Pediatric Asthma

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pediatric Asthma-OH MCD-MM-1710 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPediatric Asthma B. BackgroundAsthma is the most common chronic childhood disease – an estimated 5 million children in the United States have asthma with a disproportionate number living in poverty. Asthma is an immune-mediated, inflammatory disease, which is characterized by chronic, intermittent, and reversible lower airway obstruction caused by smooth muscle constriction and airway narrowing in response to an environmental trigger. In children, res piratory viral infections are the most common trigger of asthma exacerbation (eg, rhinovirus, influenza, and respiratory syncytial virus). In general, children are more susceptible to disease and complications , and whencombined with developmental issues makes treating asthma in children a difficult process with age-specific recommendations . For example, traditional pulmonary function testing is difficult to perform in children under 5 years of age, and physical signs of overt respiratory distress are often less prominent in older children and teens compared with infants and younger children. In addition, medication adherence and education , su ch as inhaled corticosteroids , are challenging . These issues in pediatric asthma treatment elevate the difficulty of inpatient admission during acute asthmatic distress . C. Definitions Acute Decompensation A clinical symptom of new or worsening signs and symptoms of heart failure. Forced Expiratory Volume in the First Second (FEV 1) Volume delivered in the first second of a FVC maneuver. Hemodynamic Instability An abnormality of the heart, blood vessels, or other organs resulting in cardiac arrest, obstructive shock, or persistent hypotension . Hypoperfusion A supply of O 2 that does not adequately address the needs of cells. Failure of O 2 use leads to anaerobic metabolism which is the source of several detectable products and byproducts. Hypotension Decrease in systemic blood pressure below accepted low values. Inotropic/Inotropes Medications that increase cardiac contractility, which improves cardiac output ( amount of blood pumped by the heart per minute ), aiding in maintaining mean arterial pressure and perfusion to the body. Ipratropium A bronchodilator medication that dilates the airways of the lungs. Used to treat bronchospasms associated with asthma exacerbations. Metabolic Acidosis A disturbance in the homeostasis of blood plasma leading to an increase in hydrogen ion concentration in blood plasma. Peak Expiratory Flow Rate (Peak Flow) Maximal flow rate that can be achieved during forceful expiration following full inspiration. Short-Acting Beta A gonist First-line medications for acute treatment in asthma symptoms and exacerbations. Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Vasopressors Medications that increase vasoconstriction, which leads to increased systemic vascular resistance (SVR). Increasing SVR leads to increased mean arterial pressure and increased perfusion to organs. Vital Sign Objective measurement of essential physiological functions ( eg, temperature, heart rate, respiratory rate, blood pressure) of a living organism. Wheez e A high pitched or coarse whistling sound heard in the respiratory airway when one breathes that is a result of a disease-caused airway obstruction . D. PolicyI. CareSource considers inpatient treatment for asthma in members younger than 18 years medically necessary when 1 or more of the following clinical criteria is met: A. Hemodynamic instability, as indicated by 1 or more of the following: 1. Vital sign abnormality not readily corrected by appropriate treatment, indicated by 1 or more of the following: a. hypotension that persists despite appropriate treatment (eg, volume repletion, treatment of underlying cause) b. orthostatic hypotension that persists despite appropriate treatment (eg, volume repletion) 2. Hypotension that is severe, as indicated by 1 or more of the following: a. lactate of 2.0 mmol/L (18 mg/dL) or more secondary to hypotension (ie, hypoperfusion) b. metabolic acidosis (arterial or venous pH less than 7.35) not otherwise explained c. mean arterial pressure less than 65 mm Hg d. IV inotropic or vasopressor medication required to maintain adequate blood pressure or perfusion B. Altered mental status agitation (that is not developmentally appropriate), drowsy, or confused C. Ventilatory assistance needed; D. Peak expiratory flow rate or FEV 1 less than 25% of predicted or personal best before treatment E. Peak expiratory flow rate or FEV 1 less than 40% of predicted or personal best after treatment F. Room air oxygen saturation less than 92% at the admitting facility at least 1 hour after completion of initial recommended treatment (ie, 3 doses of a short-acting beta agonist (SABA) with ipratropium for moderate to severe exacerbations administered every 20-30 minutes for 3 doses or continuously for 1 hour and administration of systemic steroids. G. Capillary, venous, or arterial pCO 2 greater than or equal to 42 (35 if pregnant) , if a previous elevated pCO 2 baseline has not been established. For members with an elevated pCO 2 at baseline, an elevation of 2 mm Hg or greater above baseline. H. Clinical finding (eg, moderate wheeze, breathlessness, head bobbing, nasal flaring, feeding difficulties, inability to maintain oral hydration, retractions, Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 prolonged expiration) that persists despite observation care (eg, beta-agonist response not sustained for at least 4 hours) I. Peak expiratory flow rate or FEV 1 between 40% and 60% of predicted or personal best despite observation care J. Radiographic evidence of complication requiring inpatient treatment (eg, tension pneumothorax) K. No baseline peak flow provided, or patient unable to perform peak flow , and ALL of the following: 1. Finding indicative of a moderate to severe asthma exacerbation, as indicated by 1 or more of the following: a. at least moderate wheeze (eg, wheeze during inspiration and expiration) b. vital sign abnormality sustained despite appropriate treatment as indicated by 1 or more of the following: 01. abnormal heart rate as defined as: (1). 180/min (for ages 3 yrs) (2). 150/min (for ages > 3 to 12 yrs) (3). 120/min (for ages > 12 yrs) c. at least moderate degree of use of accessory muscles (eg, suprasternal or scalene retractions) d. unable to speak in full sentences (as appropriate for age and development) e. moderate or severe prolongation of expiration f. silent chest (absent or markedly diminished breath sounds) g. feeding difficulties 2. Inadequate response to therapy , as indicated by 1 or more of the following: a. deterioration of symptoms despite bronchodilator therapy b. lack of significant improvement after 1 hour of bronchodilator therapy c. current presentation represents a recurrence within 48 hours of last asthma exacerbation (eg, emergency department or hospitalization) L. Change in clinical status requiring escalation of treatment, as indicated by 1 or more of the following: 1. subsequent administration of magnesium sulfate outside of emergency department 2. initiate or increase O 2 3. increased frequency in bronchodilator therapy 4. acute decompensation (eg, hospital-based rapid response system activated for timely clinical evaluation) requiring consideration of higher level of care E. Conditions of CoverageNA F. Related Policies/RulesNA Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 G. Review/Revision HistoryDATE ACTIONDate Issued 09/25/2024 New policy. Approved at Committee.Date Revised 07/30/2025 Annual review: updated references and added FEV1 to criteria. Approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. 202 5 GINA Report, Global Strategy for Asthma Management and Prevention. Global Initiative for Asthma; 202 5. Updated 202 5. Accessed July 21, 2025 . ginasthma.org 2. Abebe MM, Arefayne NR, Temesgen MM, et al. Incidence and predictive factors associated with hemodynamic instability among adult surgical patients in the post – anesthesia care unit, 2021: a prospective follow up study. Ann Med Surg (Lond) . 2022;74:103321. doi:10.1016/j.amsu.2022.103321 3. Asthma. Centers for Disease Control & Prevention. Accessed July 21, 2025 . www.cdc.gov 4. Asthma, pediatric: P-60 (ISC). MCG Health, 28 th ed. Updated March 14, 2024. Accessed August 19, 2024 . www.careweb.careguidelines.com 5. Bacharier LB, Guilbert TW, Jartti T, et al. Which wheezing preschoolers should be treated for asthma. JAllergy Clin Immunol Pract . 20231;9(7):2611-2618. doi:10.1016/j.jaip.2021.02.045 6. Bhakta NR, Bime C, Kaminsky DA, et al. Race and ethnicity in pulmonary function test interpretation: an official American Thoracic Society statement. Am JRespir Crit Care Med . 2023;207(8):978-995. doi:10.1164/rccm.202302-0310ST 7. Burger M, Schaller DJ. Metabolic Acidosis . StatPearls Publishing; 2023. Accessed August 1, 2024. www.ncbi.nlm.nih.gov 8. Chen X, Han P, Kong Y, et al. The relationship between changes in peak expiratory flow and asthma exacerbations in asthmatic children. BMC Pedatr . 2024;24(1):284. doi:10.1186/s12887-024-04754-7 9. Cloutier MM, Baptist AP, Blake KV, et al. 2020 Focused updates to the Asthma Management Guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. JAllergy Clin Immunol . 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003 10. Craig S, Powell CVE, Nixon GM, et al. Treatment patterns and frequency of key outcomes in acute severe asthma in children: a Paediatric Research in Emergency Departments International Collaborative (PREDICT) multicentre cohort study. BMJ Open Respir Res. 2 022;9(1):e001137. doi:10.1136/bmjresp-2021-001137 11. Devonshire AL, Kumar R. Pediatric asthma: principles and treatment. Allergy Asthma Proc . 2019;40(6):389-392. doi:10.2500/aap.2019.40.4254 12. DeVrieze BW, Modi P, Giwa AO. Peak Flow Rate Measurement . StatPearls Publishing; 2023. Accessed August 1, 2024. www.ncbi.nlm.nih.gov 13. Edwards LR, Borger J. Pediatric Bronchospasm . StatPearls Publishing; 2023. Updated June 12, 2023. Accessed July 21, 2025. www.ncbi.nlm.nih.gov Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 14. Ewulonu UC, Dyer H. Inpatient management of an acute asthma exacerbation using clinical care pathways. Curr Probl Pedatr Adolesc Health Care . 2021;51(5):100995. doi:10.1016/j.cppeds.2021.100995 15. Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC). 2020 Focused updates to the Asthma Management Guidelines: a report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. JAllergy Clin Immunol . 2020;146(6):1217-1270. doi:10.1016/j.jaci.2020.10.003 16. Hartert T. An overview of asthma management in children and adults. UpToDate. Updated September 30 , 2024. Accessed July 21, 2025 . www.uptodate.com 17. Hsu E, Bajaj T. Beta2-Agonists . StatPearls Publishing; 2023. Updated June 20, 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 18. Kaufman J, Marino M, Lucas J, et al. Racial and ethnic disparities in acute care use for pediatric asthma. Ann Fam Med . 2022;20(2):116-122. doi:10.1370/afm.2771 19. Levy ML, Bacharier LB, Bateman E, et al. Key recommendations for primary care from the 2022 Global Initiative for Asthma (GINA) update. NPJ Prim Care Respir Med . 2023;33(1):7. doi:10.1038/s41533-023-00330-1 20. Martin J, Townshend J, Brodlie M. Diagnosis and management of asthma in children. BMJ Paediatr Open . 2022;6(1):e001277. doi:10.1136/bmjpo-2021-001277 21. Meyer TE. Approach to diagnosis and evaluation of acute decompensated heart failure in adults. UpToDate. Updated September 27, 2024 . Accessed July 21, 2025 . www.uptodate.com 22. Miller AG, Haynes KE, Gates RM, et al. Initial modified pulmonary index score predicts hospital length of stay for asthma subjects admitted to the pediatric intensive care unit. Respir Care . 2020;65(9):1227-1232. doi:10.4187/respcare.07396 23. Patel P, Saab H, Aboeed A. Ipratropium . StatPearls Publishing; 2024. Updated February 19, 2024. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 24. Patel PH, Mirabile VS, Sharma S. Wheezing . StatPearls Publishing; 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 25. Patel SJ, Teach SJ. Asthma. Pediatr Rev . 2019;40(11):549-567. doi:10.1542/pir.2018-0282 26. Sapra A, Malik A, Bhandari P. Vital Sign Assessment . StatPearls Publishing; 2023. Updated May 1, 2023. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 27. Savona S, Rajpal S. 2019 ESC guidelines for the diagnosis and management of acute PE. American College of Cardiology. Accessed July 21, 2025 . www.acc.org 28. Scarfone RJ. Acute asthma exacerbations in children younger than 12 years: emergency department management. UpToDate. Updated April 10, 2023 . Accessed July 21, 2025 . www.uptodate.com 29. Sharma S, Hashmi MF, Bhattacharya PT. Hypotension . StatPearls Publishing; 202 5. Updated May 3, 2025. Accessed July 21, 2025 . www.ncbi.nlm.nih.gov 30. VanValkinburgh D, Kerndt CC, Hashmi MF. Inotropes and Vasopressors . StatPearls Publishing; 202 4. Updated December 11, 2024 . Accessed July 21, 2025 . www.ncbi.nlm.nih.gov Pediatric Asthma-OH MCD-MM-1710Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 31. Vyas DA, Eisenstein LG, Jones DS. Hidden in plain sight reconsidering the use of race correction in clinical algorithms. NEngl JMed . 2020;383(9):874-882. doi:10.1056/NEJMms2004740 Approved ODM 08/13/2025Independent medical review 09/2024

