While the federal government’s budget planning processes may have a certain mystique to them, some interesting tidbits are always in federal agency budgets if you know where to look. Fear not, because this blog post highlights a new legislative proposal associated with information blocking that’s been put forward by the Biden-Harris Administration for HHS. Specifically, the Administration has requested that Congress provide HHS with the authority to issue binding “advisory opinions” for the information blocking regulations as part of our implementation of the 21^st Century Cures Act (Cures Act).

The President’s fiscal year (FY) budget proposals are published every spring for the forthcoming fiscal year. This process is a way for the Executive Branch to inform the Legislative Branch of its priorities and needs, including funding and authorities. In some cases, when the Administration determines that additional or new authority is needed, the President’s budget also includes these requests.

If you gave it a quick skim or just looked at the bottom line for ONC’s requested funding level, you might have missed that the last page of the ONC portion of the Justification of Estimates of the FY23 President’s Budget included a request for new authority – to be able to issue binding advisory opinions for the information blocking regulations (45 CFR Part 171). For those familiar with other investigative and enforcement-oriented health laws, the information blocking provision of the Cures Act requires similar analyses. For instance, in order to determine whether information blocking occurred, certain legal analyses and determinations must be completed, such as whether certain actors had the requisite knowledge or “intent” and whether an “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. 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.

While ONC provides several different types of educational resources for information blocking (e.g., webinars, fact sheets, FAQs), we do not have the authority to provide a specific “actor” with a definitive, binding answer to a discrete information blocking question in a way that would help the actor with compliance details relevant to its particular situation. This is important because some actors, health IT developers of certified health IT and health information networks/health information exchanges, are subject up to $1 million civil monetary penalties for each violation of information blocking, while health care providers will be subject to appropriate disincentives that may be significant to them as well.

The requested new authority would give HHS the ability to issue a binding advisory opinion to advise whether, in HHS’ view, a specific practice would constitute information blocking, including whether an exception would or would not be met given the facts and circumstances. The advisory opinion would be binding on HHS. A requesting party that received a favorable advisory opinion would be protected from HHS penalties and disincentives for information blocking practices, so long as the specific practice(s) at issue were conducted in accordance with the facts submitted to HHS. Further, 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.

All interested stakeholders are encouraged to check out this proposal and consider its implications.