Each single-dose glass vial is filled with a solution of 29. Withhold or discontinue IMFINZI to manage adverse. Additionally, either the long or short description of CPT code 19499 has been updated. This code is effective on 11/1/2018. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. 10-digit, 3-segment number. for people with locally advanced or metastatic bladder cancer. hcpcs or cpt® code(s) drug j9217 lupron depot (1-month) j9217 lupron depot (3-month) j1950 lupron depot (3-month) j9217 lupron depot (4-month) j9217 lupron depot (6-month) j2503. com Abecma (idecabtagene vicleucel) MCP. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. It will be listed in one of the following configurations: 4-4-2: for example,. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m. Imfinzi durvalumab J91731All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. in a 10-digit format. The NDC code would be unique for all of them and can help you distinguish between those result. 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. • Should not be assigned to non-drug products. general feeling of discomfort or illness. Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:. 094 Section: Prescription Drugs Effective Date: October 1, 2022 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 4 Last Review Date: September 9, 2022 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody. Restricted Access – Do not disseminate or copyImfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the. 2 DOSAGE AND ADMINISTRATION 2. Example: rilpivirine STR=ndc_active_ingredient. PPO . Associated Documents. 21. • Administer IMFINZI as an intravenous infusion over 60 minutes. (2. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. The third segment, the package code, identifies package sizes and types. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. UB-04. Continuing therapy with Imfinz will be authorized for 12 months. 00 Inclusive of all taxes. Imfinzi [package insert]. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. Code Description Vial size Billing units. 1. 1 unit per 1000 units. The CPT procedure codes do not include the cost of the supply. Dosing for infants and children age 6 through 35 months: • Afluria 0. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. Starting April 19, 2021, a valid National Drug Code (NDC) number, unit of measure, and units dispensed for drugs administered by health care professionals in ambulatory care settings will be required on all professional and facility drug claims. 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. Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. ES-SCLC: Until disease progression, unacceptabletoxicity. 1 6. HCPCS code V2790 (amniotic membrane for surgical reconstruction, per procedure) should not be billed to Part B separately except as noted below: •HCPCS code V2790 can be reimbursed separately in an office setting when billed with CPT Code 65780. S. PD-L1 can be induced by inflammatory signals (e. IMFINZI safely and effectively. 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, 01/17Imfinzi belongs to a class of drugs called PD-L1 inhibitors. IMFINZI is administered as an intravenous infusion over 1 hour. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. 68 mg/mL), 4 mg (1. MM. frequent urge to urinate. 2 months compared to placebo. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. These files contain the Level II alphanumeric HCPCS procedure and modifier codes, their long and short descriptions, and applicable Medicare administrative, coverage and pricing data. Example 1: HCPCS description of drug is 6 mg. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. References 1. HCPCS Code Description J3489 . (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, 01/17This includes restrictions that may be on a deleted code that are continued with the replacement code(s). HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. 70461-0322-03. Loncastuximab tesirine is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and. 90672. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021. This medication can cause rare, but serious immune-related. ₹0. 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 . On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Codes Listed "By Report" There are certain drugs on the Physician Manual Fee Schedule and on the Ordered Ambulatory Fee Schedule that are designated "By Report" ("BR"). macugen. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. Sometimes, it’s used together with other immunotherapies and chemotherapy. MRP ₹45500. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading. The member's specific benefit plan determines coverage. . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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. Finished drug products. OLORADO . 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, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. The National Drug Code (NDC) Directory is updated daily. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 31, 2018. Trade Name: IMFINZI. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. The FDA assigns the labeler code, while the company assigns the product and package code. 10/10/2023. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. 1. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 2. Item Code (Source) NDC:0310-4505: Route of. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced. fatigue (lack of energy) upper respiratory infection such as the common cold. LCDC Building. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Group 1 Codes. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. 1, 2019. This medication has been identified as Imfinzi 120 mg/2. Last updated by Judith Stewart, BPharm on June 20, 2023. Simply add items worth ₹1499 to your cart & use the applicable coupon at checkout!eviCore healthcare will reimburse HCPCS codes A9587 and A9588 when used in conjunction with a PET scan, an appropriate diagnosis and an invoice for the radiopharmaceutical. claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. While always displayed as 6 digits in this file; for labeler codes 2 through. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. Food and Drug Administration (FDA) approved AstraZeneca Pharmaceuticals LP Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had not progressed after platinum-based chemotherapy and radiation. COVID -19 Related Codes U0001 CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel COVID-19 U0002 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC) COVID-19CODE=ndc_active_ingredient. By blocking these interactions, Imfinzi may help the body’s immune system attack. 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. 4%) patients. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). 4 mL in 1 VIAL Effective Date: May 1, 2017 Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. Discard unused portion. Mechanism of action. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 00. fever. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 4ml. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. 25 mg/mL bupivacaine and 0. October 2023 Alpha-Numeric HCPCS Files (ZIP) - Updated 08/28/2023. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. A10. The correct use of an ICD-10-CM code does not assure coverage of a service. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. 1)] Grade 2 Withhold doseb Initial dose of 1mg/kg/day to 2mg/kg/day prednisone or equivalent followed by a taper Grade 3 or 4. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. It is a human immunoglobulin G1 kappa. Are assigned by the Food and Drug Administration. com. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. Attention Pharmacist: Dispense the accompanying Medication. 2 months, compared to 5. 150: 33332-0322-03: 0. N/A. The 835 electronic transactions will include the reprocessed claims along with other claims. Units. of these codes does not guarantee reimbursement. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. Table 1. With IV infusions, the drug is slowly injected. Under CPT/HCPCS Codes Group 10: Codes added HCPCS code J9033. Key points to remember. 4. National Comprehensive Cancer Network, Inc. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. Rx only. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. 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. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. NDC=National Drug Code. 100 Eglantine Driveway. Manufacturer: Octapharma USA, Inc. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 90674. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. This corresponded to a. Depending on which description is used in this article, there may not be any change in how the code displays in the document: J7195; J7301; J7302. This medicinal product is subject to additional monitoring. NDC 0310-4611-50. Example 3: HCPCS description of drug is 1 mg. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Revised: 03/2021 Page 2 . Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. The 835 electronic transactions will include the reprocessed claims along with other claims. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. Indications and Usage (1. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior todue to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Durvalumab (IMFINZI ), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of. 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. 2 . Below example explain how to assign a labeler code. 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. 05 ICD-10-CM. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Alpha-Numeric HCPCS. Patients receiving the three-drug regimen had a median overall survival of 14 months, as compared with 11. Imfinzi comes as a liquid solution in single-dose vials. 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. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. EALTH . WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated appr oval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. Imfinzi [package insert]. • 80 mg/4 mL: 50242-135-01 • 200 mg/10 mL: 50242-136- 01 • 400 mg/20 mL: 50242-137-01 Sotrovimab Q: How is Sotrovimab reported via data exchange? A. What IMFINZI is and what it is used for . allergic reaction *. Prev Section 2. 1 Recommended Dosage The recommended dosages for IMFINZI as a single agent and IMFINZI in combination withSide Effects of Imfinzi are Nasopharyngitis (inflammation of the throat and nasal passages), Upper respiratory tract infection, Rash, Flu, Dermatitis, Bronchitis (inflammation of the airways), Eczema, Swelling of lymph nodes, Oropharyngeal pain. HCPCS / NDC Crosswalk for Billing Physician-administered Drugs on the Provider Services Billing Manuals page. code . aprepitant injection (Cinvanti TM) 1 mg. 1, 2019 . The product's dosage form is injection, solution, and is administered via intravenous form. NovoLogix Carelon Quantity limits . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Updated Nationally Determined Contribution of the Republic of Azerbaijan. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. 88 mg/mL meloxicam. Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . Dosage Modifications for Adverse Reactions . The Policy Bulletins are used in making decisions as to medical necessity only. They may not be reported prior to effective date. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing,. 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 Immune globulin subcutaneous (Human), 20 Percent solution (CuvitruTM) HCPCS code J3590: Billing. 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. IRST . 3)]. 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. applicant, existing HCPCS codes do not identify this product; and given that Rolvedon™ is a single source biological as defined by section 1847A(c)(6)(D) of the Social Security Act, it should be assigned a new HCPCS Level II code and paid separately by Medicare consistent with statute and CMS policy. Ottawa ON K1A 0K9. 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 theDurvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 5. (2. NDC will change for the 2020-2021 immunization season. e When tetanus or rabies products are given as part of wound management, use a primary ICD-10 code which describes the patient’s condition. locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or; who have disease progression within 12 months of neoadjuvant or adjuvant treatment with. 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. Page 3 | Imfinzi® (durvalumab) Prior Auth Criteria Proprietary Information. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 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 Quarterly Update. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). Use the units' field as a multiplier to arrive at the dosage amount. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. The approval of IMFINZI is based on the positive PFS data from the Phase III PACIFIC trial in which IMFINZI demonstrated an improvement in median PFS of 11. Generic name . Brand name . 6%). AstraZeneca ’s Imfinzi (durvalumab), administered concurrently with chemoradiotherapy, missed its primary efficacy endpoint in the Phase III PACIFIC-2 trial in non-small cell lung cancer, the company announced Tuesday. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Vaccine CPT Code to Report. In addition, code G0379 is not separately payable when a critical care service (CPT 99291), clinic service (HCPCS G0463), emergency department visit, or a service assigned a status indicator of T or V under the CMS IOCE are reported on the same date of service. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. (ii) If a labeler code is 4 digits in length, it may be combined only with a product code consisting of 4 digits and a package code consisting of 2 digits for a total NDC length of 10 digits (4. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. The U. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. IMFINZI™ (durvalumab) Injection. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. Enter the information on the . Submit PA requests . The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . X 11335. Sean Bohen, MD, Phd. provider administered drugs page 2 of 3 . 1All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. C. How to store IMFINZI . 1) 09/2022 IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. ”. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. 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. The safety and tolerability of the Imfinzi combination was consistent with previous. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113. No dose reductions are recommended. It showed an. • Universal product identifier for drugs. CPT Code Description. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. through . A. com. , "in use" labeling). Imjudo is also a monoclonal antibody, but it fosters. Code 91317 for Pfizer-BioNTech COVID-19. Be attentive to the long description of the HCPCS code. 1, 2020, the Medicaid and NC Health Choice programs cover famotidine injection (Pepcid®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs. 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. 47426-0201-01 The pooled safety population (N = 596) described in the Warnings and Precautions section reflect exposure to IMFINZI 1,500 mg in combination with tremelimumab-actl 75 mg and histology-based platinum chemotherapy regimens in 330 patients in POSEIDON [see Clinical Studies (14. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The FDA offers an NDC searchable database. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. Do not report 90460, 90471-90474 for the administration of COVID vaccines. NDC covered by VFC Program. g. This medication may cause a serious reaction during the injection. HCPCS code V2790 (amniotic membrane for surgical reconstruction, per procedure) should not be billed to Part B separately except as noted below: •HCPCS code V2790 can be reimbursed separately in an office setting when billed with CPT Code 65780. References . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . g. 2. 1) 03/2020 Dosage and Administration, Dosage Modifications (2. 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 the Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. IMFINZI™ (durvalumab) Injection. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. Approval: 2017 total bilirubin elevation. Use in Cancer. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. Imfinzi disease interactions. 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). NDC Packaging CDC Cost/ Dose Private Sector Cost/ Dose Contract End Date Manufacturer Contract Number; Hepatitis A Adult Vaqta® 00006-4096-02: 10 pack – 1 dose syringe: $38. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. S. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days 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) 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 Immune globulin subcutaneous (Human), 20 Percent solution (CuvitruTM) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab: A Review in Extensive-Stage SCLC. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. Code Description Vial size Billing units NDCThis PDF document provides the full prescribing information for JYNARQUE (tolvaptan), a drug used to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). A biologics license application (BLA) for tremelimumab for the treatment of patients with unresectable hepatocellular carcinoma (HCC) was accepted and granted priority review from the FDA was based on results from the phase 3 HIMALAYA trial (NCT03298451), according to a press release from AstraZeneca; additionally, a. 2. On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced. 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. 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. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 with the PD-1 (CD279). The recommended dose of ZYNRELEF is based on the size of the surgical site up to a maximum dose of 400 mg/12 mg (14 mL). 8. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. If the NDC on the package label is less than 11 digits, a leading zero must be added to the appropriate segment to create a 5-4-2 configuration. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. 2. Always bill device in the category described by HCPCS code C1832 with 1 of the following CPT codes: • CPT code 15110 (Epidermal autograft, trunk, arms, legs; first 100 sq cm or less, or 1% of body area of infants and children), which is assigned to APC 5054 for. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. FDA approvals of PD-1/PD-L1 mAbs. Expression of programmed cell death ligand-1 (PD-L1) protein is an adaptive immune response that helps tumours evade detection and elimination by the immune system. The Clinical Criteria information is alphabetized in the. 6 mg are administered = 1 unit is billed. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). IMFINZI safely and effectively. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . Imfinzi durvalumab J9173. Effective date is noted in the file title. (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 . 25 mg/mL bupivacaine and 0. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. 24 participants with Non-Small Cell Lung Cancer will be. 5. 4/BA. The product's dosage form is injection, solution and is administered via intravenous form. X . A. The NDC, NDC units of measure and NDC quantity must be submitted in addition to the applicable HCPCS or CPT codes and the number of HCPCS CPT units. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. Use the units' field as a multiplier to arrive at the dosage amount. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. Submit PA requests . Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. If a labeler code is 4 digits in length, it may be combined only with a product code consisting of 4 digits and a package code consisting of 2 digits for a total NDC length of 10 digits (4-4-2). IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Keep vial in original carton to protect from light. Brand Generic Codes Amvuttra vutrisiran J0225 Aphexda †,. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. trouble. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. Medicare BPM Ch 15. It is for use in adults with: non-small cell lung cancer (NSCLC) that is locally advanced (meaning it has spread into tissues around the lungs, but not to other parts of the body) and cannot be removed by surgery and is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). Call your doctor for medical advice about side effects. National. NDC: Imfinzi 120 mg/2. Cart Total.