The 21st Century Cures Act is bipartisan legislation that was passed in December 2016. The main provisions of the Cures Act were designed to accelerate the development and approval of new prescription drugs and medical devices. However, the Cures Act went far beyond those important changes. It also included important provisions for hospitals such as research funding, changes to the Hospital Readmission Reduction Program, and new requirements for EHR interoperability and data sharing. Here is how the Cures Act and its implementing regulations affect hospitals.
The Cures Act Funded Research
The Cures Act included $4.5 billion in funding for research programs at the National Institutes of Health (NIH). These funds are allocated across several NIH priorities, including the All of Us Research Program, The BRAIN Initiative, the Cancer Moonshot, and the Regenerative Medicine Innovation Project. If your hospital or health system is involved in these projects, you may receive additional research funding under the Cures Act.
The Cures Act Could Increase Competition in the Prescription Drug and Medical Device Markets
The main provisions of the Cures Act were designed to accelerate the development and approval of new prescription drugs and medical devices. Through research funding and changes to the Food and Drug Administration (FDA) drug and device approval processes, the Cures Act is expected to bring innovative new treatments to market.
At the FDA, the Cures Act created new expedited approval programs for biologics products and medical devices. It also modernized the FDA’s rules for clinical trials. These new rules encourage the use of real-world evidence and patient perspectives.
The Cures Act's changes to research and FDA approval processes could increase competition in the prescription drug and medical device markets. More competition means more choices for patients and hospitals, which could improve outcomes and allow for shared decision-making. The Cures Act’s prescription drug and medical device provisions could also lower prices, benefiting both your patients and your hospital.
The Cures Act Updated the Hospital Readmission Reduction Program
The Hospital Readmission Reduction Program (HRRP) encourages hospitals to prevent 30-day unplanned readmission through value-based payment. Hospitals that do not meet the readmission standard set by the Centers for Medicare and Medicaid Services (CMS) may have their Medicare payments reduced by up to three percent.
The Cures Act updated the HRRP program to ensure it does not disproportionately penalize safety-net hospitals. As of 2019, the HRRP now groups hospitals by the share of their patients who are dually eligible for Medicare and Medicaid. Your hospital’s performance is then compared only to other hospitals in your group. This stratification ensures that hospitals serving vulnerable populations are not penalized for readmissions that may be outside of their control.
The Cures Act Improved Interoperability
The interoperability and data sharing components of the Cures Act are designed to improve patient access to data and encourage care coordination. Sharing data can increase patient engagement, improve diagnosis and reduce duplicative testing and medical errors. To comply with the new rules, your hospital may need to make changes to your EHR systems and data sharing practices.
First, the Information Blocking Rule prevents health care actors, including hospitals and providers, from blocking or discouraging access to, use of, and exchange of electronic health information. This means hospitals must share data when requested with patients and other providers. To comply with the Information Block Rule, your hospital will need to assess your EHR capabilities and data sharing practices to ensure you are not preventing reasonable data access.
Additionally, March 2020 regulations from the US Department of Health and Human Services required additional transparency from hospitals and health plans. As of January 2021, hospitals must now share patients’ electronic admission, discharge, and transfer (ADT) messages with patients’ care teams, including primary care doctors, specialists, and post-acute care facilities. By complying with these rules, your hospital can improve care coordination and ensure smooth patient hand-offs after hospitalization.
These rules also require insurers to make patient claims data via application programming interfaces (APIs). This rule, combined with the Information Blocking Rule and the hospital data-sharing requirements, allows patients complete access to their medical records and claims history through the application of their choice.
TempDev Can Answer Your Cures Act Questions
The Cures Act was passed in December 2016, but many questions remain. If your organization needs help meeting Cures Act requirements or you simply want to know more about the law, TempDev can help. TempDev’s consultants can assess your regulatory requirements and help you comply. Plus, TempDev’s developers can get your NextGen system ready for new data sharing and interoperability requirements.
Call us at 888.TEMP.DEV or contact us here to get answers to your Cures Act questions.
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