On October 16, 2015, the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services published the Meaningful Use Stage 3 final rule (MU Final Rule) and the 2015 Edition Health Information Technology Certification Criteria (2015 Edition Certification Criteria) final rule (2015 Certification Final Rule) in the Federal Register. Together, the final rules (Stage 3 Final Rules) incentivize eligible acute care hospitals (EHs), critical access hospitals (CAHs), and physicians and other professionals (EPs) eligible for the Medicare and Medicaid electronic health record (EHR) incentive programs to engage patients in the management of their care outside traditional clinical settings and encourage technology vendors to develop mobile health and wellness applications and other software to support such efforts.

Background

The Meaningful Use Stage 2 Core Measure for Patient Electronic Access required EHs, CAHs and EPs (collectively, Eligible Providers) to encourage patients to view, download and transmit their health information through online “patient portals” in order to achieve meaningful use and earn EHR incentive payments or avoid Medicare reimbursement penalties. Once logged into a patient portal, a patient could view their health information, download it in electronic form or transmit it to third party. Signing onto a patient portal for the first time, however, often required a patient to take multiple steps outside of the provider’s office or facility. Additionally, since most EHR systems have their own portal, patients typically need to access multiple portals to interact with health information from each of their health care providers and lack a composite, patient-centric view of their health information. These issues reduced the user-friendliness of the portals and frustrated patient engagement goals of providers and the Medicare and Medicaid EHR incentive programs.

Introduction of APIs

To address the frustrations with patient portal technology and spur patient engagement efforts, the 2015 Certification Final Rule requires certified EHR technology (CEHRT) to include an application programming interface (API), and two of Stage 3 Meaningful Use measures under the MU Final Rule require Eligible Providers to make EHR data available through an API which a patient may access through a properly configured online or mobile application of their choice.

An API is a similar concept to a power outlet. By creating a common set of electric principles, a common type of outlet and plugs, any number of different electronic devices can use a power outlet to “plug in” to the power grid and receive the electricity needed to power the device. Like the power outlet, an API consists of a common set of programming principles that allows websites and mobile applications to “plug in” and receive computable information. By requiring EHR vendors to create APIs, CMS and ONC’s goal is that any number of websites and mobile applications could “plug in” to the EHR at a patient’s request, receive health information from the EHR and provide a service to the patient. According to CMS, APIs will allow a patient to collect health information from multiple providers so that they can potentially incorporate their health information into a single portal, application, program or other software.

The 2015 Edition Certification Criteria establish the requirements for CEHRT (2015 CEHRT) that Eligible Providers seeking to achieve Meaningful Use Stage 3 in 2018 will need to adopt. To be included in 2015 CEHRT, an API would need to meet three different functional requirements. First, the API will need to be able to query for identification or other token of a patient’s record to execute data requests for that record. Second, the API will need to support requests and responses for EHR data by data category. Third, the EHR’s API will need to support requests and responses for all EHR data. The API will also need to meet ONC’s privacy and security certification framework by demonstrating the capability to establish a trusted connection with the application requesting patient data, authorize the user to request data and log all interactions with the data source.

Notably, ONC elected to not create specific standards requirements for the API, with the goal of allowing EHR vendors to meet the above functional requirements in innovative ways. Without common technical standards for the API, however, EHR vendors may adopt varying programming principles for their APIs. This may make it difficult for developers to build applications that can interact with multiple EHRs’ APIs and frustrate efforts to promote the exchange of health information among providers that use different EHR systems.

ONC indicated that it may use future rulemaking to establish required standards for APIs. In light of the bipartisan disappointment about barriers to interoperability among EHR systems, we expect ONC to re-visit its decision to not establish standards.

Stage 3 Meaningful Use Objectives Focused on Patient Engagement

The Meaningful Use Stage 3 measures for the “Patient Electronic Access” and “Coordination of Care through Patient Engagement” Meaningful Use objectives establish the key patient engagement steps that Eligible Providers must take in order to achieve Stage 3 Meaningful Use beginning in 2018 (or at their option beginning in 2017).

Stage 3 Patient Electronic Access MU Objective

To achieve the Patient Electronic Access objective, EPs must meet the following two measures:

• For more than 80 percent of all unique patients seen by the EP—

  • The patient (or the patient’s authorized representative) is provided timely (i.e., within 48 hours of a patient visit) access to view online, download and transmit the patient’s health information; and

  • The provider ensures the patient’s health information is available for the patient (or patient-authorized representative) to access using any application of their choice that is configured to meet the technical specifications of the API in the provider’s CEHRT.

