• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • NSCLC
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

APA now the main control over new PPACA rules

Article

Health reform provisions must be deemed lawful by the Administrative Procedure Act.

CHECKS ON AUTHORITY

Most PPACA regulations are, or will be, subject to section 553 of the APA, which prescribes the fundamental requirement of "notice and comment" for most "rule-making." Among other requirements, agencies must publish notice of proposed rules and solicit comments before issuing any final rule.

Final rules must generally be published at least 30 days before the rule becomes effective. Regulations violating these procedures are subject to challenge under APA Section 706.

Moreover, any regulation that is arbitrary, capricious, an abuse of discretion, unlawful, contrary to constitutional right, or in excess of statutory jurisdiction or authority is subject to challenge in court. Indeed, ensuring that regulations satisfy these core requirements is an important check against agency actions in excess of their authority and will help ensure that PPACA is implemented properly and in accordance with the law.

Recently, the Eternal World Television Network (EWTN) and Legatus filed complaints against the Department of Health and Human Services (HHS), the Department of Labor and the Department of the Treasury. These plaintiffs contend that the agencies violated Section 553 of the APA in promulgating regulations to implement PPACA.

The complaints specifically challenge an interim final rule promulgated by HHS, Labor and Treasury, which required all group health plans and insurers offering group or individual plans to provide certain contraceptives, forcing individuals to violate deeply held religious beliefs. In addition to challenging these regulations on constitutional grounds, the plaintiffs' allege the regulations were illegal for violating the APA by failing to provide sufficient prior notice and time for public comment.

Other similar challenges are likely to follow. Given the outcome of the Supreme Court challenge, the APA now becomes the critical means by which the nature and reach of regulatory actions can be controlled. Thus, the regulations being promulgated to implement PPACA are a fertile battleground for disputes on how the United States' healthcare system should actually function on a day-to-day basis.

The cases discussed above are the beginning of what is very likely to be an extended struggle.

This column is written for informational purposes only and should not be construed as legal advice.

Phillip R. Seckman is a partner with McKenna Long & Aldridge LLP.

Amy Siadak is an associate with McKenna Long & Aldridge LLP.

Related Videos
Video 8 - "Risk and Value-Based Contracting for Prescription Drug Therapeutics and Manufacturer’s Support in Utilization"
Video 7 - "Prescribing Prescription Drug Therapeutics: Factors for Providers and Payers to Consider"
Video 9 -"Overcoming Implementation Barriers for Digital Therapeutics Adoption"
Video 6 - "Failing to Reach Ideal Diabetes Care: Equitable Doesn’t Mean Equal"
Video 5 - "Revising Diabetes Outcome Measures"
Video 6 - "Navigating Insurance Coverage for Prescription Digital Therapeutics"
© 2024 MJH Life Sciences

All rights reserved.