The 21st Century Cures Act was passed in December 2016. Several provisions of this important legislation are still being rolled out in 2021 and 2022. Here are the key Cures Act facts your practice needs to know.
What Is the Cures Act?
The Cures Act is bipartisan legislation designed to accelerate medical product development, promote interoperability, and support patients. It included funding for research, the FDA, and the opioid crisis. In addition, the Cures Act created new rules to promote interoperability, prevent information blocking, and ensure patients can access their electronic health information.
Research Funding in the Cures Act
The Cures Act provided $4.8 billion over 10 years to the National Institutes of Health to support medical research. It also encouraged scientific collaboration through data sharing and conference attendance. To further accelerate medical device and prescription drug breakthroughs, the Cures Act also included provisions to alleviate administrative burdens that can delay the start of clinical trials.
The research funding in the Cures Act supports four innovative initiatives at NIH, including the Precision Medicine Initiative, The BRAIN Initiative, the Cancer Moonshot, and the Regenerative Medicine Innovation Project.
FDA Updates in the Cures Act
To further speed medical product development, the Cures Act included provisions to modernize the FDA prescription drug and medical device review processes. These changes include a new expedited review option for certain biologics products and a new review process for innovative medical devices. Taken together, these changes should bring new prescription drugs and medical devices to the market faster.
Interoperability and Data Sharing Requirements in the Cures Act
Most importantly for practices and providers, the Cures Act includes new interoperability and data sharing requirements. These new rules are intended to promote data sharing and ensure patients have access to their data.
The most extensive of these provisions, the information blocking rule, went into effect on April 5, 2021. Under this rule, EHR vendors, health information exchanges, and providers are prohibited from interfering with or discouraging access to, exchange of or use of electronic health information (EHI). The rule has exceptions for safety and privacy. However, the information blocking rule is designed to increase access to EHI, especially for patients. In most cases, practices will have to comply with data sharing requests promptly. Violating the information blocking rule can result in fines of up to $1 million per violation.
The Office of the National Coordinator for Health IT (ONC) is rolling out the information blocking rules in phases. From April 5, 2021, to October 6, 2022, the new rules will only apply to data included in the United States Core Data for Interoperability. After the initial phase-in period, the rules will apply to all HIPAA-covered data, including claims and billing.
The Cures Act also included provisions to promote the use of Application Programming Interfaces (APIs). The information blocking rule, plus other rules promulgated by the US Department of Health and Human Services, ensure that patients can access their data through the application of their choice. By requiring EHR vendors, health information exchanges, and providers to open their systems to APIs, the Cures Act will encourage innovation in health management applications, cost calculators, and quality comparison tools.
What are Cures Act Facts for Practices?
What does the Cures Act mean for your practice? For providers and practices, the interoperability and information blocking rules require the most investment. To ensure compliance, your practice needs to review your data sharing processes to ensure you are not creating unreasonable barriers to EHI access, exchange, and use. You should also review your EHR capabilities to ensure all interoperability functions are turned on and up to date.
Sharing data with your patients and other practices can help you improve outcomes and care quality. Giving patients easy access to their EHI can increase satisfaction and engage patients in their care. Sharing data seamlessly with other providers can also improve diagnosis, treatment plans, and outcomes. Complying with the new information blocking rules may require some upfront investment, but the result should be better, more coordinated care.
What are Cures Act Facts for Patients?
What does the Cures Act mean for patients? Over time, the Cures Act should increase access to innovative prescription drugs and devices. By getting new products to market faster, the Cures Act should help improve health outcomes.
The data sharing and interoperability provisions will also help patients improve their care. These rules, including the information blocking rule, are designed to ensure patients can access their data from the application of their choice. This will allow patients to use their EHI in new and innovative ways. It will also ensure that patients who move, change insurance plans, or change providers have a complete, portable health record to aid in future diagnosis and treatment decisions.
How TempDev Can Help With the Cures Act
TempDev is ready to help your practice review and comply with the Cures Act. Team TempDev can update your NextGen system, review your data sharing policies and procedures and train your team. Get into compliance the easy way with TempDev.
Call us at 888.TEMP.DEV or contact us here to schedule a consultation for your Cures Act facts.