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Wednesday, May 29, 2013

Dear FDA (Food and Drug Administration), Please stop regulating the wrong things (ultrasound machines and fecal transplantation).

The Food and Drug Administration was created in 1927 in order to carry out the mission of the Food and Drug Act put into effect by Theodore Roosevelt in 1906. In the early 1900's and before, patent medicines killed and maimed people in gruesome ways and adding chemical substances to foods to mask the fact that they were rotten or substandard was felt to need some sort of legal response. The FDA initially was predominantly an organization designed to regulate sales and interstate transport of foul and dangerous foods and medicines.

Over the years the job of the FDA has expanded as technology has advanced, to include evaluation of new drugs and devices, including those designed and produced outside the US. The FDA has undoubtedly protected countless people from poisonous and malfunctioning medical products. There have also been stories of egregious failures of the FDA (see this New York Times article of 2009 regarding their inability to police conflicts of interest in biomedical research) which are often attributed to lack of funding and overwork.

In the last few weeks the FDA has caused me, personally, significant grief and frustration. I am shocked and angered, as a citizen, when cortisone products containing mold result in death and disability in hapless patients and when food additives which contribute to a nationwide obesity epidemic go unchecked, but a couple of things hit closer to home than these.

I have been shopping online for the last 8 months for an affordable ultrasound machine that I can use to train myself in some of the more specialized applications of the technology. I can't see spending $40,000 for an American machine, so I have been looking at who in the world produces ultrasound machines for the rest of the world, which also can't afford the super expensive technology. I found the perfect machine, a laptop sized scanner with 4 different transducers, so I can get good at vascular, thyroid, musculoskeletal and intestinal ultrasound, and was able to buy it from the Chinese manufacturer for a bit over $4000. I thought that after learning how well it worked it would be something that I could afford to donate to a project overseas. It was delivered to the shores of the US last week and is probably not going to ever get to me because it is not FDA approved. Ultrasound machines are felt to be of low to minimal risk to humans, so the FDA approval process is not as long as for, say, invasive medical devices, but it is too laborious and expensive for Chinese companies to go through, especially with their lower end models which they can sell just fine everywhere else in the world. I wrote the FDA investigator a letter explaining my plans but I think the chances of getting my machine are pretty poor.

The other potentially life threatening stupidity regards the increasing use of fecal transplant to treat a very difficult to treat healthcare associated infection, Clostridium Difficile. I have written about this in several blogs, and will not further harp upon the details, but repopulating the intestinal flora of a person who has this particular infection (and probably several other conditions as well, such as inflammatory bowel disease and even obesity) really works, carries minimal risk compared to our standard of care and is really cheap. I now read that the FDA has decided it needs to regulate fecal transplant. They want to treat it as an "investigational new drug" (IND). This classification is primarily to protect the consumer while fast-tracking a drug which clearly is needed into regulated use. According to the FDA site, the purpose of FDA regulation of IND's is to regulate interstate transport and establish safety before development and marketing. These two purposes are completely irrelevant to fecal transplant, which never needs to be transported across state lines and needs no development or marketing. Also, if the substance to be approved is poop, I submit that poop is not one thing. Even if the FDA did approve or reject a particular stool as being safe and effective, that is hardly known to be the case for a different sample. Why, you may ask, is fecal transplant important to me personally? It is just such an fantastically great idea, with world shifting implications in terms of living in healthy harmony with our commensal bacteria, and it has also saved a couple of my patients.

Both of these situations are excellent examples of how the economics of medicine in the US, with endless deep pockets provided by insurance companies of all ilks, fails to support the development of therapies that do not make money and are inexpensive. If a therapy or device does not have a powerful company or set of financially interested advocates to get it into accepted practice, it can potentially go nowhere for a long time. And if such a thing does make it up through the grass roots to acceptance, the FDA is right there to throw up a roadblock.

So why? If they have inadequate resources and lots to do, can't they perhaps go out there and protect us against dangerous things instead of fussing with fecal transplants and my ultrasound machine? There was an outcry early in the AIDS epidemic at which time the IND fast track and several other modifications of FDA procedures helped to allow medications into the market for patients dying for lack of options. It took some really powerful physician advocates and dying poster children to get these changes made. Perhaps a champion will stand up for the many other great ideas failing to thrive due to inappropriate regulation.

Saturday, May 25, 2013

Why are health insurance premiums still rising this fast? Blue Cross proposes hike of 24.7% for county employees.

This morning when I got the local paper, I was greeted with a lead article which reported that Blue Cross of Idaho was asking the county to pay 24.7% more for employee's premiums in 2014. Nobody can afford something like this. They will, of course, start looking for alternatives.

I remember similar situations in the clinic where I worked for 12 years, a group that had about 35 employees. We would be happy enough with our insurance plan, which cost too much but did give us reasonable medical coverage, and then the premium prices would rise, significantly faster than did our revenues. We would scramble around, getting quotes and weighing options, engaging in negotiations and eventually would have to switch everyone to a different company with slightly worse healthcare coverage and fill out many forms, with no guarantee of a stable premium or benefits for the following year. As a physician I had access to the health insurance for the group, but very soon opted out because it was so expensive, had benefits I felt I wouldn't use, and because I could actually do better in the individual market.

My individual market experience was not without its disappointments, as I faced 20+ percent premium hikes yearly, but did allow me to decide on a plan based on my family's individual needs (which, thanks to the irrational bounty of the universe in its inscrutable unfolding, were minimal.)

But since that time we have passed the Affordable Care Act (ACA), a healthcare reform bill that seemed to have promised to make insurance companies behave as good citizens. Is it really possible that Blue Cross will hike premiums by 24.7% in one year to our county employees? And this is a rather large group of customers, a significant negotiating force. What will individually insured people and smaller groups see this year?

I went back to the affordable care act to read what it actually says about insurance reform. What changes has it made or will it make to allow us all to be insured in the America of the future in which we can afford basic and not so basic healthcare?
  • In 2010 the Patient's Bill of Rights went into effect which gradually increased the cap on lifetime payouts for essential medical costs. Now this cap can be no lower than 2 million dollars, and by 2014 there will be no cap. Children with pre-existing conditions cannot be denied coverage, and that will eventually be broadened to include pretty much everybody. Adult children up to age 26 can stay on their parents' insurance plans, even those funded by employers. Certain preventive care, including cancer screening and diabetes treatment, need to be paid in full by insurance, without co-pay.  Patients with medical conditions or pre-existing conditions can get what should be affordable insurance through the government under the Pre-existing Condition Insurance Program, if they have been uninsured for over 6 months (which sounds pretty bad to me, definitely courting disaster to wait 6 months.) These reforms are not universal--certain "grandfathered" health insurance policies which have remained essentially unchanged for years can continue as they are, not complying with these regulations, and in 2013, 27.4% of employers still offered grandfathered plans to their employees. The number of people on these plans drops significantly every year.
  • Several regulations directly influence health insurance companies' costs and profits. In 2011, insurance companies were required to spend at least 80% (called the "medical loss ratio") of the money they took in on patient benefits (85% for large group plans.) Above that, 15 to 20% can go to administration costs and profits. If the entire 80 or 85% is not spent on benefits, it must be sent back to the consumer as a rebate. There are mixed reviews of how this has worked. It was thought that it ought to cut costs, but it kind of shoots itself in the foot. If insurers want to fund all of the profits and administration that makes them big and powerful, they just have to increase premiums and be sure to pay out at least 80% of those premiums on medical costs. If they can keep increasing premiums, then they don't have to do any work at all to decrease healthcare costs, because paying more for healthcare means they can also keep more money in profits and administration. Health insurers also can't save up for a bad year by making more profits on a good year which encourages strategic premium hikes, or so one economist says.
  • The ACA also requires states to review excessive premium increases, those more than 10% per year. Most states have that process up and running, with significant financial support from the federal government. There have been stories of health insurance companies backing down from rate hikes due to this process. I wonder, though, if they have responded to this by raising the initial asking price because they expect to have to bargain to reach a compromise. Insurance premium costs have gone up 131% between 1999 and 2012, which sounds like around 10% per year. This is, of course, far faster than the rise in our gross domestic product but would seem like a sweet deal compared to the 20+percent yearly increases that I have seen with my individual plan, and this proposed 24.7% increase that Blue Cross proposes here this year.
  • All insurance companies have to contribute to "transitional reinsurance" funds to help insurance companies pay for very expensive patients, as an incentive for them to provide coverage. This money goes to nonprofit reinsurance agencies which pay the insurance companies that insure these patients to cover their high costs. This also goes to fund a program which keeps early retirees on the insurance that they had received from their employers while they worked. The ACA also allows lower income taxpayers to get their health insurance tax rebates before the end of the year so they can actually use them to pay for health insurance. These regulations are called "Premium Stabilization Programs" which is kind of an overstatement, since premiums don't appear to be stabilizing. The transitional reinsurance fund seems like an awfully complex way to solve this problem, having insurance companies pay other insurance companies to pay them back for providing benefits. These programs are, however, temporary, and will be phased out in 2014 as nearly universal health insurance options become available.
  • In 2014 the ACA introduces the health insurance marketplace. This will be an online clearinghouse of health insurance options including many less expensive and subsidized programs for low income households. Many more patients will be insured through fully funded Medicaid programs, and side by side comparisons of health insurance plans will improve competition and make becoming insured easier. As I look at it, this will be better than what we have now, and allow many more people access to basic healthcare. I don't see it reducing costs in the long run, though. Still, civilized countries make basic healthcare available to their citizens, and it behooves us to join the ranks of civilized countries in this respect.
What will happen with this 24.7% premium hike that I read about in the paper this morning? I suspect Blue Cross will be talked down to some lower number by the state government. Premiums will probably still increase painfully, by double digits. The county may opt for a less expensive option and if the health insurance marketplace really fulfills its duty, in October of this year they may be able to shop for the best plan online. Whatever plan they decide upon will have excellent coverage for basic preventive services, because that is mandated by the ACA. Employees who want to opt out will have some reasonable options for individual insurance and some of them may qualify for subsidies. Some individuals and families will choose to go without insurance and pay penalties which will still be cheaper, in most cases, than paying for insurance. They will gamble that their health will remain good through the year. As insurance companies pay for more of healthcare, unless we make some deliberate changes, that care will continue to get more expensive, and those who choose not to be insured will find costs of unexpected injury or illness devastating financially (which they already do.) I look forward to getting my yearly love note from Regence Blue Shield of Idaho, letting me know what expensive options exist for me as my super-high deductible plan becomes obsolete in 2014. Stay tuned.

Friday, May 17, 2013

A better POLST (Physician's Orders for Life Sustaining Treatment) and informed consent for resuscitation: can we do this better without "playing God" ?

To resuscitate or not to resuscitate--that is the question. Whether 'tis nobler to beat the heck out of a person on his or her way out in the hope of saving his or her one precious life, or to allow death to proceed at its own pace with expectation of a peaceful passing.

The United States has come a long way in the last 2 decades since 1991 when the Patient Self-Determination Act was instituted. In most hospitals patients are asked what their wishes are regarding resuscitation and many states have instituted POLST (Physician's Orders for Life Sustaining Treatment) forms which spell out which interventions are acceptable to individual patients when they are very sick, things like blood transfusions, antibiotics, feeding by nasogastric or gastric tubes, intubation and ventilation and chest compressions and electrical cardioversion in the event of cardiac arrest. Theoretically we discuss these things with every patient when they come into the hospital, but we don't really do it very well which results in misunderstandings and needless misery.

When the patient is competent to discuss life sustaining treatments the conversation often goes like this:

Doctor: What would you want done if your heart were to stop? Would you want us to do chest compressions and put a tube down your throat so we can support your breathing?

Patient: (thinking, "Why are they asking me this? Am I gonna die? Of course I want them to save me. My heart could stop right now! What about my grandkids?") Sure I'd like that. Just give it a try. But I don't want to be kept alive if I'm a vegetable.

Doctor: (thinking, "I sure don't want to break all of this nice guy's ribs and traumatize his upper airway and, if we did get his heart started again, have him helpless in the ICU while we try to decide whether to put a feeding tube down and send him to a nursing home. With any luck he'll die in his sleep when he's not in the hospital.") OK then. We'll put you down as full code. Just sign here.

I went online to see how other countries do this, and found that there is a great deal of variation. In many middle eastern countries resuscitation is performed on all hospitalized patients in the event of cardiac arrest, regardless of patient or family preference. In Australia there are many different policies which are different in different hospitals, and may or may not involve patient and family participation in decision making. In England the patient is involved in these discussions if he or she is competent, but if not, the doctor makes the decision, and if the family has an opinion this is taken into consideration but   the doctor really has the final say. I read an online discussion about an 86 year old nursing home resident in the UK with heart failure who was admitted to a hospital and suffered a cardiac arrest. He did not have CPR due to a nurse thinking he had a DNR order, which he did not. After the event it was agreed that CPR would not likely have saved him, but it was the discussion after the article that was particularly interesting. About half of the people said that it was terrible that mistakes like this ended in a patient not getting life-saving CPR and that in many cases doctors made these decisions and "played God." The other half were people who said that they had seen CPR on old people and it was brutal and hardly ever worked.

Clearly doctors should not get to or have to "play God." Clearly, also, people who we ask to make these decisions, patients or families, usually don't know what we are really talking about when we ask them to make a decision about resuscitation ("code status.") Physicians are much less likely than our patients to request resuscitation in the event of cardiac arrest. I think our values are pretty much the same as those of our patients, we just know more about what cardiopulmonary resuscitation and its aftermath really look like.

So here is a good solution that preserves the autonomy of the patient while allowing the physician to do his or her job, which is taking care of the patient while following our Hippocratic Oath to "do no harm".

Cardiopulmonary resuscitation (CPR), intubation and ventilation are medical procedures, just like a tonsillectomy or a hip replacement. There are expected risks and benefits. The risks are not insignificant and the magnitude of the expected benefits vary with each patient. If a patient really wants CPR, he or she or a surrogate decision maker should sign a consent form  (well in advance of experiencing a cardiac arrest) which includes risks and benefits. The benefits, of course, would be to live and recover enough to be able to leave the hospital. In the least complex patient, 1 in 5 of those who have a heart event which requires CPR can be expected to survive to hospital discharge. In the most complex, the expectation is 1 in 20 or less.  The risks include, but are not limited to: pain, broken ribs, punctured lungs, trauma to mouth, teeth and upper airway, aspiration pneumonia, loss of brain function, multi-organ failure, prolonged dependence on caregivers including being confined to nursing home, monetary expense, and all the usual complications of prolonged intensive care unit and hospital stays. Also, should we not be successful, loss of the opportunity to die in peace.

Presently our POLST forms say none of that. Different states have different forms, but I have been involved in completing ones in California, Oregon, Idaho and Washington and they share similarities. They start with a check box for CPR (cardiopulmonary resuscitation) or DNR (do not resuscitate, allow natural death.) Then there are other boxes specifying the general level of interventions, including comfort care (giving only treatments that provide comfort without attempt to prolong life), limited interventions (lengthen life, but generally not in an intensive care setting and not using advanced life support techniques) and full treatment (everything, dialysis, ventilator, electrical cardioversion, the works.) Then there may be questions about whether artificial nutrition by IV or tube is acceptable, whether blood products are OK, whether antibiotics should be used. It is really hard for a patient or family to get through all of these questions, and many of them are too complex for a person without healthcare experience to understand. Still, they are a good starting point for discussion.

In general the patients who I talk to just want me, as the doctor, to make the right decisions at the right time that are most likely to get them what they want. Most of them want as much good life as possible, the relief of whatever discomfort or disease brought them in, and to have this done as quickly and economically as possible so they can go home. We have no box for this on the POLST form.

I would propose that we should add this box, up at the top, as an alternative to "CPR" vs "DNR." I would propose that the choice be called "Resuscitation at the discretion of physician, guided by my goals of care." This would allow a nuanced decision about resuscitation--from none at all if the patient had been declining and not responding to treatment and was found unresponsive and pulseless (a situation which almost never results in success) to full resuscitation for a witnessed collapse with ventricular fibrillation in a patient who had a pretty good level of function.

This does, however, require another piece of paper, which I think should be part of any patient's admission to the hospital, and probably part of the chart at the primary care doctor's office. This would be "goals of care." There was an article in the New England Journal of Medicine last year that talked about altering our ideas of success in medical care to reflect how well we helped a patient achieve their goals rather than focusing on specific markers of disease control. Some patients value not being dizzy and not taking a bunch of expensive pills more than they value good blood pressure control, for instance. I think it is important to know, at the time of hospitalization, what a patient really wants. Do they really need to be discharged by a certain date or time? Do they have lousy insurance and need their care to be as thrifty as possible? Do they really value pain control, or sleep at night, or making sure to have a certain meal on time? Do they need quiet, or visitors? Do they want to avoid antibiotics or medications that can cloud their thinking? Do they think that spending time in a nursing home would be OK? Are they hoping to die in the hospital because their burden of disease is becoming intolerable? Do they want to make it home for Christmas or live until a grandbaby is born? We don't ask these questions and we should, or at least somebody should.

If a person chooses "CPR" or "RDP" (resuscitation at the discretion of physician) they, or their surrogate, really need to read and sign the informed consent form for resuscitation, because they do need to know what this means.

I hate filling out forms, but if they help focus treatment so it is more appropriate and if they help me understand my patients and communicate with them more effectively, I'm OK with that.

So... bottom line: In order to have patients make better decisions about resuscitation, we need to share more information with them and allow them to depend on our clinical judgement to help them have the outcomes they really want. To do this we should: 1. Add a box to the POLST form that specifies "resuscitation at the discretion of physician" as an alternative to "CPR" or "DNR".  2. Create an informed consent for resuscitation which makes clear expected risks and benefits and have everyone who wants resuscitation sign it. 3. Make sure that patients are asked about their goals of care at the time of admission to the hospital and that physicians read them and honor them as much as is practical. 4. For those unable to complete a POLST form or give informed consent for resuscitation, physicians should make the decision about whether to resuscitate based on most patients' goals of care and good clinical judgement. This is, after all, what we would do for such a patient with any other procedure that we perform in the hospital.

Monday, May 13, 2013

A rant on the hopelessly ill (of course it's not their fault) and how maybe mass media could help

I have been working in the intensive care unit and have been finding it ethically difficult to facilitate the care of the some of the hopelessly and incurably ill patients who rotate through. Many of these patients live in nursing homes that are qualified to manage patients on chronic life support, not just tube feedings or oxygen, but ventilators and tracheostomy tubes. They can live like this for years, with deepening bedsores and pasty disused limbs, foley catheters, rectal tubes or colostomies, with gradually increasing colonization by multidrug resistant organisms. They are brought to the hospital and then the intensive care unit when the bacteria colonizing their endotracheal tubes finally take hold and cause pneumonia or when a catheter in a blood vessel or bladder becomes infected or when one of their vital signs tells their caregivers that some unspecified thing is terribly wrong.

Once a person is on chronic life support, usually nobody talks to them anymore and it is assumed that they will continue as they are until something happens that no force on earth can stop and they finally take their eternal rest. We, as the medical establishment, must continue to use all of the fancy medications and procedures at our disposal to keep them alive. Usually nobody even asks the family anymore if they think that we should stay the course. None of the recipients of this care--family or patient--hear that care like this costs a million dollars a year or more.

Occasionally we can't stand to do the same heroics again or add more complexity and expense for clearly horrible quality of life, and then there are debates with all of the many involved people (and there are MANY involved people with each one of these folks) about medical futility, and what is the value of a life when it has become so very small. These debates are never settled for good, and are new and interesting for every patient, with heated opinion and bitter disagreement and misunderstanding. I spent hours, this week, convincing an ethics consultant that doing chest compressions on a 90 year old non-verbal demented woman with lung cancer and, most importantly, critical aortic stenosis was unconscionable, even though, 7 years earlier, when she could still talk, she had asked to be "full code." I explained that chest compressions do not cause blood to flow through a heart when the aortic valve will no longer open more than a smidgen, and thus the procedure was as futile as removing a non-diseased appendix because a patient requests it.

But it is not necessary to revisit the debates of medical futility, at least not tonight. People with good hearts and good minds, invoking the words of scholars and philosophers, disagree vehemently on what is futile and when a physician's responsibility to do no harm outweighs a patient or family's desire for us to do "everything."

What we really need is prevention. We need to work on the attitude and the economic pressures that lead people to be in advanced care nursing homes and intensive care units when they have no hope of gaining any sort of independence.

Some doctors think a lot about this sort of thing. They suggest that perhaps patients would not ask for million dollar a year heroics in order to lie in beds getting fed through tubes in nursing homes if they, or the family that requests that we continue to treat them, had some sort of financial responsibility. If they had to pay even one tenth of the costs, or one one hundredth of the costs, there would be considerably less of this kind of care. Perhaps it isn't such a bad solution. Even the very richest of people would have to face the question of the value of life support if continuing it meant $100,000 out of pocket costs per year. One might ask if there might be some actual societal value to maintaining a patient on life support when they are never going to be well enough to be off of it, and one might think of Steven Hawking, whose remarkable brain is able to function because his shell of a body is supported in all ways by medical technology. There are undoubtedly other examples, but I can't think of any.

I'm told that the amount of excessive end of life care that I have been seeing this year is nothing compared to how things are done on the east coast of the US, in New York or Boston, at the larger hospitals. There are wards devoted entirely to patients on chronic ventilator support, most of them severely brain damaged. These patients are not paying privately and are not on private insurance but usually have both medicare and medicaid, and are using the same dollars that are pinched tightly when it comes to providing care that might lead to greater independence and function in other recipients.

So--prevention. We need, somehow, to communicate to patients what we know as physicians about the human cost, as well as the very real economic cost, of keeping people alive by artificial means when they become very old or very sick or horribly injured. Americans are on the very edge of the spectrum of world societies in terms of valuing the individual and individual autonomy over the needs of the family or the community. Nevertheless, most people, when asked, will say that they do not want to live so as to become a burden on their family or friends. In a time of crisis, though, it is of great biological value to think only of oneself, and so decisions are frequently made to "do everything" when a person is close to death, which means that they must, after being saved, get really sick many times and eventually only die because we, as caregivers, are not quick or clever enough to save them. This equates to misery and loss of dignity at the end of life.

The end of life for the various people we care for can go different ways in the hospital, depending on the patient's or family's goals of care. If we have heard, quite clearly, that a patient wishes to die in peace when it seems that death is coming, we respond to a drop in blood pressure or high fever or loss of consciousness with clean sheets, soft music, coffee and cookies in the room for family members, pain medications if they are needed, clergy visits if appropriate. If we have not heard that, people rush to the bedside, shake and prod the patient, put in IV catheters, run fluids, perform CT scans, move the patient to an intensive care unit, attach EKG leads, voices are raised, invasive procedures performed. In the first case, the patient will usually die, though definitely not always, and the second case the patient will sometimes die, but may be resuscitated to do it again, hours, days or weeks, and occasionally even years later. Both scenarios have their place, but the first is vastly underutilized.

The cost of the aggressive approach is not inconsiderable. For the day of the decompensation, depending on what actually happened, costs run upwards of $10,000, and the whole hospitalization probably more than $50,000, even if we are unsuccessful. We don't like to think of money as influencing any decisions about life and death, but they are inseparable. Money used at the very end of life is not available for prevention of illnesses in other patients, which interventions cost much less and buy much more happiness and productivity. If our electronic medical records simply told us what each thing we ordered cost, and patients had easy access to that information, behaviors would be much different, and overuse of technology would be less common. We have tripled the use of imaging procedures such as CT scans and MRIs in the last 15 years without any clear improvement in outcomes, and it is likely that reducing our behavior of frivolously doing imaging will probably have no negative effect on our patients' health. Our overuse of antibiotics, especially expensive ones, is fueling an epidemic of drug resistant organisms in our hospitals, so if some financial information made us do this less, it would be great.

Because taking care of hopeless resuscitation disasters is very emotionally draining, it increases physician and nurse burnout and worsens the quality of care for everyone. I'm torn, much of the time, between the fact that I love working with excellent ICU nurses and discussing physiology with cardiologists and intensivists and the fact that the patients for whom I do this are without hope for recovery and are huge resource sinks. I even like the patients, those who can communicate at all, I just feel terrible about the system that got them there and put them in their impossible situations.

Maybe we, as a society, really do want to support patients with all sorts of life support technology rather than allowing them to die, unless they specifically refuse such treatment. I'm pretty sure there is no clear consensus on the subject. If we do want to do this, we must gracefully accept the fact that there will continue to be more people in this situation lasting even longer and costing even more as our technology improves. This means that we will be spending progressively more health care dollars at the end of life. If we also want to be able to take care of patients who have simple and easily treated conditions, our healthcare spending will rise significantly as a proportion of our national budget, primarily through the Medicare and Medicaid programs.

As silly as it seems, I think the solution may not be in forcing doctors to make more difficult decisions, but in effectively communicating what we know with folks who have very different backgrounds. In Brazil women used to have huge families, lots of children, which was economically very hard on the country as it modernized. When they got television, they started seeing soap operas in which women had only a couple of children, or even none, and had good and interesting lives. They then started having less children. No public health campaign, just a sort of sharing of stories, using the wonders of mass communication. We have these well loved doctor shows, ER, Gray's Anatomy, House, which show how cool it is to be in a hospital having technological medicine happen to you and being resuscitated from death to good normal life. These are the stories that are fun to watch and they are mostly not true. Could it be possible to make a popular TV show that actually shows things as they are and models the choices that those of us in the know would make if it were us our the ones we love who were desperately sick in the hospital? An infomercial even? A music video? Doctors don't particularly excel at this sort of thing but perhaps there's someone out there who will take the challenge.

Tuesday, May 7, 2013

Healthcare economics and history--how we got here and how we might get out. (Notes for my talk to the League of Women Voters)

Hello and thanks for coming.

I’m going to be talking about what has taken me away from my practice this last year and what I’ve learned about how healthcare is doing and why it’s so expensive. I’m going to talk about what’s going well and not so well and the ways we can have an impact for the better.

In 2011 my friend and nurse practitioner died unexpectedly and my longtime medical partner decided to move far away to take a different job. This left me and my remaining partner to take care of our large practice.  We were both also covering patients in the hospital so had no more room to accept new patients. It  turns out that almost no more outpatient internal medicine physicians are coming out of residencies, so recruiting a new physician was not going to happen. I had also been writing and speaking about healthcare reform for a few years and felt like getting more and new experience would help flesh out my understanding of what was going on. So I left my job and the patients I loved taking care of and, since November 2011,  I have been working as a hospital physician for hospitals in Oregon, Washington, California, Alaska and here at home. I have been studying internal medicine and have recertified with the Board of Specialties. I have learned to do bedside ultrasound and taken a one month fellowship in that at University of California, Irvine medical school. I also took 3 weeks to go to the Republic of Georgia and learn new songs and performed with a trio in Tbilisi. It has been a glorious and sometimes incredibly tiring adventure. I have learned a ton and met lots of interesting people, both patients and caregivers. I have written about 80 articles for my blog, some of which have been re-published by the American College of Physicians and on other websites. I don’t seem to run out of things to say.

The big problem with American healthcare is that we spend too much money on it and for that we offer it to fewer of our citizens than other developed nations. We are only 1 of 2 OECD (Organisation for Economic Co-operation and Development, 34 countries that joined together to promote economic development) countries that do not have some sort of universal healthcare. 17% of Americans at any one time have no health insurance, and many more are underinsured. Canada, for instance, requires access to basic medical care without copay and pays about $1800 per person in healthcare costs to America’s $2800 per person. For our higher healthcare costs, with have a lower life expectancy and a higher infant mortality rate. It is hard to compare countries in this way due to the diversity of our population, but the message is pretty clear. We are paying too much for our healthcare and we are not getting excellent results.

But you could have looked all of that information up on your handheld devices. The real question is why is this true and what can we do about it?

In 1965 a very popular program came into existence. President Lyndon B. Johnson signed Medicare into existence under title 18 of the Social Security Act. Before that time only half of seniors could afford health insurance.  Medicare made sure that older people, often on reduced or fixed incomes, didn’t die of disease because they couldn’t pay for medical care or perish from bankruptcy. Prior to this, elderly people paid the equivalent of $1000 of today’s dollars in a year without a hospitalization and up to $7000 with a hospital stay. This was paid for by family, out of savings and sometimes through charity or public assistance. The average per capita healthcare costs today are over $8600 in the US and over $10,000 for patients 65 and older. Health insurance had become more common even before the inception of Medicare and Medicaid, in the 1940s, but was more like our catastrophic policies are now. With Medicare and Medicaid many more people were insured and insurance was more often comprehensive. Since consumers were no longer exposed to a significant financial disincentive to obtain healthcare, use of services expanded and because it was not the consumer who paid the majority of the bills, costs rose. Because there were deeper pockets, technology blossomed, with more and more expensive treatments and tests. Insurance companies attempted to cut costs by increasing requirement for documentation of appropriateness of care, but this just increased the administrative burden which increased costs further. Higher costs were handed back to the consumer in the form of higher premiums, which made consumers even more eager to get their money’s worth by using health insurance benefits. More and more often insurance was provided by employers which further shielded patients from the costs of healthcare.  In 1965 healthcare spending was about 5% of GNP and today it is nearly 17%. Healthcare is big and getting bigger and it acts like a bureaucracy does with little incentive to downsize or become more efficient.

You may ask how universal health insurance coverage or even a single payer system will help fix this. The answer is that it won’t. Universal healthcare coverage will make sure that everyone at least theoretically has access to healthcare, but it will not in itself reduce costs. A single payer with really good oversight (since bureaucracies do get larger and cost more if left to themselves) could potentially dictate payment levels, but does not tend to motivate elegant solutions and small efficiencies.
So what does expensive healthcare look like from my perspective? I suspect many of you have seen it in action. I have been in hospitals lately which is a pretty good vantage point from which to see high costs, since hospital costs are the largest sector of the healthcare equation. Hospital costs make up about 850 billion of the 2.7+trillion dollars that the US spends on healthcare. Hospitals continue to spend way more resources to take care of patients than are necessary for good care. Although Medicare began in the early 1980s to pay hospitals for patients according to diagnosis rather than how much was done to them, other insurance companies continued to pay “fee for service” which is to say paying for each service that was performed. Doctors not employed by the hospital also are paid according to the volume of services done. Doctors are so used to doing unnecessary tests and procedures from decades of practicing in an environment where neither the patient nor the doctor suffers from excess costs that we feel that this is the only responsible way to practice.

So what do we do that is crazy expensive? Much of what I say refers primarily to the big hospitals where I have practiced, which represent American healthcare much more than our local hospital, where we are much more circumspect. What doctors do is to order unnecessary tests, ones which could be avoided by taking a good history from the patient or contacting the patient’s regular doctor for background. Sometimes that is done because the patient is admitted to the hospital after closing time for outpatient clinics or because of lack of time.  We recommend aggressive and technological approaches to diseases where a “wait and see” approach might work just as well. We do this because of a prevailing belief that to do more means that we care more.  We  also worry that if we are conservative with our use of resources our colleagues will fault us or we will look negligent should we end up at the receiving end of a lawsuit. Because of lack of communication between many care providers, hospitalists, specialists, intensive care providers, primary care doctors, patients are often kept alive far longer than they would have wanted, with much poorer quality of life leading to more unstable patients in nursing homes and specialty centers. Some of these patients, those requiring high level chronic support including ventilators and feeding tubes, can cost upwards of a million dollars a year, paid for out of public assistance programs such as Medicaid and Medicare. These patients develop multi-drug resistant infections which are a reservoir for infecting other patients, and become increasingly medically complex, taking physicians attention and time away from care of patients whose prognoses might be better.

There is a lack of elegant solutions to common problems because elegant solutions use less resources and the healthcare system grows larger and more powerful with increased resource utilization. With no limit to the amount of money available to pay for things in the healthcare arena, the solutions become larger and more expensive, rather than simpler and cleverer as they do in so many other sectors.

What are some examples? Every physician longs for a user friendly effective computerized medical record system that has good communication across different locations and levels of care. If you even barely scratch the surface, most physicians could tell you what they want and how it needs to work. They will also tell you that there needs to be one system for the whole country and that every office needs to have it. Instead we have many medical record systems and we can only reliably access information from the hospital in which we are working. Our communication with other physicians responsible for care, if not within the hospital are haphazard and usually by telephone, since we are unable to communicate via the medical record. A universal medical record is a very feasible option but it will not happen as long as large software companies can continue to make enough money through competition with each other by making mutually exclusive products. Our computerized medical records are often owned by large multinational corporations, are very expensive, don’t do what we want them to do and don’t talk to each other. They don’t have to be inexpensive or efficient since deep pockets which extend to everyone’s pockets by secret subterranean tunnels can pay for them.

Stress tests. When I graduated from medical school I learned to perform exercise stress tests in which we had patients exercise hard on a treadmill while we monitored their electrocardiogram to see if their heart would develop abnormalities to suggest a blockage in a coronary artery. This test was very helpful in some cases, but no good for patients who couldn’t exercise and less accurate for women. Imaging of the heart with ultrasound or using chemicals could help to make this kind of a test more accurate. The most accurate pictures were obtained when a nuclear isotope was injected which went to areas of the heart well supplied with blood. Nuclear isotopes, like thallium or technetium, are made in nuclear reactors or cyclotrons, which are big, expensive, few and far between. A third of the nuclear isotopes used in north America are made in a reactor in Chalk River, Ontario, Canada. They are unstable and must be used relatively soon after being made. There is also a special machine for detecting them and doctors must have 2 months of training plus many hours of radiation safety education to be credentialed to interpret the results.  Over the 25 years since I graduated from medical school the nuclear stress tests have all but replaced the standard exercise stress tests. Standard exercise stress tests, even at hospitals, cost around $200 and nuclear stress tests, which also involve a very significant amount of radiation exposure and concomitant cancer risk, cost over $5000. Are there no other less expensive tests that can do the job? Yes, there probably are, but there is no really good incentive to find them since, in the big economic scheme of things, a nuclear stress test pays so many salaries. When you think about it, there are the jobs of all of those people who work in the nuclear power plant, the truck drivers who get the isotope to the hospital,  the people who make the machines that detect the isotope, cardiologists, folks who teach radiation safety—the financial fallout is huge.

We also do too much technological medicine at the end of life, and similar economic pressures contribute to that. Obviously the very sickest patients are the ones who will soon die, and so we naturally pull out all of our very most hi tech medicines, tests and procedures in our patients’ last few usually pretty miserable days, weeks or months of life. To be fair, it is not always clear whether the hi tech offerings will cure a patient and restore them to function, but in many cases at least discussing what we are doing with patients and families might reduce the use of medical technology that prolongs misery. It has become the standard of care to do so much that, in other countries or cultures, would be seen as cutting edge and only used in extreme need. This includes routine use of multiple very expensive antibiotics when infection is only remotely expected and invasive long term IV catheters with risk of blood clots and infection as well as high cost for patients who may not even need intravenous medications, imaging tests from neck to groin for pain complaints which then lead us on wild goose chases due to incidental findings. Exploring humane ways to spend the waning days or more uses very few resources and is reimbursed poorly. Hospitals have palliative care teams which move this process away from the acute care doctor, but this fragments care more and often increases costs. Hospice, both at home and in specific inpatient hospice facilities is big business and associated costs are huge, as we continue to medicalize the process of death.

Third party payers also influence costs by becoming part of our network of communication.  I heard once that administrative costs are half of a hospitals actual expenses. I think that it is impossible to really estimate the burden of billing for services since a significant amount of all of what we do as nurses or doctors, especially in the realm of record keeping, is about getting paid to the highest level for what we do. Legal influences also increase the cost of the care we provide. There are various estimates of the impact of the risk of being sued for malpractice on the medicine we practice. That, too, will be very difficult to estimate, since a large portion of how we think, how we document what we do, how we communicate is influenced by the internal picture of a courtroom with lawyers asking us to justify our actions based on standards of care for our profession.

Costs in hospitals are higher even than they need to be for the admittedly technologically advanced procedures we perform. This is due to the fact that much of what is done in a hospital can’t be billed for, such as the work of social workers and discharge planners, nurses and nurse managers, administrators and janitors. There are uninsured patients who require care and who are unable to pay even a little of their expenses. Hospitals do not usually function very far in the black, so the high costs we pay for care is probably about right, though individual prices for things do not necessarily correlate well with their value. Without the burden of billing and without the perverse incentives of third party payment, though, hospitals could definitely be more efficient and considerably less expensive.

Despite perverse incentives, there are bright spots, movement in the right direction. The American Board of Internal Medicine has started the Choosing Wisely Initiative in which most of the fields of medicine have chosen to unveil the most expensive least effective most commonly performed procedures or tests and marketed that information to both patients and physicians. This includes information about what procedures are appropriate to do for low back pain or chest pain, when antibiotics are helpful, which preventive procedures work and for whom.

Antibiotics in hospitals are associated with the development of Clostridium Difficile diarrhea which can be disabling and sometimes fatal. Antibiotics for this are sometimes effective but often not. It has been demonstrated for over 50 years that transplantation of healthy stool into the colon of a person with this condition can be curative, but it has been extremely slow to catch on. Hospitals are finally starting to develop protocols for doing this and it is likely to revolutionize the treatment of this disease, using a procedure that, at least theoretically, could cost next to nothing.

The evil drug companies have come up with 3 drugs to replace warfarin (Coumadin) which will probably make the use of injectable anticoagulants with associated hospital stays very rare and, since they don’t require blood test monitoring, make patients with blood clots and atrial fibrillation less dependent on doctors’ offices. This will also reduce the very common complications that warfarin patients have of bleeding or clotting due to varying levels, which is responsible for many hospitalizations and much disability. We have been slow to adopt these medications since we are more comfortable with the very resource intensive use of warfarin, but these new drugs will allow many more patients to be treated for conditions at home rather than in the hospital.

The Affordable Care Act has set up money for various pilot projects that involve delivering care in more efficient ways, including use of midlevel providers such as nurse practitioners and physicians’ assistants, and these people are becoming more important parts of healthcare teams and often do a better job than physicians of monitoring and treating chronic conditions.

I just learned how to do bedside ultrasound and am very excited about its ability to streamline and improve care. Small and affordable ultrasound machines that can live in a pocket allow me, as a physician, to get real time information about the function of internal organs that can help guide appropriate care and can reduce the need for imaging and the delays and costs associated with that. It can also help to focus my test ordering so that the imaging I do order is more appropriate. At the American College of Cardiology a researcher just announced results of a study comparing the use of a handheld ultrasound to physical exam by a cardiologist and found that it was vastly superior in many important ways. This is no surprise to me since I have been using such a machine for over a year and the impact on patient care is huge. Medical students are now learning how to use this technology and though it may take some time for it to diffuse into common use, its time will come.

Alternative therapies that tap into the connection between the mind and the body, and the mind’s ability to promote healing are gaining some respect. Because there is no technology behind this, so it doesn’t make anybody very much money, it has been slow to catch on, but folks like Herb Benson at the Harvard Medical School and Jon Kabat Zinn have been pushing to make mind body medicine take its rightful place among the medical therapies that really work. In our community we have an increasingly popular program of Mindfulness Based Stress reduction which has made a very significant dent in the burden of misery for people with physical pain, anxiety, depression and sleep problems.
Our local hospital continues to look for programs that will allow it to serve the community better. Tiny hospitals like ours don’t make much of an impact on legislation and so novel models of payment such as ACOs (accountable care organizations) which try to reduce costs by coordinating care of patients and having healthcare organizations have financial incentives to be more efficient, do not fit us.  If our hospital, along with representatives of the medical community and community members, had the money all of us spend on the healthcare we get through insurance, we could much more than pay for our medical needs. It would also become financially as well as morally desirable to prevent illness and reduce our need for medical care. This is the idea behind health care cooperatives, organizations such as Kaiser and Group Health in the Northwest, which have been quite successful.  We will soon have a clinic that serves people with poor or no insurance, the CHAS clinic, which will help provide care that will keep people out of the hospital. Their model uses multiple sources of funding to defray costs.

But what can you do about this as an individual and as a voter and community member?
As an individual: have discussions with your physicians about your goals of care.  If a doctor doesn’t know what you want or care about, he or she will likely err on the side of ordering too many tests or consultations or treatments. If your doctor doesn’t want to talk about this, there is a problem. Keep in mind that many doctors do have time constraints, but if they are juggling less data because you asked them not to order that extra test or procedure, they may just have more time for you. Go to the Choosing Wisely website and see what it says about your particular condition. If you have questions based on this, print out the information and bring it to your doctor. Discuss with your doctor what you want at the end of life. Fill out an Idaho POST form or a 5 Wishes form and have it in your chart and in your possession, discuss it with those you love as well.  Live well. Eat good food, lots of vegetables and fruits, fish, local grains and beans, fish, make meat be a treat, not a staple, same with ice cream. Do the things that give you joy, and if exercise isn’t something that gives you joy, go out for a walk regularly anyway. Don’t smoke. Take as few drugs, legal or otherwise, as possible. Stay well so none of what I have talked about needs to apply to you.

As a voter and citizen: try not to make knee jerk Democrat versus Republican judgments about legislation regarding healthcare. Neither party has it right, at least not yet. Read the legislation and think about what it says. Remember that Medicare IS too expensive and that it is not necessarily headed in the right direction, so legislation to change it in some way is not necessarily evil. Question high cost care, even if it’s something that seems sacrosanct, like hospice or preventive services. Get involved in community projects that support good health especially those which bypass or partially bypass the whole healthcare payment machine.