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“…economic forces determined outcomes with relatively little constraint from political considerations; such was the case, for example, in the original innovation of indentured servitude, in the substitution of slaves for servants…“ -- Galenson, 1984

The Sunday New York Times is reporting that technology firms are supporting, lobbying, advertising and heavily influencing the immigration reform bill now before Congress. When you think about the large Silicon Valley corporations and the 0.0001% that run these firms, progressive images usually come to mind, based on public statements, writings and less frequently, charitable acts of these magnates. Think again. Under the guise of promoting a humane and yet pragmatic solution to the general immigration problem in the U.S. which has almost nothing to do with technology companies, the leaders and investors of high tech corporations are attempting to strengthen and expand an institution that benefits their corporations (and personal wealth), regardless of its effects on the American people and human rights in general. In between “Secure the Border” and “Pathway to Citizenship”, lays a completely unrelated proposal to increase the allowance for “guest worker” visas, mostly used by high tech companies to import cheap labor from less developed countries.

The “innovation of indentured servitude” was introduced around 1609 by the Virginia Company in an attempt to increase labor mobility from England to the colonies. With some exceptions, the indenture system was simply a credit mechanism by which willing and able workers could purchase the costly passage to the New World and its endless opportunity, in return for several years of labor for a colonial master, at the end of which they became free to buy land and most likely their own fresh indentured servants. This labor management innovation worked well for upwards of three centuries, and when the costs of temporary indentured labor were judged to be too high by employers, the innovation of indentured servitude for life, a.k.a. slavery, was added to the labor market mix.

We’ve come a long way since, and after going to war with ourselves we decided that slavery, as practiced by plantation owners in the south of the country, is unacceptable within a nation built on freedom and liberty for all people. Indentured servitude though, survived into the early 20th century when the unskilled labor of desperate people was no longer a rare commodity in America. Over the years we enacted reams of legislation to protect wage workers from abuse and in the process built a “middle class” free to pursue a dream of happiness and better futures for its children. And for a brief moment in time it looked like the American experiment was going to succeed. But the insatiable need of corporations for cheap labor was not to be denied.

Fortunately, modern transportation and advances in technology rendered the corporation itself portable, and freed it to go where labor markets where not hampered by the regulations put in place by free people to protect and benefit themselves. So the corporations relocated production plants to places where governments where more understanding of the timeless business imperative to exploit cheap labor without bothersome regulations. This worked well, and it still does today, for unskilled manufacturing jobs. The suspicious and well protected workers in the free world were appeased by the availability of ever cheaper imported products and the temporary replacement of minimum-wage sweat-shop jobs with better paying skilled technology jobs. Temporary, because technology jobs are even more portable than manufacturing jobs, and as soon as cheap semi-skilled technology labor pools became available in various developing countries, corporations were quick to migrate their activities from their home countries to the greener pastures of unregulated labor conditions.

But the captains of these new global corporations have no desire to relocate themselves and their families to where sewers flow through the streets, and as portable as high tech may be, there is still a preference to have workers in close proximity to their masters. Allowing laborers to freely immigrate from one country to the next (as in the 19th century wave of European immigration to America), did not work very well for corporations, because those free laborers quickly organized and integrated themselves into the political system to obtain higher wages and better working conditions. Hence the renewed interest in the 17th century innovation of importing indentured servants into rich countries. Since outright slavery and explicit bondage are illegal nowadays in most countries, a different terminology had to be created and some operational adjustments had to be made.

Building on the mid-19th century model of labor importation from India and China to South America, where the indentured servant received wages and benefits (return passage fees) directly from his employer, was bound for a specific number of years (usually four or five) to one employer, and subject to strict performance measures, a politically acceptable system of “guest workers” was created and perfected in 20th century America. The United States laws regarding the importation of labor underwent many changes during the last half of the 20th century, alternating restrictions with relaxation as the country changed its social stance and as the economy fluctuated. In its current form, the skilled workers importation program for employers came into existence with the Immigration Reform and Control Act of 1990, and set a limit of 65,000 so called H1-B visas per year, and smaller numbers of other visas and permits for exceedingly high-skilled workers. Just like the 17th and 18th century indentured servitude contracts, the modern H1-B visas, allow workers to switch employers (easier than in earlier centuries) and provide a path to citizenship at the conclusion of the bondage years (much more difficult in the modern era).

In October of 2000, high tech corporations trying to weather the dot-com disaster, needed to find ways to lower costs of operations. While most Americans were distracted by the Bush-Gore spectacle, Congress was able to oblige its benefactors and temporarily increased the importation levels of cheap skilled labor for technology companies, as a surrealistically honest Senator told the San Francisco Chronicle:"Once it's clear (the visa bill) is going to get through, everybody signs up so nobody can be in the position of being accused of being against high tech," said Sen. Robert Bennett, R-Utah, after the vote. “There were, in fact, a whole lot of folks against it, but because they are tapping the high-tech community for campaign contributions, they don't want to admit that in public."” Silicon Valley and its largest technology firms, lobbying in favor of the bill argued that in spite of the collapse of multiple Internet companies, there were “critical worker shortages” in high tech. Personally, I don’t recall actual shortages of labor in 2000, but I do recall spiking labor prices right before everything went crashing down in flames.

So here we are a decade later, mired in a pernicious recession where the stock market is skyrocketing, alongside widespread unemployment and raising poverty, and the billionaires of Silicon Valley are whistling the same old tune. Never mind that there is no indication of shortage of labor in technology markets, where wages have been stagnant since the dot-com crash, and never mind that over one third of Americans who graduate with a technology degree either can’t find a high tech job or are able to find a better paying job in a different sector. Flooding the American high tech market with large numbers of young people, some talented and skilled and some not so much so, bound to a mighty employer by onerous bureaucratic processes, under penalty of being shipped back where they came from if they speak up or complain in any way, is necessary for one reason, and one reason only: lowering the price of labor, both native labor and “guest worker” labor.

So when Silicon Valley moguls, and the politicians they hire, speak of a global economy in which “we” must learn to compete, they mean that corporations must be given the ability to enact legislation to freely move equipment, wealth and labor assets (a.k.a. people) from one continent to another, in order to optimize production costs and maximize profit across their global operations. The Silicon Valley promotional website states that we need to “attract the world’s best and the brightest workers”. Leaving aside the moral dilemma of poaching the human capital of poor countries, is indentured servitude to corporate billionaires the best instrument we can think of for attracting the truly best and brightest to our shores? How about an exclusive invitation to come to America as free men and women?

What does this have to do with health care? If you use health IT, work in health IT or are looking for work in health IT (perhaps a "proud" holder of an ONC health IT certificate), then you know exactly how this is pertinent to you....

Disclosure: I am an engineer by education. From the time my children were old enough to think about what they will be when they grow up, I made sure that engineering will not be something they would consider, and although all of them have exceptional math and science abilities, not one of them is pursuing a career in engineering or technology. I consider this a resounding success.

Indentured Servitude: A Silicon Valley Innovation

“The Affordable Care Act, the health care law of 2010, created a Prevention and Public Health Fund.
The fund is an unprecedented investment in promoting wellness, preventing disease, and protecting against public health emergencies.
Much of this work is done in partnership with states and communities, which are already using Prevention Fund dollars to help control the obesity epidemic, fight health disparities, detect and quickly respond to health threats, reduce tobacco use, train the nation's public health workforce, modernize vaccine systems, prevent the spread of HIV/AIDS, increase public health programs’ effectiveness and efficiency, and improve access to behavioral health services.
…..
With this investment, the Affordable Care Act helps states and the nation as a whole focus on fighting disease and illness before they happen.”
HHS.gov

Sounds magnificent, doesn’t it? Section 4002 of the Affordable Care Act (ACA) authorized the appropriation of $15 billion over ten years to be used for public health by the Secretary of Health and Human Services (HHS), and last year a third of that was taken away during budget negotiations to support other unrelated worthy endeavors. During 2010 and 2011, the Fund spent $1.25 billion on various public health activities, including $198 million on additional primary care residencies and physician assistants training. In 2012 the Fund allocated approximately $1 billion to various community efforts ranging from early childhood obesity prevention to Alzheimer’s education and support. For 2013, the Fund is planning on spending half that much on prevention and public health, while diverting $453.8 billion to CMS to assist with enrollment in the new health insurance exchanges. So out of the original $15 billion allocated to public health and prevention, only a fraction will go to its intended purpose, unless of course the Republican sponsored Helping Sick Americans Now Act defunds the entire thing through 2016 to replenish the stopgap Pre-Existing Conditions Insurance Plan which ran out of money earlier this year.

The public health fund from its inception was just an effort to make communities where most Americans live and work more conducive to healthy lifestyles through a variety of small investments in infrastructure improvements, services, education and research. There is quite a bit of health IT in the Fund, but instead of the sexy fly-by-night EHR type of IT that gets all the media attention and all the money we don’t have, the Fund is supporting electronic infrastructure for immunizations, infection prevention and surveillance, data collection and analysis of health indicators for various purposes. The Fund was a long term proposition and it was never clear how businesses profit directly from its moneys, if at all, thus it came under attack almost immediately when in September 2010, Republicans proposed to defund it to pay for things that would save real dollars to the business community in the here and now. In some circles the Fund was referred to as a “slush fund for jungle gyms”, because obviously playgrounds for children are much inferior to proper pharmacotherapy for the next generation of obese diabetics.

But the Fund had many Democrat champions who (almost) consistently, and selflessly, went to bat for the wellbeing of future generations. For example, in April 2012, shortly after shaving off one third of the Fund’s money to pay for the payroll tax cut extension package, Democrats made a stand and refused to allow others to join in the pillaging of the same Fund, this time to pay for a student loan interest reduction program. In a brilliant strategic move, Minority Leader Nancy Pelosi, surrounded by an all-female legislative chorus, called the Republican bill a "continuation of the assault on women's health" and suggested that student loan interest reductions should be paid by taxation of oil companies. This of course, had nothing to do with the Presidential election and the gender issues carefully cultivated to defeat a slew of idiotic Republican candidates taking turns at making the most medieval statements about 50% of the electorate.

In the past, all attempts to take money out of the Fund somehow required Congressional approval, but in a recent development it seems that the administration that created the Fund, and valiantly defended it over the years, can now freely treat public health as a true “slush fund”, and quietly divert as much funding as it deems appropriate to other activities without an up or down vote in Congress. Obviously this does not qualify as an “assault on women’s health” because most women, and men, are not aware that hundreds of millions of dollars are proposed to be diverted from public health to paying “navigators” for the new health insurance exchanges. And as the Secretary of HHS, who is able to do what an elected Congress cannot, pointed out, the money will still indirectly support preventive care because the navigators will help Americans to enroll in health plans that give them preventive benefits.

Until now, most people were able to purchase health insurance without hiring a consultant, but it seems that the new health insurance exchanges, that were meant to simplify the process, require that the government provides us with personal shoppers to expedite the transfer of taxpayer subsidies to big corporations. And since the government is buying us preventive care, such as screening for obesity and diabetes (but not necessarily treatment for either one), we don’t need to actually prevent obesity and diabetes by building sidewalks, playgrounds or gardens in our communities. Makes sense, doesn’t it?

It didn’t make much sense to Senator Tom Harkin, who is not running for any more reelections, so is now free to stand for principles. In a seemingly unrelated move, Mr. Harkin chose to block the nomination of Marilyn Tavenner to head the Centers for Medicare and Medicaid Services (CMS), until the Obama administration is willing to negotiate its private raiding of the Preventive and Public Health Fund. The former champions of the Fund seem a bit irked by Mr. Harkin’s position, particularly because the nomination of Ms. Tavenner was a rare moment of bipartisan support (most likely because she is not seen as an obstacle to privatizing Medicare and Medicaid), and like a typical battered spouse, the Democratic Party is desperate to enjoy this brief moment of validation from its abuser.

You will not win this one, Mr. Harkin, and any “negotiation” on the amounts stolen from public health this year will be more than made up for after you retire, but sometimes making a stand on behalf of the people is more important than winning the battle, something this administration never understood, and watching an elected official represent the interest of the public instead of private or party interests, may very well affect public health infinitely more than the moneys currently at stake.
So stay the course Mr. Harkin, and let Mr. Harry Reid file cloture if he must, and let this be a lesson in integrity for future generations. Godspeed and thank you!

In Support of Senator Tom Harkin (D-Iowa)

How are you feeling today? Do you feel a bit under the weather? Maybe you have some aches and pains, or a miserable flu, or maybe you have some chronic condition like diabetes or asthma, or some other ailment. Perhaps you could benefit from medical attention, but then again getting medical care is so darn inconvenient and expensive and time consuming, and everybody knows that our health care system is broken, and that health care is full of carelessly infected people, who waited many months just to be pushed around, maimed and exploited by arrogant doctors who never wash their hands, before being packed onto jumbo jets that fall out of the sky on a daily basis. Obviously, something must be done, and soon, or we are all going to crash and burn, or worse, go bankrupt.

Fortunately the uniquely American entrepreneurial spirit of innovation, fueled by unimaginable advances in technology, is finally galvanizing its efforts to fix the American health care tragedy, just like it fixed finance, food, retail, transportation and all sorts of other industries, to our utter delight and immense benefit. It’s also nice to see that in the spirit of global cooperation, our friends across the pond are pitching in with innovative ideas of their own. In the April issue of Health Affairs, two top shelf researchers from England are informing us that a “A Key To Slower Health Spending Growth Worldwide Will Be Unlocking Innovation To Reduce The Labor-Intensity Of Care”. Observing that labor costs are the largest contributing factor to the rising costs of health care, the authors reach the inescapable conclusion that “there is great potential to reduce costs while preserving the quality of care by experimenting with delivery models that require a less costly skill mix”, and they have plenty of examples to support this theory. In Mexico, for instance, people “pay $5 per month to access a health advice hotline before setting foot in a physician’s office” and in India, “assembly line–style eye surgery has dramatically reduced cost without sacrificing quality”. The idea is to utilize technology and innovative labor arrangements to deploy health workers with limited formal training “in a variety of contexts”. “Deployed in low- and middle-income countries to address labor shortages, they could also be used in developed countries to reduce the need for the most highly skilled clinicians”. The main epiphany for me here was that poor countries, with billions of unemployed starving people, can have “labor shortages”!!

But other than that, America is way ahead on this one, and since primary care is, well, primary, it is also the primary place to begin the cutting of “highly skilled clinicians”. The latest buzz comes from Walgreens’ announcement that its NP staffed retail clinics will now begin diagnosing and treating chronic disease, thus reducing the need for the highest skilled clinicians. The prices are advertised, of course, and look pretty reasonable at between $79 and $122 for an established patient exam, excluding tests, procedures and complicating factors. To illustrate our savings, the Medicare Physician Fee Schedule for an average established patient visit (CPT 99213) is currently $72.81 (national average). For the most complex office visit for an established patient (CPT 99215), Medicare pays doctors $142.90 on average. Convenience is of course priceless, but some caution is necessary because Walgreens may not be willing to “care” for you after all.

In the same issue of Health Affairs, several folks employed by Walgreens are exploring another technology driven, cost-reducing innovation. Using data analytics and health risk assessments ($89 at its retail clinics), Walgreens is introducing the concept of “impactibility modeling” to be layered on top of predictive risk-stratification analytics in order to identify patients who “may not be amenable to the proposed preventive intervention”. So “[a]lthough certain subpopulations are at high risk, they may be denied preventive care because they are not expected to respond to it”. Basically, why spend money on lost causes, “such as people with cognitive or other mental health disabilities and those who have language barriers. Or an organization may exclude all of the very highest-risk patients, because such patients are sometimes regarded as being less amenable than others to preventive care”. Following a convoluted attempt at explaining the ethical aspects of this innovation, the authors recommend that more data should be collected, that “there should be appropriate ethical reviews” and that some pilots be initiated.

Now that we’re pretty much done with primary care doctors and really sick individuals, perhaps we can take our savings up a notch. Health Affairs seems to be a veritable treasure trove of innovation these days, and in its February issue, we find an article from Health Partners in Minnesota reporting $88 savings for each simple episode of care administered by their Virtuwell platform. I have to admit that the logic behind their savings calculations escapes me, but their exquisitely high tech platform is the epitome of labor intensity reduction. You go online, provide a valid credit card number, fill out a bunch of forms answering questions about your condition and medical history (perhaps Barton Schmitt, or something similar), and in 30 minutes or less you receive your diagnosis and plan, from an NP somewhere, including prescriptions and referrals if necessary, for a flat fee of $40. You may call if you must, and you will receive an electronic message in a few days to make sure all is well. This is way better than the Mexican hotline model as far as eliminating skilled jobs, and with some more intelligence injected into the protocols, perhaps a little Watson style analysis, we could probably get rid of the NPs altogether.

A small step in this direction can be found at Walmart, CVS and Safeway, where SoloHealth is deploying their health assessment stations which provide “free and convenient access to healthcare”. You can screen your vision, blood pressure, weight, body mass index and as many ads as will fit in 7 minutes or less. All for free. This is not really treatment of disease just yet, but the potential is certainly there. Perhaps you can talk to the Station for 7 minutes, then go shopping, and come back in 30 minutes to get your Virtuwell diagnosis and script, and 30 minutes of shopping, particularly with pediatric patients in tow, could be worth enough to the hosting retailers to be able to share a portion of earnings with the Virtuwell platform owners. Isn’t it amazing how innovations can feed of each other to generate cheaper and more convenient innovations?

If you’re still not convinced, here are a couple more things to consider. First, the fee-for-service issue is automatically resolved by switching health services venues, because retail is one of those more advanced “other industries” and therefore perfectly fine with fee-for-service. Second, everybody wins because retail health care, other than being free and very convenient for shoppers and retailers, has a built in operational feedback loop. You go to a convenience store, load up on soda, Cheetos, Doritos, gummy bears and 50% off holiday candy, screen yourself online, go buy some smokes to alleviate the tension, get diagnosed with diabetes amenable to care, get your prescription filled, and on your way out pick up some of the stuff mentioned on the screening station screen, or recommended for purchase on your patient education handouts, and some beer to go with the smokes and the generic Metformin (it’s not like the machine can tell, right?). Rinse and repeat every three months or sooner if you start experiencing chest pain. They do treat cardiovascular disorders too. And don’t worry; you will get plenty of proactive outreach reminders if you forget your next appointment, from the retailer, the various ad sponsors and your dedicated zero-skills care team. How much more convenient can it get? Problem solved.

