A True Tipping Point?

From the signing of healthcare reform legislation to the release of final rules for “meaningful use,” events in 2010 are driving toward a true transformation in the delivery of healthcare in the United States. Optimism is high that we will finally see tangible benefits from healthcare information technology as measured by enhanced quality, improved access, and lower costs. I recently reviewed some testimony given to a subcommittee of the U.S. Senate Finance Committee that highlighted the role of healthcare information technology in transforming healthcare delivery.

Here are excerpts from that testimony.

“It is with great anticipation I approach this committee today to give testimony on health care issues and the effect new information technologies will have on the delivery of care. Clearly the swirling debate on how to restructure our health care system has raised the awareness of all Americans to this important issue. It is through the management of information, in particular its dissemination, that we can address some of our health care challenges. We need to use new information technologies to provide physicians, patients, providers and payors with the appropriate, relevant information to produce good, acceptable outcomes from appropriate cost-effective care.

“The information technology revolution is changing the way medical care is delivered. These new tools provide physicians with the opportunity to access relevant clinical information on a real time basis to most likely impact on their patient care. Using standards, guidelines, protocols, and information available from profiling using normative data bases, physicians can obtain useful information on their patterns of care. Patients can obtain understandable information on their disease process, thereby becoming an informed consumer of health care. Organizations exist to educate physicians and other health care professionals in the use of these systems. For-profit firms are developing the tools and making the investment needed to convert data into information.

“My final advice to this committee is hold on tight, the medical information superhighway has no speed limit.”

Excerpts from: A True Tipping Point? PSQH, September/October, 2010.

Photo Courtesy of  Don Guerwitz Photography – A Farmhouse, Central Turkey

Is “Meaningful Use” Meaningful?

Now that the “meaningful use” rule has been finalized by the Office of the National Coordinator (ONC), many organizations turn their focus to a rapid deployment of electronic medical record (EMR) systems in an effort to achieve transformation of the United States healthcare system. Unfortunately, EMR adoption is just one tool used to transform health care, and not the single transformative activity so many believe it to be. Transformation of healthcare encompasses enhancing quality of care, improving patient safety, expanding access to care, and reducing the cost of care. EMRs deployed to satisfy the criteria for “meaningful use” can impact these factors, but only within a comprehensive framework that recognizes the role of incentives, clinical decision support, and healthcare information technology (HIT) in facilitating transformation.

Introduction of new technology often distracts us from our primary task. Our fascination with the technology leads us to focus on what the technology can do, rather than what we need the technology to do. This misguided use of technology also occurs when it is used for healthcare delivery. Many EMR implementations focused on the impressive features of the EMR software rather than the workflow requirements of the clinician users.

Healthcare transformation requires a comprehensive vision of care delivery that recognizes the interrelationships of the many stakeholders. Technology by itself only helps improve those interrelationships, while the underlying structure that the interrelationships are built on remains.

Therefore, the “meaningful use” criteria are meaningful in that they help ensure the use of EMRs in ways that can enhance healthcare delivery, they do not transform healthcare. The recently passed Patient Protection and Healthcare Reform Act (2010) does much to move us toward a better healthcare system, but it too does not transform healthcare. Transformation requires many factors working together in an iterative process to deliver the expected results. Some of those factors are outlined below.

Until economic incentives of all the stakeholders align, care delivery will remain inefficient and suboptimal in quality and safety. Providers are incented to provide more care, payors are incented to withhold care, and patients, detached from the direct costs of care, have been molded to always expect care. The culture of healthcare in America is based on the false belief that more care is better care.

Transformation of healthcare requires a complete disruption of our current system of healthcare delivery. Clinical roles require redefining. Workflows will change to meet the needs of these new clinical roles, allowing the HIT tools, such as EMRs, to be leveraged to improve care. “Meaningful use” criteria is a nice first step to help ensure the effective deployment of HIT tools such as EMRs. Nevertheless, it is just a very small step towards truly transforming healthcare.

Excerpts from: Is “Meaningful Use” Meaningful? PSQH, July/August, 2010

Photo Courtesy of  Don Guerwitz Photography – First Light. Bhaktapur, Nepal

Regulate HIT Tools as Medical Devices? Yes and No

The Food and Drug Administration recently announced it is reconsidering its previous decision to exclude health information technology (HIT) tools from regulation as medical devices. When last evaluated in the late 1990s, this decision made common sense. At that time HIT consisted of rudimentary clinical documentation systems, electronic reference materials, and administrative applications. As even these tools were not well integrated with each other and into clinical workflow, they represented more of a digitization of paper-based activities rather than something truly transformational.

