Electronic Health Records and Prospective Health Care

Last week Don Berwick announced his resignation as Administrator of CMS. In his parting speech, Dr. Berwick listed his top 5 reasons as to why there is so much waste in the US health care system.

These five reasons were as follows:
1. The over treatment of patients
2. The failure to coordinate care
3. The administrative complexity of the health care system
4. Burdensome rules
5. Fraud

In a post on this week’s Health Care Blog, Dr. John Halamka argues that a common solution which would at least in part address each of these issues is the electronic health record. I think the point he is making is on the right path but that it would be better served taking it one step further: an electronic health record in the context of Prospective Health Care. Prospective Health Care is a coordinated approach to health care and wellness which involves personalized health risk assessment and the development of a personalized health care plan to ensure maximum patient involvement and engagement in their care. IN this model, the personalized health plan is coordinated between the patient, a health coach when appropriate, and the provider system.

By focusing on an electronic health record itself, we risk missing its necessary precursor – a strategic approach which addresses the needs of each patient by tailoring their health care plan to meet their individual needs. An electronic health record is a tool which would help implement and optimize this type of approach, but would be insufficient on its own.

In the context of each of Dr. Berwick’s five reasons for waste, Dr. Halamka suggests that electronic health records would mitigate each of these factors.

To address over treatment of patients, Dr. Halamka suggests that EHRs could automate alerts and reminders as to what his patients need. If such alerts and reminders are not tailored to the specific health and wellness needs of individual patients in the context of their personal health plan, one could see how these types of systematic alerts and reminders could potentially exacerbate over treatment rather than curb it.

In terms of coordinated care, EHRs will certainly allow multiple providers greater ease of access to a patient’s health and treatment information and provide the opportunity for improved communication between different providers working with the same patient but unless the patient in question has a personal health plan in place to drive the strategic approach to their individual care, there can be no guarantee that these different providers are working with the patient towards a common goal. If providers are not working in tandem the opportunity to reduce waste is missed.

Dr. Halamka also gives examples as to how the next three contributors to waste, complexity, rules, and fraud, could be mitigated by EHRs as well – mainly by streamlining some of the administrative complexities of the health care system by having EHRs that automate care plans, provide feedback at the point of care, and process payments based on measured outcomes. He also suggests that the data generated by ERHs would allow analysts to look for patterns of care that are outliers and thus potential indicators of fraud. For each of these instances it would still be important for EHRs to be utilized in the context of personalized health planning to ensure that patients are receiving and providers are being reimbursed for providing patients optimal care for their individual health and wellness goals.

While EHRs are an important tool to help drive appropriate treatment of patients, coordination of care, and reductions in administrative burdens and the potential for fraud to help eliminate waste, they can only do so optimally in the context of prospective health care.

Hats Off to Sanjay Gupta – A Strong Voice for Personalized Health Care

I have spent almost 40 years as an academic physician involved in research, teaching, practice, and administration. During this past decade, I have become increasingly convinced of the need to change health care from its current disease event-oriented approach to one that is personalized, predictive, preventative, and focused on personalized health planning with an engaged, empowered individual at the center of their care.

I have written, spoken, organized symposiums, and created model delivery programs. Yet, my overall impact on fostering change, if any, dwarfs in comparison to the power of the mass media to gain the public’s attention. Dr. Gupta’s August 28, 2011 show on CNN entitled, “The Last Heart Attack”, while presenting some controversial views, clearly portrayed a powerful message to a vast audience. The number one killer of adults in our country is largely preventable. To do this requires personalized planning and intense engagement on the part of the individual (patient), hopefully in collaboration with an enlightened care delivery system. This is what personalized health care is all about.

True health care reform requires far more than what can ever be legislated. It requires a change in how one values health and, therefore, acts accordingly. Health is amongst our most important resources. It can be managed and enhanced but to do this most effectively, care should be personalized, planned and supported by coordinating clinical infrastructures.

When directed by enlightened individuals such as Dr. Gupta, the media can play a major role in leading health care reform by gaining the public’s understanding and support. While politicians are embroiled in issues such as health insurance and mandates, true reform requires a change in the delivery model itself. To do this appropriately, the public needs to understand the stakes and become involved.

Hats off to Sanjay Gupta and others for bringing this story to the public. As for this academic physician’s attempt, you may want to read my piece from the Huffington Post.

Personalized Health Care Drives Progress in Cancer

The American Society of Clinical Oncology is the leading professional organization committed to conquering cancer through research, education, prevention, and delivery of high quality patient care. Its Annual Meeting provides a forum where major advances in cancer are presented to its members consisting of over 30,000 physicians involved in all aspects of oncology. The meeting is also well attended by the press as well as members of the pharmaceutical, biotechnology, diagnostic, and investment communities as it provides a rich source of information about progress in cancer.

This year’s ASCO meeting, which is still in progress, has already demonstrated that personalized medicine is impacting virtually all aspects of cancer care and that its benefits are just beginning. In his presidential address, Dr. George W. Sledge, Jr., considers genomic advances will rapidly “change our understanding of cancer biology; it will identify new targets and previously hard to treat diseases, and will explain the causes of drug resistance.” In other presentations, tremendous progress in the treatment of metastatic melanoma, lung cancer, prostate cancer, sarcomas, breast cancer and others gives hope that improvement in cancer survival and remission rates will be occurring rapidly due to the application of personalized medicine to this group of dreaded diseases. A major basis of optimism in the war against cancer relates to the development of personalized approaches such as targeted therapies directed toward the specific abnormality responsible for the patient’s cancer, the use of companion diagnostics to identify the specific abnormalities, the ability to test tumors for their chemosensitivity in vitro prior to using a therapy, the availability of predictors of potential adverse outcomes of treatment, and the identification of surrogate end point biomarkers to determine whether therapy is working. These are all applications of personalized medicine tools to the treatment of patients with cancer.

Personalized health care is built on the development of a personalized health plan which identifies an individual’s specific health care needs based on a multiplicity of factors including their inherited genome as well as the impact of a lifetime of environmental factors leading to their current health status and care needs. The approaches of personalized health care work well to enhance health and well-being, to support primary care, and to personalize the treatment of chronic disease. It is in the field of cancer, however, where the importance of personalization is not only obvious, it has already contributed greatly to the quality of care and has received tremendous interest from multiple constituencies.

This year’s ASCO Annual Meeting in Chicago once again indicates that personalized approaches to care are not only the wave of the future in rationalizing and improving care, they are already being applied successfully to amongst the most dread diseases experienced by humans.

On-the-job health care clinics – the near future of Prospective Health Care?

A recent story in the Washing Post reported that an increasing number of employers are starting to implement on-the-job primary care clinics for their employees. These clinics typically offer free or inexpensive primary care onsite for employees during work hours, in addition to usual health care benefits. The goal of the large employers offering these clinics is to save money by reducing lost wages and health care costs by providing improved and convenient evidence-based preventative primary care. The article gave several interesting anecdotes about how these clinics affect the lives of employees, including one employee who was discovered to be having a heart attack that would have otherwise gone undiagnosed.

The article highlights an import ongoing trend – as we become more concerned about rising health care costs and health care concerns, the best answer isn’t to restrict services. In fact, these companies offer these clinics on top of their existing health care benefits. This evolving arrangement highlights the potential benefit of rational care over rationing care. I believe that this trend will only grow stronger with time. Businesses are starting to realize that they can improve the health of their employees, reduce lost wages, and reduce health care bills – all through being proactive and providing more health care, not less. Perhaps the most exciting consequence of these at-work clinics will be that they provide the environment in which prospective health care can both provide value and be improved upon. Employer-based clinics offers a system where both the patients and payers are on the same side, which provides a stark contrast from the fee-based incentives that currently encourage procedures over prevention and stifle rational delivery of health care. It seems like there could be a real opportunity here for academic and non-profit institutions interested in promoting prospective health to partner with industries implementing this on-the-job model to learn how we can best implement the most effective and efficient models of prospective health care.

False competition: an obstacle for prospective healthcare

By Sanjay Kishore

This past week I traveled to DC with 10 other undergrads passionate about health policy. During my visit I had the intriguing experience of visiting Housing Works, a prominent homelessness and HIV/AIDS advocacy organization famous for its history of activism, social justice, and civil disobedience. While we thought we were going on a simple tour, I soon realized that I would walk away with much more perspective on the state of health policy than when I entered.

As it turns out, the Washington Post had published an article the previous night quoting a local councilwoman who said she was considering reallocating HIV/AIDS funding to other obesity-related medical conditions affecting her district – none other than primarily diabetes, heart disease, and hypertension. Since she was the swing vote for passage of the budget, it was likely her demands would be included in the final bill. As I stood in the office of Housing Works, I saw the HIV/AIDS lobby begin to mobilize. Conference calls were made, frustrations exchanged, talking points drafted, and responses strategized. As student aides for the day, we too played a part. Our role? Drafting a letter to the councilwoman forcefully explaining that HIV/AIDS funding could not be cut by a single penny. And write we did, composing a message to be used as a call to action that would surely fill the legislator’s inbox.

To Housing Work’s credit, their rationale was this: instead of distributing money to different diseases (take from HIV, give to diabetes, etc.), why not create a better health system that addresses all of these health problems holistically? This seems completely rational - yet, there was a caveat. To accomplish health system strengthening, they wanted more overall funds devoted to health without reallocating money away from HIV/AIDS.

This example speaks to the challenges prospective health care faces as it encourages policymakers to combat chronic disease. Perhaps these funds would have helped eliminate “food deserts,” improve access to community exercise facilities, and allow free physicals in disadvantaged neighborhoods. But it would have been at the expense of helping individuals with other health needs. The reality is clear: in the midst of a $3 trillion deficit, governmental resources for health are limited. And paying more for one disease (in this case obesity) means paying less attention to another (HIV/AIDS)

Is this a false competition? Perhaps. Though we all stand for health as a human right, over-specialization may be hindering our collective progress. Can students play a role in facilitating collaboration and uniting narrow interest groups? You bet. Creating a stronger health system is not just a talking point – it’s a solution that will require compromise and force us to seek common ground. One thing is clear: it’s going to be a lot harder to de-politicize a movement to alleviate chronic disease than perhaps anyone of us youth ever thought.

Paul Krugman Gets It Wrong: The Consumer Should be the Boss in Health Care

In a New York Times editorial of April 21, 2011, Paul Krugman writes, "Patients are Not Consumers" then derides proposals to voucher Medicare as he feels this would turn patients into consumers. While not addressing the wisdom of vouchers for medicine, I strongly object to his contention that considering patients as consumers demeans patients and is a bad thing for health care. The opposite is true! The patient is the consumer of care, and the lack of attention to this fact on the part of the patient, the physician, and the delivery system is a major reason why health care in this Country is so dysfunctional.

