The Matrix

"As a third year medical student, I would also argue that this is creating a generation of dumb doctors. My school (average US MD school in the Midwest) has almost abandoned teaching physiology and understanding. We have the virtues of guidelines shoved down our throats instead. Recognize a pattern, apply the appropriate guideline. That's medical school these days...."
-Anonymous commenter
Dr. Wes blog

Dear current medical students,

Welcome to The Matrix.

-Wes

If The Hunger Games Came to Medicine

““A totalitarian state is in effect a theocracy, and its ruling caste, in order to keep its position, has to be thought of as infallible. But since, in practice, no one is infallible, it is frequently necessary to rearrange past events in order to show that this or that mistake was not made, or that this or that imaginary triumph actually happened.”
                                               - George Orwell

* * *

The brushed, steel belly of the scalpel blade pressed down on the orange antibacterial film and released the subcutaneous yellow fat globules surrounded by small beads of red blood.  The movement of his hand was fluid, purposeful, and without hesitation.  The electrocautery pen carefully seared the points where blood appeared.  A retractor was installed to spread the tissues farther apart as he worked quickly to gain access to the tissue plane just above the muscle.  His movements were deft for he knew they were watching.

The Capitol's campaign to ensure perfect outcomes was well underway. They had installed cameras throughout the hospital just four short years before: in the halls, the changing rooms, at the scrub sinks, and in the operating rooms.  The Capitol had discovered that the operating room was like yesterday's boxing ring, or even farther back in the mists, the Coliseum.  In the New World unpredictable events and venues that stirred primitive passions were few - and yet they were longed for as they were feared.  This context explained the popularity of the annual Hunger Games, created as punishment for the destruction of District 13 by a failed patient uprising after the health care financial apocalypse.  Each year, one male and one female physician "tribute" from each of the surrounding twelve Districts were selected by lottery and performance metrics to fight each other to the death. Providing spectators with a window into the drama, and ensuring that drama by creating just the right conditions, gave spectators a sense of aliveness that they barely remembered, and just enough to stimulate fear.  The Games also served as the perfect venue to deflect blame from the Capitol's expedience in sacrificing people for their own avarice.   

The call had come after a full, exhausting day.  The patient had presented to the Emergency Room only two weeks after open heart surgery for coronary disease and to replace his critically-narrowed aortic valve.  The surgeon-tribute wasn’t sure why his conduction system should fail this late after surgery but it didn’t matter; his heart rate had slowed to a dangerous 19 beats per minute. His blood pressure, while low, remained stable.  A quick review of this medication list disclosed the mandatory heart medications that included an anticoagulant for the heart valve and antiplatelet agents for his coronary disease.  No heart rate slowing medication was being used so the Capitol's appropriateness indication to proceed with the procedure was indisputable.  It was also fortunate that the anticoagulant the patient was taking hadn’t thinned his blood too far.   He decided to take him to the operating room directly.  It was 3 am.

Meanwhile, back at the TV studio:  “I tell you, Frank, every year the footage gets better and better!  How did your team know that these untenable circumstances would result in such great late night viewing?  This is so exciting!” 

The call team had been called, but was short-staffed.  Efficiency meant lower cost, fewer people, and longer work hours.  The designated scrub tech had car trouble and would be delayed.  So the other technician and nurse worked feverishly to ready the room.  The call had already been made to the device representative who brought the new pacemaker hardware, but he was barred from entering the operative suite for he was not part of the medical team.  Rules were rules.   The patient, of course, was agitated, gasping for breath.  The doctor worked as fast as possible to establish pacing – the air was tense.

“Are you kidding?  I love seeing this, don’t you?  The nervousness of his voice!  The anxiety!  The skeleton crew at night!  Beautiful!  I’m not sure it gets much better!”

John had no idea why his car wouldn’t start that night (but the spectators did).  He turned the key again and again, only to hear the engine spit in return.  He slammed his hand against the steering wheel, frustrated that he was unable to keep his car tuned for poor weather.  But such concerns were luxuries now that hospital budgets were tight thanks to the Capitol’s Bundled Payments for Care Improvement campaign.  Finding a ride to work became the imperative.  He raced back into the house to wake his wife in a panic, asking her whom he might call to give him a ride – they each knew the consequences of failure.  They called their neighbor and woke him from a sound sleep.  The pressured nature of their voices convinced him to loan them his car and five precious minutes later, he was off to work calling ahead to notify them of the delay.

At the hospital, Chloe answered John's call as she sat behind the monitoring console.  She was one of the best young technicians to graduate from her training school.  Still, her hospital’s equipment was not up to date because maintenance contracts were left to expire in these cost-saving times.  Still, although the software it ran was now several versions old, it still reliably fed data to the Capitol's chargemaster.  She looked down at the dust on the keyboard.  Seeing this, it was clear she couldn’t enter the room to assist because the risk of surgical contamination was too great.

The surgeon-tribute was glad he’d placed two venous sheaths to gain vascular access, rather than just one.   He had successfully placed both pacing wires through the sheaths to the patient’s right atrium, ready to be secured to their appropriate chamber.  But he needed a softer shaping wire – the stylette – to insert into the inner lumen of the pacing wire.  Without the stylette, the pacing wire had the consistency of a well-cooked spaghetti noodle.  With it, he could place the pacing wire to its appropriate chamber.    As he turned, his eyes left the surgical field for just a moment.  He scanned the table crammed with scattered instruments and hesitated briefly as he located the proper stylette. 

A hush fell over the audience as they saw the opening.  They leaned forward in anticipation, reveling in their luck to see such a careless mistake.

John leaned his head in the room to notify them he’d finally arrived and would assist as soon as he could change.  The surgeon smiled, acknowledging his dogged efforts to arrive as quickly as humanly possible.  He turned to the field and shaped  the stylette to the perfect curvature that would allow him to affix the pacing wire to the lower, primary pumping chamber of the patient’s heart.  He focused his blurring vision to place the tiny stylette in the endhole of the pacing lead.   Chloe broke the silence of the moment: “Hey guys, did an electrode fall off?”

