Billing and Coding Guide

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This influenza season, count on the Seqirus portfolio of influenza products.

3 EASY ORDERING METHODS:

Order online at Contact your Seqirus Email customer flu.seqirus.com account manager service at about our portfolio customerservice.us of influenza vaccines @seqirus.com BILLING AND and treatment

FOR REIMBURSEMENT SUPPORT CALL 855-358-8966, OPTION #3 CODING GUIDE 2019-2020 INFLUENZA SEASON References: 1. Influenza vaccine products for 2019-2020 influenza season. Immunization Action Coalition website. http://www.immunize.org.2. Afluria Quadrivalent [package insert]. Summit, NJ: Seqirus USA Inc; 2019. 3. FLUAD [package insert]. Summit, NJ: Seqirus USA Inc; 2019. 4. FLUCELVAX QUADRIVALENT [package insert]. Summit, NJ: Seqirus USA Inc; 2019. 5.Coding for pediatric preventive care, 2018. American Academy of Pediatrics website. https://www.aap.org/en-us/Documents/coding_preventive_care.pdf. Published 2019. Accessed October 23, 2019. 6.Medicare part B immunization billing: seasonal influenza virus, pneumococcal, and hepatitis B. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/qr_immun_bill.pdf. Published January 2018. Accessed October 23, 2019. 7. Procedural Coding Expert: The Ultimate Guide to CPT® Coding. Salt Lake City, UT: Contexo Media; 2012. 8. ED facility level coding guidelines. American College of Emergency Physicians website. https://www.acep.org/administration/reimbursement/ed-facility-level-coding-guidelines/#sm.000005vd05555heczqbvu9txsrjf3. Published 2011. Accessed October 23, 2019. 9.ICD-10-CM tabular list of diseases and injuries. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Medicare/Coding/ICD10/Downloads/2018-ICD-10-Table-And-Index.zip. Accessed October 23, 2019. 10.Rapivab [package insert]. Summit, NJ: Seqirus USA Inc; 2018. 11. Parman C. Oncology reimbursement coding update. 2017. Association of Community Cancer Centers website. https://www.accc-cancer.org/publications/pdf/Oncology- Reimbursement-Coding-Update-2017.pdf. Published 2017. Accessed October 23, 2019. 12. Nelson ME. ICD-10 cometh. CHEST Physician website. http://www.chestnet.org/~/media/chesnetorg/Publications/Documents/ CHEST%20Physician/Vol%2010%202015/0415.ashx. Published April 2015. Accessed October 23, 2019. 13. CMS manual system. Publication 100-04 Medicare claims processing. Centers for Medicare and Medicaid Services website. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/r167cp.pdf. Published April 30, 2004. Accessed October 23, 2019.

AFLURIA QUADRIVALENT, FLUAD, FLUCELVAX QUADRIVALENT, and RAPIVAB are registered trademarks of Seqirus UK Limited or its affiliates. © 2019 Seqirus USA Inc. All rights reserved. 25 Deforest Ave, Summit NJ 07901 Please see Important Safety Information on pages 6-8 and 13,

October 2019 US/CORP/1016/0004(5) and accompanying full Prescribing Information.

voluntarily during clinical practice, estimates of frequency cannot be made, but they they but made, be cannot frequency of estimates practice, clinical during voluntarily

RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates. its or Limited UK Seqirus of trademark registered a is RAPIVAB neuraminidase inhibitors, including Rapivab. Because these events were reported reported were events these Because Rapivab. including inhibitors, neuraminidase

or call 1-800-FDA-1088. call or www.fda.gov/medwatch Visit and abnormal behavior leading to injury in patients with influenza who were receiving receiving were who influenza with patients in injury to leading behavior abnormal and

You are encouraged to report negative side effects of prescription drugs to the FDA. the to drugs prescription of effects side negative report to encouraged are You cases resulting in fatal outcomes. There have been postmarketing reports of delirium delirium of reports postmarketing been have There outcomes. fatal in resulting cases

. RAPIVAB for Information Prescribing full accompanying see Please can include events such as hallucinations, delirium, and abnormal behavior, in some some in behavior, abnormal and delirium, hallucinations, as such events include can

• Influenza can be associated with a variety of neurologic and behavioral symptoms that that symptoms behavioral and neurologic of variety a with associated be can Influenza

medically indicated. medically

patients with known serious hypersensitivity or anaphylaxis to RAPIVAB. to anaphylaxis or hypersensitivity serious known with patients

avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless unless LAIV of administration before hours 48 or after weeks 2 within Rapivab of use avoid

serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in in contraindicated is RAPIVAB of use The suspected. is or occurs reaction skin serious

not been evaluated. Because of the potential for interference between these two products, products, two these between interference for potential the of Because evaluated. been not

RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a a or anaphylaxis if treatment appropriate institute and RAPIVAB Discontinue RAPIVAB.

thus may reduce vaccine efficacy). The concurrent use of Rapivab with LAIV intranasal has has intranasal LAIV with Rapivab of use concurrent The efficacy). vaccine reduce may thus

and Stevens-Johnson Syndrome have been reported in postmarketing experience with with experience postmarketing in reported been have Syndrome Stevens-Johnson and

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and and (LAIV) vaccine influenza attenuated live a of replication viral inhibit may drugs Antiviral with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis anaphylaxis of Cases experience. postmarketing in and studies clinical in RAPIVAB with

VACCINE INFLUENZA ATTENUATED LIVE WITH USE CONCURRENT

• Rare cases of serious skin reactions, including erythema multiforme, have been reported reported been have multiforme, erythema including reactions, skin serious of cases Rare

WARNINGS AND PRECAUTIONS AND WARNINGS

by dipstick analysis (3% versus 0% for oseltamivir). for 0% versus (3% analysis dipstick by

≥ 2% of pediatric subjects treated with RAPIVAB was proteinuria proteinuria was RAPIVAB with treated subjects pediatric of 2% in occurring 2) Grade (DAIDS anaphylaxis, erythema multiforme and Stevens-Johnson Syndrome. Stevens-Johnson and multiforme erythema anaphylaxis,

respectively, for each of these events). The only clinically significant laboratory abnormality abnormality laboratory significant clinically only The events). these of each for respectively, to peramivir or any component of the product. Severe allergic reactions have included included have reactions allergic Severe product. the of component any or peramivir to

(3% versus 9% for oseltamivir), fever and tympanic membrane erythema (2% versus 0%, 0%, versus (2% erythema membrane tympanic and fever oseltamivir), for 9% versus (3% RAPIVAB is contraindicated in patients with known serious hypersensitivity or anaphylaxis anaphylaxis or hypersensitivity serious known with patients in contraindicated is RAPIVAB

≥ 2% of subjects) and not reported in adults included vomiting vomiting included adults in reported not and subjects) of 2% in (occurring RAPIVAB with

CONTRAINDICATIONS

that observed in adults. Specific adverse reactions reported in pediatric subjects treated treated subjects pediatric in reported reactions adverse Specific adults. in observed that

The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to to similar generally was age of years 17 to 2 subjects in RAPIVAB of profile safety The hospitalization.

• The efficacy of RAPIVAB could not be established in patients with serious influenza requiring requiring influenza serious with patients in established be not could RAPIVAB of efficacy The

(3% versus 2%), and hypertension (2% versus 0%). versus (2% hypertension and 2%), versus (3%

compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased increased AST 0%), versus (3% insomnia 2%), versus (4% constipation placebo: to compared RAPIVAB.

(N=101), the following adverse reactions were also reported more frequently with RAPIVAB as as RAPIVAB with frequently more reported also were reactions adverse following the (N=101), influenza drug susceptibility patterns and treatment effects when deciding whether to use use to whether deciding when effects treatment and patterns susceptibility drug influenza

serious influenza requiring hospitalization treated with RAPIVAB 600 mg as monotherapy monotherapy as mg 600 RAPIVAB with treated hospitalization requiring influenza serious clinical benefit of antiviral drugs. Prescribers should consider available information on on information available consider should Prescribers drugs. antiviral of benefit clinical

