MEDICAL POLICY STATEMENTWest Virginia Marketplace Policy Name & Number Date Effective Metabolic and Bariatric Surgery-Revision-WV MP-MM-1062 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 Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Metabolic and Bariatric Surgery-Revision-WV MP-MM-1062 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. Subject Metabolic and Bariatric Surgery: Revision B. Background Revision procedures are typically done because of complications from or a failure of the initial surgical procedure. Complications may include surgical or anatomical complications as well as nutritional or metabolic complications. A failure of the initial bariatric surgery may result in an inadequate weight loss or a weight regain. C. Definitions Revisional Bariatric Surgery (RBS) Surgery to address those patients whose original operation was unsuccessful in achieving satisfactory weight loss goals, or in whom complications from the original operation have occurred. Inadequate Weight Loss Less than 50% expected weight loss and/or weight remains greater than 40% over ideal body weight (normal body weight BMI parameter = 18.5-24.9). D. Policy I. CareSource considers surgical revision of a bariatric surgery procedure a covered service when medically necessary. II. An inadequate weight loss due only to non-compliance with dietary, behavior, or exercise recommendations is not a medically necessary indication for a revision procedure. I. A revision procedure is medically necessary when all of the following criteria are met and documented in the medical record: A. surgery/procedure selected is a proven procedure and not considered experimental/investigational and B. a technical failure or major complication has occurred from the initial procedure that cannot be managed medically. Technical failure and major complication examples include the following: 1. persistent pain and recurrent bleeding occur 2. chronic stenosis remains after multiple dilations 3. faulty component or malfunction that cannot be repaired 4. candy cane roux syndrome 5. complications that cannot be corrected with band manipulation, adjustments or replacement including band slippage and port leakage or 6. obstruction confirmed by imaging studies . NOTE: Stretching of a stomach pouch formed by a previous bariatric surgery due to overeating is not considered a complication and therefore is not considered an indication for revision. . Metabolic and Bariatric Surgery-Revision-WV MP-MM-1062 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.3II. In the absence of a technical failure or major complication, individuals with weight loss failure 2 years following the initial bariatric surgery procedure must meet the medical necessity criteria in the medical policy for an initial bariatric surgery.E. Conditions of CoverageN/A F. Related Polic ies/Rules Metabolic and Bariatric Surgery Evidence of Coverage and Health Insurance Contract West Virginia G. Review/Revision History DATE ACTIONDate Issued 07/22/2020 New policy Separated out from adult and adolescent policies Date Revised 06/23/2021 06/22/2022 06/21/2023 06/19/2024 02/26 /2025PA language replaced by medical necessity criteria. PA enforced by inclusion on the PA list. Updated references. Re-wording of section IV re: medical necessity for revision bariatric surgery. Updated references Annual review; no changes. Updated references. Review: Added definition of Revisional bariatric surgery (RBS) , updated references. Approved at Committee. Review: Updated references. Approved at Committee.Date Effective 06/01/2025 Date Archived H. References 1. Eisenberg D, Shikora SA, Aarts E, et al. 2022 American Society for Metabolic and Bariatric Surgery (ASMBS) and International Federal for the Surgery of Obesity and Metabolic Disorders (IFSO): indications for metabolic and bariatric surgery. Surg Obes Relat Dis. 2022;18(12):1345-1356. Accessed January 14, 2025. www.soard.org 2. Ellsmere J. Bariatric operations: late complications with subacute presentations. Updated July 18, 2023. Accessed January 17, 2025. www.uptodate.com 3. Gastric Restrictive Procedure with Gastric Bypass (S-512). MCG. 28th ed. 2024. Accessed January 14, 2025. www.careweb.careguidelines.com 4. Mechanisk J, Apovian C, et al. Clinical practice g uidelines for the perioperative n utrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures 2020 Update: cosponsored by American Association of Clinical Endocrinologist/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Obesity . 2020;28(4):01-58. doi:10.1002/oby.22719 Metabolic and Bariatric Surgery-Revision-WV MP-MM-1062 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.45. Palep J. Reoperative bariatric surgery. Recent Advances in Minimal Access Surgery . JP Medical Ltd; 2019:14-151. 6. Weight-Loss and Weight-Management Devices . Federal Drug Administration; 2020. Accessed January 17, 2025. www.fda.gov 7. Yung-Chieh Y, Huang C, Tai C. Psychiatric aspects of bariatric surgery. Curr Opin Psychiatry . 2014;27(5):374-379. doi:10.1097/YCO.0000000000000085 I nde pendent med ica l r e view 7/2020
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
