We can all agree that healthcare laws and regulations are complex, making it difficult to understand key provisions and how they impact patients, providers, and the industry.
This article clearly explains the 21st Century Cures Act, passed in 2016, breaking down its major components and timeline while highlighting how it aims to accelerate innovation and improve care quality.
You'll learn about the Cures Act's focus on enhancing data access and exchange, boosting mental health services, streamlining drug and device approvals, and allocating funds to transform our healthcare system. We'll also examine remaining controversies and future outlook for this pivotal legislation.
Introduction to the 21st Century Cures Act
The 21st Century Cures Act is federal legislation passed in 2016 with the goal of accelerating medical product development and bringing new innovations to patients faster. Key provisions include:
Understanding the 21st Century Cures Act Fact Sheet
The 21st Century Cures Act aims to modernize health IT infrastructure, improve mental health services, provide funding for medical research, and streamline FDA approval processes. It was signed into law in December 2016.
Key Provisions and Cures Act Summary
Major components of the Cures Act include:
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Investments in cancer research and brain initiatives
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Changes to FDA processes to accelerate approval of drugs/devices
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Increased funding for opioid addiction prevention and treatment
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Interoperability requirements for health IT systems to improve data access
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Clarifications around information blocking exceptions
Timeline: When the 21st Century Cures Act Goes into Effect
While some provisions went into effect in 2016, others have multi-year phase-in periods. Key milestones include interoperability requirements starting in 2022, changes to FDA processes from 2017-2022, and over $4 billion in new funding through 2026.
What are the main points of the 21st Century Cures Act?
The 21st Century Cures Act is bipartisan legislation passed in 2016 that aims to accelerate health research and innovation. Here are some of the key points:
Improving Patient Access and Care
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Provides over $4.8 billion in funding to the National Institutes of Health (NIH) for biomedical research into diseases like cancer and Alzheimer's. This aims to speed up research and development of new treatments.
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Streamlines the FDA approval process for certain drugs and medical devices, with the goal of getting innovative treatments to patients faster while still prioritizing safety.
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Promotes personalized medicine by supporting patient-centered research and care approaches tailored to individuals.
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Seeks to enhance mental health services access and delivery, including provisions to strengthen suicide prevention programs.
Promoting Health Information Technology
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Allocates funding to states for opioid abuse prevention and treatment programs while also supporting mental health programs. This addresses the ongoing opioid epidemic.
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Aims to improve interoperability and information sharing of patient data across different electronic health record systems. This facilitates better coordination of care.
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Establishes exceptions to "information blocking" practices that unreasonably limit access to patient data and impede care coordination. This empowers patients with greater access to their health information.
In summary, the bipartisan 21st Century Cures Act contains a range of provisions focused on accelerating biomedical innovation, enhancing data interoperability, addressing public health challenges like opioid addiction, and ultimately improving patient access, choice, and outcomes.
What is the 21st Century Cures Act blocking rule?
The 21st Century Cures Act was passed in 2016 to promote interoperability and information sharing of electronic health records. A key component is the information blocking rule, which aims to prevent unreasonable interference with appropriate exchange, access, and use of electronic health information (EHI).
Specifically, the Cures Act defines information blocking as "a practice that interferes with, prevents, or materially discourages access, exchange, or use of EHI," except when required by law or covered by an allowed exception. Examples of information blocking practices include setting excessive fees for data access or exchange, implementing burdensome procedures that inhibit information sharing, and limiting EHI access to competing applications.
The information blocking rule went into effect in April 2021. It establishes new requirements for health IT developers and health information networks to support appropriate exchange, access, and use of EHI without information blocking. There are seven exceptions that allow reasonable interference with EHI in specific circumstances, such as for privacy, security, and promoting competition and innovation.
In summary, the 21st Century Cures Act information blocking rule aims to facilitate appropriate EHI sharing among patients, providers, and developers for coordinated care. It prevents problematic practices that unreasonably limit EHI access and exchange.
How does the 21st Century Cures Act affect providers?
The 21st Century Cures Act aims to promote interoperability and information sharing in healthcare. Here are some of the key ways it impacts healthcare providers:
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Disincentives for information blocking: The Act directs the HHS Secretary to establish penalties for providers that commit information blocking - the practice of unreasonably restricting patient access to their electronic health information. Exceptions are made for reasonable privacy, security, and other practices.
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ONC certification program updates: Providers using certified health IT systems must comply with new USCDI data sharing standards and API requirements that facilitate patient access and exchange of health information between providers.
