MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Skin Substitutes-DSNP-MM-1427 12/01/2025 Ohio 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 clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Market(s): Georgia Ohio Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Summary of Evidence …………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 6 Skin Substitutes-DSNP-MM-1427Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectSkin Substitutes B. Background Wounds are disruptions of the skins structural and functional integrity and normally transition through distinct phases until the skins structure and function are restored, including hemostasis, inflammation, cellular migration and proliferation, and remodeling. Chronic wounds can result in loss of function, wound recurrence, and significant morbidity. Pressure ulcers, diabetic foot ulcers, and venous leg ulcers are the three categories that comprise the majority of chronic wounds. Skin substitutes are a heterogeneous group of biologics, synthetics, or biosynthetic materials. When determining if the use of a skin substitute is appropriate, the clinician evaluates the material being used and its properties. Individual wounds have a specific microenvironment. Various manufacturers may utilize differing processes in the development of skin substitutes but generally seed selected cells onto a matrix. The matrices subsequently receive proteins and growth factors necessary to divide and develop into the desired tissue. Skin substitutes provide coverage for open wounds, both deep thermal and full-thickness wounds. Skin substitutes have the function and composition of skin or have the potential for autologous regenerative healing when applied to a wound. Uses span acute or chronic wounds, burns, or reconstruction, such as release of contractures secondary to severe burns. The most common classification system utilized to determine the type of skin substitute that would be appropriate for a particular wound is the Kumar Classification system, in which Class I includes temporary impervious dressing material, Class II includes single-layer durable skin substitutes, and Class III includes composite skin substitutes that replace both dermal and epidermal layers. C. Definitions Ankle-Brachial Index A comparison of the blood pressure measured at the ankle with blood pressure measured at the arm with lower numbers indicating narrowing or blockage of the arteries in the legs. Autologous Derived from the same individual, such as an individual serving as both donor and recipient. Chronic Wounds Wounds that have not progressed along the normal healing process, generally after a 4-week duration. Chronic Venous Ulcers A wound that takes longer than usual to heal and often occurs on the legs or ankles when oxygen-poor blood flow is impaired and pools, creating pressure in the veins. Diabetic Foot Ulcers An open sore or wound located on the foot occurring in approximately 15% of patients with diabetes. Skin Substitutes-DSNP-MM-1427Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 Pressure Ulcers Injuries to skin and underlying tissue resulting from prolonged pressure on the skin, including bedsores that most often develop on skin covering bony areas of the body, such as heels, ankles, hips, and tailbone. Tissue Engineering The practice of combining scaffolds, cells, and biologically active molecules into functional tissues to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs. D. PolicyI. For the treatment of diabetic foot ulcers (DFUs)and venous leg ulcers (VLUs) CareSource uses the medical necessity criteria found in Local Coverage Determination (LCD) L39865, Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. II. CareSource considers the use of skin substitute products medically necessary under ANY of the following circumstances: A. Treatment of burn wounds when ONE of the following criteria are met: 1. a temporary wound covering for excised full-thickness and deep partial- thickness burn wounds in individuals who require such a covering prior to autograft placement 2. treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting B. Repair of scar contractures when more conservative therapeutic options have failed when used in conjunction with a breast reconstruction procedure. C. Pressure redistribution support surfaces for pressure ulcers. III. Documentation RequirementsA. Standard of Care treatment documentation includes: 1. Comprehensive patient assessment (history, exam, vascular assessment) and diagnostic tests as indicated as part of the implemented treatment plan 2. Assessment of Type 1 or 2 diabetes for DFU patients including management history and any comorbidities (eg. vascular disease, neuropathy, osteomyelitis), current blood glucose levels (A1c) and assessment of off-loading devices and footwear. 3. Assessment of clinical history for venous insufficiency ulcer patients including a. prior ulcers b. body mass index c. history of pulmonary embolism or superficial/deep venous thrombosis d. number of pregnancies and physical inactivity e. physical exam f. evaluation of venous reflux, perforator incompetence, and venous thrombosis g. the use of any compression garments B. Treatment Plan documentation includes ALL of the following: 1. debridement as appropriate to a clean granular base 2. documented evidence of offloading for DFUs Skin Substitutes-DSNP-MM-1427Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 3. documented evidence of sustained compression dressings for venous insufficiency ulcers 4. infection control with removal of foreign body or focus of infection 5. management of exudate with maintenance of a moist environment 6. documentation of smoking history, counseling on the effects of smoking on wound healing 7. treatment for smoking cessation and current status IV. Non-Covered or Medically NecessaryA. new Quarterly skin substitutes or Q-codes that have not been used outside clinical trials B. greater than 3 applications of a skin substitute graft/CTP over 12 weeks if volume has not decreased by at least 50% C. repeat applications of skin substitute graft/CTP when a previous application was unsuccessful. Unsuccessful treatment is defined as increase in size or depth of an ulcer, no measurable change from baseline, and no sign of significant improvement or indication that significant improvement is likely (such as granulation, epithelialization, or progress towards closure) D. application of skin substitute graft/CTP in patients with inadequate control of underlying conditions or exacerbating factors, or other contraindications (e.g., active infection, progressive necrosis, active Charcot arthropathy of the ulcer extremity, active vasculitis, ischemia E. use of surgical preparation services (e.g., debridement), in conjunction with routine, simple or repeat skin replacement therapy with a skin substitute graft/CTP F. all liquid or gel skin substitute products or CTPs for ulcer care G. placement of skin substitute graft/CTP on infected, ischemic, or necrotic wound bed H. skin substitute products that are not on the applicable fee schedule may not be reimbursable and may be considered experimental and investigational. I. life expectancy would not allow long-term healing or clinical benefit or decrease of substantive morbidity. E. Summary of EvidenceA systematic review identified 20 trials of skin substitutes (Roshangar, et al, 2020). For the management of partial-thickness burns, bioengineered skin substitutes and allogeneic cultured skin were at least as effective as topical agents/wound dressings or allograft. In two trials, a bi-layered living cell construct (BLCC) had a significantly faster time to healing (11 versus 14 days) compared with autografts, allografts, or xenografts; however, the proportion of patients with 75 percent of wound closure was significantly lower. In a separate review, a skin substitute (Biobrane) significantly reduced pain during the treatment of superficial and partial thickness burn wounds compared with topical