- The HHS is asking Congress for the authority to issue binding advisory opinions on information blocking regulations, with the goal of helping health IT developers and providers comply with the complex rules finalized two years ago.
- The legislative request was included in the Office of the National Coordinator for Health IT's 2023 budget request published earlier this year. If granted, the authority would mean the ONC could provide tangible information based on real-world requests for whether a practice constitutes information blocking.
- If an actor receives a favorable advisory opinion — meaning regulators greenlight a practice as not information blocking — it would then be protected from fines or penalties for information blocking in the future, as long as the specific practices at issue are the same as those initially presented to the HHS.
The administration requested the authority from Congress in President Joe Biden's budget proposal for the 2023 fiscal year. The budget, which isn't binding but comprises a wish list for agency funding, includes in some cases what the administration deems as a need for additional or new authority.
The 21st Century Cures Act requires certain legal analyses and determinations to decide whether an actor is guilty of information blocking. That includes whether the actor had the requisite knowledge or "intent," and whether an actor met one of the eight exceptions for information blocking, such as preventing harm or protecting patient privacy.
The ONC doesn't have the authority to give definitive and legally binding answers to a specific information blocking question that would help a health IT provider, hospital or other actor with compliance.
That's important because developers of certified health IT products and health information exchanges and networks are subject to steep fines — up to $1 million per information blocking incident — while providers will eventually face disincentives "that may be significant to them as well," Posnack said. The HHS has yet to define information blocking penalties for providers, despite those actors accounting for the majority of information blocking complaints so far.
"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," Posnack wrote.
The ONC also requested the authority to collect fees for issuing opinions, and use them to offset the costs of the determination process, according to the budget proposal.
There's precedent for advisory opinion authority within the HHS. In one example, the Social Security Act requires the CMS issue certain written advisory opinions on whether a doctor's referrals for services to an entity they have a financial relationship with are allowed under Medicare.
Additionally, the HHS' Office of the Inspector General issues advisory opinions about whether certain fraud and abuse enforcement applies to a party's existing or proposed business arrangements.