Medicare Part B covers ophthalmology services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. eligible patients who meet certain objective financial and This book is open access under a CC BY 4.0 license. This open access book discusses basic clinical concepts of myopia, prevention of progression and surgical treatments for myopia and pathological myopia. Claims data from MarketScan Research Databases were retrospectively reviewed to identify treatment-naive patients with nAMD who initiated intravitreal ranibizumab or aflibercept between January 1, 2014, and January 1, 2016, and treatment-naive patients with DME who initiated intravitreal ranibizumab or aflibercept between July 29, 2014, and July 1, 2016. EYLEA AND EYLEA4U are registered trademarks of Regeneron J Manag Care Spec Pharm. The approximate cost of these medications varies from $50/dose for off-label bevacizumab to almost $2,000/dose for approved drugs (ranibizumab [$1,950/dose] and aflibercept [$1,850/dose]). Edited and written by internationally well-known experts, this state-of-the-art comprehensive overview of basic and clinical science will enhance the understanding of retinal vascular disease and help in the evaluation of current and future ... Federal government websites often end in .gov or .mil. EYLEA® (aflibercept) Injection 2 mg (0.05mL) is a This report is based on an exhaustive review of the published literature on the definitions, measurements, epidemiology, economics and interventions applied to nine chronic conditions and risk factors. 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. Contact EYLEA4U to start the application process today. Drug tariff. If you want to learn more, please your doctor about, how to approach Revenue Codes are equally subject to this coverage determination. If different medications are injected into each eye during the same DOS, the rationale for this therapy must be documented in the medical record and the billing modifier (RT/LT) must be appended to the correct drug. Privacy Policy 2019 Sep 20;9(9):e030930. Please note that if you choose to continue without enabling "JavaScript" certain functionalities on this website may not be available. 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
EYLEA® (aflibercept) Injection 2 mg (0.05mL) is a prescription medicine approved for the treatment of patients with Wet Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). CPT codes, descriptions and other data only are copyright 2020 American Medical Association. JAMA Ophthalmol. The Medicare program provides limited benefits for outpatient prescription drugs. Although the frequency and cost of ranibizumab and aflibercept injections were generally comparable among patients treated for nAMD, ranibizumab was associated with estimated per-patient-per-year cost savings of $3,500-$4,500 in those treated for DME. It is not typical to inject one anti-VEGF medication in one eye and another in the other eye. experiencing any side effects, including eye pain or Clipboard, Search History, and several other advanced features are temporarily unavailable. The most common side effects reported in patients receiving Under CPT/HCPCS Modifiers added modifiers RT and LT. Formatting, punctuation and typographical errors were corrected throughout the article. Cost is a critical consideration when deciding among therapies with similar efficacy. These materials contain Current Dental Terminology (CDTTM), copyright © 2020 American Dental Association (ADA). that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes. CONCLUSION: There is a considerable cost associated with the prevention of PDR and CI-DME with intravitreal aflibercept injections. Please review and accept the agreements in order to view Medicare Coverage documents, which may include licensed information and codes. MeSH Anti-VEGF medicines aflibercept and ranibizumab would have to drop in price by 69% and 80%, respectively, to be worth the societal cost compared with bevacizumab, a new study has found. The 4ml bottle can be fractionated to be used in 40 patients hence the 0.05 ml injection would cost 20 USD for patients. CPT codes, descriptions and other data only are copyright 2020 American Medical Association. This book explains how to use intravitreal steroids optimally in the management of patients with intraocular inflammation (uveitis) and macular edema. Subject to the terms and conditions contained in this Agreement, you, your employees and agents are authorized to use CDT only as contained in the following authorized materials and solely for internal use by yourself, employees and agents within your organization within the United States and its territories. Self-Administered Drug (SAD) Exclusion List articles list the CPT/HCPCS codes that are excluded from coverage under this category. own rules for eligibility and benefits.†. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy. PAN provides coinsurance and/or copayment assistance for In previously treated patients with nAMD, injection frequency was significantly lower among ranibizumab- versus aflibercept-treated patients over 24 months (7.98 vs. 9.63; P = 0.03), whereas treatment costs were comparable over 12 months ($11,512 vs. $12,050; P = 0.44) and 24 months ($16,303 vs. $19,361; P = 0.13). End User Point and Click Amendment:
