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.