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Pretty much everyone agrees that we need to improve the quality of healthcare delivered to patients. We’ve all heard the frightening statistics from the Institute of Medicine about medical error rates – that as many as 98,000 patients die each year as a result of them – and we also know that the US spends about 33% more than most industrialized country on healthcare, without substantial improvements in outcomes.
However, a large number of quality improvement initiatives rely on additional rules, regulations, and penalties to inspire change (for example, decreasing Medicare payments to hospitals with higher readmission rates, and decreasing provider compensation based on quality indicators). Not only am I skeptical about this stick vs. carrot strategy, but I think it will further demoralize providers, pit key stakeholders against one another, and cause people to spend their energy figuring out how to game the system than do the right thing for patients.
There is a carrot approach that could theoretically result in a $757 billion savings/year that has not been fully explored – and I suggest that we take a look at it before we “release the hounds” on hospitals and providers in an attempt to improve healthcare quality.
I attended the Senate Finance Committee’s hearing on budget options for health care reform on February 25th. One of the potential areas of substantial cost savings identified by the Congressional Budget Office (CBO) is non evidence-based variations in practice patterns. In fact, at the recent Medicare Policy Summit, CBO staff identified this problem as one of the top three causes of rising healthcare costs. Just take a look at this map of variations of healthcare spending to get a feel for the local practice cultures that influence treatment choices and prices for those treatments. There seems to be no organizing principle at all.
Senator Baucus (Chairman of the Senate Finance Committee) appeared genuinely distressed about this situation and was unclear about the best way to incentivize (or penalize) doctors to make their care decisions more uniformly evidence-based. In my opinion, a “top down” approach will likely be received with mistrust and disgruntlement on the part of physicians. What the Senator needs to know is that there is a bottom up approach already in place that could provide a real win-win here.
Some 340 thousand physicians have access to a fully peer-reviewed, regularly updated decision-support tool (called “UpToDate“) online and on their PDAs. This virtual treatment guide has 3900 contributing authors and editors, and 120 million page views per year. The goal of the tool is to make specific recommendations for patient care based on the best available evidence. The content is monetized 100% through subscriptions – meaning there is no industry influence in the guidelines adopted. Science is carefully analyzed by the very top leaders in their respective fields, and care consensuses are reached – and updated as frequently as new evidence requires it.
Not only has this tool developed “cult status” among physicians – but some confess to being addicted to it, unwilling to practice medicine without it at their side for reference purposes. The brand is universally recognized for its quality and clinical excellence and is subscribed to by 88% of academic medical centers.
In addition, a recent study published in the International Journal of Medical Informatics found that there was a “dose response” relationship between use of the decision support tool and quality indicators, meaning that the more pages of the database that were accessed by physicians at participating hospitals, the better the patient outcomes (lower complication rates and better safety compliance), and shorter the lengths of stay.
So, we already have an online, evidence-based treatment support guide that many physicians know and respect. If improved quality measures are our goal, why not incentivize hospitals and providers to use UpToDate more regularly? A public-private partnership like this (where the government subsidizes subscriptions for hospitals, channels comparative clinical effectiveness research findings to UpToDate staff, and perhaps offers Medicare bonuses to hospitals and providers for UpToDate page views) could single handedly ensure that all clinicians are operating out of the same playbook (one that was created by a team of unbiased scientists in reviewing all available research). I believe that this might be the easiest, most palatable way to target the problem of inconsistent practice styles on a national level. And as Senator Baucus has noted – the potential savings associated with having all providers on the same practice “page” is on the order of $757 billion. And that’s real money.
I highly recommend a bottom up approach, not top down. That’s how you win docs and influence patients.
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As far as I can tell, there are very few physicians currently involved in the innermost circles of healthcare reform. This is concerning to me, not because I’m one of those “paternalistic doctors” who “drive up in their Porsches threatening to pull out of Medicare” but because I think that many policy makers don’t really understand the incredible complexity associated with doing the right thing for patients. Here is an excerpt from the WhiteCoat’s Call Room blog that perfectly illustrates why practicing good medicine often requires a break from protocol:
It isn’t just the patients who think I’m a bad doctor.
