If repealing Obamacare is off the table, can we turn attention to improving it through cost-effective clinical protocols?

Paul Krugman recently wrote an article in the New York Times posing the question: if repealing Obamacare is off the table (for now), should people on the “progressive” end of the political spectrum push for a single-payer “Medicare for all” system or just advocate for incremental improvements to the privatized Obamacare model?  He says if we were starting with a blank slate, he would favor the single payer model.  But, he argues, the politics of moving to single payer are too difficult, and the evidence from other countries suggests that a privatized model can achieve comparable outcomes.  Therefore, he argues that progressive politicians should turn their attention to other social policy priorities like subsidized child care and pre-kindergarten education.

I generally agree with Krugman’s proposal to focus on incremental improvements to Obamacare, particularly if the objective is just to maintain and improve access to health insurance.  But that’s not our only objective.  We should also care about the quality and cost of health care.

I’ve long felt that policy to increase access to care should be linked to policy to assure the cost-effectiveness and value of care. Insurance is, by its nature, a collective, cooperative thing. In the long run, the people who are covered under the same insurance risk pool are sharing a finite resource. If they understood that, they would rationally desire for there to be protections against the pooled resource being squandered by other people for low value purposes. In health insurance, such protections primarily take the form of benefit policies. Benefit policies may define which services are not covered because they are considered experimental or cosmetic. They may define limitations based on age, gender, or medical history. They may also set quantity limits on coverage, such as defining the number of physical therapy visits or inpatient psychiatric hospital days covered. They may set lifetime maximum dollar amounts. But, such insurance benefit policies are very blunt instruments.  Insurance companies also protect against low-value uses of health care services using “utilization management” programs, including requiring pre-authorization processes, where doctors are required to submit justifications for proposed services and insurance company employees judge whether the proposed services meet “appropriateness” criteria.  Such utilization management programs create conflict, and insurance companies generally establish criteria that are very loose to minimize the conflict.  As a result, such programs are also very blunt instruments.

Clinical protocols, in contrast, can be more precise instruments, taking into consideration the details of a patient’s clinical situation. Clinical protocols are typically developed by physicians, and are ideally supported by evidence from clinical research studies.  Clinical protocols can take many different forms, and go by different names including “guidelines,” “algorithms,” “care maps,” and “standards of care.”  Whenever we have tried to design clinical protocols, especially for complex and costly care processes such as for low back pain, congestive heart failure, cancer or the care of frail elderly patients, we discovered that different protocols can have very different costs and outcomes.  Thoughtful design, rigorous implementation and continual evaluation and improvement of clinical protocols can lead to large improvements of outcomes and large reductions in cost. But, cost effective protocols do deny some people some treatments that would have helped them a little (just not enough to be “worth” the cost). The whole premise of designing cost-effective protocols depends on the recognition and acceptance of the collective nature of insurance and the finite nature of the resources being shared. Furthermore, it is essential that the people for whom such protocols are applied trust the people and the process of creating and implementing the protocols. In for-profit, commercial insurance companies, there is a fundamental conflict of interest if the owners of the insurance company get to control the design and implementation of the protocols and if they get to keep the money saved from denying services that could have helped people — even a little.

In a single payer system, the entire country (or each state) is treated as a risk pool, and the government plays the role of protocol developer. Some people are OK with that, while others are loathe to assign such authority to governments.  If  we continue to have private insurance companies or accountable care organizations bearing the risk for populations of patients (as in the current Obamacare system), then such organizations can make decisions about clinical protocols.  In either case, we absolutely need to create structures and mechanisms to ensure that the people receiving the care trust the people and process used to create and implement cost-effective protocols.  Some private organizations, such as Group Health Cooperative of Puget Sound (now part of Kaiser Permanente), created some structures and processes designed to build this trust back in the 1990s.

Although most other advanced countries already accept cost-effectiveness and pursue the development and implementation of cost-effective protocols, and although there would be a huge opportunity to reduce cost and improve outcomes by doing so in the U.S., making this policy shift in the U.S. will be very difficult. The U.S. population has been taught to be wary of “rationing” and “death panels” and U.S. doctors have been taught to reject “cookbook medicine.” Nevertheless, moving the health policy discussion in that direction may, in the long term, do some good.   Politicians asking “what’s next” after the apparent end of the quest to repeal Obamacare should consider turning attention to bringing cost-effectiveness to health care through clinical protocols.

