It applies to all plans except Medicare Supplemental plans. 70461-0323-03 Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. References . (B) A product code consisting of 3 digits and a package code consisting of 2 digits for a total NDC length of 10 or 11 digits (5–3–2 or 6–3–2). Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. J1745. 100 Eglantine Driveway. Possible side effects . 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. NDC covered by VFC Program. Codes Listed "By Report" There are certain drugs on the Physician Manual Fee Schedule and on the Ordered Ambulatory Fee Schedule that are designated "By Report" ("BR"). J0885. 10 mg vial of drug is administered = 10 units are billed. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Code Description Vial size Billing units. 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. HCPCS code = J3490 HCPCS units = 1 -National Drug Code (NDC) is 00009-470913 NDC units = 0. 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. ATC code: L01FF03. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). IRST . 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). FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. Imfinzi Generic Name durvalumab Strength 120 mg/2. The FDA offers an NDC searchable database. What you need to know before you are given IMFINZI . . A. The 835 electronic transactions will include the reprocessed claims along with other claims. The first 5 digits identify the labeler code representing the manufacturer of the drug and are assigned by the Food and Drug Administration (FDA). 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). Non-Small Cell Lung Cancer (NSCLC) 1. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . 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. An administration code should always be reported in addition to the vaccine product code. Medicare BPM Ch 15. 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. 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. References 1. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:. This document provides the latest information about the dosage, side effects, warnings, and interactions of IMFINZI. What is National Drug Code (NDC)? • A unique . Email: MHILPharmacy@molinahealthcare. 2 DOSAGE AND ADMINISTRATION 2. You may report side effects to FDA at 1-800-FDA-1088. Get help with Imprint Code FAQs. thyroid disorders. It showed an. 50. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. Discard unused portion. 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). View Imfinzi Injection (vial of 10. Contents of the pack and other information . CPT codes provided in the vaccine code sets are to assist with. Imfinzi 120 mg/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. 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. Specifically, we are proposing. 00310-4500-12 00310. 3. Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. A10. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. 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. 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. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior to• IMFINZI is approved for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)1 • IMFINZI is a human monoclonal antibody directed against programmed cell death ligand-1 (PD-L1)1Imfinzi™ (durvalumab) Last Review Date: January 1, 2019 Number: MG. The U. Associated Documents. 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. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. 4/BA. 17: $76. Example claim with HCPCS by itself: HCPCS rate changed 5/19. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. N/A. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. UPDATE: On March 27, 2020, the Food and Drug Administration (FDA) approved durvalumab (Imfinzi) to treat small cell lung cancer (SCLC). Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. Please see Important Safety Information throughout and Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. It is important to note that this code represents 1/10th of a vial. The new formulation the. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. Do not freeze or shake. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. NDC 0310-4611-50. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). This code is effective on 11/1/2018. This medication has been identified as Imfinzi 120 mg/2. active_ingredient: BN:. 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. hoarseness, husky, or loss of voice. IMFINZI may cause serious or life threatening infusion reactions and infections. HCPCS/CPT code: J0744 HCPCS/CPT code description: Ciprofloxacin for intravenous infusion, 200 MG Number of HCPCS/CPT units 6 NDC (11-digit billing format): 00409-4765-86 NDC description: Ciprofloxacin IV SOLN 200 MG/20 ML NDC unit of measure ML 8. For example, the same drug may be produced by many different manufacturers or the same drug may have different dosages. NDC=National Drug Code. 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. 25 mg/mL bupivacaine and 0. Enter the NDC qualifier. 5. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 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. 10/01/2022 R6 HCPCS J1554 was added to the CPT/HCPCS code section, effective date 4/1/2021. 4 mg/kg at Day 1 of Cycle 1; •. The member's specific benefit plan determines coverage. The 10-digit NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1, meaning that there are 4 or 5 digits for the labeler code, 4 or 3 digits for the product code and 2 or 1 digit(s) for the package code. Last updated on emc: 04 Sep 2023. HCPCS / NDC Crosswalk for Billing Physician-administered Drugs on the Provider Services Billing Manuals page. Attention Pharmacist: Dispense the accompanying Medication. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. 120 mg/2. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. Payers may require the. A valid HCPCS or CPT code with units of service must continue to be entered on the claim form as the basis for. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 00 17. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. 70461-0321-03. Brand name . Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. paper. Keep vial in original carton to protect from light. 1. Example 2: HCPCS description of drug is 50 mg. CPT Long Description Change: 78130. The Policy Bulletins are used in making decisions as to medical necessity only. Group 1 (9 Codes) Group 1 Paragraph. ₹0. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. Tunney’s Pasture, A. trouble. The UOM codes are: F2 = international unit. It is supplied by AstraZeneca. 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 . Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). diabetes. 569: $79. HCPCS code describes JEMPERLI. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. The list of results will include documents which contain the code you entered. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 1) 03/2020 Dosage and Administration, Dosage Modifications (2. 90674. 5 mL 10 pre-filled syringes seasonal influenza, quadrivalent, preservative free: 90688 150; 33332-0422-10 multi-dose vial, 5 mL (0. Get this at ₹37,310. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. See full prescribing information for IMFINZI. 5 mL. Example 4: When billing a NOC drug. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. Axitinib % % % % hcpcs or cpt ® code(s) drug j0256 aralast np q5121 avsola j9023 bavencio j0490 benlysta j0179 beovu j0598 cinqair j0586 dysport j9217 eligard j1325 epoprostenol sodium j0178 eylea j0180 fabrazyme j0517 fasenra j1325 flolan j0257 glassia j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis 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. 3)]. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). 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. Pre-Stata13 had a string length limit of 244 characters. fatigue (lack of energy) upper respiratory infection such as the common cold. Weight less than 30 kg: Imfinzi 20 mg/kg IV given in combination with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . See . 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. • 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. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. • Administer IMFINZI as an intravenous infusion over 60 minutes. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. Claims are priced based on HCPCS or CPT codes and units of service. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. This list includes drugs reviewed by NIOSH from January 2012 to December 2013. 150: 33332-0322-03: 0. Sean Bohen, MD, Phd. Trade name: Macrilen . October 2023 Alpha-Numeric HCPCS Files (ZIP) - Updated 08/28/2023. Generic name . Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. Example 1: HCPCS description of drug is 6 mg. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 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. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. skin rash *. Moderna Statement: “NDC codes 80777-280-99 and 80777-280-05 were provided in anticipation of FDA authorization under EUA for a bivalent booster vaccine (Moderna COVID-19 Vaccine, Bivalent). 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. Sean Bohen, MD, Phd. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Choose Generic substitutes to Save up to 50% off. 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. (2. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Each provider is responsible for ensuring all. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. With IV infusions, the drug is slowly injected. IMFINZI is administered as an intravenous infusion over 1 hour. IMFINZI safely and effectively. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. CPT Codes / HCPCS Codes / ICD-10 Codes ; Code Code Description; Other CPT codes related to the CPB: 81235: EGFR (epidermal growth factor receptor) (eg, non-small cell lung cancer) gene analysis, common variants (eg, exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q) 96365 - 96368: Intravenous infusion : 96413 - 96417 IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is . Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Fax: (855) 365-8112. Report 90461 with 90460 only. 4. g. Rx only. Although AstraZeneca did not provide specific data in its press release, the company said that patients who were. One drug can be associated with any number of ingredients. CPT Code Description. Effective Jan. 05 ICD-10-CM. D. 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). Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. Dosage Modifications for Adverse Reactions . 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 . Mechanism of action. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17This includes restrictions that may be on a deleted code that are continued with the replacement code(s). May 2021. You should be sure to bill 10 units of J1745 on the claim form when indicating that a single 100-mg vial of REMICADE® was used. IMFINZI™. The NDC is updated daily, this version offered here is from September 6th, 2022. PPO . Imfinzi durvalumab J9173A. NCCN Drugs & Biologics Compendium ® Imfinzi. • Submit the NDC code in the red-shaded portion of the detail line item starting in positions 01 • Precede the NDC with the qualifier N4 and follow it immediately by the 11-digit NDC code (e. It is for use in adults with: non-small cell lung cancer (NSCLC) that is locally advanced (meaning it has spread into tissues around the lungs, but not to other parts of the body) and cannot be removed by surgery and is not getting worse after radiation treatment and platinum-based chemotherapy (medicines to treat cancer). 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. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. HCPCS codes are reported by the physician, hospital or DME provider that purchased the item, device, or supply. The CPT procedure codes do not include the cost of the supply. pneumonitis * ( inflammation of the lungs) hair loss. 21. 3 CWF shall send/display data in separate records for Dates of Service (DOS) and NPI of each PPV HCPCS codes (90670 and 90732) from new Auxiliary to: •The third set of digits is the package code, which identifies package sizes and types. CPT Code Description. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. , "in use" labeling). The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. Covered codes. PH. ) Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347. 2 DOSAGE AND ADMINISTRATION 2. The following table shows common 10-digit National Drug Code (NDC) formatsYescarta is billed using HCPCS code Q2041 – Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per2. IMFINZI in combination with IMJUDO can cause immune-mediated rash or. renal dysfunction. CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. g. X . Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. Request# 20. 7 months in the placebo group. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. Below example explain how to assign a labeler code. NDC covered by VFC Program. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 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. 2 mL dosage, for intramuscular use. How you are given IMFINZI . Lab tests offered by us. 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). L. One (1) unit represents 10 mg of (J9035) or bevacizumab ordered/administered to patient. Full prescribing. Bevacizumab should be billed based on units, not total number of milligrams. Varun Gupta, MD Pharmacology on 5th Sep 2023. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. (2. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug List Print. Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 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 list of results will include documents which contain the code you entered. Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading. 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. NDC: 58160-0815-52 (1 dose T-L syringes. The 835 electronic transactions will include the reprocessed claims along with other claims. Table 1. 5. 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. com Abecma (idecabtagene vicleucel) MCP. • 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. claim form as follows: 1. X 11335. Finished drug products. The NDC code can be found on the outside packaging of the drug. 2ML. 1 6. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. LCDC Building. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. 5%) adverse reactions. (2. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. 21. The product's dosage form is injection, solution, and is administered via intravenous form. Serious side effects reported with use of Imfinzi include: rash*. 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 7. Epub 2021 Nov 3. Prev Section 2. 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. 2 months compared to placebo. They may not be reported prior to effective date. Imfinzi will be authorized for 6 months when criteria for initial approval are met. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related e/m service provided within the previous 7 days nor leading to an e/m. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. com. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. NDC units are based on the numeric quantities administered to the patient and the unit of measure (UOM). ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. Dossier ID: HC6-024-e195931. 708: 6/30/2023:. The next 4 digits identify the specific drug product and are. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. C. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. Key points to remember. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. National Comprehensive Cancer Network, Inc. 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. 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. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Group 1. For the following HCPCS codes either the short description and/or the long description was changed. National. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. A. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. in a 10-digit format. . As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and. g. Imfinzi is. This medication can cause rare, but serious. 50. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic Licensing Application Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who: havediseaseprogressionduringorfollowingplatinum-containingchemotherapy. . S. Enter the information on the . ‡ 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. 01 Learn More About Medical Coding Section 2. and revised HCPCS codes effective April 1, 2022, which include A4238, E2102, K1028-K1033, and V2525. The National Drug Code (NDC) Directory is updated daily. 2 SAD Determinations Medicare BPM Ch 15. VI. 3 . 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). 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . CPT Code Description. Note that the CPT codes shown are not mapped to the NDC codes, but are mapped to the CVX codes shown. of these codes does not guarantee reimbursement. Indications and Usage (1. Code 91317 for Pfizer-BioNTech COVID-19. A firm. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 7 6. 1 vial = 10 units. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. 2 . Note that not all products and NDCs under their respective CPT codes will be covered. How do I calculate the NDC units? Billing the correct number of NDC units for the.