The 21st Century Cures Act Part One: Overview

Overview

The 21st Century Cures Act (CURES) became law at the end of 2016 with broad bipartisan support. This series will discuss key aspects of this wide-ranging, 312-page act.

The CURES act addresses issues in the advancement of innovative medical products, creating pathways to remove barriers for development and bring those advancements to patients more quickly. The law covers a broad range of topics all addressing a goal to “…help modernize and personalize health care, encourage greater innovation, support research, and streamline the system…”. 

For many practicing physicians, CURES is synonymous with precision medicine or information blocking. However, the act itself is much broader in scope. CURES has far reaching consequences for not only physicians, but healthcare organizations, researchers, regulators and patients. The law focuses on research and drug development, as well as other areas that support medical innovation.

Some key provisions include:

• Funding geared towards:
  • Reducing opioid abuse
  • Precision medicine research
  • Research on medications and their implications in pregnancy and breastfeeding
  • Large research initiatives including:
    • The All of Us research program
    • The Brain Research through Advancing Innovative Neurotechnologies ® (BRAIN) Initiative
    • The Cancer Moonshot ℠
    • The Regenerative Medicine Innovation Project
  • Initiatives within the Food and Drug Administration (FDA), including:
    • Modification of the FDA drug approval process to allow the FDA to consider evidence noted in the real world, such as clinical outcome assessments, observational studies and claims data that can potentially reduce the need for dedicated clinical trials. Additionally, patient perspectives may now be included in the approval process.
    • Processes to facilitate FDA review for:
      • Selection biologics via the Regenerative Medicine Advanced Therapy (RMAT) designation.
      • Products that could improve treatment for life-threatening or permanently debilitating conditions via the Breakthrough Devices program.
      • Novel medications, such as genetic and variant protein targeted drugs for rare diseases.
    • Creating FDA inter-center institutes to coordinate between drug, biologics, and device centers and improve the regulation of combination products.
    • Relaxation of rules requiring informed consent for testing of drugs and devices that have minimal risk, while maintaining safeguards like institutional review boards.
    • Relaxation around regulation of medical software, previously considered by the FDA to be a medical device, exempting software functions used for administrative purposes, health lifestyle, electronic health records (EHRs), clinical lab test results and clinical decision tools. In particular, that the FDA should not regulate software that is unrelated to diagnosis, prevention, or treatment of disease, and encouraging a healthy lifestyle.
  • Behavioral health provisions addressing prevention and treatment of mental illnesses, substance abuse, coverage, communication permitted by the Health Insurance Portability and Accountability Act (HIPAA), and aspects of interactions with law enforcement and the criminal justice system.
  • The Qualified Small Employer Health Reimbursement Arrangement (QSEHRA) creating efficacies for small businesses to offer health insurance to their employees.
  • Provisions defining interoperability, driving for its expansion.
  • Prohibition of information blocking.

Impact to Practicing Physicians

Practicing physicians will feel the most impact from the items related to health IT (information blocking, interoperability, data access, medical applications etc.), mental health and HIPAA.

In the next part of this series, we will take a closer look at Information Blocking.

Resources:

Text of the CUREs Act

HIMSS Summary of CUREs Act

Federal Agencies Summaries for their respective domains

National Institutes of Health Summary

FDA Summary

ONC Summary

This article is brought to you by HIMSS Physician Committee members. The views and opinions expressed in this blog or by commenters are those of the authors and do not necessarily reflect the official policy or position of HIMSS or its affiliates and do not constitute legal or medical advice.