agents. One drawback of skin substitutes in the treatment of burns may be the potential for infection. In a multicenter trial that included 216 burn patients, the rate of invasive Skin Substitutes-DSNP-MM-1427Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 infection at sites treated with BLCC was 3 percent (consistent with 1 to 3 percent rate for autografting) and the superficial wound infection rate was 13 percent. In a later systematic review of studies that compared dermal substitutes and split-thickness skin grafts for the treatment of burn wounds, three trials reported either low rates of infection or no significant difference in infection rates between dermal substitutes and skin grafts, and four of the seven trials reported no significant differences in scar quality. Statistical pooling of data was not performed due to heterogeneity of the studies. Human-derived acellular dermal matrices (ADM) are sterilized and decellularized to remove immunogenic cellular material such as major histocompatibility complex (MHC) proteins, thereby diminishing host immune response and improving incorporation into the wound. With increasing frequency, surgeons are electing to use acellular dermis to assist with tissue expander or implant-based primary breast reconstruction. In 2022, of 151,641 breast reconstructions performed, as projected by the American Society of Plastic Surgeons, 82,597 (54.5%) used a tissue expander and implant, and 76,257 (50.3%) employed an acellular dermal matrix (ADM). Several authors have reported favorable results for procedures involving acellular dermis, and rapid early expansion has led to improved cosmetic outcomes. In the literature, comparisons of ADM-assisted reconstruction with traditional expander reconstruction generally do not show statistically relevant differences in overall complication rates. The overall complication rates for reconstructions using ADM range from 3.2% to 48.7%. In patients who underwent expander-to-implant procedures, a study by Marquez et al reported that at 1-year follow-up after the second stage, differences between the ADM-assisted and non-ADMassisted procedures with regard to incidence of implant rippling (24.6% vs 12.1%, respectively), capsular contracture (4.5% vs 3.3%, respectively), and explantation (6.6% vs 1.7%, respectively) were not statistically significant.F. Related Policies/RulesBreast Reconstruction Surgery Experimental or Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 02/15/2023 New policy.Date Revised 02/14/2024 02/12/2025 08/27/2025Updated references. Approved at Committee. Added I. A. 1-4. Added II. B. Life expectancy would not allow long-term healing, clinical benefit or decrease of substantive morbidity. Added new requirements for D. I .A, B, and D.II; added Sec. EDocumentation Requirements. Added more non-covered items to D.III, and Related Policies/Rules. Updated references. Approved at Committee Date Effective 12/01/2025 Date Archived Skin Substitutes-DSNP-MM-1427Effective Date: 12/01/2025The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 6 H. References 1. Ankle-brachial index. Mayo Clinic. Accessed July 14, 2025. www.mayoclinic.org 2. Bay C, Chizmar Z, Reece EM, et al. Comparison of Skin Substitutes for Acute and Chronic Wound Management. Semin Plast Surg . 2021;35(3):171-180. doi:10.1055/s- 0041-1731463 3. Bedsores (pressure ulcers). Mayo Clinic. Accessed July 14, 2025. www.mayoclinic.org 4. Hart CE, Loewen-Rodriguez A, Lessem J. Dermagraft: use in the treatment of chronic wounds. Adv Wound Care . 2012;1(3):138-141. doi:10.1089/wound.2011.0282 5. Marquez JL, French M, Ormiston L, et al. Outcomes after tissue expander exchange to implant in two-stage prepectoral breast reconstruction with and without acellular dermal matrix: A retrospective cohort study. JPlast Reconstr Aesthet Surg . 2024;89:97-104. doi:10.1016/j.bjps.2023.12.008 6. Porcine skin and gradient pressure dressings. Centers for Medicare & Medicaid Services. Accessed July 14, 2025. www.cms.gov 7. Research Protocol: Skin Substitutes for Treating Chronic Wounds . Effective Health Care Program, Agency for Healthcare Research and Quality; 2018. Reviewed January 2020. Accessed June 3, 2025. www.effectivehealthcare.ahrq.gov 8. Roshangar L, Soleimani Rad J, Kheirjou R, Reza Ranjkesh M, Ferdowsi Khosroshahi A. Skin Burns: Review of Molecular Mechanisms and Therapeutic Approaches. Wounds. 2020; 31(12):308-315. 9. Shahrokhi S. Skin substitutes. UpToDate. Updated May 8, 2023. July 14, 2025, 2025. www.uptodate.com 10. Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (L39865). Accessed July 14, 2025. www.cms.gov . 11. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer: A-0326. MCG Health. 28th ed. Accessed July 14, 2025. www.careweb.careguidelines.com 12. Tissue engineering and regenerative medicine. National Institute of Biomedical Imaging and Bioengineering. Accessed June 3, 2025. www.nibib.nih.gov 13. Venous ulcers. Cleveland Clinic. Reviewed May 26, 2022. Accessed July 14, 2025. www.myclevelandclinic.org 14. What is a diabetic foot ulcer? American Podiatric Medical Association. Accessed July 14, 2025. www.apma.org Independent medical review 01/19/2023
MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Radiofrequency and Microwave Ablation of Tumors – DSNP-MM-1354 11/01/2025 Ohio 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 Ohio Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Summary of Evidence ………………………….. ………………………….. ………………………….. ……… 5 F. State-Specific Information ………………………….. ………………………….. ………………………….. … 7 G. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 7 H. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 7 I. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 J. References ………………………….. ………………………….. ………………………….. ……………………. 7 Radiofrequency and Microwave Ablation of Tumors-DSNP-MM-1354Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectRadiofrequency and Microwave Ablation of Tumors B. BackgroundRadiofrequency ablation of a tumor involves the delivery of high frequency alternating current to induce thermal injury of targeted tissue. Evidence for the use of radiofrequency ablation is constantly evolving based on the type of tumor and its location. Hepatocellular carcinoma is the most common type of primary liver cancer. For most patients, treatment with curative intent is not possible. Treatment options include surgical excision, hepatic artery infusion chemotherapy, trans-arterial bland orchemoemb olization, selective interstitial radiotherapy (Yttrium 90 microspheres),percutaneous ethanol injection, cryoablation, and thermo-ablation. Liver transplantation for curative intent may be appropriate for some patients. Radiofrequency ablation and microwa ve ablation, which are types of thermos-ablation, have proven to be effective local therapy techniques with similar results to other treatment options for smaller tumors. Liver metastases are a common manifestation of many primary cancers. The number, location, size, and patients general health influence the choice of treatment for liver metastases. Surgical resection with curative intent is ideal, however this applies to aminority of patients. Non-surgical ablative techniques may be used for both curative and palliative intent . T his includes systemic chemotherapy, targeted therapy, immunotherapy, external beam radiotherapy, cryoablation, thermo-ablation, arterial emboliza tion techniques, and selective internal radiation therapy. Lung cancer is one of the most common types of cancer with symptoms often not appearing until advanced disease, causing poor prognosis. Common treatments for primary or metastatic cancer in the lu ng include surgery, chemotherapy, radiotherapy,photodynamic therapy, thermal ablation, immunotherapy, and biological therapy. Treatment selection is based on type, size, position and stage of cancer, and the patients overall health.Microwave ablation (MWA) uses microwave energy to cause thermal coagulation and tissue necrosis at a specific location. When a tumor is not amenable to resection or a patient is ineligible for surgery, MWA may be an appropriate alternative definitive treat ment. This procedure can be done percutaneously using minimally invasive surgicaltechniques, or during open surgery, and involves placement of one more probes directly into the tumors location, where microwave energy can be directly applied, causing dest ruction of the tumor and limited surrounding tissues. Microwave ablation does not spare vessels. Radiofrequency and Microwave Ablation of Tumors-DSNP-MM-1354Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 C. Definitions Tumor Ablation Direct application of energy to eradicate or destroy focal tumors. The method of ablation is dependent on the characteristics of the lesion and risk mitigation. o Microwave Ablation (MWA) Delivery of high-frequency microwave energy to rapidly agitate water molecules in the target tissue . T he energy is converted to heat, which causes tissue necrosis. o Radiofrequency Ablation (RFA) Delivery of radio waves to generate heat and induce tissue destruction in the targeted area. D. PolicyI. Microwave ablation for tumor treatment using an FDA-approved device is considered medically necessary when ANY (either A or B) of the following indications are met: A. Member has primary or metastatic hepatic (liver) tumor , and ALL the following: 1. The tumor is unresectable due to location of lesion(s) , or the member has comorbid condition(s) that are contraindicative to surgery. 2. The tumor is at most 5cm in size , or there are no more than 3 nodules, all of which are no more than 3 cm in size. 3. Microwave ablation may be used alone or in conjunction with open or minimally invasive resection of other liver tumors. Curative resection of all disease must be the stated goal of therapy. or B. Member has primary or metastatic lung tumor , and ALL the following: 1. The tumor is unresectable due to location of lesion(s) , or the member has comorbid condition(s) that are contraindicative to surgery. 2. Single tumor is no more than 3 cm in size. II. Microwave ablation is not covered for any other indication, including (but not limited to), the following:A. Microwave ablation for any other tumor type is considered experimental and investigational due to a lack of clinical evidence regarding efficacy. B. Microwave ablation for tumors larger than 5 cm or more than 3 nodules larger than 3 cm is considered experimental and investigational due to a lack of clinical evidence for efficacy compared to other treatment modalities. III. Radiofrequency ablation for tumor treatment is considered medically necessary for ANY of the following indications:A. Barrett esophagus with dysplasia B. bone metastases C. hepatocellular carcinoma with ALL the following: 1. Child-Pugh class A or Bliver function (score of 9 or less) 2. surgical evaluation indicates at least one of the following: a. patient is a candidate for surgical resection following radiofrequency ablation b. patient is a candidate for transplant following bridge therapy by radiofrequency ablation Radiofrequency and Microwave Ablation of Tumors-DSNP-MM-1354Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 c. patient is not a surgical candidate (or elects against surgery)d. patient is not a transplant candidate 3. tumor has all the following: a. location amenable to percutaneous, minimally invasive or open surgical ablation b. margins accessible to ablation c. not in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other intra-abdominal organs) d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 4. no portal hypertension D. kidney tumor with ALL the following: 1. clinical stage T1 renal lesion 2. patient is not candidate for or elects against active surveillance 3. patient is not a surgical candidate (or elects against surgery) 4. tumor is not a renal angiomyolipoma E. liver metastases from colorectal carcinoma with ALL the following: 1. patient is not an ideal surgical candidate (or elects against surgery) 2. tumor has all the following: a. location amenable to percutaneous or surgical ablation b. margins accessible to ablation c. not in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other intra-abdominal organs) d. single tumor 5cm or smaller in diameter OR no more than 3 tumors, each of which is 3cm or smaller in diameter 3. no extrahepatic disease F. lung cancer (non-small cell [NSCLC]) with ALL the following: 1. patient is not a surgical candidate (or elects against surgery) 2. tumor with ALL the following: a. less than 3cm in diameter b. node negative (stage I) c. not in close proximity to major pulmonary vessels or esophagus G. osteoid osteoma H. soft tissue sarcoma with at least ONE of the following: 1. gastrointestinal stromal tumor with limited progressive disease (ie, appearance of new lesion, increase in tumor size) 2. soft tissue sarcoma of extremity, superficial trunk, or head/neck, as indicated by both: a. synchronous stage IV disease b. need for treatment of tumor bulk limited to single organ that is amenable to local therapy, or palliation of disseminated metastases I. thyroid cancer with at least ONE of the following: 1. differentiated thyroid carcinoma (eg, follicular, papillary) with at least ONE of the following: a. distant metastasis or persistent disease not amenable to treatment with radioactive iodine Radiofrequency and Microwave Ablation of Tumors-DSNP-MM-1354Effective Dat e: 11/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 b. recurrent disease following treatment of locoregional disease2. medullary carcinoma with at least ONE of the following: a. palliative treatment of symptomatic metastases or progressive disease needed b. Patient asymptomatic, with at least ONE of the following: 01. disease metastasis 02. persistent disease following treatment of locoregional disease 03. recurrent disease following treatment of locoregional disease J. thyroid nodules, with ALL the following: 1. compressive symptoms from nodules (eg, cough, dysphagia, foreign body sensation, pain, voice changes) 2. patient not a surgical candidate (or elects against surgery) K. uterine leiomyomas with ALL the following: 1. laparoscopic ultrasound-guided procedure planned 2. leiomyomas documented by imaging study (eg, ultrasound) or hysteroscopy 3. patient desires uterine conservation or is not a surgical candidate 4. patient is premenopausal 5. persistent symptoms (3 months or greater in duration) directly attributed to presence of leiomyomas, as indicated by at least ONE of the following: a. abnormal uterine bleeding unresponsive to conservative management (eg, hormonal therapy) b. bowel dysfunction c. dyspareunia d. infertility e. iron deficiency anemia f. pelvic pain or pressure g. urinary dysfunction 6. testing has ruled out other potential ca uses of symptoms E. Summary of EvidenceIn 2012, Guan et al. reported the intermediate-term outcomes of a prospective randomized comparison of patients with small renal tumors (
MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Intraosseous Basivertebral Nerve Ablation-OH DSNP-MM – 1723 08/01/2025 Ohio 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 Market(s): Georgia Ohio Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Summary of Evidence ………………………….. ………………………….. ………………………….. ……… 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 I. References ………………………….. ………………………….. ………………………….. ……………………. 6 Intraosseous Basivertebral Nerve Ablation-OH DSNP-MM-1723 Effective Dat e: 08/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectIntraosseous Basivertebral Nerve Ablation B. BackgroundInterventional procedures for management of acute and chronic pain are part of a comprehensive pain management care plan that incorporates conservative treatment in a multimodality approach. Multidisciplinary treatments include promoting patient self – manag ement and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved completely. Interventional procedures for the management of pain unresponsive to conservative treatment should be provided only by physicians qualifie d to deliver these health services. Chronic low back pain (CLBP) is a common disabling condition, estimated to afflict 80% of adults at some point. Degenerative disc disease (DDD) is an important cause of CLBP. While discs are avascular with limited nerve distribution, vertebral endplates ha vethe potential to trigger a cascade of degenerative events if there is a loss of integrity. Vertebral endplates are a thin interface between bone marrow and discs and contain neural elements. Breakdown of the endplate is believed to cause vertebrogenic c hronic low back pain, a type of chronic low back pain. Endplate degeneration can be observed on MRI through Modic changes (MC). Histologically in MC type I (MC I) lesions, the endplate is disrupted as fibrous tissue replaces bone marrow, causing the disc-bone interface to be filled with vascularizedgranulation tissue. MC I represents bone marrow edema and inflammation. In MC type II(MC II) lesions, there is demonstration of fatty marrow replacement in addition to MC type I findings. MC II represents conversion of hematopoietic marrow into fatty, yellow bone marrow. MC type III (MC III) lesions are related to subchondral bone scler osis. Analysis of Modic lesions shows that MC I is characterized by high bone turnover, MC II is characterized by decreased bone turnover, and MC III are stable. Radiofrequency ablation is a minimally invasive, percutaneous treatment which uses heat to ablate the nerve pathway that conducts the pain signal. The goal of RFA is to interrupt the pain pathway without causing excessive sensory loss, motor dysfunction, o r other complications. Intracept is an RFA system designed to ablate the basivertebral nerve of the vertebral endplate. C. Definitions Chronic Low Back Pain Persistent pain in the lumbar region lasting for more than 12 weeks. Conservative Therapy A multimodality plan of care including both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, including physical therapy, occupational therapy, physician supervised home exercise program (HEP), and/or chiropractic care. Intraosseous Basivertebral Nerve Ablation-OH DSNP-MM-1723 Effective Dat e: 08/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 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 the HEP due to a stated physical reason (ie, increased pain, inability to phy sically perform exercises). Patient inconvenience or noncompliance without explanation does not constitute an inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain, including rest, ice, heat, medical devices, TENS use, and/or pharmacotherapy (prescription or over the counter [eg, non-steroidal anti-inflammatory drugs, acetaminophe n]). Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current delivered 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 endorph ins. Its use, frequency, duration, and start dates must be documented in the medical record to be considered part of conservative therapy during the period of prior authorization request. Modic Changes Vertebral bone marrow signal intensity changes that are observable on MRI and are commonly associated with degenerative disc disease. o Modic Change Type I Characterized by hypo-and hyper-intense signal intensities on T1-and T2-weighted spin-echo (T1W1 and T2W1), respectively. o Modic Change Type II Characterized by hyper-intense signal intensities on both T1W1 and T2W1. o Modic Change Type III Characterized by hypo-intense signal intensities on both T1W1 and T2W1. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial or lateral branches of the dorsal spinal nerves. D. PolicyI. CareSource considers intraosseous basivertebral nerve ablation medically necessary when ALL the following clinical criteria are met: A. Member has a diagnosis and documentation of chronic low back pain of at least 6 months duration that causes functional deficit measured on a pain or disability scale. B. 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 (see definition above) 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 of inactive conservative therapy (see definition above) within the past 6 months C. MRI demonstrates Type I or Type II modic changes at one or more vertebral endplates from level L3 to S1, as demonstrated by 1. hypointense T1-weighted signal and hyperintense T2-weighted signal (ie, bone marrow edema and inflammation), or Intraosseous Basivertebral Nerve Ablation-OH DSNP-MM-1723 Effective Dat e: 08/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 2. hyperintense T1-weighted signal and hyperintense T2-weighted signal (ie,bone marrow ischemia) D. Device is FDA-approved (eg, Intracept System) . E. Member does not have any of the following contraindications: 1. severe cardiac or pulmonary compromise 2. member has a targeted ablation zone less than 10mm from a sensitive structure not intended to be ablated (including vertebral foramen) 3. active systemic infection or localized infection in the area to be treated 4. current pregnancy 5. skeletal immaturity 6. implantable pulse generator (eg, pacemaker, defibrillator) or other electronic implant 7. scoliosis 8. spinal instability II. Repeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary, as it has not been adequately studied in the peer-reviewed medical literature. III. Monitored anesthesia and conscious sedation during intraosseous basivertebral nerve ablation are considered not medically necessary and will therefore not be reimbursed.IV. Coverage is limited to the above criteria. Intraosseous basivertebral nerve ablation is considered not medically necessary for all other indications.E. Summary of Evidence Fischgrund et al. (2018) conducted a prospective randomized double-blind sham – controlled Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical trial to evaluate the safety and efficacy of radiofrequency ablation (RFA) of the ba sivertebral nerve (BVN) for the treatment of chronic low back pain. The trial involved 225 patients diagnosed with chronic low back pain at 18 sites across the United States and Europe. Patients were skeletally mature, experienced chronic, isolated lumbar pain, had failed at least 6 months of conservative management, and demonstrated Type 1 or Type 2 Modic changes at 3 or fewer contiguous levels between L3 and S1 on MRI. At the start of the clinical trial, patients had a minimum Oswestry Disability Index (O DI) of 30 points (100-point scale) and a minimum visual analog scale (VAS) of 4cm (10cm scale). The primary endpoint was the comparative change in ODI from baseline to 3 months. At 3 months, the average ODI in the treatment arm decreased 20.5 points, compa red to a 15.2 decrease in the sham control arm. Responder analysis demonstrated that 75.6% of patients in the treatment arm compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. Out of the 147 participants tre ated with RFA of the BVN, the procedure was deemed successful by imaging in 129 of 145 patients (89%) and in 300 of 317 treated vertebral bodies (94.6%). Intraosseous Basivertebral Nerve Ablation-OH DSNP-MM-1723 Effective Dat e: 08/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 Fischgrund et al (2019) reported on the 2-year follow up from the SMART Trial.Following the 1-year mark, participants in the sham arm were allowed to cross over; 57 (73%) chose to receive the Intracept intervention. Intra-patient comparison of patient – rep orted measures from baseline to each follow-up visit were used to evaluated long – term efficacy and treatment durability in RFA arm participants with 24-month data. 106 patients completed a 24-month follow-up visit. Patients exhibited a durable ODI mean imp rovement of 23.4 points at 24 months compared to the mean improvements observed during the first year of follow up (20.3, 20.8, and 19.8 points at 3, 6, and 12 months, respectively). Using a 10-point improvement in ODI as a commonly accepted minimum clinic ally important difference in the treatment of chronic low back pain, 75.6% of treated patients existed a successful response at 3 months, which was sustained at 24 months (76.4% of treated patients). VAS improvement was also maintained at 24 months, starti ng with a baseline of 6.73 cm and improving by 2.76 and 3.59 cm at 12 and 24-months follow-up, respectively. No device or procedure-related patient deaths, unanticipated adverse device effects, or device related serious adverse events were reported. Fischgrund et al (2020) reported on the 5-year outcome for patients in the SMART Trial.Primary outcome was mean change in ODI. 100 patients of the original 117 US participants were available for review at a minimum of 5-years post BVN ablation. MeanODIs core improved from 42.81 to 16.86 at 5-year follow-up, a reduction of 25.95 points. Mean reduction of VAS pain score was 4.38 points. 66% of patients reported more than a 50% reduction in pain, 47% reported more than 75% reduction in pain, and 34% of patie nts reported complete pain resolution. 5-year results indicate a sustained improvement in patients treated with RFA of the BVN for chronic low back pain. Khalil et al (2019) reported on the INTRACEPT Trial, a prospective, randomized, multicenter study at 20 US cites which compared the effectiveness of intraosseous basivertebral nerve ablation to standard of care for the treatment of chronic low back pain. T he trial involved 140 patients experiencing chronic low back pain for at least 6months, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, who had failed to respond to conservative therapy. Similar to the SMART Trial, patients were skele tally mature, with a minimum ODI of 30 points and a minimum VAS of 4cm.Patients had a baseline average ODI of 46.1 and VAS of 6.67. Comparing the RFA arm to the standard of care arm, the mean changes in ODI at 3 months were -25.3 points versus -4.4 points , respectively, resulting in an adjusted difference of 20.9 points (p
Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Peroral Endoscopic Myotomy-DSNP-MM-1435 05/01/2025 Ohio Inactive as of 01/01/2026 Policy Type MEDICAL This policy applies to the following Market(s): Georgia b Ohio Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 3 E. Conditions of Coverage ………………………………………………………………………………………….. 3 F. Related Policies/Rules …………………………………………………………………………………………… 4 G. Review/Revision History …………………………………………………………………………………………. 4 H. References ………………………………………………………………………………………………………….. 4 Peroral Endoscopic Myotomy-DSNP-MM-1435 Effective Date: 05/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectPeroral Endoscopic MyotomyB. Background Achalasia (ie, failure to relax) is a rare esophageal disorder that affects about 1 in every 100,000 people and is usually associated with difficulty swallowing. Most people are diagnosed between the ages of 25 and 60 years. Achalasia occurs when nerves in the esophagus become damaged. As a result, the esophagus becomes paralyzed and dilated over time and eventually loses the ability to squeeze food down into the stomach. Although the condition cannot be cured, the symptoms can usually be controlled with treatment. Treatments for achalasia include oral medications, dilation or stretching of the esophagus, surgery (open and laparoscopic), endoscopic surgery, and injection of muscle-relaxing medicines (botulinum toxin) directly into the esophagus. Peroral endoscopic myotomy (POEM) is a procedure developed in Japan that is performed with the patient under general anesthesia. Studies suggest that POEM can achieve results comparable to or even better than those of pneumatic balloon dilation and laparoscopic Heller myotomy with similar safety. However, POEM is a newer procedure, and long-term outcome data is limited. POEM is a form of natural orifice transluminal endoscopic surgery. The procedure is performed perorally, without any incisions in the chest or abdomen. The advantage of this approach is to reduce procedure-related pain and return patients to regular activities sooner than surgeries requiring external incisions. C. Definitions Achalasia A rare disorder making it difficult for food and liquid to pass from the swallowing tube connecting the mouth and stomach. In achalasia, nerve cells in the esophagus degenerate. As a result, the lower end of the esophagus, the lower esophageal sphincter (LES), fails to open to allow food into the stomach, leading to complications (eg, coughing, choking, aspiration pneumonia, ulceration, and weight loss). There are 3 different achalasia types: o Type I Characterized by minimal esophageal pressurization, this type is associated with incomplete relaxation of the LES, a lack of mobility in terms of contraction and relaxation, and a small amount of pressure built up in the esophagus. o Type II Indicated by esophageal compression, this type is more severe with more massive compression in the esophagus, often caused by the failure to relax and build-up of pressure in the esophagus, typically from food. o Type III With spasms that result in sudden, abnormal squeezing of the esophagus and the LES, this type is the most severe and can also elicit the most serious symptoms (eg, chest pains that may mimic those of a heart attack and spasms that can wake a person from sleep). Eckardt Symptom Score The grading system most frequently used for the evaluation of symptoms, stages, and efficacy of achalasia treatment attributing points Peroral Endoscopic Myotomy-DSNP-MM-1435 Effective Date: 05/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 (0 to 3 points) for four symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss) with scores ranging from 0 to 12. Gastroesophageal Reflux Disease (GERD) A chronic disorder that occurs when stomach bile or acid flows into the esophagus and irritates the lining. Laparoscopic Heller Myotomy (LHM) A minimally invasive, surgical procedure used to treat achalasia. Pneumatic Balloon Dilation (PD) An endoscopic therapy for achalasia. An air-filled cylinder-shaped balloon disrupts the muscle fibers of the lower esophageal sphincter, which is too tight in patients with achalasia.D. Policy I. CareSource considers the POEM procedure to be medically necessary when all the following clinical criteria is met: A. The member has a diagnosis of primary achalasia, types I, II, or III. B. POEM is being proposed after the member has tried and failed conventional therapy, including pneumatic dilation or is not a surgical candidate for Heller myotomy. C. Eckardt symptom score is greater than or equal to 3. D. There is no history of previous open surgery of the stomach or esophagus. II. Members 18 or younger should be reviewed for medical necessity. III. POEM for any other indication is considered experimental, investigational, and unproven. IV. Contraindications for this procedure are as follows: A. severe erosive esophagitis B. significant coagulation disorders C. liver cirrhosis with portal hypertension D. severe pulmonary disease E. esophageal malignancy F. prior therapy that may compromise the integrity of the esophageal mucosa or lead to submucosal fibrosis, including recent esophageal surgery, radiation, endoscopic mucosal resection, or radiofrequency ablation V. Previous therapies for achalasia (eg, PD, botulinum toxin injection, or LHM) are not contraindications to POEM. VI. Members receiving POEM should be made aware there is a high risk in developing GERD and will need to be advised of management considerations prior to undergoing the procedure. E. Conditions of Coverage N/A Peroral Endoscopic Myotomy-DSNP-MM-1435 Effective Date: 05/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 F. Related Policies/RulesN/AG. Review/Revision History DATE ACTION Date Issued 02/15/2023 New policy Date Revised 02/14/2024 Annual review: title has been altered to remove the acronym, editorial changes to policy document language, deleted POEMdefinition, lowered Eckardt symptom score criteria to 3 to match LCD, changed reflux esophagitis in Section D.V. toGERD to match LCD, and updated references. Approved atCommittee.12/18/2024 Annual review: updated age requirement and references.Approved at Committee.03/12/2025 Archived GA DSNP due to LCD coverage. Archival effective3/31/2025.Date Effective 05/01/2025Date Archived H. References1. Aiolfi A, Bona D, Riva CG, et al. Systematic review and bayesian network meta-analysis comparing laparoscopic Heller myotomy, pneumatic dilatation, and peroral endoscopic myotomy for esophageal achalasia. JLaparoendosc Adv Surg Tech A . 2020;30(2):147-155. doi:10.1089/lap.2019.0432 2. Familiari P, de Andreis FB, Landi R, et al. Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomized controlled trial. Gut . 2023;72(8):1442-1450. doi:10.1136/gutjnl-2021-325579 3. Health technology assessment: peroral endoscopic myotomy for treatment of esophageal achalasia. Hayes; 2019. Reviewed March 7, 2023. Accessed December 5, 2024. www.evidence.hayes.inc.com 4. Huang Z, Cui Y, Li Y, et al. Peroral endoscopic myotomy for patients with achalasia with previous Heller myotomy: a systematic review and meta-analysis. Gastrintest Endosc . 2021;93(1):47-56.e5. doi:10.1016/j.gie.2020.05.056 5. Khashab MA, Vela MF, Thosani N, et al. ASGE guideline on the management of achalasia. Gastrointest Endosc . 2020;91(2):213-227. doi:10.1016/j.gie.2019.04.231 6. Khashab MA, Kumbhari V, Tieu AH, et al. Peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic Heller myotomy. Saudi JGastroenterol . 2017;23(2):91-96. doi:10.4103/1319-3767.203360 7. Kohn GP, Dirks RC, Ansari MT, et al. SAGES guidelines for the use of peroral endoscopic myotomy (POEM) for the treatment of achalasia. Surg Endosc . 2021;35(5):1931-1948. doi:10.1007/s00464-020-08282-0 8. LCD Peroral Endoscopic Myotomy (POEM) (L38747) . Centers for Medicare and Medicaid Services. Accessed December 5, 2024. www.cms.gov 9. Meng F, Li P, Wang Y, et al. Peroral endoscopic myotomy compared with pneumatic dilation for newly diagnosed achalasia. Surg Endosc . 2017;31(11):4665-4672. doi:10.1007/s00464-017-5530-0 Peroral Endoscopic Myotomy-DSNP-MM-1435 Effective Date: 05/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 10. Patel DA, Lappas BM, Vaezi MF. An overview of achalasia and its subtypes. Gastroenterol Hepatol . 2017;13(7):411-421. Accessed December 5, 2024. www.ncbi.nlm.nih.gov 11. Policies and Procedures for Physician Services . Georgia Dept of Community Health, Division of Medicaid. Revised January 1, 2024. Accessed January 25, 2024. www.mmis.georgia.gov 12. Schneider AM, Louie BE, Warren HF, et al. A matched comparison of per oral endoscopic myotomy to laparoscopic Heller myotomy in the treatment of achalasia. JGastrointest Surg. 2016;20(11):1789-1796. doi:10.1007/s11605-016-3232-x 13. Spechler SJ. Achalasia: pathogenesis, clinical manifestations, and diagnosis. UpToDate. Updated July 3, 2024. Accessed December 5, 2024. www.uptodate.com 14. Tan S, Zhong C, Ren Y, et al. Efficacy and safety of peroral endoscopic myotomy in achalasia patients with failed previous intervention: a systematic review and meta-analysis. Gut Liver. 2021;15(2):153-167. doi:10.5009/gnl19234 15. Vaezi MF, Pandolfino JE, Yadlapati RH, et al. ACG clinical guidelines: diagnosis and management of achalasia: diagnosis and management. Am JGastroenterol . 2020;115(9):1393-1411. doi:10.14309/ajg.0000000000000731 16. Vespa E, Pellegatta G, Chandrasekar VT, et al. Long-term outcomes of peroral endoscopic myotomy for achalasia: a systematic review and meta-analysis. Endoscopy . 2023;55(2):167-175. doi:10.1055/a-1894-0147Independent medical review March 2022
MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Special Needs Car Seats-DSNP-MM-1438 05/01/2025 Ohio 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 Market(s): Georgia Ohio 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 ………………………….. ………………………….. ………………………….. ….. 4 I. References ………………………….. ………………………….. ………………………….. ……………………. 4 Special Needs Car Seats-DSNP-MM-1438Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectSpecial Needs Car Seats B. BackgroundSafe transportation for individuals with certain functional needs includes not only the proper restraints but also the correct positioning to secure the person in the vehicle. Currently, the Federal Motor Vehicle Safety Standard (FMVSS) Number 213 regulate s the design and performance of restraint systems for persons weighing up to 80 pounds. However, people with special needs greater than 80 pounds in weight may require car seat restraint, and several manufacturers have tested car seats beyond an 80-pound weight maximum. Once a person has outgrown a standard 5-point harness car seat, options include carseats specially designed for full support of the persons head, neck, and back, supporting up to 115 pounds. Conventional travel vests or specialized medical seating can be used for persons who require additional trunk support but have stable neck control. Some larger people with special needs, including poor trunk control, can be transported in a special needs belt-positioning booster seat or a conventional belt – positioning booster with trunk support. C. Definitions Booster Seat A seat used for a person during transportation that lifts the person by several inches, designed for use with an adult seat belt. Car Safety Seat (CSS) A portable seat for a person weighing under 80 pounds that attaches to an automobile seat and holds the person safel y. Federal Motor Vehicle Safety Standard 213 FMVSS No. 213 requires child restraint system s (CRSs) to be equipped with attachments that enable the CRS to attach to the vehicle’s child restraint anchorage system. The agency added a height provision to make the new standard’s applicability clear to booster seat manufacturers who choose not to label their restraints with a weight . National Highway Traffic Safety Administration A division of the U.S. Department of Transportation dedicated to achieving the highest standards of excellence in motor vehicle and highway safety . Neck Loading The dynamic loading of the neck that occurs when the torso is suddenly stopped by the seat belt while the head continues pulling from the neck. Travel Vest Optimizes the existing vehicle seat belt system to protect the child by keeping a low center of gravity and allowing the vehicle seat belt and seat cushion to manage the crash forces. D. PolicyI. CareSource considers a special needs car seat medically necessary when ALL the following clinical criteria are met: A. The car seat is a restraint system that meet s National Highway Traffic Safety Administration Federal Motor Vehicle Safety Standard (FMVSS No. 213 ). Special Needs Car Seats-DSNP-MM-1438Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 B. The c ar restraint system is not modified or used in a manner other than that specified by the manufacturer unless the modified restraint system has been crash tested and has met all applicable FMVSS s approved by the NHTSA. C. The special needs car seat is the most cost-effective option while still addressing the medical/functional needs of the member. D. The safety and effectiveness of the special needs car seat has been substantiated by current evidence-based national, state, and peer-reviewed medical guidelines. E. The length or weight limits of a conventional CRS with an internal 5-point harness has been outgrown and at least one of the following criteria is met . 1. The member has respiratory issues or conditions that require enhanced positioning for safety, including any of the following (not an all-inclusive list): a. hypotonia b. craniofacial abnormalities c. primary airway problems d. cerebral palsy 2. The member has a physical condition (eg, seizure or hypertonicity/spasms) that prevents the independent maintenance of a seated position or requires support to allow a functional position or prevent further disability. 