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. 4 mL in 1 VIAL Effective Date: May 1, 2017 Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. HCPCS codes for Drugs Administered Other Than Oral Method (J Codes) are anticipated to be in NCTracks Jan. HCPCS Level II Code. 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. 2. 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). The list of results will include documents which contain the code you entered. csv file. Imfinzi will be available as a 50-mg/ml concentrate for solution for infusion . PPO . NCCN Clinical Practice Guidelines in Oncology ® Non-Small Cell Lung Cancer. Serious side effects reported with use of Imfinzi include: rash*. nervousness. After Cycle 1 of combination therapy, administer IMFINZI as a single agent every 4 weeks until disease progression or unacceptable toxicity. ₹0. Alpha-Numeric HCPCS. EALTH . Structural formula: OZEMPIC is a sterile, aqueous, clear, colorless solution. CPT Code Description. Influenza virus vaccine, quadrivalent (ccIIV4), derived from cell cultures, subunit, preservative and antibiotic free, 0. 4 ml in 1 vial of Imfinzi, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. Last updated on emc: 04 Sep 2023. The COVID-19 vaccine and administration codes are among 405 editorial changes in the 2022 CPT code set, including 249 new codes, 63 deletions and 93 revisions. IMFINZI safely and effectively. Recommended dose of IMFINZImonotherapy and combination therapy Indication Recommended IMFINZI dose Duration of therapy Monotherapy Locally Advanced. (2. Q: Does the requirement to bill NDCs apply to all plans? A: No. The product's dosage form is injection, solution, and is administered via intravenous form. 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. [NDC 58160-976-02] Prefilled syringe (package of 10 syringes per carton) 58160-976-20 0. 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. 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 theImfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. 1 unit per 1000 units. NDC covered by VFC Program. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. skin rash *. aprepitant injection (Cinvanti TM) 1 mg. , 0001-0001) or the 10 digit NDC (0001-0001-01)) Return to the FDA Label Search Page1. Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 Durvalumab Injection, For Intravenous Use (Imfinzi): HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines, 08/17 Eteplirsen injection, for intravenous use (Exondys 51): Change in Coverage, 06/17 TMImmune globulin subcutaneous (Human), 20 Percent solution (Cuvitru ) HCPCS code J3590: Billing Guidelines, 02/17 NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. 6 5. Administration codes. 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. HMO Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. Dosing for infants and children age 6 through 35 months: • Afluria 0. 5 for the booster vaccine is now being planned. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. # Step therapy required through a Humana preferred drug as part of preauthorization. The effective dates for using these documents for clinical reviews are communicated through the provider notification process. 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). Coverage of Imfinzi is available when the following criteria have been met: • Member is at least 18 years of age AND. The NDC is actually a 10-digit number that contains the three segments noted above. 90674. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). REFERENCES 1. NDC=National Drug Code. The 835 electronic transactions will include the reprocessed claims along with other claims. 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. It showed an. Example 3: HCPCS description of drug is 1 mg. 82. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . The following HCPCS codes are considered medically necessary when filed with the ICD-10 diagnosis codes listed below. Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. Identify the specific product and package size. Description . 90672. Imfinzi comes as a liquid solution in single-dose vials. 3 . hoarseness, husky, or loss of voice. 1 Recommended Dosage The recommended dosages for IMFINZI as a single agent and IMFINZI in combination withSide Effects of Imfinzi are Nasopharyngitis (inflammation of the throat and nasal passages), Upper respiratory tract infection, Rash, Flu, Dermatitis, Bronchitis (inflammation of the airways), Eczema, Swelling of lymph nodes, Oropharyngeal pain. 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,. For the following CPT/HCPCS code(s) either the short description and/or the long description was changed. Coverage PeriodExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. View or. provider administered drugs page 2 of 3 . Pre-Stata13 had a string length limit of 244 characters. They are the basis for your reimbursements. By blocking these interactions, Imfinzi may help the body’s immune system attack. Example 2: HCPCS description of drug is 50 mg. fatigue (lack of energy) upper respiratory infection such as the common cold. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. 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. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. J Code (medical billing code): J9347 (1 mg, injection) Medically reviewed by Drugs. Accessed on May 11, 2021. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. IMFINZI safely and effectively. 5 mL. MM. DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional. Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route: Intravenous. View Imfinzi Injection (vial of 2. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 2 mL dosage, for intramuscular use. J1745. Brand name . 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. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. The next 4 digits identify the specific drug product and are. 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. Images of medication. Example of NDC Labeler code assignment. J0588 - Labeled indications for Xeomin are limited to G24. 2 DOSAGE AND ADMINISTRATION 2. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. CPT Long Description Change: 78130. csv file. g. S. Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. 5%) adverse reactions. Do not freeze or shake. (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. Ottawa ON K1A 0K9. 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). 40av2 Medical Guideline Disclaimer. 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. Coverage for a Non-FDA approved indication, requires that criteria outlined in Health and Safety Code § 1367. Request# 20. Imfinzi durvalumab J9173 Imjudo ,* tremelimumab-actl ,* J9347 Imlygic talimogene laherparepvec J9325 Inflectra2,# infliximab-dyyb2,# Q5103 Infliximab 1, 2 infliximab 1,2 J1745. 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. The Policy Bulletins are used in making decisions as to medical necessity only. ‡ C9399, J3490 Aralast NP* alpha 1-proteinase inhibitor* J0256 Aranesp* darbepoetin alfa* J0881, J0882 Asceniv* immune globulin* J1554 Asparlas calaspargase pegol-mknl J9118 Atgam lymphocyte immune globulin J7504 Avastin (Authorization required only for. This video will teach you the format of these codes and how they interact with CPT codes, ICD codes, and Medicare and Medicaid. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. The third segment, the package code, identifies package sizes and types. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . 1 Melanoma KEYTRUDA® (pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma. The Clinical Criteria information is alphabetized in the. 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. Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. J-codes are a subset of the Healthcare Common Procedure Coding System (HCPCS) codes. code . D. No dose reductions are recommended. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. 2021 Nov;16 (6):857-864. fever. Generic name . This page outlines the Site of Care for Specialty Drug Administration policy and the medications to which this policy applies. 15 Providers must bill 11-digit NDCs and appropriate NDC units. Effective as of July 1, 2023, the following J-code can now be used to identify IMJUDO® (tremelimumab-actl): NDC=National Drug Code. Establish new Level II HCPCS code J9227 "Injection, isatuximab-irfc, 10 mg" Effective: 10/01/2020 . Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. 02 Medical Coding Vocabulary & Key Terms Section 2. 3. Table 1. 25 mL • Fluarix 0. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added J12. CPT Code Description. 5 mL dosage, for. 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. Code 91317 for Pfizer-BioNTech COVID-19. Related Local Coverage Documents N/A. View Imfinzi Injection (vial of 10. 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. Covered codes. While 21 CFR 801. July 2023 Alpha-Numeric HCPCS File (ZIP) -. 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. Article revised and published on 01/22/2015 to reflect the annual CPT/HCPCS code updates. 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. This medication may cause a serious reaction during the injection. 4 mL injection. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. havediseaseprogressionwithin12monthsofneoadjuvantoradjuvanttreatmentwithplatinum-containingchemotherapy. 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. 4. Trade Name: IMFINZI. See . 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 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. 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. The NDC code can be found on the outside packaging of the drug. 1 8. Finished drug products. C. 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. 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. Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. How do I calculate the NDC units? Billing the correct number of NDC units for the. Claims are priced based on HCPCS or CPT codes and units of service. (2. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89. F. The approval was based on the results of the CASPIAN clinical trial, which showed that. Code Description Vial size Billing units. If the intent of the IIS is to capture the specific NDC, an IIS could access the provider’s order (VTrckS ExIS shipment data) to identify theCoding. 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. [medical citation needed]Durvalumab is an immune checkpoint. More common side effects in people taking Imfinzi for non-small cell lung cancer include: cough*. J7605 Arformoterol, Brovana Arformoterol TartrateExplanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. The NDC code would be unique for all of them and can help you distinguish between those result. Associated Documents. HCPCS Code: J9173 – Injection, durvalumab, 10 mg; 1 billable unit = 10 mg NDC: Imfinzi 120 mg/2. IMFINZI is a programmed death -ligand 1 (PD-L1) blocking antibody indicated : • for the treatment of adult patients with unresectable, Stage III non-small cell lung cancer. National. 200 mg are administered = 4 units are billed. 58%), as well those showing a durable response at one year (23% vs. 31, 2018. After consulting with the U. Durvalumab side effects. Revised: 03/2021 Page 2 . Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. PH. The first five digits. trouble breathing. If you have any questions about these medicines, ask your doctor. Administer IMFINZI prior to chemotherapy when given on the same day. The list of results will include documents which contain the code you entered. NDC=National Drug Code. 1%) patient and Grade 3-4 in six (0. Each of the drugs in this combination is approved by the Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. 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 Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 90658 can be used for the administration of a flu shot. Units. Report code only with appropriate primary procedure. JEMPERLI is supplied in two single-dose vial (10 mL-200/6 or 20 mL-400/12) sizes. Claims cannot list 9,999 on the Procedure Code Line but must be input into the NDC Line and vice versa. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular. Imjudo (tremelimumab) is given for one cycle followed by single agent Imfinzi (durvalumab). NCCN Drugs & Biologics Compendium ® Imfinzi. HCPCS code describes JEMPERLI. Imfinzi (Durvalumab Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug. 5. 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 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 Weight 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 . 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 . Attention Pharmacist: Dispense the accompanying Medication. It’s given as an IV infusion. H. A. • 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). 10-digit, 3-segment number. swelling in your arms and legs. 2 DOSAGE AND ADMINISTRATION . 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. 2 8 8. Effective 7/1/2023-HCPCS J1576 was added to the CPT/HCPCS code section per the July HCPCS updates. Under CPT/HCPCS Codes Group 1: Codes deleted 94250, 94400 and 94750, and changed descriptors for 94002, 94003 and 94375. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. 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. 3. 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. 