By: Christopher A. Parrella, Esq., CPC, CHC, CPCO
Parrella Health Law, Boston, Ma.
A Health Law Defense and Compliance Firm

In a landmark decision, the Supreme Court significantly restricted federal agencies’ authority to regulate industries, impacting healthcare regulation. The 6-3 ruling challenges the Chevron doctrine, which allowed agencies to interpret their regulatory powers broadly since 1984. This shift means courts will now play a more prominent role in resolving statutory ambiguities, potentially leading to increased litigation in the healthcare sector.

For decades, agencies like Medicare, Medicaid, and the FDA operated under Chevron, issuing sweeping regulations without much judicial interference. The ruling suggests that agencies must now provide more explicit justifications tied to statutory texts when making regulations. Chief Justice John Roberts emphasized that agencies lack the special competence in resolving statutory ambiguities that courts possess.

This decision is poised to impact multiple areas within healthcare. Pharmaceutical companies, hospitals, and insurers might challenge Medicare’s drug price negotiation program, payment reductions, and fraud and abuse laws more aggressively. Legal experts predict a surge in litigation, as healthcare entities previously deterred by Chevron’s broad deference to agencies will now see a more favorable landscape for contesting regulations.

The ruling could also hinder the FDA’s regulatory processes. Known for its scientific and clinical expertise, the FDA might face delays and increased litigation as its decisions come under closer judicial scrutiny. This could lead to inconsistent regulations across different jurisdictions, complicating compliance for healthcare providers and manufacturers.

The ruling’s broader implications suggest a more cautious approach from federal agencies during public health emergencies. The ability to implement temporary rules, as seen during the COVID-19 pandemic, may be curtailed, potentially slowing the government’s response to future crises.

Additionally, the decision could weaken protections under the Americans with Disabilities Act (ADA). Agencies expanding ADA mandates to cover new technologies and settings might face more legal challenges, complicating efforts to enhance accessibility.

Healthcare providers should prepare for a more litigious environment and closely monitor how this ruling affects regulations and compliance requirements. For detailed guidance and assistance in navigating these changes and how they may positively affect your health care provider, contact Parrella Health Law at 857.328.0382 or email me directly cparrella@parrellahealthlaw.com. Our team is dedicated to supporting healthcare professionals through these evolving regulatory landscapes.

Christopher Parrella, ESQ, CPC, CHC, CPCO, is the founding partner of Parrella Health Law in Boston, Mass. The firm focuses exclusively on healthcare defense and compliance matters. Chris also travels the country on behalf of a wide range of healthcare organizations, lecturing on a variety of health care enforcement and compliance topics. Chris is one of a handful of health care attorney’s that are also Certified Professional Coders (CPC) and is a member of the AAPC’s National Legal Advisory Board and Ethics Committee.  He is also a Certified Professional Compliance Officer (CPCO) and Certified in Health Care Compliance (CHC.)