Friday, May 30, 2014

Maintenance of Certification and Licensure: Regulatory Capture of Medicine

An important article by Paul Martin Kempen, MD, PhD that critically reviews the American Board of Internal Medicine (ABIM) and American Board of Medical Specialty's (ABMS) Maintenance of Certification (MOC) process recently appeared in the Journal of Anesthesia and Analgesia.  Unfortunately, the article resides behind a pay wall.  As such, I can only publish a small sampling of the article for discussion here, but I think the points raised are important ones to bring to the public's attention for discussion ( I have also included the appropriate references at the end of the excerpt):


The ABMS emphatically stresses that multiple articles support MOC. A quick review of these proffered ABMS articles readily identifies the authors as overwhelmingly ABMS paid executives and/or hired paid consultants.(4,c)

These corporate authorships mitigate scientific validity and introduce significant bias into these retrospective data-base interpretations, as would occur for any proprietary medical device or drug.(5) At best, they can statistically substantiate only associations and not causality. Negative studies may never be published. Publication further occurs in journals owned, edited, managed or supported by organizations strongly influenced by ABMS senior staff or national societies, otherwise exhibiting significant financial interests in proprietary and endorsed products associated with recertification programs.(4,c) Executive members of ABMS boards are frequently found to serve as executives of all national medical societies, associated journal editorial boards, and many academic departments. Corporately sponsored/authored publications of both FSMB and ABMS affiliates, financed with the $374 million in ABMS’ gross annual receipts, repeatedly support a significant corporate advertising campaign, without significant opportunity for opposing views from practicing physicians.(6,7)

In 2002, the ABMS unsuccessfully attempted to validate board certification itself, via meta-analysis coauthored by 2 ABMS (executive and associate) vice presidents documenting, “Few published studies (5%) used research methods appropriate for the research question,” and “Perhaps one lesson to be learned from this review is the need to thoughtfully examine this recertification process to document its value.”(8) Cochrane Collective Database Review (another quality indicator) also fails to support MOC or board certification validity. The only ABMS-funded prospective randomized study found in the Cochrane database (yet missing from ABMS listing), however, did document “no benefit regarding primary outcome” from the specifically studied practice improvement module.9 These facts together emphasize significant scientific limitations supporting validation of the ABMS program, despite ABMS insistence to the contrary.


MOC practice improvement modules require physicians to define subset populations in their practice, where patient care might be improved. A plan is introduced for selected
patients, and changes in care are introduced. Data are collected to specifically demonstrate quality improvements in one’s own practice to the ABMS to enable recertification. This practice improvement modules method is initiated to facilitate the individual physician’s personal certification, that is, personal gain.

Practice improvement modules constitute an experiment: changing practice to demonstrate a positive result. This experimentation occurs without any institutional review or written informed consent. Patients unknowingly assume the costs and risks of the practitioner’s experiment. Without IRB oversight, review, and approval, practice improvement modules violate the Nuremberg Code of 1947(d) (safeguarding humans from experimentation) and the Declaration of Helsinki.(e) This represents a significant moral concern. No individual rigorous review of methods, adverse outcomes, risks, or costs is mandated or occurs.

As a physician working for an internationally recognized center of medical excellence, I should not be allowed to tamper with proven protocols merely to meet ABMS requirements for my very personal recertification needs. For example, perhaps I want to change my practice to improve (reduce) hemoglobin A1c levels. Thus, I become more aggressive with insulin management to achieve this worthy goal. However, we know that tight control of insulin can be extremely dangerous and the burden of treatment associated with therapeutic complexity and risk of harms increases with lower targets.(11,12) Such experimentation with changing insulin management to meet personal recertification needs may result in fatalities. Is such tinkering with standard practice worthwhile, ethical, or even likely to improve quality?


Recent attempts by the testing/regulatory corporation, the FSMB Inc., to legally mandate MOC nationally with testing every 5 years exemplify regulatory capture: monopolies or special interest groups co-opting policymakers, or political bodies (e.g., regulatory agencies), to further their own ends.(13,14) While current board certification is generally a prerequisite for hospital privileges and applicant hiring, informed physicians are now proactively pushing to prohibit bylaws that require recertification compliance as documented by resolutions passed at the 2013 annual meeting of the American Medical Association (AMA) in Chicago, IL. Passage of anti–MOC-MOL resolutions in New York, New Jersey, Iowa, Michigan, North Carolina, Oklahoma, and recently Florida followed Ohio’s State Medical Society’s lead in recent years. These are specific examples of the rising concern among working physicians that unproven certification restrictions and costs are becoming mandated by private and corporate interest groups. These efforts strive to place time-limited certificate holders on equal ground with grandfathered lifelong certified physicians. Nationally, the Association of American Physicians and Surgeons and Doctors for Patient Care have led the opposition, followed by AMA actions at the annual meeting in Chicago, IL, in 2013. Examples of physicians losing hospital privileges and/or the ability to participate with insurance programs including Medicare over recertification have been noted. This led the Association of American Physicians and Surgeons to file a lawsuit on behalf of the national membership against the ABMS in April of 2013 seeking redress on multiple issues regarding conspiracy and restraint of trade (see United States District Court for the District of New Jersey Docket No.  3:13-cv-2609-PGS-LHG). While the FSMB’s MOL program (linking participation to the ability to practice) goes further than the ABMS currently voluntary certification proposals, neither protects against lawsuits nor insures competence, while both limit competition from noncertified physicians and intimidate physician compliance with ABMS programs.(15) The ABA has now expanded testing, which requires mandatory passage of their part 1 test before allowing completion of any residency training program. This undermines any appearance of voluntary participation and provides a clear trend for the future.

Renowned contemporary medical leaders simply never need MOC to secure their newest or next position, their reputation suffices. Thus, certification is mostly a marketing mechanism for employment, required by industry insiders and overwhelmingly ignored and unappreciated by the general population. Multiple ABMS executives themselves have published statements indicating long-term failure to recertify or participate in MOC, complying only when it has become a recent job requirement as ABMS officers, individual chief executive officers (CEOs) having been paid 6 and 7 figure salaries (Table  1).(16,17) The chairman of the American Board of Pediatrics received $1,241,588.00 as annual income, when, in 2009, the board’s corporate deficit  (expenses-revenues per the 2009 filed Internal Revenue Service 990 forms) was documented at $2,713,406.00.(18)

These salaries pale in comparison to the $374 million yearly expenditure for ABMS certifications. The current 2013 ABMS and FSMB physician CEOs were not enrolled in MOC and have never recertified as of January 2013, as verified by ABMS databanks found at the ABMS and ABIM Web pages to verify a physician’s certification. This strongly undermines any personal statement regarding conviction of certification’s personal value versus corporate profits from ABMS programs. One might argue that these CEOs are no longer practicing medicine. However, why should the many administrative physicians be required to submit to the MOL or MOC protocols and costs to maintain licenses necessary to work in administrative or research positions? On the contrary, executives in the certification industrial complex, along with our academic colleagues pushing for certifications, are typically not those practicing full time and maintaining their clinical skills. This push for certifications by executives in the certification industrial complex may be simply reflecting their myopic prejudice arising from their academic distance from practice, when often treating patients only several hours per day, week, or month, if at all. Those physicians near retirement may be economically and inappropriately forced to retire, rather than to maintain a full license and ABMS certification protocol. With the 10-year certification intervals, retirement may become an economic enticement at 10-year intervals from first certification.

The ABMS has, nonetheless, actively and effectively lobbied Congress to pass Physician Quality Reporting System-MOC (PQRS-MOC) legislation, requiring ABMS MOC compliance for payment. The ABA openly disclosed that the 0.5% initial PQRS-MOC benefits would not cover the costs of MOC, which is soon slated to become a 2% penalty for nonparticipants. (f) Only 9 specialty boards had fulfilled PQRS-MOC requirements to become providers, leaving all other 15 physician specialist groups (ABA included) exposed to reap only PQRS-MOC’s future penalties, because 2013 is the prescribed index year required for such protections.(g) Only recently did the ABA attain provider status despite openly declining to do so in 2010, declaring then “Based on its understanding of the current CMS requirements, the ABA does not believe that the additional requirements for the MOC bonus will have a sufficient impact on patient care, nor will the reimbursement bonus justify the additional time and resource burden on its diplomates.”(f) Many individual ABMS specialty affiliates opposed transitioning to time-limited programs but succumbed to ABMS corporate directives to comply or lose ABMS accreditation and these exclusive franchise rights.

While the ABMS argues that MOC is inexpensive, the ancillary cost of travel, study, time away from patient care, locums coverage, and busywork are quite significant. However, these minor costs are deemed insignificant, if the benefit is a measurable improvement in patient care. The burden of proof for any claim rests with the claimant. If the ABMS believes there is value to offset the costs, then it has the burden of proof to support this claim and this claim remains to be conclusively demonstrated by objective and reproducible means.
If you have the time, be sure to read the whole thing.  I welcome responsible comments and encourage doctors so moved to sign the petition to roll back the MOC process.


Addendum 2 JUN 2014: The full article has now been posted online here:


(c ) ABMS Maintenance of Certification® (ABMS MOC®) Updated March 20, 2013 Myths & Facts. Available at: of_certification/pdfs/ABMS_MOCMythsFacts_3-20-13.pdf . See LISTS 1–5 (Qualidigm, Middletown, CT [Drs. Wang, Meehan, and Ho and Ms. Tate]). Accessed January 16, 2014.

(d) The Nuremberg Code. Available at: . Accessed May 28, 2013.

(e) WMA Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects. Available at: . Accessed May 28, 2013.

(f) The American Board Of Anesthesiology, Inc. Maintenance of Certification and Physician Quality Reporting System Requirements. Available at: . Accessed February 28, 2013.

(g) Qualified Maintenance of Certification Program Incentive Entities for 2012. Available at: . Accessed February 28, 2013.

(4) Chaudhry HJ, Talmage LA, Alguire PC, Cain FE, Waters S, Rhyne JA. Maintenance of licensure: supporting a physician’s commitment to lifelong learning. Ann  Intern Med 2012;157:287–9

(5) Lehman RS. Nullius in verba: don’t take anyone’s word for it. JAMA Intern Med 2013;173:1049–50

(6) Kempen P. Maintenance of licensure. Ann  Intern Med2013;158:219

(7) Chaudhry HJ, Talmage LA, Rhyne JA. Maintenance of  licensure-Reply. Ann Intern Med2013;158:219

(8) Sharp LK, Bashook PG, Lipsky MS, Horowitz SD, Miller SH. Specialty board certification and clinical outcomes: the missing link. Acad Med 2002;77:534–42

(9) Simpkins J, Divine G, Wang M, Holmboe E, Pladevall M, Williams LK. Improving asthma care through recertification: a cluster randomized trial. Arch Intern Med 2007;167:2240–8

(10) Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ 1996;313:1445–9

(11) Finfer S, Liu B, Chittock DR, Norton R, Myburgh JA, McArthur C, Mitchell I, Foster D, Dhingra V, Henderson WR, Ronco JJ, Bellomo R, Cook D, McDonald E, Dodek P, Hébert PC, Heyland DK, Robinson BG; NICE-SUGAR Study Investigators. Hypoglycemia and risk of death in critically ill patients. N Engl J Med 2012;367:1108–18

(12) Lipska KJ, Montori VM. Glucose control in older adults with diabetes mellitus–more harm than good? JAMA Intern Med 2013;173:1306–7

(13) Federation of State Medical Boards. Report from the Maintenance of Licensure Implementation Group. Euless, TX: Federation of State Medical Boards, 2011

(14) Dal Bó E. Regulatory capture: a review. Oxf  RevEcon Policy 2006;22:203–25

(15) Wallace DA. Occupational licensing and certification: remedies for denial. William Mary Law Rev 1972;14:46–127. Available at:

(16) Johnson DH. Maintenance of certification: confession of a grandfather. J Oncol Pract 2012;8:203–4

(17) Brennan TA. Recertification for internists–one “grandfather’s” experience. N Engl J Med 2005;353:1989–92

(18) American Board of Pediatrics. 2009 IRS 990 form, part VII. . Accessed January 16, 2014

Thursday, May 29, 2014

Medicine's Love-Me Wall

“We can never be gods, after all--but we can become something less than human with frightening ease.”
― N.K. Jemisin, The Hundred Thousand Kingdoms

I know it's click bait, but the top 100 most influential people in health care, according the Modern Healthcare, is worth a look. It contains the following individuals in its "Top Ten:"
  • Kathleen Sebelius (#1) who resigned as the head of Health and Human Services after the botched rollout
  • Oregon Governor John Kitzhaber (#2) who jettisoned the state's $248 million dollar attempt to arrange its own health care exchange website
  • President Barack Obama(#3) - of course
  • Mr. Stephen Hemsley of UnitedHealthcare (#4) who made a cool, $4.57 million in compensation last year and exercised $9.48 million in stock in 2013
  • Marilyn Taviner (#5), CMS who gets a little love each year from her prior employer, the Hospital Association of America on top of her salary as CMS Director
  • Mark Bertolini (#6), CEO of Aetna, who made $2.66M in compensation and exercised $4.52M in stock in 2013
  • Richard Bracken (#7), CEO of HCA, who earned $38.6 million for his role as CEO in 2013 before retiring and pocketed a cool $46.3M in 2012
  • newcomer Joseph Swedish (#8), CEO of WellPoint, who earned only $7.48M in 2013
  • George Halvorson (#9), of Kaiser Permanente, who doesn't report compensation (a bit of "Sunshine law" needed, perhaps?) but other sources pegged his compensation at $6.7 million back in 2009
  • Sister Carol Keehan (#10), of Catholic Health Association who likely made well in excess of $1M in 2011
And the list goes on...

