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Billing and Coding Guide for INFLECTRA®

INFLECTRA is a trademark of Pfizer Inc.

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Pfizer enCompass is a trademark of Pfizer Inc.

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Pfizer Inc. has developed this reference guide to assist healthcare providers (HCPs) with understanding coding for INFLECTRA® (infliximab-dyyb) for Injection, the first infliximab biosimilar to be approved in the United States (US).

The information provided in this document is intended for information purposes only and is not a comprehensive description of potential coding requirements for INFLECTRA. Coding and coverage policies change periodically and often without warning. The healthcare provider is solely responsible for determining coverage and reimbursement parameters and appropriate coding for treatment of his/her patients. The information provided should not be considered a guarantee of coverage or reimbursement for INFLECTRA.

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Pfizer enCompass provides reimbursement and patient support as well as information and resources related to patient access for INFLECTRA. With Pfizer enCompass, patients have access to a team of experienced Access Counselors trained to provide the following support:

• Investigation of patient insurance benefits and coverage details for INFLECTRA

• Navigation of prior authorization requirements

• Assistance with coding and billing challenges

• Claims and prior authorization appeals processes

• Options to help eligible patients who need financial assistance get started with INFLECTRA treatment

For additional information, please contact a Pfizer enCompass Access Counselor at:

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1-844-722-6672, Monday–Friday,

9 am–8 pm ET

Visit www.pfizerencompass.com

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Claim Information Type of Code Code and Descriptor Relevant Sites of Service

INFLECTRA

HCPCS code1* Q5103: Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg Physician office, HOPD

HCPCS modifiers1 JW: Drug amount discarded/not administered to any patient Physician office, HOPD

NDCs2 10-digit: 0069-0809-0111-digit: 00069-0809-01 Physician office, HOPD

Revenue codes3 0260: IV therapy0636: Drugs requiring detailed coding HOPD

1. Centers for Medicare & Medicaid Services. 2019 Alpha-Numeric HCPCS File. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2019-Alpha-Numeric-HCPCS-File.html. Accessed January 21, 2019.

2. INFLECTRA [package insert]. New York, NY: Pfizer Inc.; 2019.3. Centers for Medicare & Medicaid Services. Transmittal 167. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R167CP.pdf. Accessed January 21, 2019.

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*Effective for dates of service on or after April 1, 2018

IntroductionINFLECTRA was approved on April 5, 2016, under the 351(k) approval pathway as the first infliximab biosimilar in the US. For biosimilars such as INFLECTRA, the Centers for Medicare & Medicaid Services (CMS) has assigned Q codes to identify and distinguish biosimilars from the reference biologic.

Coverage for INFLECTRACoverage for INFLECTRA may vary across commercial payers, Medicare, and Medicaid, and by treatment site of care. HCPs should confirm payer policies prior to treating patients with INFLECTRA.

Coding OverviewIn the physician office and hospital outpatient department (HOPD) sites of care, Medicare Administrative Contractors (MACs), private commercial payers, and Medicaid typically recognize the following codes for reporting INFLECTRA on claim forms. Effective for dates of service on or after April 1, 2018, CMS has assigned a new product-specific HCPCS code for INFLECTRA. The previously assigned HCPCS code and manufacturer HCPCS modifier (Q5102 and modifier ZB) have been discontinued.

HCPCS=Healthcare Common Procedure Coding SystemHOPD=hospital outpatient departmentNDC=National Drug Code

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Claim Information Type of Code Code and Descriptor Relevant Sites of Services

Procedures, services, and supplies

CPT codes4

96413: Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug

96415: Chemotherapy administration, IV infusion technique; each additional hour

Physician office, HOPD

E/M codes4 99212–99215: Established patient visit Physician office

HCPCS code5 G0463: Hospital outpatient clinic visit for assessment and management of a patient HOPD

CPT modifier4 25: Significant, separately identifiable E/M service by the same physician or other qualified healthcare professional on the same day of the procedure or other service Physician office, HOPD

Revenue codes3 0500: Outpatient services, general0510: Clinic, general HOPD

E/M=evaluation and managementCPT=Current Procedural TerminologyHCPCS=Healthcare Common Procedure Coding SystemHOPD=hospital outpatient department

4. American Medical Association. 2019 CPT Professional Edition. Current Procedural Terminology (CPT®) copyright 2018. All rights reserved. CPT is a registered trademark of the American Medical Association.5. Centers for Medicare & Medicaid Services. Medicare. Hospital Outpatient Prospective Payment System, January 2019.

https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/Hospitaloutpatientpps/Downloads/2019-January-Addendum-B.zip. Accessed January 21, 2019.

