Payer Roundup—Grassley calls on HHS, CMS to explain inflated lab spending

FierceHealthcare | January 29, 2019

Senate Finance Committee Chairman Chuck Grassley, R-Iowa, is calling for the Department of Health and Human Services to explain the potential for a big increase in costs to Medicare for laboratory services. Grassley's letter follows a recent report from the Government Accountability Office which found that changes made by the Centers for Medicare & Medicaid Services (CMS) to establish a national fee schedule for laboratory services may have resulted in hundreds of millions of dollars in increased payments because it used a maximum payment rate as a baseline instead of an average payment. The report also found that Medicare changed the way it processed some laboratory tests and often paid an individual rate for panel tests instead of a lower, bundled rate, which could cost more than $10 billion.

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DIGITAL HEALTHCARE

MedX Health and Health Partners Announce Agreement to Launch MedX’s Teledermatology Screening Platform

MedX Health Corp | March 03, 2022

MedX Health Corp.("MedX" or the "Company"), a global leader in teledermatology, is pleased to announce a Memorandum of Understanding (“MOU”) and the launch of a new commercialization pilot project with Health Partners (OH) Limited, a well-respected, privately-owned corporate health, treatment and primary care services company in the United Kingdom. Serving a broad client base comprising corporates, government agencies, insurers, health trusts, pension funds and individuals, Health Partners (“HP”) employs 700+ people with telehealth, mobile and on-site operations across the UK and the Republic of Ireland. The pilot will span three to six months and involve an estimated 600 patients across two of HP’s sites. Upon the successful completion of the pilot, the MedX DermSecure® Screening Platform will be made available to Health Partners' two million-plus patients. The agreement is the latest initiative in MedX’s global commercialization strategy and follows pilots recently launched across the Europe and Middle East region. "Health Partners’ Clinical Team constantly strives to identify leading technological innovations that offer the highest level of support to our two million-plus patients. MedX's leading skin assessment technology allows dermatologists to not only make more accurate diagnoses of pigmented lesions and moles, but to do that remotely and quickly. We are very proud to be partnering with MedX Health to bring this innovative and life-changing service to our clients.” Health Partners Managing Director Andrew Noble In addition to expanding its DermSecure® Screening Platform network globally, MedX has focused on building a presence in multiple market verticals such as pharmacies, medical clinics, building hubs, medical scanning clinics, mobile and remote medical practices, as well as esthetics and skincare clinics. The partnership with Health Partners represents MedX’s expansion into a new vertical; occupational health and wellbeing services. MedX Managing Director, Europe, Middle East and Africa (EMEA), Naman Demaghlatrous, added, "MedX is pleased to have established a presence in the strategic occupational health vertical. Health Partners brings our technology to a population of more than two million workers across the United Kingdom, thus expanding our footprint in the EMEA region considerably. We continue to execute on our strategy to identify strategic partnerships in the region that will allow us to grow our business and save lives simultaneously.” Health Partners will pilot MedX’s high-definition image-capture technology, SIAscopy®, and its secure, cloud-based patient management system, DermSecure®, which transmits and stores patient data throughout the assessment process. MedX's SIAscopy® is the only technology available that captures five high-resolution images of suspicious moles, lesions and skin conditions, including four spectrophotometric images taken 2mm below the skin's surface. This technology provides detailed patient scans, which a certified dermatologist can virtually assess within 72 hours. "We are honoured to be working with Health Partners on this most important initiative. According to Health & Safety Executive-commissioned research, there are more than 3000 cases of skin cancer annually in the construction industryalone. We are delighted to be entering the occupational health services market with a leader in the industry," stated Mike Druhan, MedX President, Dermatology Services. About Health Partners (OH) Ltd. Health Partners, headquartered in Uckfield, East Sussex, United Kingdom, is a leading health and wellbeing company, providing a full range of corporate health, treatment and primary care services to corporates, government, insurers, health trusts, pension funds and families. We combine expert advice and clinical services with smart systems to deliver impact-driven health programmes, tailored to improve people’s wellbeing and performance. Health Partners is founded on patient privacy and holds a significant number of accreditations, certifications and memberships, including ISO27001, CQC, SEQOHS and ISO9001. Health Partners offers its services across the United Kingdom and the Republic of Ireland, reaching two million plus people in organisations across several industries. About MedX Health Corp. MedX, headquartered in Ontario, Canada, is a leading medical device and software company focused on skin health with its SIAscopy® on DermSecure® telemedicine platform, utilizing its SIAscopy® technology. SIAscopy® is also imbedded in its products SIAMETRICS®, SIMSYS®, and MoleMate®, which MedX manufactures in its ISO 13485 certified facility. SIAMETRICS®, SIMSYS®, and MoleMate® include hand-held devices that use patented technology utilizing light and its remittance to view suspicious moles and lesions up to 2mm beneath in a pain-free, non-invasive manner. Its patented software then creates real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are cleared by Health Canada, the U.S. Food and Drug Administration, the Therapeutic Goods Administration and Conformité Européenne for use in Canada, the U.S., Australia, New Zealand, the European Union, Brazil and Turkey.

