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Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review.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 Comments on the draft guidance are due on March 18, 2019.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

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.

Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients.

In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of the interoperable application programming interface (API) standard Fast Healthcare Interoperability Resources (FHIR). CMS encourages Medicare Advantage plans to adopt “data release platforms” that either meet or exceed the capabilities of Blue Button 2.0, and makes it clear that the agency intends to pursue rulemaking requiring such adoption for 2020.

The FHIR standard is also discussed, although not required, in the 2015 Edition Health IT Certification Criteria for API access, regulations promulgated by the Office of the National Coordinator for Health IT (ONC) that set the rules for functionality and interoperability of electronic health record systems. It seems likely that ONC further promote FHIR for API-based patient access in their upcoming rulemaking updating the certification program, expected this summer.

This move from CMS arrives alongside increased Congressional interest in patient access to information about the cost of healthcare services. This includes a recent Senate price transparency initiative led by Senator Bill Cassidy. Almost 1000 pages of feedback have already been received by Senate staffers, describing why and how payers and providers can make healthcare price and cost information more accessible for individual patients.

Health plans that wish to get ahead of the future regulatory action can check out the developer resources for Blue Button 2.0 to see how CMS envisions API access working for payer data. Plans can also participate in an ongoing ONC Tech Lab project to learn more about on how these standard resources can be used for health plan-specific information and influence standards development.

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

This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers. It also provides guidance on FDA’s interpretation of new software provisions in Section 3060 of the 21st Century Cures Act.

Given the explosion of these innovative digital health tools and their strong potential to transform healthcare, this guidance is a significant development for tech companies and investors focusing on this space. Comments will be accepted for 60 days. Continue Reading FDA Issues New Guidance for Clinical and Patient Decision Support Software

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

The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information safely and effectively.

For device manufacturers, this guidance provides clarity on how the FDA is thinking about interoperability and patient safety in the premarket submission process and provides considerations for manufacturers in the development and design of interoperability medical devices. It demonstrates the FDA’s focus on the safety and effectiveness of devices as implemented in an interconnected environment and the expectations of FDA on manufactures to anticipate and design for anticipated uses and reasonably foreseeable misuses. Manufactures should consider this guidance in the design, development, and on-going monitoring of connected medical devices.

This guidance may be helpful for other audiences as well:

  • Care providers that frequently interact with medical devices in the course of patient care
  • Hospital IT teams who make device purchasing decisions
  • Vendors of health technologies that frequently exchange data with medical devices

Continue Reading Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices