ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Bilateral Procedures-OH MCD-AD-1055 06/01/2023 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industr y standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction o f a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider M anuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the E vidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Cove rage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limita tions that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ……………………….. 2 B. Background ………………………….. ………………………….. ………………………….. …………………. 2 C. Def initions ………………………….. ………………………….. ………………………….. …………………… 2 D. Policy ………………………….. ………………………….. ………………………….. …………………………. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …. 2 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …… 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. … 3 H. Ref erences ………………………….. ………………………….. ………………………….. ………………….. 3 Bilateral Pro ced ures-OH MCD-AD-1055 Effective Date: 06/01/2023 The ADMINISTRATIVE Policy Statement detailed abo ve has recei ved d ue con sideration as defined in theADMINISTRATIVE Policy Statement Policy and is app roved.A. SubjectBilateral Procedures B. BackgroundCareSource processes bilateral procedures in accordance with The Centers for Medicare and Medicaid Services (CMS) guidelines. Bilateral procedures are those perf ormed on both sides of the body, during the same operative episode by the same provider. CareSource applies CMS guidelines f or professional reimbursement of bilateral procedures. Reimbu rsement is based on the bilateral surgery payment policy indicator assigned to the procedure code on the Medicare Physician Fee Schedule . C. Def initions Bilateral Procedures Procedures performed on both sides of the body during the same session or on the same day. Modifier A reporting indicator used in conjunction with a Current Procedural Terminology (CPT ) code to denote that a medical service or procedure that has been perf ormed has been altered by a specif ic circumstance while remaining unchanged in its def inition or CPT code. D. PolicyI. CareSource policies use Current Procedural Terminology (CPT), Centers f or Medicare and Medicaid Services (CM S) , or other coding guidelines. References to CPT or other sources are f or definitional purposes only and do not imply any right to reimbursement. A. In instances where there is a conf lict between CMS guidelines and AMA/CPT guidelines regarding modifier 5 0, CareSource will use guidelines as established by CMS to align with the Ohio Department of Medicaid (ODM) f ee schedule. II. Providers and f acilities should ref er to CMS f or appropriate modifiers and bilateral indicators when submitting claims. III. Gen eral billing guidelines apply when using CPT .A. Unless CMS specif ies dif ferently :1. General billing guidelines f or CPT code s descriptions should be f ollowed and appropriate units should be used. 2. CPT codes , with bilateral in their intent or with bilateral written in their description , should not be reported with the bilateral modi f ier 50, or modifiers LT and RT . 3. CPT co des , with unilateral in their intent or with unilateral written in their description , may be reported with the bilateral modif ier 50, or modif iers LT and RT. E. Conditions of CoverageNA Bilateral Pro ced ures-OH MCD-AD-1055 Effective Date: 06/01/2023 The ADMINISTRATIVE Policy Statement detailed abo ve has recei ved d ue con sideration as defined in theADMINISTRATIVE Policy Statement Policy and is app roved.F. Related Policies/RulesNA G. Review/Revision HistoryDATES ACTIONDate Issued 06 /01/2021 New policyDate Revised 02/03/2021 01/18/2023Policy converted f rom reimbursement policy PY – 0012. No changes to content. Updated ref erences. Date Effective 06/01/2023 Date Archived H. Ref erences1. Centers f or Med icare & Medicaid. ( 12/06/2022 ). Medicare Claims Processing Manual Chapter 3 – Inpatient Hospital Billing. Retrieved on January 5, 2023, f rom www.cms.gov 2. Centers f or Medicare & Medicaid. ( 12/08/2022 ). Medicare Claims Processing Manual Chapter 12 – Physicians/Nonphysician Practitioners. Retrieved on January 5, 2023, f rom www.cms.gov 3. Centers f or Medicare & Medicaid. (12/ 08 22 /2017). Medicare Claims Processing Manual Chapter 14 – Ambulatory Surgical Centers. Retrieved on January 5, 2023, f rom www.cms.gov 4. Centers f or Medicare & Medicaid. (12/02/2022). Medicare Claims Processing Manual Chapter 23 – Fee Schedul e Administration and Coding Requirements. Retrieved on January 5, 2023 f rom www.cms.gov
Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessar y 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, illne ss, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy S tatements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contra ct (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan c ontract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Non-Invasive Vascular Studies-OH MCD-AD-1117 05/01/2023 Policy Type ADMINISTRATIVE Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. ………………………… 2 B. Background ………………………….. ………………………….. ………………………….. ………………….. 2 C. Def initions ………………………….. ………………………….. ………………………….. ……………………. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. ….. 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. …. 3 H. Ref erences ………………………….. ………………………….. ………………………….. …………………… 3 No n-Invasive Vascular Stud ies-OH MCD-AD-1117 Effective Date: 05/01/2023 Th e ADMINISTRATIVE Po licy Statemen t detailed abo ve h as received d ue consideration as d efined in th e ADMINISTRATIVE Po licy Statemen t Po licy an d is ap p roved. A. SubjectNon-Invasive Vascular Studies B. BackgroundNon-invasive vascular studies utilize ultrasound to assess irregularities in blood f low in arterial and venous systems. Testing can be perf ormed in a vascular laboratory and at the bedside and is of ten the f irst step in diagnosing vascular disease. Results may display as a two-dimensional image with a spectral analysis and color f low. The results of these tests will determine the need f or more non-invasive testing or procedures to treat vascular disease. C. Def initions Duplex scan a non-invasive evaluation of blood flow through the arteries and veins, by combining the use of Doppler ultrasound with two-dimensional structure and motion with time and spectrum analysis and/or color f low velocity or mapping. Non-invasive testing utilize s various types of technology to evaluate f low, perf usion, and pressures within the vessels at rest and with exercise. D. PolicyI. Non-invasive vascular study includes: A. Providing patient care during the study B. Supervision of the procedure C. Interpretation of study results with hard copy output or digital storage of imaging is acceptable. II. All non-invasive vascular diagnostic studies must be performed under at least one of the f ollowing situations: A. Perf ormed by a physician who is competent in diagnostic vascular studies or under the general supervision of physicians who have demonstrated minimum entry level competency by being credentialed in vascular technology. 1. The physician perf orming and/or interpreting the stu dy must be capable of demonstrating documented training and experience and maintain any applicable documentation upon CareSources request. B. Perf ormed by a technician who is certified in vascular technology 1. The Technician perf orming the study must be capabl e of demonstrating documented training and experience and maintain any documentation upon CareSource request. III. Duplex scanning and physiologic studies may be reimbursed during the same encounter if the physiologic studies are abnormal and/or to evaluate vascular trauma, thromboembolic events or aneurysmal disease, if the physician/provider can document medical nece ssity in the patients medical record. A. The use of any Doppler device that produces a record but does not permit analysis of bidirectional vascular f low or that does not provide a hard copy or printout is part of the physical exam of the vascular system and is not reported separately. No n-Invasive Vascular Stud ies-OH MCD-AD-1117 Effective Date: 05/01/2023 Th e ADMINISTRATIVE Po licy Statemen t detailed abo ve h as received d ue consideration as d efined in th e ADMINISTRATIVE Po licy Statemen t Po licy an d is ap p roved. IV. Noninvasive vascular studies are considered medically necessary when the f ollowing criteria are met: A. The member experiences significant signs/symptoms of arterial or venous disease; B. The inf ormation provided by the test is required f or medical and/or surgical decision making; and C. The test is not redundant to other diagnostic procedures that will be perf ormed. V. CareSource may request documentation to support medical necessity, including the non-invasive vascular study hard copy or digital copy results. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATES ACTIONDate Issued 12/15/2021 Replacing PY-0163. Approved at PGC.Date Revised 12/14/2022 No changes to content. Updated ref erences Date Effective 05/01/2023 Date Archived H. Ref erences1. Leers, S. A. (2004). Duplex Ultrasound. Retrieved 11/15/2022 f rom www.vascular.org. 2. Rule 5160-1-01 | Medicaid medical necessity: definitions and principles. Ohio Administrative Code. (2015, March 22). Retrieved 11/15/2022 from www.codes.ohio.gov. 3. Non-invasive Testing f or Vascular Disease. (202 1, September 20). Retrieved 11/15/2022 from www.my.clevelandclinic.org. 4. Freeman S, Bertolotto M, Richenberg J. (2020, January 30). Ultrasound evaluation of varicoceles: Guidelines and recommendations of the European Society of Urogenital Radiology Scrotal and Penile Imaging Working Group (ESUR-SPIWG) f or detection, classif ication, and grading. Retrieved 11/15/2022 f rom www.pubmed.ncbi.nlm.nih.gov. 5. Bertolotto M, et al. (2020, December 23). Ultrasound evaluation of varicoceles: systematic literature review and rationale of the ESUR-SPIWG Guidelines and Recommendations. Retrieved 11/15/2022 from www.pubmed.ncbi.nlm.nih.gov. 6. Jedrzejewski G, Wieczorek AP, Osemlak P, Nachulewicz P. (2016 December). The role of ultrasound in the management of undescended testes bef ore and af ter orchidopexy-an update. Retrie ved 11/15/2022 f rom www.pubmed.ncbi.nlm.nih.gov. 7. McLaren PSM. (2021 August), A systematic review on the utility of ultrasonography in the diagnosis of testicular torsion in acute scrotum patients. Retrieved 11/15/2022 f rom www.pubmed.ncbi.nlm.nih.gov.
Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-AD-1129 05/01/2023-05/31/2024 Policy Type ADMINISTRATIVE Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-AD-1129 Effective Date: 05/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. A. SubjectApplied Behavior Analysis Therapy for Autism Spectrum Disorder B. Background Autism Spectrum Disorder (ASD) can vary widely in severity and symptoms, depending on the developmental level and chronological age of the patient. ASD is often defined by specific impairments that affect socialization, communication, and stereotyped (repetitive) behavior. Children with autism spectrum disorders have pervasive clinically significant deficits which are present in early childhood in areas, such as intellect ual functioning, language, social communication and interactions, as well as restricted, repetitive patterns of behavior, interests and activities. There is currently no cure for ASD, nor is there any one single treatment for the disorder. Individuals wit h ASD may be managed through a combination of therapies, including behavioral, cognitive, pharmacological, and educational interventions. The goal of treatment for members with ASD is to minimize the severity of ASD symptoms, maximize learning, facilitate social integration, and improve quality of life for both the members and their families/caregivers. C. Definitions Autism Spectrum Disorder – (ASD) Any of the following pervasive developmental disorders as defined by the most recent version of the Diagnostic and Statistical Manual of Mental Disorders (American Psychiatric Association): Autism; Asperger's Disorder or other condition that is specifically categorized as a pervasive developmental disorder. Applied Behavior Analysis – (ABA) A preventive service for ASD. BCaBA-Behavioral Analyst Certification Board (BACB) -certified assistant behavior analyst undergraduate level. BCBA-BACB certified behavior analyst graduate level. BCBA-D – BACB certified behavior analyst doctoral level. RBT-BACB Registered behavioral technician. Supervision-All supervisory activities as well as supervisor and supervisee responsibilities will be in accordance with the board from which the practitioner received a license. o Services delivered by a RBT must be supervised by a qualified RBT supervisor.o Services delivered by a BCaBA must be supervised by a BCBA, BCBA-D or a licensed/ registered psychologist certified by the American Board of Professional Psychology in Behavioral and Cognitive Psychology who has tested in ABA. o A registered behavior technician (RBT), certified by the National Behavior Analyst Certification Board (BACB), may provide ABA under the supervision of an independent practitioner. In order to provide services, they have to enroll in the Marketplace progra m and affiliate with the organization under which they are employed or contracted. RBT Supervision-Ongoing supervision must be at a minimum of 5% of the hours spent providing behavior-analytic services per month. This includes a minimum of 2 face-to-face contacts per month. Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-AD-1129 Effective Date: 05/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. D. PolicyI. Medical necessity review is required for all ABA services. A. Baseline then every 6 months thereafter or sooner, if clinically necessary. B. Medical necessity documentation must be submitted with appropriate documentation as indicated in the medical policy. II. An ASD diagnosis by a qualified practitioner is required in order for services to be reviewed for approval. III. Limitations A. A medically unlikely edit (MUE) for a CPT code is the maximum units of service that a provider can report for one member on one date of service. 1. Maximum units allowed per CPT code: CPT Max unit allowed97151 32 97152 16 97153 32 97154 18 97155 24 97156 16 97157 16 97158 16 0362T 16 0373T 32 NOTE: If CMS updates the MUE list, which generally occurs on a quarterly basis, the update will take precedence over the MUEs in this policy. B. Each RBT must obtain ongoing supervision for a minimum of 5% of the hours spent providing behavior-analytic services per month. C. The treatment codes are based on daily total units of service in 15 minute increments. A unit of time is attained when the mid-point is passed. Time interval examples:Units Number of minutes1 unit >8 minutes through 22 minutes 2 units >23 minutes through 37 minutes 3 units >38 minutes through 52 minutes 4 units >53 minutes through 67 minutes 5 units >68 minutes through 82 minutes 6 units >83 minutes through 97 minutes 7 units >98 minutes through 112 minutes 8 units >113 minutes through 127 minutes Applied Behavior Analysis for Autism Spectrum Disorder-OH MCD-AD-1129 Effective Date: 05/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. D. The Ohio Department of Medicaid (ODM) allows Mental Health Community Behavioral Health Centers (CBHCs) provider type 84s to render and be reimbursed for ABA services using the service code H0036-Community Psychiatric Supportive Treatment (CPST). 1. CareSource strongly encourages CBHCs to use the ABA CPT codes outlined here for the purposes of billing for ABA services but does accept CPST (H0036) as a service code for ABA services when submitted by an appropriately certified CBHC. 2. Expectations of this policy and the Applied Behavior Analysis for Autism Spectrum Disorder Medical policy apply to any ABA services whether they are billed using ABA CPT codes or CPST (H0036).E. Conditions of Coverage Payments may be subject to limitations and/or qualifications and will be determined when the claim is received for proces sing. Program Integrity will be engaged for an annual review of data When the member has other insurance, Medicaid is always the payor of last resort. CareSource will not pay more than the Medicaid rates total for service. Primary payer must provide evidence of determination for consideration of Medicaid coverage for services. F. Related Policies/Rules Applied Behavior Analysis for Autism Spectrum Disorder Medical policy G. Review/Revision History DATES ACTIONDate Issued 09/01/2021 New Policy-replaced reimbursement policyDate Effective 05/01/2023 Date Revised 03/30/2022 01/04/2023E-voted ODM changes including allowing ABA service provided by CPST and entire section III.D No changes to policy. Updated rferences. Date Archived 05/31/2024 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy H. References1. Behavior Analyst Certification Board. (2018, October 8). Adaptive Behavior Assessment and Treatment Code Conversion Table. Retrieved January 3, 2023 from www.bacb.com. 2. American Medical Association. (2018). Coding Update: Reporting Adaptive Behavior Assessment and Treatment Services in 2019. CPT Assistant, 28(11). 3. The Council of Autism Service Providers. (2020). Applied Behavior Analy sisApplied Behavior Analysis for Autism Spectrum Disorder-OH MCD-AD-1129 Effective Date: 05/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. Treatment of Autism Spectrum Disorder: Practice Guidelines for Healthcare Funders and Managers. Retrieved on January 3, 2023 from www.casproviders.org. 4. Behavior Analyst Certification Board. (2019, February). Clarifications Regarding Applied Behavior Analysis Treatment of Autism Spectrum Disorder. (2nd ed.). Retrieved January 3, 2023 from www.bacb.com. 5. Ohio Revised Code. (2017, April 6). 39.23.84 Coverage for autism spectrum disorder. Retrieved January 3, 2023 from www.codes.ohio.gov. 6. Ohi o Revised Code. (n.d.). 4783 Behavior Analysts . Retrieved January 3, 2023 from www.codes.ohio.gov. 7. Ohio Revised Code. (2021, January 1). 1751.84v2 Coverage for autism spectrum disorder (2017). Retrieved January 3, 2023 from www.codes.ohio.gov.
Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CSMG Co. and its affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract ( i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. Administrative Policy StatementOHIO MEDICAID Policy Name Policy Number Date Effective Medical Necessity Off Label PAD-0004-OH-MCD 01/01/2023 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Table of ContentsAdministrative Policy Statement ……………………………………………………………………………………… 1 A. Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 2 E. Conditions of Coverage ………………………………………………………………………………………….. 3 F. Related Policies/Rules ……………………………………………………………………………………………. 3 G. Review/Revision History …………………………………………………………………………………………. 3 H. References …………………………………………………………………………………………………………… 3 2 A. Subject Medical Necessity Off Label Medical Necessity Off Label Ohio Medicaid PAD-0004-OH-MCD Effective Date: 01/01/2023B. BackgroundThe U.S. Food and Drug Administration (FDA) approves drugs for specific indications included in the drugs product information label. Off-label or unlabeled drug use is the utilization of an FDA approved drug for uses other than those listed in the FDA approved labeling or in treatment regimens or populations that are not included in approved labeling. Many off-label uses are effective, well documented in the peer-reviewed literature, and widely used even though the manufacturer has not pursued the additional indications. The FDA advises physicians use of off-label or unlabeled drugs must be done in a well-informed manner in conjunction with fi rm scientific rationale and medical evidence. CareSource will employ, at its discretion, drug utilization management programs (i.e., prior authorization) to ensure appropriate and safe use of medications.NOTE: The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic or lab. This policy informs providers about when a service may be covered.C. Definitions FDA Approved medication: Is the official description of a drug product which includes indication; who should take it; adverse events; instructions for uses in pregnancy; children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging. Off-label or unlabeled drug use : Is the use of a drug approved by the U.S. Food and Drug Administration (FDA) for other uses that are not included in approved labeling. The FDA approves drugs for specific indications that are included in the drugs labeling. When a drug is used for an indication other than those specifically included in the labeling, it is referred to as an off-label use. Many off-label uses are effective, well documented in the literature, and widely used. D. PolicyCareSource will review prior authorization requests for coverage based on medical necessity. This policy will not supersede drug-specific criteria developed and approved by the CareSource Pharmacy and therapeutics Committee (P&T). Requests for off-label uses of a drug will be considered for approval according to the following criteria: I. Documentation must be submitted showing the member has tried and failed the existing FDA approved and/or clinical guideline recommended therapies unless contraindicated or not tolerated; ANDII. The prescribed use must be supported by one or more of the follow ing: a. Narrative information from American Hospital Formulary Service Drug Informatio 4 Medical Necessity Off Label Ohio Medicaid PAD-0004-OH-MCD Effective Date: 01/01/2023 (AHFS) or Clinical Pharmacology Lexicomp: Evidence level A Micromedex: Recommendation class I, IIa, or IIb Evidence from at least two published studies from major scientific or medical peer reviewed journals demonstrates safety and efficacy for the specified condition in a comparable population (i.e., age group, level of disease severity, etc.) If app licable clinical trial is yet to be published but interim results are supportive, this may be taken into consideration by the clinician reviewer . NOTE: F or off-label use of oncology drugs, please refer to the policy titled Oncology Regimens accessible from the CareSource website. E. Conditions of CoverageAUTHORIZATION PERIOD Approved authorizations are designated an appropriate authorization period. Continued treatment may be considered when the member has shown tolerability and a positive clinical response. F. Related Policies/Rules Oncology Regimens G. Review/Revision History DATES ACTIONDate Issued 06/06/2013Date Revised 10/30/2014 Added definition to excluded indications 05/05/2015 Removed indications in reference of plan specific member handbooks, EOC, etc. Removed specialty and subspecialty associations and combined with no determinations policy12/15/2015 Revised class/category and defined evidence criteria for article submissions 01/11/2018 Updated format02/12/2021 Updated format, copied to new template. General edits for clarity. Added note about clinical trials in progress. Removed content related to orphan drugs and compassionate use. Removed cancer drug section and refer to separate policy. Added component that member must try and fail available FDA approved on label drugs first. Amended list of acceptable compendia to include Lexicomp. Updated reference section.11/02/2022 Updated the title of the oncology policy that isreferenced. No other changes.Date Effective 01/01/2023 H. References 1. Medical Benefit Policy Manual. CMS website. Updated August 7, 2020. Accessed February 12, 2021. https://www.cms.gov/Regulations-and-c. d. 6 The Administrative Policy Statement detailed above has received due consideration as defined in the Administrative Policy Statement Policy and is approved. Medical Necessity Off Label Ohio Medicaid PAD-0004-OH-MCD Effective Date: 01/01/2023Guidance/Guidance/Manuals/Downloads/bp102c15.pdf This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC.