3. The member has gastrointestinal issues, including but not limited to : a. emesis b. gastroesophageal reflux (GERD) c. gastrostomy feeding tube 4. The member uses a spica cast. II. Persons with a tracheostomy tube should not use a CRS with a harness or seat belts that could dislodge the tube. It is strongly recommended that an occupational therapist or passenger safety technician with training and experience in the safe transportatio n of persons with special needs provide guidance for appropriate equipment selection and use . III. A special needs car seat will not be considered medical necessary for any of the following:A. The special needs car seat is a more recent advancement in technology when the members current special needs car seat can meet the members basic medical/functional needs. B. The special needs car seat is considered investigational, experimental, or has unproven medical indications for use. E. State-Specific InformationN/A F. Conditions of CoverageN/A G. Related Policies/RulesN/A Special Needs Car Seats-DSNP-MM-1438Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 H. Review/Revision History DATE ACTIONDate Issued 03/01/2023 New policy02/28/20242/12/2025Annual review: editorial changes, added D.I.C-D., D.I.E.2, and D.II-III., updated background, definitions , and references . Approved at Committee. Annual review: updated criteria in D.I.E. and references. Approved at Committee. Date Effective 05/01/2025 Date Archived I. References1. Adams AJ, Johnson MA, Ryan KA, et al. Safe transportation in-spica following surgical treatment of infantile DDH: solutions and threats. JPediatr Orop . 2019;39(7):e488-e493. doi:10.1097/BPO.0000000000001317 2. Angsupaisal M, Maathuis CGB, Hadders-Algra M. Adaptive seating systems in children with severe palsy across International Classification of Functioning, Disability and Health for Children and Young version domains: a systematic review. Dev Med Child Neurol. 2015;57(10):919-930. doi:10.1111/dmcn.12762 3. Car seats and booster seats. National Highway Traffic Safety Administration. Accessed January 29, 2025. www.nhtsa.gov 4. Car seat safety. National Child Passenger Safety Board. Accessed January 29, 2025. www.cpsboard.org 5. Huang PP, Durbin DR. Promoting safety in children with disabilities. UpToDate. Updated January 4, 2024. Accessed January 29, 2025. www.uptodate.com 6. Inthachom R, Prasertsukdee S, Ryan SE, et al. Evaluation of the multidimensional effects of adaptive seating interventions for young children with non-ambulatory cerebral palsy. Disabil Rehabil Assist Technol . 2021;16(7):780-788. doi:10.1080/17483107.2020.1731613 7. Legare JM, Adam MP, Feldman J, et al. Achondroplasia . GeneReviews; 2023. Revbised May 11, 2023. Accessed January 28, 2025. www.ncbi.nlm.nih.gov 8. ONeil J, Hoffman B, American Academy of Pediatrics Council on Injury, Violence, and Poison. Transporting Children with Special Health Needs. Pediatrics . 2019;14 3(5) :e20190724 . doi:10.1542/peds.2019-0724 9. Rigby P, Ryan S, Campbell K. Effect of adaptive seating devices on the activity performance of children with cerebral palsy. Arch Phy Med Rehabil . 2009;90(8):1389-1395. doi:10.1016/j.apmr.2009.02.013 10. Ryan SE. Lessons learned from studying the functional impact of adaptive seating interventions for children with cerebral palsy. Dev Med Child Neurol . 2016;58(4):78 – 82. doi:10.1111/dmcn.13046 11. Smith VC, Stewart J. Discharge planning for high-risk newborns. UpToDate. Updated April 10, 2023. Accessed January 28, 2025. www.uptodate.com 12. Transportation of Children with Disabilities, OHIO ADMIN CODE 3301-51-10 (2023). Special Needs Car Seats-DSNP-MM-1438Effective Dat e: 05/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 5 13. Vives-Torres CM, Valdamo M, Jimenez-Octavio JR, et al . Comparison of upper neck loading in young adult and elderly volunteers during low speed frontal impacts . Frontiers Bioeng Biotechnol. 2021;9 :682974 . doi :10.3389/fbioe.2021.682974 Independent med ical review 02/15/2023
Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Personal Emergency Response Systems-DSNP-MM-1426 04/01/2025 Ohio Inactive as of 01/01/2026 Policy Type MEDICAL This policy applies to the following Marketplace(s): Georgia Ohio Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 2 E. State-Specific Information ………………………………………………………………………………………. 2 F. Conditions of Coverage ………………………………………………………………………………………….. 2 G. Related Policies/Rules ……………………………………………………………………………………………. 3 H. Review/Revision History …………………………………………………………………………………………. 3 I. References …………………………………………………………………………………………………………… 3 Personal Emergency Response Systems-DSNP-MM-1426 Effective Date: 04/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectPersonal Emergency Response SystemB. Background Personal Emergency Response Systems (PERS) are devices with an integrated service that can secure help in the event of an emergency. Currently available PERS allow for communication between the user and responders with additional services and alarms incorporated into the device depending on the sophistication of the device. Trained personnel at a remote monitoring station respond to an individuals alarm signal via the individuals PERS equipment. PERS can improve safety, medication adherence, and allow for independent living when part of the physicians prescribed plan of treatment. C. Definitions Personal Emergency Response System (PERS) Includes telecommunications equipment, a central monitoring station, and a medium for two-way, hands-free communication between the individual and the station. This does not include remote video monitoring of the individual in their home or systems that only connect to emergency service personnel. D. Policy I. The use of a PERS in a members home may be medically necessary when ALL of the following criteria are met: A. Documentation by the members physician of the following: 1. Specific clinical diagnoses and/or physical-functional limitations indicating a need for PERS. 2. How PERS will improve member safety and facilitate continued residence at home. B. The member retains an appropriate mobile or landline phone system that will support the PERS device. C. To be eligible for PERS service, the member is assessed by CareSource case management to be: 1. frail and functionally impaired 2. living alone or with another functionally impaired person 3. willing to arrange for private line telephone service, if private line is not currently in place OR willing to sign a form saying that they have accepted a wireless mobile device as an alternative 4. mentally and physically able to use the equipment appropriately E. State-Specific Information Georgia: Part II Chapter 16: Policies and Procedures for EDWP (CCSP and Source) Emergency Response System Services Ohio: OAC 5160-44-02, OAC-5160-58-04, OAC 5160-44-16, and OAC 173-39-02.6 F. Conditions of Coverage N/A Personal Emergency Response Systems-DSNP-MM-1426 Effective Date: 04/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 G. Related Policies/RulesN/AH. Review/Revision History DATE ACTION Date Issued 02/01/2023 New Policy Date Revised 01/31/2024 12/18/2024Annual review: minor adjustment to background and definitions, added state-specific information, and updated the references. IN no longer covered. Approved at Committee. Annual review: updated case management eligibility and references. Approved at Committee.Date Effective 04/01/2025 Date Archived I. References1. A full guide to personal emergency response systems (PERS). Accessed December 9, 2024. www.alwaysbestcare.com 2. Bat-Erdene BO, Saver JL. Automatic acute stroke symptom detection and emergency medical systems alerting by mobile health technologies: a review. JStroke Cerebrovasc Disc. 2021;30(7):105826. doi:10.1016/j.jstrokecerebrovasdis.2021.105826 3. Breaux E. 7 Best medical alert systems of 2024: expert tested & reviewed. National Council on Aging. Updated December 1, 2024. Accessed December 9, 2024. www.ncoa.org 4. Evidence Review: New Technologies: Epilepsies in Children, Young People and Adults: Diagnosis and Management. National Institute for Health and Care Excellence (NICE); 2022. Accessed December 9, 2024. www.pubmed.ncbi.nlm.nih.gov 5. Falls and fractures in older adults: causes and prevention. National Institute on Aging. Reviewed September 12, 2022. Accessed December 9, 2024. www.nia.nih.gov 6. Get the facts on falls prevention. National Council on Aging. Updated June 1, 2024. Accessed December 9, 2024. www.ncoa.org 7. Golas SB, Nikola-Simons M, Palacholla R, et al. Predictive analytics and tailored interventions improve clinical outcomes in older adults: a randomized controlled trial. NPJ Digit Med . 2021;4(1):97. doi:10.1038/s41746-021-00463-y 8. Goyer A. How to choose a medical alert system. AARP. Updated November 20, 2024. Accessed December 9, 2024. www.aarp.org 9. Jehu DA, Davis JC, Falck RS, et al. Risk factors for recurrent falls in older adults: a systematic review with meta-analysis. Maturitas. 2021;144:23-28. doi:10.1016/j.maturitas.2020.10.021 10. Lachal F, Tchalla AE, Cardinaud N, et al. Effectiveness of light paths coupled with personal emergency response systems in preventing functional decline among the elderly. SAGE Open Med. 2016;4:1-8. Accessed January 16, 2024. www.nih.govPersonal Emergency Response Systems-DSNP-MM-1426 Effective Date: 04/01/2025 The MEDICAL Policy Statement detailed above has received due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 11. Nursing Facility-Based Level of Care Home and Community-Based Services Programs: Person-Centered Planning, OHIO ADMIN . C ODE 5160-44-02 (2021). 12. Nursing Facility-Based Level of Care Home and Community-Based Services Programs: Personal Emergency Response Systems, OHIO ADMIN . C ODE 5160-44-16 (2024). 13. ODA Provider Certification: Personal Emergency Response System, OHIO ADMIN . C ODE 173-39-02.6 (2024). 14. Okuboyejo S, Eyesan O. mHealth: using mobile technology to support healthcare. Online JPublic Health Inform . 2014;5(3):233. doi:10.5210/ojphi.v5i3.4865 15. Part II Chapter 16: Policies and Procedures for EDWP (CCSP and Source) Emergency Response System Services. Georgia Dept of Community Health; 2024. Accessed December 10, 2024. www.mmis.georgia.gov 16. Stokke R. The personal emergency response system as a technology innovation in primary health care services: an integrative review. JMed Internet Res . 2016;18(7):e187. doi:10.2196/jmir.5727 17. Thorton K, Caprio Y. Community-based care. July 2018. Accessed December 9, 2024. www.geriatricscareonline.org
MEDICAL POLICY STATEMENTD-SNP Policy Name & Number Date Effective Non-Emergency Facility to Facility Transfers-DSNP – MM-1487 04/01/2025 Ohio 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 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 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 Medica l 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.This policy applies to the following Market(s): Georgia Ohio Table of ContentsA. 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 ………………………….. ………………………….. ………………………….. ……………………. 4 Non-Emergency Facility to Facility Transfers-DSNP-MM-1487Effective Dat e: 04/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 2 A. SubjectNon-Emergency Facility to Facility Transfers B. BackgroundThis policy addresses the necessity of transferring a patient to a second acute care facility (receiving facility) when the individual requires care not available at the original facility. The goal of any transfer is to maintain the optimal health of the patient. This is accomplished by transferring the patient to the nearest facility that provides the highest specialized care needed. Inter-hospital patient transfer is an important aspect of patient care, most often toimprove patient management. During such transfers, there must be continuity of medical care. Key elements include the decision to transfer and communication, pre-transfer stabilization and preparation, choosing the appropriate mode of transfer, personnel accompanying the patient, equipment and monitoring required during the transfer, and documentation and handover of the patient at the receiving facility. Transfer, admission , and subsequent care to the receiving facility is not medicallynecessary when the needed care is available at the originating facility.C. Definitions Non-Emergency A situation for which immediate response is not needed for the provision of medical treatment. Inter-Facility Transfer The transfer of patients between two healthcare facilities. Intra-Facility Transfer The transfer of patients within the same facility. Originating Facility The current facility to which an individual has been admitted for care and from which a transfer is planned. Participating (In-Network) Facility Facility that is contracted with CareSource. Non-Participating (Out-of-Network) Facility Facility that is not contracted with CareSource. Receiving Facility The facility to which a transfer is planned. D. PolicyI. The following non-emergency transfers require a prior authorization: A. A non-emergency transfer from a participating inpatient facility to a participating inpatient facility that is not within the same healthcare system. B. A non-emergency transfer from a non-participating facility to a participating facility. C. A non-emergency transfer from a non-participating facility to a non-participating facility. II. For non-emergency transfers that require a prior authorization, the receiving facility submits the prior authorization request to CareSource. III. Requests for transfers that require a prior authorization must meet the following criteria: Non-Emergency Facility to Facility Transfers-DSNP-MM-1487Effective Dat e: 04/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 3 A. Member must be medically stable for transfer AND1. Member requires transfer to a level of care which is not available at the originating facility . 2. Member requires transfer for a medically necessary diagnostic or therapeutic service which is not available at the originating facility . 3. Member requires transfer for services of a specialist to evaluate, diagnose , or treat their condition when that specialist is not available at the originating facility . 4. Member requires transfer because member has received care at a specific prior institution for a condition not normally managed at the originating facility and return to that prior institution is needed to diagnose, manage, or treat a complication or other acute issue . 5. Member requires transfer to improve the health and welfare of the member (ie, parental bonding) . 6. Transfer to allow a parent who gave birth to remain with the neonate is considered medically necessary when the neonate transfer meets the medically necessary criteria listed above and the parent who gave birth requires continued hospitalization due to birth complications or other medically necessary conditions . IV. The following non-emergency transfers do not require a prior authorization:A. inter-facility transfers within the same healthcare system B. intra-facility transfers within the same facility V. Non-emergency (elective) transfers are not a covered service for the following:A. The criteria above have not been met . B. The transfer is for the convenience of the member , the members family, the physician, or the originating facility . E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 03/15/2023 New policy. Approved at Committee.Date Revised 02/14/2024 01/15/2025Annual review. No changes. Updated references. Approved at Committee.Annual review. Updated references. Approved at Committee. Date Effective 04/01/2025 Date Archived Non-Emergency Facility to Facility Transfers-DSNP-MM-1487Effective Dat e: 04/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL Policy Statement Policy and is approved. 4 H. References 1. Appropriate interhospital patient transfer. American College of Emergency Physicians. January 2022. Accessed December 16, 2024. www.acep.org 2. Discharges and Transfers, 42 C.F.R. 412.4 (2022). 3. Heaton JK. EMS Inter-Facility Transport. In: StatPearls . StatPearls Publishing; 2022. 4. Obstetric Care Consensus Number 9. Levels of Maternal Care. American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM); 2019. Accessed December 16, 2024. www.acep.org Independent med ical review 02/21/2023
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