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Pharmacogenomics-CYP Gene Testing

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Pharmacogenomics-CYP Gene Testing-OH MCD-AD-1342 04/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature b ased 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 n ot limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of f unction, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, are the lowest cost alternative, and are not provided mainly for the convenience of the member o r 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 Adminis trative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determina tion. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/R ules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectPharmacogenomic s CYP Gene Testing B. BackgroundPharmacogenomics is an area of precision medicine that provides information about an individua ls genes, influencing therapeutic strategies , and assessing the likelihood of benefit or toxicity to a given drug. This form of medication management has been evaluated in a variety of clinical scenarios . As pharmacogenomics expands and laborator ies offering testing proliferate, the value of a given test in terms of patient benefit may be obscured by multiple contributing factors , including exaggerated public marketing claims, inconsistencies in test standardization, continued patient variation in response to prescribed medication, incomplete knowledge of drug metabolism, and limitations in regulatory oversight. To manage these challenges, the clinical validity and clinical utility of a specific gene or biomarker with a specific drug target should demonstrate improvement in patient outcomes . C. Definitions Clinical Utility The likelihood that a test will, by prompting an intervention, result in an improved health outcome . Clinical Validity The accuracy of a test for a given clinical outcome . Unbundling HCPCS/CPT codes should be reported only if all services described by the code are performed. Multiple codes should not be reported if a single code exists that describes the services performed. The codes include all services usually performed as part of the procedure as a standard of medical/ surgical practice and should not be separately report ed s imply because codes exist for the se rvices. D. PolicyI. General Guidelines A. Biomarker testing with uncertain clinical significance in MCG will be considered experimental and investigational. B. Unbundling of codes in a panel is an incorrect billing practice and will result in payment recovery. C. Any drug, biologic, device, diagnostic, product, equipment, procedure, treatment, service, or supply used in or directly related to the diagnosis, evaluation, or treatment of a disease, injury, illness, or other health condition which CareSource determines in its sole discretion to be experimental or investigational is not covered by CareSource. II. Based on review of existing evidence, there are currently no clinical indications for the high-volume tests below , and t he current role remains uncertain. Therefore,CareSource considers these requests experimental and investigational. This is not an all-inclusive list. CPT Codes Testing Examples 81225 – CYP2C19 (cytochrome P450, family 2, subfamily C, polypeptide 19) ( eg, drug metabolism), gene analysis, common variants ( eg, *2, *3, *4, *8, *17) Genecept Assay, OneOme Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 81226 – CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) ( eg,drug metabolism), gene analysis, common variants ( eg, *2, *3, *4, *5, *6, *9, *10, *17, *19, *29, *35, *41, *1XN, *2XN, *4XN) RightMed, PGxOnePlus, CQuentia, IDGenetix, PROOVE, GARSPREDX, SureGene, PharmacoDx 81227 – CYP2C9 (cytochrome P450, family 2, subfamily C, polypeptide 9) ( eg, drug metabolism), gene analysis, common variants ( eg, *2, *3, *5, *6) 81230 – CYP3A4 (cytochrome P450 f amily 3 subfamily A member 4) ( eg, drug metabolism), gene analysis, common variant(s) ( eg, *2, *22) 81291 – MTHFR (5, 10-methylenetetrahydrofolate reductase) ( eg, hereditary hypercoagulability) gene analysis, common variants ( eg, 677T, 1298C) III. CareSource applies coding edits to medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. Proper billing and submission guidelines must be followed, including the following: A. Use of industry s tandard, compliant codes on all claims submissions, including CPT codes and/or HCPCS codes. B. Services considered to be mutually exclusive, incidental to , or integral to the primary service rendered are not allowed additional payment. C. Proprietary panel test ing requires evidence-based documentation of medical necessity. D. Submission of the most accurate and appropriate CPT/HCPCS code(s) for the product or service being provided, including coding to the highest level of specificity. IV . CareSource consider s the followin g not medically necessary (not an all-inclusive list) :A. Pharmacogen omic testing or screening in the general population. B. A non-covered test billed by using unlisted procedure codes. C. The use of multi-gene panels for genetic polymorphi sms, including, but not limited to, pain management, cardiovascular drugs, anthracyclines, or polypharmacy for evaluating drug-metabolizer status (ie, SureGene Test, PharmacoDx). D. Tests considered screening in the absence of clinical signs /symptoms of disea se. E. Tests that do not confirm new data for decision making but confirm a known diagnosis or information. F. Tests to determine risk for developing a disease or condition. G. Tests without diagnosis-specific indications. H. Tests performed to ensure a tissue specimen matches an individual. E. Conditions of CoverageCodes referenced in this policy are for informational purposes only. Inclusion or exclusion of any code (s) does not guarantee coverage. F. Related Policies/RulesOverpayment Recovery Experimental and Investigational Items and Services Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.4 G. Review/Revision HistoryDATE ACTIONDate Issued 04/26/20 23 Approved at Committee.Date Revised 01/31/2024 Removed 0345U from D.II. Updated references. Approved at Committee. Date Effective 04/01/2024 Date Archived H. References1. Clinical laboratory improvement amendments (CLIA). Centers for Disease Control and Prevention. Reviewed January 16, 2024. Accessed January 23, 2024 . www.cdc.gov 2. Clin ical Use of Pharmacogenetic Testing in Prescribing Psychotropic Medications for Children and Adolescents . American Academy of Child & Adolescent Psychiatry; 20 20 . Accessed January 23, 2024 . www.aacap.org 3. Clinical utility evaluation: APOE genetic testing for Alzheimer Disease. Hayes; 2018. Updated May 18, 2022. Accessed January 23, 2024 . www.hayesinc.com 4. Clinical utility evaluation: genetic testing for common forms of hereditary thrombophilia in adults with unprovoked venous thromboembolism. Hayes; 2019. Updated June 21, 2022. Accessed January 23, 2024 . www.evidence.hayesinc.com 5. Clinical utility evaluation: genetic testing for common forms of hereditary thrombophilia in pediatric patients with unp rovoked venous thromboembolism. Hayes; 2019. Updated June 21, 2022. Accessed January 23, 2024 . www.evidence.hayesinc.com 6. Clinical utility evaluation: genetic testing for factor VLeiden in women with unexplained recurrent pregnancy loss. Hayes; 2018. Updat ed October 24, 2022. Accessed January 23, 2024. www.hayesinc.com 7. Clinical utility evaluation: MTHRF genetic testing for hypertension. Hayes; 2023. Accessed January 23, 2024. www.hayesinc.com 8. Clinical utility evaluation: MTHRF genetic testing for nondevelop mental psychiatric disorders. Hayes; 2023. Accessed January 23, 2024. www.hayesinc.com 9. Clinical utility evaluation: MTHRF genetic testing for pregnancy complications. Hayes; 2023. Accessed January 23, 2024. www.hayesinc.com 10. Clinical utility evaluation: MTH RF genetic testing for severe MTHFR enzyme deficiency. Hayes; 20 17. Updated September 29, 2023. Accessed January 23, 2024 . www.hayesinc.com 11. Clinical utility evaluation: MTHRF pharmacogenetic genotyping for altering drug treatment. Hayes; 2017. Updated May 23, 2021. Accessed January 23, 2024 . www.hayesinc.com 12. Clinical utility evaluation: pharmacogenetic and pharmacogenomic testing for opioid treatment for pain in adults selected single-gene variants and pharmacogenomic panels. Hayes; 2019. Updated October 26, 2022. Accessed January 23, 2024 . www.evidenced.hayesinc.com Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.5 13. Clinical utility evaluation: pharmacogenetic and pharmacogenomic testing to improve outcomes related to opioid use disorder. Hayes; 2020. Updated June 30, 2023. Accessed January 23, 2024 . ww w.evidence.hayesinc.com14. Clinical utility evaluation: pharmacogenomic testing for attention-deficit/hyperactivity disorder. Hayes; 2022. Updated March 31, 2023. Accessed January 23, 2024 . www.evidence.hayesinc.com 15. Clinical utility evaluation: pharmacogenomic testing of selected mental health conditions. Hayes; 2021. Updated December 1, 2023. Accessed January 23, 2024 . www.evidence.hayesinc.com 16. Clopidogrel pharmacogenetics-CYP2C19 gene: A-0631. MCG . 27 th ed. Update d September 21, 2023. Accessed January 23, 2024. www.careweb.careguidelines.com 17. Deoxyribonucleic acid (DNA) fact sheet. National Human Genome Research Institute. Updated August 24, 2020. Accessed January 23, 2024 . www.genome.gov 18. Hefti E, Blanco JG. Docume nting pharmacogenomic testing with CPT codes. J AHIMA . 2016;87(1):56-59. Accessed January 23, 2024. www.pubmed.ncbi.nih.gov 19. Hicks JK, Bishop JR, Sangkuhl K, et al.; Clinical Pharmacogen etics Implementation Consortium. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther . 2015;98(2):127-134. doi:10.1002/cpt.147 20. Hippm an C, Nislow C. Pharmacogenomic testing: clinical evidence and implementation challenges. JPers Med . 2019;9(3):40. doi:10.3390/jpm9030040 21. Hyperhomocysteinemia: A-0629. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024 . www.careweb.caregu idelines.com 22. Kohlmann W, Slavotinek A. Genetic testing. UpToDate. Updated October 7, 2022. Accessed January 23, 2024. www.uptodate.com 23. Laboratory Requirements, 42 C.F.R. 493 (202 4). 24. Laboratory Services, OHIO ADMIN . CODE 5160-11-11 (2021). 25. List of cleared or approved companion diagnostic devices (in vitro and imaging tools). Food and Drug Administration . Updated December 21 , 2023. Accessed January 23, 2024 . www.fda.gov 26. Managed Care: Provider Network and Contracting Requirements. OHIO ADMIN . CODE 51 60-26-05 (2022). 27. Medical code brief: 0345U-PLA (U codes). Hayes; 2022. Accessed January 23, 2024 . www.evidence.hayeinc.com 28. Methotrexate pharmacogenetics: A-1009. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024 . www.careweb.careguideline s.com 29. MolDx: Genetic Testing for Hypercoagulability/Thrombophilia (Factor VLeiden, Factor II Prothrombin, and MTHFR). Centers for Medicaid and Medicare Services; 2015. LCD ID L35984. Revised July 20, 2023. Accessed January 23, 2024 . www.cms.gov 30. MolDx: Molecular Diagnostic Tests (MDT). Centers for Medicaid and Medicare Services; 2015. LCD ID L36021. Revised May 4, 2023. Accessed January 23, 2024 . www.cms.gov Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.6 31. MolDx: Pharmacogenomics Testing . Centers for Medicaid and Medicare Servic es;2020. LCD ID L38394. Updated August 24, 2023. Accessed January 23, 2024 . www.cms.gov 32. MolDx : Repeat Germline Testing . Centers for Medicaid and Medicare Services; 2020. LCD ID L38288 . Revised December 7, 2023 . Accessed January 23, 2024 . www.cms.gov 33. Mole cular test assessment: GeneSight Psychotropic (Assurex Health Inc./Myriad Neuroscience). Hayes; 2021. Updated November 13, 2023 . Accessed January 23, 2024 . www.evidence.hayesinc.com 34. National Cancer Institute (NCI). NCI Dictionary of Genetics Terms. Nationa l Institute of Health. Accesse d January 23, 2024 . www.cancer.gov 35. National Center for Biotechnology Information. Genetic testing registry. National Library of Medicine. Accessed January 23, 2024 . www.ncbi.nlm.nih.gov 36. National Correct Coding Initiative Polic y Manual For Medicaid Services . Centers for Medicaid and Medicare Services . Updated January 1, 2024 . Accessed January 23, 2024 . www.medicaid.gov 37. Opioid pharmacogenetics-CYP450 polymorphisms and OPRM1 gene: A-0992. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024. www.careweb.careguidelines.com 38. Pharmacogenetic testing. American Academy of Child and Adolescent Psychiatry. Updated December 2019. Accessed January 23, 2024 . www.aacap.org 39. Pharmacogenomic testing for Warfarin response. Cen ters for Medicaid and Medicare Services; 2009. NCD ID 90.1. Accessed January 23, 2024 . www.cms.gov 40. Precision medicine research brief: Genecept Assay (Genomind). Hayes; 2016. Accessed January 23, 2024 . www.evidence.hayesinc.com 41. Precision medicine research b rief: PGxOne Plus (Admera Health). Hayes; 2017. Accessed January 23, 2024 . www.evidence.hayesinc.com 42. Precision medicine research brief: Proove Opioid Risk Test (Proove Biosciences). Hayes; 2016. Accessed January 23, 2024 . www.evidence.hayesinc.com 43. Psychot ropic medication pharmacogenetics : A-0861. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024 . www.careweb.careguidelines.com 44. Psychotropic medication pharmacogenetics-CY450 polymorphisms: A-0692. MCG . 27 th ed. Updated September 21, 2023. A ccessed January 23, 2024. www.careweb.careguidelines.com 45. Psychotropic medication pharmacogenetics-gene panels: A-0861. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024. www.careweb.careguidelines.com 46. Raby B. Personalized medicine. UpToDate. Updated September 06, 2023. Accessed January 23, 2024 . www.uptodate.com 47. Tacrolimus pharmacogenetics-CYP3A4 and CYP3A5 genes: A-0775. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024. www.careweb.careguidelines.com 48. Tamoxifen pharmacogenetics-CYP2D6 gene: A-0647. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024. www.careweb.careguidelines.com Pharmacogen omics-CYP Gene Testing-OH MCD-AD-1342Effective Dat e: 04/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.7 49. Tantisira K, Weis s S. Overview of pharmacogenomics. Updated December 20 , 2023. Accessed January 23, 2024 . www.uptodate.com 50. Warfarin pharmacogenetics-CYP2C9, CYP4F2, and VKORC1 genes: A-0587. MCG . 27 th ed. Updated September 21, 2023. Accessed January 23, 2024 . www.careweb.c areguidelines.com Approve d by Ohio Dept. of Medicaid 02/08/2024.

