Seema Verma is administrator of the Centers for Medicare and Medicaid Services.

This article was coauthored with Alexandra Mugge, deputy chief health informatics officer at CMS, and Shannon Sartin, chief technology officer at the Centers for Medicare and Medicaid Innovation.

In 2018, the Centers for Medicare and Medicaid Services, the Office of the National Coordinator for Health IT and the White House Office of American Innovation, publicly announced our commitment to ensuring that patients would have access to their healthcare data wherever and whenever they need it, and we commenced on a journey to break down the barriers that keep critical patient health information locked in digital silos.

For decades, the path to healthcare interoperability has been a relay spanning multiple administrations, one in which each administration has passed the baton to the next, moving the healthcare industry closer to the goal, but always falling short of seamless interoperability of health data.

At the finish line lies a more coordinated, seamless system of care in which patients have electronic access to their health information and providers are offering competitive quality and patient care, providing more evidence-based care with less duplication of testing and errors. We have taken the race further by revising old policies to better achieve their intended goals, finalizing new policies to engage all stakeholders across the healthcare industry and laying a foundation for the future of interoperability.

Over the past three years, and as part of the support under the 21st Century Cures Act, our accomplishments have been numerous. Underpinning many of our accomplishments is the use of application programming interfaces that allow electronic data to flow securely and seamlessly between information systems, and, specifically, the use of the API standard for interoperability known as HL7 Fast Healthcare Interoperability Resources, or FHIR. This standard enables more efficient collaboration and a modern approach for sharing of information between the different electronic health systems essential for interoperability.

At CMS, we have promoted the use of APIs, both inside CMS and in the broader healthcare industry, to enable the secure exchange of data. Some of our externally facing APIs include:

• In March 2018, we announced the launch of Medicare’s Blue Button 2.0, a secure way for Medicare beneficiaries to access and share their personal health data using FHIR standards. Beneficiaries can choose from 74 Blue Button applications developed by private sector innovators to help manage and improve their health.
• In June 2018, we launched a prototype Documentation Requirement Lookup Service, an API-enabled repository of Medicare FFS documentation and prior authorization requirements.
• In February 2019, we launched the Beneficiary Claims Data API (BCDA), a FHIR-enabled API for Accountable Care Organizations (ACOs) participating in the Shared Savings Program to retrieve Medicare claims data for their beneficiaries. During the initial phase of BCDA, over 50 ACOs signed up for data access via the API.
• In July 2019, we announced the Data at the Point of Care (DPC) pilot, a FHIR-based API that provides Medicare claims data directly to providers via an interoperable FHIR-standard-based API to promote better patient care.

We have also refined our programs to better support interoperability and data access. In 2018, CMS overhauled the Medicare and Medicaid Promoting Interoperability Programs (formerly known as meaningful use) to prioritize interoperability and patient access.

Through these programs, hospitals and clinicians may receive reduced Medicare payments if they do not give patients electronic access to their data. In this way, we took a struggling program that was focused on EHR adoption and transformed it into a driver for data exchange among providers to give patients access to their healthcare data.

In addition, we have used our regulatory levers to engage our stakeholders in data sharing. In September 2019, CMS released the Discharge Planning Final Rule, which mandates that hospitals ensure each patient’s right to access their medical records in an electronic format, as well as requiring the seamless exchange of patient information between healthcare settings, and ensuring that a patient’s healthcare information follows them after discharge from a hospital or post-acute care provider. It requires the discharge planning process to focus on a patient’s goals and treatment preferences.

In May 2020, CMS finalized our first rule dedicated to interoperability with the CMS Interoperability and Patient Access final rule.  Based on Medicare’s Blue Button initiative that provided claims data to patients, the final rule focused on driving interoperability and patient access to health information by liberating claims and clinical data for 85 million patients.

Through our policies, CMS promotes an HHS-wide move to FHIR APIs to support interoperability across the health ecosystem. This rule also establishes a Condition of Participation, requiring hospitals receiving reimbursement from Medicare and Medicaid to provide patient event notifications at hospital admission, discharge and transfer.

These notifications inform patients’ doctors and providers that they have been in the hospital and provide relevant data pertaining to the visit, which facilitates more coordinated and seamless care. Of important note is that this notification requirement is only applicable to said hospitals with electronic health records systems or other electronic administrative systems that meet certain technical specifications.

At the same time, ONC finalized their 21st Century Cures Act final rule, which will support patient access to their electronic medical records directly from their providers through FHIR-standards-based APIs. Together, these rules addressed both technical and healthcare industry factors that cause barriers to the secure exchange of health information and limit the ability of patients to access essential health information.

By aligning FHIR-based requirements for payers and healthcare providers through the CMS Interoperability and Patient Access final rule, and health IT developers, providers and health information networks through the ONC 21st Century Cures Act final rule, we are driving an interoperable health IT infrastructure across systems and ensuring providers and patients have access to health data when and where it is needed.

Most recently, we released the CMS Interoperability and Prior Authorization proposed rule. This proposed rule would build on our efforts around FHIR APIs and would ensure that providers and payers have necessary patient data. It would require Medicaid and CHIP fee-for-service and managed care payers, as well as insurers offering individual market qualified health plans on the Federal Exchanges, to facilitate exchange of certain specified data across the healthcare ecosystem to patients, providers and to other payers.

In the Interoperability and Patient Access final rule published last May, we required that certain payers exchange information with one another at patients’ request. In this new proposed rule, we are proposing that this data exchange be done using a FHIR API when a patient changes from one payer to another, or has more than one payer.

Because the rule would require a FHIR-based API allowing different payers’ systems to communicate with each other, new plans would have access to a patients’ claims data almost as soon as they enroll, allowing them to understand their patient’s previous care and medical needs.

In addition, this rule would require payers to build APIs enabling the sending of patient claims, encounter data and clinical data directly to providers’ EHRs, again allowing for providers to have their patients’ complete medical history.

As soon as a provider requests this information from a payer, they would have access to their patient’s complete medical claims data, including diagnoses, tests, medications, previous doctors' visits and more. For providers that take full advantage, duplicative tests, unnecessary procedures and hazardous interactions between medications could almost be a thing of the past.

In effect, the rule would add another layer of communication to our earlier final rule that required certain data to be available through APIs, which would make possible for patients to directly access their data. If for whatever reason a patient did not have their data at a particular visit, their providers should be able to pull it up instead using the API.

Finally, the proposed rule would tackle one of the foremost challenges for providers, payers and patients alike: effective prior authorization. Prior authorization is an administrative process for providers to request confirmation from payers that the providers will be paid for a medical service, prescription or supply.

This process takes place before a service is rendered and is part of providers’ negotiated agreement to participate in a payer’s network. Prior authorization is an important tool to coordinate care and lower costs.

When poorly executed, however, it can drain significant time and resources from the very purpose of medicine – caring for patients – and can result in physician burnout. When done well, the process can ensure needed care for patients and help them avoid unnecessarily paying out of pocket.

The proposed rule again would build on our efforts to promote FHIR and APIs to require certain payers to build a new FHIR-based API that would allow providers to know in advance what documentation is needed for each different health insurance payer subject to the rule. We proposed that another API be built to allow providers to send prior authorization requests and receive responses electronically and within their existing workflow, eliminating the need for phone calls and faxes.

This would streamline the documentation process for the entire system and allow providers to send prior authorization requests and receive responses directly from their electronic systems.

As we look forward, we are confident that we have laid a solid foundation for interoperability on which future administrations can continue to build. We continue to look for ways to expand interoperability by examining policies that can both increase interoperability and reduce burden.

We have been committed to moving in a direction of digital quality measures and FHIR-enabled measure submission systems. CMS is currently working on regulations to adopt standards for healthcare attachments and electronic signatures that can be used in conjunction with healthcare attachments transactions.

The Center for Medicare and Medicaid Innovation is continuing to drive forward the use of standard data collection in our models and providing bulk data through FHIR APIs to our model participants. Interoperability and standardized data-sharing are essential for the future of value-based care, and we will leave no stone unturned in seeking to deliver it to our healthcare system.

Seamless interoperability of health information comes when standardized data sharing occurs with every system, device, organization and person having instantaneous access to the data they need, when they need it. This future includes requiring interoperability of all medical devices, ensuring that part of the approval process means manufacturers and technology companies have identified how they will ensure devices are connected to patients and providers.

In the era of the COVID-19 pandemic, the need for data to move seamlessly is critical for public health surveillance, both now and in the future. A truly interoperable system will allow us to rapidly detect emerging infectious diseases and make it easier for providers to share public health data.

Technology is ever evolving, and our work will constantly evolve, but our efforts have laid a foundation for future policy that will enable the secure and interoperable exchange of healthcare information, drive value-based care in America, and give patients and doctors the information they need.