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This information is intended for U.S. healthcare professionals and/or healthcare professionals involved in healthcare reimbursement.

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OPDIVO® (nivolumab)

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OpdivM
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Administration — Tutorial

Physician Office

CMS-1500

Combo Therapy

Monotherapy

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UB-04/CMS-1450

Combo Therapy

Monotherapy

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Billing and
Diagnosis Codes

Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

Reimbursement and Coding Guide for OPDIVO
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  • Codes*
  • Distribution
  • FDA Letters
Filter by keyword Clear Filter
Type a keyword to find a specific HCPCS, CPT, NDC, or ICD-10 code
Healthcare Common Procedure Coding System (HCPCS) Codes1 Issued by CMS
J9299

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Injection, nivolumab, 1 mg

Providers and suppliers are required to report the JW modifier on Part B drug claims for discarded drugs and biologicals. Also, providers and suppliers must document the amount of discarded drugs or biologicals in Medicare beneficiaries’ medical records.2

Revenue Codes (for Use in the Hospital Outpatient Setting)3
0636

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Drugs requiring detailed coding

0335

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Chemotherapy administration, IV

0260

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IV Therapy-General

Current Procedural Terminology (CPT)4,†
96413

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Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug

National Drug Codes (NDC)5 Issued by the FDA

Note:Payers require the submission of the 11-digit NDC on healthcare claim forms. Please use the 11-digit codes shown here.

00003-3772-11

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40 mg/4 mL (10 mg/mL) single-dose vial

00003-3774-12

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100 mg/10 mL (10 mg/mL) single-dose vial

00003-3756-14

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120 mg/12 mL (10 mg/mL) single-dose vial

00003-3734-13

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240 mg/24 mL (10 mg/mL) single-dose vial

International Classification of Diseases, Tenth Revision, Clinical Modification Diagnosis Codes (ICD-10-CM)6
C00

Malignant neoplasm of lip

C00.0

Malignant neoplasm of external upper lip

C00.1

COPY

Malignant neoplasm of external lower lip

C00.2

COPY

Malignant neoplasm of external lip, unspecified

C00.3

Malignant neoplasm of upper lip, inner aspect

C00.4

COPY

Malignant neoplasm of lower lip, inner aspect

C00.5

COPY

Malignant neoplasm of lip, unspecified, inner aspect

C00.6

COPY

Malignant neoplasm of commissure of lip, unspecified

C00.8

COPY

Malignant neoplasm of overlapping sites of lip

C00.9

COPY

Malignant neoplasm of lip, unspecified

C01

COPY

Malignant neoplasm of base of tongue

C02

COPY

Malignant neoplasm of other and unspecified parts of tongue

C02.0

COPY

Malignant neoplasm of dorsal surface of tongue

C02.1

COPY

Malignant neoplasm of border of tongue

C02.2

COPY

Malignant neoplasm of ventral surface of tongue

C02.3

COPY

Malignant neoplasm of anterior two-thirds of tongue, part unspecified

C02.4

COPY

Malignant neoplasm of lingual tonsil

C02.8

COPY

Malignant neoplasm of overlapping sites of tongue

C02.9

COPY

Malignant neoplasm of tongue, unspecified

C03

COPY

Malignant neoplasm of gum

C03.0

COPY

Malignant neoplasm of upper gum

C03.1

COPY

Malignant neoplasm of lower gum

C03.9

COPY

Malignant neoplasm of gum, unspecified

C04

COPY

Malignant neoplasm of floor of mouth

C04.0

COPY

Malignant neoplasm of anterior floor of mouth

C04.1

COPY

Malignant neoplasm of lateral floor of mouth

C04.8

COPY

Malignant neoplasm of overlapping sites of floor of mouth

C04.9

COPY

Malignant neoplasm of floor of mouth, unspecified

C05

COPY

Malignant neoplasm of palate

C05.0

COPY

Malignant neoplasm of hard palate

C05.1

COPY

Malignant neoplasm of soft palate

C05.2

COPY

Malignant neoplasm of uvula

C05.8

COPY

Malignant neoplasm of overlapping sites of palate

C05.9

COPY

Malignant neoplasm of palate, unspecified

C06

COPY

Malignant neoplasm of other and unspecified parts of mouth

C06.0

COPY

Malignant neoplasm of cheek mucosa

C06.1

COPY

Malignant neoplasm of vestibule of mouth

C06.2

COPY

Malignant neoplasm of retromolar area

C06.8

COPY

Malignant neoplasm of overlapping sites of other and unspecified parts of mouth

C06.80

COPY

Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89

COPY

Malignant neoplasm of overlapping sites of other parts of mouth

C06.9

COPY

Malignant neoplasm of mouth, unspecified

C09

COPY

Malignant neoplasm of tonsil

C09.0

COPY

Malignant neoplasm of tonsillar fossa

C09.1

COPY

Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8

COPY

Malignant neoplasm of overlapping sites of tonsil

C09.9

COPY

Malignant neoplasm of tonsil, unspecified

C10

COPY

Malignant neoplasm of oropharynx

C10.0

COPY

Malignant neoplasm of vallecula

C10.1

COPY

Malignant neoplasm of anterior surface of epiglottis

C10.2

COPY

Malignant neoplasm of lateral wall of oropharynx

C10.3

COPY

Malignant neoplasm of posterior wall of oropharynx

C10.4

COPY

Malignant neoplasm of branchial cleft

C10.8

COPY

Malignant neoplasm of overlapping sites of oropharynx

C12

COPY

Malignant neoplasm of pyriform sinus

C13

COPY

Malignant neoplasm of hypopharynx

C13.0

COPY

Malignant neoplasm of postcricoid region

C13.1

COPY

Malignant neoplasm aryepiglottic fold, hypopharyngeal aspect

C13.2

COPY

Malignant neoplasm of posterior wall of hypopharynx

C13.8

COPY

Malignant neoplasm of overlapping sites of hypopharynx

C13.9

COPY

Malignant neoplasm of hypopharynx, unspecified

C14

COPY

Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

C14.0

COPY

Malignant neoplasm of pharynx, unspecified

C14.2

COPY

Malignant neoplasm of Waldeyer’s ring

C14.8

COPY

Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx

C32

COPY

Malignant neoplasm of larynx

C32.0

COPY

Malignant neoplasm of glottis

C32.1

COPY

Malignant neoplasm of supraglottis

C32.2

COPY

Malignant neoplasm of subglottis

C32.3

COPY

Malignant neoplasm of laryngeal cartilage

C32.8

COPY

Malignant neoplasm of overlapping sites of larynx

C32.9

COPY

Malignant neoplasm of larynx, unspecified

C76

COPY

Malignant neoplasm of other and ill-defined sites

C76.0

COPY

Malignant neoplasm of head, face and neck

Z51.12

COPY

Encounter for antineoplastic immunotherapy

If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report ICD-10-CM code “Z51.12 Encounter for antineoplastic immunotherapy” as the primary diagnosis.

OPDIVO may be purchased through the distributors listed below.

Physician Offices

Specialty Distributor Phone Orders Fax Orders and Website
Besse Medical 1-888-711-5469
Monday-Friday,
7 AM-11 PM ET 		https://www.besse
.com
Cardinal Health Specialty Pharmaceutical Distribution 1-877-453-3972
Monday-Friday,
7 AM-6 PM CT
(24-hour emergency on call)		 https://specialty
online.cardinal
health.com
CuraScript Specialty Distribution 1-877-599-7748
Monday-Friday,
8 AM-7 PM ET		 https://www.
curascriptsd.
com
McKesson Specialty Health 1-800-482-6700
Monday-Friday,
7 AM-7 PM CT		 https://mscs.
mckesson.com
Morris & Dickson Specialty 1-800-710-6100
Monday-Friday,
8 AM-6 PM CT		 Fax: 1-318-524-3096
https://www.
mdspecialtydist.
com
Oncology Supply 1-800-633-7555
Monday-Friday,
8 AM-7 PM CT 		https://www.
oncologysupply.
com

For offices that prefer to use the services of a specialty pharmacy, specialty pharmacies can obtain OPDIVO from the distributors listed above.

Hospitals and Infusion Centers

Specialty Distributor Phone Orders Fax Orders and Website
ASD Healthcare 1-800-746-6273 Monday-Thursday,
7 AM-6:30 PM CT; Friday,
7 AM-6 PM CT 		Fax: 1-800-547-9413
https://www.
asdhealthcare.
com
Cardinal Health Specialty Pharmaceutical Distribution 1-866-677-4844 Monday-Friday,
7 AM-6 PM CT
(24-hour emergency on call)		 Fax: 1-614-553-6301
https://order
express.cardinal
health.com
DMS Pharmaceutical Group, Inc. 1-877-788-1100
Monday-Friday,
8:30 AM-5 PM CT		 Fax: 1-847-518-1105
www.dms
pharma.com
McKesson Plasma and Biologics 1-877-625-2566
Monday-Friday,
8 AM-6:30 PM CT		 Fax: 1-888-752-7626
https://connect.
mckesson.com
Morris & Dickson Specialty 1-800-710-6100 Fax: 1-318-524-3096
https://www.mdspecialtydist.com

Puerto Rico Hospitals and Clinics

Authorized Distributor Phone Orders Fax Orders and Website
AmerisourceBergen Puerto Rico 1-844-222-2273 https://abcorder.amerisourcebergen.com

Above information is accurate as of 11/21.

The OPDIVO distribution program includes extended payment terms to Bristol Myers Squibb authorized OPDIVO distributors. Healthcare providers and institutions should contact their OPDIVO distributor to understand specific payment terms that may be available to them from their distributor.

Please see U.S. Full Prescribing Information for OPDIVO.

FDA Approval Letters as Posted by the FDA:

OPDIVO for patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy - Approved on 11/10/2016

View Letter

Flat Dosing for OPDIVO (240 mg every 2 weeks) - Approved on 02/15/2018

View Letter

Flat Dosing for OPDIVO (480 mg every 4 weeks) - Approved on 03/05/2018

View Letter

Availability of OPDIVO 120 mg vial – Approved on 08/27/2021

View Letter

Please see U.S. Full Prescribing Information for OPDIVO for complete indications.

Coding for OPDIVO is dependent on the insurer and the care setting in which the drug will be administered. Oncology practices need to make coding decisions based on the diagnosis and treatment of each patient and the specific insurer requirements.

Please see U.S. Full Prescribing Information for OPDIVO.

*Healthcare providers should code healthcare claims based upon the service that is rendered, the patient's medical record, the coding requirements of each health insurer, and best coding practices. Coding information provided under this heading does not provide a guarantee of reimbursement and should be considered together with all applicable coding guidance and standards. All of the coding information presented by this website is applicable to outpatient procedures only.

†CPT codes and descriptions only are ©2019 by American Medical Association (AMA). All rights reserved. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association.

References:

  1. American Medical Association. 2020 HCPCS Level II. Professional ed. Chicago, IL: American Medical Association; 2020.
  2. Centers for Medicare & Medicaid Services. MLN Matters, Number MM9603 Revised. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf. Revised June 10, 2016. Accessed November 15, 2019.
  3. Palmetto GBA. Medicare Part A Billing Guide. May 2017. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/ Part_A_Billing_Guide.pdf/$File/Part_A_Billing_Guide.pdf. Accessed October 10, 2019.
  4. American Medical Association. CPT Professional 2020. Professional ed. Chicago, IL: American Medical Association; 2019.
  5. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  6. Centers for Medicare & Medicaid Services. ICD-10-CM tabular list of diseases and injuries. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM. Accessed September 1, 2021.

The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item.

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Use of the information on this site is subject to the terms of our Legal Notice and Privacy Statement. The coding, coverage, and payment information contained within this website is current as of 03/22.

1506-US-2101816 03/22