Admin istrative Policy Statement OHIO MEDICAID Policy Name Policy Number Date Effective Medical Necessity for Non-Formulary Medications PAD-0001-OH-MCD 01/01/2023 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Administrative Policy Statement s prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. A dministrative Pol icy Statements prepared by CSMG Co. and its affiliates (including CareSource) 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 serv ice(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract ( i.e., Evidence of Coverage), then the plan contract ( i.e., Evidence of Coverage) will be the controlling document used to make the determination .Table of ContentsAdministrative Policy Statement ……………………………………………………………………………………. 1 A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage …………………………………………………………………………………………. 4 F. Relat ed Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Archived Medical Necessity for Non-Formulary Medications Ohio Medicaid PAD-0001-OH-MCD Effective Date: 01/01/20232A. Subject CareSource uses a formulary medication list that is established, reviewed and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee and the regulatory bodies in each state in which CareSource functions. The formulary is reviewed routinely, and medication can be removed from the formulary list when the brand name becomes generically available or when it is no longer cost-effective compared to other existing or newer products. For new drugs or new indications for drugs, the P&T Committee generally reviews for formulary status decision after 180 days from market release. CareSource will follow the guidance of the state Medicaid programs in the states that it services to enforce clinically appropriate lower cost agents as first line therapy for our formulary agents. B. Background The intent of CareSource Pharmacy Policy Statements is to encourage appropriate selection of members for therapy according to product labeling, clinical guidelines, and/or clinical studies as well as to encourage use of formulary agents. The CareSource Pharmacy Policy Statement is a guideline for determining health care coverage for our members with benefit plans covering prescription drugs. Pharmacy Policy Statements are written on selected prescription drugs requiring prior authorization or step therapy. The Pharmacy Policy Statement is used as a tool to be interpreted in conjunction with the member's specific benefit plan. NOTE: The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic or lab. This policy informs providers about when a service may be covered. C. Definitions Clinical Judgment: decisions made within the scope of the expertise of a pharmacist following the review of subjective and objective medical data for a member. A pharmacist can use Clinical Judgment for a benefit determination for an exception request for a Non-Formulary Drug. If the request is outside the scope of a pharmacists expertise, a benefit determination will be made in collaboration with a medical director. Drug: a medication or substance which induces a physiologic effect on the body of a member (i.e., medication, agent, drug therapy, treatment, product, biosimilar drugs, etc.). Formulary Drug List: a list of prescription drugs which includes a group of selected generic and brand-name drugs which are covered by CareSource. Medical Necessity: health care services, supplies, or drugs needed to diagnose, treat or prevent illness, injury, conditions, diseases or the associated symptoms in accordance with accepted standards in the practice of medicine. Medical necessity will be evaluated based on the overall health and well-being of the member and when the members day to day health would be impacted. Non-Formulary Drug: a drug not on the Formulary Drug List. D. Policy CareSource will approve the use of non-formulary medications and consider their use as medically necessary when the following criteria have been met for situations as listed below. This policy will not supersede drug-specific criteria developed and approved by the CareSource P&T Archived Medical Necessity for Non-Formulary Medications Ohio Medicaid PAD-0001-OH-MCD Effective Date: 01/01/20233Committee nor drug or therapeutic category benefit exclusions. Prior authorization requests should be submitted for each non-formulary medication with chart notes and documentation supporting medical necessity. Initial Criteria: I. In accordance with the drugs package insert, the requested medication meets ALL of the following: a. FDA-approved indication and age; b. FDA-approved dosage; c. Member does not have any contraindication; AND II. Chart notes along with any relevant screening results are provided to confirm the diagnosis; AND III. The requested medication is being prescribed by or in consultation with an appropriate specialist, when applicable ( e.g., a formulary product from the same class requires a specialist in its prior authorization criteria, or the indication is a complex/rare disease state likely to require experience managing the specific diagnosis ); AND IV. Documentation has been provided supporting one of the following: a. Adequate trial and failure or intolerance of ALL formulary alternatives in the same drug class that can be used for the same diagnosis ( start/end dates must be provided or if member was a CareSource member during trial, must have paid claims in history ); OR b. If there is no alternative in the same drug class, must have adequate trial and failure or intolerance of TWO formulary alternatives, if available, that can be used for the requested indication according to clinical guidelines or standard of care ( start/end dates must be provided or if member was a CareSource member during trial, must have paid claims in histor y); OR c. Member has contraindication to ALL other formulary medications based on the members diagnosis, medical conditions, or other medication therapies; OR d. There are no other medications available on the formulary to treat members condition (e.g., orphan drug); AND V. If the requested medication is a combination product, the member has also tried a 90-day trial of the active ingredients separately taken at the same time AND a clinical reason supported by chart notes why the separate agents cannot be used ( request for the purpose of convenience does not meet medical necessity ); AND VI. If the requested medication is a long-acting product, the member has also tried a 90-day trial of a short-acting product AND/OR have a clinical reason why the short-acting product c annot be used. Initial approval i s limited to the length of request but no more than 6 months. Renewal Criteria: I. Chart notes have been provided showing the member has had a positive response to therapy; AND II. The requested use and dosage remain consistent wi th FDA-approved prescribing information in the drug package insert. Renewal approval is limited to the length of request but no more than 12 months. Notes: Adequate trial is defined as a stable dose for up to 90 days or a duration specified in treatment guidelines or package insert as a sufficient duration to observe benefit fromArchived Medical Necessity for Non-Formulary Medications Ohio Medicaid PAD-0001-OH-MCD Effective Date: 01/01/20234treatment. The pharmacist reviewer may also use clinical judgement to determine a sufficient duration of treatment. The members medication trials and adherence are determined by review of pharmacy claim data over preceding 12 months or as reported in chart notes. Additional informati on may be requested on a case-by-case basis to complete the clinical review. All other uses of Non-Formulary medications are considered experimental/investigational;therefore, will follow CareSources Medical Necessity Off Label policy.Any request for a non-formulary branded medication when a generic is available must follow CareSources Medical Necessity for DAW policy. E. Conditions of Coverage As above. F.Related Policies/Rules Medical Necessity for DAWMedical Necessity Off Label G. Review/Revision History DATE S ACTION Date Issued 12/06/2013 Date Revised 08/01/2020 Policy copied to a new template. The diagnostic requirement and drug trial requirement revised . Added durations for initial authorization and reauthorization. Added reauthorization criteria. 11/08/2022 Section Dpart III: Added complex/rare disease states. Changed renewal duration from up to 6 months to up to 12 months. Date Effective 01/01/2023 Date Archived H. References Not applicable.This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC.The Administrative Policy Stateme nt det ailed a bove has r eceived due con side ration as defined in the Administrative Policy Stateme nt Po licy a nd is a pprove d.Archived
