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 STATEMENTMarketplace Policy Name & Number Date Effective Nutritional Supports-MP-MM-1330 09/01/2025 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 ………………………….. ………………………….. ………………………….. ………………………….. .. 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-1330Effective 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. SubjectNutritional Supp orts B. BackgroundEnteral nutrition may be necessary to maintain optimal health status for individuals with diseases or structural defects of the gastrointestinal (GI) tract that interfere with transport, digestion, or absorption of nutrients. Such conditions may include an atomic 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, gastroin testinal 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 nutri tion 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 th eintestine of members with pancreatic insufficiency. The product is designed to fit in series with currently used enteral feeding circuits.Breastfeeding is recommended by healthcare professionals and the U.S. Department of Health and Human Services. Research shows that breastfeeding provides healthbenefits for both the mother and the child. In some situations, parents may look for alternative sources of human breast milk to feed their babies. Donor milk banks take voluntary steps to screen milk donors and safely collect, process, handle, test, and store the milk. C. Definitions Chronological Age The time elapsed after birth, usually described in days, weeks, months, and/or years. Corrected Age A term most appropriately used to describe children up to 3 years of age who were born preterm or before gestational age of 37 weeks. This term represents the age of the child from the expected date of delivery (mothers due date). Corrected age is calculated by subtracting the number of weeks born before 40 weeks of gestation from the chronological 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-1330Effective 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 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 nee ds 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 al l the following minimum criteria to be considered a medical food: o The product must be a food for oral or tube feeding. o The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements. o The product must be used under the supervision of a physician. Oral Nutrition ( Oral Feeding) Nutritional support given via 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-1330Effective 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 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 (e g, 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-1330Effective 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 05. diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider06. 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 25 th 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-1330Effective 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 II. Enteral Nutrition via Tube :A. Enteral nutrition requests for members with inborn error s 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 fee ding 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 d ocumentation of a medical basis for the inability of the member to maintain appropriate body weight and nutritional status (initial and ongoing) with normal or therapeutic enteral nutrition . For example, malnutrition that is moderate to severe and unresponsive to standard age-appropriate interventions. 4. There is d ocumentation of ongoing evidence of members positive response to the enteral nutrition . For example, individuals who have improved from moderate to severe malnutrition to mild malnutrition or normal health status may require documentation/evidence indicating that without the supplementation there is a risk of decline in nutritional status. 5. The product 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-1330Effective 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 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 support s medical necessity . 3. Documentation support s 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 normal 7. flavorings D. Relizorb (insufficient published evidence) E. oral nutrition products for meal replacements or snack alternatives F. feeding tubes for individuals with a dvanced dementia G. products administered in an outpatient provider setting; these items are not separately reimbursable E. State-Specific InformationA. 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-1330Effective 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 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. Kentucky 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 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 (202 4). Accessed July 1, 2024 . www.caresource.com F. Conditions of CoverageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 08/17/2022Date Revised 08/02/2023 07/17/202406/04/2025Annual review: updated references, added malnutrition definition, clarified criteria for IEM. Approved at Committee. Review: updated references, title changed from Supplements to Supports. Approved at Committee. 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.12924 Nutritional Supports-MP-MM-1330Effective 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 2. Burris A, Burris J, Jarvinen KM. Cows milk protein allergy in term and preterm infants: clinical manifestations, immunologic pathophysiology, and management strategies. NeoReviews . 2020;21(12):e795-e808. doi:10.1542/neo.21-12-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 Dept of Health and Human Services; 2023. Accessed 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. Marchand V, Motil KJ; NASPGHAN Committee on Nutrition. Nutrition support for neurologically impaired children: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. JPediatr Gastroenterol Nutr . 2006;43(1):123-135. 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. J Par enteral and Ent eral Nutr . 2017;41(5):703-900. doi:10.1177/0148607117711387 16. 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 Nutritional Supports-MP-MM-1330Effective 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.10 ASPEN Board of Directors-Approved Documents. May 2018. Accessed June 3,2025 . www.nutritioncare.org 18. U.S. Food and Drug Administration. RELiZORB K232784. December 21, 2023. Accessed June 3, 2025. www.accessdata.fda.gov 19. 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. U.S. Social Security Administration (SSA). Program Operations Manual System (POMS) – DI 24598.002. Failure to Thrive (FTT). February 9, 2016. Accessed June 3, 2025 . www.secure.ssa.gov 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? J Parenteral 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 Standing Frames-MP-MM-1336 08/01/2025 KY 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 ………………………….. ………………………….. ………………………….. … 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 I. References ………………………….. ………………………….. ………………………….. ……………………. 5 Standing Frames-MP-MM-1336Effective 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. SubjectStanding Frames B. BackgroundSupported standing is a common, adjunctive therapeutic practice in which patients with neurological conditions are enabled to assume an upright position. Home-based standing programs are commonly recommended for adults and children who cannot stand and/or walk independently and are usually part of a postural management program, which plays a role in preventing contracture, deformity, pain, and asymmetry. Standers might include prone, supine, vertical, multi-positional and sit-to-stand types. Standing frames consist of a simple base with an upright support to which the patient can be strapped. These devices provide no mobility, but research has shown medical benefits supporting use, including an enhanced ability to perform tasks, maintained or improved joint range of motion, muscle spasticity and bone density, and an enhanced ability to perform activities of daily living. In recent studies, some adults and children report a decrease in pain, suppository use, decubitus ulcers, urinary tract infec tions(UTI), and clinical depression, while reporting an increase in improved bowel function, breathing, circulation , and muscle tone.Psychological benefits have also been documented and include improved socialization, patient satisfaction and quality of life due to improved interacti on with others. Additionalbenefits for some patients can include enhanced independence, improved vocational activities, and increased recreational activities with peers and others, which have been reported to instill a heightened sense of confidence and equ ality and improved self-esteem in children and adults. Acceptance by others and a sense of integration is perceived to be higher among standing frame users. No adverse events or effects have been frequently reported or documented in literature,but some contraindications have been widely discussed. Additionally, many patients do not report pain with use of standing frames. With the added benefit of the enhancement of functional recovery with early physical rehabilitation, many providers are adding supported standing as a practice in postural management after consideration of contraindications is examined by a medical professional . C. Definitions Activities of Daily Living (ADLs) Fundamental skills required to independently care for oneself, including the following 2 categories : o Basic ADLs Skills required to manage ones basic physical needs, including ambulation, feeding, dressing, personal hygiene, continence and toileting. o Instrumental ADLs Skills that require more complex thinking (eg, transportation , s hopping, finance management, meal preparation, house cleaning , home maintenance, communication , medication management ). Durable Medical Equipment (DME) A collective term for a covered durable medical equipment item, prosthetic device, orthotic device, or medical supply item Standing Frames-MP-MM-1336Effective 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 furnished by an eligible provider to an eligible recipient , can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury , and is not worn in or on the body. Postural Management A multi-disciplinary approach incorporating a comprehensive schedule of daily and night-time positions, equipment, and physical activity to help maintain or improve body structures and function and increase activity and participation. D. PolicyI. CareSource will review medical necessity requests for non-powered standing frames on a case-by-case basis once ALL the following information is submitted for review: A. New Equipment 1. stander information, including ALL the following details as available : a. manufacturer b. model number c. type of stander d. part number, if applicable e. itemized list of additional attachments and accessories with individual prices if not included with the basic stander or if applicable 2. a prescription, which includes ALL the following: a. length of time specifying validity of the prescription b. dated signature of an appropriately licensed/certified and/or credentialed medical professional with a professional relationship with the recipient c. recipient diagnosis( -es) that document s a neuromuscular condition (eg, multiple sclerosis, cerebral palsy, spinal cord injury, stroke) or developmental delay impairing an ability to stand independently 3. documentation showing that the member or parent/guardian received training in use of standers or standing frames, which can be completed during a scheduled therapy session for the member, if applicable 4. documentation showing the member or parent/guardian can safely use the device in the home setting (eg, documentation from physical therapy or other therapy sessions documenting trials of use suffice) of member or parent/guardian training in use of standers or standing frames and an ability to safely use the device in the home setting 5. documentation that device use can be reasonably expected to provide therapeutic benefits or enable the recipient to perform certain tasks unable to perform otherwise due to the diagnosis, such as , but not limited to , 1 or more of the following: a. aids in the prevention of atrophy in the trunk and leg muscles b. improves strength and/or circulation to the trunk and lower extremities c. prevents formation of decubitus ulcers with changeable positions d. helps maintain bone and/or skin integrity e. reduces swelling in the lower extremities f. improves range of motion and/or aids normal skeletal development g. improves function of kidneys, bladder, and/or bowels Standing Frames-MP-MM-1336Effective 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. decreases muscle spasms i. strengthens the cardiovascular system and builds endurance j. prevents or decreases muscle contractures and/or progressive scoliosis k. improves social interaction and psychological well-being l. increase performance of activities of daily living (ADLs) 6. no contraindications to supported standing, such as but not limited to a. healing fracture or severe osteoporosis preclud ing weight bearing of any kind b. significant hip or knee flexion or ankle plantarflexion contractures in which stretch or pressure prevents standing c. compromised cardiovascular or respiratory systems that require frequent monitoring o f circulation and function while in a stander d. significant inflexible skeletal deformities e. lack of standing tolerance (ie, cannot maintain a standing position due to little or no residual strength in the hips, legs, or lower body) f. postural hypotension B. Replacement of a non-powered standing frame is considered medically necessary after 5 years when both the following criteria have been met: 1. medical necess ity criteria above 2. device is out of warranty and cannot be refurbished or adequately repaired II. The following items or services are not covered or separately reimbursable:A. electric, motorized or powered standing frames B. items or services covered under manufacturer or dealer warranty C. DME items duplicat ing or conflict ing with another item currently in the recipient’s possession D. replacement items or previously approved equipment that have been damaged due to perceived misuse, abuse, or negligence E. State-Specific InformationI. Kentucky A. Prescriber" in section D. I. A. 2. applies to the following medical personnel who are acting within the legal scope of clinical practice under the licensing laws of the Kentucky, are in good standing with the appropriate licensure board and CMS, and have the legal authority to write an order for a medically necessary item of durable medical equipment for a recipient 1. physician (MD or DO ) 2. advanced practice registered nurse (APRN) 3. physician assistant (PA) B. A prescriber shall examine a recipient within 60 calendar days prior to the initial order of a DME item. II. Ohio A. The dated signature noted in section D. I. A. 2. must be one of the following appropriately Ohio-licensed and/or certified and credentialed medical professionals who has a professional relationship with the recipient Standing Frames-MP-MM-1336Effective 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 1. physician (MD or DO)2. advanced practice registered nurse (APRN) with a relevant specialty 3. physician assistant (PA) B. A prescription is valid for 60 days unless a different length of time is specified. F. Conditions of CoverageNA G. Related Policies/RulesMedical Necessity Determinations H. Review/Revision HistoryDATE ACTIONDate Issued 08/31/2022 New policy.Date Revised 08/02 /2023 07/17 /2024 05/07/2025 Annual review. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Annual revew: updated references. Approved at Committee. Date Effective 08/01/2025 Date Archived I. References1. Arva J, Paleg G, Lange M, et al. RESNA position on the application of wheelchair standing devices. Assist Technol . 2009;21(3):161-171. doi:10.1080/1044393175622 2. Capati V, Covert SY, Paleg G. Stander use for an adolescent with cerebral palsy at GMFCS level with hip and knee contra ctures. Assist Technol . 2020;32(6):335-341. doi:10.1080/10400435.2019.1579268 3. Definitions , OHIO REV . CODE 4752.01 (2022). 4. Definitions-Home Medical Equipment , OHIO ADMIN . CODE 4729:11-1-01 (2022). 5. Durable Medical Equipment , IND . ADMIN . CODE 6-2.5-1-18 (2022). 6. Edemekong PF, Bomgaars DL, Sukumaran S, et al . Activities of Daily Living. In: StatPearls . StatPearls Publishing; 202 3. 7. Ferrarello F, Deluca G, Pizzi A. et al . Passive standing as an adjunct rehabilitation intervention after stroke: a randomized controlled trial. Arch Physiothe . 2015; 5(2). doi:10.1186/s40945-015-0002-05 8. Georgia Marketplace Evidence of Coverage . CareSource; 202 5. Accessed April 16, 2025 . www.caresource.com 9. Goodwin J, Lecouturier J, Basu A, et al. Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess . 2018;22(50):1-232. doi:10.3310/hta22500 10. Ibitoye MO, Hamzaid NA, Ahmed YK. Effectiveness of FES-supported leg exercise for promotion of paralysed lower limb muscle and bone health a systematic review. Biomed Tech (Berl) . 2023;68(4):329-350. doi:10.1515/bmt-2021-0195 11. Indiana Marketplace Evidence of Coverage . CareSource; 202 5. Accessed April 16, 2025 . www.caresource.com Standing Frames-MP-MM-1336Effective 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.6 12. Kentucky Marketplace Evidence of Coverage . CareSource; 202 5. Accessed April 16,2025 . www.caresource.com 13. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrs M, et al . Standing programs to promote hip flexibility in children with spastic diplegic cerebral palsy. Pediatr Phys Ther . 2015;27(3):243-249. doi:10.1097/PEP.0000000000000150 14. Martinsson C, Himmelmann K. Abducted standing in children with cerebral palsy: effects on hip development after 7 years. Pediatr Phys Ther . 2021;33(2):101-107. doi:10.1097/PEP.0000000000000789 15. Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil . 2012;26(12):1059-1077. doi:10.1177/0269215512443373 16. Ohio Marketplace Evidence of Coverage . CareSource; 202 5. Accessed April 16, 2025 . www.caresource.com 17. Paleg G, Livingstone R. Evidence-informed clinical perspectives on postural management for hip health in children and adults with non-ambulant cerebral palsy. J Pediatr Rehabil Med . 2022;15(1):39-48. doi:10.3233/PRM-220002 18. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord . 2015;16:358. doi:10.1186/s12891-015-0813-x 19. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther . 2013;25(3):232-247. doi:10.1097/PEP.0b013e318299d5e7 20. Pedlow K, McDonough S, Lennon S, et al . Assisted standing for Duchenne muscular dystrophy. Cochrane Database Syst Rev . 2019;10(10):CD011550. doi:10.1002/14651858.CD011550.pub2 21. Standing frame : A-0996. MCG . 29th ed draft . Updated January 25, 2025 . Accessed April 10, 2025 . www.careweb.careguidelines.com 22. Synnot A, Chau M, Pitt V, et al. Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev . 2017;11(11):CD 00 8929. doi:10.1002/14651858.CD008929.pub2 23. West Virginia Marketplace Evidence of Coverage . CareSource; 202 5. Accessed April 16, 2025 . www.caresource.com Independent med ical review 08/2022