Fast Medicine

In 2004 President Bush created the Office of the National Coordinator for Health Information Technology (ONC), introducing the notion that Health Information Technology (HIT) should be nationally coordinated. One of the first endeavors of ONC was the planning and design of a National Health Information Network (NHIN) as a means to facilitate the exchange of electronic health information among providers and Health Information Exchange (HIE) entities. This was, and still is, a grand vision of an interconnected health care ecosystem, inclusive of all governmental agencies and all stakeholders who in any shape or form make a living or a profit from servicing the health care needs of the nation (see image below).

To prime the pump for enough electronic information to be exchanged, the new ONC made grants to the American National Standards Institute (ANSI) for the creation of a Health Information Technology Standards Panel (HITSP) to assemble standards for the exchange, and to RTI to create the Health Information Security and Privacy Collaborative (HISPC) to work with business stakeholders at a State level. Both these committees are defunct now, but HITSP had a very productive and highly visible lifespan, attracting sponsorship from government contractors and trade associations. In addition, ONC also awarded a grant to a new entity, the Certification Commission for Health Information Technology (CCHIT), which was pulled together by the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society (HIMSS) and the National Alliance for Health Information Technology (NAHIT). Both AHIMA and HIMSS are flourishing these days, but NAHIT voluntarily dissolved itself (and removed its website). The funding for CCHIT was aimed at creating a certification program for Electronic Medical Records (EMR), including interoperability capabilities. In 2006, CCHIT began certifying EMR software and was the sole government designated Recognized Certification Body (RCB).

(click image to enlarge)
Source: CONNECTing to the Nationwide Health Information Network (NwHIN): The Road Ahead
In 2009 President Obama injected much needed stimulus dollars and empowering legislation into the ONC. The HITECH Act opened a new era of prosperity for all things HIT. The prolific HITSP and the less stellar HISPC were replaced by two brand new Federal Advisory Committees, an HIT Policy Committee and an HIT Standards Committee to make recommendation to the reinvigorated ONC in its efforts to implement the Meaningful Use incentives program. CCHIT lost its unique certifier position and became just one of several government sanctioned certifiers of Meaningful Use compliant Electronic Health Records (EHR). The NHIN, now part of the Federal Health Architecture (FHA), acquired a new open source gateway called CONNECT first deployed in 2009 to connect the Social Security Administration (SSA) and MedVirginia for the processing of electronic disability claims. But the NHIN, with its stringent requirements for blessings from the Federal Bridge Certification Authority (FBCA) and a rather uninviting CONNECT gateway, was judged to be a bit too heavy and slow to provide instant gratification. So in 2010, NHIN was given a new smaller and nimbler sibling, aptly named NHIN Direct, intended to facilitate health information exchange through something as simple and as ubiquitous as email attachments (encrypted, of course).

For one reason or another, NHIN changed its name to the much hipper NwHIN (Nationwide Health Information Exchange) and NHIN Direct dropped its NHIN name affiliation to stand on its own as the Direct Project. The ONC then initiated a major push to have its various grantees (e.g. State HIE, Regional Extension Centers, and Beacon Communities) exchange health information through the Direct Project flavor of secure email. Most HIT vendors complied and implemented the Direct Project specifications in their products. In 2011, the ONC created the Standards and Interoperability (S&I) Framework, “a collaborative community of participants from the public and private sectors who are focused on providing the tools, services and guidance to facilitate the functional exchange of health information”. Started with three initiatives, the S&I Framework now includes dozens of projects and workgroups, managed by government contractors presumably on a volunteer basis, and the Direct Project has been folded into this new framework, and shortened its name to Direct.

In the meantime outside the confines of ONC, interoperability players can trace their pedigree to 1997 when HIMSS and the Radiological Society of North America (RSNA) created an organization named Integrating the Healthcare Enterprise (IHE) to develop frameworks and specifications (profiles) for health information exchange. IHE has been very active and very prolific over the years. In 2011, the EHR/HIE Interoperability Workgroup (IWG), a consortium of States and HIT vendors, with a goal of “increasing the adoption of EHRs and HIE services”, was created by the New York eHealth Collaborative (NYeC), an organization with extensive ties to ONC, founded in 2006 to facilitate HIT adoption and health information exchange in the State of New York. Leveraging IHE work, the workgroup created guidelines and specifications “to promote a scalable approach that allows for rapid deployment at an affordable price, thereby expanding market opportunities for vendors”. Around the same time, Mayo Clinic, Geisinger, Kaiser Permanente, Intermountain Healthcare and Group Health formed the Care Connectivity Consortium (CCC) to “demonstrate that effective and timely health information exchange using the latest national IT standards is possible in a secure environment and among geographically disparate health care providers”. Things were beginning to heat up.

In May 2012, the ONC requested public comments on its strategy for governing health information exchange through its NwHIN. The ONC envisioned a set of Network Validated Entities (NVEs), similar to the Direct email intermediaries, Health Internet Service Providers (HISPs), specifically built for, or specializing in, the exchange of health information, and it outlined policies and regulations to be adhered to by participants in information exchange as “conditions for trusted exchange” (CTE). By October 2012, the ONC decided to transition the NwHIN community management to a new public-private entity named Healtheway and rename it eHealth Exchange. Almost immediately, Healtheway formed a Coalition with the NyeC spawned IWG to combine harmonization of standards and market share. The next step was an announcement that the Coalition selected CCHIT to “certify that the interfaces between the HIT and HIEs are consistent across multiple states and systems”. 2012 also saw the creation of DirectTrust, an entity whose goal is to “to develop, promote and, as necessary, help enforce the rules and best practices necessary to maintain security and trust within the Direct community, and to foster widespread public confidence in the Directed exchange of health information”. In December, ONC announced its intention to provide grant funding to “entities already involved in governance of health information exchange” and forgo its own regulatory plans.

During the 2013 HIMSS season, the Coalition announced a collaboration agreement with the CCC to take advantage of the CCC “advanced services that address the complexities of patient matching, consent management and, eventually, population care”, and CCHIT announced three new certifications, one for EHRs connecting to HIEs, one for HIE to HIE connectivity and one for Direct users. Across town, DirectTrust, in partnership with the Electronic Healthcare Network Accreditation Commission (EHNAC), announced its Direct Trusted Agent Accreditation Program, DTAAP, for HISPs, Certificate Authorities, and Registration Authorities, which may or may not be EHR or HIE vendors. Also at the HIMSS extravaganza, a new Alliance, consisting of several very large EHR vendors, named CommonWell entered the interoperability fray, announcing its plans “to promote and certify a national infrastructure with common standards and policies” and to “ensure that products that display the CommonWell Health Alliance seal have been certified to work on the national infrastructure”.

