Notification



Notification Issue Date:



Claim Payment Policy


Title:Reporting Requirements for Drugs and Biologics

Policy #:00.01.49c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.

Application of Claim Payment Policy is determined by benefits and contracts. Benefits may vary based on product line, group or contract. Medical necessity determination applies only if the benefit exists and no contract exclusions are applicable. Individual member benefits must be verified.

In products where members are able to self-refer to providers for care and services, members are advised to use participating providers in order to receive the highest level of benefits.When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

For more information on how Claim Payment Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

REPORTING REQUIREMENTS FOR DRUGS AND BIOLOGICS

Drugs and biologics must be reported according to the following requirements:
  • The most specific Healthcare Common Procedure Coding System (HCPCS) code must be reported. The units of drug administered must be reported in multiples of the dosage specified in the full HCPCS descriptor.
  • If there is no specific HCPCS code available for the drug administered, then the drug must be reported with the most appropriate unlisted code along with the corresponding National Drug Codes (NDC).
  • If the exact amount of drug administered is not a multiple of the HCPCS code, the provider must round to the next higher unit according to the HCPCS description for that code (see example in the Guideline section).
  • Providers must submit the NDC using either the 5-4-2 format when billing with hyphens (e.g., 12345-1234-12) or NDC numbers without hyphens (eg, 12345678911). Providers must not include spaces, decimals, or other characters in the 11-digit string.

A claim for a drug or biologic must not be submitted if the drug was not administered to a member (e.g., missed appointment by the member).

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, the following: 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. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

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 post-payment 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.

BILLING REQUIREMENTS

The units reported should correspond with the smallest vial available for purchase from the manufacturer that could provide the appropriate dose for the member.
Guidelines

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. 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

The provider supplies and administers 2.5 mg of Zoledronic Acid and each single-use vial of Zoledronic Acid® contains 1 mg. 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

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

The provider supplies and administers 200mg of Ketamine HCl (Ketalar®) and each 20mL vial contains 10mg/mL. This is reported with J3490 Unclassified drugs.
  • Correct reporting scenario:
    • 200mg = 1 unit
    • 200mg administered
    • J3490 is reported with 1 unit
    • J3490 is reported along with NDC 42023-0113-10


Description

The Company has established reporting requirements for drugs and biologics. These requirements include reporting the most current and specific Healthcare Common Procedure Coding System (HCPCS) 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). 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 August 23, 2018.

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 August 23, 2018.

Centers for Medicare & Medicaid Services (CMS). Ambulatory Surgical Center (ASC) Payment. Available @ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-payment/ascpayment/ Accessed August 23, 2018.

Company provider bulletin NDC code submission changes effective January 1, 2009. January 2009. Available @ https://www.ibx.com/providers/claims_and_billing/claim_requirements/ndc.html/ Accessed August 23, 2018.




Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD-10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


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

REVISION 00.01.49c:
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.


Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 01/01/2017
Version Issued Date: 01/06/2017
Version Reissued Date: 10/24/2018

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