Marketing Approval Date: 03/27/2020. It’s given as an IV infusion. 66019-0309-10. 2 DOSAGE AND ADMINISTRATION 2. 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. UB-04. 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. • NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. Possible side effects . S. 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. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . 5 for the booster vaccine is now being planned. 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). Short descriptor: SARSCOV2 VAC BVL 10MCG/0. Please see the HCPCS Quarterly Update webpage for those updates. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). 1 mL; The maximum reimbursement rate per unit is: $0. 1 unit per 1000 units. 21. 2. They are the basis for your reimbursements. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Bevacizumab should be billed based on units, not total number of milligrams. • 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). The CPT procedure codes do not include the cost of the supply. Below example explain how to assign a labeler code. NovoLogix Carelon Quantity limits . Covered services will be processed according to the chart below. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Injection, zoledronic acid, 1 mg . Administer IMFINZI prior to chemotherapy when given on the same day. One (1) unit represents 10 mg of (J9035) or bevacizumab ordered/administered to patient. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. of these codes does not guarantee reimbursement. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. 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. # Step therapy required through a Humana preferred drug as part of preauthorization. 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. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. This medication can cause rare, but serious immune-related. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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). NDC=National Drug Code. The product's dosage form is injection, solution and is administered via intravenous form. 88 mg/mL meloxicam. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. 4ml. Code Description Vial size Billing units. J0588 - Labeled indications for Xeomin are limited to G24. Q: Does the requirement to bill NDCs apply to all plans? A: No. Code Description Vial size Billing units NDC; J9347: Injection, tremelimumab-actl, 1 mg: 25 mg/1. The product's dosage form is injection, solution and is administered via intravenous. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. (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. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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 Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . in a 10-digit format. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. ES-SCLC: Until disease progression, unacceptabletoxicity. Policy Bulletins are written with medical terminology and in a style common to scientific literature and convention. (2. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. 17: $76. The new formulation the. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 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. CPT Code Description. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. 5. 20. Covered codes. (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. com. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. View Imfinzi Injection (vial of 2. Always bill device in the category described by HCPCS code C1832 with 1 of the following CPT codes: • CPT code 15110 (Epidermal autograft, trunk, arms, legs; first 100 sq cm or less, or 1% of body area of infants and children), which is assigned to APC 5054 for. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 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. HCPCS codes are reported by the physician, hospital or DME provider that purchased the item, device, or supply. 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. 5%) adverse reactions. 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 . CPT codes provided in the vaccine code sets are to assist with. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. PH. Indication: Indicated in adults and children with Hemophilia A for: On-demand. Seventeen5. Claims are priced based on HCPCS or CPT codes and units of service. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. headache. See full prescribing information for IMFINZI. Immune-Mediated Dermatology Reactions. 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). 1. You may report side effects to FDA at 1-800-FDA-1088. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. f Represents the 2019-2020 NDC. Injection, infliximab, 10 mg. Providers must include the HCPCS procedure code, billing units and corresponding covered NDC number on the claim form. Under CPT/HCPCS Codes Group 10: Codes added HCPCS code J9033. 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. allergic reaction *. The UOM codes are: F2 = international unit. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. With IV infusions, the drug is slowly injected. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . HMO Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. ( 2. 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. 3) 03/2020 Dosage and Administration (2. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Email: MHILPharmacy@molinahealthcare. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. ‡ motixafortide †,. 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). csv file. 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. PPO . FFS NDC Codes 8-1-2018 Buckeye, CareSource, Paramount NDC Codes United NDC Codes Molina. The U. NDC=National Drug Code. Epub 2021 Nov 3. 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. Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. trouble. IMFINZI may be given in combination with otheranti-cancermedicines. 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). Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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 . 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. durvalumab injection, for intravenous use (Imfinzi®) 10 mg. swelling in your arms and legs. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 099. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. After consulting with the U. In PET Scan radiopharmaceuticals and Group 1 Codes added: A9591 Fluoroestradiol f 18, diagnostic, 1 millicurie (Cerianna™). 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. Active. Payers may require the. 150: 33332-0322-03: 0. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Finished drug products. The NDC code can be found on the outside packaging of the drug. 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. 24 participants with Non-Small Cell Lung Cancer will be. IMFINZI™ (durvalumab) Injection. . Use the units' field as a multiplier to arrive at the dosage amount. immune system reactions, which can cause inflammation. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. 90658 can be used for the administration of a flu shot. These codes are also located in the Medicine section of the CPT code set. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0. 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 theDurvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 25 mL single-dose vial: 25 units: 0310-4505-25: 300. Each single-dose glass vial is filled with a solution of 29. Imfinzi disease interactions. The following CPT codes are to be reported for the procedures performed. 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. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. Group 1 (9 Codes) Group 1 Paragraph. Restricted Access – Do not disseminate or copyImfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the. This code is effective on 11/1/2018. Imfinzi was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic. Expand All | Collapse All. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Adding National Drug Codes (NDC) to ClaimsIMFINZI 120mg Injection 2. A. 1. CPT/ HCPCS Code Laboratory Code Long Descriptor Target 1. HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. National Drug Code Directory. 4 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. 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. physician payment, each CPT code is assigned a point value, known as the relative value unit (RVU), which is part of the formula to determine the payment amount. Revised: 03/2021 Page 2 . Revision DateImfinzi is a human monoclonal antibody that binds to the programmed cell death 1 receptor, unleashing immune T-cells to attack cancer cells. The Clinical Criteria information is alphabetized in the. 6 mg are administered = 1 unit is billed. Do not report 90460, 90471-90474 for the administration of COVID vaccines. They are owned by CMS and are available for use. Manufacturer: Octapharma USA, Inc. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. Identify the specific product and package size. or HCPCS Codes and/or How to Obtain Prior Authorization . 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. Influenza HCPCS and CPT Codes. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Each provider is responsible for ensuring all. The official update of the HCPCS code system is available as a public use file below. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. # Step therapy required through a Humana preferred drug as part of preauthorization. • 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. 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 . Description . 4%) patients. 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. 1)] Grade 2 Withhold doseb Initial dose of 1mg/kg/day to 2mg/kg/day prednisone or equivalent followed by a taper Grade 3 or 4. 6, 2019 retroactive to Jan. The NDC Number for each drug will be different. S. OUT OF STOCK. 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). 3%) patients including fatal pneumonitis in one (0. Although AstraZeneca did not provide specific data in its press release, the company said that patients who were. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. 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. 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). HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. How do I calculate the NDC units? Billing the correct number of NDC units for the. NCCN Drugs & Biologics Compendium ® Imfinzi. 1 vial = 10 units. Contact your patient’s• Administer IMFINZI as an intravenous infusion over 60 minutes. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. The remaining digits. 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. Some packages may display fewer than 11 digits. (2. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. 5 days (range: 24-423 days). Prev Section 2. Sean Bohen, MD, Phd. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. 2 DOSAGE AND ADMINISTRATION . renal dysfunction. IMFINZI safely and effectively. 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. Imfinzi durvalumab J9173. 25 mL • Fluarix 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. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. 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). October 2023 Alpha-Numeric HCPCS Files (ZIP) - Updated 08/28/2023. 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. 00 17. 21, including objective evidence of efficacy and safety are met for the proposed indication. The 835 electronic transactions will include the reprocessed claims along with other claims. It works by helping your immune system fight the cancer cells. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. This will allow quick identification of new safety information. Ottawa ON K1A 0K9. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. The National Drug Code (NDC) Directory data is offered here in SAS, Stata, and CSV formats to make the whole database a bit easier to use. 6. The second and third segments of NDC Labeler code are assigned by the labeler. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. The list of results will include documents which contain the code you entered. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. 21. This revision is due to the Q1 2021 CPT/HCPCS Code Update and is retroactive effective for dates of service on or after 1/1/2021. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. Related Local Coverage Documents N/A. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. It applies to all plans except Medicare Supplemental plans. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. Attention Pharmacist: Dispense the accompanying Medication. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. . 2 months compared to placebo. NDC notation containing asterisks is not accepted. Cancer Oncology Rx required. (2. The safety and tolerability of the Imfinzi combination was consistent with previous. C. NDC units are based on the numeric quantities administered to the patient and the unit of measure (UOM). As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and. The next 4 digits identify the specific drug product and are. Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. 5 Blepharospasm and G24. 5 mL dosage, for. The maximum reimbursement rate per unit is $144. 5 mL dosage, for. F. 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. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). What IMFINZI is and what it is used for . With IV infusions, the drug is slowly injected. provider administered drugs page 2 of 3 . Wilmington, DE; AstraZeneca Pharmaceuticals LP; July 2021. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. HMO . The FDA assigns the labeler code, while the company assigns the product and package code. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. Example claim with HCPCS by itself: HCPCS rate changed 5/19. 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). Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. Use the units' field as a multiplier to arrive at the dosage amount. 4. Additionally, either the long or short description of CPT code 19499 has been updated. It is a human immunoglobulin G1 kappa. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113. 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). Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. Report code only with appropriate primary procedure. Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0. An administration code should always be reported in addition to the vaccine product code. . ”. ATC code: L01FF03. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. 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. S. Wilmington, DE: AstraZeneca Pharmaceuticals LP; July 2021. 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,. 05 ICD-10-CM. (2. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. Finished drug products. The first five digits. COVID -19 Related Codes U0001 CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel COVID-19 U0002 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC) COVID-19CODE=ndc_active_ingredient. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. (2. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. Approval: 2017 . 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. 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). 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. 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. Read it carefully before using this medicine. 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 . 5. Information last updated by Dr. Imjudo is also a monoclonal antibody, but it fosters. 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. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. 31, 2018. 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. 5. Use in Cancer. 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. 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 NDC Packaged Code 0310-4611-50 is assigned to a package of 1 vial in 1 carton / 10 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 4 Adverse Reaction Severity1 Dosage Modification than 5 and up to 10 times ULN or AST or ALT is more than 3 and up to 5 times ULN at baseline and increases to more. For information about Molina pharmacy policies, contact the Pharmacy Department: Phone: (855) 866-5462. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 34 mg/mL), or 8 mg (2. How do I calculate the NDC units? Billing the correct number of NDC units for the. The National Drug Code (NDC) Directory is updated daily. Appendix X Revisions Log . 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. Sometimes, it’s used together with other immunotherapies and chemotherapy. Rx only. Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. 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. Imfinzi is. AstraZeneca has opted to voluntarily withdraw. Imfinzi [package insert]. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. Effective date is noted in the file title. 4. Assume the labeler code 12345 - 101 - 50 is for 50 ml sunscreen tube with active ingredient Zinc Oxide 20% manufactured by XYZ. , N412345678901) When entering supplemental information for NDC, add in the following order: – N4 qualifier – 11-digit NDC code – 1 spaceQ: Why is anNDC needed when drugs are already being billed with HCPCS codes? A: Billing NDCs for shared HCPCS drug codes and NOC drug codes provides the ability to determine precisely which drugs are administered.