Laws and regulations pertaining to substance abuse and mental health services, SAMHSA programs, and related topics
Federal Laws Related to SAMHSA
H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018, was made law to address the nation’s opioid overdose epidemic. The legislation includes provisions to strengthen the behavioral health workforce through increasing addiction medicine education; standardize the delivery of addiction medicine; expand access to high-quality, evidence-based care; and cover addiction medicine in a way that facilitates the delivery of coordinated and comprehensive treatment. The Support Act followed the passage of the Comprehensive Addiction and Recovery Act (CARA) and the 21st Century Cures Act in the previous Congress.
The Support Act has many important provisions, a few of which are:
- State Targeted Response Grants (STR): Reauthorizes and modifies the State Targeted Response grants from the 21st Century Cures Act to provide funding to Tribes and to improve flexibility for states in using the grants.
- First Responder Training: Continues a program that trains first responders to administer drugs for an opioid overdose and expands the program to include training on safety around fentanyl.
- Comprehensive Opioid Recovery Centers: Authorizes a grant program to establish comprehensive opioid recovery centers that will provide individuals with opioid use disorder (OUD) holistic care, including all FDA-approved MAT, counseling, recovery housing, job training, etc.
- Requires HHS to issue best practices for recovery housing. Also requires HHS to identify or facilitate the development of common indicators that could be used to identify potentially fraudulent recovery housing operators.
21st Century Cures Act
In December 2016, the 21st Century Cures Act was signed into law. The Cures Act addresses many critical issues including leadership and accountability for behavioral health disorders at the federal level, the importance of evidence-based programs and prevention of mental and substance use disorders, and the imperative to coordinate efforts across government.
The Cures Act established the position of Assistant Secretary for Mental Health and Substance Use. The Cures Act codified the role of the Chief Medical Officer, which provides a clinical perspective at the national level that is imperative to sound stewardship and implementation of high quality, effective services. The Act also codified the Center for Behavioral Health Statistics and Quality (CBHSQ), which serves as the federal government’s lead agency for behavioral health statistics. CBHSQ conducts national surveys tracking population-level behavioral health issues, including the National Survey on Drug Use and Health.
The Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC) was created by the Cures Act to ensure better coordination across the entire Federal Government related to addressing the needs of individuals with serious mental illness or serious emotional disorders and their families. The Committee represents collaboration across multiple Departments and fourteen non-federal members representing treatment providers, researchers, patients, families, criminal justice systems, and others also participate in the ISMICC.
The Cures Act created the National Mental Health and Substance Use Policy Laboratory (Policy Lab). The Policy Lab is working to promote evidence-based practices and service delivery models, and evaluating models that would benefit from further development and expansion. In particular, the Policy Lab is focusing on schizophrenia and schizoaffective disorder, as well as other serious mental illnesses. It is also focusing on evidence-based practices and services for substance use disorders with an emphasis on opioids.
Comprehensive Addiction and Recovery Act (CARA)
The Comprehensive Addiction and Recovery Act (CARA) of 2016 authorizes over $181 million each year (must be appropriated each year) to respond to the epidemic of opioid abuse, and is intended to greatly increase both prevention programs and the availability of treatment programs. CARA launched an evidence-based opioid and heroin treatment and interventions program; strengthened prescription drug monitoring programs to help states monitor and track prescription drug diversion and to help at-risk individuals access services; expanded prevention and educational efforts—particularly aimed at teens, parents and other caretakers, and aging populations—to prevent the abuse of opioids and heroin and to promote treatment and recovery; expanded recovery support for students in high school or enrolled in institutions of higher learning; and expanded resources to identify and treat incarcerated individuals suffering from addiction disorders promptly by collaborating with criminal justice stakeholders and by providing evidence-based treatment. CARA also expanded the availability of naloxone to law enforcement agencies and other first responders to help in the reversal of overdoses to save lives. CARA also reauthorizes a grant program for residential opioid addiction treatment of pregnant and postpartum women and their children and creates a pilot program for state substance abuse agencies to address identified gaps in the continuum of care, including non-residential treatment services.
Affordable Care Act (ACA)
The Affordable Care Act of 2010 is one aspect of a broader movement toward reforming the health care system. The Affordable Care Act makes health insurance more affordable for individuals, families, and small business owners. People living with mental health challenges or substance use disorders often have problems getting private health insurance. Now there are special insurance protections to help.
Tribal Law and Order Act (TLOA)
The purpose of the TLOA (PDF | 210 KB) of 2010 is to institutionalize reforms within the federal government so that justice, safety, education, youth, and alcohol and substance abuse prevention and treatment issues relevant to Indian country remain the subject of consistent focus, not only in the current administration, but also in future administrations. The law requires a significant amount of interagency coordination and collaboration between the Department of Justice (DOJ), the Department of the Interior (DOI), and the Department of Health and Human Services (HHS).
Mental Health Parity and Addiction Equity Act
The Mental Health Parity and Addiction Equity Act of 2008 requires insurance groups offering coverage for mental health or substance use disorders to make these benefits comparable to general medical coverage. Deductibles, copays, out-of-pocket maximums, treatment limitations, etc., for mental health or substance use disorders must be no more restrictive than the same requirements or benefits offered for other medical care.
- About the Mental Health Parity and Addiction Equity Act
- Interim Final Rules Under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008; Final Rule (45 CFR Part 146) (PDF | 361 KB)
Americans with Disabilities Act (ADA)
The Americans with Disabilities Act (ADA) of 1990, as amended in 2008, establishes requirements for equal opportunities in employment, state and local government services, public accommodations, commercial facilities, transportation, and telecommunications for citizens with disabilities—including people with mental illnesses and addictions.
Sober Truth on Preventing (STOP) Underage Drinking Act
The STOP Act of 2006 authorized:
- A grant program providing additional funds to current or former grantees under the Drug Free Communities Act of 1997 to prevent and reduce alcohol use among youth ages 12-20
- A national, adult-oriented public service media campaign
- The federal Interagency Coordinating Committee on the Prevention of Underage Drinking, which provides high-level leadership from SAMHSA and other federal agencies to coordinate federal efforts to prevent and reduce underage drinking. The coordinating committee is also responsible for providing an annual report to Congress.
Garrett Lee Smith Memorial Act
The Garrett Lee Smith Memorial Act (PDF | 180 KB), signed into law in October 2004, was the first legislation to provide funding specifically for youth suicide prevention programs. Under this legislation, funding was set aside for campuses, states, tribes, and U.S. territories to develop, evaluate, and improve early intervention and suicide prevention programs. This funding appropriation authorizes the GLS Suicide Prevention Program, which is administered by the SAMHSA Center for Mental Health Services (CMHS).
Children’s Health Act
The Children’s Health Act of 2000 (PDF | 531 KB) reauthorizes SAMHSA programs that work to improve mental health and substance abuse services for children and adolescents. It also provides SAMHSA the authority to implement proposals that give U.S. states more flexibility in how they use block grant funds, with accountability based on performance. The Act also allows SAMHSA to consolidate discretionary grant authorities, which provides the Secretary of HHS with more flexibility to respond to individuals and communities in need of mental health and substance abuse services. It also provides a waiver from the requirements of the Narcotic Addict Treatment Act, allowing qualified physicians to dispense (and prescribe) Schedule III, IV, or V narcotic drugs, or combinations of such drugs, approved by the Food and Drug Administration (FDA) to treat heroin addiction. Additionally, the Act provides a comprehensive strategy to combat methamphetamine use.
Federal Regulations Related to SAMHSA
Federal regulations apply to states, local governments, and religious organizations that receive Substance Abuse Prevention and Treatment Block Grants or Projects for the Assistance in the Transition from Homelessness Formula Grants, or both. The following federal regulations apply to states, local governments, and religious organizations that receive discretionary funding to pay for substance use prevention and treatment services:
The following federal regulations detail grant application procedures for states and Indian tribes to support local community emergency response related to substance use and mental illness:
Protection and Advocacy for Individuals with Mental Illness Program
The following federal regulations detail the requirements of protection and advocacy services receiving federal assistance under the Protection and Advocacy for Mental III Individuals Act of 1986:
The Synar Amendment to the Alcohol, Drug Abuse, and Mental Health Administration Reorganization Act of 1992 requires states to enact and enforce laws prohibiting the sale or distribution of tobacco products to anyone under the age of 18.
The SAMHSA Center for Substance Abuse Prevention oversees implementation of the Synar Amendment and can withhold Substance Abuse Prevention and Treatment Block Grant funds from states that do not comply with the Synar requirements.
- Tobacco Regulation for Substance Abuse Prevention and Treatment Block Grants: Final Rule - January 19, 1996 (PDF | 259)
Learn more about SAMHSA’s Synar program.
Mandated by Executive Order 12564 and Public Law 100-71, the Federal Drug-Free Workplace Program is a comprehensive program that:
- Addresses illegal drug use by federal employees
- Certifies executive agency drug-free workplace plans
- Identifies safety-sensitive positions subject to random drug testing
The SAMHSA Center for Substance Abuse Prevention is responsible for oversight of HHS-certified laboratories operating under the mandatory guidelines for federal workplace drug testing programs.
The following Federal Register notice announces proposed revisions to the mandatory guidelines for the federal workplace drug testing programs. The guidelines establish the scientific and technical procedures for federal workplace drug testing programs and establish standards for the certification of laboratories engaged in drug testing for federal agencies:
- Notice of Proposed Changes to the Mandatory Guidelines for the Federal Workplace Drug Testing Programs - April 13, 2004 (PDF | 409 KB)
The following Federal Register notice details the final notice of revisions to the mandatory guidelines for the federal workplace drug testing programs:
The following Federal Register notice highlights a correction to the effective date of the revisions to the mandatory guidelines for the federal workplace drug testing programs published in the Federal Register on November 25, 2008:
- Mandatory Guidelines for Federal Workplace Drug Testing Programs - December 10, 2008 - Corrections to the Effective Date (PDF | 138 KB)
Learn more about SAMHSA’s drug-free workplace programs.
In the United States, treatment of opioid dependence with opioid medications is governed by Federal Regulation 42 CFR Part 8, which provides for an accreditation and certification-based system for opioid treatment programs. The regulation acknowledges that addiction is a medical disorder that may require differing treatment protocols for different patients.
The Division of Pharmacologic Therapies, part of the SAMHSA Center for Substance Abuse Treatment, is responsible for overseeing accreditation standards and certification processes.
The following federal regulations specify the procedures for the certification of opioid treatment programs to dispense opioid drugs in the treatment of opioid addiction:
Learn more about medication-assisted treatment.
Patient Record Confidentiality
The following federal regulations specify restrictions concerning the disclosure and use of patient records pertaining to substance abuse treatment that federal programs maintain:
- Confidentiality of Alcohol and Drug Abuse Patient Records (CFR Title 42: Part 2)
- FAQ: Applying the Substance Abuse Confidentiality Regulations (CFR Title 42: Part 2)
Other Federal Regulations Related to SAMHSA
Many federal regulations related to SAMHSA are listed under Title 42: Public Health of the Code of Federal Regulations (CFR). The regulations are accessible online in the e-CFR, an up-to-date electronic posting of the CFR: