MEDICAL POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Fraction Flow Reserve from computer tomography (FFRct) – OH MCD-MM-1046 02/01/2025 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 which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A.Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Fraction Flow Reserve from computer tomography ( FFRct)-OH MCD-M M-1046 Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.2A. Subject Fraction Flow Reserve from Computer Tomography (FFRct) B.Background Heart disease, with coronary artery disease (CAD) being the most common, is the leading cause of death for men and women. The traditional test in management of coronary artery stenosis is a procedure where the fractional flow reserve measures t he bl ood pressure to determine adequate blood flow or blockage during an invasiv e c oronary angiography.A noninvasive alternative for stable symptomatic members with CAD is HeartflowFraction Flow Reserve from Computer Tomography (FFR ct), in which a digital 3-D m odel of the heart arteries is created to assist in determining restricted blood flow.Heartflow FFRct is intended to be used in conjunction with clinical history, symptoms,diagnostic test, and the clinicians professional judgement. C.Definitions FFRct A mathematical ly-derived quantity, computed from simulated pressure,velocity and blood flow information that was obtained from a 3D computer model derived from a coronary CT image.Heartflow FFRct Post-processing software for the clinical quantitative a nd qual itative analysis of previously acquired computed tomography. D. Policy I.Prior authorization is required.I I. Prior authorization must include the following:A. a prescriptionB. documentation supporting a clinically stable symptomatic member with coronary artery disease . For example, a member with stable angina pectoris would be a c andidate for this procedure; whereas a member with unstable angina would not be a candidate for this procedure.II I. Procedure limitationsThe safety and effectiveness of FFRct has not been evaluated for the followi ng popul ations:A. suspicion of acute coronary syndrome (where acute myocardial infarction or unstable angina have not been ruled out)B. recent prior myocardial infarction within 30 daysC. complex congenital heart diseaseD. prior coronary artery bypass graft (CABG) surgeryE. patients with a Body Mass Index >35F. patients who require emergent procedures or have any evidence of ongoing Fraction Flow Reserve from computer tomography (FFRct)-OH MCD-MM-1046Effective Date: 02/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Breast Reconstruction Surgery-OH MCD-MM-0001 02/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 4 H. References ………………………….. ………………………….. ………………………….. …………………….. 4 Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectBreast Reconstruction Surgery B. BackgroundWith an estimated 272,000 new cases yearly, breast cancer continues to be the leading cause of new cancer among women in the United States and a leading cause of cancer death. Breast reconstruction is intended to reduce post-mastectomy complications , es tablish symmetry between the surgical breast and the contralateral breast , and improve quality of life following breast cancer surgery . Breast reconstruction procedures may include breast reduction, breast augmentation with FDA-approved breast implants, nippl e reconstruction (including surgery, tattooing, or both) , and breast contouring. Reconstruction may be performed immediately following a mastectomy or can be delayed for weeks or years until the member has undergone radiation, chemotherapy, or decides th at reconstruction is want ed . Breast augmentation with an FDA-approved implant can be performed in one stage ,during which the implant is inserted during the same surgical visit as the mastectomy , or in two stages using an implanted tissue expander in the first stage followed by removal of the expander and insertion of the permanent breast implant. Complications may occur from breast implants immediately postoperatively or years later and can include exposure, extrusion, infection, contracture, rupture, and /or pain. Clinically significa nt complications may require implant removal. Autologous tissue/muscle breast flap reconstruction is a safe and effective alternative to breast implants. Muscle, subcutaneous tissue, and skin can be transposed from the donor site either locally (eg, latissimus dorsi myocutaneous [LD ] flap, pedicledtransverse rectus abdominus myocutaneous [TRAM ] flap) or distally (eg, free TRAMflap, deep inferior epigastric perforator [DIEP ] flap, superficial inferior epigastric artery perforator [SIEP ] flap, inferior or superior gluteal flap, superior gluteal artery perforator flab, Reubens flap, transverse upper gracilis [TUG ] flap). The choice of procedure can be affected by the members age and health, contralateral breast size and shape, personal preference, and expertise of the surgeon. Individuals may also select non-invasive options , such as mastectomy bras and externalbreast prostheses.Refer to MCG for complete mastectomy.C. Definitions Breast Conserving Surgery (Lumpectomy, Partial Mastectomy) Surgical removal of tumor and small amount of surrounding breast tissue. Contralateral Breast Unaffected/nonsurgical breast. Cosmetic Procedures Procedures completed to improve appearance and self – esteem and to reshape normal structures of the body. Mastectomy Surgical remov al of one or both breasts. Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.D. Policy I. Breast reconstruction is not gender specific. II. Surgical OptionsA. CareSource considers breast reconstruction following treatment for breast cancer medically necessary when ANY of the following apply: 1. following mastectomy or breast conserving surgery of the affected breast 2. producing a symmetrical appearance on the contralateral breast 3. improve breast function after conservatory therapy and related to significant abnormalities or deformities resulting from ANY of the following: a. malignant breast disease b. congenital deformities affect ing the members physical and psychological being c. severe fibrocystic breast disease that limits the members function d. unintentional trauma or injuries e. complications after breast surgery for non-malignant conditions (eg, pain, irritation, bleeding, discharge, complications causing difficulty with lactation) III. CareSource considers risk reduction mastectomy medically necessary when ALL the following apply: A. significantly elevated risk of breast cancer as indicated by ANY of the following: 1. member has BRCA1 or BRCA2 genetic mutation, Li-Fraumeni syndrome (TP53 mutation), or Cowden syndrome (PTEN mutation) 2. lifetime risk of new breast cancer diagnosis estimated to be greater than 20% 3. history of mantle chest radiation before age 30 years B. member does not consider alternative approaches to elevated risk (ie, chemoprophylaxis, close observation) as sufficient C. at least 10-year life expectancy IV. CareSource considers treatment of physical complications , including lymphedema ,following breast reconstruction medically necessary. V. Surgical Exclusions:A. CareSource does not cover any breast reconstruction procedures that are considered experimental, investigational, or unproven for this indication. B. CareSource does not cover: 1. Procedures that are considered cosmetic in nature , including natural changes due to aging and weight loss/gain. 2. Lipectomy for donor site symmetry. 3. Suction lipectomy or ultrasonically assisted suction lipectomy (liposuction) for correction of surgically induced donor site asymmetry (eg, trunk or extremity) that results from one or more flap breast reconstruction procedures. VI. Non-Surgical AlternativesBreast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.CareSource covers external breast prostheses and mastectomy bras following mastectomy or breast conserving surgery. All other indications are considered not medically necessary. VII. Breast reconstruction with free flap procedures, regardless of technique, applies to CPT code 19364 .E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 08/23/2004Date Revised 07/01/2009 07/01/2014 04/17/2015 04/18/2019 04/01/2020 02/17/2021 07/01/2021 03/16/2022 11/09/2022 09/27/2023 10/23/2024Updated with more specific criteria . Reviewed criteria .No changes to content. Updated reference dates. Approved at PGC. Added section V, updated background and references. Annual review. Approved at committee. Annual review: updated risk reduction mastectomy and reorganized policy section for clarity. Date Effective 02/01/2025 Date Archived H. References1. Alder L, Zaidi M, Zeidan B, et al. Advanced breast conservation and partial breast reconstruction a review of current available options for oncoplastic breast surgery. Ann RColl Surg Engl . 2022;104(5):319-323. doi:10.1308/rcsann.2021.0169 2. Breast reconstruction surgery. American Cancer Society . Updated September 19 , 2022 . Accessed October 23, 2024 . www.cancer.org 3. Breast cancer statistics. Centers for Disease Control and Prevention. Accessed October 23, 2024. www.cdc.gov 4. Centers for Medicare and Medicaid Services. Womens Health and Cancer Rights Act (WHCRA) . Accessed October 23, 2024 . www.cms.gov 5. Complete mastectomy: S-860. MCG Health, 28 th ed. Updated March 14, 2024. Accessed August 23, 2024. careweb.careguidelines.com Breast Reconstruction Surgery-OH MCD-MM-0001Effective Date: 02/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6. Costanzo D, Klinger M, Lisa A, et al . The evolution of autologous breast reconstruction. Breast J . 2020;26(11):2223-2225. doi:10.1111/tbj.14025 7. Colwell AS, Taylor EM. Recent advances in implant-based breast reconstruction. Plast Reconstr Surg . 2020;145(2):421e-432e. doi:10.1097/PRS.0000000000006510 8. Friedrich M, Kramer S, Friedrich D, et al. Difficulties of breast reconstruction problems that no one likes to face. Anticancer Res . 2021;41(11):5365-5375. doi:10.21873/anticanres.15349 9. Gradishar WJ, Moran MS, Abraham J, et al . NCCN guidelines insights: breast cancer, version 4.2023. JNatl Compr Canc Netw . 2023;21(6):594-608 . doi:10.6004/jnccn.2023.0031 10. Griffin C, Fairhurst K, Stables I, et al. Outcomes of women undergoing mastectomy for unilateral breast cancer who elect to undergo contralateral mastectomy for symmetry: a systematic review. Ann Surg Oncol . 2024;31(1):303-315. doi:10.1245/s10434-023-14294-6 11. Health technology assessment : c omparative effectiveness review of human acellular dermal matrix for breast reconstruction. Hayes; 2019. Reviewed February 28, 2022. Accessed October 23, 2024 . evidence.hayesinc.com 12. Health technology assessment : a utologous fat grafting for breast reconstruction after breast cancer surgery. Hayes ; 2015 . Review ed November 1 3, 202 3. Accessed October 23, 2024 . evidence.hayesinc.com 13. Nahabedian M. Options for autologous flap-based breast reconstruction. UpToDate. Updated April 29, 2024 . Accessed October 23, 2024 . www.uptodate.com 14. Pappalardo M, Starnoni M, Franceschini G, et al. Breast cancer-related lymphedema: recent updates on diagnosis, severity and available treatments. JPers Med . 2021;11(5):402. doi:10.3390/jpm11050402 15. Sable MS. Breast conserving therapy. UpToDate. Updated September 11 , 2023. Accessed October 23, 202 4. www.uptodate.com 16. Tomita K, Kubo T. Recent advances in surgical techniques for breast reconstruction. Int JClin Oncol . 2023;28(7):841-846. doi:10.1007/s10147-023-02313-1 17. Toyserkani NM, Jorgensen MG, Tabatabaeifar S, Damsgaard T, Sorensen JA. Autologous versus implant-based breast reconstruction: a systematic review and meta-analysis of Breast-Q patient-reported outcomes. JPlast Reconstr Aesthet Surg . 2020;73(2):278-285. doi:10.1016/j.bjps.2019.09.040 18. Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer . 2020;27(4):534-566. doi:10.1007/s12282-020-01076-1 Approved ODM 10/31/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which th e 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 t he 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, Mem ber 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 Cover age) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 6 Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL 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 target ed 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 orchemo em bolization, 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 microw ave 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 a minority of patients. Non-surgical ablative techniques may be used for both cur ative andpalliative intent, includ ing systemic chemotherapy , targeted therapy, immunotherapy ,external beam radiotherapy, cryoablation, thermo-ablation, arterial embolization techniques, and selective internal radiation therapy. Lung cancer is one of the most common types of cancer, with symptoms often notappearing until advanced disease, causing poor prognosis. Common treatments for primary or metastatic cancer in the lung includes surgery, chemotherapy, radiotherapy, photodynamic therapy, thermal ablat ion, 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 s pecific location. When a tumor is not amenable to resection or apatient is ineligible for surgery, MWA may be an appropriate alternativ e definitive treatment. This procedure can be done percutaneously, using minimally invasive surgical techniques, or duri ng open surgery, and involves placement of one more probe s directly into the t umors location, where microwave energy can be directly applied, causing destruction of the tumor and limited s urrounding tissues. Microwave ablation does not spare vessels. Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 C. Definitions 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 ene rgy to rapidly agitate water molecules in the target tissue; the 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. Polic yI. 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 t umor is at most 5cm in size or there are no more than 3 nodules, all of which are no more than 3cm 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 3cm 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 on its efficacy . B. Microwave ablation for tumors larger than 5cm or more than 3 nodules larger than 3cm is considered experimental and investigational due to a lack of clinical evidence on its efficacy compared to other treatment modalities. III. Radiofrequency ablation for tumor treatment is considered medically necessary forANY of the following indications : A. Bone metastases B. Osteoid osteoma 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 Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 b. patient is a candidate for transplant following bridge therapy by radiofrequency ablation c. patient is not a surgical candidate (or elects against surgery) d. patient is not a transplant candida te 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-abdomi nal 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. no t in close proximity to critical structures (eg, major vessels, major bile ducts, diaphragm, other int ra-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 d. solitary peripheral lesion G. Soft tissue sarcoma with ALL 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 o f tumor bulk limited to single organ that is amenable to local therapy, or palliation of disseminated metastases H. Thyroid cancer with ALL the following: Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 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 b. recurrent disease following treatment of locoregional disease 2. medullary carcinoma with at least ONE of the following: a. palliative treatment of symptomatic metastases or prog ressive 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 I. Uterine leiomyomas with ALL the following: 1. laparoscopic ultrasound-guided procedure planned 2. leiomyomas documented by imaging study (e g, ultrasound) or hysteroscopy) 3. patient desires uterine conservation 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. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 10/12/2022Date Revised 09/27 /2023 08/28 /2024 Annual review: updated references. Approved at Committee. Revew: updated references, approved at Committee Date Effective 01/01/2025 Date Archived Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 H. References 1. Cui R, Yu J, Kuang M, et al. Microwave ablation versus other interventions for hepatocellular carcinoma: a systematic review and meta-analysis. JCancer Res Ther . 2020;16(2):379-386. doi:10.4103/jcrt.JCRT_403_19 2. Curley SA, Stuart KE, Schwartz JM, et al. Localized h epatocellular carcinoma: liver – directed therapies for nonsurgical candidates who are eligible for local ablation. UpToDate. Updated September 16, 2022. Accessed July 26, 2024. www.uptodate.com 3. Dupuy DE. Image-guided ablation of lung tumors. UpToDate. Updat ed November 6, 2023. Accessed July 26, 2024. www.uptodate.com 4. Genshaft SJ, Suh RD, Abtin F, et al. Society of Interventional Radiology quality improvement standards on percutaneous ablation of non-small cell lung cancer and metastatic disease to the lungs. JVasc Interv Radiol . 2021;32:1242.e1-1242.e10. doi:10.1016/j.jvir.2021.04.027 5. Glassberg MB, Ghosh S, Clymer JW, et al. Microwave ablation compared with hepatic resection for the treatment of hepatocellular carcinoma and liver metastases: a systematic rev iew and meta-analysis. World JSurg Oncol . 2019;17(1):98. doi:10.1186/s12957-019-1632-6 6. Han Y, Yan X, Zhi W, et al. Long-term outcome following microwave ablation of lung metastases from colorectal cancer. Front Oncol . 2022;12:943715. doi:10/3389/fonc.2022 .943715. 7. Matsui Y, Tomita K, Uka M, et al. Up-to-date evidence on image-guided thermal ablation for metastatic lung tumors: a review. Jpn JRadiol . 2022. ;40(10):1024-1034. doi:10/1007/s11603-022-01302-0. 8. National Comprehensive Cancer Network. Clinical Prac tice Guidelines in Oncology. Hepato cellular Carcinoma . Version 2.2024 . July 2, 2024 . Accessed July 26, 2024 . www.nccn.org 9. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer . Version 7.2024 . June 26, 2024 . Accessed July 26, 2024 . www.nccn.org 10. National Institute for Health and Care Excellence. Microwave ablation for treating liver metastases [IPG553]. April 27, 2016 . Accessed July 26, 2024 . www.nice.org. 11. National Institute for Health and Care Excellence. Microwave ablation of hepatocellular carcinoma [IPG214]. March 28, 2007 . Accessed July 26, 2024 . www.nice.org 12. National Institute for Health and Care Excellence. Microwave ablation for primary or metastatic cancer in the lung [IPG 716 ]. February 2, 20 22 . Access ed July 26, 2024 . www.nice.org 13. Nelson DB, Tam AL, Mitchell KG, et al. Local recurrence after microwave ablation of lung malignancies: a systematic review. Ann Thorac Surg . 2019;107(6):1876-1883. doi:10.1016-j.athoracsur.2018.10.049 14. Palussiere J, Chomy F, Savina M, et al. Radiofrequency ablation of stage IA non – small cell lung cancer in patients ineligible for surgery: results of a prospective Radiofrequency and Microwave Ablation of Tumors-OH MCD-MM-1349Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 multicenter phase II trial. JCardiothorac Surg . 2018;1 3(1):91. doi:10/1186/s13019-018-0773-y 15. Radiofrequency Ablation of Tumor : ACG : A-0718 . MCG H ealth . 28th ed. Updated March 14, 2024. Accessed July 26, 2024 . www.careweb.guidelines.com 16. Wang N, Xu J, Wang G, et al. Safety and efficacy of mic rowave ablation for lung cancer adjacent to the interlobar fissure. Thorac Cancer . 2022 ;13(18):2557-2565 . doi:10.1111/1759-7714.14589 17. Wu X, Uhlig J, Blasberg JD, et al. Microwave ablation versus stereotactic body radiotherapy for stage I non-small cell lun g cancer: a cost-effectiveness analysis. J Vasc Interv Radiol . 2022;33(8):964-971.e2. doi:10.1016/j.jvir.2022.04.019 Independent med ical review September 2022Approved ODM 09/19/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. ………. 2 B. Background ………………………….. ………………………….. ………………………….. ………………………….. … 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………….. ….. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. ………… 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …………….. 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……………… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ……………. 3 H. References ………………………….. ………………………….. ………………………….. ………………………….. …. 4 Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 01/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.2 A. SubjectPositive Airway Pressure Devices for Pulmonary Disorders Continued Rental B. BackgroundPositive airway pressure (PAP) devices u tilize a machine with a mask or other apparatus that fits over the nose and/or mouth to provide positive pressure , keep ing airways open. Continuous positive airway pressure , or CPAP , is used to treat sleep-related breathing disorders , including sleep apnea. It also may be used to treat preterm infants who have underdeveloped lungs. Bi – level or two-level positive airway pressure , or BiPAP , is used to treat lung disorders , such as chronic obstructive pulmonary disease ( COPD). While CPAP delivers a single pressure, BiPAP delivers positive pressure both on inhalation and exhalation. PAP devices can provide better sleep quality, reduc e or eliminat e snoring, and less en daytime sleepiness. PAP devices should always be used according to the physicians order , as well as every time during sleep at home, while traveling, and during naps in order to produce the most effective outcome . C. Definitions Adherence Use of the PAP device as prescribed by the ordering physician, defined as utilization for 4 or more hours per night for 70% of the nights during the most recent consecutive 30-day period during the first initial usage. Bi-Level Positive Airway Pressure (BiPAP) Device A device that uses mild bi-level or two levels of air pressure to keep airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep airways open. Positive Airway Pressure (PAP) Device A device that uses air pressure to keep airways open , including both continuous positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices. D. PolicyI. PAP devices addressed in this policy are as follows: A. E0601 CPAP, continuous pressure capability, used with noninvasive nasal or face mask. This item is a rent to purchase. B. E0470 BiPAP, Bi-level pressure capability, without backup rate feature, used with noninvasive nasal or face mask. This item is a rent to purchase. C. E0471 BiPAP, Bi-level pressure capability, with backup rate feature, used with noninvasive nasal or face mask. This item is a rental only. D. E0472 BiPAP, Bi-level pressure capability, with backup rate feature, used with invasive tracheostomy tube. This item is a rental only. II. PAP devices CPAP (E0601) and BiPAP (E0470):A. Initial prior authorization review: PAP devices CPAP (E0601) and BiPAP (E0470): 1. During the first 3 months rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device, CareSource considers the device Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 01/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.3 medically necessary when Ohio Administrative Code clinical criteria are met. B. Continued rent to purchase period 1. For months 4-10 rental for a CPAP (E0601) or BiPAP (E0470) positive airway pressure (PAP) device documentation confirming adherence (see above definition) must be submitted. Note: CPAP (E0601) and BiPAP (E0470) machines are a 10-month rent to purchase. III. PAP devices BiPAP (E0471) and BiPAP (E0472) CareSource uses MCG Health and /orOAC clinical criteria to determine medical necessity A. During the first 6 months rental, CareSource considers the device medically necessary when the MCG Health clinical criteria are met. B. For months 7-12 rental, CareSource considers the device medically necessary when documentation confirming adherence (see above definition) is submitted . C. Documentation confirming adherence must be submitted annually with the prior authorization request. CareSource considers the device medically necessary when BOTH the following are met: 1. The MCG Health clinical criteria are met. 2. Documentation confirming adherence (see above definition) is submitted. E. Conditions of CoverageNA F. Related Policies/RulesNoninvasive Home Mechanical Ventilation G. Review/Revision HistoryDATE ACTIONDate Issued 06/10/2020 New policyDate Revised 03/31/2021 Revised medical necessity criteria language. Added definitions. Clarified types of PAP devices.05/11/2022 No changes. Updated references. Approved at PGC.03/15/2023 Added Ohio Administrative Code language. Updated02/28/202408/28/2024 references. Approved at Committee.Annual review. Removed MCG from initial review and supply chain statement. Updated references. Approved at Committee.Revised D. II. and III. Updated references. Approved at Committee. Date Effective 01/01/2025 Date Archived Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental-OH MCD-MM-1019 Effective Dat e: 01/01/2025 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in the MEDICAL PolicyStatement Policy and is approved.4 H. References1. Bi-level Positive Airway Pressure (BPAP) Device: ACG A-0994. MCG Health. 28th ed. Updated March 14, 2024. Accessed August 5, 2024. www.careweb.careguidelines.com 2. Continuous Positive Airway Pressure (CPAP) Device: ACG A-0431. MCG Health. 28th ed. Updated March 14, 2024. Accessed August 5, 2024. www.careweb.careguidelines.com 3. CPAP. National Heart, Lung, and Blood Institute. Updated March 24, 2022. Accessed August 5, 2024. www.nhlbi.nih.gov 4. DMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). 5. LCD Positive Airway Pressure (PAP) Devices for the Treatment of Obstructive Sleep Apnea (L33718) . Centers for Medicare and Medicaid. Updated January 1, 2024. Accessed August 5, 2024. www.cms.gov 6. Medical Supplies, Durable Medical Equipment, Orthoses, and Prosthesis Providers, OHIO ADMIN . CODE 5160-10-1 to 80. Accessed August 5, 2024. www.codes.ohio.gov 7. Patil SP, Ayappa IA, Caples SM, et al. Treatment of adult obstructive sleep apnea with positive airway pressure: an American Academy of Sleep Medicine clinical practice guideline. JClin Sleep Med . 2019;15(02):335-343. doi:10.5664/jcsm.7640 This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. Approved by ODM 10/03/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Hyperthermic Intraperitoneal Chemotherapy-OH MCD-MM-1340 01/01/2025 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Hyperthermic Intraperitoneal Chemotherapy-OH MCD-MM-1340Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectHyperthermic Intraperitoneal Chemotherap y B. BackgroundPatients with digestive system or ovary cancer have an increased risk of developing peritoneal metastases (PM). Hyperthermic intraperitoneal chemotherapy (HIPEC) is part of a multimodal treatment plan for PM. It is employed within the peritoneal cavity following cytoreductive surgery (CRS) of the abdominal cavity throu gh a traditional open or laparoscopic approach. The hyperthermic agents are heated to 40 42 degrees Celsius. Hyperthermia is selectively lethal for malignant cells and the effects of heat can be synergistic with those of other anticancer treatments such as chemotherapy. Th is infusion facilitates the spread of the chemotherapeutic solution throughout the entire peritoneal cavity, avoiding compartmentalized spread that would be likely following post – operative adhesion formation. Cytotoxic drugs most frequently used in HIPEC include mitomycin, doxorubicin, cisplatin, oxaliplatin and paclitaxel These drugs are combined with a carrier solution of isotonicsaline solutions or dextrose-based peritoneal dialysis solutions. Approximately 3 to 5liters are infused into the peritoneum during the procedure . The extent of tumor load is estimated through imaging methods, usually by computed tomography (CT) and magnetic resonance imaging (MRI) or preoperative laparoscopy.To describe peritoneal carcinomatosis with a universally accepted reference standard, the Peritoneal Cancer Index (PCI) was introduced initially for carcinomatosis of colorectal cancer and mesothelioma. PCI is calculated as the sum of scores in thirteen ab dominal regions. Each region receives a score of 0-3 based on the largest tumor size.Score s range from 0 to 39, with higher scores indicating more widespread and/or larger tumors in the peritoneal cavity. In colorectal cancer, PCI is the most important prognostic factor, showing a linear relationship with overall survival. A consensus on a cuto ff value for treatment has not been clearly established. However, surgery is not recommended for patients who have colorectal carcinomatosis with a PCI higher than 20. In ovarian cancer, assessment of PCI is not a standard of care in clinical practice or i n surgical studies. However, van Driel et al (2018) conducted a Phase III study to investigate whether the addition of HIPEC to interval CRS would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer. The median recurrence free survival was 10.7 months in the surgery group and 14.2 months in the surgery plus-HIPEC group. Seventy-six patients (62%) in the surgery group and 61 patients (50%) in the surgery-plus-HIPEC group had died at a median fol low-up of 4.7 years (hazard ratio, 0.67; 95% CI, 0.48 to 0.94; P=0.02). The median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery – plus-HIPEC group. HIPEC is completed with an open or closed abdominal technique. The o pen abdom inaltechnique occurs at the end of CRS and peritoneal catheters are placed through the abdominal wall. The skin edges are suspended through use of a self-retaining retractor Hyperthermic Intraperitoneal Chemotherapy-OH MCD-MM-1340Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 to maintain the open space in the abdominal cavity. The temperature probes are attached to the skin edge for intraperitoneal temperature monitoring. To prevent leakage of the chemotherapy solution, a plastic sheet is placed. The surgeon continuously manipu lates the perfusion to allow the uniform exposure of all anatomical structures to heat and chemotherapy. An external pump recirculates the chemotherapy infusion through inflow and outflow catheters. In a closed HIPEC procedure (which is more commonly used) , the peritoneal cathetersand probes are placed in the same way, but the laparotomy incision and skin edges are closed to permit perfusion through a closed circuit. The surgeon manually shakes the abdominal wall during the infusion for uniform heat distribution. Greater perfusate is used in this technique to establish the circuit and generate higher abdominal pressure, which facilitates tissue penetration. After infusion, the abdomen is reopened to r emove the perfusate. catheters, and to complete any additional surgical procedures needed (eg , anastomosis). C. Definitions Abdominal Cavity A cavity within the abdomen and continuous with the pelvic cavity and containing the stomach with lower portion of the esophagus, small and large intestines, liver, gallbladder, spleen, pancreas, kidney , and ureter. Carcinomatosis The condition of having widespread dissemination of carcinoma in the body. Cytoreductive Surgery (CRS) The removal of all sites of cancer within the abdominal cavity. Debulking Surgery The s urgical removal of as much of a tumor as possible. Debulking may increase the chance that chemotherapy or radiation therapy will kill all the tumor cells. It may also be done to relieve symptoms or help the patient live longer. Also called tumor debulking. Hyperthermic Perfusion A procedure in which a warmed solution containing anticancer drugs is used to bathe, or is passed through the blood vessels of, the tissue or organ containing the tumor. Mesothelioma A cancer that affects tissue called the mesothelium, a lining that covers and protects many internal organs. Pleural and peritoneal mesothelioma account for most of the 2,000 to 3,000 new cases of the disease diagnosed in the United States each year. The most common cause of mesothelioma is exposure to asbestos. Peritone um The serous membrane lining the abdominal cavity and covering the abdominal organs . Peritoneal Metastasis A late-stage manifestation of intra-abdominal malignancies. Pseudomyxoma Peritoneai (PMP) A build-up of mucus in the peritoneal cavity. The mucus may come from ruptured ovarian cysts, from the appendix, or from other abdominal tissues. Mucus secreting cells may attach to the peritoneal lining and continue to secrete mucus. Hyperthermic Intraperitoneal Chemotherapy-OH MCD-MM-1340Effective Dat e: 01/01/2025The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 D. PolicyI. CareSource considers HIPEC in combination with CRS medically necessary for ANY of the following indications : A. Pseudomyxoma peritoneai (PMP) B. Appendiceal neoplasms with PMP/mucinous ascites C. Diffuse m alignant peritoneal mesothelioma (DPM) with metastasis limited to the abdominal cavity D. Select patients with metastatic colorectal cancer with peritoneal involvement, with a PCI
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Clinical Trial Coverage-OH MCD-MM-0798 01/01/2025 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 …………………………………………………………………………………………………………………. 4 E. Conditions of Coverage ………………………………………………………………………………………… 5 F. Related Polic ies/Rules ………………………………………………………………………………………….. 5 G. Review/Revision History ……………………………………………………………………………………….. 5 H. References …………………………………………………………………………………………………………. 5 Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 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 Clinical Trial Coverage B. Background Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose , or treat a disease. Clinical trials evaluate new or emerging devices, treatments, and procedures. They may also compare a new treatment to a treatment that is already available. Every clinical trial has a protocol or action plan for conducting the trial. The protocol or action plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Clinical trials are scientific investigations of treatment alternatives designed to help compare the safety and efficacy of new, untested or non-standard treatments to standard currently accepted treatments. Clinical trials are intended to improve clinicians knowledge about a treatment and to improve clinical outcomes for future patients . Clinical trials generally proceed through four phases: a. Phase I the study treatment is given to a small group of people who are healthy or have the disease/condition for the first time to evaluate its safety and determine a safe dosage range; b. Phase II the study treatment is given to a large group of people who have the disease/condition to see if it is effective and to identify side effects; c. Phase III the study treatment is given usually to large groups of people who have the disease/condition to confirm its effectiveness, monitor adverse reactions, compare it to commonly used treatments and collect information that will allow the treatment to be used safely; d. Phase IV studies performed after the treatment has been marketed to collect information about its effects in various populations of people who have the disease/condition and to identify side effects associated with long-term use. NOTE: Experimental, investigational, and unproven treatment, procedures and all related services are not a covered service by Medicaid. C. Definitions Clinical Trial is a Phase I, II, III, or IV research study t hat does ONE of the following for the treatment of cancer or a life-threatening disease: o tests how to administer a health care service o tests responses to a health care service o compares effectiveness of a health care service o studies new uses of a health care service AND Is approved and funded by ONE of the following: Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 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.3o a cooperative group of research facilities that has an established peer review program that is approved by a National Institutes of Health Institute or center and assures an unbiased review of standards of care with qualified individuals who do not have an interest in the review outcome o National Institutes of Health (NIH) o The Centers for Disease Control and Prevention (CDC) o The Agency for Health Care Research and Quality (AHRQ) o The Centers for Medicare and Medicaid services (CMS) o a cooperative group or center of NIH, CDC, AHRQ, DOD, VA, or CMS o The United States Department of Veterans Affairs (VA) o The United States Department of Defense (DOD) o The Food and Drug Administration (FDA) o The United States Department of Energy o The institutional review board of an institution located in Ohio that has a multiple project assurance contract approved by the National Institutes of Health Office for Protection from Research Risks as provided in 45 CFR 46.103 o a research entity that meets eligibility criteria for a support grant from a National Institutes of Health center o a qualified non-governmental research entity in guidelines issued by the NIH for center support grants AND o is conducted in a facility where the personnel have training, and expertise required to provide type of care required in the study AND o has a written protocol for the clinical trial AND o designed to have a therapeutic intent . Routine care cost The cost of medically necessary items and services related to the care method which is under evaluation in the clinical trial. Life-threatening disease or condition A ny disease or condition from which the likelihood of death is probable unless the course of the disease or condition is interrupted. Category A (Experimental) device Per Centers for Medicare and Medicaid Services a device for which absolute risk of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. Category B (Non-experimental/investigational) device Per Centers for Medicare and Medicaid Services a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type . Experimental/investigational/unproven Any procedure, treatment, service, supply, or product that meets one or more of the following: o Is subject to Institutional Review Board review or approval . o Effectiveness on health outcomes is unproven based on clinical evidence in peer-reviewed medical literature. Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 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.4o Cannot be legally marketed in the United States without final approval from appropriate government regulatory or licensing body. ICD-10-CM Code Z00.6 A billable ICD code used to specify a diagnosis of encounter for examination for normal comparison and control in clinical research program. The Z00.6 diagnosis code reports that the service involved "examination of participant in clinical trial ." The Z00.6 diagnosis code must be used for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be conventional care for the patient absent the trial. D. Policy I. Prior authorization is required for ICD-10-CM Code Z00.6. II. Informed consent approved by an IRB accredited Association for the Accreditation of Human Research Protection Programs (AAHRPP) must be obtained from the member before enrolling in a clinical trial. III. CareSource will cover routine care costs for a member enrolled in a clinical trial as described in this policy when A. The same routine care costs would be typically covered for a member who is not enrolled in the clinical trial AND B. All items and services are medically necessary AND C. All items and services are a covered benefit . IV. CareSource will cover routine care costs for member in a clinical trial where the item or service is A. Required for the administration and provision of the item or service such as the staffing and equipment need to implant the device OR B. For the clinically appropriate monitoring of the effects of the item or service OR C. For the prevention, diagnosis , or treatment of complications from item or service provided in the clinical trial . V. CareSource will NOT cover the following items as they are not considered routine care costs typically covered by a member who is not enrolled in the clinical trial A. Item or service being evaluated. B. Item or service that is only utilized for data collection and analysis and not related to the direct clinical management of member . C. Item or service reimbursed or provided for free from another source including the research sponsor . D. Item or service only utilized to determine if individual is eligible to participate in clinical trial. E. Clinical trials designed to only test toxicity or disease pathology . F. Treatment that is not standard of care to support or administer the item or service in the clinical trial. Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.5G. Transportation, housing, food or expenses for the member or family members/companions associated with travel to or from facility providing the clinical trial. H. Experimental/investigational/unproven procedure, treatment, service, supply, device, or product . VI. All applicable plan limitations for coverage for out-or-network providers will apply to routine care costs in a clinical trial. VII. All applicable utilization management guidelines (including prior authorizations) will apply to routine care for members in a clinical trial. E. Conditions of Coverage N/A F. Related Polic ies/Rules G. Review/Revision HistoryDATE ACTIONDate Issued 05/19/2015Date Revised 05/19/2015 05/17/2016 07/10/2019 11/01/2019 10/28/2020 10/27/2021 08/31/2022 08/30/2023 09/ 05 /2024 Changed title from Clinical Trials. Changed from AD-0002. Removed all other state requirements. Added specific criteria. Added PA requirement. Updated references. Per SIU expanded definition Z00.6, Encounter for examination for normal comparison and control in clinical research program No changes; updated references Changed title to Clinical Trial Coverage. Updated references. No other changes. Updated references. Approved at Committee. Updated references. Approved at Committee .Date Effective 01/01/2025Date Archived H. References1. Associations for the Accreditation of Human Research Protection Programs (AAHRPP). Accessed August 14, 2024 . www.aahrpp.org 2. eCFR-Code of Federal Regulations. (n.d.). Accessed August 14, 2024. www.ecfr.gov 3. Local Coverage Article. Clinical Trials-Medical Policy Article (A52430). Accessed August 14, 2024 . www.cms.gov 4. Medicare and Medicaid Services Medicare Learning Network (2015). MLN Matters. Medicare Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies. Accessed August 14, 2024. www.cms.gov Clinical Trial Coverage-OH MCD-MM-0798 Effective Date: 01/01/2025 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.65. National Coverage Determination for Routine Costs in Clinical Trials (310.1). Accessed August 14, 2024. www.cms.gov 6. Denial of Coverage to Cancer Clinical Trial Participant, O HIO REV . CODE ANN 3923.80 (2009). Accessed August 14, 2024. www.codes.ohio.gov 7. Non-Covered Serv ices, O HIO ADMIN . CODE 5160-1 -61 (2022). Patient Protection and Affordable Care Act. (2010, March 23). Accessed August 14, 2024. www.govinfo.gov. 8. Patient Protection and Affordable Care Act, 42 U.S.C. 18001 (2021). Accessed August 13, 2024 . www.govinfo.gov A pproved ODM on 09/19/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Transcranial Magnetic Stimulation for Treatment of Depression – OH MCD-MM-0233 11/01/202 4 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2024 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectTranscranial Magnetic Stimulation for Treatment of Depression B. BackgroundTranscranial magnetic stimulation (TMS) was originally introduced in 1985 as a noninvasive treatment modality for treatment-resistant Major Depressive Disorder (MDD) . Brief , repetitive pulses of magnetic energy are sent to the scalp via a large electromagnetic coil , generating a low level of electrical stimulation. These magnetic fields pass through the sk ull and induce electric al currents that depolarize neurons in a focal area of the surface cortex. The magnetic field generated by this type of stimulation is very smal l and cannot be felt by the patient but is strong enough to flow into the brain without inducing seizures or creating a need for anesthesia. TMS is generally an outpatient procedure with conscious patients and sessions tha t varybetween 30 to 40 minutes. Treatment can be delivered as a single pulse or as a series of pulses. Despite variability in the number of pulses delivered per session and the number of sessions per patient, research indicates that typical courses of TMS consist of treatment up to 5 days a week for up to 6 weeks. A tapering schedule is used to end treatment. C. Definitions Acute (Index) Course of Treatment The initial series of treatment given to relieve acute symptoms of MDD . Adequate Trial of an Antidepressant Drug Taking a drug for at least 4 weeks at or near the maximum dose for the specific antidepressant as approved by the F ood and Drug Administration or documentation exists that higher doses were not tolerated when the dose is less than the FDA approved maximum. Continuation TMS Treatment beginning after the acute/index course lasting up to 6 months and designed to prevent the worsening of symptoms and continue d treatment for a depressive episode that has not yet remitted. Depression Rating Scale Standardized s cales for national use that reliably assess the range of symptoms most commonly observed in adults with MDD, including type and magnitude. Listed below are examples of commonly used scales : OBeck Depression Inventory (BDI) o Geriatric Depression Scale (GDS) o Hamilton Depression Rating Scale (HAM-D) o Patient Health Questionnaire-9 (PHQ-9) o Quick Inventory of Depressive Symptomatology (QIDS) Diagnostic and Statistical Manual of Mental Disorders , Fifth Edition , Text Revision (DSM-5-TR ) Standard language by which clinicians, researchers, and public health officials in the US communicate about mental disorders and subsequent criteria and classification. Maintenance TMS Regularly scheduled TMS sessions on a weekly, biweekly, or monthly basis used to prevent relapse of depressive symptoms. Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2024 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Major Depressive Disorder (MDD) Discrete episodes of at least 2 weeks duration involving changes in affect, cognition, and neurovegetative functions and inter – episode remission evidenced by a combination of 5 or more symptoms that must include either depressed mood or anhedonia representing a change from previous functioning. Medication Side Effects Unexpected effects that cause significant distress, inhibit daily function, have the potential to worsen health, or are life threatening. Remission The absence of significant signs or symptoms of a n MDD episode during the previous 2 months. D. PolicyI. A review of medical necessity is required for initial or continuation courses of TMS . II. Initial (acute/index) treatment is considered medically necessary when ALL the following criteria are met: A. Member is 18 years of age or older. B. Member has a confirmed diagnosis of major depressive disorder , single or recurrent , with a current severe episode as evidenced by a recent score on a standardized depression rating scale and at least one of the following: 1. Need for treatment , as indicated by one of the following: a. resistance to treatment with documented adherence as evidenced by a lack of a clinically significant response during a current or previous depressive episode and 2 or more classes of an tidepressant agents at or near maximum effective dose and duration approved by the FDA, or b. inability to tolerate pharmacotherapy evidenced by 2 antidepressants with documented side effects 2. Continuation of acute course of treatment, as indicated by all the following: a. continuation of symptoms after index (acute) course of treatment b. previous positive response to index (acute) course of treatment evidenced by a reduction of 50% in a depression severity rating scale as compared to baseline C. None of the following conditions or contraindications are present: 1. epilepsy , history of seizure or other neurologic disease that may lower seizure threshold (eg, cerebrovascular accident, severe head trauma, increased intracranial pressure) 2. acute or chronic psychotic symptoms or disorders (eg, schizophrenia, schizophreniform, or schizoaffective disorder) 3. cochlear implant s, deep brain stimulator s, or vagus nerve stimulator 4. current use of substances that may significantly lower seizure threshold (eg , alcohol or stimulants ) 5. metallic hardware or implanted magnetic-sensitive medical device s (eg, implanted cardioverter-defibrillator s, pacemaker s, metal aneurysm clips or coils) at a distance within the electromagnetic field of the discharging coil (eg, less than or equal to 30 cm to the discharging coil). Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2024 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 III. Additional treatment courses of TMS are considered medically necessary when all the following have been met: A. It has been 30 days since last session of TMS . B. There is a history of response to TMS in a previous depressive episode as evidenced by a greater than 50% improvement in a standardized depression rating scale . C. Medical necessity is met per Section II above. IV . Maintenance treatment with TMS is not considered medically necessary . T here is not sufficient evidence in peer reviewed literature to assess net benefit versus harm for patients. V. Additional criteriaA. TMS must be administered by an FDA cleared device for the treatment of MDD in a safe and effective manner according to the manufacturers user manual and specified stimulation parameters. B. A treatment course should not exceed 5 days a week for 6 weeks (total of 30 sessions), followed by a 3-week taper of 3 treatments in 1 week, 2 treatments the next week , and 1 treatment in the last week. C. TMS can be ordered by and performed under direction of a neurologist, licensed psychiatrist, or psychiatric nurse practitioner who has examined the member , reviewed the record when it is within the scope of practice , and has experience in administering TMS therapy within the scope of practice . E. Conditions of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 07/12/2018Date Revised 11/11/2020 10/28/2021 08/31/2022 01/19/2023 07/19/2023 06/19 /2024 Removed a definition, added neurologist. Revised and expanded definitions. Added Section II and IV. Updated background , d efinitions , & criteria (MCG 26 th ed). Updated title for clarity. Annual review. Updated references. Approved at Committee. Annual review. Updated references. Approved at Committee. Date Effective 11/01/2024 Date Archived Transcranial Magnetic Stimulation for Treatment of Depression-OH MCD-MM-0233 Effective Dat e: 11/01/2024 The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 H. References1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised. American Psychiatric Association; 2022. 2. Holtzheimer PE. Unipolar major depression: administering transcranial magnetic stimulation (TMS). UptoDate. Updated February 02, 2023. Accessed May 31, 2024. www.uptodate.com 3. Holtzheimer PE. Unipolar depression in adults: indications, efficacy, and safety of transcranial magnetic stimulation (TMS). UptoDate. Updated February 15, 2023. Accessed May 31, 2024. www.uptodate.com 4. Jarrett R, Vittengl J. Unipolar depression in adults: continuation and maintenance treatment. UptoDate. Updated September 15, 2022. Accessed May 31, 2024. www.uptodate.com 5. National Institute of Mental Health. Brain Stimulation Therapies . National Institutes of Health; 2023. NIH publication 0925-0648. Accessed May 31, 2024. www.nimh .nih.gov 6. Perera T, George MS, 5rammar G, et al. The Clinical TMS Society consensus review and treatment recommendations for TMS therapy for major depressive disorder. Brain Stimul . 2016;9(3):336-346. doi:10.1016/j.brs.2016.03.010 7. Thase M, Connolly R. Unipolar depression in adults: choosing treatment for resistant depression. UptoDate. Updated November 2, 2023. Accessed May 31, 2024. www.uptodate.com 8. Transcranial magnetic stimulation: B-801-T. MCG Health, 28 th edit. Updated March 14, 2024. Accessed May 31, 2024. www.careweb.careguidelines.com Approved by Ohio Department of Medicaid 07/25/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Standing Frames-OH MCD-MM-1331 11/ 01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Standing Frames-OH MCD-MM-1331Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectStanding Frames B. BackgroundSupported standing is a common, adjunctive therapeutic practice in which patients with neurological conditions are enabled to assume an upright position. Homebased standing programs are commonly recommended for adults and children who cannot stand and/or walk independently and are usually part of a postural management program, which plays a role in preventing contracture, deformity, pain, and asymmetry. Standers might include prone, supine, vertical, multi-positional , and sit-to-stand types. Standing frames consist of a simple base with an upright support to which the patientcan be strapped. These devices provide no mobility, but research has shown medical benefits supporting use, including an enhanced ability to perform tasks, maintained or improved joint range of motion, muscle spasticity and bone density , and an enhanced ability to perform activities of daily living. In recent studies, some adults and children report a decrease in pain, suppository use , decubitus ulcers, urinary tract infections (UTI), and clinical depression, while reporting an increase in improved bowel function , breathing, circulation , and muscle tone. Psychological benefits have also been documented and include improved socialization, patient satisfaction and quality of life due to improved interacti on with others. Additionalbenefits for some patients can include enhanced independence, improved vocational activities, and increased recreational activities with peers and others, which have been reported to instill a heightened sense of confidence and equality and improved self – esteem in children and adults. Acceptance by others and a sense of integration is perceived to be higher among standing frame users. No adverse events or effects have been frequently reported or documented in literature, but some contraindications have been widely discussed. Additionally, many patients do not report pain with use of standing frames. With the added benefit of the enhance mentof functional recovery with early physical rehabilitation, many providers are adding supported standing as a practice in postural management after consideration of contraindications is examined by a medical professional .C. Definitions Activities of Daily Living (ADLs) Fundamental skills required to independently care for oneself, including the following two categories : o Basic ADLs Skills required to manage ones basic physical needs, including ambulation, feeding, dressing, personal hygiene, continence and toileting. o Instrumental ADLs Skills that require more complex thinking skills, including transportation and shopping, finance management, meal preparation, house cleaning and home maintenance, communication management, and medication management. Standing Frames-OH MCD-MM-1331Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 Durable Medical Equipment (DME or DMEPOS ) A collective term for a covered durable medical equipment item, prosthetic device, orthotic device, or medical supply item furnished by an eligible provider to an eligible recipient Home Medical Equipment Equipment that can stand repeated use, is primarily and customarily used to serve a medical purpose, is not useful to a person in the absence of illness or injury and is appropriate for use in the home . Postural Management A multi-disciplinary approach incorporating a comprehensive schedule of daily and night-time positions, equipment , and physical activity to help maintain or improve body structures and function and increase activity and participation. Technologically Sophisticated Medical Equipment (TSME) Prescribed by an authorized health care professional and requir ing individualized adjustment or regular maintenance by a home medical equipment services provider to maintain a recipient s health care condition or the effectiveness of the equipmen t. Standers are considered TSME. D. PolicyI. CareSource will review medical necessity requests for non-powered standing frames on a case-by-case basis once all the following information is submitted for review: A. New Equipment 1. stander information, including all the following details: a. manufacturer b. mode l number c. type of stander d. part number, if applicable and if available e. an itemized list of any additional attachments and accessories with individual prices , if not included with the basic stander or if applicable 2. a face-to-face encounter with a medical professional who has a relationship with the member (a single encounter can serve for 12 months as the basis for a single prescription for more than 1 prescription addressing the same medical condition for which a DM EPOS item is prescribed.) 3. a prescription is valid for 1 year , unless a different length of time is specified, and must include all the following: a. dated signature of 1 of t he following appropriately Ohio-licensed and/or certified medical professionals : 01. physician (MD or DO) 03. advanced practice registered nurse (APRN) with a relevant specialty 04. physician assistant (PA) b. specific recipient diagnosis ( -es) document ing a neuromuscular condition (eg, multiple sclerosis, cerebral palsy, spinal cord injury, stroke) or documented developmental delay impairing the recipients ability to stand independently Standing Frames-OH MCD-MM-1331Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 4. documentation showing that the member or parent/guardian received training in use of standers or standing frames , which can be completed during a scheduled therapy session for the member, if applicable 5. documentation showing the member or parent/guardian can safely use the device in the home setting (eg, documentation from physical therapy or other therapy sessions documenting trials of use suffice) of member or parent/guardian training in use of standers or standing frames and an ability to safely use the device in the home setting 6. documentation that device use can be reasonably expected to provide therapeutic benefits or enable the member to perform certain tasks unable to perform otherwise due to the diagnosis, such as but not limited to 1 or more of the following: a. aids in the prevention of atrophy in the trunk and leg muscles b. improves strength and/or circulation to the trunk and lower extremities c. prevents formation of decubitus ulcers with changeable positions d. helps maintain bone and/or skin integrity e. reduces swelling in the lower extremities f. improves range of motion and/or aids normal skeletal development g. improves function of kidneys, bladder, and/or bowels h. decreases muscle spasms i. strengthens the cardiovascular system and builds endurance j. prevents or decreases muscle contractures and/or progressive scoliosis k. improves social interaction and psychological well-being l. increase performance of activities of daily living (ADLs) 7. no contraindications to supported standing, such as but not limited to a. healing fracture or severe osteoporosis preclud ing weight bearing of any kind b. significant hip or knee flexion or ankle plantarflexion contractures in which stretch or pressure prevents standing c. compromised cardiovascular or respiratory systems requir ing frequent monitoring of circulation and function while in a stander d. significant inflexible skeletal deformities e. lack of standing tolerance (ie, cannot maintain a standing position due to little or no residual strength in the hips, legs and lower ) f. postural hypotension B. Replacement of a non-powered standing frame is considered medically necessary after 5 years when both the following criteria have been met: 1. medical necess ity criteria above are met 2. device is out of warranty or not functioning properly and cannot be refurbished or adequately repaired II. The following items or services are not covered or separately reimbursable :A. electric, motorized or powered standing frames B. items or services covered under manufacturer or dealer warranty Standing Frames-OH MCD-MM-1331Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 C. DME items that duplicate or conflict with another item currently in the recipient’s possessionD. replacement items or previously approved equipment that have been damaged because of perceived misuse, abuse , or negligence E. Conditions of CoverageAdditional instructions regarding reimbursement of DME items may be located in OAC 5160-10-01. F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 08/31/2022 New policy.Date Revised 07/19/2023 07/17/2024Annual review. Updated formatting to AMA style. Updated references. Approved at Committee.Annual review. Updated prescription validity to 1 year. Added face to face encounter with provider. Updated references. Approved at Committee. Date Effective 11/01/2024 Date Archived H. References1. Arva J, Paleg G, Lange M, et al. RESNA position on the application of wheelchair standing devices. Assist Technol. 2009;21(3):161-171. doi:10.1080/1044393175622 2. Capati V, Covert SY, Paleg G. Stander use for an adolescent with cerebral palsy at GMFCS level with hip and knee contractures. Assist Technol . 2020;32(6):335-341. doi:10.1080/10400435.2019.1579268 3. Definitions , OHIO REV . CODE ANN . 4752.01 (20 18 ). 4. Durable Medical Equipment, Prosthesis, Orthoses, and Supplies (DMEPOS): General Provisions , OHIO ADMIN . CODE 5160-10-01 (202 4). 5. Edemekong PF, Bomgaars DL, Sukumaran S, et al . Activities of Daily Li ving. In: StatPearls. Updated June 26, 2023. 6. Ferrarello F, Deluca G, Pizzi A, et al. Passive standing as an adjunct rehabilitation intervention after stroke: a randomized controlled trial. Arch Physiother . 2015;5(2). doi:10.1186/s40945-015-0002-05 7. Goodwin J, Lecouturier J, Basu A, et al . Standing frames for children with cerebral palsy: a mixed-methods feasibility study. Health Technol Assess . 2018;22(50):1-232. doi:10.3310/hta22500 8. Macias-Merlo L, Bagur-Calafat C, Girabent-Farrs M, et al . Standing programs to promote hip flexibility in children with spastic diplegic cerebral pal sy. Pediatr Phys Ther . 2015;27(3):243-249. doi:10.1097/PEP.000000 00 00000150 Standing Frames-OH MCD-MM-1331Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 9. Martinsson C, Himmelmann K. Abducted standing in children with cerebral palsy:effects on hip development after 7 years . Pediatr Phys Ther . 2021;33(2):101-107. doi:10.1097/PEP.0000000000000789 10. Newman M, Barker K. The effect of supported standing in adults with upper motor neurone disorders: a systematic review. Clin Rehabil . 2012;26(12):1059-1077. doi:10.1177/0269215512443373 11. ODA Provider Certification: Home Medical Equipment and Supplies. OHIO ADMIN . CODE 173-39-02.7 (2022). 12. Paleg G, Livingstone R. Evidence-informed clinical perspectives on postural management for hip health in children and adults with non-ambulant cerebral palsy. J Pediatr Rehabil Med . 2022;15(1):39-48. doi:10.3233/PRM-220002 13. Paleg G, Livingstone R. Systematic review and clinical recommendations for dosage of supported home-based standing programs for adults with stroke, spinal cord injury and other neurological conditions. BMC Musculoskelet Disord . 2015;16:358. doi:10.1186/s12891-015-0813-x 14. Paleg GS, Smith BA, Glickman LB. Systematic review and evidence-based clinical recommendations for dosing of pediatric supported standing programs. Pediatr Phys Ther . 2013;25(3):232-247. doi:10.1097/PEP.0b013e318299d5e7 15. Pedlow K, McDonough S, Lennon S, et al . Assisted standing for Duchenne muscular dystrophy . Cochrane Database Syst Rev . 2019;10(10):CD011550. doi:10.1002/14651858. CS011550.pub2 16. Standing frame : A-0996. MCG . 28th ed. Updated March 14, 2024 . Accessed June 18, 2024 . www.careweb.careguidelines.com 17. Synnot A, Chau M, Pitt V, et al . Interventions for managing skeletal muscle spasticity following traumatic brain injury. Cochrane Database Syst Rev . 2017 ;11(11):CD008929. doi:10.1002/14651858.CD008929.pub2 Independent med ical review 08/2022Approved O hio Department of Medicaid 07/25/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Private Duty Nursing-OH MCD-MM-1510 11/01/2024 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 o f 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 cont rolling 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 fav orable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 17 F. Related P olicies/Rules ………………………….. ………………………….. ………………………….. ……. 