Yet we wonder why our health care costs are so high.



Wednesday, May 28, 2014

When Insurers Practice Non-evidence Based Care

With the approval of new, innovative, yet expensive medications, doctors can expect their lives to become miserable as insurers do their best to limit costs. No where is this more apparent than with the introduction of our latest slew of novel oral anticoagulants.

What is remarkable (yet not the least bit surprising to those of us who have been in the business of medicine for a while) is how insurers dismiss the importance of discussions that are held by those of us who attempt to explain the pros and cons of the various new medications to our patients. We see these conversations completely invalidated as soon as the insurance industry renders their "coverage decision." Discussions are immediately invalidated, the pros and cons of each medication ignored. Meanwhile, these same insurers bear no reponsibility for potential safety issues that might arise when their made-up care process is implemented. And there is no accountability, no person ultimately responsible.

When a doctor tries to call and speak with someone about their policy, we meet hushed tones that promise to approve the prescribed medication if we just send a letter explaining our rationale. Yet despite this effort, they stick by their policy nonetheless.

What a waste.

So I'm sending a few questions to Aetna about their new "coverage decision" regarding the new oral anticoagulant, apixaban:

An Aetna 'Coverage Decision' (click to enlarge)

Dear Aetna Pharmacy Management:
  1. When my patient has a GI bleed from Pradaxa, will you explain to them why you insisted I start this medication?
  2. When my patient gets nauseated from Pradaxa, will you take the call at 3 am and write the new script for him or her?
  3. When my patient accidentally overdoses on Xarelto thinking it was a twice a day drug like Pradaxa, will you explain to the plantiff's lawyer the safety of your non-evidenced based practice of switching anticoagulants on a monthly basis? 
  4. Along the same line of reasoning, where I might find data pertaining to the safety of monthly switches of anticoagulants in the world's literature?
  5. Is your effort to "manage" physician-prescribed medications in the patient's best interest or your stockholders'?
  6. Where can I send the bill for the wasted time spent by my staff and me to jump through your self-imposed hoops?
Aetna, may your latest policy find disfavor with the FDA safety brigade.

With sarcastic love of all you do -


Saturday, May 24, 2014

It's The End of The World As We Know It

Team by team, reporters baffled, trumped, tethered, cropped
Look at that low plane, fine, then
Uh-oh, overflow, population, common group
But it'll do, save yourself, serve yourself
World serves its own needs, listen to your heart bleed
Tell me with the Rapture and the reverent in the right, right
You vitriolic, patriotic, slam fight, bright light
Feeling pretty psyched

It's the end of the world as we know it
It's the end of the world as we know it
It's the end of the world as we know it, and I feel fine

- R.E.M.

I always enjoy people who predict the end of doctors.  Clearly, they have never been sick.

So I have an idea for Mr. Vinod Khosla who recently predicted that doctors cannot compete against machines.  After all, he appears fit and certainly we all wish him continuing good health.

If Mr. Khosla, a venture capitalist billionaire, truly stands by his prediction, he should be the first to take the data-driven patient care vow.  Start today.  After all, there is enough data-driven resources for Mr. Khosla available to provide his health care:  phenomenal computer power, thousands and thousands of discrete fields, zettabytes of data points, every kind of  algorithm imaginable.  This is an opportunity for serious leadership!

Go ahead and pull the trigger.  Use all that data out there to replace most physicians by a computer as you encounter the vagaries of aging and (dare I say it) mortality.

Take the pledge. Be an example. The moment is now.  Practice what you preach.

There's just one small complication, though.

You have to stick with it.


Thursday, May 22, 2014

Breaking: Senior Vice President of Doctoring

It's a job description for "Senior Vice President of Doctoring", being advertised by the American Board of Internal Medicine.  Remarkably, the position requires no patient care whatsoever. 

It's interesting how history repeats.

If you wonder why your health care costs are so high, consider what's happening in our new era of highly-paid Physician Inquisitors.


Sunday, May 18, 2014

It's Not About the Physician

In his piece, Why Physician's Are So Pissed Off, Jordan Grumet, MD explains how our current health care system is eroding patient care:
The conductor becomes less effective if also asked to manage the lighting. Nuance is lost if water balloons are hurled on stage during the most dramatic moments of performance. And so it has become with physicians.
If we can allow, even for a brief moment, that this is true across the country in every doctor's office, might this matter to you the patient when you arrive in your doctor's office in your most vulnerable state? Would you like to place your mortal physical body in the hands of a person in such a compromised position?

