10-1. Accessed August 1, 2025 . www.codes.ohio.gov 7. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JClin Sleep Med . 2019;15(02):335-343. doi:10.5664/jcsm.7640 This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. Approved by ODM 08/21/2025

Peroral Endoscopic Myotomy

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

Digital Therapy Devices for Treatment of Amblyopia

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 12/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectDigital Therapy Devices for Treatment of Amblyopia B. Background Amblyopia (ie, "lazy eye") is a neurodevelopmental disorder characterized by diminished visual acuity, usually in 1 eye, that is caused by inadequate visual processing in early childhood. When vision in 1 eye is abnormal, the brain will suppress signals from the weaker eye and rely on information from the stronger eye instead. Amblyopia is defined by the American Academy of Ophthalmology (AAO) as an interocular difference of 2 lines in acuity or acuity 20/30 with the best optical correction. According to the American Academy of Ophthalmology Preferred Practice Pattern guidelines Amblyopia (2024), most children who have moderate amblyopia (20/40 to 20/80) respond to initial treatment consisting of 2 hours of daily patching or weekend atropine. The AAOS Preferred Practice Pattern guidelines (2024) state: Refractive correction with eyeglasses is recommended as the initial step in care of children 0-17 years of age . Additionally, occlusion of the non-amblyopic eye with eye patching or pharmacological treatment with blurring atropine eye drops are each recommended in the guideline as an appropriate choice for amblyopia treatment in children who do not improve with refractive correction alone or who have incomplete resolution of their visual acuity deficit (2024). More recently, digital therapy devices have been developed to treat amblyopia in children with no strabismus or small angle strabismus with some binocularity using therapeutic dichoptic (binocular) visual stimuli. Images are presented using noninvasive, computerized systems such as virtual reality headsets or 3-dimensional glasses; typically, high-contrast images are presented to the amblyopic eye and low-contrast images are presented to the fellow eye. This is a proposed way to help the eyes work together. According to the American Academy of Ophthalmology (2024), Although data from early nonrandomized studies were promising, results from three randomized trials of early software applications failed to demonstrate that game play prescribed 1 hour per day was as good as patching prescribed 2 hours per day or better than placebo game play. Research with this technology is ongoing, which will be used to delineate use of binocular therapy for treatment of amblyopia. Another randomized prospective clinical trial studied a digital therapeutic using a desk-based computer platform, red-blue anaglyph glasses and an eye tracker found at 16 weeks the therapeutic (2.8 lines of improvement to be non-inferior to patching 2 hours per day). C. Definitions Amblyopia Also known as lazy eye, is a developmental disorder of the central nervous system that results from the abnormal processing of visual images, leading Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 to reduced visual acuity (VA) in one or both eyes due to abnormal vision development in infancy and childhood . Convergence Insufficiency Inability to maintain binocular function (keeping the two eyes working together) while working at a near distance. Typically, one eye will turn outward (intermittent exotropia) when focusing on a word or object at near distance. Occlusion Therapy Also called patching, is the mainstay of amblyopia treatment. Patching the unaffected, or good eye provides monocular stimulation to the amblyopic eye, promoting visual development. Occlusion therapy is prescribed to improve vision and as a rule, does not eliminate strabismus. Orthoptic Vision Therapy Eye exercises usually weekly over many months done in the optometrist office. Pharmacologic Penalization Therapy Therapy using eye drops, typically atropine, to blur the vision in the better-seeing eye, thus encouraging the use of the weaker, amblyopic eye. Prescription Digital Therapeutics (PDTs) Software-based therapeutic interventions for the prevention, management, or treatment of medical illnesses or diseases that have been evaluated for safety and efficacy. PDTs are authorized by the US Food and Drug Administration to treat diseases through an approved label and are differentiated from other digital health technologies (traditional health and wellness apps) by the following unique characteristics (Digital Therapeutics Alliance, 2021). Strabismus Misalignment of the eyes. Strabismus is commonly described by the direction of the eye misalignment such as esotropia, exotropia, and hypertropia. D. PolicyI. CareSource considers the following services medically necessary: A. occlusion therapy or pharmacologic penalization therapy for treating amblyopia B. orthoptic therapy or vision therapy for treating convergence insufficiency C. prism adaptation therapy for treating esotropia II. According to Centers for Medicare & Medicaid Services: Early and PeriodicScreening, Diagnostic and Treatment services (EPSDT) does not require coverage of treatments, services, or items that are experimental or investigational. However, requested treatments for children will be reviewed individually to determine the best course of treatment. III. Unproven and Not Medically Necessary A. Orthotic Vision Therapy for treating other conditions not listed above are considered unproven and not medically necessary. B. Prescription Digital Therapeutics for Amblyopia. E. Conditions of Coverage NA Digital Therapy Devices for Treatment of Amblyopia-OH MCD-MM-1841 Effective Date: 12/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 F. Related Policies/RulesExperimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/30/2025 New policy. Approved at Committee.Date Revised Date Effective 12/01/2025 Date Archived H. References1. Amblyopia Preferred Practice Pattern 2022-Updated 2024. American Academy of Ophthalmology. December 19, 2022. Accessed July 1, 2025. www.aao.org 2. Birch EE, Kelly KR. Amblyopia and the whole child. Prog Retin Eye Res . 2023;93:101168 doi:10.1016/j.preteyeres.2023.101168 3. Boniquet-Sanchez S, Sabater-Cruz N. Current Management of Amblyopia with New Technologies for Binocular Treatment. Vision (Basel) . 2021;5(2):31. doi:10.3390/vision5020031 4. EPSDT-A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents. Centers for Medicare & Medicaid Services. Accessed July 1, 2025. www.medicaid.gov 5. Levi DM. Rethinking amblyopia 2020. Vision Res . 2020;176:118-129. doi: 10.1016/j.visres.2020.07.014 6. Li T, Qureshi R, Taylor K. Conventional occlusion versus pharmacologic penalization for amblyopia. Cochrane Database Syst Rev . 2019;8(8):CD006460. doi: 10.1002/14651858.CD006460.pub3 7. Meier K, Tarczy-Hornoch K. Recent treatment advances in amblyopia. Annu Rev Vis Sci . 2022; 8:323-343. doi:10.1146/annurev-vision-100720-022550 8. Strul S. Understanding digital treatments for amblyopia. Am Acad Ophthalmol . September 24, 2024. Accessed July 1, 2025. www.aao.org 9. Tsani Z, Ioannopoulos D, Androudi S, et al. Binocular treatment for amblyopia: a systematic review. Int Ophthalmol . 2024;44(1):362. doi:10.1007/s10792-024-03259-7 10. Yeritsyan A, Surve AV, Ayinde B, et al. Efficacy of amblyopia treatments in children up to seven years old: a systematic review. Cureus . 2024;16(3): e56705. doi:10.7759/cureus.56705 Approved by ODM on 09/02/2025

Transcranial Magnetic Stimulation for Treatment of Depression

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

Skin Substitutes

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

Radiofrequency and Microwave Ablation of Tumors

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

Pediatric Asthma

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pediatric Asthma-OH MCD-MM-1710 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. 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. Forced Expiratory Volume in the First Second (FEV 1) Volume delivered in the first second of a FVC maneuver. 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. Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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. 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 or FEV 1 less than 25% of predicted or personal best before treatment E. Peak expiratory flow rate or FEV 1 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 continuously for 1 hour and administration of systemic steroids. G. Capillary, venous, or arterial pCO 2 greater than or equal to 42 (35 if pregnant) , 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, Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 prolonged expiration) that persists despite observation care (eg, beta-agonist response not sustained for at least 4 hours) I. Peak expiratory flow rate or FEV 1 between 40% and 60% of predicted or personal best despite observation care 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 CoverageNA F. Related Policies/RulesNA Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 G. Review/Revision HistoryDATE ACTIONDate Issued 09/25/2024 New policy. Approved at Committee.Date Revised 07/30/2025 Annual review: updated references and added FEV1 to criteria. Approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. 202 5 GINA Report, Global Strategy for Asthma Management and Prevention. Global Initiative for Asthma; 202 5. Updated 202 5. Accessed July 21, 2025 . 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 July 21, 2025 . 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. Updated June 12, 2023. Accessed July 21, 2025. www.ncbi.nlm.nih.gov Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 14. Ewulonu UC, Dyer H. Inpatient management of an acute asthma exacerbation using clinical care pathways. Curr Probl Pedatr Adolesc Health Care . 2021;51(5):100995. doi:10.1016/j.cppeds.2021.100995 15. 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 Prevention Program Coordinating Committee Expert Panel Working Group. JAllergy Clin Immunol . 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003 16. Hartert T. An overview of asthma management in children and adults. UpToDate. Updated September 30 , 2024. Accessed July 21, 2025 . www.uptodate.com 17. Hsu E, Bajaj T. Beta2-Agonists . StatPearls Publishing; 2023. Updated June 20, 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 18. 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 19. 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 20. 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 21. Meyer TE. Approach to diagnosis and evaluation of acute decompensated heart failure in adults. UpToDate. Updated September 27, 2024 . Accessed July 21, 2025 . 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. Patel P, Saab H, Aboeed A. Ipratropium . StatPearls Publishing; 2024. Updated February 19, 2024. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 24. Patel PH, Mirabile VS, Sharma S. Wheezing . StatPearls Publishing; 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 25. Patel SJ, Teach SJ. Asthma. Pediatr Rev . 2019;40(11):549-567. doi:10.1542/pir.2018-0282 26. Sapra A, Malik A, Bhandari P. Vital Sign Assessment . StatPearls Publishing; 2023. Updated May 1, 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 27. Savona S, Rajpal S. 2019 ESC guidelines for the diagnosis and management of acute PE. American College of Cardiology. Accessed July 21, 2025 . www.acc.org 28. Scarfone RJ. Acute asthma exacerbations in children younger than 12 years: emergency department management. UpToDate. Updated April 10, 2023 . Accessed July 21, 2025 . www.uptodate.com 29. Sharma S, Hashmi MF, Bhattacharya PT. Hypotension . StatPearls Publishing; 202 5. Updated May 3, 2025. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 30. VanValkinburgh D, Kerndt CC, Hashmi MF. Inotropes and Vasopressors . StatPearls Publishing; 202 4. Updated December 11, 2024 . Accessed July 21, 2025 . www.ncbi.nlm.nih.gov Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 31. 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 08/13/2025Independent medical review 09/2024

Nutritional Supports

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nutritional Supports-OH MCD-MM-0024 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical 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 ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………… 2 B. Background ………………………….. ………………………….. ………………………….. ………………….. 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 7 H. References ………………………….. ………………………….. ………………………….. …………………… 8 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectNutritional Sup ports B. BackgroundEnteral nutrition may be necessary to maintain optimal health status for individuals with diseases or structural defects of the gastrointestinal ( GI ) tract that interfere with transport, digestion, or absorption of nutrients. Such conditions may include anatomic obstructions due to cancer, motility disorders such as gastroparesis, or metabolic absorptive disorders such as phenylketonuria ( PKU ). Considerations are given to medical condition, nutrition and physical assessment, metabolic abnormalities, gastrointestinal function, and expected ou tcome. Enteral nutrition may be prescribed to serve as an individuals primary source of nutrition (ie, total enteral nutrition ) or as a supplement to their ordinary diet (ie, supplemental enteral nutrition ). Enteral nutrition may be delivered through oral intake or through a tube into the stomach or small intestine. RELiZORB is a prescription device that is used to break down fats in enteral formulasfrom triglycerides into fatty acids and monoglycerides to allow their absorption and utilization in the body , processes that are essential for normal growth and development .This process mimics the function of the enzyme lipase in the intestine of members with pancreatic insufficiency. The product is designed to fit in series with currently used enteral feeding circuits . Breastfeeding is recommended by healthcare professionals and the U.S. Department of Health and Human Services. Research shows that breastfeeding provides healthbenefits for both the mother and the child. In some situations, parents may look for alternative sources of human breast milk to feed their babies. Donor milk banks take voluntary steps to screen milk donors and safely collect, process, handle, test, and store the milk. C. Definitions Chronological Age The time elapsed after birth , usually described in days, weeks, months, and/or years. Corrected Age A term most appropriately used to describe children up to 3 years of age who were born preterm or before gestational age of 37 weeks. This term represents the age of the child from the expected date of delivery (mothers due date). Corrected age is calculated by subtracting the number of weeks born before 40 weeks of gestation from the chronological ag e. Donor Human Milk Breast milk that is expressed by a mother and processed by a human milk bank for use by a recipient that is not the donor s own infant. Enteral Nutrition Nutritional support given via the gastrointestinal (GI) tract, either directly or through any of a variety of tubes used in specific medical conditions. This includes oral feeding, as well as feeding using tubes such as orogastric, nasogastric, gastrostomy , or jejunostomy tubes. o Supplemental Nutrition The minority of daily calories are supplied by the enteral nutrition product(s). Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.o Total Enteral Nutrition (TEN) The majority of daily calories are supplied by the enteral nutrition products. Human Milk Bank A service which recruits human breast milk donors , collects, pasteurizes, and stores donor human milk , tests the donor milk for bacterial contamination , and distributes donor human milk to recipient infants in need. Inborn Errors of Metabolism (IEM) Inherited biochemical disorders resulting in enzyme defects that interfere with normal metabolism of protein, fat, or carbohydrate. Malnutrition Deficiencies, excesses, or imbalances in an individuals intake of energy and/or nutrients, measured by z-scores, which are statistical measurements of standard deviation from WHO and CDC growth charts , calculated from weight for length or BMI by age. o Mild Malnutrition z score equals -1 to -1.9 or z score decrease of 1 over time . o Moderate Malnutrition z score equals -2 to -2.9 or z score decrease of 2 over time . o Severe Malnutrition z score equals -3 or less or z score decrease of 3 over time . Medical Food Specially formulated and processed food for individuals who are seriously ill or who require the product as a major treatment modality. This term does not pertain to all foods fed to ill individuals. Medical foods are intended solely to meet the nutritional needs of individuals who have specific metabolic or physiological limitations restricting an ability to digest regular food. This can include specially formulated infant formulas. According to the Food and Drug Administration (FDA), a product must meet al l the following minimum criteria to be considered a medical food: o The product must be a food for oral or tube feeding . o The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements . o The product must be used under the supervision of a physician . Oral Nutrition ( Oral Feeding) Nutritional support given via oral route. Ordinarily Prepared Food Regular grocery products including typical, not specially formulated, infant formulas. RELiZORB An FDA-approved digestive enzyme cartridge indicated for use in pediatric patients (ages 2 years and older) and adult patients to treat exocrine pancreatic insufficiency. Therapeutic Oral Non-Medical Nutrition : o Food Modification Some conditions may require adjustment of carbohydrate, fat, protein, and micronutrient intake or avoidance of specific allergens (ie, diabetes mellitus, celiac disease ). o Fortified Food Food products that have additives to increase energy or nutrient density. o Functional Food Food that is fortified to produce specific beneficial health effects. o Texture Modified Food and Thickened Fluids Liquidized/thin puree, thick puree, finely minced or modified normal. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.o Modified Normal Eating normal foods but avoiding particulate foods that are a choking hazard. D. PolicyI. Any request from a member with EPSDT will be evaluated for medical necessity . II. Oral nutrition in Section II I refers to the situation where the majority of intake is provided by medical food by mouth or it is supplement al to normal food. Enteral nutrition in Section I Vrefers to the situation whe re the majority of intake is provided by medical food through a tube or it is supplemental . III. Oral NutritionA. Oral nutrition requests for members with inborn errors of metabolism meet medical necessity criteria and do not require further review when the product is specifically formulated for the members condition. B. Total oral nutrition is considered medically necessary when ALL the following apply : 1. The product is a medical food for oral feeding . 2. The product is used under medical supervision . 3. The member has the ability to swallow without increased risk of aspiration . 4. The product is the members primary source of nutrition . 5. The product is labeled and used for nutritional management of a members specific medical condition without which serious morbidities (physical or mental) may develop OR the product is used to promote normal development or function for the member . 6. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments. 7. The member has one of the following medical conditions: a. A condition caused by an inborn error of metabolism, including , but not limited to phenylketonuria homocystinuria methylmalonic academia galactosemia b. A condition that interferes with nutrient absorption and digestion, including, but not limited to 01. current diagnosis of non-IgE-mediated cows milk allergy (CMA) as defined by any of the following: (1). abnormal stools, defined as hemo ccult positive, mucous – containing, foam-containing, or diarrheal (2). poor weight gain trajectory for age (eg, malnutrition) (3). atopic dermatitis: age of onset less than 3 months, severe eczema, exacerbation of eczema noted with introduction of cows milk, cows milk formula or maternal ingestion of cows milk (if breastfed) Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.02. allergy to specific foods, including food-induced anaphylaxis, or severe food allergy indicating a sensitivity to intact protein product as diagnosed through a formal food challenge 03. allergic or eosinophilic enteritis (colitis/proctitis, esophagitis, gastroenteritis) 04. cystic fibrosis with malabsorption 05. diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider 06. malabsorption unresponsive to standard age-appropriate interventions when associated with failure to gain weight or meet established growth expectations 07. malnutrition (as defined by Nelsons Textbook of Pediatrics and not iatrogenically-or medication-induced) (formerly failure to thrive) that is moderate or severe and unresponsive to standard age-appropriate interventions ( eg , commercial shakes, protein bars) when associated with weight loss, failure to gain weight or to meet established growth expectations, including but not limited to: (1). premature infants who have not achieved the 25 th percentile for weight based on their corrected gestational age (2). individuals with end-stage renal disease and hypoalbuminemia (albumin less than 4 gm/dl) 8. Approval duration can be up to 12 months for all oral nutrition products C. Supplemental oral nutrition (including infant formula) is considered medically necessary when ALL the following apply: 1. The product is being used to supplement t he members primary source of nutrition . 2. The product is used as part of a defined and limited plan of care (eg, member transitioning from total enteral nutrition to standard diet for age , member undergoing cancer treatment) . 3. There is documentation of a medical basis for the members inability to maintain appropriate body weight and nutritional status (initial and ongoing) with normal or therapeutic oral nutrition . For example, malnutrition that is moderate to severe and unresponsive to standard age-appropriate interventions. 4. There is documentation of ongoing evidence of members positive response to the oral nutrition. For example, individuals who have improved from moderate to severe malnutrition to mild malnutrition or normal health status may require documentation/evidence indicating that without the supplementation there is a risk of decline in nutritional status. 5. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 6. The primary reason is not for convenience of the member or caregiver . 7. Approval duration can be up to 12 months for all supplemental oral nutrition products. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.IV. Enteral Nutrition Via TubeA. Enteral nutrition requests for members with inborn errors of metabolism and/or low-profile gastrostomy/jejunostomy/gastrojejunostomy tubes (eg, Mic-Key, button) meet medical necessity criteria and do not require further review. B. Total enteral nutrition via tube feeding is considered medically necessary when the member has a functioning, accessible gastrointestinal tract, and ALL the following apply : 1. Enteral nutrition comprises the majority of the members diet . 2. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 3. There is documentation that the member cannot ingest nutrients orally due to a medical condition (physical or mental) which meets any of the following: a. interferes with swallowing (eg, dysphagia from a neurological condition, severe chronic anorexia nervosa or serious cases of oral aversion in children which render member unable to maintain weight and nutritional status with oral nutrition alone) b. puts the member at risk for aspiration if nutrition is given by oral route c. is associated with anatomical abnormality of the proximal GI tract ( eg , tumor of the esophagus causing obstruction) 4. Approval duration can be up to 12 months for al l enteral nutrition products. C. Supplemental enteral nutrition via tube is considered medically necessary when ALL the following apply : 1. The product makes up the minority of the members daily intake (ie, supplement to members primary source of nutrition) . 2. The enteral product is used as part of a defined and limited plan of care (eg, member transitioning from total enteral nutrition to standard diet for age , member undergoing treatment for cancer) . 3. There is d ocumentation of a medical basis for the inability of the member to maintain appropriate body weight and nutritional status (initial and ongoing) with normal or therapeutic enteral nutrition . For example, malnutrition that is moderate to severe and unresponsive to standard age-appropriate interventions. 4. There is d ocumentation of ongoing evidence of members positive response to the enteral nutrition . For example, individuals who have improved from moderate to severe malnutrition to mild malnutrition or normal health status may require documentation/evidence indicating that without the supplementation there is a risk of decline in nutritional status. 5. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 6. The primary reason is not for convenience of the member or caregiver . 7. Approval duration can be up to 12 months for all supplemental enteral nutrition products. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.V. Limitations/Exclusions : the following are not indicated :A. therapeutic diets where non-medical foods are tolerated , including 1. food modification 2. texture modified food 3. thickened fluids without a prescription that indicates it is necessary as part of treatment plan 4. fortified food 5. functional food 6. modified normal 7. flavorings B. ordinarily prepared foods including commercial products * such as shakes, smoothies, energy bars, vitamin or mineral supplements, and baby food C. food products that a provider receives a Medicaid per diem payment D. standard infant formula when alternative coverage is available E. products for meal replacements or snack alternatives F. product s provided for convenience or preference of member/caregiver *Commercial products represented by HCPCS codes may be provided on a case-by-case basisfor individuals who use the product as their sole source of nutrition .VI. RELiZORB is considered medically necessary when ALL the following criteria are met: A. Member is at least 2 years of age per the FDA , and B. Member has a diagnosis of pancreatic insufficiency , or Member experiences symptoms of pancreatic insufficiency with current enteral formula such as fat malabsorption symptoms (eg, poor weight gain, diarrhea, abdominal pain, bloating, fatty stools, vomiting, and constipation). VII. Donor human milk is considered medically necessary when ALL the following criteria are met: A. The p rovider is in good standing with the Human Milk Banking Association of North America . B. Documentation support s medical necessity . C. Documentation support s that the provider has attested to educating the member in the donation process and about human milk . D. Consent support s that the provider discussed the risks and benefits with the member. E. Conditions of CoverageNA F. Related Polic ies/RulesNA G. Review/Revision History DATE ACTION Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.Date Issued 04/14/2004 New policyDate Revised 09/2005 04/2008 07/2009 03/2012 07/2013 07/2014 01/2015 06/28/2016 06/28/2017 09/09/2019 04/01/2020 08/19/2020 09/15/202103/16/202202/ 15 /202308/02 /202307/17/202406/04/2025Realigned with new guidelinesAdded Relizorb criteriaRemoved Medical nutrition therapy and updated PA Updated references. Approved at PGC. Added clinical coverage conditions, updated references, added definitions, split criteria into oral vs tube, and total vs supplementalAnnual review: removed WIC information, removed percentage of oral and enteral food criteria, moved exclusions to section VI , added section I for clarityOut of cycle update: clarified requirements for IEM and language on commercial products , added examples, malnutrition definition, and references . Approved at Committee. Review: removed PA language, changed title from Supplements to Supports, updated references. Approved at Committee. Review: updated references, approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. American Geriatric Society Committee ; Clinical Practice and Models of Care Committee. American Geriatrics Society feeding tubes in advanced dementia position statement. JAm Geriatrics Soc . 2014; 62(8) :1590-1593. doi :10.1111/jgs.12924 2. Burris A, Burris J, Jarvinen KM . Cows milk protein allergy in term and preterm infants: clinical manifestations, immunologic pathophysiology, and management strategies. NeoReviews . 2020 ;21(12) :e795-e808 . doi:10.1542/neo.21-12-e795 3. Cederholm T, Barazzoni R, Austin P, et al . ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr . 2017;36(1):49-64. doi:10.1016/j.clnu.2016.09.004 4. Daymont C, Hoffman N, Schaefer E, Fiks AG. Clinician diagnoses of failure to thrive before and after switch to World Health Organization growth curves. Acad Pediatr. 2020;20(3):405-412. doi:10.1016/j.acap.2019.05.126 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5. Dipasquale V, Ventimiglia M, Gramaglia SMC, et al. Health-related quality of life and home enteral nutrition in children with neurological impairment: report from a multicenter survey. Nutrients. 2019;11(12):2968 . doi:10.3390/nu11122968 6. DMEPOS: Nutrition Products , OHIO ADMIN . CODE 5160-10-26 (20 24 ). 7. Druyan ME, Compher C, Boullata JI, et al. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. JPEN JParenter Enteral Nutr . 2012;36(1):77-80. doi: 10.1177/0148607111420157 8. Early and Periodic Screening, Diagnostic, and Treatment . US Centers for Medicare and Medicaid Services. Accessed June 3, 2025 . www.medicaid.gov 9. Evolving Evidence Review. Relizorb (Alcresta Therapeutics Inc.) for Enteral Feeding in Patients with Cystic Fibrosis-Related Pancreatic Insufficiency. Hayes; 2021. Updated October 4, 2024 . Accessed June 3, 2025 . www.evidences.hayesinc.com 10. Fleet SA, Duggan C. Overview of enteral nutrition in infants and children. UpToDate. February 3, 2025 . Accessed June 3, 2025 . www.uptodate.com 11. Goodwin ET, Buel KL, Cantrell LD. Growth faltering and failure to thrive in children. Am Fam Physician . 2023;107(6):597-603. Accessed June 3, 2025 . www.aafp.org 12. Grummer-Strawn LM, Reinold C, Krebs NF; Centers for Disease Control and Prevention. Use of World Health Organization and CDC growth charts for children aged 0-59 months in the United States. MMWR Recomm Rep. 2010;59(RR-9):1-15. Accessed July 1, 2024. www.cdc.gov 13. Guidance for Industry: Frequently Asked Questions about Medical Foods . 3rd ed. US Dept of Health and Human Services; 2023. Accessed June 3, 2025 . www.fda.gov 14. Healthchek: Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Covered Services, OHIO ADMIN . CODE 5160-1-14 (2017) . 15. Homan GJ. Failure to thrive: a practical guide. Am Fam Physician . 2016;94(4):295 – 299. Accessed June 3, 2025 . www.aafp.gov 16. Klek S, Hermanowicz A, Dziwiszek G, et al. Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study. Am JClin Nutr . 2014;100(2):609-615. doi:103945/ajcn.113.082842 17. Lo L, Ballantine A. Malnutrition. In: Kliegman RM, St Geme JW, Blum NJ, et al., eds. Nelson Textbook of Pediatrics . Elsevier Inc; 2020:1869-1875. 18. Marchand V, Motil KJ ; NASPGHAN Committee on Nutrition. Nutrition support for neurologically impaired children: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. JPediatr Gastroenterol Nutr . 2006;43(1):123-135. doi: 10.1097/01.mpg.0000228124.93841.ea 19. Medicaid Medical Necessity: Definitions and Principles, OHIO ADMIN . CODE 5160-1- 01 (2022) . 20. Mehta NM, Skillman HE, Irving SY, et al. Guidelines for the provision and assessment of nutrition support therapy in the pediatric critically ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. J Par enteral and Ent eral Nutr . 2017;41(5):703-900. doi:10.1177/0148607117711387 21. Moro GE, Billeaud C, Rachel B, et al. Processing of donor human milk: update and recommendations from the European Milk Bank Association (EMBA). Front Pediatr . 2019;7(49):1-10. doi:10.3389/fped.2019.00049 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.22. Orphan Drugs , 21 C.F.R. 312 (2023) .23. Robinson D, Walker R, Adams SC, et al. American Society for Parenteral and Enteral Nutrition (ASPEN) Definition of Terms, Style, and Conventions Used in ASPEN Board of Directors-Approved Documents. May 2018. Accessed June 3, 2025 . www.nutritioncare.org 24. Services Provid ed by a Dietitian, OHIO ADMIN . CODE 5160-8-41 (20 21 ). 25. U.S. Food and Drug Administration. RELiZORB K232784. December 21, 2023. Accessed June 3, 2025 . www.accessdata.fda.gov 26. U.S. Food and Drug Administration. Use of Donor Human Milk . Updated March 22, 2018. Accessed June 3, 2025 . www.fda.gov. 27. U.S. Social Security Administration (SSA). Disability Evaluation Under Social Security – 105. 00 Digestive System Childhood . Accessed June 3, 2025. www. secure. ssa.gov 28. U.S. Social Security Administration (SSA). Program Operations Manual System (POMS) – DI 24598.002. Failure to Thrive (FTT) . February 9, 2016. Accessed June 3, 2025 . www. secure.ssa.gov 29. Wanden-Berghe C , Patino-Alonso MC, Galindo-Villardn P, et al . Complications associated with enteral nutrition: CAFANE Study. Nutrients . 2019;11(9):2041 . doi:10.3390-nu11092041 30. World Health Organization. Malnutrition. March 1, 2024 . Accessed June 3, 2025 . www.who.int 31. Worthington P, Balint J, Bechtold M, et al. When is parenteral nutrition appropriate? J Parenteral and Enteral Nutr . 2017; 41(3) :324-377. doi :10.1177/0148607117695251 Approved ODM 0 7/2 3/202 5

