Sunday, November 29, 2015

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.

Monday, November 23, 2015

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.

Wednesday, November 18, 2015

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.



Tuesday, November 17, 2015

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.