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Hospital Value-based Purchasing program 1% incentive is like homeopathic medicine — too diluted to actually work

In the June 15, 2017 issue of the New England Journal of Medicine, Andrew Ryan and colleagues from the University of Michigan published an evaluation of the Medicare Hospital Value-Based Purchasing Program (HVBP).

To summarize, if you offer a 1% incentive, and then dilute it by offering it only for the 40% of hospital patients covered by Medicare, and then dilute it further by spreading it across three domains (clinical process quality, patient experience and mortality), and then dilute each of these by basing them on multiple component metrics, and then dilute it more by choosing metrics that have already been reported for a number of years (and therefore the “low hanging fruit” improvement opportunities may already have been picked), and then further dilute it by offering the incentive mixed in with many other incentives for such things as meaningful use of EMRs…..

Wait for it….
You don’t see impact, even after 4 years.
The thinking behind HVBP is like homeopathy, where the practitioners assert that the more they dilute the homeopathic remedy ingredient, the more powerful the remedy becomes.
Imagine if a company hired a CEO and wanted to incentivize her to achieve growth and profitability. Would they consider a 1% incentive to be meaningful (even without further dilution).  No, the board would choose a number 50 to 75 times higher.
How about an equipment manufacturer choosing an incentive percentage for its sales team?  One percent sound like enough?
I’ve been exasperated for years that our value-based reimbursement designs – for both government and commercial payers – include an incentive that is far too small to motivate the types of changes they are intended to cause.  I fear we are just setting ourselves up for eventually someone saying “well, we tried incentives, and they don’t work.”
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Three ways to keep it simple — one of which is bad

“Keep it simple, stupid.”   The “K.I.S.S.” principle.  Generally a good idea, but not always.

Types of Simplification

Consider three types of simplification:

  1. Leaning.  This is about getting rid of waste. When simplifying a design, leaning involves getting rid of unnecessary features.  When simplifying communications, leaning involves getting rid of information that is duplicative, unimportant or just decorative.  Edward Tufte, one of my heroes, is a statistician, artist and graphical designer and zen master of simplicity. He famously rails against “chart junk” and advocates for maximizing the “data – ink ratio.”
  2. Summarizing.  This is about dropping one or more layers of detail.  It is accomplished by grouping smaller details into categories or themes and dropping the details from the communication.  Summarization makes the information “blurry” but still tells the truth.  Summarization satisfies some readers.  To others, it serves as an introduction and and invitation to dive deeper.
  3. Glossing.  This requires making the information conform to a desired level of simplicity, even if it means fibbing. For example, a system may have three components that interact with one another.  Describing the interactions may be tedious to explain.  The interactions may require additional arrows on a diagram.  Glossing it involves escaping this annoying complexity by denying it.   Many companies create diagrams describing the components that make up their product or solution.  As described in Ian Gorton’s book on software architecture, such marketing diagrams are colloquially called “marketecture” diagrams.  Designers of such diagrams often take great liberties with their depiction of the solution, portraying it as being made up of components that conveniently correspond to the sources of value to the prospective customer, even when the actual technology components are organized in an entirely different way.  Glossing it can sometimes be helpful to communicate some deeper truth, almost like a metaphor or parable.  But, often times, glossing involves intentionally obfuscating the truth, making the solution appear to be better or simpler than it really is.

Einstein Simplification

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First take on new CMS Comprehensive Primary Care Plus model

CMS CPC IconThis morning, I read about the recently announced next generation version of the CMS Comprehensive Primary Care model, which will require multi-payer participation and will involve up to 5K practices in 20 regions.

