Funding for the issuing of binding advisory opinions on information-blocking is one element in the proposed fiscal year (FY) 2023 budget that the Biden administration has just issued, notes Deputy National Coordinator for Health IT Stephen Posnack, in a May 24 blog on the website of the Office of the National Coordinator for Health IT (ONC).
In the blog, entitled “Information Blocking and the President’s FY23 Budget for ONC,” Posnack writes that, “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 [the Department of Health and Human Services] the authority to issue binding “advisory opinions” for the information blocking regulations as part of our implementation of the 21st Century Cures Act (Cures Act).”
Importantly, he writes, the casual reader might have missed in President Biden’s FY23 budget the inclusion of a “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.’”
Further, Posnack notes, “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,” he says, “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.”