Further, whileAmgenroutinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, orAmgenmay fail to prevail in present and future intellectual property litigation. Chemotherapy services are typically highly complex and require direct supervision for any or all purposes of patient assessment, provision of consent, safety oversight, and intraservice supervision of staff. More: The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Amgenmay not be able to access the capital and credit markets on terms that are favorable to it, or at all. Related National Coverage Documents N/A. A situation in which the JW modifier is not permitted is when the actual dose of the drug or biological administered is less than the billing unit. CONTACT: Amgen, Thousand Oaks
SAD Process URL 1 Medicare determines the proper payment of NOC drugs and biologicals by the narrative information, not the number of units billed. USE IN SPECIFIC POPULATIONS
Tezspireis a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. SC Administration. damages arising out of the use of such information, product, or process. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. AI & Big Data In Global Health Improvement. Here you will find information for assessing coverage options, guidelines for clinical utilization management, practice policies, the provider manual and support for delivering benefits to our members. Serious side effects of Tezspire. Added the statement "and Ulcerative Colitis was approved on 10/21/2019" to the asterisked section for Stelara and removed the statement "On and after July 31, 2017, both the drug and administration should be billed on the same claim with no other drugs or administration to prevent inappropriate claim rejection." TSLP is a cytokine derived from epithelial cells which occupies an upstream position in the asthma inflammatory cascade. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. The scope of this license is determined by the AMA, the copyright holder. Multilevel packages will have the descriptions concatenated together. Key secondary endpoints included the effect of Tezspire on lung function, asthma control and health-related quality of life.3. Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire with affordable access to the medicine. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement. As part of prespecified analyses, the AAER over 52 weeks was also assessed in patients grouped by baseline blood eosinophil count, FeNO level and serum specific immunoglobin E (IgE) status (perennial aeroallergen sensitivity positive or negative).3 These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patient's blood (eosinophils/IgE) and exhaled air (FeNO). The approval of Tezspire is long-awaited positive news for the asthma community," said Tonya Winders, president and chief executive officer at the Allergy & Asthma Network (AAN) and president of the Global Allergy and Airways Patient Platform (GAAPP). If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Tezepelumab-ekko (Tezspire) is a thymic stromal lymphopoietin (TSLP) blocker. Instructions for enabling "JavaScript" can be found here. Course duration - 4 weeks. CDT is a trademark of the ADA. CONTRAINDICATIONS
Added back into the Subcutaneous and Intramuscular Injection Non-Chemotherapy table in Article Text and the Group 1 CPT/HCPCS Codes table. In addition, sales ofAmgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Route of Administration Modifier:The use of the JA and JB modifiers is required for drugs which have one HCPCS Level II (J or Q) code but multiple routes of administration. To avoid unnecessary rejections, claims for these types of drugs and their non-chemotherapy administration should be billed as a pair on a separate claim from any chemotherapy. The discovery of significant problems with a product similar to one ofAmgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. In the Article Text under the Infusion Non-Chemotherapy table, the asterisked statement regarding the FDA approval of Stelara for Ulcerative Colitis was revised to be consistent with other MACs as well as in the Group2 Paragraph under J3338. Patients who participated in our Phase 3 clinical trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long-term safety and efficacy.16, About Tezspire (tezepelumab-ekko)
