On
November 4, 2020, the Department of Health and Human Services’ (HHS) issued a proposed rule entitled “Securing Updated and
Necessary Statutory Evaluations Timely” (SUNSET) (RIN 0991–AC24; Docket No.
HHS–OS– 2020–0012).
The
proposed rule would retroactively impose an expiration provision on most HHS
regulations, and establish “assessment” and “review” procedures to determine
which, if any, regulations should be retained or revised. Regulations would
have to be reviewed 2 years after this rule is effective or 10 years after
promulgation, whichever is later. Regulations that were not reviewed in a
timely manner would expire.
Building
on helpful comments drafted by the National Health Law Program (NHeLP), the
Center for Medicare Advocacy recently submitted comments in opposition to this proposed rule.
Noting
that this is an ill-conceived proposal that would create tremendous
administrative burden for HHS and would wreak havoc across a broad swath of HHS
programs, the Center for Medicare Advocacy pointed out, among other things:
- HHS is elevating a procedure or process to review regulations
over the substance of the regulations themselves. Rather than the proposed
rule’s focus on “undue regulatory burdens” on the business of health care,
many regulations define and protect the health of those receiving care.
- Because of the timeline in the proposed rule, within
approximately 2 years, HHS must review the bulk of keystone Medicare
regulations, which means many such regulations would soon be threatened
for termination absent timely review and assessment.
- Even if HHS is convinced it can complete at least assessments
of these rules within the truncated time period, it is the height of
irresponsibility to put an arbitrary expiration date on bedrock rules.
- The potential impact of an inadvertently expired regulation
due to agency negligence would go beyond just creating a gap in the text
of the Code of Federation Regulations. There would be down-stream,
cascading ripple effects, impacting a range of sub-regulatory guidance
that rely upon a given regulation, that would likely play out over
time.
- The proposed rule would create a significant, self-imposed
administrative burden that would divert resources from critical work,
including efforts to address the COVID-19 pandemic.
- Not only would the proposed rule create a significant
administrative burden on the department itself (in a seemingly
self-inflicted wound), it would also shift additional burden to the
public, relying upon outside sources to regulate the regulator. (HHS asserts
that it “anticipates that the public would remind the Department to
perform the Assessment or Review if the deadline is nearing and the
Department has not yet commenced the Assessment or Review.”)
- As noted by NHeLP, the proposal is contrary to the Administrative
Procedure Act’s (APA) requirements for rulemaking.
In
an apparent effort to push through this rule in the waning days of the Trump
Administration, HHS provided a truncated 30-day comment period (general
comments were due December 4). However, comments on Medicare-related
provisions (Title 42, Code of Federal Regulations parts 400–429 and parts 475–
499) are due January 4,
2021. Thus, we strongly urge those who are willing and able to submit
Medicare-related comments in opposition to this rule to do so before the
deadline.
For additional analyses concerning this proposed rule, see, e.g., Andy Schneider, Georgetown University Health Policy Institute, “What the Proposed “SUNSET” Regulation Means for Medicaid and CHIP” (November 11, 2020) https://ccf.georgetown.edu/2020/11/11/what-the-proposed-sunset-regulation-means-for-medicaid-and-chip/; and Jessica Schubel, Center on Budget and Policy Priorities (CBPP), “HHS’ Proposed “Rule on Rules” Could Wreak Havoc on Health Programs and Harm People” (November 24, 2020) https://www.cbpp.org/blog/hhs-proposed-rule-on-rules-could-wreak-havoc-on-health-programs-and-harm-people
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