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Coding for INFLECTRA Administration and Physician ServicesCurrent Procedural Terminology (CPT®) codes define specific medical procedures performed by physicians.4 The following codes may be used to report the administration of INFLECTRA.

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The following International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes may be appropriate when submitting a claim for INFLECTRA. HCPs are responsible for determining appropriate codes based upon actual patient circumstances.

Claim Information Indication Code and Descriptor

Diagnosis6

Crohn’s disease K50.00–K50.919: Crohn’s disease

Ulcerative colitis K51.00–K51.919: Ulcerative colitis

Rheumatoid arthritis M06.0–M06.9: Other specified rheumatoid arthritis

Ankylosing spondylitis M45.0–M45.9: Ankylosing spondylitis

Psoriatic arthritis L40.50–L40.53: Psoriatic arthritis

Plaque psoriasis L40.0: Plaque psoriasis

• Moderately to severely active Crohn’s disease*

• Moderately to severely active pediatric Crohn’s disease*

• Moderately to severely active ulcerative colitis*

• Moderately to severely active pediatric ulcerative colitis*

• Moderately to severely active rheumatoid arthritis†

• Active ankylosing spondylitis

• Active psoriatic arthritis

• Chronic severe plaque psoriasis§,II

* In patients who have had an inadequate response to conventional therapy.† In combination with methotrexate.§ Patients who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.II INFLECTRA should be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Diagnosis Coding for INFLECTRAINFLECTRA was approved for the following indications:

6. Optum360. 2019 International Classification of Diseases, 10th Revision, Clinical Modification. 2018.

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Number of 100 mg vials of INFLECTRA administered

Number of mg equivalent to the vials administered

Number of Q5103 billing units (10 mg infliximab-dyyb biosimilar per unit)

equivalent to the mg in the prior column

1 100 mg 10 units

2 200 mg 20 units

3 300 mg 30 units

4 400 mg 40 units

5 500 mg 50 units

Additional Coding InformationWhen HCPs bill and code for INFLECTRA, they should consider the following information:

INFLECTRA Billing UnitsThe INFLECTRA HCPCS code is Q5103, described as “Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg.” This HCPCS code is effective for dates of service on or after April 1, 2018. Note that this is a different HCPCS code than is used to bill for the reference product for INFLECTRA. Each dose increment of 10 mg equals 1 billing unit. A 100 mg vial of INFLECTRA represents 10 units of Q5103. See the chart below correlating vials of INFLECTRA administered with the number of mg of drug and number of billing units based on the description of Q5103.

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Physician Office Sample Claim Form: CMS-1500

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X   000-­‐00-­‐0000  

Doe,  John,  S   01    01    50   X   Doe,  John,  S  

123  Main  Street          X   123  Main  Street  

Anytown   AS   Anytown                    AS  

10101  

Medicare  

Dr.  Smith        123  456  7890  

           K50.00  

01    04    16    01    04    16    11                            96413   A                    1              123  456  7890  

01    04    16    01    04    16    11    96415    A                      1              123  456  7890  

01    04    16    01    04    16    11    Q5103    A   40              123  456  7890  

Dr.  Smith  321  South  Street  Anytown,  AS  10101  

APPROVED OMB-­‐0938-­‐1197 FORM 1500 (02-­‐12)PLEASE PRINT OR TYPE

0  Item 24G: Specify the billing units. For example, 10 units = 100 mg of infliximab biosimilar (INFLECTRA). To bill 400 mg, enter 40 units

Item 24E: Enter reference to the diagnosis for the CPT and HCPCS codes from Item 21