Today, HIT functionality far outstrips what was even dreamed about 10+ years ago. In addition, applications function in an integrated manner truly providing the clinician with a clinical experience much different than that offered using paper-based clinical documentation or simple clinical decision support tools.

The role of physicians, nurses, and other healthcare professionals is changing. These providers are becoming more dependent upon the clinical content within the HIT tools, often deferring to “decisions” made by these tools. Such examples include differential diagnosis, prescribed diagnostic and therapeutic treatments, choice of drug, and drug dose calculations. Although the previous rationale for not considering such HIT tools medical devices was based upon the intermediation of the provider between the recommended clinical activity and actual actions taken on behalf of the patient, the strong reliance on these very sophisticated HIT tools today puts this premise into question.

The FDA must study in detail the quality and safety issues inherent in integrated HIT applications before rushing to regulate HIT tools as medical devices. An uninformed effort to regulate HIT tools as medical devices may cause more harm than good. Applying the same standards used for medical devices to HIT tools makes little sense as HIT is neither a standalone application nor strictly a medical device. They are integrated applications that can impact quality and safety in ways far dissimilar to standard medical devices.

Regulation of HIT tools as medical devices is currently premature. Although HIT tools do directly impact patient care and therefore surely require some level of regulation, such regulation cannot be done without the requisite understanding of how HIT works within clinical workflow. The regulations must be constructed to advance HIT use while simultaneously protecting patients.

Excerpts from: Regulate HIT Tools as Medical Devices? Yes and No. PSQH, May/June, 2010

Photo Courtesy of  Don Guerwitz Photography – Running the Rapids, Mae Hong Son, Thailand

Health IT’s Glue

In my last column “Raison d’Être” I wrote about the importance of staying focused on making healthcare IT work to achieve the four important goals noted above: patient safety, quality care, access to care, and cost savings. In March, I addressed the HIMSS membership with these words:

Healthcare information technology is the instrument that will transform healthcare, and it is we—the informaticists, clinicians, management engineers, senior IT executives, IT specialists, and the diverse talents of so many others—who will create the applications, processes and workflows that will improve quality, safety, access and cost-efficiency.

In addition to our effort to transform care delivery through deployment of innovative software, revised processes, and creative workflows, niche applications are becoming available that allow the varied health IT tools to be sewn together to allow us to effectively tap into their potential. Without these applications we could not achieve the necessary integration of systems that permits the construction of meaningful, efficient workflows. Such workflows allow clinicians to deliver quality care safely and efficiently while satisfying the work requirements of caregivers.

The future of health IT over the next five years is in the development of these “glue” applications that allow the seamless linking of large, robust system, such as EMRs or laboratory applications, so that end users can utilize these tools in a coherent, patient-centric manner.

Excerpts from: Health IT’s Glue. PSQH, March/April, 2010

Photo Courtesy of  Don Guerwitz Photography – Angkor Watt. Siem Riep, Cambodia

Raison d’Être

What is the purpose of health information technology? Why are we spending all these billions of dollars on this “thing” we struggle to understand, implement, and use? Is it achieving the goals of its purpose?

The French elaborated on the concept of “raison d’être,” suggesting that once the reason an object exists is defined, criteria to measure the object’s value can be developed and applied. Now that the Office of the National Coordinator for Health IT has finally released the definitions of “meaningful use,” it is worthwhile to step back and reexamine the reason health IT exists.

The raison d’être of health IT includes four key items: 1) enhance patient safety, 2) improve quality of care, 3) foster greater accessibility, and 4) facilitate a reduction in medical costs. In addition, all of these items must occur simultaneously and in cooperation with each other. There is no zero sum game in achieving these goals, as failure to advance one brings failure to all.

Considering the current state of healthcare delivery in the United States, the four aspects of raison d’être for health IT, as defined above, seem appropriate and timely. While our healthcare costs per capita are the highest in the world, we endure worse outcomes, poor accessibility to care, high rates of uninsured and under insured, and unacceptable levels of medical errors. Few can deny the poor value we obtain from the resources expended on care.

So how and when do reap these rewards of health IT? Those that embrace flexibility, creativity, and tenacity will be most successful.

Flexibility. Health IT is nothing more than a tool. It is how the person that wields that tool acts that delivers real value. We are at the stage where our understanding of the health IT tool is just beginning. Therefore, we must be flexible in how we use that tool, wielding it in different ways to discover how to achieve greater and greater value.

Creativity. It is not enough just to be flexible. Flexibility has value only when it is utilized by creativity, the development of new and innovative approaches to problems. Creativity is needed in the design of processes and workflows that utilize health IT tools in a flexible manner, allowing these new approaches to be tried, reworked, and reapplied. It allows for the evolution of the use of health IT.

Tenacity. Clinical care is complicated and uniquely personal. This latter characteristic separates the use of IT in the healthcare industry from its use in other markets. This personal, and therefore human, factor makes what is very complex even more so. The complexity requires a level of tenacity, “stick-to-it-iveness,” that can carry us through challenges, problems, and failures until we are able to get the technology, processes, and workflows blended synergistically together, delivering our expected benefits.

As we consider all that has occurred in the past year, including the raucous effort to reform healthcare, the $19+ billion earmarked for health IT, and the debate on meaningful use, we must remember our need to be flexible, creative, and tenacious. No single effort or event can make health IT valuable. Only through our dedicated work, application of our professionalism, and our keeping focused on the raison d’être can we achieve the benefits we seek from health IT.

Excerpts from: Raison d’Être. PSQH, January/February, 2010

Photo Courtesy of  Don Guerwitz Photography – Bathed in Light, Strasbourg, France.

Making Meaningful Use Meaningful

A short three years ago, the Office of the National Coordinator for Health Information Technology (ONC) was funded at a level of less than $150 million. Today, thanks to the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH)—part of the American Recovery and Reinvestment Act (ARRA)—the ONC received a budget of over $2 billion. In addition, no less than an additional $19 billion is set aside to facilitate the adoption of electronic medical records over the next decade.

For both industry and government, budgets provide a more reliable picture of strategy than do policy statements. Therefore, there is little doubt that the current administration expects health information technology to play an important role in reducing healthcare costs while improving quality, safety, and access, a high priority of the president.

To accomplish this goal, adoption of technology is not enough. These new tools must be utilized effectively to achieve desirable and measureable results. Therefore, almost all of the incentive funding available to providers for the adoption of health information technology is tied to the “meaningful use” of that technology.

So what is “meaningful use?” Perhaps former Supreme Court Justice Potter Stewart provides some guidance. In a 1964 opinion on an obscenity case (Jacobellis v. Ohio) the late Justice Stewart described hard-core pornography as follows:

“It is hard to define, but I know it when I see it”

In spite of the work performed by many ONC committees to date, many working in healthcare believe the ONC is taking the same approach to defining “meaningful use.”

To its credit, the ONC is working to offer providers a hard and fast definition of meaningful use backed up by exactly defined, collectable measures. By statute, the secretary of health and human services has until December 31, 2009, to issue an interim rule on meaningful use. As the rule must go out for comment for a minimum period of time, a final rule is not expected until late Q1, 2010.

Excerpt From: Making Meaningful Use “Meaningful” – PSQH, November/December, 2009

Photo Courtesy of Don Guerwitz Photography – Young Pioneers, Havana, Cuba.

Is There Any Doubt It’s Broken?

What have we learned from the Massachusetts healthcare reform effort? Although costs to the state are running higher than anticipated - a problem in a recession – about 97% of MA residents enjoy some type of healthcare insurance. Considering the national rate is about 81%, this is a monumental achievement.

As for our lessons learned, the individual mandate is necessary to achieve universal coverage and the employer mandate helps get you there.

Additionally, a competitor to the insurers must be established, whether a public option or a non-profit regional option, to incent the insurers to better manage costs.  Currently, these options do not exist in Massachusetts. The state now subsidizes healthcare insurance for those who cannot afford it by paying private insurers to cover these individuals.

Realistically, the Massachusetts reform plan is just a partial framework for what is needed nationally, not the entire plan. Any federal effort must be more broadly based and far reaching, something states, due to existing rules on trade, Medicare, and Medicaid, cannot achieve on their own.

Success requires all stakeholders to sacrifice a bit of their pie or fiefdom. Right now that is not happening fast enough or in significant areas to deliver meaningful reform. For example, there is a good argument presented by physicians for tort reform, but there is little talk about linked changes in licensing that can help identify and retrain poor physicians.

The goal needs to be universal coverage. Actually, we have that already. Unfortunately, it is very inefficient and possibly the dumbest deployment of universal coverage possible. (See – Marking 33 Years of Universal Health Coverage) Although the uninsured eventually get care now, it is the rest of us through our insurance and taxes who pay for it indirectly. And for those unfortunate enough to get seriously ill, they often lose their homes and life savings. About 50% of all bankruptcies in the U.S. are related to medical bills.

How we get to universal coverage is through a holistic approach that addresses access, quality, and cost. Considering the number of powerful stakeholders – physicians, insurance companies, pharmaceutical companies, hospitals, and consumer groups - passing any meaningful legislation would be an amazing accomplishment.

Paying $7,300 per capita per year for healthcare is way too much considering the poor outcomes we get from spending all that money. Other countries pay less and receive more value. And if you want to make the argument that the U.S. healthcare system is better at this procedure or that treatment, considering we are spending at least 40% more than the other countries, we should be trouncing those other countries on all measures of quality, safety, and clinical outcomes. Sadly, we are not.

If George Steinbrenner expects the Yankees to win the World Series every year considering he spends 40% more than any other team on payroll, is it wrong for us to expect the same from our spending on healthcare? Should we not receive the best care in the world?

Anyone who thinks healthcare is not broken is not paying attention to the facts. How it gets fixed, is debatable. Whether it is broken, is not.

Photo Courtesy of Don Guerwitz Photography – Daycare Center, Havana, Cuba.

We Need Privacy Now

Does the Fourth Amendment apply to our medical data?

The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no warrants shall issue, but upon probable cause, supported by oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized.

According to a report by Milt Freudenheim in the New York Times (And you thought a Prescription Was Private, August 9, 2009), it sure doesn’t look like it.

More than two years ago (Patient Information: Who’s Your Daddy) I warned that for-profit entities might use private patient data to market products to consumers.

Patient data may be used to target relevant product ads to individuals based upon the data contained in the medical record.

Today, patient information is actively being used to target market products and services to patients. Large pharmacy chains such as CVS Caremark and Walgreens regularly utilize pharmacy information to identify patients to whom they send out email messages, coupons, and flyers. Although the data they utilize is de-identified, they employ reverse lookup utilities to reconstruct the information with patient identifiers.

At a meeting with several health information technology leaders at the HIMSS 2008 Annual Conference, Google’s CEO, Eric Schmidt, was cautioned about the use of patient data contained within Google Health. Although WebMD and Microsoft currently acknowledge the privacy rules outlined in ARRA apply to them, Google disagrees. Freudenheim quoted in his article a representative of Google who said:

Google is bound by the privacy policy that people agree to when they sign up.

WOW. To this day I still have not met anyone who reads those legal notices we all are asked to accept before using software or accessing certain websites. To rely on the acceptance of the privacy policy upon sign up as a defense for using patient information in any commercial way deemed appropriate seems weak and suggests exploitation.

Excerpts from: – We Need Privacy Now – PSQH, September/Ocotober, 2009

Photo Courtesy of  Don Guerwitz Photography – Surprised! Stonetown, Zanzibar, Tanzania.

Following Lance’s Lead – No Cheating

Post Update: Here is the latest article in the NY Times describing Senator Grassley’s effort to address this issue. Senator Moves to Block Medical Ghostwriting

Haven’t we had enough of cheating? According to the NYTimes (Medical Papers by Ghostwriters Pushed Therapy, 8/5/09), medical journals published articles written by ghostwriters paid for by Wyeth, the pharmaceutical company, to promote the use of Wyeth’s hormone replacement therapy for women. Further independent studies showed that the therapy promoted by these biased ghostwriters was harmful to menopausal women increasing their risk of heart disease, cancer, and dementia. Perhaps industry influence on medical literature is much more widesperead than previously known.

The cycling world has been rocked with numerous scandals where cheating seemed more the norm than the exception. This year’s Tour de France ended clean, with Lance Armstrong leading the way with frequent but negative doping tests. Isn’t it about time we figure out how to stop the cheating in medical literature? Cheating in sports is , well, just cheating in sports. No lives are lost. Cheating in the medical literature harms people. There is no place for it in science and especially in medicine. So, let’s figure out how to put a stop to it.

The use of comparative effectiveness research to identify those procedures and treatments that produce the best outcomes depends upon honest, unbiased scientific study. The effective use of clinical information tehcnology, in turn, depends on the application of trusted clinical knoweldge. So, if we expect to transform healthcare to make it safer, higher quality, and more efficient, we better be sure that the science we apply is as close to the truth as we can make it.

About two years ago I wrote an article about cheating in the medical literature. It seems that nothing has changed in the intervening time.  Here is the link to Anti-doping of Clincial IT and below are excerpts from my article that appeared in the November/December 2006 issue of Patient Safety and Quality Healthcare.

“As doping is fundamentally contrary to the spirit of sport, dishonesty in research is contrary to the spirit of medical research. An “anti-doping” policy modeled loosely upon that created for sport by the World Anti-Doping Agency must be developed for clinical research published in peer review journals. Of course, clinical research and IT issues are far removed from the factors that impact sports, but the key tenets are the same: ethics, excellence, and fairness.

“The decade-long drop in crime in the United States, according to law enforcement officials, is due mostly to deterring crime rather than catching more criminals. To reduce the prevalence of cheating in research, journals require a powerful deterrence factor that motivates authors to police themselves. To be effective, this deterrence factor requires cooperation from the research institutions, as employers and supporters of these investigators. Any anti-doping research policy must allow researchers to maintain relationships with various funding sources and influential partners. At the same time, the policy must strongly motivate the researchers to accurately and fully disclose all conflicts of interest to journal editors, peer reviewers, and readers.”

Source: Anti-doping of Clinical IT – PSQH, November/December, 2006.

HIT Alone Not the Solution

In 1980 a Stanford University School of Business professor Alain Enthoven authored a book titled Health Plan: The Only Practical Solution to the Soaring Cost of Medical Care. Dr. Enthoven provided the theoretical underpinnings of managed competition, an approach to reducing healthcare costs embraced by the Clinton administration’s Task Force on National Health Care Reform. Chaired by the then first lady Hillary Rodham Clinton, the task force failed to convince Congress to pass comprehensive healthcare reform legislation. This unsuccessful “breakthrough solution” was just one of many proposed over the last 30 years to save our healthcare system from collapse.

On the first page of Enthoven’s book he wrote about the strain healthcare costs were putting on federal, state and local governments. He then addressed the private sector, particularly the automobile industry, where soaring health insurance costs were a difficult burden on employers. According to Enthoven, healthcare costs made up 6.2% of GDP in 1965 and ballooned to 9.1% in 1978. (1) Today, healthcare costs eat up over 16% of GDP. In the 27 years since Enthoven published his book the United States has seen little progress in controlling healthcare expenditures.

Although our healthcare system struggles with access, covering the uninsured, and medical errors, generally Americans receive pretty good healthcare, especially when their illness is not routine. Unfortunately, the resources currently required to provide that level of care are beginning to impact our standard of living and competitiveness in the world.

Unequivocally, healthcare information technology alone cannot solve the problems our nation faces in delivering high quality, affordable healthcare to all Americans.

A comprehensive approach to healthcare reform is necessary. Everyone, including physicians, nurses, patients, administrators, and insurers must work together to form the solution. Continuing to approach illness and deliver care the same way we have been doing for decades is sure folly.

Physicians and nurses must begin to see their responsibilities in a different light and begin to do their tasks differently. Administrators and insurers must assist and incent them. Patients must take responsibility for their care and work to prevent illness rather than wait passively for resource intense medical miracles to fix them.

Therapies need to be driven by science and rational thinking rather than habit and personal preference.

Healthcare information technology can provide some critical tools to achieve this necessary change, but those working within the healthcare system must employ these tools in different workflows and processes. Utilizing the tools to “automate” existing processes only works to continue delivering unacceptable outcomes.

If we want to truly address our problem of spiraling healthcare costs, it is time to get to work fostering the change management necessary to reform our healthcare system for the better. Otherwise, we will read Enthoven’s book a decade hence and realize nothing has changed except for the slogan.

Source: Healthcare IT: Slogan or Solution? – PSQH, January/February, 2008