MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Peroral Endoscopic Myotomy-OH MCD-MM-1245 10/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and ap plying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between t he Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive than those that apply to M/S benefits. Table of Contents A. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 Peroral Endoscopic Myotomy-OH MCD-MM-1245 Effective Date: 10/01/2026 2 A. SubjectPeroral Endoscopic MyotomyB. BackgroundAchalasia is a rare motility disorder that results from the degeneration of ganglion cells in the wall of the esophagus leading to failed relaxation of the lower esophageal sphincter and loss of esophageal peristalsis; the cause is unknown. As the sphincte r becomes paralyzed and dilated over time, difficulty may occur passing food and liquid to the stomach. Symptoms include chest pain, heart burn, and difficulty belching. Potential complications are progressive dilation of the esophagus and increased risk o f esophageal cancer. Although achalasia cannot be cured, symptoms may be controlled with treatment such as oral medications, dilation or stretching of the esophagus, open or laparoscopic surgery, endoscopic surgery, or injection of muscle-relaxing medicine s(such as botulinum toxin) directly into the esophagus.While laparoscopic Heller myotomy (LHM) is the most common surgical procedure for the treatment of achalasia, peroral endoscopic myotomy ( POEM ) is a newer, less invasive surgical alternative. The POEM procedure is performed through a submucosal tunnel layer of the esophagus and proximal stomach endoscopically without the need for incisions in the chest or abdomen. Since POEM does not require external incisions, this approach aims to reduce procedure-related pain and return patients to regular activities sooner than surg ical modalities . A review of clinical data suggests that the overall efficacy of POEM is similar to surgical myotomy and better than pneumatic dilation. However, patients who undergo POEM show an increased risk of gastroesophageal reflux disease (GERD) and erosive esophagitis which should be discussed. C. DefinitionsAchalasia A rare disorder making it difficult for food and liquid to pass from the and the esophagus to the stomach. Nerve cells in the esophagus degenerate and 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 types of achalasia 😮 Type I ( Classic A chalasia) Minimal esophageal pressurization , t his 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 ( Panesophageal Pressurization) I ndicated by esophageal compression , t his 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 ( Sp astic A chalasia) Indicated by spasms that result in sudden,abnormal squeezing of the esophagus and the LES , t his type is the most severe Peroral Endoscopic Myotomy-OH MCD-MM-1245 Effective Date: 10/01/2026 3 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 ) . Eckardt Score Standardized , scored assessment used to evaluate symptoms,stages, and efficacy of achalasia treatment. It attributes points (0 to 3 points) for 4symptoms 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 performed laparoscopically to treat achalasia. The procedure involves making cuts in the opening of the lower esophageal sphincter (LES) to allow food to pass more easily . Pneumatic Balloon Dilation (PD) A n 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. Member h as a diagnosis of primary achalasia, type 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. Member has an Eckardt score of greater than or equal to 3. D. Member has no history of previous open surgery of the stomach or esophagus.II. Request for members 20 years or younger will undergo individualized medical necessity review based on disease severity and available evidence.III. POEM for any other indication is considered experimental, investigational , and unproven.IV. The following conditions may represent contraindications and, if present, warrant individualized clinical assessment:A. s evere erosive esophagitisB. s ignificant coagulation disordersC. l iver cirrhosis with portal hypertensionD. s evere pulmonary diseaseE. e sophageal malignancyF. p rior 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 ablationV. Previous therapies for achalasia (eg, PD, botulinum toxin injection, or LHM ) are not contraindications to POEM. Peroral Endoscopic Myotomy-OH MCD-MM-1245 Effective Date: 10/01/2026 4 VI. Members receiving POEM should be made aware there is a high risk in develop ingGERD and should be advised as such prior to undergoing the procedure.E. Conditions of CoverageN / AF. Related Policies/RulesN / AG. Review/Revision HistoryDATE ACTION Date Issued 03/30/2022 New policy Date Revised 02/15/2023 02/14/2024 12/18/2024 08/13/2025 0 6/ 17 /2026 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 r eferences. Approved at Committee. Annual review: updated references. Approved at Committee. Annual rev i ew: updated references. Approved at Committee. Annual review, updated background , definitions, and references ; revised Sec D. II. and D. IV . Approved at Committee. Date Effective 10/01/2026 Date Archived H. References1. Aiolfi A, Bona D, Riva CG, et al. Systematic review and bayesian network meta-analysis comparing laparoscopic Heller myotomy, pneumatic dilatation, and peroral endoscopic myotomy for esophageal achalasia. JLaparoendosc Adv Surg Tech A .2020;30(2):147-155. doi:10.1089/lap.2019.04322. 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-2021-3255793. Health Technology A ssessment: Peroral Endoscopic Myotomy for Treatment of Esophageal A chalasia . Hayes; 2019 ; Reviewed March 7, 2023. Accessed May 12,2026 . www.evidence.hayes.inc.com4. 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. GastrintestEndosc . 2021;93(1):47-56.e5. doi:10.1016/j.gie.2020.05.0565. Khashab MA, Vela MF, Thosani N, et al . ASGE guideline on th e management of achalasia. Gastrointest Endosc . 2020;91(2):213-2 27 . doi:10.1016/j.gie.2019.04.2316. 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:10.4103/1319-3767.2033607. Kohn GP, Dirks RC, Ansari MT, et al. SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia. Surg Endosc .2021;35(5):1931-1948. doi:10.1007/s00464-020-08282-0 Peroral Endoscopic Myotomy-OH MCD-MM-1245 Effective Date: 10/01/2026 5 8. Meng F, Li P, Wang Y, et al . Peroral endoscopic myotomy compared with pneumatic dilation for newly diagnosed achalasia. Surg Endosc . 2017;31(11):4665-4672. doi:10.1007/s00464-017-5530-09. Patel DA, Lappas BM, Vaezi MF . An o verview of a chalasia and i ts s ubtypes.Gastroenter ol Hepatol . 2017 ;13(7): 411-421. Accessed May 12, 2026 .www.ncbi.nlm.nih.gov10. 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. JGastrointest Surg . 2016;20(11):1789-17 96. doi:10.1007/s11605-016-3232-x11. Spechler SJ. Achalasia: overview of the management of treatment. UpToDate.Accessed May 12, 2026 . www.uptodate.com12. 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/gnl1923413. 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.000000000000073114. 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-1894-014715. 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 Ohio Dept of Medicaid approved 7/1/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 10/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilization and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provider Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 4 Penile Implants in the Treatment of Erectile Dysfunction-OHMCD-MM-0033Effective Date: 10/01/2026 2A. SubjectPenile Implants in the Treatment of Erectile Dysfunction B. Background Erectile dysfunction (ED) is the consistent or recurrent inability to acquire or sustain an erection, and the most common sexual problem affecting males. Surveys suggest 5-10% of men between the ages of 20 to 30 are affected, and that number increases to 35-40% of men aged 70 or older. The National Institutes of Health (NIH) estimates that up to 30 million men experience erectile dysfunction. Various treatment modalities exist for ED. One treatment option is a surgical penile implant (also called a penile prosthesis). A penile implant is indicated when there is a clear medical cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments. A basic penile prosthesis consists of a pair of bendable, silicone rods that are surgically implanted within the erection chambers of the penis. Identification of the underlying etiology is an important first step. This includes ruling out the adverse effects of medication(s), identifying, and treating risk factors. C. Definitions Erectile Dysfunction The consistent or recurrent inability to acquire or sustain an erection. Neurogenic Impotence Nervous system issues affecting the ability to maintain or have an erection. Vascular Impotence Restricted or decreased blood flow to the penis causing impotence. D. PolicyI. Medication is the first line of treatment for ED, including: A. oral phosphodiesterase type 5 inhibitors B. intra-urethral alprostadil C. intracavernous vasoactive drug injections Ohio Medicaid does not cover medications including oral, injectable, or transdermal varieties for the treatment of erectile dysfunction. II. External penile pumps or vacuum constriction devices (VCD) are the second line of treatment after first line therapy has failed. Ohio Medicaid does not cover external penile pumps or vacuum constriction devices. III. Internal penile prosthetic implants are covered in extraordinary circumstances. They are considered medically necessary when ALL of the following conditions are met: A. First and second line therapy have been documented as ineffective, or there is a compelling, well documented reason to proceed with surgery without a failed trial of first and second-line therapies. B. Absence of active alcohol or substance use disorder as documented in the medical record. C. Absence of drug induced impotence related to ANY of the following: Penile Implants in the Treatment of Erectile Dysfunction-OHMCD-MM-0033Effective Date: 10/01/2026 31. anabolic steroid use 2. anticholinergics 3. antidepressants 4. antipsychotics or central nervous system depressantsD. Neurogenic impotence due to ONE of the following: 1. diabetes 2. fractured pelvis 3. major surgery of the pelvis, retroperitoneum, radical prostatectomy, or colorectal surgery 4. multiple sclerosis 5. spina bifida 6. spinal cord injury/disease 7. syringomyelia OR E. Vascular impotence due to ONE of the following: 1. hypertension 2. intrapenile arterial disease 3. penile fracture 4. Peyronies disease 5. smoking 6. status post cavernosal infection 7. impotence due to radiation therapy to the pelvis or retroperitoneum IV. Internal penile prosthetic implant removal is considered medically necessary whenANY of the following occur: A. infection B. mechanical failure C. urinary obstruction D. intractable pain E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision History DATE ACTIONDate Issued 07/26/2016Date Revised 05/13/2020 05/11/202205/10/202305/08/2024 Updated References, Updated Background information, condensed medical criteria. Added penile implant information to Background; updated references. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee. Penile Implants in the Treatment of Erectile Dysfunction-OHMCD-MM-0033Effective Date: 10/01/2026 406/18/202506/17/2026 No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee. Date Effective 10/01/2026 Date Archived H. References1. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. JUrology . 2018;200:633-641. doi:10.1016/j.juro.2018.05.004 2. Khera M. Treatment of male sexual dysfunction. UpToDate. Updated October 24, 2023. Accessed May 8, 2026. www.uptodate.com 3. Lazarou S. Surgical treatment of erectile dysfunction. UpToDate. Updated November 14, 2023. Accessed May 8, 2026. www.uptodate.com 4. Pharmacy Services: Covered Drugs and Associated Limitations, O HIO ADMIN . C ODE 5160-9-03(B)(3) (2024). 5. Urologic Surgery or Procedure GRG: SG-US. MCG Health. 29th ed. Updated June 13, 2025. Accessed May 8, 2026. www.careweb.careguidelines.com Approved by ODM on 6/23/2026.
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pediatric Medical Strollers-OH MCD-MM-1877 10/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilization and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provider Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Pediatric Medical Strollers-OH MCD-MM-1877Effective Date: 10/01/20262A. SubjectPediatric Medical Strollers-OH MCD-MM-1877 B. Background To be eligible for coverage, pediatric medical strollers must fulfill all aspects of the definition of durable medical equipment (DME) per the OAC. Pediatric medical strollers are primarily used as mobility aids. In some cases, these strollers may be required to ensure the safety of an ambulatory person at risk of elopement. These guidelines do not apply to delays or difficulties in achieving age-appropriate walking skills. In such cases, requests should be assessed under the relevant mobility-related criteria based on the members mobility needs. C. Definitions Durable Medical Equipment (DME) Equipment and supplies ordered by a health care provider for everyday or extended use. Elopement The tendency for an individual with little or no awareness of danger, to try to leave the safety of a responsible persons care or a safe area, which can result in potential harm or injury. D. PolicyI. If any of the items below do not apply, the provider must submit a detailed explanation of why the item is not applicable. ALL the following must be documented and met: A. The member demonstrates impaired safety awareness. B. The member has a history of placing self in situations of compromised safety or where such risk is foreseeable. C. Caregivers are unable to adequately reduce safety risks. D. The member must have outgrown commercial 5-point harness stroller specifications evidenced by documented weight 50 lbs. E. Use of a stroller for safety during recreational activities or family outings (eg, shopping) is insufficient. The stroller must be needed to ensure safety in essential settings for health and well-being. 1. Essential settings include the following: a. medical or therapy appointments b. settings required for education, employment, or the free expression of religion c. transportation to the above necessary environments d. other environments supported by medical documentation 2. Documentation must support the members medical need for use of a stroller for safety in potentially dangerous situation(s). F. The needs of the member cannot be met by a less costly means, including 1. avoidance of situations in which the member is prone to safety risks 2. behavioral management of unsafe behaviors. 3. manipulation of the environment to reduce risk. Pediatric Medical Strollers-OH MCD-MM-1877Effective Date: 10/01/202634. less costly devices or more efficient use of devices already available (eg, seat belts, closing and locking doors, fences, home security systems, motion detectors, GPS-enabled location devices) 5. medical management, when appropriately prescribed by a licensed provider 6. unsuccessful behavioral methods for decreasing risk or not clinically indicated for specified reasons F. A plan for use of the stroller is submitted and includes ALL the following: 1. The stroller must be needed in the community setting but need not be exclusively for community use. 2. The member is never to be unattended in the stroller, which is not a part of respite or a break plan for caregivers or for purposes of allowing caregiver focus to be more easily shifted from the care of the member. 3. The anticipated maximum hours of daily use, based on anticipated activities and an assessment of the tolerance of the member. G. The stroller is to be used for safety only and not for discipline, restraint, or as a substitute for supervision. H. All accessories such as special push bars, knobby tires for recreation, canopies, under seat basket and hook for backpack, must be medically necessary. I. Documentation must show that the member has tried the requested stroller and can tolerate stroller use without significant agitation or aggression, as use in such conditions is unsafe. J. Documentation must be provided from a physical therapist, occupational therapist, physician, physician assistant, or nurse practitioner verifying that the requested device is appropriate and necessary for the members well-being. II. Pediatric Medical Strollers should be consistent with Manual Wheelchair BasesPolicy Article A52497 and have a depth of 14 inches or less.E. Conditions of CoverageNA F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 06/17/2026 New policy. Approved at Committee.Date Revised Date Effective 10/01/2026 Date Archived H. References1. Centers for Disease Control and Prevention. Pediatric Medical Strollers: Criteria for Safety and Mobility Needs. Updated January 28, 2026. https://www.cdc.gov. Accessed June 2, 2026. Pediatric Medical Strollers-OH MCD-MM-1877Effective Date: 10/01/202642. Centers for Medicare & Medicaid Services. Manual Wheelchair Bases-PolicyArticle. Medicare Coverage Database. Published 2026. Accessed June 3, 2026. https://www.cms.gov. 3. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, O HIO ADMIN . C ODE 5160-10-01 (2026). 4. National Autism Association. Wandering Off (Elopement). Caring for Children with Autism Spectrum Disorders: A Resource Toolkit for Clinicians, 2nd Edition. Family Handouts. Published 2026. Accessed June 3, 2026. https://nationalautismassociation.org. ODM Approved 06/30/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD – MM-1588 10/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and ap plying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between t he Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 9 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 9 H. References ………………………….. ………………………….. ………………………….. ……………………. 9 Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20262 A. SubjectNon-Invasive Home Mechanical Ventilation (E0466) B. BackgroundThis document outlines the medical necessity criteria for a non-invasive home ventilator for a member with stable, chronic respiratory failure. This device does not treat the underlying cause of respiratory failure but functions as supportive therapy, which may include reducing symptoms, improving quality of life, or sustaining or extending life. It may be used intermittently during the day and/or during sleep. A non-invasive home ventilator will not be reimbursed as such when its sole purpose isto function as a respiratory assistance device, including continuous positive airway pressure (CPAP), auto-titrating PAP, and bilevel airway pressure ( BIPAP ). Medical necessity for BIPAP and CPAP devices are determined based upon MCG criteria, A – 0431 and A-0994. C. Definitions Apnea-Hypopnea Index (AHI) The combined average number of episodes of apnea or hypopneas recorded over a period of at least 2 hours without the use of a respiratory device, reported by polysomnogram. Extrapolation or projection of the AHI is not permitted. Apnea-Hypopnea Index (AHI) Adult AHI Pediatric AHIMild OSA 5-14 1-4.9Moderate OSA 15 – 30 5-9.9 Severe OSA > 30 > 10 Home Mechanical Ventilation (HMV) An overarching term used in this policy to describe home based ventilatory support devices used in the management of chronic respiratory failure, encompassing a continuum of non invasive respiratory support modalities, including respiratory assist devices (eg, CPAP, Bilevel, and volume targeted pressure support modes such as AVAPS) and, when medically necessary, non invasive home ventilator devices (eg, E0466). For purposes of this policy, classification within the HMV continuum is determined by clinical dependence, functional capability of the device, and medical necessity, rather than by device naming conventions al one. This policy does not address invasive mechanical ventilation delivered via tracheostomy. Non-Invasive Ventilation (NIV) / Non-Invasive Home Ventilator Refers to ventilatory support delivered through a non invasive interface (eg , nasal or oronasal mask or mouthpiece) using positive airway pressure technology and includes both respiratory assist device (RADS) modes that augment spontaneous breathing and non invasive mechanical ventilation that delivers mandatory, machine generated breaths. Respiratory Assist Devices (RADs) Non-invasive positive airway pressure devices, including standard BIPAP , and volume-targeted pressure support modes such as AVAPs or iVAPs, that augment spontaneous breathing but do not provide Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20263 mandatory, machine-generated breaths as the primary source of ventilation and therefore do not constitute ventilator dependency as defined within this policy. RADs are billed under E0601, E0470, E0471, and E0472 . o Bi-level Positive Airway Pressure ( BIPAP ) Device A device that uses mild bi-level or 2 levels of air pressure to keep breathing airways open. o Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep breathing airways open. o Auto EPAP (AE) An automated feature that adjusts expiratory positive airway pressure (EPAP) in response to airflow limitation/upper airway obstruction during non invasive therapy. o Average Volume Assured Pressure Supports (AVAPS), with or without Auto-EPAP (AE) A volume targeted mode of non invasive positive airway pressure ventilation that delivers variable pressure support within prescribed limits to achieve a target ventilation (typically via a target tidal volume) and functions as a respiratory assist device that augments spontaneous brea thing, rather than as a life sustaining ventilator. o Intelligent Volume Assured Pressure Support (iVAPS) A mode of non invasive ventilation that adjusts positive airway pressure support over time to achieve a target ventilation goal while relying on the patient s spontaneous breathing effort, similar in function to AVAPS. Ventilator-Dependent (Non-Invasive) Describes a member who requires a device to provide mandatory, mechanical ventilation that serves as the primary, life – sustaining source of ventilation for 6 or more hours within a 24-hour period, and who cannot safely maintain adequate ventilation without such mechanical assistance. Discontinuation of ventilatory support would place the member at risk of serious harm or death. Use of CPAP, standard bilevel positive airway pressure devices, or volume targeted pressure support modes (eg, AVAPS or iVAPS ), when used to treat sleep apnea or mild to moderate respiratory insufficiency and to augment spontaneous breathing, do es not constitute ventilator dependenc e and such devices are not considered non invasive home ventilators under this policy. D. PolicyThe criteria below are intended to guide escalation from CPAP or BIPAP to a non – invasive home ventilator (E0466) only when the members chronic respiratory failure and clinical dependence require ventilator-level support beyond the capabilities of RADs. CareSource utilizes Ohio Administrative Code and MCG Health criteria to determine medical necessity for non-invasive home ventilator devices (ie, HVD; E0466) . Requests that do not meet the criteria for HVD will be reviewed against MCG Health criteria for BIPAP and CPAP devices (ie, A-0431 and A-0994). I. An initial approval for H VD is valid for a maximum of 3 months. A new medical necessity determination thereafter is required every 6 months with supporting documentation for continued rental use. Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20264 II. Medical Necessity Criteria for Initial Rental of Home Ventilatory DeviceMedical necessity for the initial coverage of non-invasive HV Dis based upon the following conditions in II – IV being met : A. Congenital central hypoventilation syndrome B. Chronic lung disease of infancy (eg, bronchopulmonary dysplasia), and patient unable to maintain acceptable pH and PCO 2 without ventilator support C. Chronic obstructive pulmonary disease (COPD) and ONE OR MORE of the following: 1. Chronic hypercapnia (ie, PaCO 2 > 45 mm Hg (6.0 kPa)) in stable patient 2. Non-invasive ventilation during hospitalization with persistent hypercapnia during spontaneous breathing (ie, PaCO 2 > 45 mm Hg (6.0 kPa)) 3. Palliative care for end-stage disease and advance directive states no desire for intubation D. Neuromuscular disorder accompanied by respiratory failure , as indicated by ALL the following: 1. Appropriate neuromuscular disorder, as indicated by ONE OR MORE of the following: a. amyotrophic lateral sclerosis b. congential muscular dystrophy c. Duchenne muscular dystrophy d. mitochondrial myopathy e. myotonic dystrophy f. postpolio syndrome g. spinal cord syndrome h. spinal muscular atrophy i. other neuromuscular disorder accompanied by chronic respiratory failure (eg, multiple sclerosis, myasthenia gravis, Pompe disease) 2. Documentation of respiratory failure, as indicated by ONE OR MORE : a. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) b. Forced vital capacity less than 50% predicted c. Forced vital capacity less than 80 % predicted and symptoms of respiratory failure d. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower e. Maximum sniff nasal inspiratory pressure less than 40 cm H 2O (3923 Pa) f. Oxygen saturation less than 88% for 5 consecutive minutes during nocturnal oximetry g. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: i. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . ii. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20265 greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of55 mm Hg (7.3 kPa) or greater) . E. Obesity hypoventilation syndrome , as indicated by ALL of the following: 1. BMI > 30 2. CPAP unsuccessful or not appropriate , as indicated by ONE OR MORE of the following: a. Comorbid sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer ) b. Intolerance of CPAP pressures necessary to correct obstructive sleep apnea (OSA) component (ie, difficulty exhaling against fixed airway pressure) c. Lack of resolution of hypercarbia, nocturnal desaturation, and OSA despite 3 months of CPAP use d. Titration study demonstrates OSA despite CPAP 15 cm H 2O (1471 Pa) that is responsive to BIPAP 3. Daytime hypercapnia with PaCO 2 greater than 45 mm Hg (6.0 kPa) without other etiology (eg, kyphoscoliosis, lung parenchymal disease, myopathy, severe hypothyroidism) 4. Sleep-disordered breathing or hypoventilation on polysomnography, as indicated by ONE OR MORE of the following: a. Apnea-hypopnea index of 5 or greater b. Increase in PaCO 2 during sleep by more than 10 mm Hg (1.3 kPa) above value while awake c. Significant oxygen desaturation (eg, less than 90%) not explained by obstructive apneas or hypopneas 5. TSH level does not demonstrate hypothyroidism F. OSA in child or adolescent and ONE OR MORE of the following: 1. Mild OSA (ie, apnea-hypopnea index from 1 to 5) and ONE OR MORE of the following: a. achondroplasia b. behavioral problems c. cardiovascular disease (eg, elevated blood pressure, pulmonary hypertension) d. Chiari malformation e. craniofacial abnormalities f. Down Syndrome g. excessive daytime sleepiness h. impaired cognition i. inattention or hyperactivity j. mucopolysaccharidoses k. neuromuscular disorders l. Prader-Willi syndrome 2. Moderate or severe OSA (ie, apnea-hypopnea index greater than 5) Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20266 3. Residual apnea-hypo pnea index greater than 5 in pediatric patient after adenotonsillectomy G. Restrictive disorder of chest wall , as indicated by ALL of the following: 1. Appropriate chest wall disorder as indicated by ONE OR MORE of the following: a. asphyxiating thoracic dystrophy b. kyphoscoliosis c. other chest wall disorder accompanied by chronic respiratory failure (eg, ankylosing spondylitis, fibrothorax, post-tuberculous chest wall deformity) 2. Documentation of respiratory failure as indicated by ONE OR MORE of the following : a. Arterial O 2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry b. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) c. Forced vital capacity less than 50% predicted d. Forced vital capacity less than 80% predicted and symptoms of respiratory failure e. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower f. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: 01. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . 02. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater ). III. Respiratory status is STABLE , as indicated by ALL of the following:A. Airway interface is safe with a non-invasive interface with acceptable fit . B. Airway pressure requirement appropriate, as indicated by ONE OR MORE of the following: 1. BIPAP expiratory positive airway pressure requirement is to 10 cm H 2O (981 Pa). 2. CPAP pressure requirement in child is 15 cm H 2O (1471 Pa). 3. Ventilator positive end-expiratory pressure requirement is 10 cm H 2O (981 Pa). C. Oxygen requirement does not exceed 40% FiO 2. D. Settings are stable on chosen device. E. No continuous invasive monitoring is required. IV. The criteria below define when a members clinical needs exceed the capabilities ofCPAP or standard BIPAP , such that consideration of a non-invasive home ventilator Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20267 (E0466) is appropriate. A BIPAP or CPAP device must not be clinically appropriate as indicated by ONE OR MORE of the following. A. Chronic respiratory insufficiency fails to improve with simple BIPAP device. B. Infant or child does not meet the minimum body weight requirement for CPAP device. C. Infant or child is not appropriate for simple BIPAP device due to setting or performance requirements, as indicated by ONE OR MORE of the following: 1. Breath rates delivered by device not appropriate for patient . 2. Compatible ventilator circuits not appropriate for patient (eg, circuit compliance, compressed volume, dead space) . 3. Inspiratory flows delivered by device not appropriate for patient . 4. Patient does not meet ventilator minimum body weight requirements. 5. Pressure range (eg, expiratory pressure, inspiratory pressure) not appropriate for patient . 6. Tidal volume range delivered by device not appropriate for patient . 7. Ventilator inspiratory trigger delay (ie, airway pressure rise time) not appropriate for patient . 8. Ventilator inspiratory trigger sensitivity not appropriate for patient . D. The following setting or functionality is required by the member and is not available with simple BIPAP device: 1. Alarms required by member are not available on the device . 2. Daytime ventilation using mouthpiece is required . 3. Pressure range delivered by device is not appropriate for member . 4. Member requires volume-assured pressure support or volume control mode (eg, obesity hypoventilation syndrome). E. Portable ventilator is required for mobility. F. Ventilated patient requires cough assistance via volume ventilator’s breath stacking capability. G. Ventilation is required 24 hours per day. V. Medical Necessity for Continued Device UseFor HVD continued use beyond the initial 3-month determination, medical necessity must be reestablished every 6 months thereafter . The following are to be provided for continued use: A. Re-evaluation by the treating medical professional must be completed no earlier than 61 days after initiating therapy. B. Documentation of the persistence of the disease process for which HVD has been prescribed. C. Medical records must document that the member is compliant with and benefitting from HVD . D. At least 30 consecutive days of device data, beginning after 31 days of initiation, demonstrating that the member is utilizing the device an average of 6 hours per 24-hour period. NOTE: Failure of the member to consistently use HVD for an average of 6 hours per 24-hour period would demonstrate non-compliant utilization of the device for its intended purpose and expectation of benefit, which would Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20268 constitute a denial in continued coverage as not reasonable and necessary . E. Additional information as requested. VI. In accordance with Rule 5160-10-01 for each claim, the provider cannot legitimately receive payment until necessary supporting documents have been obtained and placed in the providers files. These documents include the prescription and the following items: A. A completed CMN form: ODM 01902 . B. Practitioner order and chart notes , which support the determination of medical necessity , including ventilator settings . VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.VIII. ExclusionsAny request for a non-invasive home ventilator (E0466) that does not meet the medical-necessity criteria outlined above will be denied as not medically necessary. This includes requests where the device is used solely as a respiratory assist device to augment spontaneous breathing or to treat sleep-disordered breathing, rather than to provide life-sustaining, non-invasive mechanical ventilation beyond the capabilities of respiratory assist devices such that withdrawal would place the member at risk of serious harm or death . Devices and modes that function as RADincluding CPAP, auto-titrating PAP, standard bilevel positive airway pressure ( BIPAP ), and volume – targeted pressure support modes such as AVAPS (with or without auto EPAP (AE), or iVAPS do not qualify for coverage under E0466 when used for sleep apnea or mild to moderate respiratory insufficiency and do not, by themselves, establish venti lator dependency under this policy. E. Conditions of CoverageI. Claims for ventilators being utilized to provi de CPAP or BIPAP therapy for conditions described above and are submitted with HCPCS code E0466, will be denied as not being reasonable and necessary. If a HVD is dispensed to a Member for CPAP or BIPAP therapy, the claim must be coded in accordance with CareSource policy, Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental . All requirements in D. I. -V. of this policy must be satisfied for HVD to be considered medically necessary. II. CareSource may verify the use of the equipment through post-payment audit andrequest additional supporting medical record documentation. If the use of a more appropriate code or piece of equipment is warranted, CareSource may request recoupment. Standard DME documentation requirements can be located within section D.II.A. of the administrative policy, Medical Record Documentation Standards for Practitioners . Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/20269 F. Related Policies/RulesDMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (202 5) DMEPOS: Respiratory Assist Devices, OHIO ADMIN . CODE 5160-10-38 (2025) Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental Overpayment Recovery Medical Record Documentation Standards for Practitioners G. Review/Revision HistoryDATE ACTIONDate Issued 05/22/2024 New Policy, Approved at CommitteeDate Revised 06/04/2025 05/20/2026Annual review: Added E.II. , Updated Exclusions to includeAVAPS, EPAP, iVAPS; Approved at Committee AHI definition revised & definitions added under RAD; D.V.D. increased avg. device usage to 6 hours (from 4). Medical Record Documentation added to E.II . Approved at Committee. Date Effective 10/01/2026 Date Archived H. References1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi: 10.1513/AnnalsATS.201810-657CME 2. DMEPOS: Ventilators, OHIO ADMIN . CODE 5160-10-22 (2021). 3. Janssen DJA . Assessment and management of dyspnea in palliative care. UpToDate. Updated October 29, 2025. Accessed April 1, 2026 . www.uptodate.com 4. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (202 6). 5. Ferrell BR, Twaddle ML, Melnick A, et al. National Consensus Project clinical practice guidelines for quality palliative care guidelines, 4th edition. JPalliative Med . 2018;21(12): 1684-1689. doi:10.1089/jpm.2018.04311684 6. Freedman N. Treatment of obstructive sleep apnea: choosing the best positive airway pressure device. Sleep Med Clin . 2020;15(2):205-218. doi:10.1016/j.jsmc.2020.02.007 7. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated April 21, 2025. Accessed April 1, 2026 . www.uptodate.com 8. Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive summary: optimal NIV Medicare access promotion: a technical expert panel report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest . 2021;160(5):1808-1821. doi:10.1016/j.chest.2021.05.074 9. Hansen-Flaschen J, Ackrivo J. Practical guide to management of long-term noninvasive ventilation for adults with chronic neuromuscular disease. Resp Care . 2023;68(8):1123-1157. doi:10.4187/respcare.10349 10. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes Non-Invasive Home Mechanical Ventilation (E0466) -OH MCD-MM-1588 Effective Dat e:10/01/202610 of ventilatory support. UpToDate. Updated November 06, 2025. Accessed April 1,2026 . www.uptodate.com 11. Home Ventilator (Invasive or Noninvasive Interface): ACG A-0893. MCG Health . 2 9th ed. Accessed April 1, 2026 . www.careweb.careguidelines.com 12. Khan A, Frazer-Green L, Amin R, et al. Respiratory management of patients with neuromuscular weakness: an American College of Chest Physicians clinical practice guideline and expert panel report. Chest . 2023;164(2):394-413. doi:10.1016/j.chest.2023.03.011 13. Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Updated November 25, 2025. Accessed April 1, 2026 . www.uptodate.com 14. MacIntyre NR, Epstein SK, Carson S, et al; National Association for Medical Direction of Respiratory Care. Management of patients requiring prolonged mechanical ventilation: report of a NAMDRC consensus conference. Chest . 2005;128(6):3937-3954. doi:10.1378/chest.128.6.3937 15. Macrea M, Oczkowski S, Rochwerg B, et al. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease: an official American Thoracic Society clinical practice guideline. Am JResp Crit Care Med . 2020;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST 16. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated May 1, 2025. Accessed April 1, 2026 . www.uptodate.com 17. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 10.1177/0194599818801757 18. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasive ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev . 2021;8:CD002878. doi:10.1002/14651858.CD002878.pub3 19. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinical practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.01766 20. Sauthier M, Rose L, Jouvet P. Pediatric prolonged mechanical ventilation: considerations for definitional criteria. 2017;62(1):49-53. doi:10.4187/respcare.04881 21. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest . 2020 ;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007 Independent Medical Review 05/08/24 Approved by ODM 06 /29 /202 6
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Skin Substitutes-OH MCD-MM-1398 09/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilization and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provider Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not subject to limits or requirements that are more restrictive than those that apply to M/S benefits.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: 09/01/20262A. 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. Diabetic Foot Ulcers An open sore or wound located on the foot occurring in approximately 15% of patients with diabetes. Skin Substitutes-OH MCD-MM-1398Effective Date: 09/01/20263 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 (for example, Apligraf or Dermagraft) 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) c. dressings to maintain moist wound environment (eg, saline-moistened dressings, negative pressure wound therapy) d. sharp debridement Skin Substitutes-OH MCD-MM-1398Effective Date: 09/01/2026410. no wound infectionC. 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 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%. Skin Substitutes-OH MCD-MM-1398Effective Date: 09/01/20265C. 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 (eg, active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, ischemia). E. Use of surgical preparation services (eg. debridement), in conjunction with routine, simple, or repeat skin replacement therapy with a skin substitute graft/CTP. F. All liquid or gel skin substitute products or CTPs for ulcer care G. Placement of skin substitute graft/CTP on infected, ischemic, or necrotic wound bed. H. Skin substitute products that are not on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational. I. Life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. 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 02/12/202507/02/202506/17/2026Updated 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 references Added skin graft examples to Sec. D.I. Updated references. Approved at CommitteeDate Effective 09/01/2026 Date Archived Skin Substitutes-OH MCD-MM-1398Effective Date: 09/01/20266H. References 1. Ankle-brachial index. Mayo Clinic. Accessed May 18, 2026. www.mayoclinic.org 2. Bay C, Chizmar Z, Reece EM, et al. Comparison of Skin Substitutes for Acute and Chronic Wound Management. Semin Plast Surg . 2021;35(3):171-180. doi:10.1055/s- 0041-1731463 3. Bedsores (pressure ulcers). Mayo Clinic. Accessed May 18, 2026. www.mayoclinic.org 4. 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 5. Marquez JL, French M, Ormiston L, et al. Outcomes after tissue expander exchange to implant in two-stage prepectoral breast reconstruction with and without acellular dermal matrix: a retrospective cohort study. JPlast Reconstr Aesthet Surg . 2024;89:97-104. doi:10.1016/j.bjps.2023.12.008 6. Porcine skin and gradient pressure dressings. Centers for Medicare & Medicaid Services. Accessed May 18, 2026. www.cms.gov 7. Provider-Administered Pharmaceuticals fee schedule. Ohio Dept of Medicaid. Updated April 1, 2026. ProviderAdminDrugTable.xlsx Accessed May 19, 2026. 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 May 18, 2026. www.effectivehealthcare.ahrq.gov 9. Roshangar L, Soleimani Rad J, Kheirjou R. Skin burns: review of molecular mechanisms and therapeutic approaches. Wounds . 2020; 31(12):308-315. 10. Shahrokhi S. Skin substitutes. UpToDate. Updated July 31, 2025. Accessed May 18, 2026. www.uptodate.com 11. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer: A-0326. MCG Health. 30th ed. Accessed May 18, 2026. www.careweb.careguidelines.com 12. Tissue engineering and regenerative medicine. National Institute of Biomedical Imaging and Bioengineering. Accessed May 18, 2026. www.nibib.nih.gov 13. Venous ulcers. Cleveland Clinic. Reviewed May 26, 2022. Accessed May 18, 2026. www.myclevelandclinic.org 14. What is a diabetic foot ulcer? American Podiatric Medical Association. Accessed May 18, 2026. www.apma.org Approved by ODM on 06/23/2026 Independent medical review 01/19/2023
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nutritional Supports-OH MCD-MM-0024 09/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use d isorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not subject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………… 2 B. Background ………………………….. ………………………….. ………………………….. ………………….. 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 8 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 8 H. References ………………………….. ………………………….. ………………………….. …………………… 8 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 09/01/20262A. SubjectNutritional Sup ports B. BackgroundEnteral nutrition may be necessary to maintain optimal health status for members 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 outcome. Enteral nutrition may be prescribed to serve as a member s 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 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 for infants . Donor milk banks take voluntary steps to screen milk donors and safely collect, process, handle, test, and store human breast 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: 09/01/20263o 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 a member s 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 members who are seriously ill or require the product as a major treatment modality. This term does not pertain to all foods fed to ill members. Medical foods are intended solely to meet the nutritional needs of me mbers 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 all 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 ( including neonates and infants ) and adult patients to hydrolyze fats during enteral feeding . 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. o Modified Normal Eating normal foods but avoiding particulate foods that are a choking hazard. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 09/01/20264D. PolicyI. All members 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 diarrhea (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: 09/01/2026502. 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). member s 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, member s 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: 09/01/20266IV. 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, member s 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: 09/01/20267V. 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 , preference , or lifestyle/social consideration of member/caregiver *Commercial products represented by HCPCS codes may be provided on a case-by-case basisfor members 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 meets current FDA approval criteria . B. Member has a diagnosis of pancreatic insufficiency , or 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 in alignment with Ohio Revised Code 5164.072. C. For donor breast milk use outside of the hospital, documentation must include why elemental formula cannot be used to meet the infants needs. D. Documentation support s that the provider has attested to educating the member in the donation process and about human milk . E. Consent support s that the provider discussed the risks and benefits with the member. F. Approval duration is up to 3 months. E. Conditions of CoverageNA Nutritional Supports-OH MCD-MM-0024Effective Dat e: 09/01/20268F. Related Polic ies/RulesNA G. Review/Revision HistoryDATE ACTIONDate 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 /202307/17/202406/04/202505/20 /2026 Realigned 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. Review: expanded Relizorb age, clarified lifestyle/social limitation, added documentation requirements and approval time frame for donor milk, updated references, approved at Committee. Date Effective 09/01/2026 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 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 09/01/202692. Bischoff SC, Austin P, Boeykens K. ESPEN practical guideline: home enteral nutrition. Clin Nutr. 2022;41(2):468-488. doi:10.1016/j.clnu.2021.10.0183. 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 4. 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 5. 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 6. 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 7. DMEPOS: Nutrition Products , OHIO ADMIN . CODE 5160-10-26 (2024) . 8. 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 9. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (2026). 10. Early and Periodic Screening, Diagnostic, and Treatment . Centers for Medicare and Medicaid Services. Accessed March 31, 2026 . www.medicaid.gov 11. 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 March 31, 2026 . www.evidence.hayesinc.com 12. Fleet SA, Duggan C. Overview of enteral nutrition in infants and children. UpToDate. February 3, 2025. Accessed March 31, 2026 . www.uptodate.com 13. Goodwin ET, Buel KL, Cantrell LD. Growth faltering and failure to thrive in children. Am Fam Physician . 2023;107(6):597-603. Accessed March 31, 2026 . www.aafp.org 14. 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 March 31, 2026 . www.cdc.gov 15. Guidance for Industry: Frequently Asked Questions about Medical Foods . 3rd ed. US Dept of Health and Human Services; 2023. Accessed March 31, 2026 . www.fda.gov 16. Healthchek: Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Covered Services, OHIO ADMIN . CODE 5160-1-14 (2017) . 17. Homan GJ. Failure to thrive: a practical guide. Am Fam Physician . 2016;94(4):295 – 299. Accessed March 31, 2026 . www.aafp.gov 18. 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 19. 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. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 09/01/20261020. 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 21. Medicaid Medical Necessity: Definitions and Principles, OHIO ADMIN . CODE 5160-1- 01 (2022) . 22. 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 23. 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 24. Orphan Drugs , 21 C.F.R. 312 (2023) . 25. Pironi L, Boeykens K, Bozzetti F, et al. ESPEN practical guideline: home parental nutrition. Clin Nut r. 2023;42(3) :411-430. doi:10.1016/j.clnu.2022.12.003 26. 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 March 31, 2026 . www.nutritioncare.org 27. Services Provided by a Dietitian, OHIO ADMIN . CODE 5160-8-41 (20 24). 28. U.S. Food and Drug Administration. RELiZORB K250499 . April 17 , 2025 . Accessed March 31, 2026 . www.accessdata.fda.gov 29. U.S. Food and Drug Administration. Use of Donor Human Milk . Updated March 22, 2018. Accessed March 31, 2026 . www.fda.gov. 30. U.S. Social Security Administration (SSA). Disability Evaluation Under Social Security – 105. 00 Digestive System Childhood . Accessed March 31, 2026 . www. secure. ssa.gov 31. U.S. Social Security Administration (SSA). Program Operations Manual System (POMS) – DI 24598.002. Failure to Thrive (FTT) . February 9, 2016. Accessed March 31, 2026 . www. secure.ssa.gov 32. Volkert D, Beck AM, Cederholm T, et al. ESPEN practical guideline: clinical nutrition and hydration in geriatrics. Clin Nut r. 2022;14(4):958-989. doi:10.1016/j.clnu.2022.01.024 33. 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 34. World Health Organization. Malnutrition. March 1, 2024 . Accessed March 31, 2026 . www.who.int 35. 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 6/23/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Functional Electrical Stimulation (FES)-OH MCD-MM-1867 09/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilization and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provider Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not subject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Functional Electrical Stimulation (FES)-OH MCD-MM-1867Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectFunctional Electrical Stimulation (FES) B. Background Paralysis affects millions of Americans, and its effects are a significant public health concern. Approximately 1.7 percent of the U.S. population, or 5,357,970 people reported they were living with some form of paralysis, defined by the study as a central nervous system disorder resulting in difficulty or inability to move the upper or lower extremities. The leading cause of paralysis was stroke (33.7 percent), followed by spinal cord injury (SCI) (27.3 percent), multiple sclerosis (18.6 percent) and cerebral palsy (8.3%). Functional electrical stimulation is a technique to produce functional movements after paralysis. Electrical discharges are applied to a person's muscles making them contract in a sequence that allows performing tasks such as grasping a key, holding a toothbrush, standing, and walking. This technology was developed in the sixties, during which initial clinical use started, emphasizing its potential as an assistive device. Since then, functional electrical stimulation has evolved into an important therapeutic intervention that clinicians have used to help individuals who have had a stroke or a spinal cord injury regain their ability to stand, walk, reach, and grasp. It is a therapeutic or exercise modality for individuals with a nervous system injury to reactivate the peripheral nervous system without significant lower motor neuron damage. Similarly, Neuromuscular electrical stimulation (NMES) technology utilizes electrical stimulation to alleviate the inability of muscles to produce joint movements in stroke patients due to weak or absent innervation. It enables survivors with lower extremity motor dysfunction to reactivate their muscles and regain motor coordination C. Definitions Functional Electrical Stimulation The application of low levels of electrical current to artificially induce or modify nerve activation and muscle contraction to restore function, improve health and/or improve physiological dysfunction following disease or neurological injury. Neuromuscular Electrical Stimulation (NMES) A therapeutic technique that uses a device to deliver low-voltage electrical impulses to nerves through skin-placed electrodes, inducing involuntary muscle contractions. Paralysis complete or partial loss of function especially when involving the motion or sensation in a part of the body. Spinal Cord Injury (SCI) Damage to the bundle of nerves and fibers within the spinal column that disrupts communication between the brain and body. Stroke Sudden impairment or loss of consciousness, sensation, and voluntary motion that is caused by rupture or obstruction (as by a clot) of a blood vessel supplying the brain and is accompanied by permanent damage of brain tissue. D. PolicyI. CareSource considers functional electrical