But manufacturers will have to work creatively with other stakeholders to make these proposals reality. This article explains why and suggests the steps manufacturers, with the cooperation of other stakeholders in the healthcare value chain, can take to help overcome the current challenges and give more patients access to these innovative therapies. In some cases, a laser may be required as a condition of any coverage.2, A laser may be many multiples of the specific attachment point. Miller S. More small and midsize firms choose to self-insure. The cost of a gene therapy, however, would be much more concentratedpotentially in a single payment. Accessed November 3, 2020. advisory.com/daily-briefing/2019/09/09/gene-therapies. Potentially curative therapies have reached the market today, and as many as 50 cell and gene therapies could receive Food and Drug Administration approval by 2030.9 Although many are for limited populations, they nonetheless contribute to the frequency of high-dollar claims. August Care has a similar financing and risk transfer solution to PayRx, but instead of analytics, it focuses more on strict outcomes-based contracting and therapy warranties. Maximizing benefits, limiting risk. Stop-loss coverage became essential not only for smaller employers, but also for larger employers that once might have been able to absorb 1 or 2 million-dollar claims but now struggle with 10 or 20.8, That brings us back to innovation. Ability to AUTHOR INFORMATIONMarc Hixson, MBA, is the president and CEO of Coeus Consulting Group and has a background across many areas of biopharma and the health care system. Self-funded plans, authorized by the Early Retirement Income Security Act (ERISA), come in 2 varieties. The downside of this type of arrangement could be that manufacturers relinquish the ability to control, directly, the payment structures offered by distributors. Gene therapy has the potential to have a significant impact on health care costs by decreasing the lifetime expenses associated with organ transplants, hospital stays, and cancer CVS Health. Accessed December 29, 2021. Further, Optum notes it will negotiate outcomes-based arrangements with manufacturers, tying successful results to the investment made and a framework for recourse if clinical outcomes are outside expectations.3,4, CVS Health has taken an interesting approach. Dearment A. Cigna creates new program to pay for high-price gene therapies. This solution could provide alignment on the appropriate value of gene therapies across manufacturers and payers but may not address the other payer concerns with one-time costs and the risk they are taking on. A reinsurance fund for gene therapy could work similarlythe reinsurance program would pool risk across different payers and be responsible for all or part of the gene Brent Blake Owner/CEO, Acendas Employers can change brokers/advisors and any negotiated value amongst employer and carrier/reinsurer could change or be lost over time. But with most individuals health care costs capped at an annual out of pocket, are the parents seeing the economic value? Retrouvez toutes les discothque Marseille et se retrouver dans les plus grandes soires en discothque Marseille. Torrence R. Aetna rolls out in-network coverage for Zolgensma, other multimillion-dollar gene therapies. Where We Go From HereHistorically, stop-loss carriers have functioned as traditional insurers, using actuarial analyses to determine their potential responsibility for otherwise random risk. This section provides information on the function, composition, origins and other details of Australian Government bodies. ------------------------------------------------------------------------------------. OutcomeRx, a division of CareMetx, LLC announces first independent reinsurance product for rare disease specialty, cell and gene therapies. Jim Clement, MHA, is a partner at Coeus, specializing in strategy and outcomes and formerly with Aetna Pharmacy Services. This does not fit neatly into a spreadsheet or reflect appropriately in a simple return-on-investment (ROI) calculation. Blue distinction specialty care. We are also seeing manufacturers of the next wave of gene therapies attempt to use alternative payment models. NYSE Stocks Directory Full Listings, list of public companies on the New York Stock Exchange. Unable to load your collection due to an error, Unable to load your delegates due to an error. Find latest news from every corner of the globe at Reuters.com, your online source for breaking international news coverage. The economic value of Zolgensma is equivalent to roughly four to five years of treatment with Spinraza. Stakeholders should be aligned and incentivized to maximize clinical outcomes. Honoring a Rich Musical History. While the cost of an individual product or service may be small in the scheme of national health expenditures, a single event can be financially devastating to a self-insured plan sponsor. Read 1286 - 27th October 2022 by Jewish News on Issuu and browse thousands of other publications on our platform. 