HHS wants to return to shadow lawmaking — it should not

Millions of people directly or indirectly regulated by the Department of Health and Human Services (HHS) will be adversely affected if the agency follows the president’s order and returns to shadow lawmaking.  

Issuing guidance documents as enforceable law has been wrong for decades. Dozens of court cases interpreting the Constitution and federal statutes state so plainly — and repeatedly. In the waning years of the previous administration, HHS wrote two regulations (the Good Guidance Rule and the Civil Enforcement Rule) that implemented what the Constitution and the statutes already require.  

The rules said: (1) guidance is not enforceable and (2) agencies should follow the informal notice-and-comment rulemaking procedure, if not the formal rulemaking procedure laid out in the Administrative Procedure Act (APA). It is illegal for HHS to accomplish its policy objectives through any means it pleases. Instead, Congress empowered it to use only the APA’s formal or informal rulemaking procedures to issue binding rules.  

The rules also formalized what the Freedom of Information Act requires. HHS can enforce a rule only if it is published in the Federal Register or a publicly available repository. Documents not published in these two sources can have no legal consequences. 

The rules further codified two important Constitutional principles: (1) The Due Process Clause requires actual notice and an opportunity to respond if HHS wishes to use as binding any guidance document against the public. This basic due-process guarantee has remained intact and fundamental for more than a century. (2) The Appointments Clause requires that a principal officer must approve the agency’s binding rules. The rules codify this settled principle by requiring that the HHS secretary, a principal officer, approve any document HHS thinks has a binding effect on the public. 

Executive Order 13992, as a “policy” matter, directed all federal agencies “to use available tools” and “robust regulatory action to address national priorities.” Issued on his first day in office, President Biden via this order tried to demote the nation’s enacted laws and court precedent and elevated his policy choice above them. HHS is now using the president’s “policy” choice to attempt a repeal of the Good Guidance Rule and the Civil Enforcement Rule, both of which merely restate binding statutes and court precedent and strike no new legal ground. HHS wants to return to enforcing guidance documents and avoiding notice-and-comment rulemaking. 

By proposing a repeal of the rules, HHS intends to overrule or ignore binding law. Such agency action is unconstitutional.  

Repealing the rules based on the president’s policy choice would violate the Take Care Clause, the Supremacy Clause, and the separation-of-powers doctrine. The president has the unique constitutional duty to take care that the laws are faithfully executed. The president’s policy choice to derogate portions of the nation’s laws is forbidden by the Take Care Clause — as is his decision to demote the nation’s laws by elevating over them his policy preferences. 

Nor can HHS on its own ignore or overrule court precedent interpreting and applying the Constitution and acts of Congress. This principle is at least as old as the Hayburn’s Case, decided in 1792. Congress had enacted the Pensions Act of 1792, creating a scheme for the disabled veterans of the American Revolution to apply for pensions to federal courts. The federal-court decisions were appealable and subject to stay by the Secretary of War. Five of the then-six justices of the Supreme Court declared the Pensions Act unconstitutional.

Agencies do not have the power under the Constitution to revise, ignore, overrule or stay decisions rendered by federal courts. And federal courts are forbidden by the Constitution to decide cases subject to revision by an agency. If HHS repeals the rules, which codify court precedent, it is an act of actively ignoring or overruling such court precedent. That violates the separation-of-powers doctrine.  

The Good Guidance Rule and the Civil Enforcement Rule were not the previous administration’s policy choices. They encoded requirements that follow what is plainly mandated by the Due Process and Appointments Clauses of the Constitution, the Administrative Procedure Act, the Freedom of Information Act, and scores of court decisions. So, the Biden administration’s policy choice is insufficient for repealing the two rules. Indeed, it is unconstitutional for the administration to replace binding law with its mere policy choice.  

HHS issues rules and guidance documents that affect everyone. That is not hyperbole. We are talking of the nation’s health care agency, which includes the Food and Drug Administration and the Centers for Disease Control and Prevention. These agencies’ shadow rules affect everyone’s health and pocketbooks. HHS should have the decency to tell us openly and honestly what the rules are before we are expected to follow them. Repealing the rules robs all of us of our dignity. 

The least that HHS can do is maintain a transparent rulemaking procedure that is open and accessible to the public. Why operate in the shadows at all? It is right for Americans to expect their government to tell them what it is up to, obtain public input, and only then change the rules of the game. HHS should retain in their entirety the Good Guidance Rule and the Civil Enforcement Rule.  

Adi Dynar is an attorney at Pacific Legal Foundation, a nonprofit legal organization that defends Americans’ liberties when threatened by government overreach and abuse.