Primary care physicians acknowledge over-utilization and blame it on the lawyers.

November 5, 2011 by Dr. Ward in ACO Culture, Behavior Change | Leave a comment

Catching up on some reading, I came across this article in Medical News Today, describing the results of survey research conducted by Brenda E. Sirovich, MD, MS, and colleagues from the VA Outcomes Group (White River Junction, Vermont), and the Dartmouth Institute for Health Policy and Clinical Practice.   They surveyed primary care physicians and published their results in the Archives of internal Medicine.  They documented that primary care physicians acknowledge over-utilizationof services received by their patients.

Their #1 theory of causation?  ”It’s because of malpractice lawyers!” That is not surprising to me, and is consistent with many conversations with both front line PCPs and leaders of primary care physician organizations.

However, I personally believe that this is really the #1 rationalization of the over-utilization.  I feel that there are two main causes:

  1. Low fee-for-service reimbursement, creating the need for many short visits each day to generate enough revenue to make a good living (i.e. the “hamster wheel”).  When visits need to be short, prescriptions and referrals are important to make the patient feel satisfied that their problem is really being addressed.
  2. Lack of effective clinical leadership or even peer interaction over the actual clinical decision-making (i.e. “care-planning”) done on a day-to-day basis by the vast majority of primary care physicians

Beyond the medical school and residency stage, physicians’ care planning occurs all alone, with no-one looking over their shoulder — at least no one with sufficient quantity and quality of information to make any real assessment of clinical decision-making.  Health plans have tried to do so with utilization management programs, but the poor quality of information and the relationship distance between the physician and the health plan are too great to generate much more than antipathy.

If you eliminated malpractice worries and paid primary care physicians a monthly per-capita fixed fee, would wasteful over-utilization go down without also providing deeper clinical leadership and peer review enabled by better care planning data?  Perhaps.  But I would worry that, in that scenario, physicians would still stick with their old habits of hitting the order & referral button out of habit to please the patients who have been habituated to think of “lots of orders and referrals” as good primary care.

The “mindfulness” thing in the invited commentary by Calvin Chou, MD, PhD, from the University of California, San Francisco, is a bit much — trying too hard to coin a term.  I’ve heard that presented before, and I categorized it with “stages of change,” “empowerment,” “self-actualization,” “motivational interviewing,” and “patient activation.”   I’m not saying that such popular psychological/sociological concepts have no merit.  I’m just a Mid-Westerner who starts with more conventional theories of behavior.

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HHS Releases Final ACO Rule

October 20, 2011 by Dr. Ward in ACO Reimbursement and Gain Sharing, Care Relationship Derivation (Attribution) | Leave a comment

The Department of Health & Human Services (HHS) today released the final rule for accountable care organizations (ACO).

The new rule includes a number of changes designed to make the Medicare Shared Savings Program more palatable for health care providers who had a largely negative response to the draft rule released last March. The changes include the following:

  • Allow providers to choose to participate without any downside financial risk during the initial contract period, rather than requiring all participants to take downside risk during the third year of the contract period
  • Provide up front financial support to physician-owned ACOs to support investments in building ACO capabilities, to be repaid through gain sharing rewards in subsequent years
  • Reduce the up front investment needed by eliminating the requirement for meaningful use of electronic health records
  • Reduce the number of quality measures from 65 to 33
  • Allow providers to choose from a number of available start dates throughout 2012
  • Allow community health centers and rural health clinics to serve as ACOs
  • Prospective identification of the Medicare beneficiaries for whom the ACO will be held accountable, rather than deriving such care relationships after the accountability period
  • Eliminates the mandatory anti-trust review for newly-formed ACOs
  • Puts the burden on the federal government, rather than nascent ACOs, to gather data regarding local market share
The  text of the rule is available here, and the associated final waiver rules are available here.

In my opinion, the elimination of the requirement to accept downside risk is likely to substantially increase the willingness of providers to participate in the program, while simultaneously reducing the likelihood that participation will lead to meaningful transformation of the care process within those participants.  But, given the strong opposition to the draft rule, CMS had little choice but to dilute the requirements to at least get some players to take the field.

 

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2 min video of Harold Miller saying hospitals need to be offered a “glide path” to handle revenue reduction anticipated from new payment models

October 1, 2011 by Dr. Ward in ACO Reimbursement and Gain Sharing | Leave a comment

In this 2 minute video, Harold Miller, Executive Director, Center for Healthcare Quality & Payment Reform,talks about the changes that hospitals will face during the transition to new payment models. His remarks were part of the Massachusetts Medical Society’s program, “A Path to Accountable Care Organizations: How Do We Get There From Here?”, held on Sept. 13, 2011.

He argues that savings won’t necessarily come from reducing the revenues of specialist physicians, but that they are likely to come from reducing revenue to hospitals, device manufacturers and others.  He says hospitals need to anticipate getting smaller, and payers need to create a good “glidepath” to make that happen without being too disruptive.

I agree wholeheartedly with this principle. More generally, I am a big fan of Dr. Miller’s work. He thinks clearly about health care structures and processes, and is an effective communicator. His early framing of Accountable Care remains very useful.

http://www.youtube.com/embed/aeF9mLzCrN4

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How do we reduce errors in software and data analysis? Culture of Accountability vs. Culture of Learning

September 24, 2011 by Dr. Ward in ACO Culture, Dr. Ward's Methods Notes | 1 Comment

A young colleague recently wrote to me complaining of frustration from having to deal with a high rate of errors in software development and data analysis.  Any time you are innovating in a knowledge-intensive field such as health care, you will need to develop new software and analyze data in new ways.  Errors will inevitably result.  There’s no easy way to avoid them. Therefore, reducing errors in software development and analysis is a lifelong battle for healthcare innovators.

The conventional philosophy of reducing errors is the following:

  1. Make sure everyone clearly knows what they are responsible for
  2. Make sure you use a tightly controlled development process with clear steps, checkpoints, milestones and gates
  3. Make sure you have everything well documented, using documents created from highly detailed templates designed to assure that nothing is forgotten
  4. Make sure you have detailed testing scenarios designed in advance, and that you do “regression testing” to assure that changes to one part of a system or analysis do not cause the testing scenarios to fail
  5. Make sure everyone understands the consequences of errors, both to the organization and to them personally

These are the pillars of rigorous project management.

But, unfortunately, experience teaches that sometimes this philosophy can have some unintended consequences.  Sometimes, errors still occur. Little errors, like bugs.  And big errors, like creating something that nobody needs or wants.   For example, when you have a tightly controlled process, sometimes that communicates to people that you intend for the process to be linear, rather than iterative.  Even when you say “let’s do this iteratively,” all the steps, milestones and gates tell people that you really mean the opposite.  When you create a highly detailed template, intended to assure that nothing is forgotten, you unintentionally are switching people into a mode of “filling out the form,” rather than the much harder and more valuable work of figuring out how to effectively teach the most important concepts to the reader.  And, you unintentionally convert your quality assurance process to one that emphasizes adherence to the template, rather than the quality of the underlying ideas being taught.  When you create detailed testing scenarios, you unintentionally encourage the team to treat “passing the tests” as quality, rather than having them challenging the software or the analytic results to tests that are designed based on insights about how the software or the analytic calculations are actually structured and what types of errors might be more likely.  A software developer I know describes that as “testing smarter.” Finally, when you communicate to people the consequences to them personally of messing up, intending to increase their motivation to do error-free work, you unintentionally are telling them to allocate more of their time to avoiding blame and documentating plausible deniability.  And, you are unwittingly telling them to bury the problems that could provide the insights needed to drive real improvement.

W Edwards Deming

W. Edwards Deming famously advocated for “driving out fear.”  In his landmark book, “Out of the Crisis,” published back in 1982, Deming explains that people fear new knowledge because it could reveal their failings and because it could lead to changes that could threaten their security.  Focusing on motivating people might be a good idea if the problem is inadequate motivation.  But, in my experience, poor performance is usually not an issue of motivation, especially in professional settings. More likely, poor performance is an issue of poor tools, poor training (leading to inadequate knowledge or skills), or having the wrong talent mix for the job.

That last one — talent — is a tricky one.  We consider it enlightened to assume that everyone could do a great job if only they received the right tools and training. Saying someone lacks the necessary talent for a particular job can be considered arrogant and wrong.  I think this may be because  talent is an unchangeable characteristic, and we are taught that it is wrong to consider other unchangeable characteristics such as gender or race.  But, each person was given their own unique mix of talents.  They will make their best contribution and achieve their highest satisfaction if they are in a role that is a good fit for their talents.  On the other hand, it is devilishly hard to tell the difference between unchangeable talents vs. changeable skills and knowledge.  And, developing people’s skills and knowledge is hard work and requires patience. As a result, it is too easy for leaders to get lazy and waste real talent.  Finding the right balance between optimism and realism about peoples’ potential requires maturity, effort and some intuition.  If in doubt, take Deming’s advice and error on the side of optimism.

I’m not arguing against processes, documentation, test scenarios or accountability.  But, I am suggesting to be careful about the unintended consequences of taking those things too far and relying on them too much.

My advice to my colleague was to focus more on the following:

  1. Make sure you hire really talented people, and then invest heavily is developing their knowledge and skills
  2. Make sure you are actually analyzing data the moment you start capturing it, rather than waiting a long time to accumulate lots of data only to discover later that it was messed up all along
  3. Make sure you do analysis and develop software iteratively, with early iterations focused on the hardest and most complex part of the work to make sure you don’t discover late in the game that your approach can’t handle the difficulty and complexity
  4. Most importantly, create a culture of learning, where people feel comfortable sharing their best ideas, talking about errors and problems, taking risks, and making improvements
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What can we learn from the managed care backlash of the 1990s? Can we avoid an ACO backlash?

September 10, 2011 by Dr. Ward in ACO Culture, ACO Strategy, ACO Structure & Governance | Leave a comment

Advocates of “accountable care organizations” (ACOs) are careful to avoid the terminology of “managed care,” which is widely viewed as a failed model from the 1980s and 1990s.  But, there are obvious similarities between ACOs and managed care.  Both involve an organization taking responsibility for the quality and cost of care for a defined population.  Both emphasize the importance of primary care as the foundation of a coordinated and efficient health care delivery system.  Both involve economic incentives to physicians to improve quality and slow the upward trend in total cost of care.

But, we all remember the strong backlash against managed care during the late 1990s.   Although almost 10% of the U.S. population are still served by HMOs, the managed care vision has been largely in exile for more than a decade now.   PPOs are now the dominant model, with relatively small financial incentives to patients to seek their care from providers within relatively large provider networks.  Many PPOs have dabbled in “pay for performance,” but the physician incentives involved have been relatively small and the performance bar set relatively low.  The use of more heavy-handed managed care approaches has declined significantly.  For example, plans usually don’t require a referral authorization by a “gatekeeper” primary care physician before granting access to specialists.  And the use of pre-authorization by health plan staff for many expensive procedures has declined significantly.   Health plans did not drop these heavy-handed approached because they became convinced they were ineffective.  They dropped them because they feared they would face a consumer backlash and lose membership.

So, what can we learn from the managed care backlash?  And what can we do differently to avoid an “ACO backlash?”

I went back to some research done during the height of the managed care backlash to refresh my memory of how bad it was, and why it happened.  Most helpful was a paper from 1997 in Health Affairs by Robert Blenden and other researchers at Harvard and the Kaiser Family Foundation. Blenden reported survey results showing that Americans hated managed care companies even more than they hated banks and oil companies.

Blenden’s survey results showed that a significant proportion of Americans experienced hassles and other problems with managed care plans.  These common, minor problems were hypothesized to serve as the seeds of stronger dissatisfaction and distrust.  The survey also showed that the public overestimated the frequency of rare events that are dramatic and threatening.  For example 66% thought that HMOs sometimes or often hold back on a child’s cancer treatment.  73% thought that HMOs send newborn babies home after just one day, in spite of mothers’ concerns about their children’s health.  As shown in the following graph, there was a dose-response relationship with the “heaviness” of the health plan and the degree of mistrust that the health plan would do the right thing if they got sick.

Blenden concluded that the backlash against managed care was primarily driven by mistrust and fear, leading to calls for government regulation and reducing the market demand for managed care.  I created the following “cause-effect” diagram to illustrate this theory.

So, what can we do differently this time around?  We must do a far better job of building trust. That will require actually being trustworthy.  And, it will require being more proactive about communicating trustworthiness.

This topic is so central to the success of ACOs that it deserves a lot more attention by people who have expertise in public opinion, market communication, and brand development.  But, here is my proposed starting point for developing a strategy to build trust in ACOs and other innovative models of health care finance and delivery.

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Mayo and Cleveland Clinic are becoming franchisers. Maybe they should focus on primary care.

September 3, 2011 by Dr. Ward in ACO Structure & Governance | Leave a comment

As described in a recent article in American Medical News, the Mayo Clinic and the Cleveland Clinic are both independently offering medium to large groups of specialist physicians an opportunity to use their esteemed brand names and a variety of other resources formerly only available to employed physicians.  In return, the group has to pay a fee and agree to meet clinical criteria.

That’s a franchise model, although Mayo and Cleveland don’t use that terminology. Perhaps they are worried that the term “franchise” may conjure up unflattering comparisons to fast food chains.  But, as I’ve described in a previous blog post, the franchise model is not frivolous.  It is a serious, time-tested business structure appropriate for a business that his a mix of large scale and small scale requirements. Large scale requirements are things like infrastructure for research and development, volume purchasing, specialized management disciplines, and branding.  Small scale requirements include top local talent that is highly motivated to develop relationships and attend to the details that determine the quality of local operations.  A large, conventionally-structured company can certainly have “field” employees spread out in many local areas.  But, they may not be able to attract and retain the best local talent.  And those field employees won’t be as motivated as franchisees that are, by definition, entrepreneurial business owners.

It has to be real to avoid being cheap

Mayo Clinic and Cleveland Clinic are well aware that they have strong, valuable international brands.  They take their brands very seriously, both in local markets for care delivery and on a national and international scale when they have ventured into publishing and internet-based businesses.  So, I know they must be keenly focused on picking franchisees that won’t sully their names. The worst thing for them would be for their franchisees to deliver poor care under their logos, creating confusion in the market about what their brand stands for.  Franchisers know they need to assure that their standards are maintained consistently.  This consistent adherence to standards is one of the most essential sources of value to consumers.

But why not focus on primary care?

The fact that both Mayo and Cleveland are focused on “single specialty groups” implies to me that they are directing this franchise model on specialists rather than primary care-based organizations. But, perhaps it is the primary care providers that could benefit the most from getting access to resources that are too costly for them to develop themselves.  Things like advanced analytics, health care information technology, lean coaches, care management training, call centers, contracting professionals, and sophisticated advertising.  These are the capabilities that serve as the foundation for successful primary care-based accountable care organizations (ACOs) or to achieve favorable performance in episode-based, bundled payment for chronic diseases.  To a primary care franchisee, the brand name recognition may actually be less important than the opportunity to have world class infrastructure and management support, while still allowing the participating primary care physicians to maintain a degree of independence.

The following tongue-in-cheek video illustrates the idea.

http://www.xtranormal.com/xtraplayr/12413926/new-day-primary-care-partners

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CMS Innovations Center announces new Medicare Bundled Payments Initiative. I predict it will be popular.

August 25, 2011 by Dr. Ward in ACO Reimbursement and Gain Sharing, Episode Grouping | Leave a comment

On top of the Medicare Shared Savings Program (the original ACO initiative) and the Pioneer ACO Program, CMS is now adding four more optional approaches for providers to get reimbursed for Medicare services.  The new models all involve bundled payments, where a single negotiated payment covers all professional and facility services for a particular type of episode, such as a hip replacement.  This approach has been shown in a previous Medicare demonstration project and numerous bundled payment initiatives of commercial payers to create an incentive for physicians and hospitals to do a better job coordinating care and reducing the use of potentially unnecessary services during the episode of care, resulting in lower overall cost.

The four new models differ in terms of what the bundle includes and whether the payment is made prospectively or retrospectively.

Under the program, data about the historical cost for the services associated with the bundle will be provided by CMS. Then the provider will negotiate a discount percentage off of the historical cost, assuring that CMS receives some savings.  Then, if providers can reduce their actual cost more than the discount percentage, they get to keep the additional savings.  It’s a fair bet that, over time, CMS will ratchet down the bundled payment one way or another.

So, the idea is for providers to voluntarily sign-up for a program that will reduce their revenue.  Why would they do that?  For two reasons:

  1. They could make more bottom line profit if they decreased their fixed and variable cost faster than CMS decreases the bundled payments, and
  2. They know the market is heading back in the direction of providers bearing more risk, and this is a way to get their feet wet and establish their capabilities for care coordination, care process transformation, utilization management and the supporting information technology and analytics.

I predict that the bundled payment approach will be more popular among health care organizations than the more global ACO approach because is feels more gradual, more controllable, and more understandable.  As a result, it is less risky and scary.

More information about these bundled payment options are available on the CMS website.

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Hospitalists have been focused on reducing hospital length of stay, but not so much on smooth transitions to ambulatory care

August 20, 2011 by Dr. Ward in ACO Provider Performance Analysis, Efficiency Measurement, Provider-based Care Management | Leave a comment

A new study published in the  Annals of Internal Medicine compared the economic outcomes of hospital episodes managed by hospitalists to those managed by the patients’ primary care physicians in a Medicare population. Previous studies focused only on the cost of the hospital stay itself, and showed that hospitalists were able to reduce length of stay and hospital cost. These economic savings accrue primarily to hospitals who are reimbursed with a fixed DRG-based payment for most hospital stays. These hospital savings have motivated hospitals to hire more hospitalist physicians. According to the Society of Hospital Medicine, 80 percent of hospitals with more than 200 beds now have hospitalists.  There are now 30,000 hospitalist physicians, and the specialty continues to grow more rapidly than any other.

But, the new study measures the economic outcomes of the entire hospital episode, including care received after the patient is discharged from the initial hospital stay.   The study shows that hospital stays managed by hospitalists had an average length of stay that was 0.64 days shorter, saving an average of $282. But, those patients were more likely to return to the emergency department and more likely to be readmitted to the hospital, leading to post-discharge costs that averaged $332 higher than for hospital episodes managed by the patients’ own primary care physicians. Thus, the use of hospitalists ends up costing Medicare $50 more per episode, increasing overall costs by $1.1 billion annually.

The study authors, Yong-Fang Kuo, PhD and James S. Goodwin, MD from the University of Texas Medical Branch in Galveston, hypothesized that ”hospitalists, who typically are employed or subsidized by hospitals, may be more susceptible to behaviors that promote cost shifting.” The implication is that, if hospitalists were employed by primary care-based Accountable Care Organizations (ACOs) that were being held responsible for the total cost of care for a defined population of patients, they might be more strongly encouraged to focus on improving care transitions to reduce downstream complications and associated emergency department visits and hospital re-admissions.

Even without ACOs, there has been a great deal of effort over the last few years to improve transitions of care for patients discharged from acute care hospitals.  Most of these efforts attempt to improve both the “pitch” by the hospital-based team and the “catch” by ambulatory care providers.  But, some efforts, such as the BOOST program funded by the Hartford Foundation, have a primary emphasis on the pitch.  Other efforts, such as the STAAR program of the Commonwealth Fund and the Institute for Healthcare Improvement (IHI), tend to emphasize the catch. Hopefully such programs will lead to wide-spread improvements in quality of care and reductions in total cost of hospital episodes.  ACOs could catalyze and accelerate those improvements by linking hospital care more tightly to primary care and supporting this linkage through investments in health information exchange (HIE) capabilities designed to foster thoughtful, smooth transitions of care.

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Reports of the death of Cost-Effectiveness Analysis in the U.S. may have been exaggerated: The ongoing case of Mammography

August 13, 2011 by Dr. Ward in ACO Culture, Cost-Effectiveness Analysis (CEA), Decision Analysis, Electronic Medical Records (EMRs), Registries | Leave a comment

Guidelines for the use of mammograms to screen for breast cancer have been the topic of one of the fiercest and longest-running debates in medicine.  Back in the early 1990s, I participated in that debate as the leader of a guideline development team at the Henry Ford Health System.  We developed one of the earliest cost-effectiveness analytic models for breast cancer screening to be used as an integral part of the guideline development process.  I described that process and model in an earlier blog post.  Over the intervening 20 years, however, our nation has fallen behind the rest of the world in the use of cost-effectiveness analysis to drive clinical policy-making.  As described in another recent blog post, other advanced nations use sophisticated analysis to determine which treatments to use, while Americans’ sense of entitlement and duty have turned us against such analysis — describing it as “rationing by death panels.”  Cost-effectiveness analysis and health economics is dead.

But, maybe reports of its death have been exaggerated.

A recent paper published on July 5, 2011 in the Annals of Internal Medicine described the results of an analysis of the cost-effectiveness of mammography in various types of women.  The study was conducted by John T. Schousboe, MD, PhD, Karla Kerlikowske, MD, MS, Andrew Loh, BA, and Steven R. Cummings, MD.  It was described in a recent article in the Los Angeles Times.  The authors used a computer model to estimate the lifetime costs and health outcomes associated with mammography.  They used a modeling technique called Markov Microsimulation, basically tracking a hypothetical population of women through time as they transition among various health states such as being well and cancer free, having undetected or detected cancer of various stages and, ultimately, death.

They ran the models for women with different sets of characteristics, including 4 age categories, 4 categories based on the density of the breast tissue (based on the so-called BI-RADS score), whether or not the women had a family history of breast cancer, and whether or not the women had a previous breast biopsy.  So, that’s 4 x 4 x 2 x 2 = 64 different types of women.  They ran the model for no-screening, annual screening, and screening at 2, 3 or 4 year intervals.  For each screening interval, they estimated each of a number of health outcomes, and summarized all the health outcomes in to single summary measure called the Quality-Adjusted Life Year (QALY).  They also calculated the lifetime health care costs from the perspective of a health plan.  Then, they compared the QALYs and costs for each screening interval, to the QALYs and costs associated with no screening to calculate the cost per QALY.  Finally, they compare the cost per QALY to arbitrary thresholds of $50K and $100K to determine whether screening at a particular interval for a particular type of women would be considered by most policy-makers to be clearly costs effective, reasonably cost-effective, or cost ineffective.

The authors took all those cost effectiveness numbers and tried to convert it to a simple guideline:

“Biennial mammography cost less than $100 000 per QALY gained for women aged 40 to 79 years with BI-RADS category 3 or 4 breast density or aged 50 to 69 years with category 2 density; women aged 60 to 79 years with category 1 density and either a family history of breast cancer or a previous breast biopsy; and all women aged 40 to 79 years with both a family history of breast cancer and a previous breast biopsy, regardless of breast density. Biennial mammography cost less than $50 000 per QALY gained for women aged 40 to 49 years with category 3 or 4 breast density and either a previous breast biopsy or a family history of breast cancer. Annual mammography was not cost-effective for any group, regardless of age or breast density.”

Not exactly something that rolls off the tongue.  But, with electronic patient registries and medical records systems that have rule-based decision-support, it should be feasible to implement such logic.  Doing so would represent a step forward in terms of tailoring mammography recommendations to specific characteristics that drive a woman’s breast cancer risk.  And, it would be a great example of how clinical trials and computer-based models work together, and a great example of how to balance the health outcomes experienced by individuals with the economic outcomes borne by the insured population.  It’s not evil.  It’s progress.

It will be interesting to see if breast cancer patient advocacy groups, mammographers and breast surgeons respond as negatively to the author’s proposal as they did to the last set of guidelines approved by the U.S. Preventive Services Task Force which called for a reduction in recommended breast cancer screening in some categories of women.

 

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Health Care Heroes: Wilmer Rutt, MD – Adapting the R&D Concept to Health Care Provider Organizations

August 6, 2011 by Dr. Ward in ACO Structure & Governance, Clinical Process Improvement, Dr. Ward's Health Care Heroes | 1 Comment

Wilmer Rutt, MD - Director of Henry Ford Health System Center for Clinical Effectiveness, in his office at New Center Pavillion, 1993

This morning, I read the results from a clinical trial of ovarian cancer screening in JAMA.  The trial showed that ovarian cancer screening was not effective in saving lives.  I was interested in the article because I was one of the investigators in that trial, which began in the early 1990s.  Henry Ford Health System was the largest of many recruitment sites for the Prostate, Lung, Colorectal and Ovarian (PLCO) trial, one of the largest clinical trials ever done.  I’m not surprised by the ovarian cancer results, since our models long ago suggested it was unlikely to work.  But, it is amazing to me how long it takes to figure out whether something works in health care, particularly for interventions that are preventive services or that attempt to change the delivery system.  It is unfortunate that the “learning loop” — from innovation to implementation to evaluation and back to innovation — is often far longer than our collective attention span.

But, the back story of how Henry Ford got involved in the PLCO trial is the most interesting aspect of the PLCO story for me.  It is the story that best illustrates why Wil Rutt, MD is one of my health care heroes.  When I was fresh out of University of Chicago medical school in 1990, I moved to Detroit to work with Dr. Rutt, who had recently founded the Center for Clinical Effectiveness (CCE) at the Henry Ford Health System.

In other industries — particularly product manufacturing industries — it is typical for companies to invest in internal capacity for research and development (R&D).  Universities and governments do basic research, figuring out how nature works.  But, it is companies that do R&D to apply basic knowledge to the development of successful products.  They generate ideas for product innovations.  Then they use rigorous methods of scientific research and engineering to figure out whether those innovations are successful and to develop ways of manufacturing the product.  Separate from such R&D efforts, manufacturers also have engineers in the product manufacturing area that try to improve manufacturing processes.  To do so, these engineers use methods variously described as statistical process control, continuous quality improvement, total quality management, six sigma, and lean.  Drug and biomedical device companies are product manufacturers, and share this tradition of investing in both R&D and manufacturing process improvement.

In the field of health care delivery, there has been great progress over that last few decades in adapting the process improvement methods from manufacturing for use in health care.   Drs. Don Berwick, Paul Batalden, Brent James, and Jack Billi come to mind as zealous advocates for this advancement. And, certainly there have also been plenty of health services researchers, mostly in universities and government-sponsored think tanks, who have done research on health care delivery organizations, studying such organizations as anthropologists might study gorillas in the mist.

Mark Muller, Wei Chang, Kim Sadlocha and Rick Ward in the the offices of the Center for Clinical Effectiveness, 1993

But, as of 1990, there was little or no precedent for non-academic health care provider organizations to do R&D, the kind of practical work applying rigorous scientific and engineering methodologies to improving the design of a company’s own product or service.  Wil Rutt’s CCE was one of the first attempts to apply R&D to health care delivery. He assembled a team of doctors, PhDs, IT professionals and others to design better ways for Henry Ford Health System to deliver health care.  The CCE did extra-murally funded research intended to be generalizable to the world.  But the focus was on R&D for Henry Ford, and the grants and papers were merely a means to that end.

One of Dr. Rutt’s many innovation concepts during the early 1990s was the idea to design a care process that resembled the Jiffy Lube oil-change process to deliver clinical preventive services.  At that time, there were upwards of 50 different preventive services recommended in the U.S. Preventive Services Task Force guidelines.  Dr. Rutt’s CCE developed pocket-size guideline manuals, age and gender-specific flow sheets, and preventive services quality feedback in an effort to promote adherence to preventive services guidelines by primary care physicians.  But, he concluded that it would be better to cross train non-physician staff to efficiently deliver a whole set of preventive services to patients during a single ambulatory encounter.  He wanted these services to be delivered in a convenient setting such as a shopping mall rather than on a clinical campus. He called these “Health Assessment Labs” or “HALs.”  However, Dr. Rutt needed funding to implement and rigorously evaluate the HAL concept.  Along came the National Institutes of Health (NIH), who was sponsoring the PLCO trail.  Dr. Rutt saw the opportunity for Henry Ford to be a clinical site for the PLCO.  We won a grant to do so, and became the largest of the many PLCO clinical sites.  That grant was one of the largest research grants ever received by Henry Ford Health System, which is no slouch in clinical and basic science research.  But, Dr. Rutt’s thrill was not the research fame.  It was the opportunity to do R&D on the HAL concept.

Two decades later, we are still, as a field, at the infancy of our journey to adapt the R&D concept to health care delivery.  Certain delivery systems, such as Kaiser Permanente, Mayo Clinic, Cleveland Clinic, and Novant have discussed an R&D-like concept of developing proprietary science, technology and methods for care delivery.  But, the R&D concept has not really taken hold.  Health care provider organizations do not yet consider R&D to be a core competency.  Hardly any provider organizations have an internal department dedicated to R&D.  They don’t yet see R&D as a necessary investment required to maintain organizational competitiveness.  I feel strongly that we need to finish making that advancement.  And when we do, we’ll owe a debt of gratitude to Dr. Rutt for being the pioneer.

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