Code Description. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. Control #:. In the pivotal phase III CASPIAN trial in previously untreated. Identify the manufacturer of the drug. HCPCS Quarterly Update. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 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. The NDC is actually a 10-digit number that contains the three segments noted above. 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. 5. 21. The product's dosage form is injection, solution and is administered via intravenous. 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 . A firm. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. The radiopharmaceutical can be administered up to 96 hours before the primary procedure. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Additionally, either the long or short description of CPT code 19499 has been updated. through . 2 . 4/BA. 90674. Each single-dose glass vial is filled with a solution of 29. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. RECENT MAJOR CHANGES ----- Indications and Usage (1. 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. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. The official update of the HCPCS code system is available as a public use file below. The NDC Number for each drug will be different. Bahamas Updated. H. (NDC 0310-4611-50) 120 mg/2. If the NDC on the package label is less than 11 digits, a leading zero must be added to the appropriate segment to create a 5-4-2 configuration. active_ingredient: BN:. NDC 0310-4611-50. ES-SCLC: Until disease progression, unacceptabletoxicity. csv file. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. Imfinzi Generic Name durvalumab. See full prescribing information for IMFINZI. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. 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 list of results will include documents which contain the code you entered. Cart Total. A new formulation to incorporate Omicron strain BA. 7 months in the placebo group. IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. A biologics license application (BLA) for tremelimumab for the treatment of patients with unresectable hepatocellular carcinoma (HCC) was accepted and granted priority review from the FDA was based on results from the phase 3 HIMALAYA trial (NCT03298451), according to a press release from AstraZeneca; additionally, a. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. A. 00310-4500-12 00310. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 2 months, compared to 5. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Ottawa ON K1A 0K9. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Sometimes, it’s used together with other immunotherapies and chemotherapy. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. 50. It applies to all plans except Medicare Supplemental plans. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. 21. IMFINZI. 90672. The UOM codes are: F2 = international unit. Imfinzi [package insert]. 1 mL. IMFINZI safely and effectively. 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. 88 mg/mL meloxicam. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. hoarseness, husky, or loss of voice. 1. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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. Withhold for moderate and permanently discontinue for severe or life-Initial U. 70461-0321-03. J0885. Use the units' field as a multiplier to arrive at the dosage amount. com. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit). 4 mL injection. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . Call your doctor for medical advice about side effects. All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. skin rash *. 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. 5. 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). 20. Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0. 1, 2019 . Covered services will be processed according to the chart below. Prev Section 2. g. The Policy Bulletins are used in making decisions as to medical necessity only. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. • 80 mg/4 mL: 50242-135-01 • 200 mg/10 mL: 50242-136- 01 • 400 mg/20 mL: 50242-137-01 Sotrovimab Q: How is Sotrovimab reported via data exchange? A. S. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. 4%) patients. Sean Bohen, MD, Phd. Medication HCPCS/CPT Code Injection durvalumab, 10 mg J9173 VII. Approval: 2017 . IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 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. thyroid disorders. The service must be reasonable and necessary in the specific case and must meet the criteria specified in this determination. Choose Generic substitutes to Save up to 50% off. 1 6. 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. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. HCPCS code End-dated Dec. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. 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) • Stage III NSCLC: 10 mg/kg every 2 weeks. National. 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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. IMFINZI™. 120 mg/2. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. The second and third segments of NDC Labeler code are assigned by the labeler. allergic reaction *. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 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. Report code only with appropriate primary procedure. Request# 20. 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. Serious side effects reported with use of Imfinzi include: rash*. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17Imfinzi belongs to a class of drugs called PD-L1 inhibitors. Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. Mechanism of action. List of Vaccine Names, Best ASIIS Selection and CPT/CVX Codes This list matches the vaccine name or codes in Arizona State Immunization Information System (ASIIS) with the brand name or other common names. See full prescribing information for IMFINZI. Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . Enter the information on the . It is supplied by AstraZeneca. Get help with Imprint Code FAQs. CPT codes provided in the vaccine code sets are to assist with. Rx only. Code Description Vial size Billing units. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. 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. NDC Packaging CDC Cost/ Dose Private Sector Cost/ Dose Contract End Date Manufacturer Contract Number; Hepatitis A Adult Vaqta® 00006-4096-02: 10 pack – 1 dose syringe: $38. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. FDA approvals of PD-1/PD-L1 mAbs. IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. 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 recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. 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. com. macugen. Some side effects may occur during the injection. ( 2. The effective dates for using these documents for clinical reviews are communicated through the provider notification process. 10-digit, 3-segment number. All other Codes (ICD-10, Bill Type, and Revenue) have moved to. S. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. Related Local Coverage Documents N/A. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. 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. 05 ICD-10-CM. CanMED: NDC. S. 70461-0322-03. 10/01/2022 R5 Eff 10/1/2022: Per CR12973 added DX D81. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. This medicinal product is subject to additional monitoring. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. It’s given as an IV infusion. Continuing therapy with Imfinz will be authorized for 12 months. S. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. Indications and Usage (1. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. g. • Should not be assigned to non-drug products. 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. Adding National Drug Codes (NDC) to ClaimsIMFINZI 120mg Injection 2. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Imfinzi also increased the percentage of patients responding to treatment (68% vs. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 66019-0309-10. You can search with this number to find the exact drug you have. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 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. 