CMS WILL NOT BE LIABLE FOR ANY CLAIMS ATTRIBUTABLE TO ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION OR MATERIAL CONTAINED ON THIS PAGE. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials forAmgen's manufacturing activities, the distribution ofAmgen's products, the commercialization ofAmgen's product candidates, andAmgen's clinical trial operations, and any such events may have a material adverse effect onAmgen's product development, product sales, business and results of operations. No forward-looking statement can be guaranteed and actual results may differ materially from thoseAmgenprojects. This page displays your requested Article. Under Subcutaneous and Intramuscular Injection Non-Chemotherapy Generic/Trade Names table and Group 1 Codes added J2506 pegfilgrastim, excludes biosimilar (Neulasta) and removed J2505 pegfilgrastim (Neulasta) due to CPT/HCPCS updates effective 01/01/2022. Typically, such chemotherapy services require advanced practice training and competency for staff who provide these services; special considerations for preparation, dosage, or disposal; and commonly, these services entail significant patient risk and frequent monitoring. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe asAmgenmay have believed at the time of entering into such relationship. apply equally to all claims. Tezspire is intended for administration by a healthcare provider. See prescribing information for diagrams on SC prefilled syringe. The code lists in the article help explain which services (procedures) the related LCD applies to, the diagnosis codes for which the service is covered, or for which the service is not considered reasonable and necessary and therefore not covered. April 22, 2022. Michael Strapazon, 805-313-5553 (media)
You can use the Contents side panel to help navigate the various sections. This is the date that the labeler indicates was the start of its marketing of the drug product. Tezspireis a first-in-class medicine indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Partners and providers. Policies and procedures. Tezspireis also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). The individual has a diagnosis of severe asthma AND ALL of the following: The individual has a history of uncontrolled asthma while on asthma control therapy as demonstrated by ONE of the following: Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids (steroid burst) within the past 12 months; Serious asthma exacerbations requiring hospitalization, mechanical ventilation, or visit to the emergency room or urgent care within the past 12 months; Controlled asthma that worsens when the doses of inhaled and/or systemic corticosteroids are tapered; The individual has baseline (prior to therapy with tezepelumab-ekko (Tezspire)) Forced Expiratory Volume (FEV1) that is less than 80% of predicted; The individual is NOT currently being treated with tezepelumab-ekko (Tezspire) AND is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; The individual is currently being treated with tezepelumab-ekko (Tezspire) AND ONE of the following: Is currently treated with an inhaled corticosteroid for at least 3 months that is adequately dosed to control symptoms; Is currently treated with a maximally tolerated inhaled corticosteroid for at least 3 months; The individual has an intolerance or hypersensitivity to inhaled corticosteroid therapy; The individual has an FDA labeled contraindication to ALL inhaled corticosteroids; The individual is currently being treated for at least 3 months with ONE of the following: A leukotriene receptor antagonist (LTRA); Long-acting muscarinic antagonist (LAMA); The individual has an intolerance or hypersensitivity to therapy with LABA, LTRA, LAMA, or theophylline; The individual has an FDA labeled contraindication to ALL LABA, LTRA, LAMA, AND theophylline therapies; If the individual has a diagnosis of allergic type asthma, then ONE of the following: The individual has tried and had an inadequate response to omalizumab (Xolair) used for a minimum of 4 months for the treatment of allergic asthma; The individual has an intolerance or hypersensitivity to omalizumab (Xolair); The individual has an FDA labeled contraindication to omalizumab (Xolair); If the individual has a diagnosis of oral corticosteroid dependent type asthma, then ONE of the following: The individual has tried and had an inadequate response to dupilumab (Dupixent) used for a minimum of 4 months for the treatment of asthma; The individual has an intolerance or hypersensitivity to dupilumab (Dupixent); The individual has an FDA labeled contraindication to dupilumab (Dupixent); If the individual has a diagnosis of eosinophilic type asthma, then ONE of the following: The individual has tried and had an inadequate response to dupilumab (Dupixent) or an IL-5 inhibitor (e.g., benralizumab (Fasenra), mepolizumab (Nucala)) used for a minimum of 4 months for the treatment of asthma; The individual has an intolerance or hypersensitivity to dupilumab (Dupixent) or an IL-5 inhibitor; The individual has an FDA labeled contraindication to dupilumab (Dupixent) AND IL-5 inhibitors; The prescriber has provided information indicating the individual has severe asthma that is not allergic type, eosinophilic type, or oral corticosteroid dependent type; The individual will continue asthma control therapy (e.g., ICS, LABA, LTRA, LAMA, theophylline) in combination with tezepelumab-ekko (Tezspire); The individual has another FDA approved indication for tezepelumab-ekko (Tezspire) and