Recent HITECH regulations -- including the Stage 2 meaningful use proposed rule and the proposed rule setting forth standards, implementation specifications and certification criteria for electronic health record systems -- chart the health care system's next steps on the path toward electronic health information exchange, or HIE.
HITECH included a number of programs designed to spur electronic HIE throughout the nation, including programs to develop necessary HIE infrastructure, identify common HIE standards and policies, and supply health care providers with incentive payments to adopt and meaningfully use EHR systems. The Affordable Care Act built on the foundation that HITECH laid by implementing new payment and care delivery approaches, such as bundled payment options and accountable care organizations, that recognize HIE as a critical enabler of broad transformations in health care.
HIE can occur through a number of ways, including:
- The development of regional, local or state not-for-profit or government-sponsored exchange networks that support all providers in a community;
- Private networks consisting of hospitals and other health care providers, accountable care organizations and integrated delivery networks;
- Exchange options offered by EHR vendors; and
- Services provided by national exchange networks.
HIE also can come in multiple forms, including "directed exchange" (typically through a standards-based approach to send (or "push") information directly to known, trusted recipients over the Internet) and more robust but less widely available "query-response exchange," which allows a health care provider to request (or "pull") information about a patient that may be available from other health care providers.
HIE Requirements in Recent HITECH Regulations
The Office of the National Coordinator for Health IT stated in its Federal Health IT Strategic Plan 2011-2015 that "for as many providers as possible, the first priority [to encourage more widespread HIE] is finding the right combination of already-available exchange models that will enable them to electronically exchange lab results, patient care summaries and medication histories."
This priority informed the federal government's development of the HIE provisions in the Stage 2 meaningful use and 2014 EHR standards and certification proposed rules. In general, the HIE provisions in those rules can be satisfied through directed exchange and do not require query-response style HIE.
Stage 2 Meaningful Use Proposed Rule
As a result of Stage 1 of meaningful use, all certified EHR systems now can record, consume or produce standardized content, including medication lists, drug allergies, smoking status, lab results and care summaries. Recognizing that the stage is set for more widespread HIE, the Stage 2 meaningful use proposed rule requires actual, ongoing and secure exchange of patient information to support activities like patient transitions, public health reporting and patient engagement. Some of the HIE-related requirements included in the Stage 2 meaningful use proposed rule are highlighted below.
Requirement to exchange summary of care record. CMS proposes requiring health care providers to make available to a receiving health care provider a summary of care record for more than 65% of patient care transitions and referrals in which they engage (an increase from the Stage 1 threshold of 50%). In addition, CMS proposes requiring health care providers to transmit summary of care records to a recipient with no organizational affiliation and that uses a different EHR vendor than the sender for more than 10% of transitions of care and referrals. Health care providers would not be permitted to use USB, CD-ROM, or other physical media or electronic fax to achieve this requirement.
Requirement to communicate with patients through secure electronic messaging . CMS proposes requiring health care providers (excluding hospitals) to send a secure message using the electronic messaging function of their EHR system for more than 10% of unique patients seen by the health care provider during the EHR reporting period. Health care providers would be permitted to use alternatives, including patient portals, personal health records or other stand‐alone secure messaging applications to achieve this requirement.
Requirement to incorporate clinical lab test results into an EHR as structured data. CMS proposes increasing this requirement, which was included under Stage 1, so that health care providers must incorporate more than 55% (up from 40% in Stage 1) of all ordered clinical lab test results into their EHR as structured data.
Requirement to engage in public health reporting. Beginning in 2013, CMS proposes adding the qualification "except where prohibited" to the public health reporting-related meaningful use requirements in an attempt to encourage health care providers to engage in electronic public health reporting even when it is not required by state or local law. CMS also proposes moving certain public health reporting requirements from the "menu" to the "core" set of meaningful use requirements and adding additional reporting requirements to cancer and other specialized registries.
2014 EHR Standards and Certification Proposed Rule
The 2014 EHR standards and certification proposed rule sets the standards, implementation specifications and certification criteria for EHR systems to support health care providers in their achievement of meaningful use.
To enable health care providers to meet the meaningful use requirements that include HIE, the 2014 EHR standards and certification proposed rule sets forth a number of "transport" standards, which facilitate the movement of a patient's health information from one point to another.
For example, to support the requirement that health care providers exchange summary of care records when patients transition from one care setting to another, the proposed rule requires EHRs to support the transport standards developed under the Direct Project ("SMTP" and "SMIME" secure messaging standards), as well as external data representation ("XDR") and cross-enterprise document media interchange ("XDM") standards. ONC also proposes adopting as an optional standard -- the SOAP-Based Secure Transport RTM version 1.0 standard -- which was developed under the Nationwide Health Information Network Exchange Initiative.
The proposed rule requires adoption of these transport standards for the purpose of supporting directed exchange, as required under the Stage 2 meaningful use proposed rule. While some of the transport standards can support query-response model exchange, there is no requirement in either proposed rule that they be used for that purpose.
The 2014 EHR Standards and Certification Proposed Rule also sets forth a number of proposed messaging standards, which regulate the contents of the information being transported, to facilitate the exchange of patient visit summaries, lab results and prescriptions, including:
Summary of care records. Under the proposed rule, EHR technologies would have to be capable of incorporating, generating and transmitting a summary of care record using the Consolidated Clinical Document Architecture (CDA), Release 2.0 (US Realm) standard. This standard would support a number of meaningful use requirements, including the requirements that health care providers exchange a summary of care record and provide their patients with the ability to view online, download and transmit health information to a third party.
Lab results. EHR technologies would have to be capable of incorporating and transmitting electronic laboratory tests and values/results to ambulatory health care providers using HL7 2.5.1 and HL7 Version 2.5.1 Implementation Guide: Standards and Interoperability Framework Lab Results Interface, Release 1 (US Realm). The implementation guide was developed under the auspices of ONC's Standards and Interoperability Framework.
Electronic prescribing. EHR technologies would have to be capable of supporting NCPDP SCRIPT version 10.6 for electronic prescribing in both the inpatient and ambulatory settings. NCPDP SCRIPT standards are widely used by physicians who electronically prescribe in ambulatory office settings but are less commonly used in inpatient settings.
Finally, the proposed rule sets forth a number of proposed vocabulary standards (e.g., LOINC, SNOMED-CT, ICD-9 and ICD-10, RxNorm and HCPCs) that would complement the messaging standards described above. Vocabulary standards are nomenclatures used to ensure that medical information like clinical procedures, medications and allergies are described and interpreted in a standardized way.
Destination: Interoperability; Course: Under Debate
As of February, more than 211,500 health care providers had registered for the meaningful use incentive program, and the government had made more than $3.8 billion in payments. While meaningful use is the leading initiative driving the country's development of an interoperable nationwide health information network, the federal government has implemented a host of other initiatives to spur HIE.
These include the Health IT Policy and Standards Committees' work groups and subcommittees, the Standards and Interoperability Framework and the Direct and Nationwide Health Information Network Exchange projects, many of which are focused on developing policies and standards to support the secure electronic exchange of patient health information.
While the federal government's efforts to advance HIE are wide-ranging, they are not without debate. Some stakeholders suggest that the Stage 2 meaningful use and 2014 EHR standards and certification proposed rules' focus on directed exchange does not adequately support achievement of more robust query-response model HIE, especially given that many communities and states are developing the infrastructure to support such exchange under HITECH and independently.
Other stakeholders point out that the directed exchange model advanced by the proposed rules provides a more realistic near-term on-ramp for health care providers to exchange information and will enable more health care providers to achieve meaningful use. These stakeholders also note that the Direct Project's exchange standards can be used for more than secure email, a common criticism.
Whatever the course, the destination is clear: a health care system in which health care providers securely exchange patient health information to improve care coordination and, ultimately, patient health outcomes.