5. 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). AstraZeneca has opted to voluntarily withdraw. The CPT procedure codes do not include the cost of the supply. HCPCS/CPT code: J0744 HCPCS/CPT code description: Ciprofloxacin for intravenous infusion, 200 MG Number of HCPCS/CPT units 6 NDC (11-digit billing format): 00409-4765-86 NDC description: Ciprofloxacin IV SOLN 200 MG/20 ML NDC unit of measure ML . The Imfinzi-Imjudo-platinum chemotherapy treatment also cut the risk of cancer progression or death by a significant 28%. 100 Eglantine Driveway. 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. 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 . renal dysfunction. It is the responsibility of the provider to code to the highest level specified in the ICD-10-CM. 89 and G61. Each single-dose glass vial is filled with a solution of 29. 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. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. You can search with this number to find the exact drug you have. j1726. g. 70461-0321-03. 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. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. Keep vial in original carton to protect from light. , IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune. L. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. Imfinzi Generic Name durvalumab. Current through: 11/17/2023. Quantity Limit (max daily dose) [NDC Unit]: • Imfinzi 120 mg/2. 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 . Each single-dose glass vial is filled with a solution of 29. 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. 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. Sometimes, it’s used together with other immunotherapies and chemotherapy. T-MSIS data elements NDC-UNIT-OF-MEASURE (CIP285, CLT229, or COT224) and NDC-QUANTITY (CIP278, CLT230, or COT225) are only applicable to and therefore reported in the IP, LT, and OT files when a value is reported to the NATIONAL-DRUG-CODE data element (CIP284, CLT228, or COT217). Use the units' field as a multiplier to arrive at the dosage amount. (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. National Comprehensive Cancer Network, Inc. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . HCPCS codes HCPCS codes are used to report supplies, drugs and implants. The Cancer Medications Enquiry Database (CanMED) is a two-part resource for cancer drug treatment related studies. Non-Small Cell Lung Cancer (NSCLC) 1. 90674. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 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. Effective date is noted in the file title. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. The NDC Code 0310-4500-12 is assigned to “Imfinzi ” (also known as: “Durvalumab”), a human prescription drug labeled by “AstraZeneca Pharmaceuticals. OUT OF STOCK. ES-SCLC: Until disease progression, unacceptabletoxicity. active_ingredient_code Multum’s ingredient is a simple description of the generic chemical name of the drug. 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,. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. The molecular formula is C 187 H 291 N 45 O 59 and the molecular weight is 4113. This is not a complete list of. J0885. Get this at ₹37,310. Imfinzi durvalumab J9173. 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. ; This combination may also be used with other drugs or treatments or to treat other types of. Imfinzi, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). 4 mg/kg at Day 1 of Cycle 1; •. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. 90716 can be used for the administration of the chickenpox vaccine (varicella) 12002 can be used when a healthcare provider stitches up a 1-inch cut on your arm. This medicinal product is subject to additional monitoring. Sean Bohen, MD, Phd. 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). 708: 6/30/2023:. 1007/s11523-021-00843-0. 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. Imfinzi ® J9173. S. Sean Bohen, MD, Phd. Cancer Oncology Rx required. 6. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. The FDA offers an NDC searchable database. Code Description. Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. This medication has been identified as Imfinzi 120 mg/2. 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 . 20. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. or HCPCS Codes and/or How to Obtain Prior Authorization . 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. Mechanism of action. Page 4 | IMFINZI® (durvalumab) Prior Auth Criteria Proprietary Information. 2. 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. Submit PA requests . 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. The units submitted for HCPCS, CPT, and Revenue codes are based on the HCPCS,. An administration code should always be reported in addition to the vaccine product code. immune system reactions, which can cause inflammation. 5-fl-oz (340-mL) Bottle / Case of 12Effective with date of service Jan. Marketing Approval Date: 03/27/2020. Please see the HCPCS Quarterly Update webpage for those updates. Imfinzi, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). On the . 2 months, compared to 5. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. 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 . Loncastuximab Tesirine is for the treatment of diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). 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. Group 1 Codes. 10/31/2019 R6 NDC 0310-4611-50. The product's dosage form is injection, solution and is administered via intravenous form. IMFINZI contains the active ingredient durvalumab. thyroid disorders. The new formulation the. A unique HCPCS code is needed to implement payment provisions of the Social Security Act. The NDC Packaged Code 0310-4500-12 is assigned to a package of 1 vial in 1 carton / 2. IMFINZI is administered as an intravenous infusion over 1 hour. ( 2. The National Drug Code (NDC) Directory is updated daily. Each 3 mL pre-filled single-patient use pen contains semaglutide 2 mg (0. It is used. 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. 11: HCPCS Codes HCPCS codes are a vital part of the coding process. 34 mg/mL), or 8 mg (2. Vaccine CPT Code to Report. 120 mg/2. NCCN provides category 2A and 2B recommendations for use of Imfinzi in several types of bladder cancer. Vaccine CPT Code to Report. Note: ICD-10 codes are scheduled to go into effect October 1, 2015. By blocking these interactions, Imfinzi may help the body’s immune system attack cancer cells. You should be sure to bill 10 units of J1745 on the claim form when indicating that a single 100-mg vial of REMICADE® was used.