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. 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). liver dysfunction. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. 1, 2019 . com. 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. AstraZeneca ’s Imfinzi (durvalumab), administered concurrently with chemoradiotherapy, missed its primary efficacy endpoint in the Phase III PACIFIC-2 trial in non-small cell lung cancer, the company announced Tuesday. Imfinzi Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. Providers must bill the product with HCPCS code: A9575 - Injection, gadoterate meglumine, 0. Average progression-free survival for the Imfinzi-containing group was 7. The correct use of an ICD-10-CM code does not assure coverage of a service. 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. Code: 00310-4500-12 Description: 1 VIAL in 1 CARTON (0310-4500-12) /. PPENDIX . Food and Drug Administration (FDA), AstraZeneca has announced that Imfinzi (durvalumab) — which last year failed a confirmatory Phase 3 trial — will no longer be available in the U. 1007/s11523-021-00843-0. It is a type of immunotherapy and belongs to a group of medicines called immune checkpoint. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. IMFINZI is administered as an intravenous infusion over 1 hour. Effective Jan. 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. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. IMFINZI may cause serious or life threatening infusion reactions and infections. How do I calculate the NDC units? Billing the correct number of NDC units for the. [medical citation needed]Durvalumab is an immune checkpoint. All other Codes (ICD-10, Bill Type, and Revenue) have moved to Articles for DME MACs, as they have for the other Local Coverage MAC types. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. The second and third segments of NDC Labeler code are assigned by the labeler. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. NCCN Drugs & Biologics Compendium ® Imfinzi. 05 ICD-10-CM. PH. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . In the pivotal phase III CASPIAN trial in previously untreated. Food and Drug Administration (FDA) has approved a new dosing regimen for Imfinzi (durvalumab) for the treatment of certain non-small cell lung cancer (NSCLC) and bladder cancer patients. NDC covered by VFC Program. 1. S. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. Durvalumab (Imfinzi) has been granted a. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/175. Imfinzi (durvalumab) may be considered medically necessary for the treatment of adults with: • Unresectable, stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy • First-line treatment of extensive-stage small cell lung cancerThe HIPAA standard 11-digit NDC format is standardized such that the labeler code is always 5 digits, the product code is always 4 digits, and the package code always 2 digits. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. Bahamas. Influenza HCPCS and CPT Codes. Contents of the pack and other information . The FDA assigns the labeler code, while the company assigns the product and package code. The 835 electronic transactions will include the reprocessed claims along. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. What IMFINZI is and what it is used for . 88 mg/mL meloxicam. 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. One (1) unit represents 10 mg of (J9035) or bevacizumab ordered/administered to patient. 4 mL single-dose vial: 4 vials per 14 days • Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days B. English. 25 mg/mL bupivacaine and 0. FDA approvals of PD-1/PD-L1 mAbs. 3) 03/2020 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. The approval was based on the results of the CASPIAN clinical trial, which showed that. Enter the information on the . Recommended Treatment Modifications for IMFINZI Adverse Reactions Severitya IMFINZI Treatment Modification Corticosteroid Treatment Unless Otherwise Specified Pneumonitis[see Warnings and Precautions (5. Researchers randomized patients to receive either Imfinzi or a placebo every two weeks for up to 12. 31, 2018. A. 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 mL dosage, for. 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, 01/17Claims 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, 01/17Weight less than 30 kg: Imfinzi 20 mg/kg IV given with Imjudo 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . doi: 10. 4ml. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. (2. The first sentence in the “Coding Information” section has been revised to add ranibizumab-nuna and faricimab-svoa: The administration for ranibizumab, ranibizumab-nuna, aflibercept, brolucizumab-dbll or faricimab-svoa must be billed on the same claim as the drug, with. The third segment, the package code, identifies package sizes and types. 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). Example of NDC Labeler code assignment. The member's specific benefit plan determines coverage. • Should not be assigned to non-drug products. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. 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. 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. NOTE: Dates of service for Terminated HCPCS codes not needed. Use the units' field as a multiplier to arrive at the dosage amount. 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 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 1. 58 g/mol. 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. Vaccine CPT Code to Report. HCPCS code describes JEMPERLI. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. 3. Generic name . See full prescribing information for IMFINZI. (2. database (n=1414), of patients treated with IMFINZI 10 mg/kg every 2 weeks, immune-mediated pneumonitis occurred in 32 (2. This will allow quick identification of new safety information. (2. Brand name . 5 mL dosage, for. Generic name: durvalumab [ dur-VAL-ue-mab ] Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors) Medically reviewed by. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. . Imfinzi (durvalumab) may be used as a single agent for consolidation therapy (for a total of 1Imfinzi FDA Approval History. # Step therapy required through a Humana preferred drug as part of preauthorization. 00 • Submit a valid HCPCS or CPT code in the administrative claim lines (per diem/ nursing), in accordance with your UnitedHealthcare Participation Agreement – An invalid, incorrect or missing NDC will pay at. HCPCS codes are reported by the physician, hospital or DME provider that purchased the item, device, or supply. 2 mL dosage, for intramuscular use. HCPCS code describes JEMPERLI. NDC=National Drug Code. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. More about Imfinzi (durvalumab) Check interactions;Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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,. Injection, epoetin alfa (for non-ESRD use), 1000 units. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14. 692: 6/30/2023: Merck: 75D30122D14072: Hepatitis A Adult Havrix® 58160-0826-52: 10 pack – 1 dose syringe: $38. 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. 100 Eglantine Driveway. nervousness. REFERENCES 1. 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 . Approval: 2017 total bilirubin elevation. The official update of the HCPCS code system is available as a public use file below. Wilmington, DE: AstraZeneca Pharmaceuticals LP; February 2021. (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17ATC code: L01FF03. This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. Generic name . Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. LCDC Building. The FDA had granted Imfinzi with its bladder cancer indication through the accelerated appr oval program in 2017, with continued approval contingent upon verification of clinical benefit in confirmatory trials. 6. The recommended dosefor IMFINZI monotherapyandIMFINZI combination therapy ispresented in Table 1. Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . N/A. Seventeen5. 5 mL dose) seasonal influenza,HCPCS code Q5124 has been added to the CPT/HCPCS code section. Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 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. See . View Imfinzi Injection (vial of 2. 1 Recommended Dosage . IRST . This study has 2 parts: dose finding and dose confirmatory. paper. 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). Second claim should be billed from 5/3 through 5/31 with the HCPCS on the 5/3 - 5/31 claim. Billing Code/Information J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg Prior authorization of bene fits is not the. 82 to Group 1, ICD-10-CM Codes that Support Medical Necessity. Vaccine CPT Code to Report. 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). 68 mg/mL). dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . 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). The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Below example explain how to assign a labeler code. 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. colitis. claim form, enter the NDC information in the shaded, top-half portion of each applicable detail line, beginning at field 24A. 7 months in the control arm, according to an FDA announcement regarding the approval. Attention Pharmacist: Dispense the accompanying Medication. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. 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. Key points to remember. CPT Code Description. immune system reactions, which can cause inflammation. The product's dosage form is injection, solution, and is administered via intravenous form. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. 2 DOSAGE AND ADMINISTRATION . S. If you have any questions about these medicines, ask your doctor. 2 . renal dysfunction. PPO . Format revision completed. IMFINZI® (durvalumab) COPYRIGHT 2017 - 2022 ASTRAZENECA CANADA INC. trouble breathing. May 2021. Description . This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. Rx only. Administer IMFINZI as an intravenous. 90674. The FDA offers an NDC searchable database. (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). 569: $79. IMFINZI™ (durvalumab) Injection. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. X 11335. This medication has been identified as Imfinzi 120 mg/2. allergic reaction *. IMFINZI safely and effectively. 21. 5 days (range: 24-423 days). 10-digit, 3-segment number. (2. 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. Tunney’s Pasture, A. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. S. 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. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. 4 ml Injection) uses, composition, side-effects, price, substitutes, drug interactions, precautions, warnings, expert advice and buy online at best price on 1mg. 3) 09/2022 Dosage and Administration (2. 2) 0X/2020Admni siter IMFINZI proi r to chemothearpy on the same day . Accessed on May 11, 2021. Expand All | Collapse All. SKU Description HCPCS Code NDC-Format Code for Single NDC-Format Code for Carton NDC-Format Code for Case Adult Nutritional 53536 Glucerna 1. Imfinzi ® J9173. A physician might report code 99213-25 with diagnosis code E11. 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. The FDA has approved updated labeling for Imfinzi (durvalumab; AstraZeneca) to include overall survival data for patients with unresectable, Stage III non-small cell lung cancer (NSCLC). 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. Submit PA requests . • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. 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. Long descriptor: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, bivalent, preservative free, 10 mcg/0. The 835 electronic transactions will include the reprocessed claims along with other claims. HCPCS Level II Code. 5%) adverse reactions. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. 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. The 2022 CPT code set also includes an appendix for one-stop access to all the codes for COVID-19 vaccine reporting. 8. 5 for the booster vaccine is now being planned. J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. IMFINZI™ (durvalumab) Injection. Related Local Coverage Documents N/A. It applies to all plans except Medicare Supplemental plans. 00 Inclusive of all taxes. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination Under CPT/HCPCS Codes Group 27: Codes deleted HCPCS code C0938 and added J9204. 