No dose reductions are recommended. . 21. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 24 participants with Non-Small Cell Lung Cancer will be. 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 unit per 1000 units. 5 for the booster vaccine is now being planned. (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. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. 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. Rx only. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. 2 months, compared to 5. It will be listed in one of the following configurations: 4-4-2: for example,. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. 4%) patients. 21. The National Library of Medicine (NLM)’s DailyMed searchable database provides the most recent labeling submitted to the Food and Drug Administration (FDA) by companies and currently in use (i. Discard unused portion. CPT/HCPCS Codes. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. Varun Gupta, MD Pharmacology on 5th Sep 2023. 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. 2 . Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated appr oval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. Sometimes, it’s used together with other immunotherapies and chemotherapy. HCPCS Code Description J3489 . The NDC must follow the 5digit4digit2digit format (11-digit billing format, with no spaces, hyphens or special characters). 82. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. com) document for additional details . Code Description Vial size Billing units NDCThis PDF document provides the full prescribing information for JYNARQUE (tolvaptan), a drug used to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 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. 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,. With IV infusions, the drug is slowly injected. 2. Under CPT/HCPCS Codes Group 10: Codes added HCPCS code J9033. active_ingredient: BN:. Report 90461 with 90460 only. (2. 00 17. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. REFERENCES 1. Dosage Modifications for Adverse Reactions . 150: 33332-0322-03: 0. 70461-0322-03. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. Choose Generic substitutes to Save up to 50% off. 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. Code Description; 90296 Diphtheria antitoxin 90632 - 90634: Hepa vaccine adult im - Hepa vacc ped/adol 3 dose 90675 - 90676: Rabies vaccine im - Rabies vaccine id. , "in use" labeling). code . 10, 2021: NDC requirements have been postponed until 2022. Full prescribing. Example of NDC Labeler code assignment. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. Accessed on May 11, 2021. Code Description. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. 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. aprepitant injection (Cinvanti TM) 1 mg. 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. trouble. CPT Long Description Change: 78130. On the . IMFINZI contains the active ingredient durvalumab. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. Fax: (855) 365-8112. Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 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. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. 70461-0321-03. (2. skin rash *. NDC notation containing asterisks is not accepted. Covered services will be processed according to the chart below. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. durvalumab injection, for intravenous use (Imfinzi®) 10 mg. 6, 2019 retroactive to Jan. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. (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. and revised HCPCS codes effective April 1, 2022, which include A4238, E2102, K1028-K1033, and V2525. S. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. J0185. Approval: 2017 total bilirubin elevation. Associated NDCs . (2. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. Imfinzi Generic Name durvalumab Strength 120 mg/2. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 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. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. The National Drug Code (NDC) Directory data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). IMFINZI is a prescription medicine used to treat different types of cancer, such as lung, bladder, and liver cancer. 1)] and 266 patients with ES-SCLC in CASPIAN who received up to four. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. Imfinzi comes as a liquid solution in single-dose vials. A. For the following HCPCS codes either the short description and/or the long description was changed. 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. 3 spasmodic torticollis; payment may be made under off-label use circumstances outlined in Indications and Limitations of the LCD Botulinum Toxin Type A and B Policy (L35170). 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. 89 and G61. HCPCS / NDC Crosswalk for Billing Physician-administered Drugs on the Provider Services Billing Manuals page. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. NDC=National Drug Code. 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. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. j1726. Information last updated by Dr. Each single-dose glass vial is filled with a solution of 29. • 300 mg (NDC 0024-5914-00) • 200 mg (NDC 0024-5918-00) • 100 mg (NDC 0024-5911-00) Pre-filled pen: • 300 mg (NDC 0024-5915-00). PH. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . 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"). Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. CPT Codes / HCPCS Codes / ICD-10 Codes ; Code Code Description; Other CPT codes related to the CPB: 81235: EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) 96365 - 96368: Intravenous infusion : 96413 - 96417 IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is . Use the units' field as a multiplier to arrive at the dosage amount. 8. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Are assigned by the Food and Drug Administration. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. More common side effects in people taking Imfinzi for non-small cell lung cancer include: cough*. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Imfinzi [package insert]. CPT Code Description. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. It is used. Read it carefully before using this medicine. X . This medicinal product is subject to additional monitoring. FDA approvals of PD-1/PD-L1 mAbs. PPO . 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. 5. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. 100 Eglantine Driveway. pneumonitis * ( inflammation of the lungs) hair loss. 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. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous Substances: Name: Durvalumab Strength: 500. 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. 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. Sean Bohen, MD, Phd. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 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. Mechanism of action. 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. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). Use the units' field as a multiplier to arrive at the dosage amount. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination Under CPT/HCPCS Codes Group 27: Codes deleted HCPCS code C0938 and added J9204. 708: 6/30/2023:. 6 5. g. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. Submit PA requests . trouble breathing. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 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 . Prev Section 2. liver dysfunction. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. claim form as follows: 1. HCPCS code End-dated Dec. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. 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. Generic name . JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. 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. L. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. 00 • Submit a valid HCPCS or CPT code in the administrative claim lines (per diem/ nursing), in accordance with your UnitedHealthcare Participation Agreement – An invalid, incorrect or missing NDC will pay at. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. 2 DOSAGE AND ADMINISTRATION 2. 3. IMFINZI. ; This combination may also be used with other drugs or treatments or to treat other types of. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). Discard unused portion. Payers may require the. This study has 2 parts: dose finding and dose confirmatory. 1%) patient and Grade 3-4 in six (0. What IMFINZI is and what it is used for . Report 90472 and 90473 in addition to 90460 or 90471 or 90473. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. Yes. 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. Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. Fig. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. 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). 120 mg/2. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. 1 mL. Possible side effects . One drug can be associated with any number of ingredients. 2. It provides the criteria used to determine the medical necessity of hospital outpatient administration as the site of service for identified specialty medications (See Site of Care for Specialty Drug Infusion/Injection applicable drug therapy below. Bevacizumab should be billed based on units, not total number of milligrams. Injection, zoledronic acid, 1 mg . (2. 58 g/mol. What is National Drug Code (NDC)? • A unique . NovoLogix Carelon Quantity limits . 1 mL; The maximum reimbursement rate per unit is: $0. No needle) 90636: 104 MenHibrix (VFC) Meningococcal C/Y-HIB PRP 6 weeks -. These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma. Q4132 Grafix core and GrafixPL core, per square centimeter Q4133 Grafix prime and GrafixPL prime, per square centimeter Q4137 Amnioexcel or BioDExCel, per square centimeter Q4138 Biodfence Dryflex, per square centimeterThe following HCPCS codes have been added to the Article: Q5127 and Q5130 in the ‘Subcutaneous and Intramuscular Injection Non-Chemotherapy-Generic/Trade Names Table’ and in the ‘Group 1 CPT/HCPCS Codes Table’. 1 vial = 10 units. 90674. References . 6 mg are administered = 1 unit is billed. 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). V. g. 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). Last updated by Judith Stewart, BPharm on June 20, 2023. 5 mL dosage, for. Cart Total. 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). Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. All other Codes (ICD-10, Bill Type, and Revenue) have moved to. 2. Fig. It is a human immunoglobulin G1 kappa. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. immune system reactions, which can cause inflammation. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 with the PD-1 (CD279). For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. Vaccine CPT Code to Report. Administer IMFINZI prior to chemotherapy when given on the same day. Example 1: HCPCS description of drug is 6 mg. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. They may not be reported prior to effective date. The FDA offers an NDC searchable database. The NDC code can be found on the outside packaging of the drug. F. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. , N412345678901) When entering supplemental information for NDC, add in the following order: – N4 qualifier – 11-digit NDC code – 1 spaceQ: Why is anNDC needed when drugs are already being billed with HCPCS codes? A: Billing NDCs for shared HCPCS drug codes and NOC drug codes provides the ability to determine precisely which drugs are administered. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. 5. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Update Feb. IMFINZI is administered as an intravenous infusion over 1 hour. They are owned by CMS and are available for use. Request# 20. Email: MHILPharmacy@molinahealthcare. Please see the HCPCS Quarterly Update webpage for those updates. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. 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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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. Imfinzi durvalumab J91731All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. 2 DOSAGE AND ADMINISTRATION 2. NCCN Drugs & Biologics Compendium ® Imfinzi. How do I calculate the NDC units? Billing the correct number of NDC units for the. PPENDIX . 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. The first five digits. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. It showed an. FDA publishes the. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. Enter the information on the . Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. The list of results will include documents which contain the code you entered. The safety and tolerability of the Imfinzi combination was consistent with previous. 99397 can be used for a preventive exam if you are over age 65. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. Current through: 11/21/2023. Effective Jan. PD-L1 can be induced by inflammatory signals (e. Durvalumab (Imfinzi) has been granted a. 1) Immune-Mediated Hepatitis: Monitor for changes in liver function. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. Example 3: HCPCS description of drug is 1 mg. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Recommended dose of IMFINZImonotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced. Influenza HCPCS and CPT Codes. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 4 OVERDOSE 10 DESCRIPTION 12 12. 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. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 1 7. Report code only with appropriate primary procedure. 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). On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. One Medicaid unit of coverage is 0. Imfinzi durvalumab J9173A. • Should not be assigned to non-drug products. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. 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. Simply add items worth ₹1499 to your cart & use the applicable coupon at checkout!eviCore healthcare will reimburse HCPCS codes A9587 and A9588 when used in conjunction with a PET scan, an appropriate diagnosis and an invoice for the radiopharmaceutical. IMFINZI works by helping your immune system fight your cancer. Influenza vaccines are licensed each year with new NDCs, so it is important to report the correct code for the products you are using to avoid having claims deny with edit 00996 (Mismatched NDC) which will require the claim to be resubmitted with the correct. The NDC is actually a 10-digit number that contains the three segments noted above. Both the product and package codes are assigned by the firm. Imjudo (tremelimumab) is given for one cycle followed by single agent Imfinzi (durvalumab). Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. Specifically, we are proposing. 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. (2. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. The member's specific benefit plan determines coverage. 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. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. Appendix X Revisions Log . AstraZeneca has opted to voluntarily withdraw. LCDC Building. 1007/s11523-021-00843-0. Example NDC. Withhold or discontinue IMFINZI to manage adverse. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 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. The FDA has approved updated labeling for Imfinzi (durvalumab; AstraZeneca) to include overall survival data for patients with unresectable, Stage III non-small cell lung cancer (NSCLC). 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 . dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. pneumonitis * ( inflammation of the lungs) hair loss. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. The Clinical Criteria information is alphabetized in the. 3) 09/2022 Dosage and Administration (2. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686.