Category Archives: Electrophysiology

Update on EP Mobile and Apple #2

As some of you are aware, the Apple App Store rejected an update to the EP Mobile app based on the presence of drug dose calculators in the app. The App Store guidelines state:

22.9 - Apps that calculate medicinal dosages must be submitted by the manufacturer of those medications or recognized institutions such as hospitals, insurance companies, and universities

For those who want more background on this issue, see these two previous posts (here and here).

I have decided to go ahead and remove the drug calculators from the app. All the drug calculator code remains in the app and, should Apple ever change their mind(s) on this policy, it will only require changing this single line of code to get them back.

// Sigh!
#define ALLOW_DRUG_CALCULATORS NO

I toyed with putting a backdoor into the app to activate the drug calculators, but I realize if I do something like that it would be my last Apple app. I have modified the app to make up for the loss of the drug calculators, and I think that with these changes you will continue to be satisfied by the app.

Here are the changes.

The creatinine clearance calculator had been embedded in the drug calculators, so it has been promoted to its own discrete module (which is something I should have done anyway a long time ago.

EP Mobile Main Menu Drug calculators gone, creatinine clearance calculator added
EP Mobile Main Menu
drug calculators gone, creatinine clearance calculator added

Instead of the drug calculators, there is a drug reference section. Each of the drugs that formerly had calculators now has detailed dosing information, as well as other useful information, akin to what you find in the Medscape app. (An aside: I think drug dosage information as opposed to drug dose calculators is acceptable to Apple, as it is present in Medscape and other medical apps. Medscape does not meet the Apple criteria mentioned above any more than EP Studios does: it is not “the manufacturer of those medications or [a] recognized institution […] such as hospitals, insurance companies, and universities.”).

Two new modules: Right Ventricular Hypertrophy and Drug Reference
Two new modules: Right Ventricular Hypertrophy and Drug Reference

What makes the drug reference section more useful than the similar information in Medscape is that there is a toolbar at the bottom of the screen that allows you to calculate a creatinine clearance on the fly, and then retains that information while you are trying to figure out the appropriate drug dose. Thus the only calculation done is the creatinine clearance; the physician and not the app decides of the dose. In many ways this is superior than having a drug dose calculator, because more information is presented that may be useful to help decide on the proper dose.  The drug reference section can also be expanded in the future to include information on other EP related drugs that don’t necessary require any calculations to dose, such as amiodarone or ibutilide.

A portion of the drug reference for dofetilide. Note the detailed dosing information and the Creatinine Clearance toolbar at the bottom showing the last calculated CrCl.

 

Finally the D’Avila WPW algorithm has been added, as well as a module on diagnosing right ventricular hypertrophy. I have left in the Warfarin Clinic module too. This module was not called out by Apple on the last review, so we shall leave it alone for now.

I will submit the update to Apple in the next 24 hours. Their review process usually takes about a week. If the approve it, I will not release the update right away, but will give some advance notice on Twitter. If you really can’t live without the drug calculators, then you should turn off auto-update and not update the app. I think though that the drug reference section with the built-in creatinine clearance calculator more than makes up for the loss of the drug calculators, and I encourage you to update the app when it is available.

If you happen to be best buds with Tim Cook, let him know that rule 22.9 is stupid and should be sacked.

Update on EP Mobile and Apple

This is an update on my previous post which dealt with Apple’s rejection of an update to the EP Mobile app because it contained drug dose calculators. According to a clause buried in the App Store Review Guidelines (section 22.9, to be precise),

22.9 apps that calculate medicinal dosages must be submitted by the manufacturer of those medications or recognized institutions such as hospitals, insurance companies, and universities.

EP Mobile has included such dosage calculators from its very first version, but for some reason the current update (which just added the D’Avila algorithm [PACE 1995;8:1615-1627] for determining accessory pathway location) triggered the discovery that the app was in violation of this rule. I was unaware of this rule, and I don’t think the rule was extant when I submitted the first iOS version of the app in 2012.

I submitted an appeal to Apple stating that as physicians have to calculate drug doses every day there does not seem to be any reason a physician-programmer should not be permitted to write an app to calculate drug doses. A drug company could only produce an app for their specific drug, so they could not duplicate the functionality of having multiple drugs from different companies in one app. I don’t see any incentive for a hospital, insurance company, or university to develop this kind of app, though I suppose it is possible they could. As a physician I developed the app because it was useful in my daily work. It makes figuring out drug doses for certain anti-arrhythmic drugs or anticoagulants much easier. As far as I know that specific functionality is not duplicated in the App Store.

Apixaban Dose Calculator
Apixaban Dose Calculator

Apple stuck to their guns and maintained the app update could not be approved. On Twitter a colleague tweeted this article from iMedicalApps of June 2013 which discusses the problems that Apple has with drug dosage apps. Apple is probably concerned about the FDA’s potential scrutiny of medical apps and possible legal liability for drug dose calculators that could give erroneous information. In any case this article points out that the Medscape app also provides drug dosing information (though only as written information, not as a calculator — I’m not certain, but it appears that the App Store Review Guidelines may have changed from banning dosing information altogether to just banning dose calculators). Medscape is owned by a private company (WebMD) and is neither drug company, hospital, insurance company nor university.

Medscape iPhone app provides drug dose information
Medscape iPhone app provides drug dose information

If the Medscape model for presenting drug dose information is legitimate in Apple’s eyes (as opposed to a violation that just hasn’t been noticed yet), it would be possible to retool my app to provide a creatinine clearance calculator followed by the specific dosing information for each drug. This is not as slick as having the answer just pop up in a dialog box, but on the other hand does show exactly what the dosing criteria are and removes the computer from the decision making process. However if I go that route there is no way to save one of my favorite parts of the app, the warfarin dose calculator. It is an implementation of an algorithm from this paper and provides suggested dosing changes for patients on chronic warfarin based on their INR, INR target, weekly total dose, and tablet size. It suggests how many pills the patient should take each day of the week. Whoever makes generic warfarin is not likely to develop a warfarin dose calculator like this, nor is anyone else.

iOS Simulator Screen Shot Feb 20, 2015, 7.50.40 PMiOS Simulator Screen Shot Feb 20, 2015, 7.50.23 PM

At this point I have requested further information from Apple. Apple has rejected the update to EP Mobile, but they have not requested I withdraw the current version of the program (which still has all the drug calculators in it). Certainly they might do so. In the hopes that their position will change, I have decided to withdraw the update and leave the app as is, unless Apple tells me otherwise. This is not a good long term strategy as I like to update the app frequently to keep it up to date with what is going on in electrophysiology, and I am now blocked from making any updates that don’t remove the drug calculator functionality. If I do release an update that does not contain the drug calculators, I will announce it well ahead of time on Twitter and on this site to give users the option not to update the app. I should also point out that the Android version of the app has not been challenged (Android is very hands off compared with Apple).

I am hoping that Apple will consider this further, based on this section of their App Store Review Guidelines:

This is a living document, and new Apps presenting new questions may result in new rules at any time. Perhaps your App will trigger this.

Who Can Write a Drug Dosage Calculator?

Several years ago I had an idea for a smartphone app that could be used to calculate doses for drugs that are prescribed frequently to patients with heart rhythm problems. These drugs include antiarrhythmics such as dofetilide and sotalol, and the new oral anticoagulants such as dabigatran and rivaroxaban. These drugs are handled by the kidneys, and dosage is dependent on kidney function. The package inserts for these drugs advise the correct drug doses based on the calculated creatinine clearance, a formula that involves the patient’s weight, age, sex and serum creatinine. Once the creatinine clearance is calculated, a lookup table is used to determine the dose. For example, here is the rivaroxaban dosing information:

xarelto

Medical calculator apps are common and invariably include a creatinine clearance calculator. The problem I had was trying to remember all the different creatinine clearance cutoffs for each dose of each drug. This seemed like perfect job for an app. Just fill in the information needed to calculate the creatinine clearance and have the app figure out the creatinine clearance and look up the dose. Thus my app EP Mobile was born. Over the years I have added many more modules to the app, including everything from algorithms localizing accessory pathways to entrainment mapping, but the original concept was to provide the drug dose calculators which remain a key part of the app.

Or maybe not. I routinely update the app, and submitted an update a week ago to Apple (not related to the drug dose calculators). For the first time ever I received a rejection from Apple. They quoted this from their App Store Submission Guidelines:

22.9 Apps that calculate medicinal dosages must be submitted by the manufacturer of those medications or recognized institutions such as hospitals, insurance companies, and universities

Attached were screenshots of the offending calculators:

A drug dose calculator
A drug dose calculator

I am a physician. Part of my job is to calculate medicinal dosages, as the legalese above terms it. This is not the job of hospitals, insurance companies, or universities. Ultimately I as a physician am legally responsible for calculating correct dosages. Yet somehow physicians are left off the list of those qualified to submit apps that calculate drug dosages. The development of an app that simply does what the drug package insert instructs the physician to do in order to calculate a drug dosage, but in an easier manner, should not be restricted to drug companies, hospitals, insurance companies (insurance companies?) or universities. The few of us physicians who are also app developers are certainly in as good a position as any of these other parties to develop apps like this. The algorithms to calculate these doses are extremely simple.  As my app is open-source, the source code is freely available for anyone to inspect to make sure the calculations are coded properly.

I appealed this decision to Apple and I hope they reconsider. I doubt they will. I see the handiwork of Apple’s legal department here. Don’t trust physicians to figure out what tools are useful on their own. Far better to let them go back to carrying around a bunch of drug company propaganda plastic rulers and let them do those creatinine clearance calculations by hand, using long division. Just like back in the good old days.

How Much Money Do Academic Experts Get From Drug and Device Companies?

Screen Shot 2014-10-09 at 9.50.04 AMNow that Open Payments data is available to the public I decided to do some snooping around.  It’s not hard to do.  I was curious as to how much drug and device company money academic experts receive.  As a cardiologist specializing in electrophysiology I have been to many national meetings, and it is always the same people year after year who chair the sessions, are on the policy committees, and write the guidelines.  If you are an electrophysiologist you know whom I am talking about.  I suppose every specialty has its own cadre of experts: the 1% who set the agenda for the rest of the us.  The big names in our respective fields.

So I picked 3 names at random and downloaded their Open Payments data.  Keep in mind that there are only 6 months of payment data available, and a third or more of the data has been withheld including most of the research payments.  I only included data from the general payments database and excluded the research payments.  I just picked the first 3 names that popped into my head, and won’t identify who these doctors are.  My intent isn’t to embarrass anyone.  They are all well known and meet the criteria for being an expert given above.

Expert A had 91 payments made over 6 months totaling $58,101.  Most of the payments were from Medtronic and Boston Scientific.  The majority of payments were listed under the categories of Food and Beverage or Travel and Lodging, but the larger payments were for Consulting Fees or speakers fees.  The largest individual payment though was for travel, at just over $6000 from Medtronic.

