Bristol-Myers Squibb is committed to helping appropriate patients get access to our medications by providing access and reimbursement support services.

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

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Diagnosis Codes

Reimbursement and Coding Guide for OPDIVO

FDA Approval Letter as Posted by the FDA:

The information below is designed to help appropriate patients get access to OPDIVO by providing helpful reimbursement information for healthcare offices. It is important that offices verify each patient’s insurance coverage prior to initiating therapy. BMS Access Support may be able to help.

  • Codes
  • Distribution
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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

Effective January 1, 2017, 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 solutions

MSI/MMR CPT Testing Codes4
88342

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Immunohisto
chemistry or immunocyto
chemistry, per specimen; initial single antibody stain procedure

+88341

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Each additional single antibody stain procedure

81301

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Microsatellite instability analysis

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

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

C81

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Hodgkin lymphoma

C81.1

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Nodular sclerosis Hodgkin lymphoma

C81.10

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Nodular sclerosis Hodgkin lymphoma, unspecified site

C81.11

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Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.12

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Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes

C81.13

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Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes

C81.14

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Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.15

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Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.16

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Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes

C81.17

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Nodular sclerosis Hodgkin lymphoma, spleen

C81.18

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Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites

C81.19

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Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites

C81.2

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Mixed cellularity Hodgkin lymphoma

C81.20

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Mixed cellularity Hodgkin lymphoma, unspecified site

C81.21

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Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.22

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Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes

C81.23

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Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes

C81.24

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Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.25

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Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.26

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Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes

C81.27

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Mixed cellularity Hodgkin lymphoma, spleen

C81.28

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Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites

C81.29

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Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites

C81.3

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Lymphocyte-depleted Hodgkin lymphoma

C81.30

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Lymphocyte-depleted Hodgkin lymphoma, unspecified site

C81.31

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Lymphocyte-depleted Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.32

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Lymphocyte-depleted Hodgkin lymphoma, intrathoracic lymph nodes

C81.33

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Lymphocyte-depleted Hodgkin lymphoma, intra-abdominal lymph nodes

C81.34

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Lymphocyte-depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.35

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Lymphocyte-depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.36

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Lymphocyte-depleted Hodgkin lymphoma, intrapelvic lymph nodes

C81.37

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Lymphocyte-depleted Hodgkin lymphoma, spleen

C81.38

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Lymphocyte-depleted Hodgkin lymphoma, lymph nodes of multiple sites

C81.39

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Lymphocyte-depleted Hodgkin lymphoma, extranodal and solid organ sites

C81.4

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Lymphocyte-rich Hodgkin lymphoma

C81.40

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Lymphocyte-rich Hodgkin lymphoma, unspecified site

C81.41

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Lymphocyte-rich Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.42

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Lymphocyte-rich Hodgkin lymphoma, intrathoracic lymph nodes

C81.43

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Lymphocyte-rich Hodgkin lymphoma, intra-abdominal lymph nodes

C81.44

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Lymphocyte-rich Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.45

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Lymphocyte-rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.46

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Lymphocyte-rich Hodgkin lymphoma, intrapelvic lymph nodes

C81.47

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Lymphocyte-rich Hodgkin lymphoma, spleen

C81.48

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Lymphocyte-rich Hodgkin lymphoma, lymph nodes of multiple sites

C81.49

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Lymphocyte-rich Hodgkin lymphoma, extranodal and solid organ sites

C81.7

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Other Hodgkin lymphoma

C81.70

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Other Hodgkin lymphoma, unspecified site

C81.71

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Other Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.72

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Other Hodgkin lymphoma, intrathoracic lymph nodes

C81.73

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Other Hodgkin lymphoma, intra-abdominal lymph nodes

C81.74

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Other Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.75

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Other Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.76

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Other Hodgkin lymphoma, intrapelvic lymph nodes

C81.77

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Other Hodgkin lymphoma, spleen

C81.78

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Other Hodgkin lymphoma, lymph nodes of multiple sites

C81.79

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Other Hodgkin lymphoma, extranodal and solid organ sites

Z51.12

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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.

Z94.84

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Stem cell transplant status

For patients who have had a stem cell transplant, add "Z94.84" as a secondary code

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

C43

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Malignant melanoma of skin

C43.0

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Malignant melanoma of lip

C43.1

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Malignant melanoma of eyelid, including canthus

C43.10

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Malignant melanoma of unspecified eyelid, including canthus

C43.11

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Malignant melanoma of right eyelid, including canthus

C43.12

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Malignant melanoma of left eyelid, including canthus

C43.2

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Malignant melanoma of ear and external auricular canal

C43.20

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Malignant melanoma of unspecified ear and external auricular canal

C43.21

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Malignant melanoma of right ear and external auricular canal

C43.22

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Malignant melanoma of left ear and external auricular canal

C43.3

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Malignant melanoma of other and unspecified parts of face

C43.30

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Malignant melanoma of unspecified part of face

C43.31

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Malignant melanoma of nose

C43.39

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Malignant melanoma of other parts of face

C43.4

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Malignant melanoma of scalp and neck

C43.5

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Malignant melanoma of trunk

C43.51

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Malignant melanoma of anal skin

C43.52

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Malignant melanoma of skin of breast

C43.59

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Malignant melanoma of other part of trunk

C43.6

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Malignant melanoma of upper limb, including shoulder

C43.60

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Malignant melanoma of unspecified upper limb, including shoulder

C43.61

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Malignant melanoma of right upper limb, including shoulder

C43.62

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Malignant melanoma of left upper limb, including shoulder

C43.7

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Malignant melanoma of lower limb, including hip

C43.70

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Malignant melanoma of unspecified lower limb, including hip

C43.71

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Malignant melanoma of right lower limb, including hip

C43.72

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Malignant melanoma of left lower limb, including hip

C43.8

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Malignant melanoma of overlapping sites of skin

C43.9

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Malignant melanoma of skin, unspecified

C21

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Malignant neoplasm of anus and anal canal

C21.0

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Malignant neoplasm of anus, unspecified

C21.1

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Malignant neoplasm of anal canal

C51

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Malignant neoplasm of vulva

C51.0

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Malignant neoplasm of labium majus

C51.1

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Malignant neoplasm of labium minus

C51.2

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Malignant neoplasm of clitoris

C51.9

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Malignant neoplasm of vulva, unspecified

C52

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Malignant neoplasm of vagina

C57

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Malignant neoplasm of other and unspecified female genital organs

C57.7

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Malignant neoplasm of other specified female genital organs

C57.8

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Malignant neoplasm of overlapping sites of female genital organs

C57.9

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Malignant neoplasm of female genital organ, unspecified

C60

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Malignant neoplasm of penis

C60.0

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Malignant neoplasm of prepuce

C60.1

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Malignant neoplasm of glans penis

C60.8

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Malignant neoplasm of overlapping sites of penis

C60.9

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Malignant neoplasm of penis, unspecified

C63

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Malignant neoplasm of other and unspecified male genital organs

C63.0

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Malignant neoplasm of epididymis

C63.00

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Malignant neoplasm of unspecified epididymis

C63.01

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Malignant neoplasm of right epididymis

C63.02

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Malignant neoplasm of left epididymis

C63.1

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Malignant melanoma of spermatic cord

C63.10

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Malignant neoplasm of unspecified spermatic cord

C63.11

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Malignant neoplasm of right spermatic cord

C63.12

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Malignant neoplasm of left spermatic cord

C63.2

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Malignant neoplasm of scrotum

C63.7

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Malignant neoplasm of other specified male genital organs

C63.8

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Malignant neoplasm of overlapping sites of male genital organs

C63.9

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Malignant neoplasm of male genital organ, unspecified

Z51.12

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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.

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

C00

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Malignant neoplasm of lip

C00.0

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Malignant neoplasm of external upper lip

C00.1

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Malignant neoplasm of external lower lip

C00.2

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Malignant neoplasm of external lip, unspecified

C00.3

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Malignant neoplasm of upper lip, inner aspect

C00.4

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Malignant neoplasm of lower lip, inner aspect

C00.5

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Malignant neoplasm of lip, unspecified, inner aspect

C00.6

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Malignant neoplasm of commissure of lip, unspecified

C00.8

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Malignant neoplasm of overlapping sites of lip

C00.9

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Malignant neoplasm of lip, unspecified

C01

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Malignant neoplasm of base of tongue

C02

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Malignant neoplasm of other and unspecified parts of tongue

C02.0

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Malignant neoplasm of dorsal surface of tongue

C02.1

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Malignant neoplasm of border of tongue

C02.2

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Malignant neoplasm of ventral surface of tongue

C02.3

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

C02.4

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Malignant neoplasm of lingual tonsil

C02.8

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Malignant neoplasm of overlapping sites of tongue

C02.9

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Malignant neoplasm of tongue, unspecified

C03

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Malignant neoplasm of gum

C03.0

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Malignant neoplasm of upper gum

C03.1

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Malignant neoplasm of lower gum

C03.9

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Malignant neoplasm of gum, unspecified

C04

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Malignant neoplasm of floor of mouth

C04.0

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Malignant neoplasm of anterior floor of mouth

C04.1

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Malignant neoplasm of lateral floor of mouth

C04.8

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Malignant neoplasm of overlapping sites of floor of mouth

C04.9

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Malignant neoplasm of floor of mouth, unspecified

C05

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Malignant neoplasm of palate

C05.0

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Malignant neoplasm of hard palate

C05.1

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Malignant neoplasm of soft palate

C05.2

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Malignant neoplasm of uvula

C05.8

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Malignant neoplasm of overlapping sites of palate

C05.9

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Malignant neoplasm of palate, unspecified

C06

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Malignant neoplasm of other and unspecified parts of mouth

C06.0

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Malignant neoplasm of cheek mucosa

C06.1

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Malignant neoplasm of vestibule of mouth

C06.2

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Malignant neoplasm of retromolar area

C06.8

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

C06.80

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Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89

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Malignant neoplasm of overlapping sites of other parts of mouth

C06.9

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Malignant neoplasm of mouth, unspecified

C09

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Malignant neoplasm of tonsil

C09.0

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Malignant neoplasm of tonsillar fossa

C09.1

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Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8

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Malignant neoplasm of overlapping sites of tonsil

C09.9

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Malignant neoplasm of tonsil, unspecified

C10

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Malignant neoplasm of oropharynx

C10.0

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Malignant neoplasm of vallecula

C10.1

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Malignant neoplasm of anterior surface of epiglottis

C10.2

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Malignant neoplasm of lateral wall of oropharynx

C10.3

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Malignant neoplasm of posterior wall of oropharynx

C10.4

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Malignant neoplasm of branchial cleft

C10.8

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Malignant neoplasm of overlapping sites of oropharynx

C10.9

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Malignant neoplasm of oropharynx, unspecified

C12

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Malignant neoplasm of pyriform sinus

C13

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Malignant neoplasm of hypopharynx

C13.0

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Malignant neoplasm of postcricoid region

C13.1

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Malignant neoplasm aryepiglottic fold, hypopharyngeal aspect

C13.2

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Malignant neoplasm of posterior wall of hypopharynx

C13.8

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Malignant neoplasm of overlapping sites of hypopharynx

C13.9

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Malignant neoplasm of hypopharynx, unspecified

C14

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

C14.0

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Malignant neoplasm of pharynx, unspecified

C14.2

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Malignant neoplasm of Waldeyer’s ring

C14.8

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

C32

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Malignant neoplasm of larynx

C32.0

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Malignant neoplasm of glottis

C32.1

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Malignant neoplasm of supraglottis

C32.2

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Malignant neoplasm of subglottis

C32.3

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Malignant neoplasm of laryngeal cartilage

C32.8

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Malignant neoplasm of overlapping sites of larynx

C32.9

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Malignant neoplasm of larynx, unspecified

C76

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Malignant neoplasm of other and ill-defined sites

C76.0

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Malignant neoplasm of head, face and neck

Z51.12

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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.

