Wednesday, November 19, 2014

My Interview at AHA 2014 on ABIM's Maintenance of Certification Program

Thanks for C. Michael Gibson, MD for hosting an interview with me on my concerns with the American Board of Medical Specialties (ABMS) / American Board of Internal Medicine's Maintenance of Certification Program earlier today on his Clinical Trial Results website. A direct link to the interview is included here (if you're using a mobile phone, click the "Download video" link on the webpage).

As the physician groundswell of opposition to the ABMS's proprietary MOC program grows, physicians (especially younger physicians) must understand the complex forces that are intervening between the doctor and patient. The ABMS/ABIM Maintenance of Certification Program is just one of these forces. I encourage all doctors to educate themselves by reviewing the materials collected about MOC at It's an excellent resource from a variety of physician voices around the United States. Overseas doctors, too, should be aware that the ABIM is extending its tentacles there as well (video), all without any independently-verified evidence base upon which to impose their program as a physician quality or patient safety measure. Doctors must understand the importance of becoming more involved in preserving our profession by becoming more politically engaged.

It is interesting that the AMA just adopted the following new "Principles for MOC" in their press release of 10 Nov 2014:
The MOC principles will now include:
  • MOC should be based on evidence and designed to identify performance gaps and unmet needs, providing direction and guidance for improvement in physician performance and delivery of care.
  • The MOC process should be evaluated periodically to measure physician satisfaction, knowledge uptake, and intent to maintain or change practice.
  • MOC should be used as a tool for continuous improvement.
  • The MOC program should not be a mandated requirement for licensure, credentialing, payment, network participation or employment.
  • Actively practicing physicians should be well-represented on specialty boards developing MOC.
  • MOC activities and measurement should be relevant to clinical practice.
  • The MOC process should not be cost-prohibitive or present barriers to patient care. The policy encourages specialty boards to investigate alternative approaches to MOC and directs the AMA to report annually on the MOC process.
The American Board of Medical Specialties (ABMS) is the organization responsible for developing the MOC process. ABMS works with its 24 member boards in the ongoing evaluation and certification of physicians.

AMA policy supports physician accountability, life-long learning and self-assessment. The AMA will continue to work with the appropriate organizations to ensure the MOC process does not disrupt physician practice or reduce the capacity of the overall physician workforce. In June, the AMA and ABMS convened stakeholders in Chicago to discuss Part III of the MOC exam, focusing on the value of MOC Part III and innovative concepts that could potentially enhance or replace the current thinking around the secure exam requirement of MOC.
On first blush, this seems so promising. But we should appreciate that the ABMS and ABIM was an earlier spin-off of the AMA, making those of us familiar with these facts suspect.

Similarly, the Pennsylvania Medical Society, just released their "statement of principles" for MOC that sound eerily similar:
The Pennsylvania Medical Society is committed to lifelong learning, cognitive expertise, practice quality improvement, and adherence to the highest standards of medical practice. The Pennsylvania Medical Society supports a process of continuous learning and improvement based on evidence-based guidelines, national standards, and best practices, in combination with customized continuing education.

The Maintenance of Certification (MOC) process should be designed to identify performance gaps and unmet needs, providing direction and guidance for improvement in physician performance and delivery of care.

The Maintenance of Certification (MOC) process should be evaluated periodically to measure physician satisfaction, knowledge uptake and intent to maintain or change practice. Board certificates should have lifetime status, with Maintenance of Certification (MOC) used as a tool for continuous improvement.

The Maintenance of Certification (MOC) program should not be associated with hospital privileges, insurance reimbursements or network participation.

The Maintenance of Certification (MOC) program should not be required for Maintenance of Licensure (MOL).

Specialty boards, which develop Maintenance of Certification (MOC) standards, may approve curriculum, but should be independent from entities designing and delivering that curriculum, and should have no financial interest in the process.

A majority of specialty board members who are involved with the Maintenance of Certification (MOC) program should be actively practicing physicians directly engaged in patient care. Maintenance of Certification (MOC) activities and measurement should be relevant to real world clinical practice.

The Maintenance of Certification (MOC) process should not be cost prohibitive or present barriers to patient care.

While these "principles" from the AMA and the Pennsylvania Medical Society address many of physicians' concerns regarding these programs, both potentiate the concept of Maintenance of Certification (MOC), despite the many problems we've identified with this "program" to date (see here, here, here, and here for starters).
Neither of these "principles" insist on researching the unintended negative consequences of the MOC program on physicians should they fail to re-certify, especially since failure rates of this program is 22%.
So why have these two prominent organizations suddenly produced these two similar documents? Might it be to distance themselves from anti-trust concerns with MOC that continue to weave themselves through the courts? Might it be because they see the ABIM becoming irrelevant as more revelations of the management of these organizations comes to light? Might the AMA still want to perpetuate the loss of physician autonomy to gain favor with large hospital systems that are being created by our new health care law today?

We must wonder.

These are big issues. For young doctors overwhelmed with the realities of beginning practice, taking another test seems the easier option than confronting these realities. But all of us as treating doctors must not sit idly by as our autonomy is increasingly usurped and corrupted to benefit the system rather protecting the real health care needs of our patients.


Monday, November 17, 2014

J. Rod Gimbel: Crowdsourcing a Consumer Safety Issue

The following is a guest post by J. Rod Gimbel, MD, a cardiac electrophysiologist from Knoxville, TN who has written extensively on the issue of electronic surveillance systems and electromagnetic interference with cardiac implantable electronic devices:
I’d like to express my appreciation for allowing me to guest post in this space.

This is about crowdsourcing a consumer safety issue; specifically the public safety of consumers who happen to have CIEDs (cardiac implantable electronic devices) such as pacemakers or implantable defibrillators (ICD). Nearly 2 million such consumers (patients) have CIEDs in the U.S. alone. As you know, these devices are susceptible to EMI (electromagnetic interference). Simply put, the lead(s) act like antennas and can pick up stray EMI from any number of sources and cause the device to malfunction by either withholding therapy (no pacing or ICD rescue therapy) or through delivery of inappropriate therapy (delivering pacing output or shocks where none is needed). Either situation can be life threatening.

One source of EMI that can affect a CIED patient is electronic article surveillance system (EAS). Such systems are widely used by retailers (ref) to deter and prevent store theft, a problem commonly referred to as “shrinkage”.

About 8 years ago, an ICD patient that I was caring for received inappropriate shocks from his ICD after being near an EAS system located in a big box retailer. A colleague of mine related a similar situation where a pacemaker dependent patient reported syncope in the proximity of an EAS system after her pacemaker inhibited in response to the EMI from the EAS system. These were two disturbing, potentially life threatening events. In hopes of raising awareness of this serious problem (EAS-CIED interaction), we generated a manuscript detailing the events that was published in 2007 in the Mayo Clinic Proceedings. Notably, the New York Times picked up the story. Others have published similar unfortunate misadventures between patients and EAS systems.

Several common sense recommendations have been made in this area; recommendations that preserve a retailer’s right to deter and reduce theft (a legitimate concern), but still protect CIED patients from adverse interactions with EAS systems. For instance, after receiving reports of several adverse events caused by EAS systems the Food and Drug Administration (FDA) issued a “Safety Communication” and noted:

  • Be aware that EAS systems may be hidden/camouflaged in entrances and exits where they are not readily visible in many commercial establishments.

  • Do not stay near the EAS system or metal detector longer than is necessary and do not lean against the system.
Beyond this, we and others also suggested:
  • Retailers should not "camouflage" the EAS pedestals with advertising as this may prevent customers with devices from recognizing the threat and may actually draw device patients toward the EAS pedestal.

  • Retailers should not place goods and services near the EAS systems that effectively encourage the patients to violate the "don't linger, don't lean" dictum that physicians tell patients who have devices.

It seems entirely reasonable to suggest a shared responsibility between medical device professionals, device patients, retailers, and EAS system manufacturers. It was hoped EAS manufactures and retailers would do their part and embrace these simple recommendations and help make retail spaces safe for those with implantable devices. Unfortunately, this does not seem to always be the case.

Figure 1: Bench to "relax" placed adjacent to a camouflaged EAS pedestal at big box retailer.
Figure 2: Chair to "relax" placed adjacent to EAS pedestal while patient waits for prescription to be filled at retail pharmacy store.
Figure 3: Complimentary coffee station where device patients might linger placed adjacent to EAS pedestal at big box retailer
These pictures were taken in the last several months around the country. Clearly, the juxtaposition of EAS systems and consumer areas may undermine the dictum “don’t linger, don’t lean” and leave device patients in harm’s way. Who then, is responsible for the safety of device patients in this situation?

Finally, perhaps in an attempt to thwart a determined and “informed shoplifter” who may employ several methods that might undermine the effectiveness of EAS systems, “there are also concerns that some installations are purposefully configured to exceed the rated specifications of the manufacturer, thereby exceeding tested and certified magnetic field levels.” This may increase further the risk of adverse reactions experienced by device patients when near EAS systems.

