Bionic Body Bliss

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Rethinking How U.S. Healthcare Policy Approaches the Mouth

By MARKO VUJICIC, MD

Dental care has traditionally been financed and delivered separately from medical care. This is despite the Surgeon General’s report in 2000 that emphasizes the importance of oral health to whole body health. Now, new data show the consequences of the approach taken in U.S. health care policy to oral health.

Medicaid Children Seeing Big Gains in Access to Dental Care

The American Dental Association Health Policy Institute (HPI) recently launched The Oral Health Care System: A State-By-State Analysis. This first-of-its-kind data repository brings together data from multiple sources related to oral health and is meant to serve policy makers and researchers. One of the most significant findings from these data is that access to dental care has been increasing steadily among Medicaid children for more than a decade.

Nationally, the percent of Medicaid children who visited a dentist within the past twelve months went from 29% in 2000 to 48% in 2013, the most recent year for which data are available. What is striking is that the trend is remarkably widespread across states, with all but one state experiencing gains over this time frame. As a result, the gap in dental care utilization between Medicaid- and privately-insured children has been shrinking steadily. In fact, it narrowed in every single state for which we have data between 2005 and 2013 (see figure below). There are two states – Hawaii and Texas – where there is actually a “reverse gap”: children enrolled in Medicaid are more likely to visit a dentist than children who have private dental benefits. Moreover, this progress has all been happening during a time when the number of children enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) has been rising steadily. In 2013, nearly four out of ten children in the U.S. were enrolled in Medicaid or CHIP compared to two out of ten in 2000.

Title of Figure: Gap in Dental Care Utilization Between Medicaid-Enrolled Children and Children with Private Dental Benefits, 2005 and 2013

Source: Vujicic M, Nasseh, K. Gap in dental care utilization between Medicaid and privately insured children narrows, remains large for adults. Health Policy Institute Research Brief. American Dental Association. December 2015. Available from:

Trends for Adults Are Much Different

In contrast, the trends for adults are very different. The gap in dental care use between Medicaid- and privately-insured adults is much wider than it is for children and has actually increased in several states in recent years. Adults – especially Millennials – are nearly three times more likely than children to report avoiding dental care they need because of cost. In fact, one out of four low-income adults report that they have avoided dental care they needed in the past year due to financial reasons.

Dental care presents affordability challenges to adults to a much greater degree than any other type of health care service. Emergency room visits for dental conditions in the U.S. are on the rise, a trend that is being driven entirely by young adults.  Even among adults with private dental benefits, dental care use is declining in most states and the number one reason adults with private dental benefits do not visit the dentist is cost.

The barriers to dental care that adults face are leading to some troubling physical, social, and emotional effects. New data show that more than one out of three low-income adults say they avoid smiling and 17 percent report difficulty doing usual activities because of the condition of their mouth and teeth. Nearly one out of four low-income adults and 14 percent of all adults report that their oral health issues have led them to reduce participation in social activities.

Where Do We Go From Here?

Looking forward, policymakers and the research community ought to focus on three things to address some of the key challenges facing the U.S. oral health care system.

First, there needs to be a continued and sustained focus on implementing evidence-based policies when it comes to access. The states with the largest gains in access to dental care among Medicaid children over the past decade are those that implemented comprehensive, multi-pronged reforms. For example, Connecticut, Texas, and Maryland reformed their Medicaid programs by focusing on provider and Medicaid beneficiary outreach, provider reimbursement increases,innovations in care delivery models, and streamlined administrative procedures and saw remarkable improvements. It is important to note that the improvements in access to dental care in these three states, as well as others, did not involve any major increase in the number of dental care providers. In fact, there is strong evidence that there is significant excess capacity in the dental care system today. Nationwide, one out of three dentists report they are “not busy enough and can see more patients” suggesting that policymakers ought to focus on interventions that leverage existing unused capacity.

Second, there need to be a rethink of how oral health is defined and measured. The current focus of many government agency data collection efforts, for example,is to measure the presence and severity of dental disease and the frequency and type of dental care services people use. There is very little emphasis, in contrast, on measuring the contribution of oral health to physical, social, and emotional well being. These are the ultimate outcomes of interest that any dental care delivery system ought to be designed around. The new measures of oral health status recently developed by HPI are a significant advancement in this area but are meant to be a starting point for others, including the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality, to build on. A robust oral health status measurement system would also enable a shift toward outcomes-based delivery and reimbursement models, a critical future direction in health care in the United States.

Third, policy makers need to reconsider how dental care for adults is handled in state and federal policy. Within Medicaid, adult dental benefits are optional and most states provide only basic coverage. Under the Affordable Care Act, dental care for adults is not considered “essential” and thus, dental benefits coverage is not part of the individual mandate. Implementing a comprehensive dental benefit for Medicaid adults in the 22 states that currently lack one is estimated to cost $1.6 to $1.8billion per year. The estimated state portion of this bill translates to about 1 percent of total Medicaid spending. Compare this to the $1.6 billion spent each year on hospital emergency room visits for dental conditions, one third of which is paid for by Medicaid. Newly published research from the NBER suggests that the dental care system has the capacity to absorb the spike in demand for dental care arising from large-scale expansions of dental benefits to Medicaid adults. There are also numerous state experiences to draw on that serve as good practices in managing adult dental benefits in Medicaid. Beyond Medicaid, insurers are approaching dental benefits for children and adults differently within the health insurance marketplaces. While more and more private medical insurance plans in the health insurance marketplaces are covering dental benefits for children, there are far fewer options for adults. This is despite the fact that dental care is a high priority among adults, especially young adults,who are shopping for health insurance.

As a former U.S. Surgeon General said, “you can’t be healthy without good oral health.” There is emerging evidence that oral health is related to conditions outside of the mouth, like diabetes, pregnancy, and even mental health. Health care policy in the United States clearly emphasizes the importance of oral health for children. It might be time to reconnect mouth and body for adults.

Marko Vujicic is Managing Vice President, Health Policy Resources Center at the American Dental Association where he is responsible for overseeing all of the Association’s policy research activities. Prior to joining the American Dental Association, he was Senior Economist with The World Bank in Washington D.C. where he directed the global health workforce policy program. He was also Labor Economist at the World Health Organization in Geneva, Switzerland.

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Congress Has a Drug Problem

By BRIAN KLEPPER

The Congressional committee that recently demanded Martin Shkreli’s appearance must have hoped to spotlight a smug jerk responsible for the outrageous prescription drug pricing that we’re all up against. Of course there are lots of Shkrelis running drug companies, but most are shrewder and less brash, and might not make for such good theater.

Rep. Elijah Cummings (D-MD), one of the Committee’s questioners, seemed to think that his witness could move healthcare forward by disclosing the machinery of the drug sector’s excesses. “The way I see it, you could go down in history as the poster boy for greedy drug company executives or you could change the system. Yeah, you.”

Excessive treatment and cost are at the core of the entire U.S. healthcare crisis. The fact that other societies and a few innovative firms here consistently deliver equal or better quality care at dramatically lower cost betrays the idea that conventional U.S. healthcare is necessarily superior or even appropriate.

Every part of healthcare is guilty, but the pharmaceutical sector is a case in point. An open record of lobbying spending and what pharma has obtained from Congress makes clear that its contributions have worked to that sector’s economic advantage and against the interests of American patients and purchasers.

Open Secrets data show that, between 1997-2015, Congress accepted $3.3 billion in campaign contributions from the pharmaceutical/health products sector, 43% more than they received from insurance, the second most politically influential industry. That averages out to about $181 million annually over that 18-year period, or a stunning $411,000 per legislator per year.

These numbers are chump change compared to the drug market. At $985 per person in 2011, the U.S. has the world’s highest drug spend by far, more than double what other developed countries pay on average ($483) for approximately the same benefit. In 2015, the U.S. had aggregate prescription drug sales of $374 billion. In other words, we spent about $190 billion more on drugs last year than other industrialized countries would have for the same population. And this figure is deceptively low, since 20-30% of Americans remain uninsured or underinsured, and can’t afford drugs and other treatments.

This excessive drug spending was stoked by a lobbying investment totaling only $235 million in 2015, or just 0.06% of that year’s total prescription drug spend. Evidently, when an industry sector works at scale, policy can be influenced incredibly cheaply.

 But policies forged in the special interest yield shamelessly conflicted mechanisms. For example, once a drug is approved by the Food and Drug Administration (FDA), the drug’s manufacturer can set virtually any price it wishes without a rationale tied to the cost of development, the drug’s value to patients, or what is paid in other countries for the same drug. How does that play out? Consider Gilead’s cure for Hepatitis-C treatment, Sovaldi. At $1,000 per pill, the cost has wreaked havoc on health plan budgets and dramatically curtailed patient access to the drug. Meanwhile, the same drug is available for $11 per pill in Egypt and $4 in India.

A related head scratcher is Congress’ prohibition against Medicare negotiating drug prices. The government must pay whatever price is demanded on behalf of millions of subsidized patients using that drug. From the vendor’s perspective, it’s hard to imagine a better deal than having the purchaser let you set any price and then unreservedly guarantee that the bill will be paid.

Drug policy has become emblematic not only of the larger healthcare cost problem, but of a deeply dysfunctional Congressional practice that threatens patients’ interests and our nation’s long-term economic stability. Candidates Clinton, Sanders and Trump have vowed to address Medicare’s prohibition on drug pricing negotiation. Anticipating a challenge to the status quo, pharma has already launched a well-funded campaign that targets 7,000 policy influencers. The worry is that, unless something changes, we already know whose side Congress is on.

The Shkrelis.

Brian Klepper is a health care analyst and a Principal in Health Value Direct.

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[bionicbodybliss]

Rethinking How U.S. Health Care Policy Approaches the Mouth

By MARCO VUCIJIC

Dental care has traditionally been financed and delivered separately from medical care. This is despite the Surgeon General’s report in 2000 that emphasizes the importance of oral health to whole body health. New data show the consequences of the approach taken in U.S. health care policy to oral health and dental care.    

Medicaid Children Seeing Big Gains in Access to Dental Care

The American Dental Association Health Policy Institute (HPI) recently launched The Oral Health Care System: A State-By-State Analysis. This first-of-its-kind data repository brings together data from multiple sources related to oral health and is meant to serve policy makers and researchers.  One of the most significant finding from these data is that access to dental care has been increasing steadily among Medicaid children for more than a decade.

Nationally, the percent of Medicaid children who visited a dentist within the past twelve months increased from in 29% in 2000 to 48% in 2013, the most recent year for which data are available. What is striking is that the trend is remarkably widespread across states, with all but one state experiencing an increase over this timeframe. As a result, the gap in dental care utilization between Medicaid- and privately-insured children has been shrinking steadily. In fact, it narrowed in every single state for which there are data between 2005 and 2013 (see figure below). There are two states – Hawaii and Texas – where there is actually a “reverse gap”: children enrolled in Medicaid are more likely to visit a dentist than children who have private dental benefits. Moreover, this progress has all been happening during a time when the number of children enrolled in Medicaid and the Children’s Health Insurance Program (CHIP) has been rising steadily. In 2013, nearly four out of ten children in the U.S. were enrolled in Medicaid or CHIP compared to two out of ten in 2000.

Gap in Dental Care Utilization Between Medicaid-Enrolled Children and Children with Private Dental Benefits, 2005 and 2013

Source: Vujicic M, Nasseh, K. Gap in dental care utilization between Medicaid and privately insured children narrows, remains large for adults. Health Policy Institute Research Brief. American Dental Association. December 2015. Available from:

http://ift.tt/1jvppPK.

Trends for Adults Are Much Different

In contrast, the trends for adults are very different. The gap in dental care use between Medicaid- and privately-insured adults is much wider than it is for children and has actually increased in several states in recent years. Adults – especially Millennials – are nearly three times more likely than children to report avoiding dental care they need because of cost. In fact, one out of four low-income adults report that they have avoided dental care they needed in the past year due to financial reasons.

Dental care presents affordability challenges to adults to a much greater degree than any other type of health care service. Emergency room visits for dental conditions in the U.S. are on the rise, a trend that is being driven entirely by young adults.  Even among adults with private dental benefits, dental care use is declining in most states and the number one reason adults with private dental benefits do not visit the dentist is cost.

The barriers to dental care that adults face are leading to some troubling physical, social, and emotional effects. New data show that more than one out of three low-income adults say they avoid smiling and 17 percent report difficulty doing usual activities because of the condition of their mouth and teeth. Nearly one out of four low-income adults and 14 percent of all adults report that their oral health issues have led them to reduce participation in social activities.

Where Do We Go From Here?

Looking forward, policy makers and the research community ought to focus on three things to address some of the key challenges facing the U.S. oral health care system.

First, there needs to be a continued and sustained focus on implementing evidence-based policy to continue to improve access to dental care for Medicaid children. The states with the largest gains in access to dental care among Medicaid children over the past decade are those that implemented comprehensive, multi-pronged reforms. For example, Connecticut, Texas, and Maryland reformed their Medicaid programs by focusing on provider and Medicaid beneficiary outreach, provider reimbursement increases, and streamlined administrative procedures and saw remarkable improvements. It is important to note that the remarkable gains in access to dental care in these three states, as well as others, did not involve any major increase in the number of dental care providers. In fact, there is strong evidence that there is significant excess capacity in the dental care system today. Nationwide, one out of three dentists report they are “not busy enough and can see more patients” suggesting that policymakers ought to focus on interventions that leverage existing unused capacity. 

Second, there need to be a rethink of how oral health is defined and measured. The current focus of many government agency data collection efforts, for example, is to measure the presence and severity of dental disease and the frequency and type of dental care services people use. There is very little emphasis, in contrast, on measuring the contribution of oral health to physical, social, and emotional wellbeing. These are the ultimate outcomes of interest that any dental care delivery system ought to be designed around. The new measures of oral health status recently developed by HPI are a significant advancement in this area but are meant to be a starting point for others, including the Centers for Disease Control and Prevention and the Agency for Healthcare Research and Quality, to build on. A robust oral health status measurement system would also enable a shift toward outcomes-based delivery and reimbursement models, a critical future direction in health care in the United States.

Third, policy makers need to reconsider how dental care for adults is handled in state and federal policy. Within Medicaid, adult dental benefits are optional and most states provide only very basic coverage. Under the Affordable Care Act, dental care for adults is not considered “essential” and thus, dental benefits coverage is not part of the individual mandate. Implementing a comprehensive dental benefit for Medicaid adults in the 22 states that currently lack one is estimated to cost $1.4 to $1.6 billion per year, according to forthcoming research from HPI. The estimated state portion of this bill translates to about 1 percent of total Medicaid spending. Compare this to the $1.6 billion spent each year on hospital emergency room visits for dental conditions, one third of which is paid for by Medicaid. Newly published research from the NBER suggests that the dental care system has the capacity to absorb the spike in demand for dental care arising from large-scale expansions of dental benefits to Medicaid adults. There are also numerous state experiences to draw on that serve as good practices in managing adult dental benefits in Medicaid. Beyond Medicaid, insurers are approaching dental benefits for children and adults differently within the health insurance marketplaces. While more and more private medical insurance plans in the health insurance marketplaces are covering dental benefits for children, there are far fewer options for adults. This is despite the fact that dental care is a high priority among adults, especially young adults, who are shopping for health insurance.

As a former U.S. Surgeon General said, “you can’t be healthy without good oral health.” There is emerging evidence that oral health is related to conditions outside of the mouth, like diabetes, pregnancy, and even mental health. Health care policy in the United States clearly emphasizes the importance of oral health for children. It might be time to reconnect mouth and body for adults. Now that’s a headline.

Marco Vucijic heads research for the healthy policy group of the American Dental Association.

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The 5 Stages of EMR Acceptance (With Apologies to Kubler-Ross)

By FRANK MEISSNER

                                                   DENIAL                    I can’t believe they are making me use this system!

                                                 ANGER                 I CAN’T BELIEVE THEY ARE MAKING ME USE WHAT                       THEY LAUGHINGLY CALL A SYSTEM!

                                                BARGAINING  ‘Look if I agree too willingly and cheerfully use this system, can you ask for and fund these change orders, add these features, re-engineer this screen…..blah! blah!  Blah!, etc. ‘

                                               DEPRESSION  I can’t beeeelieeeeeeve (sob, sob, sob, sob) theeeey (sob, sob, sob) are making meeeee (pouring tears from both eye tear wells) use this system!’ 

                                             ACCEPTANCE             I believe they are making me use this system.  (Resigned Sigh) 

And just as in the original Kubler-Ross model, our only release from EMR agony is death……. an eventuality that I used to accept stoically as inevitable, but now positively look  forward to its release (as do my carpal-ly tunneled wrists!).  Over the last months and the last several years as the deployment of EMR systems have proliferated even the most enthusiastic advocates of electronic documentation have difficulty pointing to any compelling advantages of the EMR systems other than enhanced legibility of charting and improved justification for higher billing. 

The costs are enormous for the front line clinician and his patient struggling to connect across the increasing gulf of random bytes and bits that contain the essence of the second oldest 1:1 relationship on the planet. 

It is perhaps the time of life to romanticize the old in preference for the new. But I don’t think I really suffer from that illness. However, the thing that attracted many of my colleagues, and certainly myself to medicine was the unparalleled opportunity to be autonomous in a respected profession. 

However, the profession has been under systematic assault from outside and within. Furthermore, for my own part, having spent the vast majority of my time as a physician within the US military I have become totally disenchanted (if I ever was enchanted with ) with medicine for profit.

  As an undergraduate mathematics major with a heavy interest in and emphasis in computation theory during my undergraduate days, I was attracted to the field of medical informatics as a resident, just as I was attracted by the physics and mathematics that underlie most of cardiology.

  However, when I learned in my informatics training that 80(+) % of medical costs were driven by physicians decisions, it became axiomatic to me that control of those decisions was a major hidden agenda item in the field. Furthermore, my non-physician informatics mentors, most prominently Reed Gardner failed to ever understand why I would want to look at my own radiological studies since I am not a radiologist, he considered this a waste of energy and effort, and never accepted my own assertion that since I brought the patient to the film, I could (and do) find things in the study either missed or overlooked by my fine radiological colleagues.

   For me the allure of this field medical informatics was how to help myself and others make better decisions, not necessarily make standardized decisions. 

  I am really un-humble, I am an exceptionally good clinician, but then that is all I have done for an average of 12-16 hours a day, every day for about 32 years (wow has it been that long) if I can’t figure out this dance after 80,000 (+) partners I am a slow study.  

  To my eye the current quality initiatives are laughable in their simple mindedness. But the reality of statistical control theory, the soft and unpleasant underbelly of the theory is that the highs, i.e., the exceptional as well as the under performer are both squeezed/regressed to the mean. As some one never content to be within the mean, it makes me mean, and unpleasant at times to be forced towards the just barely acceptable. 

  And that is how every good doctor is feeling right about now with the drive towards poorly designed encounter capture systems (I won’t dignify these monstrous pieces of software by calling them Electronic Medical Records), we are being driven to a pabulum state of consciousness just as our teachers have been driven to teaching the test, we are driven to documentation for billing, not for caring for the patient or for doing an exceptional job clinically. 

   If I compare my professional dictations of yesterday, they were elegant, articulate, crafted with the care a good writer exerts over his/her craft;  But using the charge maximization systems now so prevalent, I can examine the chart with a magnifying glass and not find a recognizable part of my patient within the ‘sameness’ that characterize these infernal charting schemes.

Designed by engineers with the advisement of financial trolls who believe that a complete record is preferable over a patient’s story. For those of us who learned to enjoy the patient’s story and who are replenished and nourished and enchanted by these tales, there is are no real stories anymore. And the price of this de-emphasis on the unique patient in front of you, is higher medical costs, for the other 80% rule in medicine is 80% of the diagnoses are made by history and careful, intelligent, and active listening. The practice of narrative medicine is in my view, the best way to practice no matter what you practice, but the infernal button pushing, needed to be done to get paid, prevents the elucidation of the story at the center of the symptom and as such, results in good billing, but often times the wrong or incomplete answer.

  Especially in my Emergency Department work, much less so in my cardiology practice, the time pressures result in conformity to a standardized and scripted response for the problem at hand since you don’t have the time to produce a hand-crafted thoughtful response to the problem at hand. This becomes disheartening to those of us in the profession who were raised to adhere to a standard in which you did your best for everyone, no matter what the odds or inconveniences or personal sacrifices. But this atmosphere/culture of expected exceptionality has been replaced by ‘is it enough to guarantee maximum return of billing.’

  But at least for me it is the uniformity of the appearance of the products of medical work that is the output of electronic documentation systems that makes it seem like such a soul robbing endeavor. And I believe passionately that true clinical expertise is shown by what you choose to leave out, not put in the story or presentation of the patients case to colleagues.

  Again, my goal here is not to be nostalgic for the old but rather to mirror for the fresh and unprejudiced minds in our mists, that the backlash at EMR technologies being seen among my colleagues does not necessarily represent push back from techno-Luddites but rather can be interpreted as a meaningful critique of the inadequacy of the current systems to support the healer and shaman that is the core personality component of every good doctor I have ever met, trained, or practiced with.

  Existence of preventable medical errors is a feature of all types of practice, and as we well know, as detailed many times by Scott Silverstein (http://ift.tt/1bQvbDw) (also a negative nelly — but than I think in the field of medical informatics you have the choice of two diametrically opposed roles the negative nelly or the cheerleader)  that those who chant the mantra of patient safety seem perfectly content to minimize, ignore, or down play the new and more difficult to detect and prevent errors attendant to use of medical software systems. Classic example of EMR safety failings was the recent EPIC disaster (pun intended) related to the failure of diagnosis of the 1st case of Ebola virus infection in the US. (http://ift.tt/1x3CnWB). ( “Travel Information Wasn’t Communicated In Dallas Ebola Case Due To Electronic Health Record Flaw” (Huffington Post),

http://ift.tt/hFWySe2014/10/02/dallas-ebola-patient-hospital-error-electronic-health-record-flaw_n_5924698.html)

As many do not  know, the most costly software on the planet is Space Shuttle code which costs about $100,000 per line of code, and for which the code has meet the most rigorous software engineering tests, i.e., each line is proven by mathematical techniques to be complete, consistent, and free of unexpected/unpredicted program errors. Compare that level of software engineering excellence to software I have personally used where not only are there bug upon bug in the software, but the damn labels on buttons representing symptoms are misspelled. I consider it axiomatic, if the buttons are misspelled the code is flawed, but than you can’t judge a book by its cover, or can you? 

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The End of Civilization and the Real Donald Trump

By ART CAPLAN

The pandemic started quietly.  In the spring of 2017 A few hundred dead chickens appeared in markets in Hong Kong and a few other cities in China.   Public health officials in China were slow to respond.  They did not want to panic the public about an avian flu outbreak.  Nor were they eager to take the steps necessary to contain such an outbreak—the killing hundreds of thousands of chickens and poultry with devastating economic consequences.  While the delay went on a few cases began to occur on Canadian and American poultry farms.  Department of Agriculture experts traced the outbreak to waterfowl migrating from Northern flyways, probably from Asia.   Inquiries were made about avian flu outbreaks in Asian nations.  Then the unthinkable happened.   Humans in Hong Kong began to get sick.  Very sick.  Some died.  Those who died were in their twenties.

The avian flu virus had mutated.  H7N9m had transformed into an agent that not only could infect humans but did so with a transmissibility and lethality that had not been seen since the Spanish flu outbreak of 1918.

Then the first American died.  A young man back from a business trip to Hong Kong.  The media, already primed for hysterical coverage following the severe Zika outbreak in the Southern United States in the summer and fall of 2016, went into full panic-dispensing mode.  ‘Experts’ began to appear on the cable channels who suggested that the outbreak was the result of irresponsible genetic research in China.  Still others suggested that it was the bioterror work of North Korean scientists.  One or two pointed toward ISIS arguing that they had grown desperate in the face of the massive air war that the new administration had launched.  Still others saw the hand of right or left wing domestic terrorists.  And an accident at an American lab was put into the boiling cauldron of speculation and conspiracy.

The CDC issued advisories nearly everyday.  There was no vaccine available but efforts were underway to make one since the genome of the mutated virus had been sequenced.  People were urged to stay home, wear masks, cover their mouths when coughing or sneezing and to get the annual flu shot since that might confer some protection.   Then President Trump decided to act.

He issued an Executive Order declaring that the border with Canada and Mexico be semi-sealed—essential commerce only.   Passengers on all international flights were to be subjected to screening and temperature measurement.  Many pointed out that these measures did not work and that the mutated virus was already in the U.S.  Trump, dismissed those concerns, noted that immigrants often brought disease along with them, that no one could be sure whether the outbreak was part of a conspiracy and that screening was the smartest thing to do.

As other Americans sickened and died Trump moved to quarantine those who were ill and their families.  He said ‘the cowards did not do it for Ebola or zika and the thing is not gonna go out of control on my watch’.   Americans did not take kindly to quarantine especially when no provision had been made for getting them food or removing garbage.

Soon people began to break quarantine—heading to supermarkets, hardware stores, and to visit relatives who themselves were homebound.  Trump told every governor to get the state police involved to enforce quarantine but the numbers involved simply overwhelmed.  Trump declared martial law and called out the military to enforce it supplemented by National Guard troops dispatched by cooperative governors.   With lawsuits flying Trump addressed the nation, defiantly asserting that no communists would disrupt his drive to preserve a ‘great America’.  When two young black men were shot outside their home in Oklahoma after a mob confronted local police and national guardsmen Trump issued a statement that ‘these people would either obey lawful orders or they would be jailed’.  When the CDC pointed out that sending infected or exposed people to jail would only serve to boost the epidemic he ordered detention-style camps built in every state.  Many state authorities simply refused.  The media had long ago given up any pretense of public health education in favor of covering the political battle between Trump, recalcitrant governors in many states, his own CDC amidst catcalls from the international community.

Finally, after hundreds of deaths the first supply of vaccine became available.  Trump was vaccinated on national television before ordering that the military and police receive vaccine priority.  Health officials went berserk arguing that the immunosuppressed and health care workers needed priority too.  Trump however was too distracted to listen.  He became engaged in a vicious trade war with China to punish them for allowing an epidemic to spread to the greatest nation on earth.   As the epidemic began to fade many called for an assessment of what had gone wrong in battling the avian flu epidemic of 2017.  Trump ignored them.  He was too busy preparing a hand-picked slate of candidates for the 2018 mid-terms.

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Xerox–Tamara StClaire interview

By MATTHEW HOLT

Another interview from the HIMSS conference earlier this month. The idea behind these interviews is that they give you a quick overview of the companies, and a sense of where the system as a whole is going.

Today is an interview with Tamara StClaire, chief innovation officer of Xerox Healthcare. She not only has some information on what Xerox is up to (including a hint about its new population health management platform) called Health Outcomes Solutions. But also some data from a study Xerox did on the readiness of providers to move to value based care (Hint: not very!) I also want to know what inspired the eyeroll in the video still below? Not me, surely!

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The Paradox of Evidence-based Medicine

By MICHEL ACCAD, MD

Anish Koka recently wrote a great piece entitled “In Defense of Small Data” that was published on The Health Care Blog.

While many doctors remain enamored with the promise of Big Data or hold their breath in anticipation of the next mega clinical trial, Koka skillfully puts the vagaries of medical progress in their right perspective. More often than not, Koka notes, big changes come from astute observations by little guys with small data sets.

In times past, an alert clinician would make advances using her powers of observation, her five senses (as well as the common one) and, most importantly, her clinical judgment. He would produce a case series of his experiences, and others could try to replicate the findings and judge for themselves.

Today, this is no longer the case. We live in the era of “evidence-based medicine,” or EBM, which began about fifty years ago. Reflecting on the scientific standards that the medical field has progressively imposed on itself over the last few decades, I can make out that demands for better scientific methodology have ratcheted up four levels:

Beginning in the late 1960’s, and then throughout the 1970’s, some began to call attention to the need for better statistical science in research publications. Chief among those emphasizing this problem was Alvan Feinstein. Another important figure was Stanton Glantz, and there were others as well.  See, for example, this editorial in Circulation in 1980.

Then, in the late 1980’s and early 1990’s the movement that coined the term EBM emerged, notably from McMaster University in Hamilton, Ontario. Names associated with that movement include David Sackett, Gordon Guyatt, Salim Yusuf, and others. Beyond the proper use of statistics, they demanded that clinical studies be designed properly, and they anointed the randomized double-blind clinical trial as the supreme purveyor of medical evidence. Others, like Ian Chalmers and the folks at theCochrane Collaboration developed methods of “meta-analysis” whereby different trials and studies on a particular question could be analyzed in aggregate.

The mid-to-late 1990’s were the heydays of EBM. I remember the excitement in 1992 when the Evidence-Based Medicine Working Group published its teaching series in JAMAon how to properly interpret the medical literature. I was a senior in medical school at that time, and that series of papers quickly became the go-to reference for self-respecting doctors who wanted to demonstrate that they weren’t taking the conclusions of medical publications at face value. We would be able to judge for ourselves the validity of any new claim! And we began to systematically doubt old claims that were not backed by sufficient evidence. (The autobiography of EBM was recently sketched in JAMA here).

By the late 1990’s, however, it became clear that EBM was having two major effects, and the promotion of clinical judgment was not one of them. On the one hand, EBM gave rise to “guideline medicine” and cookbook recommendations that would soon provide insurers and government agencies a method to gauge “quality of care” on a large scale and to tie performance to that quality. On the other hand, the methodology also played into the hands of large pharmaceutical companies who, through the implementation of large clinical trials, could now identify small effects that physicians would feel compelled to apply to large populations of patients.

The former effect was not so problematic for the promoters of EBM who, by and large, were made up of “systems experts” and outcomes researchers for whom the “rational” provision of care by way of clinical guidelines and “appropriate use criteria” seemed like a great boon.

But the latter effect, i.e., the benefits the pharmaceutical and medical device industry reaped through the use of the mega-trial, was a tough pill to swallow. Many in the EBM movement were not particularly thrilled to see their pet methodology be at the service of major corporations, but they were hard-pressed to be able to criticize them on that basis.

An opportunity to correct that trend came when the Vioxx scandal brought to light the fact that too cozy a relationship between scientists and corporations could lead to tampering of the precious evidence. It would not be long before the next level of demand on clinical science would be made: in addition to being proficient in the use of statistics and in the designs of clinical studies, scientists would now also have to disclose any potential conflicts of interest, i.e., any financial relationship with a sponsoring corporation. Soon the sun would shine on the greed of doctors and scientists and, it was hoped, the truth would finally emerge victorious.

But even that has failed to satisfy the skeptics. After all, conflict of interest is undetectable and unavoidable. And the emphasis on conflicts of interest seems to have poisoned the atmosphere. Witness any debate between scientists on Twitter, and you will experience a new version of Godwin’s law:

The latest remedy concocted to deal with the vexing problem of scientific truth is data sharing, which I mentioned in a recent post. Soon, scientists may need to make all data forms, correspondence, and even their inner reflections, available to third parties on demand, so that, you know, we can finally be sure that the results are “true.”

I predict that statistics, optimal study designs, conflict of interest disclosures, and data sharing will never satisfy our yearnings for clinical truth. In recent days, I have been particularly struck by the epistemiological crisis in which we seem to find ourselves, despite the fact that we have access to huge data sets of information. There is no longer any medical fact or truth that can be considered reliable anymore. Skepticism is rampant and everything is in doubt, which is strange since there has never been more attention paid to being meticulous about science and methods.

