CHICAGO – The American Hospital Association has voiced support for a Federal Communications Commission proposal to create a $100 million pilot program to support telehealth for low-income Americans. The AHA called the Connected Care Pilot Program “a critical next step towards delivering affordable telehealth services to those Americans who need it the most,” in a comment letter sent to the FCC this week. The agency unanimously approved the pilot program in August. “Telehealth connects patients to vital health care services through video conferencing, remote monitoring, electronic consults, and wireless communications,” the AHA wrote in the letter. “Telehealth is rapidly emerging as a cost-effective solution for overcoming many of the obstacles to health care delivery faced in isolated communities.”
SILVER SPRING, Md. – Teva Pharmaceuticals received approval from the U.S. Food and Drug Administration to market its generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions. The company gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. “The approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement. “We’re advancing new guidance for sponsors to make the development of generic versions of complex products more efficient, and we’re prioritizing review of many complex generic drug applications.” According to the FDA, an authorized generic is made under the brand name’s existing new drug application using the same formulation, process and manufacturing facilities that are used by the brand name manufacturer, but the labeling or packaging is changed to remove the brand name or other trade dress.
SAN JOSE, Calif. – Outset Medical has raised $76.5 million in Series C equity funding. Outset’s technology, the Tablo Hemodialysis System can be used across a range of clinical settings from dialysis clinics to hospitals and skilled nursing facilities. The company will use proceeds from the financing to expand the commercial introduction of the Tablo System in acute and chronic care markets in the United States. Using sensor-based automation, wireless data transmission and a touchscreen interface, Tablo was created to feel and function more like a consumer product than a medical device, said Leslie Trigg, CEO of Outset Medical, in a statement. In the dialysis clinic setting, Tablo’s simplicity and small size allows for a new “self-serve” dialysis model in which patients can set up and monitor their own treatment independently without relying on clinic staff. The self-serve option empowers patients to take more control and ownership of their treatment, and can help create cost efficiencies for dialysis providers. The system connects directly to regular tap water, purifies it on demand and generates streaming dialysis fluid in real-time, while the patient is dialyzing. Because centralized water processing equipment is not required, Tablo expands the settings in which dialysis can be efficiently delivered, and can reduce costs in settings such as hospitals and extended care facilities. “This funding will provide the resources needed to scale our launch and brings us a step closer to making a significant and lasting impact on dialysis care,” said Trigg.
‘We have to adapt and scale our solutions or the system will not be able to sustain the trends we see’
SAN JOSE, Calif. – Remote patient monitoring is increasingly being seen as a standard of care, especially as industry experts predict the number of adults age 65 and older to double by 2060.
Nersi Nazari, CEO of VitalConnect, provider of the VitalPatch wireless biosensor, shared his thoughts on what’s behind the rapid growth in remote patient monitoring.
HHTN:The remote patient monitoring market is growing fast—Researchandmarkets.com predicts it will grow to$31.326 billion by the end of 2023. What’s driving this growth?
NAZARI:As a result of increasing health care costs, an aging population and demonstrated improved patient outcomes with advanced remote monitoring technologies, health care providers are beginning to shift eligible patients toward home care programs, including remote patient monitoring.
HHTN:Some providers are still skeptical about the benefits of remote patient monitoring. What are the challenges to a wider adoption?
NAZARI:Part of the problem has been that quality care like that traditionally found in a hospital has not been technologically or economically possible outside hospital walls on any significant scale until now.
HHTN:Now that it is, what will health care delivery look like in five years?
NAZARI:Technology is changing incredibly fast for health care right now—there are so many new concepts and ideas to approach the age-old issues of health care. I think we will see the use of technology like artificial intelligence, machine learning, biosensors and early warnings scores used commonly in all aspects of health care. Ultimately, all of these technologies should contribute to a reduction in the burden of caring for large numbers of patients efficiently and effectively. We have to adapt and scale our solutions or the system will not be able to sustain the trends we see in chronic disease, aging patients and costs. I think we will see progress toward this in the next five years, but likely it will take longer than that to make broad significant changes.
HHTN:How are the recent changes announced by the Centers for Medicare & Medicaid Services to open a path for reimbursement for remote patient monitoring going to impact the industry?
NAZARI:The changes from CMS to unbundle care for remote patient monitoring will encourage care organizations to build programs with these technologies because they can now bill for the time it takes a caregiver to review data from patients.
HHTN:How are these technologies impacting home health care?
NAZARI:The technology is enabling at-home programs to grow to meet the rising demands of quality home care. Within home care environments, “admit-to-home” patients receiving remote and continuous monitoring have shown a reduction in readmissions and an overall decrease in cost of care as compared to a traditional hospital stay. Enabling patients to be admitted to their homes, rather than the hospital, has been shown to decrease health care costs while improving patient outcomes.
CHICAGO and MINNEAPOLIS – Seventeen major health systems are teaming up to leverage technology to develop digital solutions to improve the health of underserved people in their communities through the Medicaid Transformation Project.
The project will focus on using technology and innovation to impact avoidable emergency department visits, behavioral health, women and infant care, and substance use disorder.
“We want to partner to deliver value and reduce the current trajectory of health care spending—in a way that ensures every member of our community has access to the health care services they need,” said Bettina Tweardy Riveros, chief health equity officer and senior vice president of government affairs and community engagement for Christiana Care Health System in Wilmington, Del., one of the participating health systems.
The project will be led by AVIA, creators of a network for health systems seeking to innovate, and Andy Slavitt, former acting administrator of the Centers for Medicaid & Medicare Services and founder and general partner at Town Hall Ventures, a venture capital firm that invests in entrepreneurs who are improving the health of underserved populations.
The project will assemble a core team at each health system to implement solutions. They will share best practices across the network, creating a roadmap for partner organizations to act quickly to create change.
“These health systems are ready to have an even greater impact by scaling sustainable care models and capabilities that can significantly improve the health of the underserved,” said Linda Finkel, president of AVIA, in a statement. “Thanks to the potential to unlock digital solutions, there’s a stronger business case than ever.”
The project leaders will be looking for ways to take advantage of advancements in care model innovations and health technologies to tackle persistent problems in health care.
“We believe tomorrow’s solutions for today’s health disparities will be rooted in digital solutions and technologies that are easy to implement and scale,” said Dr. Nick Turkal, president and CEO of Advocate Aurora Health in Chicago and Wisconsin, one of the participating health systems that will anchor the work of the project.
Other health systems anchoring the project are: Baylor Scott & White Health in Dallas; Dignity Health in San Francisco; Geisinger in Danville, Pa.; and Providence St. Joseph Health in Renton, Wash. Twelve other health systems, including Christiana Care, will participate.
‘We see this acquisition as a beachhead,’ says CEO
RICHFIELD, Minn. – Industry leaders are optimistic that Best Buy’s recent $800 million acquisition of GreatCall will open up access to health care.
“This could be a way to open health care access to rural or elderly patients,” said Brian Young, director of health care solutions at Vidyo, a health care video technology provider. “I think any movement in this category to try and improve access to health services is a good thing.”
Best Buy already has a growing business selling health and wellness related products, and has been investing in health-related initiatives focused on the aging population. The company introduced the Assured Living senior home monitoring service last year.
“We are acquiring a great company that is profitable and growing, with more than $300 million in annual revenue,” Hubert Joly, CEO of Best Buy, said in a Q2 earnings call on Tuesday. “We see significant value creation opportunities to create an attractive ROI, and opportunities to scale the existing business. We also see this acquisition as a beachhead for Best Buy in the health space, providing more growth and opportunities.”
Dean Mihas, managing director of private equity firm GTCR, which acquired GreatCall last year, said the deal was the right fit at the right time.
“We had a strategic buyer with a highly strategic fit for our business and that made sense for both of us,” he said.
Young said Best Buy’s acquisition is in line with a general trend in health care M&A that will have a positive impact for patients and providers.
“We’re seeing more and more consumer goods companies and retail entities moving into the health care space and that’s a good thing,” he said. “These companies are seen as innovators and they understand consumer behaviors.”
SAN MATEO, Calif. – Evidation Health is partnering with Tidepool on a sleep pilot that will capture and study real world data from people with Type 1 diabetes.
The research will develop insights from data generated by continuous glucose monitors and insulin pumps, in addition to sleep and activity trackers from smartphones and other connected sensors.
Evidation Health helps life sciences and health care companies understand how everyday behaviors and health interact. Tidepool is an open source, not-for-profit company focused on making diabetes data more accessible, actionable and meaningful for people with diabetes, their care teams and researchers.
The observational study will explore the links between nocturnal hypoglycemia, next-day behavior, sleep patterns and heart rates to contribute to ongoing research on how everyday behavior data and diabetes complications interact.
“Linking real world data from connected devices with other medical data in virtual studies allow us to measure how behaviors—outside of the doctor’s office or hospital—affect health and impact outcomes,” said Deborah Kilpatrick, CEO of Evidation Health, in a statement. “Tidepool has done a fantastic job of giving people with diabetes access to their own data, and this effort provides a new opportunity to share everyday data with researchers at scale and enable more people to contribute to diabetes innovation.”
Tidepool joins a growing list of more than 100 individually permissioned data sources that are linked to Evidation’s platform, including Apple Health, Blue Button, Dexcom, Epic and Fitbit.
“People with diabetes can use their individual data to play a key role in improving health,” said Howard Look, president, CEO, and founder of Tidepool, in a statement. “Our study with Evidation gives people with diabetes a new way to share their data with researchers, and contribute to a better understanding of dangerous low-blood sugar levels, which can often occur more frequently while sleeping.”
Since 2012, Evidation Health has built a diverse virtual pool of research participants through its Achievement app, which currently has more than 2 million users.
DURHAM, N.C. – Cerner has collaborated with Duke Clinical Research Institute to develop an atherosclerotic cardiovascular disease (ASCVD) Risk Calculator app, designed as a tool to increase communication between a patient and their doctor about ways to live a healthier life and risk factors for heart disease and stroke. The app helps health care providers estimate 10-year and lifetime ASCVD risk for patients based on information like age, race, sex, blood pressure, cholesterol levels, smoking status and diabetes status, and was designed to factor in a person’s willingness to take action to improve their health and the risks and benefits of potential therapies. “We developed the app to be able to pull important patient health data across multiple EHR suppliers at different venues of care to get a full picture of how to improve that patient’s health,” said Dr. Ann Marie Navar, assistant professor of Medicine at Duke University School of Medicine and member of the Duke Clinical Research Institute who led the collaboration, in a statement. “Cerner’s open platform encourages collaboration, which will help advance the way care is delivered regardless of the specific platform people are using.” Cerner and Duke worked together to develop the software through the Cerner Open Developer Experience that encourages innovators to build apps that advance the health care industry. Cerner wrote, maintains and hosts the ASCVD Risk Calculator under an open source license. “This collaboration demonstrates how the health care industry can come together to develop and continually improve an app that has the ability to save lives by the power of SMART on FHIR open source standards,” said Kevin Shekleton, vice president at Cerner, in a statement. “We developed this Risk Calculator for our client hospitals and health systems, but open source lets any health care organization leverage the technology to help people live healthier lives.”
SAN FRANCISCO – The Carlyle Group has invested up to $350 million in One Medical’s 1Life Healthcare. One Medical is a member-based provider of primary care and digital health to employees of mid-to-large sized companies, and the funding will allow the company to grow its offices and members throughout the U.S. over the next few years, said Amir Dan Rubin, CEO of One Medical, in a statement. “Through our incredible clinical team, technology platform, and inviting and accessible medical offices, we simplify the complex world of care for members every day,” he said. “Our latest plans are to bring this unique One Medical experience to more consumers and companies across the country and add fuel to our aggressive growth plans.” Rubin said the investment will allow One Medical to extend service to more consumers and employers, support the launch of additional offices in existing and new geographies, expand provider and clinical support teams and further advance technology platform innovation. “The primary care system in the United States is broken and One Medical is the brand poised to help fix it,” said Ram Jagannath, managing director at The Carlyle Group, in a statement. “We have partnered with One Medical because of their proven innovative model and track record, outstanding providers and leadership team and significant business momentum. One Medical pioneered the concept of a more modern primary care experience, and it has an incredibly exciting roadmap over the next several years.”
SEVEN HILLS, Ohio – Anthem Blue Cross and Blue Shield is enabling Ohio consumers enrolled in its Medicare Advantage health plans who have chronic obstructive pulmonary disease to use digital health products offered by Propeller Health. Propeller’s digital medicines for COPD and asthma management consist of sensors that attach to consumers’ existing inhalers. The sensors are paired with a mobile app to automatically track medication use and provide personal feedback and insights that help individuals manage and cope with symptoms. “This collaboration between Anthem and Propeller gives individuals access to connected care technology that will help them more easily manage their COPD to help them have a better quality of life,” said Dr. Linda Hotchkiss, managing medical director of Anthem’s Medicare Advantage Central Region, in a statement. “Anthem will continue to focus on improving consumers’ health care experience by increasing access to high-quality, meaningful solutions.” Anthem’s care management team will also use Propeller’s online provider portal to help understand consumers’ progress in managing their COPD, providing more targeted, personalized care and treatment. Consumers need a history of at least one emergency room visit or hospitalization caused by COPD to be eligible for this program. “We’re excited to partner with Anthem Blue Cross and Blue Shield in Ohio to bring the benefits of digital medicine to Anthem’s consumers who suffer from COPD,” said David Van Sickle, co-founder and CEO of Propeller Health, in a statement.