Medicare Advantage Preferred Provider Organization (MA PPO)

Applicable to enrollees from other Blue Cross Blue Shield Medicare Advantage Plans who obtain health care services within the 5-county Philadelphia service area.

Notification

Reporting Requirements for Drugs and Biologics

Notification Issue Date:

This 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.

Title:

Reporting Requirements for Drugs and Biologics

Policy #:

MA00.024c

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).
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 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.

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 200 mg of Ketamine HCl (Ketalar®) and each 20mL 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
- J3490 is reported along with NDC 42023-0113-10

The provider supplies and administers 16.8 mg of elapegademase-lvlr (Revcovi®) and each 1.5mL 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 7 units
J3590 is reported along with NDC 57665-0002-01

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). 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 November 10, 2020.

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 November 10, 2020.

Centers for Medicare & Medicaid Services (CMS). Ambulatory Surgical Center (ASC) Payment. Available: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-payment/ascpayment/. Accessed November 10, 2020.

Company provider bulletin NDC code submission. January 2009. Available: https://www.ibx.com/resources/for-providers/claims-and-billing/claims-resources-and-guides/ndc-code-submission-changes. Accessed November 10, 2020.

Company Provider Manuals.

Coding

CPT Procedure Code Number(s)

90399, 90749, 95199

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

N/A

HCPCS Level II Code Number(s)

THE FOLLOWING CODES REPRESENT UNLISTED PROCEDURE CODES THAT REQUIRE THE REPORTING OF A CORRESPONDING NATIONAL DRUG CODE:

A4641 Radiopharmaceutical, diagnostic, not otherwise classified

A9150 Nonprescription drugs

A9152 Single vitamin/mineral/trace element, oral, per dose, not otherwise specified

A9698 Nonradioactive contrast imaging material, not otherwise classified, per study

A9699 Radiopharmaceutical, therapeutic, not otherwise classified

C2698 Brachytherapy source, stranded, not otherwise specified, per source

C2699 Brachytherapy source, nonstranded, not otherwise specified, per source

C9399 Unclassified drugs or biologicals

J1599 Injection, immune globulin, intravenous, nonlyophilized (e.g., liquid), not otherwise specified, 500 mg

J3490 Unclassified drugs

J3530 Nasal vaccine inhalation

J3535 Drug administered through a metered dose inhaler

J3590 Unclassified biologics

J3591 Unclassified drug or biological used for ESRD on dialysis

J7199 Hemophilia clotting factor, not otherwise classified

J7599 Immunosuppressive drug, not otherwise classified

J7699 NOC drugs, inhalation solution administered through DME

J7799 NOC drugs, other than inhalation drugs, administered through DME

J7999 Compounded drug, not otherwise classified

J8498 Antiemetic drug, rectal/suppository, not otherwise specified

J8597 Antiemetic drug, oral, not otherwise specified

J8999 Prescription drug, oral, chemotherapeutic, NOS

J9999 Not otherwise classified, antineoplastic drugs

Q4082 Drug or biological, not otherwise classified, Part B drug competitive acquisition program (CAP)

S5000 Prescription drug, generic

S5001 Prescription drug, brand name

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

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:

10/24/2018	This 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.
01/01/2017	The 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:

03/01/2016

This 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:

01/01/2015

This is a new policy.

Version Effective Date:

1/4/2021

Version Issued Date:

1/4/2021

Version Reissued Date: