Billing and Coding Considerations for BLINCYTO®

BLINCYTO® Billing Information Sheet

Billing and Coding Considerations for BLINCYTO® This Information Sheet is intended to help healthcare professionals understand the key billing and coding considerations for BLINCYTO® and its related services and supplies when using the FDA-approved dosing options in inpatient and outpatient treatment settings.

Updates for 2018 include: • Information on billing the 7-day infusion option (7-DIO) in addition to the shorter-duration 24-hour and 48-hour bags BLINCYTO® Dosing Options1 Dose per vial X number of Dosing option Number of billing units single-dose vials (SDVs*) 24-hour 35 mcg X 1 vial 35 48-hour 35 mcg X 1-2 vials 35-70 7-day 35 mcg X 4-6 vials 140-210

• New coding requirement for BLINCYTO® administered in the outpatient setting of 340B hospitals – The Centers for Medicare & Medicaid Services (CMS) requires use of new modifiers on Medicare claims for drugs acquired under the 340B Drug Discount Program2

• Medicare patients receiving BLINCYTO® in the inpatient setting are no longer eligible for additional reimbursement3 – The new technology add-on payment (NTAP) designation has been retired; hospitals may still be eligible for outlier payments based on payer guidance and managed care contract provisions *Number of SDVs depends on dose, infusion duration, and patient's weight.1

Please note that the information in this resource is intended to be educational and is not a guarantee of reimbursement. Coverage, coding, and billing requirements vary by health plan so be sure to check with individual payers for detailed guidance.

Indications BLINCYTO® is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. BLINCYTO® is indicated for the treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults and children. BLINCYTO® Billing Information Sheet

Hospital Inpatient (HIP) Site of Service

Coding Information (ICD-10-CM5/ Item Revenue Code4,* Notes HCPCS6/NDC1/CPT9/ICD-10-PCS10) Z51.12 Encounter for antineoplastic immunotherapy AND C91.00 Acute lymphoblastic leukemia not having Report the appropriate ICD-10-CM diagnosis Diagnosis: achieved remission code(s) to describe the patient’s condition. Encounter for drug N/A OR ® therapy and ALL Basic diagnosis coding and billing for BLINCYTO C91.01 Acute lymphoblastic leukemia, in remission indication is consistent across all formulations. OR C91.02 Acute lymphoblastic leukemia, in relapse HCPCS codes are not required by Medicare in the J9039 Injection, blinatumomab, Report the appropriate HIP, but they may be used for itemization purposes 1 mcg revenue code for with all payers.7 the cost center in Some payers (eg, Medicaid) may require listing the which the service is NDC in addition to the HCPCS J-code. For most performed; eg, payers, the number of billing units per HCPCS code is • Medicare: 0250 reported using increments of the value as listed in the General pharmacy ® NDC: 55513-0160-01 BLINCYTO code description. • Other payers: 35 mcg lyophilized powder, single-dose vial (SDV) Drug: 0250 or 0636 Drugs intravenous (IV) solution stabilizer, 10 mL SDV When reporting the NDC on claims, use the 11-digit 8 BLINCYTO® and requiring detailed NDC in the 5-4-2 format. Insert a leading zero in external infusion coding (if required the appropriate section to complete the 5-4-2 digit pump (EIP) by a given payer) format. Remove the dashes prior to entering the NDC on the claim form. Report the appropriate revenue code for HCPCS codes are not required by Medicare in the the cost center in E0791 Parenteral infusion pump, stationary, single HIP, but they may be used for itemization purposes which the service is or multi-channel with all payers.7 performed; eg, • 0290 Durable E0776 IV pole Report the appropriate HCPCS code for the EIP medical equipment and supplies as documented in the medical record. (DME) 96416 Chemotherapy administration, IV infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours) requiring use of a The Medicare NTAP designation has been retired. portable or implantable pump However, hospitals will still need to report the Report the appropriate OR appropriate ICD-10-PCS code to account for the 3 Administration: revenue code for 96521 Refilling and maintenance of a portable administration procedure. Continuous the cost center in pump HCPCS codes are not required by Medicare in the intravenous which the service is HIP, but they may be used for itemization purposes infusion (CIVI) via performed; eg, XW03351 Introduction of blinatumomab with all payers.7 EIP • 0261 IV therapy: antineoplastic immunotherapy into peripheral vein, Infusion pump percutaneous approach, new technology group 1 Report the appropriate HCPCS code for the OR infusion service provided as documented in the XW04351 Introduction of blinatumomab medical record. antineoplastic immunotherapy into central vein, percutaneous approach, new technology group 1

Coding Information Definitions: ICD-10-CM – International Classification of Diseases, 10th Revision, Clinical Modification HCPCS – Healthcare Common Procedure Coding System NDC – National Drug Code CPT – Current Procedural Terminology ICD-10-PCS – International Classification of Diseases, 10th Revision, Procedure Coding System *This is not an all-inclusive list of revenue codes; revenue codes will vary by institution. Revenue codes are only required on the CMS-1450. BLINCYTO® Billing Information Sheet Completing the CMS-1450 for Hospital Inpatient Sample UB-04 (CMS 1450) Form to A/B MAC Sample UB-04Hospital (CMS-1450) Inpatient Admi Form:ssion Hospital for Dates o Inpatientf Service on Administrationor After 01/01/2015

Anytown Hospital 100 Main Street Anytown, Anystate 01010

Smith, Jane 123 Main Street, Anytown, Anystate 12345

SERVICE UNITS (Field 46): Report units of service for both units TOTAL CHARGES (Field 47): Report administered and amount of discarded drug. appropriate charges for product used BLINCYTO® dose reported as 1 unit per mcg and related procedures

N455513016001 0250 Pharmacy J9039 MM DD YY xx xxx x x (BLINCYTO®) N455513016001 0250 Pharmacy J9039-JW MM DD YY xx xxx x x (BLINCYTO®) 0290 DME E0791 MM DD YY 1 xxx x x (EIP) 0290 DME E0776 MM DD YY 1 xxx xx (IV pole) 0261 IV therapy: Infusion pump 96416 MM DD YY 1 xxx xx (CIVI service)

PRODUCT AND PROCEDURE CODES (Field 44): REVENUE CODES* (Field 42) and DESCRIPTIONS HCPCS and CPT codes are not required by Medicare in the HIP, but they may be used for (Field 43): itemization purposes with all payers Product Product Medicare: Use revenue code 0250 General pharmacy Medicare: Enter the HCPCS code representing BLINCYTO® administered through EIP; Related supplies and administration procedure eg, J9039 (blinatumomab) per 1 mcg. Use the most appropriate revenue code for cost center Verify payer requirements for reporting discarded drug with modifier JW for services (eg, 0290 Use of DME for EIP and IV pole; EIP: Enter the HCPCS code representing the EIP and supplies used; eg, eg, 0261 for CIVI therapy [initiation or refill] via EIP) • E0791 Parenteral infusion pump, stationary, single or multi-channel • E0776 IV pole

DIAGNOSIS CODES* (Field 67 and 67A–Q): Enter the appropriate diagnosis code; eg, ICD-10-CM: • Z51.12 Encounter for antineoplastic immunotherapy AND • C91.00 Acute lymphoblastic leukemia not having achieved remission OR • C91.01 Acute lymphoblastic leukemia, in remission OR PRINCIPAL PROCEDURE (Field 74): Acute lymphoblastic leukemia, in relapse • C91.02 Enter principal ICD-10-PCS procedure code Final codes depend on medical record documentation and payer requirements • XW03351 Introduction of blinatumomab antineoplastic immunotherapy into peripheral vein, percutaneous approach, new technology group 1 OR Z51.12 C91.00 • XW04351 Introduction of blinatumomab antineoplastic immunotherapy into central vein, percutaneous approach, new technology group 1 XW03351 MMDDYY

BLINCYTO NDC: 55513016001 REMARKS (Field 80): When reporting BLINCYTO®, some payers (eg, Medicaid) may (blinatumomab) XX mcg administered require listing the NDC in addition to the HCPCS J-code. When required by the payer, report via CIVI and XX mcg discarded the NDC in the 11-digit format. Verify the payer-specific claim submission requirements

