38 hospitals sue HHS over site-neutral payment rule

Healthcare Finance | January 24, 2019

A month and a half after several hospital advocacy groups joined together to sue the U.S. Department of Health and Human Services over it's finalized site-neutral payment policy, 38 hospitals have followed, filing suit against HHS Secretary Alex Azar for a policy they say will deprive hospitals of hundreds of millions of dollars and could compel them to cut patient services due to loss of reimbursement. The complaint argues that medical services provided in hospital outpatient departments are more "resource-intensive"--and therefore more costly--than those performed in an independent physician's office. It also sharply criticized Secretary Azar, saying he "has blatantly disregarded a specific and unambiguous statutory directive, acted well beyond his authority and nullified that statutory exemption" that would have had hospital outpatient centers reimbursed for services at the higher grandfathered rate previously legislated.

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MEDICAL DEVICES

CeloNova Announces New Strategic Direction Focused on Creating Partnership

CeloNova BioSciences, Inc. | April 08, 2022

CeloNova BioSciences, Inc. developer and manufacturer of a portfolio of novel surfaced coated technologies, including the proprietary Polyzene™-F nanocoating, announced the strategic decision to focus its core business on creating partnership and co-development opportunities with medical device manufacturers seeking to optimize implant interaction within the body. The company's nanocoated innovation is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. "We are pleased to offer leading medical device manufacturers access to the unique clinical advantages of our Polyzene-F nanocoated technology that has clinically demonstrated low thrombosis, restenosis and inflammation with rapid healing effects," stated Carl St. Bernard, President and Chief Executive Officer of CeloNova. "This technology offers a significant benefit to companies seeking to improve the clinical performance of their implant technologies." "I fully support CeloNova's new strategic direction which allows medical device manufacturers to benefit from long-term biocompatibility and thromboresistance of Polyzene-F. When my students and I set out to study the hemocompatibility of this inorganic polymer in our lab in Heidelberg Germany, we soon realized its potential to significantly limit a wide range of implant complications and being broadly applied in the human body and in biomedical devices." Professor Dr. Michael Grunze, Former Chair and Professor (emeritus) at the Institute of Applied Physical Chemistry of the Ruprecht-Karls-University in Heidelberg and co-inventor of Polyzene-F CeloNova is based on a rich history of medical innovation with two PzF coated medical implants successfully commercialized in the U.S. and the EU. The company's PzF coated embolic microspheres product line was sold to Boston Scientific in 2015 and the COBRA PzF NanoCoated Coronary Stent, was developed to safely and effectively treat patients who may benefit from 1-month of dual antiplatelet therapy. CeloNova's new business direction builds upon the successful application of PzF in interventional oncology and cardiology and expands its opportunities through the development of new surface coating technologies to address important unmet clinical needs. "In my pre-clinical research at CVPath since 2012, CeloNova's proprietary Polyzene-F coating has consistently demonstrated a unique advantage of allowing an implant to heal quickly and in a functional way, without the need for antiproliferative drug elution," stated Aloke Finn, MD, Medical Director and Chief Scientific Officer at CVPath and Associate Professor of Medicine at the University of Maryland. "I believe Polyzene-F will continue to play an important role in delivering safety and efficacy in clinical practice." Polyzene-F is a proprietary, ultra-pure and highly elastic surface coating possessing unique mechanical properties that allow an implant to be coated at a nanoscale level. The coating acts as a biocompatible barrier between the implant, intimal surface and circulating elements in the blood and has demonstrated thromboresistant and anti-inflammatory properties with significantly faster, higher quality healing compared to market-leading technologies.1* About CeloNova BioSciences, Inc. CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets novel surfaced coated technologies, including its proprietary Polyzene™-F nanocoating. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date.