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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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DIGITAL HEALTHCARE

Nemaura Medical Launches Metabolic Health Program for Employers and Insurers

Nemaura Medical, Inc | January 14, 2022

Nemaura Medical, Inc.(“Nemaura” or the “Company”), a medical technology company focused on developing and commercializing non-invasive wearable diagnostic devices and supporting personalized lifestyle coaching programs, announces the launch for employers and insurers of Miboko, a new metabolic health program using a non-invasive glucose sensor along with an AI mobile application. The Company’s goal is to achieve broad adoption of Miboko as a form of preventative medicine for a wide user base through these commercial channels and is aligned with the general trend in consumer digital healthcare. “Introducing Miboko to the population at-large through employers and insurers will allow Nemaura to reach a much wider audience in much faster fashion than solely relying on a direct-to-consumer campaign, and in the Western world, these institutions are the most reliable gateway toward wider adoption of preventative health maintenance practices. Being aware of one’s metabolic health and how the body uniquely regulates sugar is key to one’s health. Patients, of course, want to be as informed as possible about their health, and employers and insurers are also aligned with patients in that regard, given the massive productivity losses and healthcare costs at stake on a larger scale across their employee and insured base, respectively. Miboko can help address this substantial market opportunity through our non-invasive, revolutionary approach to healthcare.” Nemaura CEO Dr. Faz Chowdhury Nemaura has also submitted a Premarket Approval (PMA) to the United States Food and Drug Administration (FDA) for approval of its glucose monitoring device as a Class 3 medical device. The Company’s PMA was the subject an on-site FDA bioresearch monitoring (BIMO) audit that generated a single Form 483 observation, for which the Company has committed to a full response this quarter. A follow-up BIMO audit of the clinical investigator site has also been scheduled for the current financial quarter. Miboko has been in development for nearly two years and addresses a significant mass market opportunity that the Company believes could benefit roughly a third to half of the population by using a non-invasive glucose sensor to measure and monitor a user’s metabolic health score, which is based on glucose tolerance or insulin resistance. Those with prediabetes or obesity concerns -- or even those looking to maintain better health through more careful glucose control -- may benefit from such a metabolic health program. How one’s body metabolizes sugar is the main influencer of one’s appetite, weight, sleep quality, and energy and mood levels and even plays a critical factor in chronic diseases (beyond just diabetes), such as heart disease and dementia. At the heart of the Miboko offering is Nemaura’s non-invasive glucose sensor that is designed to measure insulin resistance, reported as a metabolic health score, and priced to be highly affordable with the program running for an initial two-year period. The program also uses a mobile app to provide users with personalized information by tracking their metabolism. A user can find out how well their body responds to sugar through their metabolic health score — and how what they eat and what they do every day uniquely affects their metabolic health. Along with the capability to follow metabolic health progress on the app, Miboko users receive weekly and monthly reports that show and explain their body’s unique metabolic health score and a breakdown of how each of their habits are impacting their overall health and wellbeing. Suggestions for small, manageable changes to daily routines, such as eating more or less of a certain kind of food or exercising at a different time of day to coincide with peak energy levels, provide Miboko users with personalized, usable data. About Nemaura Medical, Inc. Nemaura Medical Inc. is a medical technology company developing and commercializing non-invasive wearable diagnostic devices. The company is currently commercializing sugarBEAT® and proBEAT™. sugarBEAT®, a CE mark approved Class IIb medical device, is a non-invasive and flexible continuous glucose monitor (CGM) providing actionable insights derived from real time glucose measurements and daily glucose trend data, which may help people with diabetes and pre-diabetes to better manage, reverse, and prevent the onset of diabetes. Nemaura has submitted a PMA (Premarket Approval Application) for sugarBEAT® to the U.S. FDA. proBEAT™ combines non-invasive glucose data processed using artificial intelligence and a digital healthcare subscription service and has been launched in the U.S. as a general wellness product as part of its BEAT®diabetes program that is currently undergoing pilot studies. Additionally, Nemaura has launched Miboko, a new metabolic health and well-being program using a non-invasive glucose sensor along with an AI mobile application that helps a user understand how certain foods and lifestyle habits can impact one’s overall metabolic health and well-being. Nemaura believes that up to half the population could benefit from a sensor and program that monitors metabolic health and well-being. The Company sits at the intersection of the global Type 2 diabetes market that is expected to reach nearly $59 billion by 2025, the $50+ billion pre-diabetic market, and the wearable health-tech sector for weight loss and wellness applications that is estimated to reach $60 billion by 2023.

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DIGITAL HEALTHCARE

Graham Healthcare Group Acquires InTeliCare Health Services, Expanding Personalized Home Health Care Offering into Florida

Graham Healthcare Group | December 21, 2021

Graham Healthcare Group, a leader in homecare, palliative and hospice services, today announced its acquisition of InTeliCare Health Services, a provider of home health services in central Florida. The agreement was finalized on December 15th, 2021, and marks Graham's first expansion into Florida. Graham will integrate InTeliCare into its Residential Home Health division to accelerate access to personalized home health care throughout Florida. Residential is a leading post-acute home care network serving communities in Michigan, Illinois and Pennsylvania. Integrating InTeliCare into Residential Home Health will bring together industry-leading, patient-centered home health services to strengthen the continuum of care for patients across central Florida. "More than one-fifth of Florida's population is over 65, and that number continues to grow. With the baby boomer generation doubling in size and an increase in comorbidities, this is an ideal time for Graham Healthcare Group to begin serving people in the state of Florida in their own homes with high-quality post-acute and end-of-life care." David Curtis, Chief Executive Officer of Home Health at Graham Healthcare Group "With the addition of InTeliCare, we're poised for growth as we continue our mission to transform home care and improve patient experiences," Curtis said. "This agreement expands the ability of Graham Healthcare Group to deliver consistent, high-quality care across the spectrum of home health and further strengthens our foundation for success." Irene Tuttle, InTeliCare Founder and Chief Executive Officer, will serve in an advisory role following the deal's close. Toni Walker, InTeliCare's longstanding Vice President of Operations, will maintain leadership over day-to-day operations. "We strongly align with Residential's values of care and community," Tuttle said. "This is an extraordinary opportunity to join forces with an organization that shares our employee- and patient-driven approach to care." "We are confident that the powerful synergies and added strength this partnership creates will continue to elevate the value and experience of post-acute care and advance the continuum of home health care in central Florida," Tuttle added. Residential Home Health intends to retain InTelicare's workforce and will support them with enhanced operational efficiencies and advanced clinical and technology innovations. Both Residential Home Health and InTeliCare are known for strong, employee-friendly cultures. Residential has been recognized as a top workplace for 11 consecutive years in the Detroit market and was recognized in the Chicago and St. Louis markets in 2021. About Graham Healthcare Group A subsidiary of Graham Holdings Company, Graham Healthcare Group has designed business and technology solutions to drive better care, outcomes and productivity in home health and hospice services for more than 20 years. Itincludes Residential Healthcare Group, Allegheny Health Network-Healthcare @ Home, Mary Free Bed at Home, Clarus, and CSI Pharmacy. Itis deeply committed to radically changing the home care model by putting patients and their families at the top of the paradigm, while enhancing the quality and consistency of healthcare in the most convenient and cost-effective setting possible: at home. About Residential Home Health Based in Troy, Michigan, Residential Home Health is a leading provider of home health, palliative and hospice services in Michigan, Illinois and Pennsylvania. Residential is one of the fastest growing home health networks with 2,500 dedicated care professionals. About InTeliCare Health Services Based in Boca Raton, InTeliCare is a leading provider of home health services in central Florida. The company has 80 employees serving nearly 300 patients from three offices.

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