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Pfizer Warning De-Claws the Tiger (Tygacil)

Tiger mugIt had a great name and memorable marketing campaign, but Tygacil suffered a serious blow with Pfizer’s warning of an “All-Cause Mortality Imbalance” related to the once-promising antibiotic.

Tygacil, colloquially referred to as ‘The Tiger’ was found to increase mortality by 0.6% compared with control antibiotics.  We’ll get into the numbers in a bit, but this was enough for Tygacil to be deemed, “…reserved for use in situations when alternative treatments are not suitable.”   In other words, use something else if at all possible.

Tygacil isn’t a common antibiotic, its intravenous only and not something one is prescribed during a routine office visit.  It has three labeled indications; complicated skin/skin structure infections, complicated intra-abdominal infections, and community acquired bacterial pneumonia.

Patients who need Tygacil are sick, with a serious soft tissue infection such as extensive cellulitis, necrotizing fasciitis, or an intra-abdominal abscess as would be seen in a number of major conditions.  It was once thought as a possible treatment for diabetic foot infections, but was found not to be adequately effective for this indication.

The TigerThe marketing materials were memorable, with tiger-striped giveaways and tigers appearing on brochures and other media.  The best image, printed in countless medical journals, featured a white-coated clinician heading down the hall accompanied by an orange-and-black striped beast standing waist high and weighing around 650 lbs.  The image implies that whatever the threatening bacteria, it is going to be done for when these two get to the room.

How bad is it?  The mailing describes the results of a meta-analysis (basically, a compliation of a number of smaller studies) showing excess mortality in patients undergoing treatment for approved indications of 0.6% compared to patients treated with comparator drugs.  2.5% of patients treated with Tygacil died compared with 1.8% of patients treated with other drugs.  Put another way, Tygacil deaths occurred in excess at a rate of six per thousand patients.  It may not sound like much, but extrapolating out into national numbers means potentially thousands of excess deaths every year.

The reason for the deaths is not clear, and this is not surprising given that these patients were likely all very ill with co-morbidities, so teasing out the cause isn’t easy.  And even with the numbers presented, it isn’t certain that the drug is to blame, but the significance level is enough to put out the warning and continue to watch things closely.

The earlier studies of effectiveness were conducted with smaller numbers of patients (under 300) so rarer events will not be picked up in the majority of cases.  With new drugs, there is always some leap of faith when a product is released for wide use.  Post-marketing (Phase IV) trials are for catching problem drugs once they are released into the wild.  And in this case, the Tiger had to be hunted down.


EMR-Wars: Attack of the Clones


Cloning (Photo credit: borkweb)

A warning-shot from Medicare has advised healthcare providers that “cloned” medical records notes will result in payment denials, and the Dept. of Health and Human Services stated that billing fraud will be “vigorously prosecuted”.

This is in response to recent news coverage noting that Electronic Medical Records* (EMRs) have made it easier to “upcode”; that is to bill a visit for a higher payment level than might be done without an EMR in use.

Healthcare gurus know that Electronic Medical Records  are one of the latest discussion points.  People cannot believe that something as complex as healthcare can be delivered safely and effectively with dead-tree media products.  It can and it is.    However, the march of technology is and should always be ever upward.  So EMRs will one day become ubiquitous.

But why are visits “upcoded” with an EMR?  It is because mandated documentation requirements – externally imposed on the profession by third party payors- result in long notes simply to check off bullet points required to receive a certain payment level.   Doing this electronically isn’t difficult with an EMR; but the clinical encounter and workflow take longer.  So naturally it makes sense to bill the visit at the highest level justified by the documentation and severity of the clinical problem.  That is not fraud.

The trouble with EMRs has been well-documented by many authors, including myself.  Remember that EMRs were not something the profession needed to make clinical functions smoother or easier.  If it did, the systems would be fast and easy to use and would enhance clinical workflow, much like most electronic systems do in purely commercial settings like restaurants.

Rather, this was an external imposition by those who purport to know how to fix healthcare.  Keep in mind that small, simple practices don’t need fancy electronic record systems, and entities that do such as large integrated institutions or big clinical practices, very often have them.

So what is a cloned note and how is it fraud?  Cloned notes are copies of earlier notes used on subsequent visits.  Is that really a big deal?  Most of the notes for a traditional medical practice that bills insurance contain a lot of information to satisfy billing points as noted above.    Most of it never changes from visit to visit, such as family history, past surgeries, etc.  So a simple solution is to have the patient check their prior information at each new visit and add anything new or changed.  The clinician then reviews this and makes alternations to the old note before finalizing the new note.  Why re-create all that material?

Fraud is something different.  That involves billing for things that were not done, or making up information.

The larger issue here is the inherent conflicts in third-party payor healthcare.   The clinician needs to satisfy the documentation requirements in order to receive any payment.  The required documentation is often more than what is really needed.  So clinicians look for ways to make this process easier.

As long as cloned notes are updated and reviewed before being finalized, they should be considered acceptable   Cloning is a good example of an unintended but predictable consequence of mandated use of cumbersome EMRs.

But confusing this with fraud is a different matter, and should not be allowed to lead to unwarranted disciplinary actions.

And I’ve never seen anyone clone a note with pen and paper

*-For simplicity the differences between Electronic Health Records (EHR) and EMR is ignored in this post.

“Choosing Wisely”: Reduce Unneeded Tests and Procedures

The Choosing Wisely® campaign brings together nine medical societies to call attention to overused and often unnecessary tests and procedures.

From the official description:

“Choosing Wisely® aims to promote conversations between physicians and patients by helping patients choose care that is:

Supported by evidence
Not duplicative of other tests or procedures already received
Free from harm
Truly necessary”

Each society listed five tests or procedures to be carefully considered before helping patients choose their care.

The experts behind this effort know all about unnecessary testing.

Many physicians were taken aback by the irony of these organizations seeking to halt unneeded clinical tests while requiring already board-certified physicians to maintain their certifications with frequent tests (and fees).  Maintenance of Certification is not evidence-based, and has not been shown to benefit patients.  Concurrently, these organizations have helped to reduce residency work hours and expanded the practice domain of non-physicians.

One can imagine what Osler or Halsted might think of these developments.

Without question, there are a large number of procedures and tests that are not necessary, and are overused for a variety of reasons, roughly categorized as follows:

Knowledge gap (unsure of diagnosis)
Patient or family demand
Some form of physician self-interest (defensive medicine, revenue, community referral)

Most of the recommendations are straightforward, and controversial subjects such as age of mammogram screening and prostate testing are avoided.  Some overlap, such as back pain imaging and not treating colds with antibiotics.

My specialty (plastic surgery) is absent, perhaps because much of the field is now focused on non-medically necessary services anyhow.  That is meant in jest, but I offer one plastic surgery recommendation that makes sense and fits the theme:

“Do not order facial imaging studies for uncomplicated lacerations without clinical evidence or suspicion for fracture.”

Most of these studies do not help.  They are mainly for defensive-medicine purposes, and therefore cannot always be omitted

Getting back to the main list of procedures, I was pleased to see the radiology list included this:

“Don’t do computed tomography (CT) for the evaluation of suspected appendicitis in children until after ultrasound has been considered as an option.”

I wrote about this before, and it’s a good thing to avoid unneeded radiation in kids, and reserve CT as a second-line test.

The need for campaigns about unnecessary testing and procedures is not surprising given our non-market based healthcare system.  It has oddly structured incentives, information asymmetry (which is leveling every day), and legal pitfalls; good care but a bad outcome can result in a lawsuit.

When patients do not pay directly for care, and physicians are trained not to consider cost, and are subject to legal risks, it is no surprise that overuse occurs.  As we transition much of healthcare toward a more protocol-driven model, such lists will be refined and expanded.  Backed by good science, they may improve care while reducing costs.