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FUTURE OF HEALTHCARE

Endonovo Therapeutics Signs Agreement with NAMSA to Develop Reimbursement Strategy for Endonovo Medical Products

Endonovo Therapeutics, Inc. | April 26, 2022

Endonovo Therapeutics, Inc. announced an agreement with NAMSA – a leading Global Contract Research Organization and medical device reimbursement specialist – as strategic advisors to develop in-patient and out-patient medical reimbursement strategies for Endonovo’s flagship PEMF product SofPulse®. “Engaging NAMSA as strategy advisors to develop and apply proven medical device reimbursement strategies is a huge advantage for Endonovo and our shareholders, according to Endonovo CEO Alan Collier. “NAMSA is a proven medical device development partner with relevant therapeutic know-how that is critical when seeking acceleration of reimbursement efforts and commercialization objectives,” he pointed out. NAMSA was founded in 1967 as a scientific research company and later transitioned into a Global CRO and Medtech (Medical Technologies) reimbursement specialist. Today, it has 1,000 strategic associates who provide Medtech reimbursement advisory expertise to more than 300 clients in 15 global regions. NAMSA offers a full continuum of reimbursement services for medical technologies. Their reimbursement consultants provide: payer relations, medical policy research, coverage advocacy, Healthcare Common Procedure Coding System Current Procedural Terminology code analysis/applications and health economic analysis. “Our team strives to bring impactful products like the Endonovo SofPulse into higher adoption. With this technology, and its favorable economics, there are multiple opportunities ahead for serving populations in need. We will work together with the Endonovo team to improve market access for this novel device in the very near term.”, Joseph Sierra, Director, Reimbursement Consulting, North America, NAMSA NAMSA provides strategic guidance and tactical support to fast-track medical device commercialization and to make an immediate impact on patient healthcare worldwide. NAMSA’s services have grown to include regulatory, reimbursement and quality consulting as well as clinical research. These additions have helped NAMSA to become the pre-eminent 100% medical device-focused Global CRO that offers proven strategic solutions throughout the full development continuum. NAMSA is the only US FDA ASCA accredited medical device biocompatibility laboratory in the world. This allows medical device sponsors to fast-track commercialization efforts, while achieving time and cost efficiencies in every major market of the world. Collier stated: “We are fortunate to be working directly with Joseph Sierra, at NAMSA. With over 10 years of reimbursement experience, and his proven track-record in developing successful medical device reimbursement strategies is exemplary and will be helpful in developing the path toward reimbursement for our main product SofPulse®. Joseph is an adjunct instructor at USC Masters of Health Administration Program, and his prior professional work includes successful stints with NeoFect USA and Medtronic Ltd. where he demonstrated a record of success leading roles in reimbursement programs, analysis, and strategies for their medical devices.” NAMSA’s reimbursement expertise and track-record in the introduction and adoption of medical devices into multiple medical specialties includes: orthopedics, cardiovascular surgery, general surgery, plastic surgery, neurology, robotic surgery and wound care. Collaborating with NAMSA on global reimbursement allows Endonovo to explore reimbursement for the U.S. medical markets as well as the European Union market adoption through SofPulse® medical CE Mark. Additional target markets would be Taiwan and other Asian countries. About Endonovo Therapeutics Inc. Endonovo Therapeutics is a commercial-stage developer of noninvasive wearable Electroceuticals® therapeutic devices for pain relief, general wellness and wound curatives. The Company's current portfolio of commercial and clinical-stage wearable Electroceuticals® therapeutic devices addresses wound healing, pain, post-surgical pain and edema, cardiovascular disease, chronic kidney disease, and central nervous system disorders, including traumatic brain injury, acute concussions, post-concussion syndrome and multiple sclerosis. The Company's noninvasive Electroceutical® therapeutic device, SofPulse®, which uses pulsed short-wave radiofrequency at 27.12 MHz, has been FDA-cleared and CE marked for the palliative treatment of soft tissue injuries and post-operative pain and edema. It also has CMS national coverage for the treatment of chronic wounds. The Company's current portfolio of preclinical-stage Electroceuticals® therapeutic devices addresses chronic kidney disease, liver disease, non-alcoholic steatohepatitis cardiovascular and peripheral artery disease and ischemic stroke. The Company's noninvasive, wearable Electroceuticals® therapeutic devices work by restoring key electrochemical processes that initiate anti-inflammatory and growth factor cascades necessary for healing to occur.

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HEALTH TECHNOLOGY

Philips and IJsselland Hospital sign long-term technology partnership

Royal Philips | December 24, 2021

Royal Philips, a global leader in health technology, today announced it has signed a 12-year strategic partnership with IJsselland Hospital (Capelle aan den Ijssel, The Netherlands). As the hospital’s strategic technology partner, Philips will target improved care for patients and care providers at IJsselland Hospital and in the surrounding region. The collaboration will focus on innovation, digitalization and optimization, and includes the purchase of patient monitoring and radiology solutions including CT and MRI systems. Home monitoring collaboration expanded In addition to the new strategic partnership, Philips and IJsselland Hospital plan to expand their existing home monitoring partnership for patients with heart failure and COPD. Philips will provide clinical and patient decision support software which enables implementation of remote health and care programs and facilitates collaboration between different healthcare providers. “Technological developments in healthcare are currently moving very fast,” said Albert van Wijk, Chairman of IJsselland Hospital’s Board of Directors. “As a regional hospital, we want to keep up with these developments to provide the best care for our patients. We have chosen Philips as a technology partner to jointly develop the hospital of the future. This will be good for our patients and our healthcare professionals. Moreover, Philips’ vision fits well with our strategy.” “Over the past year, we have worked with IJsselland Hospital to convert their strategy and challenges into a partnership. I am very proud of this partnership, in which we don’t focus solely on technology but look more broadly at the challenges the hospital faces. A great deal of attention is paid to innovation, which is why we are starting a joint fund for innovation and optimization. We also want to work explicitly on optimizing care processes, so that the hospital can work smarter and save costs.” Léon Kempeneers, Health Systems, Philips Benelux About Royal Philips Royal Philipsis a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2020 sales of EUR 17.3 billion and employs approximately 78,000 employees with sales and services in more than 100 countries.

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FUTURE OF HEALTHCARE

SandboxAQ and Mount Sinai Health System Collaborate on Data Protection

Sandbox AQ | March 24, 2022

Sandbox AQ, an enterprise SaaS company leveraging quantum tech and AI, announced a collaboration with Mount Sinai Health System to launch Post-Quantum Cryptography solutions, a broad security technology solution to protect patient data against current and future cybersecurity threats. Sandbox has developed SaaS-based enterprise modules that incorporate the latest encryption protocol standards recently ratified by NIST (National Institute of Standards and Technology). Through Sandbox AQ, Mount Sinai Health System will incorporate PQC protocols into its network to provide increased security for millions of customers and their sensitive data. "Our collaboration with Sandbox AQ propels our security and technology strategies forward, enabling us to deliver advanced, secure cutting-edge products to our patients. Protecting patient data against cyber threats is incredibly important to us." Kristin Myers, Executive Vice President and Chief Information Officer at Mount Sinai Health System and Dean for Information Technology at Icahn School of Medicine at Mount Sinai "Quantum technology will quickly render today's RSA-based encryption obsolete, which is why it's imperative that we protect the world's sensitive data now against the next generation of cyberattacks," said Jack D. Hidary, CEO of Sandbox AQ, which officially launched today. "Mount Sinai is one of the first healthcare systems planning to implement PQC protocols into its health network to protect its customers and transform its business. We look forward to collaborating with them on this project." About SandboxAQ Sandbox AQ is an enterprise SaaS company delivering solutions at the nexus of quantum tech and AI. Based in Palo Alto, the inspiration for Sandbox AQ and some of the team originated at Alphabet Inc. in 2016. Sandbox AQ launched as an independent, venture-backed entity in 2022. About Mount Sinai Health System The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report's "Honor Roll" of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children's Hospital is ranked in U.S. News & World Report's "Best Children's Hospitals" among the country's best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and "The World's Best Specialized Hospitals" ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally, and the Division of Pulmonary Medicine as No. 6 globally.

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