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Retraction and the Rise of the Truth Jihadis

The Healthcare Blog - Sun, 06/26/2016 - 11:11

A petition to the British Medical Journal (BMJ) asking for Makary’s paper on medical errors to be retracted has received over 100 signatures. I, amongst others, criticized Makary’s analysis. But I shall not be signing the petition.

I applaud the editor of the BMJ, and the section editor, for publishing Makary’s analysis. The analysis was in the right journal in the right section. To be clear, I believe the editors did nothing wrong publishing the paper. The role of medical journals is not to tell us how to think, but what to think about, which the BMJ achieved.

Makary’s analysis was provocative. I almost developed laryngeal edema reading it. The analysis advanced the discourse about medical errors. The analysis made doctors think, think beyond dull platitudes. The analysis broke the taboo of questioning the number of deaths from medical errors. Whether or not this was the intention of the authors is immaterial. The BMJ achieved a vigorous debate about medical errors. Not since the NEJM series on physician relationship with industr has any publication led to such intense discourse.

Some say that the paper should be retracted because it was a scientific paper, not an opinion, and as science it is even more dubious. This is not true. The paper was an “analysis.” Look up the definition of “analysis.” But were it research, so what? Methodology for this this type of research is flawed. If all research with fallible methods are retracted, that’ll end medical research.

Some say that the paper should be retracted because the media runs with the story amplifying the error. The media is fickle. The media runs like decerebrate pigeons every time a nutritional study is published. The media doesn’t know its posterior from elbow and I, for one, find this state of affairs comical. I find it hilarious when someone, who follows nutritional advice as punctiliously as a celibate nun listens to her pastor, is later told that it is all rubbish. Nothing gives me more pleasure than seeing mirthless optimizers taken down the garden path.

It is true that the media will be quoting “medical errors are the third leading cause of death” for years. However, the root cause of this chicanery is not Makary’s analysis but the Institute of Medicine (IOM) report: To Err is Human, which stated that jumbo jets of hapless patients were crashing daily. The report created a new science and a professional empire. Should the IOM retract that report?

The problem with retraction was highlighted by my 10-year old son recently. Arguing with his younger brother he said “you must be feeling light because you left your brain back at school.” When I heard his gratuitous remark I was enraged, “Take your words back, now,” I yelled. After deep thought, and tears in his eyes, my son said “what good will that do? I already said them.” I gave him a time out for that reply. But his point was well taken – what is said can’t be unsaid.

Retraction has become like corporal punishment. Spectators would flog to the stadiums in Taliban-controlled Afghanistan to watch with glee when adulterers were being stoned. When a medical journal retracts a study there is glee amongst spectators, the glee of an aspiring saint watching a sinner unfold. Read the comments in Retraction Watch, a consumer watchdog which keeps an eye on retractions.

Inquisitive scientists seeking the objective truth embrace uncertainty. There is, however, an emerging rank of science aficionados who treat objective truth like religion. These are the Truth Jihadis. They’re indistinguishable from religious fanatics on PET scans. Truth Jihadis are not seeking the truth. They’re seeking control. “I am for the truth” is the dullest of dullest platitudes. Science, an enterprise which grows by curiosity, not control, cannot be chaperoned by the incurious.

Calls for retraction have become yet another avenue of redress for an affluent society, which has exhausted the legal system, and which increasingly yearns for perfection, is intolerant of uncertainty and can’t handle variation. Americans might introspect this November how they became more hyper regulated than the French, indeed more hyper regulated than Stalin or Mao thought it might have been possible to be hyper regulated.

When Bleyer and Welch published in the NEJM a study which showed that mammograms may have overdiagnosed breast cancer, the reaction amongst my peers was brisk and predictable. It started off with “how could this pass peer review?” – the incredulity cleverly according the skeptic with unchallenged sophistication. I asked a few, what should pass peer review? Was there a normative frame? Who developed the norm? I was met with silence.

Some asked the NEJM to retract the paper. Many called the study “fatally flawed.” One said, in a tone perfectly capturing sincerity and gravity, “this paper will kill women.” Nothing quite inspires righteousness more than believing you have God or statistics on your side.

If science has been hijacked by special interests it won’t be rescued by social justice warriors. I recall an open letter signed by UK academics asking to boycott Israel’s academia. Scientists and politicians, like pigs and farmers in Orwell’s Animal Farm, have become indistinguishable.

