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Bipartisan Budget Act of 2018 Includes Significant Changes in Medicare, Other Federal Health Programs

On February 9, 2018 after a brief shutdown, Congress passed and President Trump signed the Bipartisan Budget Act of 2018, a two-year budget agreement that includes funding for the operation of the federal government until March 23, 2018. The law includes significant health care policy changes impacting Medicare, Medicaid and other federal health agencies. In addition to raising federal spending caps enacted in the Budget Control Act of 2011, this legislation includes additional spending for health care priorities. Here we break down some of the changes affecting telehealth. Expanded Access to Telehealth Stroke Services The new law expands, beginning in 2019, the ability of patients presenting with stroke symptoms at hospitals or mobile stroke units to receive a timely telehealth consultation with a neurologist in order to determine the best course of treatment. The provision eliminates the current geographic restriction that limits originating sites to rural...

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On the Digital Health Frontier: Developments Driving Industry Change in 2018

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. ...

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Digital Health Year in Review: 2017 Trends and Looking Ahead to 2018

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. Read the full Special Report.

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Surviving Disruption: A Roadmap for Health Care Governance

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. Get critical insights on how to spot, prepare for and manage disruption in your organization now: 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...

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Slow and Steady – CMS Expands Telehealth Reimbursement Opportunities in 2018

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...

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ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria

In September, the Office of the National Coordinator for Health Information Technology (ONC) announced that it is scaling back requirements for third-party certification of criteria related to certified electronic health record (EHR) technology (CEHRT). Going forward, ONC will allow health developers to self-declare their products’ conformance with 30 of the 55 certification criteria. ONC will also exercise discretion and not enforce the requirement that certification bodies conduct randomized surveillance of two percent of the health IT certifications they issue. Read “ONC’s De-Regulatory Announcement Aims at Enticing Industry to Adopt 2015 Edition Criteria.” Copyright 2017, American Health Lawyers Association, Washington, DC. Reprint permission granted.

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Next Generation of Patient Care: Balancing Digital Engagement with Patient and Consumer Privacy

Jennifer Geetter and Lisa Schmitz Mazur wrote this bylined article on the regulatory implications of technology-supported devices, resources, and solutions that facilitate health patient-provider interaction. "Health industry regulators are struggling with how to apply the existing privacy regulatory regime, and the permitted uses and disclosures for which they provide, in this new world of healthcare innovation," the authors wrote. Continue reading.

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Texas Changes its Tone on Telemedicine

As one of the last states to retain highly restrictive (and arguably anti-competitive) telemedicine practice standards, health care providers, regulatory boards, technology companies, payors and other stakeholders have been actively monitoring Texas’ approach to telemedicine regulation and the related Teladoc case. Texas has eliminated its most restrictive requirement for delivering care via telemedicine in Texas, increasing opportunities for providers to reach patients using technology.  Senate Bill 1107 was passed on May 11, 2017, and the House added an amendment in passing Senate Bill 1107, which was approved in the Senate on May 18.  The bill was signed into law by Governor Abbott last weekend. Read the full article.

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New York AG Settlement with App Developers Serves as a Warning for the Need for Evidence-Backed Commercial Claims

On March 23, 2017, the New York Attorney General’s office announced that it has settled with the developers of three mobile health (mHealth) applications (apps) for, among other things, alleged misleading commercial claims. This settlement highlights for mHealth app developers the importance of systematically gathering sufficient evidence to support their commercial claims. Read the full article.

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Digital Health Solutions are Key to Success under Health Care Payment Innovations

Digital health—the intersection of health care related software applications, analytical tools, medical device technology and electronic data assets that are enabled and achieved through the use of the internet and hand-held devices—is empowering the innovation needed to meet the imperative for a transition from payment based on volume to payment based on value that is evaluated in terms of measurable improvements in care delivery and population health. One prominent example is the use of digital health solutions to implement the payment innovation contemplated by the Medicare Access and CHIP Reauthorization Act (known as MACRA)—which directly ties both payment increases and reductions to various, specific efficiency and value measures. The Merit-Based Incentive Payment System (MIPS), one of the two available payment pathways under MACRA, assigns points to clinicians in different performance categories, several of which promote the adoption of digital health...

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