It’s the prices, stupid.

Here’s a little nugget from Health Affairs, in many ways the flagship journal of health policy.

“Abstract: Cancer drugs account for a growing share of health care expenditure, raising questions about how much value is gained from their use. We used a proprietary international data set to examine real-world cancer drug consumption and expenditure in the period 2004–14 in Australia, Canada, France, Germany, Italy, Japan, Sweden, the United Kingdom, and the United States and to explore the value obtained. Even after adjusting for population and epidemiological factors, we found that the United States spent more than the other countries on cancer drugs, yet it often had lower utilization. All nine countries—most notably France and Japan—witnessed an improvement in neoplasm-related years of potential life lost, which suggests that although the costs of drugs have risen, their therapeutic benefits have increased as well. Net economic value derived from cancer drug expenditures appears to have remained positive, with base-case analyses indicating that the United States obtained an estimated $32.6 billion in net positive return from cancer drug care in 2014. However, the United States lags behind other countries in health gains obtained per dollar spent.”

doi://10.1377/hlthaff.2015.1453, Health Affairs May 2016 vol. 35, no. 5 813 – 823

So basically, we pay more than other nations, per unit consumed, and interestingly, use less overall. I admit the second half of that sentence flies in the face of some things I believed, and I may have to make some amends to the oncologists of America. But really, the only reason we pay more is because we, as a nation, are willing to pay through the nose in order to avoid the specter of “government interference in the free market”.  (The other nations all have national or quasi-national entities that regulate drug prices). I’m not impressed that the free market has done much for us in this area, other than enrich the pharmaceutical industry.  Other analysis says that that enrichment has not returned to us even singlefold, never mind manifold, in new drug discovery (which is always what pharmaceutical companies insist is the value we get for paying All The Money for their product.  I think it might make sense to try some of that government interference.  These are drugs that work, and are, for a change, important.  (Unlike, say, the Cialises of this world, which work but are less important-not unimportant, mind you-just less.

What does “utilization management” mean?

Having been at this for a few years now, I have found some disagreement about what an insurance company is doing when it performs “Utilization Management”. Physicians (many of them, not all; I’ve had at least one discussion during the course of my work with a physician who “welcomed my call, and was happy to discuss how they were taking care of this patient or any other”) will tell you that we are “dictating care”. That we are telling them how to do their work. While there’s something to that, they ignore the other side of the coin; the guidelines we use are required to be based on the best (or at least “good”) available science. Their practice, interestingly, is not.

Let’s take medications as a handy example. My employer has a guideline for statins, the most commonly used cholesterol lowering agents. It basically requires you to use the cheapest one first, and more expensive ones in a rough ascending order of effectiveness. (For the wonks, it’s simvastatin (cheap and fairly potent) followed by anything other than atorvastatin and rosuvastatin, followed by atorvastatin, followed by rosuvastatin). The reason for this stepwise use is simple: cost. Simvastatin and [anything lower than atorvastatin/rosuvastatin] are all (relatively) cheap. Atorvastatin just came off patent, so it’s a bit more expensive. Rosuvastatin is still on patent, so it’s stupidly expensive (relatively; we won’t discuss the hepatitis C drugs here).

“But”, you say, “Why not just go straight to the most potent drug?” Well, because the most potent drug is rosuvastatin (expensive), and most people will get good results on one of the less potent (and also cheaper) drugs. The next most potent is a tie between simvastatin (cheap) and atorvastatin (not as cheap, but less expensive than rosuvastatin). Most people, in fact, will do well on simvastatin, which is among the cheapest statins because it’s been around the longest. So the science says that the most cost-effective way (for the system; the individual patient sees none of this because they are mostly shielded from cost) to practice is to try simvastatin first, and then to ascend the ladder until you either get the result you need, or you get to rosuvastatin. If that doesn’t work, you need a second drug. And by the way, I should add that the bar to moving up the ladder is low. You must try a drug for 30 days. If it doesn’t work, you can move up. Since cholesterol is a long-term problem (exerting its effects over years), thirty days is a blip on the heart disease radar (3-6 months is a similar blip; it is a rare patient who gets *no* effect from any statin, even if they don’t get as much effect as is required). (Also: we do not check to see whether your doctor has checked you cholesterol in the interim; if you have a claim in our system for simvastatin, or your doctor merely *says* you’ve tried simvastatin, you can move to the next drug in line).

There is no incentive on the part of physicians to practice this way. I’ve had conversations where I have been told “I just know this patient needs Crestor (the brand name for rosuvastatin)”. Really? How do you know that? Because even were you to sequence the person’s genome, we simply don’t know enough (yet) about cholesterol to be able to say with any confidence “This person needs this drug, because we know from their genetic code that this other drug won’t work”. (Yet. People are working in this; I spoke with one the other day). The fact is you don’t know; putting someone on Crestor avoid all the work of deciding to try the cheap stuff first. “There; I put him on the biggest gun there is. If that doesn’t work, it’s not my fault”. It also adds to the ongoing, and always rising, cost of medical care. If frontline doctors don’t think about cost (and in general, they don’t), someone else must. I am that someone.

