Next week, on June 21, 2018, attorneys from Crowell & Moring will hold a bootcamp entitled “Early Stage Investing in Health Technology.” Crowell & Moring attorneys will present on topics of interest to entrepreneurs, investors, and early stage health technology companies. Attendees will have the opportunity to learn about a range of matters including formation
Digital Health
Transforming the Patient-Provider Relationship: A Comprehensive Approach to Patient Access and Patient-Generated Health Data
This blog post has been prepared in collaboration with Validic. Mr. Schiller is CEO of Validic. Jodi Daniel is a partner in Crowell & Moring’s Health Care Group in Washington, D.C.
Our healthcare system is in the midst of a fundamental shift toward value-based care to drive down costs and improve the quality of care. We won’t be able to achieve that goal without technology that allows providers to collect and use health data and puts patients front and center. Patient access to clinical and claims data is essential. When patients have access to their own information, they can better understand their condition and feel empowered to ask questions and shape their own care plan.
Congress and the federal government are pushing to liberate data from within the healthcare system and to promote patient access to health information. However, it is equally important to focus on the flow of data from the patient back into the healthcare system. The patient – who is gathering data at home, managing her condition, and making day-to-day decisions that impact her health – holds information that is critical to treatment decisions and outcome improvements.
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FDA’s Medical Device Safety Action Plan
On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market.
The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations for third-party certification for developing medical devices. This comes as FDA is pushing guidance and innovative approaches for oversight of digital health (see our blog).
According to FDA Commissioner Scott Gottlieb’s announcement, the FDA’s plan organized into five points that seek to balance patients’ timely access to devices and safety and effectiveness.
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FDA Advances Flexibility-Based Framework for Digital Health and AI
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation.
During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and outlined how the agency is committed to moving the ball forward in health care innovation through the following initiatives:
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Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency
On March 6, 2018 at the Healthcare Information and Management Systems Society (HIMSS) 2018 conference, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma announced a new initiative furthering the current Administration’s focus on value-based care and increasing patient access to healthcare data. The initiative — called MyHealthEData — will be led by the White House Office of American Innovation, in collaboration with the Department of Health and Human Services (HHS), CMS, the Office of the National Coordinator for Health Information Technology (ONC), the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA). (CMS press release here.)
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New Reimbursement for Remote Patient Monitoring and Telemedicine
CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and can positively affect the business model for technology developers and innovators.
What are these new rules and do they affect me?
The 2018 Quality Payment Program Final Rule provides policy updates to the Quality Payment Program (QPP), which was established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) and will be entering its second year. MACRA offers two “tracks” for eligible clinicians to take as they move toward value-based care:
- Participation in QPP and its scoring, or
- Participation in an Advanced Alternative Payment Model (APM).
The majority of Medicare payments are still tied to fee-for-service, but HHS has set a goal of moving to 50 percent of Medicare payments for alternative payment models by 2018. For previous coverage of QPP proposals, visit our summary here.
The 2018 Physician Fee Schedule Final Rule addresses revised payment policies for the Medicare physician fee schedule. Any provisions in the PFS rule typically apply to fee-for-service type providers.
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Congress Remains Focused on Electronic Health Records
Congress is considering several adjustments to health IT policy which may have significant impact on the Centers for Medicare and Medicaid Services’ (“CMS”) electronic health records (“EHR”) incentives. On July 20th and 21st, Representatives met to discuss bipartisan legislation to improve the Meaningful Use program and introduced legislation that would authorize a CMS Innovation Center (“CMMI”) project to incentivize EHR adoption by behavioral health providers. The bills may be indicative of Congress’ attitude towards the Meaningful Use program, which has garnered criticism from providers for being burdensome.
On July 21, 2017, the House Committee on Energy and Commerce Subcommittee on Health held a hearing on H.R. 3120 and featured testimony from Cletis Earle, Chairman-Elect of the College of Healthcare Information Management Executives. The bill, sponsored by a group of bipartisan lawmakers, will allow CMS to modify the requirements of the Meaningful Use program in order to give the Secretary additional flexibility in implementing the program. Currently, providers and vendors must comply with the Stage 3 measures and objectives of the Meaningful Use program starting January 1, 2018 or be subject to Medicare reimbursement penalties. Earle argued that the implementation timeline for Stage 3 of the program is too rigorous for providers to meet and may lead to an increase in hardship exemption applications. Provider and vendor groups across the industry have suggested that the HHS Secretary Tom Price delay the Stage 3 obligations, noting that software implementation and cybersecurity issues have made the 2018 deadline unreasonable. Sponsors of H.R. 3120 note that the bill will reduce the burden on providers’ use of EHR systems, allowing providers to focus on care coordination and patient outcomes. In response, CMS noted that the proposed “Medicare Program; CY 2018 Updates to the Quality Payment Program,” which is open for comment through August 21, 2017, would give eligible providers an additional year to implement EHR technology that complies with the 2014 or 2015 edition of Certified Electronic Health Record Technology (“CEHRT”) and offers the opportunity to apply for hardship exemptions for the Advancing Care Information performance category of the Merit-based Incentive Payment System (“MIPS”). For more information, see our update on key proposals of the 2018 Proposed Rule here.
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ONC Releases New Guidance on Electronic Health Record Vendor Contracting
On September 26, 2016, the Office of the National Coordinator for Health Information Technology (ONC) released guidance, entitled EHR Contracts Untangled, to help providers navigate the complexities of electronic health record (EHR) vendor contracting. The guidance breaks down important considerations for selecting EHR systems, and provides strategic pointers – including sample contract language…
FDA Finalizes Guidance on Low Risk “General Wellness Products”
In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.” This guidance, which is largely unchanged from the draft guidance issued in January…
Digital Health, Big Data, Cybersecurity, and Privacy – Four Key Takeaways from C&M’s Digital Health Strategies Conference
In late June, Crowell & Moring partnered with Accenture to host a comprehensive one-day conference on legal issues affecting the digital health landscape. The program covered a wide range of topics, some of which you can read more about via the following links: Developing Digital Health Platforms; the Health Care Economy’s Internet of Things; and New Payment Models and Data. More information on the June 23rd “Fostering Innovative Digital Health Strategies Conference” can be found on Crowell.com.
One session touched upon privacy and cybersecurity issues regarding the usage of products and data in the digital health realm. This panel was moderated by Fauzia Zaman-Malik, Accenture’s Global Legal Lead for Health Industry Offerings and North America Legal Lead for Health and Public Services Operating Group; and featured Evan Wolff, partner at Crowell & Moring; Cora Han, FTC senior attorney, Division of Privacy and Identity Protection; and Hilary Weckstein, chief privacy officer at Inovalon, Inc.
This panel focused on methods and benefits of de-identification, HIPAA requirements, the FTC’s role in regulating big data and digital health technologies, and data breach preparation and response. Keep reading for four key takeaways from this session; the full panel session can also be accessed by video at this link.Continue Reading Digital Health, Big Data, Cybersecurity, and Privacy – Four Key Takeaways from C&M’s Digital Health Strategies Conference