Nursing Facility Level of Care

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nursing Facility Level of Care-OH MCD-MM-1218 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………..11 F. Related Policies/Rules ………………………………………………………………………………………….11 G. Review/Revision History ……………………………………………………………………………………….11 H. References …………………………………………………………………………………………………………12 Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNursing Facility Level of Care B. Background Nursing facilities (NFs) provide professional skilled and non-skilled services that facilitate member recovery and stability. Nursing facility care should be considered when a member no longer requires acute care services but continues to need healthcare services that can only be managed in the recovery facility environment. When primarily rehabilitation services are needed, health professionals working in acute care hospitals should recognize members' needs for rehabilitation care and facilitate transition to appropriate rehabilitation care settings. C. Definitions Assistance Per the Ohio Administrative Code (OAC) is the hands-on provision of help in the initiation and/or completion of a task. Hands-on help is generally considered to be any aid in which the caregiver makes direct, physical contact with members to provide assistance with tasks, rather than just supervision or cueing. Intermediate Level of Care (ILOC) A level of care for members whose needs are less than skilled level of care, but more than the protective level of care, and are stable. These members also do not meet the criteria for the ICF-IID-based level of care. The member has a need for a minimum of one of the following: o Assistance with a minimum of 2 activities of daily living o Assistance with a minimum of 1 ADL and medication administration o A minimum of 1skilled nursing service or skilled rehabilitation service o 24-hour support in order to prevent harm due to a cognitive impairment as diagnosed by a physician or other licensed health professional acting within their scope of practice. Intermediate Care Facilities for Individuals with Intellectual Disability (ICF/IID) A place where someone with a disability can choose to live and get the services that help them live their lives with staff and aides who work at the facility 24 hours a day . Level of Care (LOC) The level of services and supports required by an individual to manage medical conditions and/or activities of daily living (ADL) and instrumental activities of daily living (IADL) needs. The criteria for NF based level of care includes an individual requiring assistance with mobility, bathing, grooming, toileting, dressing, and eating. The two levels of care in Ohio that qualify an individual to receive nursing facility-based care are Intermediate LOC and Skilled LOC Long-Term Services and Supports (LTSS) Encompasses an array of medical and personal care services for people who struggle with self-care due to aging, physical, cognitive, or mental conditions or disabilities. People commonly receive LTSS services for months or even years, which is the reason LTSS are sometimes referred to as long-term care. It includes cost-effective, person-centered home and case managed community-based alternatives to institutional care. LTSS include, but are not limited to: o nursing facility care Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o adult daycare programs o home health aide services o personal care services o transportation o assistance provided by a family caregiver Nursing Facility (NF) Institutions that provide nursing and medical care to members who no longer require care in an acute setting, but do require licensed nursing services, rehabilitation services, or other health-related services that must be performed by a skilled, licensed professional on a daily basis that cannot be provided in the home. The nursing facility-based level of care includes both the intermediate and skilled levels of care. Ohio Administrative Code (OAC) The rules adopted by the agencies of the state of Ohio. State agencies adopt rules to carry out the policies and intent of laws passed by the General Assembly. The rules are collected and published in the OAC. Clinical Care Reviewer (CCR) A clinical professional who reviews clinical information, applies criteria, and evaluates the care needs of a member who needs inpatient or outpatient services that require a prior authorization. Preadmission Screening/Resident Review (PASRR) A federal requirement to help ensure that individuals are not inappropriately placed in nursing homes for care. PASRR requirements must be completed prior to an individual being admitted to a Medicaid certified nursing facility. Evidence of PASRR requirements being met must be provided to CareSource at the time of the request for authorization. Protective Level of Care Care provided primarily to assist a member in meeting the instrumental activities of daily living but not requiring nursing facility based care . Protective care can reasonably and safely be provided by non-licensed caregivers in a community setting. Skilled Level of Care Skilled level of care is when: o The member's LTSS needs exceed the criteria for the protective level of care, the intermediate level of care, or the ICF-MR-based level of care. o The member requires either 1 skilled nursing service no less than 7 days a week or one skilled rehabilitation service no less than 5 days a week, or o The member has an unstable medical condition. Skilled Nursing Services Tasks that must be provided by a registered nurse directly or by a licensed practical nurse at the direction of a registered nurse. Skilled Rehabilitation Services Specific tasks that must be provided directly by a licensed or other appropriately certified technical or professional health care personnel. D. PolicyI. CareSource will review all Ohio Medicaid Nursing Facility requests (for admission and continued stays) for skilled and intermediate level of care using OAC 5160-3-08, Criteria for nursing facility-based level of care for an adult and OAC 5160-1-01, Medical Necessity. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 II. Preadmission Screening and Resident Review Requirements CareSource requires evidence that Preadmission Screening and Resident Review requirements have been met prior to the members admission to a NF as part of the prior authorization and level of care review processes in accordance with OAC 5160-3-14 process and timeframes for a level of care determination for nursing facility-based level of care programs, OAC 5160-3-15.1 Preadmission screening requirements for individuals seeking admission to nursing facilities, and OAC 5160-3-15.2 Resident Review requirements for individuals residing in nursing facilities. III. Skilled Level of Care CriteriaCareSource considers skilled care in a nursing facility medically necessary when the following factors have been met: A. Member must have an unstable medical condition as defined in OAC 5160-3- 05(B)(40) in that clinical signs and symptoms are present in an individual and a physician has determined that: 1. The individual's signs and symptoms are outside of the normal range for that individual. 2. The individual's signs and symptoms require extensive monitoring and ongoing evaluation of the individual's status and care, and there are supporting diagnostic or ancillary testing reports that justify the need for frequent monitoring or adjustment of the treatment regimen. 3. Changes in the individual's medical condition are uncontrollable or unpredictable and may require immediate interventions. 4. A licensed health care professional must provide ongoing assessments and evaluations of the individual that will result in adjustments to the treatment regimen as medically necessary. B. The member requires skilled nursing services or skilled rehabilitation services, ie, services that must be performed by or under the supervision of professional or technical personnel, that are ordered by a physician. C. The daily skilled services can be provided only on an inpatient basis in a NF. D. The services delivered are reasonable and necessary for the treatment of a members illness or injury,(ie, are consistent with the nature and severity of the individuals illness or injury), the individuals particular medical needs, and accepted standards of medical practice. E. The member requires a minimum of one of the following: 1. 1 skilled nursing service daily (or more frequently) 7 days per week 2. 1 skilled rehabilitation service daily, at least 5 days per week F. The request meets the requirements of OAC 5160-1-01 Conditions of Medical Necessity. G. There is a therapeutic plan to provide ALL of the following: 1. Case management and evaluation to meet member needs, achieve treatment goals, and ensure medical safety 2. Observation and assessment of member's changing condition to evaluate the need for treatment modification or for additional procedures until condition is stabilized Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Member education to teach member self-maintenance or to teach caregiver member care. H. When they are not safe to perform at a lower level of care, examples of direct skilled nursing services or skilled rehabilitation services include, but are not limited to: Daily nursing treatments are needed for one or more of the following: 1. Intravenous (IV) infusion, IV injection, or intramuscular injection 2. Insulin regimen establishment in presence of unstable blood sugar reading 3. Tube feeding (eg, gastrostomy tubes, jejunostomy tubes percutaneous endoscopic gastrostomy (PEG) tubes, nasogastric tubes) required because member needs feeding to supply at least 26% of daily calories and at least 501 mL of daily fluids 4. Nasopharyngeal or tracheostomy suctioning and suprapubic catheter irrigation 5. Pain management for infusion of pain medications 6. Wound care that requires dressing changes with prescription medication or clean technique and treatment for: 01. Burns 02. Foot infections or wounds 03. Open lesions 04. Surgical wound complications 05. Treatment with any stage III or IV pressure injury 06. Treatment with 2 or more wounds, including venous ulcers, arterial ulcers, or stage II pressure injuries 07. Widespread skin disorder treatments 7. Heat treatments that require nurse observation to evaluate response 8. Oxygen administration, starting or managing changes, including ventilator 9. Member care training and assistance for 1 or more of the following: 01. Exercise program (eg, range of motion, pulmonary, cardiac) 02. Preventing complications and the start or revision of the member's maintenance therapy plan 03. Safe performance of ADL (eg, dressing, communicating, eating) 04. Splint, brace, cast, prosthesis, or orthosis management 05. Urinary or bowel toileting program 10. Pain management for infusion of pain medications I. Rehabilitation therapy treatments (PT, OT, or SLP) are needed for 1 or more of the following: 1. Ongoing assessment of rehabilitation needs and potential (eg, range of motion, strength, balance) 2. Supervision of therapeutic exercises or activities to ensure member safety and treatment effectiveness 3. Gait evaluation and training 4. Preventing complications and the start or revision of the member's maintenance therapy plan 5. Therapy modalities that require PT or OT observation to evaluate response Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 6. Restoration of speech or swallowing with services of speech-language pathologist 7. Prosthetic evaluation and training. III. Intermediate Level of Care CriteriaFor members needing assistance that cannot safely be performed at a lower level of care or the resources to provide the needed care and services in a home or community-based setting are not available, the Intermediate Level of Care (ILOC) is a lower cost alternative that effectively addresses and treats the medical problem, as described in OAC 5160-1-01, Medicaid medical necessity: definitions and principles. Criteria include, but are not limited to: A. The individual's needs for long-term services and supports (LTSS) exceed the criteria for the protective level of care. B. The individuals LTSS needs are less than the criteria for the skilled level of care. C. Individual requires assistance (not necessarily a licensed professional) with the completion of a minimum of two activities of daily living (ADL) as outlined below: 1. Assistance with mobility in at least one of the following components: a. bed mobility b. locomotion c. transfer 2. Assistance with bathing 3. Assistance with grooming in ALL of the following components: a. oral hygiene b. hair care c. nail care 4. Assistance with toileting in at least one of the following components: a. Using a commode, bedpan, or urinal b. Changing incontinence supplies or feminine hygiene products c. Cleansing self d. Managing an ostomy or catheter 5. Assistance with dressing in at least one of the following components: a. Putting on and taking off items of clothing or prosthesis b. Fastening and unfastening an item of clothing or prosthesis 6. Assistance with eating D. Assistance with the completion of a minimum of 1 ADL and assistance with medication administration (ADLs listed in III C 1-6), which is required due to 1. Medication administration is required due to members inability to safely self- manage medications. Reasons may include but are not limited to: a. Does not know current medications b. Lacks insight into reasons medications are prescribed c. Lacks ability to take medications as ordered due to cognitive impairment E. Need for 24 hour support in order to prevent harm due to a cognitive impairment. Examples may include: 1. Member resides in a locked dementia unit 2. Negative results of mini mental status exam Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 F. Direct skilled rehabilitation services less than 5 days per week G. Wound care that cannot be done in the community (wounds less than stage III).NOTE: Members already enrolled in NF services, in particular those requiring intermediate care, should be individually assessed for medical necessity. CareSource supports lower cost alternatives that effectively address the problem. For example, home health or family caregivers, are viable and medically appropriate options. IV. Documentation to Support Nursing Facility-Based Care DeterminationsA. The CareSource prior authorization form or the ODM Nursing Facility Request Form will be accepted for submission of requests. B. PASRR Documentation. One of the following is required at the time of the initial request for nursing facility services: 1. PASRR Level I screen and preadmission screen (PAS) or resident review (RR) results 2. PASRR Level II evaluation and results, if indicated 3. Hospital Exemption Notice (for stays expected to be less than 30 days). Note: For stays in which the hospital exemption notice was submitted at the time of the initial request and the stay is expected to or exceeds 30 days, the PASRR Level I or II, determined by indications of serious mental illness and/or developmental disabilities or related conditions for the member, and resident review results are required to be submitted to CareSource. C. The members medical record must document all the following: 1. The history and physical exam pertinent to the members care including the response or changes in behavior to previously administered skilled services 2. The skilled services provided 3. The plan for future care based on the rationale of prior results 4. A detailed rationale that explains the need for the skilled service in light of the members overall medical condition and experiences 5. The complexity of the service to be performed 6. A decline in physical function compared to the prior level of function (PLOF) 7. Inability to safely ambulate household distance (50 feet) 8. The member requires minimum assist to perform mobility-related activities of daily living (MRADLs) 9. The need for active assistance (hands-on vs. supervision) 10. The documentation in the members medical record must be accurate and avoid vague or subjective descriptions of the members care that would not be sufficient to indicate the need for skilled care 11. Updated clinical evaluation to support on-going concurrent review 12. The services promote the documented therapeutic goals 13. Minimum Data Set (MDS) documentation of cognitive, mood, functional performance, DME use, and/or nutritional status 14. Complete discharge planning assessment and ongoing changes to the plan Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 NOTE: The treatment goal cannot be modified retrospectively.V. Bed-Hold Days A. In accordance with OAC 5160-3-16.4, CareSource will provide payment to a NF provider to reserve a bed for not more than 30 days in any calendar year when: 1. A member is authorized by CareSource for the nursing facility stay at either the skilled or intermediate level of care. 2. A member is not discharged from the NF. 3. A member, who is a resident of the NF, is temporarily absent from the NF due to a hospitalization, therapeutic leave, or visitation with friends or relatives and has the intent and ability to return to the same NF. B. Bed-hold days do not require prior authorization. VI. Non-covered services in a NFClinical documentation that does not support the medical necessity requirements outlined in OAC 5160-1-01 that meets, at a minimum, the ILOC criteria for the following services: A. Repetitious exercises to improve gait, or to maintain strength and endurance and assistive walking can be appropriately provided by supportive personnel. B. When the performance of a maintenance program does not require the skills of a therapist because it could safely and effectively be accomplished by the member or with the assistance of non-therapists, including unskilled caregivers. C. General exercises to promote overall fitness and flexibility and activities to provide diversion or general motivation or the supervision of taught exercises. D. Lack of a competent person to provide a nonskilled service regardless of the importance of the service to the member, does not make it a skilled service when a nurse provides the service. E. Protective LOC services. F. Services not expected to produce the desired outcome. VII. Transitioning from a Nursing FacilityA. Evaluation 1. As part of the discharge planning process and in conjunction with the nursing facility staff, CareSource Case Management (CM) may evaluate a member receiving nursing facility care and services for potential for referral to home and community-based services and/or other state and local resources to assist members in receiving needed services in the least restrictive environment. 2. In compliance with OAC 5160-1-01, members will be reassessed. When the member no longer meets the medical necessity criteria for skilled or intermediate nursing facility care, CareSource will evaluate for discharge to the community (ie, home with needed services and supports). 