June 2024 decision The Supreme Court of the United States (SCOTUS) decision overturning the Chevron decision and restricting how federal agencies enforce the law through regulation could significantly change the regulatory environment in the healthcare sector, potentially increasing litigation, regulation uncertainty, which can pose challenges in consistent enforcement. National health policy. This ultimately affects the health outcomes of vulnerable populations, especially those who rely on federal health programs and protections, according to the University of Pennsylvania’s Leonard Davis Health Economics Institute (LDI) Health Law Expert Panel. It is said that it may affect.
The seminar, held in the Wharton School’s Steinberg Hall-Dietrich Hall, was moderated by LDI Director of Policy and Strategy Julia Hinckley, J.D., and panelists included LDI Senior Fellow Alison Hoffman, J.D., Penn Carey Law School He was a professor at the Graduate School of Law. Kate Shaw, Doctor of the CourtProfessor of Law at Penn Carey School of Law. and LDI Senior Fellow Holly Fernandez Lynch, J.D., MBE, Associate Professor of Law at Penn Carey Law School. The event title was “What does the collapse of Chevron mean for health policy?”
Hinckley asked Shaw, host of the Supreme Court podcast “Strict Scrutiny” and a former Supreme Court law clerk, to characterize how profound a change the SCOTUS decision represents.
“The impact is huge,” Shaw said. She explained that for the past 40 years, the 1984 SCOTUS decision has allowed federal regulators to interpret laws passed by Congress and set rules and regulations for the implementation and enforcement of those laws. did.
What was Chevron?
“There are often gaps and ambiguities in the laws passed by Congress,” Shaw explained. “And when that happens, agencies are in a position to fill in the gaps in the statutes they administer, or to interpret ambiguous provisions.The interpretations they give, or what fills in those gaps, will be in a position that makes sense. As long as they are, the federal courts will follow them. That was Chevron. Now it’s gone.”
Mr Shaw said the 1984 Authority was based on two important ideas: the practical element of expertise and the question of democracy. Federal agencies are widely staffed by experts with deep and nuanced field experience. These federal agencies exist within the executive branch and have extensive ways to engage the public and elicit democratic input, including the notice-and-comment process by which agencies submit proposed regulations, making them democratically accountable. I owe it.
To illustrate how Chevron’s principles differ from the principles created by SCOTUS, which shifted the authority to interpret regulations from government agencies to courts, employers should provide workers in meat processing plants with the following: Imagine, Shaw suggested, a new law passed by Congress that would require it to be provided. Wear appropriate protective equipment. Under Chevron, the law’s term “appropriate” is not self-defining, allowing agencies like the Occupational Safety and Health Administration (OSHA) to provide guidance on what “appropriate” means in this particular industrial work environment. may provide a definition.
Subject matter expertise
OSHA may study the types of accidents that occur in meat processing plants, the types of protective equipment that workers are actually given, and what is appropriate for the hazards present in the workplace. The study may conclude that something like a fabric is needed that is thick enough and covers the body sufficiently so that the average worker will not be injured by normal use of factory equipment. This finding translates into OSHA regulations or rules that tell employers what they must do to comply with the law.
“But now that SCOTUS has struck down Chevron, imagine a court deciding on a clean slate what ‘adequate’ protective equipment means,” Shaw said. “Courts don’t have the professional experience or expertise to do that. Often the tools they have are dictionaries, so ‘appropriate’ to them means ‘appropriate’, ‘appropriate’. It can mean something like ‘consistent with common practice’ or ‘consistent with common practice’. ”
“Textualist judges essentially avoid other types of sources of statutory meaning, such as purpose or extensive invocation of legislative history,” Shaw said. “At least in theory, textualism says, ‘We’re not concerned about anything other than the text of the statute and a very short list of tools we can use to interpret those texts.'”
“So now, with the takedown of Chevron, we’re in a world where dictionaries, not agency expertise, are ubiquitous,” Shaw said. “The Supreme Court has said that it is always inappropriate for a government agency to do this job; in fact, judges are the experts in interpreting the text of the law. It has always been an abdication of judicial duty, and the courts will now take the lead.”
Possibility of destruction and fragmentation
And when you start thinking about how new concepts will impact healthcare regulation, you begin to understand the potential scale of disruption and fragmentation in an environment where corporate lobbies are working to roll back regulations.
Hoffman, an expert in the field of health care law, noted that Medicare alone issues thousands of final rules each year. “And each of these are things that interested parties may pursue,” she said. “This includes previously challenged Medicare payment rules and Affordable Care Act (ACA) regulations, such as Section 1557, which prohibits discrimination on the basis of sex. What does it mean to discriminate on the basis of? And it also applies to health programs and activities that receive federal aid. Government agencies may have interpreted it more narrowly or more broadly. These include fraud and abuse rules, privacy rules, technology rules, labor rules, drug and device rules, and more.”
“Looking back at how chevrons have been used may not be telling the future,” Hoffman says. “We will end up with regulatory instability. roper bright—and the administrative state disintegrates its brethren. corner post and jerky and Ohio v. EPA (Environmental Protection Agency)—We don’t yet know how big it is. And more layers come into play. So what does that mean for healthcare? ”
New tools for industry lobbyists
“Healthcare is big business and it’s a lot of money, and this decision puts the power in the hands of these big and powerful companies to disrupt the regulatory process,” Hoffman said. “The most important thing about this is that these big, powerful companies have new tools. The second important thing to consider is the fact that healthcare regulation is vast and complex. If these companies want to challenge the regulations, they will have a lot of leverage.”
“Think about the Department of Health and Human Services (HHS),” Hoffman continued. “This is a large agency with operational departments and offices that include the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Indian Health Service (IHS). , the Food and Drug Administration (FDA), etc. And HHS is not the only agency that regulates healthcare. It is one of the most regulated areas. .”
Panelist Fernandez Lynch pointed to the complexity of the FDA and its work in relation to the new ruling. “The Food, Drug and Cosmetic Act is a very broad piece of legislation, with a lot of ambiguities, some with a purpose and others with a less purpose,” she said. “The way it works is that the FDA is directed to approve new drugs if there is ‘substantial evidence of efficacy.’ That’s the statutory language, ‘substantial evidence of efficacy.’ The law further refers to “appropriate” and “well-controlled trials.” But what is the definition of “substantive”? What is “adequate”? What does “well controlled” mean? This is at the heart of what FDA does in drug policy. Another part of the legislation relates to accelerated approval, which directs agencies to allow use of a route if there is an endpoint that is reasonably likely to predict clinical benefit, and Authorities have a great deal of discretion in interpretation. ”
limits of control
Fernandez-Lynch noted that the SCOTUS decision sought to limit the scope of decisions regarding the interpretation of ambiguous statutory text, especially when Congress had explicitly given agencies flexibility in interpretation. “So what the court said is basically that if something is ambiguous, Congress intended that the agencies should have the power to decide and the courts should decide. It should not be assumed,” she said. “But if Congress says, ‘We want the agency to resolve this issue,’ the courts will hold off in those situations. For example, people may want to know if the FDA’s decisions about a particular drug are currently They don’t seem particularly worried about getting into heavy litigation, because that’s clearly within the FDA’s flexibility granted by Congress.”
Fernandez-Lynch also noted that “another major challenge with relying on courts to interpret these based on new decisions is that different circuit courts rule on the same regulations in contradictory ways, so ultimately This could lead to a different verdict.” There is also the question of whether the courts can issue a national injunction to suspend the rules,” she continued. “This really raises the issue that while the regulations are being ironed out, they have not been applied consistently in different parts of the country for some time,” she said. “This actually puts pressure on the Supreme Court to accept and resolve these cases, but it also means more cases going to federal court and more claims to the Supreme Court. and the amount will increase as well.”
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