Expert B had fewer payments (34) but a larger total.  Over 6 months this expert was paid $112,115.  The majority of payments were by Medtronic, with individual payments as high as $24,500.  The description for one of these large payments was “Compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program.”

Screen Shot 2014-10-09 at 9.45.58 AM
A sample from Expert B

Expert C had absolutely no entries in the database.  Zero.  Good for him!  Or should we wait until the full dataset is released before coming to conclusions?

In this extremely unscientific sampling of 3 experts, compensation from drug and device companies ranged from zero to 6 digits in 6 months.  Certainly one shouldn’t draw any firm conclusions from this.  Nevertheless, the fact that money changes hands between drug and device companies and the experts who help write guidelines and lecture about these drugs and devices is concerning.  Actual dollar amounts seem more stark and disconcerting than bland statements like Doctor X serves as a consultant for Company Y. Perhaps the Open Payments dollar amounts should be added to the disclosure slides that are shown at national meetings.  A more thorough look at this data is warranted.

What Motivates Doctors?

As a recently retired physician, I still maintain an interest in medical research, though I have to ask myself: Why? Surely not just from the point of view of a potential future patient. But not from the point of view of a practicing physician either. Perhaps I keep up just from a lifetime of habit?  Or is there something I miss about my old job?

These thoughts came to mind as I was reading some of the reports from the European Society of Cardiology meeting in Barcelona, Spain last week, in particular the results of the PARADIGM-HF trial in which a new, so far not brand-named drug, LCZ696, out-performed traditional ACE inhibition in patients with heart failure, and, in my own field of electrophysiology, the results of the STAR AF 2 study  which imply that a more limited is better than a more aggressive approach in ablation of persistent atrial fibrillation. I read these reports with a combination of excitement, my usual dose of skepticism, and perhaps a tinge of regret that, while the science of medicine advances inexorably, my own participation in this process ended as of December 31st, 2013, the day when I performed my last catheter ablation procedure for atrial fibrillation. Yes it seems odd that I was performing procedures one day and then retiring on the next, but that’s the way it was. At least I wasn’t on call my last night. And although I have written that doctors shouldn’t hesitate to retire when they are ready, sometimes I do look at my still-practicing colleagues with a bit of envy, feeling I am missing out on some of the fun of being a doctor.

Doctors just starting their medical careers, residents, fellows or newly appointed attendings, can easily get discouraged reading many of the online posts and comments from older doctors — including my own. There is a lot of negativity in these posts. We read about increasing work loads, decreasing salaries, competition from associated professionals, unmanageable electronic health record systems, terrible on-call nights, malpractice suits, loss of respect for the profession, Obamacare — the list goes on. It is probably tougher to be a doctor today than it ever has been. As my own career progressed, I had more and more of a feeling that I was swimming upstream against an opposing current of non-medical administrative, regulatory sewage. I found it easier to retire at a relatively early age (62) rather than continue the struggle. It wasn’t a brave decision, nor is it a practical decision for younger physicians, in particular those new physicians just out of medical school saddled with enormous debt. To those physicians, I would like to sound a note of optimism (which unfortunately might be drowned out in the comments section to this post).

Everyone who goes into medicine knows it is going to be hard. This was as true back when I started my internship as it is now. But there are rewards in medicine, and they still exist. I’m not talking about the traditional rewards of past years: financial success, stature in the community, pride in taking part in an old and honorable profession. Unfortunately much of this has evaporated in recent years. Nor am I talking about the occasional uplifting story whereby a patient heeds your exhortations to stop smoking and comes back years later to thank you for changing his life — as wonderful as such stories can be. No, I am talking about another aspect that is not frequently mentioned: the challenge of medicine.  Medicine is a battle against disease.  We doctors are on the front lines of this battle, and we are winning.

The challenge was there in every patient with atrial fibrillation, in every patient with ventricular tachycardia, in every patient with supraventricular tachycardia. These diagnoses were relevant to my field, but I’m sure that similar challenges exist in each specialty of medicine, and in general internal medicine as well. To me each diagnosis was a challenge, and the battle was fought using the weapons I had at hand: the ablation catheter, the pacemaker or implantable defibrillator, antiarrhythmic drugs, or simply persuasion, attempting to alter self-destructive life styles. It was immensely satisfying to ablate a pathway and control a life-threatening arrhythmia. But just as in the Wide Wide World of Sports, there was both the thrill of victory and the agony of defeat. Failures, especially complications, which, if you do enough procedures, statistically have to occur, always disproportionately tempered the successes, even though the latter were thankfully much more the norm. Such is human nature. But I think that which motivated me the most during my medical career was the wonderful adrenaline surge that came from ablating a tough atrial tachycardia or other arrhythmia. This is the sort of thing that motivates doctors despite all the other nonsense that we face. This is what keeps us going, or it least it was in my case.

And I sort of miss it.

Let the Sunshine In

sunshine_actYesterday I received an email from Medtronic. It was an early release version of the Sunshine Act data that they had sent to the government. The Sunshine Act, passed in 2010 but implemented in 2013, demands the collection and publication of data on payments to physicians in the form of food, travel, or other goods. This data will be made available online to the public in September of this year. Medtronic, a major manufacturer of pacemakers and implantable defibrillators, was nice enough to release to me the data on the money that they had spent on me. Below is a copy of the report.

Mann_III__David_E LN4CVKS

Perhaps a foreshadowing of what could go wrong with such a database, there is a $90.38 charge to Nancy’s Haute Affairs (I looked it up.  It is a restaurant, not an escort service) in Pensacola, Florida.  But I’ve never been to Pensacola in my life. So this charge is wrong. The rest of it appears to be lunch and breakfast stuff the Medtronic reps thoughtfully provided to our office, or to the break room at the various cath labs I worked at. In looking at these charges, it is important to remember that I did not ask Medtronic to go out and order some Panera. Medtronic brought it in, and once it’s there it is difficult to resist snatching a bagel, even though each bagel snatched results in another database entry under the Sunshine Act.  Given the natural tendency of hungry doctors (I almost never ate lunch at work) to partake of “free” food lying around, I think the more interesting question is not how much did each doctor consume, but rather, how much did a company such as Medtronic spend on doctors in an attempt to curry favor. I’m not sure if the Sunshine Act involves publication of that data, but it should.

There is no doubt that drug and device companies do try to target doctors in order to increase sales of their products, and money going from these companies to doctors is the major means of influence.  Doctors sign up to be on speaking panels for drug or device companies, even though they are not particularly expert on the specific drugs or devices they are talking about.  They receive a professional set of slides from the company and a nice stipend.  Other docs, particularly those in academic medicine, serve on advisory boards for companies, again resulting in a nice stipend as well as travel and lodging to exotic parts of the world.  Although there is a difference between the appearance of a conflict of interest and an actual conflict of interest, perhaps this distinction will appear a bit too fine when the actual dollar amounts these doctors receive are published.  The question becomes: how much money received is too much?  Any amount at all? More than $1000? More than $10,000? Arguments on what’s reasonable aside, there’s no doubt that some doctors are susceptible to this kind of influence, and others will just take the bagel and ignore where it came from.

When I was practicing as an electrophysiologist I felt I was in the latter category. The last thing I thought about when deciding what kind of device to put in was where my last bagel came from. My colleagues in electrophysiology I feel were similarly immune to this kind of influence. I can’t say the same about all my referring physicians.  Most didn’t care what brand device I put in, but there were some exceptions.  Some would call me with a referral of a patient who needed a pacemaker or implantable defibrillator and at the end of the presentation would close by saying: “and please put in a [insert specific brand name here] device.” Yes the device companies wine and dine the referring physicians who don’t actually put in the device, in order for them to pressure the implanting physician to use their specific devices. Admittedly some of these non-implanting referring physicians do device follow-up in their office, which usually involves a rep from the company actually coming to the office and doing the device interrogations (see my earlier post on this topic). These referring doctors will say they have a preference to follow a certain brand of device, which usually means they get along well with the particular rep from that company who comes to their office and does their work for them.  I always found this practice particularly annoying. I as the implanting physician should decide what device to put in, based on my judgment on what’s the best device for the patient. I’m sure the referring physician would not like it if I told him or her what brand stent to put in my patient.

So it would be naive to deny that there is any influence peddling going on between drug and device companies and physicians. Sure it probably pales in comparison to what goes on between lobbyists and politicians in Washington, but don’t hold your breath for Congress to shine the sunlight on their own activities. And based on the preliminary report I received, I’m sure there are going to be a lot of unhappy physicians when the final reports are released to the public in September.

 

Futurama Revisited

GM Futurama exhibit 1964 New York World's Fair
GM Futurama exhibit 1964 New York World’s Fair

Fifty years ago my parents took me to the World’s Fair in New York. The year was 1964. I was twelve years old. It was a turbulent time in American history. The prior fall John F. Kennedy had been assassinated, initiating a long period of turmoil for the United States.  But it was still the era of America’s post-war technological greatness. The country was gearing up to fulfill Kennedy’s vision of a manned flight to the moon before the end of the decade. Products were still made in America, and we used the phrase “made in Japan” as a joke to mean something cheap and junky. People had savings accounts, and there were no credit cards. At the same time, racial discrimination and segregation were widespread. There was cringe-worthy sexism present, as anyone can tell by watching movies or TV shows from that era. There was no Medicare. US poverty levels were at an all time high. Lyndon Johnson and Congress went on to address some of these issues with the Civil Rights Act and the Social Security Act of 1965 which created Medicare and Medicaid. Johnson declared the War on Poverty in 1964 and poverty levels did fall. At the same time an undeclared war in southeast Asia was to cast a large shadow over his legacy and over the lives of boys turning 18 through the next decade.

Nevertheless it was a beautiful warm summer day when we visited the Fair. I remember the day well. Having devoured the Tom Swift, Jr. books and then science fiction of the 3 grandmasters, Asimov, Clarke, and Heinlein, I was filled with boundless optimism about the future of technology. The Fair was crowded with Americans that didn’t look much like Americans of today.  Neatly dressed.  Thin.  I was old enough to notice the pretty teenage girls who were just a few years older than I, working summer jobs at the fair. I remember riding up the elevator in one of the saucer-like observation towers (you know them, they play a prominent role in the movie “Men in Black”) and shyly eying the cute girl seated on a stool operating the elevator controls. Yes, for you younger readers, elevators used to be manually operated. The fair made a lot of predictions, but I don’t think automatic elevators was one of them.

The General Motors pavilion was aptly named Futurama. There is a YouTube video showing what it was like. I waited expectantly in the heat in a long line that stretched around the rectangular concrete windowless building. Inside we sat on cushioned chairs that automatically moved through the exhibit. There were vistas of a technologically rich future. Spacecraft exploring the moon. Scientists controlling the weather from a station in Antarctica. And in the environmentally naive outlook of that era, large machines cutting down rain forests to build roads to deliver “goods and prosperity.”