Administrative Policy Statement OHIO MEDICAID Policy Name Policy Number Date Effective Medical Necessity for DAW PAD-0005-OH-MCD 01/01/2023 Policy Type Medical ADMINISTRATIVE Pharmacy Reimbursement Administrative Policy Statement s prepared by CSMG Co. and its affiliates (including CareSource) are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. A dministrative Policy Statements prepared by CSMG Co. and i t s affiliates (including CareSource) do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If t here is a conflict between the Administrative Policy Statement and the plan contract ( i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination.Table of ContentsAdministrative Policy Statement ……………………………………………………………………………………. 1 A. Subject ……………………………………………………………………………………………………………….. 2 B. Background …………………………………………………………………………………………………………. 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage …………………………………………………………………………………………. 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 4 Archived Medical Necessity for DAW Ohio Medicaid PAD-0005-OH-MCD Effective Date: 01/01/20232A. Subject CareSource uses a formulary medication list that is established, reviewed and approved by the CareSource Pharmacy and Therapeutics (P&T) Committee and the regulatory bodies in each state in which CareSource functions. The formulary is reviewed routinely, and medication can be removed from the formulary list when the brand name becomes generically available or when it is no longer cost-effective compared to other existing or newer products. For new drugs or new indications for drugs, the P&T Committee generally reviews for formulary status decision after 180 days from market release. CareSource will follow the guidance of the state Medicaid programs in the states that it services to enforce clinically appropriate lower cost agents as first line therapy for our formulary agents. B. Background The intent of CareSource Pharmacy Policy Statements is to encourage appropriate selection of members for therapy according to product labeling, clinical guidelines, and/or clinical studies as well as to encourage use of formulary agents. The CareSource Pharmacy Policy Statement is a guideline for determining health care coverage for our members with benefit plans covering prescription drugs. Pharmacy Policy Statements are written on selected prescription drugs requiring prior authorization or step therapy. The Pharmacy Policy Statement is used as a tool to be interpreted in conjunction with the member's specific benefit plan. NOTE : The Introduction section is for your general knowledge and is not to be construed as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals and is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider can also be a place where medical care is given, like a hospital, clinic or lab. This policy informs providers about when a service may be covered.C. Definitions Allergic Reaction: an allergic reaction, as defined by the American Academy of Allergy Asthma & Immunology, occurs when the immune system overreacts to a harmless substance. Types of allergic symptoms to medications range from skin rashes or hives, itching, respiratory problems, and swelling to anaphylaxis. All medications have the potential to cause side effects, but only about 5 to 10% of adverse reactions to drugs are allergic.1 Clinical Judgment: decisions made within the scope of the expertise of a pharmacist following the review of subjective and objective medical data for a member. A pharmacist can use Clinical Judgment for a benefit determination for an exception request for a Non-Formulary Drug. If the request is outside the scope of a pharmacists expertise, a benefit determination will be made in collaboration with a medical direct or. DAW: dispense as written. Drug: a medication or substance which induces a physiologic effect on the body of a member (i.e., medication, agent, drug therapy, treatment, product, biosimilar drugs, etc.). Formulary Drug List: a list of prescription drugs which includes a group of selected generic and brand-name drugs which are covered by CareSource. Medical Necessity: health care services, supplies, or drugs needed to diagnose, treat or prevent illness, injury, conditions, diseases or the associated symptoms in accordance with accepted standards in the practice of medicine. Medical necessity will be evaluated based on the overall health and well-being of the member and when the members day to day health would be impacted. Non-Formulary Drug: a drug not on the Formulary Drug List. Archived Medical Necessity for DAW Ohio Medicaid PAD-0005-OH-MCD Effective Date: 01/01/20233D. Policy CareSource will approve the use of DAW medications and consider their use as medically necessary when the following criteria have been met. This policy will not supersede drug-specifi c c riteria developed and approved by the CareSource P&T Committee nor drug or therapeutic category benefit exclusions. Prior authorization requests should be submitted for each non-formulary medication with chart notes and documentation supporting medical necessity.I. Member has tried and failed bot h of the following: A.Two generic manufacturers of the requested brand name medication at an adequat e dos e for an adequate duration (information must be provided regarding the treatment target or goal that was inadequately met) ANDB. All formulary alternatives within the same drug class as the requested brand name medication that have an FDA-approved indication to treat the members condition OR II. T he member had a serious adverse event with the generic version(s) and the prescriber has provided a copy and confirmation of a MedWatch form submission to the FDAdocumenting the adverse outcome experienced by the member that includes one of th e f ollowing (Note: The MedWatch form is available at https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf ):A.Was life threateningB. Required hospitalizationC. Caused disability or permanent damageD. Required intervention to prevent permanent impairment/damage OR III. Mem ber has a history of allergic reaction to an inactive ingredient in the generic product and the prescriber has documented the inactive ingredient, the reaction (dates and clinical details), and the manufacturer of the generic product. I V. Initial approval duration for DAW product request: up to 6 months V.S ubsequent approvals may be renewed for up to 12-month durations, such that chart notes are submitted with the request which clearly document all of the following:A. I nitial criteria were previously metB. P ositive clinical response to therapy with the requested brand name productC. N o toxicities or serious adverse reactions have been experienced with the brand n ame pr oduct A ll other uses of Brand Name Medications are considered not medically n ecessary. R equests will not be approved for treatment of non-FDA approved diagnoses or conditions not supported by compendia evidence. Please refer to the Medical Necessity Off-Label policy. N otes: If the requested medication has a Medication Specific Policy, the member will need t o meet those requirements in addition to the DAW policy. The start date and duration of the trial must be provided.There must be paid claims if the member was enrolled with CareSource when a trial of a medication occurred.Documented diagnoses must be confirmed by portions of the individuals medical record which need to be supplied with prior authorization requests. These medical records may include, but are not limited to test reports, chart notes from providers office,or hospital admission notes. Archived Medical Necessity for DAW Ohio Medicaid PAD-0005-OH-MCD Effective Date: 01/01/20234Refer to the product package insert for dosing, administration and safety guidelines . E. Conditions of Coverage As above. F.Related Policies/Rules Medical Necessity Off Label G.Review/Revision History DATES ACTION Date Issued 08/01/20 18 Date Revised 08/01/2020 Reviewed content, transferred to new template, added note about non-coverage of off-label/non-supported use. 10/28/2022 Section D, part I: Changed bullet A to address inefficacy rather than adverse events, since adverse events are addressed in part II. Created criteria to specify durations of approval and requirements for re-authorization. Made grammatical/wording changes f or readability. Date Effective 01/01/2023 Date Archived H.References 1. deShazo RD, Kemp SF. Allergic reactions to drugs and biologic agents. JAMA.1997;278:1895 906. This guideline contains custom content that has been modified from the standard care guidelines and has not been reviewed or approved by MCG Health, LLC. The Administrative Policy Stateme nt det ailed a bove has r eceived due con side ration as defined in the Administrative Policy Stateme nt Po licy a nd is a pprove d.Archived
ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Impacted Cerumen Removal-OH MCD-AD-1059 03/01/2023 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services . Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Eviden ce 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 Policies/Rules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3 Impacted Cerumen Removal-OH MCD-AD-1059 Effective Date: 03/01/2023 The ADMINISTRATIVE Polic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.A. SubjectImpacted Cerumen Removal B. Background Cerumen or ear wax is a normal substance that cleans, protects, and lubricates the ear canal. The cerumen can block the ear canal causing symptoms such as pain, hearing loss, fullness, itching, and tinnitus. Methods to removal the cerumen include irrigation, manual removal with instrumentation, and cerumenolytic agents. Cerumen removal may require a physician when methods such as irrigation or removal by cotton-tipped applicator s are not sufficient. C. Definitions Cerumen Impaction An accumulation of cerum en that is associated with symptoms and/or prevents a necessary ear examination. Modifier Two-character code used along with a CPT or HCPCS code to provide additional information about the service or procedure rendered. Modifier 25 Significant, Separat ely Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service. Modifier 59 Distinct Procedural Service. National Correct Coding Initiative (NCCI) A program developed by CMS to promote national correct coding and to prevent improper payment when incorrect code combinations are reported. D. Policy I. Claims submission for cerumen impaction should include the appropriate CPT code and ICD-10 code, such as: A. ICD-10 1. Impacted cerumen, unspecified ear; 2. Impacted cerumen, right ear ; 3. Impacted cerumen, left ear , or 4. Impacted cerumen, bilateral. B. CPT 1. Removal impacted cerumen using irrigation/lavage, unilateral; 2. Removal impacted cerumen requiring instrumentation, unilateral; or 3. Removal of impacted cerumen (one or both ears) by physician on same date of service as audiologic function testing. NOTE: Visualization aids, such as, but not limited to binocular microscopy, are considered to be included i n the CPT code and should not be billed separately . II. Evaluation and management (E&M) visit A. Impacted cerumen An E&M service may not be billed when the sole reason for the visit is to remove symptomatic impacted cerumen. Impacted Cerumen Removal-OH MCD-AD-1059 Effective Date: 03/01/2023 The ADMINISTRATIVE Polic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.1. An E&M service on the same day as rem oval of impacted cerumen may not be billed unless it represents and is documented to be a significant, separately identifiable service on the same day. B. Non impacted cerumen 1. For removal of cerumen that is not impacted, use the E&M service code. III. Modifiers A. Use modifier 25, 59, and/or 50, when appropriate. B. Follow NCCI guidelines, and use appropriate modifiers, as applicable. C. For bilateral procedures, use Centers for Medicare & Medicaid Services (CMS) guidelines. D. Separate payment is only justified when a modifier 59 or 25 is appended indicating the following: 1. Removal of symptomatic impacted cerumen; 2. Impacted cerumen impeding a physicians ability to properly evaluate or manage other signs, symptoms or conditions; or 3. Impacted cerumen impeding a physici ans or audiologists ability to perform covered audiometry. NOTE: Documentation confirming impacted cerumen and justification of the use of modifier 25 or 59 must be submitted with the claim to support medical necessity.E. Conditions of Coverage NA F. Related Policies/Rules Modifier 25 Reimbursement policy Modifier 59 Reimbursement policy G. Review/Revision History DATES ACTIONDate Issued 12/01/2020Date Revised 07/07/2021 07/20/2022 10/26/2023Removed no prior authorization needed. Added CMS reference. Referenced MM-1033. Removed Medical policy reference. Updated other references. No other changes. Added modifier 25, 50 and 59 criteria and attachment requirement. Related policies Modifier 25; Modifier 59Date Effective 03/01/2023 Date Archived H. References 1. Centers for Medicare & Medicaid Services. Local Coverage Determination Cerumen Removal L33945. (2021, February 4). Retrieved July 5, 2022 from www.cms.gov . Impacted Cerumen Removal-OH MCD-AD-1059 Effective Date: 03/01/2023 The ADMINISTRATIVE Polic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.2. Schwartz, S., Magit, A., and Rosenfeld, R. (2017, January 3). Clinical Practice Guideline (Update): Earwax (Cerumen Impaction). 156(1). Suppl. 2017 S1-S29. www. doi.org.
ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Trading Partners-OH MCD-AD-0086 02/01/2023 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry s tandards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or i njury and wit hout which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the 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 M anuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the E vidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Cove rage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limita tions that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. …………………….. 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. . 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 2 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……. 2 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 2 H. References ………………………….. ………………………….. ………………………….. ……………………. 3 Trading Partners-OH MCD-AD-0086Effective Date: 02/01/2023 The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined inthe ADMINISTRATIVE Policy Statement Policy and is approved.A. SubjectTrading Partners B. BackgroundCareSource accepts electronic claims submissions to increase the efficiency of claims processing. CareSource has specific requirements regarding electronic claims submission. This policy applies to providers who want to directly connect with CareSource for electronic filing along with trading partners and clearinghouses not already contracted with CareSource and the electronic claims submission process. C. Definitions Clearinghouses/Trading Partners Companies that function as intermediaries who forward cla ims information from healthcare providers to insurance payers. Direct Connections Direct electronic claims submissions to CareSource without the use of a clearinghouse/trading partner. Electronic Data Interchange (EDI) The computer-to-computer exchange of business data. D. PolicyI. CareSource only allows direct connections for EDI transactions with contracted trading partners/clearinghouses, States and Centers for Medicare and Medicaid Services (CMS). II. CareSource w ill not contract or approve direct connections with providers (e.g. ,hospitals, labs, offices, practitioners, etc.).III. New direct connection requests will not be granted unless they are fullydocumented and approved by CareSources I nformation Techno logy andOperations Executive Leadership. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATES ACTIONDate Issued 04/05/2018Date Revised 2/19/2020 01/19/2022 10/12/2022 Annual update completed. No changes Annual review. No changes No changes Date Effective 02/01/2023 Date Archived Trading Partners-OH MCD-AD-0086Effective Date: 02/01/2023 The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined inthe ADMINISTRATIVE Policy Statement Policy and is approved.H. References NA
ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 02/01/2023 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, natio nally 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 suppli es that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunctio n of a body organ or part, or si gnificant 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 inclu de those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statem ent 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), cove rage 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 ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 6 Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 A. Subject Sentinel Events (SE) and Provider Preventable Conditions (PPC) B. BackgroundMedical errors can cause harmful or disastrous results for patients. Others might be related to negligence or professional misconduct. Most are preventable. In 1996, The Joint Commission (TJC) introduced a formal sentinel event (SE) policy with an overarchi ng goal of improving patient care and preventing safety events. The National Quality Forum followed by developing an initial standardized list of Serious Reportable Events (SREs) to facilitate reporting of such occurrences. Since then, the list has been revised twice, most recently in 2011, and now consists of twenty-nine (29) events grouped into seven (7) categories. On June 30, 2011, Centers for Medicare and Medicaid Services published a final rule implementing the requirements of Section 2702 of the Pat ient Protection and AffordableCare Act, which directs the Secretary of Health and Human Services to issue Medicaid regulations prohibiting federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medi cal assistance for provider preventable conditions (PPCs) specified in the regulation. It also authorized States to identify other provider-preventable conditions for which Medicaid payment will be prohibited. There are two types of PPCs: health care-acqu ired conditions (HCAC), reported when occurring in inpatient acute care hospitals, and other provider – preventable conditions (OPPC), reported for any health care setting. The Provider Preventable Condition (PPC) Reduction Program encourages provider facili ties to improve patient safety and reduce the number of conditions experienced from inpatient stays, such as pressure ulcers. C. Definitions American Society of Anesthesiologists (ASA) 1 Status – A healthy, normal patient (e.g., nonsmoking, no acute or chronic illness). Centers for Medicare and Medicaid Services (CMS) – An agency within the United States Department of Health & Human Services responsible for the administration of several key fede ral healthcare programs. National Quality Forum (NQF) – A not for profit, nonpartisan, membership-based organization working to catalyze improvements in healthcare. NQF endorsement is considered the gold standard for healthcare quality, while NQF-endorsed measures are evidence-based, valid, and in tandem with the delivery of care and payment reform. Provider Preventable Condition (PPC) – A condition with a negative consequence for the member occurring in any healthcare setting found to be reasonably prevent able by the provider through the application of procedures supported by evidence-based medical guidelines and includes healthcare acquired conditions (HCACS) and other provider preventable conditions (OPPCs): o Healthcare Acquired Condition (HCAC) – Med ical conditions or complications that patients develop during a hospital stay not present on admission. HCACs apply to Medicaid inpatient hospital settings, are listed as Category 1, and Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 generally include the full list of Medicares previous inpatient h ospital acquired conditions (HAC). o Other Provider Preventable Condition (OPPC) – Conditions occurring in any health care setting that include, at a minimum, wrong surgical or other invasive procedure performed on a patient, surgical or other invasive procedure performed on the wrong body part, and/or surgical or other invasive procedure performed on the wrong patient pursuant to 42 CFR 447.26(b) and are referred to as Category 2. Sentinel Event (SE) – A patient safety event , not primarily related to the natural course of the patients illness or underlying condition , that results in death, severe harm , regardless of duration of harm, or permanent har m, regardless of severity of harm. o Severe Harm – An event or condition that reaches the individual, resulting in life – threatening bodily injury (including pain or disfigurement) that interferes with or results in loss of functional ability or quality of life that requires continuous physiological monitor ing or a surgery, invasive procedure, or treatment to resolve the condition. o Permanent Harm – An event or condition that reaches the individual, resulting in any level of harm that permanently alters and/or affects an individuals baseline. Serious Reportable Event (SRE) – Serious and costly errors in health care services that are usually preventable and harmful clinical events to beneficiaries . The Joint Commission (TJC ) – A private, nonprofit organization whose mission is to continuously improve t he safety and quality of care provided to the public through the provision of health accreditation and related services that support performance improvement in health care organizations. D. PolicySentinel Events (SE) and/ or Serious Reportable Events (SRE) CareSource will not reimburse for services associated with sentinel or serious reportable events. Notwithstanding any provision in the agreement between provider and CareSource to the contrary and in accordance with CMS guidelines, when any SE or SRE occur s with respect to a member, the provider shall neither bill, nor seek to collect from, nor accept any payment from CareSource or a member for such events. If the provider receives any payment from CareSource or a member, the provider shall refund payment t o the member or entity making the payment within ten (10) business days of becoming aware of such receipt. Further, the provider will cooperate with CareSource to the extent reasonable in any CareSource initiative designed to help analyze or reduce such ev ents. Services and procedures associated with SEs and/or SREs include but are not limited to: A. Surgical or Invasive Procedure Events: 1. Surgical procedure or surgery performed on the wrong body part 2. Surgery performed on the wrong patient 3. Wrong surgical proced ure performed on a patient 4. Intraoperative or immediately post-operative death in an ASA class I patient 5. Unintended retention of a foreign object B. Product or Device Events: Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 1. Patient death or serious disability associated with the use of contaminated drugs, devices, or biologics provided by the healthcare facility 2. Patient death or serious disability associated with the use or function of a device in patient care, in which the d evice is used or functions other than as intended 3. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a healthcare setting C. Patient Protection Events: 1. Patient suicide, or attempted suicide resulti ng in serious disability, while being cared for in a healthcare facility 2. Discharge or release of a patient/resident of any age, who is unable to make decisions 3. Patient death or serious injury associated with patient elopement D. Care Management Events: 1. Pa tient death or serious injury associated with a medication error 2. Patient death or serious injury associated with unsafe administration of blood products 3. Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a healthcare setting 4. Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy 5. Patient death or serious injury associated with a fall while being cared for in a healthcare setting 6. Any Stage 3, Stage 4 or unstageable pressure ulcers acquired after admission or presentation to a healthcare setting 7. Artificial insemination with the wrong donor sperm or wrong egg 8. Patient death or serious injury resulting from the irretrievable loss of an irreplaceable biological specimen 9. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology or radiology test results E. Environment al Events : 1. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in a healthcare setting 2. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas or are contaminated by toxic substances 3. Patient or staff death or serious injury associated with a burn incurred from any source during a patient care process in a healthcare setting 4. Patient death or serious injury associated with the us e of physical restraints or bedrails while being cared for in a healthcare setting F. Radiologic Events : 1. Death or serious injury of a patient or staff associated with the introduction of a metallic object into the MRI area G. Potential Criminal Events : 1. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist or other licensed healthcare provider 2. Abduction of a patient/resident of any age Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 3. Sexual abuse or assault on a patient or staff member within or on the ground s of a healthcare setting 4. Death or serious injury of a patient or staff member resulting from a physical assault that occurs within or on the grounds of a healthcare setting II. Provider Preventable ConditionsCareSource will not reimburse providers for provider preventable conditions, which consist of category 1 healthcare acquired conditions (HCACs) and category 2 other provider preventable conditions (OPPCs) in accordance with CMS guidelines. If CareSource ca n reasonably identify and isolate the portion of the claim which is directly related to the treatment of the HCAC, then CareSource will reduce the reimbursement of the claim by the specific amount related to the provider preventable condition. The level of reduction shall follow CMSs most recently published guidelines. The minimum set of conditions, including infections and events, that states must identify for non-payment are: A. HCACs, including but not limited to: 1. Catheter-associated urinary tract infections (CAUTI) 2. Stage 3 Or 4 pressure ulcers 3. Surgical site infection: orthopedic procedures, including spine, neck, shoulder and elbow 4. Surgical site infection, mediastinitis, following coronary artery by pass graft 5. Surgical site infection following bariatric surgery, including laparoscopic gastric bypass, gastroenterostomy, and laparoscopic gastric restrictive surgery 6. Surgical site infection following cardiac implantable electronic device (CIED) 7. Air embolism 8. Vascular catheter-associated infection 9. Blood incompatibility 10. Manifestations of poor glycemic control, including diabetic ketoacidosis, nonketotic hyperosmolar and hypoglycemic coma, secondary diabetes with ketoacidosis or h yperosmolarity 11. Falls and trauma, including fractures, dislocations, intracranial and crushing injuries, burns and/or other 12. Deep vein thrombosis (DVT)/ pulmonary embolism (PE) following certain orthopedic procedures, including total knee or hip re placement, and with some pediatric and obstetric exceptions 13. Foreign object retained after surgery 14. Iatrogenic pneumothorax with venous catheterization B. OPPCs, including but not limited to: 1. Wrong surgical or other invasive procedure performed on a member 2. Surgical or other invasive procedure performed on the wrong body part 3. Surgical or other invasive procedure performed on the wrong patient 4. OPPCs identified in a particular State plan, according to the requirements of the final regulation, including the following for the State of Ohio : 1, 2 & 3 above in section II. B. Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 III. Reporting A. Sentinel Events and Serious Reportable Events The Joint Commission collects and analyzes data from SEs reported by organizations. The de-identified data provides general awareness and dissemination of error prevention strategies to all hospitals. TJCs we bsite provides resources on SEs, statistics, webinars, and quick safety tips. Advantages of reporting SEs include increased awareness of potential events, root causes, and strategies for prevention, consultation with Joint Commission staff for systematic r eview and root cause analysis of events, and reinforcement of a culture of safety to the public regarding facilities. B. Provider Preventable Conditions Centers for Medicare and Medicaid Services (CMS) publish provider reporting requirements regarding HC ACs and Present on Admission indicators on the CMS website. CareSource complies with all federal and state regulations regarding reporting of and payment to providers and has identified a method for identifying reportableincidents from claims reporting to the Ohio Department of Medicaid (ODM), as required by ODM. This report is analyzed by the Clinical Quality & Health Safety (CQHS) team, who provides a PPC data report and analysis bi-annually for regulatory reporting and/or quality of care reporting. Claims dispute and appeal processes are in place for providers who disagree with nonpayment of claims and can be found online at www.caresource.com inthe provider portal and/or can be faxed or mailed directly to CareSources Provider Appeals Department.E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision History A DATES ACTION Date Issued 09/29/2021 New Policy Date Revised 09/29/2022 Annual review. Updated background and definitions. Added OH specific reporting requirements. Date Effective 02/01/2023 Date Archived H. References 1. Center for Medicare & Medicaid Services. Department of Health and Human Services. Code of Federal Regulations. 42 CFR.447.26. Prohibition on payment for provider-preventable conditions. Retrieved September 6, 2022 from www.cms.gov. 2. Centers for Medicar e & Medicaid Services. Hospital-Acquired Conditions. Last revised October 3, 2019. Retrieved September 6, 2022 from cms.gov. Sentinel Events and Provider Preventable Conditions-OH MCD-AD-1116 Effective Dat e: 02/01/2023 3. Center for Medicare & Medicaid Services. Department of Health and Human Services. Code of Federal Regulations. Subchapter C Me dical Assistance Programs. 42 CFR Part 438 Managed Care. Retrieved September 6, 2022 from cms.gov. 4. National Quality Forum (NQF). Never Events. Retrieved September 6, 2022 from www.cdc.gov . 5. Patra KP, De Jesus O. Sentinel Event. [Updated 2021 Oct 7]. In: StatPearls Treasure Island (FL): StatPearls Publishing; 2022 Jan . Retrieved September 22, 2022 from www.ncbi.nlm.nih.gov . 6. Ohio Administrative Code. Rule 5160-1-02. General Reimbursement Principles. (December 1, 2019). Retrieved October 3, 2022 from www.codes.ohio.gov.
ADMINISTRATIVE POLICY STATEMENT Ohio Medicaid Policy Name & Number Date Effective Policy Development Process-OH MCD-AD-0917 02/01/2023-12/31/2023 Policy Type ADMINISTRATIVE Table of Contents A.Subject ………………………………………………………………………………………………………………… 2 B. Background ………………………………………………………………………………………………………….. 2 C. Definitions ……………………………………………………………………………………………………………. 2 D. Policy ………………………………………………………………………………………………………………….. 3 E. Conditions of Coverage ………………………………………………………………………………………….. 4 F. Related Policies/Rules ……………………………………………………………………………………………. 4 G. Review/Revision History …………………………………………………………………………………………. 4 H. References …………………………………………………………………………………………………………… 4 Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industr y standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy. Policy Development Process-OH MCD-AD-0917 Effective Date: 02/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. A. SubjectPolicy Development Process B. BackgroundCareSource utilizes a systematic way to develop policies through a standard operating procedure that improves efficiency, increases productivity and quality, and provides consistent policy products to stakeholders and others. This process starts with the identification of a policy need, including policy intent and triage, and then, thorough research and collaboration leads CareSource to determine best practice for members. According to the tenets of the 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 or more restrictive than the limitations that apply to medical conditions as covered by CareSource policies. The policy development process ensures quality and consistency among both medical/surgic al and behavioral health policies.C. DefinitionsAdministrative Policies Policies written to provide guidance to providers on administration of behavioral or physical health benefits. AllMed A vendor with independent, external review specialists, who complete impartial medical reviews prior to final medical policy approval and implementation. Business Owner An individual who identifies a gap in information or benefits and recommends or requests that a topic be researched for possible creation or clarification of medical necessity criteria, reimbursement information or administrative conditions to assist in providing consistent and quality services to CareSource members. The business owner supports the development of a policy. Clinical Policy Governance Committee (CPGC) The official governing body, comprised of medical and behavioral health subject matter experts, among others, charged with the approval of new or revised clinical policies relating to medical necessity determinations. The CPGC is responsible for determining whether the proposed clinical policy is clearly defined, clinically evidenced-based, a ssures a high level of member safety and quality of care, and articulates a business value. Medical/Clinical Policies Policies written with medical criteria, including current evidence-based research, best practice, studies, etc., which will determine what the member must meet for the provider to deliver a service. PolicyTech Policy and procedure lifecycle management software for policy development and revision designed to centralize, build, and simplify policy and procedure workflows. Users have tools, such as workflow automation, document creation and review, remote access, versioning, audit-ready reporting, and employee assessments. Reimbursement Policy-Addresses a topic in what must be met from a provider regarding billing/claims criteria to receive reimbursement for services provided. Subject Matter Experts (SME) A person who is an authority on a particular topic or subject matter. Policy Development Process-OH MCD-AD-0917 Effective Date: 02/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. D.Policy I.Pre-Policy DevelopmentA. The business owner enters a policy intake into PolicyTech to start the policy development process.B. To determine the intent, need, and priority of the request, collaboration occurs between the policy writer, business owner, member benefits coder, member benefits analyst, configuration, and an appropriate business owner, such as a s ubject matter expert (SME) and/or medical director.C. If it is determined that there is a need for a policy, collaboration occurs between a m ultidisciplinary team to review codes and configuration, if applicable, and management determines if codes need sent to analytics to provide the policy team with additional data, such as financial data, claims and/or usage of benefits by members.II. Policy DevelopmentA. The policy writer researches the topic and develops a draft of the policy. This includes, but is not limited to, the following resources:1. State/federal regulations2. State contracts3. MCG Health4. Hayes5. UpToDate6. Policy Reporter7. Provider and member materials8. Professional society recommendations9. Standard of care guidelines10. Published studies11. Feedback from external sources12. Subject matter experts, including medical/surgical and/or behavioral13. EncoderProB. After the policy is approved in the PolicyTech system on several levels by subject matter experts, management, writers, applicable departments and others,a final policy revision is reviewed and approved by the following:1. Benefits, Coding and Support2. Configuration3. Utilization Management4. Independent, external medical review specialists, when applicable5. CPGC6. State approval, if applicableIII. Post Policy DevelopmentProviders and m embers of the health partner community are notified of new policiesand/or changes to existing policies via CareSources marketing process. A standard operating procedure guides a uniform, consistent process allowing for adequat e not ice of new criteria or revisions as outlined by state or company requirements. Policy Development Process-OH MCD-AD-0917 Effective Date: 02/01/2023 The ADMINISTRATIVE Policy Statement detailed above has received due consideration as defined in the ADMINISTRATIVE Policy Statement Policy and is approved. Upon adequate notice, policies are posted on CareSources website. E.Conditions of Coverage NA F. Related Policies/Rules NA G. Review/Revision History DATES ACTION Date Issued 09/30/2020 Date Revised 12/10/2021 09/13/2022 Updated definitions, resources used for research Annual review. No substantive changes. Date Effective 02/01/2023 Date Archived 12/31/2023 This Policy is no longer active and has been archived. Please note that there could be other Policies that may have some of the same rules incorporated and CareSource reserves the right to follow CMS/State/NCCI guidelines without a formal documented Policy. H.References 1. Centers for Medicare & Medicaid Services. (n.d.) Mental Health Parity and AddictionEquity Act. Retrieved September 13, 2022 from www.cms.gov.
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