Skin Substitutes

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 Medical Policy Statements may be superseded by federal and state laws and regulations, as applicable.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

Nutritional Supports

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

Functional Electrical Stimulation (FES)

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

Autonomic Nerve Testing

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

Applied Behavior Analysis for Autism Spectrum Disorder

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

Private Duty Nursing

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

ProACT Adjustable Continence Therapy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective ProACT Adjustable Continence Therapy-OH MCD-MM-1305 07/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 3 E. Conditions of Coverage …………………………………………………………………………………………. 3 F. Related Policies/Rules …………………………………………………………………………………………… 3 G. Review/Revision History ………………………………………………………………………………………… 3 H. References ………………………………………………………………………………………………………….. 4 ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectProACT Adjustable Continence Therapy B. Background Urinary incontinence is a known complication of prostate surgery which can impact quality of life. The incidence of incontinence varies by procedure, but it is transient for most individuals. Incontinence after prostate surgery is a dynamic condition that can greatly improve in the first 1 to 2 years with conservative therapies. Conservative management may include lifestyle modification, pads, compression, catheters, and pelvic floor exercises. An estimated 5% of men whose incontinence fails to resolve undergo an additional procedure for the treatment of incontinence. Surgical management, which is usually deferred for at least 12 months post-prostatectomy, may involve adjustable balloon devices for mild stress incontinence, male slings for mild to moderate stress incontinence, and artificial urinary sphincters for severe stress incontinence. ProACT is a minimally invasive adjustable continence therapy for stress urinary incontinence utilizing a proprietary balloon device. Under fluoroscopic guidance, implantation instruments are advanced via transverse perineal incisions to the area of the bladder neck. The tissue is then dilated to create space for the balloon device. A balloon is inserted bilaterally and inflated with isotonic solution. Titanium ports are placed under the skin to allow for future inflation or deflation of the balloons. While the device has demonstrated efficacy in peer-reviewed medical literature, device migration requiring revision surgery or explantation has also been documented. A shared decision-making approach between physician and patient is recommended. C. Definitions Urinary Incontinence Involuntary leakage of urine, including the following types: o Stress Urinary Incontinence (SUI) Occurs in the absence of a bladder contraction due to inadequate urethral sphincter function, either from mechanical damage to the urethral sphincter or from physiologic effects that limit sphincter function. o Urge Urinary Incontinence (UUI) A sudden and compelling desire to pass urine that is difficult to defer and is accompanied by involuntary leakage, typically associated with bladder outlet obstruction or detrusor overactivity. o Overflow Urinary Incontinence (OUI) Urine is retained in the bladder due to incomplete voiding after an attempt to urinate, potentially caused by bladder outlet obstruction or detrusor underactivity. o Mixed Urinary Incontinence A combination of stress urinary incontinence and urge urinary incontinence, occurring when both the bladder and urinary sphincter have impaired function. ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. CareSource considers ProACT adjustable continence therapy medically necessary when ALL the following clinical criteria are met: A. Member underwent radical prostatectomy or transurethral resection of the prostate at least 12 months prior without radiation therapy. B. Member has documented primary stress urinary incontinence arising from intrinsic sphincter deficiency of at least 12 months duration. C. Member has documentation of conservative therapy failure. D. Member experiences at least 3 incontinence episodes per day. E. Member has positive 24-hour pad weight test (at least 8-gram pad weight increase demonstrated in two 24-hour pad weight tests). II. Limitations/ExclusionsProACT is contraindicated in patients with any of the following: A. urge incontinence B. detrusor instability or over-activity C. residual volume of at least 100ml or at least 25% of the total bladder capacity after voiding D. active systemic or urinary tract infections E. history of bladder stones F. hemophilia or other bleeding disorders G. UI resulting from detrusor instability H. UI resulting from overactive bladder I. reduced bladder compliance J. residual urine volume exceeding 100 cubic centimeters after voiding K. suspected bladder cancer L. radiotherapy within the past 6 months E. Conditions of Coverage N/A F. Related Policies/Rules N/A G. Review/Revision HistoryDATE ACTIONDate Issued 04/13/2022 New PolicyDate Revised 03/29/2023 02/14/2024 02/12/2025 06/04/2025 03/25/2026Annual review: updated references. Approved at Committee. Annual review: editorial changes to document language and updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Review: removed age criteria. Approved at Committee Review: updated references. Approved at Committee. Date Effective 07/01/2026 ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 Date ArchivedH. References1. Angulo JC, Schnburg S, Giamm A, et al. Systematic review and meta-analysis comparing adjustable transobterator male system (ATOMS) and adjustable continence therapy (ProACT) for male stress incontinence. PLoS One . 2019;14(12):e0225762. doi:10.1371/journal.pone.0225762 2. Artificial urinary sphincter: A-0267 (AC). MCG. 29th ed draft. Updated January 25, 2025. Accessed March 5, 2026. www.careweb.careguidelines.com 3. Clemens JQ. Urinary incontinence in men. UpToDate. Updated March 6, 2024. Accessed March 5, 2026. www.uptodate.com 4. Comiter CV, Speed J. Urinary incontinence after prostate treatment. UpToDate. Updated May 16, 2024. Accessed March 5, 2026. www.uptodate.com 5. Finazzi Agr E, Gregori A, Bianchi D, et al. Efficacy and safety of adjustable balloons (ProACT) to treat male stress urinary incontinence after prostate surgery: medium and long-term follow-up data of a national multicentric retrospective study. Neurourol Urodyn . 2019;38(7):1979-1984. doi:10.1002/nau.24103 6. Klock JA, Palacios AR, Leslie SW, et al. Artificial urinary sphincters and adjustable dual-balloon continence therapy in men. Updated November 2, 2023. Accessed March 5, 2026. www.ncbi.nlm.nih.gov 7. Larson T, Jhaveri H, Yeung LL. Adjustable continence therapy (ProACT) for the treatment of male stress incontinence: a systematic review and meta-analysis. Neurourol Urodyn . 2019;38(8):2051-2059. doi:10.1002/nau.24135 8. Munier P, Nicolas M, Tricard T, et al. What if artificial urinary sphincter is not possible? Feasibility and effectiveness of ProACT for patients with persistent stress urinary incontinence after radical prostatectomy treated by sling. Nurourol Urodyn . 2020;39(5):1417-1422. doi:10.1002/nau.24355 9. Musco S, Ecclestone H, Hoen L, et al. Efficacy and safety of surgical treatments for neurogenic stress urinary incontinence in adults: a systematic review. Eur Urol Focus . 2022;8(4):1090-1102. doi:10.1016/j.euf.2021.08.007 10. Nash S, Aboseif S, Gilling P, et al. Four-year follow-up on 68 patients with a new post-operatively adjustable long-term implant for post-prostatectomy stress incontinence: ProACT. Neurourol Urodyn . 2019;38(1):248-253. doi:10.1002/nau.23838 11. Premarket approval (PMA) P130018: FDA summary of safety and effectiveness data. Food and Drug Administration. November 24, 2015. Accessed March 5, 2026. www.accessdata.fda.gov 12. ProACT: patient brochure. Food and Drug Administration. Accessed March 5, 2026. www.accessdata.fda.gov 13. ProACT: physician instructions for use. Food and Drug Administration. Accessed May 6, 2025. www.accessdata.fda.gov 14. ProACT adjustable continence therapy (Uromedica) for treatment of post-surgical incontinence in men. Hayes. Updated May 24, 2023. Accessed March 5, 2026. www.evidence.hayesinc.com ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 15. ProACT therapy for the treatment of stress urinary incontinence in males (ProACT).National Library of Medicine. Updated May 31, 2018. Accessed May 6, 2025. clinicaltrials.gov 16. Sandhu JS, Bryer B, Comiter C, et al. Incontinence after prostate treatment: AUA/SUFU guideline. JUrol . 2019;202(2):369-378. doi:10/1097/ju.00000000000314 Independent medical review February 2025ODM approved 04/02/2026