2022 MJH Life Sciences and AJMC - Managed Care News, Research, and Expert Insights. Amamos lo que hacemos y nos encanta poder seguir construyendo y emprendiendo sueos junto a ustedes brindndoles nuestra experiencia de ms de 20 aos siendo pioneros en el desarrollo de estos canales! Structures should strive to minimize administrative burden, avoidable waste, and importantly, cost. pdf?sfvrsn=35603c2f_4, 2. an ocular gene therapy company with a late-stage clinical trial product candidate designed to treat geographic atrophy, a disease for which there are currently no approved therapies. sharing sensitive information, make sure youre on a federal Understanding these new financial risks will be an important area for actuaries to focus on in the coming years. Form 144 filings not submitted via the edgar system. The program covers Luxterna and Zolgensma but may be expanded as more gene therapies are approved.1,2, Optum Gene Therapy Risk Protection (UHC/Optum), Optum will launch its response to gene therapies in January 2022. Once approved, members receive treatment at no out-of-pocket cost. Rather than a company selling its product directly to payers and other stakeholders, it could enter a partnership with a PBMand potentially, its associated specialty pharmacywhereby the PBM would agree to buy a gene therapy and act as its distributor. Jensen K. What the fund? Attachment points determine the level of risk an employer is willing to absorb and are priced on an actuarys determination of the groups expected losses. Patient portability also poses a challenge. SUBSIDY TRACKER is the first national search engine for economic development subsidies and other forms of government financial assistance to business. Fierce Healthcare. Prior experience often shapes payer thinking on coverage for gene therapy. September 16, 2019. 3. The benefits of gene therapy could last years or even a lifetime, however, posing a unique challenge for the treatment when it comes to portability. As an alternative, self-insured employers may investigate whether to form or join a captivein essence, a private insurer set up by a small employer or group of employers to pool riskto absorb some of shock from the self-funded plan. Accessed December 29, 2021. The uncertainty in how carriers may view and treat new products (see A Hypothetical Treatment for Rare Disease) underscores the need for manufacturers to communicate their pipelines in ways that convey meaningful value to each customernot just investors, but also to employers, clinical nurse reviewers at traditional insurers, and even to stop-loss claims teams. Accessibility - Company: Reinsurance Group of America - 2022 Fortune 500 rank: #222. The number of emerging therapies with catastrophic costs coming to market over the next several years is expected to more than Get the latest news and analysis in the stock market today, including national and world stock market news, business news, financial news and more That being $2.125 million today versus $750,000 in year one and a lifetime of $375,000 per year (in some forms of SMA, patients will live long into adulthood). Each of these products and solutions has advantages and shortcomings. Spark Therapeutics has already engaged CMS to examine the economic impact of installment payments and higher rebates tied to clinical outcomes. Furthermore, although the frequency and cost of gene therapy claims will certainly rise in the coming months and years, the occurrence of a claim and financial impact cannot be projected. Unlocking market access for gene therapy will be critical to its adoption and to meeting patients needs. Lets look at SMA again and consider the use of Zolgensma over Spinraza. Managed Care & Healthcare Communications, LLC. Employer Trends in Self-Insured Health Plan Coverage. An employer would need to develop a medical policy for the use of Zolgensma that includes several criteria, but lets focus on a simple oneage. Aggregate coverage provides protection against the cumulative impact of smaller claims. Filice. Because a laser can be a sweeping liability to plan assets, a self-insured employer typically can absorb only 1 or 2 such cases. Jobot Project Executive - Now Hiring Today Est. The Future of Cell & Gene Therapy Reinsurance is Here. Payers may tighten coverage policies for costly therapies, with the potential to limit or delay access to therapy. 2017. For example, in contracts between health-plan sponsors (employers and governments) and PBMs, there could be carve-outs for gene therapy that exclude gene-therapy products from net-cost guarantees. Like it or hate it, health care is a one-year deal in most cases. Understanding of the regulatory framework for the clinical development and manufacturing of gene therapy products leading to global marketing authorizations. 