Nursing Facility Level of Care

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Nursing Facility Level of Care-OH MCD-MM-1218 11/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………..11 F. Related Polic ies/Rules ………………………………………………………………………………………….11 G. Review/Revision History ……………………………………………………………………………………….11 H. References …………………………………………………………………………………………………………12 Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Nursing Facility Level of Care B. Background Nursing facilities (NFs) provide professional skilled and non-skilled services that facilitate member recovery and stability. Nursing facility care should be considered when a member no longer requires acute care services but continues to need healthcare services that can only be managed in the recovery facility environment. When primarily rehabilitation services are needed, health professionals working in acute care hospitals should recognize members' needs for rehabilitation care and facilitate transition to appropriate rehabilitation care settings. C. Definitions Assistance Assistance is defined by the Ohio Administrative Code (OAC) as the hands-on provision of help in the initiation and/or completion of a task. Hands-on help is generally considered to be any aid in which the caregiver makes direct, physical contact with member s to provide assistance with tasks, rather than just supervision or cueing. Intermediate Level of Care (ILOC) A level of care for members whose needs are less than skilled level of car e, but more than the protective level of care, and are stable. These members also do not meet the criteria for the ICF-IID-based level of care. The member has a need for a minimum of one of the following: o Assistance with a minimum of 2 activities of daily living o Assistance with a minimum of 1 ADL and medication administration o A minimum of 1 skilled nursing service or skilled rehabilitation service o 24-hour support in order to prevent harm due to a cognitive impairment as diagnosed by a physician or other licensed health professional acting within their scope of practice. Intermediate Care Facilities for Individuals with Intellectual Disability (ICF/ IID) A place where someone with a disability can choose to live and get the services that help them live their li ves with staff and aides who work at the facility 24 hours a day . Level of Care (LOC) The level of services and supports required by an individual to manage medical conditions and/or activities of daily living (ADL) and instrumental activities of daily living (IADL) needs . The criteria for NF based level of care includes an individual requiring assistance with mobility, bathing, grooming, toileting, dressing, and eating. The two levels of care in Ohio that qualify an individual to receive nursing facility based care are I ntermediate LOC and Skilled LOC Long-Term Services and Supports (LTSS) Encompasses an array of medical and personal care services for people who struggle with self-care due to aging, physical, cognitive, or mental conditions or disabilities. People commonly receive LTSS services for months or even years , which is the reason LTSS are sometimes referred to as long-term care. It includes cost-effective , person-centered home and case managed community-based alternatives to institutional care. LTSS include, but are not limited to: Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3o nursing facility care o adult daycare programs o home health aide services o personal care services o transportation o assistance provided by a family caregiver Nursing Facility (NF) I nstitutions that provide nursing and medical care to member s who no longer require care in an acute setting, but do require licensed nursing services, rehabilitation services, or other health-related services that must be performed by a skilled, licensed professional on a daily basis that cannot be provided in the home. The nursing facility-based level of care includes both the intermediate and skilled levels of care. Ohio Administrative Code (OAC) The rules adopted by the agencies of the state of Ohio. State agencies adopt rules to carry out the policies and intent of laws passed by the General Assembly. The rules are collected and published in the OAC. Clinical Care Reviewer (CCR) A clinical professional who reviews clinical information, applies criteria, and evaluates the care needs of a member who needs inpatient or outpatient services that require a prior authorization. Preadmission Screening/Resident Review (PASRR) A federal requirement to help ensure that individuals are not inappropriately placed in nursing homes for care. PASRR requirements must be completed prior to an individual being admitted to a Medicaid certified nursing facilit y. Evidence of PASRR requirements being met must be provided to CareSource at the time of the request for authorization. Protective Level of Care Care provided primarily to assist a member in meeting the instrumental activities of daily living but not requiring nursing facility based care . Protective care can reasonably and safely be provided by non-licensed caregivers in a community setting. Skilled Level of Care Skilled level of care is when: o The member's LTSS needs exceed the criteria for the protective level of care, the intermediate level of care, or the ICF-MR-based level of care. o The member requires either 1 skilled nursing service no less than 7 days a week or one skilled rehabilitation service no less than 5 days a week, or o The member has an unstable medical condition. Skilled Nursing Services Tasks that must be provided by a registered nurse directly or by a licensed practical nurse at the direction of a registered nurse. Skilled Rehabilitation Services Specific tasks that must be provided directly by a licensed or other appropriately certified technical or professional health care personnel. D. Policy I. CareSource will review all Ohio Medicaid Nursing Facility requests (for admission and continued stays) for skilled and intermediate level of care using OAC 5160-3-08 , Criteria for nursing facility-based level of care for an adult and OAC 5160-1-01, Medical Necessity. Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.4II. Preadmission Screening and Resident Review Requirements CareSource requires evidence that Preadmission Screening and Resident Review requirements have been met prior to the members admission to a NF as part of the prior authorization and level of care review processes in accordance with OAC 5160-3 -14 process and timeframes for a level of care determination for nursing facility-based level of care programs, OAC 5160-3-15.1 Preadmission screening requirements for individuals seeking admission to nursing facilities , and OAC 5160-3-15.2 Resident Review requirements for individuals residing in nursing facilities. III. Skilled Level of Care Criteria CareSource considers skilled care in a nursing facility medically necessary when the following factors have been met : A. Member must have an unstable medical condition as defined in OAC 5160-3-05(B) (40) in that clinical signs and symptoms are present in an individual and a physician has determined that: 1. The individual's signs and symptoms are outside of the normal range for that individual . 2. The individual's signs and symptoms require extensive monitoring and ongoing evaluation of the individual's status and care, and there are supporting diagnostic or ancillary testing reports that justify the need for frequent monitoring or adjustment of the treatment regimen. 3. Changes in the individual's medical condition are uncontrollable or unpredictable and may require immediate interventions . 4. A licensed health professional must provide ongoing assessments and evaluations of the individual that will result in adjustments to the treatment regimen as medically necessary. B. The member requires skilled nursing services or skilled rehabilitation services, ie, services that must be performed by or under the supervision of professional or technical personnel, that are ordered by a physician. C. The daily skilled services can be provided only on an inpatient basis in a NF. D. The services delivered are reasonable and necessary for the treatment of a member s illness or injury, ie, are consistent with the nature and severity of the individuals illness or injury, the individuals particular medical needs, and accepted standards of medical practice . E. The member requires a minimum of one of the following: 1. 1 skilled nursing service daily (or more frequently) 7 days per week 2. 1 skilled rehabilitation service within the day at least 5 days per week F. The request meets the requirements of OAC 5160-1-01 Conditions of Medical Necessity. G. There is a therapeutic plan to provide ALL of the following: 1. Case management and evaluation to meet member needs, achieve treatment goals, and ensure medical safety 2. Observation and assessment of member 's changing condition to evaluate the need for treatment modification or for additional procedures until condition is stabilized Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.53. Member education to teach member self-maintenance or to teach caregiver member care. H. When they are not safe to perform at a lower level of care, examples of direct skilled nursing services or skilled rehabilitation services include, but are not limited to: Daily nursing treatments are needed for one or more of the following: 1. Intravenous (IV) infusion, IV injection, or intramuscular injection 2. Insulin regimen establishment in presence of unstable blood sugar reading 3. Tube feeding for example, gastrostomy tubes, jejunostomy tubes percutaneous endoscopic gastrostomy (PEG) tubes, nasogastric tubes) required because member needs feeding to supply at least 26% of daily calories and at least 501 mL of daily fluids 4. Nasopharyngeal or tracheostomy suctioning and suprapubic catheter irrigation 5. Pain management for infusion of pain medications 6. Wound care that requires dressing changes with prescription medication or clean technique and treatment for: 01. Burns 02. Foot infections or wounds 03. Open lesions 04. Surgical wound complications 05. Treatment with any stage III or IV pressure injury 06. Treatment with 2 or more wounds, including venous ulcers, arterial ulcers, or stage II pressure injuries 07. Widespread skin disorder treatments 7. Heat treatments that require nurse observation to evaluate response 8. Oxygen administration, starting or managing changes , including ventilator 9. Member care training and assistance for 1 or more of the following: 01. Exercise program (eg, range of motion, pulmonary, cardiac) 02. Preventing complications and the start or revision of the member 's maintenance therapy plan 03. Safe performance of ADL (eg, dressing, communicating, eating) 04. Splint, brace, cast, prosthesis, or orthosis management 05. Urinary or bowel toileting program 10. Pain management for infusion of pain medications I. Rehabilitation therapy treatments (PT, OT, or SLP) are needed for 1 or more of the following: 1. Ongoing assessment of rehabilitation needs and potential (eg, range of motion, strength, balance) 2. Supervision of therapeutic exercises or activities to ensure member safety and treatment effectiveness 3. Gait evaluation and training 4. Preventing complications and the start or revision of the member 's maintenance therapy plan 5. Therapy modalities that require PT or OT observation to evaluate response Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.66. Restoration of speech or swallowing with services of speech-language pathologist 7. Prosthetic evaluation and training. III. Intermediate Level of Care Criteria For members needing assistance that cannot safe ly be perform ed at a lower level of care or the resources to provide the needed care and services in a home or community-based setting are not available, the Intermediate Level of Care (ILOC) is a lower cost alternative that effectively addresses and treats the medical problem , as described in OAC 5160-1- 01, Medicaid medical necessity: definitions and principles. Criteria include, but are not limited to : A. The individual's needs for long-term services and supports (LTSS) exceed the criteria for the protective level of care. B. The individuals LTSS needs are less than the criteria for the skilled level of care. C. Individual requires assistance (not necessarily a licensed professional) with the completion of a minimum of two activities of daily living (ADL) as outlined below: 1. Assistance with mobility in at least one of the following three components: a. Bed mobility b. Locomotion c. Transfer 2. Assistance with bathing 3. Assistance with grooming in all of the following three components : a. Oral hygiene b. Hair care c. Nail care 4. Assistance with toileting in at least one of the following four components: a. Using a commode, bedpan, or urinal b. Changing incontinence supplies or feminine hygiene products c. Cleansing self d. Managing an ostomy or catheter 5. Assistance with dressing in at least one of the following two components: a. Putting on and taking off items of clothing or prosthesis b. Fastening and unfastening an item of clothing or prosthesis 6. Assistance with eating D. Assistance with the completion of a minimum of 1 ADL and assistance with medication administration (ADLs listed in III C 1-6), which is required due to 1. Medication administration is required due to members inability to safely self-manage medications. Reasons may include but are not limited to: a. Does not know current medications b. Lacks insight into reasons medications are prescribed c. Lacks ability to take medications as ordered due to cognitive impairment E. Need for 24 hour support in order to prevent harm due to a cognitive impairment. Examples may include: 1. Member resides in a locked dementia unit 2. Negative results of mini mental status exam Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.7F. Direct skilled rehabilitation services less than five days per week G. Wound care that cannot be done in the community (wounds less than stage III). NOTE: Members already enrolled in NF services, in particular those requiring intermediate care, should be individually assessed for medical necessity. CareSource supports lower cost alternatives that effectively address the problem . For example home health or family caregivers, are viable and medically appropriate options. IV. Documentation to Support Nursing Facility-Based Care Determinations A. The CareSource prior authorization form or the ODM Nursing Facility Request Form will be accepted for submission of requests. B. PASRR Documentation. One of the following is required at the time of the initial request for nursing facility services: 1. PASRR Level I screen and preadmission screen (PAS) or resident review (RR) results 2. PASRR Level II evaluation and results, if indicated 3. Hospital Exemption Notice (for stays expected to be less than 30 days). Note: For stays in which the hospital exemption notice was submitted at the time of the initial request and the stay is expected to or exceeds 30 days, the PASRR Level I or II , determined by indications of serious mental illness and/or developmental disabilities or related conditions for the member , and resident review results are required to be submitted to CareSource . C. The members medical record must document all of the following: 1. The history and physical exam pertinent to the members care including the response or changes in behavior to previously administered skilled services 2. The skilled services provided 3. The plan for future care based on the rationale of prior results 4. A detailed rationale that explains the need for the skilled service in light of the member s overall medical condition and experiences 5. The complexity of the service to be performed 6. A decline in physical function compared to the prior level of function (PLOF) 7. Inability to safely ambulate household distance ( 50 feet) 8. The member requires minimum assist to perform mobility-related activities of daily living (MRADLs) 9. The need for active assistance (hands-on vs. supervision) 10. The documentation in the member s medical record must be accurate and avoid vague or subjective descriptions of the members care that would not be sufficient to indicate the need for skilled care 11. Updated clinical evaluation to support on-going concurrent review 12. The services promote the documented therapeutic goals 13. Minimum Data Set (MDS) documentation of cognitive, mood, functional performance, DME use, and/or nutritional status 14. Complete discharge planning assessment and ongoing changes to the plan Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.8NOTE: The treatment goal cannot be modified retrospectively. V. Bed-Hold Days A. In accordance with OAC 5160-3-16.4, CareSource will provide payment to a NF provider to reserve a bed for not more than 30 days in any calendar year when: 1. A member is authorized by CareSource for the nursing facility stay at either the skilled or intermediate level of care . 2. A member is not discharged from the NF. 3. A member , who is a resident of the NF, is temporarily absent from the NF due to a hospitalization, therapeutic leave, or visitation with friends or relatives and has the intent and ability to return to the same NF. B. Bed-hold days do not require prior authorization. VI. Non-covered services in a NF Clinical documentation that does not support the medical necessity requirements outlined in OAC 5160-1-01 that meets, at a minimum, the ILOC criteria for the following services: A. Repetitious exercises to improve gait, or to maintain strength and endurance and assistive walking can be appropriately provided by supportive personnel . B. When the performance of a maintenance program does not require the skills of a therapist because it could safely and effectively be accomplished by the member or with the assistance of non-therapists, including unskilled caregivers . C. General exercises to promote overall fitness and flexibility and activities to provide diversion or general motivation or the supervision of taught exercises. D. Lack of a competent person to provide a nonskilled service regardless of the importance of the service to the member , does not make it a skilled service when a nurse provides the service. E. Protective LOC services . F. Services not expected to produce the desired outcome. VII. Transitioning from a Nursing Facility A. Evaluation 1. As part of the discharge planning process and in conjunction with the nursing facility staff, CareSource Case Management ( CM) may evaluate a member receiving nursing facility care and services for potential for referral to home and community based services and/or other state and local resources to assist members in receiving needed services in the least restrictive environment. 2. In compliance with OAC 5160-1-01, members will be reassessed. When the member no longer meets the medical necessity criteria for skilled or intermediate nursing facility care, CareSource will evaluate for discharge to the community (ie, home with needed services and supports). 3. In compliance with OAC 5160-1-01, if the member no longer meets the skilled level of care, or intermediate level of care, CareSource will evaluate for Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.9discharge to an appropriate community setting that will meet the members care needs. 4. After an initial evaluation period, the UM clinical care reviewer must evaluate the member s progress. This initial evaluation may be followed by case management . These reports will include clinical review from the members care team including documentation from facility discharge planning staff. 5. CareSource may perform a re-evaluation of members to identify any changes that require modification of the treatment plan and incorporate these into discharge planning. B. Discharge Planning 1. CareSource expects discharge planning for all members admitted to a nursing facility to begin immediately upon admission. Discharge planning should not be delayed until the member is stable for discharge as this frequently leads to unnecessary delays in a discharge and unnecessary lengthening of the members facility stay. Discharge planning includes: a. Treatment plan development involving providers engaged in members care b. Evaluation of members premorbid functioning compared to current state c. Member and caregiver preferences and abilities d. Evaluation for services at next level of care as appropriate for member's continued needs e. Housing f. Evaluation of psychosocial status and needs g. Coordination of follow up appointments , planned or scheduled h. Transportation i. Coordination of prescription medications and treatments to be available to member upon discharge j. Home care services, if applicable k. Referrals made for assistance and support including to state and local programs and/or community based organizations l. Medical equipment and supplies coordinated m. Transition plan communicated to all members of member's care team 2. CareSource Utilization Management (UM) and Case Management (CM) will work , either In-person or via telephonic outreach , with the Nursing Facility to ensure a safe and timely discharge for our members. This collaboration should start within 3 days of the members admission to the NF. 3. The NF must develop and share with CareSource UM during each review a post-discharge plan of care to address the anticipated needs of a member for discharge to a private residence, to another NF, or to another type of residential facility such as a group home, medical respite facility, sober living home, or an intermediate care facility for individuals with intellectual disabilities. 4. Upon request, the discharge plan must be shared with CareSource CM. C. Discharge Criteria Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.10Once skilled nursing services (ie, wound care, IV o r IV antibiotics treatment) and/or r ehabilitation have been completed for safe transfer to lower level of care OR the member is no longer demonstrating significant functional gains and does not meet criteria for intermediate or skilled level of care, the following criteria must be completed prior to discharge: a. Medication regimen established and reconciliation completed b. Medical status stable for member's condition and manageable at lower level of care c. Any inserted or implanted device discontinued, or functioning normally and manageable at lower level of care d. Medical equipment and supplies are available at next level of care and safe use has been demonstrated e. Wound(s) or dressing changes are manageable at a lower level of care f. Skilled services (as needed) and logistical requirements can be met at a lower level of care g. Transition plans and education are understood by the member and/or the caregiver D. MCO Initiated Nursing Facility Disenrollment Process 1. Requests for member disenrollment from managed care to fee for service Medicaid due to a need for extended nursing facility care must be submitted to the Ohio Department of Medicaid by CareSource. Approval of disenrollment requests are made at the discretion of ODM. 2. To be eligible for a request for disenrollment from managed care to be submitted to ODM, the member must meet all of the following: a. Be enrolled in a Medicaid category identified by the Ohio Department of Medicaid as eligible for disenrollment. b. Be authorized by CareSource for and have a continuous stay in the nursing facility for no less than the month of admission and two complete consecutive months thereafter. c. The members discharge plan documents that nursing facility discharge is not expected in the foreseeable future and the member has a need for long-term nursing facility care. d. The member has not used hospice services during the period outlined in (D)(2)(b). 3. When the member is identified as eligible for potential disenrollment, the following occurs: a. The clinical care reviewer (CCR) reviews the continued stay request from the nursing facility and determines if the criteria for the disenrollment request is met . b. CCR will add specific criteria to Disenrollment Log . c. CCR will complete review and approve the request 60 days. d. CCR will provide update to the NF with authorization status and notification to ODM for potential member disenrollment back to FFS . Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.11e. CCR will track requests for disenrollment submitted to ODM and ensure follow up to validate status of the request if 60 day s lapse without a decision. g. The prior authorization specialist (PAS) receives ODM disenrollment outcomes and updates cases accordingly, updates NF/provider, and emails CCR team . NOTE: Modified Adjusted Gross Income (MAGI) Medicaid members in the Adult Extension (MAGI Group 8) category may not be disenrolled. 4. Requests for disenrollment will be submitted in the format specified y ODM. The disenrollment table lists the earliest disenrollment date if all criteria is met. See disenrollment table below: Month of Nursing Facility Admission Next Two Consecutive Months Earliest Disenrollment Date January February & March March 31 February March & April April 30 March April & May May 31 April May & June June 30 May June & July July 31 June July & August August 31 July August & September September 30 August September & October October 31 September October & November November 30 October November & December December 31 November Dec . & Jan . (next CY) January 31 (next CY) December January & February (next CY) Last Day of February (next CY) NOTE: If a member is admitted to a NF while enrolled with the MCP and the MCP disenrollment request is submitted after the Earliest Disenrollment Date, the member will be disenrolled as of the last calendar day of the submission month.E. Conditions of CoverageNA F. Related Polic ies/Rules NA G. Review/Revision History DATE ACTIONDate Issued 09/01/2021 New PolicyDate Revised 05/11/2022 Updated references; no changes Nursing Facility Level of Care-OH MCD-MM-1218 Effective Date: 11/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.1208/09/2022 05/10/2023 07/16/2024 E-voted adding new section V. on Bed-Hold days Changed Member Care Coordinator (PCC) to Clinical Care Reviewer (CCR). Added Preadmission Screening and Resident Review re quirements to align with Provider Agreement. Added sections IV. A and Bto align with Provider A greement and reporting requirements. Updated references. Approved at Committee. Updated section IV.B.3 documentation for the Hospital Exemption Notice. Added to section V. Bed-hold Days criteria. Checked with Legal on current contract. Updated references. Approved at Committee. Date Effective 11/01/2024 Date Archived H. References1. ASPE. An Overview of Long-Term Services and Supports and Medicaid: Final report. May 8, 2018 . Accessed June 21, 2024. www.hhs.gov 2. CareSource Desk Reference. Nursing Facility Disenrollment Process. July 1, 2019. Accessed June 21, 2024 . www.CareSource.co m. 3. CareSource Procedure. Utilization Management-Level of Care. 2023. Accessed April 10, 2024. www.CareSource.com 4. CG-GRFAC (RFC) General Recovery Facility Comparison Tool. MCG Guidelines . 28 th ed. 2024. Accessed April 10, 2024. www.careweb.careguidelines.com 5. CMS. Medicare Benefit Policy Manual . Chapter 8. Coverage of Extended Care (SNF) Services Under Hospital Insurance. October 4, 2019. Accessed June 21, 2024. www.cms.gov 6. CMS. Long Term Services & Supports. 2016. June 21, 2024. www.cms.gov 7. Criteria for Nursing Facility-Based Level of Care, O HIO ADMIN . CODE 5160-3-08 (2012). Accessed June 21, 2024. www.medicaid.ohio.gov 8. Level of Care Definitions , O HIO ADMIN . CODE 5160-3- 05 (2012) . Accessed June 21, 2024. www.medicaid.ohio.gov 9. Managed Care: Termination of Enrollment, OHIO ADMIN . CODE 5160-26-02.1 (2023). 10. Medicaid Medical Necessity: Definitions and Principles, O HIO ADMIN . CODE 5160-1- 01 (2022). Accessed June 21, 2024. www.medicaid.ohio.gov 11. Nursing Facilities (NFs): Covered Days and Bed-Hold Days , O HIO ADMIN . CODE 5160-3- 16.4 (2017) . Accessed June 21, 2024. www.medicaid.ohio.gov 12. Nursing Home and Residential Care Facility Definitions , O HIO REV . CODE 3721.01 (2023). Accessed June 21, 2024 . www. codes.ohio.gov 13. ODM. Nursing Facility Request Form. Accessed June 21, 2024. www.medicaid.ohio.gov 14. Skilled Nursing, O HIO REV . CODE 3721.011 (2023). Accessed June 21, 2024. www. codes.ohio.gov ODM approved 07/25/2024.

