The cost-effective cardiologist..

Safe, appropriate, effective care at a reasonable cost.  Such a simple goal.  The message is clear. Leaders in hospitals, congress, and even my chihuahua echo the dawning of a new age in health care. Down with the private practice, fee-for-service mentality, they all say.  I pay attention to a lot of this chatter since I happen to be in private practice.  I split my time on the internet between the latest exploits of the Kardashians and gravestones for my practice.  I can picture the epitaph:

In loving memory of 

Koka Cardiology

3/1/2013 - 3/1/2016.  

Shed not for her the bitter tear

Nor give the heart to vain regret

'Tis but mere ashes that lie here

The gem that filled it sparkles yet

As I shuffled towards this abyss, my reverie was broken by a letter.  It was from Independence Blue Cross (IBC) in Pennsylvania.  It was titled: The Cardiology/Invasive Cardiology Comparative Cost report.  It looked like a report card, so I opened it with some trepidation.

My first impression?  I was in the green! That was good. Maybe the headstone could wait.  They like me.  They really, really like me.  Of course, then I kept reading, and the headstone popped back into my head.  

I wasn't that good.  I scored an 80 out of a total score of a 100.  In the cost-effective outpatient category in the city of Philadelphia, there was a green category and a danger zone orange category.  I was comfortably in the green category, but within the green category I was 21st out of 26 sites. 

Great.

I started a solo practice in March of 2013.  I had been out of fellowship for two and a half years and parted ways with a local cardiology group with the firm belief that I wanted to be different. I had learned a lot in my two and a half years, and lived through the mass migration of private cardiology practices to hospitals.  Everyone I told about my plans to start private practice in this climate said I was crazy (and they were being polite).  The private practices that were rushing to join hospitals were doing so out of desperation, primarily because of large cuts that had been made to imaging reimbursements in 2008.  Alarmed at the rapid growth of imaging studies in the outpatient setting, CMS had instituted a 36% cut to myocardial perfusion imaging reimbursement, and a 25% cut to echocardiogram reimbursement in 2008.  This was clearly incredibly painful to many practices that had a cost structure based on high margin imaging revenue.  Practices were faced with tough choices. Luckily CMS had a reserve parachute handy - hospital outpatient prospective payment (HOPP). Physician practices leased themselves to hospitals - and voila - no more reimbursement cuts.

This was the climate I started my practice in.  I did have some advantages relative to the established practices around me.  Unfortunately, I was no more affable, intelligent, or more attractive than my colleagues. But most importantly, I had no fixed cost structure (technicians, underproductive physicians, or costly equipment), which gave me the freedom to set up a practice that was not dependent on imaging.  Since I was trained in the world of CARP (limited/no role for preoperative coronary revascularization) and COURAGE (medical management of stable angina is equivalent to revascularization), I decided to forgo an in-office stress lab.  If a patient needed a stress test, I would have it done at one of the nearby hospitals.  I focused on being accessible to subspecialists, surgeons, and patients.  As a result, after two years of being in practice, only 7% of the revenue for the practice comes from echocardiograms or the supervision/interpretation of a stress test. I saw ~3500 outpatients in 2015.  I did 537 echocardiograms, and personally supervised the ECG portion of 48 stress tests.  13% (537/3500) of my patients had an echocardiogram, which contrasts with a national average from Medicare data of 20%.  I was paid ~ $144 per echocardiogram, and $23 per stress test I supervised.  In contrast, the hospital was paid ~ $400 per echocardiogram performed, and $1140 per stress test.  

In the cat and mouse game providers and payers love to play, the payers, of course, noticed that practices like mine are a fairly good deal.  The medicare payment advisory commission (MEDPAC) specifically cited the differential reimbursement of echocardiograms in recommending that this playing field be leveled.  The reason for the difference in hospital reimbursement has always been explained by the significantly higher cost of doing business hospitals have relative to outpatient practices.  I don't have to comply with JCAHO and I don't have to staff a 24/7 ER that must take all comers regardless of ability to pay.  However, there is something fundamentally rotten if the patient mix, the providers, the equipment, and the physical space are the same, but the addition of the hospital logo doubles or triples the price of the service being delivered.  MEDPAC has recommended in 2014, and again in 2015, that "Congress should direct the Secretary of Health and Human Services to reduce or eliminate differences in payment rates between outpatient departments and physician offices for selected ambulatory payment classifications".  IBC took a different approach.  IBC set up programs that would allow for bonus payments to doctors who practiced high value/cost effective care.  In order to guide test/consult ordering physicians to cost effective facilities/providers, a comparative cost report for each facility in a certain geographic area was generated and distributed. This report was meant to highlight those providers that were practicing as hospital outpatient facilities.  This was the report I had received. 

Sure enough, all the 'penalties' (those facilities marked in orange/red) in the report were for facilities that were hospital outpatient practices.  Certainly, a very interesting first step by a private insurer to use data to give physicians information about the cost of procedures.  This does, though, provide yet another opportunity to look at why one has to be so careful about what quality metrics actually tell us. 

I called one of the medical directors at IBC to inquire about how exactly the score was arrived at, but I only got the general information that the cost/procedure performed was the primary determinant of final score.   This did serve to explain why I ranked 21/26 in the 'green' category.  Even though I did not have a stress lab and did fairly few echo's or stress tests, those stress tests I did do were at a local hospital at the 'hospital rate'.  I was actually encouraged by the medical director at IBC to get my own stress lab! Interestingly, a physician practice that did echocardiograms on 50% of its patients would come out smelling like a rose to the IBC folks.  Meanwhile, a hospital based practice that only tested 5% of their patients would be penalized.

So much for this particular score.  I understand this report as a first step that does deliver some good data, but I surmise that a lot of resources and capital went into generating a list that essentially tells you which practice is hospital-based, and which isn't.  I'm not sure how much that cost IBC.  I would have done it for half (I hope someone at IBC reads this :-) ). Saurabh Jha, Lisa Rosenbaum, and Rocky Bilhartz are a few fellow physician who have spoken eloquently about the pitfalls of quality metrics.  As I look down the list of facilities I am being compared to, I know who the most efficient, highest value providers are.  The challenge of quantifying this effectively in a reliable manner remains a vexing one.  

My response to Dr. James

What follows is an email correspondence that nicely represents the different positions Dr. James and I take on the issue.


Dear Dr. Koka,

I really appreciate the respectful way you disagreed with me, and I agree with you that it is probably time to let the issues rest in the realm of respectful disagreement. I never expected to make anyone comfortable with my analysis, least of all physicians and hospitals. Harm during hospital care is an uncomfortable topic. One comment I received on the paper from a physician was something like "How good do you expect us to be? Maybe 1% is the best we can do." I don't know the answer to that.  I think physicians and patients working together can substantially reduce the preventable harm.

What I would say to your physician colleagues that do not like my assumptions - then please go ahead and survey the data and draw your own conclusions, and then publish them in a peer-reviewed journal. Better yet, do a comprehensive study of preventable harm in hospitals that has the scope and depth to at last get irrefutable data on preventable harm in U.S. hospitals. Then we can track improvements as those unfold.

I wish you well in your efforts to heal those with heart troubles. I think there can be nothing better in life than healing another human being.

Best Regards,

john james

-----Original Message-----
From: Anish Koka 

Sent: Nov 30, 2015 7:07 PM
To: John James , dwbates@bics.bwh.harvard.edu
Subject: Re: Journal of Patient Safety article

Dear Dr. James,

Thank you again for your response. I do appreciate your time.  I don't think I'm trying to impose my beliefs on the data.  I guess you can say I am trying to strictly interpret the data, but that is what evidence based medicine is. I am fairly certain you are comfortable with your assumptions, which is why you made them in the first place.  I have yet to find a physician who takes care of patients who is comfortable with the assumptions you have made.  

My comments below, but  I think we will have to agree to disagree.  

Again, I do appreciate your time, and I do applaud your efforts to shed light on this very important issue

Respectfully,

Anish Koka

On Mon, Nov 30, 2015 at 6:13 PM, John James <john.t.james@earthlink.net> wrote:

Dear Dr. Koka,

My comments below on your thoughts. I think you are trying too hard to demand precision and impose your beliefs upon the data available. No one has performed a single study that would represent the nation as a whole. You seem to be stuck on the Landrigan study as somehow representative and it is not. There is certainly more than one way to handle the available data, but in my paper I made it clear which choices I made and why. I might point out that the number 178,000 you suggest below would make preventable adverse events the third leading cause of death.

Best Regards,

john james

-----Original Message-----
From: Anish Koka 
Sent: Nov 30, 2015 1:18 PM
To: John James , dwbates@bics.bwh.harvard.edu
Subject: Re: Journal of Patient Safety article

Dear Dr. James,

Thank you for the response. I sent a letter to the editor as I was hoping to have a peer review your approach as well.

Your response does clarify one matter I was confused with, but does reaffirm my challenge to your estimate.  The clarification that I didn't grasp in my initial email was that you assumed the total preventable harm rate to be equivalent to the lethal event harm rate. I do not feel this is a reasonable assumption.  While I understand that science and evidence based medicine must necessarily have some assumptions contained within them, I do feel your assumptions are a leap too far, especially for a paper that is intended to provide an 'evidence based' estimate of patient deaths due to medical error. 

My response to you with regards to the major issues are as follows:

1. The preventable harm rate is 69%

Only one paper has a preventable death rate noted (Landrigan).  The OIG study does not list preventable deaths, just a total preventable harm rate.

You have to assume that the Classen paper would have shown a similar rate of preventable harms.  You then have to assume that the preventable death rate is equivalent to the total preventable harm rate.  The classen authors write that all harms may in some way be preventable?  Since they have no way of telling they chose not to say so in their paper.  I don't think its fair for you to take that statement as a blessing to use all their harms as preventable.  Your attempt was to create an evidence based approach for harm data (this I applaud), but you are creating evidence in this case.  You excluded a number of papers because they didn't you the GTT, you could have excluded the Classen paper in coming up with a preventable harm rate. The actual evidence for preventable harms is below.  There are no assumptions in the numbers below.  That is what the evidence says.  If your interpretation of classen et al.,  were to hold, why not say all the harms were in fact preventable?  The OIG and landrigan paper specifically don't believe all adverse events that happen in hospitals are preventable.  Regardless of your belief or my belief, that is what the evidence says.  Again, the Classen folks could have said in their conclusion that they felt all harms were preventable.  They did not, and you shouldn't make that assumption for them.

Landrigan paper:

588 total harms,  364 preventable (63%)

OIG Medicare analysis

128 total harms, ~56 preventable (44%)

(364+56)/(128+588) = 58%

Assuming that.. (34.4 million x .58. x .0089) = 178,310.  Of course this assumes the preventable harm rate is equivalent to the preventable death rate.

PREVENTABILITY IS SUBJECTIVE AND AS I SAID, I COULD NOT IGNORE THE  OPINION OF THE WRITERS OF THE CLASSEN PAPER. CLEARLY, THEY BELIEVED THAT THE VAST MAJORITY OF ADVERSE EVENTS WERE PREVENTABLE. AS I SAID IN MY ORIGINAL RESPONSE, EVEN IF ONE TOOK THE MIDDLE VALUE OF 44, 63, AND >>63, THE RESULT IS HARDLY DIFFERENT THAN MY ORIGINAL ESTIMATE. LET ME EMPHASIZE THAT THIS IS AN ESTIMATE. YOU ARE ALSO TRYING TO TREAT EACH PAPER AS AN INDIVIDUAL SOURCE AND THIS IS NOT JUSTIFIED. ONE MUST LOOK AT THE AGGREGATE OF THE DATA.

It remains a fact that the Classen paper does not comment on preventable harms.  I also can't seem to find your quote in the article.  I searched the text for the same, with no results.  I assume this was personal communication?  I know you disagree but I certainly would not assume 100%.  I agree that this does not have a sig. effect on the number.  But of course, I don't think much of that number since I take issue with assuming total preventable harm rate is the same as preventable death.

AT THE RISK OF MORE CONTENTION, I SHOULD POINT OUT THAT I COULD HAVE WEIGHTED THE THREE LARGE PAPERS EQUALLY INSTEAD OF HEAVILY WEIGHTING THE LANDRIGAN PAPER. THAT WOULD BE OIG (2010), CLASSEN AND LANDRIGAN. IF I HAD DONE THAT, THE AVERAGE PERCENTAGE OF ADVERSE EVENTS WOULD HAVE BEEN 1.4 + 1.1 + 0.6 = 1.03%, WHICH IS A GOOD BIT HIGHER THAN THE WEIGHTED AVERAGE I USED OF 0.89%.

If you weighted the 3 papers equally that would be completely wrong, since the landrigan paper is 2-3 x larger than the other papers.

 

2. The lethal preventable harm rate is equivalent to the total preventable harm rate

In your article you assume the lethal preventable harm rate is equivalent to the total preventable harm rate.  You say in your response that you think the lethal preventable event rate is higher than the total preventable harm rate.  What basis do you have to make that assumption? The landrigan paper is the only paper that allows a comparison of this, and only in this one case does this happen to be about the same.  As a busy clinician in the hospital, I feel that of all the people dying in hospitals, much less than 63% are preventable.  Again, that doesn't give me the right to write a paper about it.  I'm just one guy, and I could be completely wrong.  But you assume this based on your feeling, and have written a evidence based paper on this.

THE LANDRIGAN PAPER DOES STATE THAT THE OVERALL PREVENTABILITY IS 63%, WHICH IS WHAT I USED. FROM THEIR TABLE ONE CAN CALCULATE THAT THE PREVENTABILITY RATE IS 9/14 = 64% FOR LETHAL EVENTS.

You, elsewhere, have taken issue using one paper as being globally representative.  However, in this case, you have no issues with using the one papers lethal preventable event rate and extrapolating to the other 3, and of course to the 34 million folks.

PLEASE, WE ARE NOT TALKING ABOUT ALL THE PEOPLE DYING IN A HOSPITAL. WE ARE TALKING ABOUT DEATHS IDENTIFIED USING THE GLOBAL TRIGGER TOOL AS APPLIED TO WHATEVER INFORMATION MAY OR MAY NOT BE CONTAINED IN THE MEDICAL RECORD. OBVIOUSLY MANY PEOPLE PEOPLE DIE IN HOSPITALS IN WAYS THAT WOULD NEVER BE FLAGGED BY THE GTT. I ALSO MADE IT CLEAR THAT MANY DO NOT ACTUALLY DIE IN HOSPITALS. THEIR DEATHS ARE HASTENED BY FAILURE TO USE EVIDENCE BASED MEDICINE. THE MURTHA EXAMPLE ATTEMPTED TO MAKE THAT CLEAR TO YOU. 

I agree completely with this comment.  But then how do we know what the number is?  This smells of something I was taught in computer science class all the time -- Garbage inputs lead to garbage outputs. 

I ASSUME YOU ARE WELL AWARE THAT CARDIOLOGISTS OFTEN DO NOT FOLLOW EVIDENCE-BASED MEDICINE IN THEIR PRACTICES. I HAVE MESSAGES FROM CARDIOLOGISTS FRUSTRATED BECAUSE THEIR COLLEAGUES IGNORE THE NEED FOR CAREFUL ELECTROLYTE MANAGEMENT IN THE FACE OF HEART ARRHYTHMIA. I READ IN THE LITERATURE THAT FAR TOO MANY CARDIAC CATHS ARE PERFORMED - AGAINST THE EVIDENCE. ONE STUDY I RECALL SHOWED THAT IF TROPONIN IS USED AS AN INDICATOR OF TISSUE DAMAGE, THEN A LARGE PERCENTAGE OF CARDIAC CATHS CAUSE SOME SUBCLINICAL TISSUE DAMAGE. THERE IS ONE NOTORIOUS EXAMPLE OF HUNDREDS OF CARDIAC BYPASS SURGERIES DONE ON PATIENTS THAT NEVER NEEDED THEM. MANY DIED.

Again, while all of this does happen, one needs to know how often this happens. What are the numbers?  How often are lethal arrhythmias happening because of inadequate electrolyte repletion , how often are inappropriate bypass surgeries being done? How often do people die?  You assume this happens commonly..again I don't know for sure, it doesn't feel like any of this is happening on a daily basis...but I would not deign to write an article based on that feeling.  With no intention to agitate/upset you I would suggest your underlying belief of the frequency of these events is shading the assumptions you make.

I THINK YOU NEED TO VIEW THIS AT A TOP LEVEL. WHAT I ASSERT IS THAT SOMEWHAT MORE THAN 1% OF THE TIME WHEN A PERSON IS HOSPITALIZED, THEIR LIFE IS SIGNIFICANTLY SHORTENED BY INAPPROPRIATE (NON-EVIDENCE BASED) CARE IN HOSPITALS. THAT DOES NOT MEAN THAT THEY DIE IN THAT HOSPITAL. PLEASE ALSO NOTE THAT MY ESTIMATE INCLUDES HOSPITAL ACQUIRED INFECTIONS, WHICH THE CDC ESTIMATED KILL 100,000 PERSONS EACH YEAR IN 2007.

Why do you think that?  A better way to think about this is that out of a 1000 patients that are presenting to hospitals in need of help, 4 are dying due to a preventable error (Landrigan).  Using your numbers (0.58 x .0089), 5 out of a 1000 patients presenting in need of help are dying due to a preventable error.  And while much can be done to prevent, for example, infections in the hospital, there are some infections that will not be preventable.  Some patients who get central lines, despite appropriate, evidence based care, will have infections.  Some patients who get put on antibiotics to save their lives from sepsis, will get Clostridium difficile, and some may die from this.  

3. The evidence for lethal preventable deaths.

You note that you can't just use one paper to make an estimate.  Why not? IT IS NOT REPRESENTATIVE OF THE NATION AS A WHOLE.  If only one paper has the answers you seek, and the other papers are not appropriate, you use whatever you can.  Regardless of whether you use one paper or four papers, you are talking about extrapolating data from ~3000 patients to 34 million patients.  It would be better to use only papers that allow you to make reasonable assumptions.  Again I would have used the Landrigan paper to be pure.  If you wanted to assume that the lethal harm rate was equivalent in the OIG analysis, I guess that may be done, but you're starting to walk on planks not supported by evidence.

Simply put, If you want to know what the lethal event rate in a population is, multiply that by the population.  

In this case, the most evidence based number is to take the landrigan papers lethal event rate (9/2341) .384% x 34,400,000 (medicare admissions 2010). That equals ~ 130,000.  

AS I HAVE SAID, ONE MUST LOOK AT ALL THE STUDIES AVAILABLE, AND THE LANDRIGAN PAPER, AS I POINTED OUT IN MY JPS PAPER, IS LIKELY TO BE A LOW ESTIMATE OF THE NATION AS A WHOLE.

I understand that one paper is a poor representation.  Obviously my argument is that pooling together, and aggregating/extrapolating inappropriately isn't a good representation either.  By the way, while you state that the north carolina folks may be better than the nation part of the conclusion of the landrigan paper is that no significant improvement has been seen in harm rates over the years (2002-2007)

4. The factor of 2.

There is little question that this approach does not capture errors not captured in the medical record, errors happening after leaving the hospital, or errors of misdiagnosis, nondiagnosis.  But again, the question, and your charge was to come up with an evidence based estimate.  Where is the evidence for your factor of 2, 3, or 4? WEISMANN IS THE BEST THERE IS. Perhaps I feel its 1, or 1.2, or 1.3 or 10?  who knows?? Again, I surmise from your response that you think the factor should be even higher.  I will submit readily to not knowing what that number is.  It doesn't 'feel' like medical errors are the 3rd leading cause of death, but again I wouldn't write a paper based on that feeling.  MEDICAL ERRORS ARE OFTEN A CONTRIBUTING FACTOR IN PATIENT DEATH; OF COURSE, A MEDICAL ERROR ALONE IS UNLIKELY TO KILL A HOSPITALIZED PATIENT - THEY ARE IN THE HOSPITAL BECAUSE THEY DO HAVE AN ILLNESS IN MOST CASES. 

In essence, you have used a feeling to come up with that number.  THAT IS NOT TRUE. THE EVIDENCE IS LIMITED, BUT THERE IS SOME EVIDENCE THAT MEDICAL RECORDS ARE MISSING INFORMATION THAT WOULD ALLOW A REVIEWING PHYSICIAN TO SEE THAT AN ADVERSE EVENT HAD OCCURRED. YOU PRESUME THERE IS NO EVIDENCE AND THAT IS NOT TRUE. This has a place in an op-ed, but not in a paper that should require some type of evidence to back up this claim.

IN MY PAPER I POINT OUT THE BASIS FOR THE ESTIMATE THAT THE GTT MISSES AT LEAST HALF OF THE ACTUAL LETHAL, PREVENTABLE, ADVERSE EVENTS. ONE CANNOT IGNORE THE LIMITATIONS OF THE SEARCH TOOL AND THE LACK OF VERACITY OF THE MEDICAL RECORDS. THE WEISMANN PAPER SUPPORTS MY CHOICE. YOU MAY HAVE CHOSEN TO IGNORE THIS FACTOR, BUT I COULD NOT. I KNOW THAT ERRORS OF OMISSION, CONTEXT AND DIAGNOSIS ARE LARGE AND NOT TYPICALLY DETECTED BY THE GTT, AND I KNOW THAT MEDICAL RECORDS ARE OFTEN NOT A TRUE REPRESENTATION OF WHAT HAPPENED WHEN THERE IS AN ADVERSE EVENT. PLEASE READ THE WEISMANN AND DUNLAY PAPERS. 

I don't see an evidence based estimate for the factor of 2.  I read the Weisman paper.  This was a paper that used post discharge interviews of patients to find events not in the medical record.  So necessarily, these were all patients that survived.  I still don't see how you come up with your factor based on this.  Again, I could say its 10, and you wouldn't (by your logic) say I was wrong.

As, an aside... I reviewed the serious adverse events deemed preventable in this paper.  Let me just give you the first one.. DVT develops after open heart surgery.  If the patient was receiving appropriate DVT prophylaxis after their open heart surgery, was it really preventable? I guess if the open heart surgery was unindicated? But who knows??  After I read this paper, I emailed Dr. landrigan to ask him if the clinical summaries on the 9 deaths in his study were available somewhere.  He has not responded :/

Respectfully,

Anish Koka

Paid family medical leave: A physician's perspective

Paid family medical leave has become a hot topic recently.  This is fairly impressive given that the news cycle includes blood thirsty terrorists bent on destroying our way of life (ISIL) and Donald Trump.  As a cardiologist that runs a very tiny practice in Philadelphia, I have to confess I have never really thought about paid family medical leave.  That is, until about 8 months ago, when I was informed that the only other physician in my practice, a part time internist, was pregnant.  I was fairly happy on hearing the news, but my mind quickly turned to dealing with the practicalities of  'coverage' while she was out.  She had been working in the office for about two years and had a small but steadily growing practice.  The practice would have to be closed to new patients, and I would cover any medical issues that would arise on her established patients.  

The economics as it relates to the practice are not desirable.  She had a fledgeling practice, and there are a number of competitors in the area.  Patients looking for a new physician during those months that the practice was not available, were likely lost to the practice forever.  Established patients who were expecting to see her, but could not, may be lost to a practice where there was more coverage/resources evident.  As a very busy cardiologist with my own panel of patients it would be impossible to simply add her panel of patients to mine for the months she was off.  Essentially, this meant no revenue for the months she was out.  The fixed costs related to malpractice, the electronic medical record, marketing on zocdoc, stay constant however.  Regardless of the short term loss of productivity and loss of revenue, I did offer one month of paid maternity leave.  At the end of the day, successful small businesses are like families and everyone is invested in each others success. Not being cognizant or empathetic to members of your family is a bad idea in the long run for many reasons.  So, if a company can afford it, I think paid family medical leave is an important benefit to offer.  Even if you aren't doing it to be 'nice' in many industries, it is necessary to be competitive, especially when employees are highly skilled.

There is of course a cost to any benefit that is provided.  This statement, I fear, is lost and almost never mentioned in the discussions about family medical leave.  All I heard on a recent NPR broadcast on the matter was that kids are better off when their father's can take off.  Its the usual soft social science that makes me roll my eyes.  Thank you for telling me that children do better if their parents spend more time with them.  The message is that hopefully we as a civilized society will wake up to the benefits of paid family medical leave.  Of course, and I think irresponsibly, there is no mention of what the cost of this benefit would be.  

When looking at cost, it is instructive to look at the cost of the current family medical leave act (FMLA) act (guaranteeing at least 12 weeks of unpaid leave to certain employees under certain conditions) that went into effect in 1993.  The employment policy foundation estimated direct costs of FMLA leave in 2004 to be $21 billion dollars.  The cost analysis accounted for the cost of lost productivity ($4.8 billion), healthcare ($5.9 billion), replacement labor ($10.3 billion).  This does not account for indirect costs of an additional $11 billion that employers spent in an effort to comply with FMLA regulations.  The total cost of FMLA in 2004 was thus estimated to be $32 billion dollars.

This is the cost of unpaid medical leave.  Mandating paid medical leave would necessarily be even more expensive.  Using the recently proposed Washington D.C proposal for paid family medical leave, the admittedly 'center-right' american action forum estimates a yearly cost of $300 billion to $1.9 trillion.  Even more troubling, the proposed 0.5-1% tax on workers salaries to pay for this program would fall alarmingly short.  Covering a full 16 weeks of paid medical leave would require an almost 4% payroll tax.

Again, my stance on paid family medical leave is fairly clear.  If I am able to, I want to be able to provide some form of this to my employees.  Perhaps we as a society think it important enough to establish a federal/state fund that pays for this.  Great.  Just be ready to pay for it.