It’s like a paradox: the more we insist on scientific reliability, the less certain our knowledge seems to become. As I mentioned before, I believe this paradox arises in part because we are bent on applying to medicine quantitative methods that are more suited for the study of falling stones and quarks than for the proper understanding of human beings. Randomized trials provide us with general rules, but the business of medicine is to particularize. When the time comes to apply our knowledge at the bedside, the evolution of EBM seems like a devolution against sound clinical judgment.

Also, quantitative methods have taken prominence because medicine has ceased to be a private affair between doctors and patients, but has turned instead into a public health endeavor. Yet patients still expect us to treat them as individuals, and most doctors hope to practice on a human scale in the context of small communities. The focus on big data and big methods is a major distraction, and it has yet to convince me that we are better doctors as a result of it.

In his magnificent essay, Koka notes

I realize it has become dangerous to use one’s clinical experience to inform one’s views….Forcing all progress through the funnel of a million strong clinical trial is a bar too high, a bar that protects us from medicine itself. No one benefits from that.

I agree with my colleague Koka. It’s time to return to the small data set. It’s time to reclaim our ability to think, judge and reason for ourselves. It’s time to put an end to the EBM madness.

Michel Accad practices cardiology in San Francisco and blogs at alertandoriented.com where this post originally appeared. He can be followed on Twitter @michelaccad

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PCMH Fails Natural Experiment

By AL LEWIS

Medical Homes Fail Yet Another “Natural Experiment”

Three “natural experiments,” three failures.  Such is the fate of patient-centered medical homes (PCMH), a well-intentioned but unsuccessful innovation now kept afloat by the interaction of promoter study design sleight-of-hand with customer innumeracy.

By way of review, a natural experiment is an experiment in which the design is outside the control of investigators, yet mimics an experiment.  The first two natural experiments below involve applying the intervention across entire states. The third involves a stimulus-response experiment in one specific community.

Statewide Natural Experiments: North Carolina and Vermont

In North Carolina, a statewide Medicaid PCMH was implemented years ago and steadily expanded until most Medicaid recipients belonged to one.  There was no reduction in relevant event rates (for ambulatory care-sensitive admissions) and costs increased. While the overall Medicaid budgets were routinely exceeded and that should have caused legislators to realize that something in their PCMH was amiss, Milliman fabricated data to pretend the PCMH program was a success.  Milliman got caught making up data (and ignoring other data that quite definitively invalidated its conclusion, and changed their story 180 degrees, a tacit admission that they lied.  And shortly thereafter (at least “shortly” by the standards of state government), North Carolina announced that it is abandoning this failed experiment.

In Vermont, the making-up-data-to-disguise-failure story was similar, following the implementation of a statewide medical home model.  Even though there was no change in relevant hospital event rates (ambulatory care-sensitive medical admissions), the PCMH model was initially alleged to save $120,000,000, or a whopping $600/eligible person.  Had this figure been real instead of completely fabricated, Vermont could have financed its long-planned move to single-payer simply by projecting that savings to the entire population.  Embarrassingly, the state was so taken with the faulty analysis that they didn’t back off their single-payer plan for a year after the savings were shown to be made up.

These two results are supported by the findings from Oregon Medicaid’s healthcare “lottery” program. Oregon Medicaid was not a “natural experiment” in PCMH’s, but rather in whether increased access to care made a difference in outcomes.  It turned out going from no insurance to insurance offering free primary care had no effect on physical health after two years.  The Law of Diminishing Returns would imply that adding even more primary care would therefore also have no effect.  We’re not counting that as a natural experiment, but rather as inferential support for the two natural experiments.

The response of the PCMH lobby to these natural proofs?  Forced to defend the indefensible against an onslaught of both fifth-grade arithmetic and actual events proving the fifth grade arithmetic accurate, the head of the PCMH special interest group, Marci Nielsen, simply made ad hominem attacks on me.  (These attacks were not html and hence not linkable.  Rather there is a healthcare policy email group to which industry thought leaders–and apparently the occasional lobbyist–are invited to participate.)

Lest I give the impression these childish displays of churlishness bother me, quite the opposite.  I’m bummed the thread isn’t linkable. In the immortal words of the great philosopher George W. Bush, bring ’em on.  The fact that these people can’t actually construct a coherent argument demonstrates the vacuity of their position.  Literally, one of Ms. Nielsen’s arguments was: “That’s the pot calling the kettle black.”

I revel in that kind of criticism. I was hoping she would accuse me of having small hands.

Flint: The Most Recent Natural Experiment

There are no redeeming features in the Flint debacle, but creating a “natural experiment” in the PCP-patient relationship – the underlying linchpin of the PCMH model — is as close as it gets.

Roughly 50 primary care physicians practice in and around Flint.  Only one figured out the obvious: their patients were all drinking poisoned water. That means 49 of them – 98% — had so little connection to their patients’ day-to-day lives that they didn’t make their patients aware of the obvious and substantial harm visible to the naked eye. All these doctors had to do was look at the water and then get it tested.  But only one did.

Yet the entire PCMH model is based on the implicit assumption that primary care physicians should be the stars in the healthcare firmament.  That hypothesis was given a simple natural experiment – helping patients avoid or at least identify obvious harms — and totally flunked.

Presumably some of those doctors in Flint had PCMH-levelrelationships (even if not a formal PCMH) with some of their patients.  It didn’t help.  What we learned in Flint is that the idea of “building a relationship” with a doctor by getting a checkup may be like building a relationship with your Amway rep by purchasing Artistry®LuXury Eye Cream.

This is not to denigrate the role of the PCP at all. That is people’s first line of care, especially for people who have enough health problems to merit regular visits, as well as for patients with acute needs.  However, the two ideas that:(1) sending more people to the doctor builds relationships and relationships matter a lot; and that (2) PCPs somehow get it right/save money both fail these three natural experiments. No natural experiment has ever shown the opposite.

So — just like in wellness where it turns out the way to save money is not to spend more of it on prevention –it’s time to reconsider the entire PCMH assumption that spending more money on PCPs saves money somewhere else.  In other words, it’s time to re-think the entire PCMH concept.

And, just for the record, my hands are fine.

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Philips — Interview with Carla Kriwet

By MATTHEW HOLT

Now I’ve got them uploaded and semi edited I’ll be running the interviews I did at the HIMSS conference earlier this month. They will hopefully give you a quick overview of the companies, and give you a sense of where the system is going.

Today is an interview with Carla Kriwet, CEO of Patient Care and Monitoring Solutions at Philips. The Dutch electronics giant has a huge footprint in the hospital and big ambitions outside it.

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Retail Clinics Raise Medical Spending: So What?

By DEVON M HERRICK

New research published in Health Affairs finds that retail clinics don’t save money. Many health policy analysts had hoped that retail clinics would reduce medical spending by replacing more costly physician office visits. The article did confirm that retail clinics are less expensive than traditional physician visits for the same service. Yet retail clinic use was associated with an increase in medical spending of $14 per year by those who used them. The $14 per person-year increase was not a complete picture, however, because the study did not compare inpatient spending or prescription drug use.

The researchers looked at Aetna insurance claims for 11 low-acuity conditions to see if people were substituting cheaper retail clinic visits for more costly doctor visits. What they found was that patients tend to visit a retail clinic when they might otherwise forgo care. In other words, patients were adding visits for conditions that would have cleared up on their own rather than necessarily substituting cheaper visits for higher cost visits. Traffic at retail clinics tends to peak during off hours (evening and weekends) when physician offices are closed.

The research was reported by Kaiser Health News and also ran in MedCity News, where I found some of the comments especially interesting. One commenter asked if changing the term “utilization” to “engagement” might make a difference, as in:“clinics increase health ‘engagement’ to the tune of about $14/person.” Increasing patient engagement sounds like a positive benefit rather than the negative connotation of utilization.

As an economist, my knee jerk reaction is patients may want to visit a retail clinic when their traditional source of care is not available. They may be willing to spend a little extra in cost-sharing to take care of a medical need rather than suffer through it.

A commenter made the argument that further analysis may reveal retail clinics reduce emergency room use when comparing less trivial conditions. It wouldn’t take very many sick kids whose parents took them to a CVS Minute Clinic instead of the hospital ER to save an extra $14 per person spent on the trivial conditions studied.

Something that boosts convenience at a slight cost is considered bad in health care whereas it would be considered great in every other sector of the economy. Has anyone ever accused Apple of increasing the cost of personal communication? It may have, but just think back to the good ole days when people had to use payphones when out, left messages on answering machines to communicate with loved ones who weren’t home or mailed letters to communicate with those far away.

Despite the cost, I willingly spent more than $1,000 to procure my iPhone 6 and my iPad Mini. Besides a phone plan,I also pay another $30 per month for streaming media services that I can watch on my phone, iPad or my home television. Compared to the rabbit ears our sole television had growing up (we only received one channel reliably), Apple has also increased my cost for television entertainment. For that matter, I pay an additional $100 per year for a Garmin Pilot app so I can use both my iPhone and iPad for GPS aircraft navigation when piloting an airplane.

My Apple devices are good examples of why consumers need to take back control over more of their health care dollars. My iPhone can tell me where my aircraft is in relation to airports across the country, pull up winds aloft and severe weather forecasts. I can watch television on it, research a report and communicate with colleagues. One thing my iPhone is not much good for is communicating with my doctor. The reason: 90% of doctor bills are paid for by third party payers. Those payers have been slow to reimburse for phone consultations because they wanted to make sure it doesn’t raise their costs unnecessarily.

Devon M. Herrick, PhD is a health economist and senior fellow at the National Center for Policy Analysis. He has written on ways consumers can lower their drug spending for more than a decade.

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The ACO Information Vacuum

By KIP SULLIVAN

In my three-part series on why we know so little about ACOs, I presented three arguments:

We have no useful information on what ACOs do for patients;

that’s because the definition of “ACO” is not a definition but an expression of hope; and

the ACO’s useless definition is due to dysfunctional habits of thought within the managed care movement that have spread throughout the health policy community.

Judging from the comments from THCB readers, there is no disagreement about points 1 and 3. With one exception (David Introcaso), no one took issue with point 2 either. Introcaso  agreed with point 1 (we have no useful information on ACOs), but he argued that the ACO has been well defined by CMS regulations, and CMS, not the amorphous definition of “ACO,” is the reason researchers have failed to produce useful information on ACOs.

Another reply by Michael Millenson did not challenge any of the three points I made. Millenson’s point was that people outside the managed care movement use manipulative labels so what’s the problem?

I’ll reply first to Introcaso’s post, and then Millenson’s. I’ll close with a plea for more focus on specific solutions to specific problems and less tolerance for the unnecessarily abstract diagnoses and prescriptions (such as ACOs) celebrated today by far too many health policy analysts.

Summary of Introcaso’s comment and my response

I want to state at the outset I agree wholeheartedly with Introcaso’s statement that something is very wrong at CMS. I don’t agree with his rationale, but his characterization of CMS as an obfuscator is correct.

Introcaso argues that in fact the ACO is well defined. He offers this syllogism:

Two-thirds of all ACOs are now MSSP ACOs;

in 2011 CMS issued regulations governing the Medicare Shared Savings Program (MSSP) which defined ACOs “regulatorily in great detail”; ergo

it just isn’t true the ACO is poorly defined.

Having explained, to his satisfaction, that in fact CMS has posted a useful definition of “ACO,” he then blames CMS for the dearth of useful research on MSSP ACOs (although the title of his article indicates he blames CMS for the lack of research on all ACOs). He argues CMS has released very little “evaluative information” on MSSP ACO spending and utilization, and this “has made it inexplicably difficult for providers and policy analysts to understand how the MSSP model works operationally.”

As I explain below, neither of Introcaso’s conclusions are correct. CMS has not defined what ACOs are, and even if CMS were to release cost and utilization data on MSSP ACOs analysts would still be unable to produce useful research on what ACOs do for patients. I agree that CMS has provided very little data on MSSP ACOs, but the same cannot be said of CMS’s Pioneer ACOs and the “practices” that participated in the Physician Group Practice (PGP) Demonstration that CMS ran between 2005 and 2010.[1] And yet researchers have produced no studies that tell us what those ACOs and PGPs did for their patients that generated those data.

Moral of story: CMS is not the fundamental problem; the flabby definition of ACO is the fundamental problem.

We don’t know how many ACOs exist

Introcaso opens his essay with the claim that two-thirds of all ACOs are MSSP ACOs. We don’t know that. Introcaso cites no document for that claim, but it doesn’t matter because estimates of the number of ACOs are all over the map and none are credible.[2] And why is that? All together now: Because the ACO has no useful definition. That means any group of clinics, hospitals and insurers can claim they have set one up, and researchers can claim they spied any number of them, and no one can argue with them.

But let’s set this issue aside and assume, for the sake of argument, that MSSP ACOs are the only ACOs we need to concern ourselves with. Is it true that MSSP ACOs acquired a useful definition in 2011 when CMS issued rules governing ACOs?

CMS’s ACO regs do not tell us what ACOs do for patients

Introcaso asserts, “Medicare ACOs are defined regulatorily in great detail. This fact is made obvious by the … 430-relevant Federal Register pages.” No, that “fact” is not only not obvious, it’s not a fact.

The MSSP ACO regulations merely define the laws governing entities that want to be designated an “ACO” by CMS. To say that these regs tell us what ACOs are is like saying that describing the laws governing trucks tells us what trucks are. If I tell you a truck is something that has to stop by the side of the road to be weighed, that its drivers must have a license, and (to take an example dear to the hearts of managed care proponents), its owner has to pester customers to fill out “satisfaction” surveys and send them to the government, have I told you what a truck is? No, I have not.

Here are some examples of what the CMS MSSP regulations tell us:

Contracts between ACOs and CMS will last for three years;

Medicare beneficiaries will not choose ACOs but rather will be “attributed” to them by CMS; and

The Office of the Inspector General will inspect the records of some ACOs.

Is there anything in those regs that tells us what ACOs do for their “attributed” patients that is different from what non-ACO providers do for their real patients? Of course not.

All of the MSSP regs are like that. If you think I exaggerate, I urge you to open this link to the 2011 Final Rule.pdf and run your eye over the table of contents on the first two pages. You will see juicy items like “Giving beneficiaries the opportunity to decline data sharing,” “Growth rate as a benchmark trending factor,” and “ACO marketing guidelines.” All that legalese will remind you why some wags say ACO stands for “Amazing Consulting Opportunity,” but it won’t help you or any researcher determine what it is ACOs are supposed to do that doctors and hospitals don’t already do.[3]

Since Introcaso’s first premise (MSSP ACOs equal two-thirds of all ACOs) is unprovable and probably wrong, and his second premise (CMS has defined the ACO) is unquestionably wrong, the first of his two conclusions fails. CMS has never published a useful definition of the ACO.

Cost and utilization data do not tell us what ACOs do

CMS may be slow in releasing data on the MSSP ACOs, but it has released five years of cost, utilization and quality data for the ten PGPs that participated in the PGP Demo  and two years of data for the 32 entities that signed up for the Pioneer ACO program.

But despite all that data, CMS and analysts cannot tell us what the PGPs/ACOs did for patients that your run-of-the-mill clinic and hospital does not do.

Consider one of the oddest findings from the evaluation of the first two years of the Pioneer ACO program by L&M Research: Only one ACO (Dartmouth Hitchcock) increased utilization of primary care visits in both 2012 and 2013, while 29 cut primary care utilization in both years (see Table 5 pp. 17-18). As every reader of this blog knows, primary care physicians are supposed to be the foundation of ACOs. What accounts for such a surprising finding? We have no idea.

I am not the only one who has noticed this problem. When CMS employees published a paper in JAMA in May 2015 based on the L&M evaluation, Modern Healthcare noted how difficult it is to make any sense of the paper. The article , entitled “Successful Pioneer journey leaves faint trail for followers” took note of the reduction in primary care visits. When Stuart Guterman, a vice president at the Commonwealth Fund (an ACO proponent), was asked by the reporter how he explained that reduction, he said, “It’s very hard to take apart the findings of a study like this,” and, “I’m not sure how to explain it.”

This anecdote is an excellent illustration of the problem created by the wish-based definition of the ACO. Even intelligent proponents of the ACO cannot explain what ACOs did to generate any of CMS’s data, be it cost, utilization or quality data. None of us can.

The solution to this problem is not to ask CMS to produce more data. Nor is the solution to hope the NCQA or some other organization will “certify” private-sector ACOs with requirements like those CMS has published for its ACOs. The solution is for ACO proponents to admit the ACO has no there there and to fix that problem.

Reply to Millenson

Michael Millenson praises my three-part series for being “insightful” and does not object to any of the three points I made. But he offers no indication that he cares about the problem I described. He devotes his entire comment to an obvious but irrelevant platitude: Managed care advocates are not the only people who traffic in manipulative labels. “It’s not just in health care reform where various ideas are given different names to make them more attractive,” he says.

Is that all Millenson has to say about this serious issue? Other people do it? That is a feeble defense of the managed care movement. With friends like Millenson, the managed care movement does not need enemies.

If I had accused professional wrestlers of using manipulative language and not caring about evidence, I might expect to hear the rejoinder that people in other walks of life do the same. But I wasn’t talking about professional wrestlers. I was talking about highly educated people who make a living as health policy experts, people who ostensibly place a high value on the basic rules of scientific discourse, people who routinely demand that doctors and patients practice evidence-based medicine.

Millenson is a recognized name in the field of health policy. If the best he can do in the face of the serious accusations I leveled against Paul Ellwood, the Robert Wood Johnson Foundation, and the rest of the managed care movement is to say other people do it, I rest my case.

I invite Millenson to stop trying to defend his colleagues with the “everybody does it argument” and apply his fine intellect to solving the problem I’m writing about – the absence of useful research on ACOs and the tolerance of sloppy thinking that allowed a concept as poorly defined as the ACO to become national health policy.

Butter knives, not chain saws

I don’t have space to comment on other interesting issues raised by readers. I hope I can respond to some of them in future articles. I’ll close by raising an issue I hope we can discuss in greater detail in the future.

The early HMO proponents and their intellectual heirs sent us down the wrong path with their addiction to unnecessarily abstract diagnoses and prescriptions. The idea that all problems with our health care system, or at least the most fundamental problems, flow from the fee-for-service system is the primary example of such excessively abstract thinking. It is the original intellectual sin that has contaminated the health care reform debate ever since.

Similarly, the notion that all the evils that flow from the fee-for-service system can be eliminated or at least ameliorated by various forms of premium-splitting – shifting risk to providers – is also unnecessarily abstract and sweeping. Pushing as many primary care doctors as possible into “medical homes” and ACOs, and punishing all hospitals for all “excessive readmissions,” are other examples of policy-making at 80,000 feet.

Let’s focus first on specific problems. Do we want to reduce central-line infections? Ok, let’s study the problem and propose specific solutions. Do we want to reduce the number of nursing home residents who wind up in the ER? Let’s determine whether that’s possible and then devise a solution to that problem. Let’s not endorse overkill. Let’s not punish all hospitals for all “excess” readmissions. That’s the equivalent of buying a chainsaw to cut butter. It’s unnecessarily expensive, it creates unwanted side effects, and it’s such a crude tool it might not even cut the butter.

[1] The PGP demo is widely regarded as a test of the ACO concept.

[2] The brief methods sections of papers that purport to count ACOs give you some idea of the problem the hollowness of the ACO definition creates. For example, in the meager “methods” section on page 5 of an un-peer reviewed document published by Leavitt Partners, Muhlestein et al. describe their methodology as follows: “Leavitt Partners has sought to pinpoint ACOs by identifying two types of organizations: those that self-identify as ACOs and those who have been specifically identified as adopting the tenets of accountable care.” That’s it. If you call yourself an ACO, that’s good enough for Leavitt Partners. And if you don’t, Leavitt might label you an ACO anyway if you “have been identified” (note the passive voice) as “adopting the tenets of accountable care” (those tenets are not named, nor is any document cited where we might find them).

Two recent surveys of ACOs in California and Minnesota (two states which led the nation in experimenting with HMOs) produced very different estimates of the prevalence of ACO “covered lives” in those states. Fulton et al. report that only 2.4 percent of Californians were “covered by an ACO” in 2014 but that 47 percent received care from “providers that bear financial risk for professional and/or hospital services” (p. 682) How could this be, they ask, if the “definition” of ACO includes risk-bearing? Their answer: “[A] key limitation of our study stems from the difficulty of determining which payer-provider relationships should be classified as an ACO.” (p. 683). Fulton et al. also reported that just 2.3 percent of California’s commercially insured are in ACOs. Meanwhile, a study of ACOs in Minnesota by IBM/KPMG  concluded 41 percent of all commercially insured Minnesotans are “attributed to ACO models,” far higher than the 2.3 percent derived by Fulton et al. KPMG couldn’t be bothered to specify the year when their survey was fielded, but the study was released in the fall of 2015 so 2014 is a good guess.

[3] The implication of Introcaso’s argument that the ACO had no definition before 2011 when CMS issued its Final Rule does not speak well of the US health policy establishment. Even assuming Introcaso is correct (that CMS’s 2011 rule finally defined the ACO), that would mean the ACO had no definition between November 2006, when Elliot Fisher and then-MedPAC chair Glen Hackbarth dreamed up the ACO concept, and March 2010 when the president of the United States signed a law endorsing the vaporous ACO. Even if we accept Introcaso’s argument, we’re left with a baffling question: How did a concept with so little definition and no research to back it up rocket from obscurity to law of the land? What does that say about the standards of the ACO advocates and of the journal editors, health policy analysts, reporters, and politicians who took the braggadocio of ACO proponents at face value?

