Thanks to NPR, I was directed to an op-ed that appeared in the New York Times in October 2012 entitled "In Cancer Care, Cost Matters." The article describes what may be one of the earliest accounts where doctors at Sloan-Kettering decided not to use a new cancer drug because of its extra cost when they were already using equally-effective drugs for their cancer treatments. The article piqued my interest. These days for any doctor who uses expensive technologies, it is easy to see where this evaluation will lead us in our new era of cost concerns in medicine. Medical device companies should take notice.
Few use more expensive technology in medicine than cardiologists and cardiac electrophysiologists. Not only is our technology expensive, it is also used frequently. Cardiovascular disease remains one of the largest cost drivers in medicine.
In the past, doctors (myself included) were complicit with device companies in our use of new technologies, implanting the latest model of defibrillator, for instance, not because it saved lives any better, but more so we could boast that our patients were receiving a "Cadillac" defibrillator rather than a "Ford" device (no disrespect intended to car companies, but you get my drift). After all, our patients deserved the best and most innovative technology available at the time. We did not want to be caught in the embarrassing position of being behind innovation power curve either.
I should acknowledge that there have been some very important recent developments with defibrillators since the 2005-2006 device recalls that plagued our specialty. The ability to monitor device reliability wirelessly facilitated the ability to detect device battery depletions or lead failures and has improved our understanding of tolerable device and lead failure rates, for instance. But it is not uncommon for a newly-named pacemaker or defibrillator to add several thousand dollars to the health care system over last year's device yet they may add only minor advances over the prior year's model.
Pacemakers, too, are being manufactured that are FDA-labelled "MRI-tolerant." But examples of safe application of MRI's to conventional pacemakers are prevalent in the medical literature, so is the extra cost of an MRI-safe pacemaker worth it? (In actuality, if you ask the informed pacemaker implanters out there, the main reason MRI pacemakers are routinely implanted is not because of safety concerns, but because of the CMS coverage decision for MRI payment in patients with pacemakers.(pdf)) How do we weigh the cost of these extra advances in technology versus their ability to improve our patients' actual morbidity and mortality?
Increasingly, doctors will soon be involved with purchasing decisions for advanced technologies. Pacemakers, defibrillators, implantable monitors, stents, catheters, and even small sheaths will be scrutinized for their utility, ease of use, and cost. (The liability of NOT using a technology will also be considered, but this issue is hard to measure and less familiar to frontline doctors.)
The real question, of course, is will the patient see these cost savings if older technologies are used? This is hard to say since there are so many layers to our health care system between the patient and the dollar. Also, how will patients react when they find out online that their model of medical device is last year's model rather than this year's? Will they seek another hospital system with shinier walls and bigger names? It's impossible to tell.
But if hospitals are smart, they'll make it clear to the patient on their bill what they saved themselves by using an earlier-year device. Medical device companies, too, might shift their marketing tactics to costs and benefits from things like size or shape of their device.
But one thing's for certain in the days ahead: device companies will have to carry not just this year's model of device, but last year's, too. Innovations in technologies will be harder to sell unless they show real patient morbidity or mortality benefit. Companies will have to adapt their marketing campaigns since cost savings, done correctly, will benefit everyone.
After all, it's now about real costs and benefits in health care, rather than just sexy bells and whistles.
-Wes
Addendum: The CMS National Coverage Decision for MRIs in patients with pacemakers is now functional.
Thursday, March 28, 2013
Tuesday, March 26, 2013
Health Care Reform Three Years Later - An Insider's Assessment
It’s been three years since the Patient Protection and
Accountable Care Act (PPACA) became law. There
have been widely divergent opinions published by journalists on the impact of
the law for Americans: from a rose-colored
account from the New York Times, to a not-so-peachy account published at
Reason.com. Few doctors have ventured
into this discussion.
The First Steps
Our New "Reform"
-Wes
The Need for Health Care Cost Reform
I should start by saying that I am biased. I grew up in the days of an idealized image of the physician –where doctors were still held in relatively high esteem by our society. I had to think this way for I was joining the system. Back then, like now for the younger doctors, medicine was a still considered a calling, not just a job. The unspoken code was that it was the patient above all else: screw the establishment, screw hospital loyalty, screw the drug company – if they couldn’t help your patient, you’d take them elsewhere. So hospitals courted doctors. Drug companies courted doctors. Insurance companies courted doctors. But the truth be known, doctors weren’t the apple in everyone’s eye, patients were. And doctors enjoyed the limelight – so much so, that a few in our ranks succumbed to the greed, too. After all, like now, patients paid everyone’s bills.
I should start by saying that I am biased. I grew up in the days of an idealized image of the physician –where doctors were still held in relatively high esteem by our society. I had to think this way for I was joining the system. Back then, like now for the younger doctors, medicine was a still considered a calling, not just a job. The unspoken code was that it was the patient above all else: screw the establishment, screw hospital loyalty, screw the drug company – if they couldn’t help your patient, you’d take them elsewhere. So hospitals courted doctors. Drug companies courted doctors. Insurance companies courted doctors. But the truth be known, doctors weren’t the apple in everyone’s eye, patients were. And doctors enjoyed the limelight – so much so, that a few in our ranks succumbed to the greed, too. After all, like now, patients paid everyone’s bills.
But health care costs for patients became increasingly hard
to cloak. Insurance companies, in the
business of making the expensive seem cheap, needed an exit strategy. The new hospital buildings, multi-million
dollar corporate earnings, drug innovations costing tens of thousands of
dollars, and the aging population that was growing too quickly weighed heavily
on the entire system’s sustainability.
Something had to be done.
The First Steps
So without belaboring the obvious: we created Health Care
Reform as we know it. Health Care Reform wasn’t just
the PPACA, though, but rather a carefully orchestrated series of legislative
achievements that laid the groundwork for payers to offload the costs of health
care on to the only other entity that could pay these high costs: our
government.
The process (as we have seen) first involved an expensive,
multibillion computer roll-out that was part of the American Recovery and Reinvestment
Act. These computer systems promised
“cost savings” by “improving efficiencies” of care. Information systems were sold as our
salvation from cost excesses like $15 Tylenols.
Corporate America
(and their political lobbyists) bought it and so did the government. To keep doctors quiet, doctors were promised
$44,000 a piece to install computers in their offices. Little did they realize their payments from
government to private offices were to be slashed forty percent in the same
legislation and computers would be required to bill the government. So, the $44,000 actually went to doctors’ new
employers. Doctors were thanked for
their services with a new $700-dollar iPad and a treasure trove of Meaningful
use regulatory benchmarks that slowed patient care rather than sped it.
Our New "Reform"
Next came the PPACA, our signature health care law. The law was spun as a way to save health care
costs while adding 34 million more uninsured patients to the system. Pulling heart strings was much more palatable
politically than the much needed reality of fiscal restraint.
But we should admit that our health care system has
flaws when it comes to the uninsured. To
prove the health care reform’s benefits, the easy-to-sell low-risk coverage for
young adults was given as a loss leader to the new health care law's Health Care Happy Meal. This benefit was universally welcomed by all because it
was needed. Yeah, it cost a bit more to provide this insurance,
but in the scheme of things, the cost of this health care was relatively cheap to provide. It was (and remains) a win-win. But our attachment to this part of the law may be a clever way to buy us off.
Preventative services, provided for free, were also included
in the PPACA. But this is a problem
because nothing is free in health care. Proving
preventative services for free perpetuates an expectation that everything will
be free in health care and have no consequences. After all, preventative services take time and
time for care providers overloaded with more and more patients entering the
system is our most precious commodity.
Others argue that catching problems early will save money but the proof
that this makes a difference to health care costs is really just a delightful narrative. In fact, even the annual physical’s benefit
to our health care has been called into question – especially when we recognize
its value to the system compared to
the benefits derived for the patient.
And people have argued that the PPACA has already reduced
costs. While I am not an economist, I
really can’t speak to this. I am just a
worker and observer. These days I see four or
five administrators where, just a few short years ago, we had one. I see fewer nurses with less experience caring for more patients now. I see bigger buildings but fewer patient beds
as wards are consolidated.
I see hospital-system employers with hiring freezes that are laying off workers in
anticipation of upcoming costs imposed by the new law.
How's the Quality?
And then there’s the overall quality of care. I can’t say I really see a difference from five years ago. Sure, I see things being done faster by fewer. I see computers moving information around like never before. But is the care to our patients really better? I see reams and reams of documentation made not for the patient’s benefit, but for bureaucrats and bean-counters more interested in our use of computers than our patients. I see better communication between doctors improved with the EMR, but has this translated to better care delivery? Not always. And when it comes to quality, the New York Times editors cited the example that health care inAmerica is cheaper because Medicare
patients have fewer re-admissions since the PPACA was enacted.
But they also failed to note that hospitals receive financial incentives
to reward this behavior. They claim this is “better coordination of care” while ignoring the fact that patients are labeled
with scarlet A’s and shunted to health care facilities that don’t "count" as re-admissions. They also failed to mention the effects of the higher costs that patients see from their higher insurance premiums. Cha-ching.
And then there’s the overall quality of care. I can’t say I really see a difference from five years ago. Sure, I see things being done faster by fewer. I see computers moving information around like never before. But is the care to our patients really better? I see reams and reams of documentation made not for the patient’s benefit, but for bureaucrats and bean-counters more interested in our use of computers than our patients. I see better communication between doctors improved with the EMR, but has this translated to better care delivery? Not always. And when it comes to quality, the New York Times editors cited the example that health care in
What's Ahead
In the end, health care reform is still about the money for the system rather than the real needs of most patients. We are cutting costs to corporations by inflating our Health Care Hindenburg with cheaper hydrogen. We have spun a narrative of providing more care for more people with less cost while ignoring the shear forces and telltale weather patterns of cost concerns that blow our way and threaten our ship's buoyancy.
In the end, health care reform is still about the money for the system rather than the real needs of most patients. We are cutting costs to corporations by inflating our Health Care Hindenburg with cheaper hydrogen. We have spun a narrative of providing more care for more people with less cost while ignoring the shear forces and telltale weather patterns of cost concerns that blow our way and threaten our ship's buoyancy.
Some doctors have leapt from the ship. More will certainly follow. Others remain silent yet quietly discontented; they do their job as just job now, marking time with little incentive for doing more. They have become the common workforce drone increasingly asked to do more by those who go home at 5pm and have no liability for the care they provide. More risk with less reward has been the mantra for care providers in health care reform. The stress is growing for everyone. Unfortunately, the doctors that leave will soon be back-filled by well-meaning young physicians with fewer hands-on hours of training that have been sculpted by an educational system dependent on tenured med-school professors complicit with our new progressive mindset.
Health care reform is here, alright, doing what it's always done: spinning reform without real reform for three years (so far) and counting.
Health care reform is here, alright, doing what it's always done: spinning reform without real reform for three years (so far) and counting.
-Wes
Friday, March 22, 2013
Spent
Why do I keep doing this? After all, I should know better. It is not efficient, logical, cost-effective or even a healthy thing to do.