Molecular Diagnostic Testing

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Molecular Diagnostic Testing-OH MCD-AD-1049 05/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industr y standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, illness, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction o f a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider M anuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the E vidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i. e., Evidence of Coverage), then the plan contract (i.e., Evidence of Cove rage) will be the controlling document used to make the determination. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limita tions that are less favorable than the limitations that apply to medical conditions as covered under this policy.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 Molecular Diagnostic Testing-OH MCD-AD-1049Effective Dat e: 05/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectMolecular Diagnostics Testing B. BackgroundMolecular diagnostic testing (MDT) , following a diagnosis or suspected diagnosis, can help guide appropriate therapy by identifying specific therapeutic targets and appropriate pharmaceutical interventions. MDT utilizes a genetic amplification technique, polymerase chain reaction (PCR), tha t uses 0.1 mg of DNA from a single cell to achieve shorter laboratory processing times for results. Knowing the gene sequence, or at minimum the borders of the target segment of DNA to be amplified, is a prerequisite to a successful PCR amplification of DN A. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Waived testsinclude test systems that are cleared by the U.S. Food and Drug Administration (FDA) for home use and those tests approved for waiver under the CLIA criteria. Although CLIA requires that waived tests must be simple and have low risk for erroneous re sults, this does not mean that waived tests are completely error-proof. CareSource may periodically require review of a providers office testing policies and procedures when performing CLIA-waived tests. C. Definitions Polymerase Chain Reaction (PCR) – A la boratory method used to look for certain changes in a gene or chromosome, which may help find and diagnose a genetic condition or a disease. It may also be used to look at pieces of the DNA from certain bacteria, viruses, or other microorganisms to help di agnose an infection. D. PolicyI. CareSource considers conventional testing, such as rapid antigen direct tests, direct fluorescent antibody testing, and cultures , as lower cost and should be utilized before the higher cost molecular diagnostic testing (MDT ) by PCR. II. Providers should utilize conventional testing first.A. If conventional testing is1. Positive no further testing is medically necessary. 2. Negative if the members presenting symptoms support the diagnosis, then MDT by PCR testing is medically necessary to confirm diagnosis. Examples of relevant diagnoses are, but not limited to, gastroenteritis, streptococcal pharyngitis, acute hepatitis, shigellosis. B. Diseases complicating pregnancy are an exception to the above. III. CareSource may request documentation to support medical necessity.Molecular Diagnostic Testing-OH MCD-AD-1049Effective Dat e: 05/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 E. Conditions of CoverageProviders must code to the highest degree of specificity when coding the CPT, HPCS code and diagnosis code. Failing to use the most appropriate code may result in a claim denial . F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 05/25/2022 New policyDate Revised 05/10/2023 01/17/2024 Annual review. No changes. Approved at Committee. Annual review. References updated. Approved at Committee Date Effective 05/01/2024 Date Archived H. References1. Polymerase chain reaction. National Cancer Institute , National Institutes of Health . Updated December 19, 2023. Accessed December 21 , 2023 . www.cancer.gov Approved by ODM on 1/25/2024

Medical Record Documentation Standards for Practitioners

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Medical Record Documentation Standards for Practitioners – OH MCD-AD-0753 05/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by Ca reSource 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 suff er prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, are the lowest cost alternative, and ar e 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 policie s 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 limitat ions 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 ………………………………………………………………………………………… 6 F. Related Policies/R ules ………………………………………………………………………………………….. 6 G. Review/Revision History ……………………………………………………………………………………….. 6 H. References …………………………………………………………………………………………………………. 7 Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.2A. Subject Medical Record Documentation Standards for Practitioners B. Background Medical record documentation is a fundamental element required to support medical necessity and is the foundation for coding and billing. Documentation relays important information such as, but not limited to, assessments completed, services provided, coordination of services, timeliness of care, plan of treatment, rationale for orders, health risk factors, member s progress, and response to treatment. C. Definitions A Valid Signature for Services Provided or Ordered-o May be handwritten or electronic : CMS permits stamped signatures if you have a physical disability and can prove to a CMS contractor you are not able to sign due to that disability , and o Is legible or can be validated by comparing to a signature log or attestation statement . Certificate of Medical Necessity (CMN) – A written statement by a practitioner attesting that a particular item or service is medically necessary for an individual . D. Policy I. Medical documentation A. General requirements 1. Each member has thei r own medical record . 2. Entries are legible . 3. Each page of the record includes the members name and date of service. 4. Entries include a. date of service b. signature, date, and credentials of practitioner 5. Documentation indicates that the services(s) billed we re the services provided. a. If CPT is based on a timed service, the total number of timed minutes and/or start and stop time with CPT codes/type of treatment is documented. b. If CPT is based on a group of members, the following is included: 01. d ocumentation to support that the member was present at each session ( If member is not present for the duration of the visit, document start and stop time for the member. ) 02. r elationships/credentials of individuals present at each session 03. n umber of participants in group therapy/treatment c. CPT/ modifiers /p lace of service codes are appropriate for service and provider . d. Note reflect s the location of service. Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.36. Documentation reflect s medical necessity for payment of services provided and utilization of resources as it relates to the service provided and the needs/desires of the member. 7. Documentation includes a problem list that includes significant illness or medical and behavioral conditions found in history or previous encounters. 8. When making changes in paper medical record: a. change is clearly visible. b. white out is not utilized. c. a single line is through an entry labeled with error, initialed, and dated 9. When making changes in electronic medical records: a. Amendment, correction, or delayed entry is identified. b. A reliable way to identify the original content, the modified content, and the date and person modifying the record is provided. 10. When documentation is over multiple pages: a. Additional pages from a continuation of a note are clearly identified. b. Continuous pages contain: 01. Member name , 02. Date of service, and 03. Page number . 11. Content of documentation show s the specific needs of the member for each encounter. Duplication of another note is not acceptable. 12. Best practice standards require documentation to be written within 24 hours of the clinical or therapeutic activity and signed and dated within 14 days . B. Ev aluation and management documentation 1. Per CPT guidelines, documentation support s the specific requirements based on the level of visit billed. 2. History documentation includes: a. chief complaint , reason for the visit , b. h istory of present illness (HPI), c. m edical history , d. review of systems (ROS) to identify signs and/or symptoms; and e. p ast family and social history (PFSH) . 3. Examination documentation includes: a. constitutional includ ing vital signs and general appearance, and b. u p to 11 organ systems/body areas depending upon the level of the examination performed and coded. 4. Complexity documentation includes: a. d iagnoses and treatment options , b. a ny labs, radiology or other diagnostic tests ordered/results reviewed, c. any counseling/coordination of care, which can include time spent face to face, and d. Assessment and medical plan of care details . C. Consents 1. Are maintained in the medical record. a. Consent includes: Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.401. Consent to treatment, refusal to consent, or withdrawal of consent, and/or 02. Authorization for release of information, and 03. Signature and date. D. Referral Documentation 1. Supports rationale for referral that includes who and what specialty member is referred to , and 2. Demonstrates evidence of : a. Coordination of referrals to specialty practitioners , and b. Physician review of or documentation of collaboration notes . E. Laboratory Testing Documentation (i.e., labs, x-rays, biopsies) : 1. Documentation s upports rationale for test , 2. An order for the test is pre sent , 3. How test results will guide treatment plan is evident , 4. Evidence of physician review of results , and 5. Evidence of a ppropriate timely f ollow up on test results with member . F. Preventative Care Documentation, when appropriate: 1. Records include: a. An age-appropriate immunization record, b. Evidence that preventative screenings/services are offered, c. Risk assessments are completed as appropriate ( i.e., substance use, suicide , depression) , and d. Cr isis/safety plan as appropriate . II. Durable Medical Equipment Prosthetics Orthotics and Supplies Documentation Requirements A. Detailed Written Order and Documentation includes: 1. The members name , 2. Item of DME ordered (ie, written description, HCPCS Code, brand name, model number ), 3. Prescribing practit ioners National Provider Identifier (NPI) , 4. Signature of the ordering practitioner , 5. Date of the order , 6. If order is for a supply: a. Frequency of use, b. Quantity to be dispensed. 7. Duration of use , 8. Certificate of Medical Necessity (CMN), if required. a. If a CMN is not required, a prescription with diagnoses is included, 9. Information that demonstrates that the item is medically necessary , 10. Any changes in the members treatment plan or needs , and 11. Proof of delivery (see II. D.). B. Refill Documentation Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.51. Documentation of a request for refill must be either a written document received from the member or a contemporaneous written record of a phone conversation/contact between the supplier and the member. 2. The refill request must occur and be documented before shipment. 3. A retrospective attestation statement by the supplier or member is not sufficient. 4. The refill record must include: a. Members name or authorized representative, if different from the member; b. A description of each item that is being requested; and c. Date of the refill request. d. For consumable supplies , for example, those that are used up ( eg, ostomy or urological supplies, sur gical dressings, etc.) the supplier must assess the quantity of each item that the member still has remaining to document that the amount remaining will be nearly exhausted on or about the supply anniversary date. C. Verbal Orders 1. When services are provided on the basis of a physicians verbal orders, a nurse, or other qualified practitioner responsible for furnishing or supervising the ordered services must document the orders in the patients clinical record, and sign, date, and time the orders. 2. Verbal orders must be followed up with written orders. 3. Suppliers must maintain the written physicians order to support medical necessity in the event of a post-payment review, D. Proof of Delivery 1. Proof of Delivery in cludes the following: a. m ember s name , b. delivery a ddress, c. item of DME ordered (i.e., written description, HCPCS Code, brand name, model number ), d. quantities delivered , e. date delivered , f. member or designee receipt signature with date; and date of s ignature, g. relationship of anyone signing the delivery ticket as a designee of the patient , h. there is a specific statement for the patient to initial stating that they attest that they are satisfied with the way the orthotic or prosthesis device(s) fit and that they were trained on the proper usage and care of the device(s) , and i. signature of the supplier and date the item was provided to the member . 2. If shipped using a third-party, shipping tracking slip or returned postage-paid delivery invoice is acceptable . 3. CareSource is able to determine from the delivery documentation that the supplier properly coded the item(s) , that the item(s) delivered are the same Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.6item(s) submitted to for reimbursement, and that the items are intended for and received by a specific member. E . Custom item documentation includes: 1. Evidence that the item was uniquely constructed or substantially modified for a specific member , 2. Description and orders of a physician, and 3. Evidence that item is so different from another item for the same purpose that the two items cannot be grouped together for pricing purposes. III. Falsified Documentation A. Providers are reminded that deliberate falsification of medical records is a felony offense and is viewed seriously when encountered. Examples of falsifying records include: 1. Creation of new records when records are requested, 2. Back-dating entries , 3. Post-dated entries , 4. Writing over, or 5. Adding to existing documentation (except where described in amendments, late entries, or corr ections). B. Corrections to the medical record legally amended prior to claims submission and/or medical review will be considered in determining the validity of services billed. If these changes appear in the record following payment determination based on m edical review, only the original record will be reviewed in determining payment of services billed. C. Appeal of claims denied based on an incomplete record may result in a reversal of the original denial if the information supplied includes pages or components that were part of the original medical record but were not submitted on the initial review. E. Conditions of Coverage N/A F. Related Policies/Rules Behavioral Health Record Documentation Standards for Practitioners G. Review/Revision History DATES ACTIONDate Issued 03/04/2020Date Revised 04/14/2021 04/13/2022 05/25/2022 05/24/2023 01/17/2024 Removed BH Documentation . Updated references. No changes; Updated references Per SIU added Refill Documentation and Verbal Orders to section II Added sec.I.A.12 for completion and signature. Updated references, Approved at Committee . Updated references, Approved at Committee. Medical Record Documentation Standards for Practitioners-OH MCD-AD-0753 Effective Date: 05/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.7Date Effective 05/01/2024 Date Archived H. References1. Customized Items, 42 C.F.R. 414.224 (2023). 2. Documentation Guidelines for Evaluation and Management Services. Centers for Medicare & Medicaid Services. Accessed January 10, 2024. www.cms.gov 3. Documentation matters toolkit . Centers for Medicare & Medicaid Services. Updated January 10, 2024. Accessed January 10, 2024. www.cms.gov 4. Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS): Scope and Conditions , 42 C.F.R. 410.38 (2023). 5. Electronic Health Records Provider. Centers for Medicare & Medicaid Services ; 2015. Accessed January 10, 2024. www.cms.gov 6. Local Determination Article: Standard Documentation Requirement for All Claims Submitted to DME MACs . Centers for Medicare & Medicaid Services; 2017. Article ID A55426. Updated January 1, 2023. Accessed January 10, 2024. www.cms.gov 7. MLN Booklet: Evaluation and Management Services. Centers for Medicare & Medicaid Services; 2023. MLN 006764. Accessed January 10, 2024. www.cms.gov 8. MLN Fact Sheet: Complying with Medicare Signature Requirements. Centers for Medicare & Medicaid Services; 2022. MLN 905364. Accessed January 10, 2024. www.cms.gov 9. Progress Notes, O HIO ADMIN . CODE 5122-27-04 (2019). 10. Pub 10-08 Medicare Program Integrity . Centers for Medicare & Medicaid Services ; 2012. Transmittal 442 . Accessed January 10, 2024. www.cms.gov Approved by ODM on 1/25/2024

Claims Editing and Review

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Claims Editing and Review-OH MCD-AD-1175 05/01/2 024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derive d 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 morbidi ty, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, are the lowest cost alternative, and are not provided mainly for the convenie nce 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 Poli cy 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 Stat ement. 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.Table of ContentsA. 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 Claims Editing and Review-OH MCD-AD-1175Effective Dat e: 05/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectClaims Editing and Review B. BackgroundAll health care providers are expected to utilize the same standard coding sets and rules to codify the services provided during encounters with patients. This codification is used to bill insurance carriers for reimbursement, known as a claim. In the codification process, there are rules that must be followed to appropriately codify the encounter into a claim, which is then sent to the insurance carrier for reimbursement. All claims submitted to CareSource for reimbursement consideration are subject to claims editing. This ensures that appropriate coding sets are used and rules are appliedin billing by the provider. This also ensures that appropriate reimbursement is made to the provider for services rendered. This policy aims to outline the source of edits and rules CareSource uti lizes for claims editing and review.C. DefinitionsNA D. PolicyI. To ensure appropriate and timely reimbursement for services rendered to enrollees, CareSource utilizes automated claims editing to enforce appropriate coding and billing practices by providers when submitting claims. A. Appropriate coding and billing of claims allows for the accurate adjudication and reimbursement for services rendered to a CareSource enrollee. B. All claims submitted to CareSource are subject to this editing. II. CareSource models edits and rules onA. industry standard coding rules, manuals, guidelines, directives, and relevant state and federal regulations for claims editing B. resources used to source these coding and billing standards include, but are not limited to, the following: 1. X12 or ASC X12 – The Accredited Standards Committee (ASC) X12 – claim submission rules and edits applied to inbound electronic claims (x12.org ) 2. WEDI SNIP or SNIP – Workgroups for Electronic Data Interchange Strategic Nati onal Implementation Process claim submission rules and edits applied to inbound electronic claims related to HIPAA compliant file exchanges 3. Current Procedural Terminology (CPT) Manual from AMA (American Medical Association) (www.ama-assn.org ) 4. HCP CS – Healthcare Common procedure Coding System Level II coding guidelines (www.cms.gov ) 5. Uniform Billing Editor – Manual from the American Hospital Association (AHA) Coding directives (ams.aha.org) 6. ICD-10-CM manual (www.cdc.gov) Claims Editing and Review-OH MCD-AD-1175Effective Dat e: 05/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 7. Center for Medicare and Medica id (CMS) rules and notifications a. CMS Billing rules and instructions (www.cms.gov) b. Medicare NCCI Instructions/ Manual c. Medicaid NCCI Instructions/ Manual d. NCD & LCD Bulletins e. National Physician Fee Schedule (NPFS) instruction s 8. Food and Drug Administration (FDA) guidelines (www.fda.gov) 9. Center of Disease Control (CDC) guidelines (www.cdc.gov) 10. U.S. Preventive Services Task Force (www.uspreventiveservicestaskforce.org) 11. state agencies (as appropriate for enrollees c overage) a. Arkansas Department of Human Services (humanservices.arkansas.gov) b. Georgia Department of Community Health (dch.georgia.gov) c. Georgia Office of Insurance and Safety (oci.georgia.gov) d. Indiana Department of Insurance (in.gov/idoi) e. Iowa Insurance Division (iid.iowa.gov) f. Kentucky Department of Insurance (insurance.ky.gov) g. North Carolina Department of Insurance (ncdoi.gov ) h. Ohio Department of Medicaid (medicaid.ohio.gov) i. Ohi o Department of Insurance (insurance.ohio.gov) j. West Virginia Offices of the Insurance Commissioner (wvinsurance.gov) 12. state and national ly recognized medical association and specialty experts including, but not limited to: a. American College of Radiolog y ( www.acr.org ) b. American Academy of Pediatrics (www.aap.org) c. Ohio State Chiropractic Association (oscachiro.org) d. American College of Obstetricians and Gynecologists (www.acog.org) 13. CareSources Website (www.caresource.com) a. policies b. provider manuals c. provider notifications III. CareSource strives to keep editing current with all changes as they occur; as such, edits may be added, modified, or removed based on changes, clarifications , and new directives received from these resources and any other resources that may become applicable. IV. CareSource sends providers the outcomes of the edits through the standard Explanation of Payment (EOP) process. Providers EOPs indicate the failures by the use of industry standard CARC and RARC coding system. The provider can obtainadditional informati on by reviewing CareSource’s Provider Portal and/or theCareSource Provider Manual (www.CareSource.com). V. Providers may file a dispute and provide additional information to support the providers position for reconsideration of reimbursement. Instruction to file a dispute Claims Editing and Review-OH MCD-AD-1175Effective Dat e: 05/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.4 related to a denial or rejection of a claim can be found at CareSources website(www.Car eSource.com) . Please refer to the Provider Manual under Claim Dispute Process. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 04/27/2022 Approved at PGC.Date Revised 05/10/2023 01/17/2024 Annual review. Updated II.B.11. Approved at Committee. Annual review. Updated resources. Approved at Committee. Date Effective 05/01/2024 Date Archived H. ReferencesNA Approved by ODM on 1/25/2024

Readmission

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Readmission-OH MCD-AD-0972 03/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilizati on 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 nec essary 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 significant pain and discomf ort. 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 Adminis trative Policy Statement. If there is a conflict between the Administrative Policy Statement and the plan contract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to make the determina tion. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.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. Re ferences ………………………….. ………………………….. ………………………….. ……………………. 7 Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectReadmission B. BackgroundFollowing a hospitalization, readmission within 30 days is often a costly preventable event and a quality-of-care issue. It has been estimated that readmissions within 30 days of discharge can cost health plans more than 1 billion dollars on an annual basi s. Readmissions can result from many situations but most often are due to lack of transitional care or discharge planning. Readmissions can be a major source of stress to the patient, family , and caregivers. The purpose of this policy is to improve the q uality of inpatient and transitional care thatis being rendered to the members of CareSource. This includes, but is not limited to, improving communication between the patient, caregivers and clinicians, providing the patient with the education needed to maintain care in the home to prevent a readmission, performing pre discharge assessment to ensure patient is ready to be discharged, and providing effective post discharge coordination of care. C. Definitions Diagnosis Related Groups (DRGs) A patient classification scheme which provides a means of relating the type of patients a hospital treats (ie, its case mix) to the costs incurred by the hospital. Inpatient Services Services which are ordinarily furnished in a hospital for the care a nd treatment of patients. Inpatient services include all covered services provided to patients during the course of their inpatient stay . Observation services Services furnished in an outpatient hospital setting, including use of a bed and periodic monit oring by a hospital’s nursing or other staff, which are reasonable and necessary to evaluate a patient’s condition or determine the need for possible admission to the hospital as an inpatient. Planned Readmission A non-acute admission for a scheduled pro cedure for limited types of care to include obstetrical delivery, transplant surgery , and maintenance chemotherapy/radiotherapy/immunotherapy. Potentially Preventable Obstetrical Readmissions A readmission due to a preterm or post-partum complication, i ncluding but not limited to: o retained placenta o retained products of conception o post-partum sepsis o other acquired hospital-acquired condition Potentially Preventable Readmission (PPR) Readmis sion to a hospital for a reason considered unplanned and potentially preventable. Pre-Existing Condition A chronic health condition the patient had before the date of the admission. Provider Preventable Condition (PPC) – A condition with a negative co nsequence for the member occurring in any healthcare setting found to be reasonably Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 preventable by the provider through the application of procedures supported by evidence-based medical guidelines Readmission An admission to the same institution within t hirty days of discharge for hospitals paid under the Ohio Department of Medicaids prospective payment system, as described in rule 5160-2-65 of the Administrative Code. Related Medical Condition Medical condition or diagnosis that is related or associated to the original admission. Same or Similar Condition A condition or diagnosis that is the same or a similar condition as the diagnosis or condition that is documented on the initial admissi on. Sentinel Event (SE) – A patient safety event, not primarily related to the natural course of a patients illness or underlying condition, resulting in death or severe or permanent harm, regardless of duration or severity of harm. Serious Reportable Ev ent (SRE) – Serious and costly errors in health care services that are usually preventable and harmful clinical events to patients. D. PolicyI. This policy defines the payment rules for hospitals and acute care facilities that are reimbursed for inpatient or observational services for the following: A. Readmissions that are potentially preventable as determined by the provision of appropriate care consistent with the criteria outlined below: 1. a medical readmission for a continuation or recurrence of the reason for the initial admission due to lack of care, or for a closely related condition (eg, a readmission for diabetes following an initial admissi on for diabetes) 2. a medical readmission for an acute decompensation of a chronic problem that was not the reason for the initial admission but was potentially related to the lack of care rendered either during or immediately after the initial admission (eg, a readmission for diabetes in a patient whose initial admission was for an acute myocardial infarction) 3. a medical readmission for an acute medical complication potentially related to the lack of care rendered during the initial admission (a patient with a hernia repair and a perioperative foley catheter readmitted for a urinary tract infection 10 days later) 4. a readmission for a surgical procedure to address a continuation or a recurrence of the problem causing the initial admission (a patient readmitted for an appendectomy following an initial admission for abdominal pain and fever) 5. a readmission for a surgical procedure to address a complication resulting from the lack of care rendered during the initial admission (a readmission for drainage of a post-operative wound abscess following an initial admission for a bowel resection) B. Readmissions for a condition or p rocedure that are clinically related to the care provided during the prior discharge or resulting from inadequate discharge planning during the prior discharge. Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.4 C. Readmissions when the PPR chain may contain one or more readmissions that are clinically relate d to the initial admission. If the first readmission is within thirty days after the initial admission, the 30-day timeframe may begin again at the discharge of either the initial admission or the most recent readmission clinically related to the initial a dmission. II. A readmission that occurs within one calendar day (ie , same day or next day), to the same institution is considered one discharge for payment purposes and will be reimbursed as one DRG payment per the OAC 5160-2-65. A. If two claims are submitted, the second claim processed will be rejected. B. The hospital will need to submit an adjusted claim for the entire hospitalization. III. If the readmission is within 2-30 days, CareSource will determine through a clinical review if the readmission was relate d to the first admission. A. If it is determined that the readmission within 2-30 days is unrelated to the first admission , the claims will be treated as two separate admissions. B. If it is determined that the readmission within 2-30 days is related to the first admission due to complications or other circumstances that arose because of an early discharge and/or other treatments errors , 1. The two inpatient stays will be combine d into one claim. 2. The hospital will need to submit a new claim with both inpatient stays and will be reimbursed as one DRG payment. C. If it is determined that the readmission does not meet the standard of care (inappropriate ), then any payment made for the separate admissions will be recouped. A new payment amount will be determined by collapsing any affected admissions into one payment. IV. Determination of Unplanned Readmissions CriteriaCareSource will review the clinical documentation on all p otential readmissions to determine if the admission was a potentially preventable readmission (PPR) based on the following: A. The readmission is due to ineffective discharge planning. A discharge planning evaluation should be completed prior to discharge , including assessment of the following: 1. the likelihood of the need for appropriate post-hospital services including addressing rehabilitation needs 2. appropriate arrangements for post-hospital care 3. availability of appropriate services, which would include services such as medical, transportation, meals, and household services 4. need for and feasibility of specialized medical equipment or permanent physical modifications to the home 5. capacity for self-care or alternatively to be cared for by others 6. criticality of the appropriate services 7. readmission risk score or severity score 8. members access to appropriate services Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.5 B. A provider should take into account a number of factors when determining if a member is ready for discharge, including, but not limited to: 1. cognitive status 2. activity level and functional status 3. current home and suitability for members condition (ie, stairs) 4. availability of family or community support 5. ability to o btain medications and services 6. ability to meet nutritional needs 7. availability of transportation for follow up care C. Documentation should support the following discharge standards: 1. a discharge plan that includes the provider(s) responsible for follow up care. The discharge planning evaluation should be used as a guide in the development of the discharge plan 2. all medical information pertinent to illness, treatment, and post-discharge goals of care was provided to the appropriate post-acute care service providers at the time of discharge 3. coordination and/or referrals with the providers responsible for follow up care 4. completion of medication reconciliation/managem ent 5. needed durable medical equipment (DME) and supplies are in place prior to discharge 6. scheduled appointments are listed with dates, times, names, telephone numbers , and addresses 7. member/guardian and family engagement, as needed V. Exclusions to readmission c linical review (2-30 days) include:A. scheduled, staged surgical procedures B. routine obstetrical or neonatal readmissions (non-preventable) C. readmissions associated with burns or cystic fibrosis D. if the member is being transferred from an out-of-network to an in-network facility or if the member is being transferred to a facility that provides care that was not available at the initial facility E. acute rehab transfers F. the original discharge was a patient-initiated discharge, was against medical advice (AMA), and the circumstances of such discharge and readmission are documented in the patient’s medical record G. the original discharge was for the purpose of securing trea tment of a major or metastatic malignancy, major trauma , transplant , or HIV H. transfers to distinct psychiatric units within the same facility 1. When transferring within the same facility, documentation must show that the diagnosis necessitating the tra nsfer was psychiatric in nature and that the patient received active psychiatric treatment. Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.6 VI. Prior authorization of the initial or subsequent inpatient stay or admission to observation status is not a guarantee of payment and are subject to administrative review at the discretion of CareSource.A. All inpatient prior authorization requests that are submitted without medical records will automatically deny which will result in a denial of the claim. VII. Post Service Review Process:A. CareSource will review post service through a medical record review to determine if the readmission is related to the previous admission . 1. Medical records for both admissions must be included with the claim submission to determine if the admission(s) is appropriate or is considered a readmission. 2. Failure for the acute care facility or inpatient hospital to provide complete medical records will result in an automatic denial of the claim 30 days allowed with 3 notifications . VIII. Provider pr eventable conditions , sentinel events and serious reportable event s are not reimbursable. IX. In the event of any conflict between this policy and a providers agreement with CareSource, the providers agreement will be the governing document.E. Conditions of CoverageNA F. Related Policies/RulesReadmission-Behavioral Health Non-Emergent-Facility to Facility Transfers Sentinel Events and Provider Preventable Conditions G. Review/Revision HistoryDATES ACTIONDate Issued 04/01/2019Date Revised 11/11/2020 12/18/202008/04 /202108/31/202211/08 /2023Changed from PY-0724. Removed reference to Medicare Advantage , updated definitions, and updated per ODM guidance Updated exclusions and revised V. 2. Changed post payment to post service in D. IV. And D.IV A. Removed appeals and peer to peer language in D. V. and D. IV. B. Updated references. Approved at PGC. No change to content. Updated references. Updated definitions. Add ed D. IV. Updated D. VII. and F. Updated references. Approved at Committee. Date Effective 03/01/2024 Readmission-OH MCD-AD-0972Effective Dat e: 03/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.7 Date ArchivedH. References1. Case Review. Quality Improvement Organization Manual Chapter 4 . US Centers for Medicare and Medicaid Services ; 2014 . Accessed October 1, 2023. www.cms.gov 2. Eliminating Serious, Preventable, and Costly Medical Errors Never Events Center for Medicare & Medicaid Services ; 2006. Accessed October 1, 2023. www.cms.gov 3. General Provisions: Hospital Services, OHIO ADMIN . CODE 5160-2-02 (2022). 4. Goldfield NI, McCullough EC, Hughes JS, et al. Identifying potentially preventable readmissions. Health Care Financing Rev . 2008;30(1):75-91. Accessed October 1, 2023. www.ncbi.nlm.nih.gov 5. Hospital-acquired conditions. Centers for Medicare & Medicaid Services. Updated September 6, 2023. Accessed October 13, 2023. www.cms.gov 6. Hospital Readmission Reduction Program (HRRP) . US Centers for Medicare and Medicaid Services ; 20 22. Accessed October 1, 2023. www.cms.gov 7. Inpatient Hospital Reimbursement, OHIO ADMIN . CODE 5160-2-65 (2022). 8. List of SREs. National Quality Forum. Accessed October 13, 2023. www.qualityforum.org 9. McIlvennan CK, Eapen ZJ, Allen LA. Hospital readmissions reduction program. Circulation . 2015;131(20):1796-1803. doi:0.1161/CIRCULATIONAHA.114.010270 10. Potentially Preventable Readmissions , OHIO ADMIN . CODE 5160-2-14 (2022). ODM Approved 01/11/202 4

Esophageal Brush Biopsy

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Esophageal Brush Biopsy-OH MCD-AD-1340 3/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on a nd 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 l ocal area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. Administrative Policy Statements prepared by CareSource and its affiliates do not ensure an authorization or payment of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced in the Administrative Policy Statement. If there is a conflic t 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 .Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/R ules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3Esophageal Brush Biopsy-OH MCD-AD-1340 Effective Date: 3/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.2A. Subject Esophageal Brush Biopsy B. Background Barretts esophagus (BE) is a metaplastic change of the distal esophagus, whereby the normal squamous epithelium is replaced by specialized columnar epithelium with goblet cells . This change, where the squamous cell s of the esophagus begin to resemble cell s of the stomach, is associated with chronic gastroesophageal reflux disease (GERD) . It is estimated that 5%12% of patients with chronic GERD symptoms will also exhibit BE. BE is the only known precursor lesion of esophageal adenocarcinoma (EAC) . Last year, the American Cancer Society estimated 20,640 new esophageal cancer cases diagnosed (16,510 in men and 4,130 in women). The most definitive, accurate, and reliable method for diagnosing esophageal lesions is esophageal endoscopy and the Seattle protocol-based, four-quadrant forceps biopsy (FB) . A new technique for detection of BE is wide-area transepithelial sampling with computer-assisted three-dimensi onal analysis (WATS3D). WATS3D, formerly known as EndoCDx, is a computer-assisted biopsy, adjunct to standard forceps biopsy of the esophagus, which claims to increase analysis accuracy of the tissue area sampled and therefore increases the yield of patients tissue identified with abnormality in the esophagus. Unlike standard cytology brushes that are typically soft and primarily designed to gently remove spontaneously exfoliated squamous cells in the esophagus, the WATS3D b iopsy is specifically designed u sing an abrasive brush which is deployed during endoscopy to consistently sample deeper layers of the more firmly attached glandular epithelium found in Barretts esophagus. WATS3D has been criticized for its susceptibility to false-negative or false-positive findings that could lead to the delay of appropriate therapy or to the administration of unnecessary therapy respectively, which represents a potential safety concern. Monitoring patients over time is needed to address these concerns. C. Definitions Barretts Esophagus (BE) A pre-malignant condition that places patients at risk for esophageal adenocarcinoma (EAC) . Esophageal Adenocarcinoma (EAC) One of the two most common types of esophageal cancer along with squamous cell carcinoma. Gastroesophageal Reflux Disease (GERD) A condition occurring when a muscle at the end of the esophagus does not close properly , allowing stomach contents to leak back, or reflux, into the esophagus and irritate it. Esophageal Brush Biopsy-OH MCD-AD-1340 Effective Date: 3/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.3D. Policy I. CareSource considers esophageal brush biopsy using wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS3D) experimental and investigational for screening, diagnosis , or surveillance of cancerous or pre-cancerous esophageal lesions because of insufficient evidence. II. Any claims for esophageal brush biopsy will be denied. III. CareSource may request documentation of services performed. Appropriate and complete documentation must be presented at the time of review to validate medical necessity. If medical necessity is not confirmed based on the documentation submitted, recoupment may occur. E. Conditions of Coverage NA F. Related Policies/Rules Experimental, Investigational and Other Non-Covered Services G. Review/Revision History DATE ACTIONDate Issued 10/11/2023 New Policy. Approved at CommitteeDate Revised Date Effective 3/01/2024 Date Archived H. References1. American Cancer Society. Key Statistics for Esophageal Cancer . Accessed September 14, 2023. www.cancer.org . 2. Health Technology Evaluation. Wide-Area Transepithelial Sampling Biopsy for Detection of Barretts Esophagus/Esophageal Dysplasia. Accessed September 14, 2023. www. evidence.hayesinc.com. 3. Odze RD, Goldblum J, Kaul V. Role of Wide-Area Transepithelial Sampling With 3D Computer-Assisted Analysis in the Diagnosis and Management of Barrett’s Esophagus. Clin Transl Gastroenterol. 2021;12(12):e00422. Published 2021 Dec 7. doi:10.14309/ctg.0000000000000422. 4. Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and Management of Barrett’s Esophagus: An Updated ACG Guideline. Am JGastroenterol. 2022;117(4):559-587. doi:10.14309/ajg.0000000000001680. 5. Spechler SJ. Barrett’s esophagus: Surveillance and management . In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Accessed September 14, 2023. www.uptodate.com . 6. Suresh Kumar VC, Harne P, Patthipati VS, et al. Wide-area transepithelial sampling in adjunct to forceps biopsy increases the absolute detection rates of Barrett’s Esophageal Brush Biopsy-OH MCD-AD-1340 Effective Date: 3/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.4oesophagus and oesophageal dysplasia: a meta-analysis and systematic review. BMJ Open Gastroenterol. 2020;7(1):e000494. doi:10.1136/bmjgast-2020-000494. PMID: 32928869. 7. Yip HC, Chiu PW. Endoscopic diagnosis and management of early squamous cell carcinoma of esophagus. JThorac Dis. 2017;9(Suppl 8):S689-S696. doi:10.21037/jtd.2017.06.57. Approved ODM 11/16/2023

Obstetrical Ultrasounds

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Obstetrical Ultrasounds-OH MCD-AD-1017 02/01/20 24 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 assess ment 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, dysfunctio n 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 Cover age 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 re fer 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 Cover age), 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 behavior al 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 ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 3 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 3 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Obstetrical Ultrasounds-OH MCD-AD-1017Effective Dat e: 02/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectObstetrical UltrasoundsB. BackgroundUltrasounds are a common procedure during pregnancy. Ultrasound s can confirm cardiac activity, estimate gestational age, determine the number of fetuses, and identify fetal anomalies. Some pregnancies will require more ultrasounds based on factors such as age or medical history. C. Definitions First Trimester Ultrasound – The uterus, cervix, adnexa, and cul de sac region is examined. The presence, size, location, and number of gestational sac(s) should be evaluated, and gestational sac(s) should be examined for the presenc e of a yolk sac and embryo/fetus. When an embryo/fetus is present, crown-rump length and cardiac activity should be documented. Pregnancy – Pregnancy begins on the date of the initial visit in which pregnancy was confirmed and extends for 280 days or 40 we eks. Second and Third Trimester Ultrasound – The American College of Radiology (ACR), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the Society for Maternal-Fetal Medicine (SMFM), the Society of Radiologists in Ultrasound (SRU), American College of Obstetricians and Gynecologists ( ACOG ), and the American Institute of Ultrasound in Medicine ( AIUM ) have adopted the following uniform terminology: standard, limited, and specialized . o A standard obstetric ultrasound examination includes evaluation of the following : fetal presentation and number amniotic fluid volume cardiac activity placental positio n fetal biometry anatomic survey examination of maternal cervix and adnexa, as clinically appropriate and when technically feasible o A limited examination is performed to answer a specific clinical question (eg, to verify fetal presentation in a patie nt who is in labor or to confirm fetal heart activity in a patient experiencing vaginal bleeding), but it does not replace a standard examination. o Specialized examinations are typically performed starting at 32 weeks of gestation but may be done earlier if there are multiple risk factors or particularly worrisome problems. A specialized anatomic ultrasound examination is performed when an anomaly (eg, fetal growth restriction) is suspected based on the history, laboratory abnormalities, or the results of a limited or standard examination. A biophysical profile (BPP) is a specialized examination that combines ultrasound examination and fetal heart rate monitoring to evaluate the amount of amniotic fluid and the fetal heart rate, breathing, body/limb movements and muscle tone. A BPP is typically Obstetrical Ultrasounds-OH MCD-AD-1017Effective Dat e: 02/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 recommended when there is an increased risk of problems that could result in pregnancy complications or lead to stillbirth. Other specialized examinations include fetal Doppler ultrasound, fetal echocardiogram, or addit ional biometric measurements. Specialized, Detailed or Targeted Examination – Performed when an anomaly is suspected on the basis of history, laboratory abnormalities, or the results of either the limited or standard examination. This is not intended to be the routine ultrasound examination performed for all pregnancies. Ultrasound Test – A test in which sound waves are used to examine internal structures. During pregnancy it can be used to examine the fetus . D. PolicyI. Ultrasounds should only be performed when there is a specific valid med ical indication .A. The timing, frequency, and type of ultrasound performed is dependent on the medical indication for the examination. Use of three-dimensional and four – dimensional ultrasound techniques require appropriate documentation. B. Medical record documentation must support the medical need for the ultrasound. II. Frequency of ultrasound s for a healthy , asymptomatic , low risk pregnancy includes up to three ultrasounds , including the standard ultrasound, with appropriate documentation per pregnancy. III. The following ultrasounds are no t considered medically necessary:A. Nonmedical use , such as t o determine the fetal sex or to provide parents with a view , video , and /or photograph of the fetus . B. Ultrasounds for growth evaluation less than 2 weeks apart. C. A follow-up first trimester routine ultrasound in the asymptomatic patient population. E. Conditions of CoverageAll obstetric ultrasound claims are subject to retrospective review , and CareSource reserves the right to adjust reimbursement in accordance with the polic y above. The reviews inclu de appropriate documentation of the specific components as defined by American College of Obstetricians and Gynecologists/American Institute of Ultrasound in Medicine . F. Related Policies/RulesNA G. Review/Revision History DATES ACTIONDate Issued 01/06/2021Date Revised 09/14/2022 10/11/2023 Annual review. Updated definitions and references. Annual review. Updated references. Approved at Committee. Date Effective 02/01/2024 Date Archived Obstetrical Ultrasounds-OH MCD-AD-1017Effective Dat e: 02/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.4 H. References 1. AUM-ACR-ACOG-SMFM-SRU practice parameter for the performance of standard diagnostic obstetric ultrasound examinations. JUltrasound Med . 2018;37(11):E13-E24. doi:10.1002/jum.14831 2. Committee on Practice Bulletins-Obstetrics and the American Institute of Ul trasound in Medicine. Practice bulletin no. 175: ultrasound in pregnancy. Obstet Gynecol . 2016;128(6):e241-e256. doi:10.1097/AOG.0000000000001815 3. Position paper: perinatal ultrasound examination. American Academy of Family Physicians. 2002. Accessed Septem ber 19, 2023. www.aafp.org 4. Ultrasound exams: frequently asked questions. The American College of Obstetricians and Gynecologists. June 2017. Reviewed October 2021. Accessed September 19, 2023. www.acog.com 5. Ultrasound imaging. US Food and Drug Administratio n. Updated September 28, 2020. Accessed September 19, 2023. www.fda.gov 6. Wax J, Minkoff H, Johnson A, et al. Consensus report on the detailed fetal anatomic ultrasound examination: indications, components, and qualifications. JUltrasound Med . 2014;33(2):189-195. doi:10.7863/ultra.33.2.189 Approved by ODM 10/26/2023.

Obstetrical Care-Hospital Inpatient Admissions

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Obstetrical Care-Hospital Inpatient Admissions-OH MCD-AD-1143 02/01/2024 Policy Type ADMINISTRATIVE Administ rative 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 whi ch the patient can be expected to suffer prolonged, increased or new morbidity, impairment of function, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the l ocal area, a re 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) wi ll 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 th at 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/R ules ………………………….. ………………………….. ………………………….. …….. 2 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 2 H. References ………………………….. ………………………….. ………………………….. ……………………. 3 Obstetrical Care-Hospital Inpatient Admissions-OH MCD-AD-1143Effective Dat e: 02/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.2 A. SubjectObstetrical Care-Hospital Inpatient Admissions B. BackgroundObstetrical care refers to the health care treatment given in relation to pregnancy anddelivery of a newborn child , including c are during the prenatal period, labor, birthing, and the postpartum period. CareSource covers obstetrical services members recei ve in a hospital or birthing center , as well all associated outpatient services. The services provided must be appropriate to the specific medical needs of the member. C. Definitions Induction – The use of pharmacol ogical and/or mechanical methods to initiate labor . Time of the Onset of Labor – When regular uterine contractions begin resulting in labor and can be with or without pharmacological and/or mechanical interventions. D. PolicyI. A prior aut horization is required for elective induction of labor for any member who is less than 39 weeks gestation. II. For a ctive/spontaneous onset of labor :A. Hospital admissions require a newborn notification. B. Medical necessity determination is the responsibility of the provider. III. For p ost-delivery hospital stays :A. CareSource supports the following federal guidelines : 1. A 2-day stay for mother and newborn after a vaginal delivery. 2. A 4-day stay for mother and newborn after a cesarean delivery. B. A medical necessity review is required if a newborn is admitted to the special care nursery or neonatal intensive care unit ( NICU ). Documentation must support medical necessity. C. Medical necessity is based on MCG. E. Conditions of CoverageNA F. Related Policies/RulesNA G. Review/Revision HistoryDATES ACTIONDate Issued 09/01/2021Date Revised 09/14/2022 10/11/2023 Annual review completed. References updated. Annual review. Updated references. Approved at Committee. Obstetrical Care-Hospital Inpatient Admissions-OH MCD-AD-1143Effective Dat e: 02/01/2024The ADMINISTRATIVE Policy Statement detailed above has recei ved due consideration as defined in theADMINISTRATIVE Policy Statement Policy and is approved.3 Date Effective 02/01/2024Date Archived H. References1. Hospital Based Triage of Obstetric Patients . Committee Opinion 667 American College of Obstetricians and Gynecologists; 2016. Committee Opinion No. 667. Reaffirmed 2023. Accessed September 20, 2023. www.acog.org 2. Newborns and mothers health protection act (NMHPA). US Centers for Medicare and Medicaid Services. Updated September 6, 2023. Accessed September 20, 2023. www.cms.gov Approved by ODM 10/26/2023