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Insulin Infusion Pump-MP-MM-1316 06/01/2025 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 ………………………….. ………………………….. ………………………….. ……………………… 3 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 Insulin Infusion Pump-MP-MM-1316Effective 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. SubjectInsulin Infusion Pump B. Background38.4 million people (11. 6% of the population) in the United States have diabetes mellitus (DM), not including the estimated 8.5 million adults who are undiagnosed. Approximately 5 to 10% of individuals with diabetes have type 1 (T1D) , while type 2 (T2D) accounts for the remaining 90 to 95% of cases. The incidence of both T1D and T2D in children and adolescents has significantly increased, according to the Centers for Disease Control (CDC) National Diabetes Statistic Report. Some of the unique challenges associated with caring for children and adolescents include the patients size, de velopmenta l concerns, and inability to communicate symptoms of hypoglycemia. Health care resources spent on diabetes are considered to be higher than all other health conditions. Immediate impacts on both physical and mental well-being are common with both severe hy poglycemia and extreme hyperglycemia. Patients with diabetes need to be closely monitored. When blood glucose levels are poorly controlled, patients are at risk of complications, including heart disease, stroke, peripheral vascular disease, retinal damage, kidney disease, nerve damage, and imp otence. Patients should also be monitored for comorbidities that may not be presentduring the early stages of the disease but develop as the disease progresses, including hearing impairment, fatty liver disease, sleep apnea, periodontal disease, depressio n, anxiety, cognitive impairment, and fractures. Reasonable glycated hemoglobin (A1C) goals for diabetic patients should be customized for the individual patient, balancing established benefits with prevention of complications and risk of hypoglycemia. Goals vary depending on age, comorbidities, and the benefitsof intensive therapy. Patients with T1D while pregnant may require stricter control.Insulin therapy is the mainstay of treatment for T1D and T2D . External insulin pumps arean option for intensive insulin therapy designed to provide continuous subcutaneous insulin infusion (CSII) to improve glycemic control, meet basal insulin requirements, and supplement bolus insulin delivery to assist in mealti me insulin needs. The AmericanAssociation of Clinical Endocrinologists (AACE), American College of Endocrinology (ACE), and American Diabetes Association (ADA) recommend CSII only in individuals with T1D and patients with T2D who are insulin dependent. Insulin absorption with CSII therapy appears to be less variable and may help members that have not been able to achieve optimum glycemic goals with multiple daily injections. The choice of insulin delivery via multiple daily injections or continuous subcutaneous delivery of a rapid – acting insulin preparation via a pump should be carefully considered and thoroughly explained to the member. Insulin pumps should only be used in patients who are motivat ed and knowledgeable in DM self-care and able to safely manage the device. Additionally, newer, sensor-augmented insulin pump systems are available with continuous glucose monitoring (CGM) integrated into the pump, which may reduce nocturnal hypoglycemia. Insulin Infusion Pump-MP-MM-1316Effective 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 C. Definitions Dawn Phenomenon An observed increase in blood sugar levels that takes place in the early morning, often between 2am and 8am. Insulin Infusion Pump An external pump used to deliver insulin subcutaneously or through an intraperitoneal route in a controlled and programmed way in order to prevent acute metabolic complications of diabetes and obtain normal blood glucose levels. Moderately Increased Albuminuria Persistent urine albumin-to-creatinine ratio values between 30 and 300mg/gram creatinine. Previously called microalbuminuria, this is usually indicative of diabetic nephropathy (unless there is some other coexistent renal disease). Sensor-Augmented Insulin Pump System An insulin infusion pump equipped with a CGM sensor that uses the glucose readings taken by the CGM sensor to modify the amount of insulin infused . D. PolicyI. CareSource considers the use of external insulin infusion pumps medically necessary when ALL the following criteria are met: A. Documented diagnosis of one of the following: 1. T1D 2. T2D with insulin dependency B. Diabetic education, equipment, and supplies must be ordered in writing by a physician or other appropriately credentialed health care provider . C. The members provider and provider team have an expert level of experience in the management and support of members with insulin infusion pumps . D. Documentation that the patient has completed a comprehensive diabetes education program within the last 12 months by a certified, registered, or licensed provider with expertise in diabetes . E. The member or members caregiver must be knowledgeable in operating the device . F. The member has been on a maintenance program for at least 6 months involving at least 3 injections of insulin per day requiring frequent self-adjustments of insulin dosage . G. The member has performed glucose self-testing at least 4 times per day on average during the last month . H. The member is at high risk for preventable complications of diabetes, early signs of which include: 1. moderately increased albuminuria (eg, microalbuminuria) 2. persistent difficulty in controlling blood sugar levels despite compliance with an intensive multiple-injection regimen, as indicated in documented member log I. The member has at least one of the following symptoms or conditions: 1. A1 Cgreater than 7% 2. history of recurring hypoglycemia Insulin Infusion Pump-MP-MM-1316Effective 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 3. wide fluctuations in blood glucose before mealtime4. dawn phenomenon frequently exceeding 200 mg/dl 5. history of severe glycemic excursions II. ExclusionsA. CareSource considers insulin pump therapy not medically necessary when any of the following apply: 1. Member has end-stage complications such as renal failure. 2. Neither the member nor anyone assisting the member is able to operate a pump or to perform frequent blood glucose monitoring. B. CareSource considers the following devices not medically necessary: 1. portable external insulin infusion pumps requested purely for convenience or member preference 2. surgically implanted infusion devices for systems 3. jet pressure devices 4. devices associated with chronic intermittent intravenous insulin therapy (CIIIT) 5. devices associated with pulsatile intravenous therapy (PIVIT) III. Device Replacement or RepairCareSource may cover the repair, adjustment, and/or replacement of purchased equipment, supplies, or appliances when approved. A. The repair, adjustment, or replacement of the purchased equipment, supply, or appliance is covered if: 1. The equipment, supply, or appliance is a covered service . 2. The continued use of the item is medically necessary . 3. There is reasonable justification for the repair, adjustment, or replacement. B. Replacement of a functioning device just because the warranty has expired is not considered medically necessary. C. Replacement of purchased equipment, supplies or appliances may be covered if: 1. The equipment, supply , or appliance is worn out or no longer functions. 2. Repair is not possible or would equal or exceed the cost of replacement. An assessment by a rehabilitation equipment specialist or vendor should be done to estimate the cost of repair. 3. Members needs have changed, and the current equipment is no longer usable due to weight gain, rapid growth, or deterioration of function, etc. 4. The equipment, supply, or allowance is damaged and cannot be repaired. 5. Benefits for repairs and replacement do not include: a. repair and replacement due to misuse, malicious breakage, or gross neglect b. replacement of lost or stolen items E. State-Specific InformationA. Georg ia marketplace. CareSource. Accessed February 13, 2025. www.caresource.com Insulin Infusion Pump-MP-MM-1316Effective 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 B. Indiana marketplace. CareSource. Accessed February 13, 2025. www.caresource.comC. Kentucky marketplace. CareSource. Accessed February 13, 2025. www.caresource.com D. Ohio marketplace. CareSource. Accessed February 13, 2025. www.caresource.com E. West Virginia marketplace. CareSource. Accessed February 13, 2025. www.caresource.com F. Conditions of CoverageN/A G. Related Policies/RulesN/A H. Review/Revision HistoryDATE ACTIONDate Issued 04/13/2022 New policy, replacing individual state policiesDate Revised 03/29/2023 03/13/202402/26/2025Annual review: updated references. Approved at Committee. Annual review: editorial changes, updated background, and updated references. Approved at Committee. Annual review : added other provider to D.I.B . Approved at Committee. Date Effective 06/01/2025 Date Archived I. References1. American Diabetes Association Professional Practice Committee. Diabetes technology: standards of care in diabetes 2024. Diabetes Care . 2024;47(Suppl 1):S126-S126-S144. doi.org/10.2337/dc24-S007 2. Blonde L, Umpieerez GE, Reddy SS, et al. American Association of Clinical Endocrinology clinical practice guideline: developing a diabetes mellitus comprehensive care plan 2022 update. Endocr Pract . 2022;28(10):923-1049. doi:10.1016/j.eprac.2022.08.002 3. Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States. Reviewed May 15, 2024. Accessed February 13, 2025 . www.cdc.gov 4. Glycemic targets: standards of medical care in diabetes 202 3. Diabetes Care . 202 3;46(Suppl 1):S 97-S110 . doi:10.2337/dc23-S006 5. Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetes Care . 2015;38(4):716-722. doi:10.2337/dc15-0168 Insulin Infusion Pump-MP-MM-1316Effective 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 6. Levitsky L L, Misra M . Overview of the management of type 1 diabetes mellitus in children and adolescents. UpToDate. Updated November 15, 2023. Accessed February 13, 2025 . www.uptodate.com 7. Levitsky L L, Misra M. Hypoglycemia in children and adolescents with type 1 diabetes mellitus. UpToDate. Updated December 30, 2022. Accessed February 13, 2025 . www.uptodate.com 8. Levitsky L L, Misra M. Insulin therapy for children and adolescents with type 1 diabetes mellitus. UpToDate. Updated October 23, 2023. Accessed February 13, 2025 . www.uptodate.com 9. Pharmacologic approaches to glycemic treatment: standards of care in diabetes – 202 3. Diabetes Care . 202 3;46(Suppl 1):S1 40-S157 . doi:10.2337/dc23-S009 10. Weinstock RS. Management of blood glucose in adults with type 1 diabetes mellitus. UpToDate. Updated January 2, 2024. Accessed February 13, 2025 . www.uptodate.com 11. Wexler DJ. Overview of general medical care in nonpregnant adults with diabetes mellitus. UpToDate. Updated August 30 , 2024. Accessed February 13, 2025 . uptodate.com Independent med ical review April 2020
MEDICAL POLICY STATEMENTWest Virginia Marketplace Policy Name & Number Date Effective Metabolic and Bariatric Surgery-WV MP-MM-0795 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 Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definition …………………………………………………………………………………………………………….. 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Polices/Rules …………………………………………………………………………………………… 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 6 Metabolic and Bariatric Surgery-WV MP-MM-0795 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. Subject Metabolic and Bariatric Surgery B. Background Obesity continues to be a major health threat in the United States affecting an increasingly larger proportion of adults and children. The Centers for Disease Control and Prevention (CDC) estimates that over 40.3 % of adults in the United States older than the age of 20 are obese (2021-2023 ). Obesity in adults aged 40 to 59 is higher ( 46.4 %) than those under aged 40 ( 35.5%). Statistics indicate that there has been a significant increase in obesity from 1999 through 2020. Only tobacco has a higher modifiable risk factor in adult mortality. If continuing to trend at the current rate, obesity will become the number one modifiable risk factor in adult mortality. Obesity-related health problems include hypertension, type II diabetes, hyperlipidemia, atherosclerosis, heart disease, stroke, diseases of the gallbladder, osteoarthritis, sleep apnea, and certain cancers. The primary goals in achieving optimal health outcomes for CareSource members are to provide noninvasive approaches to reduce or prevent obesity by promoting healthy life-styles that will improve long-term outcomes. For individuals not able to manage obesity though non-surgical interventions, metabolic and bariatric surgery options may be an effective intervention. C. Definition Body Mass Index (BMI) A persons weight in kilograms divided by the square of height in meters. Substance Use Disorder (SUD) A cluster of cognitive, behavior al, and physiological symptoms indicating continued use of substances despite significant substance-related problems, encompassing 10 separate classes of drug criteria in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition . Behavioral Health Provider A provider of behavioral health services, including a psychologist, psychiatrist, and psychiatric nurse practitioner. Weight Loss Surgery Surgery also known as bariatric and metabolic surgery. These terms are used in order to reflect the impact of these operations on patients weight and the health of their metabolism (breakdown of food into energy). In addition to their ability to treat obesity, these operations are very effective in treating diabetes, high blood pressure, sleep apnea and high cholesterol, among many other diseases. D. Policy I. Metabolic and bariatric surgery is considered medically necessary when all the following criteria are met: A. primary diagnosis of obesity B. m ember is 13 years of age or older C. one of the following BMI requirements are met: Metabolic and Bariatric Surgery-WV MP-MM-0795 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.31. BMI 35 kg/m 2 or greater 2. BMI 30 to 34.9 kg/m 2 and at least one serious obesity related condition, such as: a. high risk for type II diabetes mellitus (DM) (insulin resistance, prediabetes, and/or metabolic syndrome) b. osteoarthritis of knee or hip c. improving outcomes of knee or hip replacement d. obstructive sleep apnea (CPAP should be considered prior to undergoing surgery) e. non-alcoholic fatty liver disease f. non-alcoholic steatohepatitis g. pseudotumor cerebri h. gastroesophageal reflux disease i. severe urinary stress incontinence j. poorly controlled hypertension on multiple drug therapy or 3. BMI >30 kg/m2 with type II DM, if documentation is provided that type II DM is inadequately controlled despite optimal medical treatment by either oral or injectable medications, including insulin. II. Written clinical documentation and supporting information from the attending surgeon must include all of the following: A. Evidence of informed consent B. Letter from the Primary Care Physician (PCP) or appropriate specialist, including the following content: 1. m edical necessity for procedure 2. health-related behaviors, such as smoking history or adherence, have been addressed C. Evidence that member is receiving treatment in a multi-disciplinary program that can provide ALL of the following: 1. preoperative medical consultation 2. preoperative mental health consultation 3. nutritional counseling 4. exercise counseling 5. patient support programs D. Substance use screening results E. Evidence that harm reduction related to substance use was discussed F. Evidence that risks of nicotine were discussed G. Evidence that vitamin Bdeficiencies were monitored and treated as needed prior to surgery H. Evidence that member is free of endocrine disease as supported by an endocrine study consisting of a T3, T4, blood sugar , and a 17-Keto Steroid or Plasma Cortisol Metabolic and Bariatric Surgery-WV MP-MM-0795 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.4I. Documentation illustrating the member has been evaluated from a psychological standpoint within the past 6 months by the treating behavioral health provider, including consideration of all of the following: 1. list of co-existing psychiatric conditions 2. family and social support 3. evidence that the member understands the surgical procedure and can make a responsible decision 4. evidence that the member is stable enough to a. understand the risks and benefits b. change lifestyle through diet moderation and strategic eating c. follow through with the extensive aftercare plan d. withstand the rigors of surgery e. not show evidence of the likelihood of being suicidal or significantly decompensate if the procedure is not successful in helping to lose weight J. Complete history and physical, including an assessment, diagnoses, height, weight, BMI, and treatment plan, must be provided. The exclusion or diagnosis of genetic or syndromic obesity, such as Prader-Willi Syndrome, must also be documented. K. For women with reproductive capacity, appropriate conception counseling was discussed and documented, including the following: 1. Clear documentation that supports that the member has agreed to avoid pregnancy for at least 1 year postoperatively . 2. Potential birth defects from nutritional deficiencies that can occur if becoming pregnant during the weight stabilization period following surgery . III. Contraindications/Noncovered procedures A. Surgery is contraindicated in the following: 1. a medically correctable cause of obesity 2. current or planned pregnancy within one year of procedure 3. active suicidality or self-harm 4. active psychosis 5. active substance use disorder 6. ongoing substance abuse disorder within the previous year 7. severe coagulopathy 8. uncontrolled and untreated eating disorders and 9. inability to comply with postoperative long-term follow-up care B. The intended procedure is not covered if it is experimental or investigational. These include, but are not limited to: 1. endoscopic bariatric and metabolic therapies, such as i ntragastric balloon (IGB) 2. endoscopic sleeve gastroplasty (ESG) 3. aspiration therapy (AT) IV. The following members should be referred to an accredited comprehensive center A. BMI >55kg/m2Metabolic and Bariatric Surgery-WV MP-MM-0795 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.5B. Members with any of the following issues: 1. organ failure 2. organ transplant 3. significant cardiac or pulmonary impairment 4. on a transplant list 5. non-ambulatory E. Conditions of Coverage N/A F. Related Polices/Rules Metabolic and Bariatric Surgery : Revision G. Review/Revision History DATE ACTIONDate Issued 02/24/2015 IssuedDate Revised 04/05/2016 06/05/2019 07/22/2020 01/08/2021 06/23/2021 06/22/2022 06/21/2023 06/19/2024 02/26/2025 Included MCG 23 rd Ed. Revisions to content and Table A. I ncluded MCG 20 th Ed. Revisions to Table A Updated conservative approaches prior to surgery & BMI requirements ; added SUD & health related behaviors, Vitamin B, and nicotine requirements ; updated psychological evaluation, conception counseling, contraindications/ noncovered procedures, separated into a separate policy the revision criteria ; updated referral to comprehensive center. Clarified high risk type II diabetes PA language replaced by medical necessity criteria. PA enforced by inclusion on the PA list. Updated references. Updated demographic info in background. Removed documentation requirement from III. J. member not currently pregnant. Added E&I devices to IV. B. Title changed to Metabolic and Bariatric Surgery in Adults 19 and Older to reflect state law. Added definition for Weight Loss Surgery. Added new MCG criteria, changed title and combined adolescent and adult in all markets. Updated references . Approved at Committee. Removed I.C., added D. Note: Mandatory participation in a preoperative weight loss regimen prior to weight loss surgery is not required. (Health Equity consideration). Removed II.B.2. Documentation that member has been evaluated by a nutritionist/dietician during supervised weight loss. Updated references. Approved at Committee Updated references. Approved at Committee Date Effective 06/01/2025 Date Archived Metabolic and Bariatric Surgery-WV MP-MM-0795 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.6H. References1. AAP Updates Recommendations on Obesity Prevention: It's Never Too Early to Begin Living a Healthy Lifestyle. American Academy of Pediatrics. Accessed January 13, 2025. www.aap.org 2. Abdul Wahab R, Al-Ruwaily H, Coleman T, et al. The relationship between percentage weight loss and World Health Organization-Five Wellbeing Index (WHO-5) in patients having bariatric surgery. Obes Surg . 2022;32(5):1667-1672. doi:10.1007/s11695-022-06010-2 3. Adult obesity facts. Centers for Disease Control and Prevention. Accessed January 13, 2025. www.cdc.gov 4. Obesity management for the treatment of Type 2 Diabetes: standards of medical care in diabetes 2020. Diabetes Care. 2020;43(1). doi:10.2337/dc20-S008 5. American Society for Metabolic and Bariatric Surgery. Bariatric surgery procedures. Accessed January 13, 2025. www.asmbs.org 6. Bariatric Surgery. National Institute of Diabetes and Digestive and Kidney Diseases . Accessed January 6, 2025. www.niddk.nih.gov 7. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery. JAMA . 2004;292(14):1724. doi:10.1001/jama.292.14.1724 8. Center for Disease Control and Prevention. Prevalence of Obesity in the United States. 2024. Accessed January 13, 2025. www.cdc.gov 9. Chapman A. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery. 2004;135(3):326-351. doi:10.1016/s0039-6060(03)00392-1 10. Coverage of weight loss surgery. Medicaid Provider Manual: Hospital. Michigan Dept of Health and Human Services; 2024: 3.35.A. Accessed January 6, 2025. www.mdch.state.mi.us 11. Decision Memo for Bariatric Surgery for the Treatment of Morbid Obesity (CAG-00250R). U.S. Dept. of Health and Human Services, Centers for Medicare and Medicaid Services. February 21, 2006. www.cms.gov 12. Ellesmere JC. Bariatric operations: late complications with subacute presentations. UpToDate. Updated July 18, 2023. Accessed January 13, 2025. www.uptodate.com 13. Federal Drug Administration. Weight-Loss and Weight-Management Devices. April 27, 2020. Accessed January 13, 2025. www.fda.gov 14. Gastric Restrictive Procedure with Gastric Bypass: S-512. MCG Health; 2024. 28th ed. Accessed January 6, 2025. www.careweb.careguidelines.com 15. Guidelines for Clinical Application of Bariatric Surgery. Accessed January 13, 2025. www.sages.org 16. Health Technology Assessment: Comparative Effectiveness Review of Bariatric Surgeries for Treatment of Obesity in Adolescents. July 21, 2019. Reviewed January 20, 2022. Accessed January 6, 2025. www.hayesinc.com 17. Kalarchian M. Psychiatric disorders among bariatric surgery candidates: relationship to obesity and functional health status. Am JPsychiatry . 2007;164(2):328. doi:10.1176/appi.ajp.164.2.328 Metabolic and Bariatric Surgery-WV MP-MM-0795 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.718. Lim RB. Bariatric procedures for the management of severe obesity: descriptions. UpToDate. Updated April 13, 2023. Accessed January 13, 2025. www.uptodate.com 19. Marcus M, Kalarchian M, Courcoulas A. Psychiatric evaluation and follow-up of bariatric surgery patients. Am JPsychiatry. 2009;166(3):285 291. doi:10.1176/appi.ajp.2008.08091327 20. Mechanisk J, et al. AACE/TOS/ASMBS/OMA/ASA 2019 Guidelines. Clinical practice guidelines for the perioperative nutrition, metabolic, and nonsurgical support of patients undergoing bariatric procedures 2020 update: cosponsored by American Association of Clinical Endocrinologist/American College of Endocrinology, The Obesity Society, American Society for Metabolic & Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists. Obesity. 2020;28(4). Accessed January 6, 2025. www. onlinelibrary.wiley.com 21. Ogden CL, Carroll MD, Fryar CD, Flegal KM. Prevalence of Obesity Among Adults and Youth: United States, 2011 2014. NCHS data brief no. 219. National Center for Health Statistics; 2015. 22. Potential Candidates for Bariatric Surgery. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed January 13, 2025. www.niddk.nih.gov 23. Prevalence of Obesity Among Adults and Youth: United States, 2017-2018. NCHS Data Brief no. 360. February 2020. Accessed January 13, 2025. www.cdc.gov 24. Repeat Bariatric Surgery for Patients Who Have Not Reached Weight-loss Goals after Previous Surgery. Accessed January 6, 2025. www.ecri.org 25. Shekelle, P. Mental health assessment and psychological interventions for bariatric surgery. Accessed January 13, 2025. www.hsrd.research.va.gov 26. The Practical Guide to Identification and Treatment of Overweight and Obesity in Adults. Health and Human Services Dept; 2000. Accessed January 13, 2025. www.nhlbi.nih.gov 27. Updated Guidelines for Bariatric Surgery. Hayes. Accessed January 13, 2025. www.hayesinc.com 28. Yung-Chieh Y, Huang C, Tai C. Psychiatric aspects of bariatric surgery. Curr Opinion Psychiatry . 2014;27(5). doi:10.1097/YCO.0000000000000085. Inde pendent med ica l r e view 7/2020
MEDICAL POLICY STATEMENTMarketplace Policy Name & Number Date Effective Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401 06/01/2025 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 ………………………….. ………………………….. ………………………….. ……. 5 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 5 H. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 I. References ………………………….. ………………………….. ………………………….. …………………….. 5 Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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. SubjectPeripheral Nerve Blocks for Treatment of Pain B. BackgroundPeripheral nerve blocks are injections of medication into a specific area of the body where nerves cause pain to a specific organ or body region. Nerve blocks cause the temporary interruption of impulse conduction in peripheral nerves or nerve trunks and may or may not contain a steroid, which can be used to treat pain . Various areas of pain require different types of nerve blocks that can be administered in numerous parts of the body with some of the most common blocks being sympathetic, peripheral, and oc cipital. Sacroiliac and facet joint interventions, epidural steroid injections, and trigger point injections are addressed in other policies.C. Definitions Acute Pain Pain that lasts less than 4 weeks. Ambulatory Surgery Surgery performed in a hospital-based or freestanding ambulatory surgery center (ASC) with patient discharge the same day. Chronic Pain Pain lasting more than 3 months, which is considered beyond normal healing time. Conservative Therapy A multimodality plan including both active and inactive conservative therapies . o Active Conservative Therapies Actions or activit ies that strengthen muscle groups and target key spinal structures, including physical therapy, occupational 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 due to a stated physical reason (ie, increased pain, inability to physically perform exercises). Patient inconvenience and/ or noncompliance without explanation does not constitute inability to complete . o Inactive Conservative Therapies Passive activities by the member 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, acetaminophen]) . 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 stimulat e the release of endorphins . Use, frequency, duration, and start dates must be documented in the medical record . Emergent Medically necessary care which is immediately needed to preserve life , prevent serious impairment to bodily functions, organs, or parts, or prevent placing the physical or mental health of a patient in serious jeopardy. Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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 Low-Risk Procedu re Procedures associated with minimal physiologic effect and exclude any intrathoracic, intra-abdominal, vascular, or orthopedic procedures. Sub-Acute Pain Pain lasting between 4 and 12 weeks. D. PolicyI. CareSource considers peripheral nerve blocks (PNB) , single injection, medically necessary when appropriate documentation for the treatment of acute pain or chronic pain are included, only as part of an active component of a comprehensive pain management program. CareSource uses MCG Health guidelines to ad dress criteria for specific nerve blocks. Documentation must include indications that ALL the following criteria are met: A. Ambulatory or outpatient procedure that is not emergent, low risk, and requires no inpatient care for a preoperative disease or condition (eg, altered mental status, hypotension, hypoxemia, tachycardia) B. Acute, sub-acute or chronic, neuropathic or radicular pain, as indicated by ONE or more of the following: 1. Cancer-related pain 2. Complex Regional Pain Syndrome (CRPS) 3. Peripheral neuropathy with pain that limits activities of daily living, excluding diabetic neuropathy 4. Peripheral vascular disease with rest pain 5. Acute herpes zoster of face or neck and prevention of postherpetic neuralgia 6. Pancreatic pain, pelvic pain, or abdominal pain related to malignancy 7. Chronic, relapsing pancreatitis C. Symptoms poorly controlled by maximum medical therapy or intolerable side effects to such therapy D. Failure of non-invasive treatment(s) (eg, non-steroidal anti-inflammatory drugs (NSAIDs), exercise, physical therapy, spinal manipulation therapy) E. No coagulopathy or thrombocytopenia F. No infection at or underlying the injection site II. Acute or Sub-Acute PainPNB may provide means of analgesia for acute pain in the following (not an all – inclusive list): A. Patients at risk of respiratory depression related to systemic or neuraxial opioids (eg, obstructive sleep apnea, severe obesity, underlying pulmonary disease, advanced age). B. Patients with another indication to minimize opioid use (eg, chronic opioid use, intolerance to opioids). C. Patients with acute, severe pain poorly managed with systemic medication. D. Patients who cannot tolerate chiropractic or other physical and/or manipulative therapies. Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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 III. Chronic PainCareSource considers PNB , single injection, medically necessary when appropriate documentation for the treatment of chronic pain is included, only as part of an active component of a comprehensive pain management program when the following criteria are met: A. Failure of conservative therapy, as evidenced by ALL the following: 1. Documentation in the medical record of at least 6 weeks of active conservative therapy within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance . 2. Documentation in the medical record of at least 6 weeks inactive conservative therapy within the past 6 months . B. Insufficient evidence support s the use of PNB for chronic pain: 1. Genicular nerve or branches for chronic knee pain 2. Cluneal nerve injections or blocks for chronic low back pain or pelvic pain 3. Pudendal blocks for chronic pelvic pain conditions. IV. Peripheral Radiofrequency Ablation (RFA) or NeurotomyRadiofrequency ablation and/or neurotomy are considered experimental and investigational, or unproven for any indication, including but not limited to the treatment of acute or chronic pain due to insufficient evidence of efficacy in the peer reviewed literature. V. Limitations and ExclusionsA. A member can receive a maximum of 6 injections per area and anatomical side in a calendar year . B. Up to 2 anatomic sites (eg, specific nerve, plexus, or branch as defined by CPT code description) may be injected at any one session. C. Nerve blocks used as part of a surgical procedure or other medical procedure are not separately reimbursable but an inclusive component of that procedure. These injections will not be compensated separately or unbundled for coverage. D. Any procedure submitted for payment with an incorrect CPT code or description will be denied. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. If requesting a block to a specific part of the body, coding to the highest level of specificity should be used. E. Exclusion s 1. Treatment of peripheral neuropathy due to diabetes. 2. Use of nerve blocks with or without use of electrostimulation for treatment of multiple neuropathies or peripheral neuropathies caused by underlying systemic diseases. Medical management using systemic medications is clinically indicated for the treatment of these conditions. E. State-Specific InformationN/A Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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 F. Conditions of CoverageInterventional procedures for the management of pain unresponsive to conservative treatment should be provided only by healthcare providers within their scope of practice who are qualified to deliver these health services . G. Related Policies/RulesEpidural Steroid Injections Facet Joint Interventions Sacroiliac Joint Procedures Trigger Point Injections H. Review/Revision HistoryDATE ACTIONDate Issued 05/01/2023Date Revised 02/28/2024 07/03/2024 02/26/2025 Annual review-editorial changes ; Approved at Committee Revision – clarified limitations in D.V.A. Approved at Committee. Annual review, references updated. Approved at Committee. Date Effective 06/01/2025 Date Archived I. References1. Ailani J, Burch RC, Robbins MS; American Headache Society. The American Headache Society consensus statement: update on integrating new migraine treatments into clinical practice. Headache . 2021;61(7):1021-1039. doi:10.1111/head.14153 2. Allen SM, Mookadam F, Cha SS, et al. Greater occipital nerve block for acute treatment of migraine headache: a large retrospective cohort study. JAm Board Fam Med . 2018;31(2):211-218. doi:10.3122/jabfm.2018.02.170188 3. American Headache Society. AHS consensus statement: The American Headache Society position statement on integrating new migraine treatments into clinical practice. Headache . 2019;59(1):1-18. doi:10.1111/head.13456 4. Antolak S, Antolak C, Lendway L. Measuring the quality of pudendal nerve perineural injections. Pain Physician . 2016;19:299-306. Accessed February 9, 202 5. www.pubmed.ncbi.nlm.nih.gov 5. Caponnetto V, Ornello R, Frattale I, et al. Efficacy and safety of greater occipital nerve block for the treatment of cervicogenic headache: a systematic review. Expert Rev Neurotherapeutics . 2021; 21(5):591-597. doi:10.1080/14737175.2021.1903320 6. Chang A, Dua A, Singh K, White BA. Peripheral nerve blocks. StatPearls . StatPearls Publishing; 2024. Accessed February 9, 2025 . www.ncbi.nlm.nih.gov 7. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate. Updated May 15, 2024. Accessed February 9, 2025. www.uptodate.com 8. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC clinical practice guideline for prescribing opioids for pain. MMWR Recomm Rep. 2022;71(3):1-95. doi:10.15585/mmwr.rr7103a1 Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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 9. Evidence Analysis Research Brief: Pudendal Nerve Decompression Surgery for Treatment of Pudendal Neuralgia. Hayes; 2022. Accessed February 9, 2025. www.evidence.hayesinc.com10. Evidence Analysis Research Brief: Radiofrequency Ablation of Cluneal Nerve for Treatment of Chronic Low Back Pain. Hayes; 2023. Accessed February 9, 2025. 11. Evolving Evidence Review: Middle Cluneal Nerve Block for Treatment of Low Back Pain. Hayes; 2022. Reviewed April 4, 2023. Accessed February 9, 2025. www.evidence.hayesinc.com 12. Evolving Evidence Review: Superior Cluneal Nerve Block for Treatment of Low Back Pain. Hayes; 2021. Reviewed December 18, 2024. Accessed February 9, 2025. www.evidence.hayesinc.com 13. Frank FT, Sawsan A. Chronic pelvic pain in adult females: treatment. UpToDate. Updated August 16, 2024. Accessed February 9, 2025. www.uptodate.com 14. Garza I. Occipital neuralgia. UpToDate. Updated December 17, 2024. Accessed February 9, 2025. www.uptodate.com 15. Garza I, Schwedt TJ. Chronic migraine. UpToDate. Updated October 3, 2024. Accessed February 9, 202 5. www.uptodate.com 16. Gautam S, Gupta N, Khuba S, et al. Evaluation of the efficacy of superior cluneal nerve block in low back pain: a prospective observational study. JBodyw Mov Ther . 2022;30:221-225. doi:10.1016/j.jbmt.2022.03.001 17. Headaches in Over 12s: Diagnosis and Management . National Institute for Excellence; 2012. CG150. Updated December 17, 2021. Accessed February 9, 2025. www.nice.org 18. Health Technology Assessment: Genicular Nerve Block for the Treatment of Knee Osteoarthritis. Hayes; 2023. Reviewed December 19, 2024. Accessed February 9, 2025 . www.evidence.hayesinc.com 19. Health Technology Assessment: Greater Occipital Nerve Blocks for Treatment of Migraine. Hayes; 2019. Reviewed October 10, 2022. Accessed February 9, 202 5. www.evidence.hayesinc.com 20. Health Technology Assessment: Local Injection Therapy for Cervicogenic Headache and Occipital Neuralgia. Hayes; 2017. Reviewed November 15, 2021. Accessed February 9, 2025. www.evidence.hayesinc.com 21. Health Technology Assessment: Peripheral Nerve Field Stimulation for Treatment of Chronic Low Back Pain. Hayes; 2021. Reviewed April 17, 2024. Accessed February 9, 2025 . www.evidence.hayesinc.com 22. Hui J, Seko K, Shrikhande G, et al. A novel, nonopiod-based treatment approach to men with urologic chronic pelvic pain syndrome using ultrasound-guided nerve hydrodissection and pelvic floor musculature trigger point injections. Neurourol Urodyn . 2020;39(2):658-664. doi:10.1002/nau.24242 23. Inan L, Inan N, Unal-Artik H, et al. Greater occipital nerve block in migraine prophylaxis: narrative review. Cephalalgia . 2019;39:908-920. doi:10.1177/0333102418821669 24. Isu T, Kim K, Morimoto D, Iwamoto N. Superior and middle cluneal nerve entrapment as a cause of low back pain. Neurospine . 2018;15(1):25-32. doi:10.14245/ns.1836024.012 Peripheral Nerve Blocks for Treatment of Pain-MP-MM-1401Effective 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 25. Jeng C, Rosenblatt M. Overview of peripheral nerve blocks. UpToDate. UpdatedJanuary 10, 2024. Accessed February 9, 2025. www.uptodate.com 26. Matsumoto J, Isu T, Kim K, et al. Middle cluneal nerve entrapment mimics sacroiliac joint pain. Acta Neurochir (Wien) . 2019;161(4):657-661. doi:10.1007/s00701-019 – 03861-0 27. Mustafa A, Brooks B, Leishear K, et al. A novel treatment approach for women with chronic pelvic pain syndrome leading to increased pelvic functionality. JWomens Health Gyn . 2020;7:1-10. doi:10.17303/jwhg.2020.7.402 28. Nielsen TD, Moriggl B, Barckman J, et al. Randomized trial of ultrasound-guided superior cluneal nerve block. Reg Anesth Pain Med . 2019;44:772-780. doi:10.1136/rapm-2018-100174 29. Ornello R, Lambru G, Caponnetto V, et al. Efficacy and safety of greater occipital nerve block for the treatment of cluster headache: a systematic review and meta – analysis. Expert Rev Neurotherapeutics . 2020;20(11):1157-1167. doi:10.1080/14737175.2020.1809379 30. Pilitsis JG, Khazen O. Occipital neuralgia. American Academy of Neurological Surgeons (AANS). Accessed February 9, 2025. www.aans.org 31. Plavnik K, Tenaglia A, Hill C, et al. A novel, non-opioid treatment for chronic pelvic pain in women with previously treated endometriosis utilizing pelvic-floor musculature trigger-point injections and peripheral nerve hydrodissection. PM R . 2020;12(7):655 – 662. doi:10.1002/pmrj.12258 32. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on chronic pain management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology . 2010;112(4):810-833. doi:10.1097/ALN.0b013e3181c43103 33. Shauly O, Gould DJ, Sahai-Srivastava S, et al. Greater occipital nerve block for the treatment of chronic migraine headaches: a systematic review and meta-analysis. Plast Reconstr Surg . 2019;144(4):943-952. doi:10.1097/PRS.0000006059 34. Tu FF, As-Sanie S. Chronic pelvic pain in adult females: evaluation. UpToDate. Updated August 16, 2024. Accessed February 9, 2025. www.uptodate.com 35. Watson JC. Cervicogenic headache. UpToDate. Updated March 12, 2024. Accessed February 9, 2025. www.uptodate.com 36. Wray JK, Dixon B, Przkora R. Radiofrequency ablation. StatPearls . StatPearls Publishing; 2025. Accessed February 9, 2025. www.ncbi.nlm.nih.gov
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