Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Possible side effects . 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 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. Imfinzi ® J9173. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. While 21 CFR 801. 1 vial = 10 units. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. The UOM codes are: F2 = international unit. 88 mg/mL meloxicam. 569: $79. 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. IRST . 2021 Nov;16 (6):857-864. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. How do I calculate the NDC units? Billing the correct number of NDC units for the. D. 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. It is a human immunoglobulin G1 kappa. Attention Pharmacist: Dispense the accompanying Medication. IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. allergic reaction *. 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. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 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 . Updated Nationally Determined Contribution of the Republic of Azerbaijan. Please see the HCPCS Quarterly Update webpage for those updates. On the . Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. 00 Inclusive of all taxes. Each 3 mL pre-filled single-patient use pen contains semaglutide 2 mg (0. Prev Section 2. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. One Medicaid unit of coverage is 0. First claim should be billed from 5/1 through 5/2. 120 mg/2. Additionally, either the long or short description of CPT code 19499 has been updated. 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). This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theDurvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Imfinzi is a medicine used to treat lung cancer. Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. 2 . Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Imfinzi belongs to a class of drugs called PD-L1 inhibitors. AstraZeneca has opted to voluntarily withdraw. 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. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. 4/BA. 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. The U. 66019-0308-10. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. claim form as follows: 1. 25 mg/mL bupivacaine and 0. 1, 2019. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. nervousness. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. A. Loncastuximab tesirine is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and. Dosage Modifications for Adverse Reactions . 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 New J codes . ”. 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). NDC Packaging CDC Cost/ Dose Private Sector Cost/ Dose Contract End Date Manufacturer Contract Number; Hepatitis A Adult Vaqta® 00006-4096-02: 10 pack – 1 dose syringe: $38. 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. 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. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic. # Step therapy required through a Humana preferred drug as part of preauthorization. REFERENCES 1. Dosing for infants and children age 6 through 35 months: • Afluria 0. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. Example 3: HCPCS description of drug is 1 mg. The FDA offers an NDC searchable database. 9 in addition to the appropriate flu vaccine and administration codes. Fax: (855) 365-8112. 2. 70461-0322-03. j1726. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Cancer Oncology Rx required. N/A. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. OLORADO . 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 25 mg/mL bupivacaine and 0. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. CPT Code Description. 1 6. 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. 5. What IMFINZI is and what it is used for . A new formulation to incorporate Omicron strain BA. 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 firm. 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. 10 mg vial of drug is administered = 10 units are billed. 692: 6/30/2023: Merck: 75D30122D14072: Hepatitis A Adult Havrix® 58160-0826-52: 10 pack – 1 dose syringe: $38. 10, 2021: NDC requirements have been postponed until 2022. F. 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. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Injection, epoetin alfa (for non-ESRD use), 1000 units. Discard unused portion. 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. Covered codes. 7 months in the placebo group. Choose Generic substitutes to Save up to 50% off. Attention Pharmacist: Dispense the accompanying Medication. 120 mg/2. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. HCPCS code describes JEMPERLI. Sometimes, it’s used together with other immunotherapies and chemotherapy. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. 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. The Clinical Criteria information is alphabetized in the. Below example explain how to assign a labeler code. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. Keep vial in original carton to protect from light. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. L. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. X 11335. 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. The 2022 CPT code set also includes an appendix for one-stop access to all the codes for COVID-19 vaccine reporting. Approval: 2017 . To report via data exchange, providers would report using the NDC code that is specific to the dose administered. 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. Identify the manufacturer of the drug. renal dysfunction. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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 . Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. thyroid disorders. 3. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. Bahamas. 4 mL:The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on the surface of many cancer cells. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. Each single-dose glass vial is filled with a solution of 29. 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. NDC: Imfinzi 120 mg/2. 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). (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). How do I calculate the NDC units? Billing the correct number of NDC units for the. hoarseness, husky, or loss of voice. J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. Example of NDC Labeler code assignment. 2 months, compared to 5. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. 3) 03/2020 Dosage and Administration (2. Some side effects may occur during the injection. • 10/1/17: billing codes updated • 5/1/18: diagnosis codes updated • 1/3/19: updated billing/coding • 3/28/19: no policy changesDurvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation. • 80 mg/4 mL: 50242-135-01 • 200 mg/10 mL: 50242-136- 01 • 400 mg/20 mL: 50242-137-01 Sotrovimab Q: How is Sotrovimab reported via data exchange? A. Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. NDC covered by VFC Program. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. Dossier ID: HC6-024-e195931. Restricted Access – Do not disseminate or copyImfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the. The approval was based on the results of the CASPIAN clinical trial, which showed that. The National Drug Code (NDC) Directory is updated daily. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. Description . Sometimes, it’s used together with other immunotherapies and chemotherapy. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. Patients receiving the three-drug regimen had a median overall survival of 14 months, as compared with 11. Bevacizumab should be billed based on units, not total number of milligrams. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. 1. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. LCDC Building. 2 . 1. List of Vaccine Names, Best ASIIS Selection and CPT/CVX Codes This list matches the vaccine name or codes in Arizona State Immunization Information System (ASIIS) with the brand name or other common names. 2 8. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. UPDATE: On March 27, 2020, the Food and Drug Administration (FDA) approved durvalumab (Imfinzi) to treat small cell lung cancer (SCLC). Under CPT/HCPCS Codes added a new Group 2: Paragraph, Group 2: Codes and added C9467 with “Note: For Part A services only - effective on 04/01/2018”. NDC units are based on the numeric quantities administered to the patient and the unit of measure (UOM). durvalumab injection, for intravenous use (Imfinzi®) 10 mg. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . You may report side effects to FDA at 1-800-FDA-1088. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. doi: 10. aprepitant injection (Cinvanti TM) 1 mg. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. , 0001-), the 8 or 9 digit NDC Product Code (e. 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. . claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. Are the HCPCS/CPT/revenue code units different from the NDC units? Yes, use the HCPCS/CPT/revenue code and service units as you have in the past. Finished drug products. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. By blocking these interactions, Imfinzi may help the body’s immune system attack. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). 21. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. Table 1. com. All other Codes (ICD-10, Bill Type, and Revenue) have moved to. 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. RECENT MAJOR CHANGES ----- Indications and Usage (1. HMO . This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Read it carefully before using this medicine. 90674. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . code . A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. • 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. fatigue (lack of energy) upper respiratory infection such as the common cold. Q: Does the requirement to bill NDCs apply to all plans? A: No. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. 1007/s11523-021-00843-0. Bahamas Updated. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 4 mL injection. The 835 electronic transactions will include the reprocessed claims along with other claims. 5 for the booster vaccine is now being planned. NDC 0310-4611-50. IMFINZI™ (durvalumab) Injection. 2 SAD Determinations Medicare BPM Ch 15. 2. The radiopharmaceutical can be administered up to 96 hours before the primary procedure. 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. A. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. 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 product's dosage form is injection, solution and is administered via intravenous form. This code is effective on 11/1/2018. A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5-3-2 or 6-3-2). [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. Call your doctor for medical advice about side effects. These codes are also located in the Medicine section of the CPT code set. One drug can be associated with any number of ingredients. , "in use" labeling). 90716 can be used for the administration of the chickenpox vaccine (varicella) 12002 can be used when a healthcare provider stitches up a 1-inch cut on your arm. g. 31, 2018. 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, 01/175. N/A. 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. Imfinzi [prescribing information]. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. Information last updated by Dr. 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. The first five digits. J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. Generic Name: durvalumab. Serious side effects reported with use of Imfinzi include: rash*. 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. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. com) document for additional details . While always displayed as 6 digits in this file; for labeler codes 2 through. 5 days (range: 24-423 days). 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 . Imfinzi (durvalumab) may be considered medically necessary for the treatment of adults with: • Unresectable, stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy • First-line treatment of extensive-stage small cell lung cancerThe HIPAA standard 11-digit NDC format is standardized such that the labeler code is always 5 digits, the product code is always 4 digits, and the package code always 2 digits. 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. 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). Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. This will allow quick identification of new safety information. (2. The FDA assigns the labeler code, while the company assigns the product and package code. 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. NDC covered by VFC Program. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. csv file. 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. Abilify MyCite Kit (aripiprazole with biosensor)- (Medical Necessity) Actemra (tocilizumab). 5. 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. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Keep vial in original carton to protect from light. J0885. 200 mg are administered = 4 units are billed. 2. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theImfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics. Claims are priced based on HCPCS or CPT codes and units of service. Administer IMFINZI prior to chemotherapy when given on the same day. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. Group 1 Codes. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. Alpha-Numeric HCPCS. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. This medication has been identified as Imfinzi 120 mg/2. . Imfinzi disease interactions. (B) 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). (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. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). com. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 24 participants with Non-Small Cell Lung Cancer will be. 70461-0321-03. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). Administer IMFINZI prior to chemotherapy when given on the same day. Revised: 03/2021 Page 2 . 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). 82. Code Description Vial size Billing units. NDC=National Drug Code. The NDC Packaged Code 0310-4611-50 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. Administer IMFINZI as an intravenous. 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. It is important to note that this code represents 1/10th of a vial. Imfinzi durvalumab J9173A. The product's dosage form is injection, solution and is administered via intravenous. Example: rilpivirine STR=ndc_active_ingredient. active_ingredient: BN:. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Effective Jan. 3) 09/2022 Dosage and Administration (2. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) / 2. A. 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. The third segment, the package code, identifies package sizes and types. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. IMFINZI™. 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 . 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 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. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. Both the product and package codes are assigned by the firm. What is National Drug Code (NDC)? • A unique . It’s given as an IV infusion. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. 5 mL single-dose prefilled syringe [NDC 58160-976-02] Both UoS NDC numbers will map to the same CVX codes. IMFINZI safely and effectively. first two segments of the National Drug Code: NDC 3 segment: 0781-1506-10; 60429-324-77; 11523-7020-1; three segment format of the National Drug Code. (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.