Diabetes Updates – New Diagnostics, Increasing Rates, and Implications for Health Reform, CER, etc.

Posted on June 17, 2009 by Michael D. Miller MD

Changes in the diagnosis and treatment of diabetes is a great example for understanding how healthcare delivery constantly evolves based upon new discoveries. And the history of these changes may help illuminate some thinking about health reform and the development and use of comparative effectiveness research (CER).

First, a little background on diabetes.

Diabetes Background
Diabetes mellitus (or “sugar diabetes”) occurs when the body has problems regulating the level of sugar (specifically glucose) in the blood. This can be because the body’s pancreas doesn’t produce enough insulin, or for some reason the person’s organs become resistant to the actions of the insulin that is present – or sometimes both occur simultaneously. Impaired control of glucose means that the levels get too high, which produces problems in the eyes, (leading to blindness), in the kidney, (leading to kidney failure), and in the small blood vessels elsewhere in the body, which can lead to nerve damage and low oxygen delivery to the extremities – particularly the legs and feet, (leading to amputations).

In olden times, diabetes could be diagnosed by sugar in the urine. (Medical lore says this was done by taste….) However, until insulin was discovered in 1921 there were no therapies for severe insulin deficiency. And even once insulin became available, sugar in the urine was still the way diabetes was diagnosed and monitored – usually with a dipstick that changed color depending on the sugar concentration.

It wasn’t until the 1960s that measuring blood glucose levels became possible – and only then in the doctors’ offices because the machines were large and expensive. In the 1980s machines small and cheap enough for patients to monitor their blood sugar levels at home became available. This enabled patients to start adjusting their own insulin dosages based upon their blood sugar levels. (Before this it was too dangerous for patients to significantly alter their insulin dosages because while too little insulin leads to too high sugar levels causing long-term damage, too much insulin can drop sugar levels too low and lead to confusion, coma and death.)

In more recent years it was discovered that keeping diabetics’ sugar levels near normal could prevent essentially all the adverse consequences of diabetes, i.e. blindness, renal failure and amputations. But doing this based upon finger-stick blood sugar levels even 3 and 4 times a day was tricky – and those were just single data points. So in the mid 1970s it was proposed that monitoring the amount of hemoglobin in the blood that had combined with glucose would give a measure of the average blood sugar level for the 2-3 month life of the red blood cells. (It was known that glucose irreversibly connects to the hemoglobin in red blood cells in a way that directly correlates to the blood sugar level.) This test, known as “glycosylated hemoglobin, (or HbA1C, or simply A1C), has been increasingly used over the past few decades to monitor diabetics and adjust their treatments, with the goal to keep A1C levels below 7%, since the level in people without diabetes is 4-6%.

Care Lags Discovery and Development of Innovations
Despite improved ability to monitor diabetes, it is still under diagnosed, and poorly managed. It is estimated that there are about 6 million people in the US who have diabetes, but don’t know it – which is about 25% of all people with diabetes. And in 2003-2004, only about 57% of people with diabetes had A1C levels <7%. (The medical and lost productivity costs for all people with diabetes may be approaching $200 Billion.)

And the prevalence of diabetes is increasing – and with it so are the costs of treating people with diabetes. Last year I wrote about this, and now the CDC has updated information showing the continuing growth in the number of people in the US diagnosed with diabetes:

Source: http://www.cdc.gov/diabetes/statistics/prev/national/figpersons.htm

The treatment of diabetes has also changed. After insulin was discovered, different forms and modifications where developed to change how quickly it acted, and beef and pork sources have been replaced with biotech “human” insulins grown in bacterial cultures. Many different types of non-insulin treatments for diabetes have also been developed – these act primarily by increasing insulin production from the pancreas or the action of the insulin in the body.

Which brings us back to the A1C test. An International Expert Committee from the American Diabetes Association is now recommending that the A1C test be used to diagnose diabetes. This would replace (or supplement) the traditional fasting blood glucose diagnostic test, and the A1C test would still be used for twice yearly monitoring of the adequacy of treatment for people with diabetes.

These developments in diagnosis and treatment have progressed in tandem – each leveraging off the knowledge gained from the other – with the A1C test being part of the continuing evolution of tests for diagnosing diabetes. For example, the fasting blood glucose level for diagnosing diabetes has changed over the years. It was originally set at 140mg/dl in 1979, and then lowered to126 in 1997, when it was also decided that a level between 110-126 should be considered pre-diabetic, or “impaired fasting glucose.” And in 2003 the lower bound for “prediabetes” was lowered to 100.

Why A1C Now?
While A1C testing has been used for years, there have been problems in standardizing the measurement. (This is discussed in the ADA paper linked to above.) But now A1C measurement inconsistencies, (which occur for all lab tests), have been narrowed sufficiently so that the ADA committee is recommending that an A1C level of >6.5% be used to diagnose diabetes, (for patients who are not pregnant and do not have hemoglobin abnormalities – these can change HbA1C levels significantly), and that people with A1C levels >6.0% and <6.5% be considered to have “subdiabetic hyperglycemia” because they have a significant risk of progressing to diabetes.

So Back to Health Reform and CER – The Challenges Ahead
The challenges ahead are to make sure that we continue to utilize future discoveries in a timely and intelligent way. Which finally brings us to health reform and CER. Health reform that expands insurance coverage should dramatically improve the diagnosis and treatment of people with diabetes – which should also help control other healthcare and societal costs because poorly controlled diabetes leads to many other costly problems. However, immediate cost pressures present barriers to using the best diagnostic and therapeutic interventions.

Comparative effectiveness research is supposed to provide information about the best interventions, but as has been seen with advancements in diabetes, what is best often changes in progressive leaps based upon new discoveries. And one of the limitations of CER, (and all research for that matter), is that it takes time to do the work and analyze the results. Therefore, research really provides information about what was the best when the research started – which could have been several years before the results are known and disseminated. And this time lag effect can be even longer when the research is based upon previously published studies or analyses of clinical records.

The lesson here is that while CER and similar research can provide very important and useful information, it must be put into the proper historical and clinical contexts. What was state-of-the-art when the research protocols were developed may be 2, 3, 4 or more years out of date when the data is analyzed. This reality needs to be considered when such information is used for coverage and reimbursement, and decisions about health delivery and financing system redesign.

I am confident that most insurers are not paying for A1C tests to screen people for diabetes – and that it will likely take a year or more for even the most progressive insurers to do so…. but they eventually will. Which raises the question, what did they gain by waiting? And what did they, (and the patients), lose?

Addendum: The hospital lab my doctor uses charges $59 for a HbA1C test. So assuming that price doesn’t come down if more people are getting the test, the calculation needs to be made as to what is the ROI for using HbA1C as a screening test? And the CER questions are how to identify people who would most likely benefit from HbA1C screening, and how to determine how frequently the screening should be done?

People in Health Reform & Transformation

Posted on May 20, 2009 by Michael D. Miller MD

The importance of the “people factor” in improving the quality and efficiency of healthcare is well understood by experts in health information technology (HIT) and healthcare delivery transformation. In estimating the time and cost for implementing new technologies or processes, they appreciate how behavior change and technology adoption are very time consuming and expensive – factors that are often glossed over in policy discussions.

David Brooks’ recent Op-Ed in the New York Times about the personality traits of CEOs leading successful companies sheds some light on the people factors in health reform. Contrary to a lot of the common wisdom about the importance of good personal connections with coworkers for success in the corporate world, Brooks cites information that the most important factors for successful CEOs are “execution and organizational skills. The traits that correlated most powerfully with success were attention to detail, persistence, efficiency, analytic thoroughness and the ability to work long hours.”

He goes on to state that what produces effective CEOs are “emotional stability and, most of all, conscientiousness — which means being dependable, making plans and following through on them.”

In the medical world, this would describe most surgeons, but the difference between the corporate and medical worlds is that CEOs have greater direct control over their people and organizations than do the leaders of health delivery organizations like hospitals or clinics, which rely on the performance of many different professionals and skilled staff who function quite independently, such as doctors, nurses, and many types of therapists. Thus, while “being a good listener, a good team builder, an enthusiastic colleague, a great communicator [does] not seem to be very important when it comes to leading successful companies,” in the clinical world, these traits are very important.

Brooks’ comment that, “business leaders tend to perform poorly in Washington, while political leaders possess precisely those talents — charisma, charm, personal skills — that are of such limited value when it comes to corporate execution,” correlates very well with my observations of senior corporate managers, politicians and clinicians. I have seen business leaders who are successful in working the political circuit but have struggling corporate organizations, and politicians who enter the business world – often as leaders of lobbying or policy organizations in Washington DC – whose operations are chaotic and inefficient.

However, there are a wide variety or organizations in the healthcare universe’s 4 spheres, and the leadership qualities best suited for increasing quality and efficiency depend upon the sphere the organization is operating in, the type of organization, and the local culture. For example, leading a biotech, medical device, diagnostic, HIT, or pharmaceutical company requires the type of hyper-focused “boring” CEO described in Brook’s column. But successfully leading a hospital, clinic, or private medical office requires someone who has relatively stronger people skills. And someplace in the middle would be the leadership of health plans which have to bridge the business and clinical worlds, and leaders of government agencies which have to straddle the policy and political arenas.

Keeping the importance of the people factor in mind while developing health reform and transformation proposals will help create realistic expectations and time lines – both for the actual transformation of care delivery and the ability to achieve cost savings. For example, as CBO noted a year ago – and I’ve previously commented on – the ability of health information technology to achieve cost savings is dependent upon how those technologies actually change behaviors of clinicians, patients, and others – a process which is very time consuming and expensive.

Communicating with Clinicians to Improve Quality

Posted on May 8, 2009 by Michael D. Miller MD

At a recent public forum on improving quality and value in healthcare, an audience member asked how can patients know if the treatment or diagnostic test their clinician is recommending is really the best thing for them. This reminded me that the Agency for Healthcare Research and Policy (AHRQ), recently ppublished a two page tip sheet to help patients talk to their doctors and a web-page that helps people create a set of questions customized for their individual healthcare needs and situations.

While these are obviously useful tools, I realized that emphasizing patient-clinician communications is now more important than ever because of the growing trend toward “consumer directed healthcare” and “patient empowerment.” While these types of activities and insurance product may be able to reduce costs by incentivizing people to use less healthcare, how they effect quality is still uncertain. In addition, the enormous amount information available on the internet is making people well armed with data and facts, but not necessarily with knowledge. Even with a lot of facts and data, patients are much better off having another person, (i.e., a trained clinician), integrate all the information about their individual situation and present a complete perspective and set of recommendations. (This is why it is generally not appropriate for physicians to treat themselves or family members, i.e. because they cannot be both the patient – or family member – and provide an impartial and objective analysis.)

Asking Questions is Key for Communications and Quality Improvement
The AHRQ materials are valuable for improving the quality of care because patients may find themselves overwhelmed in a medical office, and forget to ask the right questions – particularly when faced with a new diagnosis or presented with a set of recommendations for treatment of an existing condition. Coming to the medical office with a set of written questions will help remind the patient what questions they want to ask, and help promote a conversation with the clinician about the patient’s needs and desires. Clinicians are generally much more receptive to patients who ask questions than to those who just present opinions, requests, or demands about their treatment.

AHRQ’s “Talking with Your Doctor” tip sheet, has two key messages for both policy makers and patients:

Research has shown that patients who have good relationships with their doctors tend to be more satisfied with their care – and to have better results.
Write down your questions before your visit. List the most important ones first to make sure they get asked and answered.

Checking for the Checklist
AHRQ’s web-page for creating customized question lists is a valuable resource not just for preparing to talk with clinicians, but also for choosing health plans, hospitals, long-term care facilities – as well as clinicians. While the list of suggested questions AHRQ is good, one item that I’d add is, “Does the hospital require the use of surgical checklists?” (FYI – I’ve written about how such checklists have been shown to reduce errors and improve quality, and I’ve suggested that patients ask their surgeons and hospitals if they use them – and if not, why not?)

And apparently I’m not alone in promoting greater use of checklists in hospitals. I recently heard that Health Care for All here in Massachusetts is pushing for legislation to require hospitals to use such checklists. I applaud their efforts to highlight this quality improving measure, but also want to note that there are arguments on both sides for whether legislation is the best route to improve quality of care at all hospitals. For example, how specific do we want laws to be in listing what hospitals and doctors are required to do, since laws can be difficult and time consumer to change? Conversely, how quickly and completely will hospitals and doctors change their practices if they are not compelled to do so by new laws? And are their other mechanisms besides laws to make these changes faster and more completely?

Questions are the Answer
Whatever routes are used to improve quality of healthcare, (e.g. legislation, patient empowerment, financial incentive, peer pressure, etc.), it’s clear that patients, advocates, policy makers, and others need to continue asking thoughtful and focused questions. As the website name for AHRQ’s customized questions list states, “Questions are the Answer.”

Improving Cancer Care in Medicare

Posted on May 5, 2009 by Michael D. Miller MD

This week’s AMA News includes an article about how cancer care for Medicare beneficiaries has improved because of a provision in last year’s Medicare Improvements for Patients and Providers Act (MIPPA). The provision of interest clarified that Medicare Part D plans need to pay for off label uses of medicines to treat cancer when there is supportive evidence in the peer-review literature. This changes became effective January 1st, and for at least one patient, it has improved their care. (See the Medicare Rights Center’s press release about the coverage appeal they won for a client because of the new law.)

However, as I noted in an interview with the American Medical News ReachMD Radio-XM 160, (See MP3 audio file below), because the change only applies to cancer treatments, patients with other serious and life threatening illnesses may still find their treatment options limited. That is, under current law, for non-cancer illnesses, Medicare Part D plans can still limit coverage to only the off-label uses listed in the standard compendia.

American Medical News ReachMD Interview May 5, 2009:
Off Label Coverage by Medicare Part D Plans

I had recommended that the MIPAA change go beyond cancer to include serious or life-threatening conditions – terminology that is somewhat imprecise, but widely recognized, including by the FDA. However, I suspect that because of cost concerns, this broader expansion of off-label coverage was not included in MIPPA. I find this interesting for two reasons. First, in these times of record government spending, even MIPPA’s limited coverage expansion for off-label cancer treatments raised some concerns about cost increases – which I wrote about in January. And second, that restricting coverage of treatments in this way seems philosophically opposite to the intended benefits of Comparative Effectiveness Research – which is all about using the best research findings to improve the quality of care. Of course, with the size of our health care system, I’m sure this won’t be the last time the left and right hands are not perfectly in sync.

Investment for Health Reform – Escaping the Valley of Death

Posted on April 30, 2009 by Michael D. Miller MD

The debate about health reform has mostly focused on expanding insurance coverage and controlling costs. However, successfully improving the US healthcare system will require some long-term quality improving investments.

The stimulus bill (ARRA) included two such investments. The $1.1 Billion for Comparative Effectiveness Research has been widely discussed because it is important, and a very large percentage increase in the Federal Government’s spending in this area. But the ARRA bill also included $10 Billion to increase NIH’s funding.

The significance of the increased NIH funding is twofold: First, it will provide expansion of biomedical research related jobs. And second, it will help the NIH increase the work it does in translational research, which should help biomedical research build a better bridge over what the Parkinson’s Action Network and others have labelled the “Valley of Death.”

Valley of Death
The Valley of Death, as described by PAN at a briefing last week hosted by FasterCures, is the work required to turn basic lab research discoveries into treatments that help people. Some people call this “translational research,” and the NIH has been moving in this direction by funding institutional centers with Clinical and Translational Science Awards (CTSAs). The two major activities that occur (or don’t occur readily enough), in the Valley of Death are prototype discovery and design, and preclinical development. (See PAN’s graphic below.)

The Valley of Death is a real challenge because while these activities are vitally important for improving the quality of healthcare over the long run, the incentives for doing this work are smaller than for basic or fully applied research: In the private sector, there may be small incentives for translational work, but in academia the incentives may actually be negative because successes in this area garner little or no professional prestige or recognition, and more importantly, generally doesn’t attract research grants, i.e. money to support the researcher’s lab and the university.

A Bridge to Better Care
Filling in – or bridging - the Valley of Death, (feel free to pick your metaphor), is important for improving healthcare because there are so many serious conditions where current treatments are very inadequate. For example, Parkinson’s is one of many neurodegenerative diseases where existing treatments address some of the symptoms – and often only partially or temporarily – without effecting the course of the illness. Similarly, while significant advances have been made in treating cancer, those successes have been in select types of cancer, (with leukemia being one good example), or have made the treatments much easier for the patient. Both of these are valuable, but it is also worth noting the recent article discussing how survival rates for cancer haven’t really increased over the last several decades.

The cure for this problem is clearly more (and better) research and development…. and the translational work that bridges the two. (Perhaps we should talk more about increasing R&T&D, rather than just R&D?) PAN’s description of how to do this is sophisticated and multifaceted. As their illustration below shows, not only are the NIH’s CTSAs and SBIR programs important for helping institutions and individual researchers push forward with more translational work, but other parts of the solution include DoD’s Telemedicine & Advanced Technology Research Center, and private foundations and venture philanthropy.

Increasing funding for translational work through all these sources may help build a bridge, (of fill in the Valley), but translational work will also benefit by greater coordination of efforts. At the institutional level that is part of the role of the CTSA’s, but there could also be more coordination and emphasis of translational work at the NIH itself – which is why PAN is recommending the NIH conduct an analysis and present their own recommendations for improving the translational activities of NIH funded research programs.

Institutional researchers could also benefit by having more resources about the nuts and bolts of translational work – like how to structure research and information so that it will be readily usable for filing an IND with the FDA. Universities already have Technology Transfer/Licensing offices that serve the dual function of licensing university generated research to private companies for commercialization and ensuring that the university receives fair compensation for the company’s use of these discoveries – which is required by the Federal Bayh-Dole Act. Perhaps universities should also have offices that work to educate their researchers about translational activities to help them plan their research so that the information they generate will be more readily usable by those farther down the development pipeline?

This is clearly not an easy nor readily obvious task. At the FasterCures/PAN briefing last week, someone told a story about an academic researcher who experienced a 2 year delay in moving their discovery along the development pathway because they didn’t understand the information that would be needed.

Rather than make specific recommendations about how to improve the situation for basic researchers, I’ll just note that the Bayh-Dole Act managed to get every institution receiving Federal grants to create a Technology Transfer/Licensing office. It seems that every institution could also have a Office of Translational Research Assistance too. How to structure the funding or financial incentives for this could be complicated, but certainly not impossible. And given that we are spending tens of Billions of tax dollars on biomedical research, we should also be doing everything we can to make sure that the discoveries coming out of that research gets translated into better treatments for patients ASAP. Delays because academic researchers don’t want to pitch their careers into the Valley of Death, shouldn’t be a tolerated part of the structure of our biomedical research system – which, as I’ve previously discussed, is one of the four spheres comprising our entire healthcare system.

Quality, Checklists, Patient Education, the TV Show ER, and Comparative Effectiveness

Posted on March 16, 2009 by Michael D. Miller MD

In case you missed it last week, amidst all the returning stars for one of the final episodes of the TV show ER, there was a dramatic Operating Room scene where Dr. Benton (played by Eric Lasalle) is “observing” the kidney transplant of Dr. John Carter (played by Noah Wyle), because as we see, the transplant surgeon is a very coarse and roughshod individual. The significance of the scene is that as the surgery is about to begin, Dr. Benton pulls out his pre-surgical checklist and browbeats the transplant surgeon into going through it – during which the nurses note their concern that they don’t have reperfusion solution in the OR, so they go and get some as the surgery starts. Since this is TV, this turns out to be crucial when the kidney develops a clot, and a delay in getting the solution could have meant the difference between success and failure of the kidney transplant. (Note – this connection may be taking a bit of artistic/entertainment license, but the point is that delays in having needed equipment or supplies can effect the quality of care.)

While Atul Gawande has written about such checklists in the New Yorker magazine, perhaps this fictional medical TV drama will help more people understand the importance of such quality improving steps, and even encourage them to start asking their doctors and hospitals if they use these types of quality improving checklists….. And if not, why not?

Physicians’ Perspectives
The next day I was talking with a physician friend, and mentioned the episode. I was both bemused and concerned that he said all the staff is his outpatient clinic were talking about the returning stars, and nobody had mentioned the checklist scene. We then talked about how physicians often think the way they do things is the best, yet generally lack any data to show how well they are really doing. We agreed that physicians have traditionally viewed checklist etc, as “cookbook” medicine that took away their autonomy. I pointed out that while this might be true on a very microscopic level, by systematizing what they routinely do in a way that improves outcomes, they can then focus their knowledge and skill onto the unique aspects of each patient’s needs.

This is similar to what a basic science researcher once told me about golf. (He is a near scratch golfer.) He told me that since the game has so many variables, more of them that you can eliminate the better you will perform. For example, always playing with the same clubs is obvious, but for the same reason you should also play with the same brand and type of ball and glove, and develop standard pregame and preshot routines. That way, you can focus on the variables you can’t control, such as the weather, the wind, the lie of the ball, etc. The same is true for clinical care. By standardizing the routine and repetitive actions according to protocols that have been shown to work well, clinicians can focus on what is variable and important. (This is also why I always keep the same set of things in one pocket: keys, chapstick, two blue pens, one red pen, and my migraine medicine. And why I always leave my keys, wallet, sunglasses, etc. at same place at home. That way I never have to spend time looking for things I use all the time.)

Collecting and analyzing data about individual physician performance is really going to be the next significant development in health reform and quality improvement. And it is already occurring in some places – such as within the health benefits program for Massachusetts government employees.

This data collection, analysis and reporting will be similar to what is being done for hospitals, and thus will follow the trend of taking technologies out of the hospital and using them in the outpatient world. However, as with all healthcare data analysis. the major challenge will be in adequately adjusting for patient differences so that physician performance is based upon realistically achievable outcomes rather than the severity of the patient’s underlying illnesses. (The limits of such risk adjustment have hindered the usefulness of hospital quality data reporting.)

Comparative Effectiveness
The recent stimulus legislation included $1.1 billion for comparative effectiveness research. Greater federal funding in this area has raised concerns among some people in the medical research industry because this research could focus on comparing one medicine to another, or a medicine to a device, etc. without adequate risk adjustment in the research – and then be used by insurance companies and government agencies to make coverage and payment decisions. And these concerns are legitimate because using such analysis and research for coverage decisions about medicines and devices has been done in countries such as England and Australia.

However, there is also an opportunity for comparative effectiveness research to be used to improve actual clinical practices by developing a broader array of checklists and other standardized protocols. This is part of the promise of electronic medical records, since they can easliy incorporate such standardized guidelines into their formatting. But from what I can tell, each brand and type of EMR/EHR has different standardizations and guidelines, and the way they display them can cause clinicians to quickly suffer from “alert fatigue,” so that eventually clinicians ignore all the suggestions and warnings – making them worse then nothing.

Aside from the technical issues of EMRs, the systemic challenge for successfully using comparative effectiveness to improve clinical care in this way is overcoming the resistance and fear of physicians. This factor almost ended the existence of the federal Agency for Healthcare Quality and Research, because its first major project, (when it was called the Agency for Health Care Policy and Research), found that surgery for low back pain was generally not indicated. This conclusion caused such a reaction in the medical community that Congress almost stopped funding the entire agency.

Conclusions

Innovations that are being used in hospitals will be increasingly used in outpatient clinics and private practices.
These innovations will not only be technologies, such as diagnostic tests, but also methods of care, such as standardized checklists and protocols.
Using comparative effectiveness research to develop and validate the ability of such standardization to improve outcomes, will have greater effects on increasing quality of care and controlling costs than will research comparing different treatment options for individual diseases – even for very common and costly conditions like diabetes and CHF. This will be true because even if such research shows which treatments are best, if clinicians aren’t following these recommendations in standardized ways, the value of this knowledge for patients and the healthcare system will be dramatically diminished.
Including physicians, other clinicians, and other stakeholders in the development and implementation of standardized practices will be critically important for their successful adoption and use – because as was seen in the dramatization in the ER episode, big personalities of individuals can overshadow, subvert or sidestep the proper use of standardized practices so that they may be followed in substance, but ignored in spirit.

Transparency & Accountability for Physicians in Health Reform

Posted on March 12, 2009 by Michael D. Miller MD

Yesterday I had the opportunity to give Medical Grand Rounds at Caritas Carney Hospital in Boston on the topic of “Health Reform 2009 and Beyond.” Rather than compare and contrast various national health reform proposals, I reviewed the major forces and trends that are reforming healthcare, and explained how they would likely impact different stakeholder groups – particularly physicians.

I started by discussing the major trends in cost, access and quality – noting how the first two are easier to quantify and that the debate over access to healthcare services versus insurance coverage has been resolved in favor of health insurance coverage, because only having access to free clinics and emergency rooms doesn’t enable people to get the type of healthcare that they really need. The successor debate is what insurance needs to cover to be “adequate,” and what it means to be underinsured.

Transparency & Accountability
The heart of my talk was explaining the role of transparency and accountability in health reform at the national, state and private sector levels. (One of the earliest forms of transparency for clinicians was the National Practitioner Databank, which was created about 20 years ago to try and make it easier for the healthcare organization, insurers and government agencies to learn about adverse actions – such as malpractice suits and licensing board censures.)

“What are we getting for what we’re paying for?”
The most frequently discussed transparency initiative in healthcare is the big push for electronic health records. Information and transparency are being highly valued because as more detailed information about actual clinical and cost outcomes becomes available, it can be analyzed and used to make different parts of the healthcare system accountable for their contributions. (Note: the apparent dramatic lack of transparency and accountability that contributed to the collapse and impairment of so many financial institutions has fueled public calls for more accountability and transparency in many parts of society – including healthcare.)

Capitation was an early attempt to place accountability for the cost outcomes of individual patients onto healthcare organizations. However, because information connecting clinical decisions with overall costs was lacking, capitation was less than successful, and it often evolved into schemes to reduce the volume of care since that was the only measurement available related to total costs. Fortunately, accountability mechanisms have become more refined, and now include pay-for-performance, “episodes of care, and other forms of bundling of payments. (An example of an episode of care bundled payment would be a care group receiving a single payment amount for all the clinical services in a 30 day window for a patient receiving elective heart surgery.)

The common theme in this trend of transparency and accountability is that as costs continue to increase as a percentage of personal incomes, wages and GDP, insurance companies, private payers and employers, government agencies, and even patients are all asking, “what are we getting for what we’re paying?”

Power of the Pen
I also described for the physicians at Carney Hospital how as information systems become more sophisticated and can provide insights into the performance of smaller groups and individual physicians, more proposals and initiatives will seek to place greater accountability on the individual physicians because while physicians receive ~21% of all healthcare spending in this country, their actions influence how about 70-80% of each healthcare dollar is spent.

This concept is being translated into practice for Massachusetts state government employees, whose health benefits program has collecting and analyzing information about all the primary care physicians in the state, (and selected types of specialists), and then put them into three “quality tiers”: Excellent, Good, and Standard. Accountability is added to this transparency because patients seeing physicians in the “higher quality” tiers pay lower insurance co-payments.

There is significant controversy around this profiling and tiering program – particularly about what data is used and how it is analyzed. Certainly transparency and accountability are only valuable for creating positive changes when the data is valid and reliable – something I discussed with the physicians at Carney Hospital and have written about previously. The key challenge in making this type of data valid and reliable is how adequately it is risk-adjusted in the analysis so that clinicians and providers are “graded” based upon their actual skill and work, rather than on the type of patients they see.

Medical Homes as Positive Solutions for Physicians
Another example of how the “power of the pen” concept is leading to new models for accountability in healthcare is the Medical Home. I told the medical students, residents and attending physicians at Carney Hospital that Medical Homes might be a positive opportunity for physicians to improve the quality of care while accepting and managing more financial risk and responsibility. Since the details of Medical Homes can be very complex, my one slide description was: “Medical Homes are arrangements where a physician (or group) is responsible for coordinating individual patient’s care across all sectors of the healthcare delivery system and ensuring that the patient receives appropriate preventive care and self-management assistance.” Since financial compensation is often a concern for primary care physicians, I noted that payment for Medical Home services is in addition to reimbursement for traditional care services provided to patients, and it could be a flat (risk adjusted) payment per month per patient, while also including incentive payments for actually improving patients’ clinical outcomes and/or reducing the amount of healthcare spending they generated.

Challenges and Opportunities for Physicians
I concluded by noting that these changes present challenges and opportunities for physicians. The first challenge is that if physicians don’t participate and lead in discussions about national policy issues and local delivery system reforms, then changes will be made to them rather than with them. That is, they have the choice to “Lead or be Led.”

Such leadership also needs to be paired with collaboration – both within clinician communities and with other stakeholders such as administrators, employers, payers, government agencies and patients. (These are two of the “lessons learned” from Geisinger’s experience described by Paulus et. al., in their Health Affairs article last year.) During the Grand Rounds’ Q&A it was also noted that geography and location are important factors influencing the ability of physicians and hospitals to exert leadership and promote collaboration within communities. For example, Geisinger is the major healthcare delivery entity within a relatively contained geographic community. However, this observation illustrates the importance of multi-stakeholder collaboration, because without it, everyone is working in isolation, efforts are not coordinated, time and energy are wasted, and the outcomes provide little or no benefits to anyone.

Reviews & Outcomes
While the audience was attentive and only a few people left to answer pages, it is always hard to know how much a group benefits from this type of presentation. So I was very gratifying to receive this email review from one of the organizing physicians at the hospital:

“Thank you for the fabulous grand rounds at Caritas Carney Hospital yesterday. You obviously put a great deal of time and thought into presenting to us; your lecture was a remarkable overview of so many issues affecting our health care system today! You have a great mind to be able to have both the comprehension to understand these concepts, and the ability to synthesize numerous trends and ideas into an integrated presentation. Two of the best compliments to you are 1) docs stayed until the end of grand rounds and 2) our new insights inspired conversations and debates in hospital halls and offices all day long!” Mary Lou Ashur, M.D.

The last comment is precisely the outcome I was hoping to achieve, since just educating people about different proposals may not help build their understanding of the problems and possible solutions, not give them guidance for how they can get involved, etc. And from the picture below taken after Grand Rounds, I think everyone was happy with the result – even if I do have a funny smile.

Controlling Health Care Costs and Improving Quality with Effective Care Coordination

Posted on February 16, 2009 by Michael D. Miller MD

A study published by in the New England Journal of Medicine last week examining the effects of 15 different Medicare care coordination demonstrations received wide coverage by the general media. Unfortunately, much of this focused on the study’s overall finding that these programs didn’t reduce hospitalizations or Medicare spending. For example, the AP story’s headline, “Study finds bid to cut Medicare costs failed,” was used by many papers such as the Washington Times.

However, the actual study had much more complex, important, and useful findings, and the paper’s authors from Mathematica, (which Medicare contracted to do the analysis from this project), deserve a lot of credit for extracting meaningful information from this project.

Complexity of Medicare Care Coordination Demonstration Projects
The study was very complex and presented many analytical challenges, including:

The “study” involved 15 different and diverse “care coordination” programs: 5 disease management companies, 3 community hospitals, 3 academic medical centers, 1 integrated delivery system, 1 hospice, 1 long-term care facility, and 1 retirement community
Despite being called “care coordination” programs, the major intervention was nurses communicating with patients outside of the patients’ direct clinical care team
Most of the programs’ care coordinators didn’t have significant interactions with the physicians treating the individual patients – although reports were provided to the physicians
The primary outcomes the study looked at were hospitalizations and total Medicare costs

Given that physicians direct most clinical decisions and thus influencing overall healthcare spending, it is not surprising that third party programs were ineffective in changing clinical or cost outcomes. With the patient’s physicians not being directly engaged in the development and implementation of these programs, nor vested – either financially or cognitively – in the success of these care coordination programs, this outcome is not surprising. This is like expecting travel agents to improve the safety and efficiency of air travel, i.e. while they can provide information to individuals they are not engaged in the operations of the airplane or airports. [OK – that’s an overly simplistic example, but I think it helps make the point.]

Positive “Findings” From the Study:
Despite the disparate structure of the programs in this study, the authors found that the more successful programs:

Had greater in-person contacts with the patients – nearly 1 per month
Focused their efforts on individuals with higher Medicare costs
Had greater success educating patients on how to properly take their medicines
“Worked closely with local hospitals, which provided the programs with timely information on patient hospitalizations and enhanced potential to manage transitions and reduce short-term readmissions”
“Had frequent opportunities to interact informally with physicians”

Implications for Medical Homes
These findings reinforce the importance of focusing on the role of physicians in controlling and managing clinical care decisions – which overall account for up to 80% of all healthcare spending. This observation is consistent with the conclusions the authors of the Care Coordination study reach in their NEJM article about their findings being able to help support the implementation and success of medical homes: “The successful interventions also may offer more detailed lessons for medical homes about how best to educate and monitor patients, the types of patients for whom they are likely to be most effective, and how to help patients overcome barriers to better self-care.”

This is a very timely and important conclusion since Medicare is getting ready to launch a Medical Home Demonstration Project in 8 states – and possibly more through legislation enacted last summer. Medicare’s Medical Home Demonstration has a greater likelihood of improving quality and lowering costs than the Care Coordination project because the Medical Home Demonstrations will directly put the responsibility for care coordination and improving patient self-management on the patients’ individual physicians – as opposed to providing an outside service for patients. In addition, similar to the two somewhat successful Care Coordination projects, the Medical Home Demonstrations will focus on Medicare patients with chronic conditions.

Implications for Overall Health Reform Efforts
The Care Coordination study’s observation that the successful programs differed from the unsuccessful ones in how they improved patients’ compliance with medications also has implications for broader health reform initiatives. It makes sense that patients with chronic conditions who aren’t receiving adequate medicinal treatments would have increased costs and hospitalizations, and thus improving compliance would reduce both. This finding, along with studies about the costs associated with medication errors, point to the value of focusing on medication compliance and proper usage in initiatives for reforming healthcare delivery.

For example, improving medication compliance might be improved by creating better written instructions for patients. An analogy might be to the checklists that help surgical teams and physicians placing central IV lines reduce errors and infections. Individualized patient “checklists” created in a standard format could help patients with chronic conditions take their medicines correctly and thus improve quality and lower costs. And of course, these “checklists’ should also include ALL the patient’s medicines, reminders about avoiding certain OTC medicines and herbal supplements that might interfere with their prescribed medicines, and to urge them to promptly inform their physicians if they develop certain signs or symptoms related to their medical conditions.

All of this really goes back to the benefits of improving patient-clinician communications, and strengthening their joint engagement with the broader care team that includes pharmacists, nurses, specialized clinical educators, and family members as appropriate.

Strengthening Care Teams Through Better Communications
Such checklists and more standardization of care protocols – for use by clinicians as well as patients – should help foster this communications and team-base management. However, if they are viewed by anyone in the team as cookbook medicine, or impersonal standardization – rather than guidance to protect against overlooking important actions and opportunities – then these protocols will not produce positive clinical and economic outcomes. To encourage positive attitudes and actions about such quality improving changes, clinicians and patient advocacy leaders of all types – and at all levels – will need to be educated about the value of such shifts in clinical operations, and for them to be promoted as champions of these new paradigms for clinical care. (Group visits for patients with conditions like diabetes or congestive heart failure are an example of care delivery innovations that can increase quality and lower costs through greater efficiency and engagement of patients and their care team.)

Changing Reimbursement to Support Care Delivery Reforms
Making these changes to the clinical care delivery so that they are attractive to clinicians – both in private practice and in larger care delivery systems – will likely require altering reimbursement systems to change the financial incentives. The Medicare Medical Home Demonstration project seeks to do this by directly paying physicians for their medical home management activities.