stimulation (FES) medically necessary as a component of a comprehensive ambulation rehabilitation program in members with Functional Electrical Stimulation (FES)-OH MCD-MM-1867Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 lower limb paralysis due to spinal cord injury (SCI) when ALL of the following criteria are met: A. Member has successfully completed a training program, which consists of at least 32 physical therapy sessions with the device over a 3-month period. B. Training must be directly performed by the physical therapists as part of a one- on-one training program. C. Member has intact lower motor units (L1 and below) (both muscle and peripheral nerve). D. Muscle and joint stability for weight bearing at upper and lower extremities and has balance and control to maintain an upright support posture independently. E. Brisk muscle contraction to neuromuscular electrical stimulation and sensory perception of electrical stimulation sufficient for muscle contraction F. Member has the cognitive ability to use such devices for walking and motivation to use the device long term. G. The ability to transfer independently and stand for at least 3 minutes H. Member demonstrates hand and finger function to manipulate the controls. I. Post-recovery from SCI and restorative surgery of at least 6 months J. Absence of hip and knee degenerative disease and no history of long bone fracture secondary to osteoporosis. II. ContraindicationsA. FES is unproven and not medically necessary due to insufficient evidence of efficacy for treating any other indication not listed above B. presence of cardiac pacemakers C. members with severe scoliosis or severe osteoporosis D. skin disease or cancer at area of stimulation E. irreversible contracture F. autonomic dysreflexia G. poorly controlled epilepsy H. pregnancy I. fracture or dislocation near or on the application site III. Experimental and InvestigationalA. when used to prevent or reverse muscular atrophy (wasting) and bone demineralization (loss), by stimulating paralyzed limbs for the performance of stationary exercise B. to correct gait disorders C. functional electrical stimulation ergometer devices (for example, ERGYS and ERGYS) D. when used to activate muscles of the upper limb or lower limb to produce functional movement patterns. This includes, but is not limited to, the NESS H200 Handmaster Rehabilitation System, NESS L300 Foot Drop System, ODFS Dropped Foot Stimulator, and the WalkAide System. Functional Electrical Stimulation (FES)-OH MCD-MM-1867Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 IV. CareSource considers neuromuscular electrical stimulators (NMES) medically necessary for the following indications: A. disuse muscle atrophy if: 1. the nerve supply to the muscle is intact 2. disuse muscle atrophy is not of neurological origin but results from other conditions for example casting, splinting, or contractures B. when used as part of a comprehensive lower limb rehabilitation program following total knee arthroplasty C. hemiplegia or hemiparesis with foot drop after chronic stroke, as indicated by ALL of the following: 1. ankle range of motion within limits required for normal gait 2. cognitively able to understand and comply with rehabilitation protocol 3. stroke onset greater than 3 months prior V. Contraindications/not medically necessaryA. use in members with cardiac pacemakers B. as a technique to increase circulation C. treatment of pain for various musculoskeletal conditions, including, but not limited to patellofemoral syndrome, spinal stenosis, lumbago, muscle strains/sprain D. more than 2 hours of NMES per day, as excessive duration can lead to muscle fatigue, skin irritation, or breakdown, and is not supported by literature for improved outcomes. E. Conditions of CoverageNA F. Related Policies/Rules Experimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 05/06/2026 New policy. Approved at Committee.Date Revised Date Effective 09/01/2026 Date Archived H. References1. Berenpas F, Geurts A, Keijsers N, et al. Benefits of implanted peroneal functional electrical stimulation for continual gait adaptations in people with 'drop foot' due to chronic stroke. Hum Mov Sci . 2022;83:102953. doi:10.1016/j.humov.2022.102953 2. Brown L, Street T, Adonis A, et al. Implementing functional electrical stimulation clinical practice guidelines to support mobility: a stakeholder consultation. Front Rehabil Sci . 2023;4:1062356. doi:10.3389/fresc.2023.1062356 Functional Electrical Stimulation (FES)-OH MCD-MM-1867Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Bulley C, Meagher C, Street T, et al. Development of clinical guidelines for service provision of functional electrical stimulation to support walking: mixed method exploration of stakeholder views. BMC Neurol . 2021;21(1):263. doi:10.1186/s12883 – 021-02299-1 4. Chen YH, Wang HY, Liao CD, et al. Effectiveness of neuromuscular electrical stimulation in improving mobility in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil . 2023;37(1):3-16. doi:10.1177/02692155221109661 5. Dantas MTAP, Fernani DCGL, Silva TDD, et al. Gait training with functional electrical stimulation Improves mobility in people post-stroke. Int JEnviron Res Public Health . 2023;20(9):5728. doi:10.3390/ijerph20095728 6. Duan R, Qu M, Yuan Y, et al. Clinical benefit of rehabilitation training in spinal cord injury: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2021;46(6):E398-E410. doi:10.1097/BRS.0000000000003789 7. Electrical Stimulation, Functional and Neuromuscular: A-0507 (AC). MCG Health. 29th ed. 2025. Accessed January 26, 2026. www.careweb.careguidelines.com 8. Kanakis AK, Benetos IS, Evangelopoulos DS, et al. Electrical Stimulation and Motor Function Rehabilitation in Spinal Cord Injury: A Systematic Review. Cureus . 2024;16(5):e61436. doi:10.7759/cureus.61436 9. Kang GE, Frederick R, Nunley B, et al. The Effect of Implanted Functional Electrical Stimulation on Gait Performance in Stroke Survivors: A Systematic Review. Sensors (Basel) . 2021;21(24):8323. doi:10.3390/s21248323 10. Kristensen MGH, Busk H, Wienecke T. Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post Stroke: A Systematic Review and Meta-analysis. Arch Rehabil Res Clin Transl . 2021;4(1):100167. doi:10.1016/j.arrct.2021.100167 11. Maleevi J, Konstantinovi L, Bijeli G, et al. Smart Protocols for Physical Therapy of Foot Drop Based on Functional Electrical Stimulation: A Case Study. Healthcare (Basel). 2021;9(5):502. doi:10.3390/healthcare9050502 12. Marquez-Chin C, Popovic MR. Functional electrical stimulation therapy for restoration of motor function after spinal cord injury and stroke: a review. Biomed Eng Online . 2020;19(1):34. doi:10.1186/s12938-020-00773-4 13. Martin SS, Aday AW, Almarzooq ZI, et al. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation . 2024;149(8):e347-e913. doi:10.1161/CIR.0000000000001209 14. Massey S, Vanhoestenberghe A, Duffell L. Neurophysiological and clinical outcome measures of the impact of electrical stimulation on spasticity in spinal cord injury: systematic review and meta-analysis. Front Rehabil Sci. 2022;3:1058663. doi:10.3389/fresc.2022.1058663 15. Nekoukar V. Control of functional electrical stimulation systems using simultaneous pulse width, amplitude, and frequency modulations. Neuromodulation . 2021;24(8):1467-1474. doi:10.1111/ner.13126 16. van der Scheer JW, Goosey-Tolfrey VL, Valentino SE, et al. Functional electrical stimulation cycling exercise after spinal cord injury: a systematic review of health and Functional Electrical Stimulation (FES)-OH MCD-MM-1867Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 fitness-related outcomes. JNeuroeng Rehabil . 2021;18(1):99. doi:10.1186/s12984-021-00882-8. 17. Zhu Q, Gao G, Wang K, et al. Effect of functional electrical stimulation on gait parameters in children with cerebral palsy: a meta-analysis. Comput Math Methods Med . 2022;2022:3972958. doi:10.1155/2022/3972958 Approved by ODM 06/09/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Autonomic Nerve Testing-OH MCD-MM-1783 09/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilization and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provider Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not subject to limits or requirements that are more restrictive than those that apply to M/S benefits.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 Autonomic Nerve Testing-OH MCD-MM-1783Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectAutonomic Nerve Testing B. Background The autonomic nervous system (ANS) coordinates multiple reflex actions which are essential for life. It controls the heart rate, blood pressure, digestion, respiration, pupillary reactivity, sweating, urination, sexual arousal, and regulates the functions of internal organs. This system provides the homeostasis of the cells, tissues, and organs throughout the body and protects against the disturbances imposed by the external and internal stressors. The ANS has three main divisions: the sympathetic nervous system (SNS), the parasympathetic nervous system (PNS), and the enteric nervous system. In general, the SNS and PNS have opposing effects. Each region belonging to the 'pain matrix' interacts with ANS. The descending system regulates pain and creates a regulatory effect by the contribution of aminergic neurotransmitters. Disorders of the ANS can affect any system of the body; they can originate in the peripheral or central nervous system and may be primary or secondary to other disorders. Symptoms suggesting autonomic dysfunction include orthostatic hypotension, heat intolerance, nausea, constipation, urinary retention or incontinence, nocturia, impotence, and dry mucous membranes. If a patient has symptoms suggesting autonomic dysfunction, cardiovagal, adrenergic, and sudomotor tests are usually done to help determine severity and distribution of the dysfunction. Autonomic testing using automated devices, in which software automatically generates an interpretation, has not been validated. Most of these devices generate reports automatically and do not allow physician interpretation of the raw data, which is a serious design flaw when evaluating patients who have, for example, cardiac rhythm abnormalities that mislead the testing results. C. Definitions Autonomic Nervous System The part of the nervous system that controls involuntary visceral actions. Cardiovagal innervation A test that provides a standardized quantitative evaluation of vagal innervation to parasympathetic function of the heart. Responses are based on the interpretation of changes in continuous heart recordings in response to standardized maneuvers and include heart rate response to deep breathing, Valsalva ratio, and 30:15 ratio heart rate responses to standing. A tilt table may be used but is not required. Vasomotor adrenergic innervation A test that evaluates adrenergic innervation of the circulation and of the heart in autonomic failure. The following tests are included: beat-to-beat blood pressure and R-R interval response to Valsalva Autonomic Nerve Testing-OH MCD-MM-1783Effective Date: 09/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 maneuver, sustained hand grip, and blood pressure and heart rate responses to tilt-up or active standing and must be performed with a tilt table. Sudomotor Function testing is used to evaluate and document neuropathic disturbances that may be associated with pain. The quantitative sudomotor axon reflex test (QSART), thermoregulatory sweat test (TST), sympathetic skin responses, and silastic sweat imprints are tests of sympathetic cholinergic sudomotor. Sympathetic Skin Response A test to measure a provoked change in the electrical potential of the skin. D. PolicyI. CareSource considers autonomic nerve testing medically necessary to evaluate autonomic nerve function and aid in the diagnosis of ANY of the following conditions: A. distal small fiber neuropathy B. postural tachycardia syndrome C. reflexive sympathetic dystrophy D. recurrent variants of syncope E. one or more of the following progressive autonomic neuropathies: 1. diabetic autonomic neuropathy 2. amyloid neuropathy 3. Sjogrens syndrome 4. idiopathic neuropathy 5. pure autonomic failure 6. multiple system atrophy II. LimitationsProperly trained physicians with the necessary expertise should perform and interpret these tests. Training can be obtained through accredited residency/fellowship programs or AMA-approved continuing medical education courses. III. ExclusionsA. Autonomic nerve function testing to aid in the diagnosis of ANY other condition not listed above may not be covered or reimbursable. B. Screening patients without signs or symptoms of autonomic dysfunction, including patients with diabetes, hepatic or renal disease. C. Testing results that are not used in clinical decision-making or patient management D. The use of portable automated devices for autonomic nerve testing, including ANSAR ANX 3.0, VitalScan ANS, ANSiscope, or any similar device is considered experimental, investigational and non-covered. E. Conditions of CoverageNA Autonomic Nerve Testing-OH MCD-MM-1783Effective Date: 09/01/2026The 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 05/21/2025 New policy. Approved at Committee.Date Revised 05/20/2026 Updated references. Approved at Committee. Date Effective 09/01/2026 Date Archived H. References1. Baker JR, Hira R, Uppal J, et al. Clinical Assessment of the Autonomic Nervous System. Card Electrophysiol Clin . 2024;16(3):239-248. doi:10.1016/j.ccep.2024.02.001 2. Cheshire WP, Freeman R, Gibbons CH, et al. Electrodiagnostic assessment of the autonomic nervous system: a consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation of Clinical Neurophysiology Clin Neurophysiol . 2021;132(2):666-682. doi:10.1016/j.clinph.2020.11.024 3. Gutirrez J. Electrophysiological assessment of peripheral and central autonomic disorders. Handb Clin Neurol . 2023;195:301-314. doi:10.1016/B978-0-323-98818- 6.00015-7 4. Illigens BMW, Gibbons CH. Autonomic testing, methods and techniques. Handb Clin Neurol . 2019;160:419-433. doi:10.1016/B978-0-444-64032-1.00028-X 5. Lee HJ, Lee KH, Moon JY, et al. Prevalence of autonomic nervous system dysfunction in complex regional pain syndrome. Reg Anesth Pain Med . 2021;46(3):196-202. doi:10.1136/rapm-2020-101644 6. Novak P. Quantitative autonomic testing. JVis Exp . 2011;(53):2502. doi:10.3791/2502 7. Panigrahi B, Srivastava AK, Garg D, et al. Examination of the autonomic nervous system at the bedside. Acta Neurol Belg . 2025;125(3):625-634. doi:10.1007/s13760- 024-02654-2 Approved ODM 05/22/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder – OH MCD-MM-0028 09/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will be the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use disorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not s ubject to limits or requirements that are more restrictive th an those that apply to M/S benefits.Table of Contents A. Subject ………………………….. ………………………….. ………………………….. ……………………. 2 B. Background ………………………….. ………………………….. ………………………….. ……………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………. 3 E. Conditions Of Coverage ………………………….. ………………………….. ………………………….. 8 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. .. 8 G. Review/Revision History ………………………….. ………………………….. …………………………. 8 H. References ………………………….. ………………………….. ………………………….. ………………. 9 Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectApplied Behavior Analysis Therapy for Autism Spectrum Disorder B. BackgroundThe Diagnostic and Statistical Manual of Mental Disorders, 5 th Edition, Text Revised (DSM-5-TR) classifies Autism Spectrum Disorder (ASD) as a neurodevelopmental disorder characterized by specific developmental deficits that affect socialization, communication, academic and personal functioning . Diagnoses typically occur before entering grade school, and symptoms are present across multiple contexts (eg, social reciprocity, nonverbal communicative behaviors, skills in developing, maintaining and understanding relationships ). Restricted, repetitive patterns of behavior, interests or activities are also often present. Currently, th ere is no cure for ASD, nor is there any single treatment for the disorder.The diagnosis may be managed through a combination of therapies, including behavioral, cognitive, pharmacological, and educational interventions with a goal of minimiz ing the severity of symptoms, maximiz ing learning, facilitat ing social integration, and improv ing quality of life . Applied behavior analysis (ABA), one such therapy, may be provided in centers or at home and provides evidence-ba se d practice for treatment . ABA focuses on understanding behavior functioning and interaction with theenvironment, aiming to improve human condition s through behavior change . It is a flexible treatment adapted to individual needs , teach ing useful and generalizable skills , involv ing individual, group and family training. Qualified practitioners oversee ABA programs and must meet state registration, certification or licensure requirements. Clinical decisions regarding telehealth delivery should consider individual needs, strengths, prefer red service modalit ies , caregiver availability and environmental support . Social skills instruction is an important component of management of ASD . A 2012meta-analysis of 5 randomized trials (196 participants) found that participation in social skills groups improved overall social competence and friendship quality in the short term. A 2020 study demonstrated efficacy of a modified group cognitive behavioral therapy program in children delivered in a community context . A 2021 study showed benefits of group cognitive behavioral treatment in adolescents . As children near entry in public /private school system s, research supports the use of group therapy for school readiness and improved social skills. Training must include clearly defined goals, teach desired behaviors, prompt the natural display of desired behaviors, provide reinforcement of demonstrated behaviors and include practice of desired behaviors with goals of generalizability outside the therapeutic setting (eg, impairments in social – emotional reciprocity, restrictive or obsessional interests, aggressive behaviors). The public school system becomes responsible for the provision of services and education at school-age with services outlined in an individualized education program(IEP) and reviewed annually . ASD services do not include education services available through program s funded under 20 US Code Chapter 3, section 1400 of the Individuals Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 with Disabilities Education Act (IDEA) , which was reauthorized in 2004 and amended through Public Law 114-95, Every Student Succeeds Act, in December 2015 . CareSource follows the Ohio Administrative and Revised Code (OAC , ORC ) and OhioDepartment of Medicaid (ODM) guidelines for ABA services, based on a DSM-5-TRdiagnosis . C. Definitions Caregiver/Family Trainin g Parents/caregivers learn to implement methods utilized in a clinical setting i n other environments (eg, home , community ) to maximize member outcomes by furthering the generalization of skills and reinforcing methods being taught to the member in other sessions. Functional Assessment The determination of underlying function or purpose of behavior to develop an effective treatment plan, including a variety of systematic, information gathering techniques regarding factors influencing behavior occurrence , such as interview, indirect assessment, direct observation, descriptive assessment, experimental analysis, and systematic manipulation of environmental variables to demonstrate a relationship between an event and targeted behavior. Independent Practitioner All ABA services must be provided by provider/practitioner compliant with ORC 4783.02 with approved supervision. Standardized Diagnostic Assessment Tool s Direct assessment, e vidence – based tools designed for identification of symptoms and criteria for diagnosing. Supervisio n Directing, training , and assessing individuals provid ing ABA services with responsibilities in accordance with the appliable State board and OAC 4783-6- 02 and in adherence with supervision plans as defined in OAC 47 83-3-01. Treatment Plan A written document describing presenting behavior problem(s) and goals and interventions selected to alter behavior based on in-person assessments, re cords review from other professionals, direct observation and clinical interview data, including an estimate of the length of time and/or number of sessions anticipated to achieve goals and specific statements about the measurement of progress toward achieving goals. D. PolicyI. General Guidelines A. Medical necessity review is required for all ABA services initially with a baseline and then every 6 months. Medical review must be submitted with appropriate documentation as indicated in this policy and align with the States definition of medical necessity that includes that treatment is not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results. B. ABA therapy should begin early in life, ideally by the age of 2, typically lasting up to 3 to 4 years and is subject to the members response to treatment. C. Members under the age of 21 will be assessed. Treatment goals and intensity will be based on individual needs and progress in treatment with a focus on Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 remediation of symptoms.II. Initia tion of ABA ServicesA. Documentation: CareSource must receive documentation that confirms 1. Definitive, primary ASD diagnosis made by 1 of the following upon evaluation : a. child and adolescent psychiatrist b. psychologist c. child neurologist d. developmental pediatrician 2. Standardized diagnostic assessment tools considered multidisciplinary evaluations, including a. Autism Diagnostic Observation Schedule (ADOS) b. Autism Diagnostic Interview Revised (ADI-R) c. Childhood Autism Rating Scale, 2 nd edit. (CARS-2) 3. W ritten documentation ( eg, provider letter ) descri bing DSM symptoms present in the past year requir ing treatment if the submitted diagnostic evaluation was completed more than 24 months from date of request . NOTE: Documentation should show that the member has symptoms that would benefit from treatment and must be related to the diagnosis. Symptoms reported should be specific to the member and not a re petition of DSM criteria or language (eg, stereotyped or repetitive motor movements vs. lining up toy cars by size or hypo-reactivity to sensory input vs. frequently and consistently scalds hands with use of water that is too hot) . B. Initial Behavior Assessment : Before services are provided, an initial behavior identification assessment will be performed by a BCBA , if available, and a treatment plan developed . Generally, b ehavior assessments are not to exceed 6- 10 hours every 6 months , unless additional justification is provided. C. Initial Treatment Plan: An initial ABA treatment plan individualized to the member and caregiver/family needs, values, priorities and circumstances for member goals and parent/caregiver training will be developed by the member, family/caregiver, and provide r, must be signed by the parent/guardian and BCBA, and must include the following: 1. biopsychosocial information, including, but not limited to a. current family structure and any major life changes b. medication history, including dosage and prescribing physician c. medical history d. school placement and hours in school per week, including homeschool instruction and any individualized education plans (IEP) or 504 plans NOTE: IEP/504 information must be provided for con sideration of services. e. history of ABA services, including service dates and progress notes f. all behavioral health diagn oses and services, including any hospitalizations Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 g. other services received by member (eg, speech therapy [ST] ,occupational therapy [OT], physical therapy [PT]) , including evidence of coordination with other disciplines involved in the assessment h. caregiver proficiency and involvement in treatment 2. rationale for ABA services , including a. history with symptom intensity and duration, including how symptoms affect the members ability to function in various settings b. evidence of previous therapy ( eg, outcomes from previous ABA treatment, ST, OT, PT) and how result s influence proposed treatment c. type, duration, frequency for services 3. goals related to core deficits must includ e the following: a. be outcome driven , performance-based and individualized measures focused on targeted symptoms, behaviors and functional impairments b. based on direct behavioral assessment and a standardized developmental and functional skills assessment/curriculum ( eg, Verbal Behavior Milestones Assessment and Placement Program [VB-MAPP ], Assessment of Basic Language and Learning Skills [ABLLS-R]) NOTE: For comprehensive, high intensity services direct assessments should be completed and updated with each plan of care, including initial submission. Social Savvy can be utilized for group hours in conjunction with another tool. c. a description of treatment activities and documentation of active participation by member and caregiver/family in treatment OR documentation detailing barriers to family/ caregiver participation and how those barriers are being actively addressed d. goals that define how improvement will be noted, frequency (number of hours per week) and duration of treatment 4. Behavioral Intervention Plan and/or a Plan of Care (POC) 5. requested number of ABA hours per week based on the members specific needs , not on a general program structure , as evidenced by all of the following: a. Treatment is provided at the lowest level of intensity appropriate to the members clinical needs and goals with the number of hours requested reflecting the actual number of hours intended to be provided . b. A d etailed description of problems, goals and interventions support the requested intensity of treatment . 6. a plan to modify the intensity and duration of treatment over time based on the members progress, including an individualized discharge plan specific to treatment needs 7. coordination with other behavioral health and medical providers III. Continuation of ABARequests for continuation of ABA services are to be submitted every 6 months . If services stopped or were terminated for any reason for a temporary length of tim e (eg, cancelled over summer break after school year ends, vacation or visitation with Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 a noncustodial parent, a change in school hours), additional authorizations should be submitted as continuations. CareSource will not process those requests as initial requests. D ocumentation must meet EITHER A. -C. OR D. A. A d efinitive diagnosis of ASD persists along with continued demonstrat ion of ASD symptoms that will benefit from treatment in at least 2 settings . B. A t reatment plan as noted in D. II. C., including the following: 1. an updated progress report with assessment scores that note improvement and member response to treatment from baseline targeted symptoms, behaviors and functional impairments using the same mode (s) of measurement utilized for baseline measurements 2. a plan to transition services in intensity over time C. Parent/caregiver(s) are involved and making progress in development of behavioral interventions. D. W hen requesting continuation with inadequate progress on targeted symptoms or behaviors or no demonstrable progress within a 6-month period, an assessment of the reasons for lack of progress should be documented and provided. Treatment interventions should be modified to achieve adequate progress. Documentation should include 1. change in possible treatment techniques 2. increased parent/caregiver training 3. increased time and/or frequency working on specific targets 4. identification and resolution of barriers to treatment efficacy 5. any newly identified co-existing disorders and possible treatment 6. modified or removed goals and interventions IV. Discontinuation of ABA TherapyTitration or discontinuation of ABA therapy should occur when any of the following conditions are met (not an all-inclusive list): A. Treatment ceases to produce significant meaningful progress , or maximum benefit has been reached . B. Member behavior does not demonstrate meaningful progress for 2 successive 6 – month authorization periods as demonstrated via standardized assessments. C. ABA therapy worsens symptoms, behaviors or impairments. D. Symptoms stabilize allowing member to transition to less intensive treatment or level of care. E. Parents/caregivers have refused treatment recommendations, are unable to participate in the treatment program, and/or do not follow through on treatment recommendations to an extent that compromises the effectiveness of the services for member progress. V. Parent/ Caregiver TrainingTraining will evolve as goals are met . Parent/caregiver should be actively working on at least 1 unmet goal . ABA services must include documentation of the following: A. understand ing and agree ment to comply with the requirements of treatment Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 B. how the parents/caregivers will be trained in skills that can be generalized to the home and other environmentsC. methods by which the parents/caregivers will demonstrate trained skills D. barriers to parent involvement and plans to address (eg, are treatment goals addressed when treatment professionals are not present , overall skill abilities ) E. time involvement, including materials or meetings occurring on a routine basis VI. TelehealthParent/caregiver training and supervision may be provided by telehealth . 1:1 ABA services may be provided via telehealth in instances deemed medically necessary with supporting documentation that provides a plan for the provision of service delivery. Telehealth services must be appropriate for the individual member and not used as the primary method of treatment. Providers utilizing telehealth must make consistent decisions with best availableevidence and clinical consensus. Rationale must consider assessed needs,strengths, preferences and available resources of members /caregivers. The same professional ethics governing in-person care must be followed , including interstate licensure , state regulat ions , member or caregiver discomfort with technology and technology limitations . Providers must identify protocols for clinical appropriateness , ensure therapeutic benefi t and ensure competence for delivering care via telehealth . Peer reviewed studies provides guidance on appropriate screeners /questionnaires in the determination of telehealth services for . VII. ExclusionsReimbursement for the following services or activities is not permitted: A. any services not documented in the treatment pla n B. behavioral methods or modes considered experimental C. education-related services or activities described under IDE A D. vocational services or those available through program s funded under Section 110 of the Rehabilitation Act of 1973 E. components of adult day care programs F. treatment solely for the benefit of the family, caregiver , or therapist G. treatment focused on recreational activities or in nonconventional settings, even if provided by licensed providers (eg, wilderness camps, ranch programs) H. treatment worsening symptoms, prompting member regression or not part of core symptoms or ASD I. treatment unexpected to cause measurable, functional improvement or improvement is not documented J. duplicative therapy services addressing the same behavioral goals using the same behavioral goals using the same techniques as the treatment plan, including services under an IEP K. services provided by family or household members or custodial care not requiring trained or professional ABA staff Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 L. shadowing, paraprofessional, companion services, personal training or life coaching in any settingM. services more costly than an alternative service(s) as likely to produce equivalent diagnostic or therapeutic results for the member E. Conditions Of CoverageI. Compliance with the provisions in this policy may be monitored and addressed through post payment data analysis, subsequent medical review audits, recovery of overpayments identified, and provider prepayment review. Program Integrity will be engaged for an annual review of data. II. CareSource reserves the right to request supervision documentation, particularly related to telehealth services.F. Related Policies/RulesApplied Behavior Analysis for Autism Spectrum Disorder Reimbursement Policy Medical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 10/04/2018Date Revised 01/27/2020 01/25/202108/04/202103/30/202201/04/202304/ 12 /202303/13 /202409/25/202410/23/2024Added program attributes, definitions of provider types and ABA ; title change ; clarified PA d services ; changed NP to healthcare provider trained in ASD ; added IV , willingness to participate , description of p oc, ages ; clarified provider requirements ; added ASD diagnosis, home school /IEP, doc requirements, type of ASD treatment program with PA ; revised continuation of A BA therapy requirements . Added AFLS, ESDM and PEAK-DT assessments & section on ABA transition to school , revised discontinuation criteria & exclusions; removed PA checklist. Clarified telehealt h, moved doc requirements to Medical Records Doc for Practitioners ; re moved transition to school section ; updated school section & RBT supervision ; u pdated definitions & ABA criteria. Removed PA language. III.B.1. Primary diagnosis by a qualified practitioner. Added to section 5. F.02: Removed old section M. to sec. DIII 5.g. added ABA services must include parent/family training . Edited Sec. V. Removed VII. A E-voted ODM changes Sec. B. 1 and 2 Consolidated information into Sec. IV. Initial ABA Treatment Plan. Added Sec. V.J. Pare nt/Caregiver Involvement. Updated references. Reorganized policy & updated definitions. Removed 1:1 telehealth ABA exclusion. Removed I under Exclusions . Annual review. Added VII-X. Merged AD policy info to Cond of Coverage section. Updated H. Approved at Committee. Adde d backgroun d, D.I.D, IX.E., E.IV. Updated references. Approved at Committee. Removed parent signature as requirement per ODM. Approved at Committee. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 03/26/202502/11/2026 Removed VII.A.3. and B.7. Approved at Committee. Annual review. Removed payment information PY-1638. Simplified background. Added Note: in II.A.3., C.1 & C.3. Added (III) continuations will not be processed as initials. Approved at Committee. Date Effective 09/01/2026 Date Archived H. References1. Augustyn M. Autism spectrum disorder in children an d adolescents: evaluation and diagnosis. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 2. Augustyn M. Autism spectrum disorder (ASD) in children and adolescents: terminology, epidemiology, and pathogenesis. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 3. Augustyn M, Von Hahn E. Autism spectrum disorder in children and adolescents: clinical features. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 4. Autism spectrum disorder. American Academy of Pediatrics . Accessed February 10, 2026 . www.aap.org 5. Bak M, Plavnick J, Dueas A, et al. The use of automated data collection in applied behavior analytic research: a systematic review. Behavior Analysis: Res Practice. 