Sounds interesting.  I need to study it in more detail.  But based on my initial assessment:
  • I agree with the idea of pursuing payment and delivery system changes on a multi-payer basis to make it more compelling to providers.
  • I also agree with the idea of prepaying some E&M and then paying reduced FFS for E&M to cover only marginal cost of E&M office visits to make providers incentive-neutral on encounter modes.
  • But I disagree with move away from shared savings and implicit abandonment of the idea of non-governmental primary care-based organized systems of care pursuing care process innovation in favor of CMS taking over responsibility for defining a nationally-standardized multi-payer “care delivery model” and injecting it into individual primary care practices using a CMS-developed  “learning system.”
  • I also disagree with the Track 2 idea of partnering with “CMS-convened” IT vendors and contractual commitment to specific IT capabilities.  That approach basically takes MU, which was a huge distraction from real improvement, to even more obnoxious levels of micro-management.
Overall, I share the Fed’s frustration with the limited impact of previous efforts to transform primary care payment and delivery models, but I think the solution should be to define incentives which are more timely, coherent and consequential, enabled by more meaningful transparency requirements, clearer care relationships and some empowerment of primary care delivery organizations to define their own referral networks.
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Looking back over the last 200 years, noticing progress to get energy to keep moving forward

I choose to be an optimist.  I can visualize a health care system that is better than the one we have. A system where we function as a coordinated team, learn from day-to-day care, enabled by analytic methods and information technology designed to make that happen. A system where we can measure improvement in patient experience and outcomes. A system that is efficient enough to make great care affordable and accessible to everyone.

But, I’ve been fighting the fight for long enough now that I can’t help but notice how little progress we’ve made. Whenever I come across work I did 20 years ago, I am struck by the fact that I could write the same thing today, and it would still be applicable. I might have to use my word processor to do a search-and-replace to update from old to new buzz words. But, we’re still struggling with basically the same barriers to real process transformation and still debating the same issues. It is valuable to face that reality, because the gap between expectation and reality is a source of “creative tension” that can be motivating. But, facing that reality can also be demoralizing if the gap looks more like a chasm that can’t be crossed.

It is in this context that I viewed an excellent 45-minute video created by the New England Journal of Medicine in celebration of the 200th birthday of the Journal in January, 2012. The video is entitled “Getting Better: 200 Years of Medicine.” I found it energizing to see how far we’ve come as a field, making a profound positive impact on human life — using the examples of surgery, chemotherapy, and AIDS treatment. It also exposes how long it took for changes to be accepted and adopted, before they eventually became standards of care. Maybe by the 250th anniversary presentation (shown on the holodeck?), the NEJM will celebrate breakthroughs in cost-effectiveness analysis, outcomes measurement, care coordination, team care planning, clinical process management, and patient-centered primary care.

http://nejm200.nejm.org/explore/medical-documentary-video/?emp=marcom&query=NEW

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Simon Sinek’s TED talk: Change minds by starting with why, not what

Improving health care requires convincing people to make changes. Changing a care process begins with changing the minds of the people involved in that process.

But, how can we change people’s minds?

I am a person who loves logic and numbers. Therefore, my tendency is to assume that the best way to convince people to make improvements to care processes is to clearly explain the logic supporting the change and to use rigorous, transparent and evidence-based quantitative projections of the outcomes that can be achieved by making the improvements.

But, experience teaches that solid logic and analysis does not always compel action. Often, it fails even to capture attention.

In the blog of Kevin Fickenscher, the incoming CEO of the American Medical Informatics Association, he included a link to an excellent TED talk by Simon Sinek, the author of the book “Start With Why.”  Sinek argues that ineffective people first explain what they are proposing, then they explain how it can be done, and finally they explain why the change should be made.  Sinek explains that effective people structure their communications in the exact opposite order.  They first explain the why — their consistent mission or objective.  Then, they explain how they carry out that mission.  Finally, they explain what is a specific example that people can select if they identify with that mission.  Sinek believes that people will decide to “buy” a particular change if they see it as a way to define themselves as someone who is part of a compelling, attractive mission.  That last point is totally consistent with my experience: if you hire people who are mission-driven and you allow them to focus their professional attention on that mission, they will be far more productive and effective.  And, they will inspire others to do the same.

Sinek is a talented lecturer, as are almost all the people invited to give TED talks.  Although he sometimes seems a bit too sure of himself for a topic as subjective as human behavior, he nevertheless provides excellent food for thought for mission-driven people involved in health care improvement.

http://www.ted.com/talks/lang/en/simon_sinek_how_great_leaders_inspire_action.html

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Time for change in education

I spend most of my time thinking about how to improve a broken health care system, and how to leverage information technology to enable improved health care processes.  But, our educational system is also broken.  And, information technology can also enable improvements in education processes.

In a New York Times op-ed this week, David Brooks describes the “tsumani” of change coming to the field of higher education, as web-based distance-learning approaches are embraced by top tier universities and threaten to disrupt the traditional campus-centric approach. Although some of the respondents defended the humanism of face-to-face education, most acknowledged the need for change, and embraced the concept of leveraging the internet to enable a more effective system. I think this trend is long overdue.

I am grateful for the education that I received from the University of Notre Dame and the University of Chicago.  As years have passed, I have come to appreciate the value of that education more, not less.  But, to be honest, there is a lot of room for improvement.  Far too much of the traditional college education process takes place in large lecture halls in which a fraction of the enrolled students attend lectures and take notes for many others who don’t find it sufficiently valuable to show up.  At the front of the lecture hall is a person who was selected and promoted for his or her ability to pump out research papers to be published in journals that often have little editorial rigor, a small actual readership and questionable impact.   Too often, the lecturer was not selected or promoted for being a talented lecturer.  And, since true talent at lecturing is rare, even good local lecturers are unlikely to be as good as the top lecturers around the world.  Because many classes are large, the tests often are quite mechanical, thereby creating a system of incentives in which the students focus on mechanical learning — regurgitating a fact base, rather than developing latent talents, honing skills and acquiring insights.  Then, students participate in labs or discussion seminars led by graduate students that were not selected for their ability to lead discussions.  Furthermore, as shown in the graph below prepared by Mark Perry,  our system of higher education has been growing more and more expensive, putting it out of reach for more people.

I don’t think the problem is with the educators.  As with doctors, educators do heroic, creative things to achieve the best outcomes they can. Rather, the problem is with the system.  As taught by one of my health care heroes, Don Berwick, “every system is designed perfectly to achieve exactly the results it gets.”

I am hopeful that web-based education will disrupt this old system, driving up effectiveness and driving cost way down, thereby increasing access.   I am encouraged by the high quality level of such resources as Khan Academy, an absolutely fantastic collection of interesting free lectures taught by amazingly talented lecturers.  Schools use these lectures to turn the classroom “upside down,” pushing the lecture portion of their teaching to homework hours, leaving the in-school time for students to work together and receive individual and small group coaching from the teachers to address any remaining confusion about the subject material and provide experiences that deepen learning.

But, I think the transformation will go beyond just shifting classes from physical to virtual classrooms.  I think it might lead to a system in which many more people get involved in teaching, mentoring, and coaching, and in which people can continue their education and development throughout their lives.  Our traditional process for higher education ends quite abruptly at graduation, with ongoing contact between educational institutions and their alumni focused more on fund-raising than continuing education.  And, our approach to human resource development in the workplace tends to go through periods of fad and famine.  The fads sometimes seem to be initiated by new leaders who want to demonstrate something about their leadership style, rather than a sincere and persistent effort to develop people over time.

But, when I was  in medical school going through a general surgery rotation, the department chair repeatedly implored his students to subscribe to a few medical journals to begin to build their own libraries and get familiar with the community of people that contribute to those journals.  He wanted us to become engaged in lifelong learning and to become members of those communities.  Of course, we looked at him like he had three heads — as if we could afford to spend hundreds of dollars on journal subscriptions and spend time reading them when we had tests to study for.  But, he was right in ways I did not appreciate for years.  In my professional life, when I have had the opportunity to mentor others, I have always found it rewarding and beneficial to my own learning.  When I have had the opportunity to be mentored and coached by others, I have always valued the experience.  And, when I have taken the time to read and write about advancing the field, I have felt a satisfying sense of belonging and camaraderie within our professional community.

I look forward to an educational system that blurs the boundaries between the campus experience, professional continuing education, human resource development and professional networking.  Imagine a pre-graduation higher education process that places far more emphasis on establishing ingrained habits for lifelong learning and creating durable learning networks that can morph over time as the learner moves through different industries and grows to higher levels of responsibility and leadership. Imagine university faculty continuing to check in on their students over many years.  Imagine social networking tools that go beyond just connecting people with similar interests to creating a vehicle for mentoring and teaching, perhaps with capabilities for testing and assessment, educational and career goal setting, and  financial or non-financial rewards for faculty.

Forward looking health care organizations are already pursuing some of these changes. For example, the Henry Ford Medical Group has established new processes and web-based tools to integrate continuing education, assessment and evaluation, credentialing, and professional networking for residents, fellows and senior staff physicians, facilitating and incentivizing lifelong learning and professional development.  These developments make me hopeful that our educational system is about to dramatically improve, and that the benefits will spill over into our health care system.

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Congressional Budget Office: Care management programs only work if care managers have face to face contact with patients and substantial interaction with physicians

This month, Lyle Nelson of the Congressional Budget Office (CBO) released a “working paper” summarizing the results of a decade of experience with 6 care management demonstration projects in the Medicare population.  These demonstrations included a total of 34 disease management or care coordination programs. Nelson briefly summarized the working paper in a recent blog post.

All of the 34 care management programs were designed to reduce Medicare costs primarily by maintaining or improving the health of the Medicare beneficiaries, and thereby reducing the need for expensive inpatient hospital stays.  As shown the graph below, different programs showed different effects on the rate of hospital admissions.  On average, the programs showed no effect.
 

Effects of 34 Disease Management and Care Coordination Programs on Hospital Admissions (Percentage Change in Hospital Admissions)

 

The CBO analyzed whether specific characteristics of programs led to better or worse results. They found that programs where the care management provider’s fees were at risk did not perform better or worse than those with fees not at risk.  However, they did find two things that worked.  They found that programs in which care managers had substantial direct interaction with physicians and those with significant in-person interaction with patients reduced hospital admissions by an average of 7%, while programs that did not have these features had no impact on hospital admissions.

But, after subtracting the cost of the programs themselves, almost none of the programs achieved net savings.

The programs with the most compelling performance included:

  • Massachusetts General Hospital and its affiliated physician group reduced hospital admissions between 19-24% among patients selected as “high risk” using a program that was far more tightly integrated with the health care delivery system.  Physicians in the group were involved in the design of the intervention, and care managers were staff members in primary care physicians’ practices.  The patients received the vast majority of their care within the integrated delivery system, so almost all of their health information was available and up-to-date in an electronic medical records system.  Care managers were notified immediately when a patient was admitted to the emergency room or hospital.  They had an opportunity for face-to-face interaction with patients in the clinic.  And, they had access to a pharmacist to address medication issues.
  • Two multi-specialty group practices in the Northwest reduced hospital admissions by 12-26% among high risk patients using a program that involved telemonitoring with the “Health Buddy” device that transmitted symptoms and physiologic measurements to a care manager
  • Mercy Medical Center in rural Iowa reduced hospital admissions by 17% among patients hospitalized or treated in the ER in the prior year for CHF, COPD, liver disease, stroke, vascular disease, and renal failure using a program that involved care managers, many of which were located in physician offices and/or accompanied patients on their physician visits.

The methods used for these evaluations were far stronger than those used by the self-evaluations typically advertised by vendors of care management services.  In the CBO reports, 30 of the 34 programs were evaluated based on a comparison to a randomly selected comparison group.  The remaining 4 programs were evaluated using a concurrent comparison group selected using the same selection criteria.  In all cases, the programs were evaluated on an “intent to treat” basis, where study subjects were included in the evaluation regardless of whether they participated in the voluntary programs, thereby removing a source of bias that causes mischief in less rigorous evaluations.

To me, the take-away message is that provider-based care management is promising, but health-plan-style telephonic care management has not been successful, even in a senior population, where finding high risk targets is far easier and even when the care management services provider is highly motivated to succeed.

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The Humunculus is a metaphor for Clinical Process Improvement Frameworks

During the last 20 years, we have experienced wave after wave of new frameworks for improving health care.  Each had its own terminology, ardently promoted and enforced by its zealous advocates.  Each had a lifecycle that began with a long incubation period, followed by a period of explosive growth in popularity and influence, rapidly leading to unrealistic expectations, followed by a period of decline during which the framework was declared to have been ineffective.  We’ve been through health maintenance, outcomes management, clinical effectiveness, managed care, disease management, chronic care, care management, practice guidelines, care maps, evidence-based medicine, quality functional deployment, continuous quality improvement, re-engineering, total quality management, and six sigma.  We’re still in the thick of lean, patient-centered care,  value-based benefits, pay-for-performance and accountable care.

Four things I’ve noticed about this lifecycle of health care improvement frameworks:

  1. They are formulated by conceptual thinkers, but then get taken-over by more tactically-oriented people.  The tactical folks often focus too much on the tools, terminology and associated rituals.  The framework always gets “simplified” to be more suitable for mass consumption.  For example, continuous quality improvement somehow morphed into being primarily about assigning a timekeeper during team meetings and communicating progress on a felt-backed “story board,” rather than finding people with systems-thinking talent and applying that talent to understand sources of variation in complex processes.
  2. During the early part of the growth phase, the advocates are always desperate for examples of success, and shower a great deal of attention on early projects that are described using the terminology of the framework and that appear to have succeeded.  The desperation usually leads advocates to lower their standards of evidence during this phase.  This leads to over-promising and unrealistic expectations.  It stimulates lots of superficial imitation by people interested in hopping on the bandwagon.  And, it plants the seeds for the eventual decline, when people determine that their inflated expectations were not met.
  3. The decline phase, when the framework is declared to be ineffective, seems to always happen before the framework was ever really implemented in the way envisioned by the original formulators during the incubation phase.
  4. All the frameworks are really just restatements of the same underlying concepts, but with different terminology and tools, and different emphasis.  In other words, they all have the same anatomy, but different parts of the anatomy are emphasized.

This last point reminds me of the “humunculus,” also called the “little man.” When I was in medical school in the late 1980s, we used heavy text books that generally did a bad job of teaching the information. One notable exception was clinical neuroanatomy. We used a small, paperback text book playfully entitled “Clinical Neuroanatomy Made Ridiculously Simple” by Stephen Goldberg, MD. It contained a collection of clever drawings designed to explain the structures and functions of the brain and spinal cord. Perhaps the most famous of the drawings was the humunculus.

Cross section of somatosensory cortex, showing mapping to sensory input sources

This drawing was adapted from earlier work by an innovative neurosurgeon named Wilder Penfield, who invented new surgical procedures for patients with epilepsy during the late 1930s.  During those procedures, he used electrodes to stimulate different points on the surface of the brain.  He drew diagrams similar to the drawing above showing that the surface of the brain contained a little man hanging upside down. The diagram shows that a disproportionate portion of the brain surface is dedicated to the sense of touch and muscle movements in certain parts of the body.  Lots of brain surface is dedicated to highly sensitive and nimble areas like the lips, tongue, hands and feet.  Very little brain surface is dedicated to the arms, legs and back.  Many anatomic illustrators have drawn the humunculus as a cartoon character showing how this disproportional emphasis on different parts of the body looks on the little man.

The Humunculus

The humunculus is a great teaching tool, making it easy to remember these aspects of clinical neuroanatomy.  But, I think the humunculus is also a useful metaphor for the distorted emphasis that various health care improvement frameworks have placed on various parts of the underlying anatomy of health care improvement.

Framework

Emphasis

Health maintenance Preventive services
Outcomes Management Measurement of function, patient experience and health status
Clinical Effectiveness Measurement of outcomes in real world settings, rather than laboratory controlled conditions
Managed Care Prospective review of appropriateness of referrals, procedures and expensive drugs, and retrospective review of cost of care
Disease Management Role of nurses in training patients to be more effective in self-management
Chronic Care Teamwork in primary care clinic and importance of organizational and community environment
Care Management Role of nurses in coordinating services delivered by different providers and in different settings
Practice Guidelines Consensus about which ambulatory services are appropriate in which situations
Care Maps Consensus about the sequence of inpatient services for different diagnoses
Evidence-based Medicine Weight of scientific evidence about efficacy of a service (without regard to cost)
Quality Functional Deployment Focus on the demands made by patients
Continuous quality improvement Small experiments to determine if incremental process changes are improvements
Re-engineering Designing new processes from scratch, rather than making incremental changes
Total Quality Management Importance of organizational culture and management processes
Six Sigma Focus on reducing frequency of defects
Lean Focus on eliminating non-value-adding process steps and reducing cycle time
Patient-centered care Focus on the needs of patients and the involvement of patients in their own care
Value-based Benefits Financial incentives to motivate patients to comply with recommended treatments that reduce overall cost
Pay-for-performance Financial incentives to motivate individual physicians to improve quality and reduce cost
Accountable care Financial incentives to motivate health care organizations to improve quality and reduce cost

Over the years, I have assimilated the concepts, terminology and tools from these various improvement frameworks into an approach that attempts to achieve balance, with each aspect of the framework shown without over-emphasis.

This framework puts the patient in the center, surrounded by the health care processes, which are surrounded by improvement processes.  It attempts to balance between focusing on care planning (the clinical decision-making regarding what services are needed) vs. focusing on care-delivery (the teamwork to execute the care plan and provide health care services to the patient).  It balances between measuring outcomes and measuring quality and cost performance.  It balances between implementing best practices through guidelines and protocols vs. improving practices through performance feedback and incentives. By avoiding a distorted over-emphasis on any one part of the anatomy, hopefully it can have greater lasting power than some of the more humunculus-like frameworks that have come and gone.   This framework is described more fully here.

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Health Care Heroes: Don Berwick, MD – Adapting industrial quality improvement principles to the improvement of health care processes

Last week, Don Berwick, MD, announced his resignation as Administrator of the Centers for Medicare and Medicaid Services (CMS).  Now is a good time to explain why Dr. Berwick is one of my all time health care heroes.

Don Berwick as one of the Notre Dame Four Horsemen on Ward's coffee mug

Apparently, I talk about Dr. Berwick a lot. A few years ago, I received one of my most treasured gifts from colleagues at Blue Cross Blue Shield of Michigan (BCBSM).  It was a coffee mug featuring the famous photograph of the Four Horsemen of Notre Dame, a reference to my undergraduate alma mater.  My colleagues replaced the faces of three of the horsemen with the faces of three of my health care heroes, Drs. Paul Ellwood (the person who coined the terms “health management organization” and “outcomes management”), David Eddy (the clearest thinker on the topics of clinical practice policies and the rational allocation of health care resources), and Don Berwick. The face of the forth horseman they replaced with my own face.  I considered it a great honor to be associated with my heroes, at least on a coffee mug.

My team at BCBSM had heard me repeatedly explain Dr. Berwick’s important contribution to adapting the quality improvement  principles that had been successfully used in manufacturing to the health care field.  Others had been involved in promoting “continuous quality improvement,” “statistical process control,” and “total quality management” in health care. Paul Batalden, Brent James, Eugene Nelson, and Jack Billi come to mind, to name but a few. But, in my opinion, it has always been Berwick that has been the most eloquent and persuasive. He connected the statistical tools emphasized by James with the front line worker involvement emphasized by Batalden. And, he was able to describe how these approaches applied to clinical decision-making as well as care delivery.

At the heart of Dr. Berwick’s contribution was teaching us all to distinguish between the “Theory of Bad Apples” and the “Theory of Continuous Improvement.”

According to the Theory of Bad Apples, errors come from “shoddy work” by people with deficient work performance.  Leaders who uphold this theory focus on inspection to identify such deficient performance, indicated by the undesirable tail in the distribution of provider performance as shown on the left side of the diagram above.  Then, such leaders focus on holding the bad performers “accountable” by applying disciplinary measures intended to motivate improvement in performance and by pursuing other interventions intended to re-mediate the bad performance.  In the health care context, the workers are physicians and the shoddy work is poor quality health care. According to Berwick, the predictable defensive response by the physicians who are targeted for such remedial attention includes three elements: (1) kill the messenger, (2) distort the data and (3) blame somebody else.