Physicians call me from time to time and say “I am just advocating on behalf of the patient”. That’s fine; that even admirable. That’s what they should be doing. I, at the same time, am advocating on behalf of everyone else who gives us money and requests that we pay for their health care also. If I give it all to you, or your patient, I will have none left for the next guy. Someone has to watch the dollars if treating physicians won’t. I say this to treating physicians everywhere: be happy that you have a doctor at the insurance company to help the company make these decisions. If it were up to the accountants, the rules would be a lot more restrictive, and exceptions would be unavailable. At least now if you think you need something, all you need to do is call (or write) and explain why this is. I am here, and I am listening. And I’m not hard to convince; you have to give me either science for why your way is better (and science moves quickly; sometimes there actually is science which I/we haven’t seen yet) or a patient factor I don’t know about which says why the guideline doesn’t or shouldn’t apply in this instance. For drugs this usually means the patient has to have tried the drug, or there are good, solid reasons to believe they will react poorly to the class of drugs it is in, and that is why you want to move up or over a class without trying all of the representatives of the class (this is true of allergies, for instance. If you’re allergic to simvastatin and want (say) ezitimibe (Zetia, a different class of cholesterol lowering drugs), I can waive the requirement that you have to try more than one statin first – but you have to try at least one statin, in order to show that you’re allergic. (And actually, it doesn’t need me; a pharmacist can waive it; we have a staff of them making these decisions about drugs at the front line of UM). And allergies are often transitive across an entire class of drugs. I see requests periodically for rosuvastatin stating that the patient has to have that drug because the patient is “allergic to statins”. Well, guess what? As is implied by the name, rosuvastatin is…a statin. So if they’re allergic to “all statins”, they’re likely allergic to rosuvastatin too! So no [ding!], that is not the correct answer, thankyouforplaying).

So essentially, the way I see my role is as a steward of other people’s money. My job is to do my best to ensure that 1) our members get the best possible care, at 2) the most reasonable price we can. “Best possible” is a real goal; we discuss these things at length where I work, and in general if a treatment, drug, or whatnot is more effective but also more expensive, we will cover it despite the expense. We may hedge it round with rules requiring you to try the cheaper stuff first if possible, but we will not decline to pay for something just because it costs a lot of money. It is in our interest to have you healthy if possible; healthy people in general consume less health care, and so cost us less.

More on this in a related post which will be about 15 minute visits and why physicians have only themselves to blame for the parlous state of the profession.

The business case for contraception

As many of you are probably aware, federal law (specifically, the “Hyde amendment“), does not allow federal funding for abortion. Less well known, perhaps, is Title X, which does provide federal funding for contraception. Comes now Jason Millman of The Washington Post, “who explains that public investment in family planning helped prevent 2.2 million unexpected pregnancies in 2010, saving taxpayers a total of $13.6 billion”(quoted from the WaPo, as is this):

By preventing these unintended pregnancies, Medicaid saved $15.2 billion in maternity and infant care and $409 million on miscarriage care. An additional $123 million was saved through testing for sexually transmitted infections and the HIV, and $23 million was saved through Pap and HPV testing and vaccines. According to the report, these savings translate into a $7.09 return on investment for every public dollar spent in 2010. The researchers estimate that there are more opportunities for improved health outcomes and savings as a result of the Affordable Care Act, which will likely increase patient visits to publicly-funded health centers.

Let’s look at that again: a $7 dollar return for every $1 invested. Seven dollars. Seven.

Damn, I am just not getting over that. This is the kind of return on investment free market folks love-except it’s not a product of a free market. It’s the product of a government policy which says “Hey, one of the reasons for the continued existence of poverty is unplanned childbearing. Let’s do something about that, and maybe poverty will decrease”. For those on the right, this represents thousands of welfare babies who were not born. Thousands of welfare moms who aren’t on welfare, or are using less welfare. For those on the left, it represents untold amounts of added opportunity for people who otherwise wouldn’t have had any, or would have had less. (I say “untold” here because it’s not clear to me that this little study is getting much airplay, what with OMG EBOLA WE’RE ALL GOING TO DIE RUN FOR THE HILLS!!!1!)

This is real health policy in action; what policies can we put in place which will improve people’s lives, reduce the real costs paid by everyone, and do both of these things using the fewest of everyone’s dollars possible. Apparently paying for contraception is one of the places the money should be spent. There’s likely a point of reducing return, but I doubt very much we’ve reached it yet. I recommend we work harder to find where it is, and I further note that (from the above analysis) while we may describe it differently, this is a place where (some) conservatives and (some) liberals might be able to work together. Anyone ready?

Politics and Medicine

Since my last post, we’ve had an end to the Governor’s Opiate Emergency Task Force, and an end to the legislative session. One of those events was fairly satisfactory, the other was so very very not.

Good news first. The task force got together a whole bunch of people-physicians, insurance industry types (I sat on both of those focus groups, wearing different hats), opiate users, family members of opiate users, folks from the treating community (often, but not always also physicians). Everyone had their say regarding how things should move forward, and we produced a not-bad compromise document (where “we” means “the consulting firm hired by the state, with ‘help’ from the committee). Largely it called for better information about access and more study of the issue to understand 1) What the best treatment practices were, 2) where the actual (as opposed to “perceived”) barriers to treatment access were, and a bit too little of 3) how can we best prevent the problem, rather than treating it? The time for action is when you understand the problem, not when you understand the question(s); right now all we have are questions.

I was pretty happy about the task force report, even if the rollout was, shall we say, marred by some gratuitous verbiage from the governor regarding how insurance companies are trying to get out of treating people by sending them to Medicaid. I can personally guarantee that at least one company-mine-absolutely does not do this, and I doubt anyone else does either. It’s just not how we think; members are members; at other companies they’re customers. You don’t tell people like that to go away; you try to help them. (Note: Most people in the health insurance industry, once upon a time, were health care providers of some sort. None of us go into that field for the money, or the fame and fortune). But I was willing to overlook that (and got to say a few words to Martha Bebinger from NPR on the subject, which was nice), because I still believed we’d done something useful-not complete, not finished, but the problem has been with us long and long; we’re not going to fix it anytime soon. It was a start.

The legislature, which had been making “We got this, and we’re going to by God *do* something about it” noises since the governor made his announcement, decided around now (actually shortly before) to come out with their proposals. And: They sucked. Lo, like unto a vacuum cleaner did they suck. In effect, they said “It’s all the insurance industry’s fault. We, The Legislature, will by God make them do The Right Thing.”

Next post: The Wrong Thing.

Opiate emergency

Well, now. Interesting developments in the last few months, which have led to somewhat less writing.

Personally, I’ve been promoted at work. I am now the “Medical Director for Utilization Management”. This means a couple of things. Personally, it means a lot more work; as yet, I have no one to take over the actual “utilization management” I’m doing, so I do that and work the management in the cracks, or neglect the UM and do the management stuff. It also means I get tapped for a lot of committee work. A lot of it. Apparently there are parts of the organization that have been waiting for this nob to be created, and now I’m in it, they want me to fix their particular problem. (As in medicine, sometimes I say “That’ll get better with time”, and sometimes I say “That won’t ever get better, suck it up”. Sometimes I can fix it.

Professionally, I’m in a whole new neighborhood, and am running very quickly to keep abreast of my new responsibilities. While still dong all of the above. We now quote from my esteemed colleague at Monkeybagel.com:

Managing [physicians] is like leading a neighborhood gang of neurotic pumas on jet-powered hoverbikes with nasty smack habits and opposable thumbs. Oh, and as a manager you're a neurotic junkie puma too, only they cut your thumbs off and whereas all the other pumas get to drive around on their badass hoverbikes and fire chainguns at the marketing department, YOU have to drive a maroon AMC Gremlin behind them and hand out Band-Aids and smile a lot, when all you're REALLY thinking about is how to get one of them to let you borrow his hoverbike for a few minutes so you can show those fools how it's DONE. This is because managers are usually people who proved that they were handy with a chaingun and were thus rewarded by having their thumbs cut off and their weapons handed to some punk [new] hire.

Yeah.  I admit few equals with a chaingun, and I’ve fired my share of grenades at marketing, or management, or whoever the target of the day was.  (Perhaps more than my share; I was not above stealing someone else’s grenades, if I didn’t think they were shooting fast enough).  And I’ve learned how management defends itself.  They’re like the Borg: they assimilate you.

But I digress, because none of that has anything to do with the title of the post, now does it?  In other professional news, I’ve been appointed to the Governor’s Opiate Emergency Task Force.  This came about because the Massachusetts Association of Health Plans (hereafter MAHP) needed a representative with at least some “subject matter expertise”.  So they called around, apparently also calling my uberboss, who thought of me (nice of him, I thought).  He called asking if I was interested in doing this, particularly given my general level of overcommitment.

Well, this is the kind of opportunity which does not come along daily, so hells yes I’ll do it!  Of course, this appointment did not come with any additional free time, naturally, so I’m doing the work for this in between the other work I’m doing, which you may recall I was doing quite a bit of that in between other work I had already been assigned to do.  So, I’m a bit busy; a bit busier, even than most new managers who are learning a whole new skillset.  I suspect it’ll be worth it, in the end, since I’m convinced the governor,  like most people, is a bit late to the “opiate emergency” party; there’s been an “opiate emergency” since at least 2009, and possibly since the turn of the century.  Here, have a graphic:

Opiate data1

What you’re seeing here is the death rate for various causes, showing that “poisoning” (which is the category opiate overdoses go in) overtook motor vehicle collisions as the most popular cause of death in 2009.  The discerning reader may note that the overdose death rate pretty much began to rise in the 90s; if you’re looking for when the “opiate emergency” started, that’s the place.

So, with luck we may find, not a solution, but a better stopgap, than we have right now.  At least, that’s what I’ll be working towards.  There are dozens of simple solutions which will not work. (More treatment!  Less insurance regulation! Ban Zohydro!).  A solution which will work will be a combination of prevention and treatment; neither will work in isolation.   Personally, I like more prevention; others with a different view like more treatment (parents of addicted children, for instance).  But you cannot do just one thing.

Stay tuned.

Tragedy of errors

My last post was all about death in some ways (technically it was about organ donation, but inevitably organ donation in most cases requires death); this post will be about death in a more pure sense.  Because it’s been in the papers recently, death has.

Over in Texas, there’s a woman who, unfortunately, is dead.  The hospital hasn’t confirmed this, but her family has, and I think they’re credible; we’ll assume that she’s dead.  Unfortunately, she’s also pregnant, or was pregnant before she was dead.  We will leave aside all of the arguments about the status of the fetus, as well, because in most ways they’re not relevant; whether the fetus is malformed, has had a hypoxic injury, etc. doesn’t really matter.  What does matter is whether the fetus is viable.  The fetus’ current gestational age is 22 weeks, so that’s an easy lift: the answer is No.  No reservations, no second thoughts, no disagreement: no 22 week old fetus has ever survived, full stop.  We simply don’t have the technology to do it.  We would need an artificial uterus, and we don’t have one.

Texas law does not allow withdrawing “life-sustaining treatment” from a pregnant woman.  I’m also not going to get into the issue of whether this law is a good law, a bad law, what the motivations of the lawmakers were in writing it, or any of those issues.  Because those are also irrelevant to this discussion.  I don’t like the law personally; I think it’s bad law.  But again, not relevant.  The relevant issue is the wording of the law: “life-sustaining treatment”.  Were the lady in a persistent vegetative state, we’d have a discussion about the law.  Were she gravely ill in some other way, we’d have a discussion about the law-if she had cancer, or multiple sclerosis, or any number of other things, and wanted to stop being treated, that’s a situation which falls within the law’s purview.  None of those situations apply here, because of one incontrovertible fact:  The woman is dead.  Dead people cannot be receiving “life-sustaining treatment”, because they’re dead.

This again touches on a point I raised in my previous post about organ donation: we continue to talk about brain death as if it’s some special case of death, as if you can be either dead, or “just” brain dead, but not really dead.  And that simply is not the case.  Brain dead people are dead.  They are dead as a doornail, or (to borrow an argument from Dickens, viz. A Christmas Carol) dead as a coffin nail.  They are no less dead than the person who has dependent lividity, or rigor mortis, or more than zero millimeters of separation of their head from their body.  They’re not sort of dead, or mostly dead; dead, as George Annas used to say in my law and medicine classes, is dead.  In general, (again according to George, who is my touchstone when matters of law and medicine collide) while laws may vary somewhat, in most jurisdictions, you are dead if a physician (or other appropriately empowered person; nurse, medical examiner (in Washington State, for instance, the medical examiner must be a lawyer), using commonly accepted standards of practice, says you are dead.  That has happened here, even if the hospital is unwilling to say so, and so there can be no issue of “life-sustaining treatment”.  One cannot “sustain the life” of someone who is dead.

“But Doctor!”, you ask, “What about the fetus?!  The fetus isn’t dead!  Won’t someone think of the child?!”  Well, let’s forget for a moment the fact that essentially, the law doesn’t apply to this situation (one cannot provide life-sustaining treatment to a dead person).  Leaving aside the fact that mom is dead, let’s look at this.  The natural history of children born of dead women (and there is some experience with this) is remarkably grim; their prognosis is uniformly poor.  The experience we have is largely in pulling fetuses from women in their death throes in the trauma room; once it becomes clear that saving the life of the mother is not possible, we are trained to perform an “emergency C-section”.  (I was, and I’m sure EM residents are still being so trained, while hoping as I did to never ever have to do this-and so far those prayers, for me, have been answered in the negative, as I never have had to).  This isn’t your mom’s C-section; this is a meatball-it-open-with-a-big-knife-using-a-vertical-incision-through-everything to get the fetus out as rapidly as possible, because every second of delay is a second that the fetus is dying.  Because as soon as mom starts dying, the fetus does too.

In this case, mom is dead.  It is overwhelmingly likely that the baby is also dead, using criteria similar to those we’ve used to decide that mom is dead; probably, the fetus’ brain will not work, ever; it’s dead. (There can be some questions about this, and the science here is less clear, but remember that we’ve already determined that right now the fetus will not survive outside the uterus, so right now, if the child leaves the uterus, s/he will die.  Full stop).  If  we assume the fetus is dead, the entire issue disappears.  If we assume the fetus is not dead, we are now experimenting on the fetus (and to some extent, on the corpse of the mother); we don’t know 1) what will happen (to the fetus) if we keep mom alive long enough for the fetus to be viable (it’s never been done before), 2) if we can even keep the fetus alive (as in, having a pulse, etc; leaving aside the question of brain function) for that long (in this case, the cutoff date-the absolute soonest that the fetus can be born and have a greater than 50% chance to survive-is 25 weeks.  Obviously, longer is better.  Lots longer.  But if we can get to 25 weeks, in theory, the fetus/baby has a 50/50 shot.  (This assumes nothing else wrong with the fetus; if there’s anything else going on, the chances go down precipitously).

So this is, in every sense as best as I can tell, a tragedy of errors.  The physicians, administrators, and anyone who was involved with the decision to maintain the dead woman on what I’m going to call “vital sign support” made an error in applying the law to someone who is dead.  The family hasn’t really made any specific errors, unless one is prepared to say that not modifying their living will or whatever the document is in Texas when the woman became pregnant is an error, but honestly I am not prepared to go there.  The courts have made the error, same as the physicians and administrators, of assuming the law applies to a dead person. that one can provide “life-sustaining treatment” to a dead person.  The media has made the same error; in most of the stories I’ve seen  they assume that mom is somehow susceptible to “life-sustaining treatment”.  One cannot sustain the life of a dead person. And assuming, arguendo, that the fetus is not just as brain-dead as mom (and thus, also just plain dead, without knowing it yet), the likelihood that the fetus can survive to 25 weeks is unknown, although clearly known to be very, very low.  And 25 weeks is an absolute minimum; 28 weeks is much better, and anywhere north of 30 weeks is infinitely better.  So the question in hand is, in effect, how much are we willing to flog a corpse in order to have a (much) less than 5% chance of bringing a viable fetus into the world?  And I simply do not see that as a reasonable question.  I don’t think that a civilized society should be willing to flog a corpse for this reason, or any reason; we owe the dead at least the dignity of not being desecrated in this way.

Even were we willing to do so, this is not the case to have that happen; the likelihood of a “birth outcome” as it’s usually put-that the child now in the uterus will ever survive outside the uterus-is effectively zero.  (If it’s not exactly zero, it is sufficiently low that it may as well be zero; the amount of divine intervention needed for that to happen is remarkably unlikely.  I understand that some people feel that the slightest chance of that divine intervention is enough to require flogging the dead.  If you are the dead person, or that was your wish before death, I am fine with that, but it cannot be a basis for government policy.

It cannot, especially, be the basis for a government policy for people who believe, as most conservatives claim, that they want the government to stay out of their lives.  If you want the government out of your life, it follows that others want that as well, and have the same right to that as you do.  If they have that right, then you, no matter how justified you feel you are, cannot take that right away from them while keeping it for yourself.  If the government can decide to flog someone else’s corpse, they can flog yours too.  The reasons they decide to do that may turn out to be reasons you don’t like, but you’ve given away the right to object, because if you’ve decided that the right to flog corpses exists at all, it exists for any reason that the government, in its infinite wisdom, decides is justified.  You are not special, and your reasons are not special, just because you think they are ordained by God; both the Constitution and common sense tells you this.  Agreement about what God wants is more elusive than agreement about what government should want.  Anyone can play, and my opinion about what God wants is no more privileged than yours (this is why the Constitution has a First Amendment).

In this situation, reasonable policy has to leave those questions out of the equation, and decisions must be made on more general principles.  I think we can all agree that we do not want, for ourselves or our loved ones, the state to have the right to desecrate corpses, regardless of how good the motivation is for desecration.  We want what dignity we can have in death.  If we can agree on that, then we can agree that the unfortunate situation in Texas is just that; unfortunate, and a tragedy, and we hope fervently we are never put in that situation.  And we can stop compounding the tragedy by flogging the dead.

Late and definitely lamented

Some while back, a PA judge ordered UNOS/OPTN (the national organ transplantation organization-they maintain the waiting lists, and the criteria for where you get to be on the list) to place a 10 year old girl on the adult transplant list as well as the pediatric list.  (Normally the pedi list is separate, and you need to be 12 or older to get on the adult list).  I don’t know the details of the case, but there are infinity reasons why I think this is a Bad Idea.   Here is the ruleset for thoracic organs, all 45 pages of it.  The lung ruleset is the most complex thing I’ve seen in a while.  A lot of people, including a large number of regular citizens and transplantees, as well as people awaiting transplants, worked hard to write those.  And a PA judge figures he’s smarter than them.  As I said, I don’t know all the facts of the case, but I promise you this will unleash a bunch of suits requesting the same type of relief from the rules.  I hope he enjoys his newfound career: transplant judge.  

Organ donation and transplant is an incredibly emotional subject for all who get near it.  I’ve been an organ donor since I’ve known what it meant, which was in college.  When I got my first organ donor card, I made my mother and my fiancee (later wife) sign it, so they knew I was serious.  I recommend everyone else do the same, absent real spiritual (read: religious) convictions that stand in your way.  Having been on the organ donor side of the care equation, I promise you that if you’ve heard anything implying that health care professionals do less for people who are organ donors so we can get the organs, I personally guarantee you that is bullshit. Let me tell you my personal organ donation story.  No, I haven’t donated an organ, but I was a resident in one of the busiest knife-and-gun club hospitals in Boston: The Boston City Hospital, first in general surgery (only 1 year; I am not a surgeon, nor do I play one on TV), then in emergency medicine.  Both residencies involved the occasional organ donation situation, such that I saw about 3 per year for the 4 years of residency.  I’m going to talk about just one, from my second year of residency, when I was in the Surgical ICU (emergency physicians rotate through a lot of ICU time; at City our contention was that we got more ICU time than anyone except the ICU fellows). The patient was a young woman, in her 20s at the time.  She’d been involved in a high speed motor vehicle collision, as a passenger.  I don’t believe she was wearing a seatbelt, but at this point, I don’t honestly recall.  I heard about her, as I often did, not from my supervising resident, (a surgeon) not because he didn’t like me or wasn’t interested, but because, I believe, he knew what this call was going to mean and  he didn’t much like it-but from my senior resident in emergency medicine-the man who would be chief resident the following year. He called, explained briefly that I was to take the patient to the ICU, but she wasn’t expected to live long, and would potentially be an organ donor, and I would need to shepherd her through that process.  Now, I wouldn’t be alone, he assured me; I’d have lots of support from the New England Organ Bank (NEOB), but in the meantime, would I come down and fetch her? (a physician was required to accompany all patients on the Danger List (i.e. critical patients))  And oh, by the way, I would need to sew up a laceration on her head; he’d show me when I got there. So down I go, into Trauma 1 (at the time, BCH had 2 trauma rooms; they now have 3). On my arrival, I walked into trauma 1, where I found a 22 year old female, unconscious, unresponsive, with a long laceration vertically oriented on her forehead.  “Take a good look at that lac”, says the senior resident, “and tell me what you see”.  So I took a good look, and it was easy to see that the laceration went right down through the scalp, through the skull, and there, at the base of the “laceration”, was the brain, admittedly still covered by meninges (the fibrous fascia covering the brain). For those of you not versed in medicine, this is Not Good. Basically, what it meant was that this unfortunate young woman had had a mighty whack to the head, enough to cause this injury, and as a result, almost certainly an equally mighty whack to the brain underneath it.  The brain doesn’t react well to being whacked, and her life expectancy was, as a result of only this injury, was poor.  And it appeared that this was her only injury; the rest of her was more or less untouched. I closed the laceration, had a look at the labs which were back by then (all normal), the routine xrays (equally normal, except the head CT scan), and her head CT, which showed that she had so much swelling of her brain that the normal wrinkled appearance of her brain had disappeared; the swelling had squished her brain sufficiently that all the normal gyri and sulci (the medical name for the grooves and ridges which make up the normal appearance of the brain) had been squashed together so you couldn’t see them any longer.  Again, not usually something you can fix; note that this woman already had vented her skull somewhat (the laceration meant that there was a big crack in her skull, which allowed there to be a bit more swelling than would normally have been possible without killing her immediately. Bottom line: she was dead. We say “brain dead” like it’s something different from just plain dead. It’s not. Dead is dead, no matter how we decide. This young lady was dead; the only reason she wasn’t cooling on a slab was that her heart hadn’t gotten the memo, and we were working very hard to block the memo from arriving.

So up to the ICU we went. We ended up having a chat with her family; they were entirely on board with organ donation, and were more or less prepared to sign and have us go right then; they understood clearly what the CT scan findings and our explanation of them meant (the neurosurgeon involved had made it crystal clear that he had no role in this woman’s care, much as he would have liked to). We had to wait the mandatory time, though, to make a clear determination of brain death according to the rules. Let’s be clear: I knew, the neurosurgeon knew, hell, the medical student had there been one involved would have known that this lady was done, finished, pau, kaput, thirty, game over. The nurses knew more than we did, having been through this more than a few times (the BCH ICU nurses were and are a special breed of nurse, smart, experienced, and good enough to keep the doctors from doing stupid things more often than not; along with the ED nurses I owe them a lot). Everyone was on the same page here, and yet we stalled until we could dot the i’s and cross the t’s. We had to do at least two brain flow scans showing no flow, and check brainstem reflexes (very primitive reflexes whose absence indicates that no part of the brain survives;if they are gone, everything in the brain above them is also gone) at least 6 hours apart. So we did these things; unsurprisingly, she was still dead at the end of that rigmarole, and went to the OR for harvest (a truly unfortunate word, but not inaccurate) of her organs. She donated virtually everything that can be donated, and took a little of the edge off the tragedy. (It’s always tempting to say that organ donations turn the tragedy into something good. This is of course nonsense; it’s still a tragedy, just a tragedy somewhat ablated by the happy outcomes experienced by the organ recipients).

So. We all knew this woman was dead, and yet we went through all that to prove it. Why?

Because people, specifically people not doctors, need to have faith in the process. They need to know that doctors are not chomping at the bit to let their loved ones die so we can get at their organs. Note, for instance, that the transplant surgeons have not one thing to do with this process, ever. They help work on the criteria for organ donation, but not the criteria for death, at least not for individuals. That is up to the treating physicians. Usually the treating physicians are assisted by a protocol written by the hospital with ample input from the hospital’s legal team. Doctors, more than most people, I believe, hate to lose. When a young person dies, we have lost hard. When we give up and decide that someone is dead in that age group, it is because we are stone cold certain that we’ve already lost, usually without even starting. The one body part we can’t really rescue from damage is the brain. So make no mistake, brain dead is just another way of saying plain old dead.

So how about that judge? How does he enter into it? Well, I started out with him because he decided he knows better than the people who wrote the initial rules. Perhaps he does; perhaps the case in question deserved an exception when others did not; I don’t know what the specific facts were. Perhaps he finds the equation used by the people who wrote the original guidelines tipped too far toward saving adults and not enough towards saving children. I don’t truly know what he was thinking; I personally believe that one of the purposes of having organ donation criteria, and people who administer them, is to keep the process from becoming the sideshow it will now become because this judge decided the rules should be different, either in general or for this particular child. I think that’s nonsense. If the rules are broken in the judge’s opinion, direct the responsible committees to review the rules in light of the improved understanding the judge thinks he has, and see if they can come up with a better solution in this case, or at least a different one. The issue is that, unlike many resources, the resource in this instance-donated organs-is very, very restricted, and the need is very very great. This is a situation ripe for abuse, especially for people who have money, or can convince a lawyer that there’s money in it for them. The judge played into their hands, and I think he will regret it. I’m not saying “Leave this to us doctors; we know best”. I’m not saying that because I like to think I’m not an idiot. Doctors don’t know best any more than lawyers or judges know best. But a thoughtful group of people, including some doctors, some lawyers, some transplant recipients, some organ donors, and some just plain folks, thought long and hard about what the rules should be. I’m fine if a judge says “Think about this a little more, because I don’t think it’s done yet and here’s why”, but to think he can, in the heat of a trial, come up with a better decision than is already in place is, I think, the height of hubris. It’s bad policy, bad law, and in general a bad idea. He, and we all, will live to regret it, except for the people who don’t because they cannot get an organ, because the people who would donate no longer trust the system of allocating them, because this judge has made a mockery of it. Yay. Only not.

The FDA, opiates, and me

Recently, the FDA indicated it would be increasing the level of restriction on many opiate drugs. Now, I work in both emergency medicine and addiction medicine; I’ve used opiates and believe strongly that they are a valuable, even crucial tool in the armamentarium of the physician or other health care provider. But I’ve also seen what opiates can do if left unrestrained. I’ve seen teens, twenty-somethings, fathers and mothers of small children on my gurneys in the ED, beyond my help because they had overdosed where no one could find them and were, in EMT parlance, DRT – “Dead Right There”, no need for them to be brought to an emergency department but for the need for a physician to say they were dead.

So today we see a letter to the editor in the Boston Globe. In it, the author decries the FDA action, as it will , in her opinion, leave pain patients (I prefer the term “patients with pain”, myself; the other term seems to me to denote patients who are a pain, not, I suspect, what the author had in mind) with fewer options, and thus, more pain.

The author claims, among other things, that opiates cause so few deaths that the lives saved are not worth the cost to patients with legitimate pain. I’m not going to get into the debate about the worth of a human life; people who say that no value can be assigned ignore plain economic fact (life insurance companies, for instance, assign value to human life regularly. NICE, the clinical effectiveness people in the UK, used to value human life at approximately $30,000 per “quality adjusted year”; they never said so outright, but the number could be derived from other portions of their well-written analyses. Look it up; I’ll wait). But the fact is that the letter writer plays a little fast and loose with the actual facts, as follows, in my reply to her letter:

“Let’s take at least one claim in this letter apart: “But those figures also show that only 29 percent of these deaths involved opioids alone; the rest involved alcohol, benzodiazepines, and other drugs. Yet it’s opioids — like the legitimate pain patients who need them — that get vilified.” The key word here is “alone”. As far as it goes, the sentence is accurate. Opiates alone can kill you, but in general, it’s combinations of drugs which tend to kill people. Many of the other deaths involved alcohol, benzodiazepines, and/or other drugs-usually in combination with opiates. It’s very, very difficult to die from overdosing on benzodiazepines; it can be done, but requires a lot of them. Dying from the combination of benzodiazepines and opiates is common. The same goes for alcohol, and “other drugs”. Opiates are almost always a factor in those deaths too.

The fact is that opiates are a weapon; they’re a lot like guns, actually. They’re legitimately a weapon in the fight against pain, as Ms. Foreman notes. But they’re also a weapon which, if not carefully controlled, will kill people. The FDA believes the balance between access and control is currently tipped too far towards access; as an emergency physician, and as a physician who has worked in the substance abuse field (I am technically still the research director at SECAP) I agree. I have no desire to see people in pain left without a treatment that works, and opioids work. But I am tired of seeing people fall into addictions that they could have avoided but for the easy availability of opiates during vulnerable times; adolescence in particular. The presence of too many twenty-somethings in my clinic tell me the FDA is right to rein opiates in.”

So, that. Opiates are useful, even crucially so. But damn, they cause vast amounts of pain and suffering, on a par, I would argue, with the pain and suffering caused by, well, pain and suffering. So before we say how evil the FDA is, let’s make sure the balance has all the factors on it. It’s not just deaths; it’s crimes done to get money for drugs, it’s children unfed because their parents sold their food stamps to get money for drugs, it’s the pain of the people with the addictions (do you think the people who commit the crimes or sell the food stamps *like* themselves after they’ve done those things? I am here to tell you they do not; they hate themselves unmercifully. Some of the drug related deaths are not accidents). There’s the money spent on rehabilitation; I believe that’s money well spent, but damn, rehabilitation is *hard*, people. Not just the physiology; the psychology of drug addiction is hard to clear up-people want to be clean, but they want to not have the suffering that comes with being and staying clean-the cravings, the withdrawal symptoms, the need to make amends with friends an family-all of those things are hard, and before you condemn the people who must eventually do these things by saying it’s their own fault, consider that none of these folks woke up in the morning and decided to become addicts. Each one has a story, and each story starts with some variant of “I didn’t mean for it to get this far”. So there’s pain on both sides, and to neglect to tell the whole story does an injustice to everyone in this discussion.

Utilization review-a primer for everyone

What does “utilization review” actually mean?

Well, the short version is that I, and everyone else involved in the process, evaluates requests for high cost or high use procedures, medications and so on, to make sure they’re medically necessary. And let’s make sure we’re all using the same definition of “medically necessary”, too; in our world, it means “it is necessary for this patient (or, in our parlance, member) to receive this service, drug or device in order to retain their ability to function”, (or, as a corollary, they need it to prolong that ability-stuff like statins doesn’t make anything function, but it does make you live longer). To decide what is “medically necessary,” we write guidelines for the use of a whole host of things-a bunch of medications, a fair number of operations, certain types of therapy; alternatively, we use commercially available guidelines such as “InterQual”, written by corporations which do the research for us (InterQual is written by, and is a trademark of, McKesson).

There are some limits even on the “medically necessary” rule-some things are contractually excluded (in ERISA plans-plans where a large employer uses us as an administrator, but basically pays out of pocket for the health care of its employees, the employer can decide to cover, or not cover, pretty much anything they like, without regard to the laws of any given state. Some employers use this to expand the coverage they provide, but most use it to exclude some things, often things like IVF (which costs an arm and a leg), or contraception (religious organizations lke the church, for instance). Sometimes we offer a more limited contract; dental coverage can be generous or not so much, for instance. Nursing home care is capped at some number of days. And on the subject of nursing homes-for us to cover it, you need to be there recovering from something. Just because grandma can’t handle herself at home anymore, because she’s forgetful, or can’t walk and will never be able to again, or whatnot, does not mean we pay for them to be in a nursing home; if they’re not actively getting better, it’s not “medically necessary”. Here’s the hint: if you could stay home with grandma, with no extra training (or very little) and she’d be fine (what’s called “adult supervision”-things like cooking meals, making sure the stove or the water gets turned off, the house gets cleaned), it isn’t “medically necessary”.

All of this is done for one and only one reason: to safeguard your money. Yes, yours. If you have insurance through my employer, you pay us to pay for your care under a set of rules. I enforce the rules. And it’s my job to see that they’re enforced equally and fairly. If you don’t get something, neither should anyone else insured like you, right? If the rules say “no kidney transplants” (no rules say this, but I need an easy example), wouldn’t you be angry if I told you no, but Myrna down in accounting got one? So I’m there to enforce the rules. Often the rules don’t say “No”, but they say “You have to try cheap generic drug X before you can try slightly more expensive drug Y, which you must try before you get fancy brand name Z”, or “You must have physical therapy before you have back surgery, because often, physical therapy makes you better and you don’t *need* surgery”, or “You must actually have gallstones, or some other thing wrong with your gallbladder, before you have your gallbladder out”.

Sometimes they actually *do* say “No”. So, no, you can’t have highly targeted (and extremely expensive) chemotherapy unless there’s proof it will work for what you have. Using kidney cancer chemo for colon cancer without proper study is an experiment, with a very limited number of subjects: just you. You can’t have an artificial heart-they’re all experimental, because they can’t be shown to do any good in the long term-even if the patient makes it to transplant (which is all the FDA allows, at the moment), they often do less well at transplant. We won’t let your doctor waste everyones money on a Hail Mary, God I Hope This Works one in a million shot-even if you want it. Because one in a million shots often cost many millions of dollars, and it’s not fair to all the other people who paid those millions that you get the Hail Mary pass which has either a very small, or an unknown, chance of working, and as a result they don’t get their gallbladder, their statin, or something else which *does* work, guaranteed.

Let me break this down for everyone: Every time an insurance company says “No”, it’s because someone like me (and it’s almost always a doctor-the rule in general is anyone can say yes, but only a doctor can say no) has looked hard at it, and decided that 1) there wasn’t any good reason to do it (hysterectomies fall into this on occasion, as well as gallbladder operations, spine operations and joint replacements. Trust me, I’ve seen some sad-ass excuses for doing these things. Once, it was “well, the pain is generally on the right side. Must be the gallbladder.” And then everyone is surprised when taking out the gallbladder doesn’t fix the problem), 2) it was experimental (artificial hearts, anyone? Hey, I dreamed up this cool new treatment for cancer; we tested it on a few people and they didn’t die for almost a week, and I patented it. How about you pay premium money for it?), 3) it was basically requested for the convenience of the person who is requesting it (you’re in Philadelphia and have a heart attack; you’d like an air ambulance ride back to Boston so you can get care at the MGH. Well, guess what? Philly has some adequate hospitals one of which you are currently in, and an air ambulance ride costs $30,000. What say you stay there, get the care you need, and buy a ticket on Southwest when you’re better? Saves us $30,000, and you’re just as well off as you would be here), or some variant on these themes. It’s not because I, or anyone else, doesn’t want you to get better. We wouldn’t have done health care all those years (I have 16 years of direct care experience, not counting the years since joining my current employer; the aggregate in my workgroup is probably about 160 person-years of actually giving care to patients. We’ve been around; we are, in fact, doctors and nurses). We really, really do want you to get better. Among other things, and only a little cynically-healthy people don’t use insurance dollars. But if you must use them, part of my job is to make sure they’re being used wisely. That you, and your co-members, are getting good value for their money. And when you tell me “Well, my doctor knows me better than you” I say “You’re right! And s/he’s in the best position to explain to me why I should pay for what s/he is asking on your behalf”. But if your doctor can’t make a case, likely there isn’t a case to make; it’s a waste of money, and they’re wasting money in order to either retain your business, drive up their bottom line, or because they’re not bright enough to see that they’re wrong.  (In fairness, on occasion there is a legitimate difference of opinion regarding what it means for something to be “experimental”; my experiment is someone else’s leading edge). Those guidelines I talked about? We, and the companies which make the others that we use, don’t make them up-we look at the science, we ask consultants in the fields what works and what does not-top people-Harvard, Stanford, Baylor, Penn, the folks at the bleeding edge. (Often those same people complain when we enforce the rules they’ve helped craft against them; don’t I know who they are? Well , often I do; or I don’t, but either way, I don’t care. Neither they or you are special snowflakes with different physiology or biochemistry than the rest of humanity). There are rules; I try to be fair in my application of the rules, as do my colleagues, and the reason there are doctors making these decisions and not accountants is that doctors are in a position to decide that the rules don’t cover this specific situation, and make exceptions which make sense. But they have to make sense; they can’t happen just because you are desperate, or determined, or politically connected, or loud. Because that isn’t fair.

And that, folks, is what utilization review actually is. An attempt, by frail but expert humans, to apply the rules equally-to be fair. Are we sometimes wrong? Sure. We can but do our best, and sometimes our best is ill-informed, either about you, or about the latest science. Sometimes we simply haven’t had our coffee. But we are trying to be fair, and at the same time, trying to safeguard *your money*. No matter how many dollars I save or spend on any given day through saying either no or yes to paying for something, I get paid the same; it’s not like I’m on commission. If I save a buck, it means a buck which we can spend doing something else for you or someone like you, not that I get a nicer office. So think about that before you complain about the damn insurance company telling you what to do. Maybe we’re right.

Back, for now

Jeez, it’s been a while, hasn’t it?

I’m sorry about that. Life got in the way for a while-like a year or so, apparently :-/

In happier news, I’m still employed, at the same place. And still work in Addiction Medicine on the side, same same there.

I will do my best to update this blog at least weekly. Not a promise, mind you, just…I’ll try.

In a bit, content! You should all be afraid.