We repeatedly trust our government with more demands, yet abhor its result. Our approval of Congress rests, at best, at an abysmal 15%. And yet, we indulge ourselves with the Utopian vision of progress in health care which necessitates an ignoring of the realities on the ground. Like an alcoholic, we are enabled in our denial, blindly handing our co-dependent government the keys to our own care.

Now, do we get in the car? Or do we take the wheel?


Friday, May 16, 2014

When We Worship Process More Than Patients

If you read nothing else this week, please read these words from Saurabh Jha, MD, Assistant Professor of Radiology at the University of Pennsylvania (republished here with permission):
Writing in the Wall Street Journal (WSJ) Dr. Daniel F. Craviotto Jr., an orthopedist, made a plea to physicians to declare independence from third parties and emancipate themselves from servitude to payers, mandates and electronic health records (EHR).

As rants go, this was a first class rant. But its effect was that of a Charles de Gaulle’s whisper to Vichy France rather than a Churchillian oratory at the finest hour.

The article went viral (it has been tweeted nearly 3000 times), though with little virulence. And it is not WSJ’s paywall to blame.

The author might have assumed that most the healthcare community in general and physicians in particular wish to be free from regulations. I have serious doubts that this assumption is correct in the aggregate. The relationship between regulators and physicians is more complex and symbiotic than it first appears.

Some physicians believe in bureaucracy. Rationalism will march us out of our healthcare wilderness. This belief in scientific managerialism, faith in technocracy, is the new theism. The rationale of the new theists is that regulations fail not because they are inherently useless but because there are so few of them, and even fewer that are actually smart.

Like the first religions started with polytheism, the new believers want more agencies, more alphabet soups, more gods.

This type of reasoning can empirically neither be proven nor disproven. Hence, the comparison to religion is apt. It is like the argument made by neo-Keynesian economists: stimulus failed because it was too small. How do we know it was too small? Because it failed.

This circular reasoning is immortal and akin to an infinite set; one can always impute upon it the promise of success if only one added just a little more.

Convinced of their own virtue and the vice of others, many physicians crave more regulations. They hope that in the next round will emerge the regulatory Thor wielding his nuanced hammer on evil Medicare serpents and fraudsters. Instead we receive the leviathanic, uncoordinated Moby Dick that throws Quuequeg out with Ahab and splashes a lot of salt water in the process.

Some meet any criticism of third party players, coding and regulatory waste with a false dichotomy “so now you want to abolish insurance and Medicare, what’s your alternative?” or “you are against ICD-10, so should we descend in to anarcho-capitalism and send poor kids to workhouses?”

This line of thinking reminds me of the willful scarcity of cerebral activity that allows some to interpret in any government intervention a short step to National Socialism. The phenotype is the same. The polarity is merely reversed.

The rest of us, those who can see the vast zone between a dysfunctional Electronic Health Record and Zero Government, are merely quibbling about the price, not the principle.

And quibble we must.

We should question the marginal utility of regulations, the evidence base from which they arise, the unintended consequences of their complexity, their opportunity costs and the waste of tax payer’s money for rules that do not improve outcomes.

Outcomes, remember outcomes? We hold a new drug or device to this metric, why not a regulatory decree that is both perennially alive and permanently fossilized?

And so the author of the rant has a point.

An inordinate time of physicians is spent on non-clinical work such as coding, billing and compliance. This has been estimated to be as high as 80 % (I am waiting for the regulated shape shifter to say this is clinical work, really). One recognizes that non-clinical work is unavoidable to an extent, and in saying that 80 % is too high I hope the binary minds of some do not infer that I think it should be zero percent. But if 80 % is not too high how about 90 %? 99 %? 99.5 %? Is there no limit?

If physicians spend more time in activities that allow them to be measured than the activity for which the measurements are sought, this is a sign of dysfunction. The clinical “horse” is being grounded by the regulatory “cart.”

And this has consequences for patient care. Physicians rarely make eye contact with patients these days staring, instead, at the vast dark matter of their EHR wondering how many words it takes to say the patient has a common cold.

As Nietzsche warned, well sort of, “If you gaze into the EHR, the EHR also gazes in to you. Beware physicians, lest you become an electronic health record.”

We are living an epidemic of documentation of such utter clinical irrelevance that one struggles to comprehend. And yet some demand even more rules, more codes and more metrics as more granularity is desired and imperfection of information even less tolerated.

To paraphrase Churchill “never was so little owed by so few to so many.” Never was so little achieved by so many. A giant bureaucratic sledgehammer is being wielded against a nut it repeatedly fails to crack.

Craviotto’s declaration of independence is misplaced. To rue government involvement in healthcare within the safety of a guild, protected from the vicissitudes of the market and competition with Rajeev from Bangalore is a tad rich and rather like the famous ungrateful climber who was carried on the back of Sherpas to within a canter of the summit of Everest.

He should, instead, have appealed to our sanity and common sense, the only weapons we have to tame the bipartisan regulatory Goliath.
Saurabh Jha, MD's (@RogueRad) piece first appeared on The Health Care Blog, where it caught my attention.

The Iron Triangle and Evidence-based Medicine

From the Journal of Evaluation in Clinical Practice:
It is naïve to think that we can prevent vested interests from introducing bias. Politicians cannot tally their votes and in sport we rely on umpires, not player, to call the penalties. What are we thinking relying on industry provide evidence about health interventions that they have developed, believe in and stand to profit from? We need to recognize this inherent bias and take action against it.

It is beyond the scope of this paper to discuss practical solutions in great detail, however, we make the following suggestions:

  1. The sensible campaign to formalize and enforce measure sensuring the registration and reporting of all clinical trials (see http:// should be supported – otherwise trials that do not give the answer industry wants will remain unpublished.
  2. More investment in independent research is required. As we have described, it is a false economy to indirectly finance industry-funded research through the high costs of patented pharmaceuticals.
  3. Independent bodies, informed democratically, need to set research priorities.
  4. Individuals and institutions conducting independent studies should be rewarded by the methodological quality of their studies and not by whether they manage to get a positive result (a ‘negative’ study is as valuable as a ‘positive’ one from a scientific point of view).
  5. Risk of bias assessment instruments susch as the Cochrane risk of bias tool should be amended to include funding source as an independent item.
  6. Evidence-ranking schemes need to be modified to take the evidence about industry bias into account. There are already mechanisms within EBM evidence-ranking schemes to up- or downgrade evidence based on risk of bias. For example, the Grading of Recommendation Assessment, Development and Evaluation (GRADE) system allows for upgrading observational evidence demonstrating large effects, and downgrading randomized trials for failing to adequately conceal allocation (and various other factors). However, currently such schemes are agnostic to the origins of evidence and do not expressly recognize the high risk of bias when the producers of evidence have an invested interest in the results. It would be easy to introduce an evidence quality item based on whether a trial was conducted or funded by a body with a conflict of interest. If so, the evidence could be downgraded. Given the failure of current evidence-ranking schemes to detect and rule out industry-funding bias, this is a necessary step if EBM critical appraisal is to remain credible.
Read the whole thing.


h/t: Ivan Oransky on Twitter

Wednesday, May 14, 2014

What's Wrong With This Picture?

A US medical conference opening plenary session:

Heart Rhythm Society Meeting 2014 (Click to enlarge) From

A European medical conference opening plenary session:

NICE Annual Conference 2014 (Click to enlarge) From
Just sayin' -


Friday, May 09, 2014

The Health Care Industrial Complex and the Iron Triangle

Walking to the 2014 Heart Rhythm Society (HRS) Scientific Sessions this morning, I couldn't help but marvel how beautiful San Francisco seemed today. The weather was perfect, the streets bustling, the quaint shops and eateries doing brisk business in a very hip metropolitan city with a distinctive West Coast vibe. As I walked up to the Moscone Conference Center, I was struck by the size and scope of the facility and its cool, corporate look.

"Welcome," I thought, "to the Health Care Industrial Complex."  This meeting was, after all, designed for me and the other Heart Rhythm Specialists from all over the world.

HRS Infinity Circle Supporters
After picking up my badge I shuttled off to my first session and picked up the fresh flier published on the previous day's events.  The publication was remarkably professional, processed with all the proper public relation jargon and complementary hyperbole.  The Heart Rhythm Society app that I downloaded on my iPhone, too,  looked eerily similar to the polished one at the ACC meeting earlier this year, just the sponsor page that blinked "Biotronik" instead of  "Amgen" as it had earlier this year.  Finally, as I turned by attention back to the flier, there on page two was a picture of Hugh Calkins, MD the current President of HRS and James Youngblood, the Society's "professional" CEO, honoring the "HRS Infinity Circle Supporters" from Medtronic.  Infinity Circle Gold members from Biosense Webster, Boerhinger Ingelheim, Boston Scientific and Janssen and Silver member St. Jude Medical also were honored in the picture's caption.

Of course they were.

Twenty-six years ago I entered the North American Society and Pacing and Electrophysiology (NASPE) as a young fellow in cardiac electrophysiology competing for the Young Investigator Competition.  I was nervous as hell as I practice and re-practiced by presentation.  I was competing against some of the best and brightest and was thrilled at the opportunity, the heady notoriety, and the opportunity to rub noses with the reviewers (international senior mentors) first hand.  Back then I did not have the perspective I have now with the interplay of forces that have come to define US health care.  I had no concept of the powerful influence that the vast sums of money, lobbies, special interests, regulators, and oversight agencies have in medicine.

Since that time, NASPE has changed its name to the Heart Rhythm Society to reflect a more global mission.  Over the years I have seen the bureaucratic and political influence change the landscape of medicine as I never imagined as I struggle to cope with what it means to practice medicine today.  I suppose when one considers that for many communities in America, health care is their economy, I shouldn't be surprised that the business and politics of medicine are now more important than ever.

Years ago near the start of the Vietnam War, President Dwight D. Eisenhower coined the phrase "military industrial complex" in his farewell speech to America.  He was describing the policy and monetary relationships that exist between legislators, our national armed forces, and the military industrial base that supports them.  These relationships include political contributions, political approval for military spending, lobbying to support bureaucracies and oversight of the industry.  The concept began with the concept of coordination between the government and the private sector to provide weaponry to government-run forces.

Now we have the private sector providing funding for our instruments of health care.  We see companies that supply medical devices, drugs, insurance, electronic medical records and companies that support lobbying efforts and data mining and richly-paid oversight entities.  Today, however, the budget is much, much larger for medicine than the military.  Our "health care industrial complex" has grown into the monster it is today with a supporting flotilla of corporate, special interest, regulators and oversight entities, with doctors and patient's swept up by its wake.

Some have called this the "Iron Triangle."  And just like it's original reference for the military, we should recognize that it pertains to health care, too.  While this may be distasteful to many (including myself), I have also come to recognize that like the military, we need health care.  Unfortunately for all of us, this monstrous bureaucratically-wasteful system is what we've created.   For me, I find it helpful to understand this interplay, because it helps me focus on my role as a doctor today.

The Iron Triangle

I can only hope that our younger medical students, residents, fellows, and younger doctors get taught this perspective.  Much too often I see them looking more like lambs being led to slaughter.  Hopefully, a little insight will help them cope with the seemingly endless bureaucratic and oversight "ideas" that keep surfacing as we struggle to care for our patients.  Hopefully this perspective will keep them engaged in pushing back when the onerous becomes intolerable.  Hopefully they'll come to understand what they're up against before they throw up their hands in disgust.

Perhaps bringing these concepts to consciousness will allow us to become coordinated advocates for our patients who are being affected by these very same forces.  Maybe then, we can continue to hold true to what we love about medicine, and beat back the Iron Triangle that is making it so difficult to do so.


Thursday, May 08, 2014

Case Study: When Technology Collides

With the advent of the iRhyhm Xio XT patch monitor capable of recording a single lead EKG for up to 14 days, new moments in cardiac electrophysiology have been born.  Some of these moments are anxiety producing for the individual who has to interpret the reports generated by these devices.

Here's a few pages of one I read not too long ago that disclosed some, shall we say, interesting findings and a considerable clinical conundrum.

To orient the reader, when a doctor reads the information collected by the Xio XT patch, he or she first  reviews a summary sheet of all the heart rhythm data measured by the device.  A clever graphic is supplied that permits rapid overview of the tracing with parallel vertical lines closely arranged next to each other.  Each tiny vertical line represents a  20-minute interval of heart rate whose ends represent the minimum and maximum heart rate over those 20 minutes.  A dot in the center of the line represents the mean heart rate.  Below these closely-arranged parallel lines are other dots that fall on a row representing an arrhythmia or action taken by the patient. Here's what the overview picture of the patient I reviewed looked like (note that only 5 days of heart rhythm data were collected):

Click to enlarge. Note the increase in average heart rate that occurred at the arrow.
A closer inspection of the rhythms represented by the vertical lines with high heart rates reveals some important findings:

Click to enlarge

The bottom part of the tracing continues on to the next page:

Click to enlarge (Note the artifact at the arrow)

Finally, on the next page, the wide complex rhythm stops, but a more rapid supraventricular rhythm is discovered:

Click to enlarge

So now what?  Clearly, one of the rhythms appears to be a rapid, potentially life-threatening episode of a wide-complex tachycardia.  So I called the doctor who ordered the study, a solo doctor (yes, some still exist) and reach his answering service.  I have him paged.  There was no answer, so I leave a voicemail message urging a return of my phone call.  I then attempt to call the patient.  No answer.  I call again.  No answer to either the doctor or the patient's home/work/cell phone.

Uh oh.

So here's a question: When reading such a study, how much more should the reading doctor be expected to do?


Tuesday, May 06, 2014

When We Reward Regulators More Than Doctors

Medicine has always had it regulatory fiefdoms, but in 2002 they were greatly expanded. At that time, a charter on "medical professionalism" was published by the American Board of Internal Medicine, the American College of Physicians, and the European Society of Internal Medicine in the Annals of Internal Medicine that touted three fundamental principles: (1) the principle of primacy of patient welfare, (2)  principle of patient autonomy, and (3) principle of social justice.  The first set of professional responsibilities for physicians was a "commitment to professional competence." While I would truly like to believe this article was sincere, increasingly I am concerned it was a regulatory ploy - one that is more concerned about financial gain than patient benefit.

Let me explain.

I have spent time reviewing the 2011 IRS Form 990  "Returns of Organization Exempt from Income Tax"  (the last ones publically available) for each of the member boards of the American Board of Medical Specialties (ABMS) and the ABMS itself.  I used the website to gather these.  I assembled the salaries and benefits of the senior executives from each of these organizations in descending order and was surprised what I found (here is the complete 2-page pdf of the data for your review).  No more than the top three executive salaries of these organizations represented over $16 million in total compensation in 2011 alone.  But even more troubling was the negative relationship that existed between the top-paid executives of these private ABMS member boards and the 2011 compensation for working subspecialty physicians they are supposed to represent. Recall that pediatrics, family medicine, and internal medicine are consistently some of the lowest paid physician subspecialties.

Here is a chart I made of the top 10 board members' annual income compared to the same subspecialty physician salaries in 2011 as reported by Medscape:

(Click to enlarge)

Clearly, the US physician credentialing system as it exists now overwhelmingly rewards people with regulatory oversight rather than those who provide patient care.  Was this the intent?  More specifically, was the intent of the ABIM's "medical professionalism" manuscript to line the pockets of the ABMS member boards in lieu of social justice?  What kind of justice is this?

The answer now is not so clear.

To add insult to injury, realize that front-line physicians are increasingly burdened by very high medical school and residency debt for much of their career.  As part of their rite of passage into their subspecialty, they must pay the credentialing fees that pay the salaries of these regulators.  Should we insist our doctors pay such high fees to support these expensive salaries?  How might  patients be affected, especially when they have reduced access to doctors who must undergo repetitive certification and re-certification exercises.  How do patient's benefit when the certification process appears so flawed? 

To me, it seems that we are not seeing a definition of "medical professionalism" in the credentialing juggernaut that these private organizations have created.

We're seeing the definition of "greed."


PS:  Physicians are welcome to print out the pdf of 2011 ABMS Board members' salaries to share with colleagues and to sign the petition to stop the new onerous biannual MOC recertification requirements.

Thursday, May 01, 2014

Who's In?

“If you understand, things are just as they are; if you do not understand, things are just as they are.”

― Zen Proverb

Today, the clock strikes one: One May, 2014.  Today, doctors who failed to enroll in the ABMS Maintenance of Certification (MOC) process will wear the scarlet letter of "Not Meeting MOC Standards" on the American Board of Medical Specialities' CERTIFICATION MATTERS™ website (provided you register on the website and follow the ABMS Terms of Use Agreement).

Just a few days ago, on 28 April 2014, the American Board of Internal Medicine refused to change their policy of requiring physicians to enroll in the MOC process and pay "$200-400" per year to the ABIM despite a petition signed by over 11,800 board-certified physicians who felt the frequency of participation to be expensive and excessively complex and called on the ABIM "to recall the changes in MOC and institute a simple pathway consisting of a recertification test every ten years."

Despite this request from over 11,800 board certified physicians, they refused to budge on their every-two-year MOC requirement.

So at least we know where the American Board of Internal Medicine stands.

But where do the other member boards stand?  Do they stand with practicing board certified physicians or do they stand with regulators who continue to heap more unnecessary busywork of uncertain value on already stretched physicians? We should understand that the threat to physicians and our profession is much more severe, especially when MOC is increasingly tied to hospital credentialing and doctors'  ability to earn a living.   The MOC pass rate for internists was only 78% in 2013.

Today, each member board of ABMS has a unique opportunity to demonstrate their solidarity with the practicing board-certified physicians of their subspecialty.  Each member board should publish a statement regarding the MOC petition circulated by physicians on their websites and where they stand on the issue, just as the American Board of Internal Medicine did.  Subspecialty physicians deserve a response.

Nietzche once wrote, " Hope is the evil of evils because it prolongs man's torment." What we need in the face of what Nietzche calls "a strict, hard factuality" is a clear view of the playing field.  When physicians are feeling increasingly anxious and unclear who truly represents them, we need to have "courage in the face of reality."

Here's a list of the 24 member boards of the American Board of Medical Specialties:
To the leadership of the above organizations: your board certified physician members would like to know where you stand on the new MOC changes imposed by the ABMS today.