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

C65

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Malignant neoplasm of renal pelvis

C65.1

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Malignant neoplasm of the right renal pelvis

C65.2

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Malignant neoplasm of the left renal pelvis

C65.9

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Malignant neoplasm of unspecified renal pelvis

C66

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Malignant neoplasm of ureter

C66.1

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Malignant neoplasm of the right ureter

C66.2

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Malignant neoplasm of the left ureter

C66.9

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Malignant neoplasm of unspecified ureter

C67

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Malignant neoplasm of bladder

C67.0

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Malignant neoplasm of trigone of bladder

C67.1

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Malignant neoplasm of dome of bladder

C67.2

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Malignant neoplasm of lateral wall of bladder

C67.3

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Malignant neoplasm of anterior wall of bladder

C67.4

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Malignant neoplasm of posterior wall of bladder

C67.5

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Malignant neoplasm of bladder neck

C67.6

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Malignant neoplasm of ureteric orifice

C67.8

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Malignant neoplasm of overlapping sites of bladder

C67.9

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Malignant neoplasm of bladder, unspecified

C68

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Malignant neoplasm of other and unspecific urinary organs

C68.0

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Malignant neoplasm of urethra

C68.8

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Malignant neoplasm of overlapping sites of urinary organs

C68.9

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Malignant neoplasm of urinary organ, unspecified

Z51.12

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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.

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

C33

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Malignant neoplasm of trachea

C34

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Malignant neoplasm of bronchus and lung

C34.0

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Malignant neoplasm of main bronchus, carina, and hilus of lung

C34.00

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Malignant neoplasm of unspecified main bronchus

C34.01

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Malignant neoplasm of right main bronchus

C34.02

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Malignant neoplasm of left main bronchus

C34.1

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Malignant neoplasm of upper lobe, bronchus or lung

C34.10

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Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

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Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

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Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

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Malignant neoplasm of middle lobe, bronchus or lung

C34.3

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Malignant neoplasm of lower lobe, bronchus or lung

C34.30

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Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

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Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

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Malignant neoplasm of lower lobe, left bronchus or lung

C34.8

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Malignant neoplasm of overlapping sites of bronchus and lung

C34.80

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Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

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Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

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Malignant neoplasm of overlapping sites of left bronchus and lung

C34.9

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Malignant neoplasm of unspecified part of bronchus or lung

C34.90

COPY

Malignant neoplasm of unspecified part of bronchus or lung

C34.91

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Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

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Malignant neoplasm of unspecified part of left bronchus or lung

Z51.12

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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.

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

C64

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Malignant neoplasm of kidney, except renal pelvis

C64.1

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Malignant neoplasm of right kidney, except renal pelvis

C64.2

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Malignant neoplasm of left kidney, except renal pelvis

C64.9

COPY

Malignant neoplasm of unspecified kidney, except renal pelvis

C65

COPY

Malignant neoplasm of renal pelvis

C65.1

COPY

Malignant neoplasm of right renal pelvis

C65.2

COPY

Malignant neoplasm of left renal pelvis

C65.9

COPY

Malignant neoplasm of unspecified renal pelvis

Z51.12

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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.

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

C17

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Malignant neoplasm of small intestine

C17.0

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Malignant neoplasm of duodenum

C17.1

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Malignant neoplasm of jejunum

C17.2

COPY

Malignant neoplasm of ileum

C17.8

COPY

Malignant neoplasm of overlapping sites of small intestine

C17.9

COPY

Malignant neoplasm of small intestine, unspecified

C18

COPY

Malignant neoplasm of colon

C18.0

COPY

Malignant neoplasm of cecum

C18.1

COPY

Malignant neoplasm of appendix

C18.2

COPY

Malignant neoplasm of ascending colon

C18.3

COPY

Malignant neoplasm of hepatic flexure

C18.4

COPY

Malignant neoplasm of transverse colon

C18.5

COPY

Malignant neoplasm of splenic flexure

C18.6

COPY

Malignant neoplasm of descending colon

C18.7

COPY

Malignant neoplasm of sigmoid colon

C18.8

COPY

Malignant neoplasm of overlapping sites of colon

C18.9

COPY

Malignant neoplasm of colon, unspecified

C19

COPY

Malignant neoplasm of rectosigmoid junction

C20

COPY

Malignant neoplasm of rectum

C21

COPY

Malignant neoplasm of anus and anal canal

C21.8

COPY

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

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

C22

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Malignant neoplasm of liver and intrahepatic bile ducts

C22.0

COPY

Liver cell carcinoma (hepatocellular carcinoma, hepatoma)

C22.8

COPY

Malignant neoplasm of liver, primary, unspecified as to type

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 Website
Cardinal Health Specialty Pharmaceutical Distribution 1-877-453-3972 Monday-Friday, 7 AM-7 PM CT (24-hour emergency on call) https://specialtyonline.cardinalhealth.com
CuraScript Specialty Distribution 1-866-433-3589 Monday-Friday, 8:30 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
Oncology Supply 1-800-633-7555 Monday-Thursday, 8 AM-7:30 PM CT; 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, 7:30 AM-6:30 PM CT; Friday, 7 AM-6 PM CT (24-hour emergency on call) 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) 1-888-345-4916 https://orderexpress.cardinalhealth.com
DMS Pharmaceutical Group, Inc. 1-877-788-1100 Monday-Friday, 7:30 AM-6 PM CT 1-847-518-1105
www.dmspharma.com
McKesson Plasma and Biologics 1-877-625-2566 Monday-Friday, 8 AM-6:30 PM CT 1-888-752-7626 https://connect.mckesson.com
Smith Medical Partners 1-800-292-9653 Monday-Thursday, 8 AM-6 PM CT; Friday, 8 AM-4:30 PM CT 1-630-227-9220
www.smpspecialty.com

Above information is accurate as of 04/17.

Above information is accurate as of 01/17.

Above information is accurate as of 01/17.

Above information is accurate as of 01/17.

Above information is accurate as of 01/17.

Above information is accurate as of 01/17.

Above information is accurate as of 04/17.

Above information is accurate as of 08/17.

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.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR OPDIVO

INDICATION

IMPORTANT SAFETY INFORMATION

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients.

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients.

Immune-Mediated Hepatitis

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients.

Immune-Mediated Skin Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids.

Other Immune-Mediated Adverse Reactions

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients.

Embryo-Fetal Toxicity

Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO-containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment.

Serious Adverse Reactions

Common Adverse Reactions

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

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.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR OPDIVO

INDICATION

IMPORTANT SAFETY INFORMATION

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients.

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients.

Immune-Mediated Hepatitis

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients.

Immune-Mediated Skin Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients.

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids.

Other Immune-Mediated Adverse Reactions

Infusion Reactions

OPDIVO can cause severe infusion reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. In patients receiving OPDIVO monotherapy, infusion-related reactions occurred in 6.4% (127/1994) of patients.

Embryo-Fetal Toxicity

Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with an OPDIVO-containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from an OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment.

Common Adverse Reactions

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 ©2015 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. 2017 HCPCS Level II. Professional ed. Chicago, IL: American Medical Association; 2017.
  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 January 12, 2017.
  3. Palmetto GBA. Medicare Part A Billing Guide. October 2016. http://www.palmettogba.com/Palmetto/Providers.Nsf/files/Part_A_Billing_Guide.pf/$File/Part_A_Billing_Guide.pdf. Accessed January 12, 2017.
  4. American Medical Association. Current Procedural Terminology 2017. Professional ed. Chicago, IL: American Medical Association; 2016.
  5. OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company.
  6. American Medical Association. 2017 ICD-10-CM: The Complete Official Codebook. Chicago, IL: American Medical Association; 2016.

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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