It is important to note that, all the organizations described here (except the government, of course) are not for profit corporations and most are supported by government grants to certain degrees.  They all charge, or plan on charging, some sort of membership and/or subscription fee, and by my last count at least three of them plan on offering, and charging for, certifications of software products used to exchange health information in any way. Also interesting is the fact that HIT vendors are participating in multiple organizations, so for example an EHR vendor can be part of both the Coalition and the Alliance, or part of none. Fortunately though, most leaders of these new entities, are currently, or were in the past and presumably will also be in the future, involved in the various ONC regulatory and technology specification activities.
The factions described here are by no means the only actors in the health information exchange game. Such revered standards organizations as HL7, NCPDP and ASC X12, who have been supporting practically all health care interoperability efforts on their own for many years, or the various international open standards groups, or the hot new BlueButton initiative, are not really contenders for what’s at stake here, but should be acknowledged for completeness sake. 

So last week, ONC picked its favorites and granted less than half a million dollars, split between DirectTrust and the IWG, and their partners, to bolster their existing attempts at governing the national exchange of health information. Congratulations to both.

What does this all mean? I am not sure. Season 13 looks promising, and your guess is as good as mine. I just like watching the cute little flame-throwing dragons…

Game of Interoperabilities

According to a Kaiser Family Foundation poll earlier this month, it seems that three years after its passage, opinions about the Patient Protection and Affordable Care Act of 2010 (ACA) remain divided. Interestingly, since the fall elections, Republicans seem to be slowly warming up to the ACA, while Democrats and Independents are experiencing significant disenchantment. I wonder why… So what do people dislike most about Obamacare? Obviously the individual mandate to buy insurance takes first place, and in a typical Stockholm syndrome manifestation, the second most disliked Obamacare feature is penalties for large employers that do not provide health insurance. But there are lots of other things in the law that most people seem to like. They like tax breaks for small business, closing the “doughnut hole” for Medicare prescriptions, keeping adult children on parents insurance and they like subsidies to buy insurance on the new exchanges. People even like the Medicaid expansion, and of course they like the guaranteed issue insurance. President Obama himself feels very strongly about the guaranteed issue clause as he forcefully stated in his 2011 State of the Union address: “What I’m not willing to do -- what I’m not willing to do is go back to the days when insurance companies could deny someone coverage because of a preexisting condition”. Right. So I guess we’ll have to go back to somewhere else.

In November 2012 the Departments of Health and Human Services (HHS), Labor and the Treasury jointly released proposed rules to increase the permissible “rewards” for participation in a “health-contingent wellness program” from 20% to 30% of the cost of coverage (and up to 50% for tobacco use cessation programs). In other words, for group insurance markets, consisting of insurers and large employers, people can be charged up to 50% more for coverage, based on certain health contingencies. And what are these contingencies? In order to avoid the withdrawal of said “rewards”, one only has to participate, voluntarily of course, in “wellness programs that require an individual to attain or maintain a certain health outcome in order to obtain a reward (such as not smoking, attaining certain results on biometric screenings, or meeting targets for exercise)”. And if the employee has coverage for a spouse or children, the same “health-contingent” opportunities are available to the family, although no clear decision has been made whether to penalize the entire family, or just baby Kyle, if he fails to get his BMI under the evidence-based recommended standards. To protect “consumers” from something that looks very much like wanton discrimination, the proposed rule sternly (and ad nauseam) requires that these schemes must be “reasonable”.

To be fair, “absence of rewards” based on health-contingent wellness programs, have been permitted since 2006. The new rule just increases the allowed size of rewards that can be withdrawn by group plans from 20% to 50%. By the document’s own admission there is no evidence showing that these wellness programs are effective and the Departments do not expect too many people to actually enroll. The cost analysis in the proposed rule expects minimal benefits and minimal costs and transfers, falling mainly on individuals who fail to meet “standards”. So if the benefits are expected to be “minimal”, why are we promulgating new rules? Well, there is a little math that needs to be considered here. Prior to the brave new world of ACA, large employers and group plans were prohibited from denying coverage or jacking up prices based on an employee’s preexisting conditions, and as long as an individual and his or her family maintained continuous group coverage, preexisting conditions were not a material factor. Preexisting conditions were an onerous consideration for those shopping for health insurance in individual markets. Since the ACA prohibits insurers from severely overcharging a few sick people, perhaps we can slightly overcharge many people and still come out ahead. For this to work we need to find some acceptable criteria for overcharging people, and taking a lesson from Don Corleone, we need some “buffers” to scour HIPAA protected employee health information.

So how about being fat, or being a smoker, or being a non-compliant patient? Unlike being black, or being female, or being gay, which were all acceptable criteria for discrimination at one time or another, obese smokers who look bad and smell bad seem like a reasonable place to start withdrawing “rewards”. If this becomes acceptable, and if the financials look promising, we can move on to the other possibilities of a “health-contingent wellness program” (i.e. “A program that uses a biometric screening or a health risk assessment to identify employees with specified medical conditions or risk factors (such as high cholesterol, high blood pressure, unhealthy body mass index, or high glucose level) and provides a reward to employees identified as within a normal or healthy range for biometrics (or at low risk for certain medical conditions), while requiring employees who are identified as outside the normal or healthy range (or at risk) to take additional steps (such as meeting with a health coach, taking a health or fitness course, adhering to a health improvement action plan, or complying with a health care provider's plan of care) to obtain the same reward”). Now that we have a hunting license for previously forbidden grounds, we can take away “rewards” from people with not only preexisting conditions, but also from those with non-existing conditions that may develop into preexisting conditions at some unspecified future date. So for example, if your health risk assessment states that inability to sleep due to financial concerns is most likely to lead to depression when your wages are cut again, and if you refuse to comply with the Cymbalta plan of care dictated by a health care provider, or refuse to provide evidence of such compliance, or are unable to pay your high deductible for the drugs, no “rewards” for you.

According to the United States Census Bureau, there were over 120 million people employed in 2008 in the U.S., and over 61 million of them were employed by the 18,000 firms with more than 500 employees. In other words, over 50% of American workers are employed by the 0.3% of firms that are considered large employers. Other than this statistic being frightening on its own, it also illustrates the magnitude of potential returns from withholding small to medium “rewards” from workers not adhering to “standards”. A quick back of the napkin calculation (assuming 30% non-standard workers and dependents, not rewarded to the tune of $1000 per year) yields approximately $20 Billion per year transferred from increasingly poor working people to large corporations. It’s not a fortune when divided up between all corporate interests involved, but I bet it’s better than what they made from the preexisting conditions racket.