This exhibit was a highlight of the fair. Afterwards we went to the General Electric pavilion where we witnessed a demonstration of nuclear fusion (was it real? I honestly don’t know, and the Internet is vague about it). There was a loud bang and a bright light.  All very impressive, especially at my young age.

There have been a number of recent articles (e.g.  here, here, and here)  about the Fair and about which predictions it got right and which were wrong. Curiously there weren’t any predictions about medical science that I remember. Maybe I wasn’t paying attention. I think I wanted to be an astronaut back then. Pacemakers were brand new and digitalis and quinidine were staples for treatment of abnormal heart rhythms. The huge advances in medicine that were to come between now and then could not even be imagined.

I remember there was some stuff about computers, but at the time a single computer with less memory and processing power than that in my cell phone filled a large room. And yet it’s amazing that level of computing power was able to get us to the moon. The thought that everyone would carry their own personal computer/communicator in their pocket was pretty far-fetched. A few years later in Star Trek Captain Kirk would use something that looked like a flip-phone, but gosh, no capacitive touch screen! It did have a neat ring tone however.

The networking together of the world’s computers (aka the Internet) was certainly not predicted. Having the knowledge of the world a few mouse clicks away is probably the most significant advance of the last 20 years or so. It has altered our lives, I believe mostly for the good (except when I read YouTube comments), in a fashion unimaginable 50 years ago. I’m disappointed that the exploration of space didn’t turn out as predicted. Where are our moon colonies, or our base on Mars? But I’m happy with the way the Information Age has turned out, and I wouldn’t trade my ability to spend an evening browsing Gigliola Cinquetti videos on YouTube for anything.

The social changes that have occurred since then have been significant and generally for the good. Communism has been marginalized and the threat of nuclear war diminished. Religious fundamentalism remains a thorn in the side of humanity, as it has always been. Certainly there is still sexism and racism and we have further to go in correcting social injustice. But if I had told my dad back in the 60s that the United States would elect a black president, I’m sure he would have said something like “That’ll be the day!”

The Rent is Too Damn High. Why Does Medical Software Cost So Much?

In an era when Apple gives away its Mavericks OS X operating system for free, when completely free open-source operating systems like Linux and BSD are available, when even Microsoft is considering giving away its Windows operating system for free, one has to ask the question, why is medical software, in particular EHR (Electronic Health Records) systems, so expensive?  The software industry appears to be headed towards a business model of low-cost or free software, with profits generated in other ways.  Linux distributions (“distros”) sell the Linux operating system at no or minimal cost, but generate profits by providing support services.  Apple gives away its software but profits from hardware sales.  Google gives away its software in exchange for advertising revenues.  Of course not all software is free.  Oracle still charges an arm and a leg for its database systems, but viable open-source alternatives such as Postgre, MySql exist.  Many companies have moved to these lower-cost or free alternatives due to this cost.  But even the cost of enterprise software like Oracle pales in comparison to the cost of EHR systems.

Case in point, Epic System’s EPIC EHR.  The costs of this system can only be described as astronomical.  Duke paid $700 million for their system, while UCSF managed a bargain-basement price of $120 million (see this Forbes article).  And what do you get for this price?  As a former user, I am not in the minority in my opinion that EPIC sucks.  The problem is, the other EHR systems suck worse.  EPIC is replete with useless mouse clicking to satisfy bureaucratic ideas of what doctors need to document.  It is the epitome of software written with a total disregard for the end-user.  It is difficult to go into more specifics.  Epic Systems is touchy about their software.  I know from personal experience that EPIC employs full-time staff whose sole responsibility is to scan the Internet for EPIC screenshots and have them removed.  Isn’t it remarkable to spend $700 million and not even get a screenshot to look at?

Medicine is big business, so it attracts the big business types.  I remember a simpler time.  Back in the 1980s, prior to the advent of electrophysiology recording software (like the GE Cardiolab system), I wrote some software (in Turbo Pascal — oh the nostalgia!) that used a graphics tablet to enter measurements such as A1A2 vs A2H2 intervals into an Apple II or IBM PC computer.  The software constructed tables of intervals and graphs, and could calculate such now-a-days neglected functions as the anterograde functional refractory period of an accessory pathway.  Today we don’t measure this value, we destroy it using radiofrequency ablation, but in those days of yore when we were trying to figure out why our patients placed on class I antiarrhythmic drugs for PVCs were dying suddenly, figuring out the effects of these drugs on the electrophysiology of the heart was important.  The software I wrote helped ease the pain of doing these repetitive measurements for the poor EP fellows who were wearing out their calipers otherwise, and they at least were thankful for this early example of medical software.

The American College of Cardiology or the American Heart Association (I don’t remember now which) had an abstract session back then devoted to medical computer software.  I submitted an abstract for the program and it was accepted.   I went to meeting where the ACC or AHA (darn which was it?) provided the hardware and I got to demonstrate my program to the participants milling through the exhibit area.  It was similar to showing a poster, which, if you have not done it, is one of the most fun things you can do at a medical meeting.  People who come by are nice, interested in your work, and ask good questions.  This is diametrically opposed to the nervous tension of presenting an abstract in front of a large group.  So presenting my program at the meeting was a blast.  People came by, both health care workers and from industry, and had a lot of nice things to say.   Of course a few years later the program was obsolete due to the launch of computerized EP systems as mentioned above.  But  I learned a lot from the experience, not the least of which was how to code properly linked lists.

Flash forward to modern times, about 2 years ago.  The Heart Rhythm Society (HRS) at their upcoming meeting planned to showcase medical software relating to electrophysiology.  I had written the mobile app EP Mobile for Android, and somehow HRS had gotten wind of this and invited me to show the app at their meeting.  Distant happy memories of my earlier experience with software and medical meetings came back to me, and so I eagerly replied positively to the HRS email.  Then in a follow-up email came the fine print.  HRS wanted me to pay $3000 to show my app.

A quick email exchange followed.  EP Mobile for Android was a free app.  EP Studios, my little company I set up to try to protect my personal assets from liability, though not technically a non-profit company, was in a very real sense more non-profit than any so-called non-profit company, and I could not afford to contribute $3000 to the Heart Rhythm Society for the honor of displaying my software.  I explained this to the contact at HRS, but he was not able to wrap his head around the concept of free medical software, even in the form of an mobile phone app, so the deal fell through.

Winston Churchill purportedly said:  “You can always count on Americans to do the right thing – after they’ve tried everything else.”  The use of monolithic, proprietary medical software has been foisted on us by our government, at the behest of the multi-billion dollar medical software industry.  Everyone is happy about this except the doctors and their patients.  Is it too late to fix this?  Probably.  However, maybe there is still a way out of the current disastrous situation.  There is little doubt that, if done properly, codifying medical data is good thing.  The problem is the current interfaces are terrible.  There are too few vendors and they don’t care about user feedback.  I would go back to basics.  Medical data is after all just data.  There needs to be a standard data format for medical data.  I know that HL7 exists, but it seems to be pretty messy, and only last year opened itself up as a free standard (it required a license fee before).   If all the energy devoted to making mutually incompatible EHR software systems was instead directed towards defining a good, open, free medical data standard, to be used by all computerized medical hardware, imaging, and so forth, I believe we could break down the medical software oligopoly.  Domain specific languages and APIs (application programming interfaces) could be developed and with these building blocks anyone could create medical software.  It wouldn’t have to free, but it would have to be affordable to sell, unlike the present situation, so costs would go down.   User interface quality should improve.  And Judy Faulkner, billionaire CEO of Epic Systems, might finally have some competition.

Making a MOCkery of Medicine

NotABIMI thought I’d weigh in on the American Board of Internal Medicine (ABIM) recertification process after reading an excellent article on it today. After all, I’ve been through the process several times, most recently enduring it in 2012. I was lucky enough to be “grandfathered” with regard to my Internal Medicine and Cardiology board certifications. Unfortunately no such option exists for my Cardiac Electrophysiology board certification, it having been created in 1992 after the ABIM wised up the fact that life-time certifications were not profitable. Thus there was no option but to renew the certification in 2002 and 2012, which I duly did, much to my distress. I know a few physicians who claim to enjoy taking these tests, even retaking a certification exam that they are grandfathered into. More power to them. There are a few masochists in every crowd. But the ABIM is determined to take away even their fun, by ramping up the Maintenance of Certification (MOC) requirements to the point that even the most committed connoisseur of the painful is bound to cry uncle.

There are two aspects to recertification. First there is the test that one takes for an exorbitant fee every ten years. Note that physicians are already required to take many hours of Continuing Medical Education (CME) courses per year (which is another scam, but I will pass over that for now). All the physicians I know are very interested in keeping as current as possible in their specialty and don’t require external incentives like mandatory CME or board recertification to do so. Even if one is cynical and refuses to believe that physicians do things like this for the sake of delivering the best patient care, one should at least grant that medicine is a business and it is necessary to keep up to stay competitive with other physicians. Nevertheless in addition to mandatory CME the recertification exam pops up every ten years, and one risks being ostracized if it is not taken and passed. Unfortunately I can’t say much about the test itself. Before I took it I signed a form (in blood, I think) that forbad me from revealing anything about the test. I do know something about how the questions are selected. When I was in academics I, like many of my academic colleagues, was asked to submit 4 questions on electrophysiology to the board. These questions and the hundreds of others sent in were reviewed by the ABIM question selection committee (which I believe was also primarily made up of academicians) who then picked out the actual test questions. I remember when I made up my questions I made an effort to come up with something obscure or tricky. Having taken the test before, it seemed that those were the kinds of questions the board liked. Apparently the process hasn’t changed, judging by the types of questions on the most recent test I took in 2012.

I’ve been taking tests my whole life, and, as much as I dislike them, it wasn’t the test so much as the MOC requirements that rankled me. I was told that I should start the MOC a minimum of 1 year prior to the test. Really? (footnote: now the MOC requirements have changed and start within 2 years of the last test. Ugh!) I thought to myself, what could they possibly make me do that would take a whole year? So, when the countdown to recertification reached T – 1 year, I fired up the ABIM website to find out what I had to do.

My first reaction was that I must have pulled up the wrong web page. I was re-certifying in Cardiac Electrophysiology, the subspecialty of cardiology dealing with problems with the rhythm of the heart. The options presented looked like suggestions for a high school science project. Some were so vague as to be meaningless. For example, from the current ABIM website:

Approved Quality Improvement (AQI) Pathway

The Approved Quality Improvement (AQI) pathway offers diplomates the opportunity to earn practice assessment Maintenance of Certification (MOC) points for participating in externally developed quality improvement (QI) activities that have met ABIM’s standards for measuring and improving patient care.

Whatever that means. Some of the more understandable options had to do with collecting data from patients to send to the ABIM. What they wanted this data for or what they would do with it I had no idea. The striking thing though was that NONE of the options had anything to do with the subspecialty I was certifying in, i.e. Cardiac Electrophysiology. No MOC having to do with the heart rhythm. So this was all just a rather large hoop that I had to jump through. I ended up selecting the Hypertension Module because one of my colleagues had done that option before and had managed to complete it.

