The Difference Between a Law and a Regulation in Healthcare, Post-Chevron

The distinction between laws and regulations is a fundamental aspect of governance in the United States, particularly in highly regulated sectors such as healthcare.

With the recent fall of the Chevron deference standard, which historically granted federal administrative agencies broad interpretive authority over ambiguous statutes, the balance of power between legislatures, agencies, and courts is poised to shift significantly. This article explores the differences between laws and regulations in healthcare, and examines how the change in the Chevron doctrine might affect their interpretation and implementation.

What Is a Law?

A law is a formal rule established by a legislative body, such as Congress at the federal level or state legislatures at the state level. Laws are enacted through a defined legislative process, which typically involves proposal, committee review, debate, voting, and executive approval or veto. In healthcare, major laws that shape policy and practice include the following:

• The Patient Protection and Affordable Care Act (PPACA) (2010) – Overhauled the U.S. healthcare system by expanding insurance coverage, creating health exchanges, and introducing consumer protections.

• The Health Insurance Portability and Accountability Act (HIPAA) (1996) – Established standards for protecting patient health information.

• The Medicare and Medicaid Acts (1965) – Created government-funded healthcare programs for the elderly, disabled, and low-income individuals.

• The 21st Century Cures Act (2016) – Accelerated medical innovation and streamlined Food and Drug Administration (FDA) approval processes for new drugs and devices.

Laws are typically broad frameworks that outline objectives and general principles, but leave the details of implementation to regulatory agencies.

What Is a Regulation?

Regulations are specific rules developed by administrative agencies to implement, enforce, and clarify the laws passed by legislatures. In healthcare, agencies such as the U.S. Department of Health and Human Services (HHS), the Centers for Medicare & Medicaid Services (CMS), and the FDA create and enforce regulations that give practical effect to statutory mandates.

For example:

• CMS regulations define how hospitals and providers must comply with Medicare and Medicaid rules.
• FDA regulations set standards for drug approval, medical device safety, and labeling requirements.
• The Office for Civil Rights (OCR) under HHS enforces HIPAA privacy and security standards.

Regulations undergo a rulemaking process that includes a period of public comment, analysis, and final adoption. These rules carry the force of law, but are subject to judicial review and potential legislative override.

Impact of the Fall of the Chevron Standard

The Chevron U.S.A., Inc. v. Natural Resources Defense Council (1984) decision established a doctrine that directed courts to defer to an agency’s interpretation of an ambiguous statute, provided that the interpretation was reasonable. This principle allowed agencies to exert significant influence over regulatory matters, especially in complex fields like healthcare.

With the fall of the Chevron standard, courts are now likely to exercise greater scrutiny over agency interpretations of statutes. This could have profound implications for healthcare, including:

1. Increased Judicial Oversight – Courts may now play a larger role in interpreting healthcare laws, potentially leading to more litigation over agency regulations.

2. Regulatory Uncertainty – Agencies like CMS and the FDA may face more challenges when implementing new policies, as their authority to interpret laws without explicit legislative guidance is reduced.

3. Slower Policy Implementation – Without Chevron deference, agencies may need clearer legislative authorization before enacting significant changes, slowing down the regulatory process.
4. Greater Congressional Responsibility – Congress may need to draft more precise healthcare legislation to minimize ambiguity and reduce reliance on agency interpretation.

5. Industry Challenges – Healthcare providers, insurers, and pharmaceutical companies may experience increased regulatory instability as courts reassess agency rules and interpretations.

Conclusion

The distinction between laws and regulations remains a cornerstone of the U.S. legal system. Laws provide the broad framework, while regulations fill in the details necessary for implementation. However, with the fall of the Chevron deference standard, the regulatory landscape in healthcare is set for significant transformation.

Courts will now wield greater authority in interpreting healthcare laws, potentially reshaping how regulations are developed and enforced. This shift underscores the need for legislative clarity and judicial consistency to ensure that healthcare policies remain effective and adaptable to the needs of patients and providers alike.