/L (8% vs 6%). In a subset of subjects with with subjects of subset a In 6%). vs (8% /L 10 x <1.0 neutrophils and 2%), vs (4% normal of

drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish diminish also might virulence) viral in changes example, (for factors Other effectiveness. drug 9

elevated serum glucose >160 mg/dL (5% vs 3%), elevated CPK at least 6 times the upper limit limit upper the times 6 least at CPK elevated 3%), vs (5% mg/dL >160 glucose serum elevated • Influenza viruses change over time. Emergence of resistance substitutions could decrease decrease could substitutions resistance of Emergence time. over change viruses Influenza

Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), 2%), vs (3% normal of limit upper the times 2.5 ALT elevated were placebo than Rapivab infected with influenza B virus were enrolled. were virus B influenza with infected

≥ 2%) occurring more commonly with with commonly more occurring 2%) (incidence abnormalities Lab placebo). 7% vs Rapivab the predominant influenza infections were influenza A virus; a limited number of subjects subjects of number limited a virus; A influenza were infections influenza predominant the

The most common adverse reaction in adults (18 years of age and older) was diarrhea (8% (8% diarrhea was older) and age of years (18 adults in reaction adverse common most The

• Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which which in influenza occurring naturally of trials clinical on based is RAPIVAB of Efficacy

ADVERSE REACTIONS ADVERSE

LIMITATIONS OF USE OF LIMITATIONS

prevent such complications. such prevent

IMPORTANT SAFETY INFORMATION SAFETY IMPORTANT

or occur as complications during the course of influenza. Rapivab has not been shown to to shown been not has Rapivab influenza. of course the during complications as occur or

• Serious bacterial infections may begin with influenza-like symptoms or may coexist with with coexist may or symptoms influenza-like with begin may infections bacterial Serious

and older who have been symptomatic for no more than 2 days. 2 than more no for symptomatic been have who older and

influenza should be closely monitored for signs of abnormal behavior. abnormal of signs for monitored closely be should influenza

RAPIVAB is indicated for the treatment of acute uncomplicated influenza in patients 2 years years 2 patients in influenza uncomplicated acute of treatment the for indicated is RAPIVAB

The contribution of Rapivab to these events has not been established. Patients with with Patients established. been not has events these to Rapivab of contribution The

INDICATION appear to be uncommon. These events were reported primarily among pediatric patients. patients. pediatric among primarily reported were events These uncommon. be to appear Flat Size: 24.1367" x 16.5" Finished Size: 11.625" x 8.25" w/ 2-.75" glue tabs

Coding for all THE GRID BELOW EXPLAINS HOW TO CODE FOR SEQIRUS VACCINES¹-4 Seqirus vaccines Seqirus Vaccine 2019-2020 2019-2020 NDC Presentation/ Age Vaccine Product Because there are many Current Product Description NDC Carton Unit-of-Use Dose Indication Billing Code Procedural Terminology (CPT ) codes that describe influenza CPT/Medicare Code vaccines, accurate coding for influenza vaccines is critical. FLUAD® (influenza 70461-019-03 70461-019-04 Prefilled 65 years 90653 You must code correctly based vaccine, adjuvanted) syringe 0.5 mL and older on the product you are using to 90653 = Influenza vaccine, inactivated (IIV), subunit, adjuvanted, for intramuscular use receive accurate payment.

FLUCELVAX® 70461-319-03 70461-319-04 Prefilled syringe 4 years 90674 QUADRIVALENT 0.5 mL and older (influenza vaccine) 70461-419-10 70461-419-11 Multidose vial 4 years 90756 5 mL and older

90674 = Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative- and antibiotic-free, 0.5 mL dosage, for intramuscular use 90756 = Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular usea

33332-219-20 33332-219-21 Prefilled syringe 6 through 90685 0.25 mL 35 months

AFLURIA® 33332-319-01 33332-319-02 Prefilled syringe 36 months 90686 QUADRIVALENT 0.5 mL and older (influenza vaccine) 33332-419-10 33332-419-11 Multidose viala 6 through 90687 (0.25 mL dose) 35 months 5 mL

36 months 90688 (0.5 mL dose) and older

NDC=National Drug Code. aNo more than 10 doses (0.25 mL or 0.5 mL) should be withdrawn from the Afluria Quadrivalent multidose vial.

