This corresponded to a. com. 10-digit, 3-segment number. Durvalumab, sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Topic/Issue: Request to establish a new Level II HCPCS code to identify macimorelin. 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. Clinical Studies (14) ]. 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. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1. IMFINZI safely and effectively. The 835 electronic transactions will include the reprocessed claims along with other claims. FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products. 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. 5 for the booster vaccine is now being planned. IMFINZI safely and effectively. 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. NDC covered by VFC Program. Associated Documents. 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. HCPCS codes are reported by the physician, hospital or DME provider that purchased the item, device, or supply. May 2021. Injection, zoledronic acid, 1 mg . Sometimes, it’s used together with other immunotherapies and chemotherapy. Dosing for infants and children age 6 through 35 months: • Afluria 0. 120 mg/2. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. 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). 70461-0321-03. Coding Resource Indications for IMFINZI IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:. (2. aprepitant injection (Cinvanti TM) 1 mg. 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. Formple, exa for *J1094 Injection, dexamethasone acetate, 1 mg the NDC billed should be the one that represents the drug as described in the HCPCS code definition, in this case, dexamethasone acetate. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. (2. This revision is due to 4 th quarter CPT ® /HCPCS Code update and is effective on 10/1/2019. 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. (2. g Medicare requires that you bill code G0008 when billing for the administration of influenza vaccines. 4 mL single-dose vial: 00310-4500-xx Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx . 4 mL single-dose vial: 4 vials per 14 days Imfinzi 500 mg /10 mL single-dose vial: 2 vials per 14 days. Continuing therapy with Imfinz will be authorized for 12 months. Enter the NDC qualifier. The most common side effects of IMFINZI are tiredness, muscle or bone pain, constipation, decreased appetite. 10/31/2019 R6 NDC 0310-4611-50. VI. Covered codes. Imjudo is a monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocking it and contributing to T. (2. Fig. 569: $79. 7 6. Use in Cancer. Depending. 90672. EALTH . ( 2. csv file. IMFINZI may cause serious or life threatening infusion reactions and infections. Information last updated by Dr. IMFINZI contains the active ingredient durvalumab. 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. PH. Possible side effects . 7 months in the placebo group. The next 4 digits identify the specific drug product and are. Expand All | Collapse All. S. 31, 2018. A physician might report code 99213-25 with diagnosis code E11. J0185. , 0001-), the 8 or 9 digit NDC Product Code (e. Continue IMFINZI 20 mg/kg as a single agent every 4 weeks. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. Providers must bill with CPT code: 90750 - Zoster (shingles) vaccine, (HZV), recombinant, sub-unit, adjuvanted, for intramuscular injection. S. FOLFIRINOX is used to treat: Pancreatic cancer that has metastasized (spread to other parts of the body). Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. The approval was based on data from the Phase III PACIFIC trial. OUT OF STOCK. 3%) patients including fatal pneumonitis in one. National Drug Code (NDC) 00310-4500 Drug Uses Add to Drug. 3. feeling cold. Example 3: HCPCS description of drug is 1 mg. Axitinib % % % %j9173 imfinzi q5103 inflectra j1290 kalbitor j9271 keytruda j9119 libtayo j2778 lucentis j0221 lumizyme . 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. L. Recommended Dosages of IMFINZI Indication Recommended IMFINZI Dosage Duration. 5 mL single-dose prefilled syringe [NDC 58160-976-02] Both UoS NDC numbers will map to the same CVX codes. Questions and Answers 1 Q: How do I report HCPCS code G0378 for observation care. FDA approvals of PD-1/PD-L1 mAbs. REFERENCES 1. J3301, for example, is the J-code for Kenalog (triamcinolone acetonide). Alpha-Numeric HCPCS. NDC Application Programming Interface (API) (Firefox and Chrome recommended) Finished. 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1. IMFINZI 20 mg/kg following a single dose of tremelimumab-actl †. over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. 4 mL injection Availability Prescription only Drug Class Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint. Identify the specific product and package size. NovoLogix Carelon Quantity limits . Other changes to the CPT code set. See full prescribing information for IMFINZI. The product's dosage form is injection, solution and is administered via intravenous. Attention Pharmacist: Dispense the accompanying Medication. 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. The product-specific HCPCS code for REMICADE® is J1745, infliximab, 10 mg. indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). fatigue (lack of energy) upper respiratory infection such as the common cold. Group 1 (9 Codes) Group 1 Paragraph. 66019-0309-10. Approval: 2017 . 4. Weight 30 kg or more: Imfinzi 1,500 mg IV given in combination with Imjudo 300 mg as a single . PPENDIX . About NDC HCPCS Product NDC: 00310-4611 Brand Name: Imfinzi Generic Name: Durvalumab Dosage Form Name: INJECTION, SOLUTION Administration Route:. 4. • Administer IMFINZI as an intravenous infusion over 60 minutes. 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. 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. 01 Learn More About Medical Coding Section 2. (2. 4 mL injection is not a controlled substance under the Controlled Substances Act (CSA). The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. July 2023 Alpha-Numeric HCPCS File (ZIP) -. through . Explanation of Benefits (EOB) code 06025 - CLAIM REPROCESSED TO PAY USING NADAC (NATIONAL AVERAGE DRUG ACQUISITION COST) PRICING METHODOLOGY. IMFINZI is used to treat a type of lung cancer called non- small cell lung cancer (NSCLC) in adults. 2 8 8. Submit the NDC in its 5-4-2 digit format: XXXXX-XXXX-XX. fever. Brand Generic Codes Amvuttra vutrisiran J0225 Aphexda †,. IMFINZI HCPCS IMJUDO HCPCS Jcode effective dates for dates of service on or after July 1, 2023. Search by NDC: (Type the 4 or 5 digit NDC Labeler Code with the hyphen (e. The correct use of an ICD-10-CM code does not assure coverage of a service. Appendix X Revisions Log . 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. It is supplied by AstraZeneca. 00 17. 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). 70461-0322-03. IMFINZI safely and effectively. This will allow quick identification of new safety information. Sometimes, it’s used together with other immunotherapies and chemotherapy. (2. Dosing Limits Quantity Limit (max daily dose) [NDC Unit]: Imfinzi 120 mg/2. 89 and G61. 24 participants with Non-Small Cell Lung Cancer will be. • HCPCS Level II Procedure and Modifier Codes: Primarily include non-physician products, supplies, and procedures not included in CPT. The product's dosage form is injection, solution and is administered via intravenous form. Trade name: Macrilen . Bevacizumab should be billed based on units, not total number of milligrams. 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. skin rash *. Under CPT/HCPCS Codes Group 10: Codes added HCPCS code J9033. HCPCS code G2012: Brief communication technology-based service, e. 2) 0X/2020Admni siter IMFINZI proi r to chemothearpy on the same day . Blue Cross and BCN Quantity Limits for Medical Drugs (bcbsm. Rx only. The U. Imfinzi is a medicine used to treat lung cancer. 2 Q: Are the NDC units dispensed different from the HCPCS, CPT, and Revenue code units? A: Yes. ─ NDC units are billed at the NDC level and not at the HCPCS level ─ Example: NDC Units = 9,999 and the HCPCS unit = 1. Accessed on May 11, 2021. ES-SCLC: Until disease progression, unacceptabletoxicity. 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. The member's specific benefit plan determines coverage. Last updated on Jun 28, 2023. CPT Code Description. Per 2023 CPT/HCPCS updates, HCPCS codes C7501 and C7502 were added to Group 1. Note: Third party payers may have specific policies and guidelines that might require providing additional information on their claim forms. change_type,covered_recipient_type,teaching_hospital_ccn,teaching_hospital_id,teaching_hospital_name,covered_recipient_profile_id,covered_recipient_npi,covered. A. How to store IMFINZI . Starting April 19, 2021, a valid National Drug Code (NDC) number, unit of measure, and units dispensed for drugs administered by health care professionals in ambulatory care settings will be required on all professional and facility drug claims. CPT/HCPCS Codes. 4. HCPCS Code (J codes) Update 2017, 01/17 Home Visit for Postnatal Assessment & Follow-Up Care Exceeds 60-Day Limit, 06/17 ICD-10 Annual Update, 10/17 Incomplete Manage Change Requests and Enrollment Applications, 09/17 Maintain Eligibility Process, 06/17, 07/17, 08/17, 09/17, 10/17This page provides the clinical criteria documents for all injectable, infused, or implanted prescription drugs and therapies covered under the medical benefit. 4 mL (50 mg/mL) For Intravenous Infusion After Dilution Single-dose vial. Under ICD-10 Codes that Support Medical Necessity Group 1: Codes added D89. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. The NDC number consists of 11 digits in a 5-4-2 format. csv file. Imjudo (tremelimumab) is given for one cycle followed by single agent Imfinzi (durvalumab). 7 months in the control arm, according to an FDA announcement regarding the approval. One Medicaid unit of coverage is 0. No dose reduction for IMFINZI is recommended. National Drug Code (NDC) The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. 2 7. This is not a complete list of. With IV infusions, the drug is slowly injected. 2 8. The UOM codes are: F2 = international unit. Store at 2° to 8°C (36° to 46°F). (2. For example, J1756 is an injection for iron sucrose, 1 mg for a total dosage of 100 mg: report 100 in the units' field. Below are examples of drugs and biologicals HCPCS codes, code descriptions and information on units to illustrate and assist in proper billing. The definition of the HCPCS code specifies the lowest common denominator of the amount of dosage. UB-04. 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. com. 3) 09/2022 Dosage and Administration (2. Imfinzi (durvalumab) will be used as first line therapy in combination with Imjudo (tremelimumab). HCPCS Level II Code. HCPCS codes HCPCS codes are used to report supplies, drugs and implants. 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. October 2023 Alpha-Numeric HCPCS Files (ZIP) - Updated 08/28/2023. The 835 electronic transactions will include the reprocessed claims along with other claims submitted for the checkwrite. IRST . 90658 can be used for the administration of a flu shot. for people with locally advanced or metastatic bladder cancer. 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. Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Billing Code/Availability Information HCPCS: J9173 Injection, durvalumab, 10 mg: 1 billable unit = 10 mg (effective 1/1/19) J9999 – Not otherwise classified,. dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks . A10. 10 mg vial of drug is administered = 10 units are billed. 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. NOTE: Dates of service for Terminated HCPCS codes not needed. More common side effects in people taking Imfinzi for small cell lung cancer include. Report 90472 and 90473 in addition to 90460 or 90471 or 90473. 1) • Stage III NSCLC: 10 mg/kg every 2 weeks. Do not report immunization administration codes 90460-90461 or 90471-90472, as these codes are limited to the administration of vaccine and toxoid products. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. 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. colitis. Cancer Oncology Rx required. For those PADs that are newly FDA-approved or have no assigned Healthcare Common Procedure Coding System (HCPCS) code, the use of an. 0601C. 90674. Proper billing of a National Drug Code (NDC) requires an 11-digit number in a 5-4-2 format. 21. Providers must indicate the number of HCPCS units One Medicaid and NC Health Choice unit of coverage is: 0. 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. Mechanism of action. N/A. The National Drug Code (NDC) Directory is updated daily. 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. immune system reactions, which can cause inflammation. Note that not all products and NDCs under their respective CPT codes will be covered. g. J1745. Varun Gupta, MD Pharmacology on 5th Sep 2023. NDC notation containing asterisks is not accepted. headache. 3. Preferred product information . Imfinzi targets the PD-1/PD-L1 pathway (proteins found on the body’s immune cells and some cancer cells). 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. Proper Name: Antihemophilic Factor (Recombinant) Tradename: NUWIQ. Restricted Access – Do not disseminate or copyThe Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. Submit PA requests . in a 10-digit format. Indications and Usage (1. 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). 21, including objective evidence of efficacy and safety are met for the proposed indication. e. NDC: 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 8. Example claim with HCPCS by itself: HCPCS rate changed 5/19. The National Drug Code (NDC) is a universal, unique, 3-segment number identifying drugs by manufacturer, dosage, and package size. Refer to. How do I calculate the NDC units? Billing the correct number of NDC units for the. Rx only. Both the product and package codes are assigned by the firm. Injectable medications (continued) J0896 Renflexis J2794 Q9991 Synagis J9269National Drug Code Directory. 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 Injection is used in the treatment of Urinary bladder cancer,Non-small cell lung cancer. The maximum reimbursement rate per unit is $144. of these codes does not guarantee reimbursement. 90674. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells. fatigue (lack of energy) upper respiratory infection such as the common cold. Item Code (Source) NDC:0310-4500: Route of Administration: INTRAVENOUS: Active Ingredient/Active Moiety: Ingredient Name. 6 5. 120 mg/2. MRP ₹45500. (NOC) codes require a corresponding National Drug Code (NDC) to be billed on all claims. Enter the information on the . Finished drug products. Dossier ID: HC6-024-e195931. IMFINZI may be given in combination with otheranti-cancermedicines. Trade Name: IMFINZI. Prev Section 2. The NDC must be active for the date of service. 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). 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). 5 mLCPT/HCPCS code update effective 01/01/2021: In CPT/HCPCS Group One Codes and Miscellaneous Radiopharmaceuticals Deleted: 78135. Imfinzi ® J9173. 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. NDC: 58160-0815-52 (1 dose T-L syringes. 5. The National Drug Code (NDC) Directory is updated daily. 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. Related Local Coverage Documents N/A. 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. Use the units' field as a multiplier to arrive at the dosage amount. 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. Example: rilpivirine STR=ndc_active_ingredient. The remaining digits. Code Description Vial size Billing units. 4. WARNINGS AND PRECAUTIONS Tellyourdoctor before you are given IMFINZI if you have:2. 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. Finished drug products. S. ; This combination may also be used with other drugs or treatments or to treat other types of. Injection, infliximab, 10 mg. Influenza virus vaccine, quadrivalent, live (LAIV4), for intranasal use. X . Group 1 Codes. 88 mg/mL meloxicam. HCPCS Code Maximum Allowed Brand Generic Actemra tocilizumab 800 mg J3262 800 HCPCs units (1 mg per unit). A new formulation to incorporate Omicron strain BA. 82. 99397 can be used for a preventive exam if you are over age 65. Report the administration of palivizumab and nirsevimab with code 96372 (injection of a drug or substance, subcutaneous or intramuscular). Max Units (per dose and over time) [HCPCS Unit]: • NSCLC: 112 billable units (1,120 mg) every 14 days NDC 0310-4500-12. 5. Strength/Package Size (s): Famotidine injection, 20 mg piggyback, 20 mg/2 mL single. It includes information on dosage, administration, warnings, adverse reactions, clinical studies, and more. . The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. NDC Code(s): 0310-4500-12, 0310-4611-50 Packager: AstraZeneca Pharmaceuticals LP; Category: HUMAN PRESCRIPTION DRUG LABEL ; DEA Schedule: None; Marketing Status: Biologic. They are owned by CMS and are available for use. pneumonitis * ( inflammation of the lungs) hair loss. Seventeen5. Immune-Mediated Dermatology Reactions. Some side effects may occur during the injection. IMFINZI ® (durvalumab) injection, for intravenous use Initial U. 2. Administer IMFINZI as an intravenous infusion after dilutionas recommended [seeDosage and Administration (2. 2. See full prescribing information for permanently discontinue for severe or life-threatening pneumonitis. The recommended dosages for IMFINZI as a single agent and IMFINZI in combination with chemotherapy ar e presented in Table 1 [see . 4 mL single-dose vial: 00310-4500-xx • Imfinzi 500 mg/10 mL single-dose vial: 00310-4611-xx VII. J0885. The NDC is limited to 10 digits, a firm with a 5 digit labeler code must choose between a 3 digit product code and 2 digit package code, or a 4 digit product code and 1 digit package code. The Clinical Criteria information is alphabetized in the. This medication can cause rare, but serious immune-related. 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). paper. claim form, enter the NDC information in field 43 for each detail line with an applicable HCPCS code (in field 44). doi: 10. Page 5 of 52 Urothelial Carcinoma The recommended dose of IMFINZI is 10 mg/kg every 2 weeks or 1500 mg every 4 weeks. Attention Pharmacist: Dispense the accompanying Medication. 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). Also include the NDC. 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 . 1 unit per 1000 units. (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. 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 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. They may not be reported prior to effective date. The EOB 06025 will only appear on the paper RA and will not appear on the X12 835. Table 1. • Enter the 11-digit NDC, without dashes or spaces, in the drug claim lines – An invalid, incorrect or missing NDC will pay at $0. Brand name . 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. Description . J9035 is defined in the HCPCS manual as: Injection, bevacizumab, 10 mg. Although AstraZeneca did not provide specific data in its press release, the company said that patients who were. A copy of the invoice must be submitted when billing for V2790 and 65780 on the same. As of December 2020, six anti-PD-1/PD-L1 mAbs have been approved with supplemental indications across 19 cancer types and two tissue-agnostic. CPT Code Description. 150: 33332-0322-03: 0. However, their Bladder Cancer guidelines have not been updated since the manufacturer’s decision in 2/2021 to withdraw this indication from the FDA label due to Imfinzi’s inability to meet the overall survival primary outcome measures in theImfinzi 50 mg/mL concentrate for solution for infusion - Summary of Product Characteristics. 6, 2019 retroactive to Jan. Each single-dose glass vial is filled with a solution of 29. 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. Brand name . 3) • Urothelial Carcinoma: 10 mg/kg every 2 weeks. National Drug Code (NDC) numbers for use in billing physician-administered drugs, please refer to the . Vaccine CPT Code to Report. 1) • ES-SCLC: when administered with etoposide and either carboplatin or cisplatin, administer IMFINZI 1500 mg every 3 weeks prior todue to Imfinzi’s inability to meet the overall survival primary outcome measures in the phase 3 DANUBE confirmatory trials (Powles 2020).