Preventing Patient Harm: The Real Story

The date is July 17th, 2014. It is 10am in the Dirksen Senate building, and the congressional subcommittee on health and aging is about to focus on patient harm.  The educating will be done by some of the leaders in the medical field,  Ashish Jha and Tejal Gandhi from Harvard, Peter Pronovost from Johns Hopkins. The star of the proceedings is John James, a toxicologist, a PhD from Texas, and the founder of Patient Safety America.

The tone is set from the beginning by none other than Bernie Sanders.  In somber tones, he relays that hospitals can make patients worse, and that a recent study suggests medical errors is America's third leading cause of death behind only heart disease and cancer. Hospitals are killing patients, and something needs to be done about it.  The panelists then go on to speak strongly about the ongoing epidemic of patients dying in hospitals, and re-enforce the staggering numbers introduced by Bernie Sanders.

Headlining the proceedings is an unassuming gentleman named John James.  He has a Ph. D in pathology, and he worked as a Chief Toxicologist at NASA.  He is at the congressional proceedings, and is one of the lead activists in patient safety because of personal tragedy.  His 19 year old son died in the summer of 2002 due to "uninformed, careless, and unethical" care by cardiologists.   He proceeded to write a book, "A Sea of Broken Hearts" that details the errors he believes cardiologists made in his son's care that lead to his death.  Of note 2 cardiologists that were sought by Dr. James' lawyers believe the care his son got did not violate the standards of care.  A further 2 appeals to the Texas Medical Board also rendered two opinions from two other separate cardiologists that the standards of care in this case were not only met, but exceeded.  Dr. James, armed with information he has carefully selected from a number of different sources, strongly disagrees.

Dr. James is now a crusader for patient rights.  He writes of a broken health care system on his website, and more importantly wrote a paper in 2013 in the Journal of Patient Safety that estimated 400,000 patient deaths per year that were due to medical error.  No physicians on the panel or elsewhere seem to have any issue with this number, and this has become fairly widely accepted.  Even Captain 'Sully' Sullenberger, the hero pilot who landed a plane in the Hudson, noted that this was the "equivalent of three jumbo jets going down every day with no survivors."

As a busy clinician who spends much of his time in the hospital, it doesn't feel like patients are dying daily because of medical errors.  But of course, data necessarily must trump feelings.  So, I decided to read John James's landmark paper.

The paper reviews four original articles that reported on medical error causing patient harm.  The first study was a pilot trial of 278 patients that examines one week in August of 2008.  The second trial examined 838 patients in October of 2010. The third trial was a very similar study that looked at 795 patients in October of 2004.  The most robust (because it was the largest over the longest duration of time) examined 100 hospital admission per quarter in North Carolina.  Dr. James's paper combines all four trials, but weighs the North Carolina trial the heaviest.  He simply divides the total lethal adverse events found in all four trials (38) and divides by the total number of records reviewed (4252) to come up with a lethal event rate of 0.89%.  He estimates that, of the harms found in these trials, 69% were noted to be preventable.  Since there were 34.4 million hospital admissions in 2010, simple multiplication (34,400,000 x 0.69 x .0089) reveals a number of 210,000 preventable harms that resulted in the death of a patient.  Dr. James isn't done here, however.  He notes that the tools used to find patient errors are imperfect.  He notes that failing to follow guidelines, errors not documented in the medical record, and a failure to make life saving diagnoses would necessarily add to these numbers.  He believes that at a minimum, this should increase the actual number of deaths related to medical error by a factor of 2.  That's it.  No statistical modeling for how many patients a year present with heart failure and don't leave on a beta-blocker, no examination of the number of young patients dying due to a missed diagnosis of long QT.  He just comes up with a factor of 2 because that feels about right.  And there we have it, 400,000 patients, 3 jumbo jets a day crashing, the third leading cause of death in the United States.  Dr. James notes this is likely an underestimate.  Good thing, otherwise the health care system would be the biggest killer of patients.

I was stunned.  This was the evidence?  4 trials.  One of the trials took place over one week.  All four trials did use the same error reporting tool, but were simply added together, with no regard to the varying settings the different trials took place in.  The smallest trial did not even report what percentage of cases were preventable.  One of the trials (Classen 2011) was a trial designed to test the efficacy of a patient harm reporting tool, and did not report preventable harm events.  Dr. James, inexplicably in his review, notes that 100% of the harms found in this trial were preventable.  Another trial, The Office of the Inspector General (OIG) analysis, notes a 44% preventable harm rate, but does not note which deaths were clearly preventable.  Far and away, the best quality trial is the North Carolina study from the New England Journal of Medicine.  Of the 2341 cases reviewed, there were 588 total harms identified.  364 of these harms (63%) were deemed preventable and 9 of these resulted in patient deaths (0.4%).