Item 24D: Specify appropriate HCPCS and CPT codes and modifiers, for example:• Drug: Q5103 for INFLECTRA• Administration: 96413, 96415 for drug

administration

Item 21: Specify appropriate ICD-10-CM diagnosis code(s)

Item 19: If additional information is required to describe INFLECTRA (eg, NDC), this information may be captured in Item 19

SAMPLEItem 21: Identify the type of ICD diagnosis code used (eg, enter a “0” for ICD-10-CM)

DISCLAIMER: This sample form is intended as a reference for the coding and billing of INFLECTRA. This form is not intended to be directive and the use of the recommended codes does not guarantee reimbursement. Healthcare providers may deem other codes or policies more appropriate and should select the coding options that most accurately reflect their internal guidelines, payer requirements, practice patients, and the services rendered.

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Hospital Outpatient Sample Claim Form: UB-04

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Anytown  Hospital  456  Main  Street  Anytown,  AS  10101  

John  S.  Doe                  123  Main  Street  Anytown   AS            10101    US      

01-­‐01-­‐50            M      

0636      Drugs  requiring  detailed  coding  -­‐            INFLECTRA  

Q5103                        01-­‐04-­‐16        40  

0260      IV  therapy  

0260      IV  therapy   96413                        01-­‐04-­‐16        1  

96415                        01-­‐04-­‐16      1  

Medicare  

K50.00  0  

FL 44: Specify appropriate HCPCS and CPT codes and modifiers, for example: • Drug: Q5103 for INFLECTRA• Administration: 96413, 96415 for drug

administration

FL 46: Specify the billing units. For example, 10 units = 100 mg of infliximab biosimilar (INFLECTRA). To bill 400 mg of drug, enter 40 units

FL 67: Specify appropriate ICD-10-CM diagnosis code(s)

FL 66: Identify the type of ICD diagnosis code used (eg, enter a “0” for ICD-10-CM)

Form Locator (FL) 42 and 43: Specify revenue codes and describe procedures, for example:• 0260: IV therapy• 0636: Drugs requiring specific

identification - detailed coding (For INFLECTRA)

DISCLAIMER: This sample form is intended as a reference for the coding and billing of INFLECTRA. This form is not intended to be directive and the use of the recommended codes does not guarantee reimbursement. Healthcare providers may deem other codes or policies more appropriate and should select the coding options that most accurately reflect their internal guidelines, payer requirements, practice patients, and the services rendered.

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FDA-APPROVED

Claim Information Type of Code Code and Descriptor Billing Considerations

INFLECTRA

HCPCS code1 Q5103: Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg(Effective for dates of service on or after April 1, 2018)

Codes identifying INFLECTRA

NDCs2 10-digit: 0069-0809-01 11-digit: 00069-0809-01

Procedures, services, and supplies

CPT codes4 99601: Home infusion/specialty drug administration, per visit (up to 2 hours)99602: Each additional hour Home nursing CPT codes

HCPCS codes1,7

S9359: Home infusion therapy, anti-tumor necrosis factor intravenous therapy; (e.g., infliximab); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

May be appropriate when submitting a claim for per diem specialty therapy services

J7050: Infusion, normal saline solution, 250 cc

Details other supplies utilized as part of the home infusion

A4216: Sterile water, sterile saline and/or dextrose, diluent/flush, 10 mL

NDCs

Code may vary by manufacturer for sodium chloride 0.9% 250 mL bag

Code may vary by manufacturer for sterile water, preservative-free injection, 20 mL vial

INFLECTRA Coding for Home InfusionHome infusion providers should confirm appropriate coding with the patient’s payer prior to submitting a claim for INFLECTRA.

Pfizer enCompass® is available to assist providers in navigating the coding and billing process when submitting claims for INFLECTRA.

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CPT=Current Procedural TerminologyHCPCS=Healthcare Common Procedure Coding SystemNDC=National Drug Code

7. Centers for Medicare & Medicaid Services. CMS Manual Transmittal 3153. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3153CP.pdf. Accessed January 21, 2019.

PP-IFA-USA-0565 © 2019 Pfizer Inc. All rights reserved. July 2019