Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. The FDA assigns the labeler code, while the company assigns the product and package code. IMFINZI may be given in combination with otheranti-cancermedicines. They may not be reported prior to effective date. Level I HCPCS (CPT-4 codes) for hospital providers; Level II HCPCS codes for hospitals, physicians and other health professionals who bill Medicare A-codes for ambulance services and radiopharmaceuticals; C-codes; G-codes; J-codes, and; Q-codes (other than Q0163 through Q0181) Formulate and submit the specific question you have. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. (2. While 21 CFR 801. or HCPCS Codes and/or How to Obtain Prior Authorization . T-MSIS data elements NDC-UNIT-OF-MEASURE (CIP285, CLT229, or COT224) and NDC-QUANTITY (CIP278, CLT230, or COT225) are only applicable to and therefore reported in the IP, LT, and OT files when a value is reported to the NATIONAL-DRUG-CODE data element (CIP284, CLT228, or COT217). The active substance of Imfinzi is durvalumab, an antineoplastic monoclonal antibody (ATC code: L01XC28) that potentiates T-cell response, including anti-tumour response, through blockade of PD -L1 binding to PD-1. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. The NDC number consists of 11 digits in a 5-4-2 format. Brand name . The first five digits. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. No dose reduction for IMFINZI is recommended. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. (NDC 0310-4611-50) 120 mg/2. in a 10-digit format. IMFINZI safely and effectively. The FDA has approved updated labeling for Imfinzi (durvalumab; AstraZeneca) to include overall survival data for patients with unresectable, Stage III non-small cell lung cancer (NSCLC). 00 Inclusive of all taxes. 120 mg/2. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). The effective dates for using these documents for clinical reviews are communicated through the provider notification process. HCPCS/CPT code: J0744 HCPCS/CPT code description: Ciprofloxacin for intravenous infusion, 200 MG Number of HCPCS/CPT units 6 NDC (11-digit billing format): 00409-4765-86 NDC description: Ciprofloxacin IV SOLN 200 MG/20 ML NDC unit of measure ML 8. Withhold for moderate and permanently discontinue for severe or life-Initial U. Report 90461 with 90460 only. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 • Arm 1: IMFINZI 1500 mg administered on Day 1+ gemcitabine 1000 mg/m 2 and cisplatin 25 mg/m 2 (each administered on Days 1 and 8) every 3 weeks (21 days) for up to 8 cycles, followed by IMFINZI 1500 mg every 4 weeks as long as clinical benefit is observed or until unacceptable toxicity, or Weight less than 30 kg: Imfinzi 20 mg/kg IV given in combination with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Fig. What is National Drug Code (NDC)? • A unique . 4. Dosage Modifications for Adverse Reactions . Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. It provides the criteria used to determine the medical necessity of hospital outpatient administration as the site of service for identified specialty medications (See Site of Care for Specialty Drug Infusion/Injection applicable drug therapy below. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. Code Description; 90296 Diphtheria antitoxin 90632 - 90634: Hepa vaccine adult im - Hepa vacc ped/adol 3 dose 90675 - 90676: Rabies vaccine im - Rabies vaccine id. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. They are owned by CMS and are available for use. Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing. IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. References 1. ATC code: L01FF03. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. It is important to note that this code represents 1/10th of a vial. Both the product and package codes are assigned by the firm. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). There are 11 disease interactions with Imfinzi (durvalumab) which include: adrenal insufficiency. D. Vaccine CPT Code to Report. Format of NDC: Under the proposed rule, the NDC would remain a three-segment numerical code consisting of the labeler code, the product code, and the package code. Imfinzi [prescribing information]. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. 094 Section: Prescription Drugs Effective Date: April 1, 2023 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 10, 2023 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatAt 18 months, 34% of Imfinzi-treated patients were alive, as were 25% of those in the control group. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. IMFINZI. (iii) The type(s) of drug(s) (human, animal, or both, and prescription, nonprescription, or both) to which the NDC labeler code will be applied. IRST . Last updated on Jun 28, 2023. IMFINZI™ (durvalumab) Injection. Approval: 2017 . View Imfinzi Injection (vial of 10. Date Article; Nov 11, 2022: Approval Imfinzi and Imjudo with Chemotherapy Approved in the US for Patients with Metastatic Non-Small Cell Lung Cancer: Oct 24, 2022: Approval FDA Approves Imjudo (tremelimumab) in Combination with Imfinzi for Patients with Unresectable Hepatocellular Carcinoma: Sep 11, 2022: Imfinzi and Tremelimumab. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. Imfinzi is a medicine used to treat lung cancer. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. HCPCS code describes JEMPERLI. Contact your patient’s• Administer IMFINZI as an intravenous infusion over 60 minutes. • Should not be assigned to non-drug products. If the intent of the IIS is to capture the specific NDC, an IIS could access the provider’s order (VTrckS ExIS shipment data) to identify theCoding. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. Sometimes, it’s used together with other immunotherapies and chemotherapy. How you are given IMFINZI . OLORADO . 2. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . 90672. Abilify MyCite Kit (aripiprazole with biosensor)- (Medical Necessity) Actemra (tocilizumab). View Imfinzi Injection (vial of 2. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). 15 Providers must bill 11-digit NDCs and appropriate NDC units. Expand All | Collapse All. NDC: 58160-0815-52 (1 dose T-L syringes. Billing Code/Availability Information HCPCS:. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theImfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. Revised: 03/2021 Page 2 . # Step therapy required through a Humana preferred drug as part of preauthorization. The Clinical Criteria information is alphabetized in the. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit). Sean Bohen, MD, Phd. 00 17. 4 mL injection. S. Fig. 31, 2018. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. 25 mg/mL bupivacaine and 0. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. Imfinzi durvalumab J9173A. Immune-Mediated Dermatology Reactions. 20. NOTE: Dates of service for Terminated HCPCS codes not needed. (B) A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5–3–2 or 6–3–2). csv file. Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T. Axitinib % % % % hcpcs or cpt ® code(s) drug j0256 aralast np q5121 avsola j9023 bavencio j0490 benlysta j0179 beovu j0598 cinqair j0586 dysport j9217 eligard j1325 epoprostenol sodium j0178 eylea j0180 fabrazyme j0517 fasenra j1325 flolan j0257 glassia j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis This review will provide an update on the regulatory approvals of anti-PD-1/PD-L1 therapeutics along with their companion and complementary diagnostic devices. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. X 11335. 94 Section: Prescription Drugs Effective Date: July 1, 2022 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 4 Last Review Date: June 16, 2022 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatGreater than or equal to 30 kg: 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer Imfinzi 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab-actl. The median time to onset was 55. 5 for the booster vaccine is now being planned. National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior to• IMFINZI is approved for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)1 • IMFINZI is a human monoclonal antibody directed against programmed cell death ligand-1 (PD-L1)1Imfinzi™ (durvalumab) Last Review Date: January 1, 2019 Number: MG. HCPCS Level II Code. Approval: 2017 total bilirubin elevation. FDA approvals of PD-1/PD-L1 mAbs. 1)] and 266 patients with ES-SCLC in CASPIAN who received up to four. Group 1 (9 Codes) Group 1 Paragraph. How do I calculate the NDC units? Billing the correct number of NDC units for the. No needle) 90636: 104 MenHibrix (VFC) Meningococcal C/Y-HIB PRP 6 weeks -. HCPCS/CPT code: J0744 HCPCS/CPT code description: Ciprofloxacin for intravenous infusion, 200 MG Number of HCPCS/CPT units 6 NDC (11-digit billing format): 00409-4765-86 NDC description: Ciprofloxacin IV SOLN 200 MG/20 ML NDC unit of measure ML . All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. 3. FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. 10/01/2022 R5 Eff 10/1/2022: Per CR12973 added DX D81. HCPCS / NDC Crosswalk for Billing Physician-administered Drugs on the Provider Services Billing Manuals page. 5 Cal Ready-to-Hang Institutional / 1 Liter (1000-mL) Bottle / Case of 8 B4154 70074-0535-37 Adult Nutritional 62059 Glucerna Hunger Smart Shake Vanilla Retail / 11. • Administer IMFINZI as an intravenous infusion over 60 minutes. National Comprehensive Cancer Network, Inc. Yes. 1 Recommended Dosage. CPT Code Description. provider administered drugs page 2 of 3 . The next 4 digits identify the specific drug product and are. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. nervousness. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). Use in Cancer. Tunney’s Pasture, A. Bahamas Updated. (2. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Weight less than 30 kg: Imfinzi 20 mg/kg IV given with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 5 mL 10 pre-filled syringes seasonal influenza, quadrivalent, preservative free: 90688 150; 33332-0422-10 multi-dose vial, 5 mL (0. An administration code should always be reported in addition to the vaccine product code. Labeler code portion of NDC; assigned by FDA to firm. Identify the manufacturer of the drug. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. IMFINZI is a programmed death -ligand 1 (PD-L1) blocking antibody indicated : • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. Varun Gupta, MD Pharmacology on 5th Sep 2023. NDC: Imfinzi 120 mg/2. PD-L1 can be induced by. Imfinzi Generic Name durvalumab. 0 Unit: mg/10mL Packages: Code: 00310-4611-50 Description: 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL Effective Date: May 1, 2017 CPT codes covered if selection criteria are met: VENTANA PD-L1 (SP263) Assay - no specific code: Other CPT codes related to the CPB: 96413 - 96417 : Chemotherapy administration; intravenous infusion technique : HCPCS codes covered if selection criteria are met: J9173 : Injection, durvalumab, 10 mg: Other HCPCS codes related to the CPB: C9147 NDC 0310-4500-12. S. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. MRP ₹45500. IMFINZI safely and effectively. 1. See full prescribing information for IMFINZI. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. paper. Updated Nationally Determined Contribution of the Republic of Azerbaijan. REFERENCES 1. You may report side effects to FDA at 1-800-FDA-1088. 4 Adverse Reaction Severity1 Dosage Modification than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more. Covered codes. 2. 4 mL (50 mg/mL) (NDC 0310-4500-12) Store in a refrigerator at 2°C to 8°C (36°F to 46°F) in original carton to. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. Example of NDC Labeler code assignment. The NDC is actually a 10-digit number that contains the three segments noted above. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. Alpha-Numeric HCPCS. 10, 2021: NDC requirements have been postponed until 2022. Contents of the pack and other information . The 835 electronic transactions will include the reprocessed claims along with other claims. 3)]. skin rash *. 2ML. 90674. Medicare BPM Ch 15. 90716 can be used for the administration of the chickenpox vaccine (varicella) 12002 can be used when a healthcare provider stitches up a 1-inch cut on your arm. IMFINZI contains the active ingredient durvalumab. IMFINZI™ (durvalumab) Injection. HCPCS code applications are presented within the summary document in the same sequence as the Agenda for this Public CPT Codes / HCPCS Codes / ICD-10 Codes ; Code Code Description; Other CPT codes related to the CPB : 81235: EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) 96413 - 96415: Chemotherapy administration, intravenous infusion technique The recommended dose of durvalumab is 10 mg/kg, administered as an intravenous infusion. All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. skin rash *. 90658 can be used for the administration of a flu shot. Submit PA requests . J0588 - Labeled indications for Xeomin are limited to G24. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. 4 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. hoarseness, husky, or loss of voice. Effective date is noted in the file title. Table 1. 2 Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-lineThe recommended dose of IMFINZI is 10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months. 2 . 66019-0308-10. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 6 5. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 1 vial = 10 units. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The second and third segments of NDC Labeler code are assigned by the labeler. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. , "in use" labeling). Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. 40av2 Medical Guideline Disclaimer. The official update of the HCPCS code system is available as a public use file below. Description . Please see the HCPCS Quarterly Update webpage for those updates. Imfinzi 120 mg/2. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name Basis of Strength Strength; DURVALUMAB (UNII: 28X28X9OKV) (DURVALUMAB - UNII:28X28X9OKV) DURVALUMAB: 120 mg in 2. S. through . Exclusivity End Date:0154A, 0164A, 0171A, 0172A, 0173A, 0174A), patient age, manufacturer name, vaccine name(s), 10- and 11-digit National Drug Code (NDC) Labeler Product ID, and interval between doses. 90672. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. This will allow quick identification of new safety information. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). NovoLogix Carelon Quantity limits . Learn more about how IMJUDO® (tremelimumab-actl) is approved in combination with IMFINZI® (durvalumab) as a treatment option for patients with unresectable HCC and metastatic NSCLC. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. 21. This medication has been identified as Imfinzi 120 mg/2. . The most common side effects that occurred in 20% or more of patients receiving Imfinzi were: fatigue, nausea, constipation, decreased appetite, abdominal pain, rash and fever. Although AstraZeneca did not provide specific data in its press release, the company said that patients who were. Prev Section 2. Withhold or discontinue IMFINZI to manage adverse. One (1) unit represents 10 mg of (J9035) or bevacizumab ordered/administered to patient. 