renal dysfunction. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. Imfinzi disease interactions. [medical citation needed]Durvalumab is an immune checkpoint. If the intent of the IIS is to capture the specific NDC, an IIS could access the provider’s order (VTrckS ExIS shipment data) to identify theCoding. 31, 2018. Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. The official update of the HCPCS code system is available as a public use file below. Level I HCPCS (CPT-4 codes) for hospital providers; Level II HCPCS codes for hospitals, physicians and other health professionals who bill Medicare A-codes for ambulance services and radiopharmaceuticals; C-codes; G-codes; J-codes, and; Q-codes (other than Q0163 through Q0181) Formulate and submit the specific question you have. FDA approvals of PD-1/PD-L1 mAbs. S. Also include the NDC. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. com) document for additional details . Example claim with HCPCS by itself: HCPCS rate changed 5/19. Drugs are identified and reported using a unique, three-segment number called the National Drug Code (NDC) which serves as the FDA’s identifier for drugs. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. skin rash *. NDC=National Drug Code. 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). 58%), as well those showing a durable response at one year (23% vs. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. fever. 3%) patients including fatal pneumonitis in one. Alpha-Numeric HCPCS. 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. 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). 6 5. macugen. through . FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. The Clinical Criteria information is alphabetized in the. Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic. 2 SAD Determinations Medicare BPM Ch 15. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. 21, including objective evidence of efficacy and safety are met for the proposed indication. 34 mg/mL), or 8 mg (2. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ. 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. 5. On September 2, 2022, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca UK Limited) in combination with gemcitabine and cisplatin for adult patients with locally advanced. 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. It is supplied by AstraZeneca. ─ All claims being submitted with an NDC also require a HCPCS code as well as the appropriate number of HCPCS units. 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. Depending. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. It’s given as an IV infusion. 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). Submit PA requests . V. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. • Administer IMFINZI as an intravenous infusion over 60 minutes. See . 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. References . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. • Administer IMFINZI as an intravenous infusion over 60 minutes. Table 1. g. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). Each single-dose glass vial is filled with a solution of 29. Durvalumab side effects. A. 57 rescinds legacy NHRIC and NDC numbers and requires discontinuation of their use on device labels and packages, the UDI Rule does not prohibit use of 11-digit numbers or other. 1 mL; The maximum reimbursement rate per unit is: $0. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. (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. Do not freeze or shake. Billing Code/Availability Information HCPCS:. 2 . Loncastuximab tesirine is an ADC composed of a humanized monoclonal antibody that binds to human CD19 and. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. trouble breathing. X 11335. 21. 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. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. g Medicare requires that you bill code G0008 when billing for the administration of influenza vaccines. The current update (2016) adds 34 drugs and includes a review of the 2004 list. 2. J0588 - Labeled indications for Xeomin are limited to G24. 20. 8. 90658 can be used for the administration of a flu shot. Withhold for moderate and permanently discontinue for severe or life-Initial U. Imfinzi also increased the percentage of patients responding to treatment (68% vs. In the pivotal phase III CASPIAN trial in previously untreated. 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). By attaching to PD-L1 and blocking its effects, Imfinzi increases the ability of the immune. Subject: Imfinzi Page: 4 of 4 1. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Imfinzi ® J9173. NDC notation containing asterisks is not accepted. 1. Choose Generic substitutes to Save up to 50% off. This medication may cause a serious reaction during the injection. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. • 10/1/17: billing codes updated • 5/1/18: diagnosis codes updated • 1/3/19: updated billing/coding • 3/28/19: no policy changesDurvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation. Durvalumab (Imfinzi) has been granted a. If you have any questions about these medicines, ask your doctor. Rx only. IMFINZI safely and effectively. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. # Step therapy required through a Humana preferred drug as part of preauthorization. The 835 electronic transactions will include the reprocessed claims along with other claims. 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. 21. 21. Bevacizumab should be billed based on units, not total number of milligrams. Imfinzi will be authorized for 6 months when criteria for initial approval are met. No dose reduction for IMFINZI is recommended. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 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). 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. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. The correct use of an ICD-10-CM code does not assure coverage of a service. 3%) patients including fatal pneumonitis in one (0. Approval: 2017 . claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. 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). Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. 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. 094 Section: Prescription Drugs Effective Date: April 1, 2023 Subsection: Antineoplastic Agents Original Policy Date: May 12, 2017 Subject: Imfinzi Page: 1 of 5 Last Review Date: March 10, 2023 Imfinzi Description Imfinzi (durvalumab) Background Imfinzi (durvalumab) is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody thatAt 18 months, 34% of Imfinzi-treated patients were alive, as were 25% of those in the control group. Imfinzi is. Other changes to the CPT code set. 3 . FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. com. CPT Code Description. allergic reaction *. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. See full prescribing information for IMFINZI. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing,. 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. 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. 2 DOSAGE AND ADMINISTRATION 2. 4. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. Keep vial in original carton to protect from light. The list of results will include documents which contain the code you entered. com) document for additional details . 2. NOTE: Dates of service for Terminated HCPCS codes not needed. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). provider administered drugs page 2 of 3 . Both the product and package codes are assigned by the firm. The third segment, the package code, identifies package sizes and types. What IMFINZI is and what it is used for . 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. Lab tests offered by us. 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. Epub 2021 Nov 3. 5 mL dosage, for. The next 4 digits identify the specific drug product and are. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior to chemotherapy and then everyHCPCS Code: • J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: • Imfinzi 120 mg/2. The NDC code can be found on the outside packaging of the drug. To convert a 10-digit NDC to an 11-digit HIPAA standard NDC, a leading zero is added to the appropriate segment to create the 11-digit configuration as defined above. 82. 5. Last updated on Jun 28, 2023. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in the Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. Enter the NDC qualifier. It’s given as an IV infusion. NDC: 58160-0815-52 (1 dose T-L syringes. Note that not all products and NDCs under their respective CPT codes will be covered. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Fig. 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. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated appr oval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. 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. 66019-0309-10. code . HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. What is National Drug Code (NDC)? • A unique . Administration codes. F. It works by helping your immune system fight the cancer cells. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. It will be listed in one of the following configurations: 4-4-2: for example,. claim form as follows: 1. 150: 33332-0322-03: 0. The list of results will include documents which contain the code you entered. 15 Providers must bill 11-digit NDCs and appropriate NDC units. 7 months in the placebo group. MRP ₹45500. The approval was based on the results of the CASPIAN clinical trial, which showed that. 2 DOSAGE AND ADMINISTRATION 2. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 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. pneumonitis * ( inflammation of the lungs) hair loss. 569: $79. 5 days (range: 24-423 days). 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. 5 mL single-dose prefilled syringe [NDC 58160-976-02] Both UoS NDC numbers will map to the same CVX codes. in a 10-digit format. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Rx only. National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. You may report side effects to FDA at 1-800-FDA-1088. 5. (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. , 0001-), the 8 or 9 digit NDC Product Code (e. 5 mL dosage, for. Sometimes, it’s used together with other immunotherapies and chemotherapy. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. 1. 10/10/2023. colitis. IMFINZI works by helping your immune system fight your cancer. . 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. Applicant suggested language: JXXXX macimorelin 60 mg, oral solution. Influenza HCPCS and CPT Codes. The 835 electronic transactions will include the reprocessed claims along with other claims. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Description . • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. CPT codes provided in the vaccine code sets are to assist with. (2. It is a human immunoglobulin G1 kappa. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. 5 mL. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Serious side effects reported with use of Imfinzi include: rash*. The first five digits. (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. 2. NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. ”. Discard unused portion. 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). 3. CMS Local Coverage Determinations (LCDs) and Articles LCD Article Contractor Medicare Part A Medicare Part B L34648 Bisphosphonate Drug Therapy A56907 Billing and Coding: Bisphosphonate Drug Therapy WPS . 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. 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. S. 8. Effective date is noted in the file title. AstraZeneca has opted to voluntarily withdraw. Cart Total. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 ( PD-L1 ) with the PD-1 (CD279). Bahamas. First claim should be billed from 5/1 through 5/2. ATC code: L01FF03. The CPT procedure codes do not include the cost of the supply. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. 4 mL injection. Note that the CPT codes shown are not mapped to the NDC codes, but are mapped to the CVX codes shown. Generic name . Under CPT/HCPCS Codes added a new Group 2: Paragraph, Group 2: Codes and added C9467 with “Note: For Part A services only - effective on 04/01/2018”. National. lower back or side pain. (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. 100 Eglantine Driveway. 708: 6/30/2023:. 99397 can be used for a preventive exam if you are over age 65. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). 692: 6/30/2023: Merck: 75D30122D14072: Hepatitis A Adult Havrix® 58160-0826-52: 10 pack – 1 dose syringe: $38. 01 Learn More About Medical Coding Section 2. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). 17: $76. 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. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. 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. 2 . They are the basis for your reimbursements. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. Payers may require the. 10/31/2019 R6 NDC 0310-4611-50. This code is effective on 11/1/2018. IMFINZI, , is indicated for the first -line treatment of adult patients with extensive -stage small cell lung cancer (ES-SCLC). 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 . 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. 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. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Updated Nationally Determined Contribution of the Republic of Azerbaijan. PPO . Related Local Coverage Documents N/A. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. com. How do I calculate the NDC units? Billing the correct number of NDC units for the. Seventeen5. 5 for the booster vaccine is now being planned. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Brand name . Please see the HCPCS Quarterly Update webpage for those updates. ES-SCLC: Until disease progression, unacceptabletoxicity. UB-04. 9 in addition to the appropriate flu vaccine and administration codes. Appendix X Revisions Log . immune system reactions, which can cause inflammation. Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. Q: Does the requirement to bill NDCs apply to all plans? A: No. 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. CPT Code Description. Qualifying notice amendment for Imfinzi. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name Basis of Strength Strength; DURVALUMAB (UNII: 28X28X9OKV) (DURVALUMAB - UNII:28X28X9OKV) DURVALUMAB: 120 mg in 2. 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. Imfinzi durvalumab J9173A. for people with locally advanced or metastatic bladder cancer. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. IMFINZI may cause serious or life threatening infusion reactions and infections. 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. 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. The approval of IMFINZI is based on the positive PFS data from the Phase III PACIFIC trial in which IMFINZI demonstrated an improvement in median PFS of 11. Specifically, we are proposing. g. No needle) 90636: 104 MenHibrix (VFC) Meningococcal C/Y-HIB PRP 6 weeks -. Covered services will be processed according to the chart below. Injection, epoetin alfa (for non-ESRD use), 1000 units. VI. Depending on which description is used in this article, there may not be any change in how the code displays in the document: J7195; J7301; J7302. This medicinal product is subject to additional monitoring. The effective dates for using these documents for clinical reviews are communicated through the provider notification process. How you are given IMFINZI . 1 8. The UOM codes are: F2 = international unit. 24 participants with Non-Small Cell Lung Cancer will be. Prev Section 2. 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). The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. N/A. 66019-0308-10. Identify the manufacturer of the drug. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. csv file. Xolair omalizumab 600 mg J2357 120 HCPCS units (5 mg per unit) Bavencio avelumab 800 mg J9023 80 HCPCS units (10 mg per unit) Imfinzi durvalumab 1,500 mg J9173 150 HCPCS units (10 mg per unit) Keytruda pembrolizumab 400 mg J9271 400 HCPCS units (1 mg per unit) Libtayo cemiplimab-rwlc 350 mg J9119 350 HCPCS units (1 mg per unit) Imfinzi and Tremelimumab with Chemotherapy Improved Progression-Free Survival by 28% and Overall Survival by 23% in 1st-Line Stage IV Non-Small Cell Lung Cancer vs. 68 mg/mL). S. NDC11: 00904629161: National Drug Code (NDC) in the 11 digit (no dashes) form, also referred to as the CMS 11-digit NDC derivative. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. Vaccine CPT Code to Report. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 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 . The list of results will include documents which contain the code you entered. Health Service Act for Imfinzi (durvalumab) Injection, for intravenous use.