While this Demonstration is being implemented, a more widespread and timely change in Medicare’s physician payment system may happen this year because of the unsustainability of Medicare’s “Sustainable Growth Rate” formula. Under the current SGR formula, Medicare payments for physician services are expected to be reduced by ~22% starting in January 2010. Deliberations to avoid this “broadsword” financial cliff may be a leverage point for making such changes – although it is unlikely that a dramatic, wholesale change will occur immediately. It is more likely that significant changes will be phased in over several years and across geographic regions. A gradual implementation makes sense since it provides opportunities for clinicians and Medicare enrollees to become familiar with the new payment and clinical delivery structures, it enables champions for better care delivery methods to be created, and it allows those who are more cautious to observe the changes while they are implemented for and by others.

Communicating Health Quality Measures

Posted on February 15, 2009 by Michael D. Miller MD

Educating patients, (a.k.a. “consumers”), to make the “best” health care choices has been a fundamental principle in some health reforms schools, including those advocating for more high-deductible health plans. While this concept makes sense in economic theories, it also requires belief that patients can and will make good use of the information available to them – particularly when they are ill.

Another fundamental necessity for making such consumer-directed healthcare work to improve quality and lower costs is that the information provided to people is meaningful and accurate. A study published in the November/December 2008 issue of Health Affairs illustrates the complexity of providing accurate information.

This study was based upon the very simple question, “How easy would it be for a patient in the Boston area to find the “best” hospital by using different quality rating services?” And the results were pretty fascinating: 5 different ratings systems designed to provide the public with quality information about individual hospitals didn’t agree on which were the best hospitals overall or even for specific conditions – even when the measure was death from a specific condition. For example, the article notes, “Neither the observed mortality rates nor the observed/predicted rates were consistent across [rating systems for Acute Myocardial Infarction]. The hospital ranked first by HealthGrades had the second highest observed mortality; it ranked seventh according to Mass QC [a state government run information system]. Conversely, Health Grades’ seventh-ranked hospital (the only hospital ranked statistically worse than average) was ranked first by Mass QC. This same hospital was ranked fifth in the nation by U.S. News and World Report for cardiology.”

Similarly the rating systems didn’t agree on the quality of care for heart bypass surgery:

Conclusions:
The study’s authors don’t just throw their hands up and profess rating systems to be complete failures. Rather they note that transparent quality information reporting can stimulate quality improvement activities within individual institutions, and they also make three recommendations:

Hospitals should embrace quality reporting and make sure that the data collected and the design of the analyses truly reflect the quality of care
Patient experiences must be a meaningful part of quality of care assessments
Quality rating systems must improve how they account for differences in the severity of illness of patients, (i.e. risk adjustment of the data), and for random variations

They conclude that more standardization of data collection methods, analysis and reporting may help improve the value of quality information and comparisons. These would be positive steps towards providing individual patients with better information they could use to compare their local hospitals rather than just to rate individual hospitals against national or regional averages.

Chronic Wellness Promotion v. Chronic Disease Management in Medical Homes

Posted on February 9, 2009 by Michael D. Miller MD

One of the hottest health reform topics is Medical Homes: Medicare has Demonstration Project starting this year, several states have implemented, (or are implementing), medical home related initiatives, the Center for Studying Health System Change (CSHSC) released a great white paper titled “Making Medical Homes Work,” and the New York Times just had a story about how IBM is teaming up with United Healthcare to promote Medical Homes for their 11,000 employees and dependents in Arizona.

Definition of Medical Homes
One of the controversies in Medical Homes is the definition. CSHSC and many others use the definition developed by 4 national medical societies which combines aspects of preexisting primary care and chronic care models with the goal of creating a primary care “home” that can more effectively address the needs of patients with chronic conditions.

Focus on Chronic Diseases – That’s Where the Money Is
This combination makes perfect sense since the majority of healthcare costs are used by the least well patients: In 2003, 80% of health spending went for 20% of people in the US, and the Agency for Healthcare Research and Quality estimates that 70% of healthcare spending is for treating chronic diseases.

[Source: Kaiser Family Foundation]

Emphasizing chronic disease management for Medical Homes reflects how most healthcare innovations, (including technologies, payment schemes, and care delivery changes), are first used in the most organized and intensive care settings - such as hospitals – and then migrate out into primary care and preventive settings, including home use and patient self-management. Thus Medical Homes’ focus on care coordination for chronic conditions parallels the decades old movement and growth in team-based care in hospitals.

Medical Homes and Wellness Care
Beyond improving chronic disease management, Medical Home capabilities should also help promote better wellness for all patients, i.e. the other 80% of people. Patients wellness from better exercise, diet and other actions could be improved through Medical Homes providing more targeted counseling and self-management training. Similarly, Medical Homes use of patient registries and reminder systems should increase compliance with vaccinations, prenatal vitamins, and reminders to follow-up on patient specific wellness interventions.

Long-Term Vision for Medical Homes
The long-term vision for Medical homes should include how they can improve clinical care for all people in a community – not just those with chronic or costly illnesses. As I work with payers, clinicians, and others about the desired characteristics of Medical Homes, this vision should help shape how payments for providing Medical Home services are structured and evolve, (e.g. PMPM for specific sets of Medical Home capabilities), and how additional compensation – such as bonuses – are constructed and modified to reward Medical Homes for achieving clinical and cost outcomes. Such a vision should also be part of our national long-term strategy for making healthcare delivery more efficient and coordinated, and transforming our delivery system’s culture to embrace the rapid adoption of change to provide greater clinical and societal value.

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