*This is not an all-inclusive list of revenue codes; revenue codes will vary by institution. Revenue codes are only required on the CMS-1450. This sample form is intended as a reference for coding and billing for product and associated services. It is not intended to be directive; 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 system guidelines, payer requirements, practice patterns, and the services rendered. Healthcare providers are responsible for ensuring the accuracy and validity of all billing and claims for appropriate reimbursement. BLINCYTO® Billing Information Sheet

Hospital Outpatient Department (HOPD)

Coding Information Item Revenue Code4,* Notes (ICD-10-CM5/CPT9/HCPCS6/NDC1) Z51.12 Encounter for antineoplastic immunotherapy AND Diagnosis: C91.00 Acute lymphoblastic leukemia not Report the appropriate ICD-10-CM diagnosis code(s) to Encounter for drug having achieved remission describe the patient’s condition. therapy N/A OR ® and ALL C91.01 Acute lymphoblastic leukemia, in Basic diagnosis coding and billing for BLINCYTO remission indication is consistent across all formulations. OR C91.02 Acute lymphoblastic leukemia, in relapse

96416 Chemotherapy administration, IV infusion technique; initiation of prolonged CPT codes may be used to report the CIVI procedures chemotherapy infusion (more than associated with BLINCYTO® to the Part A/B Medicare 8 hours) requiring use of a portable or Administrative Contractor (MAC) and non-Medicare payer. implantable pump For Medicare patients, HCPCS code G0498 will replace Report the appropriate OR CPT codes (96416, E0781, and 99211–99215) previously revenue code for 96521 Refilling and maintenance of portable used to bill for prolonged infusion services when the CIVI Procedure: the cost center in pump is started in the HOPD. It does not apply to BLINCYTO® Administration via which the service is OR when the CIVI is started in the inpatient setting or via CIVI using performed; eg, G0498 Chemotherapy administration, IV home infusion (HI).6,9,11 • 0261 IV therapy: infusion technique; initiation of infusion in an EIP The healthcare provider should consult the payer or Infusion pump the office/clinic setting using office/clinic MAC to determine which code is most appropriate for • 026x IV therapy pump/supplies, with continuation of the administration of BLINCYTO®. infusion in the community setting (eg, home, domiciliary, rest home, or assisted living) There are no differences in how to code for the infusion using a portable pump provided by the administration procedure among the different formulations office/clinic; includes follow-up office/clinic of BLINCYTO®. visit at the conclusion of the infusion

Medicare policies reflect the code for BLINCYTO® (J9039 per 1 mcg). However, coding requirements may vary by payer. Report the appropriate Like many payers, Medicare requires the use of the modifier revenue code for JW, which provides payment for the amount of drug or J9039 Injection, blinatumomab, the cost center in biologic discarded, as well as for the dose administered, up 1 mcg which the service is to the amount of the drug or biologic as indicated on the vial performed; eg, JW12 Discarded drug or label for an SDV.12 • Medicare: 0636 JG2 Drug or biological acquired with 340B Effective on and after dates of service starting January 1, Drug requiring Drug Pricing Program discount 2018, Medicare providers who are not exempt from the 340B detailed coding payment adjustment will report modifier "JG" to identify if a TB2 Drug or biological acquired with 340B • Other payers: 0250 2 drug pricing program discount, reported for drug was acquired under the 340B program. Drug: or 0636 General ® informational purposes Exempt facilities that include children's hospitals, certain BLINCYTO pharmacy (if required cancer centers, and rural sole community hospitals will need by a given payer) to report modifier "TB" on Medicare claims if the drug was acquired under 340B. The TB modifier is for informational purposes only and will not impact reimbursement.2

Some payers (eg, Medicaid) may require listing the NDC in addition to the HCPCS J-code. When reporting the NDC on NDC: 55513-0160-01 BLINCYTO® claims, use the 11-digit NDC in the 5-4-2 format.8 Insert a N/A 35 mcg lyophilized powder, SDV IV solution leading zero in the appropriate section to complete the 5-4-2 stabilizer, 10 mL SDV digit format. Remove the dashes prior to entering the NDC on the claim form.