By any definition, patients are consumers of health care services, and they should and do have choices and rights. They should demand the best of care and service from their provider. They have the right to be informed and empowered to make reasoned choices and to participate in their care. The fact that many patients don't get sufficiently involved in their care and blindly relegate decisions to their providers works to their disadvantage and diminishes the value of health care. In virtually all medical decisions, there are choices, and it is outrageous to think that the patient as the ultimate consumer of the therapy would not be entitled and expected to learn about and weigh in on those decisions. Moreover, for all but the most emergency-type care, the patient's active participation is essential for maximum therapeutic success.

The failure of providers and delivery systems to recognize and respect the patient as a valued consumer is amongst the greatest flaws in the system. In my professional career, in addition to having led a major academic health system, I sat on the Board of one of the world's most successful consumer-product companies. The motto of the Company is, "The consumer is boss." This isn't an empty slogan. It is at the very heart of the way the company does business. The company’s success depends on understanding and meeting the needs of the consumer. Only in health care, perhaps followed by the airline industry, do we find such an egregious neglect of the rights of the consumer.

I have often pondered why in health care does the patient (e.g. consumer) not play a far more dominant role in demanding the best in care, cost, and service? The usual explanations are that the patient rarely pays the bill directly and that issues related to health care are too complicated for the lay person to understand. While both explanations are plausible, they are increasingly less valid. Health care costs are a financial burden to all either directly or indirectly and charges are increasingly being directly borne by the patient. This trend will continue. Health care is complicated, but not incomprehensible and more and more resources are being provided to patients to allow them to weigh in on clinical decisions. Importantly, it should be incumbent on providers to provide more comprehensive patient information on their clinical options and costs of various decisions.

The health care industry must recognize that the patient is a consumer with rights and free choice. As patients become more involved in their own care decisions, they participate more in doing the things they need to do to lead to better therapeutic outcomes, greater patient satisfaction, and likely lower costs. Only recently has the medical profession begun to recognize the centrality of the patient in good clinical care. "Patient-centered care" is a new mantra and long over-due. Personalized health planning focused on prevention and active patient engagement is a great hope for meaningful health care improvement. Understanding the value and necessity of the patient as a valued partner in their own care is becoming basic to medical education and enlightened medical practice. The reason for this goes beyond the rights of the patient -- it creates better outcomes.

Thus, in medicine as in business, it is critical to understand that the patient is the consumer, the consumer is boss, and fostering this will be a good thing for health care.

The Future of Health Care Intelligence and Personalized Healthcare

Last Wednesday, Duke’s Fuqua School of Business and the Duke Center for Health Informatics hosted the second annual informatics conference on “Business Intelligence in the Health Care Age.” The conference hosted a number of high profile members of academia and industry who discussed several topics regarding the ongoing transformation of how we use and protect our health care data. Talks and panel discussions described past, ongoing, and future attempts to obtain meaningful value from patient health care data.

The conference provided a snapshot of our current ability to standardize patient data to allow for useful, automated analysis to inform health care recommendations. A common theme that emerged was that many innovation efforts are being initially driven by mandates in the HITECH act, which extends personal health information disclosure requirements to electronic health care records. Although compliance with these new standards bear the relatively low-hanging fruit of improved health care information technology, additional efforts to provide an interactive, learning health care system would provide a real value in the future. In terms of what to expect in the near future, both Asif Ahmad and Jeff Ferranti suggested that accomplishments in improved health information technology which have up until now focused mostly on compliance, are now starting to address quality improvement, and will in the future be able to perform risk prediction and help provide personalized medicine.

Perhaps one of the biggest challenges towards the automated personalization of medicine is that dictated or free-text information currently composes about 80% of the medical record. At present, few efforts have been made to address how such information, which is highly variable between specialties and from physician to physician can be usefully incorporated into the electronic health record. How to standardize and automate the crux of what makes a medical record personalized will be an ongoing challenge in how we merge the benefits of health informatics, personalized medicine, and prospective health care in the future.

Personalized Health Care: Science Provides Solutions

My interest in personalized health care began approximately a dozen years ago when as Chancellor for Health Affairs at Duke University, I realized that emerging sciences and technologies were creating medical capabilities never before known. Through the power of genomics, proteomics, metabolomics, systems biology, and bioinformatics, one could begin to predict an individual’s risk for diseases, define the exact mechanism of the disease and develop targeted therapies specifically for the patient. I was enamored with the power of science to provide better solutions than the current reactive approach of treating disease events long after chronic disease has begun. As I thought more about personalized health care, however, it became obvious that while solutions from research were important, they were not sufficient for the prevention and treatment of complex diseases which require addressing personal and societal issues as well. Moreover, scientific advances might be decades off, and we could use currently available tools now until better ones become available.

This past weekend I had a striking reminder of how powerful biomedical research can be in eliminating dreaded human diseases. I attended the Annual Joint Meeting of the American Society for Clinical Investigation (ASCI) and Association of American Physicians (AAP) in Chicago to present the Kober Medal to my close friend, Dr. Robert J. Lefkowitz, a giant in biomedical research who has contributed much to our current knowledge of how receptors work. Immediately following the presentation of his medal was the delivery of talks by Drs. Brian Drucker and Charles Sawyers, this year’s recipients of the Stanley J. Korsmeyer Award. Drs. Drucker and Sawyers received this award for their groundbreaking work in developing targeted therapies for the treatment of Chronic Myelogenous Leukemia (CML), a previous fatal disease that now has a 90% cure rate. Their work is but one example of the power of basic biological research leading to applications that entirely change the face of a disease and provides a prime example of its value in fostering the personalization of care.

CML had been a uniformly fatal disease with peak instances in people in their 40s. Research going back to 1960 identified a characteristic morphologic abnormality in the white blood cells of affected patients. This abnormality was shown to be due to the translocation of parts of two chromosomes resulting in a “Philadelphia chromosome” named as such because the discoverers were at the University of Pennsylvania in Philadelphia. Subsequent research identified the specific abnormality of this translocation as being the increased expression of a protein termed BCR-ABL, a tyrosine kinase involved in the development and progression of CML. The line of research identifying BCR-ABL as the cause of CML actually began in the earlier part of the 20th Century through the discovery that certain leukemias in mice were caused by viruses and one was associated with the over expression of BCR-ABL. This research accelerated rapidly in the last ten years to lead to a miraculous therapeutic triumph. Drs. Drucker and Sawyers became aware of a drug termed Imatinib (Gleevac) that specifically inhibited the BCR-ABL tyrosine kinase. In collaboration with scientists at Novartis, Drucker and Sawyers demonstrated the ability of Imatinib to inhibit the BCR-ABL enzyme in animals as well as in the cells of individuals with CML. In a subsequent series of brilliant experiments and clinical trials, Imatinib was shown to induce remission in patients with CML. Importantly, in the small percentage of individuals that relapsed after Imatinib treatment, they showed that the cause was a mutation in the BCR-ABL protein that rendered the drug unable to block its activity. Through the development of additional inhibitors of this tyrosine kinase, even more effective therapies were developed. Importantly, the field of cancer therapy is being revolutionized by research leading to the identification of the enzymes that are associated with the growth of different cancers. Treatment is already being targeted to each individual’s needs by using drugs specifically directed at their abnormality. I can think of no better example of personalized medicine as it relates to finding the right drug for the right individual.

The Korsmeyer Award and the purpose of the ASCI/AAP are to foster physician-led biomedical research and such research plays a fundamental role in the evolution of personalized health care. I think of advances in personalized health care as having a pull and a push. The pull comes from the needs of the individual to improve their health, minimize preventable diseases, and specifically target what they need to attain the best state of health. A push comes from the capabilities made available by science and biomedical research discoveries that provide tools to meet the needs of the individual. Biomedical research provides a more precise understanding of the molecular basis of diseases and the creation of targeted therapies. It is important that we understand this bi-directional dynamic of the pull and push. The needs of the individuals provide the market for the best capabilities to address them -- a pull. Science and technology provides specific capabilities to address them -- a push. In complex chronic diseases, solutions provided by science and technology cannot alone solve all the problems patients face, but they can play a vital part in the solution.

As we envision the development of better models of personalizing health care, we must never forget the vital role played by biomedical research in providing critical tools to address an individual’s specific health needs.

Health care reform and the deficit - it's about more than dollars and cents

As Congress hashes out the details of the budget deal made late last Friday night, my husband and I are hashing out some of our own financials from my son’s hospitalization six weeks ago. It’s quite timely, considering select lawmakers’ futile attempts to defund the Accountable Care Act during the appropriations process. I’m sure no one is surprised to read that five inpatient days at Duke Children’s are costly. To the tune of $17,255. Thankfully we have good insurance through my husband’s employer, because of that $17,000+, Blue Cross/Blue Shield “allowed” $3,265.  How’s that for collective buying power? An 81% discount!

Which brings me back to this whole federal budget/deficit turned health care debate. Again.

From the White House to members of Congress, most of the players are in agreement that, as Jay Carney said yesterday, “health care spending is a major driver of our deficit and debt problem.” And still, I have yet to hear a single member of Congress or the President talk about why costs are what they are and what they want to do about it. Lately politicians seem more concerned about making a statement for the 2012 elections – who funded Planned Parenthood, who wouldn't defund the ACA – than they are about making policy that addresses the issue of how much high quality health care really costs and what high quality care actually looks like. 

Case in point: Does a 5-day pediatric inpatient stay at one of the premier academic medical institutions in the country cost $17K or $3K? And if Duke University Health System can provide said care for $3K to some, then why don’t they charge everyone $3K? I’m fairly certain health systems like Duke's aren’t actually earning profits from the patients who cannot afford health insurance, let alone a $17K bill.  In fact, I’m sure they’re actually losing more money than the “cost” of the services they provided by the time they hire creditors and bug these folks until they declare bankruptcy and not pay their bills anyway.

And I haven’t even begun to talk about what quality health care is or the idea that, if we invested in systems and technologies that support personalized prevention, we might actually make real headway in reducing how much we as individuals  – and we as taxpayers via federal health insurance programs like Medicare, Medicaid, and SCHIP – pay for health care. This will become even more of a reality as our nation becomes unhealthier and rates of obesity and associated diseases rise in children and young adults. If folks are worried how Medicare is going to handle the Baby Boomers, they haven't seen anything yet. Wait until today's youth turn 65.

I’m all for getting the deficit under control. But when it comes to health care, we can’t continue to piecemeal solutions together without addressing the larger systemic issues: personalized chronic disease prediction and prevention beginning in childhood, coordinated care across time and providers, cost containment through quality initiatives, and of course, overhaul and transparency of pricing structures. When members of Congress stay late into Friday evening to debate and negotiate these issues, then we’ll know they’re onto something worth fighting over.

In Physicians we Trust

An article on a new physician trust measure in the recent issue of Annals of Family Medicine sparked some interesting commentary from Jessie Gruman. She challenged the idea of whether this was a measure of physician “trust” or good old-fashioned doctor-say patient-do. Using her personal experience with cancer, she explains her concerns about the article’s criteria being used to evaluate her doctor’s level of trust in her.

This is an interesting example of semantics, which is something we’ve been discussing here at the Center. Just as we ask the question, “How are we defining personalized medicine?” The same question applies here. “How are we defining physician trust?” Taken out of context, the Thom et al. Physician “Trust” measure sounds exactly as Jessie Gruman describes it – at best a paternalistic, non-participatory approach. But it’s important to remember the context in which the measure was used – HIV-positive patients on opiods for chronic, non-cancer related pain. Not cancer patients. These are two very dissimilar patient populations with significant differences in the social and cultural factors influencing their health behaviors and decisions. A scale designed for HIV-positive patients with chronic pain doesn’t make sense in an oncology setting and was never proposed by the authors.

That being said, I understand Gruman's gut reaction. The title of the Thom et al. article is misleading. Instead of “Physician Trust in the Patient,” the article title could have been: “Physician Trust in the HIV-positive Chronic Pain Patient” or “Physician Assessment of Abuse Potential in Chronic Pain of HIV-positive Patients.” And the issue of patient engagement remains. Despite the challenges these providers and patients are facing – namely, risk for drug abuse and addiction – these patients still need health care where they are involved in the process. Then a question like “How confident are you that the patient will follow the treatment plan you recommend?” might read something like: “How confident are you that you and your patient can develop a treatment plan together that the patient will follow?” It’s a subtle shift, but it brings the patient into the process of his/her care. It also attends to some of Gruman’s concerns. If nothing else, this is a perfect example where being clear in our terminology makes all the difference in how we interpret, understand, and utilize scientific information. We’ve still got a ways to go.

P4 Medicine – How do we get from current practice to future progress?

In the current issue of Nature Reviews in Clinical Oncology, Stephen Friend and Leroy Hood – the man who first described predictive, personalized, preventive, and participatory medicine as “P4 medicine” emphasize that clinical trials of the future will need to be designed so they fully capitalize on P4 medicine. Specifically with the advent of high-throughput genomic medicine, Friend and Hood note that science is experiencing a paradigm shift: what we once thought were single diseases, are in reality multiple distinct molecularly defined disease states. The natural extension is that trials previously needing 10,000 patients to show a benefit will now need tens of thousands of patients to have adequate statistical power to detect the same level of benefit. Even in large academic medical centers, the authors note, it will be difficult or even impossible to rapidly accrue proportionally small patient subsets in which personalized interventions can be feasibly explored and tested. The authors suggest the use of patient driven networks to obtain the patient numbers needed for these trials.

We at the center typically think about patient-physician interaction and patient empowerment, activation, or participation when we talk about the “participatory” P of P4 medicine. Friend and Hood extend the definition of participatory to include efforts by patients to enroll themselves in networks whose goal it is to provide access to clinical trials that would otherwise be beyond the reach of single, brick and mortar institutions. Given the authors’ backgrounds, they are understandably preoccupied with the genetics and molecular aspects of such trials, but their concept still applies to models of personalized medicine that may not involve molecular data.

Even for purely non-genomic based disease models, we are beginning to appreciate the importance of individual variation in response to therapy. We already have the tools to perform personalized, risk-based prevention and treatment for many disease states using family history, biochemical markers, and patient preference. For prospective health care to reach its maximum potential in the future, we will need to develop new models that allow iterative improvements in personalization and intervention outside of current models of clinical trials. Much in the way that the physiology-based practice of medicine of the 21st century came to embrace evidence based medicine (EBM), personalized medicine will likely require some analogous, personalized equivalent to maximize its full potential . One possibility is patient driven networks as proposed by Friend and Hood. Another is novel statistical modeling that would allow us to personalize interpretation of conventional clinical trials.

If States Opt-Out of the ACA, Will They Opt-In to Creating Better Models of Care?

Earlier this week, President Obama indicated his support for legislation that would let States opt-out of the Accountable Care Act in 2014 rather than in 2017. The President stipulated that States would be free to provide their own approaches for health care delivery as long as they cover as many people as the Accountable Care Act and not increase the federal budget. Whether this proposal will foster a compromise between Democrats and Republicans is highly doubtful, but the proposal raises an important question. Where will innovation come from to allow health care coverage for tens of millions of more Americans while not increasing the already unsustainable national burden of health care expenditures? I am pleased with the flexibility the President is showing in allowing States, rather than the Federal Government alone, to innovate in developing new models for health care delivery. States may be much better prepared to understand the needs of their constituencies than the Federal Government and may have greater flexibility to innovate.

Stimulating innovation in health care delivery and removing barriers to such innovations are critical to solving our dilemma of increasing health care costs. Expending roughly 17% of our gross national product on health care would not be a terrible thing if our country was getting its money worth. Clearly, this isn’t the case by any objective standard as the health of the American public is below that of many western countries despite our spending far more for care than any other country. The problem, of course, is that our current system is uncoordinated, reactive, and focused on intervention for episodes of late-stage, preventable, chronic diseases. The reimbursement system rewards such interventions, particularly if they involve complex procedures. Conversely, the reimbursement system punishes innovation in strategic, coordinated approaches to disease prevention and minimization. It is becoming increasingly recognized that when individuals are engaged in their care, that when delivery is coordinated and care is proactive, outcomes are improved. This leads me to point out an opportunity that States will have, if indeed, an early opt-out from the Accountable Care Act is permitted.

State budgets are greatly overburdened and their mounting deficits are the subject of national news on a daily basis. State expenditures for Medicaid and CHIP programs ($123.2 billion in 2009) are amongst the greatest financial burdens that they have and the Accountable Care Act increases this burden. Herein lies a great opportunity and need for their innovation. As an example, Community Health Centers funded by the Health Resources and Services Administration (HRSA) provide an important component of delivery systems for the indigent and for many Medicaid recipients. Currently, Community Health Centers are often the last bastions of health care for those with Medicaid or the uninsured because there is nowhere else to go. These centers are generally underfunded, overcrowded, understaffed, and often have great difficulty in meeting anything other than the individual’s most urgent needs. I encourage HRSA to allow States to work with their Community Health Centers to facilitate their transformation from over-crowded clinics to models of innovative approaches to coordinated care using personalized health planning. The National Association of Community Health Centers has already indicated a desire to lead in a primary care solution. I suggest that States begin working with their Community Health Centers to develop better approaches by applying what we know works: proactive, coordinated care with patients engaged in their own health plans. We have been strong proponents of personalized health planning as an operational means to provide patient-centered care in a coordinated, strategic fashion. To this point, the Duke University Health System found that it was less expensive and more humane to provide such programs, free of charge, for the indigent in Durham County with certain chronic diseases, thereby avoiding the cost of non-reimbursed services in its emergency rooms. The underlying principles were personalization of care, patient engagement, and mentoring. Solving the dilemma of health care reform will require better approaches to how care is delivered. Our 50 States and more than 1250 Community Health Centers can serve as innovators of such change.

Your cancer treatment decisions aren't about you - but they should be

By Michaela Dinan and Leigh Ann Simmons

There's been a lot of discussion about the role of the patient in health care decision-making. Yesterday, results from a study of Medicare patients showed where you live and which doctor you see influences whether you receive elective surgery.  For example, if you have early stage breast cancer and live in Victoria, Texas, it’s very likely that you’ll have a mastectomy. If you live in Muncie, Indiana, not so much.

In a similar vein, Jessie Gruman analyzed her cancer treatment experience to discuss how health care decisions get made.  By all accounts, Gruman is what we’d call a “highly activated” patient. She’s engaged in her care because this is what she does for a living. She’s motivated by her diagnosis. And yet still, upon reflection of her experience Gruman identified moments where her physical state was so poor that she was unable to fully participate. In fact, she has almost no recollection of a doctor visit where they decided to stop her chemotherapy treatment.

So what's going on?

Shannon Brownlee, the lead author of the Medicare study said their findings demonstrate the physician-centric nature of the U.S. healthcare system. She noted that, "....patient preferences are not always taken into account when medical decisions are made." Who, us? We care about our patients. That’s why we keep telling them to eat right, exercise regularly, reduce stress, take their medication, and [fill in doctor’s orders here].

And therein lays the rub. We’re telling them. But what are they telling us?

Unfortunately, not much right now. But they could be telling us so much more. In fact, the Brownlee et al. Medicare study is a perfect example, because the Accountable Care Act provides for an element of personalized medicine that we believe is critical – a personalized health plan. The mere act of developing a personalized health plan with patients addresses several barriers we’re experiencing to good health in this country – understanding obstacles to adhering to prescribed treatment, identifying goals that are important to the patient to support strong engagement over time and so the physician has a frame of reference when making treatment recommendations, and  involving the patient in the process of care so they become invested not only in their health, but also in the partnership with their provider (hear, hear Dr. Zeiger).  Because let’s face it. It’s human nature for many of us to take action on something if we’re involved in the decision-making rather than if someone simply tells us we “have to” or “should” do it. Furthermore, in cases like Gerson’s, if the provider has a document that includes data on the patient’s preferences, goals, and challenges, making the decision to, say, stop chemotherapy when a patient is too ill to be fully engaged becomes more about the patient than it might otherwise.

So let’s start making it about the patient. Bring them into the fold. Recognize they are experts on themselves. Involve them in the decisions about their care. And then we’ve truly entered the realm of personalized medicine.

Why Matthew Herper has it wrong

In his column today, Matthew Herper brings up an important issue in personalized medicine. Namely, pharmaceutical companies need to proceed with caution as they pursue research, development, and sales of drugs tailored to "niche populations," or those for whom the drug will work only if they have the unique genetic variation of the disease being treated. Certainly, as we develop drugs in an era where we know more about how people will respond based on their genetic make-up, we will have to simultaneously create new research and financial paradigms that can sustain this important and necessary work.

However, that's not the end - or even the beginning - of the story.

Where Herper loses me is his narrow definition of personalized medicine.  What he's talking about in this piece is pharmacogenetics (or pharmacogenomics) , which is one facet of personalized medicine. But personalized medicine is a much broader field of health care. In fact, given the relatively few targeted therapies that have actually made it to market, I would argue that pharmacogenetics is really a small piece of the personalized medicine pie.

