This medication may cause a serious reaction during the injection. Refer to. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. L. A10. paper. 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. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks Imfinzi (durvalumab) is an immunotherapy used in a variety of cancers, including lung cancer and liver cancer. Current through: 11/21/2023. 100 Eglantine Driveway. Imfinzi is. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. Full prescribing. Images of medication. 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. 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. 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. The next 4 digits identify the specific drug product and are. 5 mL single-dose prefilled syringe [NDC 58160-976-02] Both UoS NDC numbers will map to the same CVX codes. 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). The effective dates for using these documents for clinical reviews are communicated through the provider notification process. 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). 0 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. 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) 96365 - 96368: Intravenous infusion : 96413 - 96417 IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is . 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. Imfinzi ® J9173. 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. 5 mL dosage, for. NDC: 58160-0815-52 (1 dose T-L syringes. 1. 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. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. • Submit the NDC code in the red-shaded portion of the detail line item starting in positions 01 • Precede the NDC with the qualifier N4 and follow it immediately by the 11-digit NDC code (e. • Administer IMFINZI as an intravenous infusion over 60 minutes. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). 20. 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. 5. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Description . swelling in your arms and legs. J0573 All NDCs on this page are reported on claims as J0573 Example: if 24 mg administered, then 4 units submitted NDC # Brand name NDC # Brand name NDC # Brand name NDC # Brand nameprocedure code. The 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). 1 6. The COVID-19 vaccine and administration codes are among 405 editorial changes in the 2022 CPT code set, including 249 new codes, 63 deletions and 93 revisions. Example of NDC Labeler code assignment. 2. fever. Administration codes. See full prescribing information for IMFINZI. The most common side effects that occurred in 20% or more of patients receiving Imfinzi were: fatigue, nausea, constipation, decreased appetite, abdominal pain, rash and fever. 82 due to reconsideration requests. Manufacturer: Octapharma USA, Inc. 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. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . 1 vial = 10 units. (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. Group 1 (9 Codes) Group 1 Paragraph. 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. Medication HCPCS/CPT Code Injection durvalumab, 10 mg J9173 VII. • Should not be assigned to non-drug products. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. ( 2. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. (2. HCPCS code End-dated Dec. Payers may require the. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 7 6. pneumonitis * ( inflammation of the lungs) hair loss. The list of results will include documents which contain the code you entered. 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). Imfinzi [package insert]. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). X 11335. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. 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. This is not a complete list of. colitis. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. 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. Submit PA requests . immune system reactions, which can cause inflammation. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. Per 2023 CPT/HCPCS updates, HCPCS codes C7501 and C7502 were added to Group 1. diabetes. 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. NDC 0310-4611-50. 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. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113. Subject: Imfinzi Page: 4 of 4 1. 66019-0308-10. Email: MHILPharmacy@molinahealthcare. A. The approval was based on data from the Phase III PACIFIC trial. 90658 can be used for the administration of a flu shot. It is used. Contents of the pack and other information . 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. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . 82. With IV infusions, the drug is slowly injected. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. 1 Recommended Dosage . Influenza vaccines are licensed each year with new NDCs, so it is important to report the correct code for the products you are using to avoid having claims deny with edit 00996 (Mismatched NDC) which will require the claim to be resubmitted with the correct. RECENT MAJOR CHANGES ----- Indications and Usage (1. ATC code: L01FF03. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). This HCPCS Code Application Summary document includes a summary of each HCPCS code application discussed at the May 14, 2018 HCPCS Public Meeting for Drugs, Drugs, Biologicals and Radiopharmaceuticals and Radiologic Imaging Agents. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. 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. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. 05 ICD-10-CM. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. How to store IMFINZI . Level I HCPCS (CPT-4 codes) for hospital providers; Level II HCPCS codes for hospitals, physicians and other health professionals who bill Medicare A-codes for ambulance services and radiopharmaceuticals; C-codes; G-codes; J-codes, and; Q-codes (other than Q0163 through Q0181) Formulate and submit the specific question you have. (2. 3. C. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. The 835 electronic transactions will include the reprocessed claims along with other claims. Injection, infliximab, 10 mg. Lab tests offered by us. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . through . View Imfinzi Injection (vial of 10. 6, 2019 retroactive to Jan. Code Description; 90296 Diphtheria antitoxin 90632 - 90634: Hepa vaccine adult im - Hepa vacc ped/adol 3 dose 90675 - 90676: Rabies vaccine im - Rabies vaccine id. Rx only. The first five digits. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Update Feb. 1. NovoLogix Carelon Quantity limits . 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 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. 1) 03/2020 Dosage and Administration, Dosage Modifications (2. , 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. 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. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. 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. HCPCS/CPT Description; G0008: Administration of influenza virus vaccine: 90662: Influenza virus vaccine, split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use: 90672: Influenza virus vaccine, live, quadrivalent, for intranasal use:Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. Depending. 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,. ₹0. , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. 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. swelling in your arms and legs. HCPCS code describes JEMPERLI. 7 months in the control arm, according to an FDA announcement regarding the approval. In addition to the new alternateBe attentive to the long description of the HCPCS code. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. IRST . PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. 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. Use in Cancer. CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. f Represents the 2019-2020 NDC. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. Last updated on emc: 04 Sep 2023. S. Dosage Modifications for Adverse Reactions . Covered codes. A. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. 4ml. 2 DOSAGE AND ADMINISTRATION . 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. HCPCS code G2012: Brief communication technology-based service, e. 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. 3) 03/2020 Dosage and Administration (2. 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. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. This will allow quick identification of new safety information. Associated NDCs . CPT Code Description. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. Identify the manufacturer of the drug. No dose reduction for IMFINZI is recommended. 00. ‡ C9399, J3490 Aralast NP* alpha 1-proteinase inhibitor* J0256 Aranesp* darbepoetin alfa* J0881, J0882 Asceniv* immune globulin* J1554 Asparlas calaspargase pegol-mknl J9118 Atgam lymphocyte immune globulin J7504 Avastin (Authorization required only for. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. Code 91317 for Pfizer-BioNTech COVID-19. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. cough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. 21. The NDC code can be found on the outside packaging of the drug. Qualifying notice amendment for Imfinzi. Specifically, we are proposing. claim form as follows: 1. Preferred product information . 68 mg/mL). [medical citation needed]Durvalumab is an immune checkpoint. EALTH . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 21, including objective evidence of efficacy and safety are met for the proposed indication. Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0. These codes are also located in the Medicine section of the CPT code set. The FDA offers an NDC searchable database. The NDC code would be unique for all of them and can help you distinguish between those result. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic. Finished drug products. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. Related Local Coverage Documents N/A. Indication: Indicated in adults and children with Hemophilia A for: On-demand. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). A unique HCPCS code is needed to implement payment provisions of the Social Security Act. A physician might report code 99213-25 with diagnosis code E11. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. Enter the information on the . CMS Local Coverage Determinations (LCDs) and Articles LCD Article Contractor Medicare Part A Medicare Part B L34648 Bisphosphonate Drug Therapy A56907 Billing and Coding: Bisphosphonate Drug Therapy WPS . The NDC number consists of 11 digits in a 5-4-2 format. Imfinzi durvalumab J9173A. The list of results will include documents which contain the code you entered. NDC units are based on the numeric quantities administered to the patient and the unit of measure (UOM). References 1. IMFINZI is administered as an intravenous infusion over 1 hour. Brand name . Attention Pharmacist: Dispense the accompanying Medication. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. allergic reaction *. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. 10/01/2022 R6 HCPCS J1554 was added to the CPT/HCPCS code section, effective date 4/1/2021. Effective date is noted in the file title. This medication has been identified as Imfinzi 120 mg/2. NDC covered by VFC Program. • Administer IMFINZI as an intravenous infusion over 60 minutes. (2. Formple, exa for *J1094 Injection, dexamethasone acetate, 1 mg the NDC billed should be the one that represents the drug as described in the HCPCS code definition, in this case, dexamethasone acetate. Non-Small Cell Lung Cancer (NSCLC) 1. AstraZeneca has opted to voluntarily withdraw. ‡ motixafortide †,. 2. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. com. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. The National Drug Code (NDC) Directory data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. Continuing therapy with Imfinz will be authorized for 12 months. This is not a complete list of side effects and others may occur. Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ. Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. (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. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. Table 1. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. fatigue (lack of energy) upper respiratory infection such as the common cold. 01 Learn More About Medical Coding Section 2. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. NDC=National Drug Code. The U. 2 8 8. Example: rilpivirine STR=ndc_active_ingredient. 17: $76. The list of results will include documents which contain the code you entered. 4. Page 3 | Imfinzi® (durvalumab) Prior Auth Criteria Proprietary Information. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. 2 SAD Determinations Medicare BPM Ch 15. V. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. 1 unit per 1000 units. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. 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. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. nervousness. S. Claims are priced based on HCPCS or CPT codes and units of service. Serious side effects reported with use of Imfinzi include: rash*. code . 0 Unit: mg/10mL Packages: Code: 00310-4611-50 Description: 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL Effective Date: May 1, 2017 CPT codes covered if selection criteria are met: VENTANA PD-L1 (SP263) Assay - no specific code: Other CPT codes related to the CPB: 96413 - 96417 : Chemotherapy administration; intravenous infusion technique : HCPCS codes covered if selection criteria are met: J9173 : Injection, durvalumab, 10 mg: Other HCPCS codes related to the CPB: C9147 NDC 0310-4500-12. # Step therapy required through a Humana preferred drug as part of preauthorization. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. 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). Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. There are 11 disease interactions with Imfinzi (durvalumab) which include: adrenal insufficiency. 9 in addition to the appropriate flu vaccine and administration codes. Trade Name: IMFINZI. CPT Long Description Change: 78130. View Imfinzi Injection (vial of 2. (2. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 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. Identify the specific product and package size. MM. . csv file. January 2024 Alpha-Numeric HCPCS Files (ZIP) - Updated 11/21/2023. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. CPT/HCPCS Codes. g. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. 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. 90672. 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. J0885. View or. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. It works by helping your immune system fight the cancer cells. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. J1745. Biologic and Radiopharmaceutical Drugs Directorate. PH. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. 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. 4 mL injection. 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. 1 7. Do not freeze or shake. The correct use of an ICD-10-CM code does not assure coverage of a service. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Sean Bohen, MD, Phd. The maximum reimbursement rate per unit is $144. Imfinzi durvalumab J9173. It is a human immunoglobulin G1 kappa. Some packages may display fewer than 11 digits. 3 spasmodic torticollis; payment may be made under off-label use circumstances outlined in Indications and Limitations of the LCD Botulinum Toxin Type A and B Policy (L35170). Tunney’s Pasture, A. physician payment, each CPT code is assigned a point value, known as the relative value unit (RVU), which is part of the formula to determine the payment amount. Cart Total. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. FDA publishes the. HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. 4/BA. A. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking. A new formulation to incorporate Omicron strain BA. They are the basis for your reimbursements. The following CPT codes are to be reported for the procedures performed. Some side effects may occur during the injection. Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. (2. Last updated by Judith Stewart, BPharm on June 20, 2023. Use the units' field as a multiplier to arrive at the dosage amount. 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. X . 1. Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. 1%) patient and Grade 3-4 in six (0. Clinical Studies (14) ]. It applies to all plans except Medicare Supplemental plans. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. 692: 6/30/2023: Merck: 75D30122D14072: Hepatitis A Adult Havrix® 58160-0826-52: 10 pack – 1 dose syringe: $38. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. F. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. IMFINZI safely and effectively. 99397 can be used for a preventive exam if you are over age 65. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. Imfinzi also increased the percentage of patients responding to treatment (68% vs. You can search with this number to find the exact drug you have. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. in a 10-digit format. The product's dosage form is injection, solution and is administered via intravenous. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. liver dysfunction. 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. How do I calculate the NDC units? Billing the correct number of NDC units for the. The radiopharmaceutical can be administered up to 96 hours before the primary procedure. Call your doctor for medical advice about side effects. This corresponded to a. 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. Generic name . 5. # Step therapy required through a Humana preferred drug as part of preauthorization. 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. Fig. 68 mg/mL), 4 mg (1. 150: 33332-0322-03: 0. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. frequent urge to urinate.