02 Medical Coding Vocabulary & Key Terms Section 2. thyroid disorders. Imfinzi [package insert]. The new formulation the. Marketing Approval Date: 03/27/2020. • Administer IMFINZI as an intravenous infusion over 60 minutes. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. 50. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 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. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. 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. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. 2. This is not a complete list of side effects and others may occur. OLORADO . 3) 09/2022 Dosage and Administration (2. J0185. The remaining digits. Lab tests offered by us. Use in Cancer. • Universal product identifier for drugs. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. The official update of the HCPCS code system is available as a public use file below. 5. 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. The list of results will include documents which contain the code you entered. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). All existing CPT codes that describe COVID-19 vaccine products and associated administration codes that end in “A” for products that are no longer covered under an existing Emergency Use. Depending. Get this at ₹37,310. One drug can be associated with any number of ingredients. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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 . # Step therapy required through a Humana preferred drug as part of preauthorization. The NDC is updated daily, this version offered here is from September 6th, 2022. (2. The U. How to store IMFINZI . The median time to onset was 55. L. 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). 6%). Finished drug products. Please see the HCPCS Quarterly Update webpage for those updates. Loncastuximab tesirine is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and. They are the basis for your reimbursements. Associated Documents. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Each provider is responsible for ensuring all. The approval was based on the results of the CASPIAN clinical trial, which showed that. 3%) patients including fatal pneumonitis in one (0. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. 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. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. This code is effective on 11/1/2018. Be attentive to the long description of the HCPCS code. The 835 electronic transactions will include the reprocessed claims along with other claims. 5 Blepharospasm and G24. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. 90674. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 2. HMO . 2ML. HCPCS code describes JEMPERLI. View or. Rx only. • 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). Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 24 participants with Non-Small Cell Lung Cancer will be. See . Proper Name: Antihemophilic Factor (Recombinant) Tradename: NUWIQ. 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. Durvalumab side effects. This medication can cause rare, but serious immune-related. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Imfinzi [package insert]. 66019-0308-10. 7 6. 68 mg/mL). Active. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. 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 . Report 90461 with 90460 only. Manufacturer: Octapharma USA, Inc. 2 mL dosage, for intramuscular use. Per 2023 CPT/HCPCS updates, HCPCS codes C7501 and C7502 were added to Group 1. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. g. Effective Jan. 2 8 8. headache. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. 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. 1 Recommended Dosage. 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. The NDC Number for each drug will be different. Store at 2° to 8°C (36° to 46°F). IMFINZI may cause serious or life threatening infusion reactions and infections. 099. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. 1 Recommended Dosage . IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). Brand name . 2. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). 3 CWF shall send/display data in separate records for Dates of Service (DOS) and NPI of each PPV HCPCS codes (90670 and 90732) from new Auxiliary to: •The third set of digits is the package code, which identifies package sizes and types. 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. Finished drug products. claim form as follows: 1. doi: 10. 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. View Imfinzi Injection (vial of 2. Attention Pharmacist: Dispense the accompanying Medication. How do I calculate the NDC units? Billing the correct number of NDC units for the. 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). A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. 11: HCPCS Codes HCPCS codes are a vital part of the coding 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. Update Feb. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. Each single-dose glass vial is filled with a solution of 29. The NDC is actually a 10-digit number that contains the three segments noted above. Use the units' field as a multiplier to arrive at the dosage amount. 4 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. X 11335. Attention Pharmacist: Dispense the accompanying Medication. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). FOLFIRINOX is used to treat: Pancreatic cancer that has metastasized (spread to other parts of the body). Group 1. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. 25 mg/mL bupivacaine and 0. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. EALTH . See full prescribing information for IMFINZI. You should be sure to bill 10 units of J1745 on the claim form when indicating that a single 100-mg vial of REMICADE® was used. 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. 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 . 3. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. An administration code should always be reported in addition to the vaccine product code. MM. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. 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. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. of these codes does not guarantee reimbursement. 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. The National Drug Code (NDC) is the number which identifies a drug. 5. Mechanism of action. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. IMFINZI contains the active ingredient durvalumab. Last updated on Jun 28, 2023. swelling in your arms and legs. 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. CPT Code Description. The current update (2016) adds 34 drugs and includes a review of the 2004 list. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. 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. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). Claims are priced based on HCPCS or CPT codes and units of service. The NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code. Approval: 2017 . 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. References . May 2021. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. How do I calculate the NDC units? Billing the correct number of NDC units for the. 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). After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. The NDC is 00024-5841-01 (the qualifier is N4) The unit of measure is ML The quantity (number of NDC units administered ) is 16 The quantity (number of J-code units administered) is 1 The price per unit also must be included On the CMS-1500, the data would be entered as follows: N400024584101 ML16 480. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. , N412345678901) When entering supplemental information for NDC, add in the following order: – N4 qualifier – 11-digit NDC code – 1 spaceQ: Why is anNDC needed when drugs are already being billed with HCPCS codes? A: Billing NDCs for shared HCPCS drug codes and NOC drug codes provides the ability to determine precisely which drugs are administered. 