Yesterday President Obama signed the 21st Century Cures Act into law. The bill represents a rare display of bipartisanship during a divided time. A good resource for starting to understand the Act is this two-page fact sheet put together by the House Committee on Energy and Commerce.
Much of the Act is devoted to improving research around Precision Medicine, Vice President Biden's "Cancer Moonshot" and the BRAIN initiative investigating the causes of neurological diseases such as Alzheimer's. The Act also modernizes and streamlines the FDA drug approval process. But there is also a significant percentage devoted to Health IT and behavioral/mental health and substance use disorders.
We've reviewed the full text of the law and pulled out these key provisions we felt might be of particular interest to eHana customers and industry stakeholders.
The HIT Impact
Programs and process
- Identifies a goal of reducing regulatory and administrative (paperwork) burdens related to the use of Electronic Health Records. This process will include a broad period of public comment and will specifically focus on the EHR documentation burden related to Meaningful Use (Medicare & Medicad), MIPS, APMs, and other value-based purchasing programs
- Directs the National Coordinator of Health IT to further encourage development and certification of technology in specialties and sites of service where no technology is available or more is needed (possibly including BH and LTSS?)
- Initiates a process for the collection of nationwide Meaningful Use statistics for both Medicare and Medicaid MU programs
- Redefines "interoperability" from a legislative and certification standpoint (with an eye towards "information blocking" preventing effective interoperability)
- Adds significant new "Conditions of Certification" and maintenance of certification for MU and related EHR certifications: vendors may not engage in any information blocking; may not contractually prohibit or restrict communication regarding EHR usability, interoperability, or security; must have published healthcare APIs; and must have successfully demonstrated real-world interoperability
- Reduces impact on providers if they're using a product that has been "decertified" through hardship exemptions
- Implements a significant new scheme to report on EHR security, usability, interoperability, conformance, etc. nationwide (note that the process "shall be designed to ensure that small and startup health information technology developers are not unduly disadvantaged by the reporting criteria")
- Empowers the HHS Office of the Inspector General to investigate claims of information blocking by individual providers and practices
Support for Trusted Data Exchange
- Creates a process for national standards for "network-to-network" (HISP-to-HISP) information exchange (the "Trusted Exchange Framework")
- Directs definition of common standards and methods for authenticating trusted participants, rules for trusted exchange, organizational best practices for exchange, and a process for filing and adjudicating noncompliance with terms of the national standard
- Provides a three-year process for development of a "Provider Digital Contact Information Index" for both individual providers and facilities -- a holy grail of interoperability -- that should, in conjunction with the Trusted Data Exchange framework, facilitate electronic interoperability nationwide
- Attempts to minimize disruption of the Trusted Exchange Framework on existing frameworks and agreements and exchange within single networks by requiring HHS to defer to HIT standards developed and used by the private sector
New Health IT Advisory Committee
- Supports the convening of a new unified HIT Advisory Committee committee to provide input on standards, certification, implementation specifics, etc., replacing the previous HIT Policy and HIT Standards Committees.
- Creates a framework for the Committee reporting on progress and setting HIT goals and benchmarks on an annual basis
- The Committee will include 25 members from across the healthcare industry and will serve for 3-year terms (limited to two terms).
HIT Impact Summary
Overall the 21st Century Cures Act provides a robust framework for continuing the successful adoption of Health IT standards and interoperable Electronic Health Records nationwide. Many of the provisions are devoted to adapting to the reality of widely-adopted Health IT, while attempting to fill in the gaps where technology adoption remains low.
The Act does continue to escalate the compliance burden on EHR vendors, although much of the actual implementation is left up to HHS and ONC. Thus it remains to be seen how the new administration will implement the law and the impact it will ultimately have.
MH and SUD Impact
Under the title of "Compassionate Communication on HIPAA" the Act sets the stage for some potentially significant updates to the longstanding privacy and security law:
- Via a "Sense of Congress" resolution, the Act directs that clarification is needed regarding permitted uses and disclosures of PHI related to Serious Mental Illness (SMI) under HIPAA
- Requires that the HHS Secretary convene a stakeholder group to discuss upcoming updates to 42 CFR Part 2 governing appropriate uses and disclosure of PHI related to alcohol and drug abuse
- Broadly requires clarification and guidance related to permitted uses and disclosures of PHI for both MH and SUD (and that such guidance be effectively communicated to the patient and provider community via "easily-comprehensible" resources)
- Funds development of model training programs to disseminate such guidance
The Act mandates a myriad of programmatic changes and policy updates to modernize SAMHSA and HHS with respect to MH and SU. Among other things, it:
- Eliminates the SAMHSA Administrator position and replaces it with the HSS Assistant Secretary for Mental Health and Substance Use
- Establishes a Chief Medical Officer (CMO) role within SAMHSA--and requires them to have real-world experience providing MU or SUD treatment
- Requires development a new quadrennial SAMHSA strategic plan and a new biennial report to Congress on SAMHSA activities and progress
Interdepartmental SMI Coordinating Committee
There is a heavy focus on what might be titled "getting serious about SMI." One of the big changes is a new Interdepartmental SMI Coordinating Committee:
- Members will include representatives of HHS, CMS, DOH, CA, DOD, HUD, DOE, DOL, and SSA, as well as patients, providers, researchers, and law enforcement officers
- The committee will make recommendations to Congress on better coordination of SMI and SED services and will convene working groups
Aligning MH and SUD Programs with Science and Evidence Based Treatment
Many requirements of the Act attempt to improve research and implementation around MH and SUD services.
- Establishes the National Mental Health and Substance Use Policy Lab (NMHSUPL) to encourage adoption of evidence-based practices
- Directs improved access to evidenced-based programs and practices nationwide
- Identifies and funds Needs of Regional and National Significance program around MH, SUD Treatment, and SUD Prevention
The Act includes numerous changes and updates to funding priorities:
- Overhauls some components of Medicaid mental health coverage
- Creates a framework for enhanced compliance and enforcement of parity in MH and SUD insurance coverage and benefits
- Updates block grant funding for Community Mental Health Services and Substance Abuse Prevention and Treatment
- Broadly reauthorizes and updates funding to MH screening and treatment programs for women, children, and adolescents
- Increases and extends funding for Assisted Outpatient Treatment
- Specifically funds research and expansion of Assertive Community Treatment (ACT) and Forensic Assertive Community Treatment (FACT) teams
- Funds "Mental Health on Campus" initiatives and creates a new related interagency working group
- Provides other grants and funding for Treatment and Recovery of Homeless Individuals, Jail Diversion Programs, Promoting Integration of Primary & Behavioral Health Care, Assistance in Transition from Homelessness, Suicide Prevention, Access to Care, Community Crisis Programs, MH Awareness Training, and Underage Drinking
- Provides funding and program expansion for "Mental Health and Safe Communities", broadly comprising MH and SUD services within the justice system and law enforcement communities
- Changes funding and program guidelines for foster care and TANF
Training and Workforce Development
- Provides funding for MH professional training programs (psychologists, psychiatrists, social work professionals) to work in integrated care settings
- Provides funding to train paraprofessionals to "emphasize the role of lived experience"
- Provides for law enforcement training and workforce development
MH/SUD Impact Summary
There's a lot to digest here. Over the long term, the 21st Century Cures Act will likely have a meaningful impact on providers of behavioral health and substance use services, but it's highly dependent on the specific types of services and programs offered by each organization.
Author: Jacob Buckley-Fortin (CEO, eHana)