Kids Forward Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 16 -- Jon Peacock, director of policy at Kids Forward, Madison, Wisconsin, 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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Thank you for the opportunity to share our comments on the Department of Health and Human Services (HHS) proposed rule, "Securing Updated and Necessary Statutory Evaluations Timely" (which we will subsequently refer to as the "Regulations Rule").

For over a century, Kids Forward - a private, non-partisan, non-profit - has focused on improving conditions for families and children through policy change, public education, and expanded public investments that lead to improvements in publicly funded health care, education, workforce development and social services.

As an organization that works to help increase access to health insurance for low-income families and individuals, we have serious concerns about the potential effects on Medicaid and CHIP-funded health care stemming from adding a blanket expiration date to thousands of HHS regulations and establishing "assessment" and "review" procedures to determine which regulations, if any, should be retained or revised.

The Regulations Rule is a hastily developed and poorly conceived proposal that would be extremely disruptive for a broad range of HHS programs and entities, including Medicaid and Medicare, the Centers for Disease Control, and the Food and Drug Administration. We are extremely concerned that the department is seeking to rush this proposal through the rulemaking process with just a 30-day comment period. That is far too little time for a rule of such broad scope and far-reaching implications. We urge the department to immediately withdraw this proposed rule.

The proposed rule would create an immense administrative burden that would impede the ability of HHS to adequately address the highest priority issues that it needs to tackle

HHS estimates that 90 full-time staff would be needed to conduct the required reviews to administer the proposed rule, and it would increase administrative costs by nearly $26 million dollars over 10 years. Within just the first two years, the department estimates it would need to assess at least 12,400 regulations that are more than10 years old. And as alarming as those projections are, they probably do not fully account for the complications that will almost certainly arise, which could substantially increase the amount of staff time and taxpayer dollars needed for such an immense undertaking.

HHS has its hands full already as it grapples with pressing issues such as the COVID-19 pandemic, changes in telehealth, prescription drug costs and access, and many other challenges. If the proposed rule is implemented, it would interfere with the department's ability to focus on issuing new regulations and to prioritize reviewing the most pressing aspects of existing regulations.

A central focus of our work at Kids Forward is combatting the pronounced racial inequities in health outcomes and in access to quality, affordable health services. The pandemic has shined a light on those disparities and is making them even worse, which underscores the urgency of taking remedial actions. With that in mind, we are very concerned that the heavy administrative workload resulting from the proposed changes would undercut the capacity of HHS to focus attention on ending those alarming disparities.

The proposed rule could wreak havoc by causing huge gaps in the administrative framework for many HHS programs

With so many regulations needing to be reviewed, it is unlikely that all of that work could be done within two years, and the proposed Regulations Rule could result in the arbitrary rescission of very important regulations that take longer than two years to review and amend. That would create gaping holes in the administrative rules and would probably lead to costly lawsuits seeking to sort out the implications of conflicts between the statutory requirements and the patchy regulations that remain.

We are especially concerned about the confusion that could result from gaps in safety net programs such as Medicaid and the Children's Health Insurance Program (CHIP), which provide health coverage for over 75 million people, including more than one million Wisconsinites. Our work on behalf of Wisconsin children and families gives us frequent experience with how important it is for federal regulations to provide a strong regulatory framework for the smooth administration of programs like Medicaid. Those regulations give our state the clarity it needs to implement BadgerCare, EPSDT and other crucial health programs in Wisconsin. They also give managed care organizations and providers guidance as to their obligations, and they enable advocacy organizations like ours to help program participants get the benefits they are entitled to receive. The proposed rule could create gaping holes in the regulatory framework and legal uncertainty regarding the status of federal law.

The proposed rule is unnecessary and conflicts with federal statutes

HHS agencies can already update their regulations when needed, and they frequently do so, even though it can be a laborious process. The proposed rule would impede and debase that common practice because agencies would be so busy reviewing hundreds of rules that they could not devote sufficient attention to the highest priority areas.

Besides being misguided, the proposed rule is inconsistent with federal statutes. The Regulatory Flexibility Act of 1980 requires each agency to publish "a plan for the periodic review of the rules issued by the agency which have or will have a significant economic impact upon a substantial number of small entities." However, that law does not authorize agencies to retroactively impose a blanket expiration date for rescinding lawfully-promulgated regulations.

The proposed rule also conflicts with the requirements for rulemaking contained in the Administrative Procedure Act (APA). That statute establishes clear procedures for agencies seeking to modify or rescind a rule. It requires agencies 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.

Under the APA it is not legal for an agency to do what HHS is now proposing, which in one hurried process would retroactively add an expiration date to 18,000 regulations. The proposal to apply a blanket amendment to thousands of regulations violates the statutory requirements that review of an existing rule must take place on an individual basis, with specific fact-finding pertaining to the individual rule that the agency seeks to amend. Making such a sweeping change is something that Congress could do, but is not currently legal for a federal agency - unless or until the statutes are amended.

Conclusion

Kids Forward strongly opposes this rule, and we urge HHS to withdraw it immediately. The proposed rule is unnecessary, and it conflicts with federal statutes that do not allow agencies to use a single rulemaking process to amend hundreds or thousands of regulations.

The "Regulations Rule" is likely to be extremely disruptive for current HHS programs. We are also very concerned that it would impede the work of the incoming Administration by diverting attention from far more pressing issues, such as the COVID-19 pandemic, to undertake the very costly and unfocussed process of reviewing thousands of regulations.

Thank you for the opportunity to comment on this extremely important issue.

Sincerely,

Jon Peacock

Policy Director

Kids Forward

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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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