EDITORIAL Lifting the Fog of Health Delivery and Costs Hershel Jick Boston Collaborative Drug Surveillance Program, Boston University School of Medicine, Lexington, Massachusetts

KEY WORDS health care costs, Affordable Care Act, single payer system, private health care. (Pharmacotherapy 2014;34(12):1227--1229) doi: 10.1002/phar.1530

The heated intensity of the debate on the enormously complex issues related to health care in the United States has been ignited by the recent implementation of the Affordable Care Act (ACA) in January 2014. In order to reliably estimate the resulting consequences of major changes in health delivery and costs, it is necessary to design and initiate accurate standardized universal electronic systems that routinely record comprehensive medical information related to the many aspects of the new law. The United States is the only advanced country in the world that has not initiated singlepayer, government-funded health care. Overall, U.S. health care costs, however defined, have for more than a decade been estimated to be roughly twice the health care costs in other developed countries. More than 65% of the U.S. population under age 65 has been enrolled in independent private insurance companies that are only minimally regulated. The levels of health coverage and annual premiums have varied over time according to state insurance plans. Beyond those with private health insurance, millions of Americans have been covered by the local or federal government. These include the active military, veterans, civilian government employees, Medicaid recipients, and the elderly. The quality and extent of coverage, as well the costs, vary widely by region and can only be crudely estimated from available information. *Address for correspondence: Hershel Jick, Boston Collaborative Drug Surveillance Program and Boston University School of Medicine, 11 Muzzey Street, Lexington, MA 02421; e-mail: [email protected]. Ó 2014 Pharmacotherapy Publications, Inc.

More than 20 million Americans have had no private health insurance and obtain medical care, when needed, through hospital emergency rooms. In the absence of universal standardized medical record systems, the combined costs and health consequences are uncertain. The ultimate effect of the ACA on the frequency and cost of emergency department visits is yet to enfold. In the past, the necessary, detailed, reliable quantitative information required to guide public policy has been lacking and hidden in a seemingly impenetrable black box. The consequence (as in the fields of education, economics, etc.) is a seemingly endless contentious and heated debate on health care that goes back as far as the 1930s. In the absence of national systems that adequately record and quantify the wide range of issues related to health care, the public debate has been based primarily on undocumented opinion. In the climate of the ACA debate, the number of isolated anecdotal reports related to health issues has increased dramatically. Since such reports are most often at best unreliable and at worst misleading, this only adds to the combative unproductive nature of the public debate. As a result, academic economist estimates of the future costs under the ACA have varied from large increases to considerable reductions. Recent events are striking examples of the consequences of failure to clearly define and scientifically document complex issues at the core of health care. The devastating early problems related to the initial ACA enrollment Web site is one such example. A second example is the uproar related to the dysfunctional health care enrollment process for veterans together with

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alleged falsification of patient records related to their outpatient visits. Although many factors, most notably the increased number of young veterans injured in recent wars, contribute to such long-standing problems, at the core is the inability to design and construct comprehensive universal electronic medical record systems, an issue given a high priority in the 2008 presidential campaign. In 1966, the National Institutes of Health funded the first of four comprehensive anonymized electronic medical databases. The first was successfully designed and thoroughly tested by our original research group, which included Russell Miller, the founding editor of Pharmacotherapy.1 It was subsequently named the Boston Collaborative Drug Surveillance Program (BCDSP) and was implemented in seven countries. In 1978, the research group constructed a second comprehensive medical database derived from existing standardized electronic clinical data systems recorded by a health maintenance organization in Seattle. Together, the two databases were the source of more than 200 original research publications.2–4 In 1985, a new private United Kingdom company called Vamp Health was started. Their objective was to construct and sell office computers to general practitioners (GPs), which were designed to replace the prior extensive paper medical record. One of the founders was a GP who had been working for years to construct the necessary software to create a unique realtime comprehensive universal office medical record. In 1987, the company began selling the computers to more than 300 general practices representative of the U.K. population with some 1000 GPs, ranging from Belfast in the northeast to Southampton in the southwest, caring for more than 3 million patients. The BCDSP learned about the company in 1988 and explored this additional possible source for research. After a year of extensive testing, we concluded that the quality and consistency of the information recorded in the GP office was remarkably accurate and complete. We began to receive the anonymized raw data electronically in 1990 and created original software for a patient record and research file structure uniquely designed and organized for rapid interactive access. Annual data updates have continued seamlessly for more than 20 years. The new comprehensive electronic information fully encompasses and surpasses that in the prior paper-based medical record. It

includes demographics, dates of office visits, hospitalizations, emergency department visits, and referrals to specialists, together with diagnoses, procedures, drugs, vaccinations, and laboratory results. The software has yielded over 150 research publications that reflect the breadth and detail of the resource. The output includes a population-based, 20-year description of the incidence and prevalence of autism,5 a real-time chronologic record of the number of diagnosed cases of influenza, measles, and mumps,6 as well as a wide range of studies on the safety of drugs. The patient medical record system is universal and can be installed into any standard computer. The universal software for research studies is derived from the medical record input. A critical and unique aspect of this resource is that the vast amount of data it contains was routinely recorded in real time by a large number of pretrained GPs and is directly available for research at little additional cost. In a fourth continuous electronic database, we merged the U.K. data with a large electronic U.S. private insurance database that provides a precise cost for each prescribed drug. Based on six independent studies (2004–2010), we concluded that the cost of prescription drugs in the U.S. for those privately insured was regularly more than 3 times the cost of closely similar drugs prescribed in the U.K. covered by the government.7, 8 The future costs of drugs prescribed for the millions of patients newly enrolled in private insurance company health plans under the ACA should be documentable from existing sources and may be compared with the costs prior to 2014. Continuous comprehensive, universal, interactive electronic medical record software has been successfully constructed and employed for some 3 million people annually in the U.K. for more than two decades and, if properly applied in the U.S., would improve patient care and substantially reduce costs. Reliable transparent private insurance medical data costs are available and readily accessible in the U.S. They provide a sound basis for lifting the heavy fog of the current public policy debate and contribute to the future evolution of the ACA. References 1. Miller RR, Greenblatt DJ, eds. Drug effects in hospitalized patients: experiences of the Boston Collaborative Drug Surveillance Program. New York: John Wiley & Sons, 1976.

HEALTH DELIVERY COSTS Jick 2. Jick H. Learning how to control biases in studies to identify adverse effects of drugs: a brief personal history. J R Soc Med 2009;102:160–4. 3. Boston Collaborative Drug Surveillance Program. Regular aspirin intake and acute myocardial infarction. Br Med J 1974;1:440–3. 4. Jick H, Watkins RN, Hunter JR, et al. Replacement estrogens and endometrial cancer. N Engl J Med 1979;300:218–22. 5. Taylor B, Jick H, MacLaughlin D. Prevalence and incidence rates of autism in the UK: time trend from 2004-2010 in children aged 8 years. BMJ Open 2013;3:e003219.

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6. Jick H, Chamberlin DP, Hagberg KW. The origin and spread of a mumps epidemic – United Kingdom, 2003–2006. Epidemiology 2009;20:656–61. 7. Jick H, Wilson A. The cost of prescription drugs: a comparison of two countries (editorial). Pharmacotherapy 2012;32:967–9. 8. Jick H, Wilson A, Chamberlin D. Comparison of prescription drug costs in the United States and the United Kingdom, Part 4: antibiotics in young children. Pharmacotherapy 2014;34:324–9.

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