Latest news with #Authorization
Business Wire
4 days ago
- Business
- Business Wire
BIS Issues Notice of Intent to Deny Applications for Licenses to
HOUSTON--(BUSINESS WIRE)--Enterprise Products Partners L.P. ('Enterprise') (NYSE: EPD) today announced that yesterday, June 3, 2025, Enterprise received notice from the U.S. Department of Commerce's Bureau of Industry and Security ('BIS') of BIS's intent to deny Emergency Authorization Requests ('EARs') with regard to three proposed cargoes of ethane to China, totaling approximately 2.2 million barrels. Per the Notice, Enterprise has up to twenty days to respond to BIS with any comments or rebuttals with regard to these affected EARs. Unless Enterprise is advised by the 45 th day after the date of the notification, these denials will become final without further notice. As previously disclosed on May 29, 2025 in a Current Report on Form 8-K filed by Enterprise with the U.S. Securities and Exchange Commission, on the afternoon of Friday, May 23, 2025, BIS notified Enterprise of new licensing requirements for exports of 'ethane and butane, saturated, having a purity of 95 percent or more by volume' to China. This new licensing requirement was effective immediately (the licensing requirement for butane was subsequently withdrawn). According to the U.S. Energy Information Administration ('EIA'), total U.S. ethane production in 2024 was approximately 2.8 million barrels per day ('BPD') and total U.S. ethane exports were approximately 492,000 BPD. U.S. ethane exports to China were approximately 227,000 BPD in 2024, representing 8 percent of total U.S. ethane production and 46 percent of total U.S. ethane exports. Enterprise's marine export terminal on the Houston Ship Channel loaded approximately 213,000 BPD of ethane in 2024 of which approximately 40 percent, or 85,000 BPD, were destined to Chinese markets. Ethane exports destined to China from Enterprise's Morgan's Point facility in 2024 represented only 37 percent of total U.S. ethane exports to China for 2024. Currently, Enterprise estimates that total U.S. ethane exports to China has increased to approximately 290,000 BPD in 2025. Company Information and Use of Forward-Looking Statements Enterprise Products Partners L.P. is one of the largest publicly traded partnerships and a leading North American provider of midstream energy services to producers and consumers of natural gas, NGLs, crude oil, refined products and petrochemicals. Services include: natural gas gathering, treating, processing, transportation and storage; NGL transportation, fractionation, storage and marine terminals; crude oil gathering, transportation, storage and marine terminals; petrochemical and refined products transportation, storage and marine terminals; and a marine transportation business that operates on key U.S. inland and intracoastal waterway systems. The partnership's assets currently include more than 50,000 miles of pipelines; over 300 million barrels of storage capacity for NGLs, crude oil, petrochemicals and refined products; and 14 billion cubic feet of natural gas storage capacity. This press release includes 'forward-looking statements' as defined by the Securities and Exchange Commission. All statements, other than statements of historical fact, included herein that address activities, events, developments or transactions that Enterprise and its general partner expect, believe or anticipate will or may occur in the future are forward-looking statements. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from expectations, including required approvals by regulatory agencies, the possibility that the anticipated benefits from such activities, events, developments or transactions cannot be fully realized, the possibility that costs or difficulties related thereto will be greater than expected, the impact of competition, and other risk factors included in Enterprise's reports filed with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. Except as required by law, Enterprise does not intend to update or revise its forward-looking statements, whether as a result of new information, future events or otherwise.
Miami Herald
29-05-2025
- Business
- Miami Herald
1upHealth Launches Prior Authorization Solution and Technology Partnerships to Support CMS Electronic Prior Authorization Mandate for Health Plans
New Product Streamlines Prior Authorization to Improve Patient, Provider, and Payer Outcomes BOSTON, MA / ACCESS Newswire / May 29, 2025 / 1upHealth, a leader in health data interoperability, today announced the launch of its 1up Prior Authorization solution. The solution is designed to ensure compliance with the CMS Interoperability and Prior Authorization final rule (CMS-0057) while delivering measurable ROI through reduced provider burden and lower administrative costs for payers. To accelerate adoption of electronic Prior Authorization (ePA), 1upHealth is also building strategic partnerships with Utilization Management (UM) and Prior Authorization (PA) policy vendors. These partnerships aim to simplify integration and speed up deployment for payer customers. While PA programs are intended to manage costs, current processes are largely manual and create significant burdens across the healthcare system. For providers, this burden translates to less time spent on patient care; for payers, it drives up administrative costs and hinders member experience. According to the American Medical Association, 29% of physicians reported that PA led to serious adverse events for patients, and nearly 90% said it contributes to physician burnout. Separately, CAQH estimates that transitioning to ePA could save the industry at least $515M annually. The 1up Prior Authorization solution digitizes and streamlines the PA process for health plans by managing complex integrations and providing real-time visibility, flexibility, and control at every stage. Built in accordance with Da Vinci FHIR Implementation Guides, the tool enables connectivity with all major EHRs, PA policy vendors, and utilization management systems. By simplifying prior authorization workflows, 1upHealth's solution not only ensures regulatory compliance but also delivers measurable improvements for patients, providers, and payers. "The CMS final rule not only set the stage for healthcare's long overdue digital transformation, but it provided the kindling needed to solve one of the industry's biggest pain points: prior authorization," said Andrew Boyd, CEO of 1upHealth. "With 1upHealth's latest releases, we're taking away the complexity of the PA process while going beyond compliance to drive critical outcomes such as: reduced administrative costs and improved efficiency for payers; broader adoption and reduced burden for providers; and, most importantly, improved outcomes and higher satisfaction for patients." 