The doctor looked up briefly to see atrial P waves dancing across the monitor screen without any corresponding ventricular electrical activity. With that, his worst nightmare was realized.  The patient began posturing on the table, his head thrown back beneath the drapes, his arms slowly but powerfully raising.  The surgeon leaned forward to grab the patient while trying to control the leads, stylette, and surgical wound sterility.  The patient began violently thrashing beneath the drapes, his face turning blue and lips crimson as saliva and exhaled gases mixed into a frothy spraying mess.  He was seizing uncontrollably.  His once steady escape rhythm had chosen this unfortunate moment to stop. 

If the surgeon was expecting help from a sponsor it was unlikely to be forthcoming.  Just yesterday, the tribute's most likely supporter/sponsor, Sylvia, a well-to-do matriarch from the Central District, had noticed an incipient sign of aging on her neck – subtle crepe-like thinning of her skin, this despite her  rigorous adherence to all of the Wellness Initiatives the Capitol had advertised.  She had reason to hate, didn't she? She'd  been failed one too many times.   She remembered sitting with her 65 year old mother gasping for air in one of those infernal assembly-line clinics with the young doctor glancing at the red, flashing "Do Not Admit" guideline on the computer screen as he sent them home with morphine with that flat, dead, passive expression on his face!  He didn't care then and so she wouldn't care now!

Seconds felt like hours as the patient's body slowly twisted sideways.  The nurse did all she could to support his weight and keep him from falling.  The surgeon, too, felt helpless as the powerful frame shook uncontrollably beneath the drape.  The restraints tethered his arms but his involuntary leg movement forced him further sideways.  John felt powerless as he watched from the door.  Finally, he could watch no longer and ran into the room just as the patient fell to the floor.

Four cannon blasts were heard in the distance.  The spectators roared.
 

-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.

A Case of Fraud

He was a slender-framed man, mid- to late-sixties, with a kind of ridden-hard-put-away-wet complexion.  It was clear the years had not always been good to him, but being the kind soul that he was, he had plenty of friends.  It was a beautiful summer day to spend with friends for a barbecue, but he arrived feeling puzzled why he collapsed at home earlier in the day.

He stopped at the keg and poured himself a beer in a red solo cup, and as he approached his friends with a smile, he did it again, this time which such gusto that his beer went flying and the thud he made when he hit the ground made everyone gasp.  He laid motionless for a moment face down on the ground while his friends rushed to his aid.  An ambulance was summoned as others rolled him over onto his back.  He began to move - slowly at first - then more purposefully.  As sirens approached, he asked his friends, "What just happened?'

A bit later, he arrived in the Emergency Room, awake, alert, pleasant, and seemed - on the surface at least - fine.  His vital signs were normal - perfect, in fact.  About the only things immediately noticeable was his thin frame, his coffee-stained teeth, and a clump of grass in his hair that the nurse kindly removed.  He was placed in the gurney, an IV was started, blood was drawn, and EKG was performed as a few "hellos" and "what happeneds" were exchanged, then off to the CT scanner he went to rule out an intracranial process.  It was normal and his EKG showed a first-degree AV block and incomplete left bundle branch block without evidence of acute injury or prior heart attack.

He returned from the CT scanner and was examined a bit more closely.  A loud, blowing, holosystolic murmur was heard by the medical student.  In fact, it was loud enough to create a "thrill" - a palpable vibration on the thin man's chest.  The medical student seemed pleased with himself, then ordered his first echo which revealed a relatively weak heart with a few chamber walls that didn't move so well, and a very leaky heart valve.  He was admitted, placed on telemetry, and seen by a cardiology consultant.  Closer inspection of the echo revealed a dilated left ventricle with a posterior wall motion defect and a central jet of mitral regurgitation large enough to fill the left atrium with a mosaic of color that extended to the pulmonary veins.  It was clear he'd need surgery, so a diagnostic catheterization was performed.  It showed three-vessel coronary artery disease and confirmed severe mitral regurgitation.  His medications were adjusted and surgery consulted.  A date for surgery was arranged at the neighboring hospital the following week and all seemed well.

But he had different plans.

As he settled down for dinner, he felt suddenly flushed, lightheaded, and broke out in a sweat.  With that, the telemetry alarm sounded and soon the room was full of people, crash carts, and hysteria.  His dinner table was shoved aside and he was laid flat as his chest was made bare.  He didn't know what all the excitement was about, but heard the words "He's fibrillating!" and then felt the cool metal discs covered with cold goo applied to his chest.  "What are you do...?" and with that, he felt his chest and arms jerk violently just before he passed out.  "Shit, he's still fibrillating!" someone shouted.  So they charged again and shocked him, this time to sinus rhythm.  The anesthesiologists who had arrived on the scene of the arrest took no chances: he was intubated and expeditiously transferred to the ICU.

Upon arrival to the ICU, the patient was clearly recovering well and quickly extubated the next day.  Beta blockers were administered additional anti-anginal and anticoagulants given.    Once stabilized, he was transferred to the surgical hospital and underwent urgent bypass surgery with mitral valve replacement.  At the time, the surgeon could see considerable endocardial scar.

His recovery was uncomplicated, but four days after his surgery, he still required external pacing.  Cardiac electrophysiology was consulted to consider an ICD placement, given his history of sinus node dysfunction, cardiac arrest, diminished LV function, and the visible presence of endocardial scar during surgery.

The electrophysiologist reviewed the case and noted that the patient's original in-house arrhythmia at the time of his "arrest" was actually an organized, rapid ventricular tachycardia that was then shocked into ventricular fibrillation by an asynchronous defibrillation attempt.  An echocardiogram performed post-operatively showed a very low EF of 23%, but a good repair of his valve and he appeared to be progressing quite nicely in his cardiac rehabilitation.  Still, it was felt he was at high risk for another arrhythmic event, so a wearable defibrillator as ordered as they waited out his conduction system a bit longer to see if it would recover function.   It never did.

So 10 days later after the sinus node failed to recover, the electrophysiologist had a choice: implant a pacemaker, or implant a defibrillator?   It shouldn't be a difficult decision in this case, should it?

But the electrophysiologist knew he'd be committing fraud if he implanted a defibrillator and billed Medicare for the device and procedure.  That's because Medicare's 2005 National Coverage Decision requires doctors to wait 90 days and then "reassessing" the patient's heart function later before implanting a defibrillator once the heart is revascularized surgically.

But he wondered about the extra risk of infection created by two surgeries (one for a pacemaker and one later to upgrade the device to an implantable defibrillator) instead of one.   He wondered if anyone ever considered the frequent venous occlusions that preclude later upgrade of pacemakers to defibrillators via the same side as the original pacemaker implant.   Even if he implanted a defibrillator lead at the same time he implanted the original pacemaker, wouldn't he be committing fraud if a more expensive defibrillator lead were billed to Medicare instead of a pacemaker lead?   And what about the added cost, inconvenience, and poor compliance rates of patients issued wearable defibrillators as they wait out the 90-day waiting period for an ICD?  Finally, what are the ethics of asking his patient to sign a form that obligates the patient to pay for his defibrillator if Medicare fails to do so when the actual costs involved to implant a defibrillator are closely held institutional secrets?

So he wrote his note.  He documented his rationale thoroughly.

Then proceeded to commit fraud.

-Wes

Refs: 

Fogel RI, et al. The Ultimate Dilemma: The Disconnect Between the Guidelines, the Appropriate Use Criteria, and Reimbursement Coverage Decisions JACC, 2013;() doi:10.1016/j.jacc.2013.07.016.

Dr. Wes: When the Feds Come Knocking

Guideline Apathy

With yesterday's publication of the 2013 ACCF/AHA Guidelines for the management of heart failure, the 101st guideline for cardiologists since 2005 published jointly by the ACC and American Heart Association appeared in the literature (if my count is correct).  Then again, the National Guideline Clearing House set up by our own US Government suggests there are 483 previous guidelines pertaining to cardiovascular diseases, but only 52 published by either the AHA or ACCF for cardiologists.  Does ANYONE know how many guidelines there are for us to review and stay current with?  Which version should we apply to patient care?  When new guidelines are published, how long do we have to implement the new recommendations for care in real life?  Given the pace of medical innovation worldwide, are new guidelines already obsolete once they're published?

With so many publications, constantly updated over and over again, each new set of guidelines joins the maw of guideline publications for physicians that are increasingly ignored.  Worse, the level of evidence for most guidelines are meager at best.  As a result, their importance has been relegated to armament for legal authorities rather than eagerly anticipated recommendations for care.  It has also become clear that payors don't follow these guidelines for payment decisions either; instead they turn to their internal corporate medical coverage policies. 

It would be helpful to have a "What's New" section in the guidelines but, alas, we must repeatedly endure the rambling preamble that rehashes methodology and hope we don't miss the important stuff contained in these tombs when new versions are published.  Despite their effort to be all-encompassing, nuances in complex medical care inherent to sick patients with multiple organ system diseases limit the applicability of these documents in many cases.  So doctors practice their art as they always have: with care and compassion and their best clinical judgment. 

It's too bad, guidelines were once helpful years ago.  Now, clinical doctors are officially numb to them, just like they're numb to ubiquitous telemetry alarms that are overused and constantly ring on our wards. 

-Wes

Dr. John M: Autonomy vs beneficence? Shared decision-making in the patient considered for an ICD

Dr. Lin and Matlock were quoted in Dr. John Mandrola's post today:

"Convincing physicians to engage in shared decision-making is a complex undertaking, as physicians may believe that they are following clinical practice guidelines in strongly recommending an ICD to eligible patients. Because quality-improvement efforts often focus on increasing physician adherence to guidelines and reward physicians for clinical processes or outcomes rather than high-quality decision-making, the message to physicians is that guideline adherence, rather than individualized care, is best."

For implantable cardiac defibrillator (ICD) implanting physicians everywhere, if you read nothing else today, read this excellent post by Dr. John M.

-Wes

The Dark Side of EKG Screening in Athletes

They sat nervously with their son in the doctor's office, wondering why they were there.  John was, after all, the picture of health and had just received a scholarship to Stanford University to play soccer.  His mother and father had been to every soccer match through his formative years, enduring the travel schedule with its weekends away from home, long hours, horrible weather.  John was staring at his iPhone, his mother clutching a Kleenex.  John's father stared out the window.  It was raining.

The door opened.

"Hello, I'm Dr. Kiljoy.  They asked me to see your son about a finding on his EKG."

"Hello," they said back.

"As you know, we've been looking into EKG's in athletes because we have suspected for some time that an EKG will help us better detect students who might be at risk for sudden cardiac death while participating in sports.  You know, even if we can prevent one death in these young people, it would be worth it.  None of us want a young person to die.  That New York Times article yesterday... dang... with that crying family and all right there at the top... poor boy collapsed, people had no clue what happened at first, people thought he overheated, then waited... only later did they find that AED.  Then it didn't work 'cause the battery was dead.  So sad!  We really are trying to prevent that from ever happening.  Seriously.  Sad as hell.  And to think we could have caught this if that teenager had just had an EKG..."

"Yes, of course!" said John's mother.  "I'm SO glad you did this!  We'll be so reassured to know that John's going to be okay. "

A pause filled the room...

"He IS going to be okay, isn't he?" she asked.

"Well, Mrs Smith, we're not sure, we have to run some other tests.  You see he had a slight elevation to his ST segments in these leads here, see?  Then look at his heart rate, it's so slow!  And that voltage here, it's more than we usually see...  It's probably okay, but I'm going to order an echo to look at his chamber sizes."

"Okay..."

"And a then I'm going to have one of our EP people see him to make sure he doesn't have a congenital ion channel disorder..."

"A what?"

"A channelopathy - a genetic defect of some ion channels in his heart - the most common form is called Brudaga Syndrome..."

"How do you spell that?" She waited with pen and paper to jot it down...

"B-R-U-G-A-D-A.  Look, he's probably okay, be we want to be absolutely sure, especially with that ST segment elevation in those leads...  We'll also check a stress test to make sure his heart rate comes up appropriately with exercise and that there aren't any funny EKG changes with exercise that might suggest an anomalous coronary artery - I've seen three people die like a dog with that one!"

"How often does that happen?" she asked.

"Well, it's pretty uncommon, but if it's there, sometimes we have to do open heart surgery to reimplant it so that it won't get pinched between the pulmonary artery and aorta when he exercises."

"But he's never had a problem!  And no one has ever died suddenly in our family - ever!"

"Mrs. Smith.  Remember why we're doing this: John's safety.  This is all about John's safety."

"And if you find something in all these tests, then what?"

"Well, he wouldn't be able to play soccer."

John's eyes suddenly lift from his cell phone.  "What did you say?" he asked.

"You won't be able to play soccer," Dr. Kiljoy repeated.

"Mom, what the f#$*!?  If I don't play soccer, I don't go to Stanford.  If I don't go to Stanford, I'll never play soccer again!  Are you serious?"

The father, sensing his son's concern, returns to the room from his window transcendental meditation.

"Son, let's just get the tests.  Your mother's concerned."

"Mom's concerned?  What the hell do you mean 'Mom's concerned?'  What about me?  I never wanted to get this frickin' EKG anyway!  Look, I'm FINE.  I never so much as farted wrong.  We have no family history of heart disease.  I've never felt my heart race, I've never passed out, I'm faster than everyone else on my team and we just won the State Championship!  How's THAT for a stress test?  I've worked my ass off for YEARS to get this scholarship.  And now, just because of this EKG with bullshit findings that don't pertain to kids my age they're going to do a million tests just to be sure?  Seriously?  Honestly Dad, you gotta be kidding me...  How much is all this gonna cost, huh?  And maybe I'll lose my scholarship, too?  How much is THAT worth?"

"John, honey, it's for your safety," his mother whispers, tears streaming down her cheeks.  "We love you so.  We just don't want anything bad to happen to you...."

"Your Mom's right, John.  We just want to be sure... really....", Dr. Kiljoy continued.

John looked up at Dr. Kiljoy, and said slowly, painfully, with tears in his eyes:

"Doctor, f*&% you."

-Wes

P.S.: For more, please see Dr. John M's take on the New York Times's abysmal reporting on this issue.

When the Feds Come Knocking

Slightly over a year ago, the Department of Justice (DOJ) launched an investigation of a large number of institutions regarding concerns that implantable cardiac defibrillator (ICD) procedures were performed for reasons outside of the criteria set forth in Medicare’s National Coverage Decision (NCD).  This investigation occurred just after Al-Khatib and others published a report January 4, 2011 in JAMA that suggested as many as 22.5% of implantable defibrillators implanted for primary prevention of sudden death were not evidence-based.  While the physician community took issue with the Al-Khatib paper, the media firestorm it generated paired with the announcement to the Heart Rhythm Society physician community that a federal investigation was underway, had a chilling effect on ICD implantation nationwide.  Drs. Jonathan S.Steinberg and Suneet Mittal report on their experience with DOJ investigators under this heavy regulatory oversight in today’s Journal of the American College of Cardiology.

Steinberg and Mittal's diplomatic account carefully describes the challenges of retrospective audits performed by lawyers from the Department of Justice and those of their targeted health care facilities. The DOJ identified 229 cases as potentially inappropriate cases based on Medicare code criteria.  (This represented 8.7% of the de novo non-resynchronization ICD implants done for primary prevention at their institutions). After determining that some of these targeted cases were actually for secondary prevention or other coding transgressions, the authors could medically justify all but thirty-four (15%)  (or a very low 1.5% of all ICD’s implanted for primary prevention of sudden death) at their institution.  As has been the case in most reports, the majority of outside NCD-directed ICD implants occurred because of timing violations—too close to the diagnosis of heart failure, heart attack and coronary intervention. These timing constraints constitute the primary issue before implanting doctors: their professional society guidelines do not -- in all cases -- recognize similar timing restrictions.

It is surprising that we are not told what sanctions, if any, were levied against their respective institutions.   Perhaps the authors felt this important detail was unimportant to disclose or perhaps they were prohibited from doing so.  Perhaps their penalty is still being determined: after all, nothing drives behavior like fear.  To this end, we found the authors' compliments of the government's legal team unusual to report in a scientific manuscript, as if the they were suffering from Stockholm Syndrome.

We should acknowledge that the authors have added much needed clarity to the gray area of decision-making surrounding ICD implantation. Their explanations of timing violations highlight problems with coding, confusion around incidental PCI intervention in patients with dilated cardiomyopathy, and demonstrate the overlap decisions that must be made when bradycardia and tachycardia functions might be required for our patients.  This kind of clinically-relevant nuance was lacking in the impugnable Al-Khatib JAMA piece.

We can only speculate the large cost of the legal fees and man-hours devoted to this review process.  We will never know how many patients died during, or now after, the course of this investigation because they were not offered ICDs because ICDs can only be offered to patients who meet Medicare’s rigid, outdated, and still-to-be-updated National Coverage Decision for implantable defibrillators.   But perhaps this is the price of regulation that America is willing to pay in return for cost savings.  Perhaps we should not be concerned that professional guidelines for care delivery should be second fiddle to government mandates for ICD implantation.

With this latest report, a new era for medical practice is now upon us – one where priorities of low cost care and high quantity of care determined by non-medical personnel supersede the highest quality of medical care to our patients.   For regulators, it is easy to be a Monday-morning armchair quarterback evaluating health care delivery.  It is far harder, however, to decide prospectively who is likely to die (or not) when they sit before you with a newly-diagnosed cardiomyopathy and ejection fraction of 12%. 

When government and legal officials who carry no responsibility for the long-term well-being of our patients have the authority to retrospectively impugn and penalize doctors (and their health care facilities) based merely on retrospective reviews of billing codes and outdated payment mandates, they risk irrevocable harm to patients who might qualify for devices according to updated professional guidelines.  Doctors everywhere should stand up collectively to disown the practice of using NCD mandates, rather than updated professional guidelines, to determine appropriate care for patients.

After all, our patients are depending on us.

Westby G. Fisher, MD
Director, Cardiac Electrophysiology
NorthShore University Health System and
Clinical Associate Professor of Medicine
Pritzker School of Medicine, University of Chicago
Evanston, IL

John Mandrola, MD
Cardiac Electrophysiologist
Baptist Medical Associates
Louisville, KY

Addendum 27 Mar 2012: Link to Steinberg/Mittal article finally added.

Addendum 14 Sep 2012: Update on the DOJ Decision

References:

Jonathan S. Steinberg and Suneet Mittal. "The Federal Audit of Implantable Cardioverter-Defibrillator Implants: Lessons Learned." J Am Coll Cardiol. April 3, 2012, 59 (14) 1270-4. doi: 10.1016/j.jacc.2011.12.026

Epstein AE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. J Am Coll Cardiol. May 27, 2008;51(21):e1-62.

Al-Khatib S, Hellkamp A, Curtis J, et al. Non–Evidence-Based ICD Implantations in the United States JAMA. 2011;305(1):43-49. doi: 10.1001/jama.2010.1915

Note: This post also appears on Dr. John Mandrola's blog: http://www.drjohnm.org/

When Screening Teenage Athletes for Sudden Cardiac Arrest Risk, History Matters

Before reaching for tests like EKGs to screen teen athletes, we should first ask ourselves if we've taken a careful history:

The new study consisted of Madsen and his fellow researchers sending out surveys to every pediatrician and family practice doctor in Washington State. They received a good response–surveys were returned by 72 percent of pediatricians and 56 percent of family practitioners.

The results were disheartening:

• 28 percent of doctors surveyed failed to always ask if a teen experienced chest pain during exercise.
• 22 percent of doctors surveyed failed to always ask if the teen ever fainted without a known cause or explanation.
• 26 percent of doctors surveyed failed to always ask about early deaths in their family history.
• 67 percent failed to always ask about heart disease in their family history.

Dr. Gaurav Arora, associate director of electrophysiology at the Children’s Hospital of Pittsburgh and an assistant professor of pediatrics at the University of Pittsburgh, was surprised to see the number of physicians in the new study who said they didn’t ask every teen athlete about fainting or chest pain. He said, “Those are red flags in young athletes.”

-Wes

How Clinical Guidelines Are Mirroring the Tax Code

The above graph from the Cato Institute demonstrates the growing complexity of the U.S. tax code over the years. After doing my taxes recently and trying to track the ins and outs of the law for my wife's private practice, I can attest to the graph's accuracy.

But then I was reading an interesting editorial in Circulation: Arrhythmia and Electrophysiology by N.A. Mark Estes III, MD and Jonathan Weinstock, MD that reviewed an article by Roos, et al in the same journal that found only 27 of 698 guideline recommendations from the European Society of Cardiology (median 1.2% per guideline [IQR 0.95% to 3.7%]) were correctly referenced as Class I or III Level of Evidence A recommendations, calling into question the accuracy of guideline recommendations. In their editorial, Estes and Weinstock defended the guideline process but also mentioned the following shocking statistic:

There have been 2413 guidelines published by 267 organizations over the last 2 decades.

To bolster their point, they referenced the government's own website designed to tract these guidelines.

So I checked the number of guidelines so far just for cardiovascular diseases: 457 and counting.

Given this, one thing is becoming abundantly clear:

... doctors will soon be behaving less like doctors and more like tax accountants.

-Wes

References:
Estes NA M, Weinstock J. Guidelines for Cardiac Arrhythmias
Practice Makes Progress Circulation: Arrhythmia and Electrophysiology. 2011; 4: 119-122.

Roos M, Brodbeck J, Sarkozy A, Chierchia GB, De Asmundis C, Brugada P. Critical Analysis of the Scientific Evidence Behind International Guidelines Related to Cardiac Arrhythmias Circulation: Arrhythmia and Electrophysiology. 2011; 4: 202-210.

A Lawyer's Perspective on the DOJ's Investigation of Implantable Cardiac Defibrillator Use

From the lawyer-published "Healthcare Compliance Blog:"

I predict that the DOJ will be:

1.Continuing its efforts to deal with providers in an open and collaborative manner.
2.Notifying more hospitals that they are under investigation relating to ICD billing.
3.Making additional inquiries of hospitals regarding this matter.
4.Investigating doctors who have patterns of high ICD implantation rates, coupled with a potential lack of medical necessity. The medical necessity issue poses risks to both physicians and hospitals.

These are not really hard predictions to make, though I would argue that the DOJ has been anything but "open and collaborative" as they have imposed a gag order on the Heart Rhythm Society during their current investigation.

But we must acknowledge there are implanters who have scammed the system and they should be held accountable for their actions. But for the myriad of physicians who are implanting devices appropriately, no one quite knows what to do with their patient's since the government's CMS-directed guidelines are so out of date. As I mentioned before, CMS wants doctors to use their ICD guidelines based on data from 2005 that ignores the more recently published (and less restrictive) guidelines published in 2008.

We are now seeing the Draconian and covert methods that will be used to impose restrictions on our patient's care. This model will serve the government operatives for other expensive technologies, too, like hip replacements, spinal fusions, and the like.

Whether the government begins to prosecute doctors for using the newer ICD implantation guidelines remains to be seen, but the mere specter that they're looking has already achieved the government's goal since no one wants the expense and notariety of a legal investigation to contend with and as a result, ICD implantation rates are currently dramatically reduced.

Mission accomplished.

-Wes

Can the Government Keep Up With New Guidelines?

In case people are wondering if our governmental overlords really care about the latest and greatest treatment guidelines published by our professional health care organizations, take note.

