MedPAC debates reference pricing, arbitration to bring down prices in Part B

FierceHealthcare | March 07, 2019

The Medicare Payment Advisory Commission is weighing reference pricing and binding arbitration as possible solutions for rising drug prices in Part B. In a report at its monthly meeting on Thursday morning, MedPAC staffers outlined the two approaches, which could be considered individually or combined into a larger package aimed at drug costs. The goal, analysts Nancy Ray and Kim Neuman said, is to expand a reform package the commission recommended in 2017 and has yet to go anywhere in Congress. MedPAC recommended that the current pricing system for Part B drugs—average sales price plus 6%—be improved through consolidated billing codes as providers move toward an alternative system: the drug value program (DVP).

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FUTURE OF HEALTHCARE

Iris Telehealth Engages Amendola for Strategic PR and Media Relations Services

Amendola Communications | April 27, 2022

Amendola Communications, a nationally recognized, award-winning healthcare and technology marketing and public relations firm, announced that Iris Telehealth, a leading provider of telepsychiatry services for community mental health centers, community health centers, hospitals, and health systems across the U.S., has selected the firm to manage PR, media relations, and thought leadership. Iris conducted an extensive agency search and selected Amendola for its successful track record, industry acumen, and bench strength. "The COVID-19 pandemic has magnified the importance of addressing mental health as a part of overall public health. Providing easy and convenient access to accredited psychiatric services from quality behavioral health professionals is essential to this effort. Iris Telehealth's use of telemedicine to expand clinically sound psychiatric services to patients and healthcare organizations is making a tangible impact in this regard, and we're enthused to help execute their vision of enabling a better world through healthy minds." agency CEO Jodi Amendola Amendola is implementing a comprehensive public relations, thought leadership, communications, and media plan for Iris Telehealth that will showcase its value proposition, services, accomplishments, customer wins, and industry partnerships. The agency successfully kicked off the relationship by supporting the Austin, Texas-based company's recent Series B funding. Amendola garnered significant media coverage for this major milestone, including an audience reach of more than 61 million via placements in high-profile healthcare trade and business media such as MobiHealthNews, MedCity News, Digital Health Business and Technology, Axios, Fortune, and STAT as well as local Austin media. "There's a nationwide need to provide timely, quality behavioral healthcare, and our track record shows we can help health systems and community organizations sustainably improve care for their communities," said Dan Ferris, Chief Marketing Officer of Iris Telehealth. "We're teaming up with Amendola Communications to drive awareness of our unique value to the healthcare market and our mission of supporting the mental wellbeing of patient populations that need it most. Our Series B announcement was our first effort to gain more market awareness and we know that with Amendola's help, this is just the beginning." Iris Telehealth has grown exponentially over the last 18 months as healthcare organizations seek to provide timely, quality care to their patients. Iris's combination of high-quality providers, best-in-class support, expertise to optimize care models, and technology has enabled customers to reimagine how behavioral health services are provided across the continuum of care. About Amendola Communications Amendola is an award-winning, insights-driven public relations and marketing firm that integrates media relations, social media, content, and lead gen programs to move healthcare, life sciences/pharma and healthcare IT decision-makers to action. The agency represents some of the industry's best-known brands as well as groundbreaking startups that are disrupting the status quo. Nearly 90% of its client base represents multi-year clients and/or repeat client executives. Amendola's seasoned team of PR and marketing pros understand the ongoing complexities of the healthcare ecosystem and provide strategic guidance and creative direction to drive positive ROI, boost reputation and increase market share. Making an impact since 2003, Amendola combines traditional and digital media to fuel meaningful and measurable growth. About Iris Telehealth Iris Telehealth helps healthcare organizations consistently increase access to quality mental healthcare for their patients by providing the clinicians, staff support, and knowledge to build a sustainable telepsychiatry department. With clinical grounding and emphasis on human relationships, Iris Telehealth identifies best-fit providers for each unique organization and ensures long-term commitment to meeting their partner's needs, allowing them to provide the highest quality care to their patients and community.

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HEALTH TECHNOLOGY

CareCloud Launches All-New Interoperability and Data Exchange Solution for Healthcare Organizations

CareCloud, Inc | December 17, 2021

CareCloud, Inc., a leader in healthcare technology solutions for medical practices and health systems nationwide has released CareCloud Connector, a next-generation interface and data management engine, and the first product within its CareCloud Conductor suite. CareCloud Connector enables healthcare organizations with ready-to-use integrations that improve data management and deployment speed, while offering better interface visibility and control. “We have been a leading healthcare IT innovator for almost two decades, providing solutions that improve financial, clinical, and patient outcomes, at scale, and a partner to a wide array of healthcare organizations. Today we are introducing our proprietary, turn-key integration technology platform to help healthcare ecosystem partners leverage the same tools we ourselves use to manage our business across hundreds of unique integrations spanning thousands of locations.” Hadi Chaudhry, CEO and President, CareCloud As the U.S. healthcare industry’s data exchange regulations continue to evolve and vendors prepare to comply with provisions in the Cures Act, legacy integration tools will hinder progress. CareCloud Connector provides a seamless, scalable, and centralized platform with APIs, allowing healthcare IT vendors, medical billing organizations, and digital health companies to overcome interoperability challenges and effectively manage data integration and transmission hurdles. Connector includes a library of industry-tested, ready-to-use integrations, interfaces, and customizable tools in a convenient SaaS offering. "As one of the industry’s first true libraries of plug-and-play integration and customizable tools, CareCloud Connector transforms laborious developmental projects into simple and secure activations,” said Adeel Sarwar, Chief Technology Officer, CareCloud. “Connector makes data exchange and management simple and cost-effective for industry participants.” "Healthcare organizations often struggle with managing hundreds of interface requests and data migration challenges. Couple this with the complexities of new regulatory requirements embedded in the Cures Act and you set the stage for a solution like Connector,” said David Botero, Director of Integrations, CareCloud. “Connector allows us to close interoperability gaps for industry participants. We are proud to be a leader in integration consolidation, empowering health organizations and service providers to comply with new interoperability requirements while saving money and resting easy, knowing that a leading publicly-traded healthcare IT vendor is taking care of the hard work for them." CareCloud Connector is the first solution launching under CareCloud’s new technology suite, CareCloud Conductor. Conductor is a family of technologies designed to support interoperability, connectivity, and data transformation. CareCloud plans to unveil more products in the Conductor suite in 2022 with the launch of additional innovative solutions to support the growing prominence of health IT developers and investments in digital health. About CareCloud CareCloudbrings disciplined innovation to the business of healthcare. Our suite of technology-enabled solutions helps clients increase financial and operational performance, streamline clinical workflows and improve the patient experience. More than 40,000 providers count on CareCloud to help them improve patient care while reducing administrative burdens and operating costs.

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DIGITAL HEALTHCARE

Revibe Technologies Announces Clinical Development Updates for its Investigational FokusRx Prescription Digital Therapy for the Treatment of ADHD

Revibe technologies | February 09, 2022

Revibe technologies, a commercial-stage digital therapeutics company, announced today the positive results of their feasibility study examining the efficacy of FokusRx in school aged children with attention deficit hyperactivity disorder (ADHD). FokusRx is an investigational SaMD (Software as a Medical Device) that has the potential to provide a new nonpharmacologic approach to treating attention, focus and hyperactivity deficits associated with ADHD, and other mental health conditions. ADHD is one of the most commonly diagnosed and increasingly prevalent mental health disorders in children and adolescents.Inthe United States, 6.1 million children aged 2-17 years have been diagnosed with ADHD. Approximately 50% of families stop using prescription drug treatments for ADHD within a year.Over 30% of parents refuse pharmacologic treatment for their children with ADHD. In this, single-arm multi-rater feasibility study, parents (n= 38) and teachers (n= 26) rated youth aged 8-12 years with a parent-reported diagnosis of ADHD. Youth were attending in-person classroom learning and not taking medication for their ADHD. The study included a number of outcome measures including the ADHD-RS-5 (Home and School versions), Conners 4 – short version, Weiss Functional Impairment Rating Scale-Parent Form (WFIRS-P), and the Academic Performance Rating Scale (APRS). To be included in the analyses, youth had to have worn the Revibe Connect wearable device to school Monday to Friday for a at least three days per week or a minimum of 15 days total for a period of four weeks. "We are pleased that the feasibility study has proven to be a successful exercise that de-risks our upcoming randomized sham-controlled pivotal trial. The moderate to large effect sizes observed and change scores that exceed standards for minimally important (clinically significant) differences, provide encouraging preliminary evidence supporting the efficacy of our intervention", says Dr.Lindsay Ayearst, Chief Scientific Officer of Revibe. Revibe's Scientific and Medical Advisory Board member, Dr.Margaret Weiss, Director of Clinical Research in Child Psychiatry at Cambridge Health Alliance, stated, "These results are consistent across both symptoms and functioning, and across informants.They would translate into clinically significant change. Most impressive is the demonstration of an effect on academic performance." "The data from the classroom feasibility study suggests FokusRx can effectively and safely improve ADHD symptoms and functioning in school-aged children. It is our intention that FokusRx will provide kids and parents another option to help them succeed and reach their full potential. We are excited to begin designing our pivotal trial planned for the fall." Joseph Koziak, Chief Executive Officer of Revibe About FokusRx FokusRx is an investigational SaMD designed to provide a new nonpharmacologic approach to treating symptoms and impairment associated with ADHD. The FokusRx software is embedded within a dedicated smart watch to act as a digital therapeutic wearable. About Revibe Technologies Revibe Technologies is passionate about leveraging technology to help children and adults with focus and attention problems overcome obstacles in order to succeed in life. Revibe Technologies hopes to be a resource for students, parents, teachers, schools, and clinicians.

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HEALTH TECHNOLOGY

Texas Children's Hospital And Baylor College of Medicine COVID-19 Vaccine Technology Secures Emergency Use Authorization In India

