Newborn and Neonatal Intensive Care Unit (NICU) Level of Care

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Newborn and Neonatal Intensive Care Unit (NICU) Level of Care – OH MCD-PY-1430 02/01/2026 Policy Type REIMBURSEMENT Reimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billin g, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management guidelines. Medically necessary services include, but are no t limited to, those health care services or supplies that are proper and necessary for the diagnosis or treatment of disease, i llnes s, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functi on, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy 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 ma ke the determination. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. 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 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 6 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 6 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 6 H. References ………………………….. ………………………….. ………………………….. ……………………. 7 Newborn and Neonatal Intensive Care Unit (NICU) Level of Care-OH MCD-PY-1430 Effective Date: 02/01/2026 The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.2 A. SubjectNewborn and Neonatal Intensive Care Unit (NICU) Level of Care B. BackgroundThis policy aligns with guidance from the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) regarding NICU levels of care. This policy provides guidelines for determining the medically appropriate level of care for reimbursement based on available documentation. NICU admissions are reviewed to ensure that services are of an appropriate duration and level of care to promote optimal health outcomes in the most efficient manner. Clinical documentation of an ongoing NICU hospitalization will be reviewed concurrently to substantiate level of care with continued authorization based on the documentation submitted. Reimbursement for the NICU stay will be based on the authorized level of care and determined by the concurrent review process. The American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG) have defined and specified the capabilities for each of 4 facility levels of care (ie, a specific unit located in the hospital). These facilities range from a Level I Newborn Observation Unit to a Level IV Regional Neonatal Intensive Care Unit. Facilities offering neonatal intensive care must meet healthcare standards through federal/state licensing or certification.The Neonatal Intensive Care Unit (NICU) is a critical care area in a facility for newborn babies who need specialized care. The NICU designation requires a combination of advanced technology and a NICU team of licensed professionals. Newborn and NICU levels of care are based on the complexity of care that a newbornwith specified diagnoses and symptoms require. All four levels of care are represented by a unique revenue code. Any inpatient revenue codes not billed as levels 2-4 will be recognized as level 1. Newborn nursery=0170 Level 1=0171 Level 2=0172 Level 3=0173 Level 4=0174 While most infants admitted to the NICU are premature, others are born at term but suffer from medical conditions , such as infections or birth defects. A newborn also could be admitted to the NICU for associated maternal risk factors or complicated deliveries. Although the list of criteria used to determine the NICU levels of care in this policy are not all inclusive, it does provide an overview of the guidelines that are used. Newborn and Neonatal Intensive Care Unit (NICU) Level of Care-OH MCD-PY-1430 Effective Date: 02/01/2026 The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.3 C. Definitions Intensity of Care (IOC) The complexity of care that a newborn with specified diagnoses and symptoms require s. Newborn CareServices Services performed from birth to 4 weeks. Neonatal Intensive Care Services (NICU) Critical care services for a newborn. Well Baby Care Services A basic level of care to neonates who are low risk. D. PolicyI. Per federal mandate, newborn members are covered at an inpatient facility for a 2 – day stay for vaginal deliveries and a 4-day stay for cesarean sections. These stays will be covered without clinical review (notification may be required) if they are submitted with revenue codes 0170/0171 and a normal newborn DRG. II. For any newborn diagnoses/revenue codes/procedures that may be associated with care/treatment outside of routine newborn care (any revenue code 0172, 0173, 0174) , authorization is required regardless of the length of stay and is subject to medical necessity review. The provider must be able to submit documentation establishing the criteria are met for the level of care, revenue code, and/or DRG submitted on the claim. III. When a newborn require s a NICU admission or a higher IOC service, anauthorization is required.IV. If a complication develops with the mother or baby that necessitates additionalhospital days, NICU admission, or non-well-baby service, an authorization should be submitted along with clinical information to support the stay. V. If the newborn is admitted to the NICU during an initial transition period, defined as 4 hours or less, then discharged back to Newborn Nursery or pediatric level of care, NICU level of care will not be assigned regardless of interventions completed during transitional time.VI. Clinical review will determine appropriate IOC utilizing MCG standards. Care Source will adjust IOC reimbursement if clinical documentation does not support the IOC billed. VII. Inpatient admissions may be reviewed to ensure that all services are of an appropriate duration and level of care to promote optimal health outcomes. Clinical documentation of an ongoing neonatal hospitalization will be reviewed concurrently to substantiate the level of care and length of stay. A continued authorization will be based on the documentation submitted and alignment with MCG Neonatal Facility Levels of Care and Neonatal Intensity of Care Criteria , as well as CareSource policy.Newborn and Neonatal Intensive Care Unit (NICU) Level of Care-OH MCD-PY-1430 Effective Date: 02/01/2026 The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.4 VIII. In order to avoid reimbursement delay or adjustments, providers are encouraged to reference MCG guidelines as well as the clarifications and specific details below .Note: Newborn nursery babies that do not require advanced levels of care are billed using revenue code 0170. NICU Level Revenue Code Description MCG NICU Intensity of Care Level 1 0171: Newborn Level I Intensity of Care Criteria 1 Routine Care ( LOC-010 ) Neonatal care may be indicated for the p hysiologically stable infant (eg, no apnea, bradycardia, or unstable temperature) requiring care consisting of 1 or more of the following: Routine newborn care Evaluation and care of neonates with conditions that require inpatient services available at Level I Continued inpatient care during convalescence from condition(s) treated in Level II, Ill or IV while awaiting resolution of specific issues (eg , sustained weight gain, poor PO feeding ), or establishment of safe discharge destination and plan Uncomplicated jaundice treated only with phototherapy and requiring infrequent bilirubin checks Absence of parenteral medications Evaluation and management of glucose levels without IV fluids , d iagnostic work – up/surveillance, on an otherwise stable neonate where no therapy is initiated Level 2 0172: Newborn Level IIIntensity of Care Criteria 2 Continuing Care (LOC-011 )Neonatal care may be indicated for 1 or more of the following: Use of oxygen via hood ( 40%), nasal cannula oxygen ( 2L/min), with other co – morbidities stable Administration of intravenous (IV) medications IV Therapy; peripheral or PICC o IV fluids inclusive of hyperalimentation ( 2 L/minute of blended oxygen , continuous positive airway pressure (CPAP), nasal intermittent positive pressure ventilation ( NIPPV ) o conventional ventilation (via endotracheal tube, nasotracheal tube or tracheostomy tube) o high-frequency ventilation long-term (> one week) Presence of chest tubes Umbilical arterial catheter (UAC) for blood draws Active apnea/bradycardic episodes requiring PPV Suspected or proven sepsis during acute phase or with toxic appearance Persistent hypoglycemia requiring > 5 mg/kg/min of IV treatment or hypoglycemia not responsive to 1 IV dextrose bolus (200 mg/kg or 2 ml/kg of D10W ) Total parenteral nutrition or IV fluids to supplement inadequate oral intake (NG or PO) > 50% total nutrition NAS requiring initiation/escalation of medication or inability to wean Hyperbilirubinemia with evidence of hemolysis requiring IVIG or blood transfusion Acute encephalopathy that is moderate to severe and under active investigation or has been investigated and does not meet criteria for therapeutic hypothermia Surgical conditions requiring general anesthesia up to 2 days post-op , if indicated Surgical/Therapies for retinopathy of prematurity (ROP) Seizure activity requiring initiation, supplementation , or changing of seizure medications Transfusion of blood products in absence of severe acute etiology or manifestations (eg, transfusion needed for anemia of prematurity, iatrogenic anemia) Hypotension requiring IV fluid bolus Level 4 0174: Newborn Level IV Intensity of Care Criteria 4 Intensive Care (LOC-013 ) Includes Level 3 requirements and 1 or more of the following: Perioperative care following surgical repair of severe neonatal conditions, for example: o bowel resection for necrotizing enterocolitis (NEC) o tracheoesophageal fistula or esophageal atresia repair o cardiac surgery excluding PDA ligation o myelomeningocele closure (up to 48 hours post-op) Newborn and Neonatal Intensive Care Unit (NICU) Level of Care-OH MCD-PY-1430 Effective Date: 02/01/2026 The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.6 o organ transplant Medically necessary inhaled nitric oxide (iNO) Extracorporeal membrane oxygenation (ECMO) High frequency oscillatory or jet ventilation (initial week) Therapeutic cooling Exchange transfusion (day of procedure) Uncontrolled active seizures despite medications Ongoing cardiovascular support (inotropes, chronotropes, antiarrhythmics) Severe hemodynamic instability requiring ongoing IV fluid/medication support o dialysis o IV sedation that includes paralysis o prostaglandin infusion CPR in the last 24 hours (not inclusive of delivery room resuscitation) Transfusion of blood products in setting of severe acute etiology or manifestation (eg, hemolytic anemia, disseminated intravascular coagulation, hemorrhage) E. Conditions of CoverageI. Reimbursement is independent of the location of care and corresponds to the medical treatment provided and level of service the neonate requires. To ensure accurate reimbursement, submitted claims will be reviewed to align with authorized levels of care and/or clinically validate diagnoses, procedures , and other claim information that impact payment. Based on review, the following may occur: Down-code revenue codes to authorized levels of care Issue a base DRG payment Adjust claim diagnoses/procedures that are not substantiated in the medical information provided and apply DRG regrouping, A request for complete medical records and/or itemized statements to support the services on the claim may be made II. In the event of any conflict between this policy and any written agreement between the provider and CareSource, that written agreement will be the governing document.F. Related Policies/Rules NA G. Review/Revision HistoryDATE ACTIONDate Issued 03/13/202 3 New policy . Approved at Committee.Date Revised 03/12/2025 10/22/2025Periodic review. Updated definitions, section D. and references. Approved at Committee. Periodic review. Added Newborn to title and newborn nursery revenue code information. Updated references. Approved at Committee. Newborn and Neonatal Intensive Care Unit (NICU) Level of Care-OH MCD-PY-1430 Effective Date: 02/01/2026 The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.7 Date Effective 02/01/2026Date Archived H. References1. About preterm labor and birth. National Institutes of Health. Reviewed May 9, 2023. Accessed October 10, 2025. www.nichd.nih.gov 2. Admission to NICU. Specification Manual for Joint Commission National Quality Measures . The Joint Commission; 2025. Version 2025A1 . Accessed October 10, 2025. www.manual.jointcommission.org 3. Intensity of Care Criteria 1 – Routine Care: LOC-010 (ISC GRG). MCG Health. 29th ed. Accessed October 10, 2025. www.careweb.careguidelines.com 4. Intensity of Care Criteria 2 – Continuing Care: LOC-011 (ISC GRG). MCG Health. 29th ed. Accessed October 10, 2025. www.careweb.careguidelines.com 5. Intensity of Care Criteria 3 – Intermediate Care: LOC-012 (ISC GRG). MCG Health. 29th ed. Accessed October 10, 2025. www.careweb.careguidelines.com 6. Intensity of Care Criteria 4 – Intensive Care: LOC-013 (ISC GRG). MCG Health. 29th ed. Accessed October 10, 2025. www.careweb.careguidelines.com 7. Stark AR, Pursley DM, Papile L, et al. Standards for levels of neonatal care: II, III, and IV. Pediatr . 2023;151(6):e2023061957. doi:10.1542/peds.2023-061957 ODM Approved 11/05/2025

Overpayment Recovery

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Overpayment Recovery-OH MCD-PY-1115 01/01/2026 Policy Type REIMBURSEMENT Reimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billin g, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefi ts design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management 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, i llnes s, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functi on, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan con tract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to ma ke the determination. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Overpayment Recovery-OH MCD-PY-1115Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.2 A. SubjectOverpayment Recovery B. BackgroundReimbursement policies are designed to assist providers when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarant eeclaims payment.Retrospective review of claims paid to providers assist CareSource with ensuring accuracy in the payment process. CareSource will request voluntary repayment from providers when an overpayment is identified.Fraud, waste , and abuse investigations are an exception to this policy. In these investigations, the look back period may go beyond 2 years. C. Definitions Claims Adjustment A claim that was previously adjudicated and is being updated for one of the following reasons: o denied as a zero payment o a partial payment o a reduced payment o a penalty applied o an additional payment o a supplemental payment Coordination of Benefits (COB) A payment from another carrier that is received after a payment from CareSource , and the other carrier is the primary insurance for the member. Credit Balance/Negative Balance Funds that are owed to CareSource because of a claim adjustment. Explanation of Payment (E OP ) The EOP contains the payment and adjustment information for claims the provider has submitted for payment to CareSource. Forwarding Balance (FB) An adjustment that occurs within an EOP to a claim with a prior paid amount. The FB amount does not indicate funds have been withheld from the providers payment for this remittance advice. It only indicates that a past Overpayment Recovery-OH MCD-PY-1115Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.3 claim has been adjusted to a different dollar amount and that funds are owed to CareSource. Improper Payment A payment that should not have been made or an overpayment was made. Examples include, but are not limited to the following : o payments made for an ineligible member o ineligible service payments o payments made for a service not received o duplicate payments Overpayment Any payment made to a network provider by a Managed Care Organization (MCO) to which the network provider is not entitled to under Title XIX of 42 C.F.R. o A claim adjustment is only considered to result in an overpayment when a claim that previously paid is updated to a denied status as a zero payment or results in a reduced payment. Provider Level Balancing (PLB ) Adjustments to the total check / remit amount occur in the PLB segment of the remit. The PLB can either decrease the payment or increase the payment. The sum of all claim payments (CLP) minus the sum of all provider level adjustments (in the PLB segment) e quals the total payment (Beginning Segment for Payment Order/Remittance Advice (BPR ), which means total payment within the EOP ). Retroactive Eligibility A payment for a member who was retroactively terminated by the state. The member is not eligible for benefits. D. PolicyI. In accordance with 42 C .F.R. 438.608, CareSource requires providers to report any overpayment that has been received by the provider. The overpayment must be returned to CareSource within 60 calendar days after the date on which the overpayment was identified and to notify CareSource in writing of the reason for the overpayment. II. CareSource will provide all the following information when seeking recovery of an overpayment made to a provider:A. The patient’s name, date of birth, and Medicaid identification number . B. The date or dates of services rendered . C. The specific claims that are subject to recovery and the amount subject to recovery, including any interest charges, which may not exceed the amount specified in Ohio law or rule . D. The specific reasons for making the recovery for each of the claims subject to recovery . E. If the recovery is a result of member disenrollment from the CareSource, the effective date of disenrollment . F. An explanation that if a written response to the notice is not received within 30 calendar days from receipt of the notice, the overpayments will be recovered from future claims . Overpayment Recovery-OH MCD-PY-1115Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.4 G. How the provider may submit a written response disputing the overpayment .H. How the provider may submit a written request for an extended payment arrangement or settlement . III. Overpayment RecoveriesA. Lookback period is 24 months from the claim paid date. B. Advanced notification will occur 30 days in advance of recovery. C. If the recovery occurs outside of original claim timely filing limits, the corrected claim submission timeframe is 60 days from the date of the recovery. Normal timely filing limits apply to corrected claims being submitted within original claim timely fil ing guidelines. IV. Coordination of Benefit RecoveriesA. Lookback period is 12 months from claim paid date. B. Advanced notification will occur 30 days in advance of recovery. C. If the recovery occurs outside of original claim timely filing limits, the corrected claim submission timeframe is 60 days from the date of the recovery. Normal timely filing limits apply to corrected claims being submitted within original claim timely filing guidelines. V. Retro Active Eligibility RecoveriesA. Lookback period is 24 months from date CareSource is notified by Medicaid of the updated eligibility status. B. Advanced notification will occur 30 days in advance of recovery. VI. Management of Claim Credit BalancesA. Regular and routine business practices, including, but not limited to, the updating and/or maintenance of a providers record, can create claim credit balances on a providers record. This may result in claim adjustments, both increases and/or decreases in claim paid amounts, and/or forward balancing may move a providers record into a negative balance in which funds would be owed to CareSource. This information will be displayed on the EOP in the PLB section. B. Negative balance status and the associated reconciliation of that balance that is the result of a claim adjustment that increased the claim paid amount is not considered to be an overpayment recovery and does not fall under the terms of this policy. 1. Claim Adjustment Example a. A claim paid $10 previously but was updated to pay $12. The adjustment created a $10 negative balance and paid the provider the full $12 when adjusted, instead of the $2 difference. b. The $10 negative balance is not considered to be an overpayment subject to the guidelines outlined in section D.I D.IV. 2. Overpayment Example Overpayment Recovery-OH MCD-PY-1115Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.5 a. A claim previously paid $12 but is updated to pay $10. The claim adjustment with the $2 reduced payment is subject to the guidelines outlines in section D.I D.IV. b. The reduced payment will trigger a 30-day advanced notification with the details related to the claim and overpayment. C. Reconciliation of negative balance status will be done through claims payment withholds for otherwise payable claims until the full negative balance has been offset, unless otherwise negotiated. D. Providers are notified of negative balances through EOPs and 835s. Providers are expected to use this information to reconcile and maintain their Accounts Receivable (AR) to account for the reconciliation of negative balances. E. Notification of negative balances and reconciliation of negative balances may not occur concurrently. Providers are expected to maintain their AR to account for the reconciliation of negative balances when they occur. E. Conditions of CoverageReimbursement is dependent on, but not limited to, submitting approved HCPCS and CPT codes along with appropriate modifiers, if applicable. Please refer to the individual fee schedule for appropriate codes. F. Related Policies/RulesCareSource Provider Manual National Agreement, Article V. Claims and Payments , 5.11 (d). G. Review/Revision HistoryDATE ACTIONDate Issued 04/29/2020 New policyDate Revised 07/21/2021 03/30/202210/26/202202 /14 /202 4 09/10 /2025Revision: Added Management of Claims Balance information. Added compliance with 42 CFR 438.608 for requirement for provider to report identified overpayments. Approved at PGC. No changes. Updated references. Annual review. Removed V.C. Updated references. Approved at Committee. Periodic review. Updated references. Approved at Committee. Date Effective 01/01/2026 Date Archived H. References1. Ohio Medicaid Provider Agreement for Managed Care Organization . Ohio Dept of Medicaid. Updated July 1, 202 5. Accessed August 25, 2025 . www.medicaid.ohio.gov 2. Payments Considered Final Overpayment, OHIO REV . CODE 3901.388 (2002). ODM approved 09/18/2025

