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Reporting Requirements for Drugs and Biologics
MA00.024e

Policy

REPORTING REQUIREMENTS FOR DRUGS AND BIOLOGICS

Drugs and biologics must be reported according to the following requirements:
  • The most specific drug or biologic procedure code must be reported. The units of drug or biologic administered must be reported in multiples of the dosage specified in the procedure code description.
    • If the exact drug or biologic amount administered is not a multiple of dosage described in the procedure code description, the provider must round to the next higher unit according to the procedure code description for that code (see examples in the Guideline section).
    • If there is no specific procedure code available for the drug or biologic administered, then the drug or biologic must be reported with the most appropriate unlisted procedure code along with the corresponding National Drug Code (NDC). 
  • A corresponding NDC number, unit of measure, and units dispensed must be reported with the drug or biologic administered.
  • Compound drugs should be reported with the most appropriate unlisted procedure code and the NDC of the most expensive ingredient.
  • The units reported should correspond with the smallest vial available for purchase from the manufacturer that could provide the appropriate dose for the member. 
When a drug or biologic was not administered to a member (e.g., missed appointment by the member)​, a claim for the drug or biologic should not be reported. 

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

Documentation must be present in the member’s medical record with date, time, route of administration, and the amount of drug or biologic administered and the amount of drug or biologic wasted.

The Company may conduct reviews and audits of services to our members regardless of the participation status of the provider. Medical record documentation must be maintained on file to reflect the medical necessity of the care and services provided. These medical records may include but are not limited to: records from the professional provider’s office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company uses information from FDA-approved labeling, peer-reviewed literature, and consultant input to identify maximum dosage amounts per patient per date of service. Claim lines with billed units that exceed such limits will be rejected or adjusted on a pre- or postpayment basis. When dosage amounts vary based on clinical indications (e.g., patient height, weight, treatment plan), medical records may be requested and claim lines may be retrospectively adjusted if the billed units are found to be inconsistent with the medical record.

Guidelines

​National Drug Code (NDC) numbers are the industry standard identifier for drugs and biologics. It provides full transparency to the medication administered. The NDC number identifies the manufacturer, drug name, dosage, strength, package size, and quantity. 

The NDC is a unique numeric identifier assigned to medications listed under Section 510 of the United States Federal Food, Drug and Cosmetic Act. The 11-digit NDC is separated into three segments in a 5-4-2 format: 
  • The first five digits identify the manufacturer of the drug and are assigned by the US Food and Drug Administration (FDA) 
  • The remaining six digits are assigned by the manufacturer and identify the specific product and package size.
The NDC is usually found on the drug label or medication’s packaging. The number on the packaging may be less than 11 digits. If this occurs, it will be necessary to add a leading zero to the appropriate section to create a 5-4-2 configuration (e.g., 0XXXX-XXXX-XX, XXXXX-0XXX-XX, or XXXXX-XXXX-0X). The container label also displays information for the unit of measure for that medication​. Listed below are the preferred NDC units of measure with examples:
 
  • UN (Unit) – Powder-filled vials for injection (needs to be reconstituted), pellet, kit, patch, tablet, device
  • ML (Milliliter) – Liquid, solution, or suspension
  • GR (Gram) – Ointments, creams, inhalers, or bulk powder in a jar
  • F2 (International Unit) – Products described as IU/vial, or micrograms​​
EXAMPLES OF REPORTING REQUIREMENTS FOR DRUGS AND BIOLOGICS

The provider supplies and administers a 100-mg dose of infliximab (Remicade®) and each single-use vial of Remicade® contains 100 mg/​10mL. This is reported with J1745 Injection, infliximab, excludes biosimilar, 10 mg.
  • Correct reporting scenario:
    • 10 mg = 1 unit
    • 100 mg administered
    • J1745 is reported with 10 units

    • NDC: 57894-0030-01​

The provider supplies and administers 2.5 mg of zoledronic acid and each vial of zoledronic acid® contains 4 mg/100mL​. This is reported with J3489 Injection, zoledronic acid, 1 mg.
  • Correct reporting scenario:
    • 1 mg = 1 unit
    • 2.5 mg administered
    • J3489 is reported with 3 units
    • NDC: 68083-0142-01​
The provider supplies and administers 150 mg of oxaliplatin (Eloxatin®) and each single-use vial of Eloxatin® contains 50 mg or 100 mg. This is reported with J9263 Injection, oxaliplatin, 0.5 mg.
  • Correct reporting scenario:
    • 0.5 mg = 1 unit
    • 150 mg administered
    • J9263 is reported with 300 units
    • NDC: 00703-3985-01​
The provider supplies and administers 200 mg of ketamine HCl (Ketalar®) and each 20-mL vial contains 10 mg/mL. This is reported with J3490 Unclassified drugs.
  • Correct reporting scenario:
    • 200 mg = 1 unit
    • 200 mg administered
    • J3490 is reported with 1 unit
    • NDC: 42023-0113-10​​
The provider supplies and administers 16.8 mg of elapegademase-lvlr (Revcovi®) and each 1.5-mL vial contains 2.4 mg. This is reported with J3590 Unclassified biologics.
  • Correct reporting scenario:
    • 2.4 mg = 1 unit
    • 16.8 mg administered
    • J3590 is reported with 1 unit
    • NDC: 10122-0502-01
The provider supplies and administers 50 mg of remdesivir (Veklury®) and a single-use vial of Veklury®​ contains 100mg/20mL. This is reported with J0248 Injection, remdesivir, 1 mg.

  • Correct reporting scenario:
    • ​1 mg = 1 unit
    • 50 mg administered
    • J0248 is reported with 50 units
    • ​NDC: 61958-2902-02​

BENEFIT APPLICATION

Claims are processed according to the statements in this policy. When a medical policy on this topic also exists, the medical necessity criteria listed in the medical policy must be met.

Description

The Company has established reporting requirements for drugs and biologics. These requirements include reporting the most current and specific procedure codes and National Drug Codes (NDC) as appropriate, as well as the number of units that reflects the actual dosage of the drug administered to the member.

References

Centers for Medicare & Medicaid Services (CMS). Ambulatory Surgical Center (ASC) Payment. Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-payment/ascpayment/. Accessed September 21, 2023.

Centers for Medicare & Medicaid Services (CMS). Billing and Coding for Drugs and Biologics (Non-chemotherapy). Available: https://downloads.cms.gov/medicare-coverage-database/lcd_attachments/34741_55/BCG_L34741.pdf. Accessed September 21, 2023.

Centers for Medicare & Medicaid Services (CMS). Code of Federal regulations. Final Rule: 42 CFR Part 403 Subpart I. 2013. Available: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-A/part-403/subpart-I. Accessed September 21, 2023.

Centers for Medicare & Medicaid Services (CMS). Medicare Claims Processing Manual Chapter 17 - Drugs and Biologics. December 8, 2017. Available: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c17.pdf. Accessed September 21, 2023.

Company Provider Manuals.​

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
N/A
HCPCS Level II Code Number(s)
N/A
Revenue Code Number(s)
N/A


Coding and Billing Requirements

Policy History

Revisions From MA00.024e:​
11/20/2023This version of the policy will become effective 11/20/2023. The policy has been updated to align with Centers for Medicare & Medicaid Services (CMS)​ standard for reporting the National Drug Code (NDC) numbers for drugs and biologics.

The following codes have been removed from the policy: 
90399, 90749, 95199, A4641, A9150, A9152, A9698, A9699, C2698, C2699, C9399, J1599, J3490, J3530, J3535, J3590, J3591, J7199, J7599, J7699, J7799, J7999, J8498, J8499, J8597, J8999, J9999, Q4082, S5000, S5001​

Revisions From MA00.024d:
11/07/2022
The policy was issued as a result of an annual policy review and will become effective 11/07/2022.​

The following code has been added to this policy: 
J8499​​

Revisions From ​MA00.024c:
01/04/2021
An additional example of reporting drugs and biologics has been added for clarification​. 

The following codes have been added to this policy: 
90399, 90749, 95199, A4641, A9150, A9152, A9698, A9699, C2698, C2699, C9399, J1599, J3490, J3530, J3535, J3590, J3591, J7199, J7599, J7699, J7799, J7999, J8498, J8597, J8999, J9999, Q4082, S5000, S5001​

Revisions From MA00.024b:
10/24/2018This policy became effective 01/01/2017. It has been reviewed and reissued to communicate the Company’s continuing position on its reporting requirements for drugs and biologics.
01/01/2017The following CPT code has been revised in this policy, effective 01/01/2017:

FROM:

J1745 Injection, infliximab, 10 mg

TO:

J1745 Injection, infliximab, excludes biosimilar, 10 mg

Revisions From MA00.024a:
03/01/2016This version of the policy will become effective 3/1/2016.

Revised policy number MA00.024a was issued as a result of annual policy review. The References were updated accordingly. The policy was updated to be consistent with current template wording and format.

Revisions From MA00.024:
01/01/2015This is a new policy.
11/20/2023
11/20/2023
MA00.024
Claim Payment Policy Bulletin
Medicare Advantage
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