4. By blocking these interactions, Imfinzi may help the body’s immune system attack. 90674. Updated Nationally Determined Contribution of the Republic of Azerbaijan. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 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. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. 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. 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. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . Restricted Access – Do not disseminate or copyThe Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U. 1 unit per 1000 units. renal dysfunction. • Should not be assigned to non-drug products. Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). To report via data exchange, providers would report using the NDC code that is specific to the dose administered. When IMFINZI is administered in combination with chemotherapy, r efer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosni g informaoit n. 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). 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. 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. IMFINZI in combination with IMJUDO can cause immune-mediated rash or. 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 may be given in combination with otheranti-cancermedicines. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. 99214 can be used for an office visit. for people with locally advanced or metastatic bladder cancer. 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. Identify the specific product and package size. J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. They are owned by CMS and are available for use. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). # Step therapy required through a Humana preferred drug as part of preauthorization. This corresponded to a. ; This combination may also be used with other drugs or treatments or to treat other types of. V. A. pneumonitis * ( inflammation of the lungs) hair loss. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. PPO . 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). Injection, zoledronic acid, 1 mg . J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. How you are given IMFINZI . National Drug Code Directory. Brand Generic Codes Amvuttra vutrisiran J0225 Aphexda †,. 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. 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. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Code Description Vial size Billing units. 05 ICD-10-CM. A firm. (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. 2. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. No dose reductions are recommended. 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. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. 1. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). Bevacizumab should be billed based on units, not total number of milligrams. IMFINZI is a monoclonal antibody, a type of protein. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 1, 2019. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). 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. Pre-Stata13 had a string length limit of 244 characters. CPT Code Description. Rx only. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. 00 17. Average progression-free survival for the Imfinzi-containing group was 7. (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. 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). Additionally, either the long or short description of CPT code 19499 has been updated. 3. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. com. NCCN Drugs & Biologics Compendium ® Imfinzi. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 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). Expand All | Collapse All. Vaccine CPT Code to Report. NDC: 58160-0815-52 (1 dose T-L syringes. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Appendix X Revisions Log . The 835 electronic transactions will include the reprocessed claims along with other claims. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 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. 5 mL dosage, for. Imfinzi Generic Name durvalumab. Imfinzi will be authorized for 6 months when criteria for initial approval are met. This medicinal product is subject to additional monitoring. IMFINZI safely and effectively. 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. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. If you have any questions about these medicines, ask your doctor. 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. 5. Use the units' field as a multiplier to arrive at the dosage amount. It is used. 00. 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. 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. Contents of the pack and other information . PPENDIX . Example 1: HCPCS description of drug is 6 mg. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. 00 Inclusive of all taxes. Discard unused portion. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. Below example explain how to assign a labeler code. The product's dosage form is injection, solution, and is administered via intravenous form. 10, 2021: NDC requirements have been postponed until 2022. fever. IMFINZI is administered as an intravenous infusion over 1 hour. The product's dosage form is injection, solution and is administered via intravenous form. View Imfinzi Injection (vial of 10. 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. 1 mL; The maximum reimbursement rate per unit is: $0. 10/01/2022 R6 HCPCS J1554 was added to the CPT/HCPCS code section, effective date 4/1/2021. 2) 0X/2020Admni siter IMFINZI proi r to chemothearpy on the same day . National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. Generic Name: durvalumab. Do not freeze or shake. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. One Medicaid unit of coverage is 0. immune system reactions, which can cause inflammation. Control #:. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 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"). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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. 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). With IV infusions, the drug is slowly injected. j1726. (2. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 82 due to reconsideration requests. 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 code describes JEMPERLI. 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. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. 6 5. Do not report 90460, 90471-90474 for the administration of COVID vaccines. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17ATC code: L01FF03. They may not be reported prior to effective date. Generic name . 31, 2018. liver dysfunction. 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 All 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. A new formulation to incorporate Omicron strain BA. NDC notation containing asterisks is not accepted. 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. HCPCS Level II Code. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. See full prescribing information for IMFINZI. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. Code 91317 for Pfizer-BioNTech COVID-19. Example NDC. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. Submit PA requests . The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. . 90672. 150: 33332-0322-03: 0. Choose Generic substitutes to Save up to 50% off. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. com) document for additional details . Bahamas. IMFINZI. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. Keep vial in original carton to protect from light. g. skin rash *. 4/BA. 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. National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. The third segment, the package code, identifies package sizes and types. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. 1) 03/2020 Dosage and Administration, Dosage Modifications (2. S. Sean Bohen, MD, Phd. # Step therapy required through a Humana preferred drug as part of preauthorization. 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.