Ranibizumab Injection. Aflibercept (VEGF Trap-Eye, also abbreviated to VTE) is a new chemical entity, a biological Please enable "JavaScript" and revisit this page or proceed with browsing CMS.gov with
You acknowledge that the ADA holds all copyright, trademark and other rights in CDT. of the Medicare program. Your doctor will use a medicine to numb your eye before giving you the injection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the . In most instances Revenue Codes are purely advisory. following Retinal Vein Occlusion (RVO), Diabetic Macular Edema Eylea ®; Chemical name: Aflibercept Typical dosage: 2mg/0.05ml Typical type: Injection 1 Eylea ® is a medication typically used to treat macular degeneration due to age, macular swelling, diabetic macular swelling and diabetic retinopathy. Including medication and administration costs, intravitreal aflibercept, 2 mg, cost a mean of $1953. Added to CMS Manual Explanations under Associated Documents Publication 100-02, Ch. The 2021 edition features 18 new monographs, and nearly 200 new references for a total of over 24,000 total compatibility pairs. You are leaving the CMS MCD and are being redirected to the CMS MCD Archive that contains outdated (No Longer In Effect) Local Coverage Determinations and Articles, You are leaving CMS.gov and are being redirected to, AMA CPT / ADA CDT / AHA NUBC Copyright Statement, Quantity to be billed 67028 is 1 as this is a bilateral procedure.”, Article - Billing and Coding: Aflibercept (EYLEA®) (A53387). Cho H, Choi KS, Lee JY, Lee D, Choi NK, Lee Y, Bae S. BMJ Open. To bill aflibercept services, submit the following claim information on CMS Form 1500: •J0178 - Injection, aflibercept, 1 mg •67028 - Intravitreal injection of a pharmacologic agent (separate procedure) Note Quantity to be billed for 67028 is 1 as this is a bilateral procedure code. The AMA is a third party beneficiary to this Agreement. The manufacturer developed a Markov state‑transition cohort model simulating cohorts of people with wet age . that doesn’t cover EYLEA, or government-issued ranibizumab 0.5 mg every 4 weeks for a primary treatment period of 52 weeks. damages arising out of the use of such information, product, or process. 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. Pharmaceuticals, Inc. © 2021, Regeneron Pharmaceuticals, Inc. cookies on this device. Aflibercept works by changing the amount of blood that gets to the retina. Eylea's and Lucentis' significantly higher price tags reflect the costly process of FDA approval for their intended use. 2 Qualitative and Quantitative Composition. Wykoff CC, Clark WL, Nielsen JS, Brill JV, Greene LS, Heggen CL. If your session expires, you will lose all items in your basket and any active searches. injection. During the initial 16 weeks of the Phase 2 trial, adverse events (AEs) in the study eye occurred in 17.0% (9 of 53) of aflibercept 8 mg patients and 22.6% (12 of 53) of EYLEA 2 mg patients. Under CPT/HCPCS Codes added J0178 and 67028. doi: 10.1136/bmjopen-2019-030930. There is a potential but rare risk of serious and sometimes At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. Eylea (aflibercept) is a prescription drug used to treat certain eye conditions. The sponsor participated in the design of the study; collection, analysis, and interpretation of the data; preparation of the manuscript; and the decision to submit the article for publication. It is not a cure. Bethesda, MD 20894, Help 2018 Feb;24(2-a Suppl):S3-S15. Conclusions: EYLEA ® (aflibercept) Injection is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies. Optimizing Anti-VEGF Treatment Outcomes for Patients with Neovascular Age-Related Macular Degeneration. Under Article Text removed the verbiage “Note: Quantity to be billed 67028 is 1 as this is a bilateral procedure.”. Manufacturer: Novartis India Ltd. Packaging Type: 1 Solution for Injection in 1 vial. This handbook is an overview of the diagnosis, treatment and long-term management of diabetic retinopathy, within the context of overall long-term diabetes disease management. Healthcare resource use and costs of diabetic macular oedema for patients with antivascular endothelial growth factor versus a dexamethasone intravitreal implant in Korea: a population-based study. For purpose of this exclusion, "the term 'usually' means more than 50 percent of the time for all Medicare beneficiaries who use the drug. Name of the medicinal product. Aflibercept is FDA approved and the same molecule is available as hyperosmolar for oncology (cost 800 USD for 4ml) and isoosmolar for Ophthalmology (cost 1,770 USD for 0.05ml injection). If you are uninsured or find yourself without coverage for An asterisk (*) indicates a required field. shipped to your doctor’s office. foundations and cannot guarantee assistance will be "JavaScript" disabled. 3.14 The economic evidence provided by the manufacturer included a literature review, which identified one published cost‑effectiveness analysis of aflibercept in US patients with wet age‑related macular degeneration, and a de novo cost-utility analysis. Brand Name: Accentrix. the eye, eye pain or redness, or known allergies to any of the This volume starts with the fundamentals of MIVS, introducing both the mechanics and the physics of the latest generation of vitrectomy devices, followed by a description of the discrete gauge systems (i.e. 23-, 25-, and 27-gauge). 1. 2020 Oct 22;37(11):226. doi: 10.1007/s11095-020-02946-1. Aflibercept injection comes as a solution (liquid) to be injected into the eye by a doctor. The AMA does not directly or indirectly practice medicine or dispense medical services. Student's test was performed with values of the untreated monkey as control values and it showed a statistically significant increase (p<0.05) in the number of fenestrae per µm one day after aflibercept injection (median: 2.05) compared to all other groups (medians: 1.27 for aflibercept day 7, 1.46 for ranibizumab day 1, 1.29 for ranibizumab . A price per unit of change in diabetic retinopathy severity score is a new parameter which might serve as a benchmark in future utility analyses that could be used to bring perspective to cost-utility considerations. Diabetic Macular Edema occurs when high blood sugar levels damage capillaries that leak fluid into the retina, resulting in swelling and blurred vision. CPT is a trademark of the American Medical Association (AMA). recommending their use. reported with repeated injections, and your doctor may Any questions pertaining to the license or use of the CPT should be addressed to the AMA. 2 The treatment involves an injection of a drug into the vitreous using a tiny and thin needle. in the eye. Lamminsalo M, Karvinen T, Subrizi A, Urtti A, Ranta VP. indicate that patients undergo fewer injections of aflibercept than they would with ranibi-zumab," says Michael W. Stewart, MD, with the Department of Ophthalmology at Mayo Clinic in Florida and a coauthor of the review article. As our understanding of the choroid has significantly improved with the development of advanced optical coherence tomography (OCT) and its role in posterior segment diseases is gaining new significance, this book focuses on the related ... Visit Many remarkable life stories illuminate this autobiographical/biographical/historical work. Included are Louis Braille, Judah Folkman, Harold Ridley and many others who have enabled us to see in all kinds of unimaginable ways. 10591, 10/2021 EYL.21.09.0046 full Prescribing Information Therefore, if a drug is self-administered by more than 50 percent of Medicare beneficiaries, the drug is excluded from coverage" and the MAC will make no payment for the drug. Reproduced by CMS with permission. The Centers for Medicare & Medicaid Services (CMS), the federal agency responsible for administration of the Medicare,
Public Summary Document. 7500 Security Boulevard, Baltimore, MD 21244. Packaging Size: 10 ml. The approval of Aflibercept injection for intravitreal use presents a new and alternative treatment option to currently available therapies, for patients with DME, Bayer in India said in a statement. Complete with high-quality color images, this book is written and edited by leaders in the field and is geared towards ophthalmologists, including residents and fellows in training, glaucoma and cataract specialists, and vitreoretinal ... medical criteria. (2.1) _____ The recommended dose for EYLEA is 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 3 months, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). It is used to treat wet age-related macular degeneration ( AMD ), macular edema, diabetic macular edema, and diabetic retinopathy. professionals only. temporary increase in eye pressure within 1 hour of the Eylea 40 mg/mL solution for injection in a vial. Aflibercept is given by intravitreal injection by specialists experienced in the management of this condition. The first comprehensive review of the use of optical coherence tomography in neurological diseases for neurologists, neuro-ophthalmologists, and neuroradiologists. Cookies Policy. website. Effective 02/26/18, these three contract numbers are being added to this article. 2 Mean total costs for PPV plus PRP performed in facility settings (ie, in a hospital) and nonfacility settings (ie, in an ambulatory surgical center) were $4796 and $3145, respectively. This is known as the. In no event shall CMS be liable for direct, indirect, special, incidental, or consequential damages arising out of the use of such information or material. The text also incorporates a wealth of information arising from publications of the Diabetic Retinopathy Clinical Research network, highly illustrated and annotated with supporting evidence. Get the latest materials and communications about Draft articles have document IDs that begin with “DA” (e.g., DA12345). Aflibercept injection is used to treat neovascular (wet) age-related macular degeneration (AMD). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Rho-Kinase Inhibitors for the Treatment of Refractory Diabetic Macular Oedema. www.healthwellfoundation.org End User License Agreement:
Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema. Aflibercept isn't available as a biosimilar drug. Your MCD session is currently set to expire in 5 minutes due to inactivity. Added FDA dosing instructions for DR with DME. Conclusions: Although the frequency and cost of ranibizumab and aflibercept injections were generally comparable among patients treated for nAMD, ranibizumab was associated with estimated per-patient-per-year cost savings of $3,500-$4,500 in those treated for DME. Live in the United States or its territories or The submission sought a Section 100 (Efficient Funding of Chemotherapy) Authority required (Streamlined) PBS listing for the treatment, in combination with an irinotecan . Aflibercept 40 mg per 1 ml. apply equally to all claims. Conclusion: Aflibercept may allow a modest extension of the treatment interval, but cost makes IVA an expensive alternative without a visual benefit compared with IVB in patients with active wet AMD. With branded anti-VEGFs running between $1,800 and $2,000 an injection, many retina specialists have turned to off-label use of bevacizumab (Avastin, Genentech) at roughly $50 per injection, he noted. Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled “I Accept”. injection. Aflibercept 2q8/pro re nata (PRN), or as-needed, group included 134 participants administered 2-mg intravitreal injections of aflibercept every 8 weeks after 5 initial monthly doses, with PRN . But in this revolutionary book, Cyrus Khambatta, PhD, and Robby Barbaro, MPH, rely on a century of research to show that advice is misguided. COVID-19 pandemic. Bookshelf Found inside – Page 1325... Name Year Approved Cost per [Trade Name] for ARMD Type of Molecule Dosage Injection Comments Pegaptanib [Macugen] ... Four drugs—pegaptanib [Macugen], ranibizumab [Lucentis], aflibercept [Eylea], and bevacizumab [Avastin]—can be ... Methods: Total costs for managing participants with CI-DME and good baseline VA assigned to aflibercept (n = 226), laser (n = 240), or observation (n = 236) during the 2-year multicenter trial were calculated. moving spots in the field of vision, and increased pressure Added dosing instructions for BRVO. The largest component of total cost was study eye anti-VEGF injections, comprising 68%, 37%, and 63% of total cost in the aflibercept, bevacizumab, and ranibizumab groups, respectively . If you do not agree with all terms and conditions set forth herein, click below on the button labeled “I do not accept” and exit from this computer screen. Mean cost for treatment-naïve patients was $15,467 . No portion of the American Hospital Association (AHA) copyrighted materials contained within this publication may be copied without the express written consent of the AHA. Intravitreal injection for the treatment of macular edema more frequently than every 4 weeks regardless of which drug is used for any given injection i.e. Before sharing sensitive information, make sure you’re on a federal government site. Applicable FARS\DFARS Restrictions Apply to Government Use. vitreous (gel-like substance) detachment, vitreous floaters, Both studies randomized patients to treatment with intravitreal injections of aflibercept 0.5 mg every 4 weeks, aflibercept 2 mg every 4 weeks, aflibercept 2 mg every 8 weeks after 3 initial monthly injections, or . Background Vascular endothelial growth factor (VEGF) is a naturally occurring glycoprotein in the body that acts as a growth factor for endothelial cells. 2021 Jun;27(6):743-752. doi: 10.18553/jmcp.2021.27.6.743. Product background . no responsibility for the content on any such website. Found inside – Page 86Similar efficacy was noted with aflibercept injection at 4-week intervals compared to 8-week intervals after the ... The study did not compare the costs associated with treatment but did mention the Medicare allowable charges for a ... Intravitreal injection procedure The vitreous is a jelly-like substance inside the eye, sitting behind the lens and in front of the retina. Our findings indicate that there is also financial equality with a tendency for increased costs related to use of aflibercept. The second sensitivity analysis with a 10% reduction in the treatment response at 3 and 6 months, resulted in a cost of €7169.41 (10 injections) per additional responder patient treated with aflibercept, €12,197.95 (16 injections) with ranibizumab, and finally, €11,753.42 (34 injections) with bevacizumab. Added FDA dosing instructions for DME. AMD is a disorder of the retina in the eye that causes blurred vision or blindness. Avastin, at approximately $50 per average treatment, is significantly less expensive for the patient than the alternatives (~$1,800 to $2,000 for Eylea, Lucentis or Beovu). Garmo is an employee of Genentech. doctor. Although may be administered every 4 weeks, additional efficacy has not been demonstrated (compared with every 8 week administration); some patients may require every 4 week (monthly) dosing after the first 20 weeks of therapy (5 months). prescription drugs to the FDA. AHA copyrighted materials including the UB-04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution or
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You are encouraged to report negative side effects of Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license. Eylea 3.6mg/90microlitres solution for injection pre-filled syringes ( Bayer Plc ) Active ingredients. Old Saw Mill River Road, Tarrytown, NY You shall not remove, alter, or obscure any ADA copyright notices or other proprietary rights notices included in the materials. Find patient medical information for aflibercept intravitreal on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. injection. In Japan, the cost of a single intravitreal injection of aflibercept is approximately $1,500, and most patients have to pay 30% of the medical costs at every visit to the hospital in addition to the annual medical insurance fees. read our The scope of this license is determined by the AMA, the copyright holder. GOVERNMENT AND ITS EMPLOYEES ARE NOT LIABLE FOR ANY ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE INFORMATION, PRODUCT, OR PROCESSES
cost for treating a patient in the first year is £6936 (based on 8.5 aflibercept injections). This website sets cookies on your computer, to give you This article is being revised in order to adhere to CMS requirements per chapter 13, section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs and incorporate into related Billing and Coding Articles. Aflibercept costs €943 per injection, but we determined that the maximum price to be cost-effective is €533. Applicable FARS/HHSARS apply. This Agreement will terminate upon no upon notice if you violate its terms. product or publication; creating any modified or derivative work of the UB-04 Manual and/or codes and descriptions; and/or making any commercial use of UB-04
This book brings together leading specialists from around the world to discuss and outline a variety of new concepts in ovarian cancer, ranging from molecular biology and genetics through screening to both surgical and chemotherapeutic ... monitor this after each injection. This scheme provides a simple discount to the list price of aflibercept, with the discount an effective method to share Articles that Medicare contractors develop. Learn more >. or control the operations of independent charitable you must: *You will need to provide financial documentation to This thoroughly revised edition includes new chapters on advanced diagnostics, foal ophthalmology, neuro-ophthalmology, national and international regulations, and an expanded chapter on inherited ocular disease. There are different article types: Articles are often related to an LCD, and the relationship can be seen in the “Associated Documents” section of the Article or the LCD. Foundations, including the following, may be able to help eye pain or redness, or known allergies to any of the The company has agreed a patient access scheme with the Department of Health. AMD is a disorder of the retina in the eye that causes blurred vision or blindness. Advances in the past few decades have been nothing short of explosive. How can the student, physician, or basic research scientist stay in touch with these electrifying studies? The filter cannula was exchanged for a Low Dead Space Needle hub 33 G × 9 mm injection needle (TSK Laboratory) for aflibercept and ranibizumab, and 33 G × 13 mm needle for bevacizumab before . eCollection 2020. You should Please visit the, Neovascular (Wet) Aged-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO). Drug tariff price. This work highlights the use of capillary elctrophoresis for the identification, separation, detection and characterization of substances on the molecular counting level. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ... Mateos-Olivares M, García-Onrubia L, Valentín-Bravo FJ, González-Sarmiento R, Lopez-Galvez M, Pastor JC, Usategui-Martín R, Pastor-Idoate S. Cells. Response to Comment (RTC) articles list issues raised by external stakeholders during the Proposed LCD comment period. Accessibility analyzing traffic. A well-illustrated and comprehensive analysis of the treatment of diabetic retinopathy, this book covers current treatment options and guidelines, whilst also providing a detailed discussion of emerging therapeutic targets. Under Article Text corrected capitalization errors, added the registered trademark symbol, deleted the “s” from weeks in the second and fourth paragraph and added “monthly” to the fourth and fifth paragraph. This policy defines coding and coverage for Aflibercept including off-label indications. Although these agents differ in cost and labeled dosing, it is unclear whether these differences are reflected in clinical practice. Effective November 18, 2011, September 21, 2012, July 29, 2014, October 6, 2014, March 25, 2015, and May 13, 2019 respectively, Aflibercept (EYLEA®) was approved by the Food and Drug Administration (FDA) for the treatment of patients with: For AMD the recommended dose is 2 mg (0.05 mL) administered by intravitreal injection every four weeks for the first 12 weeks (3 months), followed by 2 mg (0.05 mL) once every 8 weeks (2 months) by intravitreal injection. 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. You may also contact us at ub04@aha.org. In principal, the bimonthly injection regimen of aflibercept would represent reduced treatment burden and risks associated with frequent injections compared to the monthly dosing scheme of ranibizumab. You should not use EYLEA if you have an infection in or around The ultimate source of information on the design of new anticancer agents, emphasizing small molecules, this newest work covers recent notable successes resulting from the human genome and cancer genomics projects.
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