Tuesday, October 28, 2014

Public APIs: The Ultimate Silver Bomb

Congratulations! We have a new buzzword trending in health care IT - Public APIs.  You can say public APIs everywhere you used to say interoperability. You can also replace the very unprofessional “EHRs can’t talk to each other” with “EHRs lack public APIs”. People will nod in solemn agreement, and you will sound very informed and up to date on the latest developments, but just in case you encounter the quintessential child inquiring about the king’s rather scant wardrobe, here is a little background information.

(Very) Brief Introduction to Public APIs

API stands for application programming interface. Yes, interface, like the ones you have with your claims clearinghouse or your lab service provider or pharmacies. There are several ways to classify APIs, but for our discussion, we only need to consider two types of APIs: data APIs and services APIs. Data APIs are the simplest, and go something like this: software A sends a request for information to software B, and software B sends back the required information. Another way is for software A to send unsolicited, but previously agreed upon, information to software B, which will then send back a brief thank you note to software A.

For this exchange to work well, both software A and software B need to agree on a communication protocol and both should share a common understanding of the data. This common understanding of data is called a standard. Standards usually emerge from non-profit organizations dedicated to defining such standards, so for example, your claims interface uses something called ANSI X12 as its exchange standard, your lab interface uses the HL7 standard and your pharmacy interface uses something called NCPDP Script. Turns out you’ve been using APIs all along…

Service APIs are less common in health care, although if you look at the big picture, you could say that claims clearinghouses, labs and electronic prescribing are all really services. A simple example of a pure service API, where software A invokes a piece of code executed by software B, is a warfarin dosing calculator. Here software A sends a few agreed upon parameters (i.e. demographics, diagnosis, medications, INR, genomics, etc.) to software B. Software B performs a highly specialized calculation using those parameters and sends the result back to software A.

APIs are deemed to be public, or open, if the specifications are publicly available on the Internet for anyone to use. Health care APIs are not usually public, and formal business relationships need to be established before any one software developer can use another’s APIs. Google Maps APIs, for example, are said to be public, and so are MapQuest APIs. Note however, that although both serve basically the same purpose, they are not identical or interchangeable, and they are not validated or certified by a public agency. Both Google and MapQuest publish APIs to their mapping software, because it makes business sense for Google and MapQuest to do so.

Why Now?

JASON (as in Jason and the Argonauts) “is an independent scientific advisory group that provides consulting services to the U.S. government on matters of defense science and technology”. JASON was established in 1960 and it “has conducted studies under contract to the Department of Defense (frequently DARPA and the U.S. Navy), the Department of Energy, the U.S. Intelligence Community, and the FBI. Approximately half of the resulting JASON reports are unclassified.” The latest unclassified JASON report, A Robust Health Data Infrastructure, was commissioned by the Department of Health and Human Services (HHS) “to address the nationally significant challenge of developing comprehensive clinical datasets, collected in real world environments and accessible in real time, to support clinical research and to address public health concerns. These datasets could be used to guide clinical research, enhance medical decision-making, and respond quickly to public health challenges.”

The identity of JASON group members is secret, but rumor has it that these are some of the best and brightest scientists in the country and have over the years included several Nobel Prize winners. Although we don’t know who JASON is (or are, or however one refers to an anonymously unaccountable group of advisers), we should note that JASON was introduced to the subject by 18 expert briefers (8 from research and academia, 2 from Microsoft, 2 from IBM, 1 videogames developer, 1 from HIMSS, 1 from Deloitte, 1 from Kaiser, 1 from the White House and 1 from NQF). These representatives of medicine in America guided JASON to useful materials about information technology in health care, and actively participated in subsequent JASON discussions.

Similar to a report put forward by the President’s Council of Advisors on Science and Technology (PCAST) four years ago, JASON recommends that massive amounts of clinical data be collected at the point of care in a format suitable for extraction and combination with non-clinical data, to facilitate large scale “biomedical” research. To that end, HHS should actively engage in the creation of a national clinical data exchange architecture, based on nationally enforced standards and public APIs implementing those standards, and it should engage in these activities immediately and with the full force of a government agency. All the work done to date by HHS and its various initiatives resulted in inadequate proliferation of legacy health IT systems, which should be replaced now, and the aggressive migration path suggested by JASON begins with using those public APIs to extract and reformat clinical data from the vast repositories of legacy systems.

To date, HHS has spent over $25 billion of taxpayer money on partially reimbursing hospitals and physicians for the purchase of health IT systems. The much larger remaining costs of buying, implementing and using these systems is unknown. According to the CMS data, there are close to half a million clinicians and almost five thousand hospitals registered to participate in the Meaningful Use program, all using certified EHRs. Practically all these legacy EHRs have found ways to routinely exchange billing information, medications information, laboratory and imaging information, and more recently, referral information, immunizations information, generic messaging and a host of other document based notifications. This may be a great start for patient care delivered by people who can read, but it is totally and completely unacceptable for global biomedical research.

Faced with distinguished panels of scientists and technology experts stating that medical care is basically a gigantic experimental research project, and a government thoroughly convinced that peace, prosperity and good health are a direct function of the amount of information collected about each and single one of us, what should we do next? Should we immediately start ripping and replacing the brand new legacy systems in use by 80% to 90% of doctors and hospitals, because more powerful vendors would also like to make money in health care? Or should we take a subtler approach and slap a host of new regulations on legacy vendors forcing them to build and maintain a public API infrastructure to benefit all newcomers? After vigorously protesting the JASON findings, the government seems to have chosen the latter.

As Microsoft, IBM, Apple, Google, Facebook, Verizon, Salesforce (I kid you not), and everybody with a registered web address, join the health care feast, you should expect more colorful user interfaces, with interminable scrolling screens filled with extra-large fonts, big flat smoky colored buttons, eye-popping images and practically no functionality, as is fashionable in consumer websites. Most of this “software” will be geared towards your patients, the ultimate generators of marketable biomedical research data. Your current EHR vendor will be exhausting all its resources on creating, maintaining, testing, certifying and publishing mostly data APIs, but in the short term also services APIs, to pave the road for giant technology aggregators and tiny app builders.

If your certified EHR vendor is small to medium in size, expect it to fail and go bankrupt in the next few years. If your EHR vendor is large, expect it to be acquired and decimated by a global corporation. Barring a miracle, the passive-aggressive grumbling of physicians will finally subside, and the march to defragmentation of our “broken”, “stove-piped”, “siloed”, “walled-garden” system (a.k.a. competitive, free-market, let the best man win, type of system), will continue at a brisk pace.

For better or worse, we need to recognize that in this country health care is a business, a very large and profitable business. Perhaps it shouldn’t be, but it is. Health care is being told day in and day out that it should learn from other industries. Well then, how would the banking industry react to a requirement to create public APIs allowing wholesale extraction of fully identified transactional data of their customers and all the communications conducted around such transactions between the banks and their clients? What would be the response of airlines, car manufacturers, restaurants, or even Google and Apple, if the government demanded that they invest in infrastructure solely intended to help other companies put them out of business? Take a wild guess...

Monday, October 6, 2014

How Health Care Went Tabloid

Physicians, whether practicing medicine or not, should not be involved in clinical research. They should never be consulted on development of new drugs and medical devices. Doctors should not invent new treatments, and should never supervise clinical trials. They should not travel to or speak at conferences either, and they should banish all entrepreneurial notions out of their heads. If they insist on engaging in these activities, they should do it all for free, out of the goodness of their Hippocratic heart. A medical degree should immediately disqualify you from making money in the health care industry, which is a privilege reserved for technocrats, business executives and garden variety ex-political appointees.

Matt Bai, a veteran political journalist, wrote a new book titled “All The Truth Is Out: The Week Politics Went Tabloid”, where he is attempting to pinpoint the demise of serious political journalism to the Gary Hart scandal of 1987. If you recall, Mr. Hart, the all but certain Democratic candidate for President of the United States at that time, was railroaded out of politics by a romantic dalliance with, of all people, a very pretty pharmaceutical saleswoman. Matt Bai goes on to assert that since the Gary Hart affair “the entire ethos of political journalism has really changed. Because all the attention, all the kudos, is in taking someone down, is in finding hypocrisy”. Political journalism is arguably the heart of journalism, and as the heart goes, so goes the lesser journalistic body, health care reporting included.

This week, the CMS released a new "trove" of information about payments made by pharmaceutical companies and medical devices manufacturers to physicians and hospitals. The dataset includes millions of records ranging from payments of $0.00 (?) to millions of dollars. Some of the records specify the recipient while others do not, and most list the reason for payment. The data is preliminary at best and lots of cleanup activities are to be expected, since various recipients of funds have discovered errors large and small. A database like this one could eventually be useful for example for cross checking disclosures for published papers and education materials, or for people who are studying the financials of life science sectors of the economy. As expected though, the health care media saw things differently, because these data present ample opportunity to find hypocrisy and take someone down.

To put things in perspective, here is a brief summary of the data from an angle nobody saw fit to print. Below is a breakdown of amounts received by named physicians for the largest category of general payments, which includes food, travel, honoraria, consulting, royalties, licensing fees, and a host of other frivolous activities. In addition to this dataset, there are two smaller sets, one for research payments and one for ownership, or equity, in life science companies. And then there are three parallel datasets where the CMS decided to withhold the names of recipients due to uncertainties regarding data validity. We will disregard the list of payments made to unidentified entities, and concentrate on the largest dataset of payments to doctors. There are 358,686 named physicians in this dataset, and this is how total payments are distributed.

It looks like the median payment value is approximately $100, and 9 out of 10 docs who received anything, received less than $1,000 worth of goods, services and sometimes even cash. The big money went to a fraction of a percent at the top, mostly for royalties and licensing of things they designed or invented. I randomly picked a couple of these folks and looked them up on Google. The first one turned out to be a world famous vascular surgeon who invented multiple devices to fix aneurysms, pioneered various types of surgeries, and even got himself a Medal from the Society for Vascular Surgery. The second fellow is an orthopedic surgeon, also world famous who specializes in acute trauma and posttraumatic reconstruction of feet and ankles, and is the inventor of all sorts of plating and nailing systems for his specialty. He has more credentials than you can count and some very prestigious awards to go with that. At this point I stopped searching.

Now let’s look at how the New York Times reported this data release. The first article came one day before the data was published, giving us a heads up on the impending release, educating us on already existing resources, such as the subtly titled Dollars for Docs database, and plainly stating that “most physicians that are in private practice are touched in some way” by the industry. Yes, only private practice docs are “touched” by the scourge. The next article was just a kneejerk litany of complaints about the CMS database functionality, which by the way, I found to be surprisingly nice.

The third New York Times article was cleverly titled “Detailing Financial Links of Doctors and Drug Makers”, a title as innocent as the 1987 Miami Herald story “Miami woman is linked to Hart”. Linkage implies secretive impropriety about to be exposed. You don’t often see headlines saying “Fireman linked to saving baby from burning building”. The article itself is fraught with equally innocent language such as “doctors reaping over half a million dollars each”, “murky financial ties between physicians and the health care industry”, “lucrative arrangements are just some of the findings”, and in a surreal tale of the doomed, a righteous Cleveland Clinic physician is contesting his own listing because “he had spoken at the event but deliberately skipped the lunch”.

The most recent New York Times article is titled “Financial Ties Between Doctors and Health Care Firms Are Detailed”, just in case you missed the “detailing” pun the first time around. This article opens with a series of dramatic one sentence paragraphs. “For some doctors, treating patients isn’t the only way to make money”. You can pretty much hear the thriller music in your head. “A Michigan plastic surgeon was paid more than $300,000 to travel the world teaching doctors about new cosmetic products like a breast implant”. Impropriety is best served with female body parts. “The retired chief executive of the Mayo Clinic, who once helped write its conflict of interest policy, received more than $237,000 in compensation for serving on multiple corporate boards”. Wow, a retired doctor sits on corporate boards. Even the venerable Mayo Clinic has no ethics.

Following the boilerplate “murky financial ties between physicians and the health care industry”, we are informed that “the typical doctor earned only about $1,750 from August to December 2013”. Actually, the “typical” doctor barely eked out a hundred bucks worth of crappy conference food, unless he or she skipped lunch altogether, or maybe just refused the fake ├ęclairs at the end, but math is a very flexible thing.  And on and on goes the litany of naming names, like a bad Seinfeld take on the McCarthy era.

The rationale for this abject witch hunt is that physicians who ingest pharmaceutically sponsored food are likely to return the favor and prescribe expensive brand name drugs instead of cheap generics. According to an IMS report from April 2014, generic medicines are now representing 86% of prescriptions, and have been steadily increasing over recent years. I seriously doubt that the numbers can get much better, and either way during these days of high deductibles and narrow formularies, doctors are rarely at liberty to prescribe brand name drugs when generics are available. Not to mention that as physicians are increasingly losing their independence, pharmaceutical companies are turning their efforts to hospitals, which are much better at financial wheeling and dealing. And yet, all the headlines and all the articles are about doctors, because taking down a person with a name and a face, using innuendos and baseless allegations, is so much easier than picking on a lawyered up corporation, and it is equally fulfilling, it seems.