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. Brand Generic Codes Amvuttra vutrisiran J0225 Aphexda †,. (2. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. 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. Imfinzi is a medicine used to treat lung cancer. A. or HCPCS Codes and/or How to Obtain Prior Authorization . What is National Drug Code (NDC)? • A unique . 1 8. Example of NDC Labeler code assignment. 90674. Last updated by Judith Stewart, BPharm on June 20, 2023. 3) 09/2022 Dosage and Administration (2. 5%) adverse reactions. . It will be listed in one of the following configurations: 4-4-2: for example,. (2. 00. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. ”. 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. 24 participants with Non-Small Cell Lung Cancer will be. Each provider is responsible for ensuring all. 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. nervousness. It is used. Also include the NDC. 31, 2018. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. If you have any questions about these medicines, ask your doctor. • 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). Dosing for infants and children age 6 through 35 months: • Afluria 0. IMFINZI works by helping your immune system fight your cancer. com Abecma (idecabtagene vicleucel) MCP. The National Drug Code (NDC) Directory is updated daily. Imfinzi (durvalumab) may be considered medically necessary for the treatment of adults with: • Unresectable, stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy • First-line treatment of extensive-stage small cell lung cancerThe HIPAA standard 11-digit NDC format is standardized such that the labeler code is always 5 digits, the product code is always 4 digits, and the package code always 2 digits. 90672. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) / 2. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 New J codes . There are 11 disease interactions with Imfinzi (durvalumab) which include: adrenal insufficiency. It showed an. 2 DOSAGE AND ADMINISTRATION 2. CPT Long Description Change: 78130. The maximum reimbursement rate per unit is $144. The 835 electronic transactions will include the reprocessed claims along with other claims. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 90674. 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 7. The file contains the following drug information: • NDCPackageCode (Column A): The labeler code, product code, and package code segments of the NDC number, separated by hyphens per FDA website. 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 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. Attention Pharmacist: Dispense the accompanying Medication. csv file. By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune. 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. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17ATC code: L01FF03. NDC=National Drug Code. HCPCS/CPT Description; G0008: Administration of influenza virus vaccine: 90662: Influenza virus vaccine, split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use: 90672: Influenza virus vaccine, live, quadrivalent, for intranasal use:Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 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). (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Rx only. For the following HCPCS codes either the short description and/or the long description was changed. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Discard unused portion. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. May 2021. Example 3: HCPCS description of drug is 1 mg. HMO . 90672. Imfinzi is. 4 Adverse Reaction Severity1 Dosage Modification than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more. paper. A. f Represents the 2019-2020 NDC. The NDC must follow the 5digit4digit2digit format (11-digit billing format, with no spaces, hyphens or special characters). Brand name . 2 . They may not be reported prior to effective date. 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. 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. 4 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. 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. (2. Approval: 2017 . NDC: 58160-0815-52 (1 dose T-L syringes. Imfinzi comes as a liquid solution in single-dose vials. 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. fatigue (lack of energy) upper respiratory infection such as the common cold. Get this at ₹37,310. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. The FDA assigns the labeler code, while the company assigns the product and package code. No dose reductions are recommended. Images of medication. VI. pneumonitis * ( inflammation of the lungs) hair loss. colitis. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. Administration codes. 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. 1 Recommended Dosage . Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. 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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Seventeen5. (2. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. One drug can be associated with any number of ingredients. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. Email: MHILPharmacy@molinahealthcare. 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). 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. 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. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. It works by helping your immune system fight the cancer cells. 200 mg are administered = 4 units are billed. UPDATE: On March 27, 2020, the Food and Drug Administration (FDA) approved durvalumab (Imfinzi) to treat small cell lung cancer (SCLC). Example 1: HCPCS description of drug is 6 mg. Approval: 2017 total bilirubin elevation. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. 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). Trade Name: IMFINZI. It’s given as an IV infusion. IMFINZI™ (durvalumab) Injection. 0601C. 90716 can be used for the administration of the chickenpox vaccine (varicella) 12002 can be used when a healthcare provider stitches up a 1-inch cut on your arm. LCDC Building. IMFINZI contains the active ingredient durvalumab. Keep vial in original carton to protect from light. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). 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. Item Code (Source) NDC:0310-4505: Route of. (2. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeksImfinzi (durvalumab) is an immunotherapy used in a variety of cancers, including lung cancer and liver cancer. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Revised: 03/2021 Page 2 . Abilify MyCite Kit (aripiprazole with biosensor)- (Medical Necessity) Actemra (tocilizumab). The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. . Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. The member's specific benefit plan determines coverage. NDC covered by VFC Program. The approval was based on data from the Phase III PACIFIC trial. The FDA offers an NDC searchable database. • Administer IMFINZI as an intravenous infusion over 60 minutes. Administer IMFINZI as an intravenous. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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). (2. frequent urge to urinate. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17Weight less than 30 kg: Imfinzi 20 mg/kg IV given with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Finished drug products. On the . Generic name: durvalumab [ dur-VAL-ue-mab ] Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Medically reviewed by. With IV infusions, the drug is slowly injected. (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. Fig. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. Expand All | Collapse All. IMFINZI in combination with IMJUDO can cause immune-mediated rash or. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). This will allow quick identification of new safety information. Code 91317 for Pfizer-BioNTech COVID-19. Therapy should continue as long as clinical benefit is observed or until unacceptable toxicity. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. 1All 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. Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. FDA approvals of PD-1/PD-L1 mAbs. With IV infusions, the drug is slowly injected. NOTE: Dates of service for Terminated HCPCS codes not needed. 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.