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Please see page 2 for Indication and Important Safety Information. Please click here for full Prescribing Information.
Miscellaneous coding and billing reference sheet: Hospital outpatient settingSample UB-04 CMS-1450 claim form2 for ADAKVEO® (crizanlizumab-tmca) for IV infusion Hospital outpatient administrationAlthough this sheet provides information that should facilitate the claims process, all coding information is for reference purposes only. Novartis does not guarantee payment.
The health care billing environment is constantly evolving to keep pace with scientific advances and financial constraints. Information specific to billing and coding is subject to change and should be verified for each patient prior to treatment. A provider should contact patients’ payers directly for any revised or additional requirements, information, or guidance.
IMPORTANT INFORMATION: The coding, coverage, and payment information contained herein is gathered from various resources, general in nature, and subject to change without notice. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine the appropriate health care setting, and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. Information and materials are provided to assist health care providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.
ADAKVEO Support at PANO | Phone: 1-800-282-7630 Monday-Friday, 9 am to 8 pm ET | hcp.novartis.com/access/
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ADMISSION CONDITION CODESDATE
OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCE SPANCODE DATE CODE CODE CODE DATE CODE THROUGH
VALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNT
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THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.
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42 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES 49
52 REL51 HEALTH PLAN ID
53 ASG.54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI
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58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.
64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME
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0510 Clinic
DX D57.1
ADAKVEO (crizanlizumab-tmca) infusion 300mg
96365 11152019 1 $$0636 N400078088361ME300 J3490,J3590 or C9053 11152019 1 $$
Enter the appropriate revenue code corresponding with the HCPCS code in box 44, which is required for billing the unclassified HCPCS code, and 0510 for clinic services (eg, 0636 revenue code for pharmacy drugs that require detailed coding).
Enter a detailed drug description for the payer. The N4 indicator is listed first, the 11-digit National Drug Code number is listed second, a code describing the unit of measurement qualifier is listed third (eg, ME for milligrams), and the unit quantity is listed at the end.Example: N400078088361ME300
Enter the appropriate, not-otherwise-classified HCPCS code for ADAKVEO use as required by the payer. J3490, Unclassified drug;3 or J3590, Unclassified biologics;4 may be appropriate. C90531 may be appropriate for Medicare Part B as well as other types of payers. To report the administration procedure, enter an appropriate CPT code (eg, 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis [specify substance or drug]; initial, up to 1 hour).5
Enter the total number of units of service. For ADAKVEO, payers may request that the miscellaneous code be billed at 1 unit. Please note that the appropriate number of units for an unclassified drug may vary by payer. For Medicaid, the units may vary by state also. Some payers may refer to the actual quantity administered via Box 43 and Box 80.
Enter the total amount the facility actually charged for the product.
Enter the appropriate ICD-10-CM diagnosis code (eg, D57.1 for Sickle cell disease without crisis). Code to the highest level of specificity.
Enter the drug name, the route of administration, and the amount administered. This can be required by payers when billing a miscellaneous HCPCS code.
Box 42:
Box 43:
Box 44:
Box 46:
Box 47:
Box 67A-67Q:
Box 80:
42 43 44 46 47
67 A-Q
80
NEW C-CODE (C9053)1 For ADAKVEO® (crizanlizumab-tmca) Effective April 1, 2020
INDICATIONADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.
IMPORTANT SAFETY INFORMATIONInfusion-Related ReactionsIn the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.
Laboratory Test Interference: Platelet Counts Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.
Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.
PregnancyBased on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.
Most Common Adverse Reactions The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).
Other Clinically Important Adverse Reactions Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.
Please see full Prescribing Information here.
References: 1. Centers of Medicare and Medicaid Services. April 2020 OPPS NDC - HCPCS Crosswalk for Medicare Part B Drugs. https://www.cms.gov/apps/ama/license.asp?file=https%3A//www.cms.gov/files/zip/april-2020-asp-ndc-hcpcs-crosswalk.zip. Accessed March 19, 2020. 2. Centers for Medicare & Medicaid Services. CMS Manual System. Details for title: CMS 1450 (UB-04). https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1450.html. Accessed July 12, 2019. 3. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 5. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019.
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