As discussed in a December 10, 2020 Center for Medicare Advocacy CMA Alert, 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).
As proposed, the rule would have retroactively imposed an expiration provision on most HHS regulations, and established “assessment” and “review” procedures to determine which, if any, regulations should be retained or revised. Regulations would have been reviewed 2 years after this rule was effective or 10 years after promulgation, whichever was later. Regulations that were not reviewed in a timely manner would expire.
As noted in the Center’s comments to the proposed rule, this is an ill-conceived policy that would create tremendous administrative burden for HHS and would wreak havoc across a broad swath of HHS programs (full comments are available here). Among other things, the Center noted:
- 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.
- 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.
Rule Hastily Finalized
On January 8, 2021, with less than two weeks left in the Trump Administration, HHS issued the final version of this rule (not yet published in the Federal Register, but available here; also see HHS press release here). While the final rule adds additional public notice requirements and lengthens the review period for older regulations from 2 to 5 years, the Center asserts that the rule is still fundamentally flawed, in part, since it forces an arbitrary expiration date on core Medicare (and other) rules and protections unless HHS intervenes.
In the preamble to the final rule, HHS assures that it “does not intend for any regulations to inadvertently sunset, and it is unlikely that any regulations with significant benefits would slip through the cracks” and that “the public will have the opportunity to provide comments identifying regulations that the public believes need to be Assessed and Reviewed, which mitigates the risk of inadvertent expiration” (p. 75, 58). Despite these assurances, as evidenced by the very finalization of this rule, public notice and comment is no guarantee that HHS will do the public’s bidding and intervene before a given rule expires.
On the one hand, HHS argues that its own failure to update certain rules is a justification for instituting retrospective review. In the preamble, HHS provides a list of examples of regulations that commenters “and/or Congress have requested the Department to review” but have not been so reviewed (see pp. 11-12). Curiously, offered without comment on whether HHS intends to follow through on these requests, this list includes “[r]egulations covering access to skilled therapy services, which commenters say must be updated to reflect the national settlement in the Jimmo v. Sebelius litigation to codify the fact that skilled services are covered for Medicare beneficiaries not just to improve function, but to maintain or prevent deterioration in function.”
As lead counsel in the Jimmo v. Sebelius suit, the Center for Medicare Advocacy has long called for additional action by HHS to better effectuate the settlement reached in 2013. While we appreciate HHS acknowledging that such requests have been made, we are unaware of any effort or willingness on the part of the Department to actually do so. Regardless of HHS’ intent with respect to revising these regulations, the Department, in effect, is saying that there may be things we do or do not intend to get to, but, we will put off any action until our regular retrospective review timeline. Rather than addressing issues that may need more immediate attention, this mechanism provides an excuse for HHS to punt until a later time, at which point they will still be under no obligation to make any changes to the rules in question.
On the other hand, when there are issues that HHS wants or need to address quickly, it has demonstrated the ability to do so (see, e.g., the finalization of this rule). The Department notes that its “response to the COVID-19 pandemic also indicates that the Department should perform widespread retrospective reviews. During the COVID-19 pandemic, the Department’s response has largely consisted of waiving regulatory requirements or exercising enforcement discretion to not enforce certain regulatory requirements to enhance the Nation’s response to the pandemic. […] The Department should learn from the pandemic and conduct widespread reviews to determine whether these or other regulatory requirements could hinder the Nation’s response to a future emergency, or otherwise should be amended or rescinded” (pp. 28-29).
When the COVID-19 pandemic swept the country, HHS quickly and appropriately stepped in and issued a wide range of regulatory waivers in order to foster ongoing access to care during a crisis. The assessment and debate about what waivers should be made permanent has already begun, and HHS has already taken some action (such as making some telehealth waivers permanent). Incorporating lessons learned, and planning for the next national emergency (which might not be in the form of a pandemic) should not be relegated to a periodic, retrospective review of regulations – it should be a priority.
In summarizing comments received, HHS notes that “[c]ommenters generally opposed the proposed rule, although some commenters supported it. Roughly a quarter of commenters requested that the Department withdraw the proposed rule. Some commenters requested that the Department extend the public comment period” (p. 37) [emphasis added].
The primary reason for the requests to extend the comment period is that HHS only allowed 30 days for comments relating to non-Medicare provisions impacted by the rule. As noted in the preamble, “[p]art of the proposed rule had a 30-day public comment period, and part of it had a 60-day comment period to comply with 42 U.S.C. 1395hh(b).” HHS states that it received 486 comments during the initial 30 day comment period and 532 comments throughout the total 60 day comment period, which expired on January 4, 2021 (p. 37). Without noting when the 46 additional comments were received during the last 30 day period, the rule was finalized 4 days after the end of the 60-day period on January 8, 2021. Although HHS states that “the Department has considered all comments, including those received throughout the 60-day comment period, before finalizing this rule” (p. 45), there is certainly a question regarding the scrutiny such comments received pursuant to notice and comment requirements, particularly if they were received towards the end of this period.
In an era of deregulation, when alleviating “administrative burdens” for providers has taken precedence over strengthening consumer protections, HHS has made a last ditch attempt to deregulate health programs under its purview. In its waning days, the Trump Administration rushed to finalize a flawed rule that will put an automatic expiration date on core Medicare and other regulations. We urge the incoming Biden Administration to rescind this rule.