This takes care of the money, but how about saving lives? Is it possible that the “health-contingent” wellness games actually save lives? In an article in the March 27 issue of NEJM, several researchers funded by big corporations and holding equity in a very big corporation, argue that indeed “these policies may also save lives”, and not just the wellness rewards, but also flat out not hiring people who for example are smokers, because “in the long run, such policies may indeed be for their own good”. Yes, reducing already depressed wages, and unemployment in general, have been repeatedly shown to be good for you, in the long run, and to have most beneficial effects on your overall health. To paraphrase Marine Colonel Nathan Jessup in A Few Good Men, while grotesque and incomprehensible to you, these policies save lives! …and money. People who become unemployable due to legal, but very stupid, lifestyle choices will either end up on Medicaid, where taxpayers will pay private corporations for their care, or buy insurance on the new ACA exchanges, where taxpayers will subsidize their purchases from private corporations. Win-win.

Another NEJM article in the same issue, written by Dr. Ezekiel Emanuel and colleagues, attempts to bring ethical concerns into this purely financial conversation, and incidentally sheds some light on one implementation of the “health-contingent” shell game. The article ends with a heart wrenching appeal to employers to be compassionate and supportive of employees, if not for ethical reasons, then maybe just because “employees who feel supported will probably be more productive than will those who live in fear of penalties”. I thought it was our elected government’s job to make sure that law abiding American citizens, including those who work for a living, don’t live in fear, but times are changing, and with a substantially broader and more diverse base, we are back pretty much were we started:

“I hold then, that there never has yet existed a wealthy and civilized society in which one portion of the community did not, in point of fact, live on the labor of the other. Broad and general as is this assertion, it is fully borne out by history. This is not the proper occasion, but, if it were, it would not be difficult to trace the various devices by which the wealth of all civilized communities has been so unequally divided, and to show by what means so small a share has been allotted to those by whose labor it was produced, and so large a share given to the non-producing classes. The devices are almost innumerable, from the brute force and gross superstition of ancient times, to the subtle and artful fiscal contrivances of modern. I might well challenge a comparison between them and the more direct, simple, and patriarchal mode by which the labor of the African race is, among us, commanded by the European. I may say with truth, that in few countries so much is left to the share of the laborer, and so little exacted from him, or where there is more kind attention paid to him in sickness or infirmities of age. Compare his condition with the tenants of the poor houses in the more civilized portions of Europe--look at the sick, and the old and infirm slave, on one hand, in the midst of his family and friends, under the kind superintending care of his master and mistress, and compare it with the forlorn and wretched condition of the pauper in the poorhouse.” --John C. Calhoun February 6, 1837

The Shell Game of Health-Contingent Insurance

Continuing our fantasy journey towards a patient care oriented EMR for primary care physicians, let’s quickly recap our progress. After much ado about nothing, we came up with the following set of requirements in Parts I and II:
  1. System shall assist with gathering information from various sources (TBD) at the point of care
    1. System shall assist with information recording at the point of care (needs more specificity)
    2. System shall retrieve and accept information from external sources
    3. System shall respond to all external legitimate requests for information
    4. System shall have the ability to access published clinical information (consider buying)
  2. System shall assist with synthesis of said information
  3. System shall assist with patient-doctor relationship building
  4. System shall not make the task harder to perform for the user
In the real world of software design, this would be a good place to seek validation for our thought process. We can do that here too although we have no real users. A recent issue of JAMA Internal Medicine contains several papers dealing with misdiagnosis in primary care. The main study conducted at the VA concludes the following: “Diagnostic errors identified in our study involved a large variety of common diseases and had significant potential for harm. Most errors were related to process breakdowns in the patient-practitioner clinical encounter. Preventive interventions should target common contributory factors across diagnoses, especially those that involve data gathering and synthesis in the patient-practitioner encounter [emphasis added]. In particular, those process breakdowns were mostly related to “taking medical histories, performing physical examinations, and ordering tests”. If you reread Part II in particular, it seems that we are on the right path. Although the study attributes these problems to the “relatively brief encounters” now common in primary care, neither the study authors nor the invited commentary dare suggest that we allow proper time for each encounter. Instead, the search is on for all sorts of methodologies, checklists, “metacognitive retraining”, and finally mandatory, structured recording and coding of presenting symptoms, rather than simply diagnoses, in our electronic health record systems” [emphasis added]. All this “without dramatically reducing efficiency”, i.e. without increasing the time a primary care doctor is allowed to spend with a patient. Here we are reminded of the common wisdom of software developers that suggests asking users to describe their problems, but never, ever, allow them to come up with solutions.

No more beating around the bush then. At this point we must tackle information recording at the point of care, or as fondly known by its practitioners, data collection (usually followed or preceded by unprintables). Note that we are insisting on usage of the term “information” instead of “data”. As far as computers are concerned, information comes in only one flavor: zeros and ones. We, on the other hand, have become accustomed to defining information as structured or unstructured, where structured information is considered computable, i.e. it can supposedly be analyzed by computers. This however, is not a material difference because computers can analyze all information to various degrees, depending on analyzing software capabilities. Primitive software is only capable of analyzing information provided in a predefined (in the software) content and format, but as software science advances, computers are becoming less dependent on the user to predigest and preformat their input into the software (at one time, you actually had to enter electrical signals for ones and zeros in order to have the computer do anything useful). So the structured vs. unstructured information debate is all about yesterday’s computers vs. tomorrow’s computers. We will build our imaginary EMR for tomorrow’s computers, some of which are already here today. This is our first technology decision: We are requiring a contextual parser and processor of information that can accept input from all known modalities (keyboard, mouse, microphone, camera/video, stylus, touch/gestures, and electronic interface). Here we refer to our #1-d requirement, which seems pertinent, and task an imaginary system analyst to call IBM.

