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Impacted Cerumen Removal

Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative 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.ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Impacted Cerumen Removal-MP-AD-1253 01/01/2024-12/31/2024 Policy Type ADMINISTRATIVE This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 2 E. Conditions of Coverage ………………………………………………………………………………………….. 3 F. Related Policies/Rules …………………………………………………………………………………………… 3 G. Review/Revision History …………………………………………………………………………………………. 3 H. References …………………………………………………………………………………………………………… 3 Impacted Cerumen Removal-MP-AD-1253 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 2 A. SubjectImpacted Cerumen RemovalB. Background Cerumen or ear wax is a naturally occurring substance that cleans, protects, and lubricates the ear canal. The cerumen can block the ear canal causing symptoms such as pain, hearing loss, fullness, itching, and tinnitus. Methods for removal of cerumen include irrigation, manual removal with instrumentation, and cerumenolytic agents. Cerumen removal may require a physician when methods such as irrigation or removal by cotton-tipped applicators are not sufficient. C. Definitions Cerumen Impaction An accumulation of cerumen that is associated with symptoms and/or prevents a necessary ear examination. Modifier Two-character code used along with a CPT or HCPCS code to provide additional information about the service or procedure rendered. Modifier 25 Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service. National Correct Coding Initiative (NCCI) A program developed by CMS to promote national correct coding and to prevent improper payment when incorrect code combinations are reported. D. Policy I. Claims submission for cerumen impaction should include the appropriate CPT code and ICD-10, such as A. ICD-10 1. impacted cerumen, unspecified ear 2. impacted cerumen, right ear 3. Impacted cerumen, left ear 4. impacted cerumen, bilateral B. CPT 1. removal impacted cerumen using irrigation/lavage, unilateral 2. removal impacted cerumen requiring instrumentation, unilateral 3. removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing NOTE: Visualization aids, such as, but not limited to, binocular microscopy, are considered to be included in the CPT code and should not be billed separately. II. Evaluation and management (E&M) visit A. Impacted cerumen 1. An E&M service may not be billed when the sole reason for the visit is to remove symptomatic impacted cerumen. Impacted Cerumen Removal-MP-AD-1253 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 3 2. An E&M service on the same day as removal of impacted cerumen may not be billed unless it represents and is documented to be a significant, separately identifiable service on the same day. B. Non impacted cerumen For removal of cerumen that is not impacted, use the E&M service code. III. Modifiers A. Use modifier 25, and/or 50, when appropriate. B. Follow NCCI guidelines, and use appropriate modifiers, as applicable. C. For bilateral procedures, use Centers for Medicare & Medicaid Services (CMS) guidelines. D. Separate payment is only justified when modifier 25 is appended indicating the following: 1. removal of symptomatic impacted cerumen 2. impacted cerumen impeding a physicians ability to properly evaluate or manage other signs, symptoms or conditions or 3. impacted cerumen impeding a physicians or audiologists ability to perform covered audiometry. NOTE: Documentation confirming impacted cerumen and justification of the use of modifier 25 must be submitted with the claim to support medical necessity.E. Conditions of CoverageNA F. Related Policies/Rules Modifier 25 Reimbursement G. Review/Revision History DATE ACTIONDate Issued 10/26/2023 New Policy.Date Revised 10/11/2023 Per Program Integrity, removed modifier 59. Updated references. Approved at Committee. Date Effective 01/01/2024 Date Archived 12/31/2024 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy. H. References1. Cerumen Removal. Centers for Medicare and Medicaid Services. LCD ID L33945. Revised September 13, 2023. Accessed August 8, 2023. www.cms.gov 2. Schwartz SR, Magit AE, Rosenfeld RM, et al. Clinical practiceImpacted Cerumen Removal-MP-AD-1253 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 4 guideline (update): earwax (cerumen impaction). Otolaryngol Head Neck Surg . 2017;156(1_suppl):S1-S29. doi:10.1177/0194599816671491

Esophageal Brush Biopsy

Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative 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.ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Esophageal Brush Biopsy-MP-AD-1398 01/01/2024-01/31/2025 Policy Type ADMINISTRATIVE This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 2 E. Conditions of Coverage ………………………………………………………………………………………….. 3 F. Related Policies/Rules …………………………………………………………………………………………… 3 G. Review/Revision History …………………………………………………………………………………………. 3 H. References …………………………………………………………………………………………………………… 3 Esophageal Brush Biopsy-MP-AD-1398 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 2 A. SubjectEsophageal Brush BiopsyB. Background Barretts esophagus (BE) is a metaplastic change of the distal esophagus, whereby the normal squamous epithelium is replaced by specialized columnar epithelium with goblet cells. This change, where the squamous cells of the esophagus begin to resemble cells of the stomach, is associated with chronic gastroesophageal reflux disease (GERD). It is estimated that 5% 12% of patients with chronic GERD symptoms will also exhibit BE. BE is the only known precursor lesion of esophageal adenocarcinoma (EAC). Last year, the American Cancer Society estimated 20,640 new esophageal cancer cases diagnosed (16,510 in men and 4,130 in women). The most definitive, accurate, and reliable method for diagnosing esophageal lesions is esophageal endoscopy and the Seattle protocol-based, four-quadrant forceps biopsy (FB). A new technique for detection of BE is wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D). WATS3D, formerly known as EndoCDx, is a computer-assisted biopsy, adjunct to standard forceps biopsy of the esophagus, which claims to increase analysis accuracy of the tissue area sampled and therefore increases the yield of patients tissue identified with abnormality in the esophagus. Unlike standard cytology brushes that are typically soft and primarily designed to gently remove spontaneously exfoliated squamous cells in the esophagus, the WATS3D biopsy is specifically designed using an abrasive brush which is deployed during endoscopy to consistently sample deeper layers of the more firmly attached glandular epithelium found in Barretts esophagus. WATS3D has been criticized for its susceptibility to false-negative or false-positive findings that could lead to the delay of appropriate therapy or to the administration of unnecessary therapy respectively, which represents a potential safety concern. Monitoring patients over time is needed to address these concerns. C. Definitions Barretts Esophagus (BE) A pre-malignant condition that places patients at risk for esophageal adenocarcinoma (EAC). Esophageal Adenocarcinoma (EAC) One of the two most common types of esophageal cancer along with squamous cell carcinoma. Gastroesophageal Reflux Disease (GERD) A condition occurring when a muscle at the end of the esophagus does not close properly, allowing stomach contents to leak back, or reflux, into the esophagus and irritate it. D. Policy I. CareSource considers esophageal brush biopsy using wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D) Esophageal Brush Biopsy-MP-AD-1398 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 3 experimental and investigational for screening, diagnosis, or surveillance of cancerous or pre-cancerous esophageal lesions because of insufficient evidence. II. Any claims for esophageal brush biopsy will be denied. III. CareSource may request documentation of services performed. Appropriate and complete documentation must be presented at the time of review to validate medical necessity. If medical necessity is not confirmed based on the documentation submitted, recoupment may occur.E. Conditions of CoverageNA F. Related Policies/Rules Experimental, Investigational and Other Non-Covered Services G. Review/Revision History DATE ACTIONDate Issued 10/11/2023 New Policy. Approved at CommitteeDate Revised Date Effective 01/01/2024 Date Archived 01/31/2025 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy. H. References1. American Cancer Society. Key Statistics for Esophageal Cancer. Accessed September 14, 2023. www.cancer.org. 2. Health Technology Evaluation: Wide-Area Transepithelial Sampling Biopsy for Detection of Barretts Esophagus/Esophageal Dysplasia. Hayes Inc; 2022. Reviewed July 6, 2023. Accessed September 14, 2023. www. evidence.hayesinc.com. 3. Odze RD, Goldblum J, Kaul V. Role of wide-area transepithelial sampling with 3D computer-assisted analysis in the diagnosis and management of Barrett's Esophagus. Clin Transl Gastroenterol . 2021;12(12):e00422. doi:10.14309/ctg.0000000000000422 4. Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and management of Barrett's Esophagus: an updated ACG guideline. Am JGastroenterol . 2022;117(4):559-587. doi:10.14309/ajg.0000000000001680 5. Spechler SJ. Barrett's esophagus: surveillance and management. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed September 14, 2023. www.uptodate.com. 6. Suresh Kumar VC, Harne P, Patthipati VS, et al. Wide-area transepithelial sampling in adjunct to forceps biopsy increases the absolute detection rates of Barrett'sEsophageal Brush Biopsy-MP-AD-1398 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 4 oesophagus and oesophageal dysplasia: a meta-analysis and systematic review. BMJ Open Gastroenterol. 2020;7(1):e000494. doi:10.1136/bmjgast-2020-000494 7. Yip HC, Chiu PW. Endoscopic diagnosis and management of early squamous cell carcinoma of esophagus. JThorac Dis . 2017;9(Suppl 8):S689-S696. doi:10.21037/jtd.2017.06.57

Court Mandated Health Services

ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Court Mandated Health Services-MP-AD-1236 01/01/2024 Policy Type ADMINISTRATIVE Administrative 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 industr y 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 o f a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal 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 M anuals, Member Handbooks, and/or other policies and procedures. Administrative 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 E vidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Cove rage) 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 limita tions that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 2 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 2 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 2 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 2 I. References ………………………….. ………………………….. ………………………….. ……………………. 3 Court Mandated Health Services-MP-AD-1236Effective Dat e: 01/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectCourt Mandated Health Services B. BackgroundCourt mandated health services are treatments ordered as a result of criminal, civil, or custodial judicial proceedings. Services may include withdrawal management, medication assisted treatment, community based services, behavioral health inpatient or outpatient treatment, medical inpatient or outpatient treatment, and/or other treatment related to ones overall health. C. Definitions Court Mandated Health Services – Court order issued upon the decision of a judge or the result of a judicial proceeding for health-related services. Emergency Detention – A person detained under reasonable grounds to be believed to have a mental illness, is either dangerous or gravely disabled, and is in immediate need of hospitalization and treatment . D. PolicyI. Court mandated health services are subject to all existing CareSource policies and procedures, including medical necessity determination and prior authorization as necessar y. II. If court ordered health services are determined as not meeting medical necessity criteria, the member will be referred to care management to ensure access to the proper treatment and services and assist in coordination of necessary care. E. State-Specific InformationIndiana If a member is subject to an emergency detention, the services provided will be considered medically necessary when provided in accordance with generally accepted clinical care guidelines. Medical necessity may thereafter be reviewed for additional treatment. F. Conditions of CoverageNA G. Related Policies/RulesMedical Necessity Determinations H. Review/Revision HistoryDATE ACTIONDate Issued 02/19/2020Date Revised 08/31/2022 Annual revision. Combined individual MPLOBs (IN 0801, GA 0804, OH 0800, KY 0802, WV 0803). Court Mandated Health Services-MP-AD-1236Effective Dat e: 01/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 10/11/2023 Annual Review: Added Indiana to E, updated references . Approved atCommittee Date Effective 01/01/2024 Date Archived I. Reference s1. Authority of a Court to Order Detention, IND . CODE 12-26-5-0.5(c) (2023). 2. Georgia Evidence of Coverage . CareSource; 2024. Accessed September 12, 2023. www.caresource.com 3. Indiana Evidence of Coverage . CareSource; 2024. Accessed September 12, 2023. www.caresource.com 4. Kentucky Evidence of Coverage . CareSource; 2024. Accessed September 12, 2023. www.caresource.com 5. Medically Necessary, IND . CODE 12-15-5-13.5 (2023). 6. Mental Health Detention as Medically Necessary, IND . CODE 27-8-5-15.9 (2023). 7. Ohio Evidence of Coverage . CareSource; 2024. Accessed September 12, 2023. www.caresource.com 8. West Virginia Evidence of Coverage . CareSource; 2024. Accessed September 12, 2023. www.caresource.com

Continuity of Care

Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative 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.ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Continuity of Care-MP-AD-1258 01/01/2024-01/31/2025 Policy Type ADMINISTRATIVE This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of Contents A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 3 E. State Specific Information ……………………………………………………………………………………….. 4 F. Conditions of Coverage ………………………………………………………………………………………….. 4 G. Related Policies/Rules ……………………………………………………………………………………………. 4 H. Review/Revision History …………………………………………………………………………………………. 4 I. References …………………………………………………………………………………………………………… 4 Continuity of Care-MP-AD-1258 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 2 A. SubjectContinuity of CareB. Background Continuity of care (COC) comprises a series of separate health care services so that treatment remains coherent, unified over time, and consistent with a members health care needs and preferences. To ensure that care is not disrupted, COC becomes a bridge of coverage, allowing members to transition to CareSources provider network. Newly enrolled members can continue to receive services by an out-of-network provider when an established relationship exists with that provider, and/or the member will be receiving services for which a prior authorization was received from another payer. Existing members may also utilize COC when a participating provider or acute care hospital terminates an agreement with CareSource. COC promotes safety and effective healthcare to transitioning members. C. Definitions Continuing Care Patient-An individual who, with respect to a provider or facility (1) is undergoing a course of treatment for a serious and complex condition from the provider or facility; (2) is undergoing a course of institutional or inpatient care from the provider or facility; (3) is scheduled to undergo non-elective surgery from the provider, including receipt of postoperative care from such provider or facility with respect to such a surgery; (4) is pregnant and undergoing a course of treatment for the pregnancy from the provider or facility; or (5) is or was determined to be terminally ill and is receiving treatment for such illness from such provider or facility. Continuity of Care-A process for assuring that care is delivered seamlessly across a multitude of delivery sites and transitions in care throughout the course of the disease process. Course of Treatment-A prescribed order or ordered course of treatment for a specific individual with a specific condition that is outlined and decided upon ahead of time between the member and provider and may, but is not required to, be part of a treatment plan. Covered Services – Health care services that are (1) covered by a specific benefit provision; (2) not excluded; and (3) determined to be medically necessary per medical policies and nationally recognized guidelines determined to be all the following: o provided for the purpose of preventing, diagnosing, or treating a sickness, injury, behavioral health disorder, substance use disorder, or symptoms o consistent with nationally recognized scientific evidence and prevailing medical standards and clinical guidelines o not provided for the convenience of members, providers, or any other person Serious and Complex Condition-In the case of (1) an acute illness, a condition that is serious enough to require specialized medical treatment to avoid the reasonable possibility of death or permanent harm; or (2) in the case of a chronic illness or condition, a condition that is life threatening, degenerative, potentiallyContinuity of Care-MP-AD-1258 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 3 disabling, or congenital, and requires specialized medical care over a prolonged period of time. Terminal Illness-Medical prognosis of life expectancy that is 6 months or less. Terminated-With respect to a contract, the expiration or nonrenewal of a contract excluding termination due to failure to meet applicable quality standards or fraud.D. PolicyI. Eligibility for Continuity of Care CareSource will review COC requests submitted by members or on behalf of members. A. Newly enrolled, CareSource plan members may qualify for COC coverage in the following circumstances: 1. The member chooses to receive care from a non-network provider. Prior authorization must be obtained. If the existing physician or nurse practitioner is not in the CareSource network, coverage will be extended as follows: a. eligibility up to 30 days calendar days after the coverage effective date, if 01. the physician or nurse practitioner does not participate in another plan for which a member is eligible through the Marketplace 02. the physician or nurse practitioner is providing an active course of treatment or is a members primary care physician (PCP) b. pregnant at enrollment and through the postpartum period c. until death if diagnosed with a terminal illness 2. The member is or will be receiving services for which a prior authorization was received from another plan or payer. B. Terminations of contractual relationships between CareSource and providers and/or facilities will result in changes to provider network status. Termination requests will be reviewed when any of the following qualifying events occur: 1. A contractual relationship with a CareSource health partner is terminated (see terminated definition above). 2. Benefits provided with respect to a certain provider or facility are terminated because of a change in the terms of participation in the plan or coverage. 3. A contract between a plan and health insurer offering health coverage in connection with the plan is terminated, resulting in a loss of benefits provided under the plan with respect to providers and facilities. II. Notification by CareSource Once CareSource is notified that a provider or facility is leaving the network or there is a change in the providers facility affiliation, members will be notified in writing within 30 days after the provider or facility leaves the network or of the change in provider affiliation. III. Continuing care members will be provided an opportunity to notify CareSource of the need for transitional care. Continuity of Care-MP-AD-1258 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 4 IV. The member can elect to continue to have benefits provided under the previous plan or coverage had termination not occurred with respect to the course of treatment furnished by the provider or facility relating to the members status as a continuing care patient during the period beginning on the date on which the notice was provided and ending on the earlier of the following: A. the 90-day period beginning the date notice is provided B. the date on which the member is no longer a continuing care patient with the provider or facility V. Health care services rendered by a provider who is disenrolled from the network or a non-network provider as described in this policy will only be covered when the health care services would otherwise be covered services if provided by a network provider, and the provider agrees to comply with the following: A. accept payment from CareSource at the rates CareSource pays to network providers of the same specialty or sub-specialty B. accept such payment as payment in full and not charge the member any more than the member would have paid if the provider was a network provider C. comply with CareSource's quality assurance standards D. provide CareSource with necessary medical information related to the care provided E. comply with policies and procedures, including, but not limited to, procedures regarding referrals, obtaining prior authorization, and providing covered services pursuant to a treatment approved by CareSourceE. State Specific InformationNA F. Conditions of Coverage NA G. Related Policies/Rules Medical Necessity Determinations H. Review/Revision History DATE ACTIONDate Issued 11/09/2022 New policyDate Revised 10/11/2023 Annual review. Revised definitions/policy section for compliance to No Surprises Act and 2024 EOCs. Approved at Committee. Date Effective 01/01/2024 Date Archived 01/31/2025 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy. I. References1. Continuity and Coordination of Care: A Practice Brief to Support Implementation ofContinuity of Care-MP-AD-1258 Effective Date: 01/01/2024 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 5 The WHO Framework on Integrated People-Centred Health Services . World Health Organization; 2018. Accessed September 7, 2023. www.who.int Continuation of Care Provisions, IND . C ODE 27-13-36-6 (2023). 2. Continuity of Care, 42 U.S.C. 300gg 113 (2023). 3. Georgia Evidence of Coverage. CareSource; 2024. Accessed September 7, 2023. www.caresource.com 4. Harris E. Review finds benefits of primary care continuity. JAMA . 2023;329(24):2119. doi:10.1001/jama.2023.9930 5. Indiana Evidence of Coverage. CareSource; 2024. Accessed September 7, 2023. www.caresource.com 6. Kentucky Evidence of Coverage. CareSource; 2024. Accessed September 7, 2023. www.caresource.com 7. Ohio Evidence of Coverage. CareSource; 2024. Accessed September 7, 2023. www.caresource.com 8. Standards for Certification, GA. C ODE ANN . 33-20A-5 (2023). 9. Standards for Provider Participation, K Y. R EV . S TAT . 304.17A-525 (1998). 10. The No Surprises Acts Continuity of Care, Provider Directory, and Public Disclosure Requirements . Centers for Medicare and Medicaid Services; 2021. Accessed September 7, 2023. www.cms.gov 11. West Virginia Evidence of Coverage . CareSource; 2024. Accessed September 7, 2023. www.caresource.com

Policy Development Process

ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Policy Development Process-MP-AD-1242 12/01/2023 Policy Type ADMINISTRATIVE Administrative 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 guid elines, 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 treat ment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n of a body organ or part, or significant pain and discomfort. These services meet the stan dards 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 docum ents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative 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 Adminis trative Policy Statement. If there is a conflict between the Administrative 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 determina tion. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 4 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 I. References ………………………….. ………………………….. ………………………….. ……………………. 4 Policy Development Process-MP-AD-1242Effective Dat e: 12/01/2023The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectPolicy Development Process B. BackgroundCareSource utilizes a systematic way to develop policies through a standard operating procedure that improves efficiency, increases productivity and quality, and provides consistent policy products to stakeholders and others. This process starts with the identification of a policy need, including policy intent and triage, and then, thorough research and collaboration leads CareSource to determine best practice for members. According to the tenets of Mental Health Parity Addiction Equity Act (MHPAEA), cove rage for the diagnosis and treatment of a behavioral health disorder will not besubject to any limitations that are less favorable or more restrictive than the limitations that apply to medical conditions as covered by CareSource policies. The policy deve lopment process ensures quality and consistency among both medical/surgical and behavioral health policies. C. Definitions Administrative Policies – Policies written to provide guidance to providers on administration of behavioral or physical health benefits. AllMed – A vendor with independent, external review specialists, who complete impartial medical reviews prior to final medical policy approval and implementation. Business Owner – An individual who identifies a gap in information or benefits and recommends or requests that a topic be researched for possible creation or clarification of medical necessity criteria, reimbursement information or adm inistrative conditions to assist in providing consistent and quality services to CareSource members. The business owner supports the development of a policy. Clinical Policy Governance Committee (CPGC) – The official governing body, comprised of medical an d behavioral health subject matter experts charged with the approval of new or revised clinical policies relating to medical necessity determinations. The CPGC is responsible for determining whether the proposed clinical policy is clearly defined, clinical ly evidenced-based, assures a high level of member safety and quality of care, and articulates a business value. Medical/Clinical Policies – Policies written with medical criteria, including current evidence-based research, best practice, studies, etc., wh ich will determine what the member must meet for the provider to deliver a service. PolicyTech – Policy and procedure lifecycle management software for policy development and revision designed to centralize, build, and simplify policy and procedure workflo ws. Users have tools, such as workflow automation, document creation and review, remote access, versioning, audit-ready reporting, and employee assessments. Reimbursement Policy – Addresses a topic in what must be met from a provider regarding billing/clai ms criteria to receive reimbursement for services provided. Subject Matter Experts (SME) – A person who is an authority on a particular topic or subject matter. Policy Development Process-MP-AD-1242Effective Dat e: 12/01/2023The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 D. Policy I. Pre-Policy Development A. The business owner enters a policy intake into PolicyTech to start the policy development process. B. To determine the intent, need, and priority of the request, collaboration occurs between the policy writer, business owner, member benefits coder, member benefits analyst, configuration, and an appropriate business owner , such as a subject matter expert (SME) and/or medical director. C. If it is determined that there is a need for a policy, collaboration occurs between a multidisciplinary team to review codes and configuration, if applicable , and management determine s if codes need sent to analytics to provide the policy team with additional data, such as financial data, claims and/or usage of benefits by members. II. Policy DevelopmentA. The policy writer researches the topic and develop s a draft of the policy. This includes, but is not limited to, the following resources: 1. state/federal regulations 2. state contracts 3. standard of care guidelines (ie, MCG Health, InterQual, Am erican Society of Addiction Medicine, etc) 4. Hayes 5. UpToDate 6. Policy Reporter 7. provider and member materials 8. professional society recommendations 9. published studies 10. feedback from external sources 11. su bject matter experts , including medical /surgical and/or behavioral 12. EncoderPro B. After the policy is approved in the PolicyTech system on several levels by subject matter experts, management, writers, applicable departments and others, a final policy revision is reviewed and app roved by the following: 1. Benefits, Coding and Support 2. Configuration 3. Utilization Management 4. Independent, external medical review specialists, when applicable 5. CPGC 6. State approval, if applicable III. Post Policy DevelopmentProviders and members of the health partner community are notified of new policies and/or changes to existing policies via CareSource s marketing process. A standard operating procedure guides a uniform , consistent process allowing for adequate Policy Development Process-MP-AD-1242Effective Dat e: 12/01/2023The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.4 notice of n ew criteria or revisions as outlined by state or company requirements.Upon adequate notice, policies are posted on CareSources website. E. State-Specific InformationNA F. Conditions of CoverageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 09/30/2020Date Revised 12/10/2021 09/13/202209/13/2023Updated definitions and reference list used for research. Archived individual policies ( AD: GA 0916, IN 0914, KY 0913, OH 0911, WV 0912 ) Annual review. Approved at C ommittee. Date Effective 12/01/2023 Date Archived I. References1. Mental Health Parity and Addiction Equity Act. US Centers for Medicare and Medicaid Services. Accessed August 21, 2023. www.cms.go v

Emergency Department Electrocardiogram EKG ECG Interpretation

ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Electrocardiogram (EKG/ECG) Interpretation and Imaging Interpretation-MP-AD-1237 12/01/2023 Policy Type ADMINISTRATIVE Administr ative 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 industr y 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 whic h 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 l ocal area, ar e 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, M ember Handbooks, and/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) wil l 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 tha t are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 3 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 I. References ………………………….. ………………………….. ………………………….. ……………………. 3 Electrocardiogram (EKG/ECG) Interpretation and Imaging Interpretation-MP-AD-1237 Effective Dat e: 12/01/2023 The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectElectrocardiogram (EKG/ECG) Interpretation and Imaging Interpretation B. BackgroundAn electrocardiogram (EKG/ECG) is a non-invasive test that records the electrical activity of the heart. It m ay be used when a possible cardiac issue occurs due to an emergency medical condition . An EKG/ECG may need to be performed to address the situation quickly. The recording is reviewed by a physician who provides an interpretation and written report. An EKG/ECG may be reported as the technical aspect only, the interpretation and written report only, or both aspects together as one service. For the purpose of this policy, EKG will be used to represent both EKG and ECG. C. Definitions Electrocardiogram (EKG/ECG) – A test that records the electrical activity of the heart. Emergency Medical Condition – A medical condition with sudden severity and onset that, in the absence of immediate medical attention, could place the patient’s health in serious jeopardy, including labor and delivery, but not routine prenatal or postpartum care, or services related to an organ transplant procedure. Imaging – Several different technologies th at are used to view the human body in order to diagnose, monitor, or treat medical conditions. D. PolicyI. Electrocardiogram (EKG/ECG) Interpretation A. CareSource will reimburse the first EKG interpretation claim that is received for the member on the da te of service.1. If another claim for the same EKG interpretation is received for reimbursement, CareSource will only reimburse the first claim received forthe same member on the same date of service.2. CareSource will not reimburse for duplicate claims, for the same service on the same date of service for the same member, without the appropriatemodifier.B. If a second EKG interpretation is medically necessary, on the same date of service, before the member is discharged, modifier 76 or modifier 77 must be appended to the second EKG interpretation for reimbursement.II. Imaging Interpretation A. CareSource will reimburse the first imaging interpretation claim that is received for the member on the date of service. 1. If another claim for the same imaging interpretation is received for reimbursement, CareSource will only reimburse the first claim received for the same member on the same date of service. 2. CareSource will not reimburse for duplicate claims, for the sa me service on the same date of service for the same member, without the appropriate modifier. Electrocardiogram (EKG/ECG) Interpretation and Imaging Interpretation-MP-AD-1237 Effective Dat e: 12/01/2023 The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 B. If a second imaging interpretation is medically necessary, on the same date of service, before the member is discharged, modifier 76 or modifier 77 must be ap pended to the second imaging interpretation for reimbursement.III. CareSource expects providers to work with other departments, within their organization, to determine which department will submit the claim to prevent duplicate claim submissions.E. State-Specific InformationNA F. Conditions of CoverageCareSource expects provider to use appropriate standard billing guidelines. Modifiers and place of service codes are listed below only as a reference. Modifier Description 26 Professional Component 76 Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional 77 Repeat Procedure by Another Physician or Other Qualified Health Care Professional G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 09/14/2022 New policyDate Revised 09/13/2023 Removed place of service language. Updated references. Approved at Committee. Date Effective 12/01/2023 Date Archived I. References1. Sattar Y, Chhabra L. Electrocardiogram. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023. Updated June 5, 2023. Accessed August 7,2023. www.ncbi.nlm.nih.gov 2. U.S. Food and Drug Administration. Medical Imaging. August 28, 2018 . Accessed August 7,2023. www.fda.gov 3. What Are Medical Coding Modifiers? American Academy of Professional Coders ; 2023 . Accessed August 7, 2023. www.aapc.com

Program Integrity Provider Prepayment Review

ADMINISTRATIVE POLICY STATEMENT Marketplace Policy Name & Number Date Effective Program Integrity Provider Prepayment Review-MP-AD-1222 11/01/2023-10/31/2024 Policy Type ADMINISTRATIVE This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. …………………….. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. . 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Administrative 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 industr y standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited t o, 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, a nd/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative 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 determina tion. 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.Program Integrity Provider Prepayment Review-MP-AD-1222 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 2 A. SubjectProgram Integrity Provider Prepayment Review B. BackgroundCareSource Program Integrity (PI) operates a provider prepayment review program to detect, prevent, and correct fraud, waste, and abuse, and to facilitate accurate claim payments. Physicians and other healthcare professionals may have the right to appeal results of reviews. C. Definitions Provider Prepayment Review – Reviews of medical record documentation and comparison billed services. Program Integrity (PI) – The proper management and functioning of a health insurance program to ensure that it is providing quality and efficient care while using funds from taxpayer dollars appropriately and with minimal waste. Certified Professional Coder (CPC) – The certified professional coder credential is offered through the American Academy of Professional Coders (AAPC). Professional coding is medical coding that is conducted in a professional environment, such as a physician’s office, outpatient setting, or hospital. Registered Health Information Administrator (RHIA) – A professional who handles patient health information. The RHIA role requires certification and must adhere to standards such as the Health Insurance Portability and Accountability Act and other privacy and security rules. Registered Health Information Technician (RHIT) – A certified professional who stores and verifies the accuracy and completeness of electronic health records and analyzes patient data with the goal of controlling healthcare costs and improving patient care. Soft Denial – A denial applied to claims which are selected as part of the prepayment review audit. Soft denials do not require an appeal to resolve. Upload records to the CareSource Provider Portal for the denied claim. Soft denials are identified in the remittance advice by RARC code 127 Missing patient medical record for this service. D. PolicyI. A provider prepay review involves reviewing medical records compared to services billed prior to claim adjudication. Providers are placed on prepay review to monitor for improper billing of medical claims including but not limited to the following reasons: A. overutilization of services B. billing for items or services not rendered C. selection of wrong CPT/HCPCS code or supplies D. lack of medical necessity E. billing/dispensing unnecessary services F. procedure repetition G. upcoding Program Integrity Provider Prepayment Review-MP-AD-1222 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 3 H. billing for services outside of provider specialtyII. Placement on prepayment review will require the provider to submit medical records for all identified claims allowing CareSource to review the medical records in comparison to the billed services. CareSource will provide a written notice to the provider/provider group advising the effective date of prepayment review. A. Claims selected for prepayment review will be soft denied. B. Provider must upload medical records to the CareSource Provider Portal. It is not necessary to appeal a soft denial. C. Failure to submit medical records to CareSource in accordance with this provision will result in claim remaining denied. D. Failure to meet minimal documentation standards, such as member name and date of service on each page of the medical record, a signed dated order, and a valid provider signature, will result in claim denial. E. Providers must bill timely and accurate claims while under prepayment review. III. CareSource uses widely recognized sources to conduct reviews which includes, but is not limited to, the following: A. Centers for Medicare and Medicaid Services (CMS) guidelines, as stated in Medicare manuals B. Medicare local and national coverage determinations C. CareSource published policies (Administrative, Medical and Reimbursement), code – editing policies and CareSource provider manuals D. National Uniform Billing Guidelines from the National Billing Committee E. American Medical Association Current Procedural Terminology (CPT) guidelines F. Current American Medical Association Healthcare Common Procedure Coding System (HCPCS) Level II G. ICD 10-CM official guidelines for coding and reporting H. American Association of Medical Audit Specialists national healthcare billing audit guidelines I. Industry-standard utilization management criteria and/or care guidelines, such as MCG guidelines (current edition on date of service) J. Food and Drug Administration guidance K. National professional medical societys guidelines and consensus statements L. Publication from specialty societies, such as the American Society for Parenteral and Enteral Nutrition, the Substance Abuse and Mental Health Service Administration, and the American Association of Neuromuscular & Mental Health Services Administration M. Nationally recognized, evidence-based published literature including, but not limited to, sources such as Medscape, the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) IV. The Program Integrity Provider Prepayment Review Team is comprised of clinical review and coding specialists who maintain CPC, RHIA, or RHIT designations. The team Program Integrity Provider Prepayment Review-MP-AD-1222 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 4 reviews provider documentation to determine whether the claim is appropriate for payment based on criteria including, but not limited to, provider documentation which establishes the following: A. Services were provided according to CareSource policy requirements. B. Members were benefit eligible on the date the services were provided. C. Prior authorization was obtained, if required by policy. D. Providers and staff were qualified, as required by state or federal law. E. The provider possessed the proper license, certification, or other accreditation requirements specific to the providers scope of practice at the time the service was provided to the member. V. Providers whose claims (or claim lines) are determined not payable via coding review audit after medical records submission may dispute or appeal, whichever is appropriate, within timely filing limitations as outlined in the provider manual. Providers and/or billing managers may reach out directly to the program integrity prepayment review team to discuss specific claim denials. VI. Release from prepayment review includes the following steps:A. CareSource will review provider accuracy monthly to determine if the provider is eligible for release from prepayment review. Eligibility is as follows: 1. The provider has demonstrated a high accuracy rate on claim submissions for 3 consecutive months. 2. The volume of claims submissions remained consistent with the volume before prepayment review. 3. Provider maintains a high rate of records returned after soft denial. B. Once released from prepayment review, the provider/provider group will receive notification in writing as to the effective end date of review. Providers who demonstrate accurate billing practices and have been removed from prepayment review may be subject to future follow up reviews to ensure continued compliance with billing practices. C. If the provider fails to satisfy the requirements above, the following may be necessary: 1. If after 12 months on prepayment review the provider fails to satisfy the requirements under subsection A, CareSource may do the one of following: a. outreach to provider to educate on claim accuracy issues b. require a corrective action plan c. deny payment for services rendered during a specified period of time d. terminate the provider agreement 2. If a provider has been on a prepayment review for 12 months, CareSource may terminate the provider agreement in the following conditions: a. no billing activity for 6 months b. claim submission volume during review period is not consistent with the volume before prepayment review Program Integrity Provider Prepayment Review-MP-AD-1222 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 5 E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATES ACTIONDate Issued 01/08/2020 New PolicyDate Revised 08/19/2020 Updated Section VII. 07/20/2022 Editorial updates only.08/02/2023 Added definition Soft Denial. Removed 30 day requirements and substitutes all identified claims Removed old section III. RemovedIV.A.2. Removed old section Vi. And VII. Added new IV. Release from prepayment review. Approved at Committee.Date Effective 11/01/2023Date Archived 10/31/2024 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy . H. ReferencesN/A

Pain Management Providers

ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Pain Management Providers-MP-AD-1207 11/01/2023 Policy Type ADMINISTRATIVE Administrative 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 industr y 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 o f a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal 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 M anuals, Member Handbooks, and/or other policies and procedures. Administrative 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 E vidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Cove rage) 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 limita tions that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. State-Specific Information ………………………….. ………………………….. ………………………….. … 3 F. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 G. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 H. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 I. References ………………………….. ………………………….. ………………………….. ……………………. 3 Pain Management Providers-MP-AD-1207Effective Dat e: 11/01/2023The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectPain Management Providers B. BackgroundPractitioners who have obtained additional education/certification to practice in the field of pain medicine and are able to help members manage and treat pain. C. Definitions American Board of Medical Specialties (ABMS) An organization of medical specialty boards with shared goals and standards related to the certification of medical specialists, including initial specialty and subspecialty certification, as well as maintenance of certification throughout the physicians career. American Board of Pain Medicine (ABPM) An organization that administers a psychometrically-developed and practice-related examination in the field of Pain Medicine to qualified candidates. P hysicians who have successfully completed the ABPM credentialing process and examination will be issued certificates as specialists in the field of Pain Medicine and designated as Diplomates of the American Board of Pain Medicine. American Osteopathic Asso ciation (AOA) An organization of osteopathic specialty boards with shared goals and standards related to the certification of osteopathic specialties. Certification includes primary certification, certification of special or added qualifications and oste opathic continuous certification. Pain Management The medical discipline concerned with the diagnosis and treatment of the entire range of painful disorders. D. PolicyI. All the following criteria must be met for physicians to achieve successful credentialin g as pain management specialists: A. Successful completion of residency in a pertinent residency program, such as neurology neurosurgery physical medicine and rehabilitation anesthesiology B. Board certification in one of the above specialties, as recognized by ABMS, AOA, or ABPM C. Successful completion of fellowship training in pain medicine or anesthesiology certification in pain management D. Additional board certification in Pain Management by one of the following pathways is preferred: 1. American Board of Anesthesi ology, subspecialty in Pain Medicine 2. American Board of Physical Medicine and Rehabilitation, subspecialty in Pain Medicine 3. American Board of Psychiatry and Neurology, subspecialty in Pain Medicine 4. American Osteopathic Board of Anesthesiology, certification of added qualifications in Pain Management Pain Management Providers-MP-AD-1207Effective Dat e: 11/01/2023The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 5. American Osteopathic Board of Neuromusculoskeletal Medicine, certification of added qualifications in Pain Management6. American Osteopathic Board of Physical Medicine and Rehabilitation, certification of added qualifications in Pain Management 7. American Board of Pain Medicine (not an ABMS or AOA specialty) II. Physicians board certified in one of the above specialties, but wit hout additional pain management fellowship training or certification (anesthesia route) , will not be credentialed in pain management. III. Primary care physicians and specialists other than those listed above will not be credentialed as pain management physici ans. Physicians who receive additional training in pain management and intend to do a non-interventional pain management practice will not be credentialed or listed as pain management physicians but will be privileged to do pain management as part of general medical practice depending on current level of training and experience. IV. All physicians who do not meet requirements I.A-I.C will be reviewed at thecredentialing committee for further consideration.E. State-Specific InformationNA F. Conditions of Co verageNA G. Related Policies/RulesNA H. Review/Revision HistoryDATE ACTIONDate Issued 05/25/2022 New PolicyDate Revised 07/ 19 /2023 Annual review: updated references. Approved at Committee. Date Effective 11/01/2023 Date Archived I. References1. ABMS Guide to Medical Specialties . American Board of Medical Specialties ; 2022. Accessed June 23, 2023. www.abms.org 2. Certification and American Board of Pain Medicine MOC Examinations. American Board of Pain Medicine. Accessed June 23, 2023. www.abpm.org 3. Specialties and subspecialties. American Osteopathic Association (AOA) Board Certification . Accessed June 23, 2023. www.certification.osteopathic.org

Opioid Use Disorder Medication Treatment Providers

Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative 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.ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Opioid Use Disorder Medication Treatment Providers-MP-AD-1326 11/01/2023-12/31/2024 Policy Type ADMINISTRATIVE Georgia Indiana Kentucky Ohio West VirginiaTable of Contents A. Subject …………………………………………………………………………………………………………………. 2 B. Background …………………………………………………………………………………………………………… 2 C. Definitions ……………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………… 2 E. State-Specific Information ………………………………………………………………………………………… 3 F. Conditions of Coverage …………………………………………………………………………………………… 4 G. Related Policies/Rules …………………………………………………………………………………………….. 4 H. Review/Revision History ………………………………………………………………………………………….. 4 I. References ……………………………………………………………………………………………………………. 4 Opioid Use Disorder Medication Treatment Providers-MP-AD-1326 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. A. SubjectOpioid Use Disorder Medication Treatment Providers B. Background The use of medication for opioid use disorder (MOUD) in opioid treatment programs (OTP) is governed by the 42 Code of Federal Regulations (CFR) 8. The regulation created a system to certify and accredit OTPs, allowing administration and dispensing of Food and Drug Administration (FDA) -approved medications for opioid use disorder. OTPs must be certified and accredited, licensed in the applicable state of operation, and registered with the Drug Enforcement Administration (DEA). Oversight of treatment medication remains a multilateral system involving states, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Health and Human Services (HHS), the Department of Justice (DOJ) and the Drug Enforcement Administration (DEA). State Opioid Treatment Authorities (OTAs) assist providers with information about individual state regulations. Additionally, with the passage of Section 1262 of the Consolidated Appropriations Act (2023), practitioners are no longer required to submit a Notice of Intent to prescribe certain schedule III-V medications for the treatment of opioid use disorder, commonly known as the X-Waiver. This includes buprenorphine, an FDA-approved medication that, taken daily, reduces cravings and withdrawal symptoms. C. Definitions Opioid Treatment Program (OTP) – Program/qualified practitioner accredited and certified by SAMHSA, delivering opioid treatment with an opioid agonist medication. Opioid Use Disorder (OUD) – At least 2 of 11 clinical criteria within the Diagnostic Statistical Manual-5 -Text Revised are met within a 12-month period with severity ranging from mild to severe, including tolerance and withdrawal. Practitioner-Health care professional appropriately licensed by a state to prescribe and/or dispense medications for OUD and authorized to practice within an OTP. Substance Abuse Mental Health Services Administration (SAMHSA) – Agency within the HHS leading public health and service delivery efforts that promote mental health, prevent substance misuse, and provide treatments and supports to foster recovery while ensuring equitable access and better outcomes. D. Policy I. Effective June 27, 2023, the Medication Access and Training Expansion (MATE) Act, which passed as part of the CAA 2023, implemented a new requirement for all DEA-registered practitioners to complete 8 hours of training on the treatment and management of patients with opioid or other substance use disorders. This training requirement is a one-time requirement and not required for subsequent DEA registration renewals. Practitioners are deemed to have satisfied this requirement if any of the following apply: A. board certification in addiction medicine or addiction psychiatry B. previous completion of the DATA-2000 Waiver training Opioid Use Disorder Medication Treatment Providers-MP-AD-1326 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. C. previous completion of 8 hours of cumulative training relevant to the treatment and management of patients with opioid or other SUDs from accredited groups named in the CAA 2023 II. Methadone providers must comply with all the following: A. obtain accreditation/certification as an OTP provider B. follow state laws, such as licensure, if applicable C. register with the Drug Enforcement Administration (DEA) D. provide documentation that other, traditional outpatient behavioral health services are being or have been offered, and/or provided, such as testing, assessment, evaluation, and psychotherapy III. Buprenorphine The following criteria and conditions must be met for prescribers to achieve successful credentialing with the following specialties: A. Addiction Medicine 1. Unrestricted Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) license and one of the following: a. certification by the American Board of Addiction Medicine b. subspecialty certification in addiction medicine by the American Board of Preventive Medicine c. subspecialty certification in addiction psychiatry by the American Board of Psychiatry and Neurology d. certificate of added qualification in addiction medicine from the American Osteopathic Association e. completion of accredited residency/fellowship in addiction medicine or Addiction Psychiatry 2. Unrestricted, licensed Advanced Practice Registered Nurses (APRN) must have completed Nurse Practitioner Substance Use Disorder Medical Education Project (NP-SUDMedEd) training. B. Buprenorphine Provider 1. Unrestricted MD or DO license and registered with the DEA to dispense schedule III, IV, and Vmedications for treatment of pain. 2. Other practitioners with an unrestricted license (Nurse Practitioner, Clinical Nurse Specialist, Certified Registered Nurse Anesthetist, Certified Nurse Midwife, or Physician Assistants) and all the following:a. must be in an office-based setting b. registered with the DEA to dispense schedule III, IV, and Vmedications for treatment of pain c. training or experience that demonstrates the ability to treat and manage opioid-dependent members d. supervision by or employment in collaboration with a qualifying physician as noted in III.B.1., if applicable and as required by license E. State-Specific Information NA Opioid Use Disorder Medication Treatment Providers-MP-AD-1326 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. F. Conditions of CoverageI. All providers must comply with current federal and state regulations. II. Non-participating providers require a prior authorization for services.G. Related Policies/Rules NA H. Review/Revision History DATE ACTION Date Issued 03/15/2023 Approved at Committee. Date Revised 08/02/2023 Added section D.I. Deleted III.A. Updated references. Approved at Committee. Date Effective 11/01/2023 Date Archived 12/31/2024 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy. I. References1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: Fifth Edition, Text Revision . American Psychiatric Association; 2022. 2. Drug Enforcement Administration, Department of Justice, 21 C. F. R. 1300-21. (2023). 3. Evidences of Coverage. CareSource; 2023. Accessed July 20, 2023. www.caresource.com 4. Medication Access and Training Expansion Acts, PB.L. No. 117-328. (2022). 5. Medication Assisted Treatment for Opioid Use Disorders, 42 C. F. R. 8.1 -.655. (2023). 6. National Institute on Drug Abuse. Principles of Drug Addiction Treatment: A Research-based Guide. 3rd ed. National Institutes of Health; 2018. NIH publication 12-4180. Accessed July 20, 2023. www.nida.nih.gov 7. The ASAM national practice guideline for the treatment of opioid use disorder: 2020 focused update. American Society of Addiction Medicine. Accessed July 20, 2023. www.asam.org. 8. US Dept of Health and Human Services. Certification of opioid treatment programs (OTPs). Substance Abuse and Mental Health Services Administration. Accessed July 20, 2023. www.samhsa.gov 9. US Dept of Health and Human Services. Opioids. Centers for Disease Control and Prevention. Updated May 23, 2023. Accessed July 20, 2023. www.cdc.gov 10. US Dept of Health and Human Services. Practitioner training. Substance Abuse and Mental Health Services Administration. Accessed July 20, 2023. www.samhsa.gov 11. US Dept of Health and Human Services. Removal of DATA waiver (X-Waiver) requirement. Substance Abuse and Mental Health Services Administration. Accessed July 20, 2023. www.samhsa.govOpioid Use Disorder Medication Treatment Providers-MP-AD-1326 Effective Date: 11/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. 12. US Dept of Justice. Drug scheduling. US Drug Enforcement Administration. Accessed July 20, 2023. www.dea.gov