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. Flat Size: 24.1367" x 16.5" Finished Size: 11.625" x 8.25" w/ 2-.75" glue tabs Interior Pages: 11.625" x 8.25"

FLUCELVAX® 70461-319-03 70461-319-04 Prefilled syringe 4 years 90674 National Drug Codes change each year QUADRIVALENT 0.5 mL and older (influenza vaccine) for influenza vaccines 70461-419-10 70461-419-11 Multidose vial 4 years 90756 5 mL and older The National Drug Codes (NDCs) for 2019-2020 Seqirus vaccines are listed in the grid to the left. Some Medicaid agencies and private health plans require the use of an 11-digit NDC in addition to the CPT code on claims for physician-administered products. 90674 = Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative- and antibiotic-free, However, Medicare and TriCare require both the current NDC and CPT code for billing influenza vaccines (eg, Fluad-70461-0019-03; 0.5 mL dosage, for intramuscular use the red shows where the additional zero needs to be added and is the same for all of our vaccines). Influenza vaccines are licensed 90756 = Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular usea each year with new NDCs, so it is important to report the correct code for the product you are using. Additionally, the US Food and Drug Administration (FDA) requires different NDCs on the cartons and the syringe or vial (unit-of-use), so it is important to record the correct NDC in the patient’s record as per the standard procedure in your practice. For billing/claims processing for Seqirus influenza 33332-219-20 33332-219-21 Prefilled syringe 6 through 90685 vaccines, the NDC from the carton should be used. If you have questions, call your payers to confirm their preferred NDC, either 0.25 mL 35 months carton or unit-of-use.

36 months 90688 (0.5 mL dose) and older

90685 = influenza vaccine, quadrivalent (IIV4), split virus, preservative-free, 0.25 mL dosage, for intramuscular use 90686 = Influenza vaccine, quadrivalent (IIV4), split virus, preservative-free, 0.5 mL dosage, for intramuscular use 90687 = influenza vaccine, quadrivalent (IIV4), split virus, 0.25 mL dosage, for intramuscular use DISCLAIMER: The billing and coding information contained in this document is presented as a resource and guide to billing and coding for AFLURIA 90688 = Influenza vaccine, quadrivalent (IIV4), split virus, 0.5 mL dosage, for intramuscular use QUADRIVALENT (Influenza Vaccine), FLUCELVAX QUADRIVALENT (Influenza Vaccine), FLUAD (Influenza Vaccine, Adjuvanted), plus antiviral

NDC=National Drug Code. treatment RAPIVAB® (peramivir injection). Billing and coding information is gathered from several sources and is subject to change without notice. While a No more than 10 doses (0.25 mL or 0.5 mL) should be withdrawn from the Afluria Quadrivalent multidose vial. every effort is made to ensure the accuracy of this information, appropriate billing and coding for health care services are the provider’s responsibility and should always be based on the patient’s clinical condition, services provided, and payer guidelines. Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 1 Interior Pages: 11.625" x 8.25"

Coding for the administration HCPCS Code Description of Seqirus vaccines

The method of administration of Seqirus vaccines should be reported in addition G0008 Seasonal influenza virus vaccine administration to the vaccine product code. Assign the appropriate immunization administration code based on the documentation in the medical record. The following CPT codes are for vaccines administered via injection to individuals.5 Influenza vaccine International Classification of Diseases, Tenth Revision diagnosis codes CPT Code Description Below is a suggested International Classification of Diseases, Tenth Revision (ICD-10) diagnosis code that may be appropriate when submitting claims for 99213 A mid-level outpatient or inpatient office visit. Seqirus vaccines and their administration. The code should be linked to both Level 3 code for an established patient (not for 5 a new patient who has no history). the vaccine and administration codes.

Immunization administration through 18 years of ICD-10 Code Description age via any route of administration with 90460 counseling by physician or other qualified health care professional; first or only component of each Z23 Encounter for immunization vaccine or toxoid administered

90471 Immunization administration, 1 injection Use of modifiers when billing for vaccines

90472 Immunization administration, each additional Vaccines are usually administered as a preventive service, but may also be (add-on code) injection administered as a problem-oriented evaluation and management (E/M) service. When a vaccine is administered and an illness, abnormality, or other problem is significant enough to require additional work, the modifier "25" should be attached Medicare requires use of Healthcare Common Procedure Coding System (HCPCS) to the office or other outpatient service code to indicate which E/M service was codes for the administration of the vaccines that they cover preventively, including provided by the same physician on the same day as the preventive medicine influenza vaccine. HCPCS code G0008 must be used when billing Medicare for service. Check with your payers to understand their coding requirements regarding the administration of Seqirus vaccines, regardless of patient age or provider use of the 25 modifier.5,7 counseling. Some payers, including Medicare, may require that an HCPCS code be used instead of a CPT code to report the administration of influenza vaccines. See For any reimbursement-related questions, customers may also call the the grid below for more information on this code.6 Seqirus Customer Service Center at 855.358.8966, option #3.

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 2 I�� P��: 11.625" � 8.25"

FLUAD® (Infl uenza Vaccine, Adjuvanted) administered to a patient on Medicare

A 67-year-old man is seen at an urgent care facility after a fall. The physician recommends that he also receive an infl uenza vaccine and administers FLUAD.1,3,5,7-9

Z23 = encounter for immunization

R29.6 = repeated falls

99281 = ER evaluation and management

90653 = FLUAD

G0008 = administration

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FLUCELVAX® QUADRIVALENT (Influenza Vaccine) administered at a problem-focused visit

A 34-year-old woman is seen at the physician’s office for evaluation of her asthmatic condition and related prescription refills. The physician recommends she receive an influenza vaccine and administers FLUCELVAX QUADRIVALENT.1,4,5,7,9

J45.40 = moderate persistent asthma, uncomplicated

Z23 = encounter for immunization

99212 = established outpatient

90674 = FLUCELVAX QUADRIVALENT

90471 = administration

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 4 I�� P��: 11.625" � 8.25"

AFLURIA® QUADRIVALENT (Infl uenza Vaccine) vaccine administered at a well visit

A 28-year-old woman is seen for a well visit and receives a needleless infl uenza vaccination, AFLURIA QUADRIVALENT.1,2,5,7

ICD-10: Z00.00 = encounter for routine adult health examination without abnormal fi ndings

Z23 = encounter for immunization

99213 = mid-level outpatient or inpatient offi ce visit. Level 3 code for an established patient

25 = modifi er (See page 2: Use of modifi ers when billing for vaccines) 99213

90686 90686 = AFLURIA QUADRIVALENT

90471 90471 = administration

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INDICATIONS AND USAGE ADVERSE REACTIONS FLUAD is an inactivated influenza vaccine indicated for active immunization • The most common (≥10%) local (injection site) adverse reactions observed against influenza disease caused by influenza virus subtypes A and type B in clinical studies were injection site pain (25%) and tenderness (21%). contained in the vaccine. FLUAD is approved for use in persons 65 years of age • The most common (≥10%) systemic adverse reactions observed in clinical and older. studies were myalgia (15%), headache (13%), and fatigue (13%). IMPORTANT SAFETY INFORMATION To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

CONTRAINDICATIONS For more information, please see accompanying US full Prescribing Severe allergic reaction to any component of the vaccine, including egg protein, Information for FLUAD. or after a previous dose of any influenza vaccine. FLUAD® is a registered trademark of Seqirus UK Limited or its affiliates. WARNINGS AND PRECAUTIONS • If Guillain-Barré syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks.

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 6 Interior Pages: 11.625" x 8.25"

INDICATION AND USAGE FOR FLUCELVAX® QUADRIVALENT ADVERSE REACTIONS (INFLUENZA VACCINE) • The most common (≥10%) local and systemic reactions in adults 18-64 years of FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%), myalgia immunization for the prevention of influenza disease caused by influenza A subtype (15.4%), injection site erythema (13.4%), and induration (11.6%). viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT • The most common (≥10%) local and systemic reactions in adults ≥65 years is approved for use in persons 4 years of age and older. of age were injection site pain (21.6%) and injection site erythema (11.9%).

• The most common (≥10%) local and systemic reactions in children 4 to <6 years IMPORTANT SAFETY INFORMATION of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in CONTRAINDICATIONS eating habits (10%). • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of • The most common (≥10%) local and systemic reactions in children 6 through severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine. 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and WARNINGS & PRECAUTIONS myalgia (12%). • Guillain-Barré Syndrome (GBS): If GBS has occurred within 6 weeks of receipt • The most common (≥10%) local and systemic reactions in children and of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT adolescents 9 through 17 years of age were pain at the injection site (58%), should be based on careful consideration of the potential benefits and risks. headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

Please see accompanying US full Prescribing Information for FLUCELVAX QUADRIVALENT.

FLUCELVAX QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

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INDICATION • In children 5 through 8 years, the most commonly reported injection-site AFLURIA QUADRIVALENT is an inactivated influenza vaccine indicated for active adverse reactions when administered by needle and syringe were pain (≥50%), immunization against influenza disease caused by influenza A subtype viruses and redness and swelling (≥10%). The most common systemic adverse event was type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for headache (≥10%). use in individuals 5 years of age and older. • In children 9 through 17 years, the most commonly reported injection-site adverse reactions when administered by needle and syringe were pain (≥50%), IMPORTANT SAFETY INFORMATION redness and swelling (≥10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥10%). CONTRAINDICATIONS • In children 6 months through 35 months of age, the most commonly reported • Severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine injection-site reactions were pain and redness (≥ 20%). The most common systemic including egg protein, or to a previous dose of any influenza vaccine. adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%). • In children 36 through 59 months of age, the most commonly reported injection WARNINGS AND PRECAUTIONS site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly • If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%). influenza vaccination, the decision to give AFLURIA QUADRIVALENT should be The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA based on careful consideration of the potential benefits and risks. QUADRIVALENT because both vaccines are manufactured using the same • Appropriate medical treatment and supervision must be available to manage process and have overlapping compositions: possible anaphylactic reactions following administration of the vaccine. • In adults 18 through 64 years of age, the most commonly reported injection- • Immunocompromised persons may have a diminished immune response to site adverse reactions with AFLURIA (trivalent formulation) when administered AFLURIA QUADRIVALENT. by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥80%), swelling, pain, redness (≥60%), itching (≥20%) and bruising (≥10%). ADVERSE REACTIONS The most common systemic adverse events were myalgia, malaise (≥30%), and headache (≥20%). • In adults 18 through 64 years, the most commonly reported injection-site adverse reaction when administered by needle and syringe was pain (≥40%). To report SUSPECTED ADVERSE REACTIONS, contact Seqirus USA Inc. at The most common systemic adverse events were myalgia and headache (≥20%). 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov. • In adults 65 years of age and older, the most commonly reported injection-site Please see accompanying full Prescribing Information for AFLURIA adverse reaction when administered by needle and syringe was pain (≥20%). QUADRIVALENT. The most common systemic adverse event was myalgia (≥10%). AFLURIA is a registered trademark of Seqirus UK Limited or its affiliates. PharmaJet® and STRATIS® are registered trademarks of PharmaJet. Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 8 Interior Pages: 11.625" x 8.25"

CODING FOR THE ADMINISTRATION OF RAPIVAB The administration of RAPIVAB should be reported in addition to the treatment product code. Assign the appropriate administration code based on the documentation in the medical record. The following CPT codes are for treatments administered via injection to individuals.7

Coding for Seqirus antiviral influenza CPT Code Description treatment, RAPIVAB 96365 Intravenous (IV) infusion, for therapy, prophylaxis, Some payers will require the NDC or diagnosis; initial, up to first hour to identify RAPIVAB.10 96366 IV infusion, for therapy, prophylaxis, or diagnosis; each additional hour

96374 Therapeutic, prophylactic, or diagnostic injection; Seqirus Product NDC Carton NDC Unit-of-Use Presentation IV push, single or initial substance/drug Description and Dose 96375 IV med injection—second med subsequent injection

Single-use RAPIVAB® vial contains 96376 IV med injection—first med subsequent injection (peramivir 61364-181-03 61364-181-01 200 mg per injection) 20 mL 96360 IV hydration—31 min to 1 hour

96361 IV hydration—each additional hour

Medicare requires the use of an HCPCS code for the administration of RAPIVAB. Some payers may also require that an HCPCS code be used to report RAPIVAB.11

