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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

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.