Dr. James' problem is in how he aggregates the data.  He includes trials which did not state preventable deaths, and in one case assumes that all the deaths were preventable.  If you only used the two trials that published data on preventable harms, the preventable harm rate is 58%, not the 69% listed by Dr. James.  Of course, I don't think one should use this number to estimate the preventable lethal death rate, because this assumes that the total preventable harm rate is equivalent to the lethal preventable harm rate.  Why is that a safe assumption?  Luckily, since Dr. James's statistics to arrive at his estimate uses multiplication, and I just happen to be reviewing this subject with my 6 year old, I can generate my own number. The lethal preventable death rate is .384% (9 preventable deaths/2381 total cases reviewed).  34,400,000 x  .004 = 130,000 patients. Using the sounds about right Dr. James factor of 2, that brings us to 260,000 patients.  That is still a lot of patients, but a lot less than 400,000 patients.

Medical errors are a serious problem, that is no doubt deadly, and needs attention.  We in the healthcare community need to work hard locally and nationally to combat this issue.  I applaud Dr. James and the other physicians that have shed light on this important issue.  Perhaps, the actual numbers don't matter, perhaps it's missing the point to focus on the actual number, perhaps it doesn't matter that Bernie Sanders thinks medical errors are the third most common cause of death.  Except, it does.

Bernie Sanders frequently talks about the broken health care system, and in support uses this to buttress his claim.  Others (including Dr. James) go further.  They specifically point to physicians as the problem.  We are the captains of this ship, and we are steering this ship into an iceberg.  It generates distrust among the public and foments anger against physicians when patients do not do well.  Michael Davidson, a cardiothoracic surgeon at Brigham and Women's, and more importantly a husband to a pregnant wife and three children, was shot to death by his patient's son.  The assailant's mother, Marguerite Pasceri, 78 years old, had recently died while she was in Dr. Davidson's care.  She had multiple medical comorbidities and her death was ruled as being related to these severe comorbidities.  Unfortunately,  fueled by the internet, Steven Pasceri became obsessed with the idea that use of the drug amiodarone had caused her death.  He confronted the doctor, the scene is described in chilling fashion by the Boston Globe:

{Right away, Pasceri told Davidson to open the Internet, go to Drugs.com, and look up amiodarone.

“Are you aware that this drug is extremely toxic?” Pasceri asked, St. Jean said, pointing to the website. “Do you see all of the warnings on Drugs.com?”

Davidson explained he was aware of all the side effects but said Marguerite Pasceri did not react badly and was being monitored. Any drug, he explained, even an antibiotic, has potentially dangerous side effects.

“Well, my mother died because of this,” Pasceri said, his face twisting into a snarl.}
Minutes later, Dr. Davidson was shot three times.

You would be a fool not to connect the relentless drum beat of the media, congress, and the public about the horrid broken down medical system and the even more horrid, incompetent doctors that are killing patients in hospitals to an event like this.

The facts are that 34 million patients are arriving at hospitals with an illness.  They are presenting in distress, in need of help.  Dr. James and many leading members of our profession have unfortunately whipped our representatives and the general public into a frenzy.  Three jumbo jets are going down every day!  The facts are that 0.4%, 4 out of a thousand patients, die from a medical error. Work needs to be done to reduce this rate, but it is unlikely ever to be 0.

The idea that every error in the hospital is a preventable one, the impression that physicians are by and large an incompetent group that is killing patients needs to strongly be repudiated.  The reason that it doesn't 'feel' like patients are dying on a daily basis in large numbers due to medical errors is because they are not.  Even Dr. James notes that there is no statistically rigorous way to arrive at a number.  The number we use today, 400,000, is a made up number. It is based on a feeling.  Using this to falsely indict, demoralize, and create a toxic environment for millions of medical providers is in no one's best interest.

The case against overlapping surgeries

The Boston Globe recently published an article on the dangers of overlapping surgeries at Massachusetts General Hospital (MGH).  I must say that it is a fairly gripping read.  It tells the story of an eminent orthopedic surgeon who essentially goes to war with his institution over the relatively common practice of concurrent or overlapping surgeries.  The charge is that not having an attending physician available for the entirety of a case is dangerous to patient care.  As evidence The Globe cites patients who have had complications, the orthopedic surgeon's strong opinions on the matter, as well as a smattering of anesthesiologists.

I thought the article was a fascinating behind-the-scenes look at a bitter family break up, but was incredibly short on actual evidence to back up their claims.  It is clear Dr. Burke and some anesthesiologists were troubled by the practice of concurrent surgeries, but is their evidence to suggest surgeries that have no overlap are safer?  A review by MGH and an independent former US attorney found no evidence to suggest overlapping surgeries were more dangerous.  In response to the allegations of complications being more common in overlapping cases, 25 overlapping cases with complications were examined and none of the complications were found to be due to overlapping.  The American College of Surgeons and the Massachussets Department of Public Health also find no basis for these allegations.

I am disappointed that none of the reviews of MGH practices, either done independently or internally are available for public perusal.  This, unfortunately, leaves the door open for conspiracy theorists to posit a grand cover up.  The unfortunately predictable (necessary?) response of MGH was that revealing or discussing patient information was a violation of HIPAA.  Boy do I love HIPAA. Also missing were opinions of more surgeons.  The whole article is based on Dr. Burke's strong opinion on the matter.  In the face of no evidence to buttress his claim aside from some anecdotes of complications, would it not matter if every other surgeon at MGH had another opinion?  Why not take a poll of the American College of Surgeons, or surgeons at another eminent institution?

The article is strongest when discussing the ignorance of patients to the idea that their physician may not be present for the entirety of their case.  It does seem improper that patients would not be aware of this.  The only problem with this problem is that MGH did revise their consent policy in 2012 to notify patients of the team based approach to care.  All the patient cases reported in the Globe apparently took place prior to this revision.

We clearly and perhaps always have lived in an age where the narrative matters more than the truth.
Journalism in the lay press has taken on a monotonous tone exemplified by Nick Ciubotariu's brilliant line by line rebuttal of a New York Times story on workplace practices at Amazon:

Step 1: Have biases
Step 2: Find ex-employees with anecdotal stories that fit in with your bias
Step 3: Gather old stories and criticism while glossing over changes made to improve on that, and completely ignore that it's still significantly better than industry practice
Step 4: Take half-truths and spin spin spin!!
Step 5: Publish article

It may be safer for all of us if the lay press stuck to covering the Kardashian's.

National Health Expenditures in 2014: Health Care Costs on the rise again.

Every year the nice folks over at the Centers for Medicare and Medicaid services (CMS) release a report on national health expenditures.  The most recent report was of interest because after many years of stagnant health care cost growth, costs were seen to rise in 2014.

Wait, you say, haven’t health care costs always been rising?  Well… no.

While there are many ways to look at the rise in health care cost, examining health care cost as it relates to a rise in GDP is of most interest.  This reflects the health spending share of the economy.   We would certainly fret less about rising health care costs if they rose in step with a growing economy.  This would mean that, as a percentage of the economy, health care would not be more expensive over time.  Looking at healthcare cost in this light clearly demonstrates a recent significant moderation in the rise of health care costs.  To get a sense of ‘moderation’ of health care costs, it helps to have a sense of where this all began.  

The Sixties: The beginning of the health care cost revolution

The introduction of medicare in 1965 fueled an explosion of spending.  Health care grew at a much faster rate than the rest of the economy, and went from accounting for 5% of GDP in 1960 to almost 12% of GDP in 1990. Health care continued to consume an ever larger share of the national pie as the years progressed, but growth occurred at a slower pace in the 21st century. In 2013 health care spending stood at 17.4% of GDP, (the highest ever), but the years 2009-2013 actually had no growth in healthcare care spending relative to GDP.  This meant health care spending remained flat at 17.4% of GDP from 2009-2013. (CMS data) (http://content.healthaffairs.org/content/34/8/1407.full)

Cost moderation: Smarter administrators or smarter doctors?

A number of different reasons have been forwarded, but most health economists seem to agree something structurally was different.  Sitting in the trenches, as I do in the world of private practice cardiology, that cost trend seemed to fit with what I was seeing in my world.  The world of cardiology is a small window, but is a window, nonetheless.  

The big drivers of costs in cardiology were clearly imaging and placement of elective coronary stents.  In 2008, 7.5 million echocardiograms were performed at a cost to medicare of 1.4 billion dollars.  The same year 3.4 million SPECT studies were done at a cost of 1.3 billion dollars.  Not surprisingly, reimbursements (in the outpatient setting only) were slashed for nuclear medicine studies by 36% and for echocardiograms by 25%.  Clearly, the administrators at CMS were able to score significant cost reductions in this manner with almost no effort.  

While cost containment in the hospital setting due to reduced reimbursements occurred as well, cost reductions had a more ‘grass roots’, bottom up flavor when it came to elective coronary stenting.  The aptly named COURAGE study was released in 2007 to much fanfare while I was still a cardiology fellow.  The study was a randomized control trial that took aim squarely at the practice of elective coronary stenting.  The conclusions of the trial were fairly definitive: coronary stenting was NOT superior to medical therapy for the vast majority of cases.  The results in changing practice patterns are evident to me in my local community, and nationally.  A recent JAMA study clearly demonstrated significant reductions in the volume of non-acute coronary stenting from 89,704 in 2009 to 59,375 in 2014.  This was, seemingly, a nice example of the way its supposed to work: Shifts in evidence base guiding clinical practice in a direction that is better for patients, and cost efficient.

Why are costs rising again?

Unfortunately, costs do appear to be on the rise again.  In 2014, Health care care expenditure is projected to have increased 5.5% (year over year), the first time growth would be higher than 5% since 2007.  As a consequence, in 2014 health care expenditures are now projected to be 17.7% of GDP, the first increase in the health care share of the economy since 2008.  

What happened?  Did cardiologists start ordering more tests?  Are there suddenly more unindicated stents going into patients? The answer is, unfortunately, more simple than that.  

As per the economists at CMS (Health Affairs) the rise in healthcare costs are mostly related to the expansion of healthcare coverage under the Affordable Care Act (ACA).  Not surprisingly, subsidizing coverage for millions of more people costs money.  

Amusingly, the white house released a paper in 2013, entitled “Trends in healthcare cost growth and the role of the affordable care act”, that attempted to show a link between the ACA act slowing health care costs.  This was despite the fact that health care cost reductions well preceded introduction of the ACA.  No information from the white house has been forthcoming on the ACA and cost since.  

So, yes, health care costs have resumed their inexorable rise in 2014, after flat growth for the preceding four years. The primary driver for this change is the expansion of insurance coverage to millions of people through the ACA.  The ACA may reduce costs in the long term (debatable), but there is little doubt that the ACA raises costs in the short term.