Challenges include managing patient expectations, and providing legal cover for care that follows recommendations but results in a delay in diagnosis.

How Stronger Residency Directors and Board Certification Can Work Together

Residency directors have a challenging job.  They are entrusted with selecting young doctors and training them over the course of several years.  Newly graduated medical students are thereby turned into internists, surgeons, radiologists, pathologists and the like.  Fellowship directors build upon this foundation with extra training, setting the stage for these graduates to become clinical experts in their respective fields.

The Maintenance of Certification (MOC) process adds an additional and continued requirement once doctors achieve their initial board certification, but the entire process has come under unified, multispecialty criticism.

Another article critical of the certification process noted that program directors already know plenty about the qualifications of their trainees, and seemed to suggest that program directors’ power to hold back or terminate trainees could reduce the need for the post-residency certification (and recertification) process.

It can be said that the ability to pass tests does not equate with the ability to practice ethical, high-quality medicine.  People who are good at passing tests (i.e. the majority of people who get into medical school) can keep doing it right through board certification.  But is that a good use of time and resources?  Likely not, and this is one reason why MOC has been criticized as little more than a Trojan Horse to maintain certifying board revenue.

However, there is a question whether residency directors can effectively manage their trainees, as they once did.  In past decades, residency directors’ power was near absolute, and many programs (especially surgical fields) ran pyramid structures that only graduated a few of the trainees each year.  Residents knew they were under the microscope every day, and continued progress in the program was not assured.  The old pyramids have been eliminated, although that is not the key problem.  The evidence shows that few residents are ever actually dismissed from training.  Even problem residents – as many who have been in a residency can anecdotally support – are often nudged along and graduated.  This is easier than firing them, which is often a costly and difficult endeavor.

This is not an easy topic to get data on, but the 2009-10 annual report of the Accreditation Council for Graduate Medical Education (ACGME) suggests that firings are in fact rare.

Of 111,140 full-time residents, 261 (0.2%) were dismissed.  Even counting the 112 (0.1%) who Unsuccessfully Completed Program (seems an odd word choice), the 96 (0.09%) who went on Leave of Absence, and the 943 (0.8%) who Withdrew, only 1.3% of all residents were somehow taken out of programs every year.  That seems like a small number, and perhaps represents directors’ aversion to taking hard action against sub-par trainees.

Certifying boards may say this is why post-residency evaluation is essential.  But failure in (or noncompliance with) certifying exams cannot keep sub-par physicians from practicing, though it can reduce their options.

The MOC process is imperfect, and stands to be simplified, improved, and made less expensive. Concurrently, the discretion of program directors to remove sub-par trainees should be increased.   They should also be empowered to direct a simplified initial certification process culminating in the final month of residency.

This can ensure that well-qualified people complete residencies with their initial certification, and can later maintain their qualifications with a sensible and cost-effective MOC process.

The Real Lesson from the Health Reform Contraception Battle

The recent battle over Catholic institutions being required to provide contraceptives and abortion services over their objections is illustrative of what is coming as various aspects of the law come into effect.  Nobody is really sure about what the effects will be, and we should not forget that we were told, “We have to pass the bill so that you can find out what is in it.”

The takeaway point from the contraception conflict may not be about religious freedom, constitutional protections, or women’s rights of self-determination over their own bodies.   What the contraceptive fight shows us is this:  with health reform, people will be told one thing, and they are going to get another.  As Rob Halford noted, “You’ve got another thing comin’!”.[1]

To enlist their support for health reform, Catholic leaders were assured that their beliefs on contraception and abortion would be respected.  And then they were ordered to do something quite the opposite.

In order to forcibly reorganize one-sixth of the economy, some tough tactics will be required, and that is exactly what was attempted in this case.  The ultimate success or failure of the reform effort will be influenced by the responses from the various industry segments as they get targeted by the law.