Negative Pressure Wound Therapy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Negative Pressure Wound Therapy-OH MCD-MM-0224 07/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNegative Pressure Wound Therapy B. BackgroundNegative pressure wound therapy (NPWT), also known as vacuum-assisted wound closure, is used to treat chronic wounds, such as ulcers related to pressure sores, venous or arterial insufficiency, or neuropathy. There are many causes for pressure ulcers, including diabetes, vascular insufficiencies, and other underlying medical condition s. NPWT involves the controlled application of sub-atmosph eric pressure to the surface ofa wound. This type of therapy utilizes an electrical pump connected to a specialized dressing that then removes debris and exudate from the wound and drains into a collection canister. NPWT is a noninvasive type of therapy th at has demonstrated efficacy in accelerat ing wound healing for chronic wounds . To provide a more conducive environment for wound healing, the NPWT method utilizes a semipermeable dressing that always remains moist and warm. This therapy can be done in the home or in an outpatient treatment facility. NPWT typically does not require inpatient monitoring.C. Definitions Arterial Insufficiency Ulcer A type of ulcer that develops due to the lack of delivery of oxygen-rich blood to the tissue which causes the tissue to begin to deteriorate and develop into an open wound. Deep Tissue Pressure Injury A type of injury resulting from a serious pressure ulcer that has advanced with additional necrosis of underlying soft tissue that may or may not be visible. Dehisced Wounds A wound that has ruptured along the wound margin typically due to infection. Eschar Black or brown, thick, leathery feeling dead tissue covering an ulcer. Measurable Improvement Measurable changes in wound healing, including drainage , inflammation , swelling , pain and/or tenderness , wound dimensions , surface measurements , granulation tissue , necrotic tissue/slough , tunneling , or undermining . Neuropathic Ulcer A type of ulcer that occurs due to lack of sensation secondary to neuropathy which causes skin and underlying tissue to begin to breakdown causing ulcers further complicated by infection. Pressure Ulcer A type of ulcer that develops due to an extended amount of time when there is compression of the soft tissue overlying bony prominences and an outside object causing tissue necrosis. Slough Avascular (dead) soft tissue found in higher stage ulcers. Tunneling Channels of tissue deterioration that extend from the wound to the subcutaneous tissue typically in one direction. Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Undermining Subcutaneous tissue deterioration around the margin of a wound and may occur in any direction . Venous Insufficiency Ulcer A type of ulcer that occurs due to the lack of properly functioning venous valves, which causes the veins to increase in size. Pressure Ulcer StagingStage 1 A localized area of skin that is intact with non-blanchable erythema.Changes in sensation, temperature , or firmness of the skin may be present prior to visual alterations of the skin. If discoloration is purple or maroon, this may indicate a deep tissue injury. Stage 2 A surface area of skin that has partial-thickness loss of skin with exposed dermis. May initially present as a serum-filled blister that has ruptured. The wound bed will be moist, red/pink , and the skin should be viable. There should be no evidence of visible adipose (fatty) tissue, eschar, slough , or granulation. Stage 3 A surface area of skin that has full-thickness loss of skin with visible adipose (fat) tissue and granulation. The wound edges are often rolled (epibole), and there may be visible eschar and slough. Undermining and tunneling may occur in the wound. At this stage, there should be no fascia, muscle, tendon ligament, cartilage , and/or bones exposed. Stage 4 A surface area of skin that has full-thickness loss of skin. At this stage, there will be fascia, muscle, tendon, ligament, cartilage , or bone that is visible or directly palpable. The wound edges will be rolled (epibole), and there is typically visible eschar and slough. Undermining and tunneling occur often in the wound. Unstageable Inability to fully assess the extent of the tissue damage due to eschar or slough obscuring visibility, but there is observable full-thickness skin and tissue loss that is unstageable. D. PolicyI. CareSource considers NPWT medically necessary when the following clinical criteria are met : A. Stage III or IV pressure ulcer (see staging criteria above) in members meeting ALL the following: 1. Member has been on a repositioning regimen with frequency determined by the provider based on the patients activity level and ability to reposition themselves. 2. Pressure relief techniques and/or pressure-reducing surfaces have been ordered (eg, foam overlay mattress, egg crate foam mattress, or low-air-loss devices) and documented ongoing compliance is in the member medical record . 3. Members incontinence and moisture issues have been appropriately managed . B. Chronic neuropathic ulcer that meets BOTH of the following criteria: Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 1. A comprehensive diabetic management program has been implemented, including A1C management, medication management, and ongoing diabetic education.2. Foot care has been completed by a medical professional that includes general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies that meet ALL the following criteria: 1. Compression garments/dressing/bandages are being applied consistently per physician orders in documented venous insufficiency plan of care for at least 30 days. 2. Ambulation and leg elevation have been ordered and documented ongoing compliance is in the member medical record. D. Member has any of the following: 1. high-risk open fracture 2. dehisced wound 3. post sternotomy wound complication or infection (mediastinitis) 4. surgically created wound with complications resulting in a need for accelerated granulation therapy that cannot be achieved by other treatment modalities , such as topical wound treatment 5. open non-healing amputation site in diabetic 6. delayed healing or non-healing of skin graft which is likely due to irregularly contoured or inadequate blood flow from the graft bed II. CareSource members may be eligible for the continuation of NPWT treatment when documentation by a licensed medical professional includes ALL the following criteria:A. A licensed medical professional has directly performed the dressing change and is monitoring and controlling the members underlying medical conditions. B. The wound has progressive and measurable improvement. 1. If no measurable degree of improvement in wound healing has occurred from month to month, the approval for the NPWT will be discontinued. 2. An exception to measurable improvement is when a wound has been debrided within the last approval period. Documentation of debridement must accompany the request for continuation of NPWT. Before and after images are preferred. C. If abnormal, provisions have been made to the members nutritional status. III. CareSource does not consider NPWT medically necessary for non-healing wounds or ulcers under any of the following conditions: A. exposed nerves, blood vessels, or organs in the vicinity of the wound B. uncontrolled soft tissue infection or osteomyelitis C. malignancy present in the wound D. necrotic tissue present in the wound with eschar and has not been debrided E. open fistula present to an organ or body cavity within the vicinity of the wound F. active bleeding Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 IV. When applied during surgery, CareSource does not reimburse separately for NPWT. NPWT is covered under the surgery code. V. The coverage provided for NPWT by the global surgical package is not intended to deny billing for NPWT in outpatient services. When a patient is discharged from the hospital with wounds that are still in need of NPWT treatment, outpatient wound care is cov ered when it meets medical necessity.VI. Initial approval for NPWT in the outpatient setting will be for a month. After the initial month, continued approval will be based on the medical necessity guidelines in this policy. Continued approval will be made in 1-month increments. CareSource willapprove the following allowances for supplies:A. Fifteen dressing kits per wound per month. Additional dressing kits may be requested with documentation that the wound size requires more than one kit. B. Ten canister sets per month. Additional canister sets can be requested if there is documentation showing greater than 90 ml drainage exudate per day. C. Initial approval includes NPWT equipment and supplies that are used upon discharge from an in-patient setting. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New policy.Date Revised 11/23/2022 10/11/2023 10/23/202407/30/2025 03/25/2026 Annual review: editorial changes, reference updates. Updated references and clarified coverage criteria in D. IV – VI. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 07/01/2026 Date Archived H. References1. Biancari F, Santoro G, Provenzano F, et al. Negative-pressure wound therapy for prevention of sternal wound infection after adult cardiac surgery: systematic review and meta-analysis. JClin Med . 2022;11(15):4268. doi:10.3390/jcm11154268 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 2. Chen L, Zhang S, Da J, et al. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. 2021;10(10):10830-10839. doi:10.21037/apm-21-2476 3. De Pellegrin L, Feltri P, Filardo G, et al. Effects of negative pressure wound therapy with instillation and dwell time (NPWTi-d) versus NPWT or standard of care in orthoplastic surgery: a systematic review and meta-analysis. Int Wound J . 2023;20(6):2402-2413. doi:10.1111/iwj.14072 4. Eriksson E, Liu PY, Schulz GS, et al. Chronic wounds: treatment consensus. Wound Repair Regen .2022;30(2):156-171. doi:10.1111/wrr.12994 5. Gao J, Wang Y, Song J, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis. JAdv Nurs . 2021;77(10):3980 – 3990. doi:10.1111/jan.14876 6. Gestring M. Negative pressure wound therapy. UpToDate. Updated January 30, 2025 . Accessed February 26, 2026 . www.uptodate.com 7. Gould LJ, Alderden J, Aslam R, et al. WHS guidelines for the treatment of pressure ulcers 2023 update. Wound Repair Regen . 2024;32(1):6-33. doi:10.1111/wrr.13130 8. Groenen H, Jalalzadeh H, Buis DR, et al. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis . EClinicalMedicine . 2023;62:102105. doi:10.1016/j.eclinm.2023.102105 9. Kim PJ, Attinger CE, Constantine T, et al . Negative pressure wound therapy with instillation : international consensus guidelines update . Int Wound J . 2020;17(1):174 – 186. doi:10.1111/iwj.13254 10. Li P, Li J. Effect of incisional negative pressure therapy and conventional treatment on wound complications after orthopaedic trauma surgery: a meta-analysis of randomized controlled studies. Int Wound J . 2023;20(10):4291-4299. doi:10.1111/iwj.14331 11. Negative pressure wound therapy (vacuum-assisted wound closure): A-0346. MCG, 29 th edition . Updated June 13, 2025 . Accessed February 26, 2026 . careweb.careguidelines.com 12. Negative Pressure Wound Therapy for Closed Surgical Incisions Following Total Knee Arthroplasty. Hayes; 2 023. Reviewed June 30, 2025. Accessed February 26, 2026. www.evidence.hayesinc.com 13. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev . 20 22;6(6):CD009261 . doi:10.1002/14651858.CD009261.pub7 14. Orlov A, Gefen A. The potential of a canister-based single-use negative-pressure wound therapy system delivering a greater and continuous absolute pressure level to facilitate better surgical wound care. Int Wound J . 2022;19(6):1471-1493. doi:10.1111/iwj.13744 15. Pedrazzi NE, Naiken S, La Scala G. Negative pressure wound therapy in pediatric burn patients: a systematic review. Adv Wound Care (New Rochelle) . 2021;10(5):270-280. doi:10.1089/wound.2019.1089 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 07/01/2026The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 16. PICO single use negative pressure wound therapy system (Smith & Nephew) for cesarean birth wound care. Hayes ; 2022. Reviewed July 8, 2025 . AccessedFebruary 26, 2026 . evidence.hayesinc.com 17. Poteet SJ, Schulz SA, Povoski SP, et al. Negative pressure wound therapy: device design, indications, and the evidence supporting its use. Expert Rev Med Devices . 2021;18(2):151-160. doi:10.1080/17434440.2021.1882301 18. Prevention of surgical site infections after major extremity trauma evidence-based clinical practice guideline . American Academy of Orthopaedic Surgeons. Published March 21, 2022. Accessed February 26, 2026. www.aaos.org 19. Rvsz ES, Altorjay A, Montsk V, et al. Effectiveness of negative pressure wound therapy: minimum five-year follow-up and review of the literature. Jt Dis Relat Surg . 2022;33(1):51-56. doi:10.52312/jdrs.2022.547 20. Shi J, Gao Y, Tian J, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Sys Rev . 2023;5(5):CD011334. doi:10.1002/14651858.CD011334.pub3 21. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. Accessed February 26, 2026. www.ncbi.nlm.nih.gov 22. Tian Y, Li K, Zeng L. A systematic review with meta-analysis on prophylactic negative pressure wound therapy versus standard dressing for obese women after caesarean section. Nurs Open . 2023;10(9):5999-6013. doi:10.1002/nop2.1912 23. Xie W, Dai L, Qi Y, et al. Negative pressure wound therapy compared with conventional wound dressings for closed incisions in orthopaedic trauma surgery: A meta-analysis . Int Wound J . 2022;19(6):1319-1328. doi:10.1111/iwj.13726 Independent med ical review 4/2020ODM approved 04/06/2026