Now for the crowdsourcing part:

A presentation on this topic (CIED-EAS interactions) to an extra governmental regulatory group helping set standards for the device industry is to be given soon. This presentation will be to a number of interested parties including representatives of the EAS manufactures, device manufactures, and the FDA. As noted above, the “event rate” of these interactions is rather low, but as has been suggested significant under-reporting may obscure the true significance of the problem. It is surely recognize that not everyone has the time or inclination to write up adverse events for publication or inclusion in a database. Perhaps, some events go entirely unrecognized for what they really are, being passed off as “Oh, Mom passed out at the store today, but she’s OK now”.

With your help a strong presentation and case can be made emphasizing CIED-EAS interactions are an important public safety issue. Your voice and concerns can be heard. First off, send pictures where you see EAS systems placed in a manner that might endanger a device patient (like the ones shown above). Cell phone pictures are just fine. Second, if you are a health care provider or patient, please send any “events” that you may have experienced describing an adverse interaction between an EAS system and pacemakers and or ICDs. Please post the items here or send items of interest to J. Rod Gimbel, MD ( Your response is of course appreciated and in confidence and any presentation of the material provided will be anonymized. Upon completion of the presentation, a link will be posted here.
This is an important effort that Rod is undertaking on behalf of patients with CIEDs. I hope patients and health care providers will come forward with examples of EAS systems or EAS interference in their locales to assist him in this important consumer safety effort.


Tuesday, November 11, 2014

Happy Veteran's Day

(Click image to enlarge)
Found this picture today in my basement from around 1996 when I has a staff cardiologist/cardiac electrophysiologist at the National Naval Medical Center, Bethesda, Maryland. There were so many great folks with whom I had the pleasure and honor to work beside, yet many of whom I've lost touch with, sadly.

It's fun to look back and see the the old cath lab equipment - including (dare I say it) the FILM canisters!  My, how far we've come!

Here's wishing all of these great doctors and corpsman a Happy Veteran's Day, wherever their paths have led them since. 


Thursday, November 06, 2014

Excellent Sheep

"I was teaching a class at Yale on the literature of friendship. One day we got around to talking about the importance of being alone. The ability to engage in introspection, I suggested, is the essential precondition for living life of the mind, and the essential precondition for introspection is solitude. Many students took this in for a second - introspection, solitude, the life of the mind, things they had not been asked to think about before - then one of them said, with a dawning sense of self-awareness, "So are you saying that we're all just, like, really excellent sheep?"

All? Surely not. But after twenty-four years in the Ivy League - college at Columbia; a PhD at the same institution, including five years as a graduate instructor; and ten years, altogether, on the faculty at Yale - that was more or less how I had come to feel about it. The system manufactures students who are smart and talented and driven, yes, but also anxious, timid, and lost, with little intellectual curiosity and a stunted sense of purpose: trapped in a bubble of privilege, heading meekly in the same direction, great at what they're doing but with no idea why they're doing it. I published an essay that sketched out a few of these criticisms. Titled "The Disadvantages of an Elite Education," the article appeared in the American Scholar, a small literary quarterly. At best, I thought, it might get a few thousand readers.

Instead, it started to go viral almost the moment it came out. Within a few weeks, the piece had been viewed a hundred thousand times (with many times that number in the months and years to come). Apparently I'd touched a nerve. These were not just the grumblings of an ex-professor. As it turned out from the many emails I began to get, the vast majority from current students and recent graduates, I had evoked a widespread discontent among today's young high achievers - a sense that the system is cheating them out of a meaningful education, instilling them with values they rejected but couldn't somehow get beyond, and failing to equip them to contract their futures."
 - William Deresiewicz
"Excellent Sheep: The Miseducation of the American Elite and the Way to a Meaningful Life, Free Press, New York, 2014.
Sounds an awful lot like the concerns I hear from medical students, residents, and young physicians today, doesn't it? They are excellent test-takers, rule-followers, and lock-step thinkers, for these things help people succeed in medical school.  But add the burdens of seemingly insurmountable debt, regulatory testing and re-testing, and data entry mandates that mean more to their pay than actual visits to the bedside, I wonder how many our our new physicians will be willing to really work to evoke change on behalf of their patients rather than working with the system that drives them to do otherwise.

I worry when we're breeding really excellent sheep, I'd much rather they were breeding cowboys.