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Peripheral Nerve Stimulators for Treatment of Pain-MP – MM-1403 08/01/2025Kentucky Inactive 01/01/2026Policy 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. State-Specific Information ………………………….. ………………………….. ………………………….. …. 3 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. …… 3 I. References ………………………….. ………………………….. ………………………….. …………………….. 3 Peripheral Nerve Stimulators for Treatment of Pain-MP-MM-1403Effective 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. SubjectPeripheral Nerve Stimulators for Treatment of Pain B. BackgroundThe role of peripheral nerves as sources of pain and avenues of treatment when conservative therapy has failed is being more extensively explored than in previous years. Neuromodulation of peripheral nerves to treat refractory pain is one such area of interest. The neuromodulation of peripheral nerves to reduce pain, k nown as peripheral nerve stimulation (PNS), has been developed as a minimally invasive pain management modality intended to manage acute and chronic pain. The proposed mechanism of action, referred to as the gate control theory, involves a method by which stimulation of large-diameter sensory neurons reduces transmission ofpainful stimuli from small nociceptive fibers to the brain. The stimulation system is placed adjacent to the nerve, a process commonly known as remote selective targeting. The lead is connected to a small, wearable stimulator. Depending on the device, the wearer may be able to adjust the level of stimulation using Bluetooth technology. C. Definitions Acute Pain Pain lasting 4 weeks or less. Chronic Pain A distressing feeling often caused by intense or damaging stimuli (pain) lasting more than 3 months, considered beyond normal healing time. Conservative Therapy A multimodality plan of care for treating pain non – surgically, including active and inactive conservative therapies. o Active A type of action or activity to strengthen supporting muscle groups and target key spinal structures, including physical therapy, occupational therapy, a physician-supervised home exercise program (HEP), and/or chiropractic care. o Inactive Lack of activity on behalf of the patient that aids in treating symptoms associated with pain but not necessarily the underlying source, including rest, ice, heat, medical devices, acupuncture, and/or prescription medications. Minimally Invasive Procedures involving entry into the body through small incisions to lessen recovery time, level of pain and risk of infection. Sub-Acute Pain Pain lasting between 4 and 12 weeks. D. PolicyI. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. Peripheral nerve stimulators are considered experimental and investigational and are unproven for all indications for the reduction of acute, sub-acute , and chronic pain.III. Peripheral nerve stimulators are not covered. This includes but is not limited to:Peripheral Nerve Stimulators for Treatment of Pain-MP-MM-1403Effective 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 A. IB-StimB. SPRINT PNS System C. Nal u Neurostimulation System D. StimRouter Neuromodulation System E. Moventis PNS F. StimQ PNS System E. State-Specific InformationN/A F. Conditions of CoverageN/A G. Related Policies/RulesCareSource Evidence of Coverage Medical Necessity Determinations H. Review/Revision HistoryDATE ACTIONDate Issued 01/18/2023Date Revised 01/17/2024 06/05/2024 05/07/2024 Annual Review; updated references. Approved at Committee. Revised Background, added D. III. A. Approved at Committee Annual review, references updated. Approved at Committee Date Effective 08/01/2025 Date Archived I. References1. Abd-Elsayed A, Keith MK, Cao NN, Fiala KJ, Martens JM. Temporary peripheral nerve stimulation as treatment for chronic pain. Pain Ther . 2023;12(6):1415-1426. doi:10.1007/s40122-023-00557-3 2. Albright-Trainer B, Phan T, Trainer RJ, et al. Peripheral nerve stimulation for the management of acute and subacute post-amputation pain: a randomized, controlled feasibility trial. Pain Manage . 2022;12(3):357-369. doi:10.2217/pmt-2021-0087 3. Char S, Jin MY, Francio VT, et al. Implantable peripheral nerve stimulation for peripheral neuropathic pain: a systematic review of prospective studies. Biomed . 2022;10(10)2606. doi:10.3390/biomedicines10102606 4. DSouza RS, Jin MY, Abd-Elsayed A. Peripheral nerve stimulation for low back pain: a systematic review. Curr Pain Headache Rep . 2023;27:117-128. doi:10.1007/s11916-023-01109-2 5. Evidence Analysis Research Brief: Peripheral Nerve Stimulation for the Treatment of Superior Cluneal Neuralgia. Hayes; 2024. Accessed April 10, 2024. www.evidence.hayesinc.com 6. Evolving Evidence Review: IB-Stim (NeurAxis) for Treatment of Pain Associated with Irritable Bowel Syndrome in Adolescents. Hayes; 2022. Reviewed July 17, 2024. Accessed April 10, 2025. www.evidence.hayesinc.com Peripheral Nerve Stimulators for Treatment of Pain-MP-MM-1403Effective 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 7. Evolving Evidence Review: SPRINT PNS System (SPR Therapeutics) for Chronic Pain. Hayes; 2021. Updated February 27, 2025. Accessed April 10, 2025. www.evidence.hayesinc.com8. Hatheway J, Hersel A, Song J, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3-month and 6-month results from the COMFORT-randomised controlled trial. Reg Anesth Pain Med . 2024;0:1-7. doi:10.1136/rapm-2023-105264 9. Health Technology Assessment: Percutaneous Peripheral Nerve Stimulation for Treatment of Chronic Pain. Hayes; 2022. Reviewed May 8, 2024. Accessed April 10, 2025. www.evidence.hayesinc.com 10. Health Technology Assessment: Peripheral Nerve Field Stimulation for Treatment of Chronic Low Back Pain. Hayes; 2021. Reviewed April 17, 2024. Accessed April 10, 2025. www.evidence.hayesinc.com 11. Helm S, Shirsat N, Calodney A, et al. Peripheral nerve stimulation for chronic pain: a systematic review of effectiveness and safety. Pain Ther . 2021;10(2):985-1002. doi:10.1007/s40122-021-00306-4 12. Huntoon MA, Slavin KV, Hagedorn JM, et al. A retrospective review of real-world outcomes following 60-day peripheral nerve stimulation for the treatment of chronic pain. Pain Physician . 2023;26(3):273-281. Accessed April 10, 2025. www.painphysicianjournal.com 13. Kaye AD, Ridgell S, Alpaugh ES, et al. Peripheral nerve stimulation: a review of techniques and clinical efficacy. Pain Ther . 2021;10(2):961-972. doi:10.1007/s40122 – 021-00298-1 14. Li AH, Gulati A, Leong MS, et al. Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain. an international cross-sectional survey of implanters. Pain Pract . 2022;22(5):508-515. doi:10.1111/papr.13105 15. Luna D, Hettie G, Pirrotta L, et al. Real-world long-term outcomes of peripheral nerve stimulation: a prospective observational study. Pain Manag . 2025;15(1):37-44. doi:10.1080/17581869.2025.2451605 16. McCullough M, Kenney D, Curtin C, et al. Peripheral nerve stimulation for saphenous neuralgia. Reg Anesth Pain Med . 2024;49(6):455-460. doi:10.1136/rapm-2023 – 104538 17. Smith BJ, Twohey EE, Dean KP, DSouza RS. Peripheral nerve stimulation for the treatment of postamputation pain: a systematic review. Am JPhys Med Rehabil . 2023;102(9):846-854. doi:10.1097/PHM.0000000000002237 18. Strand N, DSouza RS, Hagedorn JM. Evidence-based clinical guidelines from the American Society of Pain and Neuroscience for the use of implantable peripheral nerve stimulation in the treatment of chronic pain. JPain Res . 2022;15:2483-2504. doi:10.2147/JPR.S362204 19. Vangeison CT, Bintrim DJ, Saha AK, et al. The role of peripheral nerve stimulation in refractory non-operative chronic knee osteoarthritis. Pain Manag . 2023;13(4):213 – 218. doi:10.2217/pmt-2023-0025 20. West T, Hussain N, Bhatia A, et al. Pain intensity and opioid consumption after temporary and permanent peripheral nerve stimulation: a 2-year multicenter analysis. Reg Anesth Pain Med . 2024. doi:10.1136/rapm-2024-105704 Peripheral Nerve Stimulators for Treatment of Pain-MP-MM-1403Effective 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 21. Xu J, Sun Z, Wu J, et al. Peripheral nerve stimulation in pain management: a systematic review. Pain Physician . 2021;24(2):E131-E152. Accessed April 10, 2025. www.painphysicianjournal.com