1upHealth is also building its ecosystem of PA partners, offering a comprehensive end-to-end ePA solution that integrates into a health plan's existing technology stack. The 1up Prior Authorization solution connects to all industry EHRs, PA policy vendors, and UM vendors. Today, 1upHealth is integrated with EHR vendors Epic and Meditech; UM transformation provider Cohere Health; and prior authorization systems vendor Itiliti Health. Additional technology partners are actively testing and growing the ecosystem. "Healthcare's longstanding interoperability issues have made it frustratingly difficult to solve even the most basic challenges, such as ensuring patients receive the right care at the right time," said Mohammad Jouni, Chief Product and Technology Officer of 1upHealth. "1upHealth is changing that by making it dramatically easier to access and integrate health data. This unlocks critical use cases like electronic prior authorization that not only improve clinical outcomes, but also streamline operations and eliminate the inefficiencies the industry has long accepted as inevitable. This is the foundational infrastructure healthcare has always needed but too often overlooked, and I'm proud that 1upHealth is leading the charge." 1upHealth will host a webinar on June 4, titled "ePA in Action: Live Demo + Roadmap to CMS-0057 Compliance" to cover the ePA requirements and introduce its new solution. To learn more and register, visit this page. About 1upHealth Driven by a purpose of better healthcare for all through better data, 1upHealth is the national leader in health data interoperability and one of the fastest-growing health IT companies in the United States. Our modern data platform is built on a standards-based cloud architecture specifically designed for the healthcare industry, making it easy to acquire, manage, share, and compute data. From leading health plans and state Medicaid agencies to innovative digital health organizations and top-performing ACOs, over 90 health organizations rely on 1upHealth to seamlessly exchange data across the healthcare ecosystem to reduce risk, lower costs, and improve patient outcomes. Media Contact Elizabeth Grich Aria Marketing for 1upHealth egrich@ SOURCE: 1upHealth
Associated Press
29-05-2025
- Business
- Associated Press
1upHealth Launches Prior Authorization Solution and Technology Partnerships to Support CMS Electronic Prior Authorization Mandate for Health Plans
New Product Streamlines Prior Authorization to Improve Patient, Provider, and Payer Outcomes BOSTON, MA / ACCESS Newswire / May 29, 2025 / 1upHealth, a leader in health data interoperability, today announced the launch of its 1up Prior Authorization solution. The solution is designed to ensure compliance with the CMS Interoperability and Prior Authorization final rule (CMS-0057) while delivering measurable ROI through reduced provider burden and lower administrative costs for payers. To accelerate adoption of electronic Prior Authorization (ePA), 1upHealth is also building strategic partnerships with Utilization Management (UM) and Prior Authorization (PA) policy vendors. These partnerships aim to simplify integration and speed up deployment for payer customers. While PA programs are intended to manage costs, current processes are largely manual and create significant burdens across the healthcare system. For providers, this burden translates to less time spent on patient care; for payers, it drives up administrative costs and hinders member experience. According to the American Medical Association, 29% of physicians reported that PA led to serious adverse events for patients, and nearly 90% said it contributes to physician burnout. Separately, CAQH estimates that transitioning to ePA could save the industry at least $515M annually. The 1up Prior Authorization solution digitizes and streamlines the PA process for health plans by managing complex integrations and providing real-time visibility, flexibility, and control at every stage. Built in accordance with Da Vinci FHIR Implementation Guides, the tool enables connectivity with all major EHRs, PA policy vendors, and utilization management systems. By simplifying prior authorization workflows, 1upHealth's solution not only ensures regulatory compliance but also delivers measurable improvements for patients, providers, and payers. 'The CMS final rule not only set the stage for healthcare's long overdue digital transformation, but it provided the kindling needed to solve one of the industry's biggest pain points: prior authorization,' said Andrew Boyd, CEO of 1upHealth. 'With 1upHealth's latest releases, we're taking away the complexity of the PA process while going beyond compliance to drive critical outcomes such as: reduced administrative costs and improved efficiency for payers; broader adoption and reduced burden for providers; and, most importantly, improved outcomes and higher satisfaction for patients.' 1upHealth is also building its ecosystem of PA partners, offering a comprehensive end-to-end ePA solution that integrates into a health plan's existing technology stack. The 1up Prior Authorization solution connects to all industry EHRs, PA policy vendors, and UM vendors. Today, 1upHealth is integrated with EHR vendors Epic and Meditech; UM transformation provider Cohere Health; and prior authorization systems vendor Itiliti Health. Additional technology partners are actively testing and growing the ecosystem. 