View or. HCPCS Quarterly Update. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. 4. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). The U. National. 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. 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. How do I calculate the NDC units? Billing the correct number of NDC units for the. The NDC must follow the 5digit4digit2digit format (11-digit billing format, with no spaces, hyphens or special characters). Trade Name: IMFINZI. CanMED: NDC. IMFINZI. National Drug Code (NDC) numbers for use in billing physician-administered drugs, please refer to the . Administer IMFINZI prior to chemotherapy when given on the same day. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. for people with locally advanced or metastatic bladder cancer. 2. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. active_ingredient: BN:. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. Imfinzi 120 mg/2. A physician might report code 99213-25 with diagnosis code E11. 4%) patients. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. 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. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:. 1 unit per 1000 units. (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. ”. 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. Each single-dose glass vial is filled with a solution of 29. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. Control #:. Enter the NDC qualifier. Mechanism of action. NovoLogix Carelon Quantity limits . Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. IMFINZI safely and effectively. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). allergic reaction *. It showed an. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. Keep vial in original carton to protect from light. Attention Pharmacist: Dispense the accompanying Medication. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. • Administer IMFINZI as an intravenous infusion over 60 minutes. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Always bill device in the category described by HCPCS code C1832 with 1 of the following CPT codes: • CPT code 15110 (Epidermal autograft, trunk, arms, legs; first 100 sq cm or less, or 1% of body area of infants and children), which is assigned to APC 5054 for. Example 1: HCPCS description of drug is 6 mg. Labeler code portion of NDC; assigned by FDA to firm. 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. 20. Durvalumab (Imfinzi) has been granted a. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic Licensing Application Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: havediseaseprogressionduringorfollowingplatinum-containingchemotherapy. 90672. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Weight less than 30 kg: Imfinzi 20 mg/kg IV given with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . NDC: Imfinzi 120 mg/2. Approval: 2017 . 1%) patient and Grade 3-4 in six (0. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. 2 DOSAGE AND ADMINISTRATION . The NDC must be active for the date of service. 88 mg/mL meloxicam. 99397 can be used for a preventive exam if you are over age 65. Covered services will be processed according to the chart below. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Get this at ₹37,310. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. Non-Small Cell Lung Cancer (NSCLC) 1. 4. 8. Units. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. 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. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Example 4: When billing a NOC drug. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. This is not a complete list of side effects and others may occur. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. 4 mL in 1 VIAL Effective Date: May 1, 2017 Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Covered codes. References . 10/10/2023. 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 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. Imfinzi [package insert]. Revision DateImfinzi is a human monoclonal antibody that binds to the programmed cell death 1 receptor, unleashing immune T-cells to attack cancer cells. It’s given as an IV infusion. . 58 g/mol. 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. 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. National. The NDC Number for each drug will be different. Short descriptor: SARSCOV2 VAC BVL 10MCG/0. (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. (B) A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5–3–2 or 6–3–2). 2. How you are given IMFINZI . 4 mL injection. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). To report via data exchange, providers would report using the NDC codeThe FDA has approved AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab) plus platinum-based chemotherapy to treat adult patients with stage 4 nonsmall-cell lung cancer (NSCLC). Updated Nationally Determined Contribution of the Republic of Azerbaijan. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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,. 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. 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 . JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune. Both the product and package codes are assigned by the firm. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Description . Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading. Identify the manufacturer of the drug. 5 mL dosage, for. Bahamas. 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. general feeling of discomfort or illness. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. The FDA has approved Imfinzi (durvalumab) for the treatment of patients with locally advanced, unresectable stage 3 non—small cell lung cancer (NSCLC) who have not progressed following chemoradiotherapy. It is important to note that this code represents 1/10th of a vial. The 2022 CPT code set also includes an appendix for one-stop access to all the codes for COVID-19 vaccine reporting. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. 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. skin rash *. Billing Code/Availability Information HCPCS:. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. S. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. 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 . NDC=National Drug Code. 82 due to reconsideration requests. Continuing therapy with Imfinz will be authorized for 12 months. 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. 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. Imfinzi Generic Name durvalumab Strength 120 mg/2. 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). S. Finished drug products. Imfinzi durvalumab J9173A. 4/BA. Are assigned by the Food and Drug Administration. • 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). Note that the CPT codes shown are not mapped to the NDC codes, but are mapped to the CVX codes shown. 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. Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. 2 months, compared to 5. On the . 2 . allergic reaction *. com) document for additional details . J0185. The 835 electronic transactions will include the reprocessed claims along with other claims. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. 1. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. Imfinzi comes as a liquid solution in single-dose vials. NDC=National Drug Code. EALTH . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. Example 2: HCPCS description of drug is 50 mg. 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. A firm. Medicare BPM Ch 15. Group 1. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021. g. No dose reductions are recommended. HCPCS code describes JEMPERLI. ( 2. (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. j1726. 3. A10. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. The approval was based on the results of the CASPIAN clinical trial, which showed that. See . ATC code: L01FF03. The approval was based on data from the Phase III PACIFIC trial. ‡ motixafortide †,. hoarseness, husky, or loss of voice. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. 1) 09/2022 IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. Please see the HCPCS Quarterly Update webpage for those updates. 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. It is for use in adults with: non-small cell lung cancer (NSCLC) that is locally advanced (meaning it has spread into tissues around the lungs, but not to other parts of the body) and cannot be removed by surgery and is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). 90672. 4ml. OUT OF STOCK. HMO Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Store at 2° to 8°C (36° to 46°F). aprepitant injection (Cinvanti TM) 1 mg. 2. 10/01/2022 R6 HCPCS J1554 was added to the CPT/HCPCS code section, effective date 4/1/2021. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. immune system reactions, which can cause inflammation. Other changes to the CPT code set. The 835 electronic transactions will include the reprocessed claims along with other claims. Dossier ID: HC6-024-e195931. 2 mL dosage, for intramuscular use. First claim should be billed from 5/1 through 5/2. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. 21. Administration codes. (2. Biologic and Radiopharmaceutical Drugs Directorate. 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. S. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. References 1. FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. 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 . 10/31/2019 R6 NDC 0310-4611-50. 5 Blepharospasm and G24. 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). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. All other Codes (ICD-10, Bill Type, and Revenue) have moved to. Do not report 90460, 90471-90474 for the administration of COVID vaccines. pneumonitis * ( inflammation of the lungs) hair loss. Example 3: HCPCS description of drug is 1 mg. (2. Group 1 (9 Codes) Group 1 Paragraph. csv file. IMFINZI may be given in combination with otheranti-cancermedicines. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. Influenza HCPCS and CPT Codes. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Vaccine CPT Code to Report. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 68 mg/mL). nervousness. 1. 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). National Comprehensive Cancer Network, Inc. Update Feb. C. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. F. See . Approval: 2017 total bilirubin elevation. (2. 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. 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. 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. The product's dosage form is injection, solution and is administered via intravenous form. While always displayed as 6 digits in this file; for labeler codes 2 through. Effective date is noted in the file title. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. NDC: 58160-0815-52 (1 dose T-L syringes. infections. paper. 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. IMFINZI is a prescription medicine used to treat different types of cancer, such as lung, bladder, and liver cancer. 2. More common side effects in people taking Imfinzi for non-small cell lung cancer include: cough*. pneumonitis * ( inflammation of the lungs) hair loss. 1 All 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. Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. What IMFINZI is and what it is used for . NDC 0310-4611-50. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Generic name . Imfinzi durvalumab J9173. code . com Abecma (idecabtagene vicleucel) MCP. Imfinzi also increased the percentage of patients responding to treatment (68% vs. 3) 03/2020 Dosage and Administration (2. Keep vial in original carton to protect from light. Tunney’s Pasture, A. Epub 2021 Nov 3. Key points to remember. T-MSIS data elements NDC-UNIT-OF-MEASURE (CIP285, CLT229, or COT224) and NDC-QUANTITY (CIP278, CLT230, or COT225) are only applicable to and therefore reported in the IP, LT, and OT files when a value is reported to the NATIONAL-DRUG-CODE data element (CIP284, CLT228, or COT217). The National Drug Code (NDC) Directory is updated daily. Enter the information on the . This medication has been identified as Imfinzi 120 mg/2. 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. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. With IV infusions, the drug is slowly injected. Last updated by Judith Stewart, BPharm on June 20, 2023. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. The official update of the HCPCS code system is available as a public use file below. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. The National Drug Code (NDC) Directory is updated daily. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. 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). 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. # Step therapy required through a Humana preferred drug as part of preauthorization. The NDC is actually a 10-digit number that contains the three segments noted above. (2. J0588 - Labeled indications for Xeomin are limited to G24. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. colitis. Also include the NDC. RECENT MAJOR CHANGES ----- Indications and Usage (1. COVID -19 Related Codes U0001 CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel COVID-19 U0002 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC) COVID-19CODE=ndc_active_ingredient. 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. 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. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 3)]. 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). 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. The FDA offers an NDC searchable database. VI. • Should not be assigned to non-drug products. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. (2. Rx only. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. Imfinzi is a medicine used to treat lung cancer. 21, including objective evidence of efficacy and safety are met for the proposed indication. PPO . Example: rilpivirine STR=ndc_active_ingredient. The list of results will include documents which contain the code you entered. 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. X 11335. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. 1. 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"). Table 1. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. 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. Sometimes, it’s used together with other immunotherapies and chemotherapy. Use the units' field as a multiplier to arrive at the dosage amount. 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. lower back or side pain. The product's dosage form is injection, solution and is administered via intravenous. Code 91317 for Pfizer-BioNTech COVID-19. NovoLogix Carelon Quantity limits . Indication: Indicated in adults and children with Hemophilia A for: On-demand. Related Local Coverage Documents N/A. Injection, epoetin alfa (for non-ESRD use), 1000 units. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Qualifying notice amendment for Imfinzi. Call your doctor for medical advice about side effects. renal dysfunction. 6 5. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. For the following HCPCS codes either the short description and/or the long description was changed. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). 5. 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. The 835 electronic transactions will include the reprocessed claims along with other claims. CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. IMFINZI™ (durvalumab) Injection. 90658 can be used for the administration of a flu shot. Dosing for infants and children age 6 through 35 months: • Afluria 0. muscle cramps and stiffness. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Marketing Approval Date: 03/27/2020. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks.