eResearch Collaboratory

Health Information Exchange: Infrastructures and Market Dynamics

2011-11-12T12:45:00.000-08:00

Kuperman, G.J. 2011, “Health-information exchange: why are we doing it, and what are we doing?” Journal of the American Medical Informatics Association, 18(5), 678-682. http://jamia.bmj.com/content/18/5/678.full

This important article offers a very useful conceptual view of health information exchange – set in the context of US health care sector market dynamics. The author summarizes the early history of the Nationwide Health Information Network (NHIN) and the HITECH Act of 2009 promoting the introduction of health information technology (HIT) on a national scale. The article begins with the vision of health information exchange (HIE) as a key enabler of high quality and efficient health care. According to the author, early demonstration projects conducted from 2005-2007 have shown that the interconnection of RHIOs for health information exchange in the “network of networks” requires neither a centralized national infrastructure nor a national patient identifier. Unfortunately, these conclusions are more ideological than scientific, as there is little corroborating evidence in policy or organizational research.

Since 2005, the eHealth Initiative has reported on the development and sustainability of RHIOs and State Designated Entities (SDEs) across the United States. Kuperman cites the 2010 eHealth Initiative HIE Survey findings (available at http://www.ehealthinitiative.org/members-download/finish/4-open/35-hie-survey-report-2010-key-findings.html ) to substantiate the existence of 73 “operational” initiatives, but he does not mention that among those, the report finds that only 18 can be described as “sustainable” – sustained on operational revenue alone and not dependent on federal funding. (See page 2 of the Key Findings. One of the findings listed on page 1, states that “Sustainability is an attainable goal for health information exchange organizations. There is a small but critical mass of sustainable organizations. ” This finding is without adequate foundation in the eHealth Initiative data analysis or other studies of health care organization. Such data interpretation threatens the formulation of credible policy on health information technology in US system reform.) The terms RHIO, SDE and HIE refer to organizations that address the” business issues of interoperability”, but critical review of eHealth Initiative research as well as other published scholarly articles suggests that sustainable business models have not been identified.

My reviews of these reports reveal some methodological deficiencies that tend to weaken published study conclusions. (See http://eresearchcollaboratory.blogspot.com/2009/10/health-information-exchange-update.html . My blog review was completed before the eHealth Initiative redefined their HIE reports as proprietary – despite Federal funding supporting the research. Only the “key findings” are available for public review. The validity of such findings cannot be evaluated without access to the research methodology.) From year to year, the eHealth Initiative reports that the number of HIE entities has increased - without accounting for sample mortality or changes in their definition of HIEs.

Another publication (See Julia Adler-Milstein, David W. Bates and Ashish K. Jha, 2009, U.S. Regional Health Information Organizations: Progress And Challenges, Health Aff , 28( 2) 483-492 available at http://content.healthaffairs.org/content/28/2/483.abstract .) based in part on data from the eHealth Initiative (See http://www.ehealthinitiative.org/reports.html ) includes a measure of time spent in HIE planning. This indicator seems to be negatively associated with operational status of the entities in the sample. While Adler-Milstein et al. conclude that a lengthy planning process may challenge HIE viability, it is also possible that this result reflects the short life expectancy of HIE entities – as time spent in planning may serve as a partial surrogate for longevity.

These authors have also published another study (apparently based on some of the same data). (See Adler-Milstein et al. 2011, A Survey of Health Information Exchange Organizations in the United States: Implications for Meaningful Use, Annals of Internal Medicine, 154(10) 666-671 available at http://www.annals.org/content/154/10/666.abstract )

They elaborated the definition of a “comprehensive RHIO” in light of the HIE requirements for meaningful use of electronic health records (EHRs). This definition was developed by a panel of 9 national health policy experts using a Delphi methodology to arrive at consensus. Analysis revealed that none of the RHIOs included in the sample satisfied the criteria of this definition. This finding suggests the possible failure of the market driven “network of networks” approach to development of the NHIN.

Such failure may also be attributed to the short time frame (2-4 years) for public funding in support of RHIOs as well as the requirement that they develop business models based on revenue streams from private stakeholders and system users. Such business models are all the more difficult to identifiy given that the significant benefits of health information exchange often accrue at the system level rather than the individual provider or payer level of analysis. Adler-Milstein et al. (2011) conclude that their findings “…call into question whether RHIOs in their current form can be self-sustaining and effective in helping U.S. physicians and hospitals engage in robust HIE to improve the quality and efficiency of care.” (See abstract.) Questions raised in this study suggest that the “network of networks” strategy based on the sustainability of RHIOs cannot be assumed as in Kuperman’s analyses of other projects, such as Direct and Connect for health information exchange in the context of health sector market dynamics.

The second issue related to health information infrastructures required for national system reform is the creation of a unique patient identifier. As mentioned above, Kuperman suggests that such an identifier was shown to be unnecessary in early demonstration projects for the NHIN and the “network of networks” approach. This is another ideologically convenient finding, without an evidence base in policy experience or organizational research. Kuperman argues that the advantage of a PUSH model such as Direct is to avoid the necessity of linking patient identifiers across systems before data transfer between health care organizations. While directories of authorized organizations (and their identifiers) would have to be established – individual patients would be identified by the authorized senders and receivers using internal matching algorithms– or even manual procedures. This approach would probably be effective in small-scale systems, but may be impracticable at the regional and national levels (not to mention the global level) as the volume of data increases with mobility and diversity of patient populations served.

According to Kuperman, clinicians will expect both PUSH and PULL service dynamics for health information exchange, including transmission among providers as well as retrieval of individual patient data across the entire health care system. The responsibility for designing and managing these services apparently resides with RHIOs under the assumption of their sustainability: “As RHIOs (grapple) struggle to support interoperability-based services that improve the quality and efficiency of care, they will have the opportunity to understand how best to combine pull- and push-oriented capabilities.” (page 681) Given the ongoing failure of federal investments in RHIOs and the “network of networks” strategy to develop infrastructure, this policy direction lacks credibility and remains unfounded in research evidence or policy experience.

Kaplan and Porter: How to Solve the Cost Crisis in Health Care

2011-10-27T09:15:00.000-07:00

Commentary : R. Kaplan and M. Porter, “How to Solve the Cost Crisis in Health Care”, Harvard Business Review, September, 2011, 47-64. (See the article at http://hbr.org/2011/09/how-to-solve-the-cost-crisis-in-health-care/ar/1)

In this important publication Kaplan and Porter develop a methodology for measuring the “right” things in the “right” way to ascertain an account of costs and outcomes in health care service delivery to individual patients in the care delivery value chain (CDVC). The authors argue that most health care costs are not fixed, and therefore accessible to managerial control. (In my opinion, this argument is symptomatic of the absence of a health care “system”, as is the “rule of one” applied to costing expensive equipment in the context of a single health care enterprise competing with others.) In other commentaries on my blog at http://eresearchcollaboratory.blogspot.com/2011_04_01_archive.html - I have discussed Porter’s work on conceptualizing and measuring “value” in health care “per dollar expended”, and some of the pitfalls of reliance on this common denominator.

The methodology proposed here addresses the critical need to manage cost associated with health care services. However, some implicit ideological assumptions should be examined. First, the method of process mapping is framed in a for-profit health care services market, assuming that competition to control costs at the enterprise level will result in financial return on investments as well as system-level savings. This approach may result in unnecessary and costly process duplication at the system level as illustrated in the case of McAllen, Texas: http://www.newyorker.com/reporting/2009/06/01/090601fa_fact_gawande . Such costly duplication is all the more critical in the increasingly resource poor U.S. health care context.

The second apparent assumption is that health care services can effectively be conceptualized and mapped in the same way as manufacturing systems. Kaplan’s “Time-Driven Activity-Based Costing” (TDABC) as described in earlier HBR publications also aims specifically to augment enterprise profits in competitive markets. Many health economists reject these perspectives on service production, profitability and the efficacy of market dynamics in the health care sector.

Health care process mapping is not a new idea; it has been practiced in other national systems, including the NHS (UK- See the Institute for Innovation and Improvement at http://www.institute.nhs.uk/), Canada and Australia. Lack of reference to other national experiences leaves the HBR article reader with the impression that such methods have not been used in the health care sector.

Review of some of the recent literature suggests that the results of the process mapping methodology vary, for example, according to the choice of hierarchical vs. sequential mapping, as well as selection of participating stakeholders and the overall process perspective. (See Colligan, Anderson et al., Does the process map influence the outcome of quality improvement work? A comparison of a sequential flow diagram and a hierarchical task analysis diagram, BMC Health Services Research, 2010, 10:7doi:10.1186/1472-6963-10-7: http://www.biomedcentral.com/1472-6963/10/7)

Evidence based clinical pathways also offer an approach to link evidence to multi-disciplinary care plans for specific clinical conditions. (See Rotter, Kinsman et al., Clinical pathways: Effects on Professional practice, patient outcomes, length of stay and hospital costs (Review), The Cochran Library, Issue 7, 2010, http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD006632.pub2/pdf/abstract ). The Map of Medicine at http://eng.mapofmedicine.com/evidence/map-open/index.html (associated with the NHS) illustrates the development and use of clinical pathways in patient diagnosis and treatment. The clinical pathway methodology is designed to integrate high quality evidence from research in medicine with practice-based knowledge.

The NHS emphasizes the importance of a culture supporting performance improvement, and a focus on the patient experience. While Kaplan and Porter apply their method at the individual level of analysis, their objective is to map those activities related to a specific medical condition that can be “costed”, thus introducing an activity selection bias in the process map. The resulting focus is the cost of individual disease treatment cycles rather than a holistic view of the patient’s health care experience aggregated in the larger population perspective.

Kaplan and Porter seem to address more effectively the interests of private insurers, to “reinvent reimbursement” by measuring costs at the individual level of analysis – with increasing granularity (including…“consumable supplies such as medications, syringes, catheters, and bandages used directly in the process.” p. 54). The authors do not address the costs of such granular data collection and analysis. Furthermore, they do not demonstrate HOW the TDABC process should be informed by health care “value” or research evidence on health care outcomes – with the result that the managerial values driving the process are not adequately subordinate to the science of medicine or the care of patients and populations.

Comment on the Federal Strategic Plan to Reduce Health IT Disparities - An Update

2011-09-17T06:48:00.000-07:00

As in the initial Federal HIT Strategic Plan, the need for health information infrastructures to resolve the fragmentation of the U.S. health care system has not been adequately addressed in the Plan to Reduce Health IT Disparities available at http://www.healthit.gov/buzz-blog/from-the-onc-desk/federal-strategic-plan-disparities/ . My comments published on May 6 are still relevant on the strategy to reduce health disparities: (See http://eresearchcollaboratory.blogspot.com/2011/05/commentary-on-federal-health.html ) Individual patient empowerment and engagement in the system especially requires attention to the creation of a unique individual digital identity for health care, education for multilingual health literacy, and open access to health information and scientific research. Moving forward without infrastructures required for a patient-centered system and outreach to under-served populations will result in significant waste in funded efforts as well as loss of credibility and trust at a critical time in health care system reform.

Central to individual empowerment is the assurance of an individual digital identity in the health care services ecosystem. (See the Analysis of Unique Patient Identifier Options prepared for the Department of Health and Human Services in 1997: http://www.ncvhs.hhs.gov/app0.htm) While the individual patient is the focus of U.S. health care system reform efforts, there is no credible plan to provide a unique digital identity to every patient. The National Strategy for Trusted Identities in Cyberspace published in April, 2011, (See http://www.whitehouse.gov/sites/default/files/rss_viewer/NSTICstrategy_041511.pdf ) “recognizes that trusted digital identity, authentication and authorization processes are one part of layered security. Improvements in identification and authentication are critical to attaining a trusted online environment...” (page 8). While recognition of the critical importance of individual digital identities represents an important step, the proposed system calls for complex roles to be implemented by multiple actors in both public and private sectors. The federal government plays a significant role in the early stages of the initiative, but it is expected that new and sustainable business models will be developed for each of the service provider roles of the system (page 37) so that the identity ecosystem will become a self- sustaining market place.

The U.S. strategy for digital identities embodies the same errors as federal policies to promote the Nation-wide Health Information Network (NHIN) for health information exchange. A reliable and valid digital identity cannot be the output of complex private sector market dynamics. This policy principle virtually assures that there will not be universal access to reliable digital identity, and that the U.S. model will not be interoperable with ID models of other countries. The consequences of this stance for exclusion of underserved populations should not be underestimated. Moreover, a market supporting for-profit digital ID roles would be a fertile context for medical and administrative error, fraud and ID theft.

The lack of a unique patient identifier also has serious consequences for patient safety as the population grows and becomes more linguistically diverse and physically mobile - both nationally and internationally. U.S. patients are generally identified using an internally derived identifier created by a care provider, while between systems, “fuzzy matching” is frequently used to generate lists of patients with similar names and demographic profiles for evaluation as to the “best fit” match. (See http://www.corp.att.com/healthcare/docs/mpi.pdf for an example.) This approach certainly will incur rising costs and compromise patient safety as more diverse and multilingual health care systems become globally interconnected. (See http://gpii.info./news.php for some relevant research and publications. See also the American College of Pathologists: http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt{actionForm.contentReference}=cap_today%2F1109%2F1109j_national_id.html&_state=maximized&_pageLabel=cntvwr , and an HIMSS White Paper (2009) on Patient Identity Integrity at http://www.himss.org/content/files/PrivacySecurity/PIIWhitePaper.pdf )

In the United States, approximately 98,000 people die because of medical malpractice during hospitalization. 13% of the overall number of malpractices in surgery and 67% of errors in conjunction with blood transfusions can be traced back to erroneous patient identification. Source:

Joint Commission International Center for Patient Safety (Eds.): Technology in
Patient Safety - Using Identification Bands to Reduce Patient Identification Errors, in:
Joint Commission Perspectives on Patient Safety, 5, 2005, pp. 1-10. (See page 2 at http://ehealth.iwi.unisg.ch/fileadmin/hne/downloads/Mettler__Fitterer__Rohner__Strategies_for_a_Systematical_Patient_Identification.pdf )

Examples of strategies for unique identification in other countries include the British NHS unique patient identifier, (See http://www.connectingforhealth.nhs.uk/systemsandservices/nhsnumber/) and the Indian “Aadhaar”, a 12-digit unique number which the Unique Identification Authority of India (UIDAI) will issue for all residents. The number will be stored in a centralized database and linked to the basic demographics and biometric information – photograph, ten fingerprints and iris – of each individual. The Indian “Aadhaar” is also considered a tool to combat corruption – in particular by improving the ability to extend services to the most vulnerable citizens. (See an article in Le Nouvel Observateur (Sept. 9, 2011) at http://tempsreel.nouvelobs.com/actualite/economie/20110909.OBS0074/l-identite-biometrique-arme-anticorruption-des-indiens.html ;

see also an interesting initiative implemented in the U.S. by the NYU Langone Medical Center at http://www.computerworld.com/s/article/9217678/Hospital_turns_to_palm_reading_to_ID_patients )

The U.S. strategy for patient empowerment and engagement should include the creation of a unique biometric patient identifier to be offered on a voluntary basis to all citizens. Similar to the Indian Aadhaar, this identifier would not be mandated for citizens, but health care service providers could require it of those seeking their services.

The successful pursuit of goals for individual patient empowerment within a learning health system depends upon the public infrastructures for digital identity and health information exchange – as well as health literacy interventions to improve individual skills. Some research suggests that only one in ten adults in the U.S. may possess the knowledge and skills required to perform at a high level of health literacy. Population health literacy is prerequisite to individual empowerment as well as to creation of a learning health system – particularly in the complex, fragmented, and increasingly multilingual and multicultural U.S. context. (See http://www.hsph.harvard.edu/healthliteracy/research/ for more resources.)

The national capacity for innovation and research requires infrastructures developed as a public good as sustained public investments in health sciences and research contribute to the foundation for a learning health care system. An important aspect of learning systems is open access to information – including data and scientific publications. Some important steps have been taken in the U.S. system to improve such access to federally funded research, such as the National Institutes of Health Public Access Policy applicable to any manuscript reporting research funded by the NIH - accepted for peer-reviewed publication on or after April 7, 2008. “To help advance science and improve human health, the policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.” (See http://publicaccess.nih.gov/) While this policy represents progress toward the goal of open access to scientific publications, the delay of 12 months allowed for compliance significantly reduces its effectiveness. Lack of open access to health information and research hinders patient empowerment as well as development of a learning health system.

The Latin-American and Caribbean Center on Health Sciences Information (Bireme) illustrates a multilingual (Spanish, Portuguese and English) regional model for open access to health information and publications available through the Virtual Health Library. (The model and methodologies for development of this library are published in the VHL Guide 2011 available at http://guiabvs2011.bvsalud.org/en/presentation/.)

The U.S. should develop policies to promote open access to health information and research – taking into account the increasing linguistic and cultural diversity of the nation’s population as well as the globalization of health information systems.

Chinese and U.S. Health Care System Reform

2011-08-05T14:30:00.000-07:00

See the Westlake Forum: Healthcare Reform in China and the US: Similarities, Differences and Challenges, held at Emory University on April 10-12, 2011. Both slides and video presentations are available for review. This program is a valuable reference for researchers working on health care financing reform in any context- at the state or country levels of analysis. William Hsiao of Harvard University points out the critical importance of professionalism and ethics among both physicians and system administrators as a foundation of the reform process. He also emphasizes that China is ahead of the U.S. in designing a system to offer health care services to all Chinese citizens. On the other hand, he suggests that the Chinese strategy of hospital privatization to promote competition is not based on any policy evidence from world experience.

New Research on EHR and CDS Effectiveness

2011-06-03T10:03:00.000-07:00

The following review illustrates some of the methodological difficulties common in current research on EHR and CDS effectiveness.

Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality

Max J. Romano, BA; Randall S. Stafford, MD, PhD
Arch Intern Med. 2011;171(10):897-903. doi:10.1001/archinternmed.2010.527
This article is available at : http://archinte.ama-assn.org/cgi/content/abstract/171/10/897

Background Electronic health records (EHRs) are increasinglyused by US outpatient physicians. They could improve clinicalcare via clinical decision support (CDS) and electronic guideline–basedreminders and alerts. Using nationally representative data,we tested the hypothesis that a higher quality of care wouldbe associated with EHRs and CDS.

Methods We analyzed physician survey data on 255 402ambulatory patient visits in nonfederal offices and hospitalsfrom the 2005-2007 National Ambulatory Medical Care Survey andNational Hospital Ambulatory Medical Care Survey. Based on 20previously developed quality indicators, we assessed the relationshipof EHRs and CDS to the provision of guideline-concordant careusing multivariable logistic regression.

Results Electronic health records were used in 30% ofan estimated 1.1 billion annual US patient visits. Clinicaldecision support was present in 57% of these EHR visits (17%of all visits). The use of EHRs and CDS was more likely in theWest and in multiphysician settings than in solo practices.In only 1 of 20 indicators was quality greater in EHR visitsthan in non-EHR visits (diet counseling in high-risk adults,adjusted odds ratio, 1.65; 95% confidence interval, 1.21-2.26).Among the EHR visits, only 1 of 20 quality indicators showedsignificantly better performance in visits with CDS comparedwith EHR visits without CDS (lack of routine electrocardiographicordering in low-risk patients, adjusted odds ratio, 2.88; 95%confidence interval, 1.69-4.90). There were no other significantquality difference.

Conclusions Our findings indicate no consistent associationbetween EHRs and CDS and better quality. These results raiseconcerns about the ability of health information technologyto fundamentally alter outpatient care quality.

The conclusions reported in this study are consistent with many other recent studies, suggesting that there is no consistent relationship between the use of these tools and effective patient care. However, it is very important to examine the study design before evaluating the conclusions of this research. Critical points to be reviewed include the delay in publication with respect to data collection, generally limited use of EHRs and CDSs in US physician practice, the choice of patient visits as the unit for statistical analysis, the procedure for defining the sample, and identification of control variables in the regression model.

The topic addressed in the study is of critical importance, but the rapidly evolving technologies associated with EHR and CDS use require more current assessment. Data collected in the period 2005-2007 provides an interesting historical perspective, but may not yield analyses relevant to the current context. While EHR adoption in the US remains modest compared to some other industrialized countries (as pointed out by the study authors), state and federal expenditure to promote health information technology adoption is significant, and patterns of adoption have changed on some qualitative dimensions due to emergence of new practice arrangements such as ACOs and implementation of policies such as meaningful use.

The unit of analysis for the study is the patient visit rather than the patient, and performance quality was measured as adherence to guidelines by visit rather than by visits associated with a particular patient. It was assumed that a higher proportion of guideline adherence by visit should be interpreted as higher quality care provided to eligible patients. The data analysis does not by itself justify this interpretation. Drawing any conclusion concerning quality of patient care is further complicated by the lack of consideration of patient clinical profiles - apparently because the authors assert that the quality guidelines should apply to any patient except those presenting potentially confounding comorbidities. (Patients presenting such comorbidities have conveniently been eliminated from the sample. The authors provide the following example of comorbidity resulting in exclusion of patients - and their visits- from the sample: asthma in assessing the use of β-blockers in coronary arterydisease.) This reductionist methodological strategy does simplify the statistical analysis, but it also seems to defeat the evaluation of CDS in care of patients who should potentially benefit most from its use.

The authors also mention that they have included emergency visits in the study sample because
"they area key source of care and a setting in which EHRs have been morewidely adopted", while such visits resulting in hospitalization have been excluded. The authors do not adequately examine the consequences of these exclusions for the sample size or for interpretation of study results.

The methodology designed for analysis of the data in this study presents several critical weaknesses that may explain the lack of significant results. In analysis of data from NAMCSand NHAMCS and other similar data sets, future efforts are required to assure patient-centered assessment of care quality - taking into account complex clinical profiles as well as health outcomes over time. Such models would be especially useful for longitudinal analysis as new data become available.

Commentary on the Federal Health Information Technology Strategic Plan (2011-2015)

2011-05-06T13:25:00.000-07:00

The Federal Health Information Technology Strategic Plan (2011-2015) lays out the HIT vision, mission and principles as well as goals, objectives and strategies to be implemented in the next five years. My commentary will address first the guiding principles for health IT at the foundation of the overall strategy and how these principles affect the five goals formulated in the plan: I – Adoption and information exchange through meaningful use, II – Improvement of care and population health as well as cost reduction, III - Promotion of confidence and trust in health IT, IV – Individual empowerment with health IT to improve care processes and the health care system, and V - Achievement of learning and technological advancement. In conclusion, some recommendations will be outlined.

The principles on page 8 emphasize the needs and rights of individuals and the reliance “to the extent possible” on private markets to achieve societal objectives - with intervention only “when necessary” to correct market failures. This reliance on private markets is contrary to international development experience as well as theory and research in health economics demonstrating inadequacies of capital markets in provision of social services.[1,2] It is important to distinguish between competitive innovation in health services and the health information infrastructure (the NHIN) required to support such activities. While HIT infrastructure may be defined as a public good, both public and private services markets may share the resulting institutional ecology.

The focus on outcomes is critical to the success of health care reform, but this emphasis will not be adequate to motivate performance if national system design remains fragmented. Private markets will not foster the emergence of a system infrastructure as seems to be an implicit principle. Furthermore, costs associated with extensive micro-measurement of individual health care outcomes should not be underestimated. (I have reviewed the concept of “value” in health care outcomes as formulated by M. Porter on my blog because it seems to me that his model is consistent with the ideological viewpoint of the majority of the U.S. policy-making community.[3,4])

Building on “what works” is also an essential principle of any learning system, but as I have suggested in earlier commentaries, the focus in the U.S. health care system seems restricted to experiences within its boundaries. There are virtual natural experiments in progress in developing countries as well as industrialized nations around the world, and the U.S. could learn valuable lessons and avoid expensive mistakes through systematic analysis of selected national health care systems. This approach would encourage evidence-based learning and innovation to more rapidly close the significant lag in health care system performance that threatens the competitive stance of the U.S. in the global economy.

Goal I: Achieve Adoption and Information Exchange through Meaningful Use of Health IT (page 9) should be reformulated: Achieve Adoption and Meaningful Use of Health IT through Information Exchange. The creation of infrastructure for health information exchange is prerequisite to adoption of health information technology and its meaningful use. For example the Veterans Administration (VA) (mentioned on page 10) operates a single payer system through a federally supported infrastructure that makes possible HIE. The functionalities to exchange information integrated in EHRs and to report data relevant to public health are some of the most important intrinsic motivators for HIT adoption – affecting all stakeholders: providers, payers, patients and consumers. The VA offers a demonstration of the effectiveness of an integrated single payer system, as well as the benefits of HIE. However, the VA is a subsystem distinct from other segments of the health care sector, and thus will probably not contribute to the critical mass (or tipping point) necessary for health care system transformation as discussed on page 10. Principles guiding the VA, Medicare and Medicaid are very different from those at the foundation of private insurance markets for the majority of U.S. citizens.

On page 11 Strategy I.A.2 proposes implementation support to help health care providers through the Regional Extension Center (REC) Program. While funding for this program has been extended beyond the initial two-year time horizon, these organizations will be required to develop business models to become self sustainable. As is the case for Regional Health Information Organizations (RHIOs) and State Designated Entities (SDEs), such business models have not been identified.[5] Some observers have further noted that funded RECs may favor selected vendors for interoperability, thus introducing a significant conflict of interest in the support they offer. (See SoftwareAdvice, 9-23-2010) It may not be realistic to assume that RECs working with competing vendor consultants will “collaborate with one another and with relevant stakeholders to identify and share best practices in EHR adoption, meaningful use, and provider support.” (page 11).

Consistent with M. Porter, the strategic intention is to move away from the process requirements formulated in stage one of meaningful use towards improvements in outcomes and quality of care.[3,4] However, it should not be assumed that such improvements will be correlated with meaningful use of health information technology as in the Federal HIT Strategy. In Canada, penetration of EHR is low, comparable to rates reported in the U.S.[6], but health care system performance measured by public health indicators and overall per capita cost is ranked higher .[7] This would suggest that the superior performance of the Canadian system is explained by other factors – possibly higher rates of sustained public investment in health IT infrastructures [8]and the single payer model[9]. Furthermore, there may be a variety of paths to improvements in outcomes and quality of care as a result, for example, of major technological, institutional or medical paradigm shifts – in progress but as yet unforeseen.

Strategy I.A.5 emphasizes the process to certify EHR technology for meaningful use. The strategy as formulated does not address the financial burden on software vendors to achieve certification of their products. There is furthermore little clarification concerning validity of certification over time and the business model to be associated with continued certification: See CCHIT Town Call: ONC-ATCB 2011/2012 Certification Program (September 20,2010)

Do ONC-ATCB certified products have to undergo re-certification for each new release?

Following ONC/HHS Final Rules, Establishment of the Temporary Certification Program for Health Information Technology, certification is completed with a specific version of the technology that was tested by CCHIT and found compliant with the relevant certification criteria. For the purpose of maintaining certification, “minor product changes” are those modifications and updates to a certified product that are unlikely to affect the product’s compliance with the certification criteria. Retesting may not be required but the vendor is required to notify the ONC-ATCB and provide self-attestation that the changes are minor.

Modifications with a significant risk of affecting the product’s compliance are considered to be a “significant product change.” Retesting is required. Applicants are required to self-classify their product modifications and updates into one of these two categories.

Will software re-certification be required for each "meaningful use" stage?

Yes; the criteria, standards and test procedures will change for each stage. ONC has retained the right to change certification criteria at any time, but it is most likely that this will not occur until the next stage. The Final Rule states that the Temporary Certification Program is scheduled to sunset on December 31, 2011, unless HHS/ONC decides to extend it or hasn’t defined the permanent program.

Is there an effective period for certification? For example, if an EHR is certified in January 2011, when would the certification end and when would the technology need to be retested?

The effective period certification is determined by when ONCs publishes new rules for standards and certification criteria. If you are selling your software to providers who wish to meet the requirements of all three stages of meaningful use, you will need to recertify your EHR technology for 2013/2014 and 2015/2016.

The process of re-certification will be costly to vendors and entities implementing self-developed software products. The significant uncertainties associated with certification also increase risk inherent in such investments. Little data is available for evaluation of such risks and published information, such as the CCHIT Toolkit is often expensive as well. (The Toolkit – developed under federal funding - costs $1000 unless the entity seeking access to the information is committed to apply for certification. This policy discourages detailed review by prospective CCHIT applicants as well as researchers and the general public.)

I have already commented on policies regarding health information exchange (HIE) and meaningful use. Objective I.B cites the lack of sustainable business model to support HIE as well as fragmented policy-making at the federal, state and local levels. The federal strategy mistakenly states that there are “many sustainable exchange options … for certain providers and certain types of information.” (page 15) The federal government will: 1-Foster business models that create health information exchange, 2-Monitor health information exchange options and fill the gaps for providers that do not have viable options, and 3-Ensure that health information exchange takes place across individual exchange models. (page 15) These roles cannot be assumed by the federal government unless the necessary infrastructure is redefined as a public good sustained by significant public investment. In particular, it is not useful to propose “filling the gaps” where no system exists. It would be more constructive to leverage an existing program such as the National Information Exchange Model (NIEM), thus assuring integration with other systems for national security and disaster management- as suggested on page 18.

Another very important policy issue related to federal health IT strategy is broadband Internet access as mentioned on page 16. Comparative country analysis suggests that the U.S. lags behind other OECD countries in pricing, speed, penetration and access.[10] Some observers believe that the U.S. does not now have adequate broadband infrastructure to support full deployment of HIT meaningful use and health information exchange. The infrastructures required for HIT implementation are prerequisite to most of the policies formulated in the Federal Health IT Strategic Plan. Moving forward without these infrastructures in place will result in significant waste in funded efforts as well as loss of credibility and trust at a critical time in health care system reform.

On page 18 it is stated that the ONC is “tracking the activities of other countries and learning from their experiences with health IT and health information exchange.” There is very little evidence that this is the case, particularly with regard to our closest neighbors, Canada and the Latin American region. Regional collaboration needs to be extended across the hemisphere to facilitate system integration for health information exchange, research and education. (Large grid and cloud systems for basic and translational research are discussed on pages 27-28, while there is no mention of extension of such systems across regional boundaries.)

Goal II of the Federal Strategic Plan (page 22) is to improve care, improve population health, and reduce health care costs through the use of health IT. Strategy II.A.2 (page 24) calls for administrative efficiencies to reduce cost and burden for providers, payers, and government health programs. This is a very important but also very elusive objective as programs for payment reform such as the formation of Accountable Care Organizations call for additional administrative mechanisms to assure outcome measurement and reporting as well as distribution of savings and incentives to participants. The strategy also calls for “more granular understanding of health care treatments and outcomes, and more complete analyses of treatment costs, ultimately allowing for better disease management and more efficient health care delivery.”(page 25) Such detailed analysis of treatment costs is aligned with multiple private health insurers' requirements, and is often accomplished at the expense of a system-level focus on population health. The public funding of new health insurance exchanges -particularly in the absence of a public health insurance option - also subsidizes the interests of private health insurers by assuming the costs of infrastructure benefiting for-profit enterprise in health care services. These costs should be assigned to the private sector.

Strategy II.D.3 (page 27) calls for a mechanism to support information exchange for research and the translation of research findings back into clinical practice. This strategy also emphasizes the importance of infrastructure for HIE as well as large grid and cloud-based systems for the exploration of the wealth of existing data on the human genome. As mentioned above, extensive and sustainable public investments are essential to assure the creation and maintenance of such national infrastructures (including broadband) and to promote their interconnection with larger regional systems.

Goal III (page 29) calls for strategies to inspire confidence and trust in health information technology by protecting confidentiality, integrity and availability of health information, informing individuals of their rights, and improving safety and effectiveness of IT. Central to these issues is the assurance of an individual digital identity in the health care services ecosystem. While the individual patient is the central focus of health care system reform efforts, there is no credible plan to provide a unique digital identity to every citizen. (This is one of the most intriguing internal contradictions in the logic of the U.S. model of reform.) Privacy protections as they are currently designed are more consistent with the interests of private health care insurers than those of the individuals they serve. These protections pose obstacles to data aggregation as well as disclosure relative to insurance plan performance.

The National Strategy for Trusted Identities in Cyberspace (April, 2011)[11] “recognizes that trusted digital identity, authentication and authorization processes are one part of layered security. Improvements in identification and authentication are critical to attaining a trusted online environment; however, they must be combined with other crucial aspects of cybersecurity.” (page 8). While recognition of the critical importance of individual digital identities represents an important step, the proposed system calls for complex roles to be implemented by multiple actors in both public and private sectors. While the federal government plays a significant role in the early stages of the initiative, it is expected that new and sustainable business models will be developed for each of the service provider roles of the system (page 37) so that the identity ecosystem will become a self- sustaining market place.