3. In compliance with OAC 5160-1-01, if the member no longer meets the skilled level of care, or intermediate level of care, CareSource will evaluate for Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 discharge to an appropriate community setting that will meet the members care needs.4. After an initial evaluation period, the UM clinical care reviewer must evaluate the members progress. This initial evaluation may be followed by case management. These reports will include clinical review from the members care team including documentation from facility discharge planning staff. 5. CareSource may perform a re-evaluation of members to identify any changes that require modification of the treatment plan and incorporate these into discharge planning. B. Discharge Planning 1. CareSource expects discharge planning for all members admitted to a nursing facility to begin immediately upon admission. Discharge planning should not be delayed until the member is stable for discharge as this frequently leads to unnecessary delays in a discharge and unnecessary lengthening of the members facility stay. Discharge planning includes: 1. Treatment plan development involving providers engaged in members care 2. Evaluation of members premorbid functioning compared to current state 3. Member and caregiver preferences and abilities 4. Evaluation for services at next level of care as appropriate for member's continued needs 5. Housing 6. Evaluation of psychosocial status and needs 7. Coordination of follow up appointments, planned or scheduled 8. Transportation 9. Coordination of prescription medications and treatments to be available to member upon discharge 10. Home care services, if applicable 11. Referrals made for assistance and support including to state and local programs and/or community-based organizations 12. Medical equipment and supplies coordinated 13. Transition plan communicated to all members of member's care team 2. CareSource Utilization Management (UM) and Case Management (CM) will work, either in-person or via telephonic outreach, with the Nursing Facility to ensure a safe and timely discharge for our members. This collaboration should start within 3 days of the members admission to the NF. 3. The NF must develop and share with CareSource UM during each review a post-discharge plan of care to address the anticipated needs of a member for discharge to a private residence, to another NF, or to another type of residential facility such as a group home, medical respite facility, sober living home, or an intermediate care facility for individuals with intellectual disabilities. 4. Upon request, the discharge plan must be shared with CareSource CM. C. Discharge Criteria Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 Once skilled nursing services (ie, wound care, IV or IV antibiotics treatment) and/or rehabilitation have been completed for safe transfer to lower level of care OR the member is no longer demonstrating significant functional gains and does not meet criteria for intermediate or skilled level of care, the following criteria must be completed prior to discharge: 1. Medication regimen has been established and reconciliation completed. 2. Medical status is stable for member's condition and manageable at lower level of care. 3. Any inserted or implanted device discontinued, or functioning normally and manageable at lower level of care. 4. Medical equipment and supplies are available at next level of care and safe use has been demonstrated. 5. Wound(s) or dressing changes are manageable at a lower level of care. 6. Skilled services (as needed) and logistical requirements can be met at a lower level of care. 7. Transition plans and education are understood by the member and/or the caregiver. D. MCO Initiated Nursing Facility Disenrollment Process 1. Requests for member disenrollment from managed care to fee for service Medicaid due to a need for extended nursing facility care must be submitted to the Ohio Department of Medicaid by CareSource. Approval of disenrollment requests are made at the discretion of ODM. 2. To be eligible for a request for disenrollment from managed care to be submitted to ODM, the member must meet all of the following criteria: a. Be enrolled in a Medicaid category identified by the Ohio Department of Medicaid as eligible for disenrollment. b. Be authorized by CareSource for the NF stay and have a continuous stay in the nursing facility for no less than the month of admission and two complete consecutive months thereafter. c. The members discharge plan documents that nursing facility discharge is not expected in the foreseeable future and the member has a need for long-term nursing facility care. d. The member has not used hospice services during the period outlined in (D)(2)(b). e. In addition, when a member meets criteria outlined in D.2 a, c, and d, the following scenarios are considered: i. If a member is admitted to a nursing facility while enrolled with another MCO and changes to CareSource, CareSource will align the disenrollment request to the disenrollment table dates. ii. If the admission date to the nursing facility is greater than three months prior to enrollment with CareSource, CareSource will submit the disenrollment request during the initial enrollment month to disenroll the member the last calendar date of the month prior to the initial enrollment. Nursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 iii. If a member is admitted to a nursing facility prior to being enrolled withCareSource and was admitted under fee-for-service Medicaid, CareSource will submit a disenrollment request during the initial enrollment month to disenroll the member the last calendar date f the month prior to initial enrollment. If the disenrollment request is not submitted in the initial month, the member will be disenrolled as of the last calendar date of the submission month. 3. When the member is identified as eligible for potential disenrollment as outlined in step D 2, CareSource will submit the request for disenrollment to ODM. NOTE : Modified Adjusted Gross Income (MAGI) Medicaid members in the Adult Extension (MAGI Group 8) category may not be disenrolled. 4. Requests for disenrollment will be submitted in the format specified by ODM. The disenrollment table lists the earliest disenrollment date if all criteria is met. See disenrollment table below: Month of Nursing Facility AdmissionNext Two Consecutive Months Earliest Disenrollment Date January February & March March 31 February March & April April 30 March April & May May 31 April May & June June 30 May June & July July 31 June July & August August 31 July August & September September 30 August September & October October 31 September October & November November 30 October November & December December 31 November Dec. & Jan. (next CY) January 31 (next CY) December January & February (next CY) Last Day of February (next CY) E. Conditions of CoverageNA F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 09/01/2021 New PolicyNursing Facility Level of Care-OH MCD-MM-1218Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 Date Revised 05/11/2022 08/09/2022 05/10/2023 07/16/2024 07/30/2025Updated references; no changes E-voted adding new section V. on Bed-Hold days Changed Member Care Coordinator (PCC) to Clinical Care Reviewer (CCR). Added Preadmission Screening and Resident Review requirements to align with Provider Agreement. Added sections IV. A and Bto align with Provider Agreement and reporting requirements. Updated references. Approved at Committee. Updated section IV.B.3 documentation for the Hospital Exemption Notice. Added to section V. Bed-hold Days criteria. Checked with Legal on current contract. Updated references. Approved at Committee. Changed MCP to MCO to align language to the current provider agreement; Added disenrollment language from the new contract. Date Effective 11/01/2025 Date Archived H. References1. ASPE. An Overview of Long-Term Services and Supports and Medicaid: Final report. May 8, 2018. Accessed July 7, 2025. www.hhs.gov 2. CareSource Desk Reference. Nursing Facility Disenrollment Process. July 1, 2019. Accessed June 2, 2025. www.CareSource.com 3. CareSource Procedure. Utilization Management-Level of Care. 2023. Accessed June 12, 2025. www.CareSource.com 4. CG-GRFAC (RFC) General Recovery Facility Comparison Tool. MCG Guidelines. 28th ed. 2024. Accessed June 12, 2025. www.careweb.careguidelines.com 5. CMS. Long Term Services & Supports. 2016. June 2, 2025. www.cms.gov 6. Criteria for Nursing Facility-Based Level of Care, O HIO ADMIN . C ODE 5160-3-08 (2025). 7. Criteria for the protective level of care. O HIO ADMIN . C ODE 5160-3-06 (2025). 8. Level of Care Definitions, O HIO ADMIN . C ODE 5160-3-05 (2025). 9. Managed Care: Termination of Enrollment, O HIO ADMIN . C ODE 5160-26-02.1 (2023). 10. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . C ODE 5160-1-01 (2022). 11. Nursing Facilities (NFs): Covered Days and Bed-Hold Days, O HIO ADMIN . C ODE 5160-3-16.4 (2017). 12. Nursing Home and Residential Care Facility Definitions, O HIO R EV . C ODE 3721.01 (2023). 13. ODM. Nursing Facility Request Form. Accessed June 12, 2025. www.medicaid.ohio.gov 14. Process and timeframes for a level of care determination for nursing facility-based level of care programs. O HIO ADMIN . C ODE 5160-3-14 (2025). 15. Skilled Nursing, O HIO R EV . C ODE 3721.011 (2023). ODM approved 08/13/2025

