Coalition on Human Needs Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 15 -- Deborah Weinstein, executive director of the Coalition on Human Needs, has issued a public comment on the Department of Health and Human Services proposed rule entitled "Securing Updated and Necessary Statutory Evaluations Timely". The comment was written on Dec. 4, 2020, and posted on Dec. 8, 2020:

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On behalf of the Coalition on Human Needs, I appreciate the opportunity to comment on the Department of Health and Human Services (HHS) proposed rule, "Securing Updated and Necessary Statutory Evaluations Timely" (referred to herein as the "Regulations Rule"). 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. The Regulations Rule is an unnecessary and ill-considered proposal that would create substantial administrative burden for HHS and would wreak havoc on a wide range of Department programs and regulated entities from Medicaid and Medicare to the Administration for Children and Families, the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and others. We also strongly object to the 30-day comment period which is insufficient for a rule this broad in scope with potentially wide-reaching harmful effects. We urge HHS to immediately withdraw this proposed rule.

The Coalition on Human Needs (CHN) is an independent non-profit alliance of roughly 100 national-scope organizations, representing human service providers, people of faith, civil rights, labor, and community-based groups, policy experts, and other advocates concerned with meeting the needs of low-income and vulnerable people through effective and adequately-funded federal programs and policies. CHN members have a long history of supporting and expanding many of the programs under HHS that would be adversely affected by this proposed rule, including the Affordable Care Act, Medicare and Medicaid, the Children's Health Insurance Program, Temporary Assistance for Needy Families, child care, child support, Head Start, substance use disorder treatment and prevention programs, the Low Income Home Energy Assistance Program (LIHEAP), the Office of Refugee Resettlement, programs for seniors and for people with disabilities, mental health treatment programs, and many others. This proposed rule would harm the programs and people CHN and its members fight for.

HHS asserts that the Regulations Rule will promote "accountability, administrative simplification [and] transparency. . . ."/1

In fact, the proposed rule would create a significant administrative burden that would detract from critically important priorities that the new Administration must address, including responding to the COVID-19 pandemic. HHS itself estimates that the proposed rule would need 90 full-time staff positions to undertake the required reviews, and would cost nearly $19 million to implement in the first two years and $26 million dollars over the next 10 years./2

Considering the regulatory responsibilities of HHS agencies, it is hard to view these as anything other than gross underestimates. Within the first two years, HHS estimates that it would have to assess over 12,400 regulations that are more than 10 years old,/3 and it is likely that most of these rules would need to be reviewed as well. The Regulations Rule compounds the difficulties by defining a rule as a section of the Code of Federal Regulations (CFR). For example, in the Managed Care Rule, at 42 CFR Part 438, there are 91 different sections of the CFR. Each section of the Managed Care Rule will need to be "assessed" and, if that section is found to have a significant economic impact upon a substantial number of small entities, it will need to be "reviewed." Without additional appropriations from Congress, HHS staff would struggle to ensure key regulations do not expire - which could cause major harm - while also trying to effectively administer needed HHS programs. Right now, as the Food and Drug Administration is coping with evaluations of COVID-19 vaccines which must be safe but expeditious. It is clear that asking the staff responsible to divert time away from this important task in order to prevent potentially harmful expirations of existing regulations would be unwise. In fact, creating this log jam would endanger the public.

The Regulations Rule would adversely affect HHS's ability to focus on the administration of current programs, issue new regulations, and appropriately review current regulations that may actually need modification.

Our nation is facing many urgent concerns that HHS staff should be working on, from rebuilding child care so parents can get back to work to beefing up substance use disorder treatment programs to combat the opioid epidemic. Millions of Americans have lost their health care since the COVID-19 pandemic began. A cold winter is coming for too many who cannot afford heat. Especially when crucial efforts are needed to address the current public health crisis (including FDA review and approval of treatments and vaccines), it is critically important that HHS have the ability to shift focus and respond quickly to immediate needs instead of being handcuffed by this rule.

In addition, several important regulations implementing parts of the Affordable Care Act as well as updates to other provisions of Medicaid law are approaching their ten-year anniversary, such as the Medicaid cost-sharing rule. Regulations like these would need to be reviewed within the next two years, or they would expire. However, the underlying law still exists even if the regulations expire, leaving states without clear guidance on cost-sharing amounts. This would upend states' ability to administer their programs and could potentially harm people in need. Simply put, this is yet another attempt to undermine the Affordable Care Act and other safety net programs within HHS, and the millions of people who rely on them. This proposed rule would be harmful under normal circumstances, but enacting it during a pandemic is unconscionable.