Laboratory Testing in Office Setting

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Laboratory Testing in Office Setting-OH MCD-PY-1545 01/01/2026 Policy Type REIMBURSEMENT Reimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billin g, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefi ts design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management 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, i llnes s, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functi on, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan con tract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to ma ke the determination. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 2 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 3 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 9 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 9 H. References ………………………….. ………………………….. ………………………….. …………………… 10 Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.2 A. SubjectLaboratory Testing in Office Setting B. BackgroundDuring the course of an office visit with a physician or other qualified healthcare provider, the provider may determine that diagnostic laboratory testing is necessary to establish a diagnosis and/or determine treatment options to manage the members current health issues. W hile most laboratory tests are best performed by an independent laboratory, in some instances, results from these laboratory tests are needed immediately to manage urgent medical conditions or medical emergencies and may be performed appropriately in the p hysicians office. Due to the complexity of laboratory tests and regulations around facilities that perform these tests, only laboratory procedures on the short turnaround time (STAT ) lab list may be performed in the office, while all other tests should be referred to an independent, contracted lab provider. C. Definitions Independent Laboratory A laboratory certified to perform diagnostic and/or clinical tests independent of an institution or a providers office. Laboratory A facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for th e diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories. D. PolicyI. Codes managed by a vendor (eg, Avalon) should not be affected by this policy. II. CareSource will reimburse for laboratory procedures performed in the physicians office when ALL the following apply:A. The test results are needed immediately to manage urgent or emergent medical situations. B. The CPT code for the test is on the STAT code list. C. The place of service (POS) 11 is used. III. All other laboratory procedures performed in the office may not be reimbursed and should be referred to an independent, contracted laboratory provider. IV. This policy does not apply to Community Mental Health Centers.V. Pathology codes a re excluded. Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.3 E. Conditions of CoverageIt is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. Please refer to the individual fee schedule for appropriate codes. This code set may not be all-inclusive. Place of Service (POS) CodeDescription 11 – Office Location, other than a hospital, skilled nursing facility (SNF), military treatment facility, community health center, State or local public health clinic, or intermediate care facility (ICF), where the health professional routinely provides health examina tions, diagnosis, and treatment of illness or injury on an ambulatory basis STAT Code ListCPT / HCPCS Description 0202U Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 22 targets including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), qualitative RT-PCR, nasopharyngeal swab, each pathogen repo rted as detected or not detected 0224U Antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), includes titer(s), when performed 0226U Surrogate viral neutralization test (sVNT), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), ELISA, plasma, serum 80048 Basic metabolic panel (Calcium, total) This panel must include the following: Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) 80053 Comprehensive metabolic panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphatase, alkaline (84075) Potassium (84132) Protein, total (84155) Sodium (84295) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate amino (AST ) (SGOT) (84450) Urea nitrogen (BUN) (84520) 8006 1 Lipid panel This panel must include the following: Cholesterol, serum, total (82465) Lipoprotein, direct measurement, high density cholesterol (HDL cholesterol) (83718) Triglycerides (84478) 80 069 Renal function panel This panel must include the following: Albumin (82040) Calcium, total (82310) Carbon dioxide (bicarbonate) (82374) Chloride (82435) Creatinine (82565) Glucose (82947) Phosphorus inorganic (phosphate) (84100) Potassium (84132) Sodium (84295) Urea nitrogen (BUN) (84520) 80074 Acute hepatitis panel This panel must include the following: Hepatitis A antibody (HAAb), IgM antibody (86709) Hepatitis Bcore antibody (HBcAb), IgM antibody (86705) Hepatitis Bsurface antigen (HBsAg) (87340) Hepatitis Cantibody (86803) 80076 Hepatic function panel This panel must include the following: Albumin (82040) Bilirubin, total (82247) Bilirubin, direct (82248) Phosphatase, alkaline (84075) Protein, total (84155) Transferase, alanine amino (ALT) (SGPT) (84460) Transferase, aspartate ami no (AST) (SGOT) (84450) Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.4 80305 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; capable of being read by direct optical observation only (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]), includes sample validation when pe rformed, per date of service80306 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; read by instrument assisted direct optical observation (eg, utilizing immunoassay [eg, dipsticks, cups, cards, or cartridges]), includes sample validation when perf ormed, per date of service80307 Drug test(s), presumptive, any number of drug classes, any number of devices or procedures; by instrument chemistry analyzers (eg, utilizing immunoassay [eg, EIA, ELISA, EMIT, FPIA, IA, KIMS, RIA]), chromatography (eg, GC, HPLC), and mass spectrometry eith er with or without chromatography, (eg, DART, DESI, GC-MS, GC-MS/MS, LC-MS, LC – MS/MS, LDTD, MALDI, TOF) includes sample validation when performed, per date of service 80324 Amphetamines; 1 or 2 80325 Amphetamines; 3 or 4 80326 Amphetamines; 5 or more 80327 Anabolic steroids; 1 or 2 80328 Anabolic steroids; 3 or more 80329 Analgesics, non-opioid; 1 or 2 80330 Analgesics, non-opioid; 3-5 80331 Analgesics, non-opioid; 6 or more 80332 Antidepressants, serotonergic class; 1 or 2 80333 Antidepressants, serotonergic class; 3-5 80334 Antidepressants, serotonergic class; 6 or more 80335 Antidepressants, tricyclic and other cyclicals; 1 or 2 80336 Antidepressants, tricyclic and other cyclicals; 3-5 80337 Antidepressants, tricyclic and other cyclicals; 6 or more 80338 Antidepressants, not otherwise specified 80339 Antiepileptics, not otherwise specified; 1-3 80340 Antiepileptics, not otherwise specified; 4-6 80341 Antiepileptics, not otherwise specified; 7 or more 80342 Antipsychotics, not otherwise specified; 1-3 80343 Antipsychotics, not otherwise specified; 4-6 80344 Antipsychotics, not otherwise specified; 7 or more 80345 Barbiturates 80346 Benzodiazepines; 1-12 80347 Benzodiazepines; 13 or more 80348 Buprenorphine 80349 Cannabinoids, natural 80350 Cannabinoids, synthetic; 1-3 80351 Cannabinoids, synthetic; 4-6 80352 Cannabinoids, synthetic; 7 or more 80353 Cocaine 80354 Fentanyl 80355 Gabapentin, non-blood 80356 Heroin metabolite 80357 Ketamine and norketamine Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.5 80358 Methadone80359 Methylenedioxyamphetamines (MDA, MDEA, MDMA)80360 Methylphenidate 80361 Opiates, 1 or more 80362 Opioids and opiate analogs; 1 or 2 80363 Opioids and opiate analogs; 3 or 4 80364 Opioids and opiate analogs; 5 or more 80365 Oxycodone 80366 Pregabalin 80367 Propoxyphene 80368 Sedative hypnotics (non-benzodiazepines) 80369 Skeletal muscle relaxants; 1 or 2 80370 Skeletal muscle relaxants; 3 or more 80371 Stimulants, synthetic 80372 Tapentadol 80373 Tramadol 80374 Stereoisomer (enantiomer) analysis, single drug class 80375 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 1-3 80376 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 4-6 80377 Drug(s) or substance(s), definitive, qualitative or quantitative, not otherwise specified; 7 or more 81000 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, with microscopy 81001 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, with microscopy 81002 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; non-automated, without microscopy 81003 Urinalysis, by dip stick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen, any number of these constituents; automated, without microscopy 81005 Urinalysis; qualitative or semiquantitative, except immunoassays 81015 Urinalysis; microscopic only 81025 Urine pregnancy test, by visual color comparison methods 81513 Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal – fluid specimens, algorithm reported as a positive or negative result for bacterial vaginosis 82040 Albumin; serum, plasma or whole blood 82043 Albumin; urine (eg, microalbumin), quantitative 82044 Albumin; urine (eg, microalbumin), semiquantitative (eg, reagent strip assay) 82247 Bilirubin; total 82270 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; feces, consecutive collected specimens with single determination, for colorectal neoplasm screening (ie, patient was provided 3 cards or single triple card for consecutive collection) 82271 Blood, occult, by peroxidase activity (eg, guaiac), qualitative; other sources 82272 Blood, occult, by peroxidase activity (eg, guaiac), qualitative, feces, 1-3 simultaneous determinations, performed for other than colorectal neoplasm screening Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.6 82465 Cholesterol, serum or whole blood, total82533 Cortisol; total82565 Creatinine; blood 82731 Fetal fibronectin, cervicovaginal secretions, semi-quantitative 82947 Glucose; quantitative, blood (except