Airway Clearance Devices

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Airway Clearance Devices-OH MCD-MM-1578 07/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of 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 Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectAirway Clearance Devices B. BackgroundHealthy individuals typically produce 10 100 mL of airway secretions daily. The clearance of these secretions from the respiratory tract is accomplished primarily through ciliary action, called the mucociliary escalator and the cough reflex. Secretion retention can occur because of an increased production of secretions due to a number of conditions, including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), mucociliary disorders, neuromuscular disease (NMD), and metabolic disorders that make it more difficult to clear the airway. In patients with a weak cough, retention of these secretions is a major cause of mortality and morbidity. Conventional chest physical therapy has been shown to result in improved respiratory function through the use of percussion and postural drainage. These techniques are usually taught to family members so therapy may be continued at home when needed for chronic disease. However, this highly labor-intensive activity requires the daily intervention of a trained caregiver and may lead to poor compliance with the recommended treatment plan. Airway clearance devices can aid secretion mobilization and expectoration and assist coughing. Educating patients and families on the use of these devices and secretion management are within the scope of practice of respiratory therapists, physical therapists, nurses, and other clinicians. C. Definitions High Frequency Chest Compression Device An inflatable vest connected by tubes to a small air-pulse generator. The air-pulse generator rapidly inflates and deflates the vest, compressing and releasing the chest wall up to 20 times per second. Mechanical Insufflation-Exsufflation Device A device with a facemask that covers the nose and mouth, allowing air to be pumped into the lungs and then rapidly evacuated, facilitating the expulsion of secretions. Oscillation and Lung Expansion (OLE) Device A non-invasive, mechanical airway clearance technique (ACT) that combines continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP) to treat lung diseases. D. PolicyI. Mechanical Insufflation-Exsufflation Devices (E0482) A. CareSource considers mechanical in-exsufflation devices medically necessary when all of the following clinical criteria are met: Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 1. There is a presence of neuromuscular or chest wall disease (eg, amyotrophic lateral sclerosis, congenital muscular dystrophies, Duchenne muscular dystrophy, multiple sclerosis, post-poliomyelitis, spinal cord injury, spinal muscle atrophy). 2. The condition causes a significant impairment of chest wall and/or diaphragmatic movement, resulting in an inability to clear retained secretions. 3. The member has an inadequate response or intolerance to chest percussion and postural drainage. 4. Member has no bullous emphysema, pneumomediastinum, or pneumothorax. B. A mechanical insufflation-exsufflation device for any indication not listed above is not covered or reimbursable. II. High Frequency Chest Compression Devices (E0483)A. CareSource considers high frequency chest compression devices medically necessary when any of the following clinical criteria is met: 1. cystic fibrosis when there is failure, intolerance or contraindication to home chest physiotherapy, or it cannot be provided 2. a diagnosis of bronchiectasis which has been confirmed by a high resolution, spiral, or standard CT scan and which is characterized by a. daily productive cough for at least 6 continuous months or b. frequent (eg, more than 2 per year) exacerbations requiring antibiotic therapy B. Chronic bronchitis and chronic obstructive pulmonary disease (COPD) in the absence of a confirmed diagnosis of bronchiectasis do not meet this criterion. C. It is not reasonable and necessary for a member to use both a high frequency chest compression device and a mechanical in-exsufflation device. D. Per Ohio Administrative Code (OAC) 5160-10-08, purchase of a high-frequency chest wall oscillation (HFCWO) device will not be considered: 1. without an initial trial period lasting at least 2 months, excluding any portion that coincides with an inpatient hospital stay 2. Payment for rental may be made during this trial period. E. If use of the HFCWO device is to be continued in a residential setting after the initial trial period, a Certificate of Medical Necessity (CMN) is included that contains 1. an attestation to the effectiveness of the device during the trial period and every previous rental period as exhibited by a decrease in (not all inclusive): a. infections b. hospitalizations and c. antibiotic use 2. if applicable, specification of a change in the duration or frequency of therapy 3. a recommendation either for additional rental or for purchase III. Oscillation and Lung Expansion (OLE) DevicesA. Combination oscillation and lung expansion (OLE) devices for the treatment of respiratory conditions (e.g., the Volara System, BiWaze Clear System, and Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 MetaNeb4 System) as an alternative to conventional chest physical therapy to promote the clearance of respiratory secretions are considered to be of unproven efficacy. OLE devices are not recommended for outpatient use due to insufficient evidence and safety concerns. Requests will be reviewed on a case-by-case basis.B. A review in Clintrials.gov of the Volara device revealed 1 completed pilot study of 20 participants completed on March 19, 2025. Another study of OLE therapy was terminated on Feb.27, 2024 and a third study as of 2025-04-22 is listed as Not Yet Recruiting. C. There is insufficient evidence in the peer-reviewed published medical literature to draw conclusions regarding improvements in health outcomes of these devices compared to established alternatives. E. Conditions of CoverageBased on 2 Class 1 FDA recalls (the most recent being on May 30, 2024) as well as a Hayes 2023 Evidence Analysis Research Brief which detailed the following adverse events: injuries, 5 malfunctions, 2 deaths, Volara is not recommended for outpatient use. F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 01/17/2024 New policy. Approved at Committee.Date Revised 11/20/2024 06/18/2025 11/19/2025 Updated references. Approved at Committee. Updated references. Approved at Committee. Added effectiveness criteria to D.II.E.1, removed D.II.F. Volara section, added section D.III.A-C OLE devices, updated references. Approved at Committee. Date Effective 07/01/2026 Date Archived H. References1. Bach JR. Noninvasive respiratory management of patients with neuromuscular disease. Ann Rehabil Med . 2017;41(4):519-538. doi:10.5535/arm.2017.41.4.519 2. Basavaraj A, Choate R, Addrizzo-Harris D, et al. Airway clearance techniques in bronchiectasis: analysis from the United States Bronchiectasis and Non-TB Mycobacteria Research Registry. Chest . 2020;158(4):1376-1384. doi: 10.1016/j.chest.2020.06.050 3. Chatwin M, Wakeman RH. Mechanical insufflation-exsufflation: considerations for improving clinical practice. JClin Med . 2023;12(7):2626. doi:10.3390/jcm12072626 Airway Clearance Devices-OH MCD-MM-1578Effective Date: 07/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 4. DMEPOS: High-Frequency Chest Wall Oscillation (HFCWO) Devices, O HIO ADMIN .C ODE 5160-10-08 (2024). 5. Evidence Analysis Research Brief. Volara (Hillrom) for Respiratory Therapy. Updated August 2023. Accessed January 29, 2026. www.evidence.hayesinc.com 6. Ferreira de Camillis ML, Savi A, Goulart Rosa R, et al. Effects of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU subjects. Respir Care . 2018;63(12):1471-1477. doi:10.4187/respcare.06253 7. Finder JD, Birnkrant D, Carl J, et al. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am JRespir Crit Care Med. 2004;170(4):456-465. doi:10.1164/rccm.200307-885ST 8. High Frequency Chest Compression Device: A-0356 (AC). MCG Health. 29th ed. 2024. Updated June 13, 2025. Accessed October 24, 2025. www.careweb.careguidelines.com 9. Main E, Rand S. Conventional chest physiotherapy compared to other airway clearance techniques for cystic fibrosis. Cochrane Database Syst Rev . 2023;5(5):CD002011. Published 2023 May 5. doi:10.1002/14651858.CD002011.pub3 10. Mechanical Insufflation-Exsufflation Device: A-0884 (AC). MCG Health. 29th ed. 2025. Updated June 13, 2025. Accessed October 24, 2025. www.careweb.careguidelines.com 11. Raywood E, Shannon H, Filipow N, et al. Quantity and quality of airway clearance in children and young people with cystic fibrosis. JCyst Fibros . 2023;22(2):344-351. doi: 10.1016/j.jcf.2022.09.008 12. Strickland SL, Rubin BK, Drescher GS, et al. AARC clinical practice guideline: effectiveness of nonpharmacologic airway clearance therapies in hospitalized patients. Respir Care . 2013;58(12):2187-2193. doi:10.4187/respcare.02925 Approved by ODM on 3/20/2026