We still have to design the front end though, so information from the encounter can be transferred to our hopefully smart processor. We are reminded of our tongue in cheek #4 requirement (or constraint really), and in order to fulfill this requirement, we will need to evaluate how our users currently document encounters, with the understanding that a large number of physicians are not using computers to document, and an even larger number of doctors use computers and hate doing so. Hence, our gold standard, or limiting factor, for #4 is the paper chart. But even the paper chart comes in all sorts of shapes and flavors:
  1. Blank sheet of paper allowing free hand documentation
  2. Structured forms with predefined questions, which may contain one or a combination of:
    1. Questions with predefined multiple choice answers
    2. Open ended questions 
    3. Room for free hand written answers
    4. Room for free hand notes
    5. Anatomical drawings for annotation
  3. Dictation devices allowing transcription of voice summaries into the chart
  4. Abstracted lists of factors deemed important (medication list, problem list, allergies, etc.)
Simple electronic versions of charts have not done much other than replace hand writing with keyboard typing and mouse clicks. For physicians who type well and are relatively comfortable with computers, or those who routinely dictated everything, these simple EMRs did not violate our #4 requirement. The more elaborate EMRs, took upon themselves the noble task of speeding up the documentation task (years ago there used to be speed contests between EMRs at trade shows). And they did that by using electronic stilts. If you ever tried as a child to master circus stilts, then you know that they allow you to take much longer steps and cover a lot more ground in shorter times. The caveat though is that you will most likely experience several bruising falls while you train yourself to use the stilts, and that you can only use them for short periods of times on perfectly flat surfaces. The flexibility built into your legs and feet by millions of years of evolution, enabling you to see and respond to details and uneven ground is pretty much gone, so if you try to use circus stilts in everyday life, you will probably find it to be a handicap rather than an advantage. What we really need is shoes. Walking shoes, hiking boots, tennis shoes, cleats, basketball shoes and maybe ballet slippers, all in different sizes and widths, colors, materials, support and price ranges. For primary care, we likely need a good pair of cross trainers.

Most software programs can be divided into three parts, or layers: the data layer, where all the information is stored, the display layer, which is what users see and interact with, and the business layer, which controls the application and is the de facto processing brain of the software. As is the case with people, the beauty of software comes from within. Usability of software products is much more dependent on the intelligence and abilities of the controller brain than it is on the lipstick of the display. The things that are causing heartburn to current EMR users were created precisely to compensate for the feeble brains of the software. Since we already made a technology decision to splurge on the best and most sophisticated software brain available, we will abstain from stealing valuable time from the patient and from the art of observation. Additionally, we will not attempt to shorten the time required for a physician to record observations in brief and plain language (as difficult as that may be). We note here that unlike other professions, historically, physicians did not employ stenographers during patient encounters and recording observations was very much part of the science of medicine. Therefore our information gathering user interface will have the following features and functionalities available:
  1. Ability to record and translate to text all verbal exchange during a patient encounter. This includes the ability to identify the parties engaged in dialog and appropriately classify the information as objective or subjective (patient reported), and the ability to accept addenda to an encounter through multiple modalities (in case you are wondering, this technology already exists).
  2. Ability to accept electronic input from all medical equipment used in the practice, without any human intervention.
  3. Ability to create electronic forms dynamically, from scratch or based on scanned paper forms, including drawings, and ability to modify these as needed.
  4. Ability to accept input from keyboard, mouse, pen/stylus and voice for all form fields without exception and without prior setup or notice.
When correctly combined the last three functionalities should do no more than transport the paper chart methods of documentation to a computer screen, nothing more than a glorified Microsoft Office for medicine, while the most difficult functionality in #1 should provide our intelligent processor the context necessary to augment and perhaps in due course replace the need for deliberate documentation. Note that we are in no way restricting our users to a particular subset of their natural language. Somewhere deep in the bowels of our contextual processor there will be vocabularies, ontologies, terminologies and synonyms, but our imaginary development team does not believe that it is the responsibility of the user to adapt to the machine. We are on a quest to develop intelligent machines, not robotic people.

I can practically see the raised eyebrows of those who want to measure, analyze and provide clinical advice to practicing physicians, contending that most EMRs fail to be useful precisely because they are just electronic paper charts. Strangely enough the much touted electronic media and all its blogging/social media offshoots are doing quite well in spite of being just electronic newspapers and pamphlets, and this revolutionary transition would have failed miserably if we required authors to create content from dropdowns and checkboxes. The true power of transitioning paper to electronic media comes from the inherently better accessibility and portability of electronic media, and from the ability to insert ever improving computerized synthesis underneath the familiar look and feel of paper. As we move on to our #2 requirement and define our specifications for synthesizing and serving information, it should become apparent that although inconveniencing the user is one solution to the very difficult problem of information synthesis, it is most likely not the best solution.

We did not cover here in any detail the exchange of information imposed by 1-b and 1-c, since simple technologies for both functionalities exist today, particularly if we don’t insist on specific structures for our exchanged content, and we are not.  Since our 1-a requirement proved to be a handful, and we only scratched the surface in most general terms, we will postpone discussion on requirement #2, which includes not only intelligent synthesis of information, but also serving the results to users at the right time and in the right place, to Part IV, and we will add Part V to deal with the fuzzy requirement expressed by #3. We have a long road ahead of us, and this is just make believe design...

De Novo EMR Design Part III: Computer… Computer… Hello Computer…

We spend a lot of money on health care in the U.S., but we spend a lot of money on other amenities as well, so how do we know if we are spending too much money on health care? The phrase too much implies a frame of reference and some sort of valuation; too much for too little value, or too much compared to others, or both. Leaving aside the ideology of who should pay for what, the only thing that is increasingly obvious is that other developed nations, a natural frame of reference, are spending at most two thirds of what we do and their health results are as good, if not better than ours. You would think that the next logical step would be to observe how these other nations finance and deliver care, and apply lessons learned to our system, and there is no shortage of observational studies, surveys and reports.

Since health care is a huge and complex beast, perhaps the best place to start is primary care, which, as its name implies, should be the point of entry into any health care system. As it turns out, the Commonwealth Fund has a great survey of primary care physicians administered in various developed countries around the world, and in 2012 they published the latest one in Health Affairs. The survey includes 11 developed countries, Australia, New Zealand, the United Kingdom, France, Germany, Switzerland, the Netherlands, Norway, Sweden, Canada and the U.S. The international primary care survey can be broken down into areas pertinent to the trifecta of our health care reform efforts: provide insurance coverage to all citizens to improve access and reduce financial barriers to care, measure health care delivery and reward quality performance, use health information technology to enable cost-effective health care.

Health IT – The computerization of health care through EHR adoption and interoperability in particular are at the forefront of any health care conversation nowadays. It should be interesting to see how the U.S. compares with all those more efficient nations in this area. Rearranging the Commonwealth Fund survey results to gain a better visual understanding, here is how Health IT looks across global primary care. [Note: countries are sorted top to bottom in descending order of per-capita health care expenditures, with the U.S. at the very top of each chart.]

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There seem to be countries more advanced in adoption and availability of Health IT amongst primary care physicians, but there are also plenty of other developed countries that lag behind the U.S. The same is true for online patient access and exchange of clinical information between care facilities. Note that the exchange of discharge summaries and specialist reports does not necessarily imply the existence of EHR interoperability as we define it, and as we bemoan its non-existence, in the U.S. The survey only asked if the information was available, not how it was made available. Another observation we can make is that our three graphs do not exhibit the same behavior, which means that nations that have high EHR availability are not necessarily better at exchanging clinical information or at giving patients online access to basic transactions. We could go on and examine each data point in detail, but the immediate conclusion must be that there is practically no correlation between Health IT, including exchange of clinical information, and the cost-efficiency of health care in this cohort. We should also note that there is no one metric for which the U.S. ranks dead last.

How about quality? Is there a correlation between advanced health IT and better quality of care? The primary care survey does not provide an answer, so we add the 2012 OECD health care costs, utilization and outcomes data report, and pick a comprehensive measure such as Mortality Amenable to Health Care. France, which has the lowest rates of such mortality is also one the countries with less than stellar health IT, while the UK and New Zealand which are armed to the teeth with EHRs have some of the highest avoidable mortality rates. Obviously the U.S. is worse than any other developed OECD country.

Measuring and paying for quality – This is the other major campaign conducted by CMS because it makes sense to “align incentives” and replace “volume with value”, which is another name for reducing utilization of services across the board. Of course, only financial incentives are considered, because innovative modern thought does not recognize any other types of incentives.

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Here we see an interesting picture. While the U.S. is comfortably in the upper middle of the pack when it comes to measuring performance, it is also one of the stingiest when it comes to actually paying out incentives. Either way, the U.S. is not an outlier for any of the metrics included in this category. Similar to Health IT, countries who measure more and/or pay out more incentives are neither less expensive nor do they have better quality metrics.

Access and Barriers to Care – The common wisdom says that nations with universal health care, a.k.a. socialized medicine, are by definition doomed to suffer from poor access to care, such as long waiting times for appointments. In contrast, countries where health care is market driven will have no queues and no shortages. Unfortunately, since we all live here in addition to just looking at graphs, we all know that some doctor appointments are not as abundant as we would like, and the graphs below confirm this perception.

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First, it seems that obtaining care after business hours is much harder in the U.S. than in any other country, while the ability to see a primary care doctor at short notice in the U.S. is middling at best. On the other hand, obtaining a specialist appointment requires less waiting in the U.S. compared to most other countries, but not all (the Swiss and the Dutch do better on all counts).  When it comes to financial barriers to care the U.S. reigns supreme as 59% of America’s primary care docs report that their patients often have difficulty paying out-of-pocket costs. Another uniquely American barrier to care is posed by insurance coverage restrictions which create major time concerns for U.S. doctors.

So where is our quasi-scientific discussion taking us so far? Health IT does not seem to be a significant differentiator between the U.S. and the more efficient countries surveyed, and neither is measuring performance, or quality. Incentives for personalized services such as chronic care and home visits are generally lower in the U.S., and so is timely access to primary care doctors. Compounding an existing access problem are the significantly higher financial difficulties of Americans to pay for health care services, and restrictions on medical practice imposed by insurers. Comparing these observations with the stated goals of health care reform in the U.S., one would be inclined to conclude that other than extending health insurance coverage to all U.S. citizens, we are pretty much wasting our time and resources, if our goal is to achieve the better results enjoyed by other developed nations.

This is not to say that computerizing medical records, exchanging clinical information, or providing electronic services to patients, are not worthwhile endeavors, but we should understand that investments in Health IT are not related to either reducing health care costs or improving quality at this point. It seems logical, and we can certainly hope, that better IT will lead us to health care improvements, but hope is all it is, and there is no real evidence to support this assertion, given the current state of technology. Investments in Health IT should be viewed as a long term proposition, definitely worth researching and exploring, but expensive and often centrally planned massive Health IT deployments have been anything but cost-effective not just in the U.S., but also in the UK and Australia.   

Timely access to primary care is often discussed in the U.S. and largely attributed to a shortage of primary care physicians. Why the richest country in the world, who pays the most to its physicians, is experiencing a shortage of doctors reminiscent of third world countries, particularly in an era of globalization and workforce mobility, remains a mystery to me. Even more mysterious are the proposed solutions to said shortage, such as redefining primary care away from traditional doctors to less educated resources and other professions such as pharmacists and optometrists. Here is something to ponder for those considering moving the goal posts of primary care: in the Netherlands, for example, approximately 4% of primary care visits result in referrals to secondary care.

Our obsessive-compulsive efforts to measure performance of primary care is a slightly different problem because we are approaching measurement with a clear intent of reducing service utilization, as in “replacing volume with value”, fully knowing that U.S. utilization is already lower than most other countries (with a few notable exceptions that should be addressed individually), and with a non-existent definition of “value”, other than mid-point process metrics. However, paying primary care physicians for value added activities such as chronic care management (with or without a quality component), or for making house calls, should probably exceed the levels paid in other countries considering the higher prevalence of chronic disease in the U.S. and its disproportionate contribution  to total health care expenditures.

And while we’re on the subject of volume and value, it may be useful to peruse the Appendix of the Health Affairs article and/or another great Commonwealth Fund report, International Profiles of Health Care Systems, 2012, and see how the scourge of fee for service in the primary care cottage industry is dealt with in countries with lower costs and better health outcomes. Surprisingly, in all but one tiny nation, primary care is delivered by physicians in small private practice, paid mostly fee for service, and this includes bastions of government run health care like the UK and Canada. Perhaps the architects of health care systems in those countries understand that a system without checks and balances is bound to spiral out of control, and perhaps they understand that independent primary care, serving in the dual role of medical advisor and patient advocate, provides exactly the checks and balances required in every healthy system.

Around the Primary Care World in 80 Seconds