LCD Reference Article Billing and Coding Article

Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit / UDENYCA® ONBODY™ (On-body Injector)

A54682

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Draft Article
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.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A54682
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit / UDENYCA® ONBODY™ (On-body Injector)
Article Type
Billing and Coding
Original Effective Date
10/08/2015
Revision Effective Date
01/01/2024
Revision Ending Date
N/A
Retirement Date
N/A
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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.

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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

Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Article Guidance

Article Text

Neulasta® and UDENYCA® are leukocyte growth factors indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta® and UDENYCA® are currently available in 2 distinct delivery options. When administered to the patient by means of the prefilled syringe, the appropriate coding procedure is to report the HCPCS code for both the drug (J2506 or Q5111) and the administration of the drug (CPT® code 96372).

Part B Providers

When Neulasta® or UDENYCA® are administered to the patient by means of a pegfilgrastim injection device such as the Neulasta® Delivery Kit (Onpro®) or the UDENYCA® ONBODY™, the provider does not inject the drug, but instead fills the injector device with the drug and applies the injector device to the patient. The drug is delivered to the patient approximately 27 hours after the activation of the injector device. No CPT® code specific to the procedure for employing the Onpro® existed at the time of the introduction of this device. Providers were instructed to use CPT® code 96372 as an interim measure for reporting the administration of Neulasta® using this drug delivery method. As of 1/1/2017, a new CPT® code (96377) became effective which specifically addresses the use of the Onpro®/ONBODY™ device. Identify the injector device using CPT® code 96377 in the medical record to distinguish it from the use of the prefilled syringe which should be identified with CPT® code 96372.

Outpatient Hospital Providers

There has been no change to the information released in the Outpatient Hospital Final Rule for 2017:
For Calendar Year 2017, CPT® code 96377 (Application of on-body injector (includes cannula insertion) for timed subcutaneous injection) is assigned status indicator “N” (Items and Services Packaged into APC Rates) to indicate that the service is paid under the Outpatient Prospective Payment System (OPPS). However, payment for the administration of Neulasta® Onpro®/UDENYCA® ONBODY™ is bundled into the payment for other services and not separately payable.

Response To Comments

Number Comment Response
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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

Group 1

(4 Codes)
Group 1 Paragraph

Part B Providers

Group 1 Codes
Code Description
96372 THERAPEUTIC, PROPHYLACTIC, OR DIAGNOSTIC INJECTION (SPECIFY SUBSTANCE OR DRUG); SUBCUTANEOUS OR INTRAMUSCULAR
96377 APPLICATION OF ON-BODY INJECTOR (INCLUDES CANNULA INSERTION) FOR TIMED SUBCUTANEOUS INJECTION
J2506 INJECTION, PEGFILGRASTIM, EXCLUDES BIOSIMILAR, 0.5 MG
Q5111 INJECTION, PEGFILGRASTIM-CBQV (UDENYCA), BIOSIMILAR, 0.5 MG

Group 2

(4 Codes)
Group 2 Paragraph

Outpatient Hospital Providers

Group 2 Codes
Code Description
96372 THERAPEUTIC, PROPHYLACTIC, OR DIAGNOSTIC INJECTION (SPECIFY SUBSTANCE OR DRUG); SUBCUTANEOUS OR INTRAMUSCULAR
96377 APPLICATION OF ON-BODY INJECTOR (INCLUDES CANNULA INSERTION) FOR TIMED SUBCUTANEOUS INJECTION
J2506 INJECTION, PEGFILGRASTIM, EXCLUDES BIOSIMILAR, 0.5 MG
Q5111 INJECTION, PEGFILGRASTIM-CBQV (UDENYCA), BIOSIMILAR, 0.5 MG
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CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

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Group 1 Codes

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

Group 1

Group 1 Paragraph

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Group 1 Codes

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ICD-10-PCS Codes

Group 1

Group 1 Paragraph

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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
0x TBD
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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
01/01/2024 R15

Under Article Title revised title from “Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit (On-body Injector)” to “Billing and Coding: Neulasta® (pegfilgrastim) Onpro® Kit / UDENYCA® ONBODY™ (On-body Injector).” Under CMS National Coverage Policy added the following regulation: Title XVIII of the Social Security Act, §1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim. Under Article Text in the first paragraph, first sentence added “and UDENYCA®” after “Neulasta®”. In the second paragraph, first sentence added “and UDENYCA®” after “Neulasta®”, and in the second sentence deleted “Neulasta®” before “prefilled syringe” and added code Q5111. In the third paragraph, first sentence added “or UDENYCA®” after “Neulasta®”, added “a pegfilgrastim injection device such as” and “or the UDENYCA® ONBODY™”, and deleted “OnPro®” before “injector device”. In the second sentence replaced “OnPro®” with “injector device”; in the fifth sentence added “ONBODY™” after “Onpro®”; and in the sixth sentence replaced “OnPro®” with “injector device” and deleted “Neulasta®” before “prefilled syringe”. In the fourth paragraph, last sentence added “UDENYCA® ONBODY™” after “Onpro®”. Under CPT/HCPCS Codes Group 1: Codes added Q5111. Under CPT/HCPCS Codes Group 2: Codes added Q5111. Formatting and typographical errors were corrected throughout the article. This revision is retroactive effective for dates of service on or after 1/1/24.

01/01/2022 R14

Under Article Text changed HCPCS code from J2505 to J2506 in the second paragraph. Under CPT/HCPCS Group 1: Codes and Group 2: Codes added J2506 and deleted J2505. This revision is due to the Annual CPT/HCPCS update and is effective on 1/1/22.

10/10/2019 R13

This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles.

05/17/2018 R12

Under Article Text – Part B Providers the verbiage “Currently CPT 96377 is designated as an inactive code in the Medicare Physician Fee Schedule for Physician Office Claims System and claims submitted with this code will reject. Providers are advised to continue coding for the use of the OnPro™ as they have been prior to 1/1/2017, until further information is forthcoming from CMS regarding the use of CPT 96377. Please continue to” was deleted from the paragraph. The verbiage “using CPT® code 96377” was added after the word “injector” and the verbiage “which should be identified with CPT® code 96372” was added at the end of the paragraph. Under CPT/HCPCS Codes – Group 1: Codes added the CPT® code 96377 – Application of on-body injector (includes cannula insertion) for timed subcutaneous injection. Under CPT/HCPCS Codes – Group 2: Codes added the CPT® code 96372 – Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular. Words were capitalized or changed to lower case as appropriate and CPT® and Onpro® was inserted throughout the policy where applicable.

02/26/2018 R11 The Jurisdiction "J" Part B Contracts for Alabama (10112), Georgia (10212) and Tennessee (10312) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 02/25/18. Effective 02/26/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part B contract numbers) have been completed in this revision.
01/29/2018 R10 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this article begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this article. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
03/16/2017 R9

Annual validation with no revisions made.

03/16/2017 R8 Under Article Guidance- Article Text – Added verbiage “Onpro®” after Neulasta® under the header Outpatient Hospital Providers.
01/26/2017 R7 Under Article Text added the headings: Part B Providers and Outpatient Hospital Providers. The verbiage under Outpatient Hospital Providers was revised to include information currently found in the 2017 Outpatient Hospital Final Rule. Under Bill Type Codes deleted 12X bill type as this was a typographical error. Under CPT/HCPCS Codes Group 1: Paragraph and Group 2: Paragraph added Part B Providers and Outpatient Hospital Providers and added Group 2: Codes 96377 and J2505.
01/19/2017 R6 Under Article Text deleted the Claim Submission information and added new verbiage. Under CPT/CHCPS Codes: Group 1: Codes deleted CPT code 96377.
01/01/2017 R5 Under Article Text removed Physician from Physician Claim Submission. This article is being made an A/B MAC and will be applicable for Part A services beginning 1/1/17.
01/01/2017 R4 Under Article Title changed article title to Neulasta® (pegfilgrastim) Onpro® Kit (On-body Injector). Under Article Text deleted the sentence Neulasta is a single subcutaneous injection of 6 mg that may be administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy and added the table. Under CPT/HCPCS Codes added HCPCS code J2505.
01/01/2017 R3 Under the Article Text deleted HCPCS Code J2505 Injection, pegfilgrastim , 6 mg and added CPT Code 96377 Application of on-body injector for injection under skin under Physician Claim Submission. Under CPT/HCPCS Codes deleted the HCPCS code J2505 and added CPT Code 96377. This revision is due to the 2017 Annual CPT/HCPCS Update and becomes effective 01/01/17.
10/08/2015 R2 Under Article Text removed the incorrect verbiage for 96372 and corrected it to read "Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular”.
10/08/2015 R1 Under "Article Text">/b> removed the incorrect verbiage for 96372 and corrected it to read "Therapeutic , prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular."
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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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CMS Manual Explanations URLs
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Public Versions
Updated On Effective Dates Status
01/25/2024 01/01/2024 - N/A Currently in Effect You are here
01/03/2022 01/01/2022 - 12/31/2023 Superseded View
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Keywords

  • Neulasta
  • Pegfilgrastim