Hospice Services

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Hospice Services-OH MCD-AD-1065 02/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management 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 als o 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.Table of ContentsA. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 3 E. Conditions of Coverage ………………………………………………………………………………………… 4 F. Related Policies/Rules ………………………………………………………………………………………….. 4 G. Review/Revision History ……………………………………………………………………………………….. 4 H. References …………………………………………………………………………………………………………. 5 Hospice Services-OH MCD-AD-1065 Effective Date: 02/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.2A. Subject Hospice Services B. Background Hospice services are provided to individuals who are terminally ill and at the end of life. These services are intended to provide comfort or palliative care. Hospice care is a type of care that focuses on the palliation of a terminally ill patient's pain and symptoms and attending to their emotional and spiritual needs. Hospice care has a palliative focus without curative intent. Usually, it is used for patients with no further options for curing disease or who have decided not to pursue further options that are arduous, likely to cause more symptoms, and unlikely to succeed. C. Definitions Hospice Care Program-A coordinated program of home, outpatient, and inpatient care and services operated by a person or public agency that provides the following care and services to hospice patients and to hospice patients' families through a medically-directed interdisciplinary team: o Nursing care by or under the supervision of a registered nurse o Physical, occupational, or speech or language therapy, unless waived by the department of health o Medical social services by a social worker under the direction of a physician o Services of a home health aide o Medical supplies, including drugs and biologicals, and the use of medical appliances o Physician services o Short-term inpatient care, including both palliative and respite care , and procedures o Counseling for hospice patients and families o Services of volunteers under the direction of the provider of the hospi ce care program o Bereavement services for hospice patients' families . These services are provided under interdisciplinary plans of care established pursuant to section 3712.06 of the Revised Code to meet the physical, psychological, social, spiritual, emotional, and other special needs experienced during the final stages of illness, dying, and bereavement. Hospice Patient-A patient, other than a pediatric respite care patient, who has been diagnosed with a terminal illness, has a life expec tancy of six months or less, and has voluntarily requested and is receiving care from a person or public agency licensed under Ohio law to provide a hospice care program. Palliative Care-Specialized care for a patient of any age who has been diagnosed with a serious or life-threatening illness that is provided at any stage of the illness by an interdisciplinary team working in consultation with other health care professionals, including those who may be seeking to cure the illness aims to do all of the following : o Relieve the symptoms, stress, and suffering resulting from the illness Hospice Services-OH MCD-AD-1065 Effective Date: 02/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.3o Improve the quality of life of the patient and the patient's family o Address the patient's physical, emotional, social, and spiritual needs o Facilitate patient autonomy, access to information, and medical decision making. Pediatric Hospice Care-A program operated by a person or public agency that provides inpatient respite care and related services to pediatric respite care patients and the patients' families to meet the physical, psychological, social, spiritual, and other special needs experienced during or leading up to the final stages of illness, dying, and bereavement . Terminal Illness-A qualifying condition for which a prospective patient has received a diagnosis for a life expectancy of six months or less if the illness runs its normal course. D. Policy I. CareSource considers hospice services a covered service with the following requirements: A. Election of h ospice benefits form must be signed by the CareSource member and submitted. B. Provider must produce and submit a Certificate of Terminal Illness form. C. CareSource may request documentation to support medical necessity. Appropriate and complete documentation must be presented upon CareSource request to validate medical necessity. D. Criteria for determination of terminal illness: 1. Hospice care is provided for two ninety-day periods followed by increments of sixty-day periods, as recertifications occur . 2. Patient must have a qualifying condition with a diagnosis of a life expectancy of six months or less if the illness runs its normal course. 3. At the start of the first ninety-day benefit period, the patient must be certified as terminally ill. 4. The patient must be recertified as terminally ill at the start of each benefit period following the first ninety-day period by the hospice physician. E. Short-term inpatient care may be provided in hospital, hospice inpatient unit, or a participating Skilled Nursing Facility or Nursing Facility on an intermittent, non-routine basis : 1. For relief of the individual's caregivers, and/or 2. General inpatient care for the purpose of respite, pain control and acute or chronic symptom management that cannot feasibly be provided in other settings. F. When an individual younger than age 21 elects to receive hospice care, it does not constitute a waiver of any rights of the individual to receive curative services related to the treatment of a terminal condition. G. When an adult over the age of 21 elects to receive hospice care, he or she agrees to waive Medicaid services provided to him or her for the cure and treatment of the terminal condition. H. Ohio law considers people who are 18 years of age or older capable of giving valid, legally enforceable consent to receive hospice services. Hospice Services-OH MCD-AD-1065 Effective Date: 02/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.4II. Hospice care for under age 18 years requires the consent of a parent or guardian unless certain exceptions exist as noted under Ohio law . III. When the reason for discharge from hospice care is death, r outine home care pr ovided in an in-home visit by a registered nurse and/or a social worker during the last seven days of a patients life requires documentation of medical necessity . IV. Billing for Hospice Services A. Professional claims must be billed on a CMS 1500 (HCFA) form w ith the following documentation: 1. The Ohio Medicaid ID and the name of the nursing facility where the services were delivered and 2. The National Provider Identifier (NPI) of the service facility . 3. Consistent with the current process set forth by the OAC, provi ders must submit claims as a single line with date of service span and units billed to match . B. Institutional claims must be billed on a UB04 form with the following documentation: 1. The Ohio Medicaid ID and the name of the nursing facility where the services were delivered. 2. If the hospice services are billed in a Health Care Isolation Center (HCIC) Room and Board, the claims must be billed using the HCIC revenue codes as provided in the Ohio Department of Medicaid guidance. C. Hospice providers that deliver any component of services via telehealth must add the GT modifier on those claims, in addition to the appropriate procedure code. V. For the administration of Hospice Services, CareSource follows the rules sets forth in Chapter 5160-56, Medicaid Hospice Program in the Ohio Administrative Code (OAC) and Chapter 3712, Hospice Care in the Ohio Revised Code (ORC). E. Conditions of Coverage N/A F. Related Policies/Rules N/A G. Review/Revision Histor y DATES ACTIONDate Issued 10/11/2023 New policy. Approved at CommitteeDate Revised Date Effective 02/01/202 4 Date Archived Hospice Services-OH MCD-AD-1065 Effective Date: 02/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.5H. References1. Hospice Care, OHIO REV . CODE 3712.01- .99 (2023). Accessed September 14, 2023. www.codes.ohio.gov. 2. Hospice Services : Covered Services , O HIO ADMIN . CODE 5160-56-05 (2021) . 3. Hospice Services : Definitions , O HIO ADMIN . CODE 5160-56-01 (2021) . 4. Hospice Services : Discharge Requirements , O HIO ADMIN . CODE 5160-56-03 (2017). 5. Hospice Services : Eligibility and Election Requirements , O HIO ADMIN . CODE 5160-56-02 (2017) . 6. Hospice Services : Provider Requirements , O HIO ADMIN . CODE 5160-56-04 (2021). 7. Hospice Services : Reimbursement , O HIO ADMIN . CODE 5160-56-06 (2021) . 8. Hospital Emergency Services f or Victims of Sexual Offenses , OHIO REV . CODE 2907.29 (2012) . Accessed September 14, 2023. www.codes.ohio.gov. 9. Informed Consent t o Surgical or Medical Procedure or Course of Procedures , OHIO REV . CODE 2317.54 (202 3). Accessed September 14, 2023. www.codes.ohio.gov. 10. Outpatient Services f or Minors Without Knowledge or Consent o f Parent or Guardian,OHIO REV . CODE 5122.04 (1989) . Accessed September 14, 2023. www.codes.ohio.gov. 11. Telehealth, OHIO ADMIN . CODE 5 160-1-18. (2022 ). 12. Telehealth Billing Guidelines: Applies to Dates of Service on or After November 15, 2020. Ohio Dept of Medicaid; 2020. Updated February 8, 2021. Accessed September 14, 2023. www.medicaid.ohio.gov. Approved ODM 10/26/2023

Impacted Cerumen Removal

ADMINISTRATIVE POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Impacted Cerumen Removal-OH MCD-AD-1059 02/01/2024 Policy Type ADMINISTRATIVE Administrative Policy Statement prepared by CareSource and its affiliates are derived from literature based on and supported by clinical guidelines, nationally recognized utilization and technology assessment guidelines, other medical management industry standards, and published MCO clinical policy guidelines. Medically necessary services include, but are not limi ted 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 l ocal area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provi der. 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 confl ict 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 Healt h 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 poli cy.Table of Contents A. Subject ………………………………………………………………………………………………………………. 2 B. Background ………………………………………………………………………………………………………… 2 C. Definitions …………………………………………………………………………………………………………… 2 D. Policy …………………………………………………………………………………………………………………. 2 E. Conditions of Coverage ………………………………………………………………………………………… 3 F. Related Policies/R ules ………………………………………………………………………………………….. 3 G. Review/Revision History ……………………………………………………………………………………….. 3 H. References …………………………………………………………………………………………………………. 3Impacted Cerumen Removal-OH MCD-AD-1059 Effective Date: 02/01/2024 The ADMINISTRATIVEPolic y St ate m ent d e tail ed a bo ve h a s receiv ed due c on side ra tio n a s d e fin ed i n the ADMINISTRATIVEPo lic y St ate m ent Polic y a nd i s a pp rove d.2A. Subject Impacted Cerumen Removal B. Background Cerumen or ear wax is a naturally occurring substance that cleans, protects, and lubricates the ear canal. The cerumen can block the ear canal causing symptoms such as pain, hearing loss, fullness, itching, and tinnitus. Methods for removal of cerumen include irrigation, manual removal with instrum entation, and cerumenolytic agents. Cerumen removal may require a physician when methods such as irrigation or removal by cotton-tipped applicators are not sufficient. C. Definitions Cerumen Impaction An accumulation of cerumen that is associated with sym ptoms and/or prevents a necessary ear examination. Modifier Two-character code used along with a CPT or HCPCS code to provide additional information about the service or procedure rendered. Modifier 25 Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service. National Correct Coding Initiative (NCCI) A program developed by CMS to promote national correct coding and to prevent improper payment when incorrect code combinations are reported. D. Policy I. Claims submission for cerumen impaction should include the appropriate CPT code and ICD-10, such as: A. ICD-10 1. impacted cerumen, unspecified ear 2. impacted cerumen, right ear 3. impacted cerumen, left ear 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 in the CPT code and should not be billed separately. II. Evaluation and management (E&M) visit A. Impacted cerumen 1. An E&M service may not be billed when the sole reason for the visit is to remove symptomatic impacted cerumen. Impacted Cerumen Removal-OH MCD-AD-1059 Effective Date: 02/01/2024 The ADMINISTRATIVEPolicy Stateme nt det ailed a bove has received due con side ration as defined in the ADMINISTRATIVEPo licy Stateme nt Po licy a nd is a pprove d.32. An E&M service on the same day as removal of impacted cerumen may not be billed unless it represents and is documented to be a significant, separately identifiable service on the same day. B. Non impacted cerumen : For removal of cerumen that is not impacted, use the E&M service code. III. Modifiers A. Use modifier 25 and/or 50, when appropriate. B. Follow NCCI guidelines, and use appropriate modifiers, as applicable. C. For bilateral procedures, use Centers for Medicare & Medicaid Services (CMS) guidelines. D. Separate payment is only justified when a modifier 25 is appended indicating the fol lowing: 1. r emoval of symptomatic impacted cerumen 2. i mpacted cerumen impeding a physicians ability to properly evaluate or m anage other signs, symptoms or conditions or 3. i mpacted cerumen impeding a physicians or audiologists ability to perform covered audiom etry NOTE: Documentation confirming impacted cerumen and justification of the use of modifier 25 must be submitted with the claim to support medical necessity. E. Conditions of Coverage NA F. Related Policies/Rules Modifier 25 G. Review/Revision History DATE ACTIONDate Issued 10/11/2023 New Polic y. Approved at CommitteeDate Revised Date Effective 02/01/2024 Date Archived H. References1. Cerumen Removal. Centers for Medicare and Medicaid Services. LCD ID L33945. Revised September 13, 2023. Accessed September 13, 2023. www.cms.gov 2. Schwartz SR, Magit A E, Rosenfeld RM, et al. Clinical practice guideline (update): earwax (cerumen impaction). Otolaryngol Head Neck Surg. 2017;156(1_suppl): S1-S29. doi:10.1177/0194599816671491 Approved ODM 10/26/2023