On January 30, Attorney General Jeff Sessions announced a surge of Drug Enforcement Administration (DEA) agents and investigators over the coming month and a half, focused on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of opioid drugs. The DEA will examine distribution and inventory data reported to the DEA by prescription drug manufacturers and distributors for “patterns” and “outliers” for further investigation.
As digital health innovation continues to move at light speed, both new and incumbent stakeholders find themselves on a new frontier—one that challenges traditional health care delivery and payment frameworks, in addition to changing the landscape for product research, development and commercialization. Modernization of the existing legal framework has not kept pace with the rate of digital health innovation, leaving no shortage of obstacles, misalignment and ambiguity for those in the wake.
What did we learn in 2017 and what’s to come on the digital health frontier in the year ahead? From advances and investments in artificial intelligence (AI) and machine learning (ML) to the increasingly complex conversion of health care innovation and policy, McDermott’s Digital Health Year in Review details the key developments that shaped digital health in 2017, along with planning considerations and predictions for the health care and life science industries in 2018. Continue Reading On the Digital Health Frontier: Developments Driving Industry Change in 2018
Stephen Bernstein, global chair of McDermott’s Health Industry Advisory Practice Group, sat down with This Week in Health Innovation at the J.P. Morgan Healthcare Conference in San Francisco.
Stephen and Dr. Andre Berger, CEO of National ACO, discussed the role of advancing technologies in enhancing collaboration between key players in digital health—including doctors, heath plans, investors, and consumers and patients—and how digital health is necessary for improving care delivery and managing costs.
Throughout 2017, the health care and life sciences industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and payment as well as product research, development and commercialization for both long-standing and new stakeholders. At the same time, lawmakers and regulators made meaningful progress toward modernizing the existing legal framework in a way that will both adequately protect patients and consumers and support and encourage continued innovation, but their efforts have not kept pace with what has become the light speed of innovation. As a result, some obstacles, misalignment and ambiguity remain.
We are pleased to bring you this review of key developments that shaped digital health in 2017, along with planning considerations and predictions for the digital health frontier in the year ahead.
Blockchain is rapidly becoming the focus of conversations regarding health care disruption, and for good reason. What started out as a means for cryptocurrency is now making waves in a variety of industries, set to revolutionize how data is stored and shared.
The inability to easily and securely store and share data has long been a burden on the health system. Blockchain poses a solution to that through encryption and highly advanced technological assets which open the doors to health care innovation. Today we see blockchain being used with electronic health records (EHRs) so that a patient’s medical history is easily accessible to him/her, as well as his/her doctors, insurance providers, etc. It’s also providing the “how” in implementing value-based payment agreements, which link payment to performance of a drug or medical device. Blockchain is currently being used both in the private and public sectors, including the FDA and the CDC. While the full potential of this new technology is not yet known, the industry seems eager to find out.
Ahead of this year’s J.P. Morgan Healthcare Conference, we sat down with Lee Schneider, our top blockchain thought leader, to talk specifically about how this new technology is revolutionizing (or has the potential to revolutionize) the health care space. Continue Reading Blockchain: Health Care’s Next Great Disruptor?
As the Federal Communications Commission repeals the Open Internet Order—more commonly known as the net-neutrality rules—health care consumers and providers have been left wondering how this change will affect their ability to receive and deliver health care using digital health tools. In this On the Subject, we outline how changes in internet access will affect digital health and what the regulatory landscape will look like in the coming months and years.
China’s new data protection framework clearly creates a requirement for local storage and conducting a security assessment before personal information or important data is shared with other jurisdictions, but it is currently much less clear what types of entities fall under this requirement.
Localization and Transfer Assessment Requirements Related to CII Operators
Under the People’s Republic of China Network Security Law, also known as the Cybersecurity Law, personal information and important data collected and generated in the operation of critical information infrastructure operators (CII operators) is required to be stored in China and, before providing that information abroad, a security assessment is required to be passed. This new requirement caused a significant amount of concern for entities that fall within the category of CII operators because of the need to potentially restructure their data systems, but there was also a general appearance of acceptance within the business community due to the relatively targeted scope of the definition of CII operators and acknowledgement that critical infrastructures require elevated protections. Continue Reading Transferring Data from China: Who Must First Pass a Pre-Export Security Assessment?
Disruption of traditional health care is inevitable and poses a central challenge for health care governance. While the size and complexity of the health care industry have slowed the process of business disruption, its high costs and lack of convenience make it highly vulnerable to innovative, nontraditional competitors.
To make sure boards are well-prepared to address this challenge, McDermott Will & Emery and Kaufman Hall have partnered on a new thought leadership series designed to help you identify the signs of disruption, learn how to prepare your organization, and understand the implications for health care governance.
- Listen to Surviving Disruption Podcast, Episode 1: The Signs of Disruption.
- Download Is Your Organization Disruption Ready? Questions to Assess Preparedness.
- View our Top 5 Business Disruption Considerations for Corporate Governance infographic.
- Watch our Behind the Scenes: The Making of the Surviving Disruption Podcast Series video.
Subscribe to the Surviving Disruption podcast on iTunes, SoundCloud and Pocket Casts, and keep an eye on the Resource Center for Episode 2: The Path Through Disruption and Episode 3: A Governance Foundation, being released on December 27 and January 10.
The Centers for Medicare & Medicaid Services (CMS) reiterated its commitments to expanding access to telehealth services and paying “appropriately” for services that maximize technology in the Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program Final Rule published on November 15, 2017 (the Final Rule). Among many other developments, the Final Rule expands allowable telehealth reimbursement under the calendar year (CY) 2018 Physician Fee Schedule, List of Medicare Telehealth Services (list) and permits virtual sessions in certain circumstances under the Medicare Diabetes Prevention Program Expanded Model (MDPP, or the Program). The regulations are effective January 1, 2018.
“New” and “Add-On” Telehealth Services Slated for Reimbursement
CMS evaluates requests for the addition of telehealth services on the basis of two categories: (1) services that are similar to services already on the list and (2) services that are not similar to services already on the list. An evaluation of a category (2) service requires CMS to assess, based on the submission of evidence, whether the use of a telecommunications system to furnish the service “produces demonstrated clinical benefit to the patient.” Continue Reading Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018
Although the Illinois Biometric Information Privacy Act has been on the books for almost 10 years, a recent surge in lawsuits has likely been brought on by developments in biometric scanning technology and its increased use in the workplace. At least 32 class action lawsuits have been filed in recent months by Illinois residents in state court challenging the collection, use and storage of biometric data by companies in the state. This could potentially cause a reevaluation of company strategies and development of new defenses in the use of advancing biometric technology.