Loyola University Chicago School of Law, JD 2023
As the United States continues to grapple with the effects of the coronavirus epidemic, the U.S. Department of Health and Human Services (“HHS”) announced new rules extending compliance dates and timeframes under the Cures Act. The agency’s new rules—most of which take effect on Dec. 4, 2020—are aimed at giving IT developers and health care providers flexibility in responding to the coronavirus pandemic.
The Interim Final Rule with Comment was published in the Federal Register by the Office of the National Coordinator for Health Information Technology (“ONC”), a unit working within the HHS Secretary’s office on Nov. 4, 2020. The new ONC rules follow others issued by the Centers for Medicare and Medicaid Services (“CMS”), which announced a fourth COVID-19 Interim Final Rule on Oct. 28, 2020. The CMS rule added flexibility for health care providers and expanded access to the public for testing and treatment for COVID-19.
Now, the ONC changes extend compliance and applicability dates for information-blocking and health IT certification requirements. These ONC extensions push back the dates on which certain provisions of the Cures Act go into effect. They also extend the compliance timeline for vendors and organizations. Now, providers are no longer required to share electronic health information until Apr. 5, 2021, although some medical associations, like the American College of Cardiology, are encouraging their members to keep developing methods to allow for information sharing.
What does the final rule mean for patients?
ONC’s Cures Act final rule gives patients easier access to their health care records, protects their privacy using secure patient access to their electronic medical records, and promotes patients’ ability to shop for care and manage costs. In fact, empowering patients to take charge of their own health records is at the heart of HHS’ efforts to promote a value-based health care system, according to ONC. Patient access to health care information is a central piece of the ONC Cures Act Final Rule, which implements the Act’s interoperability provisions.
The updated rule announced in response to the coronavirus pandemic, though, extends the compliance dates and timeframes required to meet certain provisions concerning information-blocking and conditions and maintenance of certification requirements. Now, the information-blocking provisions take effect on Apr. 5, 2021; the 2015 Edition health IT certification criteria updates take effect on Dec. 31, 2022; and other submissions were given a one-year extension.
“We are hearing that while there is strong support for advancing patient access and clinician coordination through the provisions in the final rule, stakeholders also must manage the needs being experienced during the current pandemic,” said Don Rucker, MD, national coordinator for health IT, said in an Oct. 29 media release. “To be clear, ONC is not removing the requirements advancing patient access to their health information that are outlined in the Cures Act Final Rule. Rather, we are providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response.”
What does the final rule mean for health care providers?
The delayed deadlines will provide clinicians and hospitals additional time to concentrate their attention on responding to the COVID-19 pandemic. Once in effect, though, the Cures Act Final Rule will force health care providers to make changes aimed at expanded patient access to their health information.
Health care clinicians and hospitals will need to provide patients with fully automated, low-cost access to their health care information. Once fully implemented, patients will have access to their health information from an app on their phones. The Cures Act also prohibits information blocking, except when necessary to protect patient privacy and security or where it’s not feasible to transfer data.
What does the final rule mean for health IT developers?
Under the 21st Century Cures Act, developers of certified health IT must meet certain conditions and maintenance of certification requirements when participating in the ONC’s Health IT Certification Program. The changes push back the deadline to comply with the 2015 Edition health IT certification criteria updates to Dec. 31, 2022.
Once fully implemented, the ONC Cures Act Final Rule is intended to nurture innovation in health care aimed at delivering more information in a convenient way to patients and providers. The rule also encourages transparency through technological advancements anticipated to provide for easier access to health care information. But, while the health care system deals with the COVID-19 pandemic, implementation of the ONC Cures Act Final Rule is on hold.