CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. Store at 2° to 8°C (36° to 46°F). aprepitant injection (Cinvanti TM) 1 mg. 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). or HCPCS Codes and/or How to Obtain Prior Authorization . What you need to know before you are given IMFINZI . Subject: Imfinzi Page: 4 of 4 1. Expand All | Collapse All. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). Example: rilpivirine STR=ndc_active_ingredient. 21. OUT OF STOCK. 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. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days Xolair omalizumab 600 mg J2357 120 HCPCS units (5 mg per unit) Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit) Libtayo cemiplimab-rwlc 350 mg J9119 350 HCPCS units (1 mg per unit) Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 Immune globulin subcutaneous (Human), 20 Percent solution (CuvitruTM) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab: A Review in Extensive-Stage SCLC. The 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. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. 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. Use the units' field as a multiplier to arrive at the dosage amount. 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. 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. 7 6. IMFINZI may cause serious or life threatening infusion reactions and infections. HMO . 89 and G61. FDA approvals of PD-1/PD-L1 mAbs. 100 Eglantine Driveway. 66019-0309-10. 5 mL single-dose prefilled syringe [NDC 58160-976-02] Both UoS NDC numbers will map to the same CVX codes. NDC 0310-4611-50. How do I calculate the NDC units? Billing the correct number of NDC units for the. 70461-0322-03. Alpha-Numeric HCPCS. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. 3) 09/2022 Dosage and Administration (2. 1)] and 266 patients with ES-SCLC in CASPIAN who received up to four. National. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. They are owned by CMS and are available for use. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. The NDC is actually a 10-digit number that contains the three segments noted above. Withhold or discontinue IMFINZI to manage adverse. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. (2. Each single-dose glass vial is filled with a solution of 29. 15 Providers must bill 11-digit NDCs and appropriate NDC units. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Enter the NDC qualifier. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. How you are given IMFINZI . 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. 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 [prescribing information]. 1 mL; The maximum reimbursement rate per unit is: $0. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. FDA approvals of PD-1/PD-L1 mAbs. Updated Nationally Determined Contribution of the Republic of Azerbaijan. Medication HCPCS/CPT Code Injection durvalumab, 10 mg J9173 VII. 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. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. (2. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Bahamas. IMFINZI™ (durvalumab) Injection. diabetes. Dosing for infants and children age 6 through 35 months: • Afluria 0. S. 17: $76. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. No needle) 90636: 104 MenHibrix (VFC) Meningococcal C/Y-HIB PRP 6 weeks -. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. Preferred product information . Yes. Generic name . (2. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. Restricted Access – Do not disseminate or copyThe Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 • Arm 1: IMFINZI 1500 mg administered on Day 1+ gemcitabine 1000 mg/m 2 and cisplatin 25 mg/m 2 (each administered on Days 1 and 8) every 3 weeks (21 days) for up to 8 cycles, followed by IMFINZI 1500 mg every 4 weeks as long as clinical benefit is observed or until unacceptable toxicity, or 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 . 1, 2019. 58%), as well those showing a durable response at one year (23% vs. 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"). Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . 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. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. 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 . 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. FDA publishes the. infections. locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or; who have disease progression within 12 months of neoadjuvant or adjuvant treatment with. S. Durvalumab side effects. No dose reduction for IMFINZI is recommended. claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. N/A. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. 5 mL dosage, for. UB-04. Mechanism of action. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. • 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. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 2. 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. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic. 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). IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. Updated Nationally Determined Contribution of the Republic of Azerbaijan. The FDA offers an NDC searchable database. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Date Article; Nov 11, 2022: Approval Imfinzi and Imjudo with Chemotherapy Approved in the US for Patients with Metastatic Non-Small Cell Lung Cancer: Oct 24, 2022: Approval FDA Approves Imjudo (tremelimumab) in Combination with Imfinzi for Patients with Unresectable Hepatocellular Carcinoma: Sep 11, 2022: Imfinzi and Tremelimumab. 7 months in the control arm, according to an FDA announcement regarding the approval. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The 835 electronic transactions will include the reprocessed claims along. These codes are also located in the Medicine section of the CPT code set. The Policy Bulletins are used in making decisions as to medical necessity only. 0601C. C. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking. 5. Bevacizumab should be billed based on units, not total number of milligrams. code . Below example explain how to assign a labeler code. 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. 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. Revised: 03/2021 Page 2 . The 2022 CPT code set also includes an appendix for one-stop access to all the codes for COVID-19 vaccine reporting. Generic name . LCDC Building. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. On the . 1 6. How to store IMFINZI . The U. 3%) patients including fatal pneumonitis in one (0. PPENDIX . AstraZeneca ’s Imfinzi (durvalumab), administered concurrently with chemoradiotherapy, missed its primary efficacy endpoint in the Phase III PACIFIC-2 trial in non-small cell lung cancer, the company announced Tuesday. com. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. Call your doctor for medical advice about side effects. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. 5. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. A physician might report code 99213-25 with diagnosis code E11. 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. Brand name . Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. 3) 03/2020 Dosage and Administration (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 theDurvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 8. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. 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. 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. 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. This medication may cause a serious reaction during the injection. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 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. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. For information about Molina pharmacy policies, contact the Pharmacy Department: Phone: (855) 866-5462. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. The 835 electronic transactions will include the reprocessed claims along with other claims. With IV infusions, the drug is slowly injected. 10 mg vial of drug is administered = 10 units are billed. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. IMFINZI safely and effectively. Finished drug products. Q: Does the requirement to bill NDCs apply to all plans? A: No. skin rash *. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Item Code (Source) NDC:0310-4505: Route of. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17ATC code: L01FF03. Recommended dose of IMFINZImonotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced. swelling in your arms and legs. It applies to all plans except Medicare Supplemental plans. 57 rescinds legacy NHRIC and NDC numbers and requires discontinuation of their use on device labels and packages, the UDI Rule does not prohibit use of 11-digit numbers or other. HCPCS/CPT 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. Refer to. 94 Section: Prescription Drugs Effective Date: April 1, 2020 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 13, 2020 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatcough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or. NDC covered by VFC Program. fatigue (lack of energy) upper respiratory infection such as the common cold. 2ML. Each provider is responsible for ensuring all. The new formulation the. The list of results will include documents which contain the code you entered. 2. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. e When tetanus or rabies products are given as part of wound management, use a primary ICD-10 code which describes the patient’s condition. 1 Recommended Dosage . STN: BL 125555. 1 Recommended Dosage. Images of medication. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 5 Cal Ready-to-Hang Institutional / 1 Liter (1000-mL) Bottle / Case of 8 B4154 70074-0535-37 Adult Nutritional 62059 Glucerna Hunger Smart Shake Vanilla Retail / 11. Example 3: HCPCS description of drug is 1 mg. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. 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. 10/01/2022 R5 Eff 10/1/2022: Per CR12973 added DX D81. Keep vial in original carton to protect from light. Imfinzi is a medicine used to treat lung cancer. Note that not all products and NDCs under their respective CPT codes will be covered. 5. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. OLORADO . Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. 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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 68 mg/mL). The safety and tolerability of the Imfinzi combination was consistent with previous. The NDC is updated daily, this version offered here is from September 6th, 2022. Vaccine CPT Code to Report. Use in Cancer. 47426-0201-01 The pooled safety population (N = 596) described in the Warnings and Precautions section reflect exposure to IMFINZI 1,500 mg in combination with tremelimumab-actl 75 mg and histology-based platinum chemotherapy regimens in 330 patients in POSEIDON [see Clinical Studies (14. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. IMFINZI. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. The UOM codes are: F2 = international unit. The NDC Number for each drug will be different. g. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Discard unused portion. macugen. 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). (2. 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. (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. PH. Pre-Stata13 had a string length limit of 244 characters. Example 1: HCPCS description of drug is 6 mg. It showed an. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. 6 5. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. , 0001-), the 8 or 9 digit NDC Product Code (e. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. Average progression-free survival for the Imfinzi-containing group was 7. 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. j1726. Dossier ID: HC6-024-e195931. 094 Section: Prescription Drugs Effective Date: April 1, 2023 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 10, 2023 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatAt 18 months, 34% of Imfinzi-treated patients were alive, as were 25% of those in the control group. provider administered drugs page 2 of 3 . 2 8. This study has 2 parts: dose finding and dose confirmatory. The product's dosage form is injection, solution and is administered via intravenous form. 10/10/2023. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. 5. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. The recommended dose of ZYNRELEF is based on the size of the surgical site up to a maximum dose of 400 mg/12 mg (14 mL). 1 vial = 10 units. Rx only. 4. Vaccine CPT Code to Report. Contents of the pack and other information . 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. IRST . 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 . CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 2 SAD Determinations Medicare BPM Ch 15. 82 due to reconsideration requests. Attention Pharmacist: Dispense the accompanying Medication. The effective dates for using these documents for clinical reviews are communicated through the provider notification process. How do I calculate the NDC units? Billing the correct number of NDC units for the. Submit PA requests . REFERENCES 1. com. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 1. 2. 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. NCCN Drugs & Biologics Compendium ® 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 the Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 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. 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. 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). As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and. Seventeen5. Serious side effects reported with use of Imfinzi include: rash*. in a 10-digit format. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. Attention Pharmacist: Dispense the accompanying Medication. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. What is National Drug Code (NDC)? • A unique . Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). liver dysfunction. HCPCS code G2012: Brief communication technology-based service, e. 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. October 2023 Alpha-Numeric HCPCS Files (ZIP) - Updated 08/28/2023. com) document for additional details . Imfinzi durvalumab J9173A. 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. 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. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). View or. 6%). 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,. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 5. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. (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. 4. Example of NDC Labeler code assignment. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. NDC covered by VFC Program. L. Do not report 90460, 90471-90474 for the administration of COVID vaccines. Also include the NDC. An administration code should always be reported in addition to the vaccine product code. Please see the HCPCS Quarterly Update webpage for those updates. lower back or side pain. One Medicaid unit of coverage is 0. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. IMFINZI™ (durvalumab) Injection. Imfinzi [package insert]. 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). 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. IMFINZI safely and effectively. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. With IV infusions, the drug is slowly injected. • Administer IMFINZI as an intravenous infusion over 60 minutes. 2021 Nov;16 (6):857-864. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 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. S. This revision is due to 4 th quarter CPT ® /HCPCS Code update and is effective on 10/1/2019. They are the basis for your reimbursements. 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 . Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. 1, 2019 . 569: $79. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. 3 CWF shall send/display data in separate records for Dates of Service (DOS) and NPI of each PPV HCPCS codes (90670 and 90732) from new Auxiliary to: •The third set of digits is the package code, which identifies package sizes and types. Revision DateImfinzi is a human monoclonal antibody that binds to the programmed cell death 1 receptor, unleashing immune T-cells to attack cancer cells. When IMFINZI is administered in combination with chemotherapy, r efer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosni g informaoit n. 21. 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). Indications and Usage (1. Identify the specific product and package size. 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). Imfinzi Generic Name durvalumab Strength 120 mg/2. The radiopharmaceutical can be administered up to 96 hours before the primary procedure. Example 4: When billing a NOC drug.