SUPERSEDED LCD Reference Article Billing and Coding Article

Billing and Coding: Drugs and Biologicals

A52855

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Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.
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Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A52855
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Drugs and Biologicals
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
05/01/2021
Revision Ending Date
01/10/2024
Retirement Date
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CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

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Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

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Article Guidance

Article Text

This article contains coding and other guidelines that complement the Local Coverage Determination (LCD) for Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Coding Information:

General Information


Procedure codes may be subject to National Correct Coding Initiative (NCCI) edits or OPPS packaging edits. Refer to NCCI and OPPS requirements prior to billing Medicare.

A claim submitted without a valid ICD-10-CM diagnosis code will be returned to the provider as an incomplete claim under Section 1833(e) of the Social Security Act.

The diagnosis code(s) must best describe the patient's condition for which the service was performed.

Intravenous in Lieu of Oral Formulation

When billing for an IV drug which has an available oral form, please also report an additional ICD-10-CM code to indicate that the oral route is not appropriate, for example:

K91.2 POSTSURGICAL MALABSORPTION, NOT ELSEWHERE CLASSIFIED
K90.9 INTESTINAL MALABSORPTION UNSPECIFIED
T50.995A ADVERSE EFFECT OF OTHER DRUGS, MEDICAMENTS AND BIOLOGICAL SUBSTANCES, INITIAL ENCOUNTER
Y63.6 UNDERDOSING AND NONADMINISTRATION OF NECESSARY DRUG, MEDICAMENT OR BIOLOGICAL SUBSTANCE
Y63.8 FAILURE IN DOSAGE DURING OTHER SURGICAL AND MEDICAL CARE
Z87.19 PERSONAL HISTORY OF OTHER DISEASES OF THE DIGESTIVE SYSTEM


Documentation Requirements:

The patient's medical record must contain documentation that fully supports the medical necessity for services included within the LCD. (See "Indications and Limitations of Coverage.") This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

The medical record must include the following information:

  • The name of the drug or biological administered;
  • The route of administration;
  • The dosage (e.g., mgs, mcgs, cc's or IU's);
  • The duration of the administration (for CPT codes that are time based); and

When modifier –JW is used to report that a portion of the drug or biological is discarded, from single use vials, the medical record must clearly document the amount administered and the amount wasted or discarded.

For claims submitted to the Part B MAC:

Drugs with No Charges

Effective for dates of service on or after 05/07/2018,
when a drug is purchased by the beneficiary, or when the drug was supplied without charge by the manufacturer, the drug should be billed using the appropriate HCPCS code with a billed amount of $0.01.     

For dates of service prior to 05/07/2018, drugs with no charge will be accepted by Medicare even with a submitted charge of $0.00. However, the name and dosage of the drug should be listed in the narrative record of the claim, to avoid requests for additional information on the claim.

Response To Comments

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Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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CPT/HCPCS Modifiers

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1 Codes

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1 Codes

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ICD-10-PCS Codes

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Group 1 Codes

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Additional ICD-10 Information

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

Code Description

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

Code Description

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Other Coding Information

Group 1

Group 1 Paragraph

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Group 1 Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
05/01/2021 R8

The Drug Administration Services and Unlisted Code information has been removed from this article and has been added to Billing and Coding: Complex Drug Administration Coding article A58620.

11/07/2019 R7

The Revenue codes have been removed from this article. Guidance on these codes is available in the Revenue code section.

11/07/2019 R6

This article was converted to the new Billing and Coding Article format. Documentation requirements have been added. The Bill type codes have been removed from this article. Guidance on these codes is available in the Bill type code section.

08/22/2019 R5

The title of the article has been revised to add Billing and Coding. Documentation requirements have been added. 

03/22/2018 R4

The paragraph for “Drugs with No Charges” has been revised and moved under the heading “For Claims Submitted to the Part B MAC:"

03/22/2018 R3

The following language has been added in the “Drugs with No Charges” section of the article: 

    Effective for dates of service on or after 05/07/2018, the drug should be billed using the appropriate HCPCS code with a billed amount of $0.01.

Based on the 2018 annual HCPCS update, HCPCS code J3358 has been added to report ustekinumab when given IV.

07/15/2017 R2

The title of the article has been changed to "Drugs and Biologicals, Coding Article." Information on drug administration services has been added. Effective for dates of service on or after September 15, 2017, claims will be rejected for the drugs listed above when submitted with a chemotherapy administration code. 

10/01/2015 R1 The place of service instruction for the Part B MAC has been removed.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
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SAD Process URL 1
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SAD Process URL 2
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Statutory Requirements URLs
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Rules and Regulations URLs
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CMS Manual Explanations URLs
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Other URLs
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Public Versions
Updated On Effective Dates Status
01/04/2024 01/11/2024 - N/A Currently in Effect View
05/04/2021 05/01/2021 - 01/10/2024 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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