By DAN ORENSTEIN

On December 7, 2016, the United States Senate approved the 21st Century Cures Act by an overwhelming margin. Having already passed the House with similarly broad bipartisan support, it now goes to President Obama for signature. Several years in the making, the Cures Act is broad and sweeping legislation that covers many topics, mostly on streamlining and accelerating the discovery of new drugs and medical devices. It includes provisions to improve mental health and substance abuse treatment, and to improve patient access to new therapies, among many other areas covered by the Act.

The Act also includes several provisions that will help accelerate the work of health information technology (HIT) companies and providers working to use healthcare data and information to improve outcomes, reduce variations in care, and better coordinate care delivery. These provisions establish programs and oversight to promote health information interoperability and prohibit information blocking practices.

The Cures Act Promotes and Prioritizes Health Information Interoperability

The Act promotes health information interoperability. “Interoperability” is defined in the Act as HIT that:

1. Enables the secure exchange of electronic information with, and use of electronic health information from, other HIT without special effort on the part of the user,
2. Allows for complete access, exchange, and use of all electronically accessible information for authorized use under applicable State or Federal law, and
3. Does not constitute information blocking.

The Act requires the National Coordinator for HIT, in collaboration with other federal agencies, to convene public-private and public-public groups to develop or support a “trusted exchange framework” which is expected to facilitate the exchange of health information nationally and locally. A “common agreement” will be developed to enable participation in the trusted exchange framework, and a national provider contact information directory will be developed.

The Cures Act Prohibits Information Blocking Practices—with Fines up to $1,000,000

Information blocking practices are prohibited by the Act. “Information blocking” is defined as any practice that, except as required by law or specified by the Secretary of HHS, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information, and:

1. If conducted by a HIT developer, exchange, or network, they know or should know that such practice is likely to interfere with, prevent, or materially discourage the access, exchange, or use of electronic health information.

2. If conducted by a provider, the provider knows that such practice is unreasonable and likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.

The Act gives several examples of prohibited practices:

1. Implementing HIT in ways that are likely to restrict the access, exchange, or use of electronic health information with respect to exporting complete information sets or in transitioning between HIT systems; and
2. Implementing HIT in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using electronic health information.

The Secretary is required to adopt regulations to implement these provisions, including establishing exceptions for practices that do not constitute information blocking. The HHS Office of the Inspector General (OIG) is given authority to investigate and impose penalties on those engaged in information blocking practices. Penalties may include fines up to $1,000,000 per violation.

The Office of the National Coordinator for HIT is responsible for developing a process to allow the submission of information about HIT products or developers that are not interoperable or engage in information blocking practices.

A New HIT Advisory Committee—And New Priorities for HIT Exchange

A new federal advisory committee known as the HIT Advisory Committee will be formed to advise on implementing the HIT provisions of the Act. The HIT Advisory Committee consolidates and replaces the existing HIT Policy Committee and HIT Standards Committee. Among other responsibilities, the HIT Advisory Committee will recommend standards and implementation specifications to enable national HIT exchange. HIT Advisory Committee priorities for HIT exchange include: accurate patient matching, privacy and security, patient access, promoting care coordination, improving continuity of care, reducing medical errors, and managing chronic conditions.

After the Most Significant Federal HIT Legislation in Years, What’s Next?

The Cures Act is groundbreaking in promoting interoperability and prohibiting information blocking practices. But in many ways, it is just a beginning. Now the real work begins, as policies and regulations are developed to implement the legislation. The public, including providers and HIT companies, will have an opportunity to contribute comments and suggestions as implementing regulations are developed.

The partnerships that the National Coordinator is required to convene, and the emerging exchange framework, will have a critical impact on providers’ ability to access and leverage clinical, financial, and operational data to improve outcomes. As these efforts proceed, Health Catalyst expects to provide additional information on ways to participate to ensure that these efforts move in a productive direction. For example, the HIT Advisory Committee will be required to hold open public meetings and to solicit public comments on its policy recommendations.

“See something, say something.” The OIG’s enforcement process will be report and complaint based. If information blocking practices are not called out, the OIG will be unable to investigate the blocking practices. The process for providing feedback to the OIG will be made clearer once regulations are adopted.

Finally, as HHS develops the regulatory exceptions to information blocking, it may be useful to help influence the development of these regulations to ensure that some of the common information blocking practices are not granted exception status.

The Cures Act is the most significant federal legislation in years to promote interoperability and the free exchange of health information. This open information exchange will help improve healthcare and care coordination. It is important to seize this opportunity by working to help make Cures a success and promoting the positive change that it has started.