21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV - McDermott Will & Emery

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV


The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including provisions relating to health information technology (HIT) and related digital health initiatives. President Barack Obama has expressed support for the Cures legislation and is expected to sign the bill this month. This On the Subject summarizes the HIT and digital health tool provisions in title IV of the new legislation. Our continuing coverage of the 21st Century Cares Act addresses additional titles and provisions.

In Depth

On December 7, 2016, the US Congress approved the 21st Century Cures Act (Cures legislation), which is intended to accelerate the “discovery, development and delivery” of medical therapies by encouraging public and private biomedical research investment, facilitating innovation review and approval processes, and continuing to invest and modernize the delivery of health care. The massive bill, however, also served as a vehicle for a variety of other health-related measures, including provisions relating to health information technology (HIT) and related digital health initiatives. President Barack Obama has expressed support for the Cures legislation and is expected to sign the bill this month.

This On the Subject summarizes the HIT provisions in title IV of the new legislation. Other titles and provisions will be examined through other On the Subject articles.

Overview of the Health Information Technology Provisions in the Cures Legislation

The HIT provisions of the Cures legislation in general seek to

  • Reduce administrative and regulatory burdens associated with providers’ use of electronic health records (EHRs)
  • Advance interoperability
  • Promote standards for HIT
  • Curb information blocking
  • Improve patient care and access to health information in EHRs

Why These Provisions Matter

As public and private payers increasingly move from fee-for-service payments to value-based payment models, with a focus on maximizing health outcomes, population health improvement, and patient engagement, HIT—including EHRs and digital health tools—will be increasingly relied upon to collect clinical data, measure quality and cost effectiveness; assure continuity of care between patients and providers in different locations; and develop evidence-based clinical care guidelines. Further, newly implemented government programs like the Quality Payment Program will increasingly require clinicians and hospitals to use certified EHR technology (CEHRT) that meets certification guidelines specified by the Office of the National Coordinator for Health Information Technology (ONC) of the US Department of Health and Human Services (HHS). The continued evolution of these certification guidelines will also influence the development of digital health tools that are designed to interface or otherwise interact with CEHRT and assist providers to succeed under value-based payment models.

Congressman Tom Price (R-GA), a physician and a strong advocate for reducing burdens associated with the use of EHRs by providers, has been nominated to serve as HHS secretary in the administration of President-elect Donald Trump. Should Congressman Price be confirmed by the Senate, industry can likely expect HHS to use the new authority provided to it under the Cures legislation to reduce requirements of the Meaningful Use and Advancing Care Information programs, electronic clinical quality measure reporting requirements and other federal requirements relating to HIT that are perceived to make providers less efficient without improving quality or reducing costs. The new HHS secretary, however, will face competing pressures to leverage the expansion of HIT adoption and quality measure reporting to incentivize high-quality care at lower Medicare program costs.

What Is Required by These Cures Legislation Provisions

Reduction of Burdens ‒ In response to clinician and hospital concerns about the regulatory and administrative burdens associated with EHR technology

  • The HHS secretary is required within one year of enactment to develop with public comment from providers, suppliers, payers, technology developers and others a strategy and recommendations to reduce regulatory or administrative burdens related to the use of EHRs; this strategy must prioritize the Medicare and Medicaid EHR Incentive Programs, HIT certification, the Merit-based Incentive Payment System, the Hospital Value-Based Purchasing Program, Alternative Payment Models, and other value-based payment programs that the HHS secretary determines are appropriate;
  • Physicians may delegate EHR documentation requirements to unlicensed assistants, or “scribes” (to the extent permitted by state law), provided the physician signs and verifies the documentation;
  • The HHS secretary must encourage, keep or recognize voluntary certification of HIT for use in sites of services and medical specialties for which no certified technology is currently available, with the goal of making EHR certification more relevant and useful for those who use such EHRs.
  • The HHS secretary must report to the new HIT Advisory Committee statistics on attestation of Meaningful Use under the Medicare and Medicaid EHR Incentive Programs to assist in informing standards adoption and related practices. The statistics must include, to the extent practicable, the number of providers who did not meet the minimum criteria necessary to attest, and must be made publically available on the HHS website;
  • Authorizes $15 million to award grants, contracts or agreements to independent entities on a competitive basis to develop a required CEHRT reporting system to address provider concerns that CEHRT technology does not always work as intended. As a condition of certification and attestation, CEHRT would be required to report measures developed by the independent entity on attributes that include
    • Security
    • User-centered design
    • Interoperability
    • Testing in real-world conditions

This provision aims to create an unbiased reporting system on EHR product usability, interoperability and security to assist providers in choosing product. This reporting system replaces a proposed “Star Rating” plan for EHR technology found in an earlier version of the legislation.

Advancement of Interoperability ‒ In response to lawmakers’ and stakeholders’ concerns that while the Health Information Technology for Economic and Clinical Health Act (HITECH) increased the adoption by clinicians and hospitals of electronic health records, it did not sufficiently move the national needle on interoperability, the Cures legislation seeks to advance interoperability through

  • Creating a definition for “interoperability” as HIT that
    • Enables the secure exchange of electronic health information with, and use of electronic health information from, other HIT without special effort on the part of the user
    • Allows for complete access, exchange and use of all electronically accessible health information for authorized use under applicable state or federal law
    • Does not constitute information blocking as defined in the Cures legislation
  • Replacing the HIT Policy and Standards Committees with a new HIT Advisory Committee. This new committee will consist of at least 25 members, eight of whom shall be appointed by Congress, three appointed by the HHS secretary and the remainder appointed by the comptroller general of the US Government Accountability Office (GAO). Specific health sectors must be represented on the committee. This new federal advisory committee will address, in general, issues related to interoperability and privacy and security of health information and will also engage stakeholders to identify priorities for standards adoption. The Cures legislation provides additional direction on priority target areas on which the committee shall make recommendations. These directives are highly similar to those provided to the predecessor HIT Policy and Standards Committee in HITECH. This reiteration of areas for consideration likely signals that lawmakers believe that many of the objectives set forth in HITECH have not yet been fully achieved.One new priority area is patient matching, which relates to the unfulfilled directive to further interoperability between EHR systems. Specifically, the Cures legislation requires the new HIT Advisory Committee to make recommendations for “technology that provides accurate patient information for the correct patient, including exchanging such information, and avoids the duplication of patient records.” This directive and the call for a GAO study on patient matching indicates that policy makers recognize the importance of accurately identifying patients for electronic exchange of health information among providers in different organization and locations as well as for patient safety.
  • Tasking ONC to create a process by which the public could submit complaints that HIT products or developers are not interoperable or engage in information blocking.
  • Directing ONC to, within six months of enactment, convene stakeholders to develop or support (within 12 months of convening) a trusted exchange framework for trust policies and practices and for a common agreement for exchange between health information networks. ONC and the National Institute of Standards and Technology are to provide technical assistance on developing this trusted exchange framework and common agreement. A process will be established through rulemaking by which health information networks may voluntarily adopt the framework and common agreement. Federal agencies may by contracting or entering into agreements with health information exchange networks that require such networks to adopt the trusted exchange framework and common agreement.

Promotion of Standards – Lawmakers have increasingly recognized that stronger leadership is needed to ensure the consistent implementation and use of common standards. Accordingly, the Cures legislation requires the ONC to, not later than six months after the date on which the HIT Advisory Committee first meets, convene the HIT Advisory Committee to

  • Enhance the use of common standards with deference given to standards published by private standards development organizations and voluntary consensus-based standards bodies.
  • Identify priority use cases for HIT, focusing on use cases relating to
    • The implementation of Medicare’s EHR Incentive Program, the Merit-based Incentive Payment System, Alternative Payment Models, the Hospital Value-Based Purchasing Program and any other value-based payment program determined appropriate by the HHS secretary
    • Quality of patient care
    • Public health
    • Clinical research
    • Privacy and security of electronic health information
    • Innovation in the field of HIT
    • Patient safety
    • Usability of health information technology
    • Individuals’ access to electronic health information
  • Identify existing standards and implementation specifications that support such use cases.
  • Publish a report summarizing the findings of the analysis and make appropriate recommendations.
  • Evaluate the need for a core set of common data elements and associate value sets to enhance the ability of CEHRT to capture, use and exchange structured electronic health information.

Starting five years after the enactment of the Cures legislation, and every three years thereafter, the ONC must convene stakeholders to review the existing set of adopted standards and implementation specifications and make recommendations for maintaining or phasing out such standards and implementation specifications.

Combating Information Blocking The Cures legislation builds on the April 2015 ONC Report to Congress on Health Information Blocking and the voluntary ONC interoperability pledges signed earlier this year by companies that provide at least 90 percent of EHRs used by hospitals, and takes even stronger steps to combat information blocking by

  • Defining “information blocking” as a practice, except as required by law or allowed by the HHS secretary pursuant to rulemaking, that
    • Is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information
    • If conducted by an HIT developer, exchange or network, such entity knows or should know that such practice is likely to interfere with, prevent or materially discourage the access, exchange or use of electronic health information
    • If conducted by a health care provider, such provider knows that such practice is unreasonable and is likely to interfere with, prevent or materially discourage access, exchange or use of electronic health information
  • Establishing that information blocking practices may include
    • Practices that restrict authorized access, exchange or use of such information for treatment and other permitted purposes under such applicable law, including transitions between certified HIT systems
    • Implementing HIT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging or using electronic health information
    • Implementing HIT in ways that are likely to
      • Restrict access, exchange or use of electronic health information with respect to exporting complete information sets or in transitioning between HIT systems
      • Lead to fraud, waste or abuse, or impede innovations and advancements in health information access, exchange and use, including care delivery enabled by HIT
  • Establishing new civil monetary penalties of up to $1 million per information blocking violation, including false attestations, that would be applicable to HIT developers, health information exchanges and networks. In contrast, provider penalties will be determined through notice and comment rulemaking. Importantly, for enforcement purposes, information blocking does not include any practice or conduct occurring prior to the date that is 30 days after enactment

Improving Patient Care and Improving Patient Access to Their Health Information in EHRs

  • Requires the GAO to conduct two studies
    • A study on patient matching within two years of enactment. In calling for this study, lawmakers recognize that, with the increasing use of EHRs and the push toward interoperability, identifying accurately a single individual represented in multiple databases of different provider, payer and clearinghouse organizations is increasingly important for facilitating health information exchange and ensuring patient safety
    • A study on patient access to their own health information, including barriers to patient access
  • Enables developers of HIT to participate in discussions with patient safety organizations without fear of liability risk in order to help improve the safety of HIT products for patients. Within four years after the date of enactment, the HHS secretary must submit to Congress a report concerning the best practices and current trends voluntarily provided, without identifying individual providers or developers
  • Requires CEHRT to be capable of transmitting data to, and receiving data from clinician-led clinical data registries

Action Steps for Providers and Developers of HIT and Digital Tools

Providers and Developers of HIT and Digital Tools Should

  • Review the definition of information blocking and take measures necessary to avoid engaging in practices that may constitute information blocking as defined in the new statute.
  • Review applicable state laws that permit physician delegation to scribes to determine if the new federal flexibility applies.
  • Assess potential interest in seeking representation on the new HIT Advisory Committee, either directly or through an association or other group (note that it is unclear how quickly after enactment ONC will form the HIT Advisory Committee, as a timeline for the transition from the HIT Policy Committee and the HIT Standards Committee to the new HIT Advisory Committee is not specified).
  • Assess their implementation of HIT standards to determine the extent to which different standards and inconsistent implementation of the same standards may be prevalent.
  • Be aware that changes to existing government requirements relating to EHRs are likely forthcoming.

Providers Should

  • Assess their unique regulatory environment to provide input on the forthcoming HHS efforts to reduce regulatory burdens.
  • Determine whether their sites of service or specialties would benefit from CEHRT certified to meet their sites’ or specialties’ unique needs.

Developers of HIT and Digital Tools Should

  • Consider participating in stakeholder outreach efforts to advise ONC on
    • The establishment of a trusted exchange framework and common agreement
    • Criteria and measures for the new CEHRT reporting system
    • The HIT Advisory Committee’s review of the existing set of adopted standards and implementation specifications every three years
  • Adapt HIT development and testing strategies based on the criteria and measures established by the independent entity selected by ONC.
  • Consider opportunities to partner with clinician-led organizations or professional societies to develop clinician-led clinical data registries.
  • Keep abreast of new HIT requirements to inform the development of digital tools.
  • Evaluate how best to work with patient safety organizations to promote shared learning to improve HIT safety now that privilege and confidentiality protection has been extended to HIT developers.