HCPCS Code Description

J2547 Injection, peramivir, 1 mg

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INFLUENZA TREATMENT ICD-10 DIAGNOSIS CODES Below are suggested ICD-10 diagnosis codes that may be appropriate when submitting claims for RAPIVAB and its administration. The code(s) should be linked to both the product and administration codes.12

ICD-10 Code Description ICD-10 Code Description

Influenza due to other identified influenza virus Influenza due to other identified influenza J10.00 J10.83 with unspecified type of pneumonia virus with otitis

Influenza due to other identified influenza virus with Influenza due to other identified influenza virus J10.01 the same other identified influenza virus pneumonia J10.89 with other manifestations

Influenza due to other identified influenza virus with Influenza due to unidentified influenza virus with J10.08 other specified pneumonia J11.2 gastrointestinal manifestations

Influenza due to unidentified influenza virus with Influenza due to unidentified influenza virus J11.00 unspecified type of pneumonia J11.81 with encephalopathy

Influenza due to unidentified influenza virus with Influenza due to unidentified influenza virus J11.08 J11.82 specified pneumonia with myocarditis

Influenza due to unidentified influenza virus J12.9 Viral pneumonia, unspecified J11.83 with otitis media

Influenza due to other identified influenza virus with J10.1 Influenza due to unidentified influenza virus with other respiratory manifestations J11.89 other manifestations

Influenza due to unidentified influenza virus with Influenza due to identified novel influenza A virus J11.1 other respiratory manifestations J09.X1 with pneumonia

Influenza due to other identified influenza virus Influenza due to identified novel influenza A virus J10.2 with gastrointestinal manifestations J09.X2 with other respiratory manifestations

Influenza due to other identified influenza virus Influenza due to identified novel influenza A virus J10.81 J09.X3 with encephalopathy with gastrointestinal manifestations

Influenza due to other identified influenza virus Influenza due to identified novel influenza A virus J10.82 J09.X9 with myocarditis with other manifestations

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information. 10 Interior Pages: 11.625" x 8.25"

INFLUENZA TREATMENT REVENUE CODES EXAMPLES FOR BILLING RAPIVAB Below are suggested revenue codes that are used to attribute hospital charges RAPIVAB® (peramivir injection) administered to specific cost centers. Revenue codes vary by service provided and also vary at a problem-focused visit in physician's office. depending on patient status.13 A 23-year-old woman visits an urgent care facility for evaluation of her flu symptoms. The physician recommends she receive RAPIVAB.7,12 Revenue Code Description

Drugs requiring detailed coding required by 0636 Medicare to obtain pass-through payment for drugs in the outpatient department

0250 Drugs and biologicals

0260 IV therapy, general J10.2 = influenza due to other identified influenza virus with 0450 Emergency room gastrointestinal manifestations

0510 Clinic

0520 Free-standing clinic 96365 = IV infusion (CPT code)

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RAPIVAB® (peramivir injection) administered at a problem-focused visit in a hospital setting

A 71-year-old man visits the emergency room for evaluation of his flu symptoms. The physician recommends he receive RAPIVAB.7,11-13

Note: Because these services are provided in a hospital setting, a CMS-1450 claim form must be used for proper reimbursement.

0636 = Medicare revenue code

J2547 = HCPCS for Medicare

96365 = IV infusion (CPT code)

J10.00 = influenza due to other identified influenza virus with unspecified type of pneumonia

Please see Important Safety Information on pages 6-8 and 13, and accompanying full Prescribing Information.

12 Flat Size: 24.1367" x 16.5" Finished Size: 11.625" x 8.25" w/ 2-.75" glue tabs

This influenza season, count on the Seqirus portfolio of influenza products.

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October 2019 US/CORP/1016/0004(5) and accompanying full Prescribing Information.

voluntarily during clinical practice, estimates of frequency cannot be made, but they they but made, be cannot frequency of estimates practice, clinical during voluntarily

RAPIVAB is a registered trademark of Seqirus UK Limited or its affiliates. its or Limited UK Seqirus of trademark registered a is RAPIVAB

neuraminidase inhibitors, including Rapivab. Because these events were reported reported were events these Because Rapivab. including inhibitors, neuraminidase

or call 1-800-FDA-1088. call or www.fda.gov/medwatch Visit

and abnormal behavior leading to injury in patients with influenza who were receiving receiving were who influenza with patients in injury to leading behavior abnormal and