• The EP must use clinically relevant information from CEHRT to identify patient-specific educational resources and provide electronic access to those materials to more than 35 percent of unique patients seen by the EP during the EHR reporting period.

EHs and CAHs must provide the same capability as summarized above for EPs to at least 80 percent of their patients within 36 hours of a patient’s discharge (rather than within 48 hours of a patient visit). In the proposed Meaningful Use Stage 3 rule, CMS would have allowed Eligible Providers to either offer view, download and transmission capabilities through a patient portal or offer an API instead. In the MU Final Rule, however, CMS requires Eligible Providers to offer both patient portal and API functionalities to 80 percent of their patients to meet this measure.

Stage 3 Coordination of Care through Patient Engagement Objective

To achieve the Coordination of Care through Patient Engagement objective beginning in calendar year 2018, Eligible Providers must encourage patient engagement in all three of the following ways, but only achieve the percentage thresholds in two of the three: 

• At least 10 percent of unique patients seen during the calendar year (or other applicable EHR reporting period) must engage with the Eligible Provider’s CEHRT by 

  • Viewing, downloading, or transmitting their health information through a patient portal 

  • Accessing their health information through the use of an API that can be used by applications chosen by the patient and configured to the API in the provider’s CEHRT, or

  • A combination of the portal and API. The 10 percent threshold represents a marked reduction from the 25 percent threshold proposed by CMS in the Meaningful Use Stage 3 proposed rule, but still doubles Meaningful Use Stage 2’s current five percent threshold; 

• The Eligible Provider sends a secure message to patients or responds to secure messages sent from patients or their representatives for more than 25 percent of all unique patients seen during the applicable EHR reporting period; or

• The Eligible Provider incorporates patient-generated health data or data form a non-clinical setting into the CEHRT from more than five percent of all unique patients seen during the applicable EHR reporting period. CMS intends the sources of this non-clinical data to include mobile applications for tracking health and nutrition, home health devices and wearable devices, such as activity trackers or health monitors. While these non-clinical applications have proliferated rapidly in the past several years, health care providers are only beginning to interact with the data created by these applications.  CMS’ goal in creating this new measure is to incentivize the sharing of this information to improve care coordination and overall patient wellness outside of the care setting.

Joining of Provider-Generated Health Data and Patient-Generated Health Information

CMS’ and ONC’s decision to encourage the development of APIs and interaction between EHRs and third-party web and mobile applications reflects a shift in the EHR incentive programs. Previously, EHRs represented a separate informational ecosystem dis-connected from consumer technology used in non-clinical settings. While patients could view their health information from the EHR through the patient portal, the “download” and “transmit” functionalities were focused mainly on the transmission of the information to another health care provider or EHR system. The expected proliferation of APIs has the potential to facilitate the gathering of data from multiple EHR systems and consumer fitness, nutrition and wellness applications into a patient-centric personal health and wellness record, and could also further fuel the explosion of “big data” analytic tools for care improvement and personalized medicine both at the bedside and in the connected, outside world. For technology developers, it may create opportunities to create new innovative patient engagement solutions that leverage a rapidly expanding treasure trove of health data and other personal information. 

Implications for Value-Based Payment Initiatives

These innovative patient engagement solutions can also help providers participating in new governmental and commercial payers’ value-based payment arrangements that require providers to share risk for patient outcomes and incentivize quality improvement and cost reduction. The successful use of patient engagement technology to collect health and wellness data from patients, aggregate the data into sophisticated data warehouses, and analyze the data with cognitive computing and analytic tools will help providers to identify the need for care (or lack thereof) between patient visits and calibrate the quantity of care to patient need.

The Stage 3 Final Rules are subject to a 60-day comment period, which was added to account for the passage of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) after CMS had already issued a proposed rule for Meaningful Use Stage 3. MACRA will sunset the Medicare EHR Incentive Program for EPs in 2019 in favor of mandatory participation in certain alternative payment models (such as accountable care organizations) or the new Merit-Based Incentive Payment System (MIPS) that emphasize value-based payment rather than fee-for-service. While MACRA included the adoption and use of CEHRT as required criteria for evaluating EPs’ participation in alternative payment models and MIPS, CMS will need to engage in additional rulemaking to clarify whether and how the Stage 3 Meaningful Use requirements will apply when MACRA becomes effective for EPs. Interested parties may submit comments to CMS prior to December 15, 2015.