billing and coding guide for inflectra · hcpcs=healthcare common procedure coding system plaque...

INFLECTRA is a trademark of Hospira UK, a Pfizer company.Pfizer enCompass is a trademark of Pfizer.

Please see Indications and Important Safety Information on pages 12-15, and accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.

Billing and Coding

Guide for INFLECTRA®

PP-IFA-USA-0038 © 2016 Pfizer Inc. All rights reserved. Printed in USA/December 2016

Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.

Pfizer, Inc. has developed this billing and coding guide to assist healthcare professionals with understanding billing, coding, and claim submission for INFLECTRA (infliximab-dyyb) for Injection, the first infliximab biosimilar to be approved in the United States (US).

Providers are responsible for appropriate coding and should contact each insurer to determine the appropriate codes for services provided. Pfizer, Inc. does not guarantee that use of any code(s) will ensure coverage or payment at any level. The information presented is for informational purposes only and is not intended to provide reimbursement or legal advice. Consult your own resources when selecting codes for services provided.

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Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.

IntroductionTo facilitate accurate and timely reimbursement, the following resource is intended to provide an overview of billing and coding for INFLECTRA (infliximab-dyyb) for Injection.

INFLECTRA 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. In conjunction with the Q-code, claims submitted for biosimilars should also include the manufacturer-specific Healthcare Common Procedure Coding System (HCPCS) modifier to adequately distinguish the biosimilar.

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

1-844-722-6672Monday–Friday, 9 am–8 pm ET

54

Pfizer enCompass ProgramPfizer enCompass is a comprehensive reimbursement and patient support program for information and resources related to patient access for INFLECTRA. With Pfizer enCompass, you have access to a team of experienced Access Counselors trained to provide the following support to healthcare providers and patients:

• Investigate patient insurance benefits and coverage details for INFLECTRA

• Navigate prior authorization requirements

• Assist with coding and billing challenges

• Support the claims and prior authorization appeals processes

• Identify affordability options to help appropriate patients who need financial assistance get started with INFLECTRA treatment

Coverage for INFLECTRACoverage for INFLECTRA may vary across commercial payers, Medicare, and Medicaid and by treatment site of care. Providers 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.

Claim Information Type of Code Code and Descriptor Site of Service Considerations

INFLECTRA

HCPCS code1 Q5102: Injection, Infliximab, Biosimilar, 10 mg Physician office, HOPD

HCPCS modifiers1 ZB: Pfizer/HospiraJW: Drug wastage/amount discarded and not administered to any patient Physician office, HOPD

National Drug Codes (NDCs)2

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

1. Centers for Medicare & Medicaid Services. HCPCS release and code sets. HCPCS quarterly update. Other codes. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/Other-Codes-2016-July.zip. Accessed August 25, 2016.

2. INFLECTRA® (infliximab-dyyb) prescribing information. Pfizer. April, 2016.

Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket.Please see accompanying full Prescribing Information, including BOXED WARNING and Medication Guide, in pocket. 76

Claim Information Type of Code Code and Descriptor Site of Service Considerations

Procedures, services, and supplies

CPT codes3

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

Evaluation and management (E/M) codes3

99212–99215: Established patient visit Physician office

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

HCPCS code4 J7050: Infusion, normal saline solution, 250 mL HOPD

CPT modifier3 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 codes5

0260: IV therapy0636: Drugs requiring detailed coding0500: Outpatient services, general0510: Clinic, general

HOPD

3. American Medical Association. 2017 CPT Professional Edition. Current Procedural Terminology (CPT®) copyright 2016. All rights reserved. CPT is a registered trademark of the American Medical Association.

4. Centers for Medicare & Medicaid Services. Medicare Hospital Outpatient Prospective Payment System July 2016 Addendum B. https://www.cms.gov/apps/ama/license.asp?file=/Medicare/Medicare-Fee-for-Service-Payment/Hospitaloutpatientpps/Downloads/2016-July-Addendum-B.zip. Accessed August 25, 2016.

5. Centers for Medicare & Medicaid Services. Transmittal 167. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R167CP.pdf. Accessed August 25, 2016.

Diagnosis Coding for INFLECTRAINFLECTRA was approved for the following indications:

The following ICD-10-CM diagnosis codes may be appropriate when submitting a claim for INFLECTRA. Providers are responsible for determining appropriate codes.

Claim Information Indication Code and Descriptor

Diagnosis6

Rheumatoid arthritis M05.1–M05.9: Rheumatoid lung disease with rheumatoid arthritisM06.0–M06.9: Other specified rheumatoid arthritis

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

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

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

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

Plaque psoriasis L40.0: Plaque psoriasisHCPCS=Healthcare Common Procedure Coding SystemNDC=National Drug CodeCPT=Current Procedural Terminology

Coding for INFLECTRA Administration Services

6. Optum360. 2017 International Classification of Diseases, 10th Revision, Clinical Modification. 2016.

• Moderately to severely active rheumatoid arthritis+

• Moderately to severely active Crohn’s disease±

• Moderately to severely active pediatric Crohn’s disease±

• Moderately to severely active ulcerative colitis±

• Active ankylosing spondylitis

• Active psoriatic arthritis

• Chronic severe plaque psoriasis§II

+ In combination with methotrexate.± In patients who have had an inadequate response to conventional therapy.§ 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.

ICD-10-CM = International Classification of Diseases, 10th Revision, Clinical Modification


Physician Office Sample Claim Form: CMS-1500

Number of 100 mg vials of INFLECTRA administered

Number of mg equivalent to the vials administered

Number of Q5102 billing units (10 mg infliximab 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 healthcare providers bill and code for INFLECTRA, they should consider the following information:

INFLECTRA Billing UnitsThe INFLECTRA HCPCS code is Q5102, described as “Injection, Infliximab, Biosimilar, 10 mg.” Note that this is a different HCPCS code than used to bill 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 Q5102. 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 Q5102.

ModifiersThe HCPCS code for INFLECTRA, Q5102, has a modifier that identifies the manufacturer, ZB: Pfizer/Hospira, which must be included in addition to Q5102 whenever INFLECTRA is billed on a claim form. Other modifiers listed in the table on the previous pages may be applicable for billing of INFLECTRA in the physician office or HOPD sites of care.

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 Q5102 ZB 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

Item 24G: Specify the 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

Item 24D: Indicate appropriate CPT and HCPCS codes, including the INFLECTRA Q-code and “ZB” HCPCS modifier to specify INFLECTRA

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


Hospital Outpatient Sample Claim Form: UB-04

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

Q5102/ZB 01-‐04-‐16 40

0260 IV therapy

0260 IV therapy 96413 01-‐04-‐16 1

96415 01-‐04-‐16 1

Medicare

K50.00

FL 44: Specify appropriate CPT and HCPCS codes and modifiers, including the “ZB” HCPCS modifier to specify INFLECTRA

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

Form Locator (FL) 42: Specify revenue codes

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

FL 43: Describe procedure

Claim Information Type of Code Code and Descriptor Billing Considerations

INFLECTRA

HCPCS code1 Q5102: Injection, Infliximab, Biosimilar, 10 mg

Codes identifying INFLECTRAHCPCS modifier1 ZB: Pfizer/Hospira

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

Procedures, services, and supplies

CPT codes3 99601: Home infusion/specialty drug administration, per visit (up to 2 hours)99602: Each additional hour Home nursing CPT codes

HCPCS codes7,8

S9359: Home infusion therapy; anti-tumor necrosis factor intravenous therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment, 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.

7. Centers for Medicare & Medicaid Services. CMS Manual Transmittal 3153. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3153CP.pdf. Accessed August 25, 2016.8. Centers for Medicare & Medicaid Services. 2016 Alpha-Numeric HCPCS File. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Downloads/2016-Alpha-Numeric-HCPCS-File.zip.

Accessed October 18, 2016.


IMPORTANT SAFETY INFORMATION AND INDICATIONS

SERIOUS INFECTIONSPatients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue INFLECTRA® (infliximab-dyyb) if a patient develops a serious infection or sepsis.

Reported infections include:• Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should

be tested for latent TB before INFLECTRA® use and during therapy.1,2 Treatment for latent infection should be initiated prior to INFLECTRA® use.• Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present

with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with INFLECTRA® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with INFLECTRA®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab products included pneumonia, cellulitis, abscess, and skin ulceration.

MALIGNANCIESLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products. Approximately half of these cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with INFLECTRA®, especially in these patient types.

IMPORTANT SAFETY INFORMATION AND INDICATIONS (Continued)

MALIGNANCIES (Continued)In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including infliximab products, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with infliximab products was similar to that expected in the general population, whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

CONTRAINDICATIONSINFLECTRA® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. INFLECTRA® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue INFLECTRA® if new or worsening CHF symptoms appear. INFLECTRA® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.

HEPATITIS B REACTIVATIONTNF inhibitors, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating INFLECTRA®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing INFLECTRA® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with INFLECTRA®. Discontinue INFLECTRA® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of INFLECTRA® and monitor patients closely.

HEPATOTOXICITYSevere hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving infliximab products postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, INFLECTRA® should be discontinued, and a thorough investigation of the abnormality should be undertaken.

Continued on the next pageContinued on the next page



HEMATOLOGIC EVENTSCases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported in patients receiving infliximab products. The causal relationship to infliximab therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of INFLECTRA® in patients who develop significant hematologic abnormalities.

HYPERSENSITIVITYInfliximab products have been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of infliximab products. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.

NEUROLOGIC EVENTSTNF inhibitors, including infliximab products, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering INFLECTRA® in patients with these disorders and consider discontinuation if these disorders develop.

AUTOIMMUNITYTreatment with infliximab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment with INFLECTRA® if symptoms of a lupus-like syndrome develop.

ADVERSE REACTIONSIn clinical trials with infliximab products, the most common adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.

USE WITH OTHER DRUGSConcomitant use of INFLECTRA® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as INFLECTRA® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.

LIVE VACCINES/THERAPEUTIC INFECTIOUS AGENTSLive vaccines or therapeutic infectious agents should not be given with INFLECTRA® due to the possibility of clinical infections, including disseminated infections.

Bring pediatric patients up to date with all vaccinations prior to initiating INFLECTRA®. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to infliximab products.


INDICATIONS

Crohn’s Disease• Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease (CD)

who have had an inadequate response to conventional therapy• Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD

Pediatric Crohn’s Disease• Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely

active Crohn’s disease who have had an inadequate response to conventional therapy

Ulcerative Colitis• Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with

moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Rheumatoid Arthritis• Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely

active rheumatoid arthritis, in combination with methotrexate

Ankylosing Spondylitis• Reducing signs and symptoms in patients with active ankylosing spondylitis

Psoriatic Arthritis• Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic

arthritis

Plaque Psoriasis• Treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other

systemic therapies are medically less appropriate• INFLECTRA® should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician

Continued on the next page

1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.

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