Identify the specific product and package size. 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 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. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). 1, 2019. 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 . The UOM codes are: F2 = international unit. diabetes. OLORADO . Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. 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"). DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. 3. This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. 708: 6/30/2023:. or HCPCS Codes and/or How to Obtain Prior Authorization . 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. 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. Imfinzi will be authorized for 6 months when criteria for initial approval are met. This is not a complete list of. The NDC code can be found on the outside packaging of the drug. (2. 2 months, compared to 5. The file contains the following drug information: • NDCPackageCode (Column A): The labeler code, product code, and package code segments of the NDC number, separated by hyphens per FDA website. Imfinzi [prescribing information]. They may not be reported prior to effective date. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. Format revision completed. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. 4 mL single-dose vial: 00310-4500-xx • Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx VII. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. T-MSIS data elements NDC-UNIT-OF-MEASURE (CIP285, CLT229, or COT224) and NDC-QUANTITY (CIP278, CLT230, or COT225) are only applicable to and therefore reported in the IP, LT, and OT files when a value is reported to the NATIONAL-DRUG-CODE data element (CIP284, CLT228, or COT217). The National Drug Code (NDC) Directory is updated daily. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. A10. Approval: 2017 . com. C. This medication has been identified as Imfinzi 120 mg/2. code . Example claim with HCPCS by itself: HCPCS rate changed 5/19. IMFINZI™ (durvalumab) Injection. 5 mL dosage, for. Specifically, we are proposing. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. aprepitant injection (Cinvanti TM) 1 mg. com. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. Cancer Oncology Rx required. The FDA offers an NDC searchable database. 10/01/2022 R5 Eff 10/1/2022: Per CR12973 added DX D81. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Weight less than 30 kg: Imfinzi 20 mg/kg IV given with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . muscle cramps and stiffness. What IMFINZI is and what it is used for . IMFINZI works by helping your immune system fight your cancer. STN: BL 125555. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. View Imfinzi Injection (vial of 10. 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. 99214 can be used for an office visit. 1. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. NCCN Drugs & Biologics Compendium ® Imfinzi. NovoLogix Carelon Quantity limits . 1007/s11523-021-00843-0. 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. Preferred product information . 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. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 5. 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. 21. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. 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. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. g. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. 1 8. Mechanism of action. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. com) document for additional details . Table 1. com) document for additional details . 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. fatigue (lack of energy) upper respiratory infection such as the common cold. 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. Group 1. The new formulation the. Moderna Statement: “NDC codes 80777-280-99 and 80777-280-05 were provided in anticipation of FDA authorization under EUA for a bivalent booster vaccine (Moderna COVID-19 Vaccine, Bivalent). Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. Do not freeze or shake. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. S. Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). 1 unit per 1000 units. 2. Injection, infliximab, 10 mg. NDC 0310-4611-50. Approval: 2017 . . The NDC number consists of 11 digits in a 5-4-2 format. 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. By blocking these interactions, Imfinzi may help the body’s immune system attack. 099. 120 mg/2. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. 1. On the . UPDATE: On March 27, 2020, the Food and Drug Administration (FDA) approved durvalumab (Imfinzi) to treat small cell lung cancer (SCLC). , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. 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. (2. 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). Medicare BPM Ch 15. The 835 electronic transactions will include the reprocessed claims along with other claims. View or. 1)] Grade 2 Withhold doseb Initial dose of 1mg/kg/day to 2mg/kg/day prednisone or equivalent followed by a taper Grade 3 or 4. For information about Molina pharmacy policies, contact the Pharmacy Department: Phone: (855) 866-5462. 3) 09/2022 Dosage and Administration (2. com Abecma (idecabtagene vicleucel) MCP. swelling in your arms and legs. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Pre-Stata13 had a string length limit of 244 characters. 3%) patients including fatal pneumonitis in one. Current through: 11/17/2023. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Each single-dose glass vial is filled with a solution of 29. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. g. The median time to onset was 55. 100 Eglantine Driveway. 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). Adding National Drug Codes (NDC) to ClaimsIMFINZI 120mg Injection 2. 90674. IMFINZI is a prescription medicine used to treat different types of cancer, such as lung, bladder, and liver cancer. 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. S. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 90672. 4 mg/kg at Day 1 of Cycle 1; •. Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing. View Imfinzi Injection (vial of 2. Format of NDC: Under the proposed rule, the NDC would remain a three-segment numerical code consisting of the labeler code, the product code, and the package code. 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. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 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. Non-Small Cell Lung Cancer (NSCLC) 1. Both the product and package codes are assigned by the firm. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. 2 8 8. HCPCS code G2012: Brief communication technology-based service, e. 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. 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 . (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. ‡ 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. Update Feb. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). Trade Name: IMFINZI. Choose Generic substitutes to Save up to 50% off. pneumonitis * ( inflammation of the lungs) hair loss. Example 3: HCPCS description of drug is 1 mg. Code Description Vial size Billing units. The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). Epub 2021 Nov 3. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. skin rash *. 3)]. No dose reductions are recommended. See . The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. A. 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. 70461-0321-03. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. IMFINZI. 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. It works by helping your immune system fight the cancer cells. 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. Get help with Imprint Code FAQs. Refer to. Submit PA requests . Sometimes, it’s used together with other immunotherapies and chemotherapy. (NDC 0310-4611-50) 120 mg/2. 47426-0201-01 The pooled safety population (N = 596) described in the Warnings and Precautions section reflect exposure to IMFINZI 1,500 mg in combination with tremelimumab-actl 75 mg and histology-based platinum chemotherapy regimens in 330 patients in POSEIDON [see Clinical Studies (14. 1 vial = 10 units. 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. This will allow quick identification of new safety information. NDC: 58160-0815-52 (1 dose T-L syringes. Approval: 2017 total bilirubin elevation. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. HCPCS code describes JEMPERLI. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . 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. NDC will change for the 2020-2021 immunization season. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. 99397 can be used for a preventive exam if you are over age 65. 00. 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. See full prescribing information for IMFINZI. of these codes does not guarantee reimbursement. Generic name . Marketing Approval Date: 03/27/2020. NDC=National Drug Code. [medical citation needed]Durvalumab is an immune checkpoint. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. It is important to note that this code represents 1/10th of a vial. The following table shows common 10-digit National Drug Code (NDC) formatsYescarta is billed using HCPCS code Q2041 – Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per2. and revised HCPCS codes effective April 1, 2022, which include A4238, E2102, K1028-K1033, and V2525. 8. Tunney’s Pasture, A. IMFINZI safely and effectively. Indications and Usage (1. Yes. National Drug Code Directory. A new formulation to incorporate Omicron strain BA. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. 21. Revised: 03/2021 Page 2 . Example NDC. The list of results will include documents which contain the code you entered. Control #:. 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. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. National Drug Code (NDC) numbers for use in billing physician-administered drugs, please refer to the . Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. HCPCS Level II Code. 89 and G61. 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. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. Withhold or discontinue IMFINZI to manage adverse. 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. FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. 5. Enter the information on the . 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. Example 1: HCPCS description of drug is 6 mg. 70461-0322-03. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. skin rash *. ( 2. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. 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. If the intent of the IIS is to capture the specific NDC, an IIS could access the provider’s order (VTrckS ExIS shipment data) to identify theCoding. 68 mg/mL). This study has 2 parts: dose finding and dose confirmatory. 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). headache. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. Rx only. 25 mg/mL bupivacaine and 0. 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 . 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. Proper Name: Antihemophilic Factor (Recombinant) Tradename: NUWIQ. The first five digits. general feeling of discomfort or illness. through . Updated Nationally Determined Contribution of the Republic of Azerbaijan. Date Article; Nov 11, 2022: Approval Imfinzi and Imjudo with Chemotherapy Approved in the US for Patients with Metastatic Non-Small Cell Lung Cancer: Oct 24, 2022: Approval FDA Approves Imjudo (tremelimumab) in Combination with Imfinzi for Patients with Unresectable Hepatocellular Carcinoma: Sep 11, 2022: Imfinzi and Tremelimumab. for people with locally advanced or metastatic bladder cancer. Durvalumab side effects. D. 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. code . Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. claim form as follows: 1. Tell your doctor. 17: $76. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. IMFINZI is a monoclonal antibody, a type of protein. HCPCS codes are reported by the physician, hospital or DME provider that purchased the item, device, or supply. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. S. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. • Administer IMFINZI as an intravenous infusion over 60 minutes. 00 17. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. 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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Payers may require the. 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,. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). A physician might report code 99213-25 with diagnosis code E11. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 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). ES-SCLC: Until disease progression, unacceptabletoxicity. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and. 6, 2019 retroactive to Jan. One Medicaid unit of coverage is 0. com. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. NDC=National Drug Code. Generic name: durvalumab [ dur-VAL-ue-mab ] Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Medically reviewed by. While 21 CFR 801. The current update (2016) adds 34 drugs and includes a review of the 2004 list. VI. Abilify MyCite Kit (aripiprazole with biosensor)- (Medical Necessity) Actemra (tocilizumab). The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Imfinzi 120 mg/2. Vaccine CPT Code to Report. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 94 Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 13, 2020 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatcough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. FDA approvals of PD-1/PD-L1 mAbs. S. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. A. 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). Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. Rx only. V. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). 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. Table 1. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking. Active. Lab tests offered by us. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Vaccine CPT Code to Report. Keep vial in original carton to protect from light. Biologic and Radiopharmaceutical Drugs Directorate. Each provider is responsible for ensuring all. Imfinzi [package insert]. 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. Store at 2° to 8°C (36° to 46°F). 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. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Be attentive to the long description of the HCPCS code. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. A: Yes, the NDC information must be submitted in addition to the applicable HCPCS, CPT or Revenue code(s) and the number of HCPCS, CPT or Revenue code units. First claim should be billed from 5/1 through 5/2. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. Applicable Procedure Codes J9173 Injection, durvalumab, 10mg, 1 billable unit = 10mg Applicable NDCs 0310-4611-50. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. You can search with this number to find the exact drug you have. 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). COVID -19 Related Codes U0001 CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel COVID-19 U0002 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC) COVID-19CODE=ndc_active_ingredient. 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. Use the units' field as a multiplier to arrive at the dosage amount. Administer IMFINZI prior to chemotherapy when given on the same day. Last updated on Jun 28, 2023. 4. 5. NDC=National Drug Code. 90674. 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. Additionally, either the long or short description of CPT code 19499 has been updated. Continuing therapy with Imfinz will be authorized for 12 months. 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. The NDC is updated daily, this version offered here is from September 6th, 2022. 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. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. Are specific to the drug itself. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. PH. Discard unused portion. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has updated its list of hazardous drugs for 2016.