Based on the information from all the pinheads at Medicare’s “HospitalCompare” web site, I’m downright dangerous.
For those who don’t know about Hospital Compare, it is a site where the general public can compare the “quality indicators” for hospitals on measures deemed important by the AHRQ.
I failed to meet a couple of indicators recently, so I received notices from our hospital administration that I am now considered out of compliance with the HospitalCompare guidelines and am bringing down our numbers on the HospitalCompare.gov web site.
In other words, Medicare thinks I’m a bad doctor.
Let me tell you about the patients I screwed up on.
The first patient was a gentleman in his 70’s who started having chest pain at home. He got sweaty, passed out, and hit his head on the concrete floor in his house, causing a nice goose egg on the back of his noggin. When he arrived in the emergency department, he was still having chest pain, so we hooked him up to an EKG and … lo and behold … he was having a myocardial infarction.
According to the quality indicators at “HospitalCompare”, if a patient with a heart attack is going to receive thrombolytics (”clot busters”), the thrombolytics must be given within 30 minutes of the patient’s arrival at the hospital. If a health care provider takes longer than 30 minutes to administer thrombolytics to someone with a heart attack, the government considers that provider to be practicing bad medicine.
Now I’m faced with a choice:
A. Do I give clot busters to someone who sustained a significant head injury (and may be bleeding internally) so that I can look like a “good doctor” to Medicare and HospitalCompare.hhs.gov? If there is bleeding inside his brain, clot buster medications will make the bleeding worse and could kill him.
B. Do I perform a CT scan on the patient to make sure that there is no bleeding inside his brain before I give the clot-buster medications? If I do the CT scan, there is no way that we’ll get the results and be able to give the patient thrombolytics within the 30 minute window.
If I choose “A,” the hospital stays in the upper echelon of facilities that meet HospitalCompare.hhs.gov’s guidelines. Doesn’t matter if the patient dies – according to Medicare, “We’re Number ONE!”
If I choose “B” I’m doing what is right for the patient, but our hospital will look bad and HospitalCompare.hhs.gov will plaster it all over the internet that our hospital doesn’t follow Medicare’s rigid and sometimes life-threatening guidelines.
I chose “B.”
According to HospitalCompare.hhs.gov, my decision made me a bad doctor…
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When I first heard about the new emphasis on comparative clinical effectiveness research (CCER) in Obama’s economic stimulus bill I thought, “Thank goodness! Maybe now science will truly regain its rightful place and we’ll end the CAM, ‘me-too’ drug, and excessive-use-of-technology madness that is wasting so much money in healthcare.” In fact, I was so excited about the new administration’s apparent interest in objective analysis of medical treatment options, that I intended to write a jubilant blog post about it. However, as with most things that seem black and white at first glance, further analysis reduces them to shades of gray.
What Is Comparative Clinical Effectiveness Research?
The new economic stimulus bill, also known as The American Recovery and Reinvestment Act (ARRA) includes 1.1 billion dollars for clinical comparative effectiveness research. Interestingly, CCER is not defined in the bill though AHRQ describes it this way in their glossary:
“A type of health care research that compares the results of one approach for managing a disease to the results of other approaches. Comparative effectiveness usually compares two or more types of treatment, such as different drugs, for the same disease. Comparative effectiveness also can compare types of surgery or other kinds of medical procedures and tests. The results often are summarized in a systematic review.”
Any mention of “comparative cost effectiveness” or value-based language is notably absent.
How Does It Work?
The government’s new CCER initiative will be administered through a Federal Coordinating Council for clinical comparative effectiveness research. The FCC consists of a group of 15 federal employees, half of whom “must be physicians or other experts with clinical expertise.” [Meaning, none have to be physicians.] Some have suggested that the FCC is the first step toward an organization modeled after Britain’s National Institute of Health and Clinical Excellence (NICE). NICE is regularly tasked with helping the NHS to decide which medical treatments should be available to their beneficiaries, and which should not be covered (based on their efficacy and cost).
The budget for the CCER will be divvied up as follows:
400 million – left to the discretion of the Secretary of HHS with 1.5 million to go to the Institute of Medicine for a report regarding where to focus CCER attention initially
400 million – to the office of the director, NIH
300 million – to AHRQ
Here is a quote from the ARRA bill, discussing the mechanics of CCER:
“The funding appropriated in this paragraph shall be used to accelerate the development and dissemination of research assessing the comparative clinical effectiveness of health care treatments and strategies, including through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data: Provided further, That the Secretary shall enter into a contract with the Institute of Medicine, for which no more than $1,500,000 shall be made available from funds provided in this paragraph, to produce and submit a report to the Congress and the Secretary by not later than June 30, 2009 that includes recommendations on the national priorities for comparative clinical effectiveness research to be conducted or supported with the funds provided in this paragraph…”
A Game-Changer For Pharma, Medical Technology, and Biotech
There is no doubt that CCER stands to radically change how industry does business. I anticipate that industry will develop their own internal CCER teams, and begin the process of comparing their new product (to others currently available) as early as phase 3 clinical trials. By and large, that’s probably a good thing – though there are potential unintended consequences that deserve mention.
While it’s appropriate for drug, device, and equipment manufacturers to consider whether or not their new product actually contributes something new/better to our current cadre of treatment options, there will be clear winners and losers in this game. And when companies lose, we lose companies. That’s generally not good for the economy. Manufacturers without diversified product lines are more likely to go out of business – and it will become more difficult for new players to enter the marketplace.
Although comparative clinical effectiveness research is distinct from comparative cost effectiveness research – it is likely that payers will use CCER to build their formularies. This means that even though the government (at this point in time) is not mandating coverage decisions based on CCER, health insurers are going to be using the information liberally to justify coverage preferences and even potential denials of coverage.
There’s also the question of stifling innovation. Blockbuster drugs are rarely discovered in a vacuum. They are the result of incremental steps in understanding the biology of disease, with an ever improving ability to target the offending pathophysiologic process. The first few therapies may offer marginally improved outcomes, but can lead to discoveries that substantially improve their efficacy. If an early drug is found to be only marginally better than the standard of care, an unfavorable comparative effectiveness rating could kill the drug’s sale. Without sales to recoup the R&D losses and reinvestment in the next generation of the drug, development may cease for financial reasons, and the breakthrough drug that could cure patients would never exist.
As Dr. Rich argues in his excellent blog: healthcare rationing is inevitable – but it’s more ethical to do it overtly than covertly. I would also like to suggest that insofar as physicians can be enlisted to translate CCER for patients (rather than being handed down inflexible rules from on high) and help them make the best decision for them – that would be even better. The inflexibility of national decisions about healthcare rationing does make me nervous.
What’s Good For The Geese Isn’t Necessarily Good For The Goose
First of all, most key healthcare stakeholders would like to be able to compare efficacy of one treatment option over another. Informed decision-making is hard to do when head-to-head studies are simply not available for most treatment options.
However, population-based conclusions do not always provide a clear “best choice” for individual patients. Individual genetic differences, allergy profiles, complicated drug regimens, unique constellations of diseases, socioeconomic factors, and psychological issues all influence clinical decision-making.
Dr. Nancy Nielsen recently voiced concern about CCER at the Medicare Policy Summit. She said that the AMA’s position is that CCER is for information purposes, not for coverage decisions. CCER’s goal is to help patients make informed choices, not limit their choices. I’m afraid the horse may have already left the barn on that one – but I agree with Dr. Nielsen’s sentiment. It would be wonderful if CCER could remain in its supportive role for shared physician-patient informed decision-making. My fervent wish is that in doing the right thing by the geese, we don’t kill off the occasional goose. Physicians need the flexibility to make exceptions when necessary for their patients.
A certain degree of hysteria related to CCER has recently wafted up through the hallowed halls of government. Are republicans overreacting to the bill? Maybe – though the bill doesn’t include any provisions for using CCER to mandate coverage decisions or ration care, it seems that Pete Stark has made it clear that he’d like the FCC to “direct medicine” which does kind of send a shiver down my physician spine, and provides some insight into what some democrats are hoping to accomplish with CCER – laying the foundation for future government involvement in the diagnosis and treatment of patients.
Also one particular congressional report is proving helpful in “reading the tea leaves” regarding the democrats’ plan for CCER. In describing the comparative effectiveness provision, the report states that items, procedures, and interventions “that are found to be less effective and in some cases, more expensive, will no longer be prescribed.”
While congressional reports are not binding, they do give an indication of intent.
The bottom line is that though CCER is not supposed to be used for “cost effectiveness” decisions – there’s no policy in place to protect that from happening.
Information about the comparative clinical effectiveness of treatment options is critical for the practice of evidence based medicine. Such information supports informed decision-making, and could be the single most important strategy for reducing the use of wasteful or ineffective therapies in healthcare.
On the other hand, CCER will certainly have some negative consequences, both anticipated and unanticipated. When “cost effectiveness” conclusions are drawn from clinical effectiveness data, rationing ensues, patient choices are limited, people lose their jobs, and some companies go out of business. As a recent article in the New England Journal of Medicine points out, “saying no isn’t nice.” I greet this 1.1 billion dollar initiative with muted enthusiasm.
In my research for this blog post I came across some interesting quotes. I thought I’d add them here for your consideration:
And before you tell me we need such bills in order to be more scientific, take a minute and ask yourself just how scientific you think the government will be when it applies cost-cutting measures to medicine. The congress is certainly a hot-bed of evidence-based legislation, isn’t it?
– Edwin Leap, M.D.
When things go wrong, which of course they will, we reach for 2 tools to try to fix them: rules, and incentives. We see this at work in our response to the current financial crisis – but the truth is that neither rules nor incentives are enough to do the job.
When we turn increasingly to rules and incentives, they may make things better in the short run but they create a downward spiral that makes them worse in the long run. Moral skill is chipped away by an over reliance on rules that deprive us of the opportunity to improvise and learn from our improvisations, and moral will is undermined by an incessant appeal to incentives that destroy our desire to do the right thing.
Without intending it, by appealing to rules and incentives we are engaging in a war on wisdom.
Don’t get me wrong, we need rules. Most Jazz musicians need some notes on the page, and we need more rules for the bankers, God knows. But too many rules prevent jazz musicians from improvising and as a result, they lose their gifts – or worse, they stop playing altogether.
We need incentives – people have to make a living. But over-reliance on incentives demoralizes professional activity. It causes people who engage in that activity to lose morale, and it causes the activity itself to lose morality.
– Barry Schwartz, Ph.D. from his lecture at TED
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By Stacy Beller Stryer, M.D.
Bristol Palin hasn’t said anything new or different than the other teen moms I have met. When asked, every teen mom I have spoken with has said that she loves her child but it has been very difficult and, if given another chance, she would never have had a baby as a teen. All would have waited until they were much older. Bristol Palin says 10 years older. When I worked on the Navajo reservation, I did a program at a local high school where I invited teen moms to come in and speak to the students. They spent quite a long time talking about how difficult it was to have a child and how their lives, as they knew it, were gone forever. These teen moms advised every student to wait as long as possible.
During her recent interview, Bristol commented on how she is no longer living for herself and how her new life is not “glamorous” at all. And, although her son is not even two months old yet, Bristol has decided that she wants to become a spokesperson for the prevention of teen pregnancy. This teen mom thinks that merely telling a teen to be abstinent is not realistic.
Although the teen birth rate had been decreasing steadily for over a decade, the most recent national data, compiled in 2005 and 2006, documented a 3% increase in teen births from 40.5 to 41.9 births per 1,000 girls ages 15 to 19. This increase was seen in almost every age and racial group. During a similar time period, teens surveyed in schools nationwide more frequently reported being sexually active and less frequently used contraception, when compared to the previous decade. Experts in the field have speculated as to why these numbers have begun to increase again. Possible reasons include societal changes, recent high profile teen pregnancies (such as Jamie Lynn Spears and, yes, Bristol Palin), positive display and lack of consequences when sex and teen pregnancy occur in the media, fewer educational programs available, and changing policies within the nation (such as teaching abstinence only as the only alternative).
Bristol is lucky because she has a lot of family support, both emotionally and financially. However, most teen moms don’t have much help, and they face extreme financial difficulties. Teens, who are used to following their own schedule and thinking mainly about themselves, must deal with being awakened multiple times a night and basically being at their baby’s beckon call. They can no longer shower when they want, sleep when they are tired, and eat on their own schedules. Teen moms must also deal with the increased risk of medical problems in themselves and their children. They are less likely to have adequate prenatal care, their babies are more likely to be born early, at a lower birth weight, and to die in the first year of life.
In terms of education, it becomes difficult for teen moms to even finish high school. Only 40% of teen moms graduate from high school, compared to 75% of those who don’t have kids. Plus, teens are more likely to live in poverty, as greater than 75% of unmarried teen moms go on welfare within 5 years of having a baby. Their children also suffer. About 78% of them live in poverty, compared to 9% born to married, women over age 20 who have graduated from high school. These children are also more likely to do poorly in school and drop out before graduating high school.
Unlike other high profile teen parents, Bristol is speaking out. She is telling teens to wait to have kids. And she is telling adults that teaching abstinence is not enough. We need to be discussing these topics at school AND at home. We need to know where our teens are when we’re not home. And they need to know about sexually transmitted diseases, teen pregnancy and contraception before they have a sexual relationship. They must be prepared.
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By Stacy Beller Stryer, M.D.
I attended a school meeting last night – the second in two nights for my daughters, who are entering middle school and high school, respectively. My younger daughter will be entering a magnet school, while my older daughter, who is graduating in June from the same magnet school, will be starting an accelerated program within her local high school. Let me add that we live in one of the most rigorous, high-achieving counties in the United States. I am excited for both of them and, obviously, academics are stressed within our family. I want them to be excited by their studies and to push themselves to succeed.
Yet I worry about the stress that surrounds this type of environment – stress which is initiated by all – teachers, parents and the students themselves. The meeting last night included a panel of students in the accelerated high school program, each discussing various aspects of their academic and extracurricular lives. What struck me most were two things. First of all, by the time they graduate, these students will have taken an average of almost 10 AP (advanced placement) classes – classes where they can take a test to get college credit. Last year, two students had taken 13 AP classes in high school. The majority of the classes they took which were not AP were either honors classes or courses which were accelerated in some other way. The second thing that struck me was the sheer number of extracurricular activities some participated in on top of their academic schedule. When did they have time to eat or sleep? When I asked them how many hours they slept each night, the program director quickly brushed off my question and moved on to the next.
Stress in teens has become a great concern in society today, particularly for girls who not only want to succeed academically, but also in sports, social settings, and with regards to their physical appearance. These days many teens are not satisfied with just doing a good job, but they want to do the best job. So if somebody is taking 9 AP classes, they want to take 10. They don’t just want to be on the tennis team, but they want to be the captain of the team.
Stress takes its toll on teens. It increases irritability, anger, moodiness, feelings of hopelessness, inability to concentrate and sleep. It also increases physical complaints, such as stomachaches and headaches. Lack of sleep causes similar problems, plus decreased school and motor performance. It can also lead to school resentment, school burnout, and experimentation with alcohol or drugs to cope with the stress.
How do we stop this steep incline? We certainly want our children to succeed, and I am no different from the next parent. We are proud of our children when they have drive and ambition – and when they do well. After all, these are characteristics which are important and helpful in becoming successful adults. Yet, as adults, both parents and teachers need to know when to put on the brakes and slow our kids down. We need to find out how stressed our kids really feel, how much they actually sleep, and whether they are able to find time to relax for awhile each week. Perhaps we can encourage our children to take an elective rather than that 11th AP course, or to go out with their friends on a Saturday rather than spend the entire weekend studying. We don’t only want our kids to be successful, but we also want them to be happy. Don’t we?