HHS finalizes rules requiring EHR access and an end to information blocking

The U.S. Department of Health and Human Services today finalized two interoperability rules to give patients faster and safer access to their health data.

Innovation and Patient Access

The Office of the National Coordinator's final rule establishes secure, standards-based application programming interface requirements to support a patient's access and control of their electronic health information. APIs are the foundation of smartphone applications. As a result, patients will be able to obtain and use their electronic health information from their provider's medical record for free, using the smartphone app of their choice.

The final rule requires health plans in Medicare Advantage, Medicaid, CHIP, and through the federal exchanges to share claims data electronically with patients.

This Patient Access API will allow patients to access their data through any third-party application they choose to connect to the API and could also be used to integrate a health plan's information to a patient's electronic health record.

Beginning January 1, 2021, Medicare Advantage, Medicaid, CHIP, and for plan years beginning on or after January 1, 2021, plans on the federal exchanges will be required to share claims and other health information with patients in a safe, secure, understandable, user-friendly electronic format through the Patient Access API. With more complete data in their hands, patients can be more informed decision-makers, an outcome that will lead to better-informed treatment.

To further advance the mission of fostering innovation, the CMS final rule establishes a new Condition of Participation for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another healthcare facility or community provider or practitioner when a patient is admitted, discharged or transferred.

By requiring their relevant health information to be shared with them, including their claims, patients can take this information with them as they move from plan to plan and provider to provider throughout the healthcare system.

Additionally, CMS is requiring states to send enrollee data daily beginning April 1, 2022 for beneficiaries enrolled in both Medicare and Medicaid, improving the coordination of care for this population.

Addressing Interoperability and Information Blocking

The final rule identifies what constitutes information blocking and establishes new rules to prevent-information blocking practices such as anticompetitive behaviors by providers, developers of certified health IT, health information exchanges and health information networks.

Currently, many EHR contracts contain provisions that either prevent or are perceived to prevent users from sharing information related to the EHRs in use, such as screenshots or video. The ONC final rule updates certification requirements for health IT developers and establishes new provisions to ensure that providers using certified health IT have the ability to communicate about usability, user experience, interoperability and security, including, with limitations, screenshots and video, which are critical forms of visual communication for such issues.

The ONC final rule also requires electronic health records to provide the clinical data necessary, including core data-classes and elements, to promote new business models of care. This rule advances common data through the U.S. Core Data for Interoperability. 

The USCDI is a standardized set of health data-classes and data elements that are essential for a nationwide, interoperable health information exchange. The USCDI includes "clinical notes," allergies and medications, among other important clinical data, to help improve the flow of electronic health information and ensure that the information can be effectively understood when it is received. It also includes essential demographic data to support patient matching across care settings.

WHY THIS MATTERS

The rules have the goal of giving patients greater access to their healthcare data.

Putting patients in charge of their health records is a key piece of giving patients more control. Giving them the ability to get the information through smartphone applications gives them greater access.

THE LARGER TREND

The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services, implement interoperability and patient-access provisions of the bipartisan 21st Century Cures Act and support President Trump's MyHealthEData initiative.

Together, these final rules mark the most extensive healthcare data-sharing policies the federal government has implemented, and require both public and private entities to share health information between patients and other parties, while keeping that information private and secure, and a top priority for the Administration, HHS said.

CMS took the first step towards interoperability by launching Medicare Blue Button 2.0 for Medicare beneficiaries in 2018. Medicare Blue Button 2.0 gives beneficiaries the ability to securely connect their Medicare Part A, Part B and Part D claims and encounter data to apps and other tools developed by innovators. Engagement and partnership with the technology community have involved more than 2,770 developers from over 1,100 organizations working in the Medicare Blue Button 2.0 sandbox to develop innovative apps to benefit Medicare patients.

Currently, 55 organizations have applications in production.

ON THE RECORD

"President Trump is delivering on his vision for healthcare that is affordable, personalized, and puts patients in control. From the start of our efforts to put patients and value at the center of our healthcare system, we've been clear: Patients should have control of their records, period. Now that's becoming a reality," said HHS Secretary Alex M. Azar. "These rules are the start of a new chapter in how patients experience American healthcare, opening up countless new opportunities for them to improve their own health, find the providers that meet their needs, and drive quality through greater coordination."

"Delivering interoperability actually gives patients the ability to manage their healthcare the same way they manage their finances, travel and every other component of their lives. This requires using modern computing standards and APIs that give patients access to their health information and give them the ability to use the tools they want to shop for and coordinate their own care on their smartphones," said Don Rucker, national coordinator for health information technology. "A core part of the rule is patients' control of their electronic health information which will drive a growing patient-facing healthcare IT economy, and allow apps to provide patient-specific price and product transparency."

"The days of patients being kept in the dark are over," said CMS Administrator Seema Verma. "In today's digital age, our health system's data sharing capacity shouldn't be mired in the stone age. Unfortunately, data silos continue to fragment care, burden patients and providers, and drive up costs through repeat tests. Thanks to the leadership of President Trump, these rules begin a new chapter by requiring insurance plans to share health data with their patients in a format suitable for their phones or other device of their choice. We are holding payers to a higher standard while protecting patient privacy through secure access to their health information. Patients can expect improved quality and better outcomes at a lower cost."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com