CMS (Center for Medicare and Medicaid Services) is still using guidelines for defibrillator implantation from 2005 to justify payment for services in their national coverage decision, whereas the latest guidelines published by the Heart Rhythm Society published in 2008 carry signficiant differences in their recommendations for appropriate patients for this technology.

So which set of guidelines should doctors use?

The answer is obvious: if you use the latest data to decide who should receive a defibrillator, you might be subject to a Department of Justice investigation.

So much for using updated guidelines.

-Wes

For Guidelines: Hyperlinks, Please

This week, in response to the approval of Boehringer-Ingelheim's dabigatran (Pradaxa®) by the FDA, guideline writers were relatively quick to issue a 'focused update' (pdf) to the recently-released 2011 guidelines for the management of atrial fibrillation to include the new medication.

With this "focused update" came a new era for doctors.

Now, instead of guidelines for care of a malady being published in a single publication, we are finding guidelines can morph across multiple articles. As such, the size and breadth of guidelines that are increasingly used for mandates for clinical care can stretch over a virtually limitless publication domain.

In this era of electronic, near instantaneous publication with the now-apparently limitless potential to expand to unlimited size, doctors should insist that electronic hyperlinks be established between published guidelines, their addenda, and their associated references.

-Wes

Co-Opting the History and Physical Examination

This week, new "performance" guidelines were published for adults with peripheral artery disease (or as one drug company brands it, "PAD.")

Interestingly, in explaining the rationale for these performance measures, these guidelines state:

Despite the overwhelming evidence that patients with PAD are at a markedly increased risk of myocardial infarction, stroke, and death, these patients are often undertreated, in that they do not receive antiplatelet therapy or statins with the same frequency as do patients with coronary artery disease (19).

Thus, these PAD performance measures are directed at strategies to improve diagnosis and treatment of patients with PAD with an overall goal of improving patients' walking distance and speed, improving their quality of life, and decreasing cardiovascular event rates.

And we should add, giving them appropriate pharmachologic and interventional therapy.

Fair enough.

But the guidelines push for the performance of an ankle brachial index, or ABI (a part of a thorough cardiovascular physical examination), in all patients determined on the basis of a questionnaire to be at risk for peripheral vascular disease. And they push hard, with statements simultaneously published the the Journal of the American College of Cardiology, Circulation, and reportedly also later in the Journal of Vascular Nursing, the Journal of Vascular Surgery and the Vascular Medicine Journal. The ABI is nothing more than a calculated ratio of blood pressures of the lower extremety systolic pressure divided by the upper extremity systolic blood pressure. A ratio of 0.9 or less is thought to suggest significant "PAD." To speed measurement of both arms and legs simultaneously, fancy new machines have been developed and costs about $75-110 to have performed by ancillary personnel.

Now don't get me wrong, I do think we can do a better job of detecting and treating peripheral vascular disease, but I have to ask several questions:

First, if "8 million persons in the United States are afflicted with PAD" and "the prevalence of PAD is approximately 12% of the adult population, with men being affected slightly more than women," how much will these screenings cost? Cost and the issues of dealing with false positive findings were part of the reason why screening EKG's were not recommended for all high school athletes in the American Heart Association's earlier guidelines. Should we not have a similar discussion for ABI screening?

Secondly, since when did we allow portions of the history and physical examination to be co-opted into billable procedures by professional organizations interested in promoting "quality care?"

How about a few more minutes in the exam room instead?

This is not just a rhetorical question any longer. Doctors are constantly being pushed by more and more "performance measures" to focus on things that might not have anything to do with the patient's chief complaint. Like bugs to a light, we are re-directed by these performance measures, soon-to-be mandated by Medicare, to direct our thinking away from patients toward the bureaucrats in the name of professional organizations' turf preservation.

Every screening measure amplified by millions of people has the potential to raise costs, not reduce them. And this era of a real need to significantly reduce costs of health care delivery, maybe we should have an honest discussion of the costs of these "performance measures."

-Wes

It's Official: Guidelines for Care Are Now Mandates for Care

Want a pacemaker or defibrillator on your dying UnitedHealthcare patient with complete heart block? Sorry, in many states you must first ask permission from the insurer beginning 1 July 2010:

UnitedHealthcare claims this protocol is not a pre-certification, pre-authorization program or medical necessity determination. A notification number must be obtained in accordance with the Cardiology Notification process prior to perform EP implant procedures. Failure to complete the notification process will result in an administrative denial. All procedures require notification regardless if they are elective or emergent. (Emphasis mine)

Prior notification may be obtained online, by telephone or fax:

■Online: UnitedHealthcareOnline.com (User ID and password are required)
■Telephone: +1 (866) 889-8054
■Fax: 1 (866) 889-8061

Cardiology Notification process? WTF? Where, exactly, do we place this "notification number" in patient patient's chart? In their operative report?

I can see it now as P waves are dancing across the screen:

"Hold on there, Ms. Smith! Just trying to place this temporary pacing wire... Um, give me a minute, okay.... Uh, which insurance do you have?.... er, please ma'am, don't talk right now - I might hit your lung.... It wouldn't be Unitedhealthcare, would it? Wait, don't talk.... okay, which one? Yes? Does anyone have UnitedHealthcare's Cardiology Pay-to-Play number???..."

"Okay, Ms. Smith... Ms. Smith????... Ms. Smith???...."

(gurgling noises hard in background)

And will the service will be 24/7/365?

Of course not!

If notification is required on an emergent basis or notification cannot be obtained because it is outside of UnitedHealthcare’s normal business hours, the service may be performed, and notification can be requested retrospectively. Retrospective Notification requests must be made within 14 calendar days of the service. Rendering physicians should follow the same notification process outlined for a standard request. Documentation must include an explanation as to why the procedure was required on an emergent basis or why notification could not be obtained during UnitedHealthcare’s normal business hours. If a claim is submitted prior to the Retrospective Notification Process being completed, it will receive an automated denial for lack of notification; however, the claim will be reprocessed if Retrospective Notification is received within 14 calendar days of the date of service, and it meets criteria as an emergent procedure.

Just think how many hours upon hours of doctors' time will now be spent holding online waiting for a college dropout to tell us our notification number!

Damn, what a waste of resources.

This is our "guidelines" for care are now mandates for patient care and will be used against us in our new era of health care reform.

Deviate from them and your patient will pay...

... and pay dearly.

-Wes

Addendum: Dr. John Mandrola, another EP, shares a similar story, even before these new mandates go into effect.

Screen Hearts, Not Boobs

The recently-released USPSTF guidelines changed the recommendations to start mammogram screening for breast cancer in women from age 40 to age 50 based on extensive review of the costs, risks and benefits. As a result, when spun as “women’s care under siege,” the recommendation has become a potent political weapon.

Ironically in Texas, a new law was just enacted that requires insurers to pay up to $200 to screen for coronary artery disease based on controversial "entrepreneurial guidelines" proposed by SHAPE, a group of cardiologists that includes the entrepreneurs themselves.

So there you have it: how politics does preventative medicine...

... completely anatomically, of course.

-Wes

h/t: Kevin, MD

The Rationer

Every cardiac electrophysiologist has been there: a relatively young individual in their 50’s presents to the Emergency Room short of breath, sitting bolt upright in bed and is found to be in congestive heart failure. This is not their first admission; several others have come before and each with a common theme: a positive urinary screen for cocaine.

The EKG shows left bundle branch block. Catheterizations occur, coronary disease absent or moderate, discussions held, patient recommended for defibrillator or biventricular pacing to improve their heart failure after medications have been ineffective for the past year. The person seems sincere – “No more drugs, doc, really” – a line uttered near the conclusion of every one of the patient’s prior hospitalizations, but this time, really, they mean it.

I wrestle with the ethics of the management of these patients every time I’m called to see them. Our guidelines state that ejection fractions of 15% should be treated with defibrillators, especially if no improvement on adequate, aggressive medical therapy. Our guidelines also say that patients with significant social or psychological disease that precludes careful follow-up of their device should not get a defibrillator. Outside the room the decision seems obvious; inside the room after a glance at the eyes of the desperate its another thing entirely - the suffocating feeling of heart failure having taken its toll. The family, at the patient's side, is concerned and wants to help, wondering if there’s anything that can be done.

Will the patient really quit using cocaine? My father’s voice whispers in my head: “What a person has done is an indication of what they will do.” Our business manager wonders why our volumes have slipped recently. What if they die shortly after leaving the hospital suddenly?

No matter what I decide, I will fail it seems. Is the patient sincere or playing me the fool? Can I tell? Put in the defibrillator or pacemaker perhaps it will help. But if I have guessed wrong, then resources are wasted and the patient is exposed to another risk, like infection. Don’t put in the defibrillator and I revoke a lifeline or effective therapy.

On the surface, these decisions should be easy. In reality, they are anything but.

-Wes

Guidelines: Our New Health Care Derivatives Market?

I didn’t attend the American College of Cardiology meeting in Orlando, FL this year, mainly because I am concerned about my ability to pay for my son’s college. I do not quality for financial assistance for his tuition so I cannot afford the luxury of attending every cardiovascular meeting each year right now.

I’m sure many Americans feel the same way, particularly those who have seen their retirement savings evaporate in current economic mess we’re in. People are angry, frustrated, and dumbfounded that our political and financial leadership failed to realize the consequence of their actions when they permitted banks to lend more than they had assets to cover. I mean, who knew, right?

But back in the not-so-distant “glory days” of banking, it was all about “OPM:” other people’s money. You know: using other people’s money to buy a house. Using other people’s money to leverage a shopping center. Using other people’s money to buy some risky asset and sell it to another person so you could all reap some profit. OPM was the financial way to get ahead at almost no downside risk to you. What was not to like? If things went bad, well, it was other people’s money!

And now, in retrospect, we see it for what it was: a time of overindulgence; a time of greed…

… all on the backs of OPM.

Health care is kind of like that, unfortunately. We use OPM all the time when we pay for expensive treatments and procedures and don’t have a clue what it costs. Now, though, we get ridiculously inflated prices sent to us on our “Explanation of Benefits” from our insurer and are all too relieved, yes, relieved I tell you, that OPM has picked up so much of the tab for our health care.

That is, until the OPM goes away and we’re stuck paying the inflated price. Then we’re pissed. And maybe even bankrupt because, unlike the federal government, you and I can’t just print money. It doesn’t work that way. As the old Smith Barney commercial used to say in their thick British accent, “We have to earn it.”

So it was with some amazement and plenty of dismay that I read the very recently-released ”focused” 2009 Heart Failure Guidelines, guidelines that form the cornerstone of the American College of Cardiology and American Heart Association’s Hospital to Home (“H2H” as they call it) initiative to “reduce hospital heart failure re-admissions 20% by 2012.”

It’s a noble initiative, funded by OPM, to demonstrate our cardiology societies deep commitment to help President Barack Obama reduce health care costs.

But like most things with OPM, the details of the cost savings afforded by this initiative are quite vague: especially when the new guidelines include expensive medical devices to be used as therapy now, when in earlier guidelines, there were none.

Not to say that these devices may not have been shown to improve symptoms and longevity in heart failure. They certainly have. And to that extent, these guidelines are exceptional because they put the patient’s health first.

But at what cost?

When we use OPM, we don’t care about cost. OPM will pay for our guidelines’ implementation. Look how we’re helping our patients live longer! OPM will pay for the electronic medical record that will screen the chart for the patient’s ejection fraction and make sure the patient gets the proper test and therapy that is recommended by the guidelines. After all, our goal is to reduce heart failure readmissions by 20% in 2012! No need to worry what it will cost! What’s the risk? Hey, it’s OPM!

And unfortunately, just like the banking fiasco, this OPM will some day run out. The pot of gold is not limitless, but there are few doctors admitting this. We can’t. We are bound by ethics to preserve life that are in direct conflict with our duty to help our patients remain fiscally solvent.

And yet, with our children’s health care and our national economy on the brink, I wonder if we’re not being ethical to our future generations’ patients by not asking these tough questions right now.