2019;22(6):621-626. doi:10.1016/j.jval.2019.03.014, 10. A smaller provider pool may limit the adoption of gene therapy to nearby patients or those willing to travel but may result in higher-quality, specialized care. And the options are not mutually exclusive (Exhibit 2). Bookshelf Careers. Genomics, personalized medicine, and gene therapy are making rapid progress. January 15, 2019. Discover our e-Magazine. This slight difference in medical policy could expose a health plan from reinsurance coverage for the Zolgensma treatment if the reinsurer and health plan are not aligned. A payer could find itself shouldering all the costs but enjoying few of the subsequent benefits when the patient switched to a different insurer. Weintraub A. Dorothy Clinical Genomics Interests Precision medicine, gene therapy Use Case Save infant lives via rapid WGS and discovery of novel treatments. For healthcare providers, the path to adoption of gene therapy is similarly murky. El nico lmite de lo que puede vender es su imaginacin. Advising WuXi AppTec on its acquisition of OXYGENE to strengthen cell and gene therapy service. Giles PC. Reinsurance Defense Maritime Earth observation Oil and Gas. Vertically integrated traditional insurers are beginning to fill the void created by stop-loss exceptions, offering protection plans that cover 1 or more specific high-cost therapies in exchange for a per-member, per-month fee. A stop-loss-type product underwritten by Aetna is available, covering specific gene therapies for self-funded groups that do not have stop-loss covering such treatments. Showcase Laboratory for Gene Therapies. Watson Farley & Williams LLP Richard Stephens has more than 20 years experience with the firm, and has significant expertise in maritime tax, while Tom Jarvis has significant experience in the energy and infrastructure sectors. Accessed October 3, 2020. mercer.us/our-thinking/healthcare/how-big-can-bigclaims-get.html, 13. CREATE A NEW BENEFIT FOR HIGH-COST THERAPIES. See all stocks listed on NYSE for technology stocks, oil and gas stocks, consumber goods stocks. Without this alignment, a gap could be created that leaves one entity with a significant financial burden. Treatments for hemophilia A and B, sickle cell anemia, beta thalassemia, and various cancers are already in development and the suggested price tags range between $2 million and $4 million for the one-time treatments. Incluyen medios de pago, pago con tarjeta de crdito, telemetra. J Environ Public Health. Their most common delivery method is via a viral vector, such as a lentivirus or adeno-associated virus. United Healthcare. D.W. Van Dyke & Co., Inc. has developed a risk solution in the form of a reinsurance facility with network services managed by Emerging Therapy Solutions (ETS) that will offset the costs of these life-saving therapies, so that member access is not disrupted and risk takers can continue to cover at-risk members and reduce reliance on lasers. By 2017, 31% of midsized and 16% of smaller employers offered a self-funded health plan.1 For employers that have decided to go it alone, claims payouts and the risk of unanticipated losses rise in step with the cost of innovation. Between 2013 and 2017, rising insurance premiums and administrative costs, coupled with the coverage mandates of the Affordable Care Act (ACA), drove nearly a quarter of midsized (100-499 employees) and smaller (<100 employees) employers out of the traditional (or fully funded) insurance market and into self-insured (or self-funded) arrangements. MedImpact. In his role, Jason is a member of the Reinsurance Leadership team and oversees AXIS Res North America treaty reinsurance business, which includes the United States and The industry will continue to adapt, as it always has. Room 1318-19,13/F Hollywood Plaza, 610 Nathan Road Mong Kok, Kowloon HK 7. Working within the current legal and regulatory framework and market structures is the default approachand the least resource intensive. Start here! From members to health plans, pharmacy benefit managers (PBMs), plan sponsors, and reinsurers, the entire industry is grappling with how to cover, fund, and ensure the best outcomes for these new treatments. As experience drives the rates, new curative therapies can lead to In addition, a fixed, up-front pricing structure leaves the payer with all the risk of the therapy not working, given that the long-term efficacy of gene therapy as well as the risk of toxicity and other harmful effects to patients are not known with certainty at the time of first regulatory approval, though many risks will be addressed during pivotal studies and US Food and Drug Administration (FDA) review and approval. MedImpact and OutcomeRx both offer compelling reinsurance products. Deductibles, out-of-pockets, and copay reset annually for members and the same could be said of negotiated rates with providers, insurers and reinsurers. In addition, manufacturers could use Centers for Medicare & Medicaid Services (CMS) demonstration projects to test alternative payment models in an environment that allows for waiving of some requirements (for example, best price) for the purpose of the pilots. For an employer with 100 covered lives, a single million-dollar claim could be greater than the sum of all other claims in a given year.7, One insurance carrier saw its number of annual claims that exceeded $1 million rise by 68% between 2013 (the year before ACA protections were implemented) and 2016, according to the Massachusetts Institute of Technologys Center for BioMedical Innovation. They will be involved in setting medical policy as well as tracking clinical outcomes of patients. Employers should work with their third-party administrators to understand their stop-loss carriers own appetite for risk and whether the carrier is sensitive to a particular diagnosis, therapy, or dollar threshold. October 27, 2021. Please enable it to take advantage of the complete set of features! This real-world monitoring of clinical and financial outcomes can lead to the development of realistic risk profiles and may ease barriers related to portability of coverage when a patient finds new coverage and to portability of risk for the new payer. Moore R. Time for self-funded health plan sponsors to revisit stop-loss insurance. When it comes to rare diseases and treatments for them, manufacturers and payers have an opportunity to partner with one another by tracking patient outcomes over time and sharing de-identified data. Accessed December 29, 2021. In addition, some health plans only cover products in treatment facilities that have negotiated lower reimbursement rates. We usually don't think about the wonderful service fossil fuels provide in terms of being a store of heat energy for winter, the time when there is a greater need for heat energy. Beneficiaries with a history of claims for a high-cost therapy, injectable drug, or other service have long been at risk for being lasered. Bethesda, MD 20894, Web Policies But, if some or most of the cost was borne by the reinsurer, reinsurers will need methods to track durability in treatments for gene therapy patients. This site needs JavaScript to work properly. NEW YORK November 2, 2022 (GLOBE NEWSWIRE) LEXEO Therapeutics, Inc. (LEXEO), a clinical-stage biotech company advancing a pipeline of adeno-associated virus (AAV) Aetna launches gene-based, cellular and other innovative therapies (GCIT) designated network. Developing different market structures that support different payment models is another way forward that could address payer concerns with risk by distributing it across multiple players. There were no other options, until now. Epub 2021 Jan 14. May 9, 2019. Mehb Khoja, FSA, MAAA, is the chief actuary of BCS Financial and president of Medical Risk Managers. Financing the future of pharma. A reinsurance fund for gene therapy could work similarlythe reinsurance program would pool risk across different payers and be responsible for all or part of the gene-therapy claims that surpass an attachment point that triggers reinsurance. A number of forums (such as MIT CBIs New Drug Development Paradigms and Duke Universitys Robert J. Margolis, MD, Center for Health Policy Gene therapy risk protection may help cover therapies and manage financial risk. The aim would be to set a single price for a one-time, up-front payment to a manufacturer based on a robust assessment of the clinical and economic benefits, including cost effectiveness, of a product. March 9, 2021. Gene therapy solutions from the big 3. The Portfolio departments are responsible for collecting The US federal government and several states have set up reinsurance programs to protect payers against the risk of covering high-cost Patient Protection and Affordable Care Act enrollees. To the contrary, creative thinking can open several paths forward: SOLICIT COOPERATION ACROSS ENTITIES. 1 An example of this could be if Zolgensma stops working, perhaps Novartis would return the full cost of treatment (approximately $2.2 million) to the payer. In this Review, we discuss milestones in the development of gene therapies, focusing on direct in vivo administration of viral vectors and adoptive transfer of genetically engineered T Prior to the approval of Zolgensma in 2019, the only treatment for SMA was Spinraza, a treatment that costs $750,000 in the first year and $375,000 in subsequent years. The loss of secondary reinsurers may lead to health plan consolidation and a decrease in state and regional health plans, as only the large national players will be able to absorb the risk of high-cost treatments. Massachusetts Institute of Technology Center for Biomedical Innovation. Patients with this debilitating disease lack a gene that produces an essential blood-clotting protein, factor VIII. According to Kaiser,[3] 157 million Americans rely on employer-sponsored health insurance coverage, so it could be argued that employers can realize the economic value of such high cost treatments. Accessed December 29, 2021. Financing and reimbursement of cures in the US. April 22, 2021. Manufacturers whose products are at the center of this issue can help to lead a constructive discussion. and transmitted securely. The deductible for the employee who is lasered will be similar to what the underwriter believes the cost of her treatment will be.3 Cancer is a common condition for lasers; others are kidney failure, severe injuries, and conditions that may ultimately require an organ transplant.4. Deep Genomics uses artificial intelligence and machine learning to program and prioritize transformational RNA therapies for almost any gene in any genetic condition. October 18, 2017. September 8, 2019. Spark Therapeutics and Express Scripts Holding have pursued such an arrangement for Luxturna, Spark Therapeuticss adeno-associated virus gene therapy that treats certain inherited retinal diseases associated with loss of sight and, in 2017, became the first FDA-approved gene therapy (Exhibit 3). Policies are subject to underwriting on an annual basis. Inlcuyen medios depago, pago con tarjeta de credito y telemetria. November 6, 2020. official website and that any information you provide is encrypted For a beneficiary with a history of claims for large B-cell lymphoma, tisagenlecleucel may well be a predictable cost-in-waiting. EXCEPTIONS. Disclaimer, National Library of Medicine Gregory W. Daniel et al., Overcoming the legal and regulatory hurdles to value-based payment arrangements for medical products, Robert J. Margolis, MD, Center for Health Policy, December 15, 2017, healthpolicy.duke.edu. PMC MarshMcLennan Agency. ):SP112 Under normal contracts with payers, manufacturers can stipulate certain parameters (for example, that therapies are covered consistent with their labels, that benefits are processed rapidly, and that out-of-pocket costs are capped at in-network limits). Outcome Rx. GCIT will leverage a specific network of 75 designated providers that manage administration, medical management, and sourcing of the treatment and is intended to further support existing financial programs.5-7, Prime Therapeutics, in partnership with BCS Financial, launched a reinsurance solution in 2020 called PreserveRx. Now, as the cost of innovation soars to new heights, even people with a higher-than-average predisposition for a costly illness may be candidates for lasers. Self-insured employers are exempt from the EHB clause. The impact of reinsurance of gene therapies on employer financial risk. PayRx. $12.00 - $27.07 Full-time, Part-time Chicago, IL 60805 Similar jobs in Chicago, IL PAREXEL Project Leadership - Clinical Trials - Gene / Cell Therapy- Homebased (Remote) Est. High-cost gene therapies. This model does not include supportive care that a member might need and leverages aggregate volume to support claims expenses. Marc Hixson, MBA, Neil B. Minkoff, MD, Kim Gwiazdzinski, MBA, RPh, Jim Clement, MHA. Market Trends and DilemmasOnce the domain of large employers, self-insurance has become popular with smaller companies that seek to control expenses. Current price-reporting requirements in the United States limit the ability of manufacturers to offer outcomes-based payments and payments over time. Members can leave health plans and join a spouses plan. Solar energy is most abundantly available in the May-June-July period, making it Gene therapy is an up-and-coming area of research and treatment. The big names have a clear edge, though. As stop-loss contracts are subject to underwriting on an annual basis, carriers begin to review medical and prescription drug claims data a few months before a policy will renew. Accessed December 29, 2021. A Critical Analysis of Obamacare: Affordable Care or Insurance for Many and Coverage for Few? It is expected that the market for gene therapy will grow to $10 billion by 2025 (compared to $2 billion in 2019). Contact the Regenerate team to learn more. The stop-loss carriers underwriters may, in turn, set qualifications for these beneficiaries, although at times there may be no way to tell if treatment will happen in the plan year. Children's Coverage Vulnerabilities With Loss of a Parent's Employer-Sponsored Insurance. Clipboard, Search History, and several other advanced features are temporarily unavailable. It is a narrow reinsurance product, like Evernorth's, whereby and more. Not on the 2016 list, Anna Manning drove the Reinsurance Group of America to the 2017 Fortune 500 list after assuming CEO in January 2017. New forms of insurance aimed at spreading risk might also emerge. Accessed October 3, 2020. goodrx.com/blog/most-expensive-drugs-period, 12. [][][etf][]+[] Optum. -----------------------------------------------------------------------------------, Clinical Overview: Teprotumumab for Thyroid Eye Disease, Initiation of Antiretroviral Therapy Reduces Number of Active HIV-Infected Cells, Earlier Mammograms May Not be Necessary for Women With Familial History of Breast Cancer, https://medcitynews.com/2019/09/cigna-creates-new-program-to-pay-for-high-price-gene-therapies/, https://www.cigna.com/employers-brokers/cost-control/embarc-benefit-protection, https://www.optum.com/business/resources/library/gene-therapies.html, https://www.uhc.com/broker-consultant/news-strategies/resources/gene-therapy-risk-protection-may-help-cover-therapies-and-manage-financial-risk, https://www.fiercehealthcare.com/payer/aetna-debuts-gene-therapy-network-for-rare-diseases, https://mmaeast.com/blog/2021-q1-rx-newsletter-gene-therapy-solutions-from-the-big-3/, https://www.prnewswire.com/news-releases/prime-therapeutics-launches-preserverxsm-gene-therapy-financial-protection-301034259.html, https://www.bcbs.com/about-us/capabilities-initiatives/blue-distinction/blue-distinction-specialty-care, https://newdigs.mit.edu/sites/default/files/FoCUS-WP-CGT-Market-Solutions.pdf, https://www.medimpact.com/resources/client-news/surprising-impact-gene-therapies. MeSH 1. in the case of gene therapy medicinal products and medicinal products for use in in-vivo diagnosis by means of marker genes, at least two years' experience in a medically relevant field, in particular of genetic engineering, microbiology, cell biology, virology or molecular biology, 2. They will also have to develop new solutions to overcome challenges providers face with the buy-and-bill model. Thats a lot of fancy wordsbut what does it mean to the health/reinsurance actuary? It will be interesting to see how other vendors disrupt and innovate, keeping the big fish on their toes. Statements of fact and opinions expressed herein are those of the individual authors and are not necessarily those of the Society of Actuaries, the editors, or the respective authors employers. It is a narrow reinsurance product, like Evernorth's, whereby plan sponsors pay a PMPM fee in exchange for coverage of specific gene therapies. Similar to competitor solutions, Prime's offering charges a PMPM fee and reinsures eligible members that incur costs from two current FDA-approved gene therapies: Luxturna and Zolgensma. Toby AuWerter is a consultant in McKinseys Minneapolis office, Jeff Smith is a partner in the Boston office, Josh Sternberg is an associate partner at the Waltham Client Capability Hub, and Lydia The is an associate partner in the Silicon Valley office. A range of industry stakeholders, including manufacturers, patient-advocacy groups, and payers, have recognized the need to adapt or replace the standard payment system if gene therapy is to become widely available. September 5, 2019. POOL AGGREGATE RISK. It is an exciting time to be in the health reinsurance market developing solutions that risk bearers need. Evernorth has the distinct benefit of drawing upon deep expertise, relationships, and resources across entities including Accredo, Cigna, eviCore, and Express Scripts. Introducing Regenerate: the reinsurance solution offering risk protection for prospective therapies and the entire episode of care. News release. By no longer selling directly to payers, manufacturers lose some of this contracting control. Like those above, these function as carveouts for specific, covered gene therapies in exchange for PMPM fees. So much so, some reinsurers are actively excluding cell and gene therapy from their reinsurance policies/treaties. 6. Stop-loss policies usually contain 2 components: specific and aggregate coverage2: Stop-loss pricing is a complicated affair. Cell and Gene Therapy (CGT) are life-changing treatments where conditions such as cancer, hemophilia, spinal muscular atrophy and blindness are being cured. But today, groups as small as 100 beneficiaries are self-insuring. Reinsurance gene-specific programs: In 2020, Prime and BCS Insurance Company introduced PreserveRxSM, its gene therapy reinsurance solution. The law included new coverage mandates and administrative costs, and it required qualified health plans to cover 10 categories of essential health benefits (EHB), some of which were less essential to some employers than others. Perhaps in some form. Gene therapies cure or treat a condition by inactivating, introducing, or replacing a modified or new gene. The savings on premiums, taxes, and insurers reserves and administrative costs outweighed the cost of claims payments, assuming the employer also had help from a stop-loss carrier with outliers.5. While the ACA guarantees coverage for people with pre-existing conditions in ERISA plans, this protection is not incumbent on stop-loss carriers that back a self-funded plan. Aggregate attachment points are determined by estimating total claims expected and then adding a risk corridora margin of anywhere from 10% to 25% of expected claimsto account for medical inflation, fluctuations in the size of the employers workforce, or other unexpected circumstances.2,3 If, for instance, the underwriter expects total claims (not including those that exceed the specific deductible) to reach $4 million and the stop-loss carrier adds a 25% risk corridor, then the employers aggregate liability will $5 million (Figure). A new therapy might save a loved one, while simultaneously bankrupting a household or causing other significant financial strain.
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