Industry scrambling to digest and respond to proposed 'information blocking' rules

FierceHealthcare | March 11, 2019

Industry scrambling to digest and respond to proposed 'information blocking' rules
With the comment period for two major rules set to close on May 3, the clock is now ticking for industry groups to dig into the proposals aimed at boosting interoperability and patient access. Is 60 days enough time to unpack the rules? The American Medical Association (AMA) says no, joining electronic health record vendors in calling on federal policy leaders to extend the comment period on the dual information blocking and interoperability rules dropped last month. Both the AMA and the Electronic Health Record Association (EHRA), which represents most of the major EHR vendors, are asking for a 30-day extension on the rules’ comment period. Last month, ONC finally unveiled its 724-page information blocking rule (PDF), and CMS released a proposed rule (PDF) taking aim at data blocking. CMS is proposing to require Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities and QHP issuers in FFS programs to implement, test and monitor openly published FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.

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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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MEDICAL DEVICES

Medtronic announces regulatory approval and launch in Japan of Micra AV Transcatheter Pacing System

Medtronic | January 11, 2022

Medtronic plc, a global leader in healthcare technology,today announced it has received approval fromJapan'sMinistry of Health, Labor and Welfare for the sale and reimbursement of the Micra™ AV Transcatheter Pacing System (TPS), and the company will launch the product this month. This approval expands the number of patients inJapan– one of the largest markets in the world – who are eligible to receive the Micra TPS, the world's smallest pacemaker. The Micra AV is indicated for the treatment of patients with AV block, a condition in which the electrical signals between the chambers of the heart (the atria and the ventricle) are impaired. The Micra TPS is the first-ever leadless pacemaker; its first version (the Micra VR) was approved inJapanin 2017 for patients who only require single-chamber pacing. "Pacemakers have made significant progress over their approximately 60-year history, including miniaturization, improvements in pacing technology, MRI compatibility, and remote monitoring," explainedKyoko Soejima, professor of cardiovascular internal medicine at Kyorin University Hospital and a member of the Micra TPS Global Clinical Trial steering committee. "The first Micra system transformed the concept of pacemakers by eliminating surgical pockets and leads, and Micra AV promises to deliver the benefits of leadless pacing to a larger number of patients because ventricular pacing can be performed synchronously with the atrium." Historically, patients with AV block have been treated with traditional dual-chamber pacemakers which are implanted in the upper chest, under the skin below the collar bone, and connected to the heart using thin wires called "leads." Identical in size and shape to the original Micra TPS, Micra AV has several additional algorithms which detect cardiac movement, allowing the device to adjust pacing in the ventricle to coordinate with the atrium, providing "AV synchronous" pacing therapy to patients with AV block. The Micra AV approval is based on data from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study, which evaluated the safety and effectiveness of accelerometer-based atrial sensing algorithms. The study evaluated the ability of the Micra's internal sensor to monitor and detect atrial contractions and enable coordinated pacing between the atrium and ventricle, thereby providing AV synchrony. "Since introducing the first battery-powered external pacemaker in 1957 to the innovative Micra leadless pacemaker portfolio, Medtronic continues to pioneer pacing innovations for physicians and their patients." Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic About the Micra Transcatheter Pacing Systems (TPS) The Micra TPS received CE Mark inApril 2015and U.S. FDA approval in 2016. Comparable in size to a large vitamin, Micra is less than one-tenth the size of traditional pacemakers yet delivers advanced pacing technology to patients via a minimally invasive approach. During the implant procedure, the device is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, Micra does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to leads and pockets are reduced, and there is no visible sign of the device. About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered inDublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary.

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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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HEALTH TECHNOLOGY

Stryker, One of the World’s Leading Medical Technology Companies, announces definitive agreement to acquire Vocera Communications

Stryker | January 07, 2022

Strykerannounced today a definitive merger agreement to acquire all of the issued and outstanding shares of common stock of Vocera Communications, Inc.for $79.25 per share, or a total equity value of approximately $2.97 billion and a total enterprise value of approximately $3.09 billion (including convertible notes). Vocera, which was founded in 2000, has emerged as a leading platform in the digital care coordination and communication category. The importance of this growing segment has continued to expand throughout the pandemic as it aims to reduce cognitive overload for caregivers and enables them to deliver the best patient care possible. Vocera brings a highly complementary and innovative portfolio to Stryker’s Medical division that will address the increasing need for hospitals to connect caregivers and disparate data-generating medical devices, which will help drive efficiencies and improve safety and outcomes. Vocera’s highly developed software competency, unique and innovative hardware solutions, and the ability to securely enable remote communication between patients and their families, complements Stryker's Advanced Digital Healthcare offerings. The combined business will further advance Stryker’s focus on preventing adverse events throughout the continuum of care. “This acquisition underscores our commitment and focus on our customer. Vocera will help Stryker significantly accelerate our digital aspirations to improve the lives of caregivers and patients.” Kevin Lobo, Chair and Chief Executive Officer, Stryker “Today’s milestone represents an exciting opportunity for Vocera given the clear alignment of mission, goals and culture between our two organizations and our ability to drive even greater economic and clinical value for our customers,” said Brent Lang, Chairman and Chief Executive Officer, Vocera. Under the terms of the merger agreement, Stryker will commence a tender offer for all outstanding shares of common stock of Vocera for $79.25 per share in cash. The boards of directors of both Stryker and Vocera have unanimously approved the transaction. The closing of the transaction is subject to expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, completion of the tender offer and other customary closing conditions. The acquisition is expected to close in the first quarter of 2022 and is expected to have a neutral impact to net earnings per diluted share in 2022. About Stryker Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. About Vocera The mission of Vocera Communications, Inc. is to improve the lives of healthcare professionals, patients, and families. Founded in 2000, Vocera provides clinical communication and workflow solutions that help protect and connect team members, increase operational efficiency, enhance quality of care and safety, and humanize the healthcare experience. More than 2,300 facilities worldwide, including nearly 1,900 hospitals and healthcare facilities, have selected Vocera solutions to enable their workforce to communicate and collaborate with co-workers and engage with patients and families. Mobile workers can choose the right device for their role or task, including smartphones or one of the company’s wearable communication devices, and use voice commands to easily reach people by name, role, or group. The hands-free Vocera Smartbadge was named to TIME’s list of the 100 Best Inventions of 2020. Vocera solutions can integrate with more than 150 clinical and operational systems, including electronic health records, nurse call systems, ventilators, physiological monitors, and more. In addition to healthcare, Vocera solutions are found in aged care facilities, veterinary hospitals, schools, luxury hotels, retail stores, power facilities, and more.

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