Please see accompanying full Prescribing Information for for Information Prescribing full accompanying see Please . RAPIVAB can include events such as hallucinations, delirium, and abnormal behavior, in some some in behavior, abnormal and delirium, hallucinations, as such events include can

• Influenza can be associated with a variety of neurologic and behavioral symptoms that that symptoms behavioral and neurologic of variety a with associated be can Influenza

medically indicated. medically

patients with known serious hypersensitivity or anaphylaxis to RAPIVAB. to anaphylaxis or hypersensitivity serious known with patients

avoid use of Rapivab within 2 weeks after or 48 hours before administration of LAIV unless unless LAIV of administration before hours 48 or after weeks 2 within Rapivab of use avoid

serious skin reaction occurs or is suspected. The use of RAPIVAB is contraindicated in in contraindicated is RAPIVAB of use The suspected. is or occurs reaction skin serious

not been evaluated. Because of the potential for interference between these two products, products, two these between interference for potential the of Because evaluated. been not

RAPIVAB. Discontinue RAPIVAB and institute appropriate treatment if anaphylaxis or a a or anaphylaxis if treatment appropriate institute and RAPIVAB Discontinue RAPIVAB.

thus may reduce vaccine efficacy). The concurrent use of Rapivab with LAIV intranasal has has intranasal LAIV with Rapivab of use concurrent The efficacy). vaccine reduce may thus

and Stevens-Johnson Syndrome have been reported in postmarketing experience with with experience postmarketing in reported been have Syndrome Stevens-Johnson and

Antiviral drugs may inhibit viral replication of a live attenuated influenza vaccine (LAIV) and and (LAIV) vaccine influenza attenuated live a of replication viral inhibit may drugs Antiviral

with RAPIVAB in clinical studies and in postmarketing experience. Cases of anaphylaxis anaphylaxis of Cases experience. postmarketing in and studies clinical in RAPIVAB with

INFLUENZA ATTENUATED LIVE WITH USE CONCURRENT VACCINE

• Rare cases of serious skin reactions, including erythema multiforme, have been reported reported been have multiforme, erythema including reactions, skin serious of cases Rare

WARNINGS AND PRECAUTIONS AND WARNINGS

by dipstick analysis (3% versus 0% for oseltamivir). for 0% versus (3% analysis dipstick by

≥ 2% of subjects) and not reported in adults included vomiting vomiting included adults in reported not and subjects) of 2% in (occurring RAPIVAB with

CONTRAINDICATIONS

that observed in adults. Specific adverse reactions reported in pediatric subjects treated treated subjects pediatric in reported reactions adverse Specific adults. in observed that

The safety profile of RAPIVAB in subjects 2 to 17 years of age was generally similar to to similar generally was age of years 17 to 2 subjects in RAPIVAB of profile safety The hospitalization.

• The efficacy of RAPIVAB could not be established in patients with serious influenza requiring requiring influenza serious with patients in established be not could RAPIVAB of efficacy The

(3% versus 2%), and hypertension (2% versus 0%). versus (2% hypertension and 2%), versus (3%

compared to placebo: constipation (4% versus 2%), insomnia (3% versus 0%), AST increased increased AST 0%), versus (3% insomnia 2%), versus (4% constipation placebo: to compared RAPIVAB.

/L (8% vs 6%). In a subset of subjects with with subjects of subset a In 6%). vs (8% /L 10 x <1.0 neutrophils and 2%), vs (4% normal of

drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish diminish also might virulence) viral in changes example, (for factors Other effectiveness. drug 9

Rapivab than placebo were elevated ALT 2.5 times the upper limit of normal (3% vs 2%), 2%), vs (3% normal of limit upper the times 2.5 ALT elevated were placebo than Rapivab

infected with influenza B virus were enrolled. were virus B influenza with infected

≥ Rapivab vs 7% placebo). Lab abnormalities (incidence (incidence abnormalities Lab placebo). 7% vs Rapivab 2%) occurring more commonly with with commonly more occurring 2%)

the predominant influenza infections were influenza A virus; a limited number of subjects subjects of number limited a virus; A influenza were infections influenza predominant the