In Part One of our series on treatment and recovery legislation, we discussed The Comprehensive Addiction and Recovery Act (CARA). We introduced that piece by offering a brief description of the events that led to the opioid crisis, which led to the passage of three significant articles of legislation by Congress to address the crisis. CARA was the first of those three. In this article, we’ll discuss the second, The 21^st Century Cures Act. The third and final part of this series will discuss the SUPPORT Act.

Let’s get right into the 21^st Century Cures Act.

What is the 21^st Century Cures Act?

This act was introduced by Representative Suzanne Bonamici in January of 2016. It passed into law by the full Congress in December of the same year. The law creates new policy around research and treatment for mental health and substance use disorders. In addition, the law addresses several aspects of how the federal government funds and administrates various healthcare agencies and processes.

The first part of the act focused on the inner workings of the Food and Drug Administration (FDA).

We’ll offer a quick rundown of the FDA-related elements now. The act establishes and funds initiatives to:

• Incorporate patient perspectives into FDA process regarding the development of drugs, biological products, and medical devices
• Enhance the ability of the FDA to modernize clinical trials
• Improve the efficiency of developing and improving new medical products
• Create new institutes to coordinate communication regarding developments and activities in major disease research in order to improve the regulation of new products

That’s the first half of the act. It allocates five hundred million dollars to ensure the FDA has the resources to implement the law. It also establishes several benchmarks FDA administrators and scientists must meet to demonstrate their work product. These benchmarks create a forum for the FDA to receive feedback from Congress and all relevant stakeholders, including patients.

Now, we’ll discuss the aspects of the act most relevant to us: those that impact treatment and support for people living with mental health and alcohol/substance use disorders.

21^st Century Cures: Treatment and Recovery

The second half of the Act revolves around four large-scale initiatives:

1. A major reorganization of the top-level leadership at the Substance Abuse and Health Services Administration (SAMHSA). This reorganization includes:
   • The creation of the position of Assistant Secretary for Mental Health and Substance Use, to replace the position of Chief Administrator of SAMHSA.
   • The creation of a Chief Medical Officer at SAMHSA, to offer clinical perspective and ensure proper stewardship of service implementation
2. The codification of the Center for Behavioral Health Statistic and Quality (CBHSQ). The CBHSQ will oversee national surveys that track population-level behavioral health issues, such as the National Survey on Drug Use and Health (NSDUH).
3. The creation of the Interdepartmental Serious Mental Illness Committee (ISMICC). The committee will:
   • Ensure efficient coordination across all federal agencies that work in areas related to the needs of individuals (and their families) living with serious mental illnesses
   • Include members representing researchers, patients, families, criminal justice systems, and treatment providers
4. The creation of the National Mental Health and Substance Use Policy Laboratory (Policy Lab). The purpose of the Policy Lab is to:
   • Promote evidence-based practices for the treatment of mental illness and substance use disorders
   • Evaluate the practices developed by the Policy Lab
   • Enhance research on schizophrenia and schizoaffective disorders
   • Focus on developing new, evidence-based practices for the treatment of substance use disorders, with a special emphasis in opioid use disorders

This reorganization will, hopefully, streamline and improve the efficiency of all federal agencies that do work on mental health and substance use disorders. This includes how information is collected and presented, how agencies communicate and share information, and how new treatments and therapies are funded, developed, and approved.

When Government Acts

Government agencies and the bureaucracies they contain often respond slowly to developments on the ground that affect the day-to-day lives of U.S. citizens. There is no real silver lining to the opioid crisis. However, the response of the federal government, at least, is encouraging. It demonstrates that in times of need, large bureaucracies – including the federal government and the medical establishment – can work efficiently to enact public policy changes that help people sooner, rather than later. Both the Comprehensive Addiction and Recovery Act (CARA) and the 21^st Century Cures Act show government can and will respond in a timely manner when necessary – and when advocates exert enough pressure on them to act.

Coming next: Topics in Treatment Part Three – The SUPPORT Act.