Nutritional Supports

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

Nursing Facility Level of Care

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

Negative Pressure Wound Therapy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Negative Pressure Wound Therapy-OH MCD-MM-0224 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNegative Pressure Wound Therapy B. BackgroundNegative pressure wound therapy (NPWT), also known as vacuum-assisted wound closure, is used to treat chronic wounds, such as ulcers related to pressure sores, venous or arterial insufficiency, or neuropathy. There are many causes for pressure ulcers, including diabetes, vascular insufficiencies, and other underlying medical condition s. NPWT involves the controlled application of subatmosph eric pressure to the surface of awound. This type of therapy utilizes an electrical pump connected to a specialized dressing that then removes debris and exudate from the wound and drains into a collection canister. NPWT is a noninvasive type of therapy th at has demonstrated efficacy in accelerat ing wound healing for chronic wounds . To provide a more conducive environment for wound healing, the NPWT method utilizes a semipermeable dressing that always remains moist and warm. This therapy can be done in the home or in an outpatient treatment facility. NPWT typically does not require in-patient monitoring.C. Definitions Arterial Insufficiency Ulcer A type of ulcer that develops due to the lack of delivery of oxygen-rich blood to the tissue which causes the tissue to begin to deteriorate and develop into an open wound. Deep Tissue Pressure Injury A type of injury resulting from a serious pressure ulcer that has advanced with additional necrosis of underlying soft tissue that may or may not be visible. Dehisced Wounds A wound that has ruptured along the wound margin typically due to infection. Eschar Black or brown, thick, leathery feeling dead tissue covering an ulcer. Measurable Improvement Measurable changes in wound healing, including drainage , inflammation , swelling , pain and/or tenderness , wound dimensions , surface measurements , granulation tissue , necrotic tissue/slough , tunneling , or undermining . Neuropathic Ulcer A type of ulcer that occurs due to lack of sensation secondary to neuropathy which causes skin and underlying tissue to begin to breakdown causing ulcers further complicated by infection. Pressure Ulcer A type of ulcer that develops due to an extended amount of time when there is compression of the soft tissue overlying bony prominences and an outside object causing tissue necrosis. Slough Avascular (dead) soft tissue found in higher stage ulcers. Tunneling Channels of tissue deterioration that extend from the wound to the subcutaneous tissue typically in one direction. Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Undermining Subcutaneous tissue deterioration around the margin of a wound and may occur in any direction . Venous Insufficiency Ulcer A type of ulcer that occurs due to the lack of properly functioning venous valves, which causes the veins to increase in size. Pressure Ulcer StagingStage 1 A localized area of skin that is intact with non-blanchable erythema.Changes in sensation, temperature , or firmness of the skin may be present prior to visual alterations of the skin. If discoloration is purple or maroon, this may indicate a deep tissue injury. Stage 2 A surface area of skin that has partial-thickness loss of skin with exposed dermis. May initially present as a serum-filled blister that has ruptured. The wound bed will be moist, red/pink , and the skin should be viable. There should be no evidence of visible adipose (fatty) tissue, eschar, slough , or granulation. Stage 3 A surface area of skin that has full-thickness loss of skin with visible adipose (fat) tissue and granulation. The wound edges are often rolled (epibole), and there may be visible eschar and slough. Undermining and tunneling may occur in the wound. At this stage, there should be no fascia, muscle, tendon ligament, cartilage , and/or bones exposed. Stage 4 A surface area of skin that has full-thickness loss of skin. At this stage, there will be fascia, muscle, tendon, ligament, cartilage , or bone that is visible or directly palpable. The wound edges will be rolled (epibole), and there is typically visible eschar and slough. Undermining and tunneling occur often in the wound. Unstageable Inability to fully assess the extent of the tissue damage due to eschar or slough obscuring visibility, but there is observable full-thickness skin and tissue loss that is unstageable. D. PolicyI. CareSource considers NPWT medically necessary when the following clinical criteria are met : A. Stage III or IV pressure ulcer (see staging criteria above) in individuals who meet ALL the following: 1. Member has been on a repositioning regimen with frequency determined by the provider based on the patients activity level and ability to reposition themselves. 2. Pressure relief techniques and/or pressure-reducing surfaces have been ordered (eg, foam overlay mattress, egg crate foam mattress, or low-air-loss devices) and documented ongoing compliance is in the member medical record . 3. Members incontinence and moisture issues have been appropriately managed . B. Chronic neuropathic ulcer that meets BOTH of the following criteria: Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 1. A comprehensive diabetic management program has been implemented, including A1C management, medication management, and ongoing diabetic education.2. Foot care has been done by a medical professional that includes general inspection, nail care, reduction in pressure on foot ulcer, and monofilament testing. C. Ulcers related to venous or arterial insufficiencies, that meet ALL the following criteria: 1. Compression garments/dressing/bandages are being applied consistently per physician orders in documented venous insufficiency plan of care for at least 30 days. 2. Ambulation and leg elevation have been ordered and documented ongoing compliance is in the member medical record. D. Member has any of the following: 1. high-risk open fracture 2. dehisced wound 3. post sternotomy wound complication or infection (mediastinitis) 4. surgically created wound with complications resulting in a need for accelerated granulation therapy that cannot be achieved by other treatment modalities , such as topical wound treatment 5. open non-healing amputation site in diabetic 6. delayed healing or non-healing of skin graft which is likely due to irregularly contoured or inadequate blood flood from the graft bed II. CareSource members may be eligible for the continuation of NPWT treatment when documentation by a licensed medical professional includes ALL of the following criteria: A. A licensed medical professional has directly performed the dressing change and is monitoring and controlling the members underlying medical conditions. B. The wound has progressive and measurable improvement. 1. If no measurable degree of improvement in wound healing has occurred from month to month, the approval for the NPWT will be discontinued. 2. An exception to measurable improvement is when a wound has been debrided within the last approval period. Documentation of debridement must accompany the request for continuation of NPWT. Before and after images are preferred. C. If abnormal, provisions have been made to the members nutritional status. III. CareSource does not consider NPWT medically necessary for non-healing wounds or ulcers under any of the following conditions: A. exposed nerves, blood vessels, or organs in the vicinity of the wound B. uncontrolled soft tissue infection or osteomyelitis C. malignancy present in the wound D. necrotic tissue present in the wound with eschar and has not been debrided E. open fistula present to an organ or body cavity within the vicinity of the wound Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 F. active bleedingIV. When applied during surgery, CareSource does not reimburse separately for NPWT. NPWT is covered under the surgery code.V. The coverage provided for NPWT by the global surgical package is not intended to deny billing for NPWT in outpatient services. When a patient is discharged from the hospital with wounds that are still in need of NPWT treatment, outpatient wound care is cov ered when it meets medical necessity.VI. Initial approval for NPWT in the outpatient setting will be for a month. After the initial month, continued approval will be based on the medical necessity guidelines in this policy. Continued approval will be made in 1-month increments. CareSource willapprove the following allowances for supplies:A. Fifteen dressing kits per wound per month. Additional dressing kits may be requested with documentation that the wound size requires more than one kit. B. Ten canister sets per month. Additional canister sets can be requested if there is documentation showing greater than 90 ml drainage exudate per day. C. Initial approval includes NPWT equipment and supplies that are used upon discharge from an in-patient setting. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 05/31/2018 New policy.Date Revised 11/23/2022 10/11/202310/23/2024 07/30/2025 Annual review: editorial changes, reference updates. Updated references and clarified coverage criteria in D. IV – VI. Approved at Committee. Annual review: updated references. Approved at Committee. Annual review: updated references. Approved at Committee. Date Effective 11/01/2025 Date Archived H. References1. Biancari F, Santoro G, Provenzano F, et al. Negative-pressure wound therapy for prevention of sternal wound infection after adult cardiac surgery: systematic review and meta-analysis. JClin Med . 2022;11(15):4268. doi:10.3390/jcm11154268 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 2. Chen L, Zhang S, Da J, et al. A systematic review and meta-analysis of efficacy and safety of negative pressure wound therapy in the treatment of diabetic foot ulcer. Ann Palliat Med. 2021;10(10):10830-10839. doi:10.21037/apm-21-2476 3. De Pellegrin L, Feltri P, Filardo G, et al. Effects of negative pressure wound therapy with instillation and dwell time (NPWTi-d) versus NPWT or standard of care in orthoplastic surgery: a systematic review and meta-analysis. Int Wound J . 2023;20(6):2402-2413. doi:10.1111/iwj.14072 4. Definitions Home Medical Equipment, OHIO ADMIN CODE 4729-11-1-01 (2022). 5. Gao J, Wang Y, Song J, et al. Negative pressure wound therapy for surgical site infections: a systematic review and meta-analysis. JAdv Nurs . 2021;77(10):3980 – 3990. doi:10.1111/jan.14876 6. Gestring M. Negative pressure wound therapy. UpToDate. Updated January 20, 2024 . Accessed July 9, 2025 . www.uptodate.com 7. Groenen H, Jalalzadeh H, Buis DR, et al. Incisional negative pressure wound therapy for the prevention of surgical site infection: an up-to-date meta-analysis and trial sequential analysis . EClinicalMedicine . 2023;62:102105. doi:10.1016/j.eclinm.2023.102105 8. Kim PJ, Attinger CE, Constantine T, et al . Negative pressure wound therapy with instillation : international consensus guidelines update . Int Wound J . 2020;17(1):174 – 186. doi:10.1111/iwj.13254 9. Li P, Li J. Effect of incisional negative pressure therapy and conventional treatment on wound complications after orthopaedic trauma surgery: a meta-analysis of randomized controlled studies. Int Wound J . 2023;20(10):4291-4299. doi:10.1111/iwj.14331 10. Negative pressure wound therapy (vacuum-assisted wound closure): A-0346. MCG, 29 th ed draft. Updated January 25, 2025. Accessed July 25 , 2025. careweb.careguidelines.com 11. Norman G, Goh EL, Dumville JC, et al. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev . 20 22;6(6):CD009261 . doi:10.1002/14651858.CD009261.pub7 12. Orlov A, Gefen A. The potential of a canister-based single-use negative-pressure wound therapy system delivering a greater and continuous absolute pressure level to facilitate better surgical wound care. Int Wound J . 2022;19(6):1471-1493. doi:10.1111/iwj.13744 13. Pedrazzi NE, Naiken S, La Scala G. Negative pressure wound therapy in pediatric burn patients: a systematic review. Adv Wound Care (New Rochelle) . 2021;10(5):270-280. doi:10.1089/wound.2019.1089 14. PICO single use negative pressure wound therapy system (Smith & Nephew) for cesarean birth wound care. Hayes ; 2022. Reviewed July 10, 2024 . Accessed July 9, 2025 . evidence.hayesinc.com 15. Poteet SJ, Schulz SA, Povoski SP, et al. Negative pressure wound therapy: device design, indications, and the evidence supporting its use. Expert Rev Med Devices . 2021;18(2):151-160. doi:10.1080/17434440.2021.1882301 Negative Pressure Wound Therapy-OH MCD-MM-0224Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 16. Rvsz ES, Altorjay A, Montsk V, et al. Effectiveness of negative pressure wound therapy: minimum five-year follow-up and review of the literature. Jt Dis Relat Surg .2022;33(1):51-56. doi:10.52312/jdrs.2022.547 17. Shi J, Gao Y, Tian J, et al. Negative pressure wound therapy for treating pressure ulcers. Cochrane Database Sys Rev . 2023;5(5):CD011334. doi:10.1002/14651858.CD011334.pub3 18. Silverman RP. Negative pressure wound therapy with instillation and dwell time: mechanisms of action literature review. Eplasty . 2023;23:e54. Accessed July 7, 2025. www.ncbi.nlm.nih.gov 19. Tian Y, Li K, Zeng L. A systematic review with meta-analysis on prophylactic negative pressure wound therapy versus standard dressing for obese women after caesarean section. Nurs Open . 2023;10(9):5999-6013. doi:10.1002/nop2.1912 20. Xie W, Dai L, Qi Y, et al. Negative pressure wound therapy compared with conventional wound dressings for closed incisions in orthopaedic trauma surgery: A meta-analysis . Int Wound J . 2022;19(6):1319-1328. doi:10.1111/iwj.13726 Independent med ical review 4/2020ODM approved 8/12/2025

Airway Clearance Devices

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Airway Clearance Devices-OH MCD-MM-1578 11/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Airway Clearance Devices-OH MCD-MM-1578Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. 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. 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: 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). Airway Clearance Devices-OH MCD-MM-1578Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 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 2. if applicable, specification of a change in the duration or frequency of therapy 3. a recommendation either for additional rental or for purchase F. The Volara device is not approved for outpatient use. E. Conditions of Coverage NA F. Related Policies/Rules NA Airway Clearance Devices-OH MCD-MM-1578Effective Date: 11/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 01/17/2024 New policy. Approved at Committee.Date Revised 11/20/2024 06/18/2025 Updated references. Approved at Committee. Updated references. Approved at Committee. Date Effective 11/01/2025 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 4. DMEPOS: High-Frequency Chest Wall Oscillation (HFCWO) Devices, O HIO ADMIN . C ODE 5160-10-08 (2024). 5. Ferreira de Camillis ML, Savi A, Goulart Rosa R, et al. Effects of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU subjects. Respir Care . 2018;63(12):1471-1477. doi:10.4187/respcare.06253 6. Finder JD, Birnkrant D, Carl J, et al. Respiratory care of the patient with Duchenne muscular dystrophy: ATS consensus statement. Am JRespir Crit Care Med. 2004;170(4):456-465. doi:10.1164/rccm.200307-885ST 7. High Frequency Chest Compression Device: A-0356 (AC). MCG Health. 28th ed. 2024. Updated March 14, 2024. Accessed May 12, 2025. www.careweb.careguidelines.com 8. Mechanical Insufflation-Exsufflation Device: A-0884 (AC). MCG Health. 28th ed. 2024. Accessed May 12, 2025. www.careweb.careguidelines.com 9. 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 10. 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 7/22/2025

Private Duty Nursing

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Private Duty Nursing-OH MCD-MM-1510 10/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilizati on 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 ne cessary 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, dysfunctio n of a body organ or part, or significant pain and discom fort. 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 defin ed 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 o f services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 17 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 17 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 17 H. References ………………………….. ………………………….. ………………………….. …………………… 17 Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL 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 need s 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 individuals 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 asmedically necessary and only when at least 4 hours of continuous skilled care that requires 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 agency (MCHHA) that meets the requirem ents in accordance with OAC 5160-12-03, an otherwise accredited agency and 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 individuals 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 an individual 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 pl an when an individual 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 servic es 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: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 5. Bill after a ll 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 pol icies 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 healt h 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 long er 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 n ot 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: 10/01/2025The ME DICAL 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 inclu de 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 physicia ns 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” includes, but is not limited to, the following: o irrigations, catheterizations, application of dressings, and supervision of special diets o objective observation of cha nges 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 of the medication o carrying out other treatm ents 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 necessity of PDN services. IV. PDN services must meet ALL the following:A. Services performed must be within the nurses sc ope 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 individuals plan of care . C. Services must be medically necessary to care for the individuals condition, illness, or injury . D. Service must b e provided in person in the individuals place of residence unless it is medically necessary for a nurse to accompany the individual in the community. The place of service in the community cannot in clude the business location of the Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL 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 individual.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. Individuals 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 individual. 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 als o direct ly involved in the care or treatment of the individual. 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 individual. C. Access PDN in accordance with the program for the all-inclusive care of the elderly (PACE) if the individual participates in the PACE program. D. Access PDN in accordance with the individual’s provider of hospice services if the individual has elected hospice. E. Access PDN in accordance with the individual’s m anaged care plan’s process if the individual is enrolled in a Medicaid managed care plan. VII. Post hospital PDNA. Any individual receiving Medicaid, whether adult or child, may receive PDN services up to 56 hours per week and 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. A covered inpatient hospital stay is considered 1 hospital stay when an individual is transferred from 1 hospital to another hospital, either with in 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 individual is discharged from the hospital to the individual’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 individual 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. 7/2014). PDN is available to individuals only with a medical need comparable to a sk illed level of care as evidenced by a medical condition that temporarily reflects the skilled level of care Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 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 individual is under age 21 years and requires services for tre atment 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 comparab le 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 car e 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 wil l 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. An y documentation required by DODD for the review of medical necessity shall be provided 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). C. The adult has a co mparable level of care as evidenced by either: 1. Enrollment on a HCBS waiver. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 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 servic es 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 Utiliz ation Management . X. Additional PDN services beyond what ODM or its designee has authorized may be provided to an individual in an emergency when the provider has an existing PDN authorization to provide PDN services to that individual. 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 necessa ry in accordance with OAC 5160-1-01, and the services must be necessary to protect the health and welfare of the individual. 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 individuals 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. XII. The PDN acuity scale is intended to be used in conjunction with the assessment tool and the clinical and professional judg ement of the nurse completing the tool. It is not intended to be the sole determinant of all the skilled nursing needs o f the individual. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 Normal age-appropriate care and parental responsibility should be considered (ie, all3-year-olds need assistance with bath ing and dress ing , therefore needs assist, in this category is not scorable , as it is an age-appropriate need and not a medical need ). A. Skilled nursing care acuity guidelines 1. Mechanical ventilation: acuity measurement is based on number of hours used per day . 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 ho urs used per day . 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: dre ssing changes are included in the below) . 1.5 points are scored when the member is able to 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, muco sal bleeding) . 4. Oxygen: acuity measurement is based on the order for administration, either continuous or determined by pulse oximeter. 1.0 point is scored when the members oxygen use is routine and predictable (ie, member has COPD and requires oxygen when ever necessary when walking or upon exertion) . 3.0 points are scored when the members oxygen use is unpredictable (eg, unstable airways). 5. Tracheal suctioning: acuity measurement is based on frequency the skilled nurse performs this service and is only app licable when the member be unable to self-suction . 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 suctioni ng 11 20 times per day . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 4.0 points are scored when the member requires suctioning more than 20times per day. 6. Humidification: acuity measurement is based upon the need for humidification treatment: 0.5 points is scored when humidification is performed an d completed by skilled nurse. 7. Pulse oximetry monitoring: acuity measure is based on treatment that is done on a routine basis . 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 b y 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/sub cutaneous injections are not included in this scoring . 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 . 1.0 point is scored for r outine 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 adju stments by a skilled nurse. Members who have more than 3 medications which are PRN and/or requir e 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 neb ulizer 2 times per day and pulmonary vest 3 times per day, count as therapy 3 times per day). 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 . 1.0 point is scored for peripheral blood d raw 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. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 12. Blood products : acuity measurement is based upon the number of times per month it was documen ted that the member received any blood products provided by the skilled nurse during the PDN visit. 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 n urse. 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 . In order 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 lea st 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, medications such as Reglan, Zantac, or Prevacid); 3) documented treatment for aspiration pneum onia 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 diagnosis of dysphagia or difficulty swallowing, and documentation in the medical record on h ow the member is progressing. Aspiration precautions should be noted in the clinical record by the skilled nurse, as well as the interventions done to prevent aspiration. 1.0 point is scored for aspiration precautions . 1.5 points are scored for reflux or d ysphagia. 16. Seizures: acuity measurement is based upon the frequency of the seizure activity, the severity of the seizure activity, and intervention(s) required. In all instances, seizure monitoring must be recorded in the nurses notes and/or maintained in a seizure logbook. The description of the seizure should be addressed (ie, type, duration, intervention). There must also be seizure medications that are scored on a routine basis. The number of seizures per day, week, month, etc. must be documented and the average number occurring should be known. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 0.0 points are scored if there is a seizure diagnosis or history of seizures, but there is no active seizure activity . 1.0 point is scored if there is observation/monitoring only, but no skilled nursing inter vention . 2.0 points are scored if there are moderate interventions required, no injury, and Diastat has to be administered, or a magnet and vagus nerve stimulator is used to stop seizure activity. 3.0 points are scored if there is an injury, Diastat has to be administered or a magnet and vagus nerve stimulator is used to stop seizure 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, r estless), but may be a targe ted 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 assessment, then points could be scored under this assessment. 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 eve ry 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). 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. 19. Peripheral intravenous therapy (PIV) 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 I Vsolution 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 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 . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 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 1.0 point is scored when the blood sugar or ketones are checked by the skilled nurse and there is no insulin scored. It do es 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, nonmedicated creams, etc. 23. Stoma/ wound care: acuity measurement includes dressing changes /stoma care (eg , Mitrofanoff, Malone, Chait tube) . Member s with a tracheostomy or gastrostomy will not receive additional points for tracheostomy or gast rostomy dressing changes, as this task is included in the score for the tracheostomy or gastrostomy. 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. Decub itus 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 if the y 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 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 , in-dwelling and intermittent 1.5 points are scored when the member has an in-dwelling catheter and catheter care is performed by the nurse during the home visit. 2.5 points are sco red when the member has an in-dwelling catheter and the care is performed by the nurse during the home visit. This would include more complex/complicated care, (eg, flushes, insertion of catheter) . 1.0 point is scored if there is an order for a straight ca theter 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. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 2.0 points are scored if there is an order for a straight cath eter 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 nurse s notes. 27. Peritoneal dialysis: 2.0 points are scored if peritoneal dialysis is performed by the skilled nurse during the home visit. 28. Hemodialysis: 4.0 points are scored if hemodialysis is performed by the skilled nurse during the home visit. 29. 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 o r IV fluids based on the intake and output data) , or diapers are routinely weighed . 30. Acute care episodes 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 lon g-term hospitalizations (over 1 month), this section may be counted if the member is admitted for at least 3 months (eg, premature infants). 2.0 points are scored if the member has had an acute/post-procedure hospitalization (does not include admissions fo r testing 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 nursing 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 nursing score is not ro utinely added to the skilled score when a member has a skilled score less than 15. It is only added when there are significant e xtenuating circumstances. When these circumstances occur, the 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 do cumented evidence of the employment and/or school status of the primary caregivers before this is scored. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 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 le ast 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 point s are scored when there is no caregiver that lives in the home with the member . This does not mean that the consumer lives with an individual who takes primary responsibility for the consumer but refuses to deliver any care. An example of this would be a m ember 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. 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 . 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. 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 dep endents 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. 1.0 poin t 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. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 0.5 points are scored for me mbers 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 d aily living (A DL ) (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 person s, and/or Hoyer lift/trapeze. 0.5 points are scored if the member weighs less than 65 pounds and requires no or partial lift wi th 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. 2.0 points are scored if the membe r 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 pou nds 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 physi cian 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. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 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 gui dance 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 n ose, mouth, or upper throat with a bulb syringe, yankaeur, or suction catheter. 18. Ostomy care: 1.0 point is scored if the member has a n ileostomy , vesicostomy, or colostomy. 19. Impairments 0.5 points are scored for visual impairments not correctable by glasses or another assistive device. 0.5 points are scored for auditory impairments not correctable by hearing aid or another assistive device. 0.5 points are scored for tactile impairments (eg, member has the need to put everything in their mouth or has an avers ion to different touch stimuli). 1.0 point is scored if the member if blind and there is no modification they have used to compensate. 1.0 point is scored if the member is deaf and there is no modification they have used to compensate. 20. Behaviors/ developmentally delay 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 with sev ere injury. 1.5 points are scored if the member demonstrates combative behavior. 0.5 points are scored if the member requires occasional redirection. 1.0 point is scored if the member requires frequent redirection. 21. Global delays : acuity measurement is scor ed as documented by the physician on the members care plan. 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 docum entation of global delays. 22. Incontinence, toilet program (N/A for children under age 3 years) 0.5 points are scored if the member experiences occasional incontinence. 1.5 points are scored if the member experiences daily incontinence. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 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 point s 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 we ek. 5. PDN above 112 hours per week are not routinely approved. However, PDN may 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 /2025Review: added examples to criteria, updated references,approved at Committee. Review: Added clarif ying statements in D.XII, updated references, approved at Committee. Date Effective 10/01/2025 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 September 6, 2023. Accessed April 23, 2025. www.cms.gov 3. Definitions , OHIO ADMIN . CODE 3701-16-01 (2 024 ). 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 Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 10/01/2025The ME DICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 Needs . National Academy for State Health Policy. November 2018. Accessed April23, 2025 . 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):e223927 0. doi:10.1001/jamanetworkopen.2022.39270 8. Managed Care: Definitions , OHIO ADMIN . CODE 5160-26-01 (2022). 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. HCBS Waivers (n.d.) Accessed April 23, 2025 . www.medicaid.ohio.gov 13. Ohio Department of Medicaid. Private Duty Nursing (n.d.). Accessed April 23, 2025 . www.medicaid.ohio.gov 14. Private Duty Nursing: PDN-2001. MCG Health, 28th ed. Updated March 14, 2024. Accessed April 23, 2025 . 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 (2022). 17. Private Duty Nursing Services: Provision Requirements, Covera ge 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 0 6/25/2025

ProACT Adjustable Continence Therapy

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective ProACT Adjustable Continence Therapy-OH MCD-MM-1305 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 3 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectProACT Adjustable Continence Therapy B. BackgroundUrinary i ncontinence 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 indi viduals. Incontinence after prostate surgery is a dynamic condition that can greatly improve in the first one to two 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 pro cedure 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 urinaryincontinence utilizing a proprietary balloon device. Under fluoroscopic guidance, implantation instruments are advanced via transverse perineal incisions to the area of the bladder neck . T he tissue is then dilated to create space for the balloon device. Aballoon 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 , occur ring when both the bladder and urinary sphincter have impaired function . ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved 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 b ladder 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 CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 04/13/2022 New PolicyDate Revised 03/29/2023 02/14/2024 02/12/202506/04/2025 Annual 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 Date Effective 09/01/2025 Date Archived ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 H. 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 May 8, 2025. www.careweb .careguidelines.com 3. Clemens JQ. Urinary incontinence in men. UpToDate. Updated March 6, 2024 . Accessed May 6, 2025 . www.uptodate.com 4. Comiter CV, Speed J. Urinary incontinence after prostate treatment. UpToDate. Updated May 16, 2024 . Accessed May 6, 2025 . 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 May 6, 2025 . 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 May 6, 2025 . www.accessdata.fda.gov 12. ProACT : patient brochure. Food and Drug Administration. Accessed May 6, 2025. 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 May 6, 2025 . www.evidence.hayesinc.com ProACT Adjustable Continence Therapy-OH MCD-MM-1305Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved 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 med ical review February 2025ODM approved 06/11/2025

Noninvasive Home Mechanical Ventilation

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 H. References ………………………….. ………………………….. ………………………….. ……………………. 8 Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNoninvasive Home Mechanical Ventilation B. BackgroundThis document outlines the medical necessity criteria for a noninvasive home ventilator for a member with stable, chronic respiratory failure. This device does not treat the underlying cause of respiratory failure but functions as supportive therapy, which may include reducing symptoms, improving quality of life, or sustaining or extending life. It may be used intermittently during the day and/or during sleep. A noninvasive home ventilator will not be reimbursed as such when its sole purpose is to function as a respiratory assistance device, including continuous positive airway pressure (CPAP), auto-titrating PAP, and bilevel airway pressure (BiPAP).C. Definitions Apnea-Hypopnea Index (AHI) The combined average number of apneas and hypopneas that occur per hour of sleep to determine the severity of obstructive sleep apnea (OSA) . Apnea-Hypopnea Index (AHI) Adult AHI Pediatric AHIMild OSA 5-14 1-4.9Moderate OSA 15 – 30 5-9.9 Severe OSA > 30 > 10 Bi-level Positive Airway Pressure (B iPAP) Device A device that uses mild bi – level or 2 levels of air pressure to keep breathing airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep breathing airways open. Home Mechanical Ventilation (HMV) A device used in the home setting for patients with chronic respiratory failure that delivers respiratory assistance via an invasive (ie, tracheostomy) or noninvasive (ie, nose/mouth mask, mouthpiece , nasal prongs) interface. These devices possess more advanced features than a CPAP/BiPAP machine, which include monitoring, rate control, safety, and backup power features. The ventilator can custom control a ll phases of the breathing cycle . D. PolicyI. CareSource utilizes Ohio Administrative Code and MCG Health criteria to determine medical necessity for noninvasive HMV (E0466) . An initial approval for HMV is valid for a maximum of 3 months. A new medical necessity determination thereafter is required every 6 months for continued rental use. II. Initial Rental of HMVMedical necessity for the initial coverage of noninvasive HMV is based upon the following conditions in II – IV being met : Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 A. Congenital central hypoventilation syndromeB. Chronic lung disease of infancy (eg, bronchopulmonary dysplasia), and patient unable to maintain acceptable pH and PCO 2 without ventilator support C. Chronic obstructive pulmonary disease (COPD) and ONE OR MORE of the following: 1. Chronic hypercapnia with PaCO 2 of 50 mm Hg (6.7 kPa) to less than 52 mm Hg (6.9 kPa) and at least ONE of the following: a. Arterial oxygen saturation 88% for 5 consecutive minutes during nocturnal oximetry while on at least 2 liters of oxygen per minute . b. Invasive or noninvasive ventilation for acute exacerbation required during 2 or more hospitalizations per year . 2. Chronic hypercapnia with PaCO 2 of 52 mm Hg (6.9 kPa) or greater 3. Palliative care for end-stage disease and advance directive states no desire for intubation D. Neuromuscular disorder accompanied by chronic respiratory failure , as indicated by the following: Documentation of respiratory failure, as indicated by ONE OR MORE : 1. Arterial O2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry 2. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) 3. Forced vital capacity less than 50% of predicted 4. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure 5. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower 6. Maximum sniff nasal inspiratory pressure less than 40 cm H 2O (3923 Pa) 7. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: a. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . b. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater) . E. Obesity hypoventilation syndrome , as indicated by ALL of the following: 1. BMI > 30 2. CPAP unsuccessful or not appropriate , as indicated by ONE OR MORE of the following: a. Comorbid sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer ) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 b. Intolerance of CPAP pressures necessary to correct obstructive sleep apnea (OSA) component (ie, difficulty exhaling against fixed airway pressure) c. Lack of resolution of hypercarbia, nocturnal desaturation, and OSA despite 3 months of CPAP use d. Titration study demonstrates OSA despite CPAP 15 cm H 2O (1471 Pa) that is responsive to BiPAP 3. Daytime hypercapnia with PaCO 2 greater than 45 mm Hg (6.0 kPa) without other etiology (eg, kyphoscoliosis, lung parenchymal disease, myopathy, severe hypothyroidism) 4. Sleep-disordered breathing or hypoventilation on polysomnography, as indicated by ONE OR MORE of the following: a. Apnea-hypopnea index of 5 or greater b. Increase in PaCO 2 during sleep by more than 10 mm Hg (1.3 kPa) above value while awake c. Significant oxygen desaturation (eg, less than 90%) not explained by obstructive apneas or hypopneas 5. TSH level does not demonstrate hypothyroidism F. OSA in child or adolescent and ONE OR MORE of the following: 1. Mild OSA (ie, apnea-hypopnea index from 1 to 5) and ONE OR MORE of the following: a. achondroplasia b. behavioral problems c. cardiovascular disease (eg, elevated blood pressure, pulmonary hypertension) d. Chiari malformation e. craniofacial abnormalities f. Down Syndrome g. excessive daytime sleepiness h. impaired cognition i. inattention or hyperactivity j. mucopolysaccharidoses k. neuromuscular disorders l. Prader-Willi syndrome 2. Moderate or severe OSA (ie, apnea-hypopnea index greater than 5) 3. Residual apnea-hypo pnea index greater than 5 in pediatric patient after adenotonsillectomy G. Restrictive disorder of chest wall , as indicated by ALL of the following: 1. Appropriate chest wall disorder as indicated by ONE OR MORE of the following: a. asphyxiating thoracic dystrophy b. kyphoscoliosis c. other chest wall disorder accompanied by chronic respiratory failure (eg, ankylosing spondylitis, fibrothorax, post-tuberculous chest wall deformity) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 2. Documentation of respiratory failure as indicated by ONE OR MORE of the following : a. Arterial O 2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry b. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) c. Forced vital capacity less than 50% of predicted d. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure e. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower f. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: 01. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . 02. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater ). III. Respiratory status is STABLE , as indicated by ALL of the following:A. Airway interface is safe with a n oninvasive interface with acceptable fit . B. Airway pressure requirement appropriate, as indicated by ONE OR MORE of the following: 1. BiPAP expiratory positive airway pressure requirement is to 10 cm H 2O (981 Pa). 2. CPAP pressure requirement in child is 15 cm H 2O (1471 Pa). 3. Ventilator positive end-expiratory pressure requirement is 10 cm H 2O (981 Pa). C. Oxygen requirement does not exceed FiO 2 of 40%. D. Settings are stable on chosen device. E. No continuous invasive monitoring is required. IV. A BiPAP or CPAP device must not be clinically appropriate as indicated by ONE ORMORE of the following. A. Chronic respiratory insufficiency fails to improve with simple BiPAP device. B. Infant or child does not meet the minimum body weight requirement for CPAP device. C. Infant or child is not appropriate for simple BiPAP device due to setting or performance requirements, as indicated by ONE OR MORE of the following: 1. Breath rates delivered by device not appropriate for patient . 2. Compatible ventilator circuits not appropriate for patient (eg, circuit compliance, compressed volume, dead space) . Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 3. Inspiratory flows delivered by device not appropriate for patient .4. Patient does not meet ventilator minimum body weight requirements. 5. Pressure range (eg, expiratory pressure, inspiratory pressure) not appropriate for patient . 6. Tidal volume range delivered by device not appropriate for patient . 7. Ventilator inspiratory trigger delay (ie, airway pressure rise time) not appropriate for patient . 8. Ventilator inspiratory trigger sensitivity not appropriate for patient . D. The following setting or functionality is required by the member and is not available with simple BiPAP device: 1. Alarms required by member are not available on the device . 2. Daytime ventilation using mouthpiece is required . 3. Pressure range delivered by device is not appropriate for member . 4. Member requires volume-assured pressure support or volume control mode (eg, obesity hypoventilation syndrome). E. Ventilated patient requires cough assistance via volume ventilator’s breath stacking capability. F. Ventilation is required 24 hours per day. V. HMV Continued UseFor HMV continued use beyond the initial 3-month determination, medical necessity must be reestablished every 6 months thereafter . The following is to be provided for continued use: A. Re-evaluation by the treating medical professional must be completed no earlier than 61 days after initiating therapy. B. Documentation of the persistence of the disease process for which HMV has been prescribed. C. Medical records must document that the member is compliant with and benefitting from HMV. D. At least 30 consecutive days of device data, beginning after 31 days of initiation, demonstrating that the member is utilizing the device an average of 4 hours per 24-hour period. NOTE: Failure of the member to consistently use HMV for an average of 4 hours per 24-hour period would demonstrate non-compliant utilization of the device for its intended purpose and expectation of benefit, which would constitute a denial in continued coverage as not reasonable and necessary . E. Additional information as requested. VI. In accordance with Rule 5160-10-01 for each claim, the provider cannot legitimately receive payment until necessary supporting documents have been obtained and placed in the providers files. These documents include the prescription and the following items: A. A completed CMN form: ODM 01902 . Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 B. Practitioner order and chart notes , which support the determination of medical necessity , including ventilator settings . VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.VIII. ExclusionsAny application for a noninvasive home ventilator (E0466) not meeting the criteria above will be denied as being not medically necessary, including but not limited to when its sole purpose is to function as a respiratory assistance device, including settings of CPAP, auto-titrating PAP, Bilevel positive airway pressure (BiPAP, BPAP), average volume assured pressure support (AVAPS) with or without auto EPAP (AE), or intelligent volume assured pressure support (iVAPS). E. Conditions of CoverageI. Claims for ventilators being utilized to provi de CPAP or BiPAP therapy for conditions described above and are submitted with HCPCS code E0466, will be denied as not being reasonable and necessary. If a HMV is dispensed to a Member for CPAP or BiPAP therapy, the claim must be coded in accordance with CareSource policy, Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental . All requirements in D. I. -V. of this policy must be satisfied for HMV to be considered medically necessary. II. CareSource may verify the use of the equipment through post-payment audit andrequest additional supporting medical record documentation. If the use of a more appropriate code or piece of equipment is warranted, CareSource may request recoupment.F. Related Policies/RulesDMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental Overpayment Recovery G. Review/Revision HistoryDATE ACTIONDate Issued 05/22/2024 New Policy, Approved at CommitteeDate Revised 06/04/2025 Annual review: Added E.II. , Updated Exclusions to include AVAPS, EPAP, iVAPS; Approved at Committee Date Effective 09/01/2025 Date Archived Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 H. References 1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi: 10.1513/AnnalsATS.201810-657CME 2. DMEPOS: Ventilators, OHIO ADMIN . CODE 5160-10-22 (2021). 3. Dudgeon D. Assessment and management of dyspnea in palliative care. UpToDate. Updated April 04, 2025 . Accessed April 16, 2025 . www.uptodate.com 4. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (2024). 5. Ferrell BR, Twaddle ML, Melnick A, et al. National Consensus Project clinical practice guidelines for quality palliative care guidelines, 4th edition. JPalliative Med . 2018;21(12): 1684-1689. doi:10.1089/jpm.2018.04311684 6. Freedman N. Treatment of obstructive sleep apnea: choosing the best positive airway pressure device. Sleep Med Clin . 2020;15(2):205-218. doi:10.1016/j.jsmc.2020.02.007 7. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated February 5, 2025 . Accessed April 16, 2025 . www.uptodate.com 8. Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive summary: optimal NIV Medicare access promotion: a technical expert panel report from the American College of Chest Physicians, the American Association for Respiratory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest . 2021;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074 9. Hansen-Flaschen J, Ackrivo J. Practical guide to management of long-term noninvasive ventilation for adults with chronic neuromuscular disease. Resp Care . 2023;68(8):1123-1157. doi:10.4187/respcare.10349 10. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and alternative modes of ventilatory support. UpToDate. Updated November 13, 2024 . Accessed April 16, 2025 . www.uptodate.com 11. Home Ventilator (Invasive or Noninvasive Interface ): ACG A-0893. MCG Health . 2 8th ed. Accessed May 16 , 2024. www.careweb.careguidelines.com 12. Khan A, Frazer-Green L, Amin R, et al. Respiratory management of patients with neuromuscular weakness: an American College of Chest Physicians clinical practice guideline and expert panel report. Chest . 2023;164(2):394-413. doi:10.1016/j.chest.2023.03.011 13. Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate . Updated October 9, 202 4. Accessed April 16, 2025 . www.uptodate.com 14. Macrea M, Oczkowski S, Rochwerg B, et al. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease: an official American Thoracic Society clinical practice guideline. Am JResp Crit Care Med . 2020;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST 15. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated March 4, 2024. Accessed April 16, 2025 . www.uptodate.com Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588 Effective Dat e: 09/01/2025 The MEDICAL Po l i c y St a t e m e nt d e t ai l e d a bo v e h a s r ecei v e d due c on si d e ra t i o n a s d e f i n e d i n the MEDICAL Po li c y St a t e m e nt Po li c y a nd i s a pp r o v e d. 9 16. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 1 0.1177/019459981880175717. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasive ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev .2021;8:CD002878. doi:10.1002/14651858.CD002878.pub318. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinical practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.0176619. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest .2020 ;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007I nd e pe n de nt Med i ca l Re v iew 05/08/24 Approved by ODM 06/10/2025

Standing Frames

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Standing Frames-OH MCD-MM-1331 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Standing Frames-OH MCD-MM-1331Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectStanding Frames B. BackgroundSupported standing is a common, adjunctive therapeutic practice in which patients with neurological conditions are enabled to assume an upright position. Homebased standing programs are commonly recommended for adults and children who cannot stand and/or walk indepe ndently and are usually part of a postural management program, which plays a role in preventing contracture, deformity, pain, and asymmetry. Standers might include prone, supine, vertical, multi-positional , and sit-to-stand types. Standing frames consist of a simple base with an upright support to which the patient can be strapped. These devices provide no mobility, but research has shown medicalbenefits supporting use, including an enhanced ability to perform tasks, maintained or improved joint range of motion, muscle spasticity and bone density , and an enhanced ability to perform activities of daily living. In recent studies, some adults and children report a decrease in pain, suppository use , decubitus ulcers, urinary tract infections (UTI), and clinical depression, while reporting an increase in improved bowel function , breathing, circulation , and muscle tone. Psychological benefits have also been documented and include improved socialization, patient satisfaction and quality of life due to improved interacti on with others. Additionalbenefits for some patients can include enhanced independence, improved vocational activities, and increased recreational activities with peers and others, which have been reported to instill a heightened sense of confidence and equality and improved self – esteem in children and adults. Acceptance by others and a sense of integration is perceived to be higher among standing frame users. No adverse events or effects have been frequently reported or documented in literature, but some contraindications have been widely discussed. Additionally, many patients do not report pain with use of standing frames. With the added benefit of the enhance mentof functional recovery with early physical rehabilitation, many providers are adding supported standing as a practice in postural management after consideration of contraindications is examined by a medical professional .C. Definitions Activities of Daily Living (ADLs) Fundamental skills required to independently care for oneself, including the following two categories : o Basic ADLs Skills required to manage ones basic physical needs, including ambulation, feeding, dressing, personal hygiene, continence and toileting. o Instrumental ADLs Skills that require more complex thinking skills, including transportation and shopping, finance management, meal preparation, house cleaning and home maintenance, communication management, and medication management. Standing Frames-OH MCD-MM-1331Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Durable Medical Equipment (DME or DMEPOS ) A collective term for a covered durable medical equipment item, prosthetic device, orthotic device, or medical supply item furnished by an eligible provider to an eligible recipient Home Medical Equipment Equipment that can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury and is appropriate for use in the home. Postural Management A multi-disciplinary approach incorporating a comprehensive schedule of daily and night-time positions, equipment, and physical activity to help maintain or improve body structures and function and increase activity and participation. Technologically Sophisticated Medical Equipment (TSME) Prescribed by an authorized health care professional and requir ing individualized adjustment or regular maintenance by a home medical equipment services provider to maintain a recipients health care condition or the effectiveness of the equipment. Standers are considered TSME. D. PolicyI. CareSource will review medical necessity requests for non-powered standing frames on a case-by-case basis once ALL the following information is submitted for review: A. New Equipment 1. stander information, including ALL the following details: a. manufacturer b. model number c. type of stander d. part number, if applicable and if available e. an itemized list of any additional attachments and accessories with individual prices , if not included with the basic stander or if applicable 2. a face-to-face encounter with a medical professional who has a relationship with the member (a single encounter can serve for 12 months as the basis for a single prescription for more than 1 prescription addressing the same medical condition for which a DM EPOS item is prescribed.) 3. a prescription is valid for 1 year , unless a different length of time is specified, and must include ALL the following: a. dated signature of 1 of t he following appropriately Ohio-licensed and/or certified medical professionals : 01. physician (MD or DO) 03. advanced practice registered nurse (APRN) with a relevant specialty 04. physician assistant (PA) b. specific recipient diagnosis( -es) document ing a neuromuscular condition (eg, multiple sclerosis, cerebral palsy, spinal cord injury, stroke) or documented developmental delay impairing the recipients ability to stand independently Standing Frames-OH MCD-MM-1331Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 4. documentation showing that the member or parent/guardian received training in use of standers or standing frames , which can be completed during a scheduled therapy session for the member, if applicable 5. documentation showing the member or parent/guardian can safely use the device in the home setting (eg, documentation from physical therapy or other therapy sessions documenting trials of use suffice) of member or parent/guardian training in use of standers or standing frames and an ability to safely use the device in the home setting 6. documentation that device use can be reasonably expected to provide therapeutic benefits or enable the member to perform certain tasks unable to perform otherwise due to the diagnosis, such as but not limited to 1 or more of the following: a. aids in the prevention of atrophy in the trunk and leg muscles b. improves strength and/or circulation to the trunk and lower extremities c. prevents formation of decubitus ulcers with changeable positions d. helps maintain bone and/or skin integrity e. reduces swelling in the lower extremities f. improves range of motion and/or aids normal skeletal development g. improves function of kidneys, bladder, and/or bowels h. decreases muscle spasms i. strengthens the cardiovascular system and builds endurance j. prevents or decreases muscle contractures and/or progressive scoliosis k. improves social interaction and psychological well-being l. increase performance of activities of daily living (ADLs) 7. no contraindications to supported standing, such as but not limited to a. healing fracture or severe osteoporosis preclud ing weight bearing of any kind b. significant hip or knee flexion or ankle plantarflexion contractures in which stretch or pressure prevents standing c. compromised cardiovascular or respiratory systems requir ing frequent monitoring of circulation and function while in a stander d. significant inflexible skeletal deformities e. lack of standing tolerance (ie, cannot maintain a standing position due to little or no residual strength in the hips, legs and lower) f. postural hypotension B. Replacement of a non-powered standing frame is considered medically necessary after 5 years when both the following criteria have been met: 1. medical necess ity criteria above are met 2. device is out of warranty or not functioning properly and cannot be refurbished or adequately repaired II. The following items or services are not covered or separately reimbursable :A. electric, motorized , or powered standing frames B. items or services covered under manufacturer or dealer warranty Standing Frames-OH MCD-MM-1331Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 C. DME items that duplicate or conflict with another item currently in the recipient’s possessionD. replacement items or previously approved equipment that have been damaged because of perceived misuse, abuse , or negligence E. Conditions of CoverageAdditional instructions regarding reimbursement of DME items may be located in OAC 5160-10-01. F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 08/31/2022 New policy.Date Revised 07/19/2023 07/17/202405/07/2025Annual review. Updated formatting to AMA style. Updated references. Approved at Committee. Annual review. Updated prescription validity to 1 year. Added face to face encounter with provider. Updated references. Approved at Committee. Annual review: references updated. Approved at Committee. Date Effective 09/01/2025 Date Archived H. References1. Arva J, Paleg G, Lange M, et al. RESNA position on the application of wheelchair standing devices. Assist Technol. 2009;21(3):161-171. doi:10.1080/1044393175622 2. Capati V, Covert SY, Paleg G. Stander use for an adolescent with cerebral palsy at GMFCS level with hip and knee contractures. Assist Technol . 2020;32(6):335-341. doi:10.1080/10400435.2019.1579268 3. Definitions , OHIO REV . CODE ANN . 4752.01 (20 18 ). 4. Durable Medical Equipment, Prosthesis, Orthoses, and Supplies (DMEPOS): General Provisions , OHIO ADMIN . CODE 5160-10-01 (202 4). 5. Edemekong PF, Bomgaars DL, Sukumaran S, et al . Activities of Daily Li ving. In: StatPearls. Updated June 26, 2023. 6. Ferrarello F, Deluca G, Pizzi A, et al. Passive standing as an adjunct rehabilitation intervention after stroke: a randomized controlled trial. Arch Physiother . 2015;5(2). doi:10.1186/s40945-015-0002-05 7. Goodwin J, Lecouturier J, Basu A, et al . Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess . 2018;22(50):1-232. doi:10.3310/hta22500 8. Ibitoye MO, Hamzaid NA, Ahmed YK. Effectiveness of FES-supported leg exercise for promotion of paralysed lower limb muscle and bone health a systematic review. Biomed Tech (Berl) . 2023;68(4):329-350. doi:10.1515/bmt-2021-0195 Standing Frames-OH MCD-MM-1331Effective Dat e: 09/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 9. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrs M, et al . Standing programs to promote hip flexibility in children with spastic diplegic cerebral pal sy. Pediatr Phys Ther . 2015;27(3):243-249. doi:10.1097/PEP.000000 00 00000150 10. Martinsson C, Himmelmann K. Abducted standing in children with cerebral palsy: effects on hip development after 7 years . Pediatr Phys Ther . 2021;33(2):101-107. doi:10.1097/PEP.0000000000000789 11. Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil . 2012;26(12):1059-1077. doi:10.1177/0269215512443373 12. ODA Provider Certification: Home Medical Equipment and Supplies. OHIO ADMIN . CODE 173-39-02.7 (2022). 13. Paleg G, Livingstone R. Evidence-informed clinical perspectives on postural management for hip health in children and adults with non-ambulant cerebral palsy. J Pediatr Rehabil Med . 2022;15(1):39-48. doi:10.3233/PRM-220002 14. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord . 2015;16:358. doi:10.1186/s12891-015-0813-x 15. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther . 2013;25(3):232-247. doi:10.1097/PEP.0b013e318299d5e7 16. Pedlow K, McDonough S, Lennon S, et al. Assisted standing for Duchenne muscular dystrophy . Cochrane Database Syst Rev . 2019;10(10):CD011550. doi:10.1002/14651858. CS011550.pub2 17. Standing frame : A-0996. MCG . 29th ed draft . Updated January 25, 2025 . Accessed April 10, 2025 . www.careweb.careguidelines.com 18. Synnot A, Chau M, Pitt V, et al . Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev . 2017;11(11):CD008929. doi:10.1002/14651858.CD008929.pub2 Independent med ical review 08/2022Approved Ohio Department of Medicaid 05/13/2025

Autonomic Nerve Testing

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Autonomic Nerve Testing-OH MCD-MM-1783 09/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. 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-1783 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Autonomic 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 intol erance, 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 seve rity 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 serio us 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-1783 Effective Date: 09/01/2025 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3maneuver, 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. Policy I. 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. Limitations Properly 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. Exclusions A. Autonomic nerve function testing to aid in the diagnosis of ANY other condition not list ed 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 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 Coverage NA Autonomic Nerve Testing-OH MCD-MM-1783 Effective Date: 09/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4F. Related Policies/Rules Experimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 05/21/2025 New policy. Approved at Committee.Date Revised Date Effective 09/01/2025 Date Archived H. References 1. Baker JR, Hira R, Uppal J, et al . Clinical Assessment of the Autonomic NervousSystem. Card Electrophysiol Clin . 2024;16(3):239-248. doi:10.1016/j.ccep.2024.02.0012. 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 Neurophys iology 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. Published online December 5, 2024. doi:10.1007/s13760-024-02654-2 Approved ODM 06/04/2025

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