com. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. NDC covered by VFC Program. 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. CPT Code Description. Rx only. It applies to all plans except Medicare Supplemental plans. • 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. ( 2. You can search with this number to find the exact drug you have. 1. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior to chemotherapy and then everyHCPCS Code: • J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: • Imfinzi 120 mg/2. The FDA offers an NDC searchable database. 0601C. 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. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. 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. All other Codes (ICD-10, Bill Type, and Revenue) have moved to. Generic name . HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. e. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). 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. IMFINZI works by helping your immune system fight your cancer. Immune-Mediated Dermatology Reactions. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. 90674. NovoLogix Carelon Quantity limits . 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. • 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. Discard unused portion. Example 4: When billing a NOC drug. 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. 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. Vaccine CPT Code to Report. 3) 09/2022 Dosage and Administration (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, 01/17This includes restrictions that may be on a deleted code that are continued with the replacement code(s). Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Current through: 11/21/2023. Last updated on Jun 28, 2023. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. Are assigned by the Food and Drug Administration. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. csv file. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. Use the units' field as a multiplier to arrive at the dosage amount. OUT OF STOCK. The list of results will include documents which contain the code you entered. 2 . skin rash *. 7 6. 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. Billing Code/Availability Information HCPCS:. 1007/s11523-021-00843-0. Imfinzi is a medicine used to treat lung cancer. general feeling of discomfort or illness. National Drug Code (NDC) numbers for use in billing physician-administered drugs, please refer to the . Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 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. 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 . Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. renal dysfunction. Submit PA requests . 10 mg vial of drug is administered = 10 units are billed. Updated Nationally Determined Contribution of the Republic of Azerbaijan. infections. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. The list of results will include documents which contain the code you entered. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 4%) patients. 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). 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. Example claim with HCPCS by itself: HCPCS rate changed 5/19. NDC will change for the 2020-2021 immunization season. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Example: rilpivirine STR=ndc_active_ingredient. Note that not all products and NDCs under their respective CPT codes will be covered. FDA approvals of PD-1/PD-L1 mAbs. This medication can cause rare, but serious immune-related. S. Bahamas Updated. (2. J1745. Vaccine CPT Code to Report. 1%) patient and Grade 3-4 in six (0. The 835 electronic transactions will include the reprocessed claims along with other claims. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Refer to. J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. The NDC code can be found on the outside packaging of the drug. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. AstraZeneca has opted to voluntarily withdraw. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. January 2024 Alpha-Numeric HCPCS Files (ZIP) - Updated 11/21/2023. . 90672. An administration code should always be reported in addition to the vaccine product code. IMFINZI contains the active ingredient durvalumab. 692: 6/30/2023: Merck: 75D30122D14072: Hepatitis A Adult Havrix® 58160-0826-52: 10 pack – 1 dose syringe: $38. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. NDC covered by VFC Program. 6 5. Qualifying notice amendment for Imfinzi. They are owned by CMS and are available for use. 3)]. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. NDC=National Drug 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. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. Generic Name: durvalumab. Food and Drug Administration (FDA) approved AstraZeneca Pharmaceuticals LP Imfinzi to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC) who had not progressed after platinum-based chemotherapy and radiation. Possible side effects . Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . 21. 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. Approval: 2017 total bilirubin elevation. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. (2) Each person who is assigned an NDC labeler code must update the information submitted under paragraph (c)(1)of this section within 30 calendar days after any change to that information. (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. 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. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name Basis of Strength Strength; DURVALUMAB (UNII: 28X28X9OKV) (DURVALUMAB - UNII:28X28X9OKV) DURVALUMAB: 120 mg in 2. IMFINZI in combination with IMJUDO can cause immune-mediated rash or. liver dysfunction. Keep vial in original carton to protect from light. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 2ML. Starting April 19, 2021, a valid National Drug Code (NDC) number, unit of measure, and units dispensed for drugs administered by health care professionals in ambulatory care settings will be required on all professional and facility drug claims. provider administered drugs page 2 of 3 . HCPCS Quarterly Update. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. How do I calculate the NDC units? Billing the correct number of NDC units for the. F. code . # Step therapy required through a Humana preferred drug as part of preauthorization. Vaccine CPT Code to Report. Biologic and Radiopharmaceutical Drugs Directorate. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Injection, zoledronic acid, 1 mg . NDC 0310-4611-50. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. Note that the CPT codes shown are not mapped to the NDC codes, but are mapped to the CVX codes shown. Cart Total. They may not be reported prior to effective date. S. 68 mg/mL). References 1. 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). 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. 2 mL dosage, for intramuscular use. MM. 9 in addition to the appropriate flu vaccine and administration codes. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. nervousness. Last updated by Judith Stewart, BPharm on June 20, 2023. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17Imfinzi belongs to a class of drugs called PD-L1 inhibitors. See . 1 vial = 10 units. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). NDC notation containing asterisks is not accepted. 90674. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). 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. com) document for additional details . LCDC Building. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. 099. 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 . virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m. through . 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). Effective date is noted in the file title. 88 mg/mL meloxicam. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. Durvalumab side effects. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. The product's dosage form is injection, solution and is administered via intravenous form. colitis. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Finished drug products. HCPCS code describes JEMPERLI. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Imfinzi ® J9173. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. English. 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. 1, 2019 . Covered services will be processed according to the chart below. 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. NDC: Imfinzi 120 mg/2. The NDC must follow the 5digit4digit2digit format (11-digit billing format, with no spaces, hyphens or special characters). 3%) patients including fatal pneumonitis in one (0. How do I calculate the NDC units? Billing the correct number of NDC units for the. 68 mg/mL), 4 mg (1. FOLFIRINOX is used to treat: Pancreatic cancer that has metastasized (spread to other parts of the body). Imfinzi [package insert]. Appendix X Revisions Log . Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. • 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. Keep vial in original carton to protect from light. In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. How do I calculate the NDC units? Billing the correct number of NDC units for the. HCPCS code G2012: Brief communication technology-based service, e. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior todue to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . 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. Labeler code portion of NDC; assigned by FDA to firm. 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. 1 unit per 1000 units. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. With IV infusions, the drug is slowly injected. In addition, code G0379 is not separately payable when a critical care service (CPT 99291), clinic service (HCPCS G0463), emergency department visit, or a service assigned a status indicator of T or V under the CMS IOCE are reported on the same date of service. ‡ 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. Updated Nationally Determined Contribution of the Republic of Azerbaijan. Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. The U. This medication has been identified as Imfinzi 120 mg/2. J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. See full prescribing information for IMFINZI. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. See full prescribing information for IMFINZI. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. L. Approval: 2017 . dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . National Comprehensive Cancer Network, Inc. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. 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. 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). 708: 6/30/2023:. 4. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. 31, 2018. Average progression-free survival for the Imfinzi-containing group was 7. Discard unused portion. More common side effects in people taking Imfinzi for small cell lung cancer include. 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. 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. Attention Pharmacist: Dispense the accompanying Medication. 25 mg/mL bupivacaine and 0. 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. Imfinzi comes as a liquid solution in single-dose vials. The NDC is updated daily, this version offered here is from September 6th, 2022. EALTH . 21, including objective evidence of efficacy and safety are met for the proposed indication. NovoLogix Carelon Quantity limits . Below example explain how to assign a labeler code. 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. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. 1) 03/2020 Dosage and Administration, Dosage Modifications (2. FDA publishes the. Code Description Vial size Billing units. Payers may require the. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. com. Chemotherapy: May 7, 2021: Imfinzi and Tremelimumab with Chemotherapy Demonstrated Overall Survival Benefit in POSEIDON Trial for 1st-Line Stage IV Non-Small Cell Lung Cancer: Feb 5. doi: 10. The NDC must be active for the date of service. Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. Report 90461 with 90460 only. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. HMO Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. By blocking these interactions, Imfinzi may help the body’s immune system attack. NDC=National Drug Code. 2. 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 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. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. Medicare BPM Ch 15. Fig. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. Seventeen5. 1, 2019. 21. com. ”. Imfinzi 120 mg/2. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. Bevacizumab should be billed based on units, not total number of milligrams. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. . IMFINZI may be given in combination with otheranti-cancermedicines. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. g Medicare requires that you bill code G0008 when billing for the administration of influenza vaccines. 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. 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). Specifically, we are proposing. Alpha-Numeric HCPCS. 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. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. # Step therapy required through a Humana preferred drug as part of preauthorization. diabetes. (2. This review will provide an update on the regulatory approvals of anti-PD-1/PD-L1 therapeutics along with their companion and complementary diagnostic devices. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. paper. 1) Immune-Mediated Hepatitis: Monitor for changes in liver function. 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. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. # Step therapy required through a Humana preferred drug as part of preauthorization. • Universal product identifier for drugs. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. 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. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. 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 the Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Last updated on emc: 04 Sep 2023. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. Per 2023 CPT/HCPCS updates, HCPCS codes C7501 and C7502 were added to Group 1. Dosage Modifications for Adverse Reactions . Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. National Drug Code Directory. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. 8. 6%). 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. cough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. FDA approvals of PD-1/PD-L1 mAbs. Group 1 Codes. 70461-0321-03. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. Serious side effects reported with use of Imfinzi include: rash*. The current update (2016) adds 34 drugs and includes a review of the 2004 list. Withhold or discontinue IMFINZI to manage adverse. 1 Recommended Dosage. 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,. Example 1: HCPCS description of drug is 6 mg. It is used. and revised HCPCS codes effective April 1, 2022, which include A4238, E2102, K1028-K1033, and V2525. There are 11 disease interactions with Imfinzi (durvalumab) which include: adrenal insufficiency. Subject: Imfinzi Page: 4 of 4 1. These files contain the Level II alphanumeric HCPCS procedure and modifier codes, their long and short descriptions, and applicable Medicare administrative, coverage and pricing data. The official update of the HCPCS code system is available as a public use file below. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). 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. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. Durvalumab (IMFINZI ®), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). One Medicaid unit of coverage is 0. IMFINZI safely and effectively. CPT/HCPCS Codes. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. pneumonitis * ( inflammation of the lungs) hair loss. Pre-Stata13 had a string length limit of 244 characters. The second and third segments of NDC Labeler code are assigned by the labeler. Learn more about how IMJUDO® (tremelimumab-actl) is approved in combination with IMFINZI® (durvalumab) as a treatment option for patients with unresectable HCC and metastatic NSCLC. The U. 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. On the . Injection, infliximab, 10 mg. HCPCS code End-dated Dec. (2. 2 8 8. 100 Eglantine Driveway. HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. Do not freeze or shake. With IV infusions, the drug is slowly injected. Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. View Imfinzi Injection (vial of 2. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. macugen. 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. 6, 2019 retroactive to Jan. Lab tests offered by us. IMFINZI™ (durvalumab) Injection. Ottawa ON K1A 0K9. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. While always displayed as 6 digits in this file; for labeler codes 2 through. What IMFINZI is and what it is used for . STN: BL 125555. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. Imfinzi [package insert].