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. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. Trade name: Macrilen . 88 mg/mL meloxicam. Store at 2° to 8°C (36° to 46°F). ₹0. g. 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. Update Feb. Granted under priority review, the approval allows Imfinzi to be administered at a fixed dose of 1,500 mg every four weeks for patients. • NDC (National Drug Codes): The US Federal Drug Administration (FDA) Data Standards Council assigns the first 5 digits of the 11 digit code. PD-L1 can be induced by. for people with locally advanced or metastatic bladder cancer. MRP ₹45500. 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. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. code . Get help with Imprint Code FAQs. CMS Final HCPCS Coding DecisionProviders are responsible for providing medical advice and treatment, are independent contractors, and are not employees or agents of Independence. 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. Images of medication. The approval was based on data from the Phase III PACIFIC trial. skin rash *. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. Preferred product information . 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). IMFINZI in combination with IMJUDO can cause immune-mediated nephritis. Cart Total. Are specific to the drug itself. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. provider administered drugs page 2 of 3 . Each single-dose glass vial is filled with a solution of 29. Administer IMFINZI prior to chemotherapy when given on the same day. 2. NDC covered by VFC Program. National. Refer to. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. (HCPCS) codes and not otherwise classified (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all. What you need to know before you are given IMFINZI . PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. 2 . HCPCS codes HCPCS codes are used to report supplies, drugs and implants. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. J0885. Keep vial in original carton to protect from light. 1) 09/2022 IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated:The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with other therapeutic agentsare presented in Table 1. 5. Dosage Modifications for Adverse Reactions . 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). Discard unused portion. Example claim with HCPCS by itself: HCPCS rate changed 5/19. 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. Current through: 11/17/2023. CPT Long Description Change: 78130. 25 mL • Fluarix 0. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . 4. The CPT procedure codes do not include the cost of the supply. 10/10/2023. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. 00310-4500-12 00310. 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. Information last updated by Dr. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. 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. Imjudo (tremelimumab) is given for one cycle followed by single agent Imfinzi (durvalumab). National Comprehensive Cancer Network, Inc. 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. The U. skin rash *. More common side effects in people taking Imfinzi for small cell lung cancer include. 82. The UOM codes are: F2 = international unit. National. 21. EALTH . Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. 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. headache. CanMED: NDC. NovoLogix Carelon Quantity limits . IMFINZI safely and effectively. 68 mg/mL), 4 mg (1. The 835 electronic transactions will include the reprocessed claims along with other claims. swelling in your arms and legs. C. This medication can cause rare, but serious. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 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. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. 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. Different package codes only differentiate between different quantitative and qualitative attributes of the product packaging. Code Description Vial size Billing units. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Labeler code portion of NDC; assigned by FDA to firm. Some packages may display fewer than 11 digits. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 50. Also include the NDC. NovoLogix Carelon Quantity limits . Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. 1. NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. 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. NDC=National Drug Code. The safety and tolerability of the Imfinzi combination was consistent with previous. IMFINZI works by helping your immune system fight your cancer. g. 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. 2 8. NDC 0310-4611-50. 10/31/2019 R6 NDC 0310-4611-50. The NDC is actually a 10-digit number that contains the three segments noted above. (NDC 0310-4611-50) 120 mg/2. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89. The list of results will include documents which contain the code you entered. 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). 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. Control #:. 4. 01 Learn More About Medical Coding Section 2. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. While 21 CFR 801. July 2023 Alpha-Numeric HCPCS File (ZIP) -. S. They are owned by CMS and are available for use. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. 1 7. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. • 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). 66019-0310-10 Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. Be attentive to the long description of the HCPCS code. HCPCS code End-dated Dec. 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. MM. 1 mL; The maximum reimbursement rate per unit is: $0. 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. Claims that Contain NDCs Related to Vaccine CPT Codes, 04/17 Clinical Coverage Policies, 02/17, 04/17, 05/17, 06/17, 08/17 CPT Code Update: 2017, 01/17 Discontinuation of Medical/Surgical PA form DMA 372-118, 01/17 The Final 2017 Regional NCTracks Seminar is June 6, 06/17 HCPCS Code (J codes) Update 2017, 01/17 Imfinzi belongs to a class of drugs called PD-L1 inhibitors.