What you need to know before you are given IMFINZI . The 835 electronic transactions will include the reprocessed claims along with other claims. This HCPCS Code Application Summary document includes a summary of each HCPCS code application discussed at the May 14, 2018 HCPCS Public Meeting for Drugs, Drugs, Biologicals and Radiopharmaceuticals and Radiologic Imaging Agents. Below example explain how to assign a labeler code. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. Brand name . How do I calculate the NDC units? Billing the correct number of NDC units for the. HCPCS Quarterly Update. 25 mL • Fluarix 0. Imfinzi is. (2. IMFINZI may be given in combination with otheranti-cancermedicines. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. liver dysfunction. 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. Key points to remember. paper. Dosing for infants and children age 6 through 35 months: • Afluria 0. 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. Approval: 2017 . The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. The 835 electronic transactions will include the reprocessed claims along with other claims. Identify the specific product and package size. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. The FDA offers an NDC searchable database. Pre-Stata13 had a string length limit of 244 characters. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 7 months in the placebo group. The UOM codes are: F2 = international unit. National Drug Code Directory. Report code only with appropriate primary procedure. (NDC 0310-4611-50) 120 mg/2. IMFINZI safely and effectively. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Current through: 11/21/2023. NOTE: Dates of service for Terminated HCPCS codes not needed. Example claim with HCPCS by itself: HCPCS rate changed 5/19. The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. 1. Do not report 90460, 90471-90474 for the administration of COVID vaccines. Dosage Modifications for Adverse Reactions . J0185. S. Example 4: When billing a NOC drug. 5. com. . due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). Chemotherapy: May 7, 2021: Imfinzi and Tremelimumab with Chemotherapy Demonstrated Overall Survival Benefit in POSEIDON Trial for 1st-Line Stage IV Non-Small Cell Lung Cancer: Feb 5. 1 vial = 10 units. 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,. Use the units' field as a multiplier to arrive at the dosage amount. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. Brand name . Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Finished drug products. Proper Name: Antihemophilic Factor (Recombinant) Tradename: NUWIQ. UB-04. 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. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. of these codes does not guarantee reimbursement. Code Description. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. This revision is due to 4 th quarter CPT ® /HCPCS Code update and is effective on 10/1/2019. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Tell your doctor. Administer IMFINZI prior to chemotherapy when given on the same day. 5. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Group 1 Codes. frequent urge to urinate. hoarseness, husky, or loss of voice. g. How to store IMFINZI . Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 1 6. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 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. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. Last updated on emc: 04 Sep 2023. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . Refer to. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. The CPT procedure codes do not include the cost of the supply. 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. IMFINZI™ (durvalumab) Injection. 4ml. infections. NDC covered by VFC Program. Indications and Usage (1. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 1, 2019 . (2. Some side effects may occur during the injection. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. 2 8. 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). The 835 electronic transactions will include the reprocessed claims along. fatigue (lack of energy) upper respiratory infection such as the common cold. 2 DOSAGE AND ADMINISTRATION 2. 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. Fig. 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 median time to onset was 55. Recommended dose of IMFINZImonotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced. 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). Approval: 2017 . Patients receiving the three-drug regimen had a median overall survival of 14 months, as compared with 11. 200 mg are administered = 4 units are billed. 88 mg/mL meloxicam. The NDC code would be unique for all of them and can help you distinguish between those result. Be attentive to the long description of the HCPCS code. g. allergic reaction *. Note that not all products and NDCs under their respective CPT codes will be covered. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The product's dosage form is injection, solution and is administered via intravenous form. skin rash *. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. 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. 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. through . 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). Q: Does the requirement to bill NDCs apply to all plans? A: No. lower back or side pain. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. It’s given as an IV infusion. 7 6. NovoLogix Carelon Quantity limits . FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). This medication has been identified as Imfinzi 120 mg/2. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. Associated NDCs . 00310-4500-12 00310. It works by helping your immune system fight the cancer cells. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. The approval was based on the results of the CASPIAN clinical trial, which showed that. Mechanism of action. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. Format revision completed. 2 DOSAGE AND ADMINISTRATION 2. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. Manufacturer: Octapharma USA, Inc. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. Both the product and package codes are assigned by the firm. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 569: $79. It will be listed in one of the following configurations: 4-4-2: for example,. Injection, infliximab, 10 mg. Claims are priced based on HCPCS or CPT codes and units of service. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 8. No dose reduction for IMFINZI is recommended. Email: MHILPharmacy@molinahealthcare. Updated Nationally Determined Contribution of the Republic of Azerbaijan. 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. Imjudo (tremelimumab) is given for one cycle followed by single agent Imfinzi (durvalumab). The remaining digits. Imfinzi is a monoclonal antibody that counters the tumor's immune-evading tactics. The correct use of an ICD-10-CM code does not assure coverage of a service. code . Clinical Studies (14) ]. 1. Cancer Oncology Rx required. Sean Bohen, MD, Phd. 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. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. Mechanism of action. 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). SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. S. Attention Pharmacist: Dispense the accompanying Medication. The National Drug Code (NDC) Directory is updated daily. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. CPT codes provided in the vaccine code sets are to assist with. 120 mg/2. Approval: 2017 total bilirubin elevation. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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. 100 Eglantine Driveway. Report the supply separately using a HCPCS (Healthcare Procedural Coding System) code: J7307 Etonogestrel [contraceptive] implant system, including implant and. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. IMFINZI™. 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 targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 88 mg/mL meloxicam. in a 10-digit format. Simply add items worth ₹1499 to your cart & use the applicable coupon at checkout!eviCore healthcare will reimburse HCPCS codes A9587 and A9588 when used in conjunction with a PET scan, an appropriate diagnosis and an invoice for the radiopharmaceutical. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. 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. Yes. Applicable Procedure Codes J9173 Injection, durvalumab, 10mg, 1 billable unit = 10mg Applicable NDCs 0310-4611-50. Units. The NDC Number for each drug will be different. 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). diabetes. The NDC is actually a 10-digit number that contains the three segments noted above. ‡ C9399, J3490 Aralast NP* alpha 1-proteinase inhibitor* J0256 Aranesp* darbepoetin alfa* J0881, J0882 Asceniv* immune globulin* J1554 Asparlas calaspargase pegol-mknl J9118 Atgam lymphocyte immune globulin J7504 Avastin (Authorization required only for. IMFINZI 20 mg/kg in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg. Related Local Coverage Documents N/A. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . 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. Bevacizumab should be billed based on units, not total number of milligrams. If you have any questions about these medicines, ask your doctor. Store at 2° to 8°C (36° to 46°F). The NDC code can be found on the outside packaging of the drug. provider administered drugs page 2 of 3 . CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. V. What is a J-code’s unit? Each J-code’s descriptor includes a dosage amount, known as the HCPCS code dosage, which is the billable unit for that code. # Step therapy required through a Humana preferred drug as part of preauthorization. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. While always displayed as 6 digits in this file; for labeler codes 2 through. Injection, zoledronic acid, 1 mg . 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. Example 1: HCPCS description of drug is 6 mg. 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. Description . 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. 99214 can be used for an office visit. for people with locally advanced or metastatic bladder cancer. 3)]. HCPCS code describes JEMPERLI. Control #:. • 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). This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. Imfinzi Generic Name durvalumab Strength 120 mg/2. 90672. The U. fatigue (lack of energy) upper respiratory infection such as the common cold. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17 ICD-10 Annual Update, 10/17 Incomplete Manage Change Requests and Enrollment Applications, 09/17 Maintain Eligibility Process, 06/17, 07/17, 08/17, 09/17, 10/17This page provides the clinical criteria documents for all injectable, infused, or implanted prescription drugs and therapies covered under the medical benefit. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. hcpcs or cpt® code(s) drug j9217 lupron depot (1-month) j9217 lupron depot (3-month) j1950 lupron depot (3-month) j9217 lupron depot (4-month) j9217 lupron depot (6-month) j2503. . 5%) adverse reactions. Rx only. 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. Active. You may report side effects to FDA at 1-800-FDA-1088. CPT Code Description. 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. 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. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. 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. Rx only. Revised: 03/2021 Page 2 . 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. One drug can be associated with any number of ingredients. ( 2. LCDC Building. 5 mL dosage, for. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Serious side effects reported with use of Imfinzi include: rash*. Please see the HCPCS Quarterly Update webpage for those updates. Get help with Imprint Code FAQs. This code is effective on 11/1/2018. Contents of the pack and other information . Biologic and Radiopharmaceutical Drugs Directorate. 10-digit, 3-segment number. Covered services will be processed according to the chart below. Ottawa ON K1A 0K9. 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. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. IMFINZI works by helping your immune system fight your cancer. Administer IMFINZI prior to chemotherapy when given on the same day. Example: rilpivirine STR=ndc_active_ingredient. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. May 2021. HCPCS (90670 and 90732) to get the Dates of Services for these PPV HCPCS code. 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. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. Seventeen5. Exclusivity End Date:0154A, 0164A, 0171A, 0172A, 0173A, 0174A), patient age, manufacturer name, vaccine name(s), 10- and 11-digit National Drug Code (NDC) Labeler Product ID, and interval between doses. 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. How do I calculate the NDC units? Billing the correct number of NDC units for the. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. 1. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). 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. Submit PA requests . 3 . Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use. Starting April 19, 2021, a valid National Drug Code (NDC) number, unit of measure, and units dispensed for drugs administered by health care professionals in ambulatory care settings will be required on all professional and facility drug claims. NCCN Drugs & Biologics Compendium ® Imfinzi. MRP ₹45500. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. Identify the manufacturer of the drug. (2) Each person who is assigned an NDC labeler code must update the information submitted under paragraph (c)(1)of this section within 30 calendar days after any change to that information. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). Sean Bohen, MD, Phd. 2 DOSAGE AND ADMINISTRATION . 5 mL. claim form as follows: 1. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 21. 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. 0601C. 68 mg/mL). Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. Imfinzi durvalumab J9173. Durvalumab (IMFINZI ®), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma. 15 Providers must bill 11-digit NDCs and appropriate NDC units. Medication HCPCS/CPT Code Injection durvalumab, 10 mg J9173 VII. Are specific to the drug itself. 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. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. 3 spasmodic torticollis; payment may be made under off-label use circumstances outlined in Indications and Limitations of the LCD Botulinum Toxin Type A and B Policy (L35170). NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 50. Varun Gupta, MD Pharmacology on 5th Sep 2023. (2. S. The 835 electronic transactions will include the reprocessed claims along with other claims. The product's dosage form is injection, solution and is administered via intravenous. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. macugen. IRST . REFERENCES 1. , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. IMFINZI is administered as an intravenous infusion over 1 hour. Each single-dose glass vial is filled with a solution of 29. 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. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). 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. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. , 0001-), the 8 or 9 digit NDC Product Code (e. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. Vaccine CPT Code to Report. 05 ICD-10-CM. Sometimes, it’s used together with other immunotherapies and chemotherapy. (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. 2 8 8. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. How you are given IMFINZI . csv file. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. Imfinzi durvalumab J91731All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. The FDA approval was based on the results of the Phase 3 PACIFIC clinical trial ( NCT02125461 ). Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 1%) patient and Grade 3-4 in six (0. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. 90674. Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 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). 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. 1 unit per 1000 units. 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. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The following CPT codes are to be reported for the procedures performed. 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.