Berwick advocates instead for the Theory of Continuous Improvement.  The basic principles of this theory are

  • Systems Thinking: Think of work as a process or a system with inputs and outputs
  • Continual Improvement: Assume that the effort to improve processes is never-ending
  • Customer Focus: Focus on the outcomes that matter to customers
  • Involve the Workforce: Respect the knowledge that front-line workers have, and assume workers are intrinsically motivated to do good work and serve the customers
  • Learn from Data and Variation to understand the causes of good and bad outcomes
  • Learn from Action: Conduct small-scale experiments using the “Plan-Do-Study-Act” (PDSA) approach to learn which process changes are improvements
  • Key Role of Leaders: Create a culture that drives out fear, seeks truth, respects and inspires people, and continually strives for improvement

T-Shirt of "Berwickians" -- the staff of epidemiologists and biostatisticians at BCBSM

Berwick argued the point made by Dr. Deming:  if we  can reduce fear, people will not try to distort the data.  When learning is guided by accurate information and sound rules of inference, when suppliers of service remain in dialog with those that depend upon them, and “when the hearts and talents of workers are enlisted in the pursuit of better ways, the potential for improvement in quality in nearly boundless.”

I first was influenced by Dr. Berwick back in the 1980’s when he championed these ideas during his tenure at the Harvard Community Health Plan, and subsequently during the 1990’s when he led the National Demonstration Project on Quality Improvement in Health Care and the Institute for Healthcare Improvement.  His face was already on my coffee mug at the time he was nominated to lead CMS.  I was thrilled that someone from our community of people dedicated to clinical process improvement had been recognized and would be serving in a position of such influence.

The Irony of the Political Opposition to Berwick’s Role as CMS Administrator

Dr. Berwick’s candidacy as CMS Administrator faced stiff opposition from Republican leaders who were angry about anything connected to the health care reform law or, for that matter, the Obama administration itself.  The President made the decision to evade this opposition by making a recess appointment of Dr. Berwick.  But, such recess appointments have a limited lifespan.  As the deadline for making a formal, congressionally sanctioned appointment approached at the end of the 2011 legislative session, 42 Republican senators signed a letter reiterating their disapproval of Dr. Berwick as CMS Administrator.   The arguments against Dr. Berwick’s  candidacy, both at the time of his original nomination and again over the last few months, centered around comments that Dr. Berwick has made praising the British health care system.  They concluded from his comments that he was in favor of redistributing wealth to the poor and of rationing, the dreaded “R” word, the thing done by “death panels!”  He was, therefore both a bleeding heart and heartless at the same time.  Dr. Berwick denied these charges, but the opposition was unconvinced and unwilling to back down from a position of persistent opposition to anything connected to “Obamacare.”

The irony is that, of the heroes on my coffee mug, Dr. Berwick is not the one deserving of praise for having insight and bravery concerning the basic tenets of health economics. Instead, it was Dr. David Eddy’s mug that was on my coffee mug because he was brave enough to publish numerous papers in the Journal of the American Medical Association explaining why rationing was the right thing to do (e.g. this one and another one).  Eddy argued that creating evidence-based “practice policies” that rationally allocated health care resources using “explicit methods” was favorable to using implicit methods supported only by “global subjective judgement.”  What a radical thought!

Despite my great admiration for Dr. Berwick, he was the hero that disappointed me as a rationing denier.  In fact, in a 2009 paper published in Health Affairs entitled “What ‘Patient-Centered’ Should Mean: Confessions of an Extremist,” he eloquently argued that we should give any patient whatever they wanted, regardless of the cost and regardless of the evidence of effectiveness.  He discounted the role of the physician as a steward of resources.  I felt the argument was heartfelt and humanistic.  But, I felt it was a cop out.  How strange, then, that the Republican opposition hoisted him on the rationing petard.

Looking Forward to Berwick’s Next Journey

Although it is disappointing to me that Dr. Berwick will no longer be leading CMS, I am eager to see what he chooses to do next.  I’m sure he will continue to make a great contribution to our field.  Without all the administrative and political duties to clog up his day, perhaps we are about to witness a surge in his ongoing contributions to improving health care.

More information: See Health Affairs article and associated Health Affairs Blog Post praising Dr. Berwick.

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