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Information blocking exceptions: There are defined exceptions where certain practices would not constitute information blocking. However, the exceptions must meet strict criteria around promoting patient access, privacy, and security.
In summary, while aiming to improve care coordination and reduce costs, the Act creates standards and disincentives that require changes in health IT systems and data sharing practices for providers. Compliance is key to avoiding penalties.
When was the 21st Century Cures Act final rule passed?
The 21st Century Cures Act was passed by Congress and signed into law by President Obama in December 2016. This bipartisan legislation aimed to accelerate medical product development and bring new innovations to patients faster.
A key part of the Cures Act was promoting interoperability of health information technology and electronic health records. To achieve this, Congress directed the Office of the National Coordinator for Health Information Technology (ONC) to implement regulations around information blocking and interoperability.
In March 2020, ONC published the 21st Century Cures Act final rule to advance interoperability and support access exchange, and use of electronic health information (EHI). This rule went into effect on April 5, 2021 for most provisions.
Some key dates regarding the 21st Century Cures Act final rule:
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December 2016: 21st Century Cures Act signed into law
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March 2020: Publication of the Cures Act final rule
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April 5, 2021: Compliance date for most provisions of the Cures Act final rule
So while the legislation passed in late 2016, the implementing regulations from ONC took several years to develop before going into effect in 2021. This rule aims to break down barriers to EHI access and exchange to improve care coordination and health outcomes.
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Health IT and Interoperability Requirements
The 21st Century Cures Act aims to advance interoperability and health information exchange through several key provisions focused on combatting information blocking, enhancing ONC certification requirements for health IT, and expanding patient access to electronic health data.
Combatting Information Blocking
The Act clearly defines information blocking as practices likely to interfere with access, exchange, or use of electronic health information (EHI). It establishes exceptions for reasonable and necessary activities as well as a framework for disincentivizing information blocking practices. Potential penalties for violations include fines of up to $1 million per occurrence.
Enhancing the ONC Certification Program
The law calls on ONC to establish regulations and guidance around an enhanced certification program for health IT. This includes new functionalities to support standardized APIs for patient access, improved interoperability and exchange of data between systems.
Ensuring Patient Data Access and Interoperability
The Cures Act reinforces and expands a patient's right to easily access their EHI in a timely manner without special effort. It prevents health care providers and developers from limiting access or interoperability of data.
Information Blocking Exceptions and Regulations
There are exceptions for practices that may interfere with exchange or use of EHI but are reasonable and necessary. ONC has established the regulatory framework around determining exceptions and enforcement.
Electronic Health Information (EHI) and Connected Health
The act advances the use of EHI to promote fully connected health data across platforms, services and tools. It calls for adoption of interoperability standards to enable secure exchange and use of electronic patient health information.
Strengthening Mental Health Support
The 21st Century Cures Act aims to improve access to mental health services and substance abuse treatment. By investing $1 billion in state grants, better integrating mental health care into primary care, and supporting telemedicine innovations, the Act strives to provide critical support to those struggling with mental illness or addiction.
Investing in Mental Health and Substance Abuse Services
The 21st Century Cures Act allocates $1 billion in state grants over 2 years to supplement community-based mental health and substance abuse treatment programs. These grants will help states prevent opioid abuse, support recovery services, and enable more patients to access care. Expanding treatment capacity is essential to overcoming barriers that currently prevent many from receiving the help they desperately need.
Integrating Mental Health Care with Primary Services
The Cures Act promotes collaborative care models that integrate mental health services into primary care settings. It provides grants to train health care providers on early intervention and sets new reimbursement incentives for Medicare and Medicaid to cover collaborative care. By shifting towards integrated care, patients can access mental health services in trusted primary care environments, leading to earlier treatment and improved outcomes.
Embracing Telemedicine for Mental Health
The Act supports telemedicine innovations to increase access to mental health care for underserved communities. It eliminates restrictions that limit telemedicine coverage and provides funding to study the use of technology in mental health treatment and substance abuse recovery. Telemedicine delivers convenient care to patients in remote regions while maintaining privacy. Expanding its availability can connect more patients to life-saving services.
21st Century Cures Act Mental Health Initiatives
In total, the Cures Act dedicates over $3 billion towards targeted mental health initiatives. From school-based programs to suicide prevention, these investments aim to make care accessible for vulnerable groups. By focusing specifically on mental health and addiction treatment, the Act makes significant progress in addressing critical needs within the health system.