2021;21(4), 376 405. https://doi.org/10.1037/bar0000228 6. Board Certified Behavior Analyst Handbook . Behavior Analyst Certification Board. Accessed February 10, 2026 . www.bacb.com 7. Board Certified Assistant Behavior Analyst Handbook . Behavior Analyst Certification Board. Accessed February 10, 2026 . www.bacb.com 8. Certified Ohio behavior analyst supervision. State of Ohio Board of Psychology. Accessed February 10, 2026 . www.psychology.ohio.gov 9. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , I: common clinical challenges of patients with mental health or behavioral emergencies. Pediatr. 2016;138(3):e20161570. doi:10.1542/peds.2016-1570 10. Chun T, Mace S, Katz E; American Academy of Pediatrics; Committee on Pediatric Emergency Medicine and American College of Emergency Physicians; Pediatric Emergency Medicine Committee. Evaluation and management of children and adolescents with acute mental health or behavioral health problems , II: recognition of clinically challenging mental health related conditions presenting with medical or uncertain symptoms. Pediatr. 2016;138(3):e20161573. doi:10.1542/peds.2016-1573 11. Coverage for Autism Spectrum Disorder, OHIO REV . CODE 1751.84 (202 5). 12. Evidence Analysis Research Brief: Applied Behavior Analysis Training Via Telehealth for Caregivers of Children with Autism Spectrum Disorder . Hayes; 2022. Accessed February 10, 2026 . www.evidence.hayesinc.com 13. Evidence Analysis Research Brief: Direct-To-Patient Applied Behavior Analysis Telehealth for Children with Autism Spectrum Disorder . Hayes; 2022. Accessed February 10, 2026 . www .evidence.hayesinc.com Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-MM-0028 Effective Dat e: 09/01/2026 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 14. Health Technology Assessment: Comparative Effectiveness Review of IntensiveBehavioral Intervention for Treatment of Autism Spectrum Disorder . Hayes; 2019. Accessed February 10, 2026 . www.evidence.hayesinc.com 15. Hyman S, Levy S, Myers S ; Council on Children with Disabilities. Developmental and behavioral pediatrics : identification, evaluation and management of children with ASD . Pediatr . 2020 ;145(1) :e20193447 . d oi:10.1542/peds.2019-3447 16. Lim N, Russell-George A. Home-based early behavioral interventions for young children with ASD . Clin Psycho l. 2022;29(4):415-416. doi:10.1037/cps0000117 17. Registered Behavior Technician Handbook . Behavior Analyst Certification Board. Accessed February 10, 2026 . www.bacb.com 18. Sneed L, Little S, Akin-Little A. Evaluating the effectiveness of two models of applied behavior analysis in a community-based setting for children with autism spectrum disorder. Behav Anal: Res Pract . 2023;23(4):238-253. doi:10.1037/bar0000277 19. Standards for Telehealth Services, OHIO REV . CODE 4743.09 (202 5). 20. State Board of Psychology-Certified Ohio Behavior Analysts, OHIO ADMIN . CODE 4783-1 to 11 (2023). 21. Volkmar F, Siegel M, Woodbury-Smith M, et al.; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice parameter for the assessment and treatment of children and adolescents with autism spectrum disorder. JAm Acad Child Adolesc Psychiatry . 2014;53(2):237-57. doi:10.1016/j.jaac.2013.10.013 22. Weissman L. Autism spectrum disorders in children and adolescents: behavioral and educational interventions . Up ToDate. Access ed February 10, 2026 . www.uptodate.com 23. Weissman L. Autism spectrum disorder in children and adolescents: overview of management. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 24. Weissman L. Autism spectrum disorder in children and adolescents: screening tools. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 25. Weissman L. Autism spectrum disorder in children and adolescents: surveillance and screening in primary care. Up ToDate. Accessed February 10, 2026 . www.uptodate.com 26. Wergeland J, Posserud M, Fjermestad K, et al. Early behavioral interventions for children and adolescents with autism spectrum disorder in routine clinical care: a systematic review and metaanalysis. Clin Psycho l. 2022;29(4):400-414. doi:10.1037/cps0000106 27. Witwer A, Walton K, Held M. Taking an evidence-based child-and family-centered perspective on early autism intervention. Clin Psychol . 2022;29(4):420-422. doi:10.1037/cps0000122 Approved by Ohio Department of Medicaid 06/09/2026
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Private Duty Nursing-OH MCD-MM-1510 08/01/2026 Policy Type MEDICAL Medical Policy Statements are developed from a review of the available evidence-based, clinical information based on and supported by clinical guidelines from medical specialties, peer-reviewed medical and scientific studies, nationally recognized utilizat ion and technology assessment guidelines, and other medical management industry standards to aid in determining the medical necessity of a service. Medically necessary services are defined in the plan-specific Evidence of Coverage, Member Handbooks, Provid er Manuals, Medical Policy Statements, and/or other plan policies and procedures. Medical Policy Statements do not guarantee an authorization or payment of services. Please refer to the plan contract (e.g., Evidence of Coverage, Member Handbook) for the service(s) referenced in the Medical Policy Statement. Except as otherwise required by law, if there is a conflict between the Medical Policy Statement and the plan contract and/or provider agreement, then the plan contract and/or provider agreement will b e the controlling document.Reasonable discretion may be used in interpreting and applying this Policy Statement to services provided in a particular case, and the policy may be modified at any time. Medical Policy Statements may be superseded by federal a nd state laws and regulations, as applicable. In the case of a discrepancy between the Policy Statements effective date and any applicable legal or regulatory requirement, the law or regulation will govern. Coverage for mental health and substance use di sorder (MH/SUD) benefits are provided at the same level as coverage for medical and surgical (M/S) benefits, as required by the Mental Health Parity and Addiction Equity Act (MHPAEA). MH/SUD benefits are not subject to limits or requirements that are more restrictive than those that apply to M/S benefits.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 18 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 18 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 18 H. References ………………………….. ………………………….. ………………………….. …………………… 18 Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPrivate Duty Nursing B. BackgroundPrivate duty nursing (PDN ) is a Medicaid State Plan service that provides in-home skilled nursing care to Medicaid members of any age who require continuous nursing services beyond the Medicaid State Plan Home Health benefit. PDN provides care for members with complex medical needs under the direction of the members physician if it can be provided safely in a residence unless it is medically necessary for a nurse to accompany the member in the community . For members who have a medical need for part-time , intermittent , and skilled nursing or aide care and therapies, home health services may also be provided. Refer to the Home Health Services medical policy for further guidance on intermittent skilled nursing or aide care. PDN services are covered by the Ohio Department of Medicaid (ODM) when certified as medically necessary and only when more than 4 hours of continuous skilled care thatrequires the skills of either a registered nurse (RN) or licensed practical nurse (LPN)under the direction of an RN are performed. A covered PDN visit must meet the conditions imposed in 5160-12-02 of the Ohio Administrative Code (OAC) and all other applicable state regulations. Providers of PDN include a Medicare certified home health agenc y (MCHHA) that meets the requirements in accordance with OAC 5160-12-03, an otherwise accredited agency , or a non-agency nurse that meets the requirements in accordance with OAC 5160-12-03.1. In order for PDN to be covered, providers must:1. Provide appropriate PDN given the members diagnosis, prognosis, functional limitations, and medical conditions as documented by the members treating physician, physicians assistant, or advance practice nurse. 2. Provide PDN as specified in the plan of care in accordance with OAC 5160-12-03. PDN services not specified in a plan of care are not reimbursable. For member s enrolled on a home and community-based services (HCBS) waiver, the providers of PDN services must provide the amount, scope, duration, and type of PDN service within the plan of care as: a. Documen ted on the all-services plan approved by ODM or its designee when a member is enrolled on an ODM administered HCBS waiver. PDN services not identified on the all-services plan are not reimbursable . b. Documented on the services plan when a member is enrolled on an Ohio Department of Aging (ODA) or an Ohio Department of Developmental Disabilities (DODD) administered HCBS waiver. PDN services not documented on the services plan are not reimbursable. 3. Bill for provided PDN services using an appropriate procedure code and applicable modifiers in accordance with OAC 5160-12-06. 4. Bill for provided PDN services in accordance with the visit policy in OAC 5160-12-04, except as provided for in paragraph (A) of OAC 5160-12-02. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 5. Bill after all documentation is completed for services rendered during a visit in accordance with OAC 5160-12-03. The below guidelines identify clinical information that CareSource uses to determinemedical necessity and quantity of care for PDN . The guidelines are based on generally accepted standards of practice, review of medical literature, as well as federal and state policies and laws applicable to Medicaid programs. Providers should consult OAC Chapter 5160-12 for details about coverage, limitations, service conditions, and prior – authorization requirements. C. Definitions HealthChek Program The Ohio-administered version of the early and periodic screening, diagnosis, and treatment (EPSDT) program, which is a federally mandated program of comprehensive preventive health services available to Medicaid-eligible individuals from birth through age 20 years and is administered by the County Department of Job and Family Services (CDJFS). Home Health Agency A person or government entity, other than a nursing home, residential care facility, or hospice care program , that has a primary function of providing any of the following services to a patient at a place of residence used as the patients home: o skilled nursing care o physical therapy o speech language pathology o occupational therapy o medical social services o home health aide services Maintenance Care Care given to a member for the prevention of deteriorating or worsening medical conditions or the management of stabilized chronic diseases or conditions. Services are considered maintenance care if the member is no longer making significant improvement with a medical condition. Medical Necessity Procedures, items, or services that prevent, diagnose, evaluate, or treat an adverse health condition that meet ALL the following conditions: o meets generally accepted standards of medical practice o is c linically appropriate in type, frequency, extent, duration, and delivery setting o is a ppropriate to the adverse health condition for which it is provided and is expected to produce the desired outcome o is the lowest cost alternative that effectively addresses and treats the medical problem o provides unique, essential, and appropriate information if used for diagnostic purposes o is neither provided primarily for the economic benefit of the provider nor for the convenience of the provider or anyone else other than the recipient Place of Residence Wherever the individual lives, whether the residence is the individuals own dwelling, assisted living facility, relatives home, or other type of Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 living arrangement. This does not include a hospital, nursing facility, or intermediate care facility for individuals with intellectual disabilities. Plan of Care The medical treatment plan that is established, approved, and signed by a treating physician, advance practice nurse , or physicians assistant in accordance with all applicable federal and state regulations. Skilled Care Procedures that require technical skills and knowledge beyond those the untrained person possesses and that are commonly employed in providing for the physical, mental, and emotional needs of the ill or otherwise incapacitated. “Skilled nursing care” includ es, but is not limited to, the following: o irrigations, catheterizations, application of dressings, and supervision of special diets o objective observation of changes in the resident’s condition as a means of analyzing and determining the nursing care required and the need for further medical diagnosis and treatment o special procedures contributing to rehabilitation o administration of medication by any method ordered by a physician or other licensed health care professional acting within their applicable scope of practice, such as hypodermically, rectally, or orally, including observation of the resident after receipt o f the medication o carrying out other treatments prescribed by the physician or other licensed health care professional acting within their applicable scope of practice, that involve a similar level of complexity and skill in administration D. PolicyI. Private duty nursing (PDN) services are provided to any CareSource Ohio Medicaid member when considered medically necessary. II. This policy is not intended to restrict or contradict EPSDT services.III. Duplicative services are not covered. If the member is receiving other assistance (eg, family caregiver, home health services, additional supportive services), this information and the hours involved must be provided to adequately evaluate medical necessit y of PDN services.IV. PDN services must meet ALL the following:A. Services performed must be within the nurses scope of practice as defined in Chapter 4723. of the Ohio Revised Code (ORC ) and rules adopted there under . B. Services provided must be documented in accordance with the members plan of care . C. Services must be medically necessary to care for the members condition, illness, or injury . D. Service must b e provided in person in the members place of residence unless it is medically necessary for a nurse to accompany the member in the community. The place of service in the community cannot include the business location of the Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 provider of PDN. The place of service in the community cannot include the residence of the provider of PDN unless it is the same as the member .V. PDN services do not include any of the following :A. services provided for the provision of habilitative care (this is reviewed for medical necessity for EPSDT members) B. RN assessment services C. RN consultation services VI. Members who receive PDN must meet ALL the following :A. Be under the supervision of a treating physician, physician’s assistant (PA) , or advance practice nurse (APN) who is providing care and treatment to the member . The treating physician, PA , or APN is not a physician, PA , or APN not only sign s and authorize s plans of care but are also direct ly involved in the care or treatment of the member . A treating physician, PA or APN may also substitut e temporarily on behalf of a treating physician. B. Participate in the development of a plan of care with the treating physician, PA , or APN and the MCHHA , other accredited agencies , or non-agency registered nurse. An authorized representative may participate in the development of the plan of care in lieu of the member . C. Access PDN in accordance with the program for the all-inclusive care of the elderly (PACE) if the member participates in the PACE program. D. Access PDN in accordance with the members provider of hospice services if the member has elected hospice. E. Access PDN in accordance with the members managed care plan process if the member is enrolled in a Medicaid managed care plan. VII. Post hospital PDNA. When medically necessary, any member receiving Medicaid, whether adult or child, may receive PDN services up to 56 hours per week for up to 60 consecutive days from the date of discharge from an inpatient hospital stay of 3 or more covered days in accordance with OAC 5160-2-03. Additional hours may be considered for members who were receiving PDN services prior to the current hospital stay. A covered inpatient hospital stay is considered 1 hospital stay when a member is transferred from 1 hospital to another hospital, either within the same building or to another location. The member must still meet medical necessity criteria for PDN. 1. The 60 days will begin when the member is discharged from the hospital to the member ‘s place of residence from the most recent inpatient stay in an inpatient hospital or inpatient rehabilitation unit of a hospital. 2. The 60 days will begin when the member is discharged from a hospital to a nursing facility. PDN is not available while residing in a nursing facility. B. The treating physician, PA , or APN will certify the medical necessity of PDN services using the ODM 07137 “Certificate of Medical Necessity for Home Health Services and Private Duty Nursing Services” (rev. 7/201 6). PDN is available to Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 member s only with a medical need comparable to a skilled level of care as evidenced by a medical condition that temporarily reflects the skilled level of care as defined in OAC 5160-3-08. In no instance do these requirements constitute the determination of a level of care for waiver eligibility purposes or admission into a Medicaid covered long-term care institution. VIII. Children may qualify for additional PDN services beyond the post-hospitalization service when the following criteria are met: A. The member is under age 21 years and requires services for treatment in accordance with the HealthChe ck program. B. Needs, as ordered by the treating physician, PA , or APN , continuous nursing services, including the provision of on-going maintenance care (services for habilitative care are inappropriate). C. Has a comparable level of care as evidenced by either: 1. Enrollment on a HCBS waiver . 2. For a child not enrolled on a HCBS waiver, a comparable institutional level of care, including a nursing facility-based level of care pursuant to OAC 5160-3- 08 or an ICF-IID level of care pursuant to OAC 5123:2-8-01, as evaluated initially and annually by ODM or its designee. D. The provider of PDN services ensures and documents the child meets all requirements for PDN services prior to providing and billing for the services. E. The child has a PDN authorization obtained in accordance with OAC 5160-12 – 02.3 to establish medical necessity and the childs comparable level of care. A request for additional, recertification, and/or a change of PDN authorization is made as follows: 1. For a child not enrolled on a HCBS waiver, the provider of PDN shall submit the request to ODM or its designee. Any documentation required by ODM or its designee for the review of medical necessity shall be provided by the provider of PDN services. ODM or its designee will notify the provider of the amount, scope and duration of services authorized. 2. For a child enrolled on a DODD administered waiver, the provider of PDN must submit the request to the case manager of the HCBS waiver, who will forward the request to DODD. Any documentation required by DODD for the review of medical necessity shall be pr ovided by the provider of PDN services. DODD will notify the provider and the case manager of the amount, scope and duration of services authorized. 3. For a child enrolled on an ODM administered waiver, the ODM case manager will authorize PDN services through the person-centered services plan. IX. Adults may qualify for additional PDN services beyond the post-hospitalization service when the following criteria are met: A. The adult is age 21 years or older. B. The adult needs, as ordered by the treating physician, PA , or APN , continuous nursing services, including the provision of on-going maintenance care (services for habilitative care are inappropriate). Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 C. The adult has a comparable level of care as evidenced by either:1. Enrollment on a HCBS waiver. 2. A comparable institutional level of care, including a nursing facility-based level of care as evaluated initially and annually by ODM or its designee for an adult not enrolled on a HCBS waiver. The criteria for a nursing facility-based level of care are defined in OAC 5160-3-08 or ICF-IID level of care as defined in OAC 5123-8-01. D. The provider of PDN services ensures and documents that the adult meets all requirements for PDN services prior to providing and billing for services. E. The adult must have a PDN authorization obtained in accordance with OAC 5160-12-02.3 and approved by ODM or its designee to establish medical necessity and the adults level of care. A request for additional, recertification, and/or a change of PDN authorization is made as follows: 1. For an adult not enrolled on a HCBS waiver, the provider of PDN shall submit the request to ODM or its designee. Any documentation required by ODM or its designee for the review of medical necessity shall be provided by the provider of PDN services. ODM or its designee will notify the provider of the amount, scope , and duration of services authorized. 2. For an adult enrolled on a DODD administered waiver, the provider of PDN must submit the request to the county board of DD, who will forward the request to DODD. Any documentation required by DODD for the review of medical necessity shall be provided by th e provider of PDN services. DODD will notify the provider and the county board of DD of the amount, scope, and duration of services authorized. 3. For an adult enrolled on an ODM administered waiver, the case manager will authorize PDN services through Utilization Management . X. Additional PDN services beyond what ODM or its designee has authorized may be provided to a member in an emergency when the provider has an existing PDNauthorization to provide PDN services to that member . For the purposes of this rule, emergency services are provided outside of normal state of Ohio office hours when prior authorization cannot be obtained. A. PDN services may be delivered in an emergency and a new PDN authorization obtained after the delivery of services. The PDN services must be medically necessary in accordance with OAC 5160-1-01, and the services must be necessary to protect the health and welfare of the member . B. The provider shall notify ODM, or the ODA case manager, as applicable, in writing using the ODM 02374, or the county board SSA for member s enrolled on a DODD administered waiver when emergency PDN services are delivered. Notification shall be immediate, or no later than the first business day following the emergency provision of PDN services. XI. For billing information, refer to OAC 5160-12-06.Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 A. The PDN acuity scale (below) is intended to be used in conjunction with the acuity assessment tool and the clinical and professional judgement of the nurse completing the tool. It is not intended to be the sole determinant of all the skilled nursing needs of the member . Normal age-appropriate care and parental responsibility should be considered (ie, all 3-year-olds need assistance with bathing and dressing, therefore needs assist in this category is not scorable, as it is an age-appropriate need and not a medical need). The skilled section of the tool is used to determine if the member meets criteria for PDN. Skilled nursing care acuity guidelines . 1. Mechanical ventilation: acuity measurement is based on number of hours used per day. Only use ventilator scoring if device is used as a ventilator. For ventilators used as CPAP/BiPAP, go to XII.A. 2. Select up to one of the following if applicable : 1.0 point is scored when the ventilator is listed as standby (eg, just in case it would be needed) . 2.5 points are scored when the member requires a ventilator 12 hours or less per day (eg, while sleeping) . 5.0 points are scored when the member requires a ventilator for greater than 12 hours per day . 2. CPAP/BiPAP: acuity measurement is based on number of hours used per day. Select up to one of the following if applicable : 2.0 points are scored when the member is on CPAP or BiPAP 12 hours or less per day . 4.0 points are scored when the member is on CPAP or BiPAP for greater than 12 hours per day . 3. Tracheostomy: acuity measurement is used to indicate special care needed for tracheostomy (note: dressing changes are included in the below). Select up to one of the following if applic able : 1.5 points are scored when the member can tolerate the use of a speaking valve, or having the tracheostomy capped for a period of time and/or receives routine care. If a PMV is used in-line with the vent/PAP, do not mark this option if they are still replacing the trach . 3.0 points are scored when the member breathes continuously through an open tracheostomy and requires special care (eg, frequent tube changes, current infection at trach site, irritation, mucous plugs requiring intervention, mucosal bleeding) . 4. Oxygen: acuity measurement is based on the order for administration, either continuous or determined by pulse oximeter. Select up to one of the following if applicable : 1.0 point is scored when the members oxygen use is routine and predictable (ie, member has COPD and requires oxygen whenever necessary when walking or upon exertion) . 3.0 points are scored when the members oxygen use is unpredictable (eg, unstable airways). Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 5. Tracheal suctioning: acuity measurement is based on frequency the skilled nurse performs this service and is only applicable when the member is unable to self-suction. Select up to one of the following if applicable : 1.0 point is scored when the member requires suctioning once per day . 2.0 points are scored when the member requires suctioning 2 10 times per day . 3.0 points are scored when the member requires suctioning 11 20 times per day . 4.0 points are scored when the member requires suctioning more than 20 times per day. 6. Humidification: acuity measurement is based upon the need for humidification treatment: 0.5 points are scored when humidification is performed and completed by skilled nurse. 7. Pulse oximetry monitoring: acuity measure is based on treatment that is done on a routine basis. Select up to one of the following if applicable: 1.0 point is scored if monitoring is completed by the nurse 3 times per day. 2.0 points are scored if monitoring is completed by the nurse > 3 times per day or continuous. 8. Injectable medications: acuity measurement is based on number of injections per day on medication that is routinely ordered or as needed (PRN) only when the skilled nurse has administered the injectable. Insulin/subcutaneous injections are not included in this scoring. Select up to one of the following if applicable: 1.0 point is scored if 1 injection is administered per day . 2.0 points is scored if more than 1 injection is administered per day. 9. Medication schedule: acuity measurement is based on the complexity of the medication. This does not include insulin, which is scored under XII.A.21 . Select up to one of the following if applicable: 1.0 point is scored for routine medication schedule . This includes medications that do not require dosage adjustments, regardless of the number of medications . 2.0 points are scored for complex medication schedule. This includes medications which are PRN and/or require dosage adjustments by a skilled nurse. Members who have more than 3 medications which are PRN and/or require adjustment delivered within an 8-hour window by a skilled nurse would qualify for complex. 10. CPT/vest/nebulizer treatments: include treatment that is done on a routine basis, whether there is a standing or PRN order. If the treatments are done together (ie, nebulizer treatments followed by chest physiotherapy, and/or vest therapy), consider points based on the therapy provided at the highest frequency (eg, if nebulizer 2 times per day and pulmonary vest 3 times per day, count as therapy 3 times per day). Select up to one of the following if applicable: Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 1.0 point is scored when CPT/vest/nebulizer (PRN) . 2.0 points are scored when CPT/vest/nebulizer 1 2 times per day . 3.0 points are scored when CPT/vest/nebulizer 3 4 times per day . 4.0 points are scored when CPT/vest/nebulizer 5 times per day. 11. Blood draws: acuity measurement is based upon the number of blood draws per week. Select up to one of the following if applicable: 1.0 point is scored for peripheral blood draw routinely p erformed by skilled nurse during the week. 1.5 points are scored for central line blood draw routinely performed by skilled nurse during the week. 12. Blood products: acuity measurement is based upon the number of times per month it was documented that the member received any blood products provided by the skilled nurse during the PDN visit. Select up to one of the following if applicable: 1.0 point is scored for blood products administered once per month . 1.5 points are scored for blood products administered 2 3 times per month . 2.0 points are scored for blood products administered more than 3 times per month. 13. Nasogastric (N/G), gastrostomy (G), or jejunostomy (J/J) tube feedings: acuity measurement is based upon the complexity of the enteral feeding and the associated care needed from the nurse. Select up to one of the following if applicable: 2.0 point is scored for G/J and N/G tube bolus or continuous. 3.0 points are scored for G/J and N/G tube combination (bolus and continuous) . 4.0 points are scored for G/J and N/G tube complicated . To score for complicated, there must be required residual checks, aspiration precautions, postural changes , and frequent rate adjustments or formula changes. 14. Special diet, prolonged feedings: 1.0 point is scored if there is a threat of aspiration and it requires the assessment, observations, and interventions of a skilled nurse. Documentation of how long it took to feed the member must be present in the nurses notes. This is not applicable for tube feedings. 15. Reflux, dysphagia, aspiration: to receive points for reflux, the member must meet at least one of the following criteria: 1) a positive swallowing study performed within the last 12 months; 2) documented current and ongoing treatment for reflux (eg, medica tions such as Reglan, Zantac, or Prevacid); 3) documented treatment for aspiration pneumonia within the last 12 months; or 4) a need for suctions due to reflux at minimum daily (this does not include suctioning of oral secretions). Must also have the diagn osis of dysphagia or difficulty swallowing, and documentation in the medical record on how the member is progressing. Aspiration precautions should be noted in the clinical Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 record by the skilled nurse, as well as the interventions done to prevent aspiration. Choose all that apply: 1.0 point is scored for aspiration precautions . 1.5 points are scored for reflux or dysphagia. 16. Seizures /neurostorms : acuity measurement is based upon the frequency of the seizure /neurostorm activity, the severity of the activity, and intervention(s) required. In all instances, monitoring must be recorded in the nurses notes and/or maintained in a logbook. The description of the activity should be addressed (ie, type, duration, intervention). There must also be medications that are scored on a routine basis. The number of events per day, week, month, etc. must be documented and the average number occurring should be known. Select up to one of the following if applicable: 0.0 points are scored if there is a seizure /neurostorm diagnosis or history of seizures /neurostorm , but there is no active seizure /neurostorm activity. 1.0 point is scored if there is observation/monitoring only, but no skilled nursing intervention . 2.0 points are scored if there are moderate interventions required, no injury, and medicine (eg, Diastat , intranasal Valium, intranasal Versed) has to be administered, or a magnet and vagus nerve stimulator is used to stop seizure /neurostorm activity. 3.0 points are scored if there is an injury, medicine (see above) has to be administered or a magnet and vagus nerve stimulator is used to stop seizure /neurostorm activity, and apnea is present. 17. General assessments: acuity measurement is based on the frequency a complete nursing assessment is being performed and documented in the nurses notes. This does not include general statements (eg, sleeping soundly, respirations quiet, restless), but may b e a targeted assessment if there is a concern (eg, respiratory assessment, neurological checks). Points are not considered under this section if just vital signs are taken, but if targeted vital signs are taken (eg, temperature), as well as the targeted as sessment, then points could be scored under this assessment. Select up to one of the following if applicable: 1.0 point is scored if the assessment is completed and documented in the nurses notes at least once per shift . 1.5 points are scored if the assessment is completed and documented in the nurses notes every 4 hours . 18. Vital signs: acuity measurement is based on complete sets of vitals being taken at specific frequencies (otherwise use the general assessment section above). Select up to one of the following if applicable: 1.5 points are scored if a complete set of vital signs are taken 2 3 times per shift AND documented in the clinical record . 2.0 points are scored if a complete set of vital signs are taken 4 times per shift AND documented in the clinical record. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 19. Peripheral intravenous therapy (PIV) . Select up to one of the following if applicable: 1.0 point is scored when peripheral IV infuses less than 4 hours . 2.0 points are scored when there is IV therapy ordered and the skilled nurse gives the IV solution while on the visit and the IV infuses for 4 8 hours . 3.0 points are scored when there is IV therapy ordered and the skilled nurse gives the IV solution while on the visit and the IV infuses for greater than 8 hours. 20. Total parenteral nutrition (TPN), central line care, chemotherapy, IV pain control . Choose all that apply: 2.0 points are scored if there is a physician order for chemotherapy and its administered by the skilled nurse during the visit . 2.0 points are scored if there is a physician order for IV pain meds and the skilled nurse gives the IV medication during the visit . 2.5 points are scored if only central line care is scored and no IV is infusing. 3.0 points are scored if TPN is ordered by a physician and it is administered by the skilled nurse during the visit. 21. Blood sugar/ketones checks . Select up to one of the following if applicable: 1.0 point is scored when the blood sugar or ketones are checked by the skilled nurse and there is no scored insulin. It does not matter how many times it is checked. 2.0 points are scored when the blood sugar or ketones are checked by the skilled nurse and insulin is administered by the nurse. It does not matter how many times it is scored. 22. Medicated skin treatment: 1 .0 point is scored when medicated skin treatment is scored by the nurse. This does not include lotions, powders, non – medicated creams, etc. 23. Stoma/wound care: acuity measurement includes dressing changes/stoma care . Only score stoma/wound care when this is being maintained but not used. See XII.A. 26 for use plus maintenance . Select up to one of the following if applicable: 1.5 points are scored when the member has general stoma/wound care and care is documented in the nurses notes once per day, noting condition of the wound/stoma. 2.0 points are scored when the member has the above performed greater than once per day. 24. Decubitus care: 3.0 points are scored when the member has an order for decubitus care and it is performed by the nurse during the home visit. The member would not also receive points for wound/stoma care/medicated skin treatment in addition to this score i f they just have a decubitus. 25. Complex dressing changes/burn care: 3.0 points are scored when the member has an order for burn care/complex dressing change and it is Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 performed by the nurse during the home visit. The member would not also receive points for wound/stoma care/medicated skin treatment in addition to this score.26. Catheter /stoma , in-dwelling and intermittent (eg, Mitrofanoff, Malone, Chait tube , Nivana bowel irrigation system ). Select up to one of the following if applicable: 1.5 points are scored when the member has an in-dwelling catheter /stoma and care is performed by the nurse during the home visit. 2.5 points are scored when the member has an in-dwelling catheter /stoma and the care is performed by the nurse during the home visit. This would include more complex/complicated care, (eg, flushes, insertion of catheter /stoma ). 1.0 point is scored if there is an order for a straight catheter /stoma flushing AND the skilled nurse completes the task during the home visit AND it is no more than once per 8-hour shift AND it is documented in the nurses notes. 2.0 points are scored if there is an order for a straight catheter /stoma flushing AND the skilled nurse completes the task during the home visit AND it is more than once per 8-hour shift AND it is documented in the nurses notes. 27. Dialysis. Select up to one of the following if applicable: Peritoneal dialysis: 2.0 points are scored if peritoneal dialysis is performed by the skilled nurse during the home visit. Hemodialysis: 4.0 points are scored if hemodialysis is performed by the skilled nurse during the home visit. 28. Strict intake and output (I&O): 1.0 point is scored when the I&O requires interventions (ie, the skilled nurse has to make adjustments to feedings or IV fluids based on the intake and output data) , or diapers are routinely weighed . 29. Acute care episodes . Choose all that apply: 1.5 points are scored if the member has had bone surgery in the last 45 days from the time of assessment. 2.0 points are scored if the member has a new or revised trach within the last 30 days from the assessment date. 2.0 points are scored if the member has had abdominal/thoracic surgery with the last 45 days from the date of assessment. 2.5 points are scored if member has had a ventriculoperitoneal ( VP ) shunt new or revised within the last 30 days . 3.0 points are scored if the member has acute/post-procedure hospitalization at least 3 times per year one year from the date of assessment (this does not include admissions for testing or ER visits). For long-term hospitalizations (over 1 month), this section may be counted if the member is admitted for at least 3 months (eg, premature infants). Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 2.0 points are scored if the member has had an acute/post-procedure hospitalization (does not include planned admissions for testing /procedures or ER visits) within the last 30 days from time of assessment. 1.0 point is scored if the member has been discharged from an ECF within the last 30 days . 2.0 points are scored if the member has had documented by the physician at least 2 episodes of any respiratory issue (to include apnea, respiratory distress, etc.) within the last year from the date of the assessment . B. Non-skilled care: can be used if the member does not meet for PDN based on the skilled score alone, but there are extenuating psychosocial circumstances. The non-skilled score is not routinely added to the skilled score when a member has a skilled score less than 15. It is only added when there are significant extenuating circumstances. When these circumstances occur, t he score from this section is added to the skilled nursing care score for the total number of hours that the member would need per day/week. 1. Caregiver availability: acuity measurement requires documented evidence of the employment and/or school status of the primary caregivers before this is scored. Select up to one of the following if applicable: 1.0 point is scored when there are 2 caregivers and neither is employed or attends school. 2.0 points are scored when there are 2 caregivers and at least one is employed or attends school . 2.5 points are scored when there is only 1 caregiver and the caregiver is not employed or attends school . 3.5 points are scored when there is only 1 caregiver and the caregiver is employed or attends school. 8.0 points are scored when there is no caregiver that lives in the home with the member . This does not mean that the member lives with an individual who takes primary responsibility for the member but refuses to deliver any care. An example of this would be a member that assumes responsibility for their own care and lives alone or is on a waiver and has supplemental staffing from agencies and independent providers . 2. Sleeping status: acuity measurement is based on the amount of time the member is awake during the night. Nurse/caregiver waking the member over the course of the night is not scored. Select up to one of the following if applicable: 1.0 point is scored if the member is awake 1 3 times per night. 1.5 points are scored if the member is awake 4 or more times per night. 1.5 points are scored if the member sleeps less than 5 hours consecutively . 2.0 points are scored if the member sleeps less than 3 hours consecutively . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 3. Number of dependents: acuity measurement takes into consideration the number and ages of dependents the caregiver is directly responsible for and does not include episodic visits. Select up to one of the following if applicable: 1.0 point is scored if the caregiver is directly responsible for 1 2 dependents at least 5 years old . 1.5 points are scored if the caregiver is directly responsible for 1 2 dependents under 5 years old . 2.0 points are scored if the caregiver is directly responsible for 3 or more dependents. 4. Communication ability: acuity measurement is based on the cognitive ability of the member to communicate or make their needs known. Select up to one of the following if applicable: 1.0 point is scored if the member has a limited ability to communicate their needs. 2.0 points are scored if the member is unable to communicate their needs. 5. Orientation/cognition impairment (N/A for children under age 3 years): acuity measurement is based on the members ability to be oriented in all 3 spheres (person, time, place). Members with episodic confusion requiring reminders and members with cognitive impairment who are completely dependent on the caregiver may be scored here. Select up to one of the following if applicable: 0.5 points are scored for members who do not meet all 3 spheres of orientation . 1.0 point is scored if the member experiences confusion requiring reminders. 1.5 points are scored if the member has cognitive impairment and is dependent upon the caregiver. 6. Personal care/activities of daily living (ADL) (N/A for children under 3 years): 2.0 points are scored if the member requires assistance with personal care/ADLs including bathing, dressing, and grooming. 7. Oral feedings/assist/supervision (N/A for children under 3 years): 1.5 points are scored if the member requires assistance and supervision with oral feeds. Documentation in the clinical record on how the member tolerated the feeding should be recorded. 8. Weight/transfers: acuity measurement is based on the members weight and their ability to transfer from one surface to another, with 1 2 persons, and/or Hoyer lift/trapeze. Select up to one of the following if applicable: 0.5 points are scored if the member weighs less than 65 pounds and requires no or partial lift with 1 person. 1.0 point is scored if the member weighs at least 65 pounds and requires no or partial lift with 1 person. 1.0 point is scored if the member weighs less than 55 pounds and requires a total lift with 1 person. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 2.0 points are scored if the member weighs at least 55 pounds and requires a total lift with a Hoyer and/or 2 persons. 2.5 points are scored if the member weighs greater than 125 pounds and requires partial lift with 1 person. 3.5 points are scored if the member weighs greater than 125 pounds and requires a total lift with a Hoyer and/or 2 persons. 9. Spasticity or tremors, quadriplegia, paraplegia, hemiplegia, dysfunctional limbs: select a maximum of one of the below when applicable. 1.0 point is scored if the member has spasticity or tremors. 1.5 points are scored if the member has hemiplegia. 1.5 points are scored if the member has a dysfunctional limb. 2.0 points are scored if the member has paraplegia. 2.5 points are scored if the member has quadriplegia. 10. AFO/splint/orthotics application: 0.5 points are scored if there is a physician order for the device and the skilled nurse applies them to the member during the visit, which is documented in the clinical notes. 11. Range of motion: 1.0 point is scored if range of motion is ordered by the physician and is documented as being performed by the nurse in the clinical record. 12. W heelchair /walker dependent : 2.0 points are scored if the member does not have the ability to walk unaided and is either wheelchair-or walker – dependent. 13. Turn every 2 hours : 1.5 points are scored if there is a physician order and the nurse performs during the visit. Skin assessment should be documented by the nurse in the clinical record. 14. Ambulation/ assists: 1.0 point is scored if the member requires hand-in-hand assist or guidance with turning a wheelchair/walker . 15. Weakness /fall risk : 1.0 point is scored if the member has weakness and/or is a fall risk. There must be a protocol in place to decrease the fall risk of the member which is monitored by the nurse. 16. Recording of I&O: 0.5 points are scored if normal daily measurement of intake and output is recorded by the nurse without the need to assess for fluid replacement or restriction. This may include weighing diapers. 17. Oral suctioning: 1.0 point is scored if suctioning of the nose, mouth, or upper throat with a bulb syringe, yankaeur, or suction catheter. 18. Ostomy care: 1.0 point is scored if the member has an ileostomy, vesicostomy, or colostomy. 19. Visual impairments . Select up to one of the following if applicable: 0.5 points are scored for visual impairments not correctable by glasses or another assistive device. 1.0 point is scored if the member if blind and there is no modification they have used to compensate. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 20. Tactile impairments. 0.5 points are scored for tactile impairments (eg,member has the need to put everything in their mouth or has an aversion to different touch stimuli). 21. Auditory impairments . Select up to one of the following if applicable: 0.5 points are scored for auditory impairments not correctable by hearing aid or another assistive device. 1.0 point is scored if the member is deaf and there is no modification they have used to compensate. 22. Self-abusive behavior . Select up to one of the following if applicable: 1.0 point is scored if the member demonstrates self-abusive behavior with no injury. 1.5 points are scored if the member demonstrates self-abusive behavior with moderate injury. 2.0 points are scored if the member demonstrates self-abusive behavior with severe injury. 23. Combative behavior: 1.5 points are scored if the member demonstrates combative behavior. 24. Redirection. Select up to one of the following if applicable: 0.5 points are scored if the member requires occasional redirection. 1.0 point is scored if the member requires frequent redirection. 25. Global delays: acuity measurement is scored as documented by the physician on the members care plan. Select up to one of the following if applicable: 1.0 point is scored if the members current age is age 4 years or under and has documentation of global delays. 2.0 points are scored if the members current age is over age 4 years and has documentation of global delays. 26. Incontinence (N/A for children under age 3 years) . Select up to one of the following if applicable: 0.5 points are scored if the member experiences occasional incontinence. 1.5 points are scored if the member experiences daily incontinence. 27. Toilet program . 1.0 point is scored if the member has a toilet program documented in the clinical record. C. The following point/care guideline may be adjusted based on a case-by-case review : 1. 15-24 points equate to 4 to 8 hours of care per day, or less than 56 hours per week. 2. 25-34 points equate to 8 to 12 hours of care per day, or between 56 and 84 hours per week. 3. 35-40 points equate to 12 to 14 hours of care per day, or between 85 and 98 hours per week. 4. 40+ points equate up to 16 hours of care per day, or between 99 and 112 hours per week. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 5. PDN above 112 hours per week are not routinely approved. However, PDNmay be extended beyond 112 hours per week based on medical necessity. E. Conditions of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 07/19/2023 New policy. Approved at Committee.Date Revised 06/19/2024 05/07 /202504/08 /2026Review: added examples to criteria, updated references, approved at Committee. Review: Added clarif ying statements in D.XII, updated references, approved at Committee. Review: changed terminology to member, clarified points system regarding skilled and unskilled needs, score selections, stoma maintenance vs use, insulin and ventilator points, added neurostorm and medications to seizure section, separated impairments, a busive/combative/redirection behaviors, and incontinence/toileting program, updated references, approved at Committee. Date Effective 08/01/2026 Date Archived H. References1. Burgdorf JG, Arbaje AI, Chase J, et al . Current practices of family caregiver training during home health care: a qualitative study. JAm Geriatr Soc . 2022;70(1):218-227. doi:10.1111/jgs.17492 2. Centers for Medicare and Medicaid Services (CMS). Home-and Community-Based Services. Modified March 10 , 2026 . Accessed March 16, 2026 . www.cms.gov 3. Definitions , OHIO ADMIN . CODE 3701-16-01 (2024). 4. Developmental Disabilities Level of Care, OHIO ADMIN . CODE 5123-8-01 (2024). 5. Home Health and Private Duty Nursing: Visit Policy, OHIO ADMIN . CODE 5160-12-04 (2021). 6. Honsberger K, Holladay S, Kim E, et al. How States Use Medicaid Managed Care to Deliver Long-Term Services and Supports to Children with Special Health Care Needs . National Academy for State Health Policy. November 2018. Accessed March 16, 2026 . www.nashp.org 7. Kusma JD, Davis MM, Foster C. Characteristics of Medicaid policies for children with medical complexity by state. JAMA Netw Open . 2022;5(10):e2239270. doi:10.1001/jamanetworkopen.2022.39270 8. Managed Care: Definitions , OHIO ADMIN . CODE 5160-26-01 (2022). Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 08/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.19 9. Medicaid Medical Necessity: Definitions and Principles, OHIO ADMIN . CODE 5160-1-01 (2022 ). 10. Medicare Certified Home Health Agencies: Qualifications and Requirements, OHIO ADMIN . CODE 5160-12-03 (2015). 11. Non-Agency Nurses and Otherwise-Accredited Agencies: Qualifications and Requirements, OHIO ADMIN . CODE 5160-12-03.1 (2015). 12. Ohio Department of Medicaid. Ohio HCBS Waiver Programs. Accessed March 16, 2026 . www.medicaid.ohio.gov 13. Ohio Department of Medicaid. Private Duty Nursing . June 24, 2024. Accessed March 16, 2026 . www.medicaid.ohio.gov 14. Private Duty Nursing: PDN-2001. MCG Health, 2 9th ed. Updated June 13, 2025 . Accessed March 16, 2026 . www.careweb.careguidelines.com 15. Private Duty Nursing: Procedures for Service Authorization, OHIO ADMIN . CODE 5160 – 12-02.3 (2017). 16. Private Duty Nursing Services, 42 C.F.R. 440.80 (202 6). 17. Private Duty Nursing Services: Provision Requirements, Coverage and Service Specification, OHIO ADMIN . CODE 5160-12-02 (2021). 18. Registered Nurse Assessment and Registered Nurse Consultation Services . OHIO ADMIN . CODE 5160-12-08 (2021). 19. Reimbursement: Exceptions , OHIO ADMIN . CODE 5160-12-07 (2015). 20. Reimbursement: Private Duty Nursing Services, OHIO ADMIN . CODE 5160-12-06 (202 4). 21. Sobotka SA, Lynch E, Peek ME, et al . Readmission drivers for children with medical complexity: home nursing shortages cause health crises. Pediatr Pulmonol . 2020;55(6):1471-1480. doi:10.1002/ppul.24744 22. Sobotka SA, Dholakia A, Berry JG, et al. Home nursing for children with home mechanical ventilation in the United States: key informant perspectives. Pediatr Pulmonol . 2020;55(12):3465-3476. doi:10.1002/ppul.25078 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.Independent med ical review July 2023Approved by ODM 05/ 19/2026
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