Interoperability Review: The Journey of Meaningful Use

The challenge of Health Information Technology (HIT) standards has been long-standing, and few would argue that it held a high profile in the healthcare industry. There was no shortage of efforts to rectify the situation in the United States, perhaps most notably reaching some coherency with the formation of the Health Information Standards Planning Panel by ANSI in 1991. This was succeeded by the Health Information Standards Board, a chartered organization by ANSI, in 1994. While this Board operated for over a decade, only its most ardent core would argue that it had substantial influence on the healthcare industry in the United States or elsewhere.

 

The advent of the HIPAA legislation in 1996, which included a segment on administrative simplification and data exchange standards, is the first time in U.S. legislative history that the healthcare industry was subject to a standards mandate; though the requirement that we all use ICD codes and common billing forms seems quite tame in retrospect. The National Committee for Vital and Health Statistics (NCVHS), which was a long-standing federal advisory committee, was rechartered by HIPAA to oversee health information exchange standards associated with administrative simplification, and became the first designated committee for HIT standards.

 

The Bush administration accelerated the process by creating the Office of the National Coordinator (ONC) in 2004, which contractually sponsored the formation of the Health Information Technology Standards Panel (HITSP) in partnership with ANSI and HIMSS shortly thereafter. The federal sponsorship of a standards forum, HITSP, was unprecedented. HITSP produced 18 interoperability specifications involving hundreds of thousands of volunteer person-hours, drawing from HL7 and related standards. In its closing phases last year, HITSP generated modular and coherent standards capabilities and components that constitute a consensus specification for detailed HIT standards.

 

Meaningful Use today refers to a body of specifications and standards designed to address the question of whether electronic health records (EHRs) are being "meaningfully used." The term arises from the American Recovery and Reinvestment Act (ARRA) of 2009 and specifically the HITECH (Health Information Technology for Economic and Clinical Health) components of it. ARRA legislation specified incentive payments to healthcare providers that promote the adoption and meaningful use of interoperable health information.

 

Associated with HITECH were additional funds, including $2 billion to establish ONC programs and activities and also making permanent the existence of the Office which previously had been authorized only by a presidential Executive Order.

 

HITECH also authorized the creation of two new federal advisory committees, the HIT Policy and HIT Standards Committees. These committees had an initial charge of recommending what constituted Meaningful Use. This question is of material interest to the healthcare provider community, since HITECH authorized $20 billion for incentive payments for providers conforming to Meaningful Use specifications. Specifically, CMS would, over a three-year period, provide $44,000 per physician for conforming organizations and begin to fiscally penalize non-conforming organizations. For large groups and hospitals, the joint incentives and penalties comprise a palpable if synthetic economic force for standards adoption.

 

The legislation requires that initial components of Meaningful Use focus on healthcare quality. Thus, the HIT Policy Committee proposed the adoption of many NQF (National Quality Forum) and related quality metrics, for which the HIT Standards Committee specified how these metrics would be generated from electronic medical records. These recommendations were mostly adopted by the government and published in two parts in the Federal Register on 13 January 2010, as a Notice of Proposed Rule Making (NPRM) from CMS on reporting requirements, and an Interim Final Rule (IFR) from ONC on the interoperability standards that would be used.

As a practical matter, most of the IFR standards were drawn from the two-decade legacy of standards coordination efforts in the United States outlined above. In fact, many of the HITSP components and capabilities were explicitly referenced. These in turn are familiar to the health informatics community, since at their core they embody HL7 standards such as a Common Document Architecture (CDA) and two variations on the continuity of care standards, including the CDA conformant Continuity of Care Document (CCD) and the original specification of the Continuity of Care Record (CCR).

 

The IFR also specifies terminologies and implies value sets. Again, their sources will not be surprising as they continue traditions established by HIPAA and HITSP including ICD9CM for problem lists with the integration of SNOMED and ICD10CM by 2013. Similarly, drugs would embrace the RxNorm standards published by the National Library of Medicine, while laboratory data must be mappable to LOINC.

 

Implications for the informatics community are profound. For the first time, regulatory requirements of how clinical data should be formatted, with incentives and penalties for nonconformance, are being imposed on the U.S. healthcare industry. Many believe that this will result in inevitably enhanced data interoperability and exchange, and potential reuse of standardized clinical data for quality, practice improvement, decision support, and outcomes research; all of which should contribute to improved healthcare quality.

 

The advantages to the informatics community of having, at least in the United States, a high probability of comparable and consistent clinical data for decision support, information aggregation, and other informatics applications, are profound. A major stumbling block for having highly generalizable informatics resources or deep penetration into the healthcare industry has been the absence of standardized data; Meaningful Use portends to fundamentally alter that restriction.

 

The question that remains is how will meaningful use impact the international community? While the United States may choose reasonable standards, many, such as the Nscript pharmacy standard, have little traction outside of the United States. The healthcare community is increasingly becoming global, and certainly vendors recognize the importance of having products that are not restricted by geographical area or local jurisdiction. The AMIA community can participate in addressing these challenges, through engagement with organizations such as ISO-TC215 on Health Informatics or HL7. These organizations have international scope, and may facilitate the harmonization of data standards internationally.