Mechanical Stretching Devices

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Mechanical Stretching Devices-OH MCD-MM-1225 06/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectMechanical Stretching Devices B. Background Mechanical stretching devices are intended to restore range of motion (ROM) for joint stiffness or contracture by stretching joints. These devices provide passive stretching to an adjustable degree for a selected duration for multiple sessions. A variety of mechanical stretching devices are available for extension or flexion of the shoulder, elbow, wrist, fingers, knee, ankle, and toes. These devices can provide stretching for longer periods than a physical therapist and are generally used as adjunct treatment to physical therapy and/or exercise. Mechanical Stretching Devices (also known as dynamic splinting systems) include: Low-load prolonged duration stretch devices (LLPS) Static progressive stretch (SPS) splint devices Patient actuated serial stretch (PASS) devices C. Definitions Low-Load Prolonged Duration Stretch Devices (LLPS) These devices permit resisted active and passive motion (elastic traction) within a limited range. LLPS devices maintain a set level of tension by means of incorporated rubber bands or springs. Patient Actuated Serial Stretch (PASS) Devices These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). This type of device itself does not exert a stress on the tissue unless the joint angle is set at the maximum ROM. Static Progressive Stretch Devices (SPS) These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). D. Policy I. CareSource considers dynamic splinting devices medically necessary durable medical equipment (DME) as an adjunct treatment to physical therapy, massage, and/or exercise for an existing joint contracture when the following clinical criteria is met: A. medically necessary only for the following joints: knee, elbow, wrist, finger, ankle and toe B. after 3 weeks of exercise, physical therapy and skilled therapy in the initial subacute injury or post-operative period in members with: 1. signs and symptoms of persistent joint stiffness or contracture 2. limited range of motion that poses a meaningful functional limitation as judged by a physician C. documentation showing compliance with wear and compliance with any additional activity and exercise recommended by medical professional Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. may be used for an initial period of 4 weeks, a subsequent 4-week period with reevaluation, and then up to 4 months based on continued improvement. E. documentation to show objective ROM and functional improvement II. In the acute post-operative period for members who have undergone additional surgery to improve the range of motion of a previously affected joint, CareSource considers use of an LLPS device medically necessary for: A. an initial 4-week period B. an additional 4-week period, if improvement was noted after the initial 4 weeks, for up to 4 months. III. Non-Covered ServicesA. CareSource considers the use of dynamic splinting experimental and investigational for the following indications, including but not limited to: 1. adhesive capsulitis 2. carpal tunnel syndrome 3. cerebral palsy 4. foot drop associated with neuromuscular diseases 5. hallux valgus 6. head and spinal cord injuries 7. improvement of outcomes following botulinum toxin injection for treatment of limb spasticity 8. injuries of the ankle and shoulder 9. multiple sclerosis 10. muscular dystrophy 11. plantar fasciitis 12. rheumatoid arthritis 13. stroke 14. trismus B. CareSource considers the following devices experimental and investigational due to insufficient scientific evidence of efficacy: 1. patient Actuated Serial Stretch (PASS) devices (for example, ERMI Knee Extensionater and ERMI Shoulder Extensionater) 2. static Progressive Stretch devices (SPS) (for example, Joint Active Systems (JAS) splints (for example, JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination) E. Conditions of CoverageAll claims for LLPS are subject to post-payment review by CareSource. F. Related Policies/Rules NA Mechanical Stretching Devices-OH MCD-MM-1225Effective Date: 06/01/2026The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision History DATE ACTIONDate Issued 11/09/2023 New PolicyDate Revised 02/15/2023 06/07/2023 05/22/2024 03/12/2025 03/11/2026 e-voted addition of ankle and toe to policy to match fee schedule and MCG. Annual review. Added examples of PASS and SPS devices. Annual review. Updated references. Approved at Committee. Updated references. Approved at Committee. Added compliance documentation requirements to Sec.I. C. and ROM and improvement documentation to I. E. Updated references. Approved at Committee. Date Effective 06/01/2026 Date Archived H. References1. Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther . 2013;30(8):763-770. doi:10.1007/s12325-013-0052-1 2. Dynamic Joint Extension and Flexion Devices: ACG A-0882. MCG. 29th ed. 2025. Accessed February 3, 2026. www.careweb.careguidelines.com 3. Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution predictors of contracture resolution. J Hand Ther . doi:10.1016/j.jht.2011.03.001 4. Harvey LA, Katalinic OM, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database of Systematic Reviews . 2017;1(1):CD007455. doi:10.1002/14651858.CD007455.pub3 5. Karjalainen TV, Lusa V, Page MJ, O'Connor D, Massy-Westropp N, Peters SE. Splinting for carpal tunnel syndrome. Cochrane Database Syst Rev. 2023;2(2):CD010003. doi:10.1002/14651858.CD010003.pub2 6. Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Hayes; 2022. Accessed February 3, 2026. www.hayesinc.com 7. Zatarain LA, Smith DK, Deng J, et al. A randomized feasibility trial to evaluate use of the jaw dynasplint to prevent trismus in patients with head and neck cancer receiving primary or adjuvant radiation-based therapy. Integr Cancer Ther . 2018. 17(3):960- 967. doi:10.1177/1534735418784363. Independent medical review 12/21Approved by ODM 03/17/2026

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System Details