Doctors, healthcare executives, insurers and state governments have some idea what the changes will mean, but most of this experiment will be subject to improvisation as various consequences – intended and otherwise, come to light.

Patients may be less aware of the implications, because only the positive elements have been emphasized; no lifetime insurance limits, no pre-existing condition exclusions, and so forth.  But they will be the last of the stakeholders to realize the likely downsides of reform; less physician-provided care, long waits for appointments, difficulty accessing specialized services, and much higher cost-sharing.

The decision to tackle the health care problem with greater expansion of government-control rather than seeking market-determined solutions will lead to many interesting days ahead.  One positive element of the law is that it runs a number of experiments, and in theory this will lead to a trial-and-error process of coming up with workable solutions for the various problems.

Another positive is that more and more physicians are realizing that in order to best serve patients, they need to take control of their businesses and work on creating real value for consumers, both in quality and cost.  In some way, the great expansion of a non-market derived reorganization of the system may be the spark that leads to the creation of a more transparent,  private system emerging parallel to the current one (as has been seen in countries with national health systems).  This may be the most lasting legacy of the reform law.

[1] The author apologizes to readers unfamiliar with the work of the Judas Priest vocalist.

James Bond and the Proton Beam Device

James Bond slowly came to.  His head ached.  He could not move his arms.  Looking down, he saw his limbs were firmly attached to a large table. He was positioned beneath a huge, complex machine, from which a conical probe jutted straight at him.  Before he could make sense of his surroundings, his ears were filled with the booming voice of a familiar nemesis.

“Good morning Mr. Bond!  I trust you are well-rested?”

Bond:  “Professor Blocash!  I should have known.  What is this?”

Blocash:  “Why, you’re the first guest of my new Proton Beam Device.  There are only nine of them in America, and we control seven.  Your name is fitting.  You should have seen the size of the bond issue we had to float to finance this one.”

Bond:  “Do you expect me to talk?”

Blocash:  “Of course not.  But what I am going to do is demonstrate the device on your unsightly forearm mole.”

Bond:  “I thought this machine delivers precise energy to internal tumors without damaging surrounding tissue?”

Blocash:  “It does that, but we will eventually expand the indications.”

Bond:  “But this technology hasn’t been proven to be equivalent or superior to standard radiation!*”

Blocash:  “Mr. Bond, don’t you understand that doesn’t matter?  Medicare still pays for it.  It’s the same story with the DaVinci surgical robot and many other treatments.  Payments flow directly into my account.  And I don’t have to hire a single armed henchman!   This is far easier and more profitable than my other plans!”  [Rubs hands together menacingly]

Bond:  “But why would they pay you to provide expensive treatments that are of unproven value?”

Blocash:  [Pacing with hands clasped behind his back] “My organization donates generously to both American political parties, keeping them in a state of perpetual and profitable gridlock!  Even the simplest fixes could save their taxpayers a fortune.  Consider that for years Medicare continued to pay for outdated HIV infusion therapies.  Instead of writing a few lines of computer code, they didn’t react until a huge fraud ring in Miami stole millions billing those outdated codes!”

Bond:  “But if you build a Proton Beam Machine, other hospitals will have to do the same thing.  That leads to a hugely inefficient medical arms race.”

Blocash:  “We are not interested in an efficiently developed healthcare system.  Here the Byzantine regulations allow for far more creative options.  Also, patients don’t directly pay for the care they consume.  Skillful marketing can make them demand any technology we build!”

Bond:  “This can’t go on forever.  Patients do pay, just through increasing health costs borne by their employers.  They’ll stop you!”

Blocash:  “Perhaps, but not anytime soon.  Enough talk!  Engage the Proton Beam!”

Nurse:  “Professor we can’t do that.”

Blocash:  “Why not?”

Nurse:  “We haven’t completed the Time Out.”




