CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.

Virtual Check-Ins

CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.” Continue Reading Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes.

The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides a framework for healthcare delivery organizations to use in preparing for and responding to cybersecurity threats against patient medical devices.

Given rapid changes in technology and increasing innovation in the digital health market, the guidance intends to decrease the risk of cyberattacks that could render medical devices inoperable and potentially harm patients. Comments on the draft guidance are due on March 18, 2019. Continue Reading FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices

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 of a start-up, protection of intellectual property, FDA and product safety requirements, and how to commercialize a product through government and commercial reimbursement. Specifically, the bootcamp will feature the following presentations:

  • Building an Investible Health Tech Company;
  • IP Basics for Health Tech;
  • Navigating The Existing Regulatory and Product Safety Landscape In A New Digital World;
  • Healthcare Reimbursement:  Commercialization Strategies and Approaches; and
  • Adding Value: Managed Care Contracting Issues.

The bootcamp is a co-sponsored event with the Inova Center for Personalized Health (“ICPH”). Following the bootcamp, there will be a networking reception and panel presentation on the State of Heathcare Investing. For more information, contact a participant listed below or your regular Crowell & Moring contact.

Crowell & Moring Participants:

A. Xavier Baker

Troy A. Barsky

Lex Eley

Michael H. Jacobs

Lisa A. Adelson

Rebecca Baden Chaney

Joe Records

Roma Sharma

Maya Uppaluru

Chalana N. Williams

Danielle Winston

 

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. Continue Reading Transforming the Patient-Provider Relationship: A Comprehensive Approach to Patient Access and Patient-Generated Health Data

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. Continue Reading FDA’s Medical Device Safety Action Plan

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:

  1. Multi-Function Device Draft Guidance. FDA’s new draft guidance, “Multiple Function Device Products: Policy and Considerations,” explains the FDA’s regulatory approach to multi-function digital health devices—where some functionalities fall under the FDA’s definition of a medical device, and other functionalities do not. The guidance, mandated by the 21st Century Cures Act, provides examples in which the FDA will review certain functional software capabilities in a medical device. Consistent with previous guidance and risk-based frameworks from the FDA, the agency’s enforcement focus will be on medical device functions that diagnose and treat patients. For example, data analysis will be considered a device function for which the FDA would enforce compliance, but data tracking and trending will not.
  2. Software Precertification Pilot Program Expansion and “Pre-Cert 1.0” Roll-Out. Gottlieb outlined three updates to the Software Pre-Cert Pilot Program, originally announced last Fall. The FDA will hold a “user session” on May 10, 2018 to discuss the agency’s general progress on the pilot program, and to conduct an in-depth discussion of the three updates:
    • Draft Working Model – An initial framework and vision which outlines the program’s key components: Excellence Appraisal and Determining Precertification Level, Review Pathway Determination, Streamlined Premarket Review Process, and Monitoring Real-world Performance.
    • Challenge Questions – Key questions about various components of the Pre-Cert program for stakeholders to consider with regard to the areas outlined in the Draft Working Model.
    • Roadmap – An overview of the program’s milestones and timeline toward launching the first version of the program (“PreCert 1.0”).
  3. Expansion of Digital Health Tools for Drug Development. The FDA announced its intention to establish clear policies for integrating the review and validation of digital health tools into drug development programs. The FDA will publish a policy framework, through new guidance, and seek public input on the best practices to incorporate software intended for use with prescription drugs.
  4. Precertification Approach to Artificial Intelligence (AI). Gottlieb recognized the novel role that AI and machine learning can have on the medical device submission process (obviating the need to make multiple submissions) and new software validation tools. Gottlieb also discussed “employing the Pre-Cert approach to AI.” This suggests the FDA’s interest in a more effective approach to regulation of medical devices that use AI. This announcement expands upon the FDA’s brief mention of regulatory oversight of devices using “proprietary algorithms,” included in December’s Draft Clinical Decision Support and Patient Decision Support Guidance. (See our prior blog post analyzing the guidance.)
  5. Premarket Digital Safety Program Launch. Gottlieb announced the creation of a Premarket Digital Safety Program, which would allow for electronic submissions of premarket safety reports for an Investigational New Drug Application.
  6. Information Exchange and Data Transformation Incubator. Gottlieb announced the agency’s new digital health/technology incubator, to be known as the Information Exchange and Data Transformation (INFORMED). The incubator will initially be launched in the cancer context, with fellowship collaborations between the FDA and the National Cancer Institute, as well as with Harvard on AI and machine learning. Crowell & Moring’s Digital Health team is ready to assist with the submission of industry input, as well as strategic counseling on these issues.

The various initiatives, guidance, and calls for industry input reflect the FDA’s quest to be flexible in the face of digital health opportunity and innovation. Not only will the FDA’s newest initiatives support its quest to advance safe, patient-centered care, but these initiatives will provide the regulatory predictability critical to encouraging business investment in innovative technologies and products.

Crowell & Moring’s Digital Health team is ready to assist with the submission of industry input, as well as strategic counseling on these issues.

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.) Continue Reading Liberating Data to Transform Value-Based Care: MyHealthEData, Blue Button 2.0, and Price Transparency

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. Continue Reading New Reimbursement for Remote Patient Monitoring and Telemedicine

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. Continue Reading Congress Remains Focused on Electronic Health Records

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 – to help facilitate the contracting process. While the guidance is largely an attempt to level the playing field for providers in the EHR arena, it also has broader applicability to contract negotiations for a variety of other digital health tools.

For the most critical “need-to-know” points from ONC’s new guidance, see our recent client alert.