'Healthcare's longstanding interoperability issues have made it frustratingly difficult to solve even the most basic challenges, such as ensuring patients receive the right care at the right time,' said Mohammad Jouni, Chief Product and Technology Officer of 1upHealth. '1upHealth is changing that by making it dramatically easier to access and integrate health data. This unlocks critical use cases like electronic prior authorization that not only improve clinical outcomes, but also streamline operations and eliminate the inefficiencies the industry has long accepted as inevitable. This is the foundational infrastructure healthcare has always needed but too often overlooked, and I'm proud that 1upHealth is leading the charge.' 1upHealth will host a webinar on June 4, titled 'ePA in Action: Live Demo + Roadmap to CMS-0057 Compliance' to cover the ePA requirements and introduce its new solution. To learn more and register, visit this page. About 1upHealth Driven by a purpose of better healthcare for all through better data, 1upHealth is the national leader in health data interoperability and one of the fastest-growing health IT companies in the United States. Our modern data platform is built on a standards-based cloud architecture specifically designed for the healthcare industry, making it easy to acquire, manage, share, and compute data. From leading health plans and state Medicaid agencies to innovative digital health organizations and top-performing ACOs, over 90 health organizations rely on 1upHealth to seamlessly exchange data across the healthcare ecosystem to reduce risk, lower costs, and improve patient outcomes. Media Contact Elizabeth Grich Aria Marketing for 1upHealth [email protected] SOURCE: 1upHealth press release
Business Insider
23-05-2025
- Health
- Business Insider
Soleno Therapeutics seeking regulatory approval in treatment of PWS
Soleno Therapeutics (SLNO) 'announced that Soleno's Marketing Authorization Application seeking regulatory approval of Diazoxide Choline Prolonged-Release Tablets for the treatment of adults and children four years and older with Prader-Willi syndrome who have hyperphagia had been validated by the European Medicines Agency.' 'The validation of our MAA represents the next significant milestone in our mission to deliver this important therapy to the broad PWS community, including those in the EU,' said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. 'Based on the data generated, DCCR has the potential to help treat hyperphagia, which is the most life-limiting aspect of PWS. We look forward to working closely with European regulators during the review process and intend to make DCCR available to patients in the EU as expeditiously as possible, if approved.' Confident Investing Starts Here:
Int'l Business Times
14-05-2025
- Health
- Int'l Business Times
Over 75,000 Cases of Eye Drops Recalled Nationwide Over Sterility Concerns
Serbia's Novak Djokovic uses eye drops during a break as he plays Russia's Daniil Medvedev in the US Open tennis tournament men's singles final match at the USTA Billie Jean King National Tennis Center in New York on September 10, 2023. A major recall has been issued for over 75,000 cases of eye drop solutions sold nationwide after a safety concern was raised about the sterility of the products. The recall affects several ophthalmic solutions and was voluntarily initiated by BRS Analytical Service, a pharmaceutical testing lab. The recall was reported by AvKare, a company that manufactures and distributes medical and pharmaceutical products. The recall follows an audit by the US Food and Drug Administration (FDA) that uncovered manufacturing violations related to Good Manufacturing Practices (cGMP), NBC News said. These practices ensure that pharmaceutical products are produced under safe conditions to protect consumer health. According to AvKare, these deviations in manufacturing could result in products of poor quality, and there is a potential risk to patients who use these products. The FDA report specifically cited concerns about the lack of assurance that the recalled products were sterile. Sterility is crucial for eye care products, as contamination can lead to serious eye infections or other health complications. The affected products are commonly used to relieve dry or irritated eyes. The recall includes a variety of eye lubricants and ophthalmic solutions shipped between May 26, 2023, and April 21, 2025. If you have any of the following products, stop using them immediately: NDC# 50268-043-15 Artificial Tears Ophthalmic Solution NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC# 50268-126-15 Lubricant Eye Drops Solution NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution A pharmaceutical distributor issued an urgent notice about a voluntary recall for five over-the-counter eye care products over concerns with sterility. — First Coast News (@FCN2go) May 14, 2025 How to Return Recalled Eye Drops and Get a Refund These products are commonly used to treat dry eyes, but they may not meet the required safety standards. If you have any of the recalled eye drops, AvKare recommends filling out a Recall Form and sending it via email. According to USA Today , after submitting the form, you will receive a Return Authorization Form from the company. This form should be used to return the affected products to the following address: R&S Northeast LLC 8407 Austin Tracy Rd Fountain Run, KY 42133 Consumers will receive a full credit for the returned products, including shipping costs. If you are experiencing dry, itchy, or irritated eyes, experts suggest several alternatives to help relieve symptoms. Dr. Yuna Rapaport, a board-certified ophthalmologist, recommends using a warm compress over your eyes for 30 seconds each day to treat aqueous dry eye, also known as blepharitis. Additionally, using a humidifier in your bedroom can help ease symptoms of evaporative dry eye. Originally published on © {{Year}} All rights reserved. Do not reproduce without permission.