reagent strip) 82948 Glucose; blood, reagent strip 82950 Glucose; post glucose dose (includes glucose) 82951 Glucose; tolerance test (GTT), 3 specimens (includes glucose) 82952 Glucose; tolerance test, each additional beyond 3 specimens (List separately in addition to code for primary procedure) 82962 Glucose, blood by glucose monitoring device(s) cleared by the FDA specifically for home use 83036 Hemoglobin; glycosylated (A1C) 83037 Hemoglobin; glycosylated (A1C) by device cleared by FDA for home use 83525 Insulin; total 83655 Lead 83861 Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity 83986 pH; body fluid, not otherwise specified 83992 Phencyclidine (PCP) 84132 Potassium; serum, plasma or whole blood 84443 Thyroid stimulating hormone (TSH) 84484 Troponin, quantitative 84520 Urea nitrogen; quantitative 84703 Gonadotropin, chorionic (hCG); qualitative 85007 Blood count; blood smear, microscopic examination with manual differential WBC count 85013 Blood count; spun microhematocrit 85014 Blood count; hematocrit (Hct) 85018 Blood count; hemoglobin (Hgb) 85025 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) and automated differential WBC count 85027 Blood count; complete (CBC), automated (Hgb, Hct, RBC, WBC and platelet count) 85049 Blood count; platelet, automated 85610 Prothrombin time; 85651 Sedimentation rate, erythrocyte; non-automated 86308 Heterophile antibodies; screening 86318 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); 86328 Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV – 2) (coronavirus disease [COVID-19]) 86408 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]); screen 86409 Neutralizing antibody, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]); titer 86580 Skin test; tuberculosis, intradermal 86756 Antibody; respiratory syncytial virus 86769 Antibody; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.7 87070 Culture, bacterial; any other source except urine, blood or stool, aerobic, with isolation and presumptive identification of isolates87172 Pinworm exam (eg, cellophane tape prep)87205 Smear, primary source with interpretation; Gram or Giemsa stain for bacteria, fungi, or cell types 87210 Smear, primary source with interpretation; wet mount for infectious agents (eg, saline, India ink, KOH preps) 87220 Tissue examination by KOH slide of samples from skin, hair, or nails for fungi or ectoparasite ova or mites (eg, scabies) 87270 Infectious agent antigen detection by immunofluorescent technique; Chlamydia trachomatis 87301 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; adenovirus enteric types 40/41 87400 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Influenza, A or B, each 87420 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; respiratory syncyt ial virus 87426 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respiratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) 87428 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; severe acute respi ratory syndrome coronavirus (eg, SARS-CoV, SARS-CoV-2 [COVID-19]) and influenza virus types A and B 87430 Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], fluorescence immunoassay [FIA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative; Streptococcus, gro up A 87490 Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, direct probe technique 87491 Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, amplified probe technique 87492 Infectious agent detection by nucleic acid (DNA or RNA); Chlamydia trachomatis, quantification 87493 Infectious agent detection by nucleic acid (DNA or RNA); Clostridium difficile, toxin gene(s), amplified probe technique 87501 Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, includes reverse transcription, when performed, and amplified probe technique, each type or subtype 87502 Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription , when performed, and multiplex amplified probe technique, first 2 types or sub-types 87503 Infectious agent detection by nucleic acid (DNA or RNA); influenza virus, for multiple types or sub-types, includes multiplex reverse transcription, when performed, and multiplex Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.8 amplified probe technique, each additional influenza virus type or sub-type beyond 2 (List separately in addition to code for primary procedure 87591 Infectious agent detection by nucleic acid (DNA or RNA); Neisseria gonorrhoeae, amplified probe technique 87631 Infectious agent detection by nucleic acid (DNA or RNA) ; respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or sub-types, 3-5 targets 87632 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when perform ed, and multiplex amplified probe technique, multiple types or subtypes, 6-11 targets 87633 Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when perform ed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets 87634 Infectious agent detection by nucleic acid (DNA or RNA) ; respiratory syncytial virus, amplified probe technique 87635 Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]), amplified probe technique 87636 Infectious agent detection by nucleic acid (DNA or RNA) ; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique 87637 Infectious agent detection by nucleic acid (DNA or RNA) ; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) and influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique 87650 Infectious agent detection by nucleic acid (DNA or RNA) ; Streptococcus, group A, direct probe technique 87651 Infectious agent detection by nucleic acid (DNA or RNA) ; Streptococcus, group A, amplified probe technique 87800 Infectious agent detection by nucleic acid (DNA or RNA), multiple organisms; direct probe(s) technique 87802 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Streptococcus, group B 87803 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Clostridium difficile toxin A 87804 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Influenza 87806 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies 87807 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; respiratory syncytial virus 87808 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Trichomonas vaginalis 87811 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) 87880 Infectious agent antigen detection by immunoassay with direct optical (ie, visual) observation; Streptococcus, group A 87905 Infectious agent enzymatic activity other than virus (eg, sialidase activity in vaginal fluid) Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.9 G0480 Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/MS (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), (2) stable isotope or other universa llyrecognized internal standards in all samples (e.g., to control for matrix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrumen t variations and mass spectral drift); qualitative or quantitative, all sources, includes specimen validity testing, per day; 1-7 drug class(es), including metabolite(s) if performed G0481 Drug test(s), definitive, utilizing (1) drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including, but not limited to, GC/MS (any type, single or tandem) and LC/M S (any type, single or tandem and excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase)), (2) stable isotope or other universally recognized internal standards in all samples (e.g., to control for mat rix effects, interferences and variations in signal strength), and (3) method or drug-specific calibration and matrix-matched quality control material (e.g., to control for instrument variations and mass spectral drift); qualitative or quantitative, all so urces, includes specimen validity testing, per day; 8-14 drug class(es), including metabolite(s) if performed G0659 Drug test(s), definitive, utilizing drug identification methods able to identify individual drugs and distinguish between structural isomers (but not necessarily stereoisomers), including but not limited to, GC/MS (any type, single or tandem) and LC/MS (an y type, single or tandem), excluding immunoassays (e.g., IA, EIA, ELISA, EMIT, FPIA) and enzymatic methods (e.g., alcohol dehydrogenase), performed without method or drug-specific calibration, without matrix-matched quality control material, or without use of stable isotope or other universally recognized internal standard(s) for each drug, drug metabolite or drug class per specimen; qualitative or quantitative, all sources, includes specimen validity testing, per day, any number of drug classes Q0111 Wet mounts, including preparations of vaginal, cervical or skin specimens Q0112 All potassium hydroxide (KOH) preparations U0001 CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel U0002 2019-nCoV coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 09/25/2024 New policy, approved at Committee.Date Revised 12/18/2024 05/07/202508/27 /2025Review: removed CLIA and QW modifier from policy. Approved at Committee. Review: added D.III, updated code list and references, approved at Committee. Review: updated code list , removed laboratory procedures definition , added D. I and V, approved at Committee. Date Effective 01/01/2026 Date Archived Laboratory Testing in Office Setting-OH MCD-PY-1545Effective Dat e: 01/01/2026The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.10 H. References 1. CPT overview and code approval. American Medical Association. Accessed May 5, 2025. www.ama-assn.org 2. Definitions, OHIO ADMIN CODE 3701-32-01 (2021). 3. Diagnostic X-Ray Tests, Diagnostic Laboratory Tests, and Other Diagnostic Tests: Conditions, 42 U.S.C. 410.32 ( 2023 ). 4. Healthcare Common Procedure Coding System (HCPCS). Accessed May 5, 2025. www.nlm.nih.gov 5. Laboratory Requirements, 42 U.S.C. 493 ( 2023 ). 6. Laboratory Services, 42 U.S.C. 441.17 ( 2023 ). 7. Laboratory Services, OHIO ADMIN CODE 5160-11-11 (2021). 8. Managed Care: Provider Network and Contracting Requirements, OHIO ADMIN CODE 5160-26-05 (2022). 9. Other Laboratory and X-Ray Services, 42 U.S.C. 440.30 ( 2023 ). 10. Place of Service Code Set. Centers for Medicare and Medicaid Services; 202 5. Accessed April 30, 2025 . www.cms.gov ODM approved 09/24 /2025

Monitored Anesthesia Care

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Monitored Anesthesia Care-OH MCD-PY-1685 11/01/2025 Policy Type REIMBURSEMENT Reimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billin g, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefi ts design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management 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, i llnes s, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functi on, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan con tract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to ma ke the determination. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 5 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 5 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 Monitored Anesthesia Care-OH MCD-PY-1685Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.2 A. SubjectMonitored Anesthesia Care B. BackgroundICD-10 guidelines are a set of rules regarding the classification of diagnoses and reasons for health care visits in all settings based on the statistical classification of disease published by the World Health Organization. The guidelines are approved by the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), the Centers for Medicare and Medicaid Services (CMS), and the National Center for Health Statistics (NCHS). Under the Health Insurance Portability and Accountability Act (HIPAA), adherence to these guidelines is mandatory. Code assignment is based on the providers documentation outlining the relationship between the condition and the care or procedure, unless otherwise instructed by theclassification. There must be a cause-and-effect relationship between the care provided and the condition. In addition to general coding guidelines, there are guidelines for specific diagnoses and/or conditions in the classification. Unless otherwise indicated, these guidelines apply to all health care settings. Current Procedural Terminology (CPT) codes are the official code set for compliancemandated by HIPPA for healthcare procedures and services and are developed and maintained by the American Medical Association (AMA). CPT includes the use of modifiers to clarify the service reported and increase reimbursement accuracy and coding consistency. In billing, medical necessity is demonstrated by the diagnosis code assigned and whether the documented elements are consistent with the problems addressed (CPT). The Medicaid National Correct Coding Initiative (NCCI) aims to reduce improper payments in the Medicaid program and includes edits for Procedure-to-Procedure (PTP),Medically Unlikely Edits (MUE), and Add-on Code (AOC). Claims denied by NCCI edits are based on a determination of inappropriate coding and not on the basis of medical necessity. Clinical judgment is not nee ded to deny a claim based on correct coding. Certain surgical procedures may include anesthesia services as part of a global fee. In such cases, procedure-to-procedure edits may prevent separate billing for monitoredanesthesia care (M AC ) when it is not allowed. These edits help ensure that claims for anesthesia services are consistent with clinical guidelines and that services billed together are appropriate. CareSource follows guidance from the Ohio Dept of Medicaid (ODM) for payment of MAC. C. Definitions Anesthesia Services The administration of any drug or combination of drugs to create deep sedation/analgesia, regional anesthesia or general anesthesia but does not include topical or local anesthesia or moderate sedation/analgesia. Monitored Anesthesia Care-OH MCD-PY-1685Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.3 Claim A bill from a provider for health care services assigned a unique identifier ,including a bill for services , a line item of services and/or all services for one member within a bill . Edit Adjusting 1 or more procedure codes billed by a participating provider on a claim for payment or a practice that results in o Payment for some but not all of the procedure code originally billed . o Payment for a different procedure code than the procedure code originally billed. o A reduced payment as a result of services claimed under more than 1 procedure code on the same service date. Office Se tting An office or portion thereof utilized to provide medical and/or surgical services to the physician’s own patients but not includ ing an office or portion thereof licensed as an ambulatory surgical facility pursuant to ORC 3702.30, a registered hospital pursuant to ORC 3701.07 or an emergency department located within such a hospital . Procedure Codes The AMAs CPT code, the American Dental Associations Current Dental Terminology , and CMSs Health Care Common Procedure Coding Syste m (HCPCS) . Provider A physician or any qualified healthcare practitioner who is legally accountable for establishing a members diagnosis. D. PolicyI. General Reimbursement Guidelines A. All claims for MAC are to be submitted in accordance with established guidelines managed by the Ohio Administrative and Revised Codes (OAC and ORC, respectively), particularly as related to OAC 5160-4-21 . B. In accordance with the ODM, claims are to be submitted pursuant to the NCCI and coding standards set forth in the following guides: 1. Healthcare Common Procedure Coding System 2. Current Procedural Terminology Codebook 3. Current Dental Terminology Codebook 4. Internal Classification of Diseases Handbook C. When adjudicating claims, CareSource utilizes code editing software to evaluate the accuracy of diagnos es and procedure codes to ensure that claims are processed consistently, accurately, and efficiently. The software evaluate s accuracy of the procedure code only, not medical necessity for the procedure. The edits utilized include 1. Medicaid NCCI 2. ICD-10 guidelines 3. CPT guidelines 4. HCPCS guidelines 5. CMS published materials, as applicable 6. state published reimbursement guidelines 7. state and federal statutes and regulations Monitored Anesthesia Care-OH MCD-PY-1685Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.4 D. Per correct coding, the ICD-10 diagnosis and the CPT/HCPCS code demonstrate the cause-and-effect relationship of the condition and care provided. Claims may be denied due to an improper grouping of codes. E. It is the providers responsibility to select codes carried out to the highest level of specificity and selected from the ICD-10-CM code book appropriate to the year in which the service is rendered for the claim(s) submitted. The provider must also use ap plicable modifiers, as necessary , including those that indicate whether a procedure was personally performed, medically directed or medically supervised. II. MACA. MAC should be provided by qualified anesthesia personnel continuously present to monitor the member and provide care in accordance with state licensure requirements. B. During MAC, the attending anesthetist should assess the member s oxygenation, ventilation, circulation, and temperature using the most appropriate methods available , including advanced non-invasive monitoring techniques . Close observation is essential to foresee the need for administering general anesthesia or addressing adverse physiological reactions. The potential for the procedure to become more complex or lead to unexpected complications necessitates thorough monitoring and possible anesthetic interven tion. C. Certain anesthesia procedures are typically performed by the attending surgeon and are included in the global fee, no t billed separately. However, in specific cases, MAC may be deemed reasonable and necessary for procedures usually handled by the attending surgeon, provided certain conditions exist. In these scenarios, MAC may be essential to address serious accompanying conditions and ensure a smooth anesthesia process (a nd surgery) by preventing adverse physiological complications. It is important that any special conditions or criteria are documented in the medical record. D. High-quality MAC is essential and demands the same level of expertise and effort as administering general anesthesia. If the necessary criteria are not met or if the procedures are deemed unnecessary, full payment may be denied. E. For procedures that typically do not necessitate anesthesia services, MAC may be covered if the member s condition warrants qualified anesthesia personnel to provide monitoring alongside the physician performing the procedure . This must be documented in the medical record. F. The presence of an underlying condition may not be adequate justification for the necessity of MAC. The medical condition must be substantial enough to require MAC (eg, member being on medication , member exhibiting symptoms ). Simply having a stable, managed condition is not, by itself, sufficient. G. No additional payment will be made on account of physical status, age, body temperature (hypothermia or hyperthermia), emergency conditions or time of day. Monitored Anesthesia Care-OH MCD-PY-1685Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.5 E. Conditions of CoverageI. Anesthesia services must be submitted with at least 1 CPT anesthesia code. These codes are reimbursed based on time units using the standard anesthesia formula. II. All documentation must be maintained in the medical record and made available upon request, including the following:A. legible pages with appropriate member identification information (eg, complete name, dates of service[s]) B. legible signature of the physician or non-physician practitioner responsible for and providing care C. support for medical necessity of the services and selected ICD-10 code(s) and CPT/HCPCS codes performed /used D. the reason for MAC E. a pre-anesthesia evaluation, including a history and physical exam F. evidence of continuous monitoring of member oxygenation, ventilation, circulation , and temperature G. a post-anesthesia evaluation, including any unusual events or complications H. member status on discharge III. Required anesthesia modifiers may include the following, which are provided as a courtesy only: Modifier Provider Type AA Anesthesiologist physician, personally performed AD Anesthesiologist physician, supervising over 4 qualified non-physician anesthetists performing concurrent anesthesia procedures QK Anesthesiologist physician, supervising 2-4 qualified non-physician anesthetists performing concurrent anesthesia procedures QS Monitored anesthesia care reported with an anesthesia procedure code QX CRNA or AA directed by anesthesiologist physician QY Anesthesiologist physician, supervising 1 qualified non-physician anesthetist QZ CRNA, personally performed F. Related Policies/RulesNA G. Review/Revision HistoryDATE ACTIONDate Issued 07/16/2025 New policy. Approved at Committee.Date Revised Date Effective 11/01/2025 Date Archived H. References1. 2025 ICD-10-CM Official Guidelines for Coding and Reporting . AAPC; 2025. Monitored Anesthesia Care-OH MCD-PY-1685Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.6 2. American Medical Association CPT Editorial Panel . cpt 2025 Professional Edition .American Medical Association; 2024. 3. Anesthesia Services, OHIO ADMIN . CODE 5160-4-21 (2024). 4. CPT codes. American Medical Association. Accessed June 5, 2025. www.ama – assn.org 5. Health Care Contracts Definitions, OHIO REV . CODE 3963.01 (2024). 6. Medicaid NCCI Coding Policy Manual . Centers for Medicare and Medicaid Services; 2025. 7. Office Based Surgery , OHIO ADMIN . CODE Chapter 4731-25 (2024). 8. Ohio Medicaid Provider Agreement for Managed Care Organization. The Ohio Dept of Medicaid. Revised January 2025. 9. Provider Manual Ohio Medicaid . CareSource; 2024. Accessed June 16, 2025. www.caresource.com 10. Submission of Medicaid Claims, OHIO ADMIN . C ODE 5160-1-19 (2023). Approved by Ohio Department of Medicaid 08/05/2025

Coding Guidelines

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name & Number Date Effective Coding Guidelines-OH MCD-PY-1677 11/01/2025 Policy Type REIMBURSEMENT Reimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billin g, coding and documentation guidelines. Coding methodology, regulatory requirements, industry-standard claims editing logic, benefi ts design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, m edical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable referral, authorization, notification and utilization management 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, i llnes s, or injury and without which the patient can be expected to suffer prolonged, increased or new morbidity, impairment of functi on, dysfunction of a body organ or part, or significant pain and discomfort. These services meet the standards of good medical practice in the local area, are the lowest cost alternative, and are not provided mainly for the convenience of the member or provider. Medically necessary services also include those services defined in any federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statements, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy and the plan con tract (i.e., Evidence of Coverage), then the plan contract (i.e., Evidence of Coverage) will be the controlling document used to ma ke the determination. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage for the diagnosis and treatment of a behavioral health disorder will not be subject to any limitations that are less favorable than the limitations that apply to medical conditions as covered under this policy.Table of ContentsA. Subject ………………………….. ………………………….. ………………………….. …………………………. 2 B. Background ………………………….. ………………………….. ………………………….. …………………… 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 3 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Coverage ………………………….. ………………………….. ………………………….. …… 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 4 Coding Guidelines-OH MCD-PY-1677Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.2 A. SubjectCoding Guidelines B. BackgroundCode assignment for claims is based upon the providers (ie, physician or other qualified healthcare practitioner legally accountable for establishing the patients diagnosis) documentation outlining the relationship between the condition and the care or procedure, unless otherwise instructed by the classification. There must be a cause-and – effect relationship between the care provided and the condition. ICD-10 guidelines are a set of rules regarding the classification of diagnoses andreasons for health care visits in all settings based on the statistical classification of disease published by the World Health Organization. These guidelines are approved by the American Hospital Association (AHA), the American Health Information Management Association (AHIMA), the Centers for Medicare and Medicaid Services ( CMS), and the National Center for Health Statistics (NCHS). Under the Health Insurance Portability and Accountability Act (HIPAA), adherence to these guidelines is mandatory. In addition to general coding guidelines outlined by the ICD-10 manual , additionalguidelines are provided within for specific diagnoses and/or conditions in the classification. Unless otherwise indicated, these guidelines apply to all health care settings. The Current Procedural Terminology (CPT) is the official code set for compliancemandated by HIPPA for healthcare procedures and services. These codes are developed and maintained by the American Medical Association (AMA). These codes and their guidelines are designed to communicate as a statistical classification of clinically recognized and generally accepted services provided by healthcare professionals. The use of these codes and guidelines simplifies the reporting and processing of services for advance d analytics of these procedures. CPT includes the use of modifiers to clarify the service that is being reported. Using modifiers increases reimbursement accuracy and coding consistency. In billing, medical necessity is demonstrated by the diagnosis code assigned ( ie, ICD-10) and whether thedocumented elements are consistent with the problems addressed ( ie, CPT).The Medicaid National Correct Coding Initiative (NCCI) aims to reduce improper payments in the Medicaid program. It includes edits for Procedure-to-Procedure (PTP),Medically Unlikely Edits (MUE), and Add-on Code (AOC). Claims denied by NCCI edits are based upon a determination of inappropriate coding and not on the basis of medical necessity. Clinical judgment is not needed to deny a claim based on correct coding. Coding Guidelines-OH MCD-PY-1677Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.3 C. Definitions Claim A bill from a provider for health care services assigned a unique identifier. A claim can include any of the following: (1) a bill for services (2) a line item of services (3) all services for one member within a bill Edit Adjusting one or more procedure codes billed by a participating provider on a claim for payment or a practice that results in any of the following: (1) Payment for some, but not all of the procedure code originally billed by a participating provider. (2) Payment for a different procedure code than the procedure code originally billed by a participating provider. (3) A reduced payment as a result of services provided to an enrollee that are claimed under more than one procedure code on the same service date. Procedure Codes Includes the American Medical Associations current procedural terminology code, the American Dental Associations current dental terminology, and the Centers for Medicare and Medicaid Services health care common procedure coding system. Provider A physician or any qualified healthcare practitioner who is legally accountable for establishing the patients diagnosis. D. PolicyI. In accordance with the Ohio Department of Medicaid (ODM), claims are to be submitted pursuant to the national correct coding initiative and according to the coding standards set forth in the following guides: A. the healthcare common procedure coding system B. the current procedural terminology codebook C. the current dental terminology codebook D. the internal classification of diseases handbook II. When adjudicating claims, CareSource utilizes code editing software to help evaluate the accuracy of diagnosis and procedure codes on submitted claims to ensure claims are processed consistently, accurately, and efficiently. The software helps evaluate the accuracy of the procedure code only, not the medical necessity of the procedure.The edits utilized include A. Medicaid NCCI Policy Manual B. ICD-10 guidelines C. CPT guidelines D. HCPCS guidelines E. CMS published materials, as applicable F. state published reimbursement guidelines G. state and federal statutes and regulations Coding Guidelines-OH MCD-PY-1677Effective Dat e: 11/01/2025The REIMBURSEMENT Policy Statement detailed above has recei ved due consideration as defined inthe REIMBURSEMENT Policy Statement Policy and is approved.4 III. Per ICD-10 guidelines , there must be a cause-and-effect relationship between the care provided and the condition. As such, the ICD-10 diagnosis and the CPT/HCPCS code demonstrate th is through analytics in coding software . Claims may be denied due to an improper grouping of codes. E. Conditions of CoverageN/A F. Related Policies/RulesN/A G. Review/Revision HistoryDATE ACTIONDate Issued 07/30/2025 Approved at Committee.Date Revised Date Effective 11/01/2025 Date Archived H. References1. 2025 ICD-10-CM Official Guidelines for Coding and Reporting . AAPC; 2025. 2. CPT Codes. American Medical Association. Accessed July 30, 2025. www.ama – assn.org 3. Current Procedural Coding Expert . A merican Medical Association ; 2024. 4. Health Care Contracts Definitions, OHIO REV . CODE 3963.01 (2024). 5. Medicaid NCCI Coding Policy Manual . Centers for Medicare and Medicaid Services; 2025. 6. Ohio Medicaid Provider Agreement for Managed Care Organization. The Ohio Dept of Medicaid. Revised January 2025. 7. Provider Manual Ohio Medicaid . CareSource; 2024. 8. Submission of Medicaid Claims, OHIO ADMIN . CODE 5160-1-19 (2023). Approved by ODM 08/14/2025

Single Dose Vial – Claims Modifiers

REIMBURSEMENT POLICY STATEMENTOhio Medicaid Policy Name Policy Number Effective Date Single Dose Vial Claims Modif ier s PY-PHARM-0100 07-01-2023 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policy Statement : R eimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, indust ry-standard claims editing lo gic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utilization management 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 patien t 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 lowes t 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 federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statem ents, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy 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. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify thi s Policy at any time. 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 limitatio ns that apply to medical conditions as covered under this policy.Table of ContentsReimbursement Policy Statement ………………………….. ………………………….. ………………………. 1 A. Subject ………………………….. ………………………….. ………………………….. ……………………….. 2 B. Background ………………………….. ………………………….. ………………………….. …………………. 2 C. Def initions ………………………….. ………………………….. ………………………….. …………………… 3 D. Policy ………………………….. ………………………….. ………………………….. …………………………. 3 E. Conditions of Coverage. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …… 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. … 4 H. Ref erences ………………………….. ………………………….. ………………………….. ………………….. 4 Sin g le Do se Vial Claims Mo d ifiersOh io Med icaidPY-PHARM-0100 Effective Date: 07-01-2023 2 A. SubjectThis policy provides guid ance for claims billing documentation and reimbursement of single dose injectable vials. B. Background Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and polic y clarif ication. These proprietary policies are not a guarantee of payment. Reimbursement f or claims may be subject to limitations and/or qualif ications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received f or processing. Health care providers and their of f ice staf f are encouraged to use self-service channels to verif y members eligibility. It is the responsibility of the submitting provider to submit the most a ccurate andappropriate CPT/HCPCS /ICD-10 code(s) f or the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. This policy describes documentation require ments and reimbursement guidelines f orbilling of the administered and discarded portion (s) of drugs and biologicals . Providers shall bill and receive reimbursement f or both the dose administered and the unused portion of weight-based or variable dosing injectable drugs that are manuf actured and supplied only in single dose or single use f ormat. The JW modif ier is required to be reported on a claim to report the amount of drug that is discarded and e ligible f or payment and should be used only f or claims that bill single-dose container drugs. The discarded portion of single use or single dose vials must be identif ied with the JW Modif ier as a separate line item f rom the dose or administered portion. Pr oviders may be reimbursed f or the discarded portions of drugs and biologicals in single-dose vials (otherwise known as drug waste) only when appropriately reported based on the policy reimbursement guidelines. As of July 1, 2023, providers and suppliers a re required to report the JZ modif ier on allclaims that bill f or drugs f rom single-dose containers when there are no discarded amounts. The JZ modif ier is reported on a claim to attest that no amount of drug was discarded and should only be used f or claim s that bill f or single-dose container drugs. Claims containing drug administered f rom multi-dose vials are not subject to this requirement. Under this policy, a ll claims for separately payable single dose format injectabledrugs must include either a JW modifier or a JZ modifier after 7-1-2023 in order to be reimbursed Sin g le Do se Vial Claims Mo d ifiersOh io Med icaidPY-PHARM-0100 Effective Date: 07-01-2023 3 MODIFIER SHORT DESCRIPTOR LONG DESCRIPTORJW Discard ed p o rtio n o f d rug no t ad ministered Drug amo unt d iscard ed /no t ad ministered to any p atient JZ All d rug ad ministered no ne d iscard ed Zero d rug amount d iscarded/not administered to any p atient C. Def initionsModif ie r JW ref ers to the drug amount discarded (wasted)/not administered to any patient . Modif er JZ ref ers to zero drug amount discarded/not administered to any patient. Discarded Wastage or Unused Portion is def ined as the amount of a single use/dose vial or other single use/dose package that remains af ter administering a dose/quantity of a drug or biological. Single Dose Vial is def ined as a vial of medication intended f or administration by injection or inf usion that is meant f or use in a single patient f or a sing le procedure. These vials are labeled as single-dose or single-vial by the manuf acturer and typically do not contain a preservative. Multi-Dose Vial is def ined as a vial of medication intended f or administration by injection or inf usion that contains more than one dose of medication. These vials are labeled as multi-dose by the manuf acturer and typically contain an antimicrobial preservative to help prevent the growth of bacteria. D. PolicyModif ier JW should be billed on the detail line that denotes the discarded portion of the drug or biological. The amount administered to the patient should be billed on a separate detail line without modif ier JW. Both details are reimbursable. CareSource will consider reimbursement f or: I. A single-dose or single-use vial drug that is wasted, when Modif ier JW is appended. II. The wasted amount when billed with the amount of the drug that was administered to the member. III. The wasted amount billed that is not administered to another patient. CareSource will NOT consider reimburse ment f or:I. The wasted amount of a multi-dose vial drug. II. Any drug wasted that is billed when none of the drug was administered to the patient. III. Any drug wasted that is billed without using the most appropriate size vial, or combination of vials, to deliver the administered dose. NOTE: The JZ modif ier is required when there are no discarded amounts of a single – dose container drug f or which the JW modif ier would be required if there were discarded Sin g le Do se Vial Claims Mo d ifiersOh io Med icaidPY-PHARM-0100 Effective Date: 07-01-2023 4 amounts. The JZ modif ier is required to attest that there were no discarded amounts,and no JW modif ier amount is reported. E. Conditions of Coverage Providers must not use the JW modif ier f or medications manuf actured in a multi – dose vial f ormat. Providers must choose the most appropriate vial size(s) required to prepar e a dose to minimize waste of the discarded portion of the injectable vials. Claims considered f or reimbursement must not exceed the package size of the vial used f or preparation of the dose. Providers must not bill f or vial contents overf ill. Providers must not use the JW modif ier when the actual dose of the drug or biological administered is less than the billing unit. The JW Modif er is only applied to the amount of drug or biological that is discarded (wasted). The discarded (wasted) drug should be billed on a separate line with the JW modif ier. 1. Claim Line #1 HCPCS code f or drug administered and the amount admistered to the patien t. 2. Claim Line #2 HCPCS code f or drug discarded (wasted) with JW modif ier appended to indicate waste and the amount discarded (wasted). The JZ Modif ier is applied when zero amounts of a single-dose container drug is discarded. F. Related Policies/Rules Chapt er 17, Section 40.1 of CMS Medicare Claims Processing Manual G. Review/Revision History DATE ACTIONDate Issued 01-22-2023 Original ef f ective dateDate Revised 08-25-2023 Updated policy to include JZ modif ier. Updated policy name and ref erences. Date Effective 07-01-2023 Date Archived H. Ref erences 1. Billin g an d Co d ing : JW an d JZ Mo d ifier Billin g Guid elines Article – Billin g an d Co d in g : JW an d JZ Mo d ifier Billin g Guid elin es (A55932) (cms.g o v) 2. New JZ Claims Mo d ifer fo r Certain Med icare Part BDru gs h ttp s://www.cms.g o v/files/d ocumen t/mm13056-n ew-jz-claims-modifier-certain-med icare-part-b- d rug s.p d f 3. Discard ed Drug s an d Bio lo g icals JW Mo d ifier an d JZ Mo d ifier Po licy FAQs. jw-mo d ifier – faq s.p d f (cms.g o v) The Reimbursement Policy Statement detailed abo ve has recei ved due con sideration as defined in theReimbursement Policy Statement Policy and is app roved.

340B Drug Pricing Policy

REIMBURSEMENT POLICY STATEMENTOHIO MEDICAID Policy Name Policy Number Effective Date 340B Drug Pricing PY-PHARM-008 7 10-1-2022 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policy Statement : R eimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, indust ry-standard claims editing logic, benefit s design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utilization management 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 patien t 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 lowes t 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 federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statem ents, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service(s) referenced herein. If there is a conflict between this Policy 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. CareSource and its affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify thi s Policy at any time. 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 limitatio ns that apply to medical conditions as covered under this policy.Table of ContentsReimbursement Policy Statement ………………………….. ………………………….. ………………………… 1 A. Subject ………………………….. ………………………….. ………………………….. ………………………….. 2 B. Background ………………………….. ………………………….. ………………………….. ……………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ……………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. .. 3 E. Conditions of Cov erage ………………………….. ………………………….. ………………………….. ……. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. …….. 4 G. Review/Revision History ………………………….. ………………………….. ………………………….. ….. 4 H. References ………………………….. ………………………….. ………………………….. ……………………. 5 340B Drug PricingOHIO MEDICAIDPY-PHARM-008 7 Effective Date: 10-01-2022 2 A. Subject340B Drug Pricing B. Background Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office staff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate andappropriate CPT/HCPCS /ICD-10 code(s) for the product or service that is being provided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. The 340B Drug Pricing Pro gram is a fed eral program, which limits the cost of coveredoutpatient drugs to eligible health care organizations and covered entities. The purpose of the program was to enable covered entities to stretch scarce federal resources as far as possible, reac h more eligible patients and provid e more comprehensive services. This policy describes the claim submission requirements for outpatient pharmacy and provider administered drugs. C. Definitions 340 BCovered Entity (CE) A facility t hat is eligible to purch ase drugs through the 340B Program and appears on the HRSA Office of Pharmacy Affairs Information System (OPAIS). 340B Drug Discount Program (340B) Section 340B of the Public Health Service (PHS) Act (1992) that requires drug manufactures participating i n the Medicaid Drug Rebate Program to sign a pharmaceutical pricing agreement (PPA) with the Secretary of Health and Human Services. Actual Acquisition Cost The actual prices paid to acquire drug products sold by a specific manufacturer. Care Management Organization (CMO) Organizations, such as CareSource, contracted by the Ohio Department of Medicaid to coordinate services for Medicaid members. Contract Pharmacy A pharmacy contract ed with a Covered Entity to dispense 340B medications purchased by the Covered Entity . Current Procedural Terminology (CPT) A medical code set maintained by the American Medical Association to describe and bill for medical, surgical, and diagnostic services. Fee-for-Service (F FS) Claims billed directly to Ohio Medicaid for prescriptions and physician administered drugs provided to FFS members. 340B Drug PricingOHIO MEDICAIDPY-PHARM-008 7 Effective Date: 10-01-2022 3 Healthcare Common Procedure Coding System ( HCPCS ) A set of health care procedure codes based on CPT. Health Resources and Services A dministration (HRSA) The primary federal agency responsible for administering the 340B program. National Council for Prescription Drug Programs (NCPDP) the standards organization that creates the standard format through which pharmacy claims are submit ted to a Pharmacy Benefit Manager (PBM). National Drug Code (NDC) A drug product that is identified and reported using a unique, three-segment number, which serves as a universal product identifier for the specific drug. Pharmacy Benefit Manager (PBM) The entity that processes retail pharmacy or PBM benefit claims for CareSource. Provider Administered Drugs Drugs administered directly by a health care provider to a patient. D. Policy I. Pharmacies Allowed to Bill 340B Claims A. Only Covered Entities that elected to dispense 340B medications to Medicaid members on the HRSA Medicaid Exclusion File may bill 340B claims. B. Contract pharmacies are not allowed to bill for 340B purchased drugs. II. Retail Pharmacy (Point-of-Sale) 340B Claim s A. In addition to the NDC and other fields consistently submitted to the PBM for payment, a ll 340B Covered Entities must identify 340B claims using either of the two below NCPDP Telecommunication Standard D.0 fields: Submission Clarification Code (SCC – Field 420-DK) of 20 and/or: Basis of Cost Determination – (Field 423-DN) of 08 plus their 340B acquisition cost in the Ingredient Cost Submitted (Field 49-D9) B. When submitting 340B claims, providers are permitted, but no t required to, submit Basis of Cost Determination Code 08. Providers electing to identify 340B claims using this field must also submit their 340B acquisition code in the Submitted Ingredient Cost field 409-D9. C. For drugs not purchased at 340B rates, do n ot include either of the 340B identifiers listed above. III. Provider Administered 340B Drug Claims A. In addition to the HCPCS/CPT code, NDC, and other fields consistently submitted for claims payment, 340B Covered Entit ies should submit the claim on a CMS 1500 or UB-04 claim form with the either of the following modifiers: SE Drug or biological acquired through the 340B drug pricing program discount 340B Drug PricingOHIO MEDICAIDPY-PHARM-008 7 Effective Date: 10-01-2022 4 IV. Auditing a nd MonitoringA. To ensure compliance with 340B billing requirements, CareSource will monitor both 340B and non-340B claim submissions to identify potential 340B claims. Should we identify a claim we believe is 340B, we will inform the provider of the potent ial billing error and ask for validation, as well as correction. E. Conditions of Coverage Reimbursement is dependent on, but not limited to, submitting the appropriate and applicable drug-related codes (HCPCS, CPT, NDC) along with appropriate 340B claim fiel ds , if applicable . F. Related Policies/Rules ORC 5167.123 requires the following regarding managed care organization contracts with 340B providers: A) No contract between a medicaid managed care organization, including a third – party administrator, and a 340B covered entity shall contain any of the following provisions: (1) A payment rate for a prescribed drug that is less than the national average drug acqu isition cost rate for that drug as determined by the United States centers for medicare and medicaid services, measured at the time the drug is administered or dispensed, or, if no such rate is available at that time, a reimbursement rate that is less than the wholesale acquisition cost of the drug, as defined in 42 U.S.C. 1395w – 3a(c)(6)(B); (2) A fee that is not imposed on a health care provider that is not a 340B covered entity; (3) A fee amount that exceeds the amount for a health care provider that is n ot a 340B covered entity. (B) The organization, or its contracted third-party administrators, shall not discriminate against a 340B covered entity in a manner that prevents or interferes with a medicaid recipient’s choice to receive a prescription drug fro m a 340B covered entity or its contracted pharmacies. (C) Any provision of a contract entered into between the organization and a 340B covered entity that is contrary to division (A) of this section is unenforceable and shall be replaced with the dispensin g fee or payment rate that applies for health care providers that are not 340B covered entities. G. Review/Revision HistoryDATE ACTIONDate Issued 08/26/2021Date Revised 08/25/2022 Date Effective 10/01/2022 Date Archived 340B Drug PricingOHIO MEDICAIDPY-PHARM-008 7 Effective Date: 10-01-2022 5 H. References1. Frequently Asked Questions: 340B Drug Pricing Program. Available from: https://pharmacy.medicaid.ohio.gov/sites/default/files/2018-6- 4%20340B%20FAQ.pdf . Revis ed June 2018 2. Section 5167.123 Medicaid MCO contracts with 340B program participants. Ohio Revised Code, Tital 51 Public Welfare, Chapter 5157 Medicaid Managed Care. Available from: https://codes.ohio.gov/ohio-revised-code/section-5167.123 . Effective April 12, 2021 3. Modifiers Recognized by Ohio Medicaid . Revised January 2 8, 2022. https://medicaid.ohio.gov/static/Providers/Billing/BillingInstructions/ModifiersODM.pdf The Reimbursement Policy Statement detailed abo ve has recei ved due con sideration as defined in the Reimbursement Policy Statement Policy and is app roved.

Standard Medical Billing Guidance

REIMBURSEMENT POLICY STATEMENT OHIO MEDICAID Policy Name Policy Number Effective Date Standard Medical Billing Guidance PY-PHARM-0125 – OH-MCD 02-01-202 3 Policy Type Medical Administrative Pharmacy REIMBURSEMENT Reimbursement Policy Statement : R eimbursement Policies prepared by CareSource and its affiliates are intended to provide a general reference regarding billing, coding and documentation guidelines. Coding methodology, regulatory requirements, indust ry-standa rd claims editing logic, benefits design and other factors are considered in developing Reimbursement Policies. In addition to this Policy, Reimbursement of services is subject to member benefits and eligibility on the date of service, medical necessity, adherence to plan policies and procedures, claims editing logic, provider contractual agreement, and applicable re ferral, authorization, notification and utilization management 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 patien t 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 lowes t 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 federal or state coverage mandate, Evidence of Coverage documents, Medical Policy Statem ents, Provider Manuals, Member Handbooks, and/or other policies and procedures. This Policy does not ensure an authorization or Reimbursement of services. Please refer to the plan contract (often referred to as the Evidence of Coverage) for the service (s) referenced herein. If there is a conflict between this Policy 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. CareSource and it s affiliates may use reasonable discretion in interpreting and applying this Policy to services provided in a particular case and may modify this Policy at any time. According to the rules of Mental Health Parity Addiction Equity Act (MHPAEA), coverage f or 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 ContentsReimbursement Policy Statement ………………………….. ………………………….. ………………………….. . 1 A. Subject ………………………….. ………………………….. ………………………….. ………………………….. … 2 B. Background ………………………….. ………………………….. ………………………….. ………………………. 2 C. Definitions ………………………….. ………………………….. ………………………….. ………………………… 2 D. Policy ………………………….. ………………………….. ………………………….. ………………………….. ….. 3 E. Conditions of Coverage. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …….. 5 H. References ………………………….. ………………………….. ………………………….. ………………………. 5 Standard Billing Reimbursement StatementOHIO MEDICAIDPY-PHARM-0125-OH-MCD Effective Date: 02-01-2023 2 A. SubjectStandard Medical Billing Guid ance B. Background Reimbursement policies are designed to assist you when submitting claims to CareSource. They are routinely updated to promote accurate coding and policy clarification. These proprietary policies are not a guarantee of payment. Reimbursement for claims may be subject to limitations and/or qualifications. Reimbursement will be established based upon a review of the actual services provided to a member and will be determined when the claim is received for processing. Health care providers and their office sta ff are encouraged to use self-service channels to verify members eligibility. It is the responsibility of the submitting provider to submit the most accurate and appropriate CPT/HCPCS /ICD-10 code(s) for the product or service that is beingprovided. The inclusion of a code in this policy does not imply any right to reimbursement or guarantee claims payment. This reimbursement policy applies to all health care services reported using theCMS 1500 Health Insurance Professional Claim Form (a/k/a HCFA ), th e CMS 1450Health Insurance Institutional Claim Form (a/k/a UB04) or its electronic equivalent or any successor form. This policy applies to all products, all network and non-network physicians and other qualified health care professionals, including, but not limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals. Additionally, this policy applies to drugs and biologicals being used for FDA-approved indications or label s. Drugs and biologi cals used for indications other than those in the approved labeling may be covered if it is determined that the use is medically accepted, taking into consideration the major drug compendia, authoritative medical literatures and/or accepted standards of me dical practice. C. Definitions Indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given. is defined as birth before 37 weeks of gestation. FDA approved Indication /Label is the offic ial description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging. Off-label/Unlabeled use of a drug is defined as a use for a non-FDA approved indication, that is, one that is not listed on the drugs official label/prescribing information. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration and frequency of ad ministration, and population to whom the drug would be administered. Standard Billing Reimbursement StatementOHIO MEDICAIDPY-PHARM-0125-OH-MCD Effective Date: 02-01-2023 3 Unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label . Drug compendia , defined as summaries of drug information that are compiled by experts who have reviewed clinical data on drugs. CMS (Center for Medicare and Medicaid Services) recognizes the following compendia: American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia-Drug Information (USP-DI) or its successor publication and American Hospital Formulary Service-Drug Information (AHFS-DI) as authoritative sources for use in the determination of a “medical ly-accepted indication” of drugs and biologicals used off – label in an anticancer chemotherapeutic regimen. The USP DI is a database of drug information developed by the U.S. Pharmacopoeia but maintained by Micromedex, which contains medically accepted uses for generic and brand name drug products D. PolicyCare Source requires that the u se of a drug or biological must be safe and effective and otherwise reasonable and necessary. Drugs or biologicals approved for marketing by the Food and Drug Administration (FDA) are considered safe and effective for purposes of this requirement when used for indications specified on the labeling. Therefore, reimbursement may be provided for the use of an FDA approved drug or biological, if: It was administered on or after t he date of the FDAs approval; It is reasonable and necessary for the individual patient; and All other applicable coverage requirements are met. An unlabeled use of a drug is a use that is not included as an indication on the drug’s label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered if it is determined that the use is medically necessary , taking into consideration the major drug compendia, authoritative medical literatur e and/or accepted standards of medical practice. The following guidelines identify three categories in which medications would not be reasonable and necessary according to accepted standards of medical practice. Not for Particular Illness Medications gi ven for a purpose other than the treatment of a particular condition, illness, or injury are not covered (except for certain immunizations .) Route of Administration Not Indicated Medication given by injection (parenterally) is not covered if standard me dical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration. Excessive Medications Medications administered for treatment of a disease which exceed the freque ncy or duration of dosing indicated by accepted standards of medical practice are not covered. Effective January 1, 1994, off-label, medically accepted indications of Food and Drug Administration -(FDA) approved drugs and biologicals used in an anti-neoplas tic chemotherapeutic regimen are identified under the indications described below. A Standard Billing Reimbursement StatementOHIO MEDICAIDPY-PHARM-0125-OH-MCD Effective Date: 02-01-2023 4 regimen is a combination of anti-neoplastic agents clinically recognized for the treatment of a specific type of cancer. Off-label, medically accepted indications are supp orted in either one or more of the compendia or in peer-reviewed medical literature. E. Conditions of Coverage A medically accepted indication is one of the following: An FDA approved, labeled indication or a use supported in the American Hospital Formulary Service Drug Information (AHFS-DI), NCCN Drugs and Biologics Compendium, Truven Health Analytics Micromedex Drug Dex , Elsevier/Gold Standard Clinical Pharmacology and Wolters Kluwer Lexi – Drugs as the acceptable compendia based on CMS’ Change Request 619 1 (Compendia as Authoritative Sources for Use in the Determination of a “Medically Accepted Indication” of Drugs and Biologicals Used Off-Label in an Anti-Cancer Chemotherapeutic Regimen); or Articles o f Local Coverage Determinations (LCDs) published by C MS. In general, a use is identified by a compendium as medically accepted if the: Indication is a Category 1 or 2A in NCCN, or Class I, Class IIa, or Class IIb in DrugDex; or, Narrative text in AHFS-DI or Clinical Pharmacology is supportive, or Indication is listed in Lexi-Drugs as Use: Off-Label and rated as Evidence Level A A use is not medically accepted by a compendium if the: Indication is a Category 3 in NCCN or a Class III in DrugDex; or, Narrative text in AHFS or Clinical Pharmacol ogy is not supportive, or Indication is listed in Lexi-Drugs as Use: Unsupported If a use is identified as not indicated by CMS or the FDA, or if a use is specifically identified as not indicated in one or more of the compendia listed, or if it is dete rmined, based on peer-reviewed medical literature, that a particular use of a drug is not safe and effective, the off-label use is not supported and the drug will not be covered. Reimbursement is dependent on, but not limited to claims submissions reporte d usingCMS 1500/HCFA, CMS 1450/UB 04 or electronic equivalent, and must include the following: 11-digit NDC (National Drug Code) HCPCS/CPT Code Correct HCPCS units ( not NDC units) Correct NDC unit of measure PLEASE NOTE THE FOLLOWING: Providers are responsible for sourcing and submitting accurate codes. Multi-source brands are not accepted without an additional medical necessity review for Dispense as Written (DAW). Medical Necessity for DAW policies can be found at CareSource.com under the applicable markets administrative policies tab. Standard Billing Reimbursement StatementOHIO MEDICAIDPY-PHARM-0125-OH-MCD Effective Date: 02-01-2023 5 If applicable, individual drug reimbursement information may be found in a drugs Pharmacy Policy .F. Related Policies/Rules G. Review/Revision History DATE ACTIONDate Issued 07/22/2022 Original effective dateDate Revised 12/06/2022 Additions to clarify claims submission requirements, responsibility for sourcing of codes, and MSBs not accepted without additional DAW review. Individual drug reimbursement information may be found in a drugs Pharmacy Policy Date Effective 02/01/2023 Date Archived H. References1. Drugs@FDA Glossary of Terms https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda – glossary-terms 2. Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publi cations and services https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals 3. United States Federal Food, Drug and Cosmetic Act https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act The Reimbursement Policy Statement detailed abo ve has recei ved due con sideration as definedin the Reimbursement Policy Statement Policy and is app roved.

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