A major concern of human needs advocates is that the proposed rule will cause important regulations to be arbitrarily rescinded simply because there are not enough HHS staff or resources to undertake such a sweeping review process. Regulations that do not complete the complicated and time-consuming review process would expire, potentially leaving vast, gaping holes in the regulatory framework needed to implement HHS programs and policies. Arbitrarily rescinding such numerous regulations would create chaos in HHS programs, leading to untold harm to the millions of Americans who rely on these programs. As is the case with many safety net programs, people with low incomes, communities of color, children, older Americans, and people with disabilities are likely to disproportionally suffer when these programs are attacked.

Many of the programs that would be harmed by this proposed rule have already been hampered by years of funding cuts. According to analysis from the Coalition on Human Needs, funding for the CDC's Healthy Homes and Lead Poisoning Prevention program has been cut by more than 50 percent since FY10 despite its essential function. Funding for the Low Income Home Energy Assistance Program has been cut by nearly 40 percent. Child welfare services funding dropped by more than 20 percent. Saddling immense burdens onto programs that are already struggling to meet the growing need for their services will only serve to harm more people with low incomes. The Coalition on Human Needs supports strengthening all of these programs with additional resources rather than further curtailing their already-strained staff.

Child care is a particularly challenging area now, with pandemic-related shutdowns crippling many child care centers. Rebuilding access to quality affordable child care once it is possible to reopen the economy will be a critical priority for HHS. Current regulations regarding state matching expenditures for the Child Care and Development Fund (CCDF) are more than 10 years old. They provide flexibility states need to meet the match requirements, which is likely to be especially needed now. HHS should not have to scramble to prevent these regulations from being automatically rescinded while it is trying to shore up the struggling child care industry.

The proposed rule is also unnecessary. The Regulations Rule incorrectly claims that automatic expiration dates give HHS the incentive necessary to conduct regular assessments of existing regulations and comply with the Regulatory Flexibility Act (RFA). However, HHS agencies already periodically review and update regulations when needed, as required by the RFA, a far more systematic way to undertake review. For example, HHS annually reviews and updates the Notice of Benefits and Payment Parameters for insurance exchanges and issuers, as well as certain Medicare regulations to reflect new program parameters and policy and technical changes. Ironically, the proposed rule would likely impede rather than further HHS efforts to meaningfully update regulations where needed, as staff time would instead be dedicated to the unnecessary reviews mandated by the rule.

In fact, this proposal is contrary to the Administrative Procedure Act's (APA) requirements for rulemaking. Under the APA, agencies are required to go through the same rulemaking process to revise or rescind a rule as they would for a new rule, with public notice and the opportunity to comment./4

In contrast, the Regulations Rule would apply a blanket amendment to 18,000 regulations across HHS in one fell swoop, in violation of the APA requirements that review of an existing rule take place on an individual basis. This alone should be grounds for HHS to withdraw this proposed rule.

Changes to existing rules as well as new rules should occur with time for public comment. In 2016 HHS responded to statutory changes made by the 2014 Child Care and Development Block Grant reauthorization by seeking input from a wide range of stakeholders. The revised regulations were carefully designed, based on that input, to carry out the new law's intent to protect child health and safety in child care settings, to provide low-income children with access to stable, high-quality child care, and to help parents make good choices of the most appropriate child care settings for their children. The two-year process resulted in improvements in federally-funded child care. It is an example both of the fact that HHS already does engage in appropriate regulatory updating and that doing it well takes time. If instead HHS were forced to meet arbitrary deadlines to prevent rules from expiring, no matter what urgent concerns are facing the services HHS provides, it is inconceivable that the result will be thoughtful updating of rules.

The members of the Coalition on Human Needs believe the Regulations Rule is simply an attempt to sabotage duly promulgated regulations and overwhelm HHS staff who need to be focusing on ways to help recover from the pandemic and to move our country forward. As previously noted, our nation is facing many urgent concerns that HHS staff should be working on. This rule is unnecessary, will grievously undermine current HHS programs, and will unnecessarily tie the hands of the incoming Administration by detracting from critical issues like the COVID-19 pandemic. As such, the proposed rule has the potential to harm millions of Americans. We strongly oppose this rule and urge HHS to withdraw it immediately.

Thank you for taking these comments into consideration. If you have further questions, please contact me at [email protected] or at 202-223-2532.

Sincerely,

Deborah Weinstein

Executive Director

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Footnotes:

1/ 85 Fed. Reg. 70104

2/ 85 Fed. Reg. 70116

3/ 85 Fed. Reg. 70112

4/ 5 U.S.C. Sec. 551(5)

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The proposed rule can be viewed at: https://beta.regulations.gov/document/HHS-OS-2020-0012-0001

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