Negative Pressure Wound Therapy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Negative Pressure Wound Therapy-OH MCD-MM-0224 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNegative Pressure Wound Therapy B. BackgroundNegative pressure wound therapy (NPWT), also known as vacuum-assisted wound closure, 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, including diabetes, vascular insufficiencies, and other underlying medical condition s. 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 demonstrated efficacy 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 be done 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. Tunneling Channels of tissue deterioration that extend from the wound to the subcutaneous tissue typically in one direction. Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 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 . B. Chronic neuropathic ulcer that meets BOTH of the following criteria: Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 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 that includes general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies, that meet ALL 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 wound 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 exception 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 members 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 F. active bleedingIV. When 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 initial month, continued approval will be based on the medical necessity guidelines in this policy. Continued approval will be made in 1-month increments. CareSource willapprove 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 CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New policy.Date Revised 11/23/2022 10/11/202310/23/2024 07/30/2025 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. Annual review: updated references. Approved at Committee. Date Effective 11/01/2025 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 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 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 January 20, 2024 . Accessed July 9, 2025 . 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, 29 th ed draft. Updated January 25, 2025. Accessed July 25 , 2025. careweb.careguidelines.com 11. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane 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 July 9, 2025 . 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 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 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 18. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. Accessed July 7, 2025. www.ncbi.nlm.nih.gov 19. 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 4/2020ODM approved 8/12/2025

© Copyright CareSource 2025. All rights reserved.

System Details