I finish, look up, and realize the day is gone. I realize I have so much other work to do: notes to type, orders to type, instructions to give, phone messages to return, emails to check, meals to eat, wives to call, meals to eat, kids to help. What was I thinking?
I stop, feel my sore knees and swollen legs, and realize: I'm spent.
An eight-hour case will do that to you.
For eight straight hours, I was focused, engaged, challenged, incrementally approaching a success, I was sure, only to be challenged again and again. Okay, it's not this, could it be this? If it's not here, then where? Can't reach it with this, what else could I try? Got to be careful here - this where I've had problems before - but it's where I have to go. Easy on the power, could get ugly. Where is this damn thing? Could it be here? Where haven't we looked? Maybe there? What's the ACT? Give more heparin, please.
On.
And On.
And On.
Until finally, exhausted, you quit. You have to quit. It's safer to quit.
Dammit.
Then you look up, and the fourteen-hour day is gone but the case isn't. It circulates in you mind for hours while you try to pick up the day's pieces. You come home starved for you've not eaten. If your still married, your wife looks at you as if you've contracted a terminal illness. Your kids roll their eyes since your not much help to them now.
"Go to bed, Dad, you're worthless."
-Wes
I finish, look up, and realize the day is gone. I realize I have so much other work to do: notes to type, orders to type, instructions to give, phone messages to return, emails to check, meals to eat, wives to call, meals to eat, kids to help. What was I thinking?
I stop, feel my sore knees and swollen legs, and realize: I'm spent.
An eight-hour case will do that to you.
For eight straight hours, I was focused, engaged, challenged, incrementally approaching a success, I was sure, only to be challenged again and again. Okay, it's not this, could it be this? If it's not here, then where? Can't reach it with this, what else could I try? Got to be careful here - this where I've had problems before - but it's where I have to go. Easy on the power, could get ugly. Where is this damn thing? Could it be here? Where haven't we looked? Maybe there? What's the ACT? Give more heparin, please.
On.
And On.
And On.
Until finally, exhausted, you quit. You have to quit. It's safer to quit.
Dammit.
Then you look up, and the fourteen-hour day is gone but the case isn't. It circulates in you mind for hours while you try to pick up the day's pieces. You come home starved for you've not eaten. If your still married, your wife looks at you as if you've contracted a terminal illness. Your kids roll their eyes since your not much help to them now.
"Go to bed, Dad, you're worthless."
-Wes
Wednesday, March 20, 2013
Stuck
By now, the majority of America has noticed the new Windows 8 advertisement with young hipsters clicking iPad-like computer screens to a keyboard computer base: touch screens, magnetic attachments to computer bases, pretty colors with cool graphic user interfaces. It all looks so cool, so hip.
But doctors should forget these things for the Electronic Medical Record of tomorrow. After all, our biggest EMR, EPIC, has been developed and tested with Windows XP or Windows 7 and it uses the MUMPS programming language.
I wonder, how long will the our next Windows platforms remain backwardly compatible to support our expensive EMRs? How long will a non-graphic and cumbersome user interface MUMPS survive in tomorrow's graphical computer world? More to the point: how much would updating to a more current operating system cost in the future?
Yeah, we're stuck with what we've got for a very long time.
-Wes
But doctors should forget these things for the Electronic Medical Record of tomorrow. After all, our biggest EMR, EPIC, has been developed and tested with Windows XP or Windows 7 and it uses the MUMPS programming language.
I wonder, how long will the our next Windows platforms remain backwardly compatible to support our expensive EMRs? How long will a non-graphic and cumbersome user interface MUMPS survive in tomorrow's graphical computer world? More to the point: how much would updating to a more current operating system cost in the future?
Yeah, we're stuck with what we've got for a very long time.
-Wes
Our New Inquisitors
A phone conference had been arranged. They wanted to talk to me about a denial for payment on a portion of a patient's pre-authorized procedure after the fact. It's participants: the regional medical director of a large insurance company, his female assistant administrator, and me.
He cordially introduced himself as a pediatrician by trade from a large well-known (and highly respected) academic institution with impeccable credentials responsible for our region of the United States. It was clear we must remain professional. I listened. I was told there are proper ways to discuss claim denials - proper steps to follow - websites to consult. We all must follow protocol.
Yet I had just learned by separate letter that my second request for the claim approval had already been denied. I mentioned this. It was unfortunate, but I was assured the the claim was re-reviewed by a specialist in my field. Remaining professional, I wondered silently if that specialist still practiced. Then I pleaded my case once again on the phone to no avail. I would have to submit my patient's claim a third time to an "independent" centralized reviewer, quietly please.
So I hung up and another letter was drafted. This time a highlighted copy of our guidelines was included for review. "Standard of care," I thought, as if that would matter. Guidelines for care mean little for payment when they are trumped by corporate policy directives.
We'll see.
* * *
For unclear reasons, a few members of our own traditionally underpaid or politically well-connected physician tribe are elevated to work for insurance companies. Who can blame them? Decisions must be made and who better than one of our own? Whether a medical director of an insurance company or a member of an Independent Payment Advisory Board, these individuals must be carefully chosen. They must believe with all of their heart in the process. They must believe the siren song that helping people achieve their "best possible personal health and wellness" rightfully sidelines the real-life costs of care that patients endure through no fault of their own. Most of all, they must never, ever, speak of the money.
Then they are crowned the guild-masters, the rest of us, mere journeymen. To them, it's about clipboards, corporate policy directives, and cost savings. To the rest of us, clinical reality. Increasingly, we we will be finding ourselves facing these modern-day Inquisitors - where principles for the "common good" supersede the needs of the commoner.
Medical decisions made by email, phone or fax.
No faces, please.
Quiet.
-Wes
He cordially introduced himself as a pediatrician by trade from a large well-known (and highly respected) academic institution with impeccable credentials responsible for our region of the United States. It was clear we must remain professional. I listened. I was told there are proper ways to discuss claim denials - proper steps to follow - websites to consult. We all must follow protocol.
Yet I had just learned by separate letter that my second request for the claim approval had already been denied. I mentioned this. It was unfortunate, but I was assured the the claim was re-reviewed by a specialist in my field. Remaining professional, I wondered silently if that specialist still practiced. Then I pleaded my case once again on the phone to no avail. I would have to submit my patient's claim a third time to an "independent" centralized reviewer, quietly please.
So I hung up and another letter was drafted. This time a highlighted copy of our guidelines was included for review. "Standard of care," I thought, as if that would matter. Guidelines for care mean little for payment when they are trumped by corporate policy directives.
We'll see.
* * *
For unclear reasons, a few members of our own traditionally underpaid or politically well-connected physician tribe are elevated to work for insurance companies. Who can blame them? Decisions must be made and who better than one of our own? Whether a medical director of an insurance company or a member of an Independent Payment Advisory Board, these individuals must be carefully chosen. They must believe with all of their heart in the process. They must believe the siren song that helping people achieve their "best possible personal health and wellness" rightfully sidelines the real-life costs of care that patients endure through no fault of their own. Most of all, they must never, ever, speak of the money.
Then they are crowned the guild-masters, the rest of us, mere journeymen. To them, it's about clipboards, corporate policy directives, and cost savings. To the rest of us, clinical reality. Increasingly, we we will be finding ourselves facing these modern-day Inquisitors - where principles for the "common good" supersede the needs of the commoner.
Medical decisions made by email, phone or fax.
No faces, please.
Quiet.
-Wes
Friday, March 15, 2013
Psychocardiology: An New Cardiovascular Subspecialty?
I kid you not (sorry, Medscape registration required):
Psycho, indeed.
-Wes
At the recently held World Psychiatric Association Thematic Conference on Intersectional Collaboration and 4th European Congress of the International Neuropsychiatric Association in Athens, Greece, Angelos Halaris, MD, PhD, made the case for this new subspecialty, which he believes would forge closer working relationships between psychiatrists and cardiologists, provide the training and expertise needed to detect cardiovascular disease (CVD) risk in psychiatric patients (and vice versa), provide continuing education regarding the safe use of medications for patients with these comorbid disorders, and raise public awareness.Wow. More subspecialty regulation and titles? This is the best we can do?
"The formation of a formal subspecialty is a bit of a pipe dream at this point," Dr. Halaris, professor in the Department of Psychiatry and Behavioral Neurosciences at Loyola University Stritch School of Medicine in Maywood, Illinois, told Medscape Medical News.
"But I wanted to put it out there because our colleagues in cardiology as well as in psychiatry need to realize there is a very clear association between emotional/psychiatric/psychological conditions and cardiovascular health."
He noted that 40% to 60% of patients with CVD also have clinical depression. And 30% to 50% who have a diagnosis of depression are at risk of developing CVD.
"Multidisciplinary teams need to forge an alliance because of these comorbidities. This will allow an earlier diagnosis of our patients, vigorous treatment, and the prevention of worse conditions that would happen otherwise," said Dr. Halaris.
Psycho, indeed.
-Wes
The Importance of Recess in our Era of Sequestration
You can see it in doctors' eyes now, especially after 5 pm.
The spring in the step that used to be there is fading; the excitement of discovery being replaced by routine. Change and uncertainty bear down on the continual demands for perfection and quality. Independent entrepreneurial spirit is systematically quashed by clinical pathways, metrics and RVU productivity quotas that fail to represent the time it takes to smile, to do the extra something that makes the case a success, to hold a hand, to explain things. Hiring freezes. Three-month delays for appointments. All occurring with the certainty that the best is yet to come: more cuts are coming. Yes, we've been sequestered too.
Be we dare not speak of this things. We must be positive, upbeat, a leader. Change requires leaders. If you're not the lead dog, the view never changes.
Yet even our doctor-leaders look tired. They are leaders no longer. Someone without a medical degree is "leading" now. The business world is like that. Oh, sure, there are the Chosen Ones, but in reality, they are the spokespersons for business and, unfortunately, business has become medicine's reality. The proverbial bloom is off the rose.
So it is surprising that I say this, but doctors' need a break. Nurses and technicians, too. We need to stop and look around and take care of ourselves. Trust me: no one else in the corporate cog of medicine has an interest in this right now. After all, productivity will suffer.
Yet it needn't be much, but it must be something. Something separate from medicine. Something separate from the hospital or the clinic. Something that breaks from the daily and opens the eyes again. And it can come in the strangest places.
For me, it was jury duty.
Yesterday I had the luxury if turning off my pager for a day. I rode a train. I saw the sea of humanity that exited the train and hurried, eyes downward, to their work. I got to hear the guy hawking newspapers and playing a saxophone on the street, to look up at the huge skyscrapers downtown, to stop for the traffic lights and to smell the acrid smell of diesel fuel as the trucks went by. I had the uncertainty of direction and the pleasure of discovery. I went through security, found the jury assembly room, rode a non-medical elevator, and took a number. I read, I watched other people - lots of other people - and suddenly felt pretty good. I sat and did nothing, then got called and sat again. I was a doctor, so I got bounced early (another personal injury case) and received my $17.20 from the court bailiff. I saw the fountains were already dyed green for St. Patricks Day this weekend, and I saw the homeless guy on the street hugging his dog wrapped in a blanket.