* Author’s note:  The avoidance of damage to surrounding tissue may be one key indication for proton beam therapy, and this is not to suggest that the technology should never be used, only that it should be carefully studied before being implemented on a wide scale.

EMR Designers: Borrow From the Titans of Technology

Steve Jobs while presenting the iPad in San Fr...

Steve Jobs was referenced several times during the recent State of the Union address.  Healthcare was conspicuously absent from the speech, for a variety of reasons.  What might Steve thought of electronic medical records?  I would imagine he had some thoughts on the healthcare system, having unfortunately needed to access it during his illness.  Perhaps we will eventually learn what he thought of it.  However, his experience was almost certainly far smoother than an average person’s, given who he was.

Apple products are known for excellent function and design simplicity.  Would an Apple-EMR look anything like the presently available products?  Probably not.  Had he watched a surgeon (as I once did) fumble for 45 minutes trying to put in orders and notes for a procedure that took 30 minutes, his designers would likely receive a profanity-laden tirade.

The trouble with most EMRs is that they are written by techies, and are focused on capturing a large amount of extraneous data that has little to do with the overall care at hand.  Healthcare is a complex area that is made up of many fairly simple components.  The current generation of EMRs are overly complex and have not been implemented because practitioners or consumers (patients) demand or require them, but because government incentives (and soon, coercion) have been required to force their adoption by a sector that does not have a true need for the product.

Consider the quick-service restaurant sector.  Their version of the EMR is ubiquitous and necessary in order to serve customers and compete.  It enhances the operator-customer experience.  Here’s how it would look if a current EMR was adopted for restaurant use:

(From a recent exchange at McDonald’s.  Yes, even doctors occasionally eat there.)

Me:  “I’d like a Southern Chicken Sandwich.”

Staff:  “Your height and weight please?”

Me:  “Six feet four, 205 lbs.”

Staff: [narrows eyes in disbelief]

Staff:  “Any pets in the home?”

Me:  “What does this have to do with my order?”

Staff:  “What color is your couch?”

Me:  “Well, I’m still trying to clean a butter stain, and the cat  made a mess on it.  Let’s call it  beige-to-yellow.”

You get the point.  This sort of data collection erodes the user experience and impedes the purpose for which the system is supposed to serve.

Future EMRs will solve these problems.  It is not that the data is completely useless, but most is unnecessary and collecting it in the current fashion saps productivity and leads to all sorts of unintended consequences.  For example, specialists may scan, skip or ignore most of the pre-generated information from EMR referrals, focusing only on the issue for which they are being consulted.  Copy-and-paste can lead to absurd rounds of the children’s “Telephone Game”.  (Amputees with normal pulses in the limb, etc.)

Healthcare will eventually have full, well-designed EMR adoption.  But getting there will take a few more software generations.  Here are three easy ideas just by borrowing from what already works in tech.

  1. Touchscreen navigation:  Akin to the old lightpen (precursor to the mouse), this makes it quick and easy to enter information.  Hand sanitizer at every workstation will help with germ fears.
  2. Smart Software:  If Amazon knows what products you likely want, the EMR should know your order sets and what medications you typically prescribe.  An orthopod shouldn’t sift through a hundred obscure medications to select antibiotics and pain meds, and to put in his standard orders.
  3. Simplify documentation:  When patients are seen for a specific problem, notes only need a small amount of information.  Extraneous details can be captured at the initial visit and any changes made later.  Put it on the sidebar of the page, so it is visible but does not crowd out the important information.

This is only a start, and larger organizations should lead the way as EMR costs are unfriendly for most offices.  Community physicians could use web-based EMRs hosted at the local hospital (free if on staff, perhaps subscription-based otherwise).

The U.K.’s scrapping of their EMR project should be considered carefully.  It’s high time for someone with a touch of Steve Jobs’ vision to create an EMR here so good that it won’t need carrots or sticks to be adopted.