*This is not an all-inclusive list of revenue codes; revenue codes will vary by institution. Revenue codes are only required on the CMS-1450. BLINCYTO® Billing Information Sheet

Hospital Outpatient Department (HOPD) (continued)

Coding Information Item Revenue Code4,* Notes (HCPCS6)

E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater E0781 Ambulatory infusion pump, single Please note that Medicare specifically requires DMEPOS or multiple channels, electric or battery accreditation in order to bill a DME MAC. Non-Medicare operated, with administrative equipment, payers may allow billing for all services and supplies under a worn by patient medical or other benefit.

G0498 Chemotherapy administration, IV Report the appropriate EIP code and appropriate modifier(s) infusion technique; initiation of infusion in as documented in the medical record. the office/clinic setting using office/clinic Report the appropriate pump/supplies, with continuation of the Modifiers may be used to provide additional detail when revenue code for the infusion in the community setting (eg, home, billing for the EIP to the DME MAC.6 cost center in which domiciliary, rest home, or assisted living) DME: the service using a portable pump provided by the Note: Drug administration codes may get billed to the EIP and supplies is performed; eg, office/clinic; includes follow-up office/clinic MAC and the E-codes may get billed separately to the 0290 Durable medical visit at the conclusion of the infusion DME MAC. equipment Modifiers -KD Drug or biologic infused through DME If the clinic bills the G-code to the MAC, the cost of the -RR Rental pump and supplies is bundled and should not be billed -KH Durable medical equipment, prosthetics, separately to the DME MAC using the E-codes.13 orthotics, and supplies (DMEPOS) item, initial claim or first rental month Report any supplies as necessary. -KI DMEPOS item, second or third rental ® months Basic coding and billing for a BLINCYTO -related EIP is -KJ DMEPOS item, fourth to 15th consistent across all formulations. rental months A4222 Infusion supplies for external drug infusion pump, per cassette or bag

*This is not an all-inclusive list of revenue codes; revenue codes will vary by institution. Revenue codes are only required on the CMS-1450. BLINCYTO® Billing Information Sheet

Sample UB-04 (CMS-1450) Form: Hospital Outpatient Administration

Anytown Hospital 100 Main Street Anytown, Anystate 01010

Smith, Jane 123 Main Street, Anytown, Anystate 12345

SERVICE UNITS (Field 46): Report units of service for both units administered and amount of discarded drug. BLINCYTO® dose reported as 1 TOTAL CHARGES (Field 47): Report unit per mcg. Report 1 unit for initiation of appropriate charges for product used CIVI via EIP or refill of EIP and related procedures

N455513016001 0636 Drugs requiring detailed information J9039 MM DD YY xx xxx xx N455513016001 0636 Drugs requiring detailed information J9039-JW MM DD YY xx xxx xx 0261 IV Therapy: Infusion pump 96416 MM DD YY 1 xxx xx (Initiation or refill of CIVI in clinic)

PRODUCT AND PROCEDURE CODES (Field 44): REVENUE CODES* (Field 42) and DESCRIPTIONS Administration procedure (Field 43): Use the CPT code representing the procedure performed, such as initiation or refill; eg, Administration procedure 96416 Chemotherapy administration, intravenous infusion technique; initiation of Use most appropriate revenue code for cost center for prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or services (eg, 0261 for CIVI therapy [initiation or refill] implantable pump via EIP) OR 96521 Refilling and maintenance of portable pump OR G0498 Chemotherapy administration, IV infusion technique; initiation of infusion in the office/clinic setting using office/clinic pump/supplies, with continuation of the infusion in the community setting (eg, home, domiciliary, rest home, or assisted living) using a portable pump provided by the office/clinic; includes follow-up office/clinic visit at the conclusion of the infusion DIAGNOSIS CODES (Field 67 and 67A–Q): Enter the appropriate diagnosis code; eg, ICD-10-CM: • Z51.12 Encounter for antineoplastic immunotherapy AND • C91.00 Acute lymphoblastic leukemia not having achieved remission OR • C91.01 Acute lymphoblastic leukemia, in remission OR • C91.02 Acute lymphoblastic leukemia, in relapse Final codes depend on medical record documentation

Z51.12 C91.02

REMARKS (Field 80): Identify the drug being administered as BLINCYTO® and provide a BLINCYTO NDC: 55513016001 concise description of the services provided. Some payers (eg, Medicaid) may require listing (blinatumomab) XX mcg administered the NDC in addition to the HCPCS J-code. When required by the payer, report the NDC in the via CIVI and XX mcg discarded 11-digit format. Verify the payer-specific claim submission requirements

Physician Office

Coding Information Item Notes (ICD-10-CM5/CPT9/HCPCS6/NDC1)

Z51.12 Encounter for antineoplastic immunotherapy AND Diagnosis: Report the appropriate ICD-10-CM code(s) to describe the C91.00 Acute lymphoblastic leukemia not having achieved remission Encounter for drug patient’s condition. OR therapy ® C91.01 Acute lymphoblastic leukemia, in remission Basic diagnosis coding and billing for BLINCYTO and ALL OR indication is consistent across all formulations. C91.02 Acute lymphoblastic leukemia, in relapse CPT codes may be used to report the CIVI procedures 96416 Chemotherapy administration, intravenous infusion associated with BLINCYTO® to the Part A/B MAC and technique; initiation of prolonged chemotherapy infusion (more non-Medicare payers. For Medicare patients, HCPCS than 8 hours) requiring use of a portable or implantable pump code G0498 will replace CPT codes (96416, E0781, OR and 99211–99215) previously used to bill for prolonged 96521 Refilling and maintenance of portable pump infusion services when the CIVI is started in the physician Procedure: OR office. It does not apply to BLINCYTO® when the CIVI is Administration via G0498 Chemotherapy administration, IV infusion technique; started in the inpatient setting or via HI.6,9,11 CIVI using initiation of infusion in the office/clinic setting using office/ an EIP The healthcare provider should consult the payer or clinic pump/supplies, with continuation of the infusion in MAC to determine which code is most appropriate for the community setting (eg, home, domiciliary, rest home, or administration of BLINCYTO®. assisted living) using a portable pump provided by the office/ clinic; includes follow-up office/clinic visit at the conclusion of There are no differences in how to code for the infusion the infusion administration procedure among the different formulations of BLINCYTO®. Medicare requires use of the HCPCS code in the physician office setting. However, coding requirements may vary by payer.7 J9039 Injection, blinatumomab, 1 mcg Like many payers, Medicare requires the use of the JW12 Discarded drug modifier JW, which provides payment for the amount of drug or biologic discarded, as well as for the dose Drug: administered, up to the amount of the drug or biologic as BLINCYTO® indicated on the vial or label for an SDV.12 Some payers (eg, Medicaid) may require listing the NDC in addition to the HCPCS J-code. When reporting the NDC: 55513-0160-01 BLINCYTO® 35 mcg lyophilized powder, NDC on claims, use the 11-digit NDC in the 5-4-2 format.8 SDV IV solution stabilizer, 10 mL SDV Insert a leading zero in the appropriate section to complete the 5-4-2 digit format. Remove the dashes prior to entering the NDC on the claim form. E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater Report the appropriate EIP code and appropriate Ambulatory infusion pump, single or multiple channels, E0781 modifier(s) as documented in the medical record. electric or battery operated, with administrative equipment, worn by patient Modifiers may be used to provide additional detail when G0498 Chemotherapy administration, IV infusion technique; billing for the EIP to the DME MAC.6 initiation of infusion in the office/clinic setting using office/ clinic pump/supplies, with continuation of the infusion in Note: Drug administration codes may get billed to the MAC the community setting (eg, home, domiciliary, rest home, or and the E-codes may get billed separately to the DME DME: assisted living) using a portable pump provided by the office/ MAC. EIP and supplies clinic; includes follow-up office/clinic visit at the conclusion of the infusion If the office bills the G-code to the MAC, the cost of the pump and supplies is bundled and should not be billed Modifiers for EIP separately to the DME MAC using the E-codes.13 -KD Drug or biologic infused through DME -RR Rental Report any supplies as necessary. -KH DMEPOS item, initial claim or first rental month -KI DMEPOS item, second or third rental months Basic coding and billing for a BLINCYTO®-related EIP is -KJ DMEPOS item, fourth to 15th rental months consistent across all formulations. A4222 Infusion supplies for external drug infusion pump, per cassette or bag BLINCYTO® Billing Information Sheet

Sample CMS-1500 Form: Physician Office Administration Completing the CMS-1500 for Physician Office

Sample CMS 1500 Form to DME MAC – Only DME suppliers can bill to the DME MAC. Physician Office for Dates of Service on or After 01/01/2015

DIAGNOSIS (BOX 21): Enter the appropriate diagnosis code; eg, ICD- NDC (BOX 24A SHADED AREA): When reporting 10-CM: ® BLINCYTO , some payers (eg, Medicaid) may require listing • Z51.12 Encounter for antineoplastic the NDC in addition to the HCPCS J-code. When required immunotherapy AND by the payer, report the NDC qualifier “N4,” indicating that an • C91.00 Acute lymphoblastic NDC follows, and the NDC in the 11-digit format. Verify the leukemia not having achieved payer-specific claim submission requirements remission OR • 9C91.01 Acute lymphoblastic leukemia, in remission OR DIAGNOSIS POINTER (Box 24E): • C91.02 Acute lymphoblastic Enter the letter (A–L) that corresponds leukemia, in relapse to the diagnosis in Box 21 Final codes depend on medical record Z51.12 C91.02 documentation

UNITS (Box 24G): N455513016001 Report units of service for both 1 MM D D YY MM DD YY 11 J9039 A B XXX XX X units administered and amount of ® 2 N455513016001 discarded drug. BLINCYTO dose MM D D YY MM DD YY 11 J9039 JW A B XXX XX X reported as 1 unit per mcg. Report 3 1 unit for initiation of CIVI via EIP MM D D YY MM DD YY 11 96416 A B XXX XX 1 4 or refill of EIP MM D D YY MM DD YY 11 E0781 A B XXX XX 1

PLACE OF SERVICE (Box 24B): PROCEDURES/SERVICES/SUPPLIES (Box 24D): Enter the appropriate administration procedure. Enter the appropriate 2-digit place of Use the CPT code representing the procedure performed, such as initiation OR refill; eg, service code that corresponds to the 96416 Chemotherapy administration, intravenous infusion technique; initiation of prolonged location where services are rendered; eg, chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump • 22 Hospital outpatient OR • 11 Physician office 96521 Refilling and maintenance of portable pump • 12 Home OR G0498 ChemotherapyPLEASE PRINT administration, OR TYPE IV infusion technique; initiation of infusion in the office/clinic setting using office/clinic pump/supplies, with continuationAPPROVED ofOMB the-0938 infusion-1197 FORM in the1500 community(02-12) setting (eg, home, domiciliary, rest home, or assisted living) using a portable pump provided by the office/clinic; includes follow-up office/clinic visit at the conclusion of the infusion

This sample form is intended as a reference for coding and billing for product and associated services. It is not intended to be directive; 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 system guidelines, payer requirements, practice patterns, and the services rendered. Healthcare providers are responsible for ensuring the accuracy and validity of all billing and claims for appropriate reimbursement. BLINCYTO® Billing Information Sheet

Home Infusion - Multiple Payers (Medicare and non-Medicare)

Coding Information Item Notes (ICD-10-CM5/CPT9/HCPCS6/NDC1)

99601 Home infusion/specialty drug administration, per visit Providers may report HI services, routine and non-routine (up to 2 hours) medical supplies, and home health aide and medical 99602 Each additional hour social services for the treatment of illness or injury. For the service to be covered under fee-for-service (FFS) S9329 HI therapy, chemotherapy infusion; administrative services, professional pharmacy services, care coordination, Medicare, patients must be certified “homebound” (eg, and all necessary supplies and equipment (drugs and nursing homebound certification form CMS-485) and under 14 visits coded separately), per diem a physician’s plan of care. Nursing services are not covered by Medicare if the patient, who is not certified as S9330 HI therapy, continuous (24 hours or more) “homebound,” has only FFS Medicare or FFS Medicare Procedure: chemotherapy infusion; administrative services, professional with a Medicare supplement. These services may be Administration via pharmacy services, care coordination, and all necessary covered by Medicaid, commercial plans, or Medicare CIVI using supplies and equipment (drugs and nursing visits coded Advantage plans.14,15 an EIP separately), per diem Please note that FFS Medicare does not recognize S9338 HI therapy, immunotherapy, administrative services, S-codes, although other payers might.15 professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits The healthcare provider should consult the payer coded separately), per diem to determine which code is most appropriate for administration of BLINCYTO®. S9379 HI therapy, infusion therapy, not otherwise classified; administrative services, professional pharmacy services, care There are no differences in how to code for the infusion coordination, and all necessary supplies and equipment (drugs administration procedure among the different formulations ® and nursing visits coded separately), per diem of BLINCYTO . Many payers require the use of the modifier JW, which J9039 Injection, blinatumomab, 1 mcg provides payment for the amount of drug or biologic discarded, as well as for the dose administered, up to the JW12 Discarded drug amount of the drug or biologic as indicated on the vial or label for an SDV.12 Drug: BLINCYTO® Some payers (eg, Medicaid) may require listing the NDC in addition to the HCPCS J-code. When reporting the NDC: 55513-0160-01 BLINCYTO® 35 mcg lyophilized powder, NDC on claims, use the 11-digit NDC in the 5-4-2 format.8 SDV IV solution stabilizer, 10 mL SDV Insert a leading zero in the appropriate section to complete the 5-4-2 digit format. Remove the dashes prior to entering the NDC on the claim form. E0779 Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater E0781 Ambulatory infusion pump, single or multiple channels, Report the appropriate EIP code and appropriate electric or battery operated, with administrative equipment, modifier(s) as documented in the medical record. worn by patient Modifiers may be used to provide additional detail when DME: Modifiers for EIP billing for the EIP to the MAC.6 EIP and supplies -KD Drug or biologic infused through DME -RR Rental Report any supplies as necessary. -KH DMEPOS item, initial claim or first rental month -KI DMEPOS item, second or third rental months Basic coding and billing for a BLINCYTO®-related EIP is -KJ DMEPOS item, fourth to 15th rental months consistent across all formulations. A4222 Infusion supplies for external drug infusion pump, per cassette or bag BLINCYTO® Billing Information Sheet

Sample CMS-1500 Form: Non-Medicare Payer by Home Infusion Provider Completing the CMS-1500 for DME Supplier

Sample CMS 1500 Form to DME MAC – Only DME suppliers can bill to the DME MAC. DME Supplier for Dates of Service on or After 01/01/2015

NDC (BOX 24A SHADED AREA): When reporting BLINCYTO®, some payers (eg, Medicaid) may require listing the NDC in addition to the HCPCS J-code. When required by the payer, report the NDC qualifier “N4,” indicating that an NDC follows, and the NDC in the 11-digit format. Verify the payer-specific claim DIAGNOSIS (BOX 21): Enter the appropriate diagnosis code; eg, ICD-10-CM: submission requirements • Z51.12 Encounter for antineoplastic immunotherapy AND • C91.00 Acute lymphoblastic leukemia not having achieved remission OR • C91.01 Acute lymphoblastic leukemia, in remission OR Acute lymphoblastic leukemia, in relapse • C91.029 Z51.12 C91.02 Final codes depend on medical record documentation

DIAGNOSIS POINTER (Box 24E): N455513016001 Enter the letter (A–L) that corresponds 1 MM D D YY MM DD YY 12 J9039 A B xxx xx x to the diagnosis in Box 21 N455513016001 2 MM D D YY MM DD YY 12 J9039 JW A B xxx xx x

3 MM DD YY MM DD YY 12 99601 A B xxx xx x

4 MM D D MM YY DD YY 12 A4222 A B xxx xx x

PLACE OF SERVICE (Box 24B): PROCEDURES/SERVICES/ Enter the appropriate 2-digit place of SUPPLIES (Box 24D): Enter the service code that corresponds to the appropriate CPT/HCPCS codes and UNITS (Box 24G): location where services are rendered; eg, modifiers; eg, Report units of service for both ® units of service and amount of • 22 Hospital outpatient • Drug: J9039 for BLINCYTO ® • 11 Physician office • 99601 Home infusion/specialty discarded drug. BLINCYTO dose • 12 Home drug administration, per visit (up to reported with 1 unit per 1 mcg 2 hours) APPROVED OMB-0938-1197 FORM 1500 (02-12) • A4222PLEASE Infusion PRINT ORsupplies TYPE for external drug infusion pump, per cassette or infusion option Other codes may be appropriate. Check with individual payers for detailed guidance

Key Considerations for the BLINCYTO® 7-day Infusion Option (7-DIO)

Minor variations are expected in coding, billing, and claims filing for the BLINCYTO® 7-DIO.15

The 7-DIO requires 6 vials of BLINCYTO® and 1 vial of IV Solution Stabilizer for patients ≥ 45kg. For patients weighing 22 to 44kg, 4 to 5 vials are required.1 Refer to the Prescribing Information for details on handling and preparation.

If the units field on a claim form cannot accommodate more than 99 units, utilize multiple lines to capture all units (eg, 99+98+13). Payers may require separate reporting of drug units administered and discarded.15

Less frequent claim submissions are expected with utilization of the 7-DIO. Typically the entire 7-DIO can be billed on the day of administration/refill. However, be sure to refer to payer guidelines for maximum daily quantity limits. Apply the appropriate dates of service as needed.15

If the 7-DIO is interrupted mid-treatment, refer to payer guidelines for reporting and documentation in these cases. If full reimbursement is withheld by the payer, refer to Amgen’s Product Return Policy for assistance.

Existing codes and modifiers are adequate to report BLINCYTO® and its related services; however, payer requirements may vary with respect to:15 – The entities that can bill for DME and the associated supplies – The number of units billed for BLINCYTO® J9039 – Covered diagnosis codes – Covered nursing services (eg, infusion services at patient's home) – Drug claim submission options (eg, 1 or more dates of service on claims) Indications BLINCYTO® is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.

This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

BLINCYTO® is indicated for the treatment of relapsed or refractory B‑cell precursor acute lymphoblastic leukemia (ALL) in adults and children. Please note: The information provided in this document is of a general nature and for informational purposes only; it is not intended to be comprehensive or instructive. 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 their own patients and procedures. In no way should the information provided in this document be considered a guarantee of coverage or reimbursement for any product or service.

Please click here to access the full Prescribing Information, including Boxed WARNINGS and Medication Guide, for BLINCYTO®.

1. BLINCYTO® (blinatumomab) prescribing information. Amgen. 2. Centers for Medicare & Medicaid Services (CMS). Medicare-FFS Program: Billing 340B Modifiers Under the Hospital Outpatient Prospective Payment System (OPPS) Frequently Asked Questions. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/ Billing-340B-Modifiers-under-Hospital-OPPS.pdf. Accessed January 16, 2018. 3. CMS. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals. Fed Regist. 2017;82(155):37990-38589. 4. Value Healthcare Services. Understanding Hospital Revenue Codes. http://valuehealthcareservices.com/education/understanding-hospital- revenue-codes/. Accessed December 7, 2017. 5. American Academy of Professional Coders (AAPC). 2018 ICD-10-CM Expert for Providers and Facilities. AAPC; 2017. 6. CMS. 2018 Alpha-numeric HCPCS file. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric- HCPCS-Items/2018-Alpha-Numeric-HCPCS-File-.html. Accessed December 7, 2017. 7. CMS. Medicare Claims Processing Manual. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf. Accessed December 12, 2017. 8. CMS. Health Insurance Reform: Standards for Electronic Transactions. Fed Regist. 2000;65(160):50313-50372. 9. American Medical Association (AMA). CPT 2018 Professional Edition. Chicago, IL: AMA; 2017. 10. CMS. 2018 ICD-10-PCS Codes and Tables Index. https://www.cms.gov/Medicare/Coding/ICD10/2018-ICD-10-PCS-and-GEMs.html. Accessed December 7, 2017. 11. CMS. CMS Manual System. Pub 100-04. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3728CP.pdf. Accessed December 7, 2017. 12. CMS. JW Modifier FAQs. https://www.cms.gov/ Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf. Accessed December 7, 2017. 13. Association of Community Cancer Centers (ACCC). Oncology Reimbursement Coding Update 2017. https://www.accc-cancer.org/publications/pdf/Oncology-Reimbursement-Coding- Update-2017.pdf. Accessed December 7, 2017. 14. CMS. CMS Manual System. Pub 100-08. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/ R704PI.pdf. Accessed December 7, 2017. 15. Data on file, Amgen; [Xcenda, Coding and Market Research Reimbursement Analysis for BLINCYTO® (blinatumomab) 7-day Infusion Option; August 2017].