Perspective.
So tonight, after work, we're all taking a break on me. It will be somewhere we like, somewhere non-medical, somewhere fun. We need it. The stress in my colleagues is palpable.
After all, I have to spend my $17.20 somewhere.
-Wes
The spring in the step that used to be there is fading; the excitement of discovery being replaced by routine. Change and uncertainty bear down on the continual demands for perfection and quality. Independent entrepreneurial spirit is systematically quashed by clinical pathways, metrics and RVU productivity quotas that fail to represent the time it takes to smile, to do the extra something that makes the case a success, to hold a hand, to explain things. Hiring freezes. Three-month delays for appointments. All occurring with the certainty that the best is yet to come: more cuts are coming. Yes, we've been sequestered too.
Be we dare not speak of this things. We must be positive, upbeat, a leader. Change requires leaders. If you're not the lead dog, the view never changes.
Yet even our doctor-leaders look tired. They are leaders no longer. Someone without a medical degree is "leading" now. The business world is like that. Oh, sure, there are the Chosen Ones, but in reality, they are the spokespersons for business and, unfortunately, business has become medicine's reality. The proverbial bloom is off the rose.
So it is surprising that I say this, but doctors' need a break. Nurses and technicians, too. We need to stop and look around and take care of ourselves. Trust me: no one else in the corporate cog of medicine has an interest in this right now. After all, productivity will suffer.
Yet it needn't be much, but it must be something. Something separate from medicine. Something separate from the hospital or the clinic. Something that breaks from the daily and opens the eyes again. And it can come in the strangest places.
For me, it was jury duty.
Yesterday I had the luxury if turning off my pager for a day. I rode a train. I saw the sea of humanity that exited the train and hurried, eyes downward, to their work. I got to hear the guy hawking newspapers and playing a saxophone on the street, to look up at the huge skyscrapers downtown, to stop for the traffic lights and to smell the acrid smell of diesel fuel as the trucks went by. I had the uncertainty of direction and the pleasure of discovery. I went through security, found the jury assembly room, rode a non-medical elevator, and took a number. I read, I watched other people - lots of other people - and suddenly felt pretty good. I sat and did nothing, then got called and sat again. I was a doctor, so I got bounced early (another personal injury case) and received my $17.20 from the court bailiff. I saw the fountains were already dyed green for St. Patricks Day this weekend, and I saw the homeless guy on the street hugging his dog wrapped in a blanket.
Perspective.
So tonight, after work, we're all taking a break on me. It will be somewhere we like, somewhere non-medical, somewhere fun. We need it. The stress in my colleagues is palpable.
After all, I have to spend my $17.20 somewhere.
-Wes
Thursday, March 14, 2013
The Generality of the FDA's Recommendations on Zithromax
Tuesday's warning about Zithromax causing heart irregularities reportedly came after the FDA completed its own review of a New England Journal of Medicine article published in May 2012 and after reviewing additional data provided by Pfizer. I have already voiced my concerns over the way this study was conducted in the first place since the data upon which the authors' risk estimates were made were shoddy at best. Still, it is quite obvious to those of us in the business of cardiac arrhythmias that Zithromax, when combined with other medications likely to prolong QT interval or given to sick patients, could increase one's arrhythmic risk.
But we should look closer at the FDA's new Drug Safety Communication on Zithromax which says: "Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events."
Gee, who knew?
If we probe deeper, we find the FDA recommends caution in prescribing antibiotics in patients likely to develop life-threatening cardiac arrhythmias like those with advanced age who are hospitalized, have low potassium or magnesium blood levels, or have slow heart rhythms. The truth be known, each one of these conditions in and of themselves increases the risk of QT prolongation and makes them more susceptable to cardiac arrhythmias irrespective of the drug admininstered.
So how helpful was the FDA's warning on Zithromax to America's doctors?
Not very.
Perhaps we should add that warning to every drug out there, eh?
-Wes
But we should look closer at the FDA's new Drug Safety Communication on Zithromax which says: "Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events."
Gee, who knew?
If we probe deeper, we find the FDA recommends caution in prescribing antibiotics in patients likely to develop life-threatening cardiac arrhythmias like those with advanced age who are hospitalized, have low potassium or magnesium blood levels, or have slow heart rhythms. The truth be known, each one of these conditions in and of themselves increases the risk of QT prolongation and makes them more susceptable to cardiac arrhythmias irrespective of the drug admininstered.
So how helpful was the FDA's warning on Zithromax to America's doctors?
Not very.
Perhaps we should add that warning to every drug out there, eh?
-Wes
Wednesday, March 13, 2013
Want Cheaper Life Insurance? Have an Ablation!
When I see patient's with supraventricular tachycardia, we discuss the the various options for therapy: (a) conservative treatment, (b) medical treatment, or (c) catheter ablation therapy for their arrhythmia. More often than not, patients elect to have catheter ablation of their arrhythmia because of the procedure's proven track record for success, safety, and the need to avoid long-term medical therapy to suppress the arrhythmia.
But in adults, the mortality of supraventricular tachycardia is actually quite low. Also, there are a group of patients who find they're not too bothered by the arrhythmia, or it's self-limited, or it's well-controlled with a minimal amount of medication. For these patients, an invasive ablation procedure seems excessive, so they avoid it.
But now, it seems, there's another reason patient's might want to have a catheter ablation of their supraventricular tachycardia. A patient recently brought us a letter they received after they inquired about a recent premium hike they noticed from their life insurance company:
But I have to wonder, is a adult patient with symptomatic paroxysmal supraventricular tachycardia really going to have reduced mortality if they undergo a catheter ablation procedure? While mortality of SVT ablation has been quoted as low as 0.1%, that low mortality comes with an adverse event rate of 2.9%. I am unaware of a direct comparison of conservative or medical therapy mortality to catheter ablation, but I suspect with such a low incidence of mortality, such a mortality trial will never be performed because of the large number of patients required to show a statistical difference in mortality between the treatment arms.
So I wonder where the data are that support USAA's higher life insurance premium rate for adults?
-Wes
But in adults, the mortality of supraventricular tachycardia is actually quite low. Also, there are a group of patients who find they're not too bothered by the arrhythmia, or it's self-limited, or it's well-controlled with a minimal amount of medication. For these patients, an invasive ablation procedure seems excessive, so they avoid it.
But now, it seems, there's another reason patient's might want to have a catheter ablation of their supraventricular tachycardia. A patient recently brought us a letter they received after they inquired about a recent premium hike they noticed from their life insurance company:
"Dear Ms. Frigamafratz (not her read name):I should be quick to mention that the recommendations or information given on this blog are not an endorsement nor recommendation of any medical treatment either, but at least you now know one more advantage to catheter ablation for supraventricular tachycardias: the potential for cheaper life insurance premiums!
Thank you for your inquiry regarding the change in premium. The original premium estimate was given, as is customary, in the absence of all known medical history. With the information now available from your verbal responses and physician records, an updated current premium quote is now provided. USAA strives to insure every member at competitive premiums which fairly reflect risk.
Careful review of your medical history reveals recurrent problems with supraventricular tachycardia. In some cases, lesser premiums are permissible for members who have successfully undergone the ablation procedures to remedy the problem, and subsequently remain without manifestations for at least six months. Alternatively, we can consider a more favorable premium for individuals with supraventricular tachycardia who have had a thorough cardiac evaluation and documented spontaneous remission of the problem for at least five years. The latter is not an endorsement nor recommendation of any medical treatment, but gives insight to elements of risk approval used to determine your life insurance premium quote. You are encouraged to provide any new medical information to support a better rate and we will be happy to review."
But I have to wonder, is a adult patient with symptomatic paroxysmal supraventricular tachycardia really going to have reduced mortality if they undergo a catheter ablation procedure? While mortality of SVT ablation has been quoted as low as 0.1%, that low mortality comes with an adverse event rate of 2.9%. I am unaware of a direct comparison of conservative or medical therapy mortality to catheter ablation, but I suspect with such a low incidence of mortality, such a mortality trial will never be performed because of the large number of patients required to show a statistical difference in mortality between the treatment arms.
So I wonder where the data are that support USAA's higher life insurance premium rate for adults?
-Wes
Sunday, March 10, 2013
Gruntdoc: Talk Like A Healthcare Management Robot
Saturday, March 09, 2013
The PREVAIL Flail: A Contrarian View
"The good thing about bad news - it sells."
At first, it seemed like such an embarrassment. A brand new therapy for treating atrial fibrillation is slated as the day's Late Breaking Clinical Trial at the 2103 Scientific Sessions of the American College of Cardiology meeting. A "press release" containing the results of the trial is sent to investors at 6:30 AM PST, breaking a pre-specified embargo time of 9:10 AM PST. In response, the American College of Cardiology pulls the presentation.
And with that, the Twitterverse erupts. Scandal. Intrigue. An heir of deception. News organizations, some of whom have been on the receiving end of such scandal, snicker and publish accountings of the event, detail by gory detail. The principle investigator describes his disappointment as "an awful event" and doctors who attended the session feel "cheated," "penalized," and found the event "unhelpful."
And then the results (as they are known) appear anyway in the Wall Street Journal, on Forbes, and nearly a hundred other places on the Internet, instantly.
Can it get any better for marketing?
You see the Watchman device needs some help, especially in the era where at least one novel oral anticoagulant has shown not just equivalency, but a mortality advantage over warfarin, Watchman's trial comparator.
And Watchman has had the difficult time getting FDA approval even though its competitor's device, the Lariat, was (incredibly) already "approved" for sale in the US using the FDA's own 510k exemption.
So Boston Scientific should feel good about the negative buzz about their trial. It'll help overcome their sales headwind provided, of course, their device gets approved by the FDA.
-Wes
Friday, March 08, 2013
Boston Scientific Issues Alert Regarding Their New Subcutaneous ICD
From Massdevice.com:
The company has received reports of 4 instances in which a fuse inside the subcutaneous ICD was activated inappropriately, which could cause the devices to fail. No adverse events have yet been reported, according to Boston Scientific.-Wes
"The company is issuing a software update that takes less than a minute to complete using a programmer in the physician's office," Boston Scientific senior VP of global corporate communications Denise Kaigler told us today. "We recommend patients with recently implanted S-ICDs meet with their doctors for a follow-up visit to receive the software update."
Thursday, March 07, 2013
Health Care Reform's Inattentional Blindness
Dr. Lisa Rosenbaum politely hits the nail on the head in today's New England Journal of Medicine:
-Wes
When it comes to health care, we have embraced a story that, by promising the delivery of high-value care, has become as easy to believe as it is to tell. The value framework for physicians means being held accountable for patient outcomes and resource consumption, whereas patients are reminded that value simply means getting what matters to them. By fostering divergent foci for our attention, this narrative allows us to continue ignoring the tough choices facing our health care system.Read the whole thing.
If we want to simultaneously improve quality and cut costs, we must first stop creating incentives that effectively split patients and physicians onto different teams. We must acknowledge that shared decision making is just that: shared. We must admit that turning health care into a customer-service industry may to some extent undermine the delivery of evidence-based care. And we must admit how little we actually know about patients' values and about how they should or might influence our decision making, the delivery of evidence-based care, rising costs, and patient outcomes.
-Wes
Tuesday, March 05, 2013
What's Missing in Scientific Journal Articles on New Innovations in Medicine
My perspective on scientific publications has been greatly affected by my experience with this blog and social media in particular. The ability to serve as author, reviewer, advertiser and marketer can be easily achieved in this space thanks to the power of self-publishing. But with this new platform comes new responsibilities and for those of us who chose to work with people daily, perhaps none is as great as maintaining the trust of our patient readers.
This week's New England Journal of Medicine opened my eyes to another revelation in scientific reporting where doctors have not been completely honest with our patients. While few are as enamored with scientific innovation as myself, I find there is an gaping hole in scientific discourse that doctors have not forced to the surface when new innovations arise.
What's that hole?
Cost.
In an era where scientific discovery has only been eclipsed by price inflation, doctors have not taken responsibility for insisting this cost of any new innovation's impact on our health care system be disclosed in scientific articles reviewing the medication's risks and benefits. We have not insisted that major medical journals reveal which articles are provided free to the public through tacit collusion with their pharmaceutical sponsors. (While the exact price might not be known at the time of publication of these articles, the estimated cost to our health care system can probably be guessed depending on the novelty of the medication or device and the expected return on investment a manufacturer would hope to achieve.) To be fair, most reputable journals do require disclosure of manufacturer's sponsorship of the reported trial, but no where do the journals report the money they receive from those same manufacturers for making favorable articles about a drug or device open access to the public.
Take this week's New England Journal of Medicine.: Three articles appear on our new novel oral anticoagulants that lack cost information and disclosure information from the journal regarding if they paid for the article to be open access:
Increasingly I find the cost of these novel oral anticoagulants relative to warfarin factors in to conversations I have with patients during their decision about which drug to start. Granted, it is just one factor, but an important one. I also find the deluge of pharmaceutical benefit manager denial letters to be a real thorn in my side as I have to constantly justify to payers why one drug has better benefits for an individual patient than another. Not being armed with cost information puts me at a disadvantage when speaking with these deterrents to care. The reality is this: we simply HAVE to have honest discussions with our patients about cost these days, especially since more and more costs for care are being shouldered by our patients than ever before and the financial impact of their care has huge psychological implications. If I have to disclose everything about my relationship with industry thanks to the Sunshine Law, our scientific journals should do the same.
It is for this reason that we should insist on at least relative cost information of new technologies appear in scientific reporting, especially when the cost of new innovations exceed existing innovations by over a factor of 10. In this era of health care reform and growing cost concerns, patients (and their doctors) deserve disclosure of at least a relative benchmark of price so we can make the best informed medical treatment decisions with our patients that benefits not only their physical well-being, but also their psychological and social well-being too.
-Wes
This week's New England Journal of Medicine opened my eyes to another revelation in scientific reporting where doctors have not been completely honest with our patients. While few are as enamored with scientific innovation as myself, I find there is an gaping hole in scientific discourse that doctors have not forced to the surface when new innovations arise.
What's that hole?
Cost.
In an era where scientific discovery has only been eclipsed by price inflation, doctors have not taken responsibility for insisting this cost of any new innovation's impact on our health care system be disclosed in scientific articles reviewing the medication's risks and benefits. We have not insisted that major medical journals reveal which articles are provided free to the public through tacit collusion with their pharmaceutical sponsors. (While the exact price might not be known at the time of publication of these articles, the estimated cost to our health care system can probably be guessed depending on the novelty of the medication or device and the expected return on investment a manufacturer would hope to achieve.) To be fair, most reputable journals do require disclosure of manufacturer's sponsorship of the reported trial, but no where do the journals report the money they receive from those same manufacturers for making favorable articles about a drug or device open access to the public.
Take this week's New England Journal of Medicine.: Three articles appear on our new novel oral anticoagulants that lack cost information and disclosure information from the journal regarding if they paid for the article to be open access:
Apixiban for Extended Treatment of Venous Thromboembolism: The article is open access and not a word about the cost of the drug. Did Bristol-Myers Squiibb or Pfizer (or both) pay to be sure this article was open to all?
Extended Use of Dabigatran, Warfarin or Placebo for Venous Thromboembolism: The article is open access and not a word about cost of the drugs. Did Boehinger Ingelheim pay to be sure this article was open to all?
Rivaraoxaban for Thromboprophylaxis in Acutely Ill Medical Patients: The article is open access and not a word about the cost of the drugs. Did Bayer Healthcare Pharamceuticals and Janssen Research and Development pay to be sure this article was open to all?
Increasingly I find the cost of these novel oral anticoagulants relative to warfarin factors in to conversations I have with patients during their decision about which drug to start. Granted, it is just one factor, but an important one. I also find the deluge of pharmaceutical benefit manager denial letters to be a real thorn in my side as I have to constantly justify to payers why one drug has better benefits for an individual patient than another. Not being armed with cost information puts me at a disadvantage when speaking with these deterrents to care. The reality is this: we simply HAVE to have honest discussions with our patients about cost these days, especially since more and more costs for care are being shouldered by our patients than ever before and the financial impact of their care has huge psychological implications. If I have to disclose everything about my relationship with industry thanks to the Sunshine Law, our scientific journals should do the same.
It is for this reason that we should insist on at least relative cost information of new technologies appear in scientific reporting, especially when the cost of new innovations exceed existing innovations by over a factor of 10. In this era of health care reform and growing cost concerns, patients (and their doctors) deserve disclosure of at least a relative benchmark of price so we can make the best informed medical treatment decisions with our patients that benefits not only their physical well-being, but also their psychological and social well-being too.
-Wes
Monday, March 04, 2013
Need an Expert? There's an App for That!
"Sally, we need an EP consult on Mr. Smith here. He has some trouble walking now due to pain from his multiple myeloma, but he also has a history of a heart attack, left bundle branch block, some non-sustained VT on his telemetry monitor, and is still a pretty young guy..."
"No problem!" said Sally, reaching for her iPhone. "I think there's a app for that!"
She scoured the apps on her iPhone 5. She clicked on her Heart Rhythm Society Sudden Cardiac Death Primary Prevention Protocol app walked through the algorithms there.
"Hmmm. Looks like I need to order an echo," she thought. * Click click * “Echo ordered! Damn I’m good,” thought Sally.
She continued with her Heart Rhythm Society app. "Says something here NYHA Class? I wonder how I figure that out....Wait! I have a MedCalc app for that, too!" A few taps later, "Looks like NYHA Class II!"
"Let's see, back to the Heart Rhythm Society app..."
A few more clicks and...
"Yipee! Looks like he qualifies for one! But wait, will the government pay for it? Let's check the CMS ICD app!"
A few more clicks and then...
"If we wait ninety days... he might get it paid for... but will I be investigated by the DOJ because I ordered it inappropriately? Hmmm. Oh, wait! There's an app for that, too! I can just use the American College of Cardiology Foundation's Appropriateness Use Criteria (AUC) app© ..." she thought to herself, “After all, it covers 369 clinical scenarios… Wait, looks like there’s an update to the app. This is only Version 1.1… I think I'm going to need Version 1.2…”
She left the "AUC app©" and went to the App Store icon on here phone. She waited a few seconds while the screen refreshed and then:
“There it is: the latest update!. Seems those guys update these scenarios every week. Wouldn’t want to be out of date on this.” She clicked the “Update” button. “I sure like how those clever app developers have all he right data I need right here at my fingertips,” she thought.
After it updated, she went back to the American College of Cardiology Foundation’s "AUC app©" on her iPhone and began entering the patient's scenario...
"Wow," she thought. "This is making it so easy for me! There's nothing to this! Hmm, can't seem to find anything in here about multiple myeloma ... Oh, heck, I'll just click on the 'no' button ... There we go, I got a green box! Looks like we'll still be okay to implant his ICD and stay out of jail." She turned to the resident, beaming.
"Well, did you get that EP consult I asked you to get on Mr. Smith?" the resident asked.
"I didn't need to, it looks like he's good to go!" Sally announced.
"Great!" said the resident, impressed with Sally's performance. "So when does the device go in?"
"I'm not sure. As soon as the next iOS version becomes available I'll check the new software updates." said Sally.
"Awesome. You think his low grade fever will be a problem?"
"Let me check," said Sally, reaching for her iPhone again...
-Wes
"No problem!" said Sally, reaching for her iPhone. "I think there's a app for that!"
She scoured the apps on her iPhone 5. She clicked on her Heart Rhythm Society Sudden Cardiac Death Primary Prevention Protocol app walked through the algorithms there.
"Hmmm. Looks like I need to order an echo," she thought. * Click click * “Echo ordered! Damn I’m good,” thought Sally.
She continued with her Heart Rhythm Society app. "Says something here NYHA Class? I wonder how I figure that out....Wait! I have a MedCalc app for that, too!" A few taps later, "Looks like NYHA Class II!"
"Let's see, back to the Heart Rhythm Society app..."
A few more clicks and...
"Yipee! Looks like he qualifies for one! But wait, will the government pay for it? Let's check the CMS ICD app!"
A few more clicks and then...
"If we wait ninety days... he might get it paid for... but will I be investigated by the DOJ because I ordered it inappropriately? Hmmm. Oh, wait! There's an app for that, too! I can just use the American College of Cardiology Foundation's Appropriateness Use Criteria (AUC) app© ..." she thought to herself, “After all, it covers 369 clinical scenarios… Wait, looks like there’s an update to the app. This is only Version 1.1… I think I'm going to need Version 1.2…”
She left the "AUC app©" and went to the App Store icon on here phone. She waited a few seconds while the screen refreshed and then:
“There it is: the latest update!. Seems those guys update these scenarios every week. Wouldn’t want to be out of date on this.” She clicked the “Update” button. “I sure like how those clever app developers have all he right data I need right here at my fingertips,” she thought.
After it updated, she went back to the American College of Cardiology Foundation’s "AUC app©" on her iPhone and began entering the patient's scenario...
"Wow," she thought. "This is making it so easy for me! There's nothing to this! Hmm, can't seem to find anything in here about multiple myeloma ... Oh, heck, I'll just click on the 'no' button ... There we go, I got a green box! Looks like we'll still be okay to implant his ICD and stay out of jail." She turned to the resident, beaming.
"Well, did you get that EP consult I asked you to get on Mr. Smith?" the resident asked.
"I didn't need to, it looks like he's good to go!" Sally announced.
"Great!" said the resident, impressed with Sally's performance. "So when does the device go in?"
"I'm not sure. As soon as the next iOS version becomes available I'll check the new software updates." said Sally.
"Awesome. You think his low grade fever will be a problem?"
"Let me check," said Sally, reaching for her iPhone again...
-Wes
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