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. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. (2. 5. V. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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. S. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. Identify the manufacturer of the drug. 200 mg are administered = 4 units are billed. (2. Cart Total. Rx only. 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. Table 1. References . • Universal product identifier for drugs. • Administer IMFINZI as an intravenous infusion over 60 minutes. Discard unused portion. Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. . 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. Injection, infliximab, 10 mg. 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. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 4. English. National Comprehensive Cancer Network, Inc. Last updated by Judith Stewart, BPharm on June 20, 2023. 6, 2019 retroactive to Jan. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. 66019-0308-10. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated approval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. 1. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 2 8 8. 34 mg/mL), or 8 mg (2. The file contains the following drug information: • NDCPackageCode (Column A): The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens per FDA website. Administration codes. skin rash *. The first five digits. 4ml. Active. Applicable Procedure Codes J9173 Injection, durvalumab, 10mg, 1 billable unit = 10mg Applicable NDCs 0310-4611-50. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. Do not freeze or shake. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. It is important to note that this code represents 1/10th of a vial. Brand name . (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. 2 . 4 OVERDOSE 10 DESCRIPTION 12 12. Example 3: HCPCS description of drug is 1 mg. Imfinzi [package insert]. 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. The maximum reimbursement rate per unit is $144. 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. The first sentence in the “Coding Information” section has been revised to add ranibizumab-nuna and faricimab-svoa: The administration for ranibizumab, ranibizumab-nuna, aflibercept, brolucizumab-dbll or faricimab-svoa must be billed on the same claim as the drug, with. Fax: (855) 365-8112. Report 90461 with 90460 only. An administration code should always be reported in addition to the vaccine product code. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. Restricted Access – Do not disseminate or copyThe Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . 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). NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 00310-4500-12 00310. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The safety and tolerability of the Imfinzi combination was consistent with previous. 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. Full prescribing. NovoLogix Carelon Quantity limits . Do not report 90460, 90471-90474 for the administration of COVID vaccines. 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. (2. C. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17ATC code: L01FF03. Pre-Stata13 had a string length limit of 244 characters. 1 7. 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. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. See full prescribing information for IMFINZI. NDC=National Drug Code. 5 mL dosage, for. The CPT procedure codes do not include the cost of the supply. This corresponded to a. • 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. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . headache. 10/31/2019 R6 NDC 0310-4611-50. liver dysfunction. 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). JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. 1 Recommended Dosage . havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. g. The National Drug Code (NDC) Directory is updated daily. 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. IMFINZI may be given in combination with otheranti-cancermedicines. Adding National Drug Codes (NDC) to ClaimsIMFINZI 120mg Injection 2. The list of results will include documents which contain the code you entered. J0588 - Labeled indications for Xeomin are limited to G24. No dose reduction for IMFINZI is recommended. Depending. References 1. IMFINZI works by helping your immune system fight your cancer. HCPCS code G2012: Brief communication technology-based service, e. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. 88 mg/mL meloxicam. 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. 1. (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. How do I calculate the NDC units? Billing the correct number of NDC units for the. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/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, 01/17Imfinzi belongs to a class of drugs called PD-L1 inhibitors. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. 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. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. 569: $79. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 5 mL. Withhold or discontinue IMFINZI to manage adverse. • 300 mg (NDC 0024-5914-00) • 200 mg (NDC 0024-5918-00) • 100 mg (NDC 0024-5911-00) Pre-filled pen: • 300 mg (NDC 0024-5915-00). 57 rescinds legacy NHRIC and NDC numbers and requires discontinuation of their use on device labels and packages, the UDI Rule does not prohibit use of 11-digit numbers or other. Format revision completed. 3%) patients including fatal pneumonitis in one. MM. 708: 6/30/2023:. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. 2 months compared to placebo. fever. Average progression-free survival for the Imfinzi-containing group was 7. N/A. The NDC is updated daily, this version offered here is from September 6th, 2022. Short descriptor: SARSCOV2 VAC BVL 10MCG/0. Adding NDC: 504190390, 504190391 Adding NDC: 635390187, 635390188 bendamustine (C9042, J9033, J9034, J9036) and rituximab (J9310, J9312) Changing HCPCS: J9999 to J9309 Adding HCPCS for combination bendamustine: J9036 C9044, J9119 Adding HCPCS: J9119 C9045, J9313 Adding HCPCS: J9313 C9474, J9205 Adding NDC: 150540043. com) document for additional details . 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. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. 1 mL; The maximum reimbursement rate per unit is: $0. CPT Code Description. IMFINZI is a monoclonal antibody, a type of protein. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 15 Providers must bill 11-digit NDCs and appropriate NDC units. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. • Administer IMFINZI as an intravenous infusion over 60 minutes. 099. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. durvalumab injection, for intravenous use (Imfinzi®) 10 mg. 2 mL dosage, for intramuscular use. The 835 electronic transactions will include the reprocessed claims along with other claims. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . The NDC Packaged Code 0310-4611-50 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 21, including objective evidence of efficacy and safety are met for the proposed indication. 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"). 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). 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. Please also refer to the full prescribing information for etoposide, carboplatin or cisplatin, inThe openFDA drug NDC Directory endpoint returns data from the NDC Directory, a database that contains information on the National Drug Code (NDC). 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. NovoLogix Carelon Quantity limits . 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 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. 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. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior to chemotherapy and then everyHCPCS Code: • J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: • Imfinzi 120 mg/2. The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. 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. 00 • Submit a valid HCPCS or CPT code in the administrative claim lines (per diem/ nursing), in accordance with your UnitedHealthcare Participation Agreement – An invalid, incorrect or missing NDC will pay at. Request# 20. Dosage Modifications for Adverse Reactions . , 0001-), the 8 or 9 digit NDC Product Code (e. cough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. 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. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . View Imfinzi Injection (vial of 10. A firm. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). 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. 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. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic Licensing Application Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: havediseaseprogressionduringorfollowingplatinum-containingchemotherapy. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. IMFINZI is administered as an intravenous infusion over 1 hour. Finished drug products. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). Covered codes. 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). Until we get public consultationon national Medicare benefit category determinations and payment determinations for these codes, the Medicare benefit category and coverage/paymentdevice category described by HCPCS code C1832 (Auto cell process). Possible side effects . hoarseness, husky, or loss of voice. colitis. More about Imfinzi (durvalumab) Check interactions;Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. It works by helping your immune system fight the cancer cells. com) document for additional details . Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. 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. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. While 21 CFR 801. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. . • Administer IMFINZI as an intravenous infusion over 60 minutes. (2) Each person who is assigned an NDC labeler code must update the information submitted under paragraph (c)(1)of this section within 30 calendar days after any change to that information. through . Biologic and Radiopharmaceutical Drugs Directorate. With IV infusions, the drug is slowly injected. View Imfinzi Injection (vial of 2. See full prescribing information for IMFINZI. 3. PPO . 5 Blepharospasm and G24. 2 8. The list of results will include documents which contain the code you entered. This is not a complete list of side effects and others may occur. 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. RECENT MAJOR CHANGES ----- Indications and Usage (1. HCPCS Code Description J3489 . 90674. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 1, 2019 . Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. 1) Immune-Mediated Hepatitis: Monitor for changes in liver function. S. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. Administer IMFINZI prior to chemotherapy when given on the same day. # Step therapy required through a Humana preferred drug as part of preauthorization. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . The official update of the HCPCS code system is available as a public use file below. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). Trade name: Macrilen . Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. g. For information about Molina pharmacy policies, contact the Pharmacy Department: Phone: (855) 866-5462. Imfinzi durvalumab J9173A. 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. 3. of these codes does not guarantee reimbursement. CanMED: NDC. (2. Updated Nationally Determined Contribution of the Republic of Azerbaijan. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. 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 . It’s given as an IV infusion. feeling cold. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Example 4: When billing a NOC drug. The NDC code would be unique for all of them and can help you distinguish between those result. Store at 2° to 8°C (36° to 46°F). Mechanism of action. Lab tests offered by us. Generic name . S. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. VI. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous Substances: Name: Durvalumab Strength: 500. Attention Pharmacist: Dispense the accompanying Medication. ; This combination may also be used with other drugs or treatments or to treat other types of. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Bahamas Updated. g Medicare requires that you bill code G0008 when billing for the administration of influenza vaccines. 2 DOSAGE AND ADMINISTRATION 2. CPT codes provided in the vaccine code sets are to assist with. 66019-0309-10. 90672. Manufacturer: Octapharma USA, Inc. through . 120 mg/2. The third segment, the package code, identifies package sizes and types. (2. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. 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). CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. 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, 01/17Claims 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, 01/17Weight 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 . 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. Subject: Imfinzi Page: 4 of 4 1. Approval: 2017 . Information last updated by Dr. 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. 5 mL dosage, for. nervousness. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. 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. Mechanism of action. 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. Also include the NDC. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 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. 99214 can be used for an office visit. CPT Code Description. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Influenza HCPCS and CPT Codes. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. 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. The median time to onset was 55. 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. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. The product's dosage form is injection, solution, and is administered via intravenous form. com. 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 Imfinzi belongs to a class of drugs called PD-L1 inhibitors. 2 . 6 mg are administered = 1 unit is billed. The 10-digit NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1, meaning that there are 4 or 5 digits for the labeler code, 4 or 3 digits for the product code and 2 or 1 digit(s) for the package code. 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 . , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. Dossier ID: HC6-024-e195931. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 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. swelling in your arms and legs. FDA Approved: Yes (First approved May 1, 2017) Brand name: Imfinzi Generic name: durvalumab Dosage form: Injection Company: AstraZeneca Treatment for: Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Tumor,. A new formulation to incorporate Omicron strain BA. NDC covered by VFC Program. 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). (2. 2. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Administer IMFINZI as an intravenous. IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. diabetes. The NDC is actually a 10-digit number that contains the three segments noted above. Payers may require the. S. This is not a complete list of. Qualifying notice amendment for Imfinzi. 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. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. 5. 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 patients with extensive-stage small cell lung cancer (ES-SCLC). What IMFINZI is and what it is used for . Medicare BPM Ch 15. FDA approvals of PD-1/PD-L1 mAbs. Payers may require the submission of the 11-digit NDC on health care claim forms, and electronic claims may be denied for drugs billed without a valid 11-digit NDC. 1. Store at 2° to 8°C (36° to 46°F). It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 ( PD-L1 ) with the PD-1 (CD279). Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. To convert a 10-digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to the appropriate segment to create the 11-digit configuration as defined above. 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 (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. . 10 mg vial of drug is administered = 10 units are billed. 5 mL dosage, for. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). It’s given as an IV infusion. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. NDC 0310-4611-50. This medication has been identified as Imfinzi 120 mg/2. Serious side effects reported with use of Imfinzi include: rash*. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. 10-digit, 3-segment number. Additionally, either the long or short description of CPT code 19499 has been updated. Update Feb. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). Imfinzi Generic Name durvalumab Strength 120 mg/2. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 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. Are assigned by the Food and Drug Administration. Durvalumab side effects. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. Covered services will be processed according to the chart below.