Texas Children Hospital | December 29, 2021

Texas Children's Hospital and Baylor College of Medicine announced today that CORBEVAX™, a protein sub-unit COVID-19 Vaccine, whose technology was created and engineered at its Center for Vaccine Development (CVD), has received Emergency Use Authorization (EUA) approval from the Drugs Controller General ofIndia(DCGI)to launch inIndiawith other underserved countries to follow. Dubbed "The World's COVID-19 Vaccine", it uses a traditional recombinant protein-based technology that will enable its production at large scales making it widely accessible to inoculate the global population. The initial construct and production process of the vaccine antigen was developed at Texas Children's Hospital CVD, led by co-directors Drs. Maria Elena Bottazzi and Peter Hotez and in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialization team, to Hyderabad-based vaccine and pharmaceutical company Biological E. Limited (BE). CORBEVAX™ after completing two Phase III clinical trials involving more than 3000 subjects was found to be safe, well tolerated and immunogenic: CORBEVAX™ demonstrated superior immune response in comparison with COVISHIELD™ vaccine when assessed for Neutralizing Antibody (nAb) Geometric Mean Titers (GMT) against the Ancestral-Wuhan strain and the globally dominant Delta variant. CORBEVAX™ vaccination also generated significant Th1 skewed cellular immune response. CORBEVAX™ nAb GMT against Ancestral-Wuhan strain is indicative of vaccine effectiveness of >90% for prevention of symptomatic infections based on the Correlates of Protection assessment performed during Moderna and Astra-Zeneca vaccine Phase III studies. CORBEVAX™ nAb GMT against the Delta strain indicates a vaccine effectiveness of >80 percent for the prevention of symptomatic infections based on published studies. While none of the subjects who took CORBEVAX™ or COVISHIELD™ had serious adverse events, CORBEVAX™ had 50 percent fewer adverse events than COVISHIELD™. In the continuous monitoring of phase II studies, CORBEVAX™ showed high persistence of immune response as indicated by <30% drop in nAb GMT till 6 months second dose as compared to >80% drop observed with majority of the vaccines. "Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world," said Dr. Maria Elena Bottazzi, Professor and Associate Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Our decade-long studies advancing coronavirus vaccine prototypes has led to the creation of this vaccine, which will fill the access gap created by the more expensive, newer vaccine technologies and that today are still not able to be quickly scaled for global production." The need for safe, streamlined, low-cost vaccines for middle- to low-income countries is central to the world's fight against the COVID-19 pandemic. Without widespread vaccination of populations in the Global South, additional virus variants will arise, hindering the progress achieved by currently available vaccines in the United States and other Western countries. "This announcement is an important first step in vaccinating the world and halting the pandemic. Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low- and middle-income countries face against the delta variant," said Dr. Peter Hotez, Professor and Dean of the National School of Tropical Medicine at Baylor and Co-Director of the Texas Children's Hospital Center for Vaccine Development. "Widespread and global vaccination with our Texas Children's-Baylor-BE vaccine would also forestall the emergence of new variants. We have previously missed that opportunity for the alpha and delta variant. Now is our chance to prevent a new global wave from what might follow." "Over the years, we have worked to make quality vaccines and pharmaceutical products accessible to families around the world. With this as our backdrop, we resolved to develop an affordable and effective COVID-19 vaccine. It has now become a reality. We deeply appreciate Texas Children's Hospital Center for Vaccine Development, Baylor, CEPI, the Bill and Melinda Gates Foundation, and the government of India for their continuous support and cooperation during this journey. The combined efforts & unceasing support demonstrate that we can collectively overcome any challenge". Mahima Datla, Managing Director, Biological E. Limited ABOUT TEXAS CHILDREN'S HOSPITAL Texas Children's Hospital, a not-for-profit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children's hospital in Texas, and among the top in the nation, Texas Children's has garnered widespread recognition for its expertise and breakthroughs in pediatric and women's health. The hospital includes the Jan and Dan Duncan Neurological Research Institute; the Feigin Tower for pediatric research; Texas Children's Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children's Hospital West Campus, a community hospital in suburban West Houston; and Texas Children's Hospital The Woodlands, the first hospital devoted to children's care for communities north of Houston. The organization also created Texas Children's HealthPlan, the nation's first HMO for children; has the largest pediatric primary care network in the country, Texas Children's Pediatrics; Texas Children's Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that's channeling care to children and women all over the world. Texas Children's Global Health program leads efforts that advance health care equity through innovative collaboration in care, education and research for underserved populations globally. Texas Children's Hospital is affiliated with Baylor College of Medicine. ABOUT TEXAS CHILDREN'S HOSPITAL CENTER FOR VACCINE DEVELOPMENT Texas Children's Hospital Center for Vaccine Development is one of the leading vaccine development centers in the world. Established in Washington DC as the Sabin Vaccine Institute Product Development Partnership (PDP) in the year 2000 and after relocating to the Texas Medical Center in 2011, it rebranded as Texas Children's Center for Vaccine Development. For the past two decades it has acquired an international reputation as a non-profit PDP, advancing vaccines for poverty-related neglected tropical diseases (NTDs) and emerging infectious diseases of pandemic importance. In addition, it builds and strengthens capacity for vaccine development locally and with foreign nations and leads global efforts to guide and influence vaccine policy and advocacy through "vaccine diplomacy" as an international bridge for peace and vaccine development capacity. ABOUT BCM VENTURES Baylor College of Medicine Ventures is the commercial engine of the health sciences university, created to support the translation of academic knowledge and intellectual assets for the benefit of society. We do this by engaging university innovators, entrepreneurs and industry to fully develop ideas along their best commercial path. We foster a culture of commercialization and engage with industry to identify market opportunities for collaborative ventures. ABOUT BIOLOGICAL E. LIMITED Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to over 100 countries and its therapeutic products are sold in India and the USA. BE currently has 8 WHO-prequalified vaccines in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing generic injectable products for the regulated markets, exploring synthetic biology and metabolic engineering as a means to manufacture APIs sustainably and developing novel vaccines for the global market.

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Fitbit users awake or restless 25.5 minutes every night on average. On average, Women sleep 25 minutes longer each night than men. Users who are obese or overweight get 70 Minutes less sleep per week.

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