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 Breast Reconstruction Surgery-MP-MM-1360 07/01/2025 KY 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 ………………………….. ………………………….. ………………………….. … 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 I. References ………………………….. ………………………….. ………………………….. ……………………. 4 Breast Reconstruction Surgery-MP-MM-1360Effective 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. SubjectBreast Reconstruction Surgery B. BackgroundWith an estimated 272,000 new cases yearly, breast cancer continues to be the leading cause of new cancer among women in the United States and a leading cause of cancer death. Breast reconstruction is intended to reduce post-mastectomy complications , es tablish symmetry between the surgical breast and the contralateral breast , and improve quality of life following breast cancer surgery . Breast reconstruction procedures may include breast reduction, breast augmentation with FDA-approved breast implants, nippl e reconstruction (including surgery, tattooing, or both) , and breast contouring. Reconstruction may be performed immediately following a mastectomy or can be delayed for weeks or years until the member has undergone radiation, chemotherapy, or decides th at reconstruction is want ed . Breast augmentation with an FDA-approved implant can be performed in one stage ,during which the implant is inserted during the same surgical visit as the mastectomy, or in two stages using an implanted tissue expander in the first stage followed by removal of the expander and insertion of the permanent breast implant. Complications may occur from breast implants immediately postoperatively or years later and can include exposure, extrusion, infection, contracture, rupture, and /or pain. Clinically significa nt complications may require implant removal. Autologous tissue/muscle breast flap reconstruction is a safe and effective alternative to breast implants. Muscle, subcutaneous tissue, and skin can be transposed from the donor site either locally (eg, latissimus dorsi myocutaneous [LD] flap, pedicled transverse rectus abdominus myocutaneous [TRAM] flap) or distally (eg, free TRAM flap, deep inferior epigastric perforator [DIEP] flap, superficial inferior epigastric artery perforator [SIEP] flap, inferior or superior gluteal flap, superior gluteal artery perforatorflab, Reubens flap, or transverse upper gracilis [TUG] flap). The choice of procedure can be affected by the members age and health, contralateral breast size and shape, personal preference, and expertise of the surgeon. Individuals may also select non-invasive options, such as mastectomy bras and externalbreast prostheses.Refer to MCG for complete mastectomy.C. Definitions Breast Conserving Surgery (Lumpectomy, Partial Mastectomy) Surgical removal of tumor and small amount of surrounding breast tissue. Contralateral Breast Unaffected/nonsurgical breast. Cosmetic Procedures Procedures completed to improve appearance and self – esteem and to reshape normal structures of the body. Mastectomy Surgical remov al of one or both breasts. Breast Reconstruction Surgery-MP-MM-1360Effective 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 D. Policy I. Breast reconstruction is not gender specific. II. Surgical OptionsA. CareSource considers breast reconstruction following treatment for breast cancer medically necessary when ANY of the following apply:1. following mastectomy or breast conserving surgery of the affected breast 2. producing a symmetrical appearance on the contralateral breast B. Breast reconstruction surgery to improve breast function after conservatory therapy and related to significant abnormalities or deformities is considered medically necessary when ANY of the following apply : 1. malignant breast disease 2. congenital deformities that affect the members physical and psychological being 3. severe fibrocystic breast disease that limits the members function 4. unintentional trauma or injuries 5. unintentional complications after breast surgery for non-malignant conditions (eg, pain, irritation, bleeding, discharge , complication s causing difficulty with lactation ) III. CareSource considers bilateral risk-reducing mastectomy medically necessary. Refer to MCG Guidelines Mastectomy, Complete for more information. IV. CareSource considers treatment of physical complications , including lymphedema ,following breast reconstruction medically necessary. V. Surgical ExclusionsA. CareSource does not cover any breast reconstruction procedures that are considered experimental, investigationa l, or unproven. B. CareSource does not cover: 1. procedures that are considered cosmetic in nature , including natural changes due to aging and weight loss/gain 2. lipectomy for donor site symmetry 3. suction lipectomy or ultrasonically assisted suction lipectomy (liposuction) for correction of surgically induced donor site asymmetry (eg, trunk or extremity) that results from one or more flap breast reconstruction procedures VI. Non-Surgical AlternativesCareSource covers external breast prostheses and mastectomy bras following mastectomy or breast conserving surgery. All other indications are considered not medically necessary. VII. Breast reconstruction with free flap procedures, regardless of technique, applies to CPT code 19364.Breast Reconstruction Surgery-MP-MM-1360Effective 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 E. State-Specific Information NA F. Conditions of CoverageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 11/09/2022Date Revised 09/27/2023 10/23/202404/09/2025Annual review. Updated background. Deleted IV. C. Updated references. Approved at committee. Annual review: updated risk reduction mastectomy and reorganized policy section for clarity. Approved at committee. Review : elevated post-lumpectomy criteria, updated risk – reducing mastectomy . Approved at Committee. Date Effective 07/01/2025 Date Archived I. References1. Alder L, Zaidi M, Zeidan B, et al. Advanced breast conservation and partial breast reconstruction a review of current available options for oncoplastic breast surgery. Ann RColl Surg Engl . 2022;104(5):319-323. doi:10.1308/rcsann.2021.0169 2. Breast reconstruction surgery. American Cancer Society . Updated September 19 , 2022 . Accessed March 18, 2025. www.cancer.org 3. Breast cancer statistics. Centers for Disease Control and Prevention. Accessed March 18, 2025. www.cdc.gov 4. Centers for Medicare and Medicaid Services. Womens Health and Cancer Rights Act (WHCRA) . Accessed March 18, 2025. www.cms.gov 5. Colwell AS, Taylor EM. Recent advances in implant-based breast reconstruction. Plast Reconstr Surg. 2020;145(2):421e-432e. doi:10.1097/PRS.0000000000006510 6. Costanzo D, Klinger M, Lisa A, Maione L, Battistini A, Vinci V. The evolution of autologous breast reconstruction. Breast J . 2020;26(11):2223-2225. doi:10.1111/tbj.14025 7. Friedrich M, Kramer S, Friedrich D, Kraft C, Maass N, Rogmans C. Difficulties of breast reconstruction problems that no one likes to face. Anticancer Res . 2021;41(11):5365-5375. doi:10.21873/anticanres.15349 8. Gradishar WJ, Moran MS, Abraham J, et al . NCCN guidelines insights: breast cancer, version 4.2023. JNatl Compr Canc Netw . 2023;21(6):594-608 . doi:10.6004/jnccn.2023.0031 Breast Reconstruction Surgery-MP-MM-1360Effective 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 9. Griffin C, Fairhurst K, Stables I, et al. Outcomes of women undergoing mastectomy for unilateral breast cancer who elect to undergo contralateral mastectomy for symmetry: a systematic review. Ann Surg Oncol . 2024;31(1):303-315. doi:10.1245/s10434-023-14294-6 10. Guliyeva G, Torres RA, Avila FR, et al. The impact of implant-based reconstruction on persistent pain after breast cancer surgery: a systematic review. JPlast Reconstr Aesthet Surg . 2022;75(2):519-527. doi:10.1016/j.bjps.2021.09.079 11. Health technology assessment : c omparative effectiveness review of human acellular dermal matrix for breast reconstruction. Hayes Inc. Reviewed February 28, 2022. Accessed March 18, 2025. evidence.hayesinc.com 12. Health technology assessment : a utologous fat grafting for breast reconstruction after breast cancer surgery. Hayes, Inc. Review ed November 13, 2023 . Accessed March 18, 2025. evidence.hayesinc.com 13. Mastectomy, complete: S-860. MCG Health, 29th ed draft. Updated January 25, 2025. Accessed March 20, 2025. careweb.careguidelines.com 14. Nahabedian M. Options for autologous flap-based breast reconstruction. UpToDate. Updated April 29, 2024. Accessed March 18, 2025. www.uptodate.com 15. Nahabedian M. Overview of breast reconstruction. UpToDate. Updated May 24, 2023. Accessed March 18, 2025. www.uptodate.com 16. Pappalardo M, Starnoni M, Franceschini G, et al. Breast cancer-related lymphedema: recent updates on diagnosis, severity and available treatments. JPers Med . 2021;11(5):402. doi:10.3390/jpm11050402 17. Sab el MS. Breast conserving therapy. UpToDate. Updated September 11, 2023. Accessed March 18, 2025. www.uptodate.com 18. Tomita K, Kubo T. Recent advances in surgical techniques for breast reconstruction. Int JClin Oncol . 2023;28(7):841-846. doi:10.1007/s10147-023-02313-1 19. Toyserkani NM, Jorgensen MG, Tabatabaeifar S, Damsgaard T, Sorensen JA. Autologous versus implant-based breast reconstruction: a systematic review and meta-analysis of Breast-Q patient-reported outcomes. JPlast Reconstr Aesthet Surg . 2020;73(2):278-285. doi:10.1016/j.bjps.2019.09.040 20. Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer . 2020;27(4):534-566. doi:10.1007/s12282-020-01076-1
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
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Breast Reduction Surgery-MP-MM-1421 06/01/2025 KY 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 ………………………….. ………………………….. ………………………….. … 6 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 7 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 I. References ………………………….. ………………………….. ………………………….. ……………………. 7 Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectBreast Reduction Surgery B. BackgroundWomen diagnosed with macromastia (excessively large breasts) seeking breast reduction typically present with complaints of a feeling of heaviness, chronic pain, and tension in the neck, shoulders, and upper back. Macromastia commonly causes permanent grooving an d ulceration of the shoulder following years of wearing support bras to try to minimize symptoms. The physical and psychological symptoms of macromastia can significantly and negatively impact an individuals life and should be taken into considerati on when evaluating surgical intervention. Reduction mamm aplasty is a surgical procedure that reduces the weight and volume ofthe breast. As much as 1 to 5 pounds of excess breast tissue is routinely removed during a reduction mamm aplasty depending on breast and body mass . Indications for surgery include chronic pain and skin symptoms , neuropathy, breast discomfort, physical impairment , and psychological symptoms that can be associated with poor self-esteem and loss of desire to engage in activities. Gynecomastia is a benign proliferation of glandular tissue of the breast in males . Thiscondition may be caused by androgen deficiency, congenital disorders, medications,chronic medical conditions, tumors, or endocrine disorders. Depending on the cause of the tissue proliferation, surgical removal may be considered cosmetic or medically necessary. C. Definitions Body Surface Area (BSA) A metric used for physiologic measurements, pharmacologic dosing, and therapeutic calculations, including the Schnur Sliding Scale for breast reduction surgery. Cosmetic Procedures Procedures performed for aesthetic purposes that do not improv e or restor e physiologic function. Functional/Physical or Physiological Impairment Impairment causes deviation from the normal function of a tissue or organ. This results in a significantly limited, impaired or delayed capacity to move and coordinate actions or perform physical activities and is exhibited by difficulties in physical and m otor tasks, independent movement, or performing basic life functions. Gynecomastia Enlargement of the male breast secondary to a proliferation of ductal, stromal, and/or fatty tissue. Gynecomastia Scale A qualitative classification system for gynecomastia developed by the American Society of Plastic Surgeons (ASPS). o Grade I Small breast enlargement with localized button of tissue that is concentrated around the areola. o Grade II Moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest. Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 o Grade III Moderate breast enlargement exceeding areola boundaries with edges that are distinct from the chest with skin redundancy present. o Grade IV Marked breast enlargement with skin redundancy and feminization of the breast. Intertriginous Rash Dermatitis occurring between juxtaposed folds of skin , caused by retention of moisture and warmth and providing an environment favoring overgrowth of normal skin micro-organisms. Kyphosis Over-curvature of the thoracic vertebrae (upper back) associated with degenerative diseases , such as arthritis, developmental problems, or with osteoporotic compression fractures of vertebral bodies. Macromastia (Breast Hypertrophy) An increase in the volume and weight of breast tissue relative to the general body habitus. Symptomatic Breast Hypertrophy A syndrome of persistent neck and shoulder pain, shoulder grooving from brassiere straps, chronic intertriginous rash of the infra – mammary fold and/or frequent episodes of headache, backache, and upper extremity neuropathies caused by an increase in the volu me and weight of breast tissue beyond normal proportions. Schnur Sliding Scale Use d in calculating the amount of breast tissue to be removed in reduction mammoplasty (Appendix A). D. PolicyI. CareSource considers breast reduction surgery for macromastia medically necessary when ALL the following criteria are met and have been documented : A. Member is 18 years or older or under 18 years with evidence that breasts have finished growing for a minimum of 1 year . P arental/guardian consent is required for members under age 18 . B. Breast size interferes with activities of daily living, as indicated by 1 or more of the following: 1. arm numbness consistent with brachial plexus compression syndrome 2. cervical pain 3. chronic breast pain 4. headaches 5. nipple position greater than 21 cm below suprasternal notch 6. persistent redness and erythema (intertrigo) below breasts 7. restriction of physical activity 8. severe bra strap grooving or ulceration of shoulder 9. shoulder pain 10. thoracic kyphosis 11. upper or lower back pain C. Preoperative evaluation by surgeon concludes that amount of breast tissue to be removed (by mass or volume) will provide a reasonable expectation of symptomatic relief. D. No evidence of breast cancer 1. physical exam completed by a physician within the last year if under 40 years of age Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 2. women 40 to 54 years of age or older with mammogram negative for cancer performed within the year prior to the date of the planned breast reduction surgery 3. women 55 years of age and older with negative mammograms for cancer every 2 years 4. women with family history of breast cancer with mammograms starting at least 7 years prior to when the youngest family member was diagnosed with breast cancer (as early as 30 years old) II. Breast reduction surgery following mastectomy to achieve symmetry is covered as part of the Womens Health and Cancer Rights Act (WHCRA). Please refer to the CareSource Medical policy , Breast Reconstruction Surgery , for additional information. III. CareSource considers breast reduction surgery for gynecomastia medically necessary when ALL the following clinical criteria are met and have been documented: A. Member is 18 years or older , or under 18 years with evidence that breasts have finished growing for a minimum of one year . Parental/guardian consent is required for members under age 18 . B. A physical exam has been conducted by an appropriately credentialed provider and confirms the presence of gynecomastia: 1. pubertal male (adolescent) a. gynecomastia present for more than 1 year after pathological causes ruled out b. Gynecomastia Grade II, III, or IV 2. postpubertal male a. gynecomastia present for more than 3 months after pathological causes ruled out b. Gynecomastia Grade III or IV C. The tissue being removed is glandular breast tissue and not the result of obesity, adolescence, or reversible effects of drug treatment that can be discontinued. D. The gynecomastia is attributed to an underlying condition (not an all-inclusive list), including: 1. androgen deficiency 2. chronic liver disease that causes decreased androgen availability 3. Klinefelter syndrome 4. adrenal tumors that cause androgen deficiency or increased secretion of estrogen 5. brain tumors that cause androgen deficiency 6. testicular tumors that cause androgen deficiency or tumor secretion of estrogen 7. endocrine disorders (eg, hyperthyroidism) E. The gynecomastia causes functional impairment (eg , pain, chronic irritation) and breast reduction surgery is not for cosmetic reasons. F. Breast malignancy was ruled out. Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 IV. Schnur Sliding Scale The Schnur Sliding Scale is one of several evaluation tool s used to determine the appropriate volume of tissue to be removed relative to a members total body surface area ( BSA ). This estimation can be instrumental in determining whether breast reduction surgery is being planned for cosmetic reasons or as a medically necessary procedure. A. The weight of tissue to be removed from each breast is recommended to be above the 22 nd percentile on the Schnur Sliding Scale (Appendix A below) based on the members BSA. B. The BSA in meters squared (m 2) is calculated using the Mosteller formula (square root of the result of height (in ches ) multiplied by weight (lbs) and divided by 313 1). Appendix A: Schnur Sliding ScaleBody Su rface Ar ea an d M inim um Re quire ment for Breast Tissue R emoval Body Surface Area ( m2)Gr ams per Br east of Minimum Breast T issue to be Remo ved1.350-1.374 1991.375-1.399 208 1.400-1.424 218 1.425-1.449 227 1.450-1.474 238 1.475-1.499 249 1.500-1.524 260 1.525-1.549 272 1.550-1.574 284 1.575-1.599 297 1.600-1.624 310 1.625-1.649 324 1.650-1.674 338 1.675-1.699 354 1.700-1.724 370 1.725-1.749 386 1.750-1.774 404 1.775-1.799 422 1.800-1.824 441 1.825-1.849 461 Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 1.850-1.874 4821.875-1.899 504 1.900-1.924 527 1.925-1.949 550 1.950-1.974 575 1.975-1.999 601 2.000-2.024 628 2.025-2.049 657 2.050-2.074 687 2.075-2.099 717 2.100-2.124 750 2.125-2.149 784 2.150-2.174 819 2.175-2.199 856 2.200-2.224 895 2.225-2.249 935 2.250-2.274 978 2.275-2.299 10 22 2.300-2.324 10 68 2.325-2.349 11 17 2.350-2.374 11 67 2.375-2.399 12 19 2.400-2.424 