2 DOSAGE AND ADMINISTRATION 2. swelling in your arms and legs. List of Vaccine Names, Best ASIIS Selection and CPT/CVX Codes This list matches the vaccine name or codes in Arizona State Immunization Information System (ASIIS) with the brand name or other common names. trouble. . Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . 2021 Nov;16 (6):857-864. 17: $76. of these codes does not guarantee reimbursement. How do I calculate the NDC units? Billing the correct number of NDC units for the. EALTH . Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. Administer IMFINZI as an intravenous. Last updated on emc: 04 Sep 2023. ES-SCLC: Until disease progression, unacceptabletoxicity. For information about Molina pharmacy policies, contact the Pharmacy Department: Phone: (855) 866-5462. Imfinzi also increased the percentage of patients responding to treatment (68% vs. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. J0573 All NDCs on this page are reported on claims as J0573 Example: if 24 mg administered, then 4 units submitted NDC # Brand name NDC # Brand name NDC # Brand name NDC # Brand nameprocedure code. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 70461-0322-03. IMFINZI safely and effectively. Xolair omalizumab 600 mg J2357 120 HCPCS units (5 mg per unit) Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit) Libtayo cemiplimab-rwlc 350 mg J9119 350 HCPCS units (1 mg per unit) Imfinzi and Tremelimumab with Chemotherapy Improved Progression-Free Survival by 28% and Overall Survival by 23% in 1st-Line Stage IV Non-Small Cell Lung Cancer vs. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). Subject: Imfinzi Page: 4 of 4 1. The labeler code is the first segment of the National Drug Code. References . It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. • NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. 99397 can be used for a preventive exam if you are over age 65. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. IMFINZI works by helping your immune system fight your cancer. 2 SAD Determinations Medicare BPM Ch 15. The approval was based on the results of the CASPIAN clinical trial, which showed that. Q4132 Grafix core and GrafixPL core, per square centimeter Q4133 Grafix prime and GrafixPL prime, per square centimeter Q4137 Amnioexcel or BioDExCel, per square centimeter Q4138 Biodfence Dryflex, per square centimeterThe following HCPCS codes have been added to the Article: Q5127 and Q5130 in the ‘Subcutaneous and Intramuscular Injection Non-Chemotherapy-Generic/Trade Names Table’ and in the ‘Group 1 CPT/HCPCS Codes Table’. J0885. NDC notation containing asterisks is not accepted. of these codes does not guarantee reimbursement. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. Code Description. UB-04. S. The National Drug Code (NDC) Directory is updated daily. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 4%) patients. Injection, infliximab, 10 mg. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination Under CPT/HCPCS Codes Group 27: Codes deleted HCPCS code C0938 and added J9204. Under CPT/HCPCS Codes added a new Group 2: Paragraph, Group 2: Codes and added C9467 with “Note: For Part A services only - effective on 04/01/2018”. After consulting with the U. Weight less than 30 kg: Imfinzi 20 mg/kg IV given in combination with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . The file contains the following drug information: • NDCPackageCode (Column A): The labeler code, product code, and package code segments of the NDC number, separated by hyphens per FDA website. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). 1007/s11523-021-00843-0. immune system reactions, which can cause inflammation. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. S. J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. diabetes. IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. How do I calculate the NDC units? Billing the correct number of NDC units for the. ₹0. What is a J-code’s unit? Each J-code’s descriptor includes a dosage amount, known as the HCPCS code dosage, which is the billable unit for that code. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. Cancer Oncology Rx required. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. 99214 can be used for an office visit. 1 8. Approval: 2017 . The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Rx only. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . S. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. It is used. NDC covered by VFC Program. 88 mg/mL meloxicam. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. N/A. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. 120 mg/2. Sometimes, it’s used together with other immunotherapies and chemotherapy. CanMED: NDC. Do not freeze or shake. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs.