The 21st Century Cures Act (H.R. 34) is the most significant piece of health IT legislation passed by Congress since the Health Information Technology for Economic and Clinical Health (HITECH) Act became law in 2009. Although there has been some debate about whether the bill’s provisions will advance priorities like interoperability (for contrasting opinions, see here and here), its passage provides new opportunities for stakeholders to engage with the Department of Health and Human Services (HHS) on new regulations, recommendations, guidance documents and partnerships.
At Congress’s direction, HHS must consult a wide array of stakeholders on major new programs and initiatives. By design, it won’t just be the usual suspects. HHS is required to consult with non-traditional stakeholders like health IT investors, experts in health IT market economics, and experts in human factors engineering, among others, bringing a blend of fresh new perspectives to these issues.
Major opportunities for stakeholders created by the 21st Century Cures Act include:
- Strategy to Reduce Provider Burden: H.R. 34 requires HHS to undertake a public process to develop a strategy and recommendations for reducing regulatory and administrative burden relating to electronic health records (EHRs).
- Certification of EHRs: The 21st Century Cures Act requires HHS to modify the existing program for certifying EHR technology, to undertake a public process for selecting additional specialties and sites of service for the program, and to create a new program to certify EHRs for use in pediatrics.
- New EHR Reporting Program: One of the most significant EHR-related provisions in the bill requires HHS to develop a new reporting program for any developer seeking EHR certification. The new program – which would be run by HHS through a contractor or other independent entity – will be focused on gathering relevant information from developers, as well as other stakeholders, on topics like security, usability and user-centered design, interoperability, and conformance to certification testing. The terms of the program will be outlined in rulemaking, and will be updated over the years through the regulatory process.
- New Public-Private Exchange Network: Another substantial provision in the 21st Century Cures Act requires the HHS Secretary and other relevant federal agencies to convene public-private partnerships to build consensus, develop, and pilot a network for the trusted exchange of health information. HHS is also required to establish a process for organizations to voluntarily adopt the framework through regulation, and must publish a list of the health information networks that have adopted the common agreement.
- Standards Adoption: Starting in 5 years and every 3 years thereafter, HHS is required to convene stakeholders to review the existing health IT standards and specifications, and make recommendations with respect to which should be maintained or phased out.
- Definition of Information Blocking: Many provisions of the 21st Century Cures Act are aimed at addressing “information blocking.” The act defines “information blocking” and further states that the Secretary shall identify specific “reasonable and necessary” activities that do not constitute information blocking through rulemaking.
Information Blocking Reporting System: H.R. 34 requires HHS to implement a standardized process for the public to report instances of perceived information blocking.
- Clinical Data Registry Certification: Under the bill, certified EHRs must be able to transmit to and, where applicable, receive and accept data from clinician-led data registries. The legislation gives HHS the authority to use rulemaking to develop standards and criteria for certifying that clinical data registries have the technical capability to exchange data.
- Public-Private Partnerships for Patient Access: The 21st Century Cures Act directs HHS to encourage partnerships between health information exchange organizations and networks and health care providers, health plans, and other appropriate entities with the goal of offering patients access to their electronic health information.
Guidance on Trusted Exchange, Best Practices, and Patient Access: Finally, the bill includes several provisions requiring HHS to release guidance on discrete topics, including barriers that prevent the trusted exchange of electronic health information, best practices for health information exchange, and best practices for requesting personal health information in a computable format.
- Health IT Advisory Committee: H.R. 34 replaces the current Health IT Policy and Standards Committees with a new Health IT Advisory Committee charged with making recommendations to the Secretary. Although the practical reality is that the new Advisory Committee is likely to function similarly to its predecessors, pushing the “reset” button allows the opportunity to reshape the Committee’s priorities and agenda while also adding new people to the roster of members.
Making Your Voice Heard
The 21st Century Cures Act resets the health IT policy development process, and creates many new opportunities for the private sector to advance its priorities. Although public-private collaboration has become more common in recent years, stakeholders are often limited to tinkering around the edges of existing programs and/or policies. This legislation creates a rare opening to influence health IT policy from the ground up, to create new policies and programs out of whole cloth while working with new Administration leadership.
Over the next months and years, stakeholders should anticipate that requests for input will come through a variety of informal and formal mechanisms, including regulations, public meetings, guidance documents, blog posts, listening sessions and more. It will be critical to seize these opportunities early by setting an advocacy agenda and strategy that uses multiple levers to achieve results.