Biden 2023 Budget Proposes Advisory Opinions for Information Blocking

In the 2023 budget proposal, the Biden-Harris Administration has requested that Congress provide HHS with the authority to issue a binding advisory opinion for information blocking regulations, ONC explained in a recent HealthITBuzz blog post.

Every spring, the president’s fiscal year (FY) budget proposals are released, by which the executive branch and legislative branch make informed decisions about national needs and priorities.

In some cases, when the Administration determines that additional or new authority is needed, the President’s budget also includes these requests.

“As we look towards the future, we are focused on driving change that actively uses the digital foundation built over the past decade,” Micky Tripathi, PhD, MMP, the National Coordinator for Health IT, said in a public statement about the proposed request. “ONC’s FY 2023 Budget Request reflects the actions and investments necessary to take these earlier investments to the next level and drive the transformation to a ‘digitally native’ healthcare system.”

In 2021, ONC officially enabled the 21st Century Cures Act’s information blocking provisions, prohibiting healthcare providers, certified health IT developers, and health information exchanges from interfering with health information access.

However, specific legal analyses and determinations must be completed to determine if information blocking occurred, such as whether certain actors did it with intent or if the actor met an information blocking exception.

“The information blocking regulations implement Congress’ instruction in the Cures Act that the Secretary identify reasonable and necessary activities that do not constitute information blocking, which are labeled ‘exceptions’ in the regulations,” Steven Posnack, Deputy National Coordinator, wrote in the HealthITBuzz blog post.

“After five-plus years implementing the Cures Act along with over two years of answering regulatory implementation questions and receiving stakeholder feedback, we believe that being able to issue binding advisory opinions for the information blocking regulations would be a substantial added benefit to the industry at large.”

Over the last year, ONC has released multiple educational resources about information blocking for providers, developers, and health information networks and exchanges. Healthcare organizations even joined together to help physicians understand the information blocking regulations.

Yet, ONC has expressed the need for an authority to provide a specific actor with a definitive answer to information blocking questions.

This is essential for actors, health IT developers of certified health IT, and health information exchanges, as they can be penalized up to $1 million for each violation of information blocking, Posnack mentioned. In addition, healthcare providers are subject to appropriate disincentives for breaches.

A requesting party that received a favorable advisory opinion would be safe from HHS penalties and disincentives for information blocking practices.

“We believe that the public availability of the facts and practice(s) associated with such advisory opinions would aid actors and non-actors by providing tangible compliance and non-compliance perspectives based on real-world requests,” Posnack stated.