What the Hypertension Module involved was collecting a huge amount of data on 50 to 100 office patients. Supposedly the patients were to enter this data on their own on the Internet. In Kentucky this just wasn’t going to happen. So as an alternative I ordered 100 questionnaire booklets from the ABIM. I handed these out to the office patients and asked them to answer the questions. There was no IRB consent form or real explanation as to why I wanted this data from them. I told them that the ABIM required me to collect this data from my patients for some unknown reason but participation was voluntary. Most of my patients were nice enough to fill out the forms.

Not having my own staff of dedicated data entry personnel, I had my long-suffering medical assistant enter the data from the forms into the computer. I did pay her for this out of pocket, though not as much as she deserved (Thank you Karen!). Up until this point I really didn’t know what would happen once all the data was in. The ABIM site was very mysterious about where this module was heading. I was still in Step 1, and couldn’t go on to Step 2 until at least 50 sets of patient data were in the computer. So, after several months of data collection (I now saw why it was important to start the process a year ahead of time), the data was in, and the Step 2 button, which had been grayed out and disabled, stood before me in an activated state, ready to be pushed. It reminded me a little of a computer game, in which you try to open a door but it just gives a rattly sound and a text appears that says “you don’t have the key” until you actually find the key. So without further ado I clicked on the button and the computer churned away, analyzing my trove of what was admittedly somewhat sketchy data to begin with. Then after a dramatic pause the ABIM website announced its findings.

I wasn’t sure what it had to do with hypertension (this was the Hypertension Module, wasn’t it?) but the grand analysis revealed that a greater percentage of my patients than was deemed acceptable were failing to meet goals for lowering of serum cholesterol. (Flash forward 2 years: those goals have been thrown out the window anyway in the latest guidelines). Hmm. So my patients referred to me for the most part by other cardiologists for consideration of pacemaker or defibrillator implantation or catheter ablation of arrhythmias were not meeting standards for cholesterol lowering. I thought to myself: whose fault is that? I don’t usually have anything to do with managing lipid levels. I am a subspecialist, which one would think the ABIM would be aware of as they were requiring me to take their subspecialty certification test. As a matter of fact most of the cardiologists who referred patients to me had little to do with managing cholesterol levels either. In Louisville, Kentucky the management of lipid levels is the jealously guarded province of the family practice doctors. But there it was staring me in the face. After several months of effort that completely distracted me from my real job as an electrophysiologist, the answer to the question of Life, the Universe and Everything was a faulty cholesterol level.

So on to Step 3. The ordeal was not over. For the next step in the MOC Holy Quest was to develop a plan to address this dreadful oversight in my clinical practice and implement it. After that there was Step 4, which was to assess the wonderful success of my innovative plan and show how it had revolutionized my clinical practice so that I would be eternally grateful to the ABIM for my enlightenment that was only possibly through the MOC program. And they wanted me to do this assessment by repeating the data collection in another 50 patients after I had put my fool-proof-amazing-cholesterol-lowering plan into effect.

Excuse me, ABIM, but I do have a real job, and is there any way I can get on with it, instead of spending the rest of my life on your science project? Well, reading the proverbial fine print, there was a way. I could, if I so desired and were so lazy (though they would so much prefer the more complete option) only collect the specific data that was identified in the original number crunching and submit that to them. In other words, I could get 50 cholesterol levels (never mind that I virtually never order a cholesterol level in my field of work) and show that they were better than before. Ah, I know an out when I see one.

So I wrote my MASTER PLAN FOR THE LOWERING OF CHOLESTEROL AND THE SALVATION OF THE HUMAN RACE which I think had something to do with asking the patients to exercise more and eat fewer buckets of Kentucky Fried Chicken, and immediately put the plan into effect. Then, after waiting what I thought was a realistic number of months, I resubmitted my data. Wow, the cholesterol levels were much, much better. The plan had worked! I just hope the ABIM is not planning to publish my data. Because… I made it all up!  And I bet I’m not the first to have done so.

As a medical professional and former academic researcher, I never would dream of falsifying data under any normal circumstances, but I was driven to this by the completely unreasonable nature of the MOC requirement. To summarize this unreasonableness:

1) There were no MOC module options that were relevant to my subspecialty.

2) My patients, my staff and I were forced to waste time on a project of no clinical value.

3) There was ZERO educational value to this project.

4) There seemed to be some undisclosed (sinister?) ulterior motive for the ABIM to collect this data from my patients.

5) I was an unpaid data gatherer for the ABIM (No. Worse, I paid them for the privilege).

6) My patients were unwitting participants in a project that was not important to them or me. I’m sure many participated because they trusted me, but by asking them to participate I was violating or abusing that trust.

I’m not sure what else to say. It is unbelievable that physicians have to go through this process. As much as taking a clinically irrelevant test every 10 years irks me, it is still far preferable to the sham that is the MOC. It really has to go.

Fair Use Justification of CPT® Codes in EP Coding

The following is a formal justification for use of a limited number of CPT® codes under the US Copyright law fair use exemption in the soon-to-be-released mobile app EP Coding.

EP Coding icon
EP Coding icon

 

Introduction

As CPT® codes are copyrighted by the American Medical Association, it is important to make the case that use of a very small percentage of these codes, with paraphrased descriptions in a mobile app is covered under the Fair Use doctrine of US copyright law. Note that the AMA does acknowledge the possibility of fair use of CPT® codes. Also please note the following:

CPT copyright 2012 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Fair use criteria

Four criteria are used in determining fair use of copyrighted material:

  • The purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes.
  • The nature of the copyrighted work.
  • The amount and substantiality of the portion used in relation to the copyrighted work as a whole.
  • The effect of the use upon the potential market for or value of the copyrighted work.

The purpose and character of the use, including whether such use is of a commercial natue or is for nonprofit educational purposes.

EP Coding is intended not for coders, who definitely need the AMA documentation, but for physicians who need to document with codes (in addition to documentation in their procedure notes) the procedures that they do. With the advent of EHR (Electronic Health Records) there is frequently a need to enter codes by the physician directly into the system. This is true of the EPIC EHR that I’ve had experience using. Entering codes is not an easy task. As the CPT® descriptions are obtuse, at least as presented in EPIC, looking up codes by description is difficult if not impossible. For example, a search for “PPM” which is a common abbreviation for pacemaker yields 0 hits in EPIC. Searching for “PACEMAKER” or “PACER” yields a very long list of hits, but they are all hardware codes for individual pacemaker types and not procedure codes. Searching by code, such as the code for dual chamber pacemaker implant, code 33208, yields this:

33208 PR INS NEW/RPPLCMT PRM PM W/TRANSV ELTRD ATRIAL&VENT

Hardly intuitive! Similarly searching for “ABLATION” yields over 50 choices, many not related to cardiology, and search for “AFB” yields “AFB stain” used to diagnose tuberculosis. The actual code for AFB ablation, 93656 yields this:

93656 PR EPHYS EVL TRANSPTL TXATRIAL FIB ISOLAT PULM VEIN

So there is a need for a “cheat sheet,” a list of codes relevant to his or her specialty that the physician carries around to help remember the codes and enter them in the computer. This list of codes may not be enough however. One must remember that one can’t code transseptal puncture or LA pacing and recording with AFB ablation, or that 3D mapping is already included in VT ablation. This sort of information is ideal for encoding into a mobile app.

As the app improves physician coding skills and thus enhances the ability of the physician to code accurately and quickly so he or she can then turn his or her attention to more pressing matters, the app meets the criterion that its purpose is educational and benefits science and the public. There is no benefit from keeping the physician in the dark regarding these codes. The physician is not going to buy or carry the whole AMA CPT® code book around, nor should he or she, given the very limited number of codes that need to be used in his or her line of practice. Certainly an actual written “cheat sheet” that is commonly used is considered fair use. The EP Coding app merely is a more intellegent version of that cheat sheet.

Regarding the commercial nature of the work, the app is priced at a very low cost (99 US cents) both to help defray the costs of development and to discourage downloading by those who don’t need access to these codes. EP Studios does generate some income, but has not generated a profit. Its main purpose is to help my colleagues by developing apps relevant to practicing medicine.

Thus with these points I believe the app qualifies for “fair use” by the first criterion.

The nature of the copyrighted work.

Despite their absolute necessity for the practice of medicine in the United States, the AMA has a copyright on the CPT® codes. This is despite the fact that the CPT® codes are also the level I codes required by Medicare for all providers to use. The AMA code books are expensive and license fees are required to use the codes as well. The amount may be debatable, but there is no doubt the AMA makes a lot of money from their codes. The codes are essentially a database, matching code numbers with descriptions, as well as information of what codes cover and what codes can and cannot be used together. Professional coders definitely need to know all the ins and outs of these codes, however physicians only need to know a subset of the codes. The EP Coding app uses some of the numbers and paraphrases the descriptions of the codes. As such it is not a direct copy, other than of the numbers. Numbers as such may not be subject to copyright. It should also be noted the the CPT® manual is largely a functional and not artistic work, and as such may be more subject to fair use than other less functional works.

The amount and substantiality of the portion used in relation to the copyrighted work as a whole.

A Google search for number of CPT codes gives various sites stating a number from 7800 to 8800. These figures are unsourced, but there is no doubt the number of CPT® codes in in the thousands. As of February 16, 2014 there are 73 codes in EP Coding. Assuming 7800 total codes, that is 73/7800, i.e. 0.9% of the total number of CPT® codes. This is a small percentage of codes. Note that the codes used in EP Coding are only codes for electrophysiology and are limited further to only non-surgical codes (i.e. excludes codes utilizing thoracotomy). In addition codes for office visits, hospital visits, and device checks are not included. The text of the descriptions is not copied from the AMA manuals, but is a paraphrase. Thus the amount of text copied is limited to a small subset of the code numbers. The ideas associated with these numbers are used, but not copied directly. Note that copyright protects literal text, but not the ideas underlying the text. Per the US Copyright Office:

“Copyright does not protect facts, ideas, systems, or methods of operation, although it may protect the way these things are expressed.”

In addition, most if not all of the information in this app is readily available online. For example this article outlines how to code EP procedures.

The effect of the use upon the potential market for or value of the copyrighted work.

EP Coding is intended for physicians, who are not the intended audience of the AMA documentation. That audience is made up of professional coders. EP Coding is more akin to a cheat sheet than a work competing with the AMA code book. Physicians are not likely to purchase the AMA book whether or not they use EP Coding. Coders cannot substitute EP Coding for the AMA book. Thus there is no real competition between the app and the AMA copyrighted works.

In summary, I believe that use of CPT® codes in a limited way in the context of the mobile app EP Coding meets all 4 criteria for fair use under US Copyright law.