This strategy for trusted identities in cyberspace embodies the same errors as federal policies for promotion of the Nation-wide Health Information Network (NHIN) for health information exchange. A reliable and valid digital identity cannot be the output of complex private sector market dynamics. This policy principle assures that there will not be universal access to reliable digital identity, and that the U.S. model will probably not be interoperable with those of other countries. The consequences of this stance for U.S competitive advantage in the global economy should not be underestimated. Moreover, a market supporting for-profit digital ID roles would be a fertile context for fraud and ID theft as well as other illegal transactions based on digital ID information.

Examples of strategies for unique citizen identification in other countries include the British NHS unique patient identifier,[12]and the Indian “Aadhaar”, a 12-digit unique number which the Unique Identification Authority of India (UIDAI) will issue for all residents. The number will be stored in a centralized database and linked to the basic demographics and biometric information – photograph, ten fingerprints and iris – of each individual. (The U.S. State Department has shown some interest in the Indian system - for reasons related to National Security-according to cable communications made public by Wikileaks.[13])

Goal IV (page 36) calls for individual empowerment for improvement of health and the health care system. The successful pursuit of this goal depends upon the public infrastructures for digital identity and health information exchange as discussed above – as well as health literacy interventions to improve individual skills. [14][15] These studies suggest that only one in ten adults in the U.S. may possess the knowledge and skills required to perform at a high level of health literacy. Population health literacy is prerequisite to individual empowerment as well as to creation of a learning health system (Goal V).

Goal V (page 42) calls for achievement of rapid learning and technological advancement through creation of a learning health system to support quality, research and population health, as well as increased capacity for innovation and research. The national capacity for innovation and research requires infrastructures developed as a public good. Sustained public investments contribute to the foundation for a learning health care system. Another important aspect of learning systems and capacity for innovation and research is open access to information. Some important steps have been taken in the U.S. system to improve such access to federally funded research, such as the National Institutes of Health Public Access Policy applicable to any manuscript reporting research funded by the NIH - accepted for peer-reviewed publication on or after April 7, 2008. “To help advance science and improve human health, the policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.” While this policy represents progress toward the goal of open access to scientific information, the delay of 12 months allowed for compliance significantly reduces its effectiveness.

The Latin-American and Caribbean Center on Health Sciences Information (Bireme) illustrates a regional model for open access to health information available through the Virtual Health Library. The model for this library is published in the VHL Guide 2011 now available for comment and consultation. Background information is available in the publications of A. Packer, former director of Bireme.[16]. Dr. Pedro Urra, the new director of Bireme, has been responsible for the creation and development of INFOMED,[17-20] the Cuban National Health Care Telecommunications Network and Portal. [21] The U.S. should develop policies to join this important regional initiative and to further promote open access to health sciences research.

Summary recommendations

1. Public investment in a national health information infrastructure to promote interoperability for both public and private services - a single infrastructure does not necessarily imply a single payer design.

2. Federal government provision of goal oriented services and tools - rather than financial incentives.

3. Restriction of public reimbursement for basic health care products and services to not-for-profit enterprises.

4. Extension of open access policies governing availability of public health information and published research in medicine and the health sciences.

5. Collaboration across the Americas as a foundation for large scale grid and cloud infrastructures to support regional research and innovation through the Latin-American and Caribbean Center on Health Sciences Information – BIREME.

References

[1] Arrow K, Auerbach A, Bertko J, Brownlee S, Casalino LP, Cooper J, et al. Toward a 21st-Century Health Care System: Recommendations for Health Care Reform. Ann.Intern.Med. 2009 April 7;150(7):493-495.

[2] Arrow K. Uncertainty and the Welfare Economics of Medical Care. The American Ecocomic Review 1963;53(5):941-973.

[3] Porter ME. What Is Value in Health Care? N.Engl.J.Med. 2010;363(26):2477-2481.

[4] Porter ME. A Strategy for Health Care Reform -- Toward a Value-Based System. N.Engl.J.Med. 2009 July 9;361(2):109-112.

[5] Adler-Milstein J, Bates DW, Jha AK. U.S. Regional Health Information Organizations: Progress And Challenges. Health Aff. 2009 March 1;28(2):483-492.

[6] Rozenblum R, Jang Y, Zimlichman E, Salzberg C, Tamblyn M, Buckeridge D, et al. A qualitative study of Canada's experience with the implementation of electronic health information technology. CMAJ 2011 March 22;183(5):E281-288.

[7] Mirror, Mirror on the Wall: How the Performance of the U.S. Health Care System Compares Internationally 2010 Update.Davis K, Schoen C, Stremikis K. 2010.

[8] Anderson G, Frogner B, Johns R, Reinhardt U. Health Care Spending and Use of Information Technology in OECD Countries. Health Affairs 2006;25(3):819-831.

[9] Tuohy CH. Single Payers, Multiple Systems: The Scope and Limits of Subnational Variation under a Federal Health Policy Framework. Journal of Health Politics Policy and Law 2009 August 1;34(4):453-496.

[10] Next Generation Connectivity: A review of broadband Internet transitions and policy from around the world.Benkler Y, Faris R, Gasser U. 2010.

[11] National Strategy for Trusted Identities in Cyberspace: Enhancing Online Choice, Efficiency, Security, and Privacy.The White House. 2011.

[12] Smyth RL. Regulation and governance of clinical research in the UK. BMJ 2011 January 13;342.

[13] U.S. interest in unique identification project.Srivathsan. A. The Hindu 2011;Opinion.

[14] The Health Literacy of America's Adults: Results From the 2003 National Assessment of Adult Literacy.National Center for Education Statistics. 2006;NCES 2006–483.

[15] Health Literacy Interventions and Outcomes: An Updated Systematic Review.Berkman N, Sheridan S, Donahue K, et al. 2011;11-E006.

[16] Packer AL. The SciELO Open Access: A Gold Way from the South. Canadian Journal of Higher Education 2009;39(3):111-126.

[17] Urra González P. Internet a la Cubana: El Ser Humano en el Centro de la Red. ACIMED 2003;11(1).

[18] Urra González P. Letter: Global Alliance for Health Information. BMJ 2001;321(7264).

[19] Urra González P, Rodrígues Perojo K, Concepcíon Báez C, Canedo Andalia R. Intranet of the National Medical Sciences Information Centre- Infomed: A Working Space in the Network for the Health Information System in Cuba. ACIMED 2006;14(1).

[20] Urra González P. Program for Strengthening the Scientific and Technical Health Information System of Cuba. ACIMED 2005;13(3).

[21] Séror A. A Case Analysis of INFOMED: The Cuban National Health Care Telecommunications Network and Portal. Journal of Medical Internet Research 2006;8(1):e1.

Porter on Value in Health Care II

2011-04-11T08:38:00.000-07:00

In his most recent NEJM article on value in health care (2010), Michael Porter expands the definition and measurement of this complex and elusive construct. He considers value as health outcomes relative to costs, or efficiency. Although he comments on outcomes as condition-specific and multidimensional, he does not adequately define effectiveness of delivered care. As is the case throughout the U.S. health care system, the model of value is an attempt to associate cycles of health care and the “outcome measures hierarchy” with an estimate of dollar cost for individual patients. Certainly time is a critical dimension in evaluation of health care value, but scaling this dimension to condition-specific cycles of individual care is itself a costly operation in measuring value. Furthermore, this approach ignores individuals of the population in sustainable good health due to effective preventive health care strategies or other social welfare policies. The individual patient should not be considered in isolation from the relevant population. Rather data on patient outcomes related to value should be aggregated to reflect not only cycles of care for particular conditions of disease or ill-health, but also the presence of sustainable good health.

Porter advocates a market-based vision of health care and deplores the lack of competition among providers based on actual results, but appears very careful to recognize the threat posed by public access to data describing such provider performance. Instead of patient choice of provider based on performance data, he emphasizes evidence based provider innovation and improvement through analysis of their own performance. Health care services markets in the U.S. are substantially weakened by the lack of patient access to provider performance data as well as a professional culture highly protective of provider privacy with respect to such data. Evidence based patient choice in health care services markets would significantly enhance value provided.

Health information systems for such data in the U.S. are primarily designed to support billing processes in the pervasive fee-for-service business model. This is the underlying motivation for ever more detailed and multidimensional data collection on the care of individual patients. Relentless focus on the individual renders more difficult the measurement of teamwork contributions to patient care. Thus one of the most important value-creating organizational reforms tends to be obscured in the complexity of rigorous attribution of shared clinical services and reponsibilities to individual care. It should also be emphasized that the use of billing codes for compilation of clinical conditions and treatments results in an unresolved bias in the quality of such data.

Porter's “value equation” does not consider the administrative component of the care cycle,apparently under the assumption that these costs remain invariant across medical conditions. Institutional arrangements designed to improve delivery of value in health care include Federally Qualified Health Centers (FQHCs), Rural Health Clinics (RHCs), Accountable Care Organizations (ACOs), and Patient Centered Medical Homes (PCMHs). They require varying administrative arrangements to incentivize and transact payment schemes for improvement of service quality to specific populations. These arrangements may increase the administrative component of health care costs as well as the complexity of the integrated system. Although difficult to estimate, such costs must be taken into account in the “value equation,” especially in the U.S. health care context.

I mentioned in an earlier commentary on Porter's value framework that the exclusive focus on financial dimensions of care obscures the more elusive ideological, cultural and ethical assumptions underlying the U.S. health care system. In particular, the value framework assumes that individual patients have a sustainable relationship with their care providers, which is obviously not the case. Even if it were feasible to calculate value in the “equation” suggested by Porter, the model would not be applicable in a context where there is such a high rate of patient mobility among providers as well as in and out of various insurance arrangements over relatively short time horizons. The relationship between the patient and his or her providers is probably the most important dimension of value in health care – encompassing values of access, trust, sustainability and continuity. The U.S. corporate health insurance business has designed this relationship out of the system – and thus destroyed the very foundation of health care value-creation.

References

[1] Bohmer RMJ, Lee TH. The Shifting Mission of Health Care Delivery Organizations. N.Engl.J.Med. 2009 August 6;361(6):551-553.

[2] Lee TH. Putting the Value Framework to Work. N.Engl.J.Med. 2010 12/23;363(26):2481-2483.

[3] Porter M. What is Strategy? Harvard Business Review 1996 November/December;74(6):61-78.

[4] Porter ME. A Strategy for Health Care Reform -- Toward a Value-Based System. N.Engl.J.Med. 2009 July 9;361(2):109-112.

[5] Porter ME. What Is Value in Health Care? N.Engl.J.Med. 2010;363(26):2477-2481.

[6] Porter ME, Teisberg EO. How Physicians Can Change the Future of Health Care. JAMA 2007 March 14;297(10):1103-1111.

Virtual Health Care Infrastructures: Mapping Large Systems

2011-03-29T13:57:00.001-07:00

Qualitative case research methods offer a flexible approach to the understanding of large and complex health service delivery systems embedded within their extended social context. Taken as the relevant unit of analysis, the Indian national health care system is a complex inter-organizational network valuable to the process of scientific study as a critical case, particularly for analysis of the co-evolution and integration of networks under a diverse ideologies. Despite recognition of the importance of systems science in medical informatics, little research has focused on studies of health care at the national system level, in part because of the size and complexity of such systems and the lack of interdisciplinary consensus regarding appropriate methodologies and theoretical foundations for this important field of study. Some authors suggest that there is a pragmatist epistemic argument for use of qualitative and mixed research methodologies in the field of medical informatics as clinical practice is a hybrid sociotechnical field. This view rejects belief in a single “scientific method” and recognizes that research is always situated in a particular context.

This research contributes to development of a methodology and conceptual framework for comparative analysis of the virtual infrastructures of national health care systems. Health care is defined as the preservation of mental and physical health by prevention or treatment of illness through services offered by the health professions. A health care system is a dynamic set of interconnected individuals, institutions, organizations, and projects offering products and services in health care markets. The functions of the health system include all categories of service delivery, resource generation and allocation, and governance. Governance includes both policy making and regulation of the system. Service delivery encompasses information, research, and education services as well as public health and delivery of patient care, both preventative and curative. These functions, as well as their interrelations, are critically important to the performance of an integrated health care system and the quality of health care services.

Data are drawn from published accounts of system development and the websites of the constituent organizations, networks and services to describe the configuration of virtual infrastructures. The context of the case analysis is developed using historical data to show how the current system has unfolded over time. E-mapping software is used to visualize the linkages among institutions and resources identified in the case analysis. Electronic linkages among institutions and services are considered in the analysis as well as linkages integrating national health care systems with international institutions. Using this specialized software, an online database includes a dynamic electronic representation of virtual infrastructures identified in the research program. Visualization of data reveals how information resources are linked and integrated in development of the virtual infrastructure. These data describe configurations of web-based services revealing patterns associated with electronic markets and hierarchies.

1. India

2. Bireme: The Latin American Region

Meaningful Use Rap

2011-03-16T08:29:00.000-07:00

Have a look at this!

The U.S. Health Care System Infrastructure for Health Information Exchange (HIE)

2011-03-02T09:58:00.000-08:00

Here is the abstract of a presentation on HIE infrastructure in the US:

Abstract
Health information technology and infrastructures for increasingly web-based services will drive the future development of national health care systems. However, implementation of HIT without attention to institutional infrastructure will only amplify the uncontrollable surge in health care expenditures. The objective of this talk is to consider published evidence and develop a conceptual framework for design of a national health information infrastructure integrating public and private enterprise in the health sector. A comparative analysis of the National Information Exchange Model (NIEM) and the Nationwide Health Information Network (NHIN) concludes that the NIEM would be more effective in reducing barriers to health information exchange.

Recent studies of national health care systems in the industrialized world demonstrate that health care service delivery in the U.S. performs poorly in light of the level of per capita expenditure in the sector. The U.S. lags significantly behind other developed countries in public investments for HIT; as of 2005 the U.K. had spent $192.79 per capita compared to a U.S. investment of $.43. One reason for this is policy failure in development of sustainable business models based on private investment for health information exchange (HIE).

In the U.S. multiple payer system, competing health care providers and insurance companies focus on automation of financial transactions and implementation of redundant proprietary HIS. Their incentives for new technology adoption do not take into account system level efficiencies often external to private HIS purchasers in the health care sector. While policy emphasis on electronic health records (EHR) focuses on internal efficiencies and improved health care quality, these investments require public infrastructures for effective health information exchange at the system level.
The nationwide health information network (NHIN) refers to a proposed system linking data intermediaries for health information exchange. Related policies rely primarily on the principle of regional health information organizations (RHIOs) that can collaborate and exchange data. An assumption fundamental to this model is incremental development by linkage of state designated entities (SDEs) and regional health information organizations (RHIOs). However, research on the performance of RHIOs shows a high failure rate among these organizations and offers no significant evidence to substantiate interoperability among their systems. No sustainable RHIO business model has been identified to integrate public and private stakeholders. Further complicating the design of health information exchange are policies promoting medical homes and accountable care organizations (ACOs) competing for government incentives. These organizations often lack motivation to exchange health information.

More promising than the NHIN configured among fragmented local and regional RHIOs is the National Information Exchange Model (NIEM). 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. Extension of the NIEM to the U.S. health care system would offer much needed cost reduction advantages and help reduce barriers to health information exchange among competing organizations.

Conclusions and Recommendations:
1. Public investment in health information infrastructures and the NIEM - a single infrastructure does not necessarily imply a single payer design.
2. Design of public health information infrastructure as a public good required to promote interoperability for both public and private services offered in the U.S. health care sector.
3. Collaboration across the Americas integrating the Canadian Infoway and BIREME – the Latin American Regional Library of Medicine will serve as a foundation for large scale grid and cloud infrastructures to support research and innovation.

Stage 2 Meaningful Use Objectives

2011-02-21T09:27:00.000-08:00

The following text is a commentary on stage 2 meaningful use objectives, criteria and measures - mainly from the perspectives of social and organizational sciences - in response to the call for public comment issued by the HIT Policy Committee. My previous commentaries on MU, Regional Health Information Organizations (and update) and Extension Centers also remain pertinent to the discussion context.

Commentary on the MU stage 2 matrix (with page references to the call for public comment):
On page 6, MU objectives refer to "unique patients" for recording vital signs and smoking status. This criterion raises a question concerning the definition of "unique patient". (It is somewhat ironic that in the US system that purports to focus on empowering the individual patient and his or her needs/choices, a unique patient identifier seems to be out of the question.) On December 9, 2010, a Patient Linking Hearing hosted by the ONC Health Information Technology Policy Committee heard testimony on idividual patient identification. Paul Oates of Cigna pointed out that in the US patient ID (and that of his/her family) is generally tied to an employer. When patients lose their jobs or move from one employment to another, their identification may be compromised. Oates further clarifies:

"The historical purpose of keeping person data was to derive eligibility for benefits and pay claims, not primarily to improve care or service an individual. So, the primary data attributes linked to a person largely revolved around tying a person to their dates of eligibility, their plan type and features."(Page 1-See oates-patient-linking-hearing-tigerteam.pdf)

This testimony suggests the tenuous relationship between clinical and claims information resulting in a dual view of patient/consumer identity. Problems in linking patient ID to relevant data further hamper the integrity of research efforts in medicine and public health. Some of these difficulties and possible solutions were suggested at the hearing by Assistant Professor Bradley Malin of the Department of Biomedical Informatics, School of Medicine, Vanderbilt University.

(The logical conclusion to this discussion would be a call for a unique biometric patient identifier, similar to that being implemented in India.)
On page 7 formulary checks are prescribed for MU, but accomplishment of this objective depends on the collaboration of multiple health plans which may or may not offer the necessary electronic support. Care must be taken to assure that this provision does not result in an excessive administrative burden to meaningful users of EHRs and health information technology.
Also on page 7, where it is stipulated that lab results should be entered into EHRs as structured data, it may be important to distinguish between test results and their interpretation. For example, where digital images are not included in the EHR, lab results constitute interpretation rather than original data. The lack of available raw data may contribute to requirements for unnecessary repetition of clinical tests in some clinical decision processes.
On page 10, the new requirement that secure online patient messaging be in use depends on the existence of supporting infrastructures and health information exchange. Individual EHR users cannot be responsible for the availability of such infrastructures. Also on page 10, the requirement that patient preferences for communication medium be recorded is not really useful under real operational contingencies. Availability of media depends on the context and may change as a patient moves from one facility or geographical area to another. Communication also frequently requires a dynamic suite of synchronous as well as asynchronous media.
Electronic self management tools (page 10) require content beyond the functions of the EHR. Patients choose such tools depending on their health care culture and provider affiliations as well as their ability to invest time and other resources in self management. The patient has access to his or her health information, but content other than that within the patient-specific EHR should not be included in criteria for MU.
For care coordination it is suggested in stage 2 (page 11) that the meaningful user connect to at least three external providers in "primary referral network" (but outside delivery system that uses the same EHR) or establish an ongoing bidirectional connection to at least one health information exchange. As I have frequently mentioned in other commentaries, requirements for health information exchange imposed on meaningful users assume the existance of effective telecommunications infrastructures and institutions such as RHIOs. Such assumptions are invalid. While policies to promote RHIOs, state health information exchanges and the Nationwide Health Information Network (NHIN) are in place, they are so far not sustainable, and public investments remain inadequate.
Submission of data including clinical and patient generated information to public health agencies (pages12-13) also depends on the availability of telecommunications infrastructures for such health information exchange. There are not necessarily any preparatory steps to be taken by health care practitioners for these stage 3 objectives. Public initiatives and investment are required rather than individual EHR user steps in stage 2 of MU. Privacy and security protections also depend significantly on design of infrastructures for health information exchange.
Section D-questions 3, 5, 6, 9, and 10 (pages 14-15):Question 3: What strategies should be used to ensure that barriers to patient access – whether secondary to limited internet access, low health literacy and/or disability – are appropriately addressed? Strategies to promote patient access to their EHRs and other electronic health information are outside the criteria for MU. However, I would like to suggest the possible usefulness of mentoring among patients and patient support groups focused on competencies necessary for access to and meaningful use of electronic health information. These programs could be offered by public or private entities, including health plans, health care providers, and patient advocacy groups. Physical access to the Internet might further be facilitated through the use of self-service kiosks designed to guide patients lacking experience in the use of electronic information and the Internet. Such kiosks could be set up in medical centers, hospitals, clinics and offices of physicians as well as other health care service providers.

Question 5: For future stages of meaningful use assessment, should CMS provide an alternative way to achieve meaningful use based on demonstration of high performance on clinical quality measures? This would be an important strategy to recognize that there may be many paths to high performance in clinical quality - with or without meaningful use of EHRs. Measurement of clinical quality is also more accessible than assessment of complex and dynamic processes of meaningful use. This strategy would focus users' motivation on the quality objective rather than the means to its achievement - and open the door to incentivize innovative methods other than meaningful use.
Question 6 : Should Stage 2 allow for a group reporting option to allow group practices to demonstrate meaningful use at the group level for all EPs in that group? The answer to this question depends on the organizational and infrastructural health care context. Groups might be defined as medical homes or accountable care organizations. Some EPs may perform part of their practice within such organizational structures. How might such participation be taken into account? Physicians and other health care professionals have multi-affiliated practices and they may also be highly mobile, moving from one US region to another - or even outside the country. It is difficult to imagine how the MU objectives, criteria and measures can take this dynamic context into account.

Question 9: What additional meaningful-use criteria could be applied to stimulate robust information exchange? As mentioned above with reference to page 11 of the MU matrix, requirements for health information exchange imposed on meaningful users assume the existence of effective telecommunications infrastructures and institutions such as RHIOs. Such assumptions are invalid. While policies to promote RHIOs, state health information exchanges and the Nationwide Health Information Network (NHIN) are in place, they are so far not sustainable, and public investments remain inadequate. EHR users cannot participate in electronic HIE without these infrastructures.

Question 10: There are some new objectives being considered for stage 3 where there is no precursor objective being proposed for stage 2 in the current matrix. We invite suggestions on appropriate stage 2 objectives that would be meaningful stepping-stone criteria for the new stage 3 objectives. The achievement of MU is not a linear process due to its complexity as well as the high rates of technological change and innovation. It may not be necessary to define stage 2 "stepping stones" towards achievement of stage 3 objectives.

The evidence base (Section E, page 15):
The list of studies presented to justify formulation of new MU objectives illustrates the difficulty in the linear (and static) definition of meaningful use. These studies represent single data points in the literature review and meta-analysis required for the propositions guiding meaningful use - under the assumption that these research results will continue to be relevant irregardless of fast moving processes of health care system reform and technological innovation. Meaningful use will also be affected by institutional evolution in the formation of regional (RHIOs) and state organizations for health information exchange as well as accountable care organizations (ACOs) and medical homes. There is little or no research evidence (or other policy information) to substantiate any scenario describing the development of these institutions - while they lie at the foundation of meaningful use.

Concluding thoughts and references:Much progress has been made in development of national policies for implementation of health information technology in the US. [1] However, as I have mentioned in earlier commentaries, rapid change and innovation[2,3,4] may result in new policy models - invalidating or competing with the current policy model of MU. The significant risk of a technological paradigm shift may compromise the credibility of MU policies as well as user motivation to accomplish early stage 1 and 2 steps to satisfy MU criteria at stage 3 - after 2015. Unfortunately, even though Blumenthal[5] describes the adoption of EHRs in the US as “inevitable,” recent research on effectiveness of EHRs (as well as ehealth more generally) has shown inconclusive results regarding both improved quality of care and cost effectiveness. [6-8] These studies suffer from a paucity of theoretical frameworks[9] as well as many methodological weaknesses. The absence of an evidence base substantiating the benefits of EHR implementation tends to discredit current policy discourse and undermine efforts to incentivize EHR adoption and meaningful use in the US. It would be useful in this regard to broaden focus on EHR context to include social networks and global telecommunications, and to consider the benefits of enhanced international collaboration for health care service delivery as well as for research in medicine and the health sciences. [10]

[1] Buntin MB, Jain SH, Blumenthal D. Health Information Technology: Laying The Infrastructure For National Health Reform. Health Affairs 2010 June 01;29(6):1214-1219.
[2] Sittig DF, Singh H. A new sociotechnical model for studying health information technology in complex adaptive healthcare systems. Quality and Safety in Health Care 2010 October 01;19(Suppl 3):i68-i74.
[3] Golembiewski RT, Billingsley K, Yeager S. Measuring Change and Persistence in Human Affairs: Types of Change Generated by OD Designs. The Journal of Applied Behavioral Science 1976 April 01;12(2):133-157.
[4] Millsap R, Hartog S. Alpha, Beta, and Gamma Change in Evaluation Research: A Structural Equation Approach. Journal of Applied Psychology 1988;73(3):574-585.
[5] Blumenthal D, Tavenner M. The “Meaningful Use” Regulation for Electronic Health Records. N.Engl.J.Med. 2010 08/05;363(6):501-504.
[6] Romano MJ, Stafford RS. Electronic Health Records and Clinical Decision Support Systems: Impact on National Ambulatory Care Quality. Arch.Intern.Med. 2011 January 24.
[7] Black A, Car J, Pagliari C, et al. The Impact of EHealth on the Quality and Safety of Health Care: A Systematic Overview. PLoS Medicine 2011;8(1):e1000387.
[8] Jones S, Adams J, Schneider E, et al. Electronic Health Record Adoption and Quality Improvement in US Hospitals. American Journal of Managed Care 2010;16(12).
[9] Pingree S, Hawkins R, Baker T, DuBenske L, Roberts LJ, Gustafson DH. The Value of Theory for Enhancing and Understanding e-Health Interventions. Am.J.Prev.Med. 2010 1;38(1):103-109.
[10] Shachak A, Jadad AR. Electronic Health Records in the Age of Social Networks and Global Telecommunications. JAMA: The Journal of the American Medical Association 2010 February 03;303(5):452-453.

Addendum: Other significant issues raised in response to the call for public comment:Issues raised concerning MU objectives, critera and measures include (1) the integration of digital imaging in EHRs and (2) consistency of public policies to promote eprescribing. These are mentioned below:

In a recent policy document, the Medical Imaging and Technology Alliance (MITA) deplores the absence of MU criteria regarding formats and electronic transmission of medical imaging. The criteria so far only address data that may be entered into the record by descriptive text or numerical data - while software certification and meaningful use of EHRs will not take medical imaging into consideration until after 2015. MITA points out the need for EHR standards to support sharing digital images generated by equipment made by different manufacturers. The Digital Imaging and Communications in Medicine (DICOM) Standard was developed by the American College of Radiology (ACR) and the National Electrical Manufacturers Association (NEMA). The current standard, DICOM 3.0 is nearly universally accepted to enable data exchange among DICOM compliant systems, either on CDs or through available transfer functions. An industry and professional initiative, Integrating the Healthcare Enterprise (IHE), further promotes adoption of EHRs by facilitating service coordination and data exchange among health care information systems. IHE tests more than 100 systems for compliance every year. These efforts supporting DICOM and health information exchange should be an integral part of the EHR MU scenario.

Another important issue is the lack of coherency between two CMS incentive programs promoting use of electronic prescriptions and EHRs. The GAO has published an analysis of program inconsistencies and their consequences.(See Electronic Prescribing: CMS Should Address Inconsistencies in Its Two Incentive Programs that Encourage Use of Health Information Technology - February 2011 - GAO-11-159)

Regional Extension Centers and HIE

2010-09-27T11:20:00.001-07:00

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
Health Information Exchange and RHIO Handbook
The Office of the National Coordinator for Health Information Technology (ONC)
Wikipedia Regional Health Information Organization
Nationwide Health Information Network Overview (ONC)
Public Health and Electronic Information Exchange: A Guide to Local Agency Leadership

Reflections on Business Models

2010-09-27T07:24:00.000-07:00

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.

Meaningful Use and Health Care Reform (Commentary updated)

2010-03-23T14:45:00.000-07:00

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

Meaningful Use and Health Care Reform

2010-01-27T14:11:00.000-08:00

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...)

Democracy in the U.S. Health Care Reform Debate

2009-10-14T07:07:00.000-07:00

Yesterday (October 13) I sent the following feedback to AHIP regarding K. Ignagni's performance in an interview on CNN:

This is just to express my deep concern regarding the interview of K. Ignagni by W. Blitzer on CNN this afternoon. Ms. Ignagni has demonstrated a disturbing lack of understanding of the research issues raised in the PWC report. I do hope that there is some other research expertise at AHIP. The instructions given to PWC are not clear, nor is the contractual arrangement between PWC and AHIP. It is also a very significant concern that the names of the researchers involved in the report are not mentioned on the document made available to the public. There seems to be no avenue for questions concerning data analysis or interpretation. I hope that in the future AHIP will be able to fund more competent research.

In other feedback to CNN I deplored the absence of a specific reference to the AHIP report in some of their reporting. There are two issues affecting the democratic process here:

A report without reference or authors is interpreted without an evidence base.
The confidential contract research executed and interpreted by an organization (PwC) with no accountability to show research competence creates misinformation to inform public opinion. Ms. Ignagni, herself paid to initiate misinformation, represented PwC as a "world-class research organization," while refusing to identify the conditions of this paid contract. No world-class research organization would consent to execute such a contract. Ms. Ignagni probably does not possess any competence in research methodology, nor do the authors of the report.

The health insurance industry has acted irresponsibly in this democratic process, mobilizing what the public in general would recognize as "authoritative research" in order to manipulate public opinion in their favor.

AHIP-PWC Report: Potential Impact of Health Reform on the Cost of Private Health Insurance Coverage

2009-10-13T09:24:00.000-07:00

A new headline on CNN, Pushback grows against insurance industry report, points out some significant criticisms of the AHIP-PWC report as self-serving and flawed.

This morning I identified a link where the much publicized report may be accessed:
Potential Impact of Health Reform on the Cost of Private Health Insurance Coverage (October, 2009). (Unfortunately the authors of the report are not listed.)

Review of the analyses in this report reveals methodological features that require comment. CNN has reported (Accessed October 13, 2009):
The report from the group America's Health Insurance Plans concludes that, under the Baucus plan, the costs of private health insurance would rise by 111 percent over the next decade. Under the current system, costs would rise by 79 percent, the report said.

This scenario is partially founded on the following proposition regarding the excise tax to be imposed on Cadillac plans. (See page 6 of the report.) This proposition appears spurious. (Certainly in the next ten years it would be reasonable to assume that the threshold values for assessment of the excise tax would be adjusted):

PwC also examined the impact of the excise tax on the mandated plans expected to be offered under the state health insurance exchanges detailed in the Senate Finance Committee Bill. We estimate that in many metropolitan areas, which tend to have higher than average medical costs, the lowest option plan (Bronze Plan) would be considered a "Cadillac plan" as early as 2016. By 2016 at least one of the mandated plans will be considered a "Cadillac plan" and be subject to the 40 percent excise tax in 17 of 50 states. By 2019 at least one of the mandated plans will be considered a "Cadillac plan" and be subject
to the 40 percent excise tax in 24 of 50 states.

The "baseline" assumptions for this scenario from the Senate Finance Committee Bill include a 6 percent annual trend (premium increase); 15 percent supplemental load for additional benefits, age, morbidity and other factors. Certainly the CBO should examine this industry financed report to evaluate data and assumptions at the foundation of its conclusions.

WellPoint Litigation II

2009-10-12T11:27:00.000-07:00

In my last post, I highlighted litigation launched by Anthem, a subsidiary of WellPoint, against the state of Maine. This case raises a number of questions for further investigation of private health insurers' conduct in the U.S. health care services market:

What legal and other strategies are undertaken against state regulatory agencies to promote acceptance of annual rate revisions? How do state agencies respond to these initiatives. What public expenditures are required for these defensive regulatory actions? What proportion of premium revenues is spent on such litigation by private insurance companies against public authorities?

Why are individual policy holders more vulnerable to discriminatory rate increases than other classes of insurance purchasers? What issues and practices restrict the choices and mobility of individual policy holders among insurance alternatives? Consider the discovery of pre-existing conditions making it impossible for individuals to seek other coverage. In general - how do confidentiality and privacy laws prevent publication of systematic information on health insurance performance to guide individual choices?

Why should any rate of profit be guaranteed in a "free market economy"? How is this demand at the state level correlated with the insurer's dominant position in the state economy?

Further examination of WellPoint's record reveals other cases of public interest - for example:

Last year the California Department of Managed Health Care reached agreement with Anthem Blue Cross on contentious cases of rescission. (Accessed October 12, 2009)

Lawsuits filed over health insurers’ payments
for out-of-network care:
A group of health insurers have been named defendants in
multiple lawsuits stemming from payments made to
out-of-network providers.

One lawsuit was filed by the American Medical Association.
It claims thatWellpoint Inc. and others conspired to pay
reduced rates to out-of-network providers. Another lawsuit
was filed by Michael Roberts. Roberts’ lawsuit claims that as
a result of the scheme, consumers were forced to pay increased
costs associated with their care. The lawsuit filed by
Roberts names Wellpoint along with UnitedHealth Group
Inc., Ingenix Inc. and Blue Cross of California.
Roberts v. UnitedHealth Group Inc., No. 09-1886 (C.D.
Cal. complaint filed Mar. 19, 2009)
Counsel for Roberts: Christopher M. Burke, Kristen M. Anderson, Scott
& Scott L.L.P., 213-985-1274, Los Angeles.
Am. Med. Ass’n v. Wellpoint Inc., No. 09-2039 (C.D.
Cal. complaint filed Mar. 25, 2009)
Counsel for AMA: Edith M. Kallas, Joe R. Whatley Jr.,W. Tucker Brown,
Laurence J. Hasson, Whatley Drake & Kallas L.L.C., 212-447-7070,
New York; Stanley G. Grossman, D. Brian Hufford, Robert J. Axelrod,
Pomerantz Haudek Block Grossman & Gross L.L.P., 212-661-1100,
New York; Raymond P. Boucher, Helen Zukin, Michael Eyerly, Kiesel
Boucher Larson L.L.P., 310-854-4444, Beverly Hills, Cal.

Source: http://media.straffordpub.com/products/insurance-law-and-litigation-week/free-sample.pdf (Accessed October 12, 2009)

See also AMA Implicates WellPoint in Price-Fixing Plot at http://www.law360.com/articles/93856 (Accessed October 12, 2009)

An American Psychological Association Practice Update describes a class-action suit brought by state governments and solicits information from psychologists affected:

The complaint seeks damages under the Employee Retirement Income Security Act (ERISA), the federal antiracketeering law known as RICO and antitrust law for past underpayments. Further, plaintiffs will seek changes to make WellPoint’s out-of-network rate setting fairer and more transparent. (Accessed October 12, 2009 )

An investigative report- Underpayments to Consumers by the Health Insurance Industry - was published on June 24, 2009, by the SENATE COMMERCE COMMITTEE in its federal roles of oversight on interstate commerce and regulation of consumer products and services. This report found widespread reliance on Ingenix medical charge databases for calculation of out-of-network reimbursement rates as well as contract arrangements between Ingenix and insurers providing rate data specifically prohibiting disclosure of such information to consumers or doctors. Ingenix does not have any systematic procedures in place for validation of information included in the databases. More than 2 million federal employees and military families are enrolled in health plans affected.

(Accessible publications including what should be the public record are very difficult to find.)

WellPoint Litigation against the State of Maine

2009-10-10T14:38:00.000-07:00

The lawsuit recently brought by WellPoint against the state of Maine has not been adequately covered in the conventional media. This case deserves to be more seriously researched to illustrate the market information culture created by private insurance companies in the United States. Documents related to regulatory decisions against Anthem Blue Cross and Blue Shield, a subsidiary of WellPoint, are publicly available on the website of the Bureau of Insurance - Department of Professional and Financial Regulation -of the State of Maine. The mission of the Bureau is to regulate the insurance industry to protect and to serve the public. Specifically the Bureau licenses insurance producers and companies, performs examinations and audits, reviews rates and coverage forms, investigates complaints, educates consumers about their legal rights and responsibilities, and sponsors programs to promote compliance with state laws. The Anthem rate filing for 2009 and the Bureau decision are publicly available even though WellPoint has consistently attempted to have this and related documents and proceedings treated as confidential.

In 1999 Anthem, a subsidiary of WellPoint, bought the Blue Cross and Blue Shield not-for-profit health plans operating in Maine and transformed them into a for-profit business. Since that time premium rates paid into the plans by average individual subscribers have increased 4 fold. (There are approximately 12,000 individual subscribers to Anthem health insurance products in Maine.) The rate increase submitted to the Maine Bureau of Insurance in 2009 was 18.2% to guarantee Anthem a minimum profit margin of 3%. This increase has been rejected as unfair and excessive in favor of an increase of just 10.9%. Anthem is suing the State of Maine for this regulatory action judged discriminatory.

Brave New Films has posted a very informative video account of this suit. See also Sick for Profit:

The Main Public Broadcasting Network aired the story: "Anthem Sues State of Maine over Rate Hike Request Denial" on October 5. The Columbia Journalism Review published an article entitled WellPoint versus the State of Maine on October 9 giving some additional details about the litigation.

Health Information Exchange Update

2009-10-10T09:53:00.000-07:00

As already discussed in earlier posts, the eHealth Initiative has published a series of annual reports on the progress of RHIOs across the United States. The most recent report, "Migrating toward Meaningful Use: The State of Health Information Exchange" presents the results of the 2009 Sixth Annual Survey of Health Information Exchange. A review of this report reveals some serious methodological considerations affecting interpretation of study results. Current U.S. policy for health care system reform is founded on the proposition that emerging RHIO networks will coalesce into a national health information infrastructure for HIE. There still is no evidence base to substantiate this proposition, and as pointed out earlier, there is no business model for development of sustainable RHIOs.

The summary results of the 2009 survey claim a 40% increase in the number of "advanced or “operational” initiatives exchanging information," as well as positive impact on efficiency of care and return on HIE investment. Evaluation of the sample described in the full report shows however that the increase in number of initiatives (n=150 organizations - up from 130 in 2008) is based on a shift in the earlier sample. In the report section on study methodology, it is stated that 344 individuals responded to the survey announced through a variety of media and incentivized with $10 Starbucks Cards. It is not clear how these individuals were qualified to respond to survey questions, and there was no control for variance in responses due to different positions held by respondents. After review of responses received, 150 HIE initiatives were judged valid to be included in the analysis although there was no systematic verification of information provided by individuals completing the survey, and no uniform definition of an HIE initiative.

Although authors of the study attempted to obtain responses from all organizations responding to the survey in 2008, only 66 of the earlier sample responded in 2009, while 84 (more than half) of the 2009 sample were new respondents. This shift indicates a highly significant "mortality" rate among HIE initiatives which is not even addressed by the study authors - except as they state that 43 of these initiatives appear to continue their pursuit of HIE. Such "mortality" may suggest the lack of sustainability in business model design. Some of the data presented seem to corroborate this interpretation. While public funds seem very significant in initial HIE start-up (See figure 12.) - including federal, state and local government grants and contracts (n=99) - private payers contribute to start-up much less frequently (n=26). Ongoing sources of revenue shown in figure 13 indicate the withdrawal of public sector funding. This pattern is particularly interesting in light of the exchange of data for insurance enrolment, claims, and eligibility determination (See figure 9.). HIE seems heavily focussed on the management of the financial dimension of health care (n=52). While public funding is mobilized for HIE start-up, the private sector appears to benefit disproportionately from services offered. For example, the Utah Health Information Network is well developed for coordination of information for payers, but offers virtually no clinical services at this time. This network is also characterized as "uniquely Utah", with no provision for future linkage outside the state.

The Directory of Health Information Exchange Initiatives offers a useful database for further examination of emerging RHIOs.

CCHIT has made available a presentation of its New 2011 Certification Programs, including HIE, but there is increasing recognition of the need for a national health information infrastructure. There will be much waste in certification fees paid for an uncertain and ill defined process. Without necessary and sustained public investment in infrastructure, the promise of health information exchange across the U.S. will remain unfulfilled. While some experts and lobbyists claim that this promise will be realized within a time frame of two years, many understand that the ideologically charged debate concerning infrastructure design and implementation will probably extend well beyond 2014. Unfortunately for American patients and taxpayers, many business opportunities reside in the prevailing confusion of future scenarios for U.S. health care reform.

NEJM Online Health Care Reform Center

2009-09-04T08:24:00.000-07:00

The New England Journal of Medicine has created an online Health Care Reform Center designed to inform the ongoing U.S. national policy debate in both political and academic arenas. The Center features themed collections of more than 100 NEJM articles as well as links to relevant resources. Visitors to the site are invited to participate in discussions on a series of important health care policy questions. One such question is: "Which countries’ health care systems offer lessons for the United States? What are they?" To date, this discussion seems to have generated little interest.

Other industrialized countries as well as developing countries have designed a wide variety of systems to integrate the diverse functions of their health care institutions. In some cases, they offer natural experiments demonstrating the effects of ideological foundations as well as the strengths and weaknesses of diverse strategies. In the U.S. debate, there has been little reference to the valuable evidence available in international experience. The U.S. academic community has conducted no research programs on the complex social systems associated with health care in other countries, and influential professional associations such as the U.S. Academy of Management have generally rejected such research production as invalid on the methodological pretext that qualitative analysis lacks rigor. The American Medical Informatics Association (AMIA) tends to define research problems at the individual level of analysis (patient or care provider) and to advocate randomized controlled trials (RCT) or experimental methods applied to the study of social implications related to biomedical informatics; there is little place for system-level thinking. Where there should be an extensive body of interdisciplinary research on comparative national health care systems relevant to U.S. policy reform, there is none. Some of the reasons for this appear to be related to American "exceptionalism" and a fundamental ideological rejection of values related to collective social responsibility. (This is evidenced in the Academy of Management's widely held view that public health is unrelated to the problem definition of health care management as business process.)

Political opponents of health care reform have aimed substantial attacks on Obama's "public option" as an attempt to replicate a "socialist" system after the Canadian or British models. Politicians in both countries have been called upon to defend their health care systems in the face of often fanciful calumny. In an editorial published on August 24, the Canadian Medical Association Journal took a position arguing for a better informed and more logical debate considering lessons that could be learned from the Canadian experience. The Economist also published an article on August 20 entitled Keep it honest: Rationing is not a four letter word, pointing out the superior performance of the NHS in cost effectiveness when compared to the U.S. system, and deploring the impoverished and dishonest character of some "delirious" rants of the past few weeks heard from American politicians. Citizens of both Canada and the U.K. seem perplexed at the debate in the U.S.. Certainly a more thoughtful democratic process will be required for any meaningful reform. While policy makers around the world seek to create a forum on global health, the U.S. has lost its leadership role.

Recently CNN's Lou Dobbs introduced a series of reports on other national health care systems and the lessons that could be learned from these experiences. These brief reports provoked an attack on Dobbs from some political quarters accusing him of being a latent socialist, or even communist. Included in the series are Canada, Denmark, Japan, the Netherlands, Spain, Switzerland, the U.K., as well as vignettes on India, China and Cuba. The series seems to have been dropped from broadcast but some of the short vignettes have been moved to Anderson Cooper's 360 Blog Archive, where a number of the comments posted suggest that readers would be interested in learning more.

Smartphones for Health Care

2009-08-11T08:38:00.000-07:00

Software Advice is an online consultancy currently offering an advisory service to connect software buyers and vendors in the health care sector (among others). They recently conducted a survey to determine which smartphone is emerging as the device of choice in U.S. health care markets. Although the survey is not scientific, the results are interesting. There were 700 emails sent out to invite participation, while only just over 10% responded (n=71). (There was no option to indicate that the respondent did not own a smartphone.)

Here is the breakdown of respondents by profession:
22 Physician
9 Student
6 Nurse
16 Healthcare IT professional
2 Administrative support
16 Other

While health care service providers including physicians and nurses preferred the iPhone, personnel in administrative support (n=2) chose the Blackberry - a result consistent with anecdotal observations from my informants in the health care sector. This may be because the Blackberry offers superior infrastructure for large enterprise functions including management and security (the BlackBerry Enterprise Server), while the iPhone delivers attractive software applications and facilities for reference and research. (See the debate on Computerworld Mobile and Wireless.)

Especially interesting is the apparently predominant use of smartphones for email communication and note taking in spite of the strong expectation that such devices should be used for medical imaging, patient records (EHRs) and e-prescribing. These results, although unscientific, suggest that smartphone systems are inadequately integrated in institutional information systems, and that the infrastructures required for EHR functions including health information exchange (HIE) generally remain unavailable.

Related to the question of smartphone choice is scenario analysis of future IT infrastructures for health care service delivery in the U.S. and around the globe. In my opinion, the emergence of cloud computing and web-based services will shift the focus of this debate away from the characteristics of access devices and software - to the design of national and international infrastructures with sustained public investment. This paradigm shift in the next five years would invalidate current definitions of "meaningful use" of HIT at the individual practitioner level of analysis and render irrelevant CCHIT certification policies and procedures. (See a Chilmark research presentation entitled "What's Really Going On? or PHRs, Platforms, & Consumer Trends" .)

U.S. Health Care Reform: Continued...

2009-07-28T19:33:00.000-07:00

As the debate over U.S. health care reform continues, much of the controversy seems to center on the creation of a "public option" for health care coverage, and the widely-held fear that private plans cannot survive in competition with such an option. Why should private plans survive if they cannot perform in a competitive environment? This question seeks to justify the public plan in the ideological context of its opponents. It is not yet clear whether this logic will be effective in the political process.

In reality, I think that private plans should not survive in their present form as they appropriate either undeserved financial benefits of not-for-profit status - or excessive profits and CEO salaries - while they fail to provide services to American citizens. Other industrialized nations have designed single payer national systems that provide superior care to their citizens at a cost generally half of the per capita cost in the U.S.. (It is interesting to note that neither the Kennedy bill, nor HR 3200, contains reference to a "national system" or "national infrastructure," but the prevailing ideology as well as an essentially "bottom-up" system change process are assumed throughout the text of the legislation.)

Those who doubt the necessity of rapid reform should review the unfolding story of Remote Area Medical Volunteer Corps. While this organization was founded in 1985 by Stan Brock to deploy health care relief services in the developing world - it now has a growing mission in the United States. RAM recently offered free dental and medical services in Wise, Virginia, where as many as 1600 people showed up each day to receive free care, and on August 11-18, a clinic will be open in Los Angeles where as many as 10000 people are expected. (CBS 60 Minutes produced a segment on RAM in March 2008.) The success of RAM in the U.S. is a testament to the suffering of ordinary citizens across the country and a document of third-world America.

On June 15, President Obama made a speech to the American Medical Association in which he pointed out some of the disastrous economic effects of the dysfunctional U.S. health care system:
Our largest companies are suffering as well. A big part of what led General Motors and Chrysler into trouble in recent decades were the huge costs they racked up providing health care for their workers; costs that made them less profitable, and less competitive with automakers around the world. If we do not fix our health care system, America may go the way of GM; paying more, getting less, and going broke.

According to Obama, not only the health care industry but all of "America may go the way of GM." He is right. He is attempting to convince health-care policy holders that the reform legislation under committee review will improve their coverage in the following ways:

No Discrimination for Pre-Existing Conditions: Insurance companies will be prohibited from refusing you coverage because of your medical history.
No Exorbitant Out-of-Pocket Expenses, Deductibles or Co-Pays: Insurance companies will have to abide by yearly caps on how much they can charge for out-of-pocket expenses.
No Cost-Sharing for Preventive Care: Insurance companies must fully cover, without charge, regular checkups and tests that help you prevent illness, such as mammograms or eye and foot exams for diabetics.
No Dropping of Coverage for Seriously Ill: Insurance companies will be prohibited from dropping or watering down insurance coverage for those who become seriously ill.
No Gender Discrimination: Insurance companies will be prohibited from charging you more because of your gender.
No Annual or Lifetime Caps on Coverage: Insurance companies will be prevented from placing annual or lifetime caps on the coverage you receive.
Extended Coverage for Young Adults: Children would continue to be eligible for family coverage through the age of 26.
Guaranteed Insurance Renewal: Insurance companies will be required to renew any policy as long as the policyholder pays their premium in full. Insurance companies won't be allowed to refuse renewal because someone became sick.
(Source: The Washington Post)

Background:
National Conference of State Legislatures: Federal Health Care Reform:
Congressional Budget Office - Special Collection on Health
Commonwealth Fund
National Academies Press: Health and Medicine

On July 15, Congressman Kevin Brady (R-TX), the lead House Republican on the Joint Economic Committee, unveiled a detailed flow chart of the complex health care reform proposal by Democratic congressional leaders.

Kennedy "Affordable Health Choices Act"
CBO evaluation - Letter to Senator Edward Kennedy (June 15, 2009)

HR 3200 : ‘‘America’s Affordable Health Choices Act of 2009’’(July 14, 2009)
CBO Analysis - Letter to Representative Charles Rangel, Chairman: Committee on Ways and Means (July 17, 2009)

Qualitative Case Analysis for Study of National Health Care Systems

2009-07-16T11:35:00.000-07:00

Research in science policy, institutional economics, telecommunications, and organization theory has contributed to the growing literature on health care system performance, management and control. The current focus on health care system reform in the U.S. has made apparent the lack of relevant research evidence from country level studies. While many policy makers point to a fragmented health care delivery infrastructure, few reform efforts are framed at the national system level. Systems thinking seems anathema in an ideologically restricted political process.

The premise of my program of research is that study of configurations of virtual institutional health care infrastructures is critical to understanding global and regional health care ideologies and market dynamics. Little research has considered the effects of telecommunications and internet infrastructures on these dynamics, largely because theory, methods and tools have not been adapted adequately to analysis of these structures and processes profoundly transformed by new technologies at every system level.

Such analysis requires qualitative research strategies because of increasing system complexity and high rates of social, cultural and technological change. First, case analysis facilitates validation of patterns identified in data collected from diverse sources and construction of comparative frameworks from grounded theory principles. Historical analysis exposes the logic and possible path dependence of system evolution as in the phases of system creation through local unit design, control through centralization, and integration through horizontal coordination.

Another promising qualitative approach is system mapping for sociometric analysis of virtual infrastructures and their contributions to health care services markets and hierarchies. System configurations reflect institutional patterns of information management and control, including free market and centralized social medicine dynamics. For example, density or connectedness may describe the number or proportion of possible linkages appearing in a network, while hierarchy or dominance may describe the distribution of linkages throughout the network. Configurations may be interpreted as complex systems or as cases embedded in a broad context.

Taken together, case analysis, historical analysis and system mapping offer strategies to approach study of the important coherence between underlying ideologies and virtual health care infrastructures.

Some published research programs address country level case analysis of national health care systems - with a view to creation of an evidence base for comparison. Most extensive among these is the program of the European Observatory on Health Systems and Policies of the World Health Organization. The data collected for the 25 member states of the European Union include: (1)Health Systems in Transition (HiT) profiles, (2) other health-related information such as reports from institutions and health reform policy papers, and (3)
links to health-related web sites - ministries of health, national public health institutes, and research centers for health policy, public health and health economics.

The most recent template (2007) for development of Health Systems in Transition (HiT) country profiles includes some data on HIT in sections on planning and health information management (4.2) as well as physical resources (5.1). Information technology must be defined for each country profile in the context of a national IT strategy for the health care system as well as general statistics on Internet access and usage.(page 74)

Another research program on ehealth in national health care systems was initiated by the Rockefeller Foundation in the series of conferences at the Bellagio Center on Making the eHealth Connection organized by the World Health Organization-July-August 2008. The themes covered in the collection of country case studies include:

The path to inter-operability

Public health informatics and national health information systems

Access to health information and knowledge-sharing

eHealth capacity building

Electronic health records

Mobile phones and telemedicine

Unlocking eHealth markets

National eHealth policies

One background paper addresses The Case for a National Health Information System Architecture: A Missing Link to Guiding National Development and Implementation (by Stansfield, S.; Orobaton, N.; Lubinski, D.; Uggowitzer, S.; Mwanyika, H.) According to the authors, "a national health information system (HIS) plays an important role in ensuring that reliable and timely health information is available for operational and strategic decision making that saves lives and enhances health."(page 1) While this definition is generally acceptable, the strong ideological bias evident in the report is not. The enterprise architecture framework has been applied in the context of the U.S. federal government, but requires a careful adaptation to each country culture under consideration for health care sector applications. For example, in the Latin American social medicine tradition, the definition of health care work flow as a business process would be unacceptable.

The country case studies available in the collection are South Africa, Turkey, Vietnam, Rwanda, and Peru. These studies are generally organized according to the conference themes listed above as adapted by the authors. The greatest weakness of this research program is the lack of a theoretical framework or logic to guide methodological choices as well as data interpretation. Comparative analysis of the cases is especially hampered by lack of theory and the convenience sampling of country cases. According to Yin, selection of a single case for analysis may reflect a typical, critical, or unique set of observations for theory development. I have learned in my study of BIREME (Brazil) and INFOMED (Cuba) that regional leadership dynamics must be taken into account in case selection, and that regional network structures may be critical in the understanding of national health information systems.

Other collections of country studies of interest to researchers on national health information systems include Health Systems Country Briefs produced by USAID (August, 2007) to identify areas for investment in effective health systems strengthening. Published briefs include Mozambique, Rwanda, South Africa, Tanzania, and Zambia.

Earlier case studies (2005-6) examined the systemwide effects of the Global Fund to Fight AIDS, Tuberculosis and Malaria on the national health care systems of Benin, Ethiopia, and Malawi. The interim report on findings from these three cases focused on Global Fund effects on the policy environment, human resources, the public/private sector mix, and the pharmaceuticals and commodities markets.

The larger Global HIV/AIDS Initiatives Network including researchers in 21 countries conducts research on how these programs affect national health care systems. The GHIN promotes cross-country case comparability through common research methods, builds research capacity, informs health care policy through multi-country comparisons, and coordinates dissemination of research conclusions and recommendations. The GHIN has contributed to the WHO Positive Synergies Initiative to strenthen its institutional role in national and global health policy. The WHO also publishes a very useful set of country profiles including data for cross-country comparisons.

The International Telecommunication Union offers country case studies by region and topic-providing context for analysis of national health information systems. (Many of these cases require an update.) Another series of ITU cases (2000-2004) addresses Internet diffusion in various stages of country development. (See also publications of the Mosaic Group on the Global Diffusion of the Internet Project.)

Porter's Value-Based Strategy for Health Care Reform

2009-07-10T06:46:00.000-07:00

The New England Journal of Medicine has just published an article entitled "A Strategy for Health Care Reform — Toward a Value-Based System" by M.J. Porter - which has already attracted some international attention. (I learned of the publication as I read a communiqué from the Indian Association for Medical Informatics.) The principles of his approach to health care require critical review-especially as they are aligned with the U.S. health care industry for the promotion of competition as a driver of value, defined as health outcomes achieved per dollar spent. I am particularly concerned about the misuse of Dr. Porter's influence to pedal a U.S. model for health care reform where there exists no evidence in support of such a model.

According to Dr. Porter, while both universal health care insurance coverage and national system redesign are necessary to achieve "true reform", value takes precedence over universal coverage. It seems to me that he is confusing the concepts of universal access to services and universal health care insurance coverage. (In the U.S. system, the private health care insurance industry effectively denies access to millions of U.S. citizens - either by demanding prohibitive deductibles and co-payments or refusing to cover a particular claim for treatment.) Dr. Porter suggests that lower health care costs in other countries are due to universal insurance coverage, but this advantage too is unsustainable without improved value. He fails to recognize the single payer system design with publicly funded health information infrastructures as critical to controlling costs in other national systems. While certainly there has been "no convincing approach to changing the unsustainable trajectory" of the U.S. system, it is inaccurate to suggest that other countries such as Finland, far more advanced than the U.S. in design of an efficient national health care system, should reform their systems according to his recommendations. Rather, the U.S. should be learning from the examples set by other industrialized countries such as the UK, France and Taiwan as well as developing countries such as Cuba and Brazil.

According to Porter, there are six principles to guide health care system reform - all of which address financing:

Reform health insurance competition to focus on improvement in subscribers' health.
Motivate employers to stay in the system by penalizing "free riders". (The presence of employers in health care insurance markets will foster competition based on value.)
Address the unfair burden on those without access to employer-based coverage by equalizing tax deductibility of premiums paid by individuals independently or through their employers.
Create regional insurance pools (instead of a national pool) similar to the Massachusetts Health Insurance Connector. Regional pools apparently would be more effective in promoting value-based competition. Reinsurance programs are also critical to "spread risk" related to coverage of very expensive conditions.
Create income-based subsidies to assist low-income citizens in purchase of insurance.
Require all citizens to purchase health insurance.

This value-based delivery system requires "mutually reinforcing" steps to implementation. The most important features of such implementation appear to be outcome measurement, organization of care according to medical conditions with bundled payments for reimbursement of care, value-based competition for patients across geographical boundaries, adoption of HIT architectures and standards for electronic medical records, and patients' responsibility for their own health.

While many of these features seem painfully obvious, Porter offers no evidence in support of his claims that his framework will bring about the needed reforms in the U.S. system. The use of electronic medical records, for example, is assumed to bring about improved health care efficiency and quality by many researchers and policy-makers. Porter also asserts that "electronic medical records will facilitate both delivery restructuring and outcome measurement" without providing any qualitative or quantitative empirical support for this "bottom-up" change process. Porter's statement has not been demonstrated in any health care system. It would be just as reasonable to suggest that HIT infrastructures for health information exchange form a prerequisite for implementation of electronic health records. The existence of such national HIT infrastructures is certainly required to deliver the comprehensive program of outcome measurement at the foundation of Porter's strategy.

The framework does not mention the role of the public sector in health care system reform, except to affirm the superiority of the private sector to create accountability and value-based care through competition. (Again, there is no research evidence to support this claim. On the other hand, Amartya Sen has pointed out that national health care system performance is related to rate of public health investment. See Sudhir Anand and Martin Ravallion, Human development in poor countries: on the role of private incomes and public services, Journal of Economic Perspectives, 1993, 7: 133-150.)

Porter suggests that his reform strategy requires new independent institutional roles to oversee outcome measurement, set HIT standards, and regulate bundled reimbursement; and that Medicare might be able to "take the lead in some areas." (These new roles should probably be assumed by state or federal entities to assure their independence. Controversies surrounding the Certification Commission for Healthcare Information Technology (CCHIT) illustrate this dilemma.) The Commonwealth Fund has published a comparison of public investment per capita in HIT (2005) (slide #72) showing that the U.S. lags far behind the U.K., Canada, Germany and Australia. This lag probably reflects the lack of public infrastructure to support EHRs and health information exchange at the regional or national levels.

Aside from a significant pro-business ideological bias, Porter's strategy lacks clarity in the definition of "value" as "the health outcomes achieved per dollar spent." Although in the past he has emphasized the role of physicians in health care reform, his perspective has shifted to the system level of analysis. However, value is consistently defined at the individual rather than the population level. In my opinion this conceptual definition is impossible to operationalize for measurement as prescribed - primarily because "value" is to be measured at the individual treatment level of analysis, while the relevant outcome may occur in the aggregate - at the family, community, or population level.

"Value" is a highly subjective dimension at the individual as well as the collective level. How can consensus be developed to prescribe the definition of "value" for such a comprehensive program of outcome measures? Criteria for patient, doctor and provider choices are also very subjective. Objective characteristics of health care delivery would be more useful to inform subjective patient choices. (Porter has not addressed the immense costs associated with production of his outcome measures, including the conduct of extensive comparative effectiveness research programs required to serve as an evidence base.)

The definition of value related to "bundled" services poses substantial methodological problems. Bundled services and reimbursement schemes assume a level of standardization not consistent with the complexity of individual cases - including comorbidity. This design feature would also encumber the dynamics of market competition. (Certain provider organizations would integrate their services in competing industry clusters.) In any event, there is no research to substantiate Porter's far-reaching claims on the benefits of health care services bundled according to medical condition. A CMS (Medicare and Medicaid) initiative to introduce bundled reimbursement in the mid-1990s failed due to provider resistence. The reasons for this failure should be examined to ensure the validity of new proposals in the current environment.

Porter also needs to clarify how the dynamics of consolidation and competition co-evolve in health care services markets. While he deplores "hyperfragmentation and duplication of services", such duplication of services is implicit in the competitive environment he advocates. Certainly the regional structuring of risk pooling would create boundaries to competition and structural redundancy across regions. I do not understand why Porter considers that regional organization "will result in greater accountability to subscribers and closer interaction with regional provider networks, fostering value-based competition." The case of McAllen, Texas and Doctors Hospital illustrates the possible dysfunction of such a model at the local level of analysis-including the exorbitant costs in public CMS reimbursement. (Hear an interview with Dr. A. Gawande on NPR.) Some dimensions of health care in the future will remain anchored in geographic proximity, but others will be more efficiently organized at the national level. Not only will HIT contribute to efficiencies redefined at the national level, but patients will probably be more mobile in pursuit of both work and health care services.

My review has suggested only a few of the many questions to be answered concerning Porter's strategy for health care reform. As many American authors on policy for U.S. health care reform, he needs to consider other national health care systems to identify an evidence base relevant to the American challenge. He refers only to his own publications, and mentions the case of Finland not as an example for study, but as an illustration of the universal crisis in controlling health care costs. One very instructive country case is Taiwan where single payer system reform was implemented in 1995 after thoughtful examination of other national systems to identify desirable features transferable to the Taiwanese context. U.S. policy-makers would have much to learn from this change strategy.

I would like to conclude this review by deploring the excessive emphasis on finance to the exclusion of any reference to medical ethics in the debate on U.S. health care system reform. While financial incentives are certainly important, especially from a business standpoint, physicians and health care professionals should not require micro-management through financial rewards to motivate their service. Implementation of such complex reward systems is very expensive as well as vulnerable to fraud and legal challenge. The most important incentives should be the intrinsique rewards associated with the priviledge of offering a public good through health care service.

Commentary: Meaningful Use

2009-06-22T13:13:00.000-07:00

“The American Recovery and Reinvestment Act authorizes the Centers for Medicare & Medicaid Services (CMS) to provide a reimbursement incentive for physician and hospital providers who are successful in becoming “meaningful users” of an electronic health record (EHR). These incentive payments begin in 2011 and gradually phase down. Starting in 2015, providers are expected to have adopted and be actively utilizing an EHR in compliance with the “meaningful use” definition or they will be subject to financial penalties under Medicare.” Source: Meaningful Use: A Definition, Recommendations from the Meaningful Use Workgroup to the Health IT Policy Committee, June 16, 2009.

The Office of the National Coordinator for Health Information Technology (ONC) is seeking comments on the preliminary definition of “Meaningful Use,” as presented to the HIT Policy Committee on June 16, 2009.

The definition and measurement of "meaningful use" in the context of health information technology (HIT) implementation has emerged as a critical policy discussion - particularly in light of the need to establish benchmarks for incentive payments mandated in ARRA. The most important difficulties in this discussion result from confusion in other definitions including electronic health records (EHRs) and health information exchange (HIE). Although CCHIT has apparently made progress in presenting criteria for certification of both EHRs and HIEs, their clear definition remains elusive and subject to ongoing debate. In their call for public comment, the HIT Policy Committee proposes a Preamble: Meaningful Use – A Definition and a Meaningful Use Matrix structured according to health care policy priorities. The ultimate goal of meaningful use - as stated in the Preamble – is to “enable significant and measurable improvements in population health through a transformed health care delivery system.” While this broad goal encompasses the entire system, health information technology seems narrowly defined as an Electronic Health Record (EHR), excluding any discussion of infrastructures required to support health information exchange and other core functions of EHRs. The challenge in this framework is to demonstrate how the adoption of an EHR can be associated with emergence of a transformed health care delivery system for improved population health. What are the dimensions of this goal and how should they be operationalized and measured within a particular health care context? The Matrix is an attempt to identify health care policy priorities on five axes – regardless of context: (1) Improve quality, safety, efficiency, and reduce health disparities; (2) Engage patients and families; and (3) Improve care coordination; and (4) Improve population and public health; and (5) Ensure adequate privacy and security protections for personal health information. Each of these axes yields a set of care goals with more specific objectives and measures to be applied in 2011, 2013, and 2015.

Unfortunately, the logic of the Matrix is highly inconsistent. The five policy axes are certainly not orthogonal, but must be interrelated in different ways among complex care delivery systems. For example, improving population and public health would be closely associated with reduction in health disparities, and improved coordination would certainly be linked with better health care quality. Some of the goals listed for particular policy priorities seem misplaced while corresponding objectives and measures seem unrelated or indistinguishable. For example, the goal to “Report to patient registries” in Priority #1 would seem more appropriate to the public health priority (#4). The goal to “Apply clinical decision support at the point of care” (under priority #1) appears also as an objective in 2013 and 2015. Logically the objectives and measures in the Matrix should represent more specific instances within each stated goal. Clinical decision support is a very complex problem inadequately presented as a required component in the determination of meaningful use.

The Matrix time frame in general poses a challenge as the measures for achievement of objectives appear to lose definition (or disappear entirely) from 2011 to 2015, when they are mostly “to be determined” (tbd). (What happened to measurement of health disparities in 2015? Are they supposed to have been resolved by then?) In my opinion there are several reasons for the inadequacy of the Matrix framework.
(1) The logic of the Matrix assumes the existence of infrastructures required for HIT implementation – including the adoption of EHRs. As I have already commented on the proposal for regional extension centers, it is unrealistic to assume that existing policies to foster formation of RHIOs and HIEs will effectively promote a Nationwide Health Information Network (NHIN) without sustained public investment at the federal level. Essential institutions excluded from the ONC discussion of meaningful use include educational and research providers. The eventual NHIN infrastructure - including education and research institutions - will have a very substantial impact on the evolving parameters of HIT and EHR meaningful use in health care delivery, especially for health information exchange and interoperability.
(2) Another invalid assumption is that HIT or EHRs – implemented at the physician, group practice or hospital level - will reduce costs or improve the quality of health care without very significant national system redesign. HIT implemented in the existing fragmented system may only result in greater redundancies and inefficiencies – as well as higher costs. (See the report by the CBO: Evidence on the Costs and Benefits of Health Information Technology, 2008. See also the very provocative article by A. Gawande in the New Yorker: The Cost Conundrum: What a Texas town can teach us about health care, 2009)
(3) Information technologies evolve very quickly and new innovations as yet unforeseen may radically affect the field of biomedical informatics and the redesign of the U.S. health care system, especially in this time of crisis. Since the logical structure of the Matrix appears fatally flawed, it is unlikely that this framework would survive even relatively small technology-driven adjustments - to be useful as a robust theory would. This framework would therefore not be effective in motivating the individual or institutional decision-maker to make the sustained financial and human resource investments required for effective EHR implementation and meaningful use.

Like the ONC, professional associations such as AMIA and HIMSS appear to have avoided issues related to operational definition of meaningful use by considering EHR adoption as an essentially binary variable and emphasizing the association between presence of EHR technology and health care outcomes. There should be more careful attention to the complex health care processes linking HIT with such outcomes. According to AMIA, criteria for meaningful use of EHRs should focus on "clinical endpoints achieved," and the "relationship between, and effectiveness of, key EHR functions and performance on quality measures over time." (See AMIA letter to James Scanlon dated April 30, 2009) HIMSS states unequivocally that "quality measures are a by-product of the successful implementation of CCHIT-certified EHR technology, not separate initiatives." (See lines 74-86: Definition of Meaningful Use of Certified EHR Technology for Hospitals - Approved by the HIMSS Board of Directors on April 24, 2009) They formulate an untested assumption of a unique causal link between certified EHR usage and quality - for which there is no logical or empirical justification - except apparently to promote the value and necessity of CCHIT certification.

Unfortunately, there is no evidence base to associate HIT or EHR usage (certified, meaningful or otherwise) with many of the measures of general health care quality outcomes appearing in the Matrix. The low rate of EHR adoption in the U.S. renders quantitative research on the relationship between EHR technology and health care quality impossible at this time. One recent study by Li Zhou et al. to appear in JAMIA attempts to examine EHR functions and performance based on data from the Healthcare Effectiveness Data and Information Set (HEDIS) - only to report that there is no statistical association between usage of EHRs and such performance data. Although this result is probably due to numerous methodological weaknesses - including sample sizes and construct definitions - the study suggests to me that reductionist research designs cannot capture the complexity of EHR meaningful use or the possible causal effects on quality of health care. Furthermore, had this study demonstrated such a statistically significant association, there would have been no validity to any claim of causality. Many unmeasured and uncontrolled contextual variables may co-vary to explain quality of health care.

The lack of a research program and evidence base demonstrating the positive health care outcomes promised with implementation of HIT or EHRs has serious consequences for the motivation to adopt these technologies as well as the determination of financial incentives as mandated through Medicare and Medicaid. Where research evidence for meaningful use of HIT and EHRs does not exist and cannot be generated in the proposed framework, the program of incentives will be wasteful of public funds not only through ineffective incentive payments but also through vulnerability to legal challenge.

Rather than attempting to prescribe and incentivize implementation of HIT and EHRs, the government should directly offer public services funded through sustained federal investment - such as the NHIN - that will shape meaningful use of these technologies. An incentive for example, might be access to technical support services freely available through linkage to the NHIN.

Commentary: U.S. Health Information Technology Extension Program

2009-06-22T12:04:00.000-07:00

Department of Health and Human Services

Office of the National Coordinator for Health Information TechnologyHealth Information Technology Extension Program

The following commentary on the proposed Health Information Technology Extension Program addresses the general context of U.S. health care reform under the American Recovery and Reinvestment Act of 2009 (ARRA). It was submitted to DHHS on June 11.

Comparative studies of national health care systems in the industrialized world demonstrate that health care service delivery in the U.S. performs poorly in light of the level of per capita expenditure in the sector. [1] Even though there is agreement among physicians that the U.S. health care system is broken, there is no consensus on political action for system reform integrating health information technologies (HIT) in support of evidence-based medical practice, research and education. The U.S. lags significantly behind other developed countries in public investments for HIT; [2] as of 2005 the U.K. had spent $192.79 per capita compared to a U.S. investment of $.43. [3] One reason for this lack of public investment is U.S. policy emphasis on development of sustainable business models for private investment in health information infrastructures.

In the U.S. multiple payer system, competing health care providers and insurance companies focus on automation of financial transactions and implementation of redundant proprietary HIT. Their incentives for new technology adoption do not take into account system level efficiencies often external to private HIT purchasers in the health care sector. While policy emphasis on electronic health records (EHR) focuses on internal efficiencies and improved health care quality, these investments require public infrastructures in some form of partnership with a variety of stakeholders for effective health information exchange (HIE) at the state and system level. [4]

The nationwide health information network (NHIN) refers to a proposed system linking data intermediaries for health information exchange. Related policies rely primarily on the emergence of locally sustainable infrastructures. An assumption fundamental to this model is incremental development by linkage of regional health information organizations (RHIOs) to form the NHIN. However, early research on the performance of RHIOs shows a high failure rate among these organizations and offers no significant evidence to substantiate interoperability among their systems. No sustainable RHIO business model has been identified to integrate public and private stakeholders. [5-7] Although public policy on HIT seems optimistic about future development of infrastructures based on health information exchange (HIE) and RHIOs, there is no foundation of evidence or experience to justify such apparent assumptions. The insignificant rate of comprehensive EHR adoption (1.5% in U.S. hospitals) further suggests that HIT infrastructures and other technical and training support services are either inadequate or nonexistent. [8]

Few studies in any scholarly discipline or field of professional practice have investigated the reasons for this lack of progress at the level of national U.S. health care systems or markets. While successful efforts for health information exchange seem to align with business models integrating payers and large collaborative systems such as hospital corporations, RHIO organizations are designed to promote flows of health information across competing business entities as well as public health agencies in the health care sector. Such entities will not share the health information that describes their proprietary services and clienteles (albeit de-identified), especially when there is no competitive advantage or service offered as a return on substantial investments required.

The design of the Health Information Technology Extension Program seems to assume the emergence of infrastructures for health information exchange through linkage of regional organizations. Major problems with the design include:

Lack of definition of regions under the governance of the National Health Information Technology Research Center (HITRC). Applicants for Regional Extension Centers are designated broadly as “affiliated with any United States-based nonprofit organization or group thereof…”. One of the criteria for successful application is definition of the geographic region and the provider population within that region to be served. This provision would mean that applicants might compete on the basis of their definition of a region as well as other criteria. The result would be a fragmented and/or overlapping national extension infrastructure.
The logic of regional extension center design may not be consistent with the structure of many providers offering regional health care services across the U.S.. Some providers may have access to more than one extension center by virtue of such inconsistencies, thus fostering redundant and inefficient services. Differences in regulations among states included in regions defined by extension centers may also create significant problems in developing extension programs.
The short term strategic vision with two-year awards in FY 2010 from ARRA funding does not justify the substantial investment probably necessary for preparation of applications. This difficulty is further exacerbated by uncertainties associated with the priority accorded to applicants identifying “viable sources of matching funds”.

In my opinion, the weaknesses of existing policies for development of the NHIN information infrastructure must be resolved before related programs can be implemented. In particular, this infrastructure should be fully funded at the federal level with a long term strategic vision. Design of the NHIN as a public good is required to support both public and private enterprise in an integrated health care sector. [9]

REFERENCES

[1] Nolte E, McKee CM. Measuring the Health of Nations: Updating an Earlier Analysis. Health Affairs 2008;27(1):58-71.
[2] Anderson GF, Frogner BK, Johns RA, Reinhardt UE. Health Care Spending And Use Of Information Technology In OECD Countries. Health Aff. 2006 May 1;25(3):819-831.
[3] Health System Performance in Selected Nations: A Chartpack. Shea K, Holmgren A, Osborn R, Schoen C. 2007.
[4] Public Governance Models for a Sustainable Health Information Exchange Industry: Report to the State Alliance for E-Health. State Alliance for E-Health. 2009.
[5] Adler-Milstein J, McAfee A, Bates D, Jha A. The State of Regional Health Information Organizations: Current Activities and Financing. Health Affairs 2008;27(1):w60-w69.
[6] Fifth Annual Survey of Health Information Exchange at the State and Local Levels. eHealth Initiative. 2008.
[7] Adler-Milstein J, Bates DW, Jha AK. U.S. Regional Health Information Organizations: Progress And Challenges. Health Aff.; Health Aff. 2009 March 1;28(2):483-492.
[8] Jha AK, DesRoches CM, Campbell EG, Donelan K, Rao SR, Ferris TG, et al. Use of Electronic Health Records in U.S. Hospitals. N.Engl.J.Med.; N.Engl.J.Med. 2009 March 25.
[9] Clancy CM, Anderson KM, White PJ. Investing In Health Information Infrastructure: Can It Help Achieve Health Reform? Health Affairs 2009 March 1;28(2):478-482

Education for Implementation of Health Information Technology

2009-04-29T08:34:00.000-07:00

A thought provoking debate was opened at the Washington Post (April 26, 2009) with publication of an article entitled "End the University as We Know It" by op-ed contributor Mark C. Taylor, chairman of the Religion Department, Columbia University. Dr. Taylor deplores the "division-of-labor model of separate departments" and calls for a new curriculum model structured as a complex adaptive network. In my opinion, as suggested by Dr. Taylor, such a structure would foster interdisciplinary and cross-cultural teaching and research required to face the challenges of the new millennium, including scholarship in the growing field of biomedical informatics. However, it seems unlikely that formal educational programs in biomedical informatics will meet practical workforce needs for development of health information systems in the U.S., particularly in light of the American Recovery and Reinvestment Act (ARRA) of 2009. In 2005, the American Medical Informatics Association created a university-based training curriculum - AMIA 10x10 - designed to present a set of competencies for technology champions acting in their professional settings. The goal of these distance-learning courses is to train ten thousand health care workers by 2010. An evaluation of partner institution OHSU course offerings before the end of 2006 seemed to suggest that support for interaction among participants should be increased, although overall satisfaction with content and process was high. To date, I think only about 2000 participants have completed courses in this program. More generally, the technology champions now active in health care organizations are probably innovators - autonomous learners - working alone or in cross-disciplinary communities of practice, advancing ahead of expensive and rapidly outdated academic curricula. Unfortunately, in the U.S. context there is no national infrastructure to guide these fragmented efforts towards formation of an integrated health information network with standards for interoperability.

Published Evidence: RHIOs and HIE

2009-04-14T06:25:00.000-07:00

I have been searching for evidence about the performance of existing RHIOs, and have had some difficulty identifying published research - whether in journals or grey literature. An excerpt from the minutes of a meeting of CCHIT's working group on networks (October 28) refers to a study conducted by Gartner in late 2007. This report should be in the public domain as it was funded by the ONC. Gartner also refers to its research methodology as "proprietary"- contradicting the basic principles of scientific enterprise. (Hype Cycles and Magic Quadrants constitute questionable conceptual frameworks for this type of business intelligence.) While privately funded research results might logically be defined as proprietary, research methodology should always be considered open to review by the scientific and professional communities concerned.

The Healthcare IT Transition Group published reports in 2006 and 2007. While summaries of these reports (2006, 2007) are freely accessible, the full reports are still considered proprietary even though they contain "old news". Some discussion of the study results is available on the organization's blog. One other report on RHIO financing published in 2005 is available in PDF .

The eHealth Initiative has published annual surveys of HIE initiatives since 2005. The 2008 Fifth Annual Survey of Health Information Exchange at the State and Local Levels finds that although the number of organizations surveyed has increased, the extent of health information exchange remains limited and a sustainable business model has yet to be defined.

Chilmark Research, specialized in IT trends in the health care sector, projects a decline in formation of interorganizational RHIOs while HIE, designed for particular organizational entities, may constitute a growing market. The reasons for this are related to difficulties in identifying a viable business model for health information exchange. HIE is focussed on business partnerships much like a supply chain configuration in manufacturing, including suppliers and payers. While RHIOs enable health information "liquidity", HIE incorporates business processes associated with health information flows. According to Chilmark, public investment in RHIOs should be suspended, while the NHIN is an unrealistic goal based on HIE growth; the growth of HIE will not bring development of interoperable networks across the U.S..

An important issue in the distinction between RHIOs and HIE involves the risks of integrating billing and clinical information. For a variety of reasons, billing codes may distort medical conditions and treatments they represent, posing a danger to patient health as in the case of Dave deBronkart as reported in the Boston Globe (April 13 2009).

Another strategy for creation of the NHIN involves development and diffusion of open-source software solutions to allow public and private organizations to link into the NHIN for health information exchange. The U.S. Social Security Administration was the first federal agency to use this solution requiring the user entity to assume costs related to software development, implementation and maintenance.

Websites:
NHINWatch - maintained by the editors of Healthcare IT News
HIMSS Government Health IT
HHS: NHIN
Health Record Banking Alliance
Connect Community Portal - Open Source Gateway
HHS: Federal Health Architecture
Information and Technology Innovation Foundation
Practice Fusion a web-based EMR service and community of practice

Articles on topics related to RHIOs include:
Adler-Milstein, J., McAfee, A., Bates, D., & Jha, A. 2008. The state of regional health information organizations: Current activities and financing. Health Affairs, 27(1): w60-w69. (Comments on this article)
Adler-Milstein, J., Bates, D., & Jha, A. 2009. U.S. regional health information organizations: Progress and challenges. Health Affairs, 28(2): 483-492.
eHealth Initiative. 2008. Fifth annual survey of health information exchange at the state and local levels. Washington, D.C.: .
Marchibroda, J. M. 2007. Health information exchange policy and evaluation. Journal of Biomedical Informatics, 40(6, Supplement 1): S11-S16.
McDonald, C. 2009. Protecting patients in health information exchange: A defense of the HIPAA privacy rule. Health Affairs, 28(2): 447-449.
McMurry, J., Gilbert, C. A., Reis, B. Y., Chueh, H. C., Kohane, I. S., & Mandl, K. D. 2007. A self-scaling, distributed information architecture for public health, research, and clinical care. Journal of the American Medical Informatics Association, 14(4): 527-533.
Solomon, M. 2007. Regional health information organizations: A vehicle for transforming health care delivery? Journal of Medical Systems, 31(1): 35-47.
Thielst, C. B. 2007। Regional health information networks and the emerging organizational structures. Journal of Health Care Management, 52(3): 146-150.
Tripathi, M., Delano, D., Lund, B., & Rudolph, L. 2009. Engaging patients for health information exchange. Health Affairs, 28(2): 435-443.

Stimulus Bill & HIE, RHIO Market

2009-04-05T06:13:00.001-07:00

HIMSS has published a very useful Health Information Exchange Industry Listing of resources. There is still no evidence of a sustainable business model for development of RHIOs or a methodology for scaling up to a national network-NHIN.

Review this SlideShare presentation for a perspective on economic stimulus measures and their effects on industry markets:

Stimulus Bill & HIE, RHIO Market

View more presentations from John Moore.

Health Information Exchange and CCHIT

2009-03-23T10:06:00.000-07:00

The U.S. Commission for Certification of Health Information Technology (CCHIT) is developing criteria for certification of health information exchange (HIE) - including a process of public comment accessible through their website. This agency (a government contractor) shows a bias in favor of proprietary software solutions in certification for ambulatory, inpatient, emergency department and enterprise EHR. Health information exchange, however, poses a particular challenge to CCHIT as it really cannot be defined as a software product - as evident in the minutes of meetings of the HIE (formerly Network) Working Group. On October 28, 2008, the WG considered the results of a Gartner report on vendors providing services to HIEs - commissioned in 2007 by the ONC. (This report has not been made available for public review, probably because it contains evidence that existing HIEs are unsustainable; no viable business model has been identified, and these organizations generally fail after initial public or private funding is exhausted. In my opinion, such a report belongs in the public domain and should be required to inform public consultations.)

The WG mentioned that discussions would be continued to decide whether vendor certification should be different than HIE certification. (See page 3.) On November 25, 2008, questions were raised concerning the location of patient and document registries as well as the content of current HIE data exchange. Confusion over the parallel roles of CCHIT and the Healthcare Information Technology Standards Panel (HITSP) was resolved by asserting that HITSP should adapt its standards to CCHIT certification requirements.

The WP seemed to recognize that the interoperability construct is difficult to address in the absence of "an overarching plan for how HIEs will interact as mediators of information exchange." (See page 2.) On January 27, 2009, a substantial commentary and discussion explored the distinctions between HIE certification and accreditation under the Electronic Healthcare Network Accreditation Commission (EHNAC) . According to this discussion and ISO definitions, certification is more appropriate to software products and vendors, while accreditation applies to organizational entities. (ISO definitions: Accreditation is a "third‐party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks" in other words an organization or entity can be accredited. "Certification is a third‐party attestation related to products, processes systems or persons" in other words not an organization. See comment 7 on page 5, minutes of the January 27 WH meeting.)

While the minutes of WG meetings raised the critical need for HIE definition, this question was never directly addressed. What are HIEs? How will they be connected to form the Nationwide Health Information Network (NHIN)? What organizations and institutions may join in these networks? Where does health information reside in the HIE context? The document for public comment offered by CCHIT suffers from this lack of clarity, with the probable result that comments will focus on trivial technical details rather than the more important "big picture".

EHR Debate

2009-03-20T09:43:00.000-07:00

In India a political debate is developing from publication of an IT vision paper,"Transforming Bharat" (India is called Bharat in Hindi), by an opposition party - the Bharatiya Janata Party (BJP). (See a post by Indrajit Basu: Digital Community Innovations from around the World - India's Opposition Party Promises IT Nirvana for All - for discussion of the Indian context.)

An excerpt:

The BJP’s IT Vision will help India (a) overcome the current economic crisis; (b) create productive
employment opportunities on a large scale; (c) accelerate human development through vastly
improved and expanded education and healthcare services; (d) check corruption and (e) make
India’s national security more robust.

Some highlights of this IT Vision are (page 2):

@ Multipurpose National Identity Card with Citizen Identification Number (CIN) in 3 years; to replace all other identification systems.
@ 1 crore students to get laptop computers at Rs 10,000. Interest-free loan for anyone unable to afford it.
@ All schools and colleges to have internet-enabled education.
@ National Mission for Promotion of IT in Indian Languages.
@ Broadband Internet in every town and village, with unlimited upload and download data transfer limits, at cable TV prices.
@ Mobile penetration to be raised in five years from 40 crore to 100 crore subscribers.

@ 100% financial inclusion through Bank accounts, with eBanking facilities, for all Indian citizens. Direct transfer of welfare funds.

@ A basic health insurance scheme for every citizen, using the IT platform. Cash-less hospitalisation.
@ All PHCs to be connected to a National Telemedicine Service Network.
@ National eGovernance Plan to cover every Government office from the Centre to the
Panchayats. The ‘E-Gram Vishwa Gram’ scheme in Gujarat to be implemented nationwide.

Regarding ehealth (page 24) the BJP promises that every hospital and primary health care center (PHC) in rural areas would be connected to a National Telemedicine Service Network, every citizen would have an electronic health record and universal health care would be offered through a basic health insurance program using the IT platform. Service to rural areas would be improved through IT-enabled mobile diagnostic vans and health care work force training programs.

Distinctive features of this Indian vision include the commitment to universal health care with a unique citizen identifier, and integration of government (including health care and education) and financial services through public telecommunications infrastructures.

This Indian example shows how the EHR may be effectively viewed in the broader context of a national IT platform. Patient identification is a fundamental issue which also needs to be addressed in U.S. policy before EHR implementation can be meaningfully promoted through economic stimulus or other measures.

EHR Stimulus

2009-03-18T08:39:00.000-07:00

An international debate on solutions for EHR software solutions has recently received more extensive coverage as the US economic stimulus programs focus on promotion of health information technologies in general and electronic health records (EHR) in particular. (See text versions of the American Recovery and Reinvestment Act -HR 1: TITLE XIII--HEALTH INFORMATION TECHNOLOGY )

Many important questions guide this debate, including the role of national information infrastructures and the appropriateness of proprietary vs. open source software solutions. Austin Merritt of SoftwareAdvice.com, an online resource that helps physicians find electronic medical records, offers very salient arguments for caution in evaluating cost savings as a result of EHR adoption in the health care sector: http://www.softwareadvice.com/articles/medical/get-ready-for-ehr-failures-but-dont-blame-the-software-2031209/ An excerpt of the article is copied below.
_____________________________
With the Economic Stimulus Bill signed and available to subsidize EHR purchases (for more information see “The Stimulus Bill and Meaningful Use of Qualified EHRs/EMRs“), we are seeing a dramatic increase in electronic health records (EHR) buyer interest. Assuming these buyers make use of the stimulus subsidy to buy an EHR, we expect to see a lot of EHR failures over the next couple years.

Don’t get us wrong! We are HUGE advocates of EHR technology. Doctors should be using EHRs. The stimulus subsidy is great. EHR software programs (and software companies) are not the problem.
Our concern is that the subsidies won’t change healthcare providers’ late adopter mindsets about information technology. Providers may jump at “free software” and try to avoid penalties (starting in 2015), but will they:

Truly believe in the value of an EHR over traditional paper charts?

Take a leadership role in advocating adoption of the new EHR in their practice?

Change their old workflows to match the best practices in leading EHRs?

Take part in intensive training to learn the new system?

Ride out the difficult stages of new software adoption and change management?

Traditionally, the substantial costs of EHR systems keep the luddites from buying technology in the face of these challenges. But with “free” EHR software, we expect more than a few providers to throw caution to the wind, buy an EHR and overlook the critical implementation and change management practices that are critical to success.
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The issues raised in this article are of critical importance, especially those related to workflow analysis and training. EHR implementation concerns also need to be evaluated in light of the lack of an effective National Health Information Network (NHIN) with associated national or international standards for interoperability.

2008-08-14T13:28:00.000-07:00

Listen to a very interesting discussion with Enrico Coiera on IT infrastructures for health systems. He contrasts the NHS approach focused on development of large centralized databases with the US approach aimed at interconnecting disparate HIE systems: http://www.abc.net.au/news/audio/2008/08/07/2328038.htm

Health Information Infrastructures: RHIOs

2008-01-31T09:18:00.000-08:00

Recently much has been written about regional health information exchange and RHIOs. Adler-Milstein et al. (The State of Regional Health Information Organizations: Current Activities and Financing, Health Affairs, published online: 11 December 2007 at http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.1.w60v1) examine whether "the current US. market-oriented approach - offering small grants and waiting to see which RHIOs flourish - will work." Evidence suggests that this approach will not work. These authors surveyed 145 RHIOs in early 2007, and found that of these only 32 were functioning to facilitate data exchange across independent entities on January 1, 2007, and only 20 were medium to large size organizations. Analyses report per centages (n=20) of this sample processing data from hospitals. ambulatory services, labs, imaging centers, payers, public health services, pharmacies and pharmacy benefit management organizations. Categories of data include test results, inpatient data, medication history, outpatient data, and public health. Support for RHIOs studied (n=20) included time or in-kind resources, one-time financial contributions, grants, and recurring fees. Results reported are very misleading due to use of percentages and the inadequate sample size. This study objective is a very important one but methodological weaknesses of the research design obscure results that might have been drawn from qualitative case analysis of the RHIOs. The reader learns nothing about HOW these organizations work, but it seems clear from the large number of failed or stalled efforts that the policy model for development of RHIOs yields only small scale, unsustainable and fragmented initiatives.

The reasons for this evident failure are many, including reliance on market dynamics with a "bottom-up" approach, for-profit definition of sustainability, and lack of attention to public sector information infrastructures required as a foundation for the success of information exchange. Issues related to privacy impede concept development while lack of regional or national consensus on standards and interoperability prevent the process of "scaling up." (See also Walker et al., The Value of Health Care Information Exchange and Interoperability, Health Affairs, 19 January 2005, at http://content.healthaffairs.org/cgi/content/full/hlthaff.w5.10/DC1 )

Financial services networks offer another model useful as a reference for development of a national and international health information systems satisfying criteria of individual privacy and confidentiality. Viewpoint papers published by Electronic Data Systems (EDS at http://www.eds.com/) show IT infrastructure developments in other industry sectors - especially finance and communications - that might be very instructive for the health care industry. See for example:
Converged Communications Network for Financial Services (2007) available at http://www.eds.com/services/whitepapers/convergednetworks_financialservices.aspx
Governance – The Key to Unlocking the Challenges of SOA (Service-Oriented Architecture) (2007) available at http://www.eds.com/services/whitepapers/soa_governance.aspx
Virtualization: The EDS Perspective (2007)
http://www.eds.com/services/whitepapers/virtualization.aspx

Gartner has developed a conceptual framework for research on application infrastructure: the "Magic Quadrant" (2007) available at http://www.computerworld.com/pdfs/intersystems_gartner_wp.pdf

Evaluating and Reforming the U.S. Health Care System

2008-01-25T13:59:00.000-08:00

Many new studies and policy reports focus on the comparative performance of the U.S. health care system and recommendations for its redesign and improvement.

Websites and key publications:

The Commonwealth Fund: http://www.commonwealthfund.org/
Mirror, Mirror on the Wall- An International Update on the Comparative Performance of American Health Care (2007): http://www.commonwealthfund.org/publications/publications_show.htm?doc_id=482678
A Roadmap to Health Insurance for All - Principles for Reform (2007): http://www.commonwealthfund.org/publications/publications_show.htm?doc_id=553840

The United Health Foundation: http://www.unitedhealthfoundation.org/
America's Health Rankings (2007): http://www.unitedhealthfoundation.org/ahr.html

The Institute of Medicine: http://www.iom.edu/
Knowing What Works in Health Care - A Roadmap for the Nation (2008): http://www.nap.edu/catalog.php?record_id=12038

The U.S. Census Bureau: http://census.gov/
Income, Poverty and Health Insurance Coverage in the United States (2006): http://www.census.gov/hhes/www/hlthins/hlthin06.html

The American Medical Association: http://www.ama-assn.org/
Voice for the Uninsured - The AMA Proposal: http://www.ama-assn.org/ama/pub/category/17712.html

Physicians for a National Health Program: http://www.pnhp.org/
Proposal of the Physicians' Working Group for Single-Payer National Health Insurance (JAMA, vol.290, no. 6 (2003): http://www.pnhp.org/physiciansproposal/proposal/Physicians%20ProposalJAMA.pdf

California HealthCare Foundation: http://www.chcf.org/
Gauging the Progress of the National Health Information Technology Initiative (2008): http://www.chcf.org/documents/chronicdisease/GaugingTheProgressOfTheNationalHITInitiative.pdf

Resources for qualitative health services research

2008-01-24T13:29:00.000-08:00

The use of qualitative methods for health services research poses significant challenges in effective study design and data collection particularly when study objectives include information technology. The British National Health Service (NHS) Health Technology Assessment Program offers an extensive review of these methods entitled-
Qualitative Research Methods in Health Technology Assessment: A Review of the Literature (1998) available at http://www.ncchta.org/fullmono/mon216.pdf
Although this report is now ten years old, it provides a very rich historical overview of qualitative methods in technology assessment as well as a discussion of the relation between quantitative and qualitative approaches and criteria for methods selection.

The online journal The Qualitative Report at http://www.nova.edu/ssss/QR/index.html offers a wide range of links in addition to online articles.

Another resource is:

Qualitative Research Methods: A Data Collector's Field Guide (2005)
By Natasha Mack, Cynthia Woodsong, Kathleen M. MacQueen, Greg Guest, and Emily Namey

This ebook from Family Health International is available in PDF format at http://www.fhi.org/en/RH/Pubs/booksReports/QRM_datacoll.htm
The following is a description of the reference from the website:

This how-to guide covers the mechanics of data collection for applied qualitative research. It is appropriate for novice and experienced researchers alike. It can be used as both a training tool and a daily reference manual for field team members. Its question and answer format and modular design make it easy for readers to find information on a particular topic quickly. The Data Collector's Field Guide includes:

-Self-contained modules for each research method (including participant observation, in-depth interviews, and focus group discussions)
-Ethical guidelines for each method
-Case study samples with notes, forms, and transcripts
-Tips for taking field notes for specific methods
-Steps and checklists for what to do and bring for each type of data collection
-Exercises for training data collectors in each method
-Tools for data managers
-Suggested readings

This guide is particularly useful for its focus on research in public health and development.

Research methods for health care system evaluation

2008-01-23T10:11:00.000-08:00

Methods for health care system evaluation are gaining prominence in the scientific discourse of a number of related disciplines including medicine, public health, and medical informatics. A new website by Academy Health (http://www.academyhealth.org/) for health services researchers is available at http://www.hsrmethods.org/. The website mission states:

HSRmethods.org provides current information on key research methods and resources in HSR, and aims to spur dialogue about analytic methods among health services researchers.

This important collection of resources effectively frames the debate on appropriate choice of methods and statistics for evaluation research in this interdisciplinary field. The resources offered cover research ethics, privacy issues and data sources as well texts and other readings on quantitative and qualitative research methodologies.

Published evaluation research tends to favor quantitative methods. For example, articles appearing in the journal Health Affairs on comparative country analyses often present tabulations of public health data such as per capita spending and population statistics to construct country rankings. While highly instructive, these analyses shed little light on social or organizational logics explaining country level health care system performance. See for example:

Ellen Nolte and C. Martin McKee
Measuring The Health Of Nations: Updating An Earlier Analysis
Health Affairs, January/February 2008; 27(1): 58-71.

Gerard F. Anderson, Bianca K. Frogner, and Uwe E. Reinhardt
Health Spending In OECD Countries In 2004: An Update
Health Affairs, September/October 2007; 26(5): 1481-1489.

William D. Savedoff
What Should A Country Spend On Health Care?
Health Affairs, July/August 2007; 26(4): 962-970.

Qualitative methods offer more opportunities to assess how health care processes work as well as how medical and public health interventions perform. See for example:

Harald Walach, Torkel Falkenberg, Vinjar Fønnebø, George Lewith, and Wayne B Jonas
Circular instead of Hierarchical: Methodological Principles for the Evaluation of Complex Interventions
BMC Medical Research Methodology. 2006; 6: 29.
Available at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1540434

Maria Grypdonck,Qualitative Health Research in the Era of Evidence-Based Practice, Qualitative Health Research, 16 (10) 2006, 1371-1385.

See also a report from the Cosmos Corporation by Robert Yin and Darnella Davis: ADDING NEW DIMENSIONS TO CASE STUDY EVALUATIONS: THE CASE OF EVALUATING COMPREHENSIVE REFORMS (2006) available at http://www.cosmoscorp.com/MSPDocs%5CNew%20Directions.pdf

Research and Collaboration on Organizational Systems

2007-08-27T11:34:00.000-07:00

The objective of this blog is to contribute to the debate regarding the role of new technologies in the global information society. Special interdisciplinary attention is focused on health care systems at the institutional, national and global levels of analysis. I recently gave a talk at the American Medical Informatics Association Spring Congress. I outlined my research program to create a framework for analyzing the development of virtual infrastructures in ideologically diverse health care systems, considering a variety of studies including U.S., British, Indian, Cuban and Ugandan national cases. Market dynamics and system control mechanisms define the logic of system structures, processes and ideologies. Ideology is expressed in patterns of stakeholders’ participation in the financing, administration, and regulation of health care, including the roles of government, health care professionals, and patients. Globalization of health care services markets requires compatible general institutional frameworks with governance through international organizations such as the United Nations, the World Health Organization, and the World Bank. While globalization brings about increased interaction among national economies, this does not necessarily imply convergence of institutional arrangements. This blog explores how virtual infrastructures and ICTs are transforming health care systems and shaping the emergence of global services markets.

The research methodology for this program of research is qualitative case analysis. Technological innovation and economic globalization motivate rapid social changes inaccessible to nomological model identification. Idiographic case research methods yield holistic descriptive analysis and assessment of complex health care management systems within their social, economic, and cultural contexts. Multiple sources of data include published studies and research reports well as the Internet sites of the health care infrastructures under study and their network configurations. The holistic level of analysis includes health care systems and their virtual institutional environments. Comparative case analyses of virtual infrastructures suggest that while powerful trends such as health care service decentralization and privatisation have profoundly affected global markets, national systems display unique ideologies and social logics reflecting local cultures and values as well as varying stages of development.

From week to week I will add discussion and resources useful to this research program. Your commentaries, suggestions and collaboration are very welcome.

References

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