Metabolic and Bariatric Surgery Revision

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 11/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Metabolic and Bariatric Surgery: Revision B. Background Revision procedures are typically done because of complications from or a failure of the initial surgical procedure. Complications may include surgical or anatomical complications, as well as nutritional or metabolic complications. A failure of the initial bariatric surgery may result in an inadequate weight loss or a weight regain. C. Definitions Revisional bariatric surgery (RBS) surgery to address those patients whose original operation was unsuccessful in achieving satisfactory weight loss goals, or in whom complications from the original operation have occurred . Inadequate weight loss Less than 50% expected weight loss and/or weight remains greater than 40% over ideal body weight (normal body weight BMI parameter = 18.5-24.9). D. Policy I. CareSource considers surgical revision of a bariatric surgery procedure a covered service when medically necessary. II. An inadequate weight loss due only to non-compliance with dietary , behavior, or exercise recommendations is not a medically necessary indication for a revision procedure . III. A revision procedure is medically necessary when all of the following criteria are met and documented in the medical record: A. Surgery/procedure selected is a proven procedure and not considered experimental/investigational ; and B. A technical failure or major complication has occurred from the initial procedure that cannot be managed medically . 1. Technical failure and major complication examples : a. Persistent pain and recurrent bleeding occur ; b. Chronic stenosis remains after multiple dilations; c. Faulty component or malfunction that cannot be repaired; d. Candy cane Roux syndrome; e. Complications that cannot be corrected with band manipulati on; adjustments or replacement including band slippage and port leakage; or f. Obstruction confirmed by imaging studies ; NOTE: Stretching of a stomach pouch formed by a previous bariatric surgery due to overeating, is not considered a complication and therefore would not be considered a medically necessary procedure . Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 11/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3IV. In the absence of a technical failure or major complication, individuals with weight loss failure two years following the initial bariatric surgery procedure must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. V. CareSource does not consider endoscopic bariatric and metabolic therapies such as Intragastric balloon (IGB) , Endoscopic sleeve gastroplasty (ESG), or Aspiration therapy (AT) to be weight loss surgery. Individuals with weight loss failure from prior endos copic therapies must meet medical necessity requirements in the medical policy that applies to an initial bariatric surgery. E. Conditions of Coverage N/A F. Related Polic ies/Rules MCG Guidelines. 28 th ed. Gastric Restrictive Procedure with Gastric Bypass (S-512) Medical Necessity Determinations Experimental and Investigational Item or Service G. Review/Revision History DATE ACTIONDate Issued 07/22/2020 New policy Separated out from adolescent and adult policies Date Revised 06/23/2021 06/22/2022 06/21/2023 06/19/2024PA language replaced by medical necessity criteria. PA enforced by inclusion on the PA list. Updated references. Re-wording of section IV re: medical necessity for revision bariatric surgery. Sec. V. Added IGB, ESG and AT non-coverage. Updated references. Annual review; no changes, Updated references, Approved at committee. Added definition of Revisional bariatric surgery (RBS). Updated references. Approved at Committee.Date Effective 11/01/2024 Date Archived H. References1. Ellsmere, J. (2020, May). Late complications of bariatric surgical operations. Accessed May 13, 2024. www.uptodate.com. 2. Federal Drug Administration. (2020, April 27). Weight-Loss and Weight-Management Devices . Accessed May 13, 2024. www.fda.gov. 3. Mechanisk, J, Apovian C, et al. (April 2020). AACE/TOS/ASMBS/OMA/ASA 2019 Guidelines. Clinical practice Guidelines for the Perioperative Nutrition, metabolic, and Metabolic and Bariatric Surgery-Revision-OH MCD-MM-1061 Effective Date: 11/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.4nonsurgical support of patients undergoing bariatric procedures 2020 Update: Cosponsored by American Association of Clinical Endocrinologist/American college of Endocrinology, The obesity society, American Society for metabolic & Bariatric surgery, Obesi ty medicine Association, and American Society of Anesthesiologists. Obesity . 28(4). Accessed May 13, 2024. www.onlinelibrary.wiley.com. 4. Palep, J. (2019, May 31). Reoperative Bariatric Surgery in Khanna S, Recent Advances in Minimal Access Surgery . (pp 14-151). JP Medical Ltd. 5. Yung-Chieh, Y, Huang, C, Tai, C. (2014, September). Current Opinion in Psychiatry . 27(5). doi: 10.1097/YCO.0000000000000085. Inde pendent med ica l r e view 7/2020 Approved by ODM 07/25/2024

Genetic Testing and Counseling

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Genetic Testing and Counseling-OH MCD-MM-0003 11/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence o f Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the cont rolling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less fav orable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Polices/Rules ………………………….. ………………………….. ………………………….. ……… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 11/01/2 024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectGenetic Testing and Counseling B. BackgroundAdvancements in technology have contributed to the rapid expansion of identified genetic variations . Some of these variations have been identified as disease-causing, while others are considered common variants with no clinical impact . With the ev er- expanding number of genetic tests available , it can be clinically difficult to determine the most appropriate tests for a particular patient. When clinically appropriate, genetic testing may provide diagnostic and/or actionable therapeutic results which can impact a patients outcome. Due to the complexity of genetic tests and th eir results , consultation with m edical genetics professionals and counselors may be required to assist members. According to the National Society of Genetic Counselors of the United States, genetic counseling is meant to integrate the following goals: 1) interpretation of family and medical histories to assess the chance of disease occurrence or recurrence; 2) educat ion about the natural history of the condition, inheritance pattern, testing,management, prevention, support resources, and research; 3) counseling to promote informed choices in view of risk assessment, family goals, ethical and religious values; and 4) support to encourage the best possible adjustment to the disorder in an affected family member and/or to the risk of recurrence of that disorder. Genetic counselors are healthcare professionals trained to provide this care ; however , access issues may requi re other healthcare professionals to assume this role. Genetic counseling , whether provided by a certified genetic counselor or other qualified healthcare professional, is an integral component of genetic testing that is informative and supportive to membe rs, both before and after they undergo testing. C. Definitions Genetic Screening Th e process of testing a population for a genetic disease to identify a subgroup of people who either have the disease or the potential to pass it to offspring. Genetic Testi ng A medical test that identifies changes in genes, chromosomes, or proteins to confirm or rule out a suspected genetic condition , either hereditary or acquired. Human Leukocyte Antigen (HLA) Typing A test used to match patients and donors for bone marrow or cord blood transplants. Inherited Genetic Variant A type of DNA sequence change passed from parent to offspring (ie, germline). Precision Medicine A field of medicine that selects pharmacotherapies based on the patients genetics. Soma tic Gene Variant A type of DNA sequence change that is not inherited from a parent but acquired during a persons life. Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 11/01/2 024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 D. PolicyI. Prior authorization may be required for genetic testing . This includes both somatic and germline genetic testing. II. CareSource will review for medical neces sity using published MCG criteria whenavailable and the Medical Necessity Determinations administrative policy . This policy does not apply to requests that have MCG or InterQual guidelines with clear genetic counseling requirements/recommendations. III. Proprietary panel testing requires evidence-based documentation per the MedicalNecessity Determinations administrati ve policy. Individual genetic tests may be requested separately based on the Medical Necessity Determinations administrati ve policy for panels not meeting medical necessity requirements. IV. Genetic counseling is required for all germline genetic testing , as indicated by ALLthe following: A. Counseling is provided by a healthcare professional with education and training in genetic issues relevant to the genetic tests under consideration . B. Counsel ing is provided to enable members informed decision making concerning proposed testing (eg, purpose of testing, management that may be informed by result, heritable nature informed by 3-generation family history, range of possible results, potential benef its and risks of testing (eg, psychological, social, economic). V. Somatic genetic testing (eg, cancer testing) does not require genetic counseling described above. VI. Human leukocyte antigen (H LA ) typing is not part of the genetic testing policy and do es not require pre-authorization. VII. W hile most inherited genetic testing is only necessary on ce in a lifetime, CareSource recognizes that a germline genetic test could be appropriately repeated in extraordinary circumstances due to changes in technology. This situation will be considered with the proper medical necessity documentation. E. Conditions of CoverageNAF. Related Polices/RulesMedical Necessity Determinations Cystic Fibrosis Testing Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 11/01/2 024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 02/24/2015 New PolicyDate Revised 06/05/2019 09/03/2020 07/07/2021 05/25/2022 05/10 /202304/10/202407/03/2024 Revised title, removed MCG table, condensed background Reviewed, updated referencesAnnual review: updated definitions, background, and references, re-organized criteria Annual review: updated background, definitions, and references , rephrased genetic counseling process. Approved at Committee. Review: updated references, approved at Committee Review: clarified genetic counseling requirements, added language regarding MCG. Approved at Committee Date Effective 11/01/2024 Date Archived H. References1. Ambulatory care : genetic medicine. MCG Health . 28 th ed. Accessed June 19 , 2024 . www.careweb.careguidelines.com 2. Cohen SA, Bradbury A, Henderson V, et al. Genetic counseling and testing in a community setting: quality, access, and efficiency. Am Soc Clin Oncol Educ Book . 2019;e34-e44. doi:10.1200/EDBK_238937 3. Crooke A, Jacobs C, Newton-John T, et al. Genetic counseling and testing practices for late-onset neurodegenerative disease: a systematic review. JNeurol. 2022;269(2):676-692. doi:10.1007/s00415-021-10461-5 4. Kohlmann W, Slavotinek A. Genetic testing. UpToD ate. Updated April 22, 2024 . Accessed June 19 , 2024 . www.uptodate.com 5. Mundy J, Davies HL, Radu M, et al. Research priorities in psychiatric genetic counselling: how to talk to children and adolescents about genetics and psychiatric disorders. Eur JHum Gen et. 2023;31(3):262-264. doi:10.1038/s41431-022-01253-0 6. National Center for Biotechnology Information (NCBI). Genetic Testing Registry (GTR) National Library of Medicine. Accessed June 19 , 2024 . www.ncbi.nlm.nih.gov 7. National Human Genome Research Institute. Coverage and Reimbursement of Genetic Tests. National Institutes of Health. Updated February 6, 2024 . Accessed June 19 , 2024 . www.genome.gov 8. National Human Genome Research Institute. Regulation of Genetic Tests. National Institutes of Health. Updated February 19, 2024 . Accessed June 19 , 2024 . www.genome.gov 9. Raby BA, Kohlmann W. Genetic counseling: family history interpretation and risk assessment. UpToDate. Updated April 9 , 2024. Accessed June 19 , 2024 . www.uptodate.com 10. Sarata AK. Genetic Testing: Background and Policy Issues . Congressional Research Service Re port ; 2015 . RL33832. Accessed June 19 , 2024 . www.sgp.fas.org Genetic Testing and Counseling-OH MCD-MM-0003Effective Dat e: 11/01/2 024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 11. Senter L, Austin JC, Carey M, et al. Advancing the genetic counseling profession through research: identification of priorities by the National Society of GeneticCounselors research task force. JGenet Couns. 2020;29(6):884-887. doi:10.1002/jgc4.1330 12. White S, Jacobs C, Phillips J. Mainstreaming genetics and genomics: a systematic review of the barriers and facilitators for nurses and physicians in secondary and tertiary care. Genet Med. 20 20;22(7):1149-1155. doi:10.1038/s41436-020-0785-6 Approved by ODM 07/25 /2024

Gender Affirming Surgery

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Gender Affirming Surgery-OH MCD-MM-0034 11/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ……………………….. 2 B. Background ………………………….. ………………………….. ………………………….. …………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. …………………… 3 D. Policy ………………………….. ………………………….. ………………………….. …………………………. 3 E. Conditions Of Coverage ………………………….. ………………………….. ………………………….. … 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. .. 6 H. References ………………………….. ………………………….. ………………………….. …………………. 7 Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectGender Affirming Surgery B. BackgroundIn the rapidly evolving field of transgender healthcare, an overarching goal of gender – affirming care is to partner with transgender and gender diverse (TGD) individuals to holistically address social, mental, and medical health needs and well-being while affirming gender identity. Care should support TGD people across the lifespan, from first signs of gender incongruence in childhood through adulthood and into older age. Guidelines, such as the World Professional Association for Transgender Health (WPATH) Standards of Care (SOC-8), encourage the use of a patient-centered care model for initiation of gender affirming interventions. Communication and coordination of care should occur between providers to optimize outcomes and the timing of gender – affirming in terventions centered on the patients needs and desires and to minimize harm. Globally, TGD people have differing needs for gender-affirming care related to individualgoals and characteristics, available health care resources, and sociocultural and political contexts. Prevalent guidelines call for healthcare professionals who can p rovide clinical guidance to assist access to safe and effective pathways that achieve lasting personal comfort with a gendered self. This care aims to optimize overall physical health, psychological well-being, and self-fulfillment and assistance may inclu de, but is not limited to, hormonal and surgical treatments, voice and communication therapy, primary care, hair removal, reproductive and sexual health, and behavioral health (BH) care. TGD people commonly experience transphobia, stigmatization, and refusal of care when seeking services, which contributes to significant health disparities. Minority stress is associated with mental health disparities exemplified by increased rates of depre ssion,suicidality, and non-suicidal self-injuries than rates in cisgender populations. WhileGender Dysphoria (GD) is still considered a mental health condition in the Diagnostic – and Statistical Manual of Mental Disorders (DSM-5-TR) of the American Psych iatric Association, gender incongruence is no longer seen as pathological or a mental disorder in the world health community. Gender Incongruence is recognized as a condition in the International Classification of Diseases and Related Health Problems, 11th Version of the World Health Organization (ICD-11). Gender Incongruence focuses on the persons experienced identity, any need for gender-affirming treatment, and supports a care model emphasizing patients active participation in decision-making about hea lth care supported a rights-based approach. Nomenclature is subject to change and new terminology and classifications may be adopted by various health organizations or administrative bodies as the field progresses, but the medical necessity of treatment an d care is recognized for people experiencing dissonance between sex assigned at birth and gender identity. Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 C. Definitions Behavioral Health Provide r Provider of BH services (minimum masters level) , including a psychologist, psychiatrist, or psychiatric nurse practitioner. Cisgender Denoting or relating to a person whose gender identity corresponds with the sex registered for the individual at birth . Diagnostic and Statistical Manual of Mental Disorders , 5th Ed ., Text Revised (DSM-5-TR ) Standard language by which clinicians, researchers, and public health officials in the US communicate about mental disorders and subsequent criteria and classification. Female-to-Male ( FtM or Transmasculine ) An individual born or assigned female at birth (natal female) changing (-ed) to a more masculine body or gender role. Gender Affirmation The process of recognizing or affirming TGD people in gender identity, whether socially, medically, legally, behaviorally, or some combination. Gender Dysphori a Affective and/or cognitive discontent accompany ing incongruence between experienced or expressed gender and assigned gender, lasting at least 6 months and meeting diagnostic criteria listed in the DSM-5-TR . Gender Identit y A persons inner sense or identification as male, female, a combination of both, or neither, which may be different from sex assigned at birth. Male-to-Female ( MtF or Transfeminine ) An individual born or assigned male at birth (natal male) changing (-ed) to a more feminine body or gender role. Minority Stress Unique, socially based, and chronic stress that may increase the likelihood of TGD individuals vulnerability to developing BH concerns (eg, anxiety, depression, substance use). Non-Binary/Gender Quee r An individual identif ying as neither exclusively male nor female but different from the gender assigned at birth, including changing to a more masculinized or feminized gender role. Se x Based on the appearance of external genitalia and defined as male or female as understood in the context of reproductive capacity (eg , sex hormones, chromosomes, gonads , non-ambiguous external and internal genitalia ). At times, sex is assigned when external genitalia are ambiguous. Transgender and Gender Diverse (TGD) A comprehensive term describing members of varied, global communities with gender identities or expressions differing from the gender socially attributed to the sex assigned at birth, including those with culturally specific and/or language-specific exp eriences, identities or expressions, which may or may not be based on or encompassed by Western conceptualizations of gender or the language used to describe it. D. PolicyCareSource compl ies with state and federal regulations and treats all members consistent with gender identity CareSource covers medically necessary services by utiliz ing neutral standards supported by evidence-based criteria and reviews literature and policies annually and as needed when new literature becomes available, particularly regarding long-term outcomes, safety data, and US Institutional Review Board oversight. All requests are reviewed on a case-by-case basis. Members under the age of 21 years Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 will be reviewed for medical necessity as required by the Early Periodic Screening, Diagnosis and Treatment (EPSDT) program. Federal and state regulations are followed regarding sterilization. I. CareSource considers gender affirming surgeries medically necessary for transitioning and nonbinary members ages 18 and older when ALL the following clinical criteria are met: A. General Requirements Both gender affirming chest surgery and genital surgery require all the following criteria to be met: 1. Marked and sustained gender incongruence is assessed and documented by a clinician experienced in the care of and with competency (eg, formal training, significant clinical experience, capable in evaluation and diagnosis of gender incongruence) in assessme nt for transgender and gender-diverse people (eg, physician, primary care provider, endocrinologist, psychiatrist, other licensed mental health professional). Content of documentation must include the following: a. an individualized treatment plan that addresses treatment, including hormone therapy, surgical interventions, and behavioral health care during the transition period b. behavioral health issues, if present, are well controlled (ie, no active intravenous drug use for the past 3 months , no suicide attempts or behaviors present for the past 6 mo nths ) c. the degree to which the member has followed the standards of care to date and the likelihood of future compliance d. 12-month or longer real-life experience congruent with chosen gender identity, unless the timeline was modified with corroborating documentation indicating a safety concern e. duration of evaluators relationship with the member 2. Gender incongruence is not due to reversible cause (eg, psychosis) . 3. Member grants informed consent and is able to understand risks of adverse events, complications, procedure options, benefits, irreversibility, and reproductive impact . 4. Member has no physical or BH illness that will interfere with adherence to short-term and long-term postoperative treatment. 5. Stability on gender-affirming hormone treatment (GAHT) for at least 6 months unless contraindicat ion has been documented. Me dication must be prescribed to the member and managed by an endocrinologist or experienced prescriber working in a center or clinic specializing in the treatment of gender affirming care. Evidence of lab monitoring of hormone levels must be provided. 6. Social transition (eg, name change, pronoun change, communication of affirmed gender identity to others) is in place or judged by clinician to be unnecessary (eg, nonbinary gender identity). 7. Surgical requirements for chest or genital surgery include submission of the following documentation: Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 a. results of medical and psychological assessments, including diagnosis( -es) and identifying characteristics b. surgery plan c. notation of discussion of risks, benefits, and alternatives to treatment, including no hormonal or surgical treatment and member understanding that surgery may not resolve gender dysphoria d. medical stability for surgery and anesthesia e. expected outcome B. Gender Affirming Chest Surgery 1. Any chest surgery requests require meeting I.A. above. 2. Mastectomy for female to male transition does not require a hormone trial. C. Gender Affirming Genital Surgery Genital surgery requests require meeting criteria in I.A. above. 1. If a physician (eg, PCP, endocrinologist, surgeon) completes documentation requirements outlined in I.A.1., a BH professional (eg, psychiatrist, licensed mental health professional) must submit documentation meeting those requirements as well. 2. Hair removal may be approved based on medical necessity when the skin flap area contains hair needing to be removed. Hair removal must be included on the request for review of medical necessity. II. Procedures or surgeries to enhance secondary sex characteristics are considered cosmetic and are not medically necessary. A list of services, procedures or surgeries not covered is included below . T his list may not be all inclusive. A. reversal of genital surgery or surgery to revise secondary sex characteristics B. abdominoplasty C. blepharoplasty D. brow lift E. body contouring F. botulinum toxin treatments (i.e., Botox, Dysport, Xeomin, Jeuveau) G. calf , cheek, chin, malar, pectoral and/or nose implants H. collagen injections I. drugs for hair loss or hair growth J. face lifts, facial bone reduction , or facial feminization K. perineal skin hair removal L. hair removal for vaginoplasty without creation of neovagina or when genital surgery is not yet required or not approved M. hair replacement N. lip enhancement or reduction O. liposuction P. mastopexy Q. neck tightening R. plastic surgery on eyes S. reduction thyroid chondroplasty T. rhinoplasty Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 U. skin resurfacingV. voice modification surgery (laryngoplasty or shortening of the vocal cords) , voice therapy or voice lessons W. any other surgeries or procedures deemed not medically necessary X. reproduction services , including , but not limited to , sperm preservation, oocyte preservation, cryopreservation of embryos, surrogate parenting, donor eggs and donor sperm , and host uterus III. CareSource treats all members consistent with gender identity and does not deny or limit health services that ordinarily or exclusively are available to individuals of one sex to a transgender individual because the individuals sex or gender is different from the one to which health services are normally or exclusively available. Examples of such services include: A. breast cancer screening for transgender men and nonbinary people who were assigned female at birth B. prostate cancer screening for transgender women and nonbinary people who were assigned male at birth E. Conditions Of CoverageNA F. Related Policies/RulesMedical Necessity Determinations G. Review/Revision HistoryDates Action Date Issued 05/18/2017 Date Revised 05/29/2019 09/02/202007/07/202105/19/202206/21 /202307/17/2024Updated evidence, changed policy # (MM-0080), removed pharmacy info , added addtl requirements for surgery, specifics on hair removal, items not covered & types of surgery for medical necessary review . Updated definitions, removed research & codes , added references, changed letter recommendation requirement, changed title. Removed endocrinologist rule, added psychiatric NP, added safety considerations . Annual review. Updated /added definitions. Added PCP to hormone therapy requirement. Removed conception counseling for bottom surgery. Removed breast augmentation from the exclusion list. Annual review. Updated background, definitions, and reference list. Approved at Committee. Annual review. Top changed to chest, bottom to genital. Rewrote background. Added cisgender, TGD, minority stress (WPATH). Combined letter info into 1 section. Updated references. Approved at Committee. Date Effective 11/0 1/202 4 Date Archived Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 H. References1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revised (DSM-5-TR). Arlington, VA; 2022. 2. American Psychological Association. Guidelines for psychological practice with transgender and gender nonconforming people. Amer Psych . 2015;70(9):832-864. doi.org/10.1037/a0039906 3. Evidence analysis research brief: body contouring procedures in patients with gender dysphoria. Hayes, Inc; 2022. Accessed July 8, 2024. www.evidence.hayesinc.com 4. Evidence analysis research brief: hair removal in patients with gender dysphoria. Hayes, Inc; 2022. Accessed July 8, 2024. www.evidence.hayesinc.com 5. Evidence analysis research brief: vocal cord surgery for voice feminization in patients with gender dysphoria. Hayes, Inc; 2022. Accessed July 8, 2024. www.evidence.hayesinc.com 6. Evolving evidence review : combination facial feminization surgery in patients with gender dysphoria. Hayes, Inc; 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 7. Evolving evidence review : feminizing voice and communication therapy for gender dysphoria. Hayes, Inc; 2022. Reviewed August 18, 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 8. Evolving evidence review : gender-affirming body-contouring procedures in patients with gender dysphoria. Hayes, Inc; 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 9. Evolving evidence review : gender-affirming hair removal for patients with gender dysphoria. Hayes, Inc; 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 10. Evolving evidence review : hair removal procedures before gender affirming surgery in patients with gender dysphoria. Hayes, Inc; 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 11. Evolving evidence review : masculinizing voice and communication therapy for gender dysphoria. Hayes, Inc; 2022. Reviewed September 27, 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 12. Evolving evidence review : Wendler glottoplasty surgery for voice feminization in patients with gender dysphoria. Hayes, Inc; 2023. Accessed July 8, 2024. www.evidence.hayesinc.com 13. Feldman J, Deutsch MB. Primary care of transgender individuals. UpToDate. Updated June 30, 2023. Accessed July 8, 2024. www.uptodate.com 14. Ferrando C. Adverse events associated with gender affirming vaginoplasty surgery. Am JObstet Gynecol . 2020;223(2):267. doi:10.1016/j.ajog.2020.05.033 15. Ferrando C. Gender-affirming surgery: male to female. UpToDate. Updated April 3, 2024. Accessed July 8, 2024. www.uptodate.com 16. Ferrando C, Zhao LC, Nikolavsky D. Gender-affirming surgery: female to male. UpToDate. Updated January 2, 2024. Accessed July 8, 2024. www.uptodate.com 17. Gender Affirming Surgery or Procedure GRG: GG-FMMF. MCG. 28th edit. Updated March 14, 2024. Accessed July 8, 2024. www.careweb.careguidelines.com Gender Affirming Surgery-OH MCD-MM-0034Effective Dat e: 11/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 18. Health technology assessment: sex reassignment surgery for the treatment of gender dysphoria. Hayes, Inc; 2018. Reviewed July 27, 2022. Accessed July 8, 2024. www.evidence.hayesinc.com19. Hembree W, Cohen-Kettenis P, Gooren L, et al. Endocrine treatment of gender – dysphoric/gender-incongruent persons: an endocrine society clinical practice guideline. Journ of Clin End & Metab . 2017;102(11):3869-3903. doi.org/10.1210/jc.2017-01658 20. Li V, Demzik A, Snyder L, et al. Genital gender affirming surgery. Am Surg . 2022;88(12):2817-2822. doi:10.1177/00031348221109479 21. McTernan M, Yokoo K, Tong W. A comparison of gender-affirming chest surgery in nonbinary versus transmasculine patients. Ann Plast Surg . 2020;84:S323-S328. doi:10.1097/SAP.0000000000002254 22. Park R, Liu Y, Samuel A, et al. Long-term outcomes after gender-affirming surgery: 40-year follow-up study. Ann Plast Surg . 2022;89(4):431-436. doi:10.1097/SAP.0000000000003233. 23. Shin SJ, Kumar A, Safer JD. Gender-affirming surgery: perioperative medical care. Endocr Pract . 2022;28(4):420-424. doi:10.1016/j.eprac.2022.02.007 24. Society guideline links: transgender health. UpToDate. Accessed July 8, 2024. www.uptodate.com 25. Tangpricha V, Safer JD. Transgender women: evaluation and management. UpToDate. Updated October 12, 2023. Accessed July 8, 2024. www.uptodate.com 26. Tangpricha V, Safer JD. Transgender men: evaluation and management. UpToDate. Updated June 30, 2023. Accessed July 8, 2024. www.uptodate.com 27. Tollinche L, Rosa W, van Rooyen CD. Perioperative considerations for person – centered gender-affirming surgery. Adv Anesth . 2021;39:77-96. doi:10.1016/j.aan.2021.07.005 28. van der Sluis WB, Schfer T, Nijhuis THJ, et al. Genital gender-affirming surgery for transgender women. Clin Obstet Gynaecol . 2023;86:102297. doi:10.1016/j.bpobgyn.2022.102297 29. World Professional Association for Transgender Health (WPATH). Standards of care for the health of transsexual, transgender and gender nonconforming people, 8th edit. Accessed July 8, 2024. www.wpath.org 30. Zhang W, Garrett G, Arron S, et. al. Laser hair removal for genital gender affirming surgery. Trans Andro and Urol. 2017;5(3):381-387. doi:10.21037/tau.2016.03.27 Approved by Ohio Department of Medicaid 07/25/202 4

Penile Implants in the Treatment of Erectile Dysfunction

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 09/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the cont rolling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less fav orable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Polic ies/R ules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Penile Implants in the Treatment of Erectile Dysfunction B. Background Erectile dysfunction (ED) is the consistent or recurrent inability to acquire or sustain an erection, and the most common sexual problem affecting males. Surveys suggest 5-10% of men between the age s of 20 to 30 are a ffected, and that number increas es to 35-40 % of men aged 70 or older . The National Institutes of Health (NIH) estimates that up to 30 million men experience erectile dysfunction. Various treatment modalities exist for ED. One treatment option is a surgical penile implant (also called a penile prosthesis) . A penile implant is indicated when there is a clear medic al cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments. A basic penile prosthesis consists of a pair of bendable, silicone rods that are surgically implanted within the erection chambers of the penis. Identification of the underlying etiology is an important first step. This includes ruling out the adverse effects of medication(s), identifying, and treating risk factors. C. Definitions Erectile Dysfunction The consistent or recurrent inability to acquire or sustain an erection. Neurogenic Impotence Nervous system issues affecting the ability to maintain or have an erection . Vascular Impotence Restricted or d ecreased blood flow to the penis causing impotence . D. Policy I. Medication is the f irst line of treatment for ED , including A. oral phosphodiesterase type 5 inhibitors B. intra-urethral alprostadil C. intracavernous vasoactive drug injections Ohio Medicaid does not cover m edications including oral, injectable, and transdermal varieties for the treatment of erectile dysfunction. II. External penile pumps or vacuum constr iction devices (VCD) are the s econd line of treatment after first line therapy has failed. III. Ohio Medicaid does not cover e xternal penile pumps and vacuum constr iction d evices . Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3IV. Internal penile prosthetic implants are covered in extraordinary circumstances . They are consi dered medically necessary when all of the following conditions are met: A. First and second line therapy has been documented ineffective, or there is a compelling, well documented reason to proceed with surgery without a failed trial of first and second line therapies. B. Absence of active alcohol or substance use disorder as documented in the medical record. C. Absence of drug induced impotence related to ALL of the following: 1. anabolic steroid use 2. anticholinergics 3. antidepressants 4. antipsychotics or central nervous system depressants D. Neurogenic impotence due to ONE of the following: 1. diabetes 2. fractured pelvis 3. m ajor surgery of the pelvis, retroperitoneum, radical prostatectomy, or colorectal surgery 4. m ultiple sclerosis 5. spina bifida 6. spinal cord injury/disease 7. syringomy elia OR E. Vascular impotence due to ONE of the following: 1. hypertension 2. intrapenile arterial disease 3. penile fracture 4. Peyronies disease 5. smoking 6. status post cavernosal infection 7. impotence due to radiation therapy to the pelvis or retroperitoneum V. Internal penile prosthetic implant removal is considered medically necessary when ANY of the following are met: A. infection B. mechanical failure C. urinary obstruction D. intractable pain E. Conditions of Coverage N/A F. Related Polic ies/Rules N/A Penile Implants in the Treatment of Erectile Dysfunction-OH MCD-MM-0033 Effective Date: 09/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4G. Review/Revision History DATE ACTIONDate Issued 07/26/2016Date Revised 05/13/2020 05/11/2022 05/10/2023 05/08/2024Updated References, Updated Background information, condensed medical criteria. Added penile implant information to Background; updated references. No changes. Updated references. Approved at Committee. No changes. Updated references. Approved at Committee.Date Effective 09/01/2024 Date Archived H. References1. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. JUrology. 2018;200:633-641. doi:10.1016/j.juro.2018.05.004 2. Khera M. Treatment of male sexual dysfunction. UpToDate. Updated October 24, 2023. Accessed April 1, 2024. www.uptodate. com 3. Lazarou S. Surgical treatment of erectile dysfunction. UpToDate. Updated November 14, 2023. Accessed April 1, 2024. www.uptodate.com 4. Pharmacy Services: Covered Drugs and Associated Limitations, O HIO ADMIN . CODE 5160-9- 03(B)(3) (2024). 5. Urologic Surgery or Procedure GRG: SG-US. MCG Health. 28th ed. Updated February 1, 2024. Accessed April 1, 2024. www.careweb.careguidelines.com Inde pendent med ica l rev iew 05/2020Approved by ODM on 05/23/2024.

Peripheral Nerve Stimulators for Treatment of Pain

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333 10/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSou rce 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 guideli nes. 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 p rolonged, 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 n ot provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinat ion. 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 me dical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 3 Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 10/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectPeripheral Nerve Stimulators for Treatment of Pain B. BackgroundThe role of peripheral nerves as sources of pain and avenues of treatment when conservative therapy has failed is being more extensively explored than in previous years. Neuromodulation of peripheral nerves to treat refractory pain is one such area of interest. The neuromodulation of peri pheral nerves to reduce pain, known as peripheral nerve stimulation (PNS), has been developed as a minimally invasive pain management modality intended to manage acute and chronic pain. The proposed mechanism of action, referred to as the gate control the ory, involves amethod by which stimulation of large-diameter sensory neurons reduces transmission of painful stimuli from small nociceptive fibers to the brain. The stimulation system is placed adjacent to the nerve, a process commonly known as remote sel ective targeting. The lead is connected to a small, wearable stimulator. Depending on the device, the wearer may be able to adjust the level of stimulation using Bluetooth technology. C. DefinitionsAcute Pain Pain lasting 4 weeks or less. Chronic Pain A distressing feeling often caused by intense or damaging stimuli (pain) lasting more than 3 months, which is considered beyond normal healing time. Conservative Therapy A multimodality plan of care for treating pain non – surgically, including active and inactive conservative therapies. o Active A type of action or activity to strengthen supporting muscle groups and target key spinal st ructures, including physical therapy, occupational therapy, a physician-supervised home exercise program (HEP), and/or chiropractic care. o Inactive Lack of activity on behalf of the patient that aids in treating symptoms associated with pain but not neces sarily the underlying source, including rest, ice, heat, medical devices, acupuncture, and/or prescription medications. Minimally Invasive Procedures involving entry into the living body through a small incision to lessen recovery time, level of pain, an d risk of infection . Sub-Acute Pain Pain lasting between 4 and 12 weeks. D. PolicyI. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. Peripheral nerve stimulators are considered experimental and investi gational and areunproven for all indications for the reduction of acute, sub-acute, and chronic pain.Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 10/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 III. Peripheral nerve stimulators are not covered. This includes, but is not limited to:A. IB-Stim B. SPRINT PNS System C. Nalu Neurostimulation System D. StimRouter Neuromodulation System E. Moventis PNS F. StimQ PNS System E. Conditions of CoverageN/A F. Related Policies/RulesMedical Necessity Determinations Experimental and /or Investigational Item or Service G. Review/Revision HistoryDATE ACTIONDate Issued 10/01/2022Date Revised 07/29/2022 02/15/202301/17/202406/05/2024Converted from administrative policy (AD-1201) to medical policy. Annual review. Updated definitions. Annual review : references updated ; approved at Committee. Revised Background, added D. III. A. Approved at Committee Date Effective 10/01/2024 Date Archived H. References1. Abd-Elsayed A, Keith MK, Cao NN, Fiala KJ, Martens JM. Temporary peripheral nerve stimulation as treatment for chronic pain. Pain Ther . 2023;12(6):1415-1426. doi:10.1007/s40122-023-00557-3 2. Albright-Trainer B, Phan T, Trainer RJ, et al. Peripheral nerve stimulation for the management of acute a nd subacute post-amputation pain: a randomized, controlled feasibility trial. Pain Manage . 2022;12(3):357-369. doi:10.2217/pmt-2021-0087 3. Char S, Jin MY, Francio VT, et al. Implantable peripheral nerve stimulation for peripheral neuropathic pain: a systemat ic review of prospective studies. Biomed . 2022;10(10)2606. doi:10.3390/biomedicines10102606 4. DSouza RS, Jin MY, Abd-Elsayed A. Peripheral nerve stimulation for low back pain: a systematic review. Curr Pain Headache Rep . 2023;27:117-128. doi:10.1007/s11916-023-01109-2 5. Evidence Analysis Research Brief: Peripheral Nerve Stimulation for Treatment of Chronic Pain. Hayes; 2021. Accessed January 2, 2024. www.evidence.hayesinc.com Peripheral Nerve Stimulators for Treatment of Pain-OH MCD-MM-1333Effective Dat e: 10/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 6. Evolving Evidence Review: IB-Stim (NeurAxis) for Treatment of Pain Associated withIrritable Bowel Syndrome in Adolescents. Hayes; 2022. Reviewed July 31, 2023. Accessed April 30 , 2024. www.evidence.hayesinc.com 7. Evolving Evidence Review: SPRINT PNS System (SPR Therapeutics) for Chronic Pain. Hayes; 2021. Reviewed March 16, 2023. Accessed J anuary 2, 2024. www.evidence.hayesinc.com 8. Health Technology Assessment: Percutaneous Peripheral Nerve Stimulation for Treatment of Chronic Pain. Hayes; 2022. Reviewed May 31, 2023. Accessed January 2, 2024. www.evidence.hayesinc.com 9. Helm S, Shirsat N, Cal odney A, et al. Peripheral nerve stimulation for chronic pain: a systematic review of effectiveness and safety. Pain Ther . 2021;10(2):985-1002. doi:10.1007/s40122-021-00306-4 10. Kaye AD, Ridgell S, Alpaugh ES, et al. Peripheral nerve stimulation: a review of techniques and clinical efficacy. Pain Ther . 2021;10(2):961-972. doi:10.1007/s40122 – 021-00298-1 11. Li AH, Gulati A, Leong MS, et al. Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain. an international cross-sectional survey of implanters. Pain Pract . 2022;22(5):508-515. doi:10.1111/papr.13105 12. Smith BJ, Twohey EE, Dean KP, DSouza RS. Peripheral nerve stimulation for the treatment of postamputation pain: a systematic review. Am JPhys Med Rehabil . 2023;1 02(9):846-854. doi:10.1097/PHM.0000000000002237 13. Strand N, DSouza RS, Hagedorn JM. Evidence-based clinical guidelines from the American Society of Pain and Neuroscience for the use of implantable peripheral nerve stimulation in the treatment of chronic pai n. JPain Res . 2022;15:2483-2504. doi:10.2147/JPR.S362204 14. Xu J, Sun Z, Wu J, et al. Peripheral nerve stimulation in pain management: a systematic review. Pain Physician . 2021;24(2):E131-E152. Accessed January 2, 2024. www.painphysicianjournal.com Approve d by ODM on 06/27 /2024

Mechanical Stretching Devices

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Mechanical Stretching Devices-OH MCD-MM-1225 10/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry 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 th e 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 s ervices meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/R ules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 10/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Mechanical Stretching Devices B. Background Mechanical stretching devices are intended to restore range of motion (ROM) for joint stiffness or contracture by stretching joints. These devices provide passive stretching to an adjustable degree for a selected duration for multiple sessions. A variety of mechanical stretching devices are available for extension or flexion of the shoulder, elbow, wrist, fingers, knee, ankle, and toes. These devices can provide str etching for longer periods than a physical therapist and are generally used as adjunct treatment to physical therapy and/or exercise. Mechanical Stretching Devices (also known as dynamic splinting systems) include: Low-load prolonged duration stretch devices (LLPS) Static progressive stretch (SPS) splint devices Patient actuated serial stretch (PASS) devices C. DefinitionsLow-L oad Prolonged Duration Stretch Devices (LLPS) These devices permit resisted active and passive motion (elastic traction) within a limited range. LLPS devices maintain a set level of tension by means of incorporated rubber bands or springs. Patient Actuated Serial Stretch (PASS) Devices These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction). This type of device itself does not exert a stress on the tissue unless the joint angle i s set at the maximum ROM. Static Progressive Stretch Devices (SP S) These devices hold the joint in a set position but allow for manual modification of the joint angle and may allow for active motion without resistance (inelastic traction) . D. Policy I. CareSource considers dynamic splinting devices medically necessary durable medical equipment (DME) as an adjunct treatment to physical therapy, massage, and/or exercise for an existing joint contracture when the following clinical criteria is met: A. Medically necessary only for the following joints: knee, elbow, wrist, finger , ankle and toe . B. After three weeks of exercise and skilled therapy in the initial subacute injury or post-operative period in members with: 1. Signs and symptoms of persistent joint s tiffness or contracture. 2. Limited range of motion that poses a meaningful functional limitation as judged by a physician. C. May be used for an initial period of 4 weeks , a subsequent 4-week period with reevaluation, and then up to 4 months based on continued improvement . Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 10/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.3II. In the acute post-operative period for members who have undergone additional surgery to improve the range of motion of a previously affected joint , CareSource considers use of an LLPS device medically necessary for : A. An initial four-week period. B. An additional four-week period, if improvement was noted after the initial four weeks, for up to 4 months . III. Non-C overed Services A. CareSource considers the use of dynamic splinting experimental and investigational for the following indications, including but not limited to: 1. adhesive capsulitis 2. carpal tunnel syndrome 3. cerebral palsy 4. foot drop associated with neuromuscular diseases, 5. hall ux valgus 6. head and spinal cord injuries 7. improvement of outcomes following botulinum toxin injection for treatment of limb spasticity 8. injuries of the ankle and shoulder 9. multiple sclerosis 10. muscular dystrophy 11. plantar fasciitis 12. rheumatoid arthritis 13. stroke 14. tris mus B. CareSource considers the following devices experimental and investigational due to insufficient scientific evidence of efficacy: 1. Patient Actuated Serial Stretch (PASS) devices (for example, ERMI Knee Extensionater and ERMI Shoulder Extensionater) 2. Static Progressive Stretch devices (SPS) (for example, Joint Active Systems (JAS) splints (for example, JAS Elbow, JAS Shoulder, JAS Ankle, JAS Knee, JAS Wrist, and JAS Pronation-Supination)E. Conditions of CoverageAll claims for LLPS are subject to post-payment review by CareSource. F. Related Policies/Rules NA Mechanical Stretching Devices-OH MCD-MM-1225 Effective Date: 10/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4G. Review/Revision History DATE ACTIONDate Issued 11/09/2023 New PolicyDate Revised 02/15/2023 06/07/2023 05/22/2024e-voted addition of ankle and toe to policy to match fee schedule and MCG. Annual review. Added examples of PASS and SPS devices. Annual review. Updated references. Approved at Committee.Date Effective 10/01/2024 Date Archived H. References1. Furia JP, Willis FB, Shanmugam R, et al. Systematic review of contracture reduction in the lower extremity with dynamic splinting. Adv Ther . 2013;30(8):763-770. Accessed April 24, 2024. www.ncbi.nlm.nih.gov 2. Dynamic Joint Extension and Flexion Devices: ACG A-0882. MCG. 28th ed. 2024. Accessed April 24, 2024. www.careweb.careguidelines.com 3. Glasgow C, Tooth LR, Fleming J, et al. Dynamic splinting for the stiff hand after trauma: predictors of contracture resolution predictors of contracture resolution. JHand Ther . Accessed April 24, 2024. www.jhandtherapy.org 4. Harvey LA, Katalinic OM, Herbert RD, et al. Stretch for the treatment and prevention of contractures. Cochrane Database of Systematic Reviews. 2017. Accessed April 24, 2024. www.pubmed.ncbi.nlm.nih.gov 5. Medical Technology Directory. Mechanical Stretching Devices for the Treatment of Joint Contractures of the Extremities. Hayes , Inc. May 9, 2018. Accessed April 24, 2024. www.hayesinc.com 6. Jongs RA, Harvey LA, Gwinn T, et al. Dynamic splints do not reduce contractur e following distal radial fracture: a randomised controlled trial. JPhysiother . 2012;58(3):173-180. Accessed April 24, 2024. www.reader.elsevier.com 7. Zatarain LA, Smith DK, Deng J, et al. A randomized feasibility trial to evaluate use of the jaw dynasplint to prevent trismus in patients with head and neck cancer receiving primary or adjuvant radiation-based therapy. Integr Cancer Ther . 2018. I nde pendent med ica l rev iew 12/21Approved by ODM 06/27/2024

Facet Joint Interventions

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Facet Joint Interventions-OH MCD-MM-0967 09/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature ba sed 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 n ot 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 f unction, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflic t between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity A ddiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. … 3 E. Conditions of Coverag e ………………………….. ………………………….. ………………………….. ……. 5 F. Related Polices/Rules ………………………….. ………………………….. ………………………….. ………. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …… 5 H. References ………………………….. ………………………….. ………………………….. …………………….. 6 Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectFacet Joint Interventions B. BackgroundAn estimated 84% of adults experience back pain during their lifetime . Long-term outcomes are largely favorable for most patients, but a small percentage of patients symptoms persist . Persistent pain is categorized as subacute when it lasts between 4 and 12 weeks and chronic when it persists for at least 3 months. Facet joint pain comprises 27% -40% of patients with chronic low back pain (LBP) . Comprehensive pain management care plans are most effective in managing a patients chronic pain. These plans focus on a person-centered approach and incorporateconservative treatment with other modalities. These multidisciplinary treatments promot e self-management and aim to reduce the impact of pain on a patients daily life, even if the pain cannot be relieved co mpletely. In addition to conservative therapy, treatment options may include nonpharmacologic or pharmacologic treatments, and nonsurgical or surgical interventions. Only physicians qualified in i nterventional procedures for pain unresponsive to conservati ve treatment should perform these health services. Spinal structures may be the source of LBP, including intervertebral discs, facet joints, sacroiliac joints, and nerve roots. While some of these can be diagnosed by imaging, discogenic pain without disc herniation and facet joint or sacroiliac joint pain are difficultto diagnose with imaging alone. Medial branch nerve blocks are a diagnostic tool to identify the cause of pain and can provi de short term pain relief with certain medications. Following a pre sumptive diagnosis of facet joint pain through a physical examination and plain radiography or axial imaging , the diagnosis may be confirmed by relief of pain through injection of local anesthetic to the medial branches of the posterior rami of the dorsal spinal nerves supplying the proposed facet joint(s). Medial branch nerve blocks may be performed at the targeted joint itself, one joint above and one joint below on the same side, or bilaterally per treatment session. Medial branch nerve blo ck injections should be performed with fluoroscopy or computed tomography . A patient may receive a diagnostic injection of a short-acting local anesthetic agent to identify the pain generator. If p ain is relieved by the injection, then a radiofrequency ablation (RFA), which uses energy to destroy the nerve , can be performed . A successful radiofrequency facet ablation of the affected nerve (same anatomic location of the positive diagnostic block) may relieve pain for a period of months up to a year or more until nerve regeneration occurs. C. Definitions Conservative Therapy A multimodality plan of care including both active and inactive conservative therapies. o Active Conservative Therapies Actions or activities that strengthen muscle groups and target key spinal structures, i nclud ing physical therapy, occupational Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 therapy, a physician supervised home exercise program (HEP), and/or chiropractic care. HEP A 6-week program requiring an exerci se prescription and/or plan and a follow-up documented in the medical record after completion, or documentation of the inability to complete a HEP due to a stated physical reason (ie, increased pain, inability to physically perform exercises). Patient inco nvenience or noncompliance without explanation does not constitute an inability to complete. o Inactive Conservative Therapies Passive activities by the patient that aid in treating symptoms associated with pain including rest, ice, heat, medical devices, acupuncture, TENS use , and/or pharmacotherapy (prescription or over the counter [eg, NSAIDS, acetaminophen]) . Transcutaneous Electrical Nerve Stimulator (TENS) A device that utilizes electrical current directed through e lectrodes placed on the surface of the skin to decrease the patients perception of pain by inhibiting the transmission of afferent pain nerve impulses and/or stimulating the release of endorphins. Its use, frequency, duration, and start dates must be docu mented in the medical record to be considered part of conservative therapy . Medial Branch Nerve Block Injection A diagnostic procedure in which a short – acting anesthetic (eg, lidocaine) is injected near small medial nerves connected to a specific facet joint. It may also be performed to treat back pain caused by facet joint(s) with a longer acting anesthetic (eg, bupivacaine). o Successful Diagnostic Injection An injection that achieves greater than 80% reduction in pain within the duration of effectiveness for the anesthetic used. Radiofrequency Ablation (RFA) Minimally invasive treatment modality that percutaneously introduces an electrode under fluoroscopic guidance to thermocoagulate medial branches of the dorsal spinal nerves. D. PolicyCareSource considers facet joint interventions for management of chronic back pain medically necessary when the clinical criteria in this policy are met. Documentation, including dates of service for conservative therapies , are not required for medical necessity review but must be available upon request. I. Medial Branch Nerve Block InjectionsA. Up to 2 diagnostic medial branch nerve block injections in the cervical , thoracic , or lumbar regions are considered medically necessary when ALL of the following criteria are met: 1. Initial d iagnostic block confirm s facet joint as sour ce of spinal pain and provides 80% or greater primary pain relief and duration of relief is consistent with agent employed. 2. Second diagnostic block confirms validity of the initial injection and is injected at the same level where the initial produced a po sitive response. 3. Each diagnostic block may treat up to 3 spinal levels (unilateral or bilateral) for a maximum of 6 spinal levels per spinal region per session . Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 4. Radiofrequency ablation is being considered as a therapeutic intervention.5. Injections should be at least 2 weeks apart . 6. Imaging studies and physical exam ruled out other causes of spinal pain (eg, fracture, tumor, infection, herniated disk, spinal stenosis, significant deformity) . 7. Patient history with at least 3 months of moderate to severe pain with functional impairment that has not adequately responded to active and inactive conservative therapy . 8. Failure of conservative therapy as evidenced by ALL of the following: a. Documentation in the medical record of at least 6 weeks of active co nservative therapy (as defined above) within the past 6 months OR inability to complete active conservative therapy due to contraindication, increased pain, or intolerance. b. Documentation in the medical record of at least 6 weeks of inactive conservative th erapy (as defined above) within the past 6 months. 9. No coagulopathy . 10. No current infection at the injection site. B. Diagnostic medial branch nerve blocks are NOT considered medically necessary when RFA is not being considered as a treatment option. II. Radiofrequency Ablation (RFA) for Facet Joint PainA. Initial RFA for Facet Joint Pain is considered medically necessary when in the past 36 months 1. The clinical criteria above (I.A.1-10 ) have been met . 2. 2 successful medial branch nerve block injections were performed at the same spinal region and achiev ed 80% or more pain relief . B. Repeat RFA for facet joint pain is considered medically necessary when in the past 36 months 1. Prior successful single or multilevel facet RFA in the same spinal region (cervical, thoracic, or lumbar) and side provid ed at least 50% pain relief over a minimum of 6 months . 2. The m ost recent RFA was at least 6 months prior . 3. No more than 4 RFAs per rolling 12 months ( 2 left and 2 right per spinal region) are considered appropriate . III. SedationA. Neither conscious sedation nor monitored anesthesia care (MAC) is routinely necessary for intra-articular facet joint injections or medial branch blocks and are not routinely reimbursable. B. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented. IV. Inconclusive or Non-Supportive EvidenceFacet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 A. Medial branch nerve block inje ctions are unproven for the treatment of chronic spinal pain. Routine therapeutic injections will not be authorized for chronic pain management . B. Intra-articular facet joint injections for neck and back pain are not considered medically necessary as there is limited evidence and the efficacy has not been established. C. Intra-articular facet joint injections do not qualify as diagnostic information for a proposed neurotomy . V. Spinal Cord Stimulators/Pain PumpsPatients with indwelling implanted spinal cord stimulators or pain pumps should include a device interrogation rep ort with the required medical records for medical necessity review requests. If a device is not functioning properly, an escalation in pain may warrant evaluation and management of the implanted device. E. Conditions of CoverageN/A F. Related Polices /R ulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 05/13/20 20 This policy replaces the Facet Medial Branch Nerve Block and Radiofrequency Facet Ablation policies. Added c riteria re: exclusion of repea t diagnostic injections for RFA. Date Revised 07/22/2020 11/11/202007/21/202106/22/2022 06 /21 /202305/08 /2024Revisions: Medial Branch Nerve Block injection clinical criteria; requirement of one successful RFA session. Revision: RFA language revised around benefit limit for clarity. (This revision does not require a network notification or a change of the Effec tive Date). Annual Update: Removed PA language. Annual Review: updated background, references, definitions, re-organized criteria, added coagulopathy and infection language Annual Review: revised language, added RFA requirement for diagnostic injections, updated references; Approved at Committee. Annual review: updated references, approved at Committee Date Effective 09/01/2024 Date Archived Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 H. References 1. Ashmore ZM, Bies MM, Meiling JB, et al. Ultrasound-guided lumbar medial branch blocks and intra-articular facet joint injections: a systematic review and meta – analysis. Pain Rep. 2022;7(3):e1008. doi:10.1097/ PR9. 0000000000001008 2. Boswell MV, Manchikanti L, Kaye AD, et al. A best-evidence systematic appraisal of the diagnostic accuracy and utility of facet (zygapophysial) joint injections in chronic spinal pain . Pain Physician . 2015;18(4):E497-E533. Accessed April 25, 2024. www.pain physicianjournal.com 3. Chou R. Subacute and chronic low back pain: nonsurgical interventional treatment. UpToDate . Updated June 10, 2021. Access ed April 25, 2024 . www.uptodate.com 4. Chou R. Subacute and chronic low back pain: surgical treatment. UpToDate . Updated September 27, 2023 . Access ed April 25, 2024 . www.uptodate.com 5. Chou R, Deyo R, Friedly J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline . Ann Intern Med . 2017;166(7):493-505. doi:10.7326/M16-2459 6. Cohen SP, Bhaskar A, Bhatia A, et al. Consensus practice guidelines on interventions for lumbar facet joint pain from a multispecialty, international working group. Reg Anesth Pain Med . 2020;45(6):424-467. doi:10.1136/rapm-2019-101243 7. Cohen SP, Moon JY, Brummett CM, et al . Medial branch blocks or intra-articular injections as a prognostic tool before lumbar facet radiofrequency denervation: a multicenter, case-control study . Reg Anesth Pain Med . 2015;40(4):376-383. doi:10.1097/AAP.0000000000000229 8. Copenhaver DJ, P ritzlaff SG, Jung M, et al. Interventional therapies for chronic pain. UpToDate. Updated April 16, 2024. Accessed April 25, 2024. www.uptodate.com 9. Curtis L, Shah N, Padalia D. Facet joint disease. StatPearls . StatPearls Publishing; updated January 9, 2 023. Accessed May 18, 2023. www.ncbi.nlm.nih.gov 10. Facet Joint Injection. MCG Health . 28th ed . MCG Health; 2024. Updated March 14, 2024 . Accessed April 25, 2024 . www.careweb.careguidelines.com 11. Hurley RW, Adams MCB, Barad M, et al. Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group. Reg Anesth Pain Med . 2022;47(1):3-59. doi:10.1136/r apm-2021 – 103031 12. Isaac Z, Kelly H. Evaluation of the adult patient with neck pain. UpToDate . Updated May 31, 2023 . Accessed April 25, 2024. www.uptodate.com 13. Le DT, Alem N. Facet Joint Injection. StatPearls . StatPearls Publishing; updated February 5, 2023 . Accessed May 18 , 202 3. www.ncbi.nlm.nih.gov 14. Lee DW, Pritzlaff S, Jung MJ, et al. Latest Evidence-Based Application for Radiofrequency Neurotomy (LEARN): best practice guidelines from the American Society of Pain and Neuroscience (ASPN). JPain Res . 2021;14:2807-2831. doi:10.2147/JPR.S325665 15. Manchikanti L, Kaye AD, Soin A, et al. Comprehensive evidence-based guidelines for facet joint interventions in the m anagement of chronic spinal pain : American Society of Interventional Pain Physicians (ASIPP) guidelines facet joint interventions Facet Joint Interventions-OH MCD-MM-0967Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 2020 guidelines . Pain Physician . 2020;23(3S):S1-S127. Accessed April 25, 2024. www.painphysicianjournal.com 16. Perolat R, Kastler A, Nicot B, et al. Facet joint syndrome: from diagnosis to interventional management. Insights Imaging . 2018;9(5):773-789. doi:10.1007/s13244-018-0638x 17. Won HS, Yang M, Kim YD. Facet joint injections for manag ement of low back pain: a clinically focused review. Anesth Pain Med (Seoul) . 2020;15(1):8-18. doi:10.17085/apm.2020.15.1.8 Approved by ODM 0 5/23/2024 .

Noninvasive Home Mechanical Ventilation

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588 09/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clin ical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standard s, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without w hich the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area , are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manua ls, Member Handbooks, and/or other policies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Polic y Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determinatio n. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions a s covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 7 F. Related P olicies/Rules ………………………….. ………………………….. ………………………….. …….. 7 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 7 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.2 A. SubjectNoninvasive Home Mechanical Ventilation B. BackgroundThis document outlines the medical necessity criteria for a noninvasive home ventilator for a member with stable, chronic respiratory failure. This dev ice does not treat the underlying cause of respiratory failure but functions as supportive therapy, which may include reducing symptoms, improving quality of life, or sustaining or extending life. It may be used intermittently during the day and/or during sleep. A noninvasive home ventilator will not be reimbursed as such when its sole purpose is to function as a respiratory assistance device, including continuous positive airway pressure (CPAP), auto-titrating PAP, and bilevel airway pressure (BiPA P).C. Definitions Apnea-Hypopnea Index (AHI) The combined average number of apneas and hypopneas that occur per hour of sleep to determine the severity of obstructive sleep apnea (OSA) . Apnea-Hypopnea Index (AHI) Adult AHI Pediatric AHIMild OSA 5-14 1-4.9Moderate OSA 15 – 30 5-9.9 Severe OSA > 30 > 10 Bi-level Positive Airway Pressure (B iPAP) Device A device that uses mild bi – level or 2 levels of air pressure to keep breathing airways open. Continuous Positive Airway Pressure (CPAP) Device A device that uses mild continuous air pressure to keep breathing airways open. Home Mechanical Ventilation (HMV) A device used in the home settin g for patients with chronic respiratory failure that delivers respiratory assistance via an invasive (ie, tracheostomy) or noninvasive (ie, nose/mouth mask, mouthpiece , nasal prongs) interface. These devices possess more advanced features than a CPAP/BiPAP machine, which include monitoring, rate control, safety, and backup power features. The ventilator can custom control a ll phases of the breathing cycle . D. PolicyI. CareSource utilizes Ohio Administrative Code and MCG Health criteria to determine medical necessity for noninvasive HMV (E0466) . An initial approval for HMV is valid for a maximum of 3 months. A new medical necessity determination thereafter is requ ired every 6 months for continued rental use. II. Initial Rental of HMVMedical necessity for the initial coverage of noninvasive HMV is based upon the following conditions in II – IV being met : Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.3 A. Congenital central hypoventilation syndromeB. Chronic lung disease of infancy (eg, bronchopulmonary dysplasia), and patient unable to maintain acceptable pH and PCO 2 without ventilator support C. Chronic obstructive pulmonary disease (COPD) and ONE OR MORE of the following: 1. Chronic hypercapnia with PaCO 2 of 50 mm Hg (6.7 kPa) to less than 52 mm Hg (6.9 kPa) and at least ONE of the following: a. Arterial oxygen saturation 88% for 5 consecutive minutes during nocturnal oximetry while on at least 2 liters of oxygen per minute . b. Invasive or noninvasive ventilation for acute exacerbation required during 2 or more hospitalizations per year . 2. Chronic hypercapnia with PaCO 2 of 52 m m Hg (6.9 kPa) or greater 3. Palliative care for end-stage disease and advance directive states no desire for intubation D. Neuromuscular disorder accompanied by chronic respiratory failure , as indicated by the following: Documentation of respiratory failure, as indicated by ONE OR MORE : 1. Arterial O2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry 2. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) 3. Forced vital capacity less than 50% of predicted 4. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure 5. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower 6. Maximum sniff nasal inspiratory pressure less than 40 cm H 2O (3923 Pa) 7. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: a. Adult with sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . b. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tida l, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater) . E. Obesity hypoventilation syndrome , as indicated by ALL of the following: 1. BMI > 30 2. CPAP unsuccessful or not appropriate , as indicated by ONE OR MORE of the following: a. Comorbid sleep-related hypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer ) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.4 b. Intolerance of CPAP pressures necessary to correct obstructive sleep apnea (OSA) component (ie , difficulty exhaling against fixed airway pressure) c. Lack of resolution of hypercarbia, nocturnal desaturation, and OSA despite 3 months of CPAP use d. Titration study demonstrates OSA despite CPAP 15 cm H 2O (1471 Pa) that is responsive to BiPAP 3. Daytime hyper capnia with PaCO 2 greater than 45 mm Hg (6.0 kPa) without other etiology (eg, kyphoscoliosis, lung parenchymal disease, myopathy, severe hypothyroidism) 4. Sleep-disordered breathing or hypoventilation on polysomnography, as indicated by ONE OR MORE of the following: a. Apnea-hypopnea index of 5 or greater b. Increase in PaCO 2 during sleep by more than 10 mm Hg (1.3 kPa) above value while awake c. Significant oxygen desaturation (eg, less than 90%) not explained by obstructive apneas or hypopneas 5. TSH level does not demonstrate hypothyroidism F. OSA in child or adolescent and ONE OR M ORE of the following: 1. Mild OSA (ie, apnea-hypopnea index from 1 to 5) and ONE OR MORE of the following: a. achondroplasia b. behavioral problems c. cardiovascular disease (eg, elevated blood pressure, pulmonary hypertension) d. Chiari malformation e. craniofacial abnorma lities f. Down Syndrome g. excessive daytime sleepiness h. impaired cognition i. inattention or hyperactivity j. mucopolysaccharidoses k. neuromuscular disorders l. Prader-Willi syndrome 2. Moderate or severe OSA (ie, apnea-hypopnea index greater than 5) 3. Residual apnea-hypo pnea index greater than 5 in pediatric patient after adenotonsillectomy G. Restrictive disorder of chest wall , as indicated by ALL of the following: 1. Appropriate chest wall disorder as indicated by ONE OR MORE of the following: a. asphyxiating thoracic dystrophy b. kyphoscoliosis c. other chest wall disorder accompanied by chronic respiratory failure (eg, ankylosing spondylitis, fibrothorax, post-tuberculous chest wall deformity) Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.5 2. Documentation of respiratory failure as indicated by ONE OR MORE of the following : a. Arterial O 2 saturation less than 88% for 5 consecutive minutes during nocturnal oximetry b. Daytime PCO 2 (arterial or capillary) greater than 45 mm Hg (6.0 kPa) c. Forced vital capacity less than 50% of predicted d. Forced vital capacity less than 80% of predicted and symptoms of respiratory failure e. Maximum inspiratory pressure 60 cm H 2O (5884 Pa) or lower f. Polysomnography demonstrates sleep hypoventilation, as indicated by ONE OR MORE of the following: 01. Adult with sleep-related h ypoventilation (ie, arterial, end-tidal, or transcutaneous PCO 2 greater than 55 mm Hg (7.3 kPa) for 10 minutes or longer, or increase in arterial, end-tidal, or transcutaneous PCO 2 of 10 mm Hg (1.3 kPa) or greater above awake supine value resulting in PCO 2 greater than 50 mm Hg (6.7 kPa) for 10 minutes or longer) . 02. Child with sleep-related hypoventilation (ie, sleeping arterial, end-tidal, or transcutaneous PCO 2 of greater than 50 mm Hg (6.7 kPa) for greater than 25% of total sleep time, or peak sleep end-tidal PCO 2 of 55 mm Hg (7.3 kPa) or greater ). III. Respiratory status is STABLE , as indicated by ALL of the following:A. Airway interface is safe with a n oninvasive interface with acceptable fit . B. Airway pressure requirement appropriate, as indicated by ONE OR MORE of the following: 1. BiPAP expiratory positive airway pressure requirement is to 10 cm H 2O (981 Pa). 2. CPAP pressure requirement in child is 15 cm H 2O (1471 Pa). 3. Ventilator positive end-expiratory pressure requirement is 10 cm H 2O (981 Pa). C. Oxygen requirement does not exceed FiO 2 of 40%. D. Settings are stable on chosen device. E. No continuous invasive monitoring is required. IV. A BiPAP or CPAP device must not be clinically approp riate as indicated by ONE ORMORE of the following. A. Chronic respiratory insufficiency fails to improve with simple BiPAP device. B. Infant or child does not meet the minimum body weight requirement for CPAP device. C. Infant or child is not appropriate for simple BiPAP device due to setting or performance requirements, as indicated by ONE OR MORE of the following: 1. Breath rates delivered by device not ap propriate for patient . 2. Compatible ventilator circuits not appropriate for patient (eg, circuit compliance, compressed volume, dead space) . Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.6 3. Inspiratory flows delivered by device not appropriate for patient .4. Patient does not meet ventilator minimum body weight requirements. 5. Pressure range (eg, expiratory pressure, inspiratory pressure) not appropriate for patient . 6. Tidal volume range delivered by device not appropriate for patient . 7. Ventilator inspiratory trigger delay (ie, airway pressure rise time) not ap propriate for patient . 8. Ventilator inspiratory trigger sensitivity not appropriate for patient . D. The following setting or functionality is required by the member and is not available with simple BiPAP device: 1. Alarms required by member are not available on th e device . 2. Daytime ventilation using mouthpiece is required . 3. Pressure range delivered by device is not appropriate for member . 4. Member requires volume-assured pressure support or volume control mode (eg, obesity hypoventilation syndrome). E. Ventilated patient requires cough assistance via volume ventilator’s breath stacking capability. F. Ventilation is required 24 hours per day. V. HMV Continued UseFor HMV continued use beyond the initial 3-month determination, medical necessity must be reestablished every 6 months thereafter . The following is to be provided for continued use: A. Re-evaluation by the treating medical professional must be completed no earlier than 61 days after initiating therapy. B. Doc umentation of the persistence of the disease process for which HMV has been prescribed. C. Medical records must document that the member is compliant with and benefitting from HMV. D. At least 30 consecutive days of device data, beginning after 31 days of initiation, demonstrating that the member is utilizing the device an average of 4 hours per 24-hour period. NOTE: Failure of the member to consistently use HMV for an average of 4 hours per 24-hour period would demonstrate non-compliant utilization of the device for its intended purpose and expectation of benefit, which would constitute a denial in continued coverage as not reasonable and necessary . E. Additional information as requested. VI. In accordance with Rule 5160-10-01 for each claim, the provider cannot legitimately receive payment until necessary supporting documents have been obtained and placed in the providers files. These documents include the prescription and the following items: A. A completed CMN form: ODM 01902 . B. Practitioner order and chart notes , which support the determination of medical necessity. Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.7 VII. Regardless of its authorized length, a rental period ends when the rented item is no longer medically necessary.VIII. ExclusionsAny application for a noninvasive home v entilator (E0466) not meeting the criteria above will be denied as being not medically necessary, including but not limited to when its sole purpose is to function as a respiratory assistance device, including CPAP, auto-titrating PAP, and BiPAP. E. Conditi ons of CoverageClaims for ventilators being utilized to provi de CPAP or BiPAP therapy for conditions described above and are submitted with HCPCS code E0466, will be denied as not being reasonable and necessary. If a HMV is dispensed to a Member for CPAP or BiPAP therapy, the claim must be coded in accordance with CareSource policy, Positive Airway Pressure Devices for Pulmonary Disorders Continued Rental . All requirements in D. I. -V. of this policy must be satisfied for HMV to be considered medically necessary. F. Related Policies/RulesDMEPOS: Positive Airway Pressure Devices, OHIO ADMIN . CODE 5160-10-19 (2021). Positive Airway Pressure Devices for Pulmonar y Disorders Continued Rental G. Review/Revision HistoryDATE ACTIONDate Issued 05/22/2024 New Policy, Approved at CommitteeDate Revised Date Effective 09/01/2024 Date Archived H. References1. Coleman JM, Wolfe LF, Kalhan R. Noninvasive ventilation in chronic obstructive pulmonary disease. Ann Am Thorac Soc . 2019;16(9):1091-1098. doi: 10.1513/AnnalsATS.201810-657CME 2. DMEPOS: Ventilators, OHIO ADMIN . CODE 5160-10-22 (2021). 3. Dudgeon D. Assessment and management of dyspnea in palliative care. UpToDate. Updated October 31, 2023. Accessed May 16 , 2024. www.uptodate.com 4. Durable Medical Equipment, Prostheses, Orthoses, and Supplies (DMEPOS): General Provisions, OHIO ADMIN . CODE 5160-10-01 (2024). 5. Ferrell BR, Twaddle ML, Melnick A, et al. National Consensus Project clinical practice guidelines for quality palliative care guidelines, 4th edition. JPalliative Med . 2018;21(12): 1684-1689. doi:10.1089/jpm.2018.0431168 4 6. Freedman N. Treatment of obstructive sleep apnea: choosing the best positive airway pressure device. Sleep Med Clin . 2020;15(2):205-218. doi:10.1016/j.jsmc.2020.02.007 Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.8 7. Gay PC. Nocturnal ventilatory support in COPD. UpToDate. Updated January 4, 2024. Acce ssed May 16 , 2024. www.uptodate.com8. Gay PC, Owens RL; ONMAP Technical Expert Panel. Executive summary: optimal NIV Medicare access promotion: a technical expert panel report from the American College of Chest Physicians, the American Association for Respir atory Care, the American Academy of Sleep Medicine, and the American Thoracic Society. Chest . 2021;160(5):1808-1821. doi: 10.1016/j.chest.2021.05.074 9. Hansen-Flaschen J, Ackrivo J. Practical guide to management of long-term noninvasive ventilation for adults with chronic neuromuscular disease. Resp Care . 2023;68(8):1123-1157. doi:10.4187/respcare.10349 10. Hill NS, Kramer NR. Noninvasive ventilation in adults with chronic respiratory failure from neuromuscular and chest wall diseases: patient selection and altern ative modes of ventilatory support. UpToDate. Updated January 18, 2024. Accessed May 16 , 2024. www.uptodate.com 11. Home Ventilator (Invasive or Noninvasive Interface): ACG A-0893. MCG Health . 2 8th ed. Accessed May 16 , 2024. www.careweb.careguidelines.com 12. Khan A, Frazer-Green L, Amin R, et al. Respiratory management of patients with neuromuscular weakness: an American College of Chest Physicians clinical practice guideline and expert panel report. Chest . 2023;164(2):394-413. doi:10.1016/j.chest.2023.03.011 13. Klin e LR. Clinical presentation and diagnosis of obstructive sleep apnea in adults. UpToDate. Updated October 5, 2023. Accessed May 16 , 2024. www.uptodate.com 14. Local Coverage Determination: Respiratory Assist Devices. Medicare Coverage Database; 2021. LCD ID L3 3800. Revised January 1, 2024. Accessed May 16 , 2024. www.cms.gov 15. Macrea M, Oczkowski S, Rochwerg B, et al. Long-term noninvasive ventilation in chronic stable hypercapnic chronic obstructive pulmonary disease: an official American Thoracic Society clinica l practice guideline. Am JResp Crit Care Med . 2020;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST 16. Martin TJ. Noninvasive positive airway pressure therapy for obesity hypoventilation syndrome. UpToDate. Updated March 4, 2024. Accessed May 16 , 2024. www.upt odate.com 17. Mitchell RB, Archer SM, Ishman SL, et al. Clinical practice guideline: tonsillectomy in children (update). Otolargtngology Head Neck Surg. 2019;160(1S):S1-S42. doi: 10.1177/0194599818801757 18. Raveling T, Vonk J, Struik FM, et al. Chronic non-invasiv e ventilation for chronic obstructive pulmonary disease: review. Cochrane Database Syst Rev . 2021;8:CD002878. doi:10.1002/14651858.CD002878.pub3 19. Restrepo RD, Walsh BK. Humidification during invasive and noninvasive mechanical ventilation 2012: AARC clinica l practice guideline. Respir Care . 2012;57(5):782-788. doi:10.4187/respcare.01766 20. van den Biggelaar RJM, Hazenberg A, Cobben NAM, et al. A randomized trial of initiation of chronic noninvasive mechanic ventilation at home vs in-hospital in patients with neuromuscular disease and thoracic cage disorder. Chest . 2020;158(6):2493-2501. doi: 10.1016/j.chest.2020.07.007 Noninvasive Home Mechanical Ventilation-OH MCD-MM-1588Effective Dat e: 09/01/2024The MEDICAL Policy Statement detailed above has recei ved due consideration as defined in theMEDICAL Policy Statement Policy and is approved.9 Independent Medical Review 05/08/24 Approved by ODM 06/06/2024

Breast Cancer Index (BCI) for Managing Breast Cancer Treatment

MEDICAL POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Breast Cancer Index (BCI) for Managing Breast Cancer Treatment – OH MCD-MM-1513 07/01/2024 Policy Type MEDICAL Medical Policy Statement prepared by Car eSource 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 suff er 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 polic ies and procedures. Medical Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Medical Policy Statement. If there is a conflict between the Medical Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determ ination. 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 t o medical conditions as covered under this policy.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 3 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Polic ies/R ules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Breast Cancer Index (BCI) for Managing Breast Cancer Treatment-OH MCD-MM-1513 Effective Date: 07/01/2024 The MEDICALPolic y St ate m ent d etail ed a bo ve h a s r eceiv ed due con sidera tio n a s d e fin ed i n the MEDICAL Polic y St ate m ent Po lic y a nd is a pp rove d.2A. Subject Breast Cancer Index (BCI) for Managing Breast Cancer Treatment B. Background According to the CDC , e ach year in the United States about 260 ,000 individuals are expected to be diagnosed with invasive breast cancer, of which approximately 90% are diagnosed with early-stage disease. Hormone-receptor positive (HR+) breast cancer is the most common subtype of breast cancer (~80% of cases) and has the most favorable p rognosis overall. Standard-of-care treatment for HR+ disease includes primary adjuvant anti-estrogen therapy with tamoxifen, an aromatase inhibitor (AI), or a sequence of these. A long with anti-estrogen therapy, there are two additional key treatment decisions which are priorities in the management of early stage breast cancer . The first decision is whether the patient is of sufficient risk of recurrence to recommend systemic adjuvant chemotherapy. In addition, while HR+ early-stage breast cancer patients have a favorable prognosis overall, there is an ongoing risk of distant recurrence (DR) beyond year 5 (late recurrence), and 75% of deaths occur more than 5 years post-diagnosis . The second decision is whether to recommend extension of endocr ine therapy beyond the initial primary adjuvant therapy. For each treatment decision, physicians and patients must weigh whether the potential benefit from the additional treatment regimen is likely to outweigh the risks of cardiovascular toxicity, bone fr actures, and other side effects that impair quality of life and compliance. The Breast Cancer Index (BCI) is a gene expression based signature that consists of two functional biomarker panels, the HOXB13/IL17BR (H/I) ratio and the molecular grade index (M GI), that evaluate important estrogen signaling and proliferation pathways in breast cancer. It analyzes the activity of 11 genes that can influence how likely the cancer is to come back 5 to 10 years after diagnosis, as well as how likely a patient is to benefit from 5 additional years of hormonal therapy. The test provides both prognostic and predictive results . The BCI Prognostic result estimates how likely the cancer is to come back 5 to 10 years after diagnosis (late recurrence). The result is given as a percentage. Example: a prognostic result of 2.2% means the patient has a 2.2% risk of the cancer coming back 5 to 10 years after diagnosis. The BCI Predictive result is reported as "yes" or "no." A yes result means the patient is likely to benefit fro m 5 more years of hormonal therapy. A no result means the patient i s not likely to benefit from 5 more years of hormonal therapy. BCI is tested once per patient lifetime on formalin-fixed, paraffin-embedded (FFPE) tissue from the primary tumor specimen obtained prior to adjuvant treatment. Breast Cancer Index (BCI) for Managing Breast Cancer Treatment-OH MCD-MM-1513 Effective Date: 07/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.3C. Definitions Adjuvant Therapy for Early-stage Breast Cancer Tamoxifen is FDA approved for adjuvant hormone treatment of premenopausal and postmenopausal women (and men) with ER-positive early-stage breast cancer, and the aromatase inhibitors anastrozole, letrozole, and exemestane are approved for this use in postmenopausal women. Gene Expression Testing A laboratory test that analyzes mRNA patterns to determine gene activity . Predictive Molecular Markers Biomarkers which can be used to evaluate the likelihood of benefit from a specific clinical intervention, or the differential outcomes of more than one intervention. Prognostic Molecular Markers Biological characteristics that are objectively measured and evaluated to predict the course of a disease or a response to a therapeutic intervention among patients with the same characteristic. Examples include the presence of a particular gene variant, patterns of gene expression or levels of a particular protein in body fluids . D. Policy I. CareSource considers Breast Cancer Index for breast cancer as a technique for managing the treatment of breast cancer in females or males with invasive breast cancer medically necessary in the following situations : A. Member is newly diagnosed (within the last 6 months) and ALL of the following criteria are met: 1. Lymph node negative or 1-3 positive ipsilateral axillary lymph nodes . 2. No distant metastases. 3. Estrogen receptor positive (ER+), or progesterone receptor positive (PR+), or both. 4. HER2 (human epidermal growth factor receptor-2) receptor negative. 5. Adjuvant chemotherapy is not precluded due to any other factor ( eg, , advanced age and/or significant co-morbidities). B. Member is currently receiving adjuvant hormonal therapy (e.g., Tamoxifen or an aromatase inhibitor) for a breast cancer and ALL of the following c riteria are met: 1. Hormone receptor-positive (estrogen receptor positive, progesterone receptor positive or both) . 2. HER2 receptor negative. 3. The member and treating physician have had a discussion prior to testing a. regarding the potential results of the test and b. use of the results to guide a decision regarding extended adjuvant hormonal therapy. II. Gene expression profiling in breast cancer are unproven and not medically necessary for all other indications, including ductal carcinoma in situ (DCIS), due to insufficient evidence. Breast Cancer Index (BCI) for Managing Breast Cancer Treatment-OH MCD-MM-1513 Effective Date: 07/01/2024 The MEDICALPolicy Stateme nt det ailed a bove has r eceived due consideration as defined in the MEDICALPo licy Stateme nt Po licy a nd is a pprove d.4E. Conditions of Coverage N/A F. Related Polic ies/Rules Medical Necessity Determinations G. Review/Revision History DATE ACTIONDate Issued 06/21/2024 New Policy. Approved at committee.Date Revised 03/13/2024 Updated reference. Approved at Committee. Date Effective 07/01/2024 Date Archived H. References1. Andre F, Ismaila N, Allison KH, et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer : ASCO guideline update . JClin Oncol. 2022;40(16):1816-1837. doi:10.1200/JCO.22.00069 2. Local Coverage Determination: MolDX: Breast Cancer Index (BCI) Gene Expression Test. Medicare Coverage Database; 2023. Accessed February 28, 2024. www.cms.gov 3. Molecular Test Assessment: Breast Cancer Index (BioTheranostics Inc.) for Lymph NodeNegative Patients. Hayes; 2020 . Updated December 5, 2023. Accessed February 28, 2024. www.hayesinc.com 4. Molecular Test Assessment: Breast Cancer Index (BioTheranostics Inc.) for Lymph NodePositive (1-3) Patients. Hayes; 2020 . Updated December 6, 2023. Accessed February 28, 2024. www.hayesinc.co m 5. National Cancer Institute (NCI) Fact Sheet. Hormone Therapy for Breast Cancer . Accessed February 28, 2024. www.cancer.gov 6. Noodhoek I, Treuner K, Putter H, et al. Breast Cancer Index p redicts extended e ndocrine benefit to individualize selection of p atients with HR+ e arly-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res . 2021;27(1):311-319. doi:10.1158/1078-0432.CCR-20-2737 7. Optum EncoderPro for Payer Professionals . CPT code 81518. Accessed February 28, 2024 . www.enc oderprofp.com . 8. Sanft T, Aktas B, Schroeder B, et al. Prospective assessment of the decision-making impact of the Breast Cancer Index in recommending extended adjuvant endocrine therapy for patients with early-stage ER-positive breast cancer. Breast Cancer Res Treat . 2015;154(3):533-41. doi:10.1007/s10549-015-3631-9 Approved by ODM on 3/21/2024

© Copyright CareSource 2025. All rights reserved.

System Details