17 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 17 H. References ………………………….. ………………………….. ………………………….. …………………… 17 Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPrivate Duty Nursing B. BackgroundPrivate duty nursing (PDN) is a Medicaid State Plan service that provides in-home skilled nursing care to Medicaid members of any age who require continuous nursing services beyond the Medicaid State Plan Home Health benefit. PDN provides care for members with complex medical needs under the direction of the members physician if it can be provided safely in a residence unless it is medically necessary for a nurse to accompany the member in the community . For individuals who have a medical need for part-time , intermittent , and skilled nursing or aide care and therapies, home health services may also be provided. Refer to the Home Health Services medical policy for further guidance on intermittent skilled nursing or aide care. PDN services are covered by the Ohio Department of Medicaid (ODM) when certified asmedically necessary and only when continuous skilled care that requires the skills of either a registered nurse (RN) or licensed practical nurse (LPN) under the direction of an RN are performed. A covered PDN visit must meet the conditions imposed in 5160-12 – 02 of the Ohio Administrative Code (OAC) and all other applicable state regulations. Providers of PDN include a Medicare certified home health agency (MCHHA) that meets the requirements in accordance w ith OAC 5160-12-03 , an otherwise accredited agency and a non-agency nurse that meets the requirements in accordance with OAC 5160-12 – 03.1 . In order for PDN to be covered, providers must:1. Provide appropriate PDN given the members diagnosis, prognosis, functional limitations, and medical conditions as documented by the members treating physician, physicians assistant, or advance practice nurse. 2. Provide PDN as specified in the plan of care in accordance with OAC 5160-12-03 . PDNs ervices not specified in a plan of care are not reimbursable. For individuals enrolled on a home and community-based services (HCBS) waiver, the providers of PDN services must provide the amount, scope, duration, and type of PDN service within the plan of care as: a. Documen ted on the all-services plan approved by ODM or its designee when an individual is enrolled on an ODM administered HCBS waiver. PDN services not identified on the all-services plan are not reimbursable . b. Documented on the service s plan when an individual is enrolled on an Ohio Department of Aging (ODA) or an Ohio Department of Developmental Disabilities (DODD) administered HCBS waiver. PDN services not documented on the services plan are not reimbursable. 3. Bill for provided PDN se rvices using an appropriate procedure code and applicable modifiers in accordance with OAC 5160-12-06 . 4. Bill for provided PDN services in accordance with the visit policy in OAC 5160-12-04 , except as provided for in paragraph (A) of OAC 5160-12-02 . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 5. Bill after all documentation is completed for services rendered during a visit in accordance with OAC 5160-12-03 .The below guidelines identify clinical information that CareSource uses to determinemedical necessity and quantity of care for PDN . The guidelines are based on generally accepted standards of practice, review of medical literature, as well as federal and state policies and laws applicable to Medicaid programs. Providers should consult OAC Chapter 5160-12 for details about coverage, limitations, service conditions, and prior – authorization requirements. C. Definitions HealthChek Program The Ohio-administered version of the early a nd periodic screening, diagnosis, and treatment (EPSDT) program, which is a federally mandated program of comprehensive preventive health services available to Medicaid-eligible individuals from birth through age 20 years and is administered by the County Department of Job and Family Services (CDJFS). Home Health Agency A person or government entity, other than a nursing home, residential care facility, or hospice care program , that has a primary function of providing any of the following services to a patient at a place of residence used as the patients home: o skilled nursing care o physical therapy o speech language pathology o occupational therapy o medical social services o home healt h aide services Maintenance Care Care given to a member for the prevention of deteriorating or worsening medical conditions or the management of stabilized chronic diseases or conditions. Services are considered maintenance care if the member is no long er making significant improvement with a medical condition. Medical Necessity Procedures, items, or services that prevent, diagnose, evaluate, or treat an adverse health condition that meet ALL the following conditions: o meets generally accepted standards of medical practice o is c linically appropriate in type, frequency, extent, duration, and delivery setting o is a ppropriate to the adverse health condition for which it is provided and is expected to produce the desired outcome o is the lowest cost alternative that effectively addresses and treats the medical problem o provides unique, essential, and appropriate information if used for diagnostic purposes o is n ot provided primarily for the economic benefit of the provider nor for the convenience o f the provider or anyone else other than the recipient Place of Residence Wherever the individual lives, whether the residence is the individuals own dwelling, assisted living facility, relatives home, or other type of Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 living arrangement. This does not include a hospital, nursing facility, or intermediate care facility for individuals with intellectual disabilities. Plan of Care The medical treatment plan that is established, approved, and signed by a treating physician, advance practice nurse , or ph ysicians assistant in accordance with all applicable federal and state regulations. Skilled Care Procedures that require technical skills and knowledge beyond those the untrained person possesses and that are commonly employed in providing for the physical, mental, and emotional needs of the ill or otherwise incapacitated. “Skilled nursing care” includes, but is not limited to, the following: o irrigations, catheterizations, application of dressings, and supervision of special diets o objective observation of changes in the resident’s condition as a means of analyzing and determining the nursing care required and the need for further medical diagnosis and treatment o special procedures contributing to rehabilitation o administration of medication by any method ordered by a physician or other licensed health care professional acting within their applicable scope of practice, such as hypodermically, rectally, or orally, including observation of the resident after receipt of the medication o carrying out o ther treatments prescribed by the physician or other licensed health care professional acting within their applicable scope of practice, that involve a similar level of complexity and skill in administration D. PolicyI. Private duty nursing (PDN) services are provided to any CareSource Ohio Medicaid member when considered medically necessary. II. This policy is not intended to restrict or contradict EPSDT services.III. Duplicative services are not covered. If the member is receiving other assistance (eg, family careg iver, home health services, additional supportive services), this information and the hours involved must be provided to adequately evaluate medical necessity of PDN services. IV. PDN services must meet ALL the following:A. Services performed must be within the nurses scope of practice as defined in Chapter 4723. of the Ohio Revised Code (ORC). and rules adopted there under . B. Services provided must be documented in accordance with the individuals plan of care . C. Services must be medically necessary to care for the individuals condition, illness, or injury . D. Service must b e provided in person in the individuals place of residence , unless it is medically necessary for a nurse to accompany the individual in the community. The pla ce of service in the community cannot include the business location of the provider of PDN. The place of service in the community cannot Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 include the residence of the provider of PDN unless it is the same as the individual.V. PDN services do not include any of the following :A. services provided for the provision of habilitative care B. RN assessment services C. RN consultation services VI. Individuals who receive PDN must meet ALL the following :A. Be under the supervision of a treating physician, physician’s assistant (PA) , or advance practice nurse (APN) who is providing care and treatment to the individual. The treating physician, PA , or APN is not a physician, PA , or APN not only sign s and author ize s plans of care but are also direct ly involved in the care or treatment of the individual. A treating physician, PA or APN may also substitut e temporarily on behalf of a treating physician. B. Participate in the development of a plan of care with the treat ing physician, PA , or APN and the MCHHA , other accredited agencies , or non-agency registered nurse. An authorized representative may participate in the development of the plan of care in lieu of the individual. C. Access PDN in accordance with the program for the all-inclusive care of the elderly (PACE) if the individual par ticipates in the PACE program. D. Access PDN in accordance with the individual’s provider of hospice services if the individual has elected hospice. E. Access PDN in accordance with the individual’s managed care plan’s process if the individual is enrolled in a Medicaid managed care plan. VII. Post hospital PDNA. Any individual receiving Medicaid, whether adult or child, may receive PDN services up to 56 hours per week and up to 60 consecutive days from the date of discharge from an inpatient hospital stay of 3 or more covered days in accordance with OAC 5160-2-03 . A covered inpatient hospital stay is considered 1 ho spital stay when an individual is transferred from 1 hospital to another hospital, either within the same building or to another location. 1. The 60 days will begin when the individual is discharged from the hospital to the individual’s place of residence from the most recent inpatient stay in an inpatient hospital or inpatient rehabilitation unit of a hospital. 2. The 60 days will begin when the individu al is discharged from a hospital to a nursing facility. PDN is not available while residing in a nursing facility. B. The treating physician, PA , or APN will certify the medical necessity of PDN services using the ODM 07137 “Certificate of Medical Necessity f or Home Health Services and Private Duty Nursing Services” (rev. 7/2014). PDN is available to individuals only with a medical need comparable to a skilled level of care as evidenced by a medical condition that temporarily reflects the skilled level of care as defined in OAC 5160-3-08 . In no instance do these requirements constitute Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 the determination of a level of care for waiver eligibility purposes or admission into a Medicaid covered long-term care institution.VIII. Children may qualify for additional PDN services beyond the post-hospitalization service when the following criteria are met: A. The individual is under age 21 years and requires services for treatment in accordance with the HealthChek program. B. Needs, as orde red by the treating physician, PA , or APN , continuous nursing services, including the provision of on-going maintenance care (services for habilitative care are inappropriate). C. Has a comparable level of care as evidenced by either: 1. Enrollment on a HCBS wai ver . 2. For a child not enrolled on a HCBS waiver, a comparable institutional level of care, including a nursing facility-based level of care pursuant to OAC 5160-3- 08 or an ICF-IID level of care pursuant to OAC 5123:2-8-01 , as evaluated initially and annually by ODM or its designee. D. The provider of PDN services ensures and documents the child meets all requirements for PDN services prior to providing and billing for the services. E. The ch ild has a PDN authorization obtained in accordance with OAC 5160-12 – 02.3 to establish medical necessity and the childs comparable level of care. A request for additional, recertification, and/or a change of PDN authorizatio n is made as follows: 1. For a child not enrolled on a HCBS waiver, the provider of PDN shall submit the request to ODM or its designee. Any documentation required by ODM or its designee for the review of medical necessity shall be provided by the provider of PDN services. ODM or its designee will notify the provider of the amount, scope and duration of services authorized. 2. For a child enrolled on a DODD administered waiver, the provider of PDN must submit the request to the case manager of the HCBS waiver, who will forward the req uest to DODD. Any documentation required by DODD for the review of medical necessity shall be provided by the provider of PDN services. DODD will notify the provider and the case manager of the amount, scope and duration of services authorized. 3. For a child enrolled on an ODM administered waiver, the ODM case manager will authorize PDN services through the person-centered services plan. IX. Adults may qualify for additional PDN services beyond the post-hospitalization service when the following criteria are met : A. The adult is age 21 years or older. B. The adult needs, as ordered by the treating physician, PA , or APN , continuous nursing services, including the provision of on-going maintenance care (services for habilitative care are inappropriate). C. The adult has a c omparable level of care as evidenced by either: 1. Enrollment on a HCBS waiver. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 2. A comparable institutional level of care, including a nursing facility-based level of care as evaluated initially and annually by ODM or its designee for an adult not enrolled on a HCBS waiver. The criteria for a nursing facility-based level of care are defined in OAC 5160-3-08 or ICF-IID level of care as defined in OAC 5123-8-01 . D. The provider of PDN services ensures and documents that the adult meets all requirements for PDN services prior to providing and b illing for services. E. The adult must have a PDN authorization obtained in accordance with OAC 5160-12-02.3 and approved by ODM or its designee to establish medical necessity and the adults level of care. A request for additi onal, recertification, and/or a change of PDN authorization is made as follows: 1. For an adult not enrolled on a HCBS waiver, the provider of PDN shall submit the request to ODM or its designee. Any documentation required by ODM or its designee for the revie w of medical necessity shall be provided by the provider of PDN services. ODM or its designee will notify the provider of the amount, scope , and duration of services authorized. 2. For an adult enrolled on a DODD administered waiver, the provider of PDN must submit the request to the county board of DD, who will forward the request to DODD. Any documentation required by DODD for the review of medical necessity shall be provided by the provider of PDN services. DODD will notify the provider and the county board of DD of the amount, scope, and duration of services authorized. 3. For an adult enrolled on an ODM administered waiver, the case manager will authorize PDN services through the person-centered services plan. X. Additional PDN services beyond what ODM or its designee has authorized may be provided to an individual in an emergency when the provider has an existing PDN authorization to provide PDN services to that individual. For the purposes of this rule, emergency services are provided outside of normal state of Ohio office hours when prior authorization cannot be obtained. A. PDN services may be delivered in an emergency and a new PDN authorization obtained after the delivery of services. The PDN services must be med ically necessary in accordance with OAC 5160-1-01 , and the services must be necessary to protect the health and welfare of the individual. B. The provider shall notify ODM, or the ODA case manager, as applicable, in writing usi ng the ODM 02374, or the county board SSA for individuals enrolled on a DODD administered waiver when emergency PDN services are delivered. Notification shall be immediate, or no later than the first business day following the emergency provision of PDN se rvices. XI. For billing information, refer to OAC 5160-12-06 .XII. The PDN acuity scale is intended to be used in conjunction with the assessment tool and the clinical and professional judg ement of the nurse completing the to ol. It is not intended to be the sole determinant of all the skilled nursing needs of the individual. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 Normal age-appropriate care and parental responsibility should be considered (ie, all3-year-olds need assistance with bath ing and dress ing , therefore needs assist, in this category is not scorable , as it is an age-appropriate need and not a medical need ). A. Skilled nursing care acuity guidelines 1. Mechanical ventilation: acuity measurement is based on number of hours used per day . 1.0 point is s cored when the ventilator is listed as standby (e g, just in case it would be needed) . 2.5 points are scored when the member requires a ventilator 12 hours or less per day (e g, while sleeping) . 5.0 points are scored when the member requires a ventilat or for greater than 12 hours per day . 2. CPAP/BiPAP: acuity measurement is based on number of hours used per day . 2.0 points are scored when the member is on CPAP or BiPAP 12 hours or less per day . 4.0 points are scored when the member is on CPAP or BiPAP for greater than 12 hours per day . 3. Tracheostomy: acuity measurement is used to indicate special care needed for tracheostomy (note: dre ssing changes are included in the below) . 1.5 points are scored when the member is able to tolerate the use of a speaking valve, or having the tracheostomy capped for a period of time and/or receives routine care. Do not mark this option if a PMV is used in line with the ventilator or PAP. 3.0 points are scored when the member breathes continuously through an open tr acheostomy and requires special care (e g, frequent tube changes, current infection at trach site, irritation, mucous plugs requiring intervention, mucosal bleeding) . 4. Oxygen: acuity measurement is based on the order for administration, either continuous o r determined by pulse oximeter. 1.0 point is scored when the members oxygen use is routine and predictable (i e, member has COPD and requires oxygen whenever necessary when walking or upon exertion) . 3.0 points are scored when the members oxygen use is unpredictable (eg, unstable airways). 5. Tracheal suctioning: acuity measurement is based on frequency the skilled nurse performs this service and is only applicable when the member be unable to self-suction . 1.0 point is scored when the member requires suc tioning once per day . 2.0 points are scored when the member requires suctioning 2 10 times per day . 3.0 points are scored when the member requires suctioning 11 20 times per day . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 4.0 points are scored when the member requires suctioning more than 20times per day. 6. Humidification: acuity measurement is based upon the need for humidification treatment: 0.5 points is scored when humidification is performed and completed by skilled nur se. 7. Pulse oximetry monitoring: acuity measure is based on treatment that is done on a routine basis . 1.0 point is scored if monitoring is completed by the nurse 3 times per day. 2.0 points are scored if monitoring is completed by the nurse > 3 times per day or continuous. 8. Injectable medications: acuity measurement is based on number of injections per day on medication that is routinely ordered or as needed ( PRN ) only when the skilled nurse has administered the injectable. Insulin/sub cutaneous injections a re not included in this scoring . 1.0 point is scored if 1 injection is administered per day . 2.0 points is scored if more than 1 injection is administered per day. 9. Medication schedule: acuity measurement is based on the complexity of the medication . 1.0 po int is scored for routine medication schedule . This includes medications that do not require dosage adjustments, regardless of the number of medications . 2.0 points are scored for complex medication schedule . This includes medications which are PRN and/or require dosage adjustments by a skilled nurse. Members who have more than 3 medications which are PRN and/or requir e adjustment delivered within an 8-hour window by a skilled nurse would qualify for complex. 10. CPT/ vest/ nebulizer treatments: include treatment that is done on a routine basis, whether there is a standing or PRN order. If the treatments are done together (i e, nebulizer treatments followed by chest physiotherapy, and/or vest therapy), consider points based on the therapy provided at the highest frequency (e g, if nebulizer 2 times per day and pulmonary vest 3 times per day, count as therapy 3 times per day). 1.0 point is scored when CPT/vest/nebulizer (PRN) . 2.0 points are scored when CPT/vest/nebulizer 1 2 times per day . 3.0 points are scored when CPT/vest/nebulizer 3 4 times per day . 4.0 points are scored when CPT/vest/nebulizer 5 times per day. 11. Blood draws : acuity measurement is based upon the number of blood draws per week . 1.0 point is scored for peripheral blood draw routinely p erformed by skilled nurse during the week. 1.5 poin ts are scored for central line blood draw routinely performed by skilled nurse during the week. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.10 12. Blood products : acuity measurement is based upon the number of times per month it was documented that the member received any blood products provided by the skilled nurse during the PDN visit. 1.0 point is scored for blood products administered once per month . 1.5 points are scored for blood products administered 2 3 times per month . 2.0 points are scored for blood products administered more than 3 times per month. 13. Nasogastric (N/G), gastrostomy (G), or jejunostomy (J/J) tube feedings: acuity measurement is based upon t he complexity of the enteral feeding and the associated care needed from the nurse. 2.0 point is scored for G/J and N/G tube bolus or continuous. 3.0 points are scored for G/J and N/G tube combination (bolus and continuous) . 4.0 points are scored for G/J and N/G tube complicated . In order to score for complicated, there must be required residual checks, aspiration precautions, postural changes , and frequent rate adjustments or formula changes. 14. Special diet, prolonged feedings: 1.0 point is scored if there i s a threat of aspiration and it requires the assessment, observations, and interventions of a skilled nurse. Documentation of how long it took to feed the member must be present in the nurses notes. This is not applicable for tube feedings. 15. Reflux, dyspha gia, aspiration: to receive points for reflux, the member must meet at least one of the following criteria: 1) a positive swallowing study performed within the last 12 months; 2) documented current and ongoing treatment for reflux (e g, medications such as Reglan, Zantac, or Prevacid); 3) documented treatment for aspiration pneumonia within the last 12 months; or 4) a need for suctions due to reflux at minimum daily (this does not include suctioning of oral secretions). Must also have the diagnosis of dys phagia or difficulty swallowing, and documentation in the medical record on how the member is progressing. Aspiration precautions should be noted in the clinical record by the skilled nurse, as well as the interventions done to prevent aspiration. 1.0 poin t is scored for aspiration precautions . 1.5 points are scored for reflux or dysphagia. 16. Seizures: acuity measurement is based upon the frequency of the seizure activity, the severity of the seizure activity, and intervention(s) required. In all instances, s eizure monitoring must be recorded in the nurses notes and/or maintained in a seizure logbook. The description of the seizure should be addressed (i e, type, duration, intervention). There must also be seizure medications that are scored on a routine basis. The number of seizures per day, week, month, etc. must be documented and the average number occurring should be known. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.11 0.0 points are scored if there is a seizure diagnosis or history of seizures, but there is no active seizure activity . 1.0 point is scored if there is observation/monitoring only, but no skilled nursing intervention . 2.0 points are scored if there are moderate interventions required, no injury, and Diastat has to be administered , or a magnet and vagus nerve stimulator is used to stop seizure activity . 3.0 points are scored if there is an injury, Diastat has to be administered or a magnet and vagus nerve stimulator is used to stop seizure activity , and apnea is present. 17. General assessments: acuity measurement is based on the frequency a complete nursing assessment is being performed and documented in the nurses notes. This does not include general statements (e g, sleeping soundly, respirations quiet, r estless), but may be a targeted assessment if there is a concern (eg, respiratory assessment, neurological checks). Points are not considered under this section if just vital signs are taken, but if targeted vital signs are taken (eg, temperature), as well as the targeted assessment, then points could be scored under this a ssessment. 1.0 point is scored if the assessment is completed and documented in the nurses notes at least once per shift . 1.5 points are scored if the assessment is completed and documented in the nurses notes every 4 hours . 18. Vital signs: acuity measureme nt is based on complete sets of vitals being taken at specific frequencies (otherwise use the general assessment section above). 1.5 points are scored if a complete set of vital signs are taken 2 3 times per shift AND documented in the clinical record . 2.0 points are scored if a complete set of vital signs are taken 4 times per shift AND documented in the clinical record. 19. Peripheral intravenous therapy (PIV) 1.0 point is scored when peripheral IV infuses less than 4 hours . 2.0 points are scored when there is IV therapy ordered and the skilled nurse gives the IV solution while on the visit and the IV infuses for 4 8 hours . 3.0 points are scored when there is IV therapy ordered and the skilled nurse gives the IV solution while on the visit and the IV infuses for greater than 8 hours. 20. Total parenteral nutrition (TPN), central line care, chemotherapy, IV pain control 2.0 points are scored if there is a physician order for chemotherapy and its administered by the skilled nurse during the visit . 2.0 point s are scored if there is a physician order for IV pain meds and the skilled nurse gives the IV medication during the visit . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.12 2.5 points are scored if only central line care is scored and no IV is infusing. 3.0 points are scored if TPN is ordered by a physic ian and it is administered by the skilled nurse during the visit . 21. Blood sugar checks 1.0 point is scored when the blood sugar or ketones are checked by the skilled nurse and there is no insulin scored. It does not matter how many times it is checked. 2.0 points are scored when the blood sugar is checked by the skilled nurse and insulin is administered by the nurse. It does not matter how many times it is scored. 22. Medicated skin treatment: 1 .0 point is scored when medicated skin treatment is scored by the n urse. This does not include lotions, powders, nonmedicated creams, etc. 23. Stoma/ wound care: acuity measurement includes dressing changes. Members with a tracheostomy or gastrostomy will not receive additional points for tracheostomy or gast rostomy dressing changes, as this task is included in the score for the tracheostomy or gastrostomy. 1.5 points are scored when the member has general stoma/wound care and care is documented in the nurses notes once per day, noting condition of the wound/stoma. 2.0 points are scored when the member has the above performed greater than once per day. 24. Decubitus care: 3.0 points are scored when the member has an order for decu bitus care and it is performed by the nurse during the home visit. The member would not also receive points for wound/stoma care/medicated skin treatment in addition to this score if they just have a decubitus. 25. Complex dressing changes/ burn care: 3.0 point s are scored when the member has an order for burn care/complex dressing change and it is performed by the nurse during the home visit. The member would not also receive points for wound/stoma care/medicated skin treatment in addition to this score. 26. Cathet er, in-dwelling and intermittent 1.5 points are scored when the member has an in-dwelling catheter and catheter care is performed by the nurse during the home visit. 2.5 points are scored when the member has an in-dwelling catheter and the care is perfor med by the nurse during the home visit. This would include more complex/complicated care, (eg, flushes, insertion of catheter ). 1.0 point is scored if there is an order for a straight cath eter AND the skilled nurse completes the task during the home visit AND it is no more than once per 8-hour shift AND it is documented in the nurses notes. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.13 2.0 points are scored if there is an order for a straight cath eter AND the skilled nurse completes the task during the home visit AND it is more than once per 8-hour shift AND it is documented in the nurse s notes. 27. Peritoneal dialysis: 2.0 points are scored if peritoneal dialysis is performed by the skilled nurse during the home visit. 28. Hemodialysis: 4.0 points are scored if hemodialysis is performed by the skilled nurse during the home visit. 29. Strict intake and output (I&O): 1.0 point is scored when the I&O requires interventions (ie, the skilled nurse has to make adjustments to feedings or IV fluids based on the intake and output data). 30. Acute care episodes 1.5 points are scored if the member has had bone surgery in the last 45 days from the time of assessment. 2.0 points are scored if the member has a new or revised trach within the last 30 days from the assessment date. 2.0 points are scored if the member h as had abdominal/thoracic surgery with the last 45 days from the date of assessment. 2.5 points are scored if member has had a ventriculoperitoneal ( VP ) shunt new or revised within the last 30 days . 3.0 points are scored if the member has acute/post-proced ure hospitalization at least 3 times per year one year from the date of assessment (this does not include admissions for testing or ER visits). For long-term hospitalizations (over 1 month), this section may be counted if the member is admitted for at leas t 3 months (eg, premature infants). 2.0 points are scored if the member has had an acute/post-procedure hospitalization (does not include admissions for testing or ER visits) within the last 30 days from time of assessment. 1.0 point is scored if the membe r has been discharged from an ECF within the last 30 days . 2.0 points are scored if the member has had documented by the physician at least 2 episodes of any respiratory issue (to include apnea, respiratory distress, etc.) within the last year from the dat e of the assessment . B. Non-skilled nursing care: can be used if the member does not meet for PDN based on the skilled score alone , but there are extenuating psychosocial circumstances . The score from this section is added to the skilled nursing care score for the total number of hours that the member would need per day/week. 1. Caregiver availability: acuity measurement requires documented evidence of the employment and/or school status o f the primary caregivers before this is scored. 1.0 point is scored when there are 2 caregivers and neither is employed or attends school. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.14 2.0 points are scored when there are 2 caregivers and at least one is employed or attends school . 2.5 points are scored when there is only 1 caregiver and the caregiver is not employed or attends school . 3.5 points are scored when there is only 1 caregiver and the caregiver is employed or attends school. 8.0 points are scored when there is no caregiver that lives in the home with the member . This does not mean that the consumer lives with an individual who takes primary responsibility for the consumer but refuses to deliver any care. An example of this would be a member that assumes responsibility for t heir own care and lives alone or is on a waiver and has supplemental staffing from agencies and independent providers . 2. Sleeping status: acuity measurement is based on the amount of time the member is awake during the night. Nurse/caregiver waking the membe r over the course of the night is not scored. 1.0 point is scored if the member is awake 1 3 times per night. 1.5 points are scored if the member is awake 4 or more times per night. 1.5 points are scored if the member sleeps less than 5 hours consecutive ly. 2.0 points are scored if the member sleeps less than 3 hours consecutively . 3. Number of dependents: acuity measurement takes into consideration the number and ages of dependents the caregiver is directly responsible for and does not include episodic visi ts. 1.0 point is scored if the caregiver is directly responsible for 1 2 dependents at least 5 years old . 1.5 points are scored if the caregiver is directly responsible for 1 2 dependents under 5 years old . 2.0 points are scored if the caregiver is dir ectly responsible for 3 or more dependents. 4. Communication ability: acuity measurement is based on the cognitive ability of the member to communicate or make their needs known. 1.0 point is scored if the member has a limited ability to communicate their needs. 2.0 points are scored if the member is unable to communicate their needs. 5. Orientation/ cognition impairment (N/A for children under age 3 years): acuity measurement is based on the members ability to be oriented in all 3 spheres (person, time, place). Members with episodic confusion requiring reminders and members with cognitive impairment who are completely dependent on the caregiver may be scored here. 0.5 points are scored for members who do not meet all 3 spheres of orientation . Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.15 1.0 point is scored if the member experiences confusion requiring reminders. 1.5 points are scored if the member has cognitive impairment and is dependent upon the caregiver. 6. Personal care/ activities of daily living (A DL ) (N/A for children under 3 years) : 2.0 points are scored if the member requires assistance with personal care/ADLs including bathing, dressing, and grooming. 7. Oral feedings/ assist/ supervision (N/A for children under 3 years): 1.5 points are scored if the member requires assistance and super vision with oral feeds. Documentation in the clinical record on how the member tolerated the feeding should be recorded. 8. Weight/ transfers : acuity measurement is based on the members weight and their ability to transfer from one surface to another, with 1 2 person s, and/or Hoyer lift/trapeze. 0.5 points are scored if the member weighs less than 65 pounds and requires no or partial lift wi th 1 person. 1.0 point is scored if the member weighs at least 65 pounds and requires no or partial lift with 1 person. 1.0 point is scored if the member weighs less than 55 pounds and requires a total lift with 1 person. 2.0 points are scored if the membe r weighs at least 55 pounds and requires a total lift with a Hoyer and/or 2 persons. 2.5 points are scored if the member weighs greater than 125 pounds and requires partial lift with 1 person. 3.5 points are scored if the member weighs greater than 125 pou nds and requires a total lift with a Hoyer and/or 2 persons. 9. Spasticity or tremors, quadriplegia, paraplegia, hemiplegia, dysfunctional limbs : select a maximum of one of the below when applicable . 1.0 point is scored if the member has spasticity or tremors. 1.5 points are scored if the member has hemiplegia. 1.5 points are scored if the member has a dysfunctional limb. 2.0 points are scored if the member has paraplegia. 2.5 points are scored if the member has quadripl egia. 10. AFO/ splint/ orthotics application: 0.5 points are scored if there is a physician order for the device and the skilled nurse applies them to the member during the visit, which is documented in the clinical notes. 11. Range of motion: 1.0 point is scored if range of motion is ordered by the physician and is documented as being performed by the nurse in the clinical record. 12. W heelchair /walker dependent : 2.0 points are scored if the member does not have the ability to walk unaided and is either wheelchair-or w alker – dependent. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.16 13. Turn every 2 hours : 1.5 points are scored if there is a physician order and the nurse performs during the visit. Skin assessment should be documented by the nurse in the clinical record. 14. Ambulation/ assists: 1.0 point is scored if the membe r requires hand-in-hand assist or guidance with turning a wheelchair/walker . 15. Weakness /fall risk : 1.0 point is scored if the member has weakness and/or is a fall risk. There must be a protocol in place to decrease the fall risk of the member which is monito red by the nurse. 16. Recording of I&O: 0.5 points are scored if normal daily measurement of intake and output is recorded by the nurse without the need to assess for fluid replacement or restriction. This may include weighing diapers. 17. Oral suctioning: 1.0 point is scored if suctioning of the nose, mouth, or upper throat with a bulb syringe, yankaeur, or suction catheter. 18. Ostomy care: 1.0 point is scored if the member has a n ileostomy , vesicostomy, or colostomy. 19. Impairments 0.5 points are scored for visual impairments not correctable by glasses or another assistive device. 0.5 points are scored for auditory impairments not correctable by hearing aid or another assistive device. 0.5 points are scored for tactile impairments (eg, member has the need to put eve rything in their mouth or has an aversion to different touch stimuli). 1.0 point is scored if the member if blind and there is no modification they have used to compensate. 1.0 point is scored if the member is deaf and there is no modification they have used to compensate. 20. Behaviors/ developmentally delay 1.0 point is scored if the member demonstrates self-abusive behavior with no injury. 1.5 points are scored if the member de monstrates self-abusive behavior with moderate injury. 2.0 points are scored if the member demonstrates with severe injury. 1.5 points are scored if the member demonstrates combative behavior. 0.5 points are scored if the member requires occasional redirec tion. 1.0 point is scored if the member requires frequent redirection. 21. Global delays : acuity measurement is scored as documented by the physician on the members care plan. 1.0 point is scored if the members current age is age 4 years or under and has doc umentation of global delays. 2.0 points are scored if the members current age is over age 4 years and has documentation of global delays. 22. Incontinence, toilet program (N/A for children under age 3 years) 0.5 points are scored if the member experiences occ asional incontinence. 1.5 points are scored if the member experiences daily incontinence. Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.17 1.0 point is scored if the member has a toilet program documented in the clinical record.C. The following point/care guideline may be adjusted based on a case-by-case review : 1. 15-24 points equate to 4 to 8 hours of care per day, or less than 56 hours per week. 2. 25-34 points equate to 8 to 12 hours of care per day, or between 56 and 84 hours per week. 3. 35-40 points equate to 12 to 14 hours of care per day, or between 85 and 98 hours per week. 4. 40+ points equate up to 16 hours of care per day, or between 99 and 112 hours per week. 5. PDN may be extended beyond 112 hours per week if there is an emergent short-term need for additional care. E. Conditions of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDATE ACTIONDate Issued 07/19/2023 New policy. Approved at Committee.Date Revised 06/19 /2024 Review: added examples to criteria, updated references, approved at Committee. Date Effective 11/01/2024 Date Archived H. References1. Burgdorf JG, Arbaje AI, Chase J, Wolff JL. Current practices of family caregive r training during home health care: a qualitative study. JAm Geriatr Soc . 2022;70(1):218-227. doi:10.1111/jgs.17492 2. Centers for Medicare and Medicaid Services (CMS). Home-and Community-Based Services. Modified September 6, 2023 . Accessed May 20, 2024 . www.cms.gov 3. Definitions , OHIO ADMIN . CODE 3701-16-01 (2018). 4. Developmental Disabilities Level of Care, OHIO ADMIN . CODE 5123-8-01 (202 4). 5. Home Health and Private Duty Nursing: Visit Policy, OHIO ADMIN . CODE 5160-12-04 (2021). 6. Honsberger K, Holladay S, Kim E, VanLandeghem K. How States Use Medicaid Managed Care to Deliver Long-Term Services and Supports to Children with Special Health Care Needs . National Academy for State Health Policy. November 2018. Accessed May 20, 2024 . www.nashp.org Private Duty Nursing-OH MCD-MM-1510Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.18 7. Kusma JD, Davis MM, Fos ter C. Characteristics of Medicaid policies for children with medical complexity by state. JAMA Netw Open . 2022;5(10):e2239270. doi:10.1001/jamanetworkopen.2022.39270 8. Managed Care: Definitions , OHIO ADMIN . CODE 5160-26-01 (2022). 9. Medicaid Medical Necessity: Definitions and Principles, OHIO ADMIN . CODE 5160-1- 01 (2022 ). 10. Medicare Certified Home Health Agencies: Qualifications and Requirements, OHIO ADMIN . CODE 5160-12-03 (2015). 11. Non-Agency Nurses and Otherwise-Accredited Agencies: Qualifications and Requirements, OHIO ADMIN . CODE 5160-12-03.1 (2015). 12. Ohio Department of Medicaid. HCBS Waivers (n.d.) Accessed May 20, 2024 . www.medicaid.ohio.gov 13. Ohio Department of Medicaid. Private Duty Nursing (n.d.). Accessed May 20, 2024 . www.med icaid.ohio.gov 14. Private Duty Nursing: PDN-2001. MCG Health, 28th ed. Updated March 14, 2024. Accessed June 19, 2024. www.careweb.careguidelines.com 15. Private Duty Nursing: Procedures for Service Authorization, OHIO ADMIN . CODE 5160 – 12-02.3 (2017). 16. Private Duty Nursing Services, 42 C.F.R. 440.80 (2022). 17. Private Duty Nursing Services: Provision Requirements, Coverage and Service Specification, OHIO ADMIN . CODE 5160-12-02 (2021). 18. Registered Nurse Assessment and Registered Nurse Consultation Services . OHIO ADMIN . CODE 5160-12-08 (2021). 19. Reimbursement: Exceptions , OHIO ADMIN . CODE 5160-12-07 (2015). 20. Reimbursement: Private Duty Nursing Services, OHIO ADMIN . CODE 5160-12-06 (202 4). 21. Sobotka SA, Lynch E, Peek ME, Graham RJ. Readmission drivers for children with medical complexity: home nursing shortages cause health crises. Pediatr Pulmonol . 2020;55(6):1471-1480. doi:10.1002/ppul.24744 22. Sobotka SA, Dholakia A, Berry JG, et al. Home nursing for children with home mechanical ventilation in the United States: key informant perspectives. Pediatr Pulmonol . 2020;55(12):3465-3476. doi:10.1002/ppul.25078 This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. Independent med ical review July 2023Approved by ODM 07/25/2024
MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nutritional Supports-OH MCD-MM-0024 11/01/2024 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 o f 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 cont rolling 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 fav orable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………… 2 B. Background ………………………….. ………………………….. ………………………….. ………………….. 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. 4 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 7 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 8 H. References ………………………….. ………………………….. ………………………….. …………………… 8 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.A. SubjectNutritional Sup ports B. BackgroundEnteral nutrition may be necessary to maintain optimal health status for individuals with diseases or structural defects of the gastrointestinal ( GI ) tract that interfere with transport, digestion, or absorption of nutrients. Such conditions may include anatomic obstructions due to cancer, motility disorders such as gastroparesis, or metabolic absorptive disorders such as phenylketonuria ( PKU ). Considerations are given to medical condition, nutrition and physical assessment, metabolic abnormalities, gastrointestinal function, and expected ou tcome. Enteral nutrition may be prescribed to serve as an individuals primary source of nutrition (ie, total enteral nutrition ) or as a supplement to their ordinary diet (ie, supplemental enteral nutrition ). Enteral nutrition may be delivered through oral intake or through a tube into the stomach or small intestine. RELiZORB is a prescription device that is used to break down fats in enteral formulasfrom triglycerides into fatty acids and monoglycerides to allow their absorption and utilization in the b ody , processes that are essential for normal growth and development .This process mimics the function of the enzyme lipase in the intestine of members with pancreatic insufficiency. The product is designed to fit in series with currently used enteral feedi ng circuits . Breastfeeding is recommended by healthcare professionals and the U.S. Department of Health and Human Services. Research shows that breastfeeding provides healthbenefits for both the mother and the child. In some situations, parents may look for alternative sources of human breast milk to feed their babies. Donor milk banks take voluntary steps to screen milk donors and safely collect, process, handle, test, and store the milk. C. Definitions Chronological Age The time elapsed after birth , usually described in days, weeks, months, and/or years. Corrected Age A term most appropriately used to describe children up to 3 years of age who were born preterm or before gestational age of 37 weeks. This term repr esents the age of the child from the expected date of delivery (mothers due date). Corrected age is calculated by subtracting the number of weeks born before 40 weeks of gestation from the chronological age . Donor Human Milk Breast milk that is expresse d by a mother and processed by a human milk bank for use by a recipient that is not the donor s own infant. Enteral Nutrition Nutritional support given via the gastrointestinal (GI) tract, either directly or through any of a variety of tubes used in spec ific medical conditions. This includes oral feeding, as well as feeding using tubes such as orogastric, nasogastric, gastrostomy, or jejunostomy tubes. o Supplemental Nutrition The minority of daily calories are supplied by the enteral nutrition product(s ). Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.o Total Enteral Nutrition (TEN) The majority of daily calories are supplied by the enteral nutrition products. Human Milk Bank A service which recruits human breast milk donors , collects, pasteurizes, and stores donor human milk , tests the donor milk for bacterial contamination , and distributes donor human milk to recipient infants in need. Inborn Errors of Metabolism (IEM) Inherited biochemical disorders resulting in enzyme defects that interfere with normal metabolism of protei n, fat, or carbohydrate. Malnutrition Deficiencies, excesses, or imbalances in an individuals intake of energy and/or nutrients, measured by z-scores, which are statistical measurements of standard deviation from WHO and CDC growth charts , calculated from weight for length or BMI by age. o Mild Malnutrition z score equals -1 to -1.9 or z score decrease of 1 over time . o Moderate Malnutrition z score equals -2 to -2.9 or z score decrease of 2 over time . o Severe Malnutrition z score equals -3 or less or z score decrease of 3 over time . Medical Food Specially formulated and processed food for individuals who are seriously ill or who require the product as a major treatment modality. This term does not pertain to all foods fed to ill individuals. Medical foods are intended solely to meet the nutritional needs of individuals who have specific metabolic or physiological limitations restricting an ability to digest regular food. This can include specially formulated infant formulas. According to the Food and Drug Administration (FDA), a product must meet all the following minimum criteria to be considered a medical food: o The product must be a food for oral or tube feeding . o The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements . o The product must be used under the supervision of a physician . Oral Nutrition ( Oral Feeding) Nutritional support given via oral route. Ordinarily Prepared Food Regular grocery products including typical, not specially formulated, infant formulas. RELiZORB An FDA-approved digestive enzyme cartridge indicated for use in pediatric patients (ages 2 years and older) and adult patients to treat exocrine pancreatic insufficiency. Therapeutic Oral Non-Medical Nutrition : o Food Modification Some conditions may require adjustment of carbohydrate, fat, protein, and micronutrient intake or avoidance of specific allergens (ie, diabetes mellitus, celiac disease ). o Fortified Food Food products that have additives to increase energy or nutrient de nsity. o Functional Food Food that is fortified to produce specific beneficial health effects. o Texture Modified Food and Thickened Fluids Liquidized/thin puree, thick puree, finely minced or modified normal. Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.o Modified Normal Eating normal foods but av oiding particulate foods that are a choking hazard. D. PolicyI. Medical necessity requests for nutritional supplements will be considered under EPSDT for individuals under 21 years old . II. Oral nutrition in Section II I refers to the situation where the majority of intake is provided by medical food by mouth or it is supplement al to normal food. Enteral nutrition in Section I Vrefers to the situation whe re the majority of intake is provided by medical food through a tube or it is supplemental . III. Oral NutritionA. Oral nutrition requests for members with inborn errors of metabolism meet medical necessity criteria and do not require further review when the product is specifically formulated for the members condition. B. Total oral nutrition is considered medically necessary when ALL the following apply : 1. The product is a medical food for oral feeding . 2. The product is used under medical supervision . 3. The member has the ability to swallow without increased risk of aspiration . 4. The product is the members primary source of nutrition . 5. The product is labeled and used for nutritional management of a members specific medical condition without which serious morbidities (physical or mental) may develop OR the product is used to promote normal development or function for the member . 6. The product is used un der the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments. 7. The member has one of the following medical condition s: a. A condition caused by an inborn error of metabolism, including , but not limited to phenylketonuria homocystinuria methylmalonic academia galactosemia b. A condition that interferes with nutrient absorption and digestion, including, but not limited to 01. current diagnosis of non-IgE-mediated cows milk allergy (CMA) as defined by any of the following: (1). abnormal stools, defined as hemo ccult positive, mucous – containing, foam-containing, or diarrheal (2). poor weight gain trajectory for age (eg, malnutrition) (3). atopic dermatitis: age of onset less than 3 months, severe eczema, exacerbation of eczema noted with introduction of cows Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.milk, cows milk formula or maternal ingestion of cows milk (if breastfed)02. allergy to specific foods, including food-induced anaphylaxis, or severe food allergy indicating a sensitivity to intact protein product as diagnosed through a formal food challenge 03. allergic or eosinophilic enteritis (colitis/proctitis, esophagitis, gastroenteritis) 04. cystic fibrosis with malabsorption 05. diarrhea or vomiting resulting in clinically significant dehydration requiring treatment by a medical provider 06. malabsorption unresponsive to standard age-appropriate interventions when associated with failure to gain weight or meet established growth expectations 07. maln utrition (as defined by Nelsons Textbook of Pediatrics and not iatrogenically-or medication-induced) (formerly failure to thrive) that is moderate or severe and unresponsive to standard age-appropriate interventions ( eg , commercial shakes, protein bars) when associated with weight loss, failure to gain weight or to meet established growth expectations, including but not limited to: (1). premature infants who have not achieved the 25 th percentile for weight based on their corrected gestational age (2). individuals with end-stage renal disease and hypoalbuminemia (albumin less than 4 gm/dl) 8. Approval duration can be up to 12 months for all oral nutrition products C. Supplemental oral nutrition (including infant formula) is considered medically necessary when ALL the following apply: 1. The product is being used to supplement t he members primary source of nutrition . 2. The product is used as part of a defined and limited plan of care (eg, member transitioning from total enteral nutrition to standard diet for age , member undergoing cancer treatment) . 3. There is documentation of a medical basis for the members inability to maintain appropriate body weight and nutritional status (initial and ongoing) with normal or therapeutic oral nutrition . For example, malnutrition that is moderate to severe and unresponsive to standard age-appropriate interventions. 4. There is documentation of ongoing evidence of members positive response to the oral nutrition. For example, individuals who have improved from moderate to severe malnut rition to mild malnutrition or normal health status may require documentation/evidence indicating that without the supplementation there is a risk of decline in nutritional status. 5. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 6. The primary reason is not for convenience of the member or caregiver . Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7. Approval duration can be up to 12 months for all supplemental oral nutrition products. IV. Enteral Nutrition Via TubeA. Enteral nutrition requests for members with inborn errors of metabolism and/or low-profile gastrostomy/jejunostomy/gastrojejunostomy tubes (eg, Mic-Key, button) meet medical necessity criteria and do not require further review. B. Total enteral nutrition via tube feeding is considered medically necessary when the member has a functioning, accessible gastrointestinal tract, and ALL the following apply : 1. Enteral nutrition comprises the majority of the members diet . 2. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 3. There is documentation that the member cannot ingest nutrient s orally due to a medical condition (physical or mental) which meets any of the following: a. interferes with swallowing (eg, dysphagia from a neurological condition, severe chronic anorexia nervosa or serious cases of oral aversion in children which render m ember unable to maintain weight and nutritional status with oral nutrition alone) b. puts the member at risk for aspiration if nutrition is given by oral route c. is associated with anatomical abnormality of the proximal GI tract ( eg , tumor of the esophagus caus ing obstruction) 4. Approval duration can be up to 12 months for al l enteral nutrition products. C. Supplemental enteral nutrition via tube is considered medically necessary when ALL the following apply : 1. The product makes up the minority of the members daily intake (ie, supplement to members primary source of nutrition) . 2. The enteral product is used as part of a defined and limited plan of care (eg, member transitioning from total enteral nutrition to standard diet for age , member undergoing treatment fo r cancer) . 3. There is d ocumentation of a medical basis for the inability of the member to maintain appropriate body weight and nutritional status (initial and ongoing) with normal or therapeutic enteral nutrition . For example, malnutrition that is moderate t o severe and unresponsive to standard age-appropriate interventions. 4. There is d ocumentation of ongoing evidence of members positive response to the enteral nutrition . For example, individuals who have improved from moderate to severe malnutrition to mild malnutrition or normal health status may require documentation/evidence indicating that without the supplementation there is a risk of decline in nutritional status. 5. The product is used under the supervision of a physician, physicians assistant, or nurse practitioner, or ordered by a registered dietician upon referral by a health care provider authorized to prescribe dietary treatments . 6. The primary reason is not for convenience of the member or caregiver . Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7. Approval duration can be up to 12 months for all supplemental enteral nutrition products. V. Limitations/Exclusions : the following are not indicated :A. therapeutic diets where non-medical foods are tolerated , including 1. food modification 2. texture modified food 3. thickened fluids without a prescription that indicates it is necessary as part of treatment plan 4. fortified food 5. functional food 6. modified normal 7. flavorings B. ordinarily prepared foods including commercial products * such as shakes, smoothies, energy bars, vitam in or mineral supplements, and baby food C. food products that a provider receives a Medicaid per diem payment D. standard infant formula when alternative coverage is available E. products for meal replacements or snack alternatives F. product s provided for convenien ce or preference of member/caregiver *Commercial products represented by HCPCS codes may be provided on a case-by-case basisfor individuals who use the product as their sole source of nutrition .VI. RELiZORB is considered medically necessary when ALL the following criteria are met: A. Member is at least 2 years of age per the FDA , and B. Member has a diagnosis of pancreatic insufficiency , or Member experiences symptoms of pancreatic insufficiency with current enteral formula such as fat malabsorption symptoms (eg, poor weight gain, diarrhea, abdominal pain, bloating, fatty stools, vomiting, and constipation). VII. Donor human milk is con sidered medically necessary when ALL the following criteria are met: A. The p rovider is in good standing with the Human Milk Banking Association of North America . B. Documentation support s medical necessity . C. Documentation support s that the provider has attested to educating the member in the donation process and about human milk . D. Consent support s that the provider discussed the risks and benefits with the member. E. Conditions of CoverageNA F. Related Polic ies/RulesNA Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.G. Review/Revision History DATE ACTIONDate Issued 04/14/2004 New policyDate Revised 09/2005 04/2008 07/2009 03/2012 07/2013 07/2014 01/2015 06/28/2016 06/28/2017 09/09/2019 04/01/2020 08/19/2020 09/15/202103/16/202202/ 15 /202308/02 /202307/17 /2024Realigned with new guidelinesAdded Relizorb criteria Removed Medical nutrition therapy and updated PA Updated references. Approved at PGC. Added clinical coverage conditions, updated references, added definitions, split criteria into oral vs tube, and total vssupplementalAnnual review: removed WIC information, removed percentage of oral and enteral food criteria, moved exclusions to section VI , added section I for clarity Out of cycle update: clarified requirements for IEM and language on commercial products , added examples, malnutrition definition, and references . Approved at Committee. Review: removed PA language , changed titl e from Supplements to Supports , u pdated re ferences. Approved at Committee. Date Effective 11/01/2024 Date Archived H. References1. American Geriatric Society Committee ; Clinical Practice and Models of Care Committee. American Geriatrics Society feeding tubes in advanced dementia position statement. JAm Geriatrics Soc . 2014; 62(8) :1590-1593. doi :10.1111/jgs.12924 2. Burris A, Burris J, Jarvinen KM . Cows milk protein allergy in term and preterm infants: clinical manifestations, immunologic pathophysiology, and management strategies. NeoReviews . 2020 ;21(12) :e795-e808 . doi:10.1542/neo.21-12-e795 3. Cederholm T, Barazzoni R, Austin P, et al . ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr . 2017;36(1):49-64. doi:10.1016/j.clnu.2016.09.004 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4. Daymont C, Hoffman N, Schaefer E, Fiks AG. Clinician diagnoses of failure to thrive before and after switch to World Healt h Organization growth curves. Acad Pediatr.2020;20(3):405-412. doi:10.1016/j.acap.2019.05.126 5. Dipasquale V, Ventimiglia M, Gramaglia SMC, et al. Health-related quality of life and home enteral nutrition in children with neurological impairment: report fro m a multicenter survey. Nutrients. 2019;11(12):2968 . doi:10.3390/nu11122968 6. DMEPOS: Nutrition Products , OHIO ADMIN . CODE 5160-10-26 (20 24 ). 7. Druyan ME, Compher C, Boullata JI, et al. Clinical guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients: applying the GRADE system to development of A.S.P.E.N. clinical guidelines. JPEN JParenter Enteral Nutr . 2012;36(1):77-80. doi: 10.1177/0148607111420157 8. Early and Periodic Screening, Diagnostic, and Treatment . US Centers for Medicare and Medicaid Services. Accessed July 1 , 2 024 . www.medicaid.gov 9. Evolving Evidence Review. Relizorb (Alcresta Therapeutics Inc.) for Enteral Feeding in Patients with Cystic Fibrosis-Related Pancreatic Insufficiency. Ha yes; 2021. Updated November 14, 2023. Accessed July 1, 2024. www.evidences.hayesinc.com 10. Fleet SA, Duggan C. Overview of enteral nutrition in infants and children. UpToDate. November 15, 2023. Accessed July 1, 2024. www.uptodate.com 11. Goodwin ET, Buel KL, Can trell LD. Growth faltering and failure to thrive in children. Am Fam Physician . 2023;107(6):597-603. Accessed July 1, 2024. www.aafp.org 12. Grummer-St rawn LM, Reinold C, Krebs NF; Centers for Disease Control and Prevention. Use of World Health Organization and CDC growth charts for children aged 0-59 months in the United States. MMWR Recomm Rep. 2010;59(RR-9):1-15. Accessed July 1, 2024. www.cdc.gov 13. Gui dance for Industry: Frequently Asked Questions about Medical Foods . 3rd ed. US Dept of Health and Human Services; 2023. Accessed July 1 , 2024 . www.fda.gov 14. Healthchek: Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Covered Services, OHIO ADMIN . CODE 5160-1-14 (2017) . 15. Homan GJ. Failure to thrive: a practical guide. Am Fam Physician . 2016;94(4):295 – 299. Accessed July 1, 2024. www. aafp .gov 16. Klek S, Hermanowicz A, Dziwiszek G, et a l. Home enteral nutrition reduces complications, length of stay, and health care costs: results from a multicenter study. Am JClin Nutr . 2014;100(2):609-615. doi:103945/ajcn.113.082842 17. Lo L, Ballantine A. Malnutrition. In: Kliegman RM, St Geme JW, Blum NJ , et al., eds. Nelson Textbook of Pediatrics . Elsevier Inc; 2020:1869-1875. 18. Marchand V, Motil KJ ; NASPGHAN Committee on Nutrition. Nutrition support for neurologically impaired children: a clinical report of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition. JPediatr Gastroenterol Nutr . 2006;43(1):123-135. doi: 10.109 7/01.mpg.0000228124.93841.ea 19. Medicaid Medical Necessity: Definitions and Principles, OHIO ADMIN . CODE 5160-1- 01 (2022) . 20. Mehta NM, Skillman HE, Irving SY, et al. Guidelines for the provision and assessment of nutrition support therapy in the pediatric criti cally ill patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. J Par enteral and Ent eral Nutr . 2017;41(5):703-900. doi:10.1177/0148607117711387 Nutritional Supports-OH MCD-MM-0024Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.21. Moro GE, Billeaud C, Rachel B, et al. Processing of donor human milk: update and recommendations from the European Milk Bank Association (EMBA). Front Pediatr .2019;7(49):1-10. doi:10.3389/fped.2019.00049 22. Orphan Drugs , 21 C.F.R. 312 (2023) . 23. Robinson D, Walker R, Adams SC, et al. American Society for Parenteral and Enteral Nutrition (ASPEN) Definition of Terms, Style, and Conventions Used in ASPEN Board of Directors-Approved Documents. May 2018. Accessed July 1 , 202 4. www.nutritioncare.org 24. Services Provided by a Dietitian, OHIO ADMIN . CODE 5160-8-41 (20 21 ). 25. U.S. Food and Drug Administration. RELiZORB K232784. December 21, 2023. Accessed July 1, 2024. www.accessdata.fda.gov 26. U.S. Food and Drug Administration. Use of Donor Human Milk . Update d March 22, 2018. Accessed July 1 , 202 4. www.fda.gov. 27. U.S. Social Security Administration (SSA). Disability Evaluation Under Social Security – 105. 00 Digestive System Childhood . Accessed July 1, 2024 . www. secure. ssa.gov 28. U.S. Social Security Administration (SSA). Program Operations Manual System (POMS) – DI 24598.002. Failure to Thrive (FTT) . February 9, 2016. Accessed July 1 , 2024 . www. secure.ssa.gov 29. Wanden-Berghe C , Patino-Alonso MC, Galindo-Villardn P, et al . Complications associated with enteral nutrition: CAFANE Study. Nutrients . 2019;11(9):2041 . doi:10.3390-nu11092041 30. World Health Organization. Malnutrition. March 1, 2024 . Accessed July 1, 2024 . www.who.int 31. Worthington P, Balint J, Bechtold M, et al. When is parenteral nutrition appropriate? J Parenteral and Enteral Nutr . 2017; 41(3) :324-377. doi :10.1177/0148607117695251 Approved ODM 0 7/25/2024
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