We and others have defined personalized medicine as a predictive, preventive, participatory, and prospective approach to care that is individualized to patients based not only on their unique molecular information, but also on their unique clinical, social, behavioral, and environmental data. Planning for health is a critical component of personalized care. While many patients may have similar goals - continued health and wellness, weight loss, reduced blood pressure, improved insulin sensitivity - how they reach those goals is customized based on their unique profile identified through a comprehensive health risk assessment. Furthermore, a key component to the success of personalized medicine is engaging patients in the process - whether that means getting them on board with taking that tailored prescription medication, or getting in the recommended 2.5 hours of physical activity a week. Thus, tracking markers of health and disease, as well as compliance with recommended therapies over time, helps to keep both patient and provider mutually informed about how a patient is doing - and whether preventive action might be necessary to avert an event. Finally, when we get to the point in personalized medicine where we're using tailored pharmaceuticals, the patient likely has already developed disease - at least as far as where pharmacogenetics currently stands. Personalized medicine, if practiced as we're describing, is aimed first at preventing disease, and then mitigating the negative consequences of disease after it has developed. This is the true promise of personalized medicine - disease prevention that will reduce the skyrocketing rates of chronic diseases that cost the U.S. $2 trillion annually.

I agree with Herper - something "big and dangerous" did happen in personalized medicine today: An exciting drug discovery prompted debate over the promise of personalized medicine without considering personalized care beyond pharmacogenetics. By equating the two, we undermine the true possibilities of a personalized approach to care that goes well beyond what drugs to prescribe. And if we don't start implementing the features of personalized medicine that are readily accessible to us today at relatively minimal cost, then that truly will be a giant mess.

A Cancer Patient’s Plea for Personalized Medicine

A compelling piece was published in Forbes Magazine recently. Adriana Jenkins, who passed away this month, writes from the perspective of a dying cancer patient to advocate for the passing of a law to encourage drug makers to developed Personalized Medicine drugs for cancer and other deadly diseases. Her perspective, as both a patient and an individual who worked in biotech for 15 years, is both unique and moving.

Personalized health records promote horizontal integration within ACOs

ACOs, or Accountable Care Organizations, continue to be a hot discussion topic in health care reform. In the current issue of JAMA, Duke’s own Barak Richman and Kevin Schulman provide a unique business perspective on the implementation of ACOs. One of the issues they raise is the potential for the establishment of ACOs to result in health care system monopolies. They warn that health care systems might align under the promise of market dominance and not necessarily with the intention of improving health care quality or efficiency. In order to prevent a misaligning of goals, they urge that evaluation of ACOs should maintain focus on health care quality and efficiency.

Another recommendation they suggest is for health care systems to align under a horizontal vs. vertical or “bricks and mortar” approach. Whereas vertical networks focus on established hospitals and other infrastructure, horizontal networks would connect more fluid, geographically diverse care specialists. To me it seems like this idea mirrors themes in social and professional networking. Horizontal networks may take less time, investment, and have the potential to spread much more quickly than conventional geographically constrained networks. However, in my opinion a key challenge to the horizontal vs. vertical approach is how seemingly unconnected groups will be able to share information and provide coordinated care. I think that a potential solution would be the establishment of personalized health care records. Electronic personalized health care records would follow the patients, contain all their health care information, including their personalized health plan, and provide a virtual medical home that could provide a universal medium for exchanging health care information among horizontally connected providers. Without a universal medium to maintain coordination of care and ensure that information is efficiency conveyed, it may be difficult to envision how horizontal networks could provide cohesive care. In an ongoing era of rapid technology development, a personalized health care record would provide a potential means of increased portability and exploration of new options for new health care delivery models.

Controversy over reform – what’s the deal?

By Sanjay Kishore:

While healthcare has already become a firestorm of controversy for the Obama Administration, the President’s recent reform bill received another blow this past week – once again, from the courts. As reported by the New York Times on January 31st, a federal judge in Florida followed the precedent set by a Virginia court and struck down the constitutionality of the March 2010 Patient Protection and Affordable Care Act (PPACA).

In both court decisions, the issue in contention was the law’s inclusion of an “individual mandate” – a provision that requires all Americans to obtain health insurance or otherwise face a monetary penalty. Essentially, these two justices believe the federal government has overstepped its bounds by pressuring people into purchasing insurance – a sentiment recently echoed by Republican legislators as they passed a symbolic vote to repeal PPACA in the House of Representatives earlier this month.

Obviously, momentum for healthcare reform has shifted in the past year. But, what does all this controversy actually mean – especially in the context of prospective health?

Many advocates of PHC – including students like myself – realize the first step to increasing prediction and prevention in our healthcare system isn’t developing new technologies or utilizing fancy screenings: it’s extending access to what we already have. Before 2010, uninsured Americans had no financial incentive to seek preventive medical treatment – after all, if you’re an individual living on a tight-income, why visit a doctor when you’re healthy? As a result, almost 45 million Americans faced an economic pressure to delay seeking medical assistance until a traumatic incident – say, a heart attack – became too severe to bear.

Though PPACA’s expansion of insurance to 32 million Americans didn’t solve the problem, it was a solid start. If we are serious about halting the spread of chronic disease and promoting wellness in the US, we must extend access to health insurance.

As students interested in preventive healthcare, it’s in our best interests to keep our ears tuned – and our voices loud – for the next few years could be telling for the future of American healthcare!

Health Affairs Special Issue on ACOs

This month’s issue of the health care journal Health Affairs was a special issue dedicated to the discussion of Accountable Care Organizations, also known as ACOs. The issue describes a number of exciting changes in approaches to health care being explored using ACOs. ACOs are organizations that provide care for a defined population. Under the new health care legislation pilot ACOs must provide universal care for a population of no less than 5,000 Medicare beneficiaries. The idea is akin to a large scale version of capitation. Instead of getting paid a set rate per patient, an organization gets paid for performing capitated care in bulk, providing all the health care needs for an entire community. The benefit of such a structure is that it creates the potential for novel, community-based interventions to save costs.
ACOs provide an exciting, rational reimbursement structure that would provide powerful incentives for decreasing costs through better care. If all patients within an ACO had electronic, perspective health care medical records, the community could potentially track not only health care needs of individuals, but could also identify health care needs of an entire community. For examples if a large number of patients were finding it difficult to find the time to exercise at work or were decreasing in cognitive decline due to a lack of social interaction, the ACO could use this information to intelligently guide community innovation that would benefit individuals on a large scale and result in further cost savings, improved health, and perhaps even quality of how the elderly live their lives.

State of the Union: Health care debate continues

Despite reassurances from the President in Tuesday’s State of the Union Address that the Affordable Care Act will slow rising health care costs, debate on the health care law didn’t skip a beat come Wednesday morning on Capitol Hill. The House Budget Committee is holding hearings this week to evaluate the economic impact of health care reform. On Wednesday the testimony of the CMS Actuary garnered quite a bit of attention when he expressed his doubt that the law will be able to bring down unsustainable health care costs. The White House was quick to respond with a post by Stephanie Cutter pointing out key elements of the law which independent experts have argued will result in cost savings. Notably, Cutter highlights both payment reform and the creation of Accountable Care Organizations to coordinate care as a means to improve health care quality and efficiency. These same sentiments are echoed in a letter released on Wednesday which was signed by over 200 health care leaders stating that the Affordable Care Act contains almost every cost-containment provision that is considered effective at reducing health care costs. The letter counts increased emphasis on wellness and prevention as one of the effective cost containment measures in addition to models of coordinated care and rational reimbursement.
We at the Center believe that providing smarter health care can both improve quality and decrease costs. Although there are a staggering number of variations on the theme of coordinated care, pilot projects in patient populations have shown considerable cost savings in a number of such projects. This is particularly true in populations with heavy burdens of chronic disease, whose inherently high disease costs provide an equally high potential to save costs over conventional approaches to care. My colleagues and I published a piece in Academic Medicine back in November discussing how personalized medicine provides a standardized approach to overcome impediments to both coordination of care and rational reimbursement. As a model of health care which is equally effective at disease prevention and treatment, prospective health care provides an approach on which to base many of these cost containment measures.

Medicare Jumpstarts Wellness and Prevention Efforts

As of January 1st of this year, Medicare must now provide free annual wellness visits and personalized prevention plans to their beneficiaries as stipulated by PPACA. An article by Francine Russo in this month’s Time Magazine discusses what these wellness visits and personalized prevention plans might look like in practice and some of the barriers providers might face in implementing these new measures. The wellness visits and prevention plans described in the article focus exclusively on lifestyle interventions aimed at improving diet, increasing exercise and limiting smoking – a far cry from utilizing an array of risk predictions tools to quantify all of a patient’s individual health and disease risks over time – but an important and critical movement in the right direction. The article points out the difficulty physicians might have in finding the time to fit a comprehensive personalized prevention plan that is thorough enough to be effective, yet compact enough to squeeze into their already packed visits with patients. These types of behavioral modifications are notoriously difficult to initiate and maintain over time. With this new tenet of health care reform going into effect, physicians will now be reimbursed by Medicare for taking the time to work with patients to try and address these lifestyle issues. Such a large undertaking will require the coordination of care between physicians, patients, and nutritionists, lifestyle coaches, etc. in order to be effective. These changes in reimbursement may be just what was needed to kick-start the wellness and prevention movement.

The ghost of past, present, and future health care – cost.

On Christmas Eve, Uwe Reinhardt posted a piece which raised a familiar ghost of healthcare past, present, and future: cost. The post reminds us that between 2000 and 2009, Medicare spending on physician services per beneficiary rose a whopping 61 percent, even though physician fee rates only increased by 7 percent. Reinhardt argues that he culprit behind this pattern of cost increases is increased utilization, with the fastest growing sectors of health care utilization (imaging and diagnostic testing) increasing by 80% between 2000 and 2009. Increased use of health care resources is not necessarily a sign of bad healthcare, but it is a sign of expensive healthcare. If we knew what was driving increasing utilization and how to control it, we would be able to largely rein in skyrocketing health care costs. Although a portion of these increases may reflect new, valuable health care technology and improvements, a larger portion likely just reflects more health care. The underlying etiology of this latter type of health care spending includes self-referral, a misaligned fee for service reimbursement model, and patient demand. A prospective model of health care would address all of these issues by coordinating patient care and removing duplication of diagnostic testing, providing rational reimbursement to discourage unneeded and self-referral driven testing, and engaging the patient in the decision making process so that they might be less likely to demand costly services that often lead to little, no, or potentially negative health benefit.