On November 24, 2020, the Department of Health and Human Services (HHS) announced two policy statements and a request for information on the rulemaking process and transparency.
Rulemaking Policy Statement
In the first policy statement, published in the Federal Register on November 27, 2020, HHS directed its agencies to ensure that proposed rules are both consistent with and do not overlap with any regulation that has already been proposed. Concurrent with that statement, HHS issued a request for information (RFI), seeking input on HHS regulations that are redundant, inconsistent, or overlapping, as well as input on how to best resolve those issues.
This first policy statement requires agencies to not recommend issuing a rule until it can also recommend steps to avoid the issues of redundancy, inconsistency, or overlapping. HHS believes that redundancy, overlap, and inconsistency inject uncertainty and increase costs. The accompanying RFI is open for comment through December 21, 2020. While the statement has been issued, the incoming Biden administration is not obligated to either abide by this policy statement or to take responses to the RFI into account. However, it is possible that new HHS leadership could consider comments that align with their priorities. Comments are due no later than 11:59 PM ET that night, and will be reviewed on a rolling basis until that date.
Transparency Policy Statement
In the second policy statement, HHS called for expanding the transparency that is associated with rules’ and demonstration projects’ impact analysis. According to the statement, one such way to expand the transparency is by requiring the disclosure of assumptions, working papers, models, and other information. Therefore, the statement as signed by HHS Secretary Alex Azar, requires that all assumptions, working papers, models, and other information used for an impact analysis be published on the HHS website at the same time the results of the analyses are disclosed. In addition, HHS must also make public and post all data and assumptions that would be necessary for a third party to replicate the agency’s analytic work. The exact online location of where the analyses will be posted will be determined separately by each HHS division. Interestingly, while there are exceptions for analyses undertaken for settlement or litigation purposes, there do not appear to be exceptions for proprietary information.
While this policy is set to apply to rulemakings or demonstrations proposed after November 30, similar to the other policy statement, HHS is also not under any obligation to continue to abide by the transparency policy statement upon the inauguration of a new Administration. However, if the incoming administration opts to ignore or reject it, it may open them up to criticism.