MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Transcranial Magnetic Stimulation for Treatment of Depression-MP-MM-1339 09/01/2025 Kentucky Inactive 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. …. 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. ….. 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……… 4 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 H. Review/Revision History ………………………….. ………………………….. ………………………….. ……. 4 I. References ………………………….. ………………………….. ………………………….. ………………………. 4 Transcranial Magnetic Stimulation for Treatment of Depression-MP-MM-1339 Effective Dat e: 09/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTranscranial Magnetic Stimulation for Treatment of Depression B. BackgroundTranscranial magnetic stimulation (TMS) was originally introduced in 1985 as a noninvasive treatment modality for treatment-resistant Major Depressive Disorder (MDD) . Brief, repetitive pulses of magnetic energy are sent to the scalp via a large electromagnetic coil, generating a low level of electrical stimulation. These magnetic fields pass through the skull and induce electrical currents that depolarize neurons in a focal area of the surface cortex. The magnetic field g enerated by this type of stimulation is very small and cannot be felt by the patient but is strong en ough to flow into the brain without inducing seizures or creating a need for anesthesia. TMS is generally an outpatient procedure with conscious patients and sessions that varybetween 30 to 40 minutes. Treatment can be delivered as a single pulse or as a series of pulses. Despite variability in the number of pulses delivered per session and the number of sessions per patient, research indicates that typical TMS consist of treatment up to 5 days a week for up to 6 weeks. A tapering schedule is used to end treatment. C. Definitions Acute (Index) Course of Treatment The initial series of treatment given to relieve acute symptoms of the MDD . Adequate Trial Taking a drug at least 4 weeks at or near the maximum dose for the specific medication as approved by the F ood and Drug Administration (FDA) or documentation exists that higher doses were not tolerated when the dose is less than the FDA-approved maximum. Continuation TMS Treatment beginning after the acute/index course lasting up to 6 months and designed to prevent the worsening of symptoms and continue d treatment for a depressive episode that has not yet remitted. Depression Rating Scale Scales standardized for national use that reliably assess the range of symptoms , both type and magnitude, most commonly observed in adults with MDD . Listed below are examples of commonly used scale s: o Beck Depression Inventory (BDI) o Geriatric Depression Scale (GDS) o Hamilton Depression Rating Scale (HAM-D) o Patient Health Questionnaire-9 (PHQ-9) o Quick Inventory of Depressive Symptomatology (QIDS) Maintenance TMS Regularly scheduled TMS sessions on a weekly, biweekly, or monthly basis to prevent relapse of depressive symptoms. Medication Side Effects Unexpected effects that cause significant distress, inhibit daily function, have the potential to worsen health, or are life threatening. Remission The absence of significant signs or symptoms of a major depressive episode during the previous 2 months. Transcranial Magnetic Stimulation for Treatment of Depression-MP-MM-1339 Effective Dat e: 09/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. A review of medical necessity is required for initial and continuation courses of TMS. II. TMS is considered medically necessary when all the following criteria are met:A. Member is 18 years of age or older .B. There is a c onfirmed diagnosis of MDD , single or recurrent, with a current severe episode as evidenced by a recent score on a standardized depression rating scale and at least 1 of the following: 1. resistance to treatment evidenced by a lack of a clinically significant response during a current or previous depressive episode and adequate trials of 2 antidepressant agents , including at least 2 different agent classes at or near the maximum effective dose and duration for each class approved by the FDA 2. inability to tolerate a therapeutic dose of medications evidenced by documentation in the medical record of 2 trials of antidepressant agents with distinct side effects 3. history of response to TMS in a previous depressive episode , as evidenced by a greater than 50% improvement on a standard ized depression rating scale 4. currently receiving or is a candidate for and has declined electroconvulsive therapy (ECT) with TMS considered a less invasive treatment option C. Completion of a trial of evidence-based psychotherapy for MDD with appropriate frequency and duration without significant improvement for 12 weeks , alone or combined with psychopharmacologic agents . D. None of the following conditions or contraindications are present: 1. epilepsy or history of seizure or presence of other neurologic disease s that may lower seizure threshold (eg, cerebrovascular accident, severe head trauma, increased intracranial pressure) 2. acute or chronic psychotic symptoms or disorders (eg, schizophrenia, schizophreniform, schizoaffective disorder) 3. cochlear implant s or deep brain stimulator s 4. current use of substances that may significantly lower seizure threshold (eg, alcohol or stimulants ) 5. metallic hardware or implanted magnetic-sensitive medical device s (eg, implanted cardioverter-defibrillator s, pacemaker s, metal aneurysm clips or coils) at a distance within the electromagnetic field of the discharging coil (eg, less than or equal to 30 cm to the discharging coil) 6. unstable medical disorder s III. Additional treatment courses of TMS are considered medically necessary when all the following have been met : A. 30 days since last session of TMS B. a history of response to TMS in a previous depressive episode evidenced by a greater than 50% improvement on a standardized depression rating scale C. medical necessity is met per Section II above Transcranial Magnetic Stimulation for Treatment of Depression-MP-MM-1339 Effective Dat e: 09/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 IV. TMS m aintenance treatment is not considered medically necessary. There is not sufficient evidence in peer reviewed literature to assess net