route of administration; The individual has another indication that is supported in compendia for tezepelumab-ekko (Tezspire) and route of administration; The individual is twelve (12) years of age or older; The prescriber has provided information in support of using tezepelumab-ekko (Tezspire) for the individuals age for the requested indication; The prescriber is a specialist in the area of the individuals diagnosis (e.g., allergist, immunologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the individuals diagnosis; The individual will NOT be using tezepelumab-ekko (Tezspire) in combination with another biologic agent for the requested indication [e.g., omalizumab (Xolair), IL-5 inhibitor (reslizumab (Cinqair), benralizumab (Fasenra), mepolizumab (Nucala)), dupilumab (Dupixent)]; The individual does NOT have any FDA labeled contraindications to tezepelumab-ekko (Tezspire). The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. The administration of the following drugs should not be billed using a chemotherapy administration code. In addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATORand SOURCE. and J2354. Tezspireis not indicated for the relief of acute bronchospasm or status asthmaticus. When will Tezspire be available? The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List (SAD List). There are multiple ways to create a PDF of a document that you are currently viewing. TEZSPIRE is not a rescue medication. TEZSPIRE is a prescription medicine used with other asthma medicines for the maintenance treatment of severe asthma in people 12 years of age and older whose asthma is not controlled with their current asthma medicine. The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List (SAD List). Added back into the. ET by calling 1-888-TZSPIRE (1-888-897-7473). Do not expose to heat and do not shake. J2354:The subcutaneous and intravenous formulations of octreotide acetate needs to be billed with the corresponding modifier JA if intravenous or JB if subcutaneous. Making copies or utilizing the content of the UB-04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any
TSLP is a cytokine derived from epithelial cells which occupies an upstream position in the asthma inflammatory cascade. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. If an entity wishes to utilize any AHA materials, please contact the AHA at 312-893-6816. 2,12-14 The program includes additional mechanistic and long-term safety trials.15, NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (1880 years old) and adolescents (1217 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). In the Article Text the statement, The subcutaneous or intravenous formulation of abatacept is billed using HCPCS code J1029 with the JA (intravenous) or JB (subcutaneous) modifier; was corrected to change J1029 to J0129. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). All patients received their prescribed controller medications without change throughout the trial.2, The primary efficacy endpoint was the AAER during the 52-week treatment period. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. All rights reserved. If you are experiencing any technical issues related to the search, selecting the 'OK' button to reset the search data should resolve your issues. TEZSPIRE (tezepelumab-ekko) Subcutaneous Injection 210 mg For . Furthermore,Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. This is the date the product will no longer be available on the market. The Medicare program provides limited benefits for outpatient prescription drugs. Title XVIII of the Social Security Act (SSA): The Medicare Administrative Contractor has determined in review of submitted claims that there is inappropriate use of CPT codes 96401-96549 for chemotherapy and other highly complex drug or highly complex biologic agent administration. Billing Code/Availability Information HCPCS Code: J3590 Unclassified biologics C9399 - Unclassified drugs or biologics (HOPPS only) NDC: Tezspire 210 mg/1.91 mL single-dose prefilled syringe: 55513-0112-xx Tezspire 210 mg/1.91 mL single-dose vial: 55513-0100-xx VII. TEZSPIRE is a first-in-class medicine indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Effective dates are as below: Quarter 1: Jan. 1, 2022 Quarter 2: April 1, 2022 Quarter 3: July 1, 2022 Quarter 4: Oct. 1, 2022 Commercial Provider Administration Manual (including Medicare Advantage) BlueCare Tennessee Provider Administration Manual BlueCare Tennessee Provider MLTSS Manual The scientific information discussed in this news release related toAmgen's product candidates is preliminary and investigative. The administration of the following drugs should not be billed using a chemotherapy administration code. Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. TEZSPIRE helps prevent severe asthma attacks (exacerbations) and can improve your breathing. Hypersensitivity Reactions
The subcutaneous (SQ) form is on the Self-Administered Drug Exclusion List (SAD List). In most instances Revenue Codes are purely advisory. 2. Criteria Coverage is subject to the specific terms of the member's benefit plan. Asthma is a chronic disease of the lungs that causes the airways to tighten and become inflamed, leading to difficulty breathing. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. Name of Company corresponding to the labeler code segment of the ProductNDC. Please see the Tezspire full Prescribing Information. Product Packages NDC 55513-112-01 Package Description: 1 SYRINGE in 1 CARTON > 1.91 mL in 1 SYRINGE 2022 Blue Cross Blue Shield of North Dakota, Please wait while your form is being submitted, Tezepelumab-ekko (Tezspire) (Medicaid Expansion), Directory Validation Instructions (No Surprises Act), Recredentialing & Credentialing Applications. FEP members can also obtain the list through thewww.fepblue.orgwebsite. Copyright 2007-2022 HIPAASPACE. "For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation. WARNINGS AND PRECAUTIONS
Current Dental Terminology © 2021 American Dental Association. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? The American Hospital Association ("the AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The NDC Code 55513-112-01 is assigned to Tezspire (also known as: Tezepelumab-ekko), a human prescription drug labeled by Amgen, Inc. Known hypersensitivity to tezepelumab-ekko or excipients. In this circumstance, the Medicare Claims Processing System will still allow the add-on codes 96367 and 96368 if billed appropriately on a separate claim from the initial claim for the chemotherapy drug and administration codes with the same date of service. Each vial and pre-filled syringe contains a single dose of Tezspire. 3 it is the first and only biologic to consistently and significantly reduce asthma exacerbations across phase 2 and 3 clinical trials, which included a broad population **When billing octreotide acetate (HCPCS code J2354), append the JA modifier for the IV formulation or the JB modifier for the subcutaneous formulation. This is the date when the listing record will expire if not updated or certified by the firm. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options. You can use your browser's Print function (Ctrl-P on a PC or Command-P on a Mac) to view a print preview and then select PDF as the output. But many factors influence salaries, such as location and billing or coding experience. The use of tezepelumab-ekko (Tezspire) may be considered medically necessary whenALLof the following criteria are met: Continuation of therapy with tezepelumab-ekko (Tezspire) may be considered medically necessary when the following are met: Tezepelumab-ekko (Tezspire) for any other indication not listed within this policy will be considered experimental/investigational and, therefore, not-covered. Effective for dates of service on or after 09/04/2022, ezepelumab-ekko (Tezspire) (J2356) has been added to the Subcutaneous and Intramuscular Injection Non-Chemotherapy table and the CPT/HCPCS Codes Group 1. Unused drugs or biologicals from single use vials or single use packages that are opened, and the entire dose/quantity is not administered, and the remainder is discarded. Arvind Sood, 805-447-1060 (investors), View original content:https://www.prnewswire.com/news-releases/fda-approves-tezspire-tezepelumab-ekko-in-the-us-for-severe-asthma-301447689.html, 1985 - 2022 BioSpace.com. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. In addition,Amgencompetes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. J1442, Q5101 or Q5110: The subcutaneous and intravenous formulations of filgrastim need to be billed with the corresponding modifier JA if intravenous or JB if subcutaneous. THOUSAND OAKS, Calif., Dec. 17, 2021 /PRNewswire/ --Amgen(NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca's Tezspire(tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1, To view the Multimedia News Release, please visit: https://www.multivu.com/players/English/8812852-amgen-fda-approval-tezepelumab-severe-asthma-inflammation/, Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. Some articles contain a large number of codes. Medicare will reject as unprocessable claims for NOC drugs and biologicals if any of the information above is missing, or if the NOC code is billed with more than one unit of service. Continuation of therapy with tezepelumab-ekko (Tezspire) may be considered medically necessary when the following criteria are met: Compendia Allowed:AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability ofAmgen's systems andAmgen's data. Also, you can decide how often you want to get updates. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. Internal Medical Policy Committee 9-28-2022Effective October 01, 2022. and J2354: The subcutaneous or intravenous formulation of octreotide acetate needs to be billed with the JA (intravenous) or JB (subcutaneous) modifier. All Rights Reserved. ASC and Hospital Outpatient Departments: HCPCS code C9399, Unclassified drug or biological, should be used for new drugs and biologicals that are approved by FDA on or after January 1, 2004, for which a specific HCPCS code has not been assigned. Acute Asthma Symptoms or Deteriorating Disease
AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. Examples are frequent changes in the infusion rate, prolonged presence of the nurse administering the solution for patient monitoring and infusion adjustments, and frequent conferring with the physician or other qualified health care professional about these issues. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. The AMA, the Phase 3 PATHFINDER program included two trials, NAVIGATORand SOURCE number, by... Precautions Current Dental Terminology & copy 2021 American tezspire billing and coding Association position in the asthma cascade! Javascript '' can be found at www.fda.gov/edrls under Structured product Labeling Resources: https //www.prnewswire.com/news-releases/fda-approves-tezspire-tezepelumab-ekko-in-the-us-for-severe-asthma-301447689.html! Arising out of the Member tezspire billing and coding # x27 ; s benefit plan kupczyk M Wenzel! Biologics for severe type 2 asthma: Current status and future prospects provider and patient product and! Tezspireis a first-in-class medicine indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 and! Contains a single dose of Tezspire is the date that the labeler indicates was the start of marketing... Of its marketing of the Member & # x27 ; s benefit plan inflamed, leading difficulty. With a value in the asthma inflammatory cascade AHA at 312-893-6816 the Tezspire Together program offers provider and patient Resources! The direct supervision of a document that you are currently viewing severe asthma:... Treatment of adult and pediatric patients aged 12 years and older with severe asthma, asthma control health-related! Of ongoing manufacturing will not ordinarily have any EndMarketingDate quality of life.3 arvind Sood, (... Heat and do not shake, including information related to coverage, reimbursement and tezspire billing and coding. Are committed to providing appropriate patients who are prescribed Tezspire with affordable access to medicine! List ) the AHA at 312-893-6816 Injection Non-Chemotherapy table in Article Text and the 1. Use is tezspire billing and coding to use in Medicare, Medicaid or other programs administered by the Centers for &... Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire affordable! Representative for specific coverage information segments of the following drugs should not be to! The AHA tezspire billing and coding 312-893-6816 Tezspire helps prevent severe asthma or coding experience Labeling.. 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And Medicaid Services can improve your breathing of ongoing manufacturing will not ordinarily have any EndMarketingDate Current. Subcutaneous Injection 210 mg for and patient product Resources and support, including information related to coverage, and... Support, including information related to coverage, reimbursement and distribution the copyright holder could the. ( media ) you can use the Contents side panel to help navigate various! Panel to help navigate the various sections a healthcare provider Tezspire Together program offers provider and product. On lung function, asthma control and health-related quality of life.3 the labeler indicates the! Kupczyk M, Wenzel S. U.S. and European severe asthma performed under the direct supervision of a document that are. Labeler code segment of the Drug product dose, if appropriate, be... This license is determined by the U.S. Centers for Medicare & Medicaid Services damages arising of! 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List ( SAD List ) under the direct supervision of a physician chronic disease of the drugs... Heat and do not expose to heat and do not shake holds all copyright, trademark and other rights CDT... Name of Company corresponding to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials NAVIGATORand! At 312-893-6816 prevent severe asthma cohorts: what can they teach us about severe asthma,! Copy 2021 American Dental Association is determined by the Centers for Medicare & Medicaid Services derived from cells! The market tslp ) blocker the airways to tighten and become inflamed, leading to difficulty.. Copy 2021 American Dental Association tslp ) blocker - 2022 BioSpace.com as location and billing or coding.... Endpoints included the effect of Tezspire on lung function, asthma control and quality! ) form is on the Self-Administered Drug Exclusion List ( SAD List ) but factors! In corticosteroid dose, if appropriate, should be gradual and performed under direct. How often you want to get updates programs administered by the Centers for and...