Continuing in its bold move up the ladder of electronic health record (EHR) interoperability, the Centers for Medicare and Medicaid Services (CMS) and the Office of National Coordinator for Health Information Technology (ONC) jointly finalized two rules on March 9, 2020 that were originally proposed February 11, 2019. The rules are designed both to allow patients access to their own records and data via smartphone apps and to provide strong deterrents to those who would block data.

While the American Society of Nephrology (ASN) strongly supported the proposals, the unusually long period to finalize the rule reflected the intransigence of some members of the healthcare community to allowing patients full access to their data. Efforts to block the administration’s push for open information spilled over to Congress and may well end up before the courts. CMS Administrator Seema Verma maintained her strong commitment to this issue in an open call to discuss the announcement on March 9 saying “EHR vendors don’t own this data – patients do!”

“Putting patients in charge of their health records is a key piece of giving patients more 

control in healthcare, and patient control is at the center of the Trump administration’s work toward a value-based healthcare system,” the Department of Health and Human Services (HHS) wrote in its release statement.

The two rules implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act) and support HHS’ MyHealthEData initiative originally announced in 2018. MyHealthEData is designed to empower patients by giving everyone access to their medical information – particularly through apps – to help patients make healthcare decisions. These rules require both public and private entities to share health information between patients and other parties while keeping that information private and secure.

HHS Secretary Alex M. Azar characterized the steps taken saying “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.”  HHS maintains, and ASN agrees, that delivering interoperability gives patients the ability to manage their healthcare the same way they manage their finances, travel, and every other component of their lives.

“The days of patients being kept in the dark are over,” added Verma. “In today’s digital age, our health system’s data sharing capacity shouldn’t be mired in the stone age.”
 

Innovation Through Technology

ONC’s final rule establishes secure, standards-based application programming interface (API) requirements to support a patient’s access and control of their electronic health information. APIs are the foundation of smartphone apps. The CMS final rule requires health plans in Medicare Advantage, Medicaid, CHIP, and through the federal Exchanges to share claims data electronically with patients. CMS’ rule builds on the Medicare Blue Button 2.0 program – part of the MyHealthEData initiative. 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 through apps and other tools developed by innovators. Verma announced CMS’ partnership with the technology community has involved more than 2,770 developers from over 1,100 organizations working in the Medicare Blue Button 2.0 sandbox to develop apps to achieve the goals of the program. Currently, 55 organizations have applications in production. Beginning January 1, 2021, Medicare Advantage, Medicaid, CHIP, and 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 leading to better informed treatment.”

CMS final rule also establishes a new Condition of Participation (CoP) for all Medicare and Medicaid participating hospitals, requiring them to send electronic notifications to another healthcare facility, community provider, or practitioner when a patient is admitted, discharged, or transferred. Additionally, CMS is requiring states to send enrollee data daily beginning April 1, 2022 for beneficiaries enrolled in both Medicare and Medicaid, to improve the coordination of care for this population.