12 75 2.425-2.449 13 33 2.450-2.474 13 93 2.475-2.499 14 55 2.500-2.524 15 22 2.525-2.549 15 90 2.550 or grea ter 16 62 E. State-Specific InformationN/A F. Conditions of CoverageN/A Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 G. Related Policies/Rules Breast Reconstruction Surgery Medical Necessity Determinations H. Review/Revision HistoryDATE ACTIONDate Issued 01/18/2023 New policyDate Revised 03/15/2023 06/21/202302/28/202404/24/202403/12 /2025Revised D.I, D.I.A., D.II. and D.II.A. Updated references. Approved at Committee . Removed II. C. Updated references. Approved at Committee. Revision: editorial changes, removed definitions, expanded policy to cover members under 18 years of age, and updated references. Approved at Committee. Revision: added BI-RADS to background, aligned gynecomastia surgery with EOC, added Section II I, added references. Approved at Committee. Annual review: updated background and definitions, added D.I.D.4., revised gynecomastia criteria, and updated references. Approved at Committee. Date Effective 06/01/2025 Date Archived I. References1. ASPS recommended insurance coverage criteria for third-party payers: gynecomastia. American Society of Plastic Surgeons. Accessed March 3, 2025. www.plasticsurgery.org 2. ASPS recommended insurance coverage criteria for third-party payers: reduction mammaplasty. American Society of Plastic Surgeons. Accessed March 3, 2025. www.plasticsurgery.org 3. Billa E, Kanakis GA, Goulis DG. Imaging in gynecomastia. Andrology . 2021;9(5):1444-1456. doi:10.1111/andr.13051 4. Biro FM, Chan YM. Normal puberty. UpToDate. Updated September 24, 2024 . Accessed January 31, 2025 . www.uptodate.com 5. Braunstein G D, Anawalt BD. Clinical features, diagnosis, and evaluation of gynecomastia in adults. UpToDate. Updated April 26, 2023. Accessed January 31, 2025. www.uptodate.com 6. Braunstein G D, Anawalt BD . Management of gynecomastia. UpToDate. Updated September 27, 2024. Accessed January 31, 2025. www.uptodate.com 7. Briefing paper: plastic surgery for teenagers. American Society of Plastic Surgeons. Accessed January 31, 2025 . www.plasticsurgery.org 8. Guliyeva G, Cheung JY, Avila FR, et al. Effect of reduction mammoplasty on pulmonary function tests: a systematic review. Ann Plast Surg . 2021;87(6):694-698. doi:10.1097/SAP.0000000000002834 Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 9. Hansen J, Chang S. Overview of breast reduction. UpToDate. Updated April 19, 2023. Accessed January 31, 2025 . www.uptodate.com10. Holzmer SW, Lewis PG, Landau MJ, et al. Surgical management of gynecomastia: a comprehensive review of the literature. Plast Reconstr Surg Glob Open . 2020;8(10):e3161. doi:10.1097/GOX.0000000000003161 11. Kanakis GA, Norkap L, Bang AK, et al. EAA clinical practice guidelines gynecomastia evaluation and management. Andrology . 2019;7(6):778-793. doi:10.1111/andr.12636 12. Kimia R, Magee L, Caplan HS, et al. Trends in insurance coverage for adolescent reduction mamm aplasty. Am JSurg . 2022;224(4):1068-1073. doi:10.1016/j.amjsurg.2022.07.030 13. Klement KA, Hijjawi BJ, Neuner J, et al. Discussion of preoperative mammography in women undergoing reduction mamm aplasty. Breast J . 2019;25(3):439-44. doi:10.1111/tbj.13237 14. Knox JA, Nelson DA, Latham KP, et al. Objective effects of breast reduction surgery on physical fitness. Ann Plast Surg . 2018;80(1):14-17. doi:10.1097/SAP.0000000000001167 15. Lewin R, Liden M, Lundberg J, et al. Prospective evaluation of health after breast reduction surgery using the Breast-Q, Short-Form 36, Breast-Related Symptoms Questionnaire, and Modifed Breast Evaluation Form. Ann Plast Surg . 2019;83(2):143-151. doi:10.1097/SAP.0000000000001849 16. Magny SJ, Shikhman R, Keppke AL. Breast Imaging Reporting and Data System . StatPearls Publishing; 2024. Accessed January 31, 2025 . www.ncbi.nlm.nih.gov 17. Mastectomy for gynecomastia. MCG. 28 th ed draft. Updated March 14, 2024. Accessed March 3, 2025. www.careweb.careguidelines.com 18. Morrison KA, Vernon R, Choi M, et al. Quantifying surgical complications for reduction mammaplasty in adolescents. Plast Reconstr Surg . 2023;151(3):376e – 383e. doi:10.1097/PRS.0000000000009905 19. NCCN guidelines for patients 2022: breast cancer screening and diagnosis. NCCN. www.nccn.org 20. Nuzzi LC, Firriolo JM, Pike CM, et al. The effect of reduction mamm aplasty on quality of life in adolescents with macromastia. Pediatrics . 2017;140(5):e20171103. doi:10.1542/peds.2017-1103 21. Nuzzi LC, Pramanick T, Walsh LR, et al. Optimal timing for reduction mamm aplasty in adolescents. Plast Reconstr Surg . 2020;146(6):1213-1220. doi:10.1097/PRS.0000000000007325 22. Patel K, Corcoran J. Breast reduction surgery in adolescents. Pediatr Ann . 2023;52(1):e31-e35. doi:10.3928/19382359-20221114-06 23. Perdikis G, Dillingham C, Boukovalas S, et al. American Society of Plastic Surgeons evidence-based clinical practice guideline revision: reduction mammaplasty. Plast Reconstr Surg . 2022;149(3):392e-409e. doi:10.1097/PRS.0000000000008860 24. Perez-Panzano E, Gascon-Catalan A, Sousa-Dominguez R, et al. Reduction mamm aplasty improves levels of anxiety, depression and body image satisfaction in Breast Reduction Surgery-MP-MM-1421Effective Dat e: 06/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 patients with symptomatic macromastia in the short and long term. JPsychosomObstet Gynaecol . 2017;38(4):268-275. doi:10.1080/0167482X.2016.1270936 25. Reduction mamm aplasty: A-0274. MCG. 28th ed. Updated March 14, 2024 . Accessed January 31, 2025 . www.careweb.careguidelines.com 26. Reeves RA, Kaufman T. Mammography . StatPearls . StatPearls Publishing; 2023. Accessed January 31, 2025 . www.ncbi.nlm.nih.gov 27. Sears ED, Lu YT, Swiatek PR, et al. Use of preoperative mammography during evaluation for nononcologic breast reduction surgery. JAMA Surg . 2019;154(4):356 – 358. doi:10.1001/jamasurg.2018.4875 28. Womens Health and Cancer Rights Act (WHCRA). Centers for Medicare and Medicaid Services . Accessed January 31, 2025. www.cms.gov 29. Taylor SA. Gynecomastia in children and adolescents. UpToDate. Updated July 12, 2024. Accessed January 31, 2025. www.uptodate.com 30. Xia TY, Scomacao I, Duraes E, et al. Aesthetic, quality-of-life, and clinical outcomes after inferior pedicle oncoplastic reduction mammoplasty. Aesthetic Plast Surg . 2023;47(3):905-911. doi:10.1007/s00266-023-03257-7 31. Zeiderman MR, Kelishadi SS, Tutela JP, et al. Reduction mammoplasty: intraoperative weight versus pathology weight and its implications. Eplasty . 2017;17:e32. Accessed January 31, 2025 . www.pubmed.ncbi.nlm.nih.gov
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