Billing and Coding Guide

Please see Important Safety Information on the last page, and please click here for Full Prescribing Information for JELMYTO.

* Providers are responsible for the selection of appropriate codes for claims forms. This document contains possible coding options relating to the use of Company products, which may vary by health insurance or healthcare provider. The Company cannot guarantee that the billing codes listed in this document will result in coverage or payment. Please verify all codes with private and public plan sponsors prior to submitting claims. Since final coding is at the discretion of the health plan or healthcare provider, the codes in this document should be used for reference purposes only.

Billing and Coding GuideEnsure proper reimbursement for JELMYTO™ (mitomycin) for pyelocalyceal solutionThis Guide is designed to provide the information you need as you prepare forms for acquiring JELMYTO and submitting reimbursement claims.*

International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)2

Diagnosis codes used for identifying and capturing a specific diagnosis

Code Description

Relevant codesNational Drug Code (NDC)1

Universal 10- or 11-digit product identifier for human drugs; each NDC identifies the labeler, product, and trade package size.

72493-103-03

72493-0103-03

C65.9

C65.1

C65.2

Malignant neoplasm of unspecified renal pelvis

Malignant neoplasm of right renal pelvis

Malignant neoplasm of left renal pelvis

Please see Important Safety Information on the last page, and please click here for Full Prescribing Information for JELMYTO.

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Healthcare Common Procedure Coding System (HCPCS)3

Payer requirements for coding of newly approved medicines may vary, including which miscellaneous code to use. Until a specific HCPCS code is received, the miscellaneous codes below may be used.

Per the Centers for Medicare & Medicaid Services, final ASC payment indicators for calendar year 2020 show that drugs and biologicals are paid separately when integral to a surgical procedure on the ASC list; payment based on OPPS rate.4

Code Description

J3490 Unclassified drugs

J9999 Not otherwise classified, antineoplastic drugs

C9399 Unclassified drugs or biologicals (Medicare hospital outpatient setting or ambulatory surgical center)

ASC=ambulatory surgical center; OPPS=outpatient prospective payment system.

Current Procedural Terminology (CPT)5

CPT codes are used to universally identify medical, surgical, diagnostic, and therapeutic services.

Code Description

52005 Cystoscopy & ureter catheter

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Please see Important Safety Information on the last page, and please click here for Full Prescribing Information for JELMYTO.

Please see Important Safety Information on the last page, and please click here for Full Prescribing Information for JELMYTO.

DK

0

John DoeJELMYTO (mitomycin) for pyelocalyceal solution instilled via ureteral catheter or nephrostomy tube; NDC 72493-103-03; dose 4 mg/mL.

0123456789

J3490

52005

1

1

XXXX

XXXX

XX

XX

A

A

C65.9

24

24

MM

MM

MM

MM

DD

DD

DD

DD

YY

YY

YY

YY

Annotated CMS-1500 formThe CMS-1500 form is commonly used for billing for prescribed medications administered in healthcare provider offices.

Refer to the notes below when populating the essential fields that health plans require for reimbursement. You are required to code to the highest level of specificity.

Providers are responsible for the selection of appropriate codes for claims forms. This document contains possible coding options relating to the use of Company products, which may vary by health insurance or healthcare provider. The Company cannot guarantee that the billing codes listed in this document will result in coverage or payment. Please verify all codes with private and public plan sponsors prior to submitting claims. Since final coding is at the discretion of the health plan or healthcare provider, the codes in this document should be used for reference purposes only.

Box 17: Name of referring provider or other sourceEnter the appropriate provider to the left side of the dotted line:DK – Ordering provider DQ – Supervising provider DN – Referring provider

Box 17b: National Provider Identifier (NPI) Enter the referring provider’s NPI.

Box 19: Comment field or Box 24D in shaded area above HCPCS code Enter the appropriate drug identifying information. For example, National Drug Code (NDC), as requested by payer. Use: NDC 7249-3103-03. Also, enter the JELMYTO (mitomycin) for pyelocalyceal solution instillation route. For example, ureteral catheter or nephrostomy tube.

Box 21: Diagnosis code(s)Enter the appropriate ICD-10-CM diagnosis code(s) that reflect(s) the patient’s condition. Do not insert a period in the ICD-10-CM code.

Box 21: ICD indicatorEnter the ICD indicator as a single digit between the vertical, dotted lines: 0 – ICD-10-CM diagnosis.

Box 24B: Place of serviceEnter the appropriate site of service code:11 – Physician office19 – Off-campus outpatient hospital22 – On-campus outpatient hospital24 – Ambulatory surgical center

Box 24D: HCPCS and CPT® codesProductBill for Unclassified drugs with HCPCS code J3490, Not otherwise classified, antineoplastic drugs with HCPCS code J9999, or Unclassified drugs or biologicals (Medicare hospital outpatient setting or ambulatory surgical center) C9399.

Administration procedure Enter the CPT® code that accurately describes the administration service performed. Use CPT code 52005 for cystoscopy and ureter catheter.

Box 24G: Days or service unitsProductWhen billing with a miscellaneous HCPCS code (C9399, J3490, or J9999), bill only 1 unit.

Sample

Annotated CMS-1500 form6

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Annotated CMS-1450 (UB-04) hospital outpatient formThe CMS UB-04 form is used for billing for prescribed medications administered in hospital outpatient settings.

Refer to the notes below when populating the essential fields that health plans require for reimbursement. You are required to code to the highest level of specificity.

Providers are responsible for the selection of appropriate codes for claims forms. This document contains possible coding options relating to the use of Company products, which may vary by health insurance or healthcare provider. The Company cannot guarantee that the billing codes listed in this document will result in coverage or payment. Please verify all codes with private and public plan sponsors prior to submitting claims. Since final coding is at the discretion of the health plan or healthcare provider, the codes in this document should be used for reference purposes only.

Form Locator (FL) 42Enter the 4-digit revenue code that best describes the service provided, in accordance with hospital billing policy.

FL 43 Enter the description of service.

FL 44 Enter the relevant HCPCS and CPT codes.

FL 46Enter service units. When billing with unclassified HCPCS code, bill only 1 unit.

FL 66Enter the appropriate ICD-10-CM diagnosis codes for low-grade upper tract urothelial cancer being treated.

FL 80Provide any required detailed information such as drug name, total dosage and strength, method of administration, 11-digit NDC, and basis of measurement (attach separately if needed). Note the JELMYTO (mitomycin) for pyelocalyceal solution instillation route. For example, ureteral catheter or nephrostomy tube.

C9399

52005 1

XXXX

XXXX

Drugs requiring detailed information

Cystoscopy & ureter catheter

0636

0360

C65.90

JELMYTO (mitomycin) for pyelocalyceal solution instilled via ureteral catheter or nephrostomy tube; NDC 72493-103-03; dose 4 mg/mL.

Annotated CMS-1450 (UB-04) hospital outpatient form7

Sample

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Please see Important Safety Information on the last page, and please click here for Full Prescribing Information for JELMYTO.

JELMYTO and UroGen Support are trademarks of UroGen Pharma, Ltd. ©2020 UroGen Pharma, Inc. All rights reserved. US-JEL-00213 05/20

References: 1. JELMYTO [package insert]. Princeton, NJ: UroGen Pharma, Inc.; 2020. 2. Centers for Medicare & Medicaid Services. 2020 ICD-10-CM. 2020 Code Descriptions in Tabular Order. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-CM. Updated January 27, 2020. Accessed April 17, 2020. 3. Centers for Medicare & Medicaid Services. HCPCS Release & Code Sets: 2019. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2019-Alpha-Numeric-HCPCS-File.html. Accessed November 20, 2019. 4. Centers for Medicare & Medicaid Services. Final ASC payment indicators CY 2020. https://www.cms.gov/apps/ama/license.asp?file=/files/zip/cy2020-cn-asc-addendum-aa-bb-dd1-dd2-ee.zip. Accessed March 13, 2020. 5. Centers for Medicare & Medicaid Services. Physician fee schedule. https://www.cms.gov/apps/physician-fee-schedule/overview.aspx. Accessed April 29, 2019. 6. Centers for Medicare & Medicaid Services. CMS 1500 form. https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf. Accessed November 20, 2019. 7. Centers for Medicare & Medicaid Services. Pub 100-04 Medicare Claims Processing. Uniform Billing (UB-04) form. https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1450. Accessed November 20, 2019.

Your UroGen field reimbursement manager is available to answer your questions about billing and coding for JELMYTO

855-JELMYTO (855-535-6986) Contact@UroGenSupport.com833-664-7216 www.JELMYTO.com/hcp/support

Indications and Usage

JELMYTO™ (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

Important Safety Information

ContraindicationsJELMYTO is contraindicated in patients with perforation of the bladder or upper urinary tract.

Ureteric ObstructionUreteric obstruction, including ureteral stenosis and hydronephrosis, occurred in patients receiving JELMYTO. Monitor patients for signs and symptoms of ureteric obstruction, including flank pain, and fever, and for changes in renal function. Patients who experience obstruction may require transient or long-term ureteral stents or alternative procedures. Withhold or permanently discontinue JELMYTO based on the severity of ureteric obstruction.

Bone Marrow SuppressionThe use of JELMYTO can result in bone marrow suppression, particularly thrombocytopenia and neutropenia. The following tests should be obtained prior to each treatment: Platelet count, white blood cell count differential and hemoglobin. Withhold JELMYTO for Grade 2 thrombocytopenia or neutropenia. Permanently discontinue for Grade 3 or greater thrombocytopenia or neutropenia.

Embryo-Fetal ToxicityBased on findings in animals and mechanism of action, JELMYTO can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of mitomycin resulted in teratogenicity. Advise females of reproductive potential to use effective contraception during treatment with JELMYTO and for 6 months following the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with JELMYTO and for 3 months following the last dose.

Common Adverse ReactionsThe most common adverse reactions in ≥ 20% of patients treated with JELMYTO were ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting.

Additional Adverse Reactions InformationSelected clinically relevant adverse reactions in < 10% and ≥ 2% of patients who received JELMYTO include urinary tract inflammation, bladder spasm, urosepsis, hypersensitivity, and instillation site pain.

Use in Specific PopulationsLactationBecause of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with JELMYTO and for 1 week following the last dose.

Preparation and Administration InformationJELMYTO is for pyelocalyceal use only and not for intravenous use, topical use, or oral administration. JELMYTO must be prepared and administered by a healthcare provider. To ensure proper dosing, it is important to follow the preparation instructions found in the JELMYTO Instructions for Pharmacy and administration instructions found in the JELMYTO Instructions for Administration.

JELMYTO may discolor urine to a violet to blue color following the instillation procedure. Advise patients to avoid contact with urine for at least six hours post-instillation, to void urine sitting on a toilet, and to flush the toilet several times after use.

JELMYTO is a cytotoxic drug. Follow applicable special handling and disposal procedures.

Please click here for Full Prescribing Information, Instructions for Pharmacy and Instructions for Administration.

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