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 . A. 2 . 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). For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. The safety and tolerability of the Imfinzi combination was consistent with previous. 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. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. Vaccine CPT Code to Report. 4 mg/kg at Day 1 of Cycle 1; •. 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 . 20. Listen to a soundcast of the September 2nd, 2022 FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. Control #:. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 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. 70461-0321-03. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. ‡ motixafortide †,. 58%), as well those showing a durable response at one year (23% vs. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02. Approval: 2017 . 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. 1, 2019 . Group 1 (9 Codes) Group 1 Paragraph. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. Cancer Oncology Rx required. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. A firm. While 21 CFR 801. 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). S. Item Code (Source) NDC:0310-4505: Route of. Description . View Imfinzi Injection (vial of 2. • Should not be assigned to non-drug products. 9 in addition to the appropriate flu vaccine and administration codes. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. allergic reaction *. Bahamas Updated. renal dysfunction. 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. NOTE: Dates of service for Terminated HCPCS codes not needed. 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 HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1,. One drug can be associated with any number of ingredients. Adding NDC: 504190390, 504190391 Adding NDC: 635390187, 635390188 bendamustine (C9042, J9033, J9034, J9036) and rituximab (J9310, J9312) Changing HCPCS: J9999 to J9309 Adding HCPCS for combination bendamustine: J9036 C9044, J9119 Adding HCPCS: J9119 C9045, J9313 Adding HCPCS: J9313 C9474, J9205 Adding NDC: 150540043. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 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 . 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). Each 3 mL pre-filled single-patient use pen contains semaglutide 2 mg (0. They may not be reported prior to effective date. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. The UOM codes are: F2 = international unit. LCDC Building. About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. nervousness. A. The Drug Name and NDC Reference Data file: The Drug Name and NDC Reference Data are delivered in one pipe-delimited . Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. 0 Unit: mg/10mL Packages: Code: 00310-4611-50 Description: 1 VIAL in 1 CARTON (0310-4611-50) / 10 mL in 1 VIAL Effective Date: May 1, 2017 CPT codes covered if selection criteria are met: VENTANA PD-L1 (SP263) Assay - no specific code: Other CPT codes related to the CPB: 96413 - 96417 : Chemotherapy administration; intravenous infusion technique : HCPCS codes covered if selection criteria are met: J9173 : Injection, durvalumab, 10 mg: Other HCPCS codes related to the CPB: C9147 NDC 0310-4500-12. Imfinzi durvalumab J9173A. 3%) patients including fatal pneumonitis in one. 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. Proper Name: Antihemophilic Factor (Recombinant) Tradename: NUWIQ. National Comprehensive Cancer Network, Inc. 2 8. com. Use the units' field as a multiplier to arrive at the dosage amount. 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 in combination with IMJUDO can cause immune-mediated nephritis. The list of results will include documents which contain the code you entered. Revised: 03/2021 Page 2 . IMFINZI is administered as an intravenous infusion over 1 hour. Current through: 11/21/2023. hoarseness, husky, or loss of voice. Influenza vaccines are licensed each year with new NDCs, so it is important to report the correct code for the products you are using to avoid having claims deny with edit 00996 (Mismatched NDC) which will require the claim to be resubmitted with the correct. IMFINZI 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 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. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. 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. 5 mL dosage, for. 4 mL:The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to attach to a protein called PD-L1, which is present on the surface of many cancer cells. 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. Prev Section 2. PPO . 11: HCPCS Codes HCPCS codes are a vital part of the coding process. 2 months, compared to 5. IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. 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. 24 participants with Non-Small Cell Lung Cancer will be. 82. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. CPT Code CVX NDC PRESENTATION DESCRIPTION BRAND NAME VFC COVERED? 317 Adults Covered? Public Clinic "Billables"? 90686. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. 6. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. 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. Store at 2° to 8°C (36° to 46°F). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 2ML. 0601C. (2. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. This medication has been identified as Imfinzi 120 mg/2. 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 . Imfinzi [prescribing information]. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. The Clinical Criteria information is alphabetized in the. Mechanism of action. Group 1 Codes. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. Refer to. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. Dossier ID: HC6-024-e195931. due to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020). . HCPCS code(s) below does not signify or imply member coverage or provider reimbursement. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 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. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. # Step therapy required through a Humana preferred drug as part of preauthorization. HCPCS code G2012: Brief communication technology-based service, e. Under CPT/HCPCS Codes Group 10: Codes added HCPCS code J9033. Manufacturer: Octapharma USA, Inc. The first five digits. Trade name: Macrilen . What you need to know before you are given IMFINZI . 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. HMO . Choose Generic substitutes to Save up to 50% off. • Administer IMFINZI as an intravenous infusion over 60 minutes. 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). 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,. 34 mg/mL), or 8 mg (2. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeksImfinzi (durvalumab) is an immunotherapy used in a variety of cancers, including lung cancer and liver cancer. The second and third segments of NDC Labeler code are assigned by the labeler. This corresponded to a. It’s given as an IV infusion. See . The NDC Number for each drug will be different. Coverage Period Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 2 DOSAGE AND ADMINISTRATION 2. 2 mL dosage, for intramuscular use. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. 10 mg vial of drug is administered = 10 units are billed. The third segment, the package code, identifies package sizes and types. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. Associated Documents. 21. What IMFINZI is and what it is used for . Administer IMFINZI prior to chemotherapy when given on the same day. Effective date is noted in the file title. 4%) patients. This will prevent the service from receiving a reason code for invalid HCPCS based on the 5/3 “from date. Seventeen5. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. See full prescribing information for IMFINZI. 7 months in the placebo group. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Please see the HCPCS Quarterly Update webpage for those updates. IMFINZI works by helping your immune system fight your cancer. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The NDC must be active for the date of service. applicant, existing HCPCS codes do not identify this product; and given that Rolvedon™ is a single source biological as defined by section 1847A(c)(6)(D) of the Social Security Act, it should be assigned a new HCPCS Level II code and paid separately by Medicare consistent with statute and CMS policy. 1, 2019. The list of results will include documents which contain the code you entered. 6 5. infections. With IV infusions, the drug is slowly injected. View Imfinzi Injection (vial of 10. See . (2. Brand name . STN: BL 125555. 4 mL injection. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 099. 2 . UB-04. Under the approval, durvalumab can be used as an initial treatment for people with extensive-stage SCLC. Last updated on Jun 28, 2023. 6%). 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. 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. 68 mg/mL), 4 mg (1. The active substance of Imfinzi is durvalumab, an antineoplastic monoclonal antibody (ATC code: L01XC28) that potentiates T-cell response, including anti-tumour response, through blockade of PD -L1 binding to PD-1. Report 90461 with 90460 only. 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). Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing. Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 1. Generic name . 3 spasmodic torticollis; payment may be made under off-label use circumstances outlined in Indications and Limitations of the LCD Botulinum Toxin Type A and B Policy (L35170). [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. 2. The list of results will include documents which contain the code you entered. PPO . N/A. Clinical Studies (14) ]. 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). Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. Example 4: When billing a NOC drug. All existing CPT codes that describe COVID-19 vaccine products and associated administration codes that end in “A” for products that are no longer covered under an existing Emergency Use. S. As of April 2020, the Alpha-Numeric HCPCS File is a quarterly file. To report via data exchange, providers would report using the NDC code that is specific to the dose administered. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. Example 3: HCPCS description of drug is 1 mg. A10. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. The CPT procedure codes do not include the cost of the supply. Serious side effects reported with use of Imfinzi include: rash*. trouble. These Prior Approval supplementals biologics application provide for the addition of alternate treatment schedule of 1500 mg every 4 weeks for stage 3 unresectable non-small cell lung cancer and urothelial carcinoma. Each single-dose glass vial is filled with a solution of 29. NDC=National Drug Code. 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. REFERENCES 1. 90674. A: Yes, the NDC information must be submitted in addition to the applicable HCPCS, CPT or Revenue code(s) and the number of HCPCS, CPT or Revenue code units. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 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). 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. 82 due to reconsideration requests. IMFINZI™. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. 2. They are owned by CMS and are available for use. Dosage Modifications for Adverse Reactions . # Step therapy required through a Humana preferred drug as part of preauthorization. The most common side effects that occurred in 20% or more of patients receiving Imfinzi were: fatigue, nausea, constipation, decreased appetite, abdominal pain, rash and fever. 58 g/mol. The correct use of an ICD-10-CM code does not assure coverage of a service. Are specific to the drug itself. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. (2. Converting National Drug Code (NDC) from a 10-digit to an 11-digit format requires a strategically placed zero, dependent upon the 10-digit format. 4ml. (2. Do not report 90460, 90471-90474 for the administration of COVID vaccines. 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. 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,. 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. 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 (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. MM. Rx only. It’s given as an IV infusion. 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. 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. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. 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. 2 SAD Determinations Medicare BPM Ch 15. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). . It is used. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. OLORADO . Tunney’s Pasture, A. Dosage Modifications for 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 . 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. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Generic name: durvalumab [ dur-VAL-ue-mab ] Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Medically reviewed by. immune system reactions, which can cause inflammation. Injection, infliximab, 10 mg. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. 90674. lower back or side pain. 4. 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. On the . Imfinzi (durvalumab) is infused into the veins, usually every 2-4 weeks, depending on the cancer. Non-Small Cell Lung Cancer (NSCLC) 1. Information last updated by Dr. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. Example claim with HCPCS by itself: HCPCS rate changed 5/19. IMFINZI safely and effectively. Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. S. 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. 120 mg/2. Imfinzi 120 mg/2. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals LP”. NDC: 58160-0815-52 (1 dose T-L syringes. Durvalumab (IMFINZI ), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of. 4. The 835 electronic transactions will include the reprocessed claims along with other claims. com. Indications and Usage (1. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Restricted Access – Do not disseminate or copyThe Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. 1 8. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. 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. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. AstraZeneca’s Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) has received FDA approval for treatment of adult patients with unresectable hepatocellular carcinoma (HCC). (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. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89. 15 Providers must bill 11-digit NDCs and appropriate NDC units. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. in a 10-digit format. Imfinzi durvalumab J91731All shared Healthcare Common Procedure Coding System (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. 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. Are assigned by the Food and Drug Administration. 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. • 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. Page 3 | Imfinzi® (durvalumab) Prior Auth Criteria Proprietary Information. swelling in your arms and legs. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. 3, IMFINZI. A. 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. The Policy Bulletins are used in making decisions as to medical necessity only. 2021 Nov;16 (6):857-864. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. The approval is based on the phase III PACIFIC trial, in which the PD-L1 inhibitor Imfinzi improved median progression-free. liver dysfunction. • Administer IMFINZI as an intravenous infusion over 60 minutes. Abilify MyCite Kit (aripiprazole with biosensor)- (Medical Necessity) Actemra (tocilizumab). The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. 6, 2019 retroactive to Jan. The file contains the following drug information: • NDCPackageCode (Column A): The labeler code, product code, and package code segments of the NDC number, separated by hyphens per FDA website. 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. Administer IMFINZI prior to chemotherapy when given on the same day. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. Updated Nationally Determined Contribution of the Republic of Azerbaijan. Revision DateImfinzi is a human monoclonal antibody that binds to the programmed cell death 1 receptor, unleashing immune T-cells to attack cancer cells. 10/10/2023. Q4132 Grafix core and GrafixPL core, per square centimeter Q4133 Grafix prime and GrafixPL prime, per square centimeter Q4137 Amnioexcel or BioDExCel, per square centimeter Q4138 Biodfence Dryflex, per square centimeterThe following HCPCS codes have been added to the Article: Q5127 and Q5130 in the ‘Subcutaneous and Intramuscular Injection Non-Chemotherapy-Generic/Trade Names Table’ and in the ‘Group 1 CPT/HCPCS Codes Table’. 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. diabetes. 65 Unit of measure (UOM) is mL Pricing calculation: 105% of the wholesale acquisition cost (WAC) of the NDC billed by the provider. 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. The NDC code would be unique for all of them and can help you distinguish between those result. doi: 10. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. 3. 3) 03/2020 Dosage and Administration (2. 90672. 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 • Arm 1: IMFINZI 1500 mg administered on Day 1+ gemcitabine 1000 mg/m 2 and cisplatin 25 mg/m 2 (each administered on Days 1 and 8) every 3 weeks (21 days) for up to 8 cycles, followed by IMFINZI 1500 mg every 4 weeks as long as clinical benefit is observed or until unacceptable toxicity, or 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 . 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. 17: $76. Fig. 5. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. The NDC number consists of 11 digits in a 5-4-2 format. (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. IMFINZI may cause serious or life threatening infusion reactions and infections. Continuing therapy with Imfinz will be authorized for 12 months. 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”. Injection, epoetin alfa (for non-ESRD use), 1000 units.