Appropriateness Criteria® and Our New Medical Ethic

"I swear by Apollo the physician and AEsculapius and Health (Hygieia) and All-Heal (Panacea) and all the gods and goddesses, that, according to my ability and judgment, I will keep this oath and this stipulation—to reckon him who taught me this art equally dear to me as my parents, to share my substance with him, and relieve his necessities if required; to look upon his offspring in the same footing as my own brothers, and to teach them this art, if they shall wish to learn it, without fee or stipulation; and that by precept, lecture, and every other mode of instruction, I will impart a knowledge of my art to my own sons, and those of my teachers, and to disciples bound by a stipulation and oath according to the law of medicine, but to none others. I will follow that system of regimen which, according to my ability and judgement, I consider for the benefit of my patients, and abstain from whatever is deleterious and mischievous.

I will give no deadly medicine to anyone if asked, nor suggest any such counsel; and in like manner I will not give to a woman a pessary to produce abortion.

With purity and with holiness I will pass my life and practice my art.

(I will not cut persons labouring under the stone, but will leave this to be done by men who are practitioners of this work.)

Into whatsoever houses I enter, I will go into them for the benefit of the sick, and will abstain from every voluntary act of mischief and corruption, and, further, from the abduction of females or males, of freemen and slaves. Whatever, in connection with my professional practice, or not in connection with it, I see or hear, in the life of men, which ought not to be spoken of abroad, I will not divulge, as reckoning that all such should be kept secret.

While I continue to keep this Oath unviolated, may it be granted to me to enjoy life and the practice of the art, respected by all men, in all times! But should I trespass and violate this Oath, may the reverse be my lot!"

(Adams, II, 779, cf. Littre, IV, 628.)

The Hippocratic Oath. Most medical students in America recite some version of this oath at their medical school graduation. Its text implies a sacred and overriding respect (ethic if you will) for the individual.

Doctors are currently witnessing the profession of medicine moving from the ethic of the individual to the ethic of the collective. The passage of the Affordable Care Act has solidified this treatment ethic and, as a consequence, often creates conflicts between the treating physician and their individual patients.

Nowhere is this shift to the ethic of the collective clearer than our expanding attempt to determine treatment "appropriateness" using a look-up chart of euphemistically-scored clinical scenarios owned and trademarked as "Appropriateness Criteria®" or "AUC®" by our own medical professional organizations. For those unfamiliar, these "criteria" label the care rendered in hypothetical clinical situations as "appropriate", "uncertain" or "inappropriate." (ed's note: oops, this year's update labels these "appropriate," "may be appropriate," or "rarely appropriate"). While touted as "evidence-based," these criteria simply are not - they are a consensus opinion of a collection of physicians for clinical scenarios unrelated to any real patient.

What happened to doctors serving as advocates for their patients? Are doctors really turning to these tables to decide which clinical care to render? Or do we really use them to make sure their EMR note reflects aspects that will assure third-party payment for care?

As we wallow in this latest unfortunate mandate being served to doctors, perhaps there is some use in investigating the origins of these ridiculously-complex criteria, for it is telling.

A few clicks of a computer will show the idea of "appropriateness" came from the Europeans via the RAND corporation. The organization quickly spread abroad and is now RAND Health in Santa Monica, California, USA and RAND Europe in Leiden, the Netherlands. Most of all, it is telling who now sits on the RAND Health Advisory board (ed note: Vice President, Global Affairs for Anheiser-Busch, really?). Not surprisingly, it is those who stand to gain from the business of medicine, the vast majority of whom are not even doctors. It is also worth noting that this is the same RAND organization that promoted unrealistic estimates of cost-savings to our health system afforded by Electronic Medical Records subsidized and promoted by the government today; the same business interests who make billions upon billions on Wall Street.

Our professional subspecialty societies, often funded by these very same organizations who sit as board members of the RAND Corporation, have turned a blind eye to this conflict of interest. They have adopted the process "in response to the imperative for improving the utilization of cardiovascular procedures in an efficient and contemporary fashion" and few have ever questioned its downside. In turn, doctors who use these methods collude with our well-meaning professional society colleagues to perpetuate a health care delivery model that prioritizes business interests on behalf of the "collective" above those of the individual patient. Why are we allowing trademarked intellectual properties like "Appropriateness Criteria®" to substitute for clinical judgment about our patient's individual clinical circumstance?  Could our societal self-appointed gurus ever know anything about the constellation of complicated medical and social circumstances that patients bring before us in the private confines of our office?  Of course not.

Yet here we are.

It seems a day never ends that physicians aren't being instructed on what else we must do to massage a chart for the good of the collective without a moment's consideration of what their "criteria" might mean for our patient's best care.

This is our new ethic, our new reality.

Speak out against this practice and the doctor is instantly labeled "non-evidence-based," "greedy," "self-serving," and "unconcerned" about the "patient collective." So doctors actively put their heads down and care for their patients as best they can.  Daily, doctors experience the angst of this movement. We don't want to admit what has happened. Time and again we find ourselves constrained by these "guideline"- or "appropriateness use"-directed care that has been authorized by our own "physician collective" as "appropriate" when, by its very nature, is outdated by the time the guidelines are published, static and fail to incorporate newly-vetted therapies, and conflict with our patient's actual medical needs.   Our field of medicine has become so complicit with this movement that we've even allowed our political and justice systems to threaten or impugn those who step outside these or other outdated care guidelines.

When doctors abandon our most basic ethic of caring for the individual for that of the collective, we are served our just desserts. Perhaps writing something like this will open our eyes. Or perhaps, as we've been so quick to do, we'll choose to keep them closed and not admit that this has happened.

Remember this when others say no to the care your patient needs.

-Wes

Mobile Health Apps and The Privacy Surrender

It has been interesting watching the development of Alivecor's mobile phone EKG app.

At first with the beta release of the device it just so cool to see your EKG in real time: just tap the app, put your hands in the device's over-sized electrodes on the specialized iPhone case and *bam* there it was - your heart's realtime EKG displayed right before your eyes.

Then a new software upgrade to the app came quite a bit later after the device's FDA approval.  You had to enter a name before the app would proceed to the EKG screen.

Okay, makes sense.  Don't want to confuse data.

Screenshot of Alivecor EKG app software
(click image to enlarge)

But now there's a new twist with the latest app release: before you can even load the app, you have agree to surrendering your "sensitive personal information" to the company "and other companies within the Alivecor group."

Welcome to the mobile health care privacy surrender. After all, these days if it's mobile, it's Big Data.

We've seen it with Google tracking their customers. We've seen it with Apple's Terms of Service agreement, too. And just like the big internet giants, the money in medical apps is not the app, but the data they produce. Alivecor has to develop a business model and nowhere in the world is there bigger business than health data, especially your personal data.

My purpose here is not to bash Alivecor.  On the contrary, I think they are leaders in moving forward in the mobile health care app arena that might be a viable business entity.  But I think patients should be aware of what we're surrendering each time we use any health care app that deals with anything medical and click "I Agree" to the app's broad "Terms of Service" that surrenders one's "sensitive personal information."

Perhaps people won't care about their privacy any more. Perhaps so much about us is already available on the internet, that we've already unwittingly surrendered our souls.  We want our iPhone or Galaxy visuals and we want them now.  So we agree.  But given the implications of what this might mean to a future insurance premiums or health care marketing tactics, shouldn't we at least wonder?

One of the most important abstracts at the recent American Heart Association this year was this little gem entitled "Do ICDs Prevent Hip Fractures or Are Physicians Selecting Appropriate Candidates for ICDs?" (thanks to John Mandrola MD, for pointing me to this).  The abstract underscores the pitfalls of observational comparative effectiveness research - the cornerstone for the latest internet promise of Big Data.  Believe it or not, correlation does not equal causation.

And yet increasingly we see Big Data analysis revered and marketed as scientific gospel.  Even our own FDA has used bench data over clinical data to specify pill dosages using this extrapolation, for instance.

Big data is becoming a means to justify the ends.

Think about that the next time you click on "I agree" and then see next month's higher insurance premium.

-Wes

When The Carrot Is Removed From the Stick

The field of medicine is one of the most rewarding occupations out there.  Few occupations allow such an incredible opportunity to directly impact the life of a fellow human being and see the amazing results of something you did.  Few occupations are allowed inside the most intimate and vulnerable moments of the human condition.  In a word: amazing.

But medicine for people has quickly given way to medicine for business.

Business needs results.  Business need productivity.  Business needs profit.  And profit in the increasingly competitive world of medicine is getting harder and harder to come by.

To assure these business needs, medicine has hired legions of support personnel.  These include administrators looking for ways to remain "value-added," collectors to assure the cash flow, insurance plan negotiators to cut the best deal, quality assurance and safety officers (you can never be "too safe"), database operators adept in last-year's technology, concierges to make it all seem happy, survey takers to under-sample opinion, and negotiators adept at keeping the price spread. 

To lower costs, patients are made outpatients, personnel ranks are thinned, and beds are closed. 

Yet for the most part, it has worked because doctors have stayed true to their calling.

But what if that calling dies?

What if the insurances hassles grow too great or the income doctors receive fails to cover the cost of their education?  What happens?

In truth, little right away.  Given the time commitment, it's hard for doctors to pull the plug entirely. Many doctors don't complete their training until their early thirties, and by then, they likely have families and kids, and if they are lucky, a home. So they hang in there.  They do the best they can.  Like most Americans, the cut back, budget, and make do.  But as their hours grow and incomes dwindle, some of the rose-color in medicine turns to grey.  They still love what they do, when they can do it, but if there is less reward, there is less effort. For some, mediocrity will replace exceptionalism. For others unwilling to bow to mediocrity, the desire to stay late to squeeze another patient in dissolves.

This morning's revelation of the latest physician cuts proposed by the insurance industry should give us all pause, because if it's true, you won't hear a word from doctors.

You just might not be able to see one.

-Wes

When We Empower Patients to Pay for Expertise

"I know what you're thinking, punk. You're thinking "did he fire six shots or only five?" Now to tell you the truth I forgot myself in all this excitement. But being this is a .44 Magnum, the most powerful handgun in the world and will blow you head clean off, you've gotta ask yourself a question: "Do I feel lucky?" Well, do ya, punk?

Harry Callihan (played by Clint Eastwood) in "Dirty Harry"

Today, Alivecor accounced the launch of their AliveInsights(TM) EKG interpretation service where patients decide with their own dollars and sense, who interprets the single-lead EKG generated by Alivecor's EKG iPhone case. If the patient feels fine with a technician and wants a response in 30 minutes, they can get their answer if they elect to pay $2. If that same patient wants a "Board Certified" US cardiologist to interpret their tracing and are are willing to wait up to 24 hours, they can elect to cough up $12 instead.

Gee, which would you take?

My bet is that Alivecor's guessing people will accept the cheaper alternative. But will prescribing doctors?

It is an interesting model. I learned from Dr. Dave Alpert, the inventor of the Alivecor iPhone case, that "board certified" cardiologists get to keep $10 of the interpretation fee for providing the service - no insurance forms to fill out, no worry about a technical fee for the patient - just a plain ol' cash payment model.

Perhaps what is most interesting to me is how incredibly disruptive this model is to our current medical model.

But there are other concerns for doctors who might elect to "prescribe" an Alivecor case to their patients.

If the patient elects to pay $2 and a "technician" mis-reads the EKG, is the prescribing physician legally responsible for adverse outcomes that might occur? Who is responsible if a cardiologist mis-reads the transmitted EKG - the prescribing physician or the interpreting physician (presuming they are not always the same individual)?

These are interesting questions to ponder as this service launches. Certainly other issues are likely to arise where the lines of patient responsibility become blurred. Still, I like the fact that Alivecor is moving head-on into this space. It sets an exciting opportuntity for patients to have more control over their health concerns, and if this helps them, then all the better.

So as Harry Callihan said, "Feel lucky, punk?"

-Wes

Appropriate Use Criteria's Next Steps

Dr. Kussmaul, you are my hero for publishing this letter to the editor:

"With detailed evidence-based regulation of our professional lives already in full swing, it seems inevitable that the same process will eventually extend to our personal lives. The SCAI (ed's note: Society for Cardiovascular Angiography and Interventions) has always striven to stay ahead of regulatory developments, so as to exert a leadership role.

In that spirit, I offer the following as a beginning of the conversation. Should an interdisciplinary committee be convened on this matter, I hereby volunteer to serve."

William G. Kussmaul III, MD
FSCAI Hahnemann University Hospital
Philadelphia, Pennsylvania

-Wes

PS: Heh. Reminds me of another post I wrote a while back along the same line.

Reference: Kussmaul WG. Letter to the Editor: "Appropriate Use Criteria: What's Next?" Catheterization and Cardiovascular Interventions 82:848 (1 Nov 2013), pg 848.

When Medical Content Providers Go Political

It is an interesting time in medicine.

If we step back a few thousand feet and look down on America's medical world, we see a mess.  We see rules and regulations run amok.  We see doctors under unprecedented pressure to click rather than to care. We see government websites built with the promise of access to health care, collapsing under its own weight.  We see politicians promising one thing, then delivering another.  Then we see them give exceptions to some or outright lying to others.  Then we see them get cozy with the insurance lobby after they're caught red-handed  in hopes of making a "fix."

We, the lowly patients and doctors in this political power game, turn our heads in disgust as we struggle to help people live (literally) another day.

US medicine is now all about power and money.  As such, medicine is now more about a political vision rather than reality.   Politics, after all, is all about sales: selling a vision to stay elected and to stay in charge.

So where better to turn to promote your political sales job than WebMD (and their subsidiaries like Medscape and theheart.org), that "trusted" purveyor of all things medical?  It seems WebMD and its MedScape affiliates like theheart.org have quietly accepted a $4.8 million grant  to promote the Affordable Care Act and have refused to disclose this little factoid to doctors and their readers.

There does not need to be a  Sunshine law for politicians and medical content providers these days, only doctors.

But it doesn't stop there.  Ironically, shortly after this disclosure by the Washington Times, an article entitled "Conflicts of Interest: Concepts, Conundrums, and Course of Action" appeared on theheart.org/Medscape Cardiology's website.  (Update: this morning there's an article on the Physician Payment Sunshine Act, too!)  As I tried to read this article I laughed as I clicked through a Brilinta ad and was subject to Bystolic and Belviq ads in Medscape's sidebar.

Here's a real "course of action" I'd suggest to doctors bothered by the double-standard of disclosure imposed on us from our political class: dump the Medscape app on your cellphone, give a little shout-out to theheart.org, er, Medscape Cardiology, and ask why they haven't said anything.

Then cancel anything related to WebMD.

Then, at least, we'd be sure we're getting past the political propaganda and back to medicine.

-Wes

h/t: A faithful reader.

Addendum 16 Nov 2013 @ 12:20 PM CST: It seems WebMD felt compelled to release this press release regarding their editorial integrity, but it did not reference the above conflict disclosed here specifically.

Maintenance of Certification in Cardiac Electrophysiology: Taking the Stick

Shuzan, a Buddhist monk of the tenth century, once held up a bamboo stick before his disciples. "Call this a stick," he bellowed, "and you assert; call this not a stick, and you negate. Now, do not assert or negate, what would you call this stick? Speak! Speak!"

From out the ranks, a young monk ventured forth, grabbed the bamboo, and, breaking it in two, exclaimed to Shuzan, "What is this?"*

After coughing up thousands of dollars and enduring months of test preparation for the third time to “maintain” my designation as “board certified” in my specialty according to a group I do not know called the American Board of Internal Medicine (ABIM), I have decided to do as the young monk has done in the passage above and take the stick. We need a different paradigm.  

So why not create our own, free and publicly vetted "certification?"  As part of this effort, I will ask for help from my physician colleagues who frequent this blog: please serve as test content providers.

While this will be a work in progress, there are a few rules (we must have rules, you see, to maintain legitimacy).  The rules for this high calling include the following:

1)      This certification process must, and always should be, free.  It is for doctors, by doctors.

2)      The development of this test and its scoring will be transparent.

3)      The content of questions created will always be relevant to clinical practice and apply to disease processes that occur with a prevalence of greater than one in a million of the population (no zebras allowed).

4)      Content created here can be re-used, reprocessed, and pureed without restriction and without cost, anywhere worldwide.  Any attempt to sell content created herein for purposes other than the support of patient care will be disclosed. (Enticements like "free" iPad Airs are particularly discouraged, especially when the content for a weekend course is sold for $1695.)

No conflicts of interest, period.

Here are my first two example questions so others get the point (I encourage others to add their own questions in the comments):

1. You are about to begin a permanent pacemaker implant on an 85 year old woman with a serum creatinine level of 3.2 who presented with complete heart block and a wide complex escape rhythm of 35 to your emergency room.  Her vital signs are otherwise stable.  You know you don't receive payment for placement of a temporary pacemaker wire before the permanent pacemaker is implanted.  Your patient is right-handed, so an IV is started in her left arm in anticipation of an ipsilateral pacemaker implant.  She receives appropriate skin prep (another question in this, perhaps?) and prophylactic antibiotics (maybe another on this?) before her procedure.  The next best approach before proceeding would be:

A.) Place a temporary pacing wire via the right femoral venous approach before proceeding anyway.
B) Use vascular ultrasound to carefully identify the precise location of the axillary vein before attempting a blind stick based on classic subclavian access techniques.
C) Withdraw the stylette approximately 2 cm before advancing the RV lead in the patient's ventricle to minimize the chance of ventricular perforation.
4) B and C above.
5) A, B, and C above.

2.  The new "pacemaker in situ" ICD-10 code to minimize patient hassles receiving payment for your services is:

A) 996.01
B) V43.3
C) Z95.0
D) 996.04

There, Questions 1 and 2 for our OWN new certification process are in.

Now, who's got some more?

-Wes

What Our Politicians Should Fear the Most

... is when patients start telling their real life stories:

"Before the Affordable Care Act, health-insurance policies could not be sold across state lines; now policies sold on the Affordable Care Act exchanges may not be offered across county lines.

What happened to the president's promise, "You can keep your health plan"? Or to the promise that "You can keep your doctor"? Thanks to the law, I have been forced to give up a world-class health plan. The exchange would force me to give up a world-class physician.

For a cancer patient, medical coverage is a matter of life and death. Take away people's ability to control their medical-coverage choices and they may die. I guess that's a highly effective way to control medical costs. Perhaps that's the point."

-Wes