Standard Medical Billing Guidance

REIMBURSEMENT POLICY STATEMENTGEORGIA MEDICAID Policy Name Policy Number Effective Date Standard Medical Billing Guidance PY-PHARM-0123 – GA-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 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 Coverage. 4 F. Related Policies/Rules ………………………….. ………………………….. ………………………….. ……….. 5 G. Review/Revision History ………………………….. ………………………….. ………………………….. …….. 5 H. References ………………………….. ………………………….. ………………………….. ………………………. 5 Standard Billing Reimbursement StatementGEORGIA MEDICAIDPY-PHARM-0123-GA-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. 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 StatementGEORGIA MEDICAIDPY-PHARM-0123-GA-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 : Standard Billing Reimbursement StatementGEORGIA MEDICAIDPY-PHARM-0123-GA-MCD Effective Date: 02-01-2023 4 A 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 StatementGEORGIA MEDICAIDPY-PHARM-0123-GA-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.