Monday, September 27, 2010

Regional Extension Centers and HIE

The Software Advice team has written an interesting critique on recently created Regional Extension Centers (RECs) designed to advance adoption of EHRs. You are invited to complete their online survey with special emphasis on reporting anecdotal experience with these organizations. Although it is probably too early to draw substantial conclusions, I agree with Houston Neal that RECs will remain ineffective. My arguments suggest inadequate public funding and institutional arrangements, while his deplore the slow pace of government programs and their interference with free market dynamics.

As Neal points out, the eHealth Initiative has published a disappointing report on RECs to assess progress in their implementation across the US. They have also issued their 2010 report on Health Information Exchange (HIE).

Under the Health Information Technology Research Center (HITRC), RECs were created to provide technical assistance, guidance and information on best practices to support meaningful use of Electronic Health Records (EHRs). The competitively selected RECs - announced in February and April 2010 - serve health care providers within their geographical areas. The Survey of Regional Extension Centers, Planning for Adoption: The Early Direction of Regional Extension Centers (September 2010), presents the following findings (page 3):
  • Many Regional Extension Centers remain in the planning stages.
  • Progress has been slow in transitioning pre-award letters of commitment
    by providers to signed contracts by PCPs with a Regional Extension
    Center.
  • Opinion is evenly divided on progress toward REC objectives being reliant
    upon assistance from the Health Information Technology Research Center.
  • Among Regional Extension Centers planning to offer a preferred EHR
    vendor list to PCPs, the most important criteria for selecting a preferred
    EHR vendor are:
    o Price/ total cost of ownership over 3 years
    o Guarantee of meaningful use functionality
    o The number of installations locally
    o Use of an ASP hosted model
  • After stimulus funds are removed, a majority of Regional Extension
    Centers will change their fees as a means to sustainability.
The sample for this survey included only 46 of the 60 RECs in operation. The above findings suggest difficulties in defining the relationships among RECs and other health care institutions, as well as the lack of a sustainable business model. It is also not clear how these centers will provide support services across the US. The competitive selection process for RECs considered neither the issue of comprehensive geographical coverage, nor design of the requisite institutional arrangements with RHIOs, the HITRC or SDEs. I pointed out some of these weaknesses in my commentary on the proposed REC design and selection process last year.

The eHealth Initiative has also published a report based on their Seventh Annual Survey of Health Information Exchange - The State of Health Information Exchange in 2010: Connecting the Nation to Achieve Meaningful Use. The survey identified 234 active health information exchange initiatives (HIEs) in the US, among which 199 responded to and qualified for inclusion in the 2010 Annual Survey on Health Information Exchange. It should be noted that 48 of 56 state designated entities (SDEs) have been included in this sample. This shift in the definition of health information organizations needs to be taken into account in the survey findings reported. On page five, a description of the geographical coverage of organizations included in the survey shows that they cannot be considered comparable in size or clientele:

"Most non-SDE initiatives are operating at a multi-county coverage area. Fifty-five
initiatives report covering a multi-county area, while 21 initiatives report covering an
entire state. Other coverage areas include: 17 at a multi-state level, 11 at a county level,
7 at a metro level, 5 that do not cover a geographic area, and 6 initiatives that cover
another area such as part of a city or county, or are working with a specific population
group."


While the 2010 survey claims an increase in the number of operational exchanges, the rate of "mortality" among the sample from 2009-2010 is not considered, nor is the redefinition of "exchange initiatives" (defined as RHIOs in earlier reports) to include state designated entities (SDEs). The interpretation of survey results makes no distinction between state and federal programs for health information exchange.

In 2009, 57 health information exchange initiatives reported being operational. In 2010,
the number of operational health information exchanges increased to 73, 5 of which
report being SDEs. (page 8)


At least 28 of the 2009 respondents who did not respond to the 2010 survey were thought to continue their pursuit of HIE - although there is no data presented to support this assertion. The research methodology does not clearly state the total number of organizations included in the 2009 survey who did not respond in 2010. This number is essential to evaluate the 2010 survey response rate as well as sample mortality. (In my commentary on the 2009 survey, I identified similar problems in the research methodology.)

The significant methodological deficiencies of the surveys conducted by the eHealth Initiative seriously undermine the optimistic claims made by their authors.
Some useful websites:

The State HIE Toolkit
The State Health Information Exchange Leadership Forum
HIMSS Health Information Exchange
The Office of the National Coordinator for Health Information Technology (ONC)
Wikipedia Regional Health Information Organization
Nationwide Health Information Network Overview (ONC)
Public Health Informatics Institute (PHII)

Reflections on Business Models

In commentaries on US policies to promote meaningful use of health information technologies and electronic health records, I have pointed out the importance of a system level view of infrastructures for health information exchange. Key to the development of such infrastructures is the underlying business model to assure nationwide integration and system sustainability. A number of papers on health care system business models are available from a variety of agencies:





A Strong State Role in HIE: Lessons from the South Carolina Health Information Exchange

(2010) AHIMA



Abstract:

HIEs provide the infrastructure for information exchange, including the business model, governance structure, operating principles, legal model, and technology model for the exchange of healthcare information among various organizations. HIEs and regional health information organizations (RHIOs) have struggled with development and sustainability. The causes of failures are varied, but a lack of a compelling value proposition for all stakeholders is often cited as the prevailing reason.1
The primary beneficiary from an HIE is often the patient, who contributes the least directly toward the HIE’s development and operational costs. Other vested stakeholders, such as payers and providers, all receive varying benefits and bear varying responsibilities for the costs. A major barrier in the development of HIEs then is the identification of a model that fairly and equitably distributes the costs and benefits among the various stakeholders. At the crux of this issue is whether HIEs should follow a private, market-driven model that requires the generation of profit and value for the participants, or if HIEs are a public good that requires public financing. RHIOs and HIEs typically rely on a mix of government and private grants in the start-up phase, with the expectation of self-sustainability in the future: Four categories of business models are: not-for-profit, public utility, physician-payer collaborative, and for-profit.




ICT for the Health Unit, Directorate General Information Society and Media, European Commission: Business Models for eHealth (2010)


Abstract:

The evidence suggests that a solid business model is required for developing and
implementing a value-creating and sustainable eHealth service. In particular, this business
model needs to map all key supporting activities, value chain relationships and
dependencies impacted by the introduction of an eHealth service. This state of affairs can
be achieved if a set of activities and steps are implemented.
First, the structuring and implementation of such business model requires strong senior
management involvement throughout the various phases of the design, development and
delivery of an eHealth service. More importantly, senior management should not just act
as a project or programme manager; instead, it should make sure that the eHealth system
that it is supporting is provided with the required funding throughout its entire
development and implementation phases. Essentially, senior management is expected to
have a clear vision of what its healthcare delivery organisation wants to achieve with a
specific eHealth service and system, and lead the required operational steps.
In addition, staff involvement is essential in designing a business model of an eHealth
service. They need to be given the opportunity to understand how the specific service is to
change their activity or role, and need to provide evidence for mapping their interactions
in order to see how the eHealth service is going to improve or modify them. All of these
activities are aimed at making sure that business models do not fall short of reflecting the
interactions of those actors who are to use them in their day-to-day professional activities.
A business model of a value-creating and sustainable eHealth system is a static entity. It
might change as a consequence of technological and organisational evolution. However, it
can evolve following an evaluation aimed at measuring the potential and current impact of
the eHealth system. This may require data collection concerning activity, costs and
benefits. It also involves the need to apply sensitivity analysis to assess different scenarios
through which it is possible to design or modify a business model. Although the literature
provides several eHealth evaluation models, their implementation requires strong senior
management and process management, since regular performance data needs to be
collected and examined in order to assess current performance and estimate future
developments.





US Regional Health Information Organizations and the Nationwide Health Information Network: Any Lessons for Canadians? D. Protti ElectronicHealthcare, 6(4) 2008: 96-103


Abstract:
There seems to be general agreement in the United States that a Regional Health Information Organization (RHIO) is a neutral, non-governmental, multi-stakeholder organization that adheres to a defined governance structure to oversee the business and legal issues involved in facilitating the secure exchange of health information to advance the effective and efficient delivery of healthcare for individuals and communities. The geographic footprint of an RHIO can range from a local community to a large multi-state region. As regional networks of stakeholders mature, they often find the need for a formal independent organizational and governance structure (i.e., an RHIO) with systems to ensure accountability and sustainability for the benefit of all stakeholders. Experts maintain that RHIOs will help reduce administrative costs associated with paper-based patient records, provide quick access to automated test results and offer a consolidated view of a patient's history. The terms RHIO and Health Information Exchange (HIE) are often used interchangeably though most would see HIE as a "concept" relating to the mobilization of healthcare information electronically across organizations within a region or community as opposed to an "organization." Typically, an HIE is a project or initiative focused around electronic data exchange between two or more organizations or stakeholders. This exchange may include clinical, administrative and financial data across a medical and or business trading area. HIEs may or may not be represented through a legal business entity or a formal business agreement between the participating parties. Local Health Information Infrastructure (LHII) is a term occasionally used synonymously with RHIO. LHII was originally termed by the Office of the National Coordinator of Health Information Technology (ONCHIT) to describe the regional or local initiatives that are anticipated to be linked together to form an envisioned National Health Information Network (NHIN). The NHIN describes the technologies, standards, laws, policies, programs and practices that enable health information to be electronically shared among multiple stakeholders and decision makers to promote healthcare delivery. When completed, the NHIN will provide the foundation for an interoperable, standards- based network for the secure exchange of healthcare information in the United States.


eHealth Initiative (2007): Health Information Exchange: From Start-up to Sustainability





University of Copenhagen Masters Thesis (2009):

Behind the Internet Business Models: An E-health Industry Case





OECD International Futures Project on
“The Bioeconomy to 2030: Designing a Policy Agenda”

Health Biotechnology:
Emerging Business Models and Institutional Drivers (2008)


Abstract:
Up until today, two business models have been dominant within the application of
biotechnology for human health, or what is called health biotech in this report. One is the
classical biotechnology model. In this model, scientific discoveries and technological
inventions have been quickly developed within entrepreneurial firms, usually based upon
venture capital. They compete through their specialized scientific knowledge, often sold to
large companies, and they also compete through their flexibility, especially quick
commercialization of new fields. The other dominant business model is that of the large,
vertically integrated company. These large firms have integrated everything inside the
boundaries of the firm, from research and development (R&D) to production to marketing
and after sales monitoring. Firms in pharmaceuticals have competed through finding the
next ‘blockbuster drug’ and those in medical devices have also competed through
developing specific technologies and devices for large numbers of customers.
The report argues that four institutional drivers will form a very different context to deliver
human health care. Those four institutional drivers for change are 1) Scientific and
technological advances; 2) Public research and the public-private interface; 3) Public policy,
institutions and regulation; and 4) Demand and consumers.



Tuesday, March 23, 2010

Meaningful Use and Health Care Reform (Commentary updated)

Since my last commentary on "meaningful use" of an electronic health record (EHR) on June 22, 2009, progress has been made in elaborating relevant definitions as well as specific metrics for evaluation and measurement. Progress has also been made in developing certification criteria for EHR software products available on the market. The Proposed Rule on the CMS Electronic Health Record Incentive Program, published on January 13 in the Federal Register, builds on previous consultations and hearings concerning definition and measurement of "meaningful use" of EHRs. "This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology." (Page 1844, Federal Register, Vol. 75, No. 8) My comment and recommendations address the context of the U.S. health care system through the lens of organizational behavior and theory.
On December 30, 2009, CMS proposed a definition of meaningful use of EHR technology. In summary this definition considers three phases of EHR adoption and meaningful use. In stage I (2011): "... criteria for meaningful use focus on electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information." Definitions to be applied for stages 2 and 3 remain to be finalized in time for 2013 and 2015 incentive payment years, as do corresponding dimensions of EHR certification. (In the proposed rule published on January 13, CMS refers to ONC definitions of qualified and certified EHR technology.)

This linear design of EHR adoption omits critical dimensions of organizational context and the reticular, multilevel process of change and development in social systems. Furthermore the logical structure of the process has been reversed in two important ways. First, narrow, short-term criteria have been defined for 2011 in stage 1, leaving adopters at a loss to understand how early adoption prepares them for future returns on their investment. Second, infrastructures necessary for meaningful use seem to be viewed as an outcome of the process rather than a prerequisite. The absence of health information exchange (HIE) organizations forming a Nationwide Health Information Network (NHIN) invalidates the most important intrinsic benefit of meaningful use, the communication of health information across institutional and geographical boundaries.

Discussion of the EHR reporting period for determination of ARRA incentive payments (page 1849) reveals concern for a tradeoff between "robust verification and time available to achieve compliance." To resolve this tradeoff, the EHR reporting period in the first incentive payment year is defined as any continuous 90 day period, while subsequent reporting periods should be extended over the entire payment year for more robust measurement of compliance rates. This provision recognizes neither the dynamic, nonlinear character of this complex process nor the critical importance of the initial determination of meaningful use in the process of awarding incentive payments. It might be more reasonable to establish continuous monitoring, for example over a period of the previous 3 to 6 months of EHR use. Measurement of health information exchange (HIE) would further require identification of the organizational configuration of associated Regional Health Information Organizations (RHIOs) or the Nationwide Health Information Network.

The policy priorities for meaningful use presented in the proposed rule are generally consistent with the recommendations of the HIT Policy Committee: 1- To improve quality, safety, efficiency and to reduce health disparities; 2- To engage patients and families in their health care; 3- To improve care coordination; 4- To improve population and public health; and 5- to ensure adequate privacy and security protections for personal health information. Stage 1 criteria for meaningful use include a set of objectives for each policy priority, along with the requirement that all objectives be satisfied for provider qualification. This requirement may be too rigid to accommodate the increasing diversity of health care providers in the U.S.. For example, physician and emerging mid-level provider organizations may satisfy different objectives.

Careful review of the proposed rule reveals that issues related to development of a national health information infrastructure have not been addressed since June, 2009. The criteria for meaningful use exclude functions requiring effective health information exchange - in recognition of the absence of HIT infrastructure and the current low rate of EHR adoption in the U.S.: "Given the anticipated maturity of HIT infrastructure inherent in the strengthening criteria (through 3 stages of meaningful use) and the increased adoption of certified EHR technology predicted in section V. of this proposed rule, these barriers to meaningful use will be removed." (page 1853) Unfortunately, there is no evidence-based argument to support these apparent assumptions at the foundation of EHR meaningful use.

In the proposed rule, there are several examples of criteria adjusted to the lack of infrastructure for HIE. For example, the use of computer provider order entry (CPOE) is defined as "the provider's use of computer assistance to directly enter medical orders (from a computer or mobile device) captured in a digital, structured and computable format for use in improving safety and organization. It does not include the transmittal of that order to the pharmacy, laboratory, or diagnostic imaging center in 2011 or 2012."(page 1856) The formulation of this meaningful use criterion illustrates how the intrinsic motivations for CPOE - the ability to communicate such orders to other health care providers - may be compromised where no infrastructure exists for HIE. Another example is the exclusion of the objective to provide access to patient-specific education resources upon request. An important reason for this exclusion is the lack of infrastructure for open access to such resources.

On the other hand, on page 1856, the goals associated with improved care coordination require health information exchange, and the proposed rule apparently assumes the presence of necessary infrastructure. For example, qualified providers and eligible hospitals must demonstrate capability to exchange key clinical information (such as problem list, medication list, allergies and diagnostic test results) among providers of care and patient authorized entities electronically. Furthermore, concerning meaningful use objectives related to administrative simplification, it is proposed that the phrase "where possible" be deleted from the requirement that insurance eligibility be checked and that claims be submitted electronically since these are already standard HIPAA transactions. However, there is no indication that these electronic transactions are "standard" in practice. An AMA interpretation of HIPAA regulations (AMA Practice Management Center, Understanding the HIPAA Standard Transactions: The HIPAA Transactions and Code Set Rule, published in 2009 -page 7) states that CMS will focus on "...voluntary and complaint-driven enforcement." The responsibility for securing insurer compliance appears to belong to the physician and his or her practice - a substantial additional burden associated with "meaningful use."

The above discussion shows that the assumption of available NHIN infrastructure varies from one section of the proposed rule to another. This is especially inappropriate in the formulation of Stage 1 criteria for meaningful use.

As stated on page 1858, it is surely important to measure conformity with the objectives of meaningful use. However, the measures presented in the proposed rule focus mainly on percentages based on frequency, for example in use of CPOE. This measure ignores the fact that without appropriate HIE, such orders cannot be effectively communicated. The data generated for these measures (the numerator and denominator for calculation of conformity to the required percentage of use) are further difficult to verify, and would be subject to legal challenge especially for qualified providers practicing in multiple settings and through multiple payers (page 1859). EPs practicing in multiple settings are required to conduct 50% of their patient encounters in locations or practices equipped with certified EHR technology. Is it really feasible that "…in evaluating the 50 percent threshold, our proposal is to review all locations-organizations at which an EP practices."? (page 1859) Among EPs whose pattern of practice is changing over time, this suggested review cannot be valide. The measurement further excludes HIE :

"As this objective (CPOE) relies solely on a capability included as part of certified EHR technology and is not, for purposes of Stage 1 criteria, reliant on the electronic exchange of information, we believe it would be appropriate to set a high percentage threshold....For other objectives that are reliant on the electronic exchange of information, we are cognizant that in most areas of the country, the infrastructure necessary to support such exchange is not yet currently available..."(page 1859) The effect of these stipulations will be conflation of "meaningful use" with implementation of certified EHR. The entry of data in a certified EHR is not by itself evidence of meaningful use.

The most persistent problem in creation of infrastructure for HIE is the business model for these enterprises to be created across the U.S.. Until this problem is solved, no meaningful use of EHR will be possible. In a study reported by Wright et al. (Physician Attitudes Toward Health Information Exchange: Results of a Statewide Survey, JAMIA 2010 17: 66-70), 45% of respondents reported no usage of EHR while 28% reported usage of a simple EHR defined as "an integrated clinical information system that tracks patient health data and may include such functions as visit notes, prescriptions, lab orders, etc." (page 67). It is difficult to conclude from this survey that physicians would be willing to pay for HIE, as so few have any meaningful experience with this function. Further, in a study by Adler-Milstein et al. (Characteristics Associated with Regional Health Information Organization Viability, JAMIA 2010 17: 61-65), it is concluded that "Exchanging a narrow set of data and invoking a broad group of stakeholders were independently associated with a higher likelihood of being operational." (Abstract page 61)

This conclusion omits reference to the extremely low rate of viability observed among RHIOs under study. In another very recent study by Ross et al. (Health Information Exchange in Small-to-Medium Sized Family Medicine Practices: Motivators, Barriers, and Potential Facilitators of Adoption, IJMI 2010 79: 123-129), electronic prescribing was ranked favorably among health information exchange functions, but no surveyed practice identified available government incentives as a significant motivator for adoption of this function in HIE, particularly in practices where eprescribing was already included in EHR functions.

In conclusion to this commentary, I would agree with some other observers: physicians and other health care providers should not wait for U.S. government incentives for adoption of certified EHR or "meaningful use". Rather they should assess the intrinsic benefits to their workflow as well as ROI resulting from prospective software adoption, and they should act in accordance with internal scenario analysis. System level efficiencies at the regional or national levels of analysis will only become accessible with sustained public investment in necessary infrastructures. Unfortunately in the U.S. health care sector such investment remains unlikely.
More promising than the NHIN configured among local and regional RHIOs is the National Information Exchange Model (NIEM) originated in 2005 by the Department of Justice (DOJ) and the Department of Homeland Security (DHS) to address information exchange among government agencies in the context of national security. Even though this development of the NIEM has suffered some of the same difficulties as HIE in defining an effective and sustainable business model, it has benefited from more consistent and longer term public funding.
While the NHIN is designed as a many to many mapping of communication among participating entities, the NIEM proposes a canonical mapping through the common infrastructures of the model shared among communities of interest. Such a national – and eventually global - infrastructure offers services as well as a system of governance to assure economies of scale and scope in information exchange across enterprise domains served. [1] [2] [3] [4]
Websites: Justice Information Sharing ; National Information Exchange Model

RECOMMENDATIONS
­
1-Emphasize intrinsic benefits available through meaningful use rather than unsustainable extrinsic incentives. NIEM implementation model values stakeholder participation in system development and governance. HIE is a fundamental intrinsic motivation for meaningful use of EHRs as well as a central criterion for its assessment. For example, where CPOE does not include the functionality for communication across health care providers and pharmacies, it seems meaningless to require that 80% of such orders be entered electronically. Modest financial incentives for individual providers will not be adequate to motivate behavior perceived to be meaningless.
­
2-Recognize the benefits of meaningful use of certified EHR software to integrate clinical research and practice. According to Chris Thorman of Software Advice, a website that reviews electronic health records this important motivation for EHR adoption surpasses the HITECH incentives in terms of return on investment in health information technology. According to Synergyst Research only 10% of more than 720,000 licensed American physicians participate in clinical trials, mostly because of the significant burdens associated with data collection, extra paperwork, compliance with regulations, and staff training. EHRs contribute to solve these problems. Chris Thorman has summarized the usefulness of EHRs in clinical trial participation in the following table appearing in his article, Electronic Health Records and Clinical Trials, An Incentive to Integrate:
Identify potential opportunities
EHR vendors whose software integrates with clinical trial providers will have access to trials, studies, and registries that your practice is eligible to participate in.
Identify number of potential trial subjects
The search function in an EHR database allows a user to quickly identify how many of a practice's patients are potentially eligible for a clinical trial. From there, the clinical trial provider can determine if a practice would be a good partner.
Patient enrollment
The EHR has the capability to implement trial-specific screening requirements into new patient records to determine their eligibility for a study. The EHR will also have the ability to identify patients who meet the exact requirements of a study.
Study execution
During the trial, the EHR can create trial-specific data fields that can be populated during routine patient encounters. Conflict alerts can also be created to notify providers of actions that violate a study's protocol.
Data submission
The EHR will be able to submit information to EDC software without having to convert the data. This eliminates redundant data entry and increases accuracy of the data.

­3-Recognize the reticular, nonlinear process of EHR adoption and meaningful use by considering the configuration of communities of interest in the process of use assessment. Greater emphasis, particularly in definition of the time frame, should be placed on evaluation of meaningful use at the initial and most important phase. Failure to adequately assess the initial phase will result in serious problems in subsequent phases of evaluation for incentives. The time frame should be a moving period of 3 to 6 months to better reflect the dynamic character of the process.
­
4-Examine assumptions related to HIE infrastructures as they shape the formulation of the rules throughout the document. These assumptions appear to vary, affecting whether the exchange of information is required or not. They should be realistic and consistent throughout. Furthermore, qualified providers should not be charged with obtaining compliance on the part of insurers or other partners, as appears to be the case in checking insurance eligibility.
­
5-The U.S. could develop a more effective long-term strategy through collaboration with the Brazilian BIREME and the Canadian Infoway. This approach would contribute as well to creation of an effective regional and hemispheric health information system.
­
­
[1] Allen, C. Information sharing and the federal state and local levels. Testimony before the Senate Committee on Homeland Security and Governmental Affairs. July 23, 2008. Washington, DC. http://www.dhs.gov/xnews/testimony/testimony_1216992676837.shtm
[2] Carter DL, Carter JG. The Intelligence Fusion Process for State, Local, and Tribal Law Enforcement. Criminal Justice and Behavior 2009 December 1;36(12):1323-1339.
[3] Garson GD. Securing the Virtual State: Recent Developments in Privacy and Security. Social Science Computer Review 2006 November 1;24(4):489-496.
[4] Rollins J. Fusion Centers: Issues and Options for Congress. 2008; RL34070. http://fas.org/sgp/crs/intel/RL34070.pdf

Wednesday, January 27, 2010

Meaningful Use and Health Care Reform

Since my last commentary on "meaningful use" of an electronic health record (EHR) on June 22, 2009, much progress has been made in elaborating relevant definitions as well as specific metrics for evaluation and measurement. Progress has also been made in developing and applying certification criteria for EHR software products available on the market. Chris Thorman of Software Advice has published a very useful article, "Updates on Meaningful Use, Certified EHR Technology and the Stimulus Bill", to help physicians and hospitals evaluate their software needs and qualify for EHR incentive payments under the HITECH Act. An earlier article, "Don't wait for the Government to Start Your EHR Implementation," provides important background information on EHR return on investment (ROI).

The following resources contribute to my updated commentary on "meaningful use":

Proposed Rule: Medicare and Medicaid Programs: Electronic Health Record Incentive Program – CMS-2009-0117-0002- Posted 01-13-10

National Committee on Vital and Health Statistics
Observations on “Meaningful Use” of Health Information Technology
June 1, 2009

Adler-Milstein, J., Landefeld, J., Jha, A. Characteristics Associated with Regional Health Information Organization Viability, Journal of the American Medical Informatics Association, 2010, 17(1), 61-65.

Sweeney, L. The Medical Billing Framework as the Backbone of the National Health Information Infrastructure. Carnegie Mellon University, AdvanceHIT Project. Working Paper 1001. October 2009. PDF

Wright, A. Soran, C., Jenter, A., et al., Physician Attitudes Toward Health Information Exchange: Results of a Statewide Survey, Journal of the American Medical Informatics Association, 2010, 17(1), 66-70.

The Proposed Rule on the CMS Electronic Health Record Incentive Program, published on January 13 in the Federal Register, builds on previous consultations and hearings concerning definition and measurement of "meaningful use" of EHRs. "This proposed rule would implement the provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) that provide incentive payments to eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology." (Page 1844, Federal Register, Vol. 75, No. 8) This comment focuses on the context of the U.S. health care system as well as the definitions of "meaningful use" and software certification.

On December 30, 2009, CMS proposed a definition of meaningful use of EHR technology. In summary this definition considers three phases of EHR adoption and meaningful use. In Stage I (2011): "... criteria for meaningful use focus on electronically capturing health information in a coded format, using that information to track key clinical conditions, communicating that information for care coordination purposes, and initiating the reporting of clinical quality measures and public health information." Definitions to be applied for stages 2 and 3 remain to be finalized in time for 2013 and 2015 incentive payment years, as do corresponding dimensions of EHR certification. (In the proposed rule published on January 13, CMS refers to ONC definitions of qualified and certified EHR technology.)

Discussion of the EHR reporting period for determination of ARRA incentive payments (page 1849) reveals concern for a tradeoff between "robust verification and and time available to achieve compliance." To resolve this tradeoff, the EHR reporting period in the first incentive payment year is defined as any continuous 90 day period, while subsequently the reporting period should be extended over the entire payment year for more robust measurement of compliance rates. This provision recognizes neither the dynamic and nonlinear character of this complex process nor the critical importance of the initial determination of meaningful use. It might be more reasonable to establish a process of continuous monitoring, for example over a period of the previous 3 to 6 months of EHR use. Measurement of health information exchange (HIE) would further require identification of the organizational configuration of associated RHIOs or the Nationwide Health Information Network.

The policy priorities for meaningful use presented in the proposed rule are generally consistent with the recommendations of the HIT Policy Committee: 1- To improve quality, safety, efficiency and to reduce health dispartities; 2- To engage patients and families in their health care; 3- To improve care coordination; 4- To improve population and public health; and 5- to ensure adequate privacy and security protections for personal health information. Stage 1 criteria for meaningful use include a set of objectives for each policy priority, along with the requirement that all objectives be satisfied for provider qualification. This requirement may be too rigid to accommodate the increasing diversity of health care providers in the U.S.. For example, physician and emerging mid-level provider organizations may satisfy different objectives.

(Commentary to be continued...)