benefit versus harm for patients. V. Additional criteria :A. TMS must be administered by an FDA-cleared device for the treatment of MDDin a safe and effective manner according to the manufacturers user manual and specified stimulation parameters. B. A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 treatments in 1 week, 2 treatments the next week, and 1 treatment in the last week. C. TMS can be ordered by and performed under direction of a neurologist, licensed psychiatrist, or psychiatric nurse practitioner who has examined the member, reviewed the record when it is within scope of practice, and has experience in administering TMS the rapy within scope of practice. E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesMedical Necessity Determinations H. Review/Revision HistoryDATE ACTIONDate Issued 07/12/2018Date Revised 08/31/2022 10/25/202201/19/202308/02 /2023 06/19/2024 06/04/2025 Annual review. Combined individual policies (GA 0861, IN 0237, KY 0239, OH 0235, WV 0240). Added IA MP. Evote received 12/8/22. Changed title for clarity. Removed IA. Annual review. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Annual review. Changed medication trial prior to TMS from 4 to 2. Updated references. Approved at Committee. Date Effective 09/01/2025 Date Archived I. References1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised . American Psychiatric Association; 2022. 2. Georgia Marketplace Evidence of Coverage . CareSource; 2025. Accessed May 29, 2025. www.caresource.com Transcranial Magnetic Stimulation for Treatment of Depression-MP-MM-1339 Effective Dat e: 09/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 3. Holtzheimer PE. Unipolar major depression: administering transcranial magnetic stimulation (TMS). Up ToDate. Updated January 22, 2025. Accessed May 29, 2025. www.uptodate.com 4. Holtzheimer PE. Unipolar depression in adults: indications, efficacy, and safety of transcranial magnetic stimulation (TMS). Up ToDate. Updated January 22, 2025. Accessed May 29, 2025. www.uptodate.com 5. Indiana Marketplace Evidence of Coverage . CareSource; 2025. Accessed May 29, 2025. www.caresource.com 6. Jarrett R, Vittengl J. Unipolar depression in adults: continuation and maintenance treatment. Up ToDate. Updated October 3, 2024. Accessed May 29, 2025. www.uptodate.com 7. Kentucky Marketplace Evidence of Coverage . CareSource; 2025. Accessed May 29, 2025. www.caresource.com 8. Transcranial Magnetic Stimulation : B-801-T. MCG Health, 28th ed . Updated March 14, 2024 . Accessed May 29, 2025. www.careweb.careguidelines.com 9. National Institute of Mental Health. Brain Stimulation Therapies . National Institutes of Health; 2023. NIH publication 0925-0648. Accessed May 29, 2025. www.nimh.nih.gov 10. Ohio Marketplace Evidence of Coverage . CareSource; 2025. Accessed May 29, 2025. www.caresource.com 11. Perera T, George MS, Grammer G, et al. The Clinical TMS Society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimul . 2016;9(3):336-346. doi:10.1016/j.brs.2016.03.010 12. Thase M, Connolly R. Unipolar depression in adults: choosing treatment for resistant depression. UpToDate. Updated November 2 , 2023. Accessed May 29, 2025. www.uptodate.com 13. West Virginia Marketplace Evidence of Coverage . CareSource; 2025. Accessed May 29, 2025. www.caresource.com
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. MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Nutritional Supports-MP-MM-1330 09/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 4 E. State-Specific Information ………………………………………………………………………………………. 7 F. Conditions of Coverage ………………………………………………………………………………………….. 8 G. Related Policies/Rules ……………………………………………………………………………………………. 8 H. Review/Revision History …………………………………………………………………………………………. 8 I. References …………………………………………………………………………………………………………… 8 Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectNutritional SupportsB. Background Enteral 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 outcome. 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 formulas from triglycerides into fatty acids and monoglycerides to allow their absorption and utilization in the body. 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 health benefits 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 age. 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 mothers 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, and jejunostomy tubes. o Supplemental Nutrition The minority of daily calories are supplied by enteral nutrition products. Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 o Total Enteral Nutrition (TEN) The majority of daily calories are supplied by 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 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 their ability to digest regular food. This can include specially formulated infant formulas. According to the Food and Drug Administrations (FDA), a product must meet all the following minimum criteria to be considered a medical food: o The product must be a food for oral or tube feeding. o The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements.o The product must be used under the supervision of a physician. Oral Nutrition (Oral Feeding) Nutritional support given via the 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 (e.g., 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 minces, or modified normal.Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 o Modified Normal Eating normal foods by avoiding particulate foods that are a choking hazard.D. PolicyI. Oral Nutrition A. 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 criteria are met: 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 hemoccult 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) 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 eosinophilic enteritis (colitis/proctitis, esophagitis, gastroenteritis) 04. cystic fibrosis with malabsorption Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 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 to 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 25th percentile for weight based on their corrected gestational age (2). individuals with end-stage renal disease and hypoalbuminemia (albumin less than 4gm/dl) 8. Approval duration can be up to 12 months for all oral nutrition products. C. Supplemental oral nutrition is considered medically necessary when ALL the following apply: 1. The product is being used to supplement the 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. 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 must be 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. All avenues of coverage available must be exhausted first. For example, members eligible for their county Women, Infant, and Children (WIC) program must apply for an eligibility evaluation before supplemental nutrition coverage will be considered.8. Approval duration can be up to 12 months for all supplemental oral nutrition products. Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 6 II. Enteral Nutrition via Tube : A. 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: 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 all enteral nutrition products. C. Supplemental enteral nutrition via tube is considered medically necessary when ALL the following criteria are met: 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 documentation 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 documentation 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 must be 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. All avenues of coverage available must be exhausted first (eg, members eligible for their county Women, Infant, and Children (WIC) program must apply for an eligibility evaluation before supplemental nutrition coverage will be considered).Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 7 8. Approval duration can be up to 12 months for all supplemental enteral nutrition products. III. Donor human milk: See Section Efor additional criteria for Kentucky and Georgia. A. CareSource considers human milk medically necessary when ALL the following criteria are met: 1. Provider must be in good standing with the Human Milk Banking Association of North America. 2. Documentation supports medical necessity. 3. Documentation supports that the provider has attested to educating the member in the donation process and about human milk. 4. Documentation supports that the provider discussed the risks and benefits with the member. B. Per the Food & Drug Administration, only human milk banks that screen their milk donors and take precautions to ensure the safety of its milk should be utilized. IV. CareSource does NOT consider the following medically necessary: A. nutritional formulas and dietary supplements that can be purchased over the counter, which by law do not require either a written prescription or dispensing by a licensed pharmacist, UNLESS administered through a pre-existing feeding tube B. use of a nutritional product for the convenience or preference of the member or caregiver C. therapeutic diets where non-medical foods are tolerated, including any of the following: 1. food modification 2. texture modified food 3. thickened fluids 4. fortified food 5. functional food 6. modified normal7. flavorings D. Relizorb (insufficient published evidence) E. oral nutrition products for meal replacements or snack alternatives F. feeding tubes for individuals with advanced dementia G. products administered in an outpatient provider setting; these items are not separately reimbursableE. State-Specific Information A. Georgia 1. As per the Evidence of Coverage, a benefit is provided for 100% human diet, if the 100% human diet and supplemented milk fortifier products are prescribed for the prevention of necrotizing enterocolitis and associated co-morbidities and administered under the direction of a physician. 100% human diet means the Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 8 supplementation of a mothers expressed breast milk or donor milk with a milk fortifier.2. Evidence of Coverage and Health Insurance Contract. Marketplace Plan, Georgia (2024). Accessed July 1, 2024. www.caresource.com B. Indiana Evidence of Coverage and Health Insurance Contract. Marketplace Plan, Indiana (2024). Accessed July 1, 2024. www.caresource.com C. Kentucky1. As per the Evidence of Coverage, a benefit is provided for 100% human diet, if the 100% human diet and supplemented milk fortifier products are prescribed for the prevention of necrotizing enterocolitis and associated co-morbidities and administered under the direction of a physician. 100% human diet means the supplementation of a mothers expressed breast milk or donor milk with a milk fortifier. 2. Evidence of Coverage and Health Insurance Contract. Marketplace Plan, Kentucky (2024). Accessed July 1, 2024. www.caresource.com D. Ohio Evidence of Coverage and Health Insurance Contract. Marketplace Plan, Ohio (2024). Accessed July 1, 2024. www.caresource.com E. West Virginia Evidence of Coverage and Health Insurance Contract. Marketplace Plan, West Virginia (2024). Accessed July 1, 2024. www.caresource.com F. Conditions of Coverage NA G. Related Policies/Rules NA H. Review/Revision History DATE ACTION Date Issued 08/17/2022 Date Revised 08/02/2023 Annual review: updated references, added malnutrition definition, clarified criteria for IEM. Approved at Committee.07/17/2024 Review: updated references, title changed fromSupplements to Supports. Approved at Committee.06/04/2025 Review: updated references, approved at Committee.Date Effective 09/01/2025 Date Archived I. 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.12924Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 9 neurologically impaired children: a clinical report of the North American Society for2. 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-e7953. 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, et al. 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 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. 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 7. Fleet SA, Duggan C. Overview of enteral nutrition in infants and children. UpToDate. February 3, 2025. Accessed June 3, 2025. www.uptodate.com 8. 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 9. 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 June 3, 2025. www.cdc.gov 10. Guidance for Industry: Frequently Asked Questions about Medical Foods . 3rd ed. US June 3, 2025. www.fda.gov 11. Homan GJ. Failure to thrive: a practical guide. Am Fam Physician . 2016;94(4):295-299. Accessed June 3, 2025. www.aafp.org 12. 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 13. 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. 14. Pediatric Gastroenterology, Hepatology, and Nutrition. JPediatr Gastroenterol Nutr . 15. 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. JParenteral and Enteral Nutr . 2017;41(5):703-900. doi:10.1177/014860711771138716. 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 17. Robinson D, Walker R, Adams SC, et al. American Society for Parenteral and Enteral Nutrition (ASPEN) Definition of Terms, Style, and Conventions Used in 2006;43(1):123-135. Marchand V, Motil KJ; NASPGHAN Committee on Nutrition. Nutrition support for Dept of Health and Human Services; 2023. Accessed Nutritional Supports-MP-MM-1330 Effective Date: 09/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 10 (POMS) – DI 24598.002. Failure to Thrive (FTT). February 9, 2016. AccessedU.S. Social Security Administration (SSA). Program Operations Manual System ASPEN Board of Directors-Approved Documents. May 2018. Accessed June 3, 2025. www.nutritioncare.org18. U.S. Food and Drug Administration. RELiZORB K232784. December 21, 2023. Accessed June 3, 2025. www.accessdata.fda.gov19. U.S. Food and Drug Administration. Use of Donor Human Milk . Updated March 22, 2018. Accessed June 3, 2025. www.fda.gov 20. U.S. Social Security Administration (SSA). Disability Evaluation Under Social Security-105.00 Digestive System Childhood. Accessed June 3, 2025. www.secure.ssa.gov 21. 3, 2025. www.secure.ssa.gov June 22. 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 23. World Health Organization. Malnutrition. March 1, 2024. Accessed June 3, 2025. www.who.int 24. Worthington P, Balint J, Bechtold M, et al. When is parenteral nutrition appropriate? JParenteral and Enteral Nutr . 2017;41(3):324-377. doi:10.1177/0148607117695251
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Noninvasive Home Mechanical Ventilation-MP-MM-1796 09/01/2025 Kentucky Inactive 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia 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 ………………………….. ………………………….. ………………………….. ……………………. 7 Noninvasive Home Mechanical Ventilation-MP-MM-1796Effective 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 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-MP-MM-1796Effective 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-MP-MM-1796Effective 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-MP-MM-1796Effective 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-MP-MM-1796Effective 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. A provider may not receive payment until necessary supporting documents have been obtained and placed in the providers files. These documents include the prescription , practitioner order and chart notes , and ventilator settings, which support the determination of medical necessity. VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.Noninvasive Home Mechanical Ventilation-MP-MM-1796Effective 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 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, BiPAP , 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/RulesPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental Overpayment Recovery G. Review/Revision HistoryDATE ACTIONDate Issued 06/04/2025 Approved at CommitteeDate Revised Date Effective 09/01/2025 Date Archived H. References1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi:10.1513/AnnalsATS.201810-657CME 2. Dudgeon D. Assessment and management of dyspnea in palliative care. UpToDate. Updated April 4, 2025 . Accessed May 9, 202 5. www.uptodate.com 3. 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 Noninvasive Home Mechanical Ventilation-MP-MM-1796Effective 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 4. 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 5. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated February 5, 2025. Accessed May 9, 202 5. www.uptodate.com 6. 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 7. 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 8. 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 May 9, 202 5. www.uptodate.com 9. Home Ventilator (Invasive or Noninvasive Interface): ACG A-0893. MCG Health . 2 8th ed. Accessed May 9, 202 5. www.careweb.careguidelines.com 10. 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 11. Kline LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Updated October 9, 202 4. Accessed May 9, 202 5. www.uptodate.com 12. 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 13. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated March 4, 2024. Accessed May 9, 202 5. www.uptodate.com 14. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 10.1177/0194599818801757 15. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasive ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev . 2021;8:CD002878. doi:10.1002/14651858.CD002878.pub3 16. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinical practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.01766 17. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest . 2020;158(6):2493-2501. doi:10.1016/j.chest.2020.07.007 Noninvasive Home Mechanical Ventilation-MP-MM-1796Effective 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.9 Independent Medical Review 05/08/24
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Genetic Testing and Counseling-MP-MM-1322 08/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 3 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 I. References ………………………….. ………………………….. ………………………….. ……………………. 4 Genetic Testing and Counseling-MP-MM-1322Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectGenetic Testing and Counseling B. BackgroundAdvancements in technology have contributed to the rapid expansion of identified genetic variations . S ome of these variations have been identified as disease-causing, while others are considered common variants with no clinical impact. With the ever – expanding number of genetic tests available, it can be clinically difficult to determine the most appropriat e tests for a particular patient. When clinically appropriate, genetic testing may provide diagnostic and/or actionable therapeutic results which can impact a patients outcome. Due to the complexity of genetic tests and possible results, consultation with medical genetics professionals and counselors may be required to assist members . According to the National Society of Genetic Counselors of the United States, genetic counseling is meant to integrate the following goals: 1) interpretation of family and medical histories to assess the chance of disease occurrence or recurrence; 2) educa tion about the natural history of the condition, inheritance pattern, testing,management, prevention, support resources, and research; 3) counseling to promote informed choices in view of risk assessment, family goals, ethical and religious values; and 4) support to encourage the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence of that disorder. Genetic counselors are healthcare professionals trained to provide this care; however, access issues may requ ire other healthcare professionals to assume this role. Genetic counseling, whether provided by a certified genetic counselor or other qualified healthcare professional, is an integral component of genetic testing that is informative and supportive to memb ers, both before and after the completion of testing. C. Definitions Genetic Screening Th e process of testing a population for a genetic disease to identify a subgroup of people who either have the disease or the potential to pass it to offspring. Genetic Testing A medical test that identifies changes in genes, chromosomes, or proteins to confirm or rule out a suspected genetic condition either hereditary or acquired. Human Leukocyte Antigen (HLA) Typing A test used to match patients and donors for bone marrow or cord blood transplants. Inherited Genetic Variant A type of DNA sequence change passed from parent to offspring (ie, germline). Precision Medicine A field of medicine that selects pharmacotherapies based on the patients genetics. Somatic Gene Variant A type of DNA sequence change that is not inherited from a parent but acquired during a persons life. Genetic Testing and Counseling-MP-MM-1322Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. Prior authorization may be required for genetic testing. This includes both somatic and germline genetic testin g. II. CareSource will review for medical necessity using published MCG criteria when available and the Medical Necessity Determinations administrative policy. This policydoes not apply to requests that have MCG or InterQual guidelines with clear genetic counseling requirements/recommendations.III. Proprietary panel testing requires evidence-based documentation per the MedicalNecessity Determinations administrative policy. Individual genetic tests may be requested separately based on the Medical Necessity Determinations administrative policy for panels not meeting medical necessity requirements. IV. Genetic counseling is required for all germline genetic testing , as indicated by ALLthe following: A. Counseling is provided by a healthcare professional with education and training in genetic issues relevant to the genetic tests under consideration. B. Counseling is provided to enable members informed decision making concerning proposed testing (eg, purpose of testing, management that may be informed by result, heritable nature informed by 3-generation family history, range of possible results, potential benefits and risks of testing (eg, psychological, social, economic). V. Somatic genetic testing does not require genetic counsel ing described above.VI. Human leukocyte antigen (H LA ) typing is not part of the genetic testing policy and does not require pre-authorization. VII. While most inherited genetic testing is only necessary once in a lifetime, CareSource recognizes that a germline genetic test could be appropriately repeated in extraordinary circumstances due to changes in technology. This situation will be considered wit h the proper medical necessity documentation.E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesMedical Necessity Determinations Cystic Fibrosis Testing Genetic Testing and Counseling-MP-MM-1322Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 H. Review/Revision HistoryDATE ACTIONDate Issued 05/25/2022 New PolicyDate Revised 05/10 /2023 04/10 /202407/03/202404/23/2025Annual review: updated background, definitions, and references , rephrased genetic counseling process . Approved at Committee. Review: updated references, moved state-specific information to section E, approved at Committee. Review: clarified genetic counseling requirements, added language regarding MCG. Approved at Committee Review: updated references, approved at Committee. Date Effective 08/01/2025 Date Archived I. References1. Ambulatory care: genetic medicine. MCG Health . 28 th ed. Accessed April 8, 2025 . www.careweb.careguidelines.com 2. Cohen SA, Bradbury A, Henderson V, et al. Genetic counseling and testing in a community setting: quality, access, and efficiency . Am Soc Clin Oncol Educ Book. 2019 ;e34-e44. doi:10.1200/EDBK_238937 3. Crooke A, Jacobs C, Newton-John T, et al. Genetic counseling and testing practices for late-onset neurodegenerative disease: a systematic review. JNeurol. 2022;269(2):676-692. doi:10.1007/s00415-021-10461-5 4. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated July 22, 2024 . Accessed April 8, 2025 . www.uptodate.com 5. Mundy J, Davies HL, Radu M, et al. Research priorities in psychiatric genetic counselling: how to talk to children and adolescents about genetics and psychiatric disorders. Eur JHum Genet. 2023;31(3):262-264. doi:10.1038/s41431-022-01253-0 6. National Center for Biotechnology Information (NCBI). Genetic Testing Registry (GTR) National Library of Medicine. Accessed April 8, 2025 . www.ncbi.nlm.nih.gov 7. National Human Genome Research Institute. Coverage and Reimbursement of Genetic Tests. National Institutes of Health. Updated February 6, 2024 . Accessed April 8, 2025 . www.genome.gov 8. National Human Genome Research Institute. Regulation of Genetic Tests. National Institutes of Health. Updated February 19, 2024. Accessed April 8, 2025 . www.genome.gov 9. Raby BA, Kohlmann W. Genetic counseling: family history interpretation and risk assessment. UpToDate . Updated April 9 , 2024. Acces sed April 8, 2025 . www.uptodate.com 10. Sarata AK. Genetic Testing: Background and Policy Issues . Congressional Research Service Report ; 2015 . RL33832. Accessed April 8, 2025 . www.sgp.fas.org 11. Senter L, Austin JC, Carey M, et al. Advancing the genetic counseling profession through research: identification of priorities by the National Society of Genetic Counselors research task force. JGenet Couns . 2020;29(6):884-887. doi:10.1002/jgc4.1330 Genetic Testing and Counseling-MP-MM-1322Effective Dat e: 08/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 12. Whit e S, Jacobs C, Phillips J. Mainstreaming genetics and genomics: a systematic review of the barriers and facilitators for nurses and physicians in secondary and tertiary care. Genet Med. 2020;22(7):1149-1155. doi:10.1038/s41436-020-0785-6
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Facet Joint Interventions-MP-MM-1326 07/01/2025 Kentucky inactive as of 01/01/2026 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 5 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 I. References ………………………….. ………………………….. ………………………….. ……………………. 5 Facet Joint Interventions-MP-MM-1326Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectFacet Joint Interventions B. BackgroundAn estimated 84% of adults experience back pain during their lifetime. Long-term outcomes are largely favorable for most patients, but a small percentage of patients symptoms persist. Persistent pain is categorized as subacute when it lasts between 4 and 12 weeks and chronic when it persists for at least 3 months. Facet joint pain comprises 27% -40% of patients with chronic low back pain (LBP) . Comprehensive pain management care plans are most effective in managing a patients chronic pain. These plans focus on a person-centered approach and incorporateconservative treatment with other modalities. These multidisciplinary treatments promot e self-management and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved completely. In addition to conservative therapy, treatment options may include nonpharmacologic or pharmacologic treatments , and nonsurgical or surgical interventions. Only physicians qualified in i nterventional procedures for pain unresponsive to conservative treatment should perform these health services. Spinal structures may be the source of LBP, including intervertebral discs, facet joints, sacroiliac joints, and nerve roots. While some of these can be diagnosed by imaging, discogenic pain without disc herniation and facet joint or sacroiliac joint pain are difficultto diagnose with imaging alone. Medial branch nerve blocks are a diagnostic tool to identify the cause of pain and can provid e short term pain relief with certain medications. Following a presumptive diagnosis of facet joint pain through a ph ysical examination and plain radiography or axial imaging , the diagnosis may be confirmed by relief of pain through injection of local anesthetic to the medial branches of the posterior rami of the dorsal spinal nerves supplying the proposed facet joint(s). Medial branch nerve blocks may be performed at the targeted joint itself, one joint above and one joint below on the same side, or bilaterally per treatment session. Medial branch nerve block injections should be performed with fluoroscopy or computed tomography . A patient may receive a diagnostic injection of a short-acting local anesthetic agent to identify the pain generator. If pain is relieved by the injection, then a radiofrequency ablation (RFA), which uses energy to destroy the nerve, can be performed. A successful radiofrequency facet ablation of the affected nerve (same anatomic location of the positive diagnostic block) may relieve pain for a period of months up to a year or more until nerve regeneration occurs. C. Definitions Conservative Therapy A multimodality plan of care includ ing both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, i nclud ing physical therapy, occupational Facet Joint Interventions-MP-MM-1326Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 therapy, a physician supervised home exercise program (HEP), and/or chiropractic care. HEP A 6-week program requiring an exercise prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete a HEP due to a stated physical reason (ie, increased pain, inability to physically perform exercises). Patient inconvenience or noncompliance without explanation does not constitute inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms with pain including rest, ice, heat, medical devices, acupuncture, TENS u se , and/or pharmacotherapy (prescription or over the counter [eg, NSAIDS, acetamino phen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current directed through electrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphin s. Use, frequency, duration, and start dates must be documented in the medical record . Medial Branch Nerve Block Injection A diagnostic procedure in which a short – acting anesthetic (eg, lidocaine) is injected near small medial nerves connected to a specific facet joint. It may be performed to treat back pain caused by facet joint(s) with a longer acting anesthetic (eg, bupivacaine) . o Successful diagnostic Injection An injection that achieves greater than 80% reduction in pain within the duration of effectiveness for the anesthetic used. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial branches of the dorsal spinal nerves. D. PolicyCareSource considers facet joint interventions for management of chronic back pain medically necessary when the clinical criteria in this policy are met. Documentation, including dates of service for conservative therapies , are not required for medical necessity review but must be available upon request. I. Medial Branch Nerve Block InjectionsA. Up to 2 diagnostic medial branch nerve block injections in the cervical , thoracic , or lumbar regions are considered medically necessary when ALL of the following criteria are met : 1. Initial diagnostic block confirms facet joint as source of spinal pain and provides 80% or greater primary pain relief and duration of relief is consistent with agent employed. 2. Second diagnostic block confirms validity of the initial injection and is injected at the same level where the initial produced a positive response. 3. Each diagnostic block may treat up to 3 spinal levels (unilateral or bilateral) for a maximum of 6 spinal levels per spinal region per session. Facet Joint Interventions-MP-MM-1326Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 4. Radiofrequency ablation is being considered as a therapeutic intervention.5. Injections should be at least 2 weeks apart . 6. Imaging studies and physical exam ruled out other causes of spinal pain (eg, fracture, tumor, infection, herniated disk, spinal stenosis, significant deformity ). 7. Patient history with at least 3 months of moderate to severe pain with functional impairment that has not adequately responded to active and inactive conservative therapy . 8. Failure of conservative therapy as evidenced by ALL of the following: a. Documentation in the medical record of at least 6 weeks of active conservative therapy (as defined above) within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance. b. Documentation in the medical record of at least 6 weeks of inactive conservative therapy (as defined above) within the past six months. 9. No coagulopathy . 10. No current infection at the injection site. B. Diagnostic medial branch nerve blocks are NOT considered medically necessary when RFA is not being considered as a treatment option. II. Radiofrequency Ablation (RFA) for Facet Joint PainA. Initial RFA for facet joint pain is considered medically necessary when in the past 36 months : 1. The clinical criteria above (I. A.1-10 ) have been met . 2. 2 successful medial branch nerve block injections were performed at the same spinal region and side and achieved 80% or more pain relief. B. Repeat RFA for facet joint pain is considered medically necessary when in the past 36 months : 1. Prior successful single or multilevel facet RFA in the same spinal region (cervical, thoracic, or lumbar) and side provided at least 50% pain relief over a minimum of 6 months. 2. The most recent RFA was at least 6 months prior. 3. No more than 4 RFAs per rolling 12 months ( 2 left and 2 right per spinal region) are considered appropriate. III. SedationA. Neither conscious sedation nor monitored anesthesia care (MAC) is routinely necessary for intra-articular facet joint injections or medial branch blocks and are not routinely reimbursable. B. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented. IV. Inconclusive or Non-Supportive EvidenceA. Medial branch nerve block injections are unproven for the treatment of chronic spinal pain . Routine therapeutic injections will not be authorized for chronic pain management. Facet Joint Interventions-MP-MM-1326Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 B. Intra-articular facet joint injections for neck and back pain are not considered medically necessary as there is limited evidence and the efficacy ha s not been established. C. Intra-articular facet joint injections do not qualify as diagnostic information for a proposed neurotomy . V. Spinal Cord Stimulators/Pain PumpsPatients with indwelling implanted spinal cord stimulators or pain pumps should include a device interrogation report with the required medical records for medical necessity review requests. If a device is not functioning properly, an escalation in pain ma y warrant evaluation and management of the implanted device. E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 06/22/2022 New PolicyDate Revised 06 /21 /2023 05/08 /202404/09/2025Annual Review: revised language, added RFA requirement for diagnostic injections, updated references; Approved at Committee. Annual review: updated references. Approved at Committee. Review: updated references, approved at Committee. Date Effective 07/01/2025 Date Archived I. References1. Ashmore ZM, Bies MM, Meiling JB, et al. Ultrasound-guided lumbar medial branch blocks and intra-articular facet joint injections: a systematic review and meta – analysis. Pain Rep. 2022;7(3):e1008. doi:10.1097/ PR9. 0000000000001008 2. Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain . Pain Physician . 2015;18(4):E497-E533. Accessed March 20, 2025 . www.painphysicianjournal.com 3. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate. Updated May 15, 2024 . Access ed March 20, 2025 . www.uptodate.com 4. Chou R. Subacute and chronic low back pain: surgical treatment. UpToDate. Updated September 27, 2023 . Access ed March 20, 2025 . www.uptodate.com Facet Joint Interventions-MP-MM-1326Effective Dat e: 07/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 5. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline . Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 6. Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med . 2020;45(6):424-467. doi:10.1136/rapm-2019-101243 7. Cohen SP, Moon JY, Brummett CM, et al . Medial branch blocks or intra-articular injections as a prognostic tool before lumbar facet radiofrequency denervation: a multicenter, case-control study . Reg Anesth Pain Med . 2015;40(4):376-383. doi:10.1097/AAP.0000000000000229 8. Copenhaver DJ, Pritzlaff SG, Jung M, et al. Interventional therapies for chronic pain. UpToDate. Updated January 23, 2025. Accessed March 20, 2025 . www.uptodate.com 9. Curtis L, Shah N, Padalia D. Facet joint disease. StatPearls . StatPearls Publishing; updated January 9, 2023. Accessed March 20, 2025 . www.ncbi.nlm.nih.gov 10. Facet Joint Injection. MCG Health. 2 8th ed. MCG Health; 202 4. U pdated March 14, 2024 . Accessed March 20, 2025 . www.careweb.careguidelines.com 11. Hurley RW, Adams MCB, Barad M, et al. Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group. Reg Anesth Pain Med . 2022;47(1):3-59. doi:10.1136/rapm-2021 – 103031 12. Isaac Z, Kelly H. Evaluation of the adult patient with neck pain. UpToDate. Updated May 31, 2023 . Accessed March 20, 2025 . www.uptodate.com 13. Le DT, Alem N. Facet Joint Injection. StatPearls . StatPearls Publishing; updated June 20 , 2023. Accessed March 20, 2025 . www.ncbi.nlm.nih.gov 14. Lee DW, Pritzlaff S, Jung MJ, et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): best practice guidelines from the American Society of Pain and Neuroscience (ASPN). JPain Res . 2021;14:2807-2831. doi:10.2147/JPR.S325665 15. Manchikanti L, Kaye AD, Soin A, et al. Comprehensive evidence-based guidelines for facet joint interventions in the management of chronic spinal pain : American Society of Interventional Pain Physicians (ASIPP) guidelines facet joint interventions 2020 guidelines . Pain Physician . 2020;23(3S):S1-S127. Accessed March 20, 2025 . www.painphysicianjournal.com 16. Perolat R, Kastler A, Nicot B, et al. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging . 2018;9(5):773-789. doi:10.1007/s13244-018-0638x 17. Won HS, Yang M, Kim YD. Facet joint injections for management of low back pain: a clinically focused review. Anesth Pain Med (Seoul) . 2020;15(1):8-18. doi:10.17085/apm.2020.15.1.8
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Mechanical Stretching Devices-MP-MM-1382 06/01/2025 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.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 4Mechanical Stretching Devices-MP-MM-1382 Effective Date: 06/01/2025 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. SubjectMechanical Stretching Devices B. Background Mechanical stretching devices are intended to restore range of motion (ROM) for joint stiffness or contracture by stretching joints. These devices provide passive stretching to an adjustable degree for a selected duration for multiple sessions. A variety of mechanical stretching devices are available for extension or flexion of the shoulder, elbow, wrist, fingers, knee, ankle, and toes. These devices can provide stretching for longer periods than a physical therapist and are generally used as adjunct treatm ent to physical therapy and/or exercise. Mechanical Stretching Devices (also known as dynamic splinting systems) include: Low-load prolonged duration stretch devices (LLPS) Static progressive stretch (SPS) splint devices Patient actuated serial stretch (PASS) devices C. DefinitionsLow-load Prolonged Duration Stretch Devices (LLPS) These devices permit resisted active and passive motion (elastic traction) within a limited range. LLPS devices maintain a set level of tension by means of incorporated rubber bands or springs. Patient Actuated Serial Stretch (PASS) Devices These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). This type of device itself does not exert a stress on the tissue unless the joint angle is set at the maximum ROM . Static Progressive Stretch Devices (SP S) These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction) . D. Policy I. CareSource considers dynamic splinting devices medically necessary durable medical equipment (DME) as an adjunct treatment to physical therapy, massage, and/or exercise for an existing joint contracture when the following clinical criteria is met: A. m edically necessary only for the following joints: knee, elbow, wrist, finger , ankle and toe . B. after three weeks of exercise and skilled therapy in the initial subacute injury or post-operative period in members with: 1. signs and symptoms of persistent joint stiffness or contracture. 2. limited range of motion that poses a meaningful functional limitation as judged by a physician. C. m ay be used for an initial period of 4 weeks , a subsequent 4-week period with reevaluation, and then up to 4 months based on continued improvement . Mechanical Stretching Devices-MP-MM-1382 Effective Date: 06/01/2025 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. 3II. In the acute post-operative period for members who have undergone additional surgery to improve the range of motion of a previously affected joint , CareSource considers use of an LLPS device medically necessary for : A. a n initial four-week period B. a n additional four-week period, if improvement was noted after the initial four weeks, for up to 4 months III. Non-Covered Services A. CareSource considers the use of dynamic splinting experimental and investigational for the following indications, including but not limited to: 1. adhesive capsulitis 2. carpal tunnel syndrome 3. cerebral palsy 4. foot drop associated with neuromuscular diseases, 5. hallux valgus 6. head and spinal cord injuries 7. Improvement of outcomes following botulinum toxin injection for treatment of limb spasticity 8. injuries of the ankle and shoulder 9. multiple sclerosis 10. muscular dystrophy 11. plantar fasciitis 12. rheumatoid arthritis 13. stroke 14. trismus B. CareSource considers the following devices experimental and investigational due to insufficient scientific evidence of efficacy: 1. p atient Actuated Serial Stretch (PASS) devices (for example, ERMI Knee Extensionater and ERMI Shoulder Extensionater) 2. st atic Progressive Stretch devices (SPS) (for example, Joint Active Systems (JAS) splints (for example, JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination)E. Conditions of Coverage All claims for LLPS are subject to post-payment review by CareSource. F. Related Policies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 11/09/2023 New PolicyDate Revised 02/15/2023 06/07/2023e-voted addition of ankle and toe to policy to match fee schedule and MCG. Annual review. Added examples of PASS and SPS devices. Mechanical Stretching Devices-MP-MM-1382 Effective Date: 06/01/2025 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. 405/22/202403/12/2025 Annual review . Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee Date Effective 06/01/2025 Date Archived H. References1. Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther. 2013;30(8):763-770. Accessed January 29, 2025. www.ncbi.nlm.nih.gov 2. Dynamic Joint Extension and Flexion Devices: ACG A-0882. MCG. 28th ed. 2024. Accessed January 29, 2025. www.careweb.careguidelines.com 3. Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution predictors of contracture resolution. JHand Ther. Accessed January 29, 2025. www.jhandtherapy.org 4. Harvey LA, Katalinic OM, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database of Systematic Reviews. 2017. Accessed January 29, 2025. www.pubmed.ncbi.nlm.nih.gov 5. Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Hayes, Inc. 2022. Accessed January 29, 2025. www.hayesinc.com 6. Jongs RA, Harvey LA, Gwinn T, et al. Dynamic splints do not reduce contracture following distal radial fracture: a randomised controlled trial. JPhysiother. 2012;58(3):173-180. Accessed January 29, 2025. www.reader.elsevier.com 7. Zatarain LA, Smith DK, Deng J, et al. A randomized feasibility trial to evaluate use of the jaw dynasplint to prevent trismus in patients with head and neck cancer receiving primary or adjuvant radiation-based therapy. Integr Cancer Ther. 2018;17(3):960-967. doi:10.1177/1534735418784363. I nde pendent med ica l rev iew 12/21
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