[4] For a quicker, gentler and kinder introduction to CMS’s umpteen MSSP regulations, you might read pages 3-7 of this summary of the regs produced by CMS 

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Troubles at Amazon?

By INDUSTRY STANDARD

An internal memo at Amazon is circulating around. It is a bad news message to its part-time workers stating that their health coverage is being cancelled. Whether the note is authentic or not I do not know, so I will not reproduce it here. If that is true it should come as no surprise. Read on.

Jeff Bezos, who had a vision for an internet-based retailer, founded Amazon in 1994. In a short time Amazon became a household name as the go-to place for books, music, and millions of products. It’s stock soared and it spawned hundreds if not thousands of imitators. It is truly a global marketplace and a brilliant one at that.

Sales last year were $107 Billion, propelled in part by aggressive innovation, e.g., Amazon prime, and the fact that many Americans do not pay sales tax on Amazon purchases.

Amazon is cool, easy, and, convenient, but they just don’t make much profit. In a January 29, 2016, Wall Street Journal article author Greg Bensinger asked this question, “Is Amazon.com Inc. finally getting serious about profits?

Amazon has probably wrung all they can out of vendors and delivery firms, and is possibly now cutting employees benefits. If true Amazon has limited options. If it hikes up delivery fees and prices they risk driving low to middle income customers back to Walmart, Target, etc.

Here is the big question: is Amazon a house of cards? It has a market cap of $265 Billion and has made only very thin profits.Yet Jeff Bezos’ net worth is a stunning $46.7 Billion. While it appears to have a positive cash flow, according to Timothy Green of the Motley Fool* “its adjusted free cash flow is actually negative.” Negative cash flow is a huge risk for any going concern.

While Amazon seems to be a house of cards, it has been a darling on Wall Street. As soon as mutual fund analysts wake up, Amazon’s stock may well wilt, a situation that may have already begun. Their stock price was almost $700/share. It was recently down to $564. That may be a sign of big trouble ahead in the next 5-10 years.

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Tom Emerick is the President of Emerick Consulting, LLC, and Partner and Chief Strategy Officer with Laurus Strategies, a Chicago-based consulting firm, and co-founder of Edison Health. Tom Emerick is the President of Emerick Consulting, LLC, and Partner and Chief Strategy Officer with Laurus Strategies, a Chicago-based consulting firm, and co-founder of Edison Health. 

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Feeling the Bern on Universal Single-Player Healthcare

By JIM PURCELL

“Elephant in the living room” is an English metaphorical idiom for an obvious untruth going unaddressed. In most political platforms about healthcare and its coverage, there is a most resolutely immovable elephant in our living room. It is there with every single candidate.  But with Bernie….

You’ve just got to love Bernie Sanders.  It makes me feel like I’m 22 years old in the 1960’s and dumb as all get out about how you pay for things. But let us consider Mr. Sanders’ healthcare proposal. From his own website:

“Bernie’s plan would create a federally administered single-payer health care program.  Universal single-payer health care means comprehensive coverage for all Americans.  Bernie’s plan will cover the entire continuum of health care, from inpatient to outpatient care; preventive to emergency care; primary care to specialty care, including long-term and palliative care; vision, hearing and oral health care; mental health and substance abuse services; as well as prescription medications, medical equipment, supplies, diagnostics and treatments. Patients will be able to choose a health care provider without worrying about whether that provider is in-network and will be able to get the care they need without having to read any fine print or trying to figure out how they can afford the out-of-pocket costs…[etc.].”

Bernie sure didn’t go half way on this one. All care, whenever, wherever, however. A fundamental right with no filter. OK. So he jumped in with both feet. You’ve got to admire his elan.  But what might this mean and how can he ignore what happened in his own home state?

Yes, I agree that access to quality healthcare is a fundamental human right for every man, woman and child legally in this country, and for America not to be responsibly working toward that is seriously problematic. But we have to do this with our eyes open. We don’t usually celebrate December holidays by giving the children unlimited access to Toys R Us.

Let us consider for the moment what happened in Vermont, Senator Sanders’ home state, when they attempted to implement their universal health care system called Green Mountain Care. To put it mildly, Senator Sanders was supportive of this venture. But this is not the sort of venture where you retain liberal economists to do the financial projections.  Bottom line: It never left the ground.

As the Boston Globe reported in early 2015 (plenty of time for Bernie to reconsider):

“The numbers were stunning. To implement single-payer, the analysis showed, it would cost $4.3 billion in 2017, with Vermont taxpayers picking up $2.6 billion and the federal government covering the rest. To put the figures into perspective, Vermont’s entire fiscal 2015 budget, including both state and federal funds, is about $4.9 billion.”

The Globe went on to report that the Governor’s office estimated needed tax increases on income and payroll that more than doubled existing taxes. The Governor, who ran on this issue, pulled the plug, and the predictable howls followed.

I mentioned liberal economists. Even they stead fastedly ignore the elephant in the living room. By way of example, and this is by no means atypical:

Dr. Gerald Friedman, an economics professor at UMass-Amherst and a part-time Vermonter, has worked with [Bernie Sanders] to develop and calculate the cost of his plan and says the budget wasn’t the problem for the Vermont proposal. The governor was the problem.  “On the economics, it would have been cheaper, but the governor just lost the political will,” Friedman said.

Huh?  This was not “political headwinds.”  It was economic reality.

Or as put so indelicately:

“According to critics, from the New York Times’ Paul Krugman to USA Today’s editorial board, Sanders’s single-payer plan is something between a well-intentioned fool’s errand and a political pipe dream, an unrealistic idea that has been proven not to work in the senator’s own backyard.”

And to a less spectacular extent this is also being played out in Massachusetts with Romneycare, and federally with Obamacare (don’t you love these titles?). The programs are being overwhelmed with costs, and the savings are almost nonexistent. These programs were implemented with almost complete disregard for their costs. For Obamacare, I’d refer you to Stephen Brill’s, “America’s Bitter Pill.”

So what is really going on here?  As I’ve said before when commenting on Mr. Trump’s healthcare proposal, it’s always about the claims expense. You cannot (I repeat cannot) ignore the claims expense, which as a component of overall healthcare costs, particularly when you include Medicare, approaches 90% of the total bill. And under Mr. Sanders’ plan, there is a “right” to unfettered access for all such costs without any filter of any kind.  No bean counter HMO getting between the and her doctor or pharmacist.

IF under today’s environment where there are at least some (albeit inadequate) attempts to control the rate of use of services, the total claims expense nationwide were $3 Trillion, what might it be under Berniecare?

Senator Sanders, like so many other pols and even seemingly intelligent commentators, always point to the administrative costs and profits of insurers as the whipping boy of why American healthcare costs are so high. While significant, they are a relatively small part of the bill.  Perhaps 15%. Mr. Sanders and others try to prove commercial insurer bloat by comparing their admin costs of say 12% with Medicare’s admin costs of somewhere, allegedly, under 2%. That is unfair for so many reasons that we haven’t time to list them all.  But consider, if an insurer had the economies of scale Medicare has; did as little as Medicare does on all the things regulators require the commercial insurers to do (quality of care, utilization review, managed care, wellness, population health, fraud and abuse, etc.);and only insured the elderly who have much higher claims expense,they too might approach such a low administrative charge. And insurers (unlike the government) need reserves.  I think you get my point here. Oh, and the oft-touted Medicare admin expense figure of 1.4% is just flat wrong.  See, e.g., Forbes, “The Myth of Medicare’s ‘Low Administrative Costs’.”

Could a universal healthcare system reduce administrative costs?  Sure, but at what price so to speak? The result would be virtually no controls over the rate of use of services, which (to repeat) remains the specific ill-tempered elephant in the living room.

It’s an inconvenient reality, but claims expense consists of two major elements:  price and use. Price is the fees we pay ($100/office visit) and use is the rate of use of services per person (office visits of say 3.6 per year per person). The fees we pay providers here in America far exceed those of other countries. And the fees Medicare pays providers are far less than the fees paid by commercial insurers. Commercial insurer fees are in some instances the difference between solvency and bankruptcy for physician groups and hospitals. I’m assuming we won’t move suddenly nationwide to paying doctors and hospitals something at or below the Medicare fee schedule. Imagine! But in any event, it’s not the fees that break the bank. It’s the use.

When it comes to use, Americans are (to be blunt) bellying up to the bar for the free lunch.And we are encouraged (seduced?) to do so by doctors and hospitals and big pharma and mid-afternoon ads on TV. We use services at a rate heretofore unknown to the human race. And even if the citizens of other countries were inclined to use medical services at the rate we use them, they couldn’t. Call it rationing (the “R” word) or simply delays in scheduling, but it wouldn’t happen.

And we believe we have a fundamental human right to continue this pattern. Fee increases over the last 15 years have been significantly less than 5% per year. Use increases have been double digit, on average. And our unhealthy lifestyles and failure to access the delivery system appropriately will ensure that this will continue unabated, unless something is done. I assure you, that “something” will not be Berniecare.

To lay it out plainly: We cannot with any fiscal responsibility implement universal healthcare and coverage without serious planning that addresses the nature and rate of use by Americans of medical services. The root causes are many, and if it were an easy thing to correct, we would have done it by now. Much of the problem is cultural, something very different from most other countries. And of course, what we pay for pharmaceutical drugs is truly obscene, but that is for another day and another blog.

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Telehealth Piece on New Medcaid Requirements

By KOFI JONES

Approximately 12 million Americans utilize some type of home health care every year.  From home health aides visiting the infirmed in their homes, to physical therapy services to aide in recovery, to medical equipment being used to treat the chronically ill, home health has been a critical component of care management for decades.

One of the Medicare payment requirements for these services is for the prescribing practitioner to have a “face to face” encounter with the patient within a reasonable timeframe. This has widely been viewed as a burden on patients, many of whom face mobility issues and other barriers to meeting this obligation. It has also been a barrier for our overburdened physician supply.

Just recently, CMS published a new rule extending this requirement to states – stating that home healthcare matching Medicaid funds will be linked to this same requirement.  But, there’s another component of the rule which mirrors Medicare and will have a tremendously positive impact on the home health care community – the face-to-face requirement can be met through telehealth.

Telehealth is increasingly being acknowledged as a vital component of our healthcare ecosystem. Thirty states mandate commercial payment for care provided through these technologies and nearly every state offers some level of telehealth payment within Medicaid. Early this month, a bipartisan bill was introduced which would greatly increase the amount of payment which exists for telehealth within Medicare. And, all across our healthcare ecosystem, from health plans to health systems, telehealth is being integrated to increase access and lower costs.

Now, as states and providers prepare to operationalize this new Medicaid rule and deal with the budgetary and organizational requirements that will naturally result from it, they can breathe a sigh of relief. The caveat that telehealth can meet this requirement is significant.

Now, providers can examine and appropriately prescribe home health while their patient is remote – streamlining treatment time frames and maximizing the utilization of their clinical resources.

And in 2016 these technologies offer so much more. Telehealth brings the ability to manage these patients on an on-going basis, much of which is now payable in a fee-for-service Medicaid environment. Modern telehealth technologies also provide HIPAA compliance, integration with back-end systems, claims submission, continuity of care, and support multi-disciplinary collaboration, including Accountable Care Organizations and Patient Centered Medical Homes.

The end result – compliance with the new rule and a vastly broader ability to treat and manage patients. This rule may, at first blush, seem like a burden too far, but with telehealth, the good news outweighs the bad.

Kofi Jones is VP of Government Affairs for American Well, a national provider of telehealth technology and services and creator of Amwell for online doctor visits.

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Cancer and Moonshot Economics

By STEVE FINDLAY

The Obama Administration’s cancer “moonshot” initiative, announced in January and now being debated in Congress, comes at a time of significant advances in cancer treatment and a spurt of cultural attention to the disease.

A batch of new immunotherapy drugs approved in the last few years, such as Bristol-Myers Squibb’s Opdivo and Merck’s Keytruda, are being widely touted as breakthrough medicines—and aggressively advertised to both doctors and the public.  Jimmy Carter’s unexpected remission from melanoma that had spread to his liver and brain is attributed to Keytruda.

At the same time, a cancer memoir (When Breath Becomes Air by Dr. Paul Kalanithi) tops The New York Times nonfiction best-seller list.  The Death of Cancer by Dr. Vincent DeVita, a former director of the National Cancer Institute, has also garnered positive reviews and wide attention for its critical assessment of today’s cancer research establishment.

Before these two books, John Green’s 2012 novel The Fault in Our Stars—the touching story of two teens with cancer—was widely acclaimed and read, especially after it was made into a blockbuster movie in 2014.

The administration’s initiative comes at a significant time for me personally, too.  My brother, 70, was diagnosed with stage IV lung cancer 10 months ago.  Unlike Jimmy Carter, one of the new immunotherapy drugs (Opdivo) did not defeat his cancer.  He continues to fight for his life.  As with so many families, cancer has stalked ours.  My sister died of colon cancer in 2006, age 54.  My mother died of lung cancer in 1985, at 65.  Like anyone over age 60, I’ve seen friends suffer and succumb, their lives cut short.  And I’ve battled two cancers myself, melanoma (localized) and a salivary gland tumor.

Fight, battle, war…….moonshot.  We uniquely use these metaphors in the context of cancer and not other diseases.  While some patient advocacy groups think this risks leaving cancer patients and their families feeling as if they have failed if they “lose the battle,” the framing occurs for good reason.  Cancer is a fierce enemy, a vexing group of diseases that angers, scares, and humbles us, even as it earns our respect for it’s evil cleverness. Mutant cells that grow out of control and find innumerable ways to invade organs and flesh, and defy assault with chemotherapy.

Cancer remains by far the largest medical research challenge—scientifically and in the toll of lives it takes and cost it engenders.

In this context, the administration’s cancer moonshot deserves mostly praise.  It’s gotten that, but has also come in for a measure of criticism, and even cynicism.  That’s because this isn’t the first time a president has called for a surge against cancer.  Nixon launched a high profile “war on cancer” in 1971 and George W. Bush called for a “medical moonshot” to cure cancer in the 2000 presidential campaign.  (He didn’t really follow through.)

Critics see this latest effort as a PR ploy by the Obama administration in its last year in office, and they point to the proposed $1 billion in funding as inadequate to the task at hand.  By comparison, for example, the original “moonshot” – Jack Kennedy’s 1961 pledge to put men on the moon by 1970 (it happened in 1969)—cost $160 billion in today’s dollars.

Critics also note that it can cost $300 to $700 million to develop, test, and bring to market just one cancer drug.  nd, as quoted it newspaper articles—see this one in The New York Times, for example—cancer researchers worry that a call to “cure cancer once and for all” (Obama’s words in his 2016 State of the Union speech) is misleading, unrealistic, and based on an outdated view of the disease.

These criticisms have merit.  But I agree with this piece by David Grahamin Atlantic Monthly:  even though $1 billion a year is probably not enough to propel a transformation in cancer research, it’s not nothing and could be deployed meaningfully.   And, of course, any allegation that Obama or Joe Biden, whose son died of brain cancer last year and who is leading the effort, are launching the initiative for PR or political reasons is stupid, and itself politically motivated.

Moreover, the initiative is just getting off the ground, with the White House seeking broad input from scientists and others on priorities and how best to spend the money.  An initial detailed plan is due from the White House in June.   (Until then, read here.)

Meantime, the cancer moonshot is, in fact, wrapped up in politics.  That’s because funding for it is proposed in the administration’s FY 2017 budget, and because in the Senate, the moonshot has been attached to contentious health care legislation now being processed by the Senate Health, Education, Labor and Pensions (HELP) committee.

Namely, the cancer moonshot is now part of a package of related bills that form the Senate’s version of legislation passed (with bipartisan support) by the House last year, dubbed the 21st Century Cures Act. This legislation funds NIH and makes substantial changes to FDA funding and drug approval policy. The Senate bills also incorporate a related initiative from the White House on advancing “precision medicine.” I wrote about these interrelated initiatives in THCB in February. I will follow-up soon on that blog and this one with a piece on 21st Century Cures.

For now, what you need to know is that HELP committee Republicans and Democrats are fighting over how much all this is going to cost, and how the money will be earmarked.  Democrats this month proposed $5 billion in additional “mandatory” funding each year over the next 10 years, to be divided up between NIH, FDA, the moonshot, and precision medicine initiative—with about $1 billion per year dedicated to cancer, as the administration requested.  NIH would get the lion’s share.  It’s a substantial increase; NIH’s current annual budget is $32 billion, with the National Cancer Institute at $5.2 billion.

Republicans have signaled their support for additional funding but at an as-yet unspecified lower level.  And they have not yet supported mandatory funding—meaning Congress would have a tougher time clawing back the money in future years.

The House 21st Century Cures bill would have increased NIH and FDA spending far less—NIH funding would have increased about $3 billion over three years, for example, according to this CBO score.  Thus, we can anticipate that if the Senate passes the package of bills over the next few months, a House-Senate conference committee will end up compromising somewhere in between.

Of course, the debate is about much more than just money. A third and final markup of the Senate package is scheduled for April 6.  More about that in future blogs.

Steven Findlay is an independent journalist and editor who covers medicine and healthcare policy and technology.

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The Trump Healthcare Interview: Part 2

By IAN MORRISON

Donald Trump is leading the Republican delegate count and has the best chance of becoming the Republican nominee and, just maybe, even President. In February, we at THCB asked Scottish-Canadian-Californian healthcare futurist Ian Morrison to conduct an interview with Trump, figuring that Morrison would have an in with Trump given Trump’s praise for Scottish and Canadian healthcare. Fittingly, that interview was published on THCB on President’s Day, February 16th. Since then Donald Trump has racked up impressive victories and more importantly has released some specifics of his healthcare proposal. THCB thought it was time for Morrison to reach out to Mr. Trump again–Matthew Holt

MORRISON: Thanks for making time Mr. Trump, it is a pleasure to have a chance to follow up with you.

TRUMP: You were a little rough on me last time, but I enjoyed it, I thought I did very well in the interview.

MORRISON: Indeed you did, it was incredible. Mr. Trump before we get to your healthcare plan, let’s just catch up on the race. Since we last talked you have had some impressive victories in a wide variety of states from Hawaii to Mississippi. Why do you think you have done so well?

TRUMP. I’m winning everywhere, everywhere, and with all the groups: vets, high income, low income (we love the low-income). I won Hispanics in Nevada? Hispanics, Trump? They like me because I am a winner, and I’m winning everywhere. I am winning by a lot.

MORRISON: You did particularly well in the South, the so called SEC primaries, where Ted Cruz was expected to do well, particularly with evangelicals. You won by more than 20 points in Alabama for example.

TRUMP: Well they loved me in South Carolina, I won big there and then I did the dog whistle to the Klan and that probably helped, in the South.

MORRISON: You mean being slow to disavow David Duke and the Klan before those southern primaries?

TRUMP: It worked well, we had hats ready: “Make America White Again” but Corey (Editor’s note–He’s referring to Corey Lewandowski Trump’s Campaign Manager who himself made news recently by manhandling a female reporter) told me it probably wouldn’t work in the General, but we trademarked them anyway, I couldn’t believe it was available, so we may use the “Make America White Again” hats later, we’ll see. But now I disavow, I disavow, how many times do I have to say it.

MORRISON: Mr. Trump are you a racist?

TRUMP: Look I told the New York Times Editorial Board the whole story on deep background. Republican primaries are about getting angry, white people to turn up. Those people are tired and angry at the Mexicans, the Muslims, and Obama (we still don’t know if he was born in Kenya). So when we win, we can be nicer in the general election, because I get along with everyone.

MORRISON: But in the meantime Mr. Trump you have called Mexican immigrants rapists and murderers and only “some of them are nice people”. A set of assertions that are factually incorrect. You plan to deport 11 million undocumented immigrants, separating families, and build a wall to prevent anyone from returning. You also called for a temporary ban on all Muslims coming to the US, regardless of their circumstances or legal immigration status. You stereotyped Jewish people as being “good at making deals”. You have young black demonstrators forcibly thrown out of your rallies, urging supporters to rough them up. And you criticized the Pope for being too political. All of this sounds like you are a xenophobic, racist, bigot with fascist tendencies.

TRUMP: Maybe that’s why I am winning……. Look I love immigrants. I married two of them. But they came here……legally.

MORRISON: Did Melania come on an H1B Visa like the ones you are trying to eliminate?

TRUMP: She’s a supermodel. They have special visas for supermodels and world class golfers. Look Adam Scott just won my tournament at Trump Doral, he’s Australian, he can come in. Rory from Ireland, in, no problem. Supermodels, in, no problem, but they have to be a 10.

MORRISON: Mitt Romney criticized you in a remarkable speech in Utah two weeks ago, basically arguing that you were unfit to be president; you weren’t much of a businessman; and that the party should vote for Rubio in Florida, Kasich in Ohio, denying you the delegates and leading to a contested convention in which anyone, maybe even Romney, might win. So far that strategy seemed to have backfired on the Republican establishment with your victories this week. How do you see it?

TRUMP: Romney choked. He’s a stiff who should have beaten Obama. He begged me for his endorsement in 2012: he would have gone down on his knees to get it, and now he turns on me? But we won easily this week in a lot of states, and we had a great event in Jupiter with the Trump steaks, and the Trump water, and the Trump wine, and the Trump winning. So Romney is a loser. I have a store worth more than Romney.

MORRISON: What about Rubio and Kasich.

TRUMP: We will win Florida. Bye-Bye Little Marco.

MORRISON: Why so much animosity towards Senator Rubio?

TRUMP: He hit me with the hands thing. He said I had little hands…and you know, the implication. But, I’m a counter puncher, so I had to come back with the schlong at the debate. I guarantee you there is no problem. That I can assure you. I would have pulled it out at the debate, but Melania told me to be presidential.

MORRISON: And Kasich?

TRUMP: We win Ohio and Kasich goes bye-bye. Then it’s me and Lyin’ Ted–I can’t wait.

MORRISON: You match up well against Senator Cruz?

TRUMP: Look Cruz is not likeable. He has no friends. And he has a problem with the Goldman Sachs and Citi loans, so we will beat Ted. We will win all the big ones: New York, New Jersey, California and we will wrap it all up by the Convention and then we can go after Hillary or Bernie. It might be Bernie, because Hillary may get indicted and Bernie is winning so we may end up against Bernie. We’ll see. Either way we win easily. Bernie is a socialist Jew from New York who has never had a real job. I am a very successful businessman. I have built a terrific business. I employ tens of thousands of people. I’m a very good Christian (remember 2 Corinthians and the crackers). And, you know, they’re chipping away at Christianity. We’re not going to let that happen anymore..So you put me, a Christian businessman up against a Jewish socialist. Who do you think will win?

MORRISON: Which brings me to healthcare. You recently released some specifics about your health plan. Let me quote a respected conservative health care commentator Avik Roy who wrote in Forbes magazine about your plan: “It has the look and feel of something that a 22-year-old congressional staffer would write for a back-bencher based on a cursory review of Wikipedia.” Mr. Trump, a lot of pundits from the right and left have criticized your 7 point plan as a hackneyed rehash of old Republican ideas, none of which would work. I thought Trump healthcare was going to be amazing?

TRUMP: I told you last time. We will repeal and replace Obamacare and it will be amazing.

MORRISON: But the 7 point plan didn’t seem very amazing, or new; do you want to talk about it and explain how exactly it would be amazing.

TRUMP: Look this is simply a place to start the negotiation. I told you already, it will be different when I win I am President. I get along with people and I will make a great deal on healthcare.

MORRISON: So you are not a real conservative?

TRUMP: Look I am a conservative, I like to conserve, I just don’t believe in free trade, and I like Planned Parenthood. But with the health plan we start with the conservative ideas and then we will negotiate.

MORRISON: You want to keep guaranteed issuance and in earlier interviews supported the individual mandate.

TRUMP: I disavow the mandate, I disavow. But I want to keep the pre-existing conditions. I told you I don’t want people dying in the streets. And the Trump healthcare plan will do all that.

MORRISON: So what are the specifics?

TRUMP: First, we get rid of the lines around the states. Once we get rid of the lines then there will be more competition and the prices will fall so fast.

MORRISON: Most healthcare analysts agree that this is impractical to implement given that health insurance is regulated at the state level.

TRUMP: Once the lines are down, the prices will drop I guarantee there isn’t a problem..

MORRISON: Just like your….

TRUMP: Exactly.

MORRISON: The second point in your plan is making health insurance tax deductible for everyone. But only half of people pay income tax, and anyone who is self-employed or has employment-based insurance already has the benefit of tax deductibility, so it is just a tiny sliver of the population who would benefit.

TRUMP: But it sounds good, to say everyone gets a tax break. That’s why we are winning because we say things that sound good to the Trump voter, even if they won’t make much difference.

MORRISON: Your next point is Health Savings Accounts.

TRUMP: It was really Ben’s idea, but I liked but. I like Ben. He is a doctor, so you have to listen to him about this stuff so we will do the Health Savings Account thing.

MORRISON: But Health Savings Accounts have been around as described in your plan since 2003. Ben Carson didn’t invent them. 20 million Americans already have them, how is this a new idea? How is this amazing?

TRUMP: Trump Health Savings Accounts would be a much better brand. People would sign up in droves. We would have hats.

MORRISON: You want to have increased price transparency for doctors, hospitals, and drugs and many people support that. But again it is not a new idea and many groups and organizations from the Obama administration to industry leaders are already promoting this so how is this amazing?

TRUMP: The difference is we will get it done. We will get them all around the table and get it done.

MORRISON: You are in favor of block grants to the states for Medicaid, but you and many other conservatives want to eliminate the lines around the states for regulation of health insurance. Which is it? Should states have more authority or not?

TRUMP: States should have more authority apart from the lines …we need to get rid of the lines.

MORRISON: You also plan on saving healthcare dollars currently spent on illegal immigrants–some $11 billion you estimate. Will that money be used to pay for the wall?

TRUMP: No, the Mexican government will pay for the wall, I can assure you, because of the trade deficit. We have so much leverage with them on trade, and the Mexicans are bringing drugs into the country especially to New Hampshire where it is the number one problem. I couldn’t believe the beautiful hills, and roads and the little towns and the nice people and the number one problem is heroin from Mexico. So we will build a wall and stop it.

MORRISON: Which brings me to a final point of your plan which is to increase free trade on pharmaceuticals and allow importation from other countries where pharmaceutical prices are much lower, like Mexico. Don’t you think that is somewhat ironic, given what you just said?

TRUMP: No, we would bring in the drugs legally. Like oxy. And the prices would come down for oxy so no one would have to buy heroin from the Mexicans.

MORRISON: While we are on pharmaceuticals, earlier in the race you claimed you will save $300 billion on the drugs spend for Medicare recipients, which is remarkable given that the total spend by Medicare on drugs is about $75 billion. How could that possibly work?

TRUMP: Carl.

MORRISON: Excuse me?

TRUMP: Carl Icahn. He is a good friend, a terrific businessman and a fantastic negotiator. He is tough. So I am going to get Carl to lead the negotiation with China on trade. But I will also ask him to negotiate with the drug companies for the drugs for Medicare.

MORRISON: But what if pharmaceutical companies don’t want to reduce prices given they have strong patent protection and monopoly pricing power.

TRUMP: Maybe we will use eminent domain. We’ll see.

MORRISON: What if that is rejected by the courts, what could you do to get drug companies to comply?

TRUMP: Waterboarding….and more.

MORRISON: Mr. Trump that truly is amazing. Thank you.

Editor’s note. As if you needed reminding. This interview is fake. But Donald Trump is real. And his support is growing.

Ian Morrison is health care futurist and former President of the Institute for the Future

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A New Federal Agency to Oversee Patient Safety?

By TEJAL GANDHI, MD

Patient safety should be a major priority for the United States, and that requires designating a centralized entity or coordinating body to oversee efforts to ensure it. Such centralized oversight is one of the key recommendations of “Free from Harm,” a report published in December by the National Patient Safety Foundation. The report highlights the need to create a safety culture, since preventable medical errors in hospitals are estimated to result in as many as 440,000 deaths annually. That would make it the third leading cause of death – after heart disease and cancer.

A new report by the U.S. Government Accounting Office illuminates the challenges that hospitals face in implementing evidence-based safety practices. One of those challenges – determining which patient safety practices should be implemented – underscores the need for a coordinating entity and resource. The report states: “(Hospital) Officials noted that they face challenges identifying which evidence-based patient safety practices should be implemented in their own hospitals, such as when only limited evidence exists on which practices are effective. For example, officials from one hospital told GAO that the hospital tried several different practices in an effort to reduce patient falls without knowing which, if any, would prove effective.”

What’s more, preventing medical errors in hospitals is only part of the national challenge, as most health care is provided outside of hospital settings: in physicians’ offices and clinics; in outpatient surgical, medical, and imaging centers; and, in long-term, hospice, and home-care settings, among others. There are about 1 billion ambulatory visits each year in the United States, compared to 35 million hospital admissions. Those ambulatory settings are subject to medical errors as well. According to studies cited in “Free from Harm,” more than half of annual, paid, medical malpractice claims were for events in the outpatient setting.

Reducing the incidence of preventable medical errors in all settings requires the designation of a centralized entity or coordinating body to oversee patient safety. Such an entity exists for other high-risk industries. The Federal Aviation Administration oversees aviation; the Nuclear Regulatory Commission does the same for the nuclear power industry. These agencies investigate safety issues and then create and disseminate best practices to drive effective improvement. A similar vehicle is needed for patient safety, and it could be an existing or newly formed entity or coordinating body.

A number of federal agencies are already involved in valuable patient safety initiatives. The Centers for Disease Control and Prevention (CDC) has launched major initiatives to prevent healthcare-associated infections and to reduce the risk of unintentional medication overdose among children. The Centers for Medicare and Medicaid Services (CMS) launched the Partnership for Patients, a public-private partnership focused on reducing preventable hospital-acquired conditions and improving care transitions. The U.S. Agency for Healthcare Research and Quality (AHRQ) funds research and worked to create patient safety organizations that promote shared learning to enhance quality and safety nationally.

The CDC, CMS, and AHRQ are all part of the Department of Health and Human Services, but there are other federal regulatory bodies also involved in patient safety activities and oversight including the Food and Drug Administration and the U.S. Office of the National Coordinator for Health Information Technology. There are nonprofit safety organizations such as the National Patient Safety Foundation, the Leapfrog Group, The Joint Commission, and the Institute for Healthcare Improvement. There are patient advocacy groups as well as collaboratives of health care providers. All are testing or advancing patient safety innovations of one kind or another.

But there is no central entity in the United States designated to coordinate and align the initiatives and best practices emerging from various organizations involved in patient safety. Without a designated entity or coordinating body to galvanize will and act as a focal point for prioritizing patient safety efforts, there will be fragmentation, duplication, inefficiency, and unacceptably high levels of preventable medical errors. The idea of designating such an agency is not a new one. The Institute of Medicine’s landmark study To Err Is Human called in 2000 for coordinating patient safety efforts.

One option is to create a new agency, analogous to the FAA or the NRC. Another is to designate an existing agency – perhaps the AHRQ, CDC, or CMS. A third would be a public-private partnership. Regardless of the structure, it’s time to create a focal point for patient safety. The rate at which patients are dying from preventable errors cannot be accepted as business as usual.

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