Experimental, Investigational and Other NonCovered Services

ADMINISTRATIVE POLICY STATEMENTMarketplace Policy Name & Number Date Effective Experimental, Investigational and Other Non – Covered Services-MP-AD-1354 11/01/2023 Policy Type ADMINISTRATIVE Administrative 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 s tandards, 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 wit hout 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 l ocal 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. Administrative 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 Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.This policy applies to the following Marketplace(s): Georgia Indiana Kentucky Ohio West Virginia Table of ContentsA. 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 …………………………………………………………………………………………………………. 5 Experimental, Investigational and Other Non-Covered Services-MP-AD-1354 Effective Date: 11/01/2023 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d. 2A. SubjectExperimental, Investigational and Other Non-Covered Services B. Background Experimental and/or investigational items or services are not covered. This includes , among other things, services or procedures considered to be investigational, cosmetic, or not medically necessary, and in some cases, providers may bill members for these non-covered services or procedures. Providers are encouraged to inform members in advance when they may be financially responsible for the cost of non-covered or excluded services. To determine whether a medical technology is a proven, m edically necessary service, device, or procedure, CareSource conducts literature searches and evaluates the published scientific evidence related to each technology. The published evidence is reviewed against five (5) technology assessment criteria. In order for a technology to be considered medically necessary, all five (5) criteria must be met. If any one or more of the following criteria are not met, then the technology is considered investigational : 1. The technology must have final approval from the appr opriate government regulatory bodies (i.e., Food and Drug Administration [FDA]). An approval granted as an interim step (i.e., Treatment IND) in the governmental bodys regulatory process is not sufficient. 2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes and consist of well-designed and well-conducted investigations published in peer-reviewed journals. The quality of the studies and the consistency of the results are considered when evaluating t he evidence. 3. The technology must improve the net health outcome (the technologys beneficial effects on health outcomes should outweigh any harmful effects on health outcomes. 4. The technology must be as beneficial as any established alternatives of a similar cost effectiveness . This means the technology should improve the net health outcome as much as or more than established alternatives. 5. The improvement must be attainable outside the investigational settings. When used under the usual conditions of medical practice, the technology should be reasonably expected to satisfy technology evaluation criteria #3 and #4. The following additional criteria apply to new diagnostic technologies (e.g., imaging studies, laboratory procedures, home monitoring devices): 1. Technical feasibility is demonstrated, including reproducibility and precision. For comparison among studies, a common standardized protocol for the new diagnosti c technology is established. 2. For accurate interpretation of study results, sensitivities, specificities, and positive and negative predictive values compared to standards are established. 3. The clinical utility of a diagnostic technique, i.e., how the result s of the study can be used to benefit patient management, is established. The clinical utility of both positive and negative tests must be established. Experimental, Investigational and Other Non-Covered Services-MP-AD-1354 Effective Date: 11/01/2023 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d. 3C. Definitions CPT Category III Codes-a set of temporary (T) codes assigned to emerging technologies, services, and procedures. These codes are intended to be used for data collection to substantiate more widespread usage or to provide documentation for the Food and Drug Administration (FDA) approval process . Experimental or Investigational I tems or Services-Medical, surgical, diagnostic, psychiatric, substance use disorders treatment or other health care services, technologies, equipment, supplies, treatments, procedures, therapies, biologics, drugs, or devices (each a Health Care Item or Ser vice) that, at the time CareSource has made a determination regarding coverage in a particular case, are: o Not approved by the United States Food and Drug Administration (FDA) to be lawfully marketed for the proposed use , o Not identified in the American Hospital Formulary Service or the United States Pharmacopoeia Dispensing Information as appropriate for the proposed use, or o Determined by the FDA to be contraindicated for the specific use, o Subject to review and approval by any institutional rev iew board or other body serving a similar function for the proposed use, and such final approval has not been granted, o The subject of an ongoing clinical trial that meets the definition of a Phase 1, 2 or 3 clinical trial set forth in the FDA regulations, regardless of whether the trial is actually subject to FDA oversight , o Provided as part of a clinical research protocol or clinical trial or is provided in any other manner that is intended to evaluate the safety, toxicity, or efficacy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply , o Provided pursuant to informed consent documents that describe the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply as e xperimental or i nvestigational, or otherwise indicate that the safety, toxicity, or effica cy of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply is under evaluation. Devices that are FDA approved under the Humanitarian Use Device exemption are not considered to be experimental or investigational. Drugs used in Phase 4 trials may be covered if they are part of the formulary . D. Policy I. Any health care item or service CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. Any health care item or service not deemed experimental or investigational based on the criteria in Section III may still be deemed experimental or investigational if it is not supported by credible research that soundly demonstrates that such item or serv ice will have a measurable and beneficial health outcome. Experimental, Investigational and Other Non-Covered Services-MP-AD-1354 Effective Date: 11/01/2023 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d. 4III. When reviewing requests, CareSource will consider information and evidence from the following non-exhaustive list: A. Published authoritative, peer-reviewed medical or scientific literature, or the absence thereof, B. Evaluations of national medical associations, consensus panels, and other technology evaluation bodies, C. Documents issued by and/or filed with the FDA or other federal, state or local agency with the authority to approve, regulate, or investigate the use of the drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply, D. Documents of an institutional review board or other similar body performing substantially the same function, E. Consent document(s) and/or the written protocol(s) used by providers studying substantially the same drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply, F. Medical records, or G. The opinions of consulting providers and other experts in the field IV. The codes listed in this policy come from the following sources, and are typically reviewed twice a year: Center for Medicare and Medicaid Services (CMS) The American Medical Association V. The following items , procedures and services are non-covered. This list is not intended to be an all-inclusive list. Other services not included in this list may also be non-covered. The absence or removal of a code from this medical policy does not imply coverage.Codes Description Rational for non – coverage 0745T Cardiac focal ablation utilizing radiation therapy for arrhythmia; noninvasive arrhythmia localization and mapping of arrhythmia site (nidus), derived from anatomical image data (eg, CT, MRI, or myocardial perfusion scan) and electrical data (eg, 12-lead ECG data), and identification of areas of avoidance As of most recent review, no FDA approval 0746T Cardiac focal ablation utilizing radiation therapy for arrhythmia; conversion of arrhythmia localization and mapping of arrhythmia site (nidus) into a multidimensional radiati on treatment plan As of most recent review, no FDA approval 0747T Cardiac focal ablation utilizing radiation therapy for arrhythmia; delivery of radiation therapy, arrhythmia As of most recent review, no FDA approval 0749T analysis of bone mineral density (BMD) utilizing data from a digital Xray, retrieval and transmission of digital X-ray data, assessment of bone strength and fracture risk and BMD, interpretation and report . As of most recent review, no FDA approval Experimental, Investigational and Other Non-Covered Services-MP-AD-1354 Effective Date: 11/01/2023 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d. 5Codes Description Rational for non-coverage 0750T Bone strength and fracture-risk assessment using digital X – ray radiogrammetry-bone mineral density (DXR-BMD) analysis of bone mineral density (BMD) utilizing data from a digital Xray, retrieval and transmission of digital X-ray data, assessment of bone strength and fracture risk and BMD, interpretation and report; with single-view digital X-ray examination of the hand taken for the purpose of DXR-BMD As of most recent review, no FDA approval 0776T Therapeutic induction of intra-brain hypothermia, including placement of a mechanical temperature-controlled cooling device to the neck over carotids and head, including monitoring (eg, vital signs and sport concussion assessment tool 5 [SCAT5]), 30 minutes of treatment The pro2cool device is not currently cleared for use by the FDA. 0778T Surface mechanomyography (sMMG) with concurrent application of inertial measurement unit (IMU) sensors for measurement of multi-joint range of motion, posture, gait, and muscle function . As of most recent review, no FDA approval 0779T Gastrointestinal myoelectrical activity study, stomach through colon, with interpretation and report As of most recent review, no FDA approval 0783T Transcutaneous auricular neurostimulation, set-up, calibration, and patient education on use of equipment . FDA approved but experimental and investigational E. Conditions of CoverageNA F. Related Policies/Rules Clinical Trial Coverage Medical Necessity Determinations policy G. Review/Revision History DATES ACTIONDate Issued 07/19/2023 New PolicyDate Revised Date Effective 11/01/2023 Date Archived H. References 1. Biological Products, 21 C.F.R. 600 (2021). Accessed June 13, 2023. www.ecfr.gov.2. Centers for Medicare & Medicaid Services (CMS). EPSDT-A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents. Experimental Treatments. HHS-0938-2014-F-1347. Accessed July 14, 2023. www.hhs.gov.3. Coverage and Authorization of Services, 42 C.F.R. 438.210 (2021). Accessed June 13, 2023. www.ecfr.gov. Experimental, Investigational and Other Non-Covered Services-MP-AD-1354 Effective Date: 11/01/2023 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d. 64. Department of Health and Human Services Centers for Medicare & Medicaid Services. (2015, January 1). Medicare Coverage of Items and Services in Category A and BInvestigational Device Exemption (IDE) Studies MLN Matters MM8921. Accessed June 13, 2023. www.cms.gov. 4. ECFR. (n.d.). E-CFR Title 21 Part 312.21 Phases of an investigation. Accessed June 13, 2023. www.ecfr.gov. 5. ECFR. (2019, June 21). E-CFR Title 21 Part 812 Investigational Device Exemptions. Accessed June 13, 2023. www.ecfr.gov. 6. ECFR. (2019, June 21). E-CFR Title 21 Part 814 Premarket Approval of Medical Devices. Accessed June 13, 2023. www.ecfr.gov. 7. 42 Part 405 Subpart BMedical Services Coverage Decisions That Relate to Health Care Technology Authority. Accessed June 13, 2023. www.ecfr.gov. 8. ECFR. (2019, April 16). 42 CFR 438.210 Coverage and authorization of services. Accessed June 13, 2023. www.ecfr.gov. 9 . Ohio Administrative Code (OAC). Rule 5160-1-61 Non-covered services. June 13, 2023. www. codes.ohio.gov. 10. Premarket Approval of Medical Devices, 21 C.F.R. 814 (2021). Accessed June 13, 2023. www.ecfr.gov. 11. Utilization Control, 42 C.F.R. 456.1-725 (2021). June 13, 2023. www.ecfr.gov .