December 14, 2016
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016 but not advanced by the Senate. A substantial portion of the legislation relates to mental health and substance use disorders, reflecting the rise in mental health and substance use disorder awareness over the last several years. This On the Subject discusses the applicable provisions related to mental health and substance use disorders. Our continuing coverage of the 21st Century Cures Act addresses additional titles and provisions.
On December 7, 2016, the US Congress approved the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and approval processes, among other things. The massive bill also serves as a vehicle for a variety of other health-related measures, including portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016 but not advanced by the Senate.
A substantial portion of the 900+-page legislation relates to mental health and substance use disorders, in line with the rise in mental health and substance use disorder awareness over the last several years. The Act reflects a shift in thinking about the treatment of such disorders, which in the past was typically offered separate from other types of health care treatment, but now is more commonly integrated into physical care settings. The Cures Act calls for enhanced cooperation among agencies, provides funding for the development of innovative evidence-based models of treatment, provides for additional resources within the US Department of Health and Human Services (HHS), and includes a variety of provisions addressing mental health and substance use disorders within the context of law enforcement and judicial proceedings. The Act also enhances opportunities available under Medicaid waiver programs regarding mental health and substance use disorder treatment.
Most notably from a reimbursement perspective, the Cures Act reflects a concern that the expected parity in reimbursement for mental health treatment (per the Mental Health Parity and Addiction Equity Act of 2008) has not been achieved. The Act includes substantial requirements that HHS, the US Department of the Treasury and the US Department of Labor (DOL) develop compliance guidance (including detailed examples) related to the manner in which health plans address quantitative and non-quantitative limits related to behavioral health. The Act calls for increased “consumer friendliness” regarding parity expectations for mental health and substance use disorder treatment. Finally, the Cures Act allocates substantial funding ($1 billion over two years) to assist states in combatting the opioid and heroin abuse epidemic. The Cures Act does not make substantial changes in federal privacy laws or other controlling data use provisions, however, and therefore data sharing initiatives to coordinate the care of patients dealing with mental health or substance use disorders with other types of care may remain frustrated.
Increased Reimbursement and Funding for Mental Health and Substance Use Disorder Services
Medicaid Mental Health Coverage (Sections 12001 to 12006)
The Cures Act enhances Medicaid reimbursement for services related to mental health and substance use disorders. Chiefly, the Act clarifies that separate payment for the provision of mental health and primary care services provided to an individual on the same day is not prohibited under Medicaid, and, effective January 1, 2019, children receiving Medicaid-covered inpatient psychiatric hospital services are eligible for the full range of early and periodic screening, diagnostic and treatment services.
Additionally, the Act requires the Administrator of the Centers for Medicare and Medicaid Services (CMS) to take specific actions relating to mental health and substance use disorder treatment. First, the Administrator must conduct a study and submit a report to Congress within three years of the enactment of the Act on the provision of care to adults aged 21 to 65 enrolled in Medicaid managed care plans who are receiving treatment for a mental health disorder in an Institution for Mental Diseases. Second, within one year of enactment of the Act, the CMS Administrator must issue a State Medicaid Director letter on opportunities to design innovative service delivery systems to improve care for individuals with serious mental illness or serious emotional disturbance. Third, the CMS Administrator must collect, analyze and—no later than two years after enactment of the Cures Act—report on data from states that participated in the Medicaid Emergency Psychiatric Demonstration Project established under Section 2707 of the Affordable Care Act.
Mental Health Parity (Sections 13001 to 13007)
The Cures Act takes steps to strengthen enforcement of mental health parity laws in a number of ways. First, it requires the HHS, DOL and Treasury to release compliance program guidance with illustrative examples of past findings of compliance and noncompliance with existing mental health parity requirements, including disclosure requirements and both quantitative and non-quantitative treatment limitations. Second, it requires HHS to issue guidance to assist health plans in complying with mental health parity requirements. Finally, the Act provides the Secretaries of HHS, Labor and Treasury with the authority to audit health plans to assess their compliance with mental health parity laws.
To ensure measurable success in enforcement of mental health parity laws, the Act requires HHS to produce an action plan for improved federal and state coordination related to the enforcement of mental health parity requirements. The action plan is expected to build on the recommendations of President Obama’s Mental Health and Substance Use Disorder Parity Task Force Final Report released in October 2016. Specifically, the action plan must identify strategic objectives regarding how the various federal and state agencies charged with enforcement of mental health parity and substance use disorder equity requirements will collaborate to improve enforcement, and must provide a timeline for when such objectives shall be met and examples of how they will be met. Further, the Act requires the US Government Accountability Office (GAO), within three years of enactment of the Act, to conduct a study on the enforcement of existing mental health parity requirements, including compliance with non-quantitative treatment limitations; an assessment of how the Secretary has used its authority to conduct audits; a review of how the various federal and state agencies responsible for enforcing mental health parity requirements have improved enforcement; and recommendations for additional enforcement, education and coordination activities.
The Cures Act specifically aims to help men and women with eating disorders. This is the first time Congress has passed a bill that directly addresses eating disorders and their resultant harms. The Act dictates that group plans or individual health insurers that provide coverage for eating disorder benefits, including residential treatment, must provide such coverage consistent with mental health parity requirements. The Act also allows HHS, through the Director of the Office on Women’s Health, to update resource lists and fact sheets related to eating disorders, and to increase public awareness of the following:
Further, the Act allows HHS to facilitate the identification of model programs and materials for educating and training health professionals in effective strategies to identify individuals with eating disorders, provide early intervention services, refer patients to appropriate treatment, prevent the development of eating disorders and provide appropriate treatment to individuals with eating disorders.
State Response to the Opioid Abuse Crisis (Section 1003)
A focal point in the diagnosis, treatment and prevention of substance use disorders has been the United States’ opioid abuse crisis. The Cures Act provides $1 billion over two years for grants to states to supplement opioid use prevention and treatment activities, such as improving prescription drug monitoring programs, implementing prevention activities, developing and providing training to health care providers, and expanding access to opioid treatment programs. The Act also attempts to provide accountability without increased burden on states by requiring grantees to report on activities funded by the grant in a substance use disorder block grant report.
Mental Health and Safe Communities (Sections 14001 to 14029)
The Cures Act provides several initiatives to increase community awareness, prevention and treatment of mental health and substance use disorders. Consistent with the thematic changes throughout the Act, the Cures Act shifts the focus from criminalization to crisis intervention and prevention. As part of that shift, the Act amends the Byrne Justice Assistance Grant Program to allow law enforcement to use funds for the creation of mental health response and corrections programs, including police crisis intervention teams. It also provides increased funding to train and educate state and federal law enforcement personnel and first responders on crisis de-escalation. Such initiatives include funding the federal Drug Court Grant Program to be used for the training of drug court professionals to identify and respond to these co-occurring disorders, and authorizing funding for the US Department of Justice (DOJ) VALOR Initiative to provide crisis response training and active-shooter training for federal, state and local law enforcement officials. To analyze the effectiveness of these training and education efforts, the GAO is required to submit a report to Congress detailing (1) the practices and procedures that federal first responders, tactical units and corrections officers are trained to use in responding to individuals with mental illness; (2) the application of evidence-based practices in criminal justice settings; and (3) recommendations on how the DOJ can improve information sharing and dissemination of best practices.
The Act provides for an increase in the data used in the criminal justice system to analyze the prevalence of offenders with mental health and substance use disorders. Specifically, the Act amends the America’s Law Enforcement and Mental Health Project Act to allow state and local governments to use funds for the creation and deployment of behavioral health risk and needs assessments for mentally ill individuals in the criminal justice system. The Act also requires the Attorney General to collect and disseminate data regarding the involvement of mental illness in all homicides, as well as in deaths or serious bodily injuries involving law enforcement officers. Further, the Act requires the Comptroller General of the United States to submit a report to Congress detailing the federal, state and local costs of imprisonment for individuals with serious mental illness, including the number and types of crimes committed by mentally ill individuals.
The Act establishes funding for various community-based initiatives aimed at preventing and treating mental health and substance use disorders. The Act reauthorizes and amends the Mentally Ill Offender Treatment and Crime Reduction Act (MIOTCRA) to allow state and local governments to use existing authorized grant funds for the operation of Forensic Assertive Community Treatment (FACT) Initiatives. FACT Initiatives provide high-intensity community-based services for individuals with mental illness who are involved in the criminal justice system. The amendment to the MIOTCRA also authorizes funds to award grants to nonprofit organizations for the creation of a National Criminal Justice and Mental Health Training and Technical Assistance Center, which would coordinate best practices for responding to mental illness in the criminal justice system and would provide technical assistance to governmental agencies that wish to implement these best practices.
The Act also amends the Residential Substance Abuse Treatment grant program to allot funds for the purpose of developing and implementing specialized residential substance abuse treatment programs that provide treatment to individuals with co-occurring mental health and substance use disorders.
Shifts in the National Approach to Mental Health and Substance Use Disorder Treatment
As noted previously, the Act demonstrates a change in language and attitudes regarding substance use disorders and behavioral health. In the legislation, Congress has shifted from using the term “substance abuse” to the term “mental health and substance use disorder.” This is not merely a change in nomenclature, but places substantive emphasis on the medical (disorder) as opposed to the criminal (abuse). Also, as discussed in further detail below, the Act encourages the integration of mental health and substance use disorder treatment into primary care.
Comprehensive Care Model (Section 9003)
To date, the health care system has been largely fractured between physical health and behavioral health. The Cures Act takes steps to bridge this gap. Specifically, the Act reauthorizes grants for comprehensive care models through the appropriation of $51.878 million for each of fiscal years 2018–2022. As part of this grant funding, the Act requires grant applicants to submit a plan to provide integrated services to patient populations with substance use disorders.
Compassionate Communication on HIPAA (Sections 11001 to 11004)
Per the Act, the sense of Congress is that the health care community is unsure of the permissible uses and disclosures of mental health and substance use disorder-related health information to family members and caregivers, and traces such confusion to the HIPAA regulations. The Act indicates that certain stakeholders feel that these HIPAA regulations have hindered the appropriate communication of health care information or treatment preferences. The sense of Congress is that clarification is necessary regarding existing permitted uses and disclosures of health information by health care professionals to caregivers of adults with serious mental illness, in order to facilitate care decisions in situations where serious mental health illness may affect the capacity of an individual to determine a course of treatment without assistance. The Cures Act requires the Director of the Office of Civil Rights to issue guidance that clarifies, among other things, the circumstances under which a health care provider may disclose protected health information of adults or minor patients to family members, caregivers, other individuals involved in the care of such patients, and law enforcement, particularly in situations where patients present a serious and imminent threat of harm to themselves or others.
HIPAA does not distinguish between different types of health information (except for psychotherapy notes as defined in 2 CFR 164.501), although state law and other federal laws often impose different regulatory obligations depending on the type of health information involved—for example, mental health and substance use disorder records. Although HIPAA imposes its own obligations that can be confusing or difficult to meet, in many cases the regulatory hurdle to sharing information about a patient’s mental health and substance use disorder stems not from HIPAA but from state law and the federal law specifically addressing substance use disorder information. The Cures Act proposes no changes, however, to the relevant provision of the Public Health Services Act pursuant to which the Part 2 regulations are promulgated. Although the Substance Abuse and Mental Health Services Administration (SAMHSA), the agency that enforces Part 2, has recently sought to modify the regulations to facilitate data sharing by and among health care providers, care coordinators, health plans and other stakeholders, any proposed regulatory changes are limited to what the statute would permit.
Instead of attempting to modify the underlying statute, the Act proposes that the Secretary convene relevant stakeholders one year after promulgation of the final modifications to Part 2 to determine the effect of the regulations on patient care, health outcomes and patient privacy. To fully realize mental health and substance use disorder parity, patients suffering from these conditions must be able to access the same integrated patient outreach and care coordination efforts as patients with other medical disorders. The eventual Part 2 final rule may help advance this cause, but further legislative action may still be necessary. This working group may assist in maximizing what can be achieved by regulation and may help to guide further congressional action in balancing efforts to reckon with the particular privacy risks posed by the unauthorized sharing of information related to an individual’s mental health and/or substance use disorder diagnosis or treatment with enabling such information to be shared sufficiently to ensure that the health care system’s approaching to caring for such patients is not hindered. In the interim, developers of digital health tools seeking to serve this patient population will need to develop and implement innovative consent models to comply with federal law.
Changes to Enhance Coordination Among Various Agencies (Sections 6002 and 6031)
With the understanding that it will take input from many stakeholders to help solve the growing problem of mental health and substance use disorders, the Cures Act provides for increased collaboration between state and federal agencies and local communities. As part of the collaborative effort, the Act creates a coordinating committee charged with evaluating federal programs related to serious mental illness and providing recommendations to better coordinate mental health services for people with serious mental illness. The committee is made up of HHS, CMS, DOJ, DOL, the US Department of Veterans Affairs (VA), the US Department of Defense (DOD), the US Department of Housing and Urban Development (HUD), the US Department of Education and the Social Security Administration, as well as patients, health care providers, researchers, a judge and a law enforcement officer. The committee will make recommendations to Congress for better coordination of mental health services for people with serious mental illness and serious emotional disorders. The committee sunsets six years after the enactment of the Act. Further, the Assistant Secretary of SAMHSA is required to collaborate with other federal departments, including the DOD, VA, HUD and DOL, to improve care for veterans and support programs addressing homelessness.
Strengthening Leadership and Accountability (Sections 6001 to 6009, and 6021 to 6023)
The Cures Act provides for several changes to the leadership and functions of SAMHSA to ensure that programs related to the prevention and treatment of mental illness and substance use disorders, and the promotion of mental health and recovery, are carried out in a manner that reflects the best available evidence-based practices. Specifically, the Cures Act establishes an Assistant Secretary for Mental Health and Substance Use to head SAMHSA and a Chief Medical Officer (CMO) within SAMHSA to (1) assist the Assistant Secretary in evaluating, organizing, integrating and coordinating programs within SAMHSA; (2) promote evidence-based best practices regarding the prevention and treatment of mental health and substance use disorders; and (3) assess the use of performance metrics to evaluate programs and activities, and ensure that such metrics are used to evaluate grant programs.
The Cures Act also codifies the existing Center for Behavioral Health Statistics and Quality to improve the quality of services provided by SAMHSA. The Act amends current law regarding the advisory councils for SAMHSA, Center for Substance Abuse Treatment (CSAT), Center for Substance Abuse Prevention (CSAP) and Center for Mental Health Services (CMHS) to (1) include the CMO and the Directors of the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute of Alcohol Abuse and Alcoholism as members of the applicable advisory councils; (2) ensure that at least half of the appointed advisory council members for CMHS have a medical degree, doctoral degree in psychology, or an advanced degree in nursing or social work, and specialize in mental health; and (3) ensure that at least half of the appointment advisory council members for CSAP and CSAT have a medical degree, doctoral degree or an advanced degree in nursing, public health, behavioral or social sciences, or social work, or are a certified physician assistant, and have relevant experience.
The Act also creates the Interdepartmental Serious Mental Illness Coordinating Committee to evaluate federal programs related to serious mental illness and provide recommendations to better coordinate mental health services for people with serious mental illness. The committee is made up of the Secretary of HHS, the Assistant Secretary for Mental Health and Substance Use, the Attorney General, the Secretary of Veterans Affairs, the Secretary of Defense, the Secretary of Housing and Urban Development, the Secretary of Education, the Secretary of Labor, the CMS Administrator and the Commissioner of Social Security, as well as patients, health care providers, researchers, a judge and a law enforcement officer. As part of its oversight activities, the Committee must, no later than one year after the date of enactment of the Act and five years thereafter, submit to Congress a report evaluating, summarizing and making recommendations regarding advances in serious mental illness and serious emotional disturbance research. The Committee will sunset six years after enactment of the Cures Act.
SAMHSA is required to develop a strategic plan no later than September 30, 2018, and every four years thereafter, for the planning and operation of activities carried out by SAMHSA, including evidence-based programs to increase access to quality services for individuals with mental and substance use disorders, and is required to collaborate with state and local government. The demand for mental health services is growing nationally, and with it there is an increasing shortage of mental health providers. To address this shortage, SAMHSA’s strategic plan must including a strategy for encouraging individuals to pursue careers as mental health professionals and for improving the recruitment, training and retention of the mental health workforce. SAMHSA must make biennial reports available to Congress containing a review of SAMHSA’s progress toward strategic priorities, goals and objectives identified in the strategic plan, as well as an assessment of programs and a description of coordination activities. The Cures Act also requires the Assistant Secretary to consult with stakeholders to improve community-based and other mental health services and improve the recruitment and retention of mental health and substance use disorder professionals.
The Cures Act provides for an increase in the oversight and accountability of mental health and substance use disorder programs. The Act establishes peer review groups made up of licensed and experienced professionals in the prevention, diagnosis, treatment of, or recovery from, mental illness or co-occurring mental illness and substance use disorders, that are charged with reviewing grants, cooperative agreements or contracts related to mental illness treatment. The Act also outlines the roles and responsibilities of the Assistant Secretary for Planning and Evaluation at HHS, which include developing a strategy for conducting ongoing evaluations of key programs across the agency within 180 days of enactment of the Helping Families in Mental Health Crisis Reform Act of 2016. Additionally, the GAO must conduct a study on programs funded under the Protection and Advocacy for Individuals with Mental Illness Act to review, among other things, (1) the programs carried out by states and private nonprofit organizations, (2) compliance with statutory and regulatory responsibilities, (3) responsibilities related to prospective clients or their family members, (4) availability of adequate medical and behavioral health treatment, and (5) denial of rights for individuals with mental illness.
Numerous Pilot Projects and Studies Established or Reauthorized to Support Initiatives Related to Mental Health and Substance Use Disorders (Sections 7001 to 7005, 8001 to 8004, and 9001 to 9003)
Many of the efforts in the Cures Act to address mental health and substance use disorders are facilitated through various pilot programs and focus on mental health and substance use disorder awareness, prevention, treatment and intervention. As it pertains to the various pilot programs and studies, the Cures Act:
Specific to efforts to increase and strengthen the health care workforce dedicated to mental health and substance abuse disorders, the Act:
Strengthening Mental Health and Substance Use Disorder Care for Specific Vulnerable Populations (Sections 10001 to 10006, and 14001 to 14029)
The Cures Act increases funding and initiatives aimed at certain vulnerable populations, including children, adolescents, women and non-violent offenders who suffer from mental health or substance use disorder issues. The Act reauthorizes and updates programs to provide comprehensive community mental health services to children with serious emotional disorders and provides for $119.026 million in funding for fiscal years 2018–2022. The Act also authorizes HRSA to award grants to promote behavioral health integration in pediatric primary care, including establishing eligibility requirements for statewide or regional pediatric mental health care telehealth programs in order to receive grant funding. As applicable to telehealth programs, the Act requires the state receiving the grant to match at least 20 percent of the federal funds. Further, the Act establishes a grant program to develop, maintain or enhance mental health prevention, intervention and treatment programs for infants and children at significant risk of developing or showing early signs of mental disorders, including serious emotional disorders, or social or emotional disability. Grant funding of $20 million for the period of fiscal years 2018–2022 is available for mental health prevention, intervention and treatment programs for infants and children; however, states that receive the grant funding must match at least 10 percent of the federal funds.
The Act reauthorizes and makes technical updates to grants for substance use disorder treatment and early intervention for children and adolescents to provide early identification and services, and appropriates $29.6 million for each of fiscal years 2018–2022. The Act also reauthorizes the National Child Traumatic Stress Initiative (NCTSI), which supports a national network of child trauma centers, including university, hospital and community-based centers and affiliate members. As part of the NCTSI, the Act encourages collaboration between NCTSI and HHS to disseminate evidence-based and trauma-informed interventions, treatments and other resources to appropriate stakeholders, and provides for $46.9 million for each of fiscal years 2018–2022 to support such collaboration.
The Act also provides for grant funding aimed at women who suffer from mental health disorders. Specifically, the Act establishes a grant program for states to establish, improve or maintain programs for screening assessment and treatment services for women who are pregnant, or who have given birth within the preceding 12 months, for maternal depression.
Consistent with the shift from criminalization to crisis prevention and intervention, the Act provides funding and initiatives to the criminal justice system to mitigate the criminalization of non-violent offenders with mental health and substance use disorders. The Act allows federal mental health court grant funds to be used for the creation of court-ordered outpatient treatment programs to prevent the escalation of mental health crises. Additionally, the Act requires the Attorney General and the Director of the Administrative Office of US Courts to create a Drug and Mental Health Court pilot program in at least one federal judicial district. As part of this program, low-level offenders who are mentally ill or addicted to narcotics would be eligible for diversion from prison if they comply with an intensive court-mandated treatment program. Many state and local governments operate similar problem-solving court programs, which have had success diverting eligible offenders, but under the current law, funding for such programs is allowable only for addressing substance abuse issues. Therefore, the Act updates the Treatment Alternative to Incarceration Program to allow state and local governments to use grant funds for these diversion programs for offenders with mental illness and co-occurring disorders. As part of the full spectrum of mental health and substance abuse disorder intervention, the Act amends the Second Chance Act to allow state and local governments to use re-entry demonstration project grant funds for the provision of mental health services, and to coordinate transitional services (including housing) for individuals re-entering society with mental illness, substance abuse problems or chronic homelessness. The initiatives aimed at non-violent offenders would likely reduce the risk of recidivism when a mentally ill offender is released.
For more information please contact Jason Caron, Jennifer Geetter, Karen Owen Gibbs, and Joel Rush.
This article previously appeared on www.mwe.com