Decoding the Demise of Chevron Deference: Navigating the Future of Healthcare Regulation and Enforcement

The recent Supreme Court decision to overturn the Chevron Deference marks a significant shift in the regulatory landscape, with profound implications for federal healthcare agencies like the Centers for Medicare & Medicaid Services (CMS), the Assistant Secretary for Technology Policy , and the Centers for Disease Control and Prevention . This ruling could disrupt decades of regulatory practice and oversight to protect public health, underscoring the potential impact on the population's well-being.

The demise of Chevron Deference will, in my opinion, have significant consequences for federal healthcare agencies as they work to uphold patient safety and ensure access to quality care. With the increased scrutiny of their decisions and actions, these agencies may need to be more cautious and transparent in their regulatory processes. This could also result in longer wait times for new regulations or changes to existing ones, creating potential barriers to innovation. This ruling may have gone unnoticed by some healthcare organizations, who take for granted the support of innovation in the healthcare sector. However, for those professionals (myself included) who write the policies that govern the development and implementation of innovative solutions requiring federal oversight, a collective "The F_ck?" can be heard across the industry.

Understanding Chevron Deference

Chevron Deference, established by the 1984 Supreme Court case Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., is a doctrine that compels courts to defer to a federal agency's interpretation of ambiguous laws as long as the interpretation is reasonable. This principle has allowed agencies to use their expertise to effectively fill legislative gaps and enact regulations. Pay attention; "expertise" is the operative term.

These federal healthcare care agencies represent decades of research, policy development and implementation, oversight, and a mechanism for protecting the public. It also means the scholarship of doctors, researchers, and policy specialists; you get the gist.

As healthcare professionals, we need to understand the background and implications of this decision. The Chevron Deference was a legal doctrine that defaced federal agencies in interpreting ambiguous statutes, allowing them to exercise discretion in implementing regulations. However, the Supreme Court's ruling has now shifted the burden of interpretation back onto the courts, potentially leading to more challenges and delays in regulatory processes.

Why SCOTUS Ended Chevron Deference 🤔

In the 6-3 decision in Loper Bright Enterprises v. Raimondo, the Supreme Court concluded that Chevron Deference violated the Constitution's separation of powers by allowing the executive branch too much interpretive authority. Justices Clarence Thomas and Neil Gorsuch argued that it undermines judicial independence and overextends executive power. Chief Justice John Roberts emphasized that this decision returns interpretive authority to the judiciary, ensuring laws are interpreted without systemic bias toward government agencies. I was struck by John Roberts's audacity in mentioning bias. The call is coming from inside the house, sir.

Impact on Federal Healthcare Agencies: Let's break it down.

1. CMS: The end of Chevron Deference is expected to lead to increased litigation challenging CMS's regulatory decisions, particularly those involving ambiguous statutory language. For example, CMS's rules on reimbursement and minimum staffing requirements in nursing homes could face heightened scrutiny and legal challenges. Additionally, CMS may face more pressure to provide clear and comprehensive guidance in its rulemaking process. This could lead to longer timelines for finalizing regulations and potentially stifle innovation within the agency. Any pro who has had to wait for a final rule to be published will surely see this as an act of aggression towards healthcare agencies.

2. FDA: This ruling could also call into question the FDA's authority to regulate drug pricing and approvals. Without Chevron Deference, the courts may examine whether the FDA has exceeded its statutory authority in these areas. This could create uncertainty for pharmaceutical companies and potentially delay the approval of new drugs.

3. NIH: This decision may challenge the National Institutes of Health (NIH) 's funding decisions. For example, grants given to research projects that some deem controversial or politically charged could be subject to legal challenges without the protection of Chevron Deference, which could hinder crucial scientific research and progress.

4. ONC and CDC: These agencies may also experience constraints on their ability to implement new health IT standards and public health regulations. The ONC’s efforts to advance health IT interoperability and the CDC's public health directives could become more vulnerable to judicial challenges, potentially slowing down critical health initiatives.

5. Regulatory Caution and Inconsistency: Agencies will likely adopt a more cautious approach to rulemaking to mitigate the risk of litigation. This could slow the implementation of new health policies and create inconsistencies as different courts may interpret regulations variably across jurisdictions, leading to a fragmented regulatory environment.

Agencies at Risk

The most at-risk agencies include those that rely heavily on their regulatory authority to implement health and safety measures. The FDA, for instance, could face challenges to its rules on drug approval and laboratory-developed tests, potentially delaying the introduction of new medical products.

Are you starting to get the picture?

So, how can those of us in the media support the healthcare regulatory environment?

Healthcare media can play a crucial role in supporting the regulatory environment by:

1. Raising Awareness: Highlighting the potential risks and consequences of diminished regulatory oversight on public health.

2. Advocating for Clear Legislation: Encouraging legislators to draft more precise statutes to reduce ambiguities that lead to judicial challenges.

3. Promoting Expertise: Emphasizing the importance of agency expertise in making informed regulatory decisions that courts may lack.

4. Holding Agencies Accountable: Holding regulatory agencies accountable for their decisions and actions.

5. Facilitating Dialogue: Providing a platform for open dialogue between regulators, industry stakeholders, and the public to promote transparency and understanding.

By fulfilling these roles, healthcare media can help ensure that the regulatory environment is well-informed and effective and ultimately promotes the health and safety of the public. Without proper oversight and regulation, there is a risk of compromised patient care and potential delays in introducing life-saving medical products.

Additionally, healthcare media can support the regulatory environment by reporting successful cases where regulation has led to positive outcomes, such as improved patient safety or expedited approval processes for new medical products. This can help build trust in the regulatory process.

Future of Healthcare Regulation

The future of healthcare regulation by federal agencies will likely involve more direct congressional involvement to address statutory ambiguities. Agencies may need to work closely with lawmakers to ensure their regulatory frameworks are clear and less susceptible to judicial overturning. Additionally, the judicial system will now play a more prominent role in interpreting healthcare laws, which may lead to increased legal battles and a slower regulatory process. Let's be clear: no current SCOTUS justice has a competency in medicine or healthcare law. We're a long way from the days of Justice Harry Blackmon.

Here's the thing...,

The Supreme Court’s decision to end Chevron Deference fundamentally alters the balance of power between federal agencies and the judiciary. This shift poses significant challenges for healthcare regulation, potentially undermining the effectiveness of agencies tasked with protecting public health. It is crucial for stakeholders, including healthcare providers, policymakers, and the media, to navigate this new landscape thoughtfully to safeguard the health and well-being of U.S. citizens.

Sources:

1. SCOTUSblog on the Supreme Court decision to end Chevron Deference
2. Foley & Lardner LLP on the impact on federal health programs
3. Fierce Healthcare on the implications for CMS and other health agencies
4. AlPHA's statement on the potential disruption to public healthcare systems