Quick Reference Coding Guide

The Biologics License Application for ALPROLIX has been transferred from Biogen to Bioverativ and, while most changes are aesthetic in nature (eg, new corporate logos and colors), NDC numbers are affected by the transfer. Updated NDCs will be released on a rolling schedule throughout 2018 and Bioverativ will communicate these changes prior to each release. ICD-10 codes, J-codes, and CPT codes remain the same.

This guide provides the correct codes to help you with accurate billing and coding for reimbursement during this transition.

ALPROLIX NATIONAL DRUG CODES (NDC)1,a

Component Biogen NDC Bioverativ NDC

250 IU carton and case 64406-966-01 71104-966-01

250 IU vial label 64406-952-01 71104-952-01

500 IU carton and case 64406-911-01 71104-911-01

500 IU vial label 64406-953-09 71104-953-09

1000 IU carton and case 64406-922-01 71104-922-01

1000 IU vial label 64406-954-09 71104-954-09

2000 IU carton and case 64406-933-01 71104-933-01

2000 IU vial label 64406-955-09 71104-955-09

3000 IU carton and case 64406-944-01 71104-944-01

3000 IU vial label 64406-956-09 71104-956-09

4000 IU carton and case 64406-977-01 71104-977-01

4000 IU vial label 64406-951-09 71104-951-09

Diluent Label 64406-045-01 71104-045-01 a Medicaid programs require the NDC to be used in addition to the HCPCS code for all drugs classified as “physician-administered drug.” In some states, this includes specialty drugs, such as factor products that are self-administered in the home. CPT, Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System; ICD-10, International Classification of Diseases, Tenth Revision; NDC, National Drug Code.

Only the first 5 digits changed from a Biogen number to a Bioverativ number 64406 71104

Please see last page for Indications, Important Safety Information, and Full Prescribing Information. Billing and Coding

Diagnosis: Hemophilia B (Factor IX Disorder)2

Type Code Description

ICD-10-CM diagnosis code D67 Hereditary factor IX deficiency

Healthcare Common Procedure Coding System (HCPCS) Reimbursement Code3

Provider Code Description

Injection, factor IX, Fc fusion Physician office or home care pharmacy J7201 protein (recombinant), per IU

Infusion/Drug Administration Codes4,5

CPT code Setting Description

96374 Physician/outpatient Intravenous push, single or initial substance/drug

96375 Physician/outpatient Each additional sequential intravenous push of a new substance/drug

99601 Home nurse visit Home infusion/specialty drug administration, per visit (up to 2 hours)

Home infusion/specialty drug administration, each additional hour 99602 Home nurse visit (list separately in addition to primary procedure)

HCPCS Level II code Setting Description

Home infusion therapy, antihemophilic agent infusion therapy (eg, FIX); administrative services, professional pharmacy services, care S9345a Home care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

aHCPCS Code S9345 should only be billed with CPT Code 99601.

Hospital Revenue Code6

Provider Code Description

Hospital 0636 Pharmacy, drugs requiring detailed coding

2 Tips for Accurate Billing

Coding for ALPROLIX is based upon NDC numbers for ALPROLIX will the NDC number associated with the depend on the packaging label manufacturer

Only the first 5 digits will change In order to ensure the right code is from a Biogen number to a Bioverativ used, copy the NDC on the packaging number (eg, 64406-922-01 to label when coding for ALPROLIX 71104-922-01)1

Please refer to the changes on the packaging highlighted below to guide you through the billing process.

NDC

For ordering, please go to: www.bioverativordering.com

We are available to answer any questions: 1-855-MyALPROLIX (1-855-692-5776) [email protected]

Manufacturer logo

Please see last page for Indications, Important Safety Information, and Full Prescribing Information.

3 Indications and Important Safety Information

INDICATIONS: ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is a recombinant DNA derived, coagulation Factor IX concentrate indicated for adults and children with hemophilia B for: • On-demand treatment and control of bleeding episodes • Perioperative management of bleeding • Routine prophylaxis to reduce the frequency of bleeding episodes

Limitation of Use ALPROLIX is not indicated for induction of immune tolerance in patients with hemophilia B.

CONTRAINDICATIONS: ALPROLIX is contraindicated in patients who have a known history of hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

WARNINGS AND PRECAUTIONS: Hypersensitivity reactions have been reported with ALPROLIX. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with Factor IX replacement products. Discontinue use of ALPROLIX if hypersensitivity symptoms occur, and initiate appropriate treatment.

Formation of neutralizing antibodies (inhibitors) to Factor IX has been reported following administration of ALPROLIX, including in previously untreated patients. Patients using ALPROLIX should be monitored for the development of Factor IX inhibitors. Clotting assays (e.g., one-stage) may be used to confirm that adequate Factor VIII levels have been achieved and maintained.

The use of Factor IX products has been associated with the development of thromboembolic complications.

ADVERSE REACTIONS: Common adverse reactions (incidence ≥1%) observed in clinical trials were headache, oral paresthesia, and obstructive uropathy.

Please see Full Prescribing Information.

References: 1. Data on file, Bioverativ.2. 2017 ICD-10-CM and GEMs. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Coding/ICD10/2017-ICD-10-CM- and-GEMs.html. Updated June 27, 2017. Accessed March 21, 2018. 3. 2017 Alpha-Numeric HCPCS File. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/ Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2017-Alpha-Numeric-HCPCS-File.html?DLPage=1&DLEntries=10&DLSort=0&DLSortDir=descending. Updated November 17, 2016. Accessed March 21, 2018. 4. Injection and Infusion Services Policy. UnitedHealthcare Oxford website. https://www.oxhp.com/secure/policy/injection_and_infusion_services_policy.pdf. Accessed March 21, 2018. 5. Assisted Administration of Clotting Factors and Coagulant Blood Products. UnitedHealthcare Oxford website. https://www.oxhp.com/secure/policy/clotting_ factors_coagulant_blood_products.pdf. Accessed March 21, 2018. 6. Medicare Claims Processing Manual. Center for Medicare & Medicaid Services website. https://www.cms.gov/Regulations- and-Guidance/Guidance/Manuals/downloads/clm104c18.pdf. Accessed March 21, 2018.

FOR MORE INFORMATION, VISIT ALPROLIX.com