Voglio sapere a riguardo di…

15406

Federal Register / Vol. 86, No. 54 / Tuesday, March 23, 2021 / Rules and Regulations
exceeds the Departments authority under the APA, substantive organic statutes, and the Regulatory Flexibility Act RFA because it schedules the rescission of thousands of regulations that were required by statute, amends regulations without the same level of process and statutory considerations required for the original regulations, and provides for automatic elimination of regulations without considering the requirements of the RFA. The Complaint further alleges that the SUNSET final rule is arbitrary and capricious and lacks a rational basis because, among other reasons, it assumes that HHS will conduct RFA
reviews at an implausible pace; does not adequately consider the extreme degree of regulatory uncertainty the SUNSET
final rule creates; underestimates the burden imposed on Plaintiffs for monitoring HHS regulations to ensure they do not expire; and fails to consider the specific regulations being amended to automatically expire.
Given the volume of HHS agency regulations that the Department would need to assess and, as applicable, review in a short period of time, HHS now believes it is likely some regulations would expire without any additional administrative process contrary to the conclusions reached in the SUNSET
final rule. Under the SUNSET final rule, for each covered regulation, HHS
agencies would need to: Collect data to conduct the relevant evaluation, perform an assessment and possibly a review, consider any comments to the public docket related to the evaluation, publish the results of this process in the Federal Register including the full underlying analyses and data used to support the results, 86 FR at 5712, and, if warranted, complete a rulemaking to amend or rescind the regulation, which would itself require an additional investment of agencies resources and public input. If the work is unable to be conducted within the final rules time frames, the regulations would expire.
That outcome could raise interrelated administrative law questions regarding:
Whether regulations promulgated through notice and comment rulemaking can be terminated through an umbrella rule without individualized consideration of the expiring regulations, including any reliance interests of parties affected by them;
and, if so, whether the proposed/final rule provided an adequate justification for implementing a process of automatic expiration.
The expiration component of the SUNSET final rule also raises significant policy and public health questions
VerDate Sep<11>2014

16:06 Mar 22, 2021

Jkt 253001

concerning the value of the assessment and review processes and whether those processes are so important that they outweigh the value of the regulations that would likely expire.
The potential automatic expiration of regulatory programs could create uncertainty and unpredictability regarding large swathes of the rules governing health care, which would upend the status quo and in turn could result in compliance costs to HHS
grantees, contractors, and health care providers and suppliers, many of whom may have structured matters such as financial arrangements and business operations to satisfy the conditions set forth in the current regulations. The resulting disruption in the marketplace could impact stakeholders who rely on the regulatory functions of each HHS
agency. This uncertainty could have serious implications for insurance markets, hospitals, physicians, and patients, among other affected parties, which could lead physicians and other regulated entities to forgo future investments because of the lack of clarity. In addition, because States depend on HHS to set national standards and have built vast regulatory systems within that framework, the possibility that many regulations would lapse could pose a direct threat to the States healthcare systems and the health and safety of individuals. The expiration of regulations could also muddle the clarity and predictability of existing regulations, which in turn would impede program implementation and reduce HHSs overall efficiency.
HHS is similarly concerned that the SUNSET final rule may have significantly underestimated the burden of the assessments and reviews for this magnitude of regulations and fails to account for the substantial resources that would be needed for the HHS
agencies to simultaneously evaluate thousands of regulations in a short period of time. For example, the Regulatory Impact Analysis RIA
included in the final rule appears to focus on the number of staff and staff hours required for reviews, but provides an incomplete estimate for the cost of the initial assessment phase.
That raises questions regarding whether the RIA significantly underestimated the costs that will be incurred by agencies and overestimates the purported cost savings. Currently, there is no accurate impact analysis of the substantial redirection of resources both financial and employee required to provide the necessary expertise and input from economists, epidemiologists, medical officers, legal and regulatory counsel, and other subject matter experts.

PO 00000

Frm 00010

Fmt 4700

Sfmt 4700

The Complaint also alleges that the promulgation of the SUNSET final rule suffered from procedural deficiencies.
Plaintiffs allege that, despite widespread requests for more time, HHS issued the SUNSET final rule after providing 30
days to comment on the rules effect on non-Medicare regulations and 60 days to comment on its effects on Medicare regulations, seriously interfering with meaningful public participation. The comments likewise raised concerns about the adequacy of the comment period for a rule with this magnitude of impact and the timing of the proposal, particularly during the COVID19
pandemic, both of which may have impeded the full and deliberate consideration of all of the potential issues related to the SUNSET rule. For example, at the Public Hearing, almost all commenters agreed that HHS should have lengthened the comment period, and offered several reasons in support of a longer comment period, all of which were expressed by multiple commenters: That a proposal with this breadth, scope, and potential harmful impact, including unintended detrimental consequences to regulated industries, merited more time for thoughtful public input; that impacted stakeholders included small businesses that would not be able to digest and comment on a rule of this breadth in such a short period of time; that it was irresponsible for HHS to engage in this rulemaking during the height of the pandemic when stakeholder resources were devoted to addressing the public health emergency; and that the already short comment period included Thanksgiving weekend, which exacerbated the time-crunch for commenters. See Transcript, Public Hearing on the Securing Updated and Necessary Statutory Evaluations Timely Notice of Proposed Rulemaking Public Hearing Transcript Nov. 23, 2020
available at https
www.regulations.gov/document/HHSOS-2020-0012-0501. As with Plaintiffs above substantive claims, HHS requires additional time to review the SUNSET
final rules compliance with these procedural obligations, in light of Plaintiffs claims, before determining how to proceed in litigation and before creating uncertainty among the regulated community. The SUNSET
final rule is uniquely situated in that it affects an extraordinarily large number of regulations, which lends support for Plaintiffs procedural claims.
The Complaint also alleges that, despite the SUNSET final rules sweeping scope and tribal implications, the Department neglected to consult
E:FRFM23MRR1.SGM

23MRR1