Department of Justice says entire ACA should be thrown out

Healthcare Finance | March 26, 2019

The U.S. Department of Justice has agreed with a Texas district court judge in releasing an opinion that the Affordable Care Act should be struck down. This is a reversal of the DOJ's earlier opinion in the district court in which the DOJ previously defended all of the ACA other than the individual mandate, including pre-existing condition provisions. The DOJ's opinion was issued as the Fifth Circuit Court of Appeals considers the constitutionality of the ACA, in Texas vs. United States. The DOJ supports the decision of the court of the Northern District of Texas invalidating the entirety of the Affordable Care Act, now that the individual mandate is gone. "Because the United States is not urging that any portion of the district court's judgment be reversed, the government intends to file a brief on the appellees' schedule," the DOJ said in a letter filed Monday evening with the Fifth Circuit, U.S. Court of Appeals.

Spotlight

The growing thirst for information – reliably accurate information, is dramatically changing the health care industry in many ways. Externally, the government, industry groups, payers, employers and patients are demanding more insightful information, accountability and transparency. Internally, there is increasing demand for clinicians and leaders to improve service quality, patient satisfaction and clinical outcomes. At the same time, health care providers are being constantly challenged to provide better results with fewer resources and at a lower cost. These external and internal forces can induce greater performance risk and are driving health care organizations to develop a better understanding of their clinical and financial outcomes.


Other News
FUTURE OF HEALTHCARE

Skylight Health Announces Series A Preferred Stock Cash Dividend

Skylight Health Group | December 14, 2022

Skylight Health Group Inc. a healthcare platform combining technology and analytics focused on transitioning patients into value based care to drive better health outcomes and experiences in the United States, announced that its Board of Directors has authorized, and the Company has declared, a dividend on its 9.25% Series A Cumulative Redeemable Perpetual Preferred Shares for the month of January 2023. The Series A Preferred Shares trade under the “SLHGP” stock ticker symbol. In accordance with the terms of the Series A Preferred Shares, the Series A dividend will be payable in cash in the amount of $0.1927 per share on January 20, 2023 to the shareholders of record of the Series A Preferred Stock as of the dividend record date of December 30, 2022. The Company also wishes to update details of the Company’s previously announced shares for debt on September 15 and 16, 2022. The Company will settle a total of $438,400 in debt by issuing an aggregate of 626,286 common shares to the creditors at a deemed price of $0.70 per common share, in satisfaction of the debt. About Skylight Health Group Skylight Health Group is a healthcare services and technology company, working to positively impact patient health outcomes. The Company operates a US multi-state primary care health network comprised of physical practices providing a range of services from primary care, sub-specialty, allied health, and laboratory/diagnostic testing. The Company is focused on helping small and independent practices shift from a traditional fee-for-service model to value-based care (“VBC”) through tools including proprietary technology, data analytics and infrastructure. In an FFS model, payors (commercial and government insurers) reimburse on an encounter-based approach. This puts a focus on the volume of patients per day. In a VBC model, the providers offer care that is aimed at keeping patients healthy and minimizing unnecessary health expenditures that are not proven to maintain the patient’s well-being. This places emphasis on quality over volume. VBC will lead to improved patient outcomes, reduced cost of delivery and drive stronger financial performance from existing practices.

Read More

FUTURE OF HEALTHCARE, DIGITAL HEALTHCARE

BioNJ Hosts Its Inaugural Health Equity in Clinical Trials MBA Business Plan Case Competition

BioNJ | December 07, 2022

BioNJ, New Jersey's life sciences trade association, hosted an Inaugural Health Equity in Clinical Trials MBA Business Plan Case Competition on Saturday, December 3, at Rutgers Business School. BioNJ's Business Plan Case Competition, which is part of a broader BioNJ strategic initiative of Health Equity in Clinical Trials, was designed to promote the next generation of diverse clinical trial innovators and identify innovative approaches and successful models that can be used nationally to strengthen diversity in clinical trials and expand health equity. BioNJ believes that health equity in clinical trials is critical to deepening the understanding of the safety and efficacy of medicines in under-represented populations, expanding access to medical innovation for these populations and increasing dialogue and trust among the biopharma industry, communities and healthcare systems. By discovering new approaches, utilizing new technologies and developing new business standards to make trials more accessible, we can work to create more agile, efficient and Patient-centered medical research. Eight teams, competing for more than $20,000 in prize money, were tasked with developing a business plan defining a new solution, application or technology to help address this important and challenging problem. Teams identified one particular type of health disparity on which to frame their proposed solutions and connected with community-based organizations to better understand the real-world barriers that exist for their chosen populations to engage in clinical trials. The disease areas on which the respective teams focused included Alzheimer's, heart failure, multiple sclerosis, diabetes type 1 and type 2, colorectal and cervical cancers, and oncology. "There is an urgent need to bring more diversity to clinical trials in order to better serve Patients and their communities…thereby helping to address health inequities. Only by improving diversity in clinical trials will we be able to deepen our understanding of the safety and efficacy of medicines for all populations. I am extremely proud of our teams. Each of the business plans offered a unique out-of-the-box solution – helping advance our ambition to have no Patient left behind." Amadou Diarra, Ph.D., Senior Vice President, Global Policy, Advocacy & Government Affairs for Bristol Myers Squibb; BioNJ Board Member and Chair of the BioNJ Health Equity in Clinical Trials Initiative Live pitch presentations were made throughout the day to a Panel of Judges comprised of industry experts Naikia Atkinson, Director, U.S. Clinical Trials Diversity and Inclusion, Sanofi Schylr Greggs, Director, Technology Operations, Medidata Sharon Hanlon, Head, Clinical Trial Engagement & Enrollment, Bristol Myers Squibb Maribel Hernandez, Vice President, Clinical Operations & Special Projects, PTC Therapeutics Jack Rosenberg, Manager, Investments and Business Development, TrialSpark Del Smith, Co-Founder & CEO, Acclinate Lolita Smith, Program Manager, Rare Disease Diversity Coalition, Black Women's Health Imperative Matt Walz, CEO, TrialBee "Although ultimately three winning teams were presented with cash prizes, each team has made a difference for Patients by offering new solutions and technologies to better serve Patients, build community trust and address gaps in health care delivery," said Paul Howard, Ph.D., BioNJ Business Case Competition Steering Committee Chair and Senior Director, Public Policy for Amicus Therapeutics. "This is just the start as we work to share these proposals more broadly." A white paper with all of the presentations will be published in April and rolled out during BioNJ's acclaimed BioPartnering Conference – which brings together more than 500 industry professionals from around the globe. The three winning teams will present their plans during the April 18 BioPartnering Conference and all of the students are invited to attend to meet the community. About BioNJ BioNJ is the life sciences trade association for New Jersey, representing close to 400 research-based life sciences organizations and stakeholders across the healthcare ecosystem from the largest biopharmaceutical companies to early stage start-ups for nearly 30 years. Because Patients Can't Wait®, BioNJ is dedicated to ensuring a vibrant ecosystem where Science is Supported, Companies are Created, Drugs are Developed and Patients Have Access to Lifesaving Medicines.

Read More

MEDICAL DEVICES

Study Reveals Florence Healthcare’s Site Enablement Platforms Can Accelerate Clinical Trials by Six Weeks and Reduce Costs by Over $1M per Study

Florence Healthcare | November 18, 2022

Florence Healthcare™, a clinical research technology company headquartered in Atlanta, Georgia, announced the completion of a year-long third-party study on the impact of Site Enablement Platforms™ on clinical research timelines and costs. The study by Marketcap Consulting is the first to compare how traditional site management approaches differ from site-first Site Enablement Platforms. The study looked at the impact of traditional sponsor portals and new Site Enablement Platforms on research sponsor and Contract Research Organization study timelines and budgets. “Pharma sponsors and CROs realize the importance of enabling sites to do their best work - but only recently have they discovered that traditional site portals are more hindrance than help. Yet, these organizations weren't able to measure the true impact of switching to a Site Enablement Platform. This year-long study aimed to fix that and highlight how linking fragmented workflows accelerates the full lifecycle of clinical trials.” Ryan Jones, CEO of Florence Healthcare Site enablement is a new technology category that prioritizes the needs of the site, a major shift from past technology that only looked at the experience of the sponsor. These platforms, including Florence Healthcare’s SiteLink™, insist on ease-of-use and ease-of-setup for the site, quality support, and simplified integrations. SiteLink works in conjunction with eBinders™, an electronic Investigator Site File solution used by over 12,000 research sites in 45 countries. About the Study Marketcap Consulting conducted interviews with clinical research operations leaders harnessing SiteLink, examined timelines and study costs, and analyzed the impact across the sites in the study. On average, the team found that SiteLink accelerated study start-up by four weeks and study close-out by two weeks at every site. For a 50-site study, this six-week acceleration reduced cash burn by one million dollars. “We can see a clear positive impact on study timelines and cash burn when research sponsors and CROs implement Site Enablement Platforms,” said Joel White, founder of Marketcap Consulting. “This early study reveals that by enabling sites to do their best work, the clinical research industry unlocks value across the full research cycle.” “While the financial impact of switching to SiteLink makes investing in site enablement an easy choice for sponsors and CROs, it’s really the acceleration of studies that gets our team at Florence Healthcare excited,” said Jones. “We aim to double the output of research teams by the end of the decade, and enabling sites is the way to do it.” About Florence Healthcare Florence Healthcare’s clinical trial software helps more than 12,000 research sites in 45 countries manage their documents, data, and workflows. The Florence Healthcare™ platform also provides remote access so sponsors and Contract Research Organizations can collaborate with their sites around the world. Florence Healthcare users now perform 5.8 million remote monitoring activities each month.

Read More

MEDICAL DEVICES

Carestream Health Unveils New X-ray Detectors, Enhanced X-ray Rooms at World’s Largest Radiology Exhibition

Carestream Health | November 29, 2022

Carestream’s legacy of delivering quality medical imaging technology continues with the launch of new digital X-ray detectors that help improve clinical outcomes, while enhancements to its existing product portfolio reflect the company’s deep understanding of the radiology profession. At the annual meeting of the Radiological Society of North America (RSNA) in Chicago, the company is displaying its expanding portfolio of medical imaging systems that provide quantifiable benefits to healthcare organizations and their patients, including New Carestream Focus HD 35 and Focus HD 43 detectors that offer higher resolution with a 100 micron pixel pitch that allows for image magnification for better visibility of small objects and microstructures. The detectors’ Cesium (CsI) scintillator is ideal for dose-sensitive pediatric patients; and the detectors have an IP56 rating for better protection against dust and fluid ingress. Next generation of long-length imaging, the Carestream DRX-LC Detector (INVESTIGATIONAL – NOT AVAILABLE FOR COMMERCIAL SALE) captures long-bone and spine images with a single exposure, making it ideal for pediatric imaging and long-bone and spine images of people with limited mobility. In contrast, the traditional multi-shot approach requires three to five exposures followed by manipulation and stitching of the images. The new detector is designed to capture the full image in a single exposure to minimize dose and mitigate motion artifact that can appear from patient movement with a multi-shot exam. The DRX-LC Detector is designed with X-Factor so the detector can be shared across different Carestream X-ray systems and is compatible with both rooms and mobile units. Enhancements to the Carestream DRX-Evolution Plus that provide improved patient comfort and a better ergonomic experience along with improved workflow for the radiographer. Its new tabletop design eliminates rails that can cause strain and discomfort for both radiographer and patient, enabling patients to be moved more smoothly and with less effort to the exam table. New features in the Carestream DRX-Excel Plus provide a better staff experience with faster workflow and better diagnostic image quality. Designed specifically for large and mid-size hospitals and medical centers, this innovative system combines fluoroscopy and general radiology capabilities in one compact unit. It delivers accelerated workflow, high-resolution images and a wide range of patient exam options. “Our commitment to quickly respond to the needs of the radiology community with ideas that clearly work is as strong as ever, and we are solidly positioned to continue developing solutions that have quantifiable benefits to our customers and their patients. Organizations can have complete confidence in our ability to provide high-value technology that helps lower costs, and improves imaging workflow for radiology departments, technologists and other healthcare professionals—all with the goal of improving patient care.” David C. Westgate, Chairman, President and CEO of Carestream About Carestream Health Carestream is a worldwide provider of medical imaging systems; X-ray imaging systems for non-destructive testing; and precision contract coating services for a wide range of industrial, medical, electronic and other applications—all backed by a global service and support network.

Read More

Spotlight

The growing thirst for information – reliably accurate information, is dramatically changing the health care industry in many ways. Externally, the government, industry groups, payers, employers and patients are demanding more insightful information, accountability and transparency. Internally, there is increasing demand for clinicians and leaders to improve service quality, patient satisfaction and clinical outcomes. At the same time, health care providers are being constantly challenged to provide better results with fewer resources and at a lower cost. These external and internal forces can induce greater performance risk and are driving health care organizations to develop a better understanding of their clinical and financial outcomes.

Resources