Laws and Regulations
Laws and regulations pertaining to substance abuse and mental health services, SAMHSA programs, and related topics.
Federal Laws Related to SAMHSA
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.
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
The Consolidated Appropriations Act, 2023 (PDF | 4.1 MB) (Public Law 117–328) (CAA, 23) was enacted in December of 2022. The CAA, 23 funded SAMHSA for Fiscal Year 2023 and included several provisions that reauthorized, strengthened, and expanded mental health and substance use disorder (MH/SUD) programs administered by SAMHSA. The law builds upon previous MH/SUD related law including the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), the 21st Century Cures Act, and the Comprehensive Addiction and Recovery Act (CARA).
The CAA 23 contained many provisions that fall under SAMHSA’s jurisdiction. Many of these provisions are organized by SAMHSA’s five key priorities:
- Preventing Substance Use and Overdose – Reauthorized the State Opioid Response program, reauthorized and renamed the substance use block grant, reauthorized several CARA and 21st Century Cures substance use programs, included additional Part 8 rule language, repealed the requirement for providers who prescribe medications for opioid use disorder to obtain a waiver and implemented new education requirements for these prescribers.
- Enhancing Access to Suicide Prevention & Mental Health Services - Codified the Behavioral Health Crisis Coordinating Office and the Mental Health Crisis Response Partnership Pilot Program; required SAMHSA to engage in crisis care coordination with our sister agencies, reauthorized the Garret Lee Smith and adult suicide programs, reauthorized the Mental Health Block Grant and codified the block grant’s crisis set aside.
- Promoting Resilience and Emotional Health for Children, Youth & Families – Established the Maternal Mental Health Task Force, extended the Pregnant and Postpartum Women Program state pilot; reauthorized the Children’s Mental Health Initiative, reauthorized the Sober Truth on Preventing Underage Drinking Act (STOP Act), and reauthorized the Infant Early Childhood Mental Health grant program.
- Integrating Behavioral and Physical Health Care – Reauthorized the Primary and Behavioral Health Care Integration Grant and required a 10% set-aside to support the psychiatric Collaborative Care Model.
- Strengthening the Behavioral Health Workforce – Codified the Center of Excellence on Eating Disorders, authorized the Mental Health Peer Support Program, and reauthorized the Minority Fellowship Program.
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.
The Garrett Lee Smith Memorial Act (PDF | 161 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).
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.
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.
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.
The purpose of the TLOA (PDF | 193 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).
Federal Regulations Related to SAMHSA
Federal regulations apply to states, local governments, and religious organizations that receive Substance Use Prevention, Treatment, and Recovery Services Block Grant 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:
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 | 375 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 | 106 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.
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.
The following federal regulations specify restrictions concerning the disclosure and use of patient records pertaining to substance abuse treatment that federal programs maintain:
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 Use Prevention, Treatment, and Recovery Services Block Grant funds from states that do not comply with the Synar requirements.
- Tobacco Regulation for Substance Use Prevention, Treatment, and Recovery Services Block Grants: Final Rule - January 19, 1996 (PDF | 264 KB)
Learn more about SAMHSA’s Synar program.