Advancing Regulatory Processes for Medical Products
The 21st Century Cures Act introduces several changes aimed at streamlining the FDA's processes for reviewing and approving new drugs and medical devices.
Accelerating Drug Approval Pathways
The Act establishes new approval pathways for certain drugs, allowing the FDA to rely on data summaries or surrogate endpoints rather than full clinical trials. This has the potential to accelerate access to innovative treatments, particularly for serious conditions with unmet needs. However, critics argue that relying on less substantial data could put patients at risk. There are open questions around finding the right balance between speed and safety.
Incorporating Real-World Evidence
The Cures Act allows drug and device makers to use real-world evidence (RWE) - data gathered outside of traditional clinical trials - to support new uses for approved products. For example, RWE could help justify label changes or new indications. Proponents believe this will modernize approvals and enable innovations. However, best practices for collecting, analyzing, and validating real-world data are still evolving.
Promoting Medical Device Innovation
The Act mandates changes intended to streamline device approvals, particularly for certain low-to-moderate risk products. It allows greater reliance on consensus standards to demonstrate safety and effectiveness. Additionally, the law promotes coordination between FDA and CMS to enable efficient coverage decisions for breakthrough devices. While promising, the impact remains to be seen as updated regulations and guidance are still pending in this area.
In summary, the Cures Act introduces incremental but meaningful changes to modernize regulatory pathways for drugs and devices. It aims to promote innovation and efficiency balanced by the continued need to demonstrate safety and efficacy, albeit through evolving standards. Effective implementation will rely on collaboration between industry, regulators, patients, and healthcare systems.
Funding the Future of Healthcare Innovation
Allocating Billions: Authorization and Use of Funds
The 21st Century Cures Act authorizes $6.3 billion in funding over 7 years to support key healthcare programs and innovations focused on biomedical research and health information technology advancements. This includes $4.8 billion allocated to the National Institutes of Health (NIH) for the Precision Medicine Initiative and cancer research, $500 million to the FDA to accelerate drug and device development processes, and $1 billion to states to supplement opioid abuse prevention and treatment programs.
The Act outlines specific purposes and initiatives where this funding can be utilized, ensuring it directly enables research, infrastructure, and programs that align with the core focuses and priorities of the Cures Act. Strict oversight and planning will govern the release and use of funds to guarantee maximum impact and advancement of the Act's central healthcare innovation goals.
Identifying Funding Sources and Financial Planning
The $6.3 billion in authorized Cures Act spending will come from a combination of discretionary health program spending changes, savings from Medicare and Medicaid policy adjustments, and strategic sales of oil from the Strategic Petroleum Reserve.
Specifically, $3.5 billion will come from discretionary health spending changes, $3.5 billion from Medicare and Medicaid savings over 10 years, and $500 million from oil sales over 5 years. This carefully constructed funding equation allows investment in Cures Act programs without increasing the federal deficit.
Ongoing financial planning and fiscal responsibility will be required to ensure the Act's provisions are sufficiently and sustainably funded over time from these identified sources.
Ensuring Accountability and Effective Oversight
To guarantee Cures Act funding is utilized appropriately and impactfully, the legislation establishes accountability and oversight structures. This includes requiring the Government Accountability Office (GAO) to regularly audit Cures Act programs and report to Congress.
Additionally, the Act mandates the Department of Health and Human Services (HHS) provide annual reports to Congress summarizing Cures Act progress and performance. This reporting enables continuous assessment of successes, challenges, and opportunities to enhance the Act's effectiveness over time through responsive policy and program adjustments.
With billions in public funds supporting the Act's biomedical innovation goals, maintaining accountability and oversight to ensure responsible allocation, use, and impact of this investment will be critical. The planning, auditing, and reporting provisions of the Cures Act establish mechanisms to enable this oversight for the benefit of patients and taxpayers.
Conclusion: Reflecting on the 21st Century Cures Act
The 21st Century Cures Act aims to accelerate medical product development and bring new innovations to patients. By promoting data sharing and transparency, updating regulations for digital health technology, and providing additional funding for medical research, the Act seeks to streamline processes and reduce barriers that delay patient access to treatments.
While the goals are admirable, there are still challenges around full implementation and questions on if it will achieve the intended outcomes. As the healthcare landscape continues to evolve with emerging technologies, policymakers must continue assessing the Act's impact and introducing adjustments as needed. The coming years will reveal if the Cures Act successfully ushered in a new era of improved care quality, efficiency, and value for all.