-Wes

More Alphabet Soup

"ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging"

I could not make those initials up. This was the title of the recently published paper in the Journal of the American College of Cardiology from the writing committee organized to develop clinical data standards for cardiac imaging.

Translation:
ACC = American College of Cardiology
AHA = American Heart Association
ACR = American College of Radiology
ASE = American Society of Echocardiography
ASNC = American Society of Nuclear Cardiology
HRS = Heart Rhythm Society
NASCI = North American Society for Cardiovascular Imaging
RSNA = Radiological Society of North America
SAIP = Society for Atherosclerosis Imaging and Prevention
SCAI = Society for Cardiovascular Angiography and Interventions
SCCT = Society of Cardiovascular Computed Tomography
SCMR = Society for Cardiovascular Magnetic Resonance
SIR = Society of Intervential Radiology

Wow, that's a tour-de-force of cardiac imaging specialists.* These are smart men and women who understand how the Medicare payment game is paid played. They understand that data, lots and lots of data, in fact, so much data that your head will spin, is the way to assure Medicare payment. In short: gather lots and lots of data, any way you can, to assure the folks on the Hill that you are really serious about showing the cost effectiveness of all of this testing:

The ACC and AHA recognize the importance of the use of clinical data standards for patient management, to assess outcomes, and conduct research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality improvement initiatives. Hence, clinical data standards strive to define and standardize data relevant to clinical topics in cardiology, with the primary goal of assisting data collection by providing a platform of data elements and definitions applicable to various conditions. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across studies and assess the applicability of research to clinical practice. The growing adoption of electronic medical records renders an even more imperative and urgent need for such definitions and standards. Therefore, the ACC and AHA have undertaken the task of defining and disseminating clinical data standards—sets of standardized data elements and corresponding definitions to collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary for accomplishing the ACC/AHA’s mission of fostering optimal cardiovascular care and disease prevention.

On the surface, these efforts seem like the best way to begin to get a handle on the cost-effectiveness of cardiac testing. No doubt the shear volume of data generated will be heretofore unmatched and a rich source of research grants for academe for years to come.

But tied to each of these data element sets created for every cardiac imaging test, is the requirement to include as an "administrative" data element the patient's insurance information. The writing group explains this data-element necessity as a means to "foster optimal cardiovascular care and disease prevention" because:

The insurance payer element was included to be certain that patients of all payer status were included in studies equitably, especially those funded federally (ed: emphasis mine). The inclusion of this data was not to in any way suggest that cardiac imaging patients should be screened on the basis of ability to pay.

Yep, it's all to justify to the Medicare National Bank that, yes sir, we really DID need this test. While the test might be ordered irrespective of the ability of the patient to pay as the writing committee suggests, for the first time we will be granting insurers direct automated line-item access to clinical information and the test results. The implications of this are concerning.

Imagine, line item data on your renal function, ejection fraction, stress test results, cardiac risk factor analysis - all instantly available to an insurance company's computer database and conveniently entered unwittingly by the echocardiography clerical staff in the hospital of your choice. Imagine the next time you then go to purchase insurance. Best of luck to you.

Or imagine you are a doctor without an electronic medical record and ordering system - best of luck to you as you complete the test-request form that will soon look more formidable than the MCAT bubble answer sheet used to qualify for medical school. Remember to use a number 2 pencil.

Or consider if a clerical error is made during data entry: what recourse will you have? Will you have the option of editing the data entered to assure insurer payment for the test they claim was not appropriate because four data fields were left blank? "Sorry Mr. Jones, on the basis of a creatinine of 1.6, and four empty data fields on the ordering questionnaire, this test should not have been ordered, so * b-o-o-i-i-n-n-g-g *, we're not going to pay for that test after all."

But in this era of "evidenced-based medicine," these convoluted, complicated, and thoughtfully-produced-but-arbitrary data forms (Note: 20 pages were devoted in the article just for the medical history fields alone. And what is an "equivocal" test anyway?) are being feverishly developed by these cardiac imaging societies. They must justify continued testing and Medicare payments on the basis of a promise of future as-yet-undeveloped studies based on retrospective utilization data completed by the non-medical clerks at the time of test ordering. And thanks to hoards of well-meaning academics that are eager to secure more grant funding, this same dubious retrospective data will soon serve as paradigms upon which our treatment and further testing "guidelines" will be based.

But retrospective data collection like this is far easier and less expensive to gather rather than a prospective, randomized trial. Who needs those?

Heck, I guess I should stop complaining.

After all, I am a cardiologist.

-Wes

* The conflicts of interest of the authors of this document warrant notice. They are not insignificant - so much so that the article reviewers conflicts were also disclosed as an appendix to reassure a more "non-biased" critical review of paper occurred.

Reference:

"ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging." J Am Coll Cardiol, 2009; 53:91-124, doi:10.1016/j.jacc.2008.09.006 (Published online 8 December 2008).

Pharmaceutical Overreaching?

I stand in awe.

Despite admitting "not 'a whole lot' of data on pediatric use of cholesterol-lowering drugs, recent research showed that the drugs were generally safe for children" and that "average total cholesterol levels as well as LDL and HDL cholesterol have remained stable, while triglyceride levels have dropped, based on data collected from 1988 to 2000" it seems we have an "epidemic" of hypercholesterolemia that now requires drug therapy:

The nation’s pediatricians are recommending wider cholesterol screening for children and more aggressive use of cholesterol-lowering drugs starting as early as the age of 8 in hopes of preventing adult heart problems.

The new guidelines were to be issued by the American Academy of Pediatrics on Monday.

I can see it now: a young, overweight teenager with a family history of heart disease is placed on a statin drug. She later becomes pregnant.

Oops.

Given the unknown implications of statins in pregnancy, one wonders if we should know more before promulgating such far-reaching recommendations.

-Wes

For a more detailed review, please see Sandy Szwarc's recent excellent review following similar recommendations that emanated from the American Heart Association.

Addendum 8 Jul 2008: Statins for kids: the New York Times reconsiders.