The most famous retraction is Wakefield’s discredited paper in the Lancet about the link between autism and vaccination. It must be understood why the paper was retracted. It was not retracted because the link was later shown to be wrong. As the editor of the Lancet, Richard Horton, reminded with frustration – science is self-correcting. It was not retracted because it unleashed havoc, including a congressional hearing. I’m always amazed how congress chooses the most dubious entities to debate over. It takes skill to be so consistently and exceptionally useless. The paper was retracted because Wakefield was struck off the General Medical Council, because he obtained the tissue samples of the children through deceit. The study was retracted because Wakefield had been dishonest.

The most disturbing part of the autism-MMR debacle is not that the Lancet published the study. It is that the Lancet had to retract the study before people believed the dubiousness of the link. Wakefield had to be discredited (he deserved to be), shown to be a bad man before people believed in vaccines again. It was not the scientific evidence that persuaded people, but the (bad) character of the researcher.

Thus, we cannot debate facts on their own merit but we must involve the person behind the facts. If he is sincere, “a good guy,” we must believe what he has to say. If the evidence is dubious he must be dubious, too. The religious undertones in the scientific enterprise are ironic. Pope Urban VIII is probably laughing in his grave.

It is a small logical step from saying that because dodgy scientists produce dodgy science, that dodgy science is produced by dodgy scientists. And an even smaller step from concluding that because dodgy research is later contradicted, that research which is later contradicted is dodgy. Retraction is a Spanish inquisition, of sorts. Calls for retraction are reminiscent of pitchfork-carrying righteous puritans in Salem. I’m getting tired of puritans.

It is precisely because Makary’s analysis is flawed that it should not be retracted. For it to be retracted would be to set a standard for medical journals that is neither achievable nor desirable. Knowledge grows by error, not perfection. Perfection merely picks out the lowest-lying fruit which everyone can agree about. Makary’s study received several online comments on the BMJ website. Voices were heard, which would not have been heard but for this paper. Were I the editor of the BMJ I’d open a bottle of champagne and celebrate a job well done.

Categories: OIG Advisory Opinions

Just-in-Time Healthcare Information

The Healthcare Blog - Sat, 06/25/2016 - 21:11

One of the things that can cause physician burnout is the arcane way information flows in medical offices. In essence, due to EMRs we are the recipients of increasing amounts of unfiltered data without context.

Pre-EMR, team members sorted incoming data, which allowed us to deal with it more efficiently. We would have piles of things that needed a signature just as a formality, other piles for normal reports, smaller piles for abnormal reports, or whatever system worked best for us and our practices.

Because EMRs were created by people who never imagined that doctors themselves knew anything about how to maximize their own efficiency, results and reports now fill our inboxes in random order and demand our attention and our electronic signatures more or less immediately.

There is a better way. It is standard practice in manufacturing. They call it “Just in Time”.

First, let me describe the way it works now:

I saw Mrs. Keller three months ago for her diabetes. Next week, she will be back for her three month followup appointment. In the next few days, I will get her blood test results, each requiring my electronic signature. This time that might be her HbA1c and her annual urine microalbumin and a chemistry profile. I might also have received an eye doctor report from last week and a progress report from her podiatrist, neither one of which requires any action on my part. That means I must “steal” time from this week’s patients to peruse and electronically sign off five items, which I will have to review again when I see her next week. I also have to remember to flag the eye doctor report for my medical assistant to enter in the flowsheet so we can keep up our quality reports.

In my mind, I multiply Mrs. Keller’s five sign-offs by the number of followup visits I have every week. Even CT scans, MRIs and other imaging could be reviewed and signed off at the time of the followup visit; the radiology departments at all my area hospitals have routines in place to flag critical results.

Why should I look at everything twice? Why are physicians, the highest paid members of the health care team, essentially opening and sorting the mail?

I imagine how my day would flow if none of those five items cluttered my inbox, but popped up when I sat down with Mrs. Keller to talk about her diabetes or with Bill Watterson to talk about his partially torn meniscus.

In the lean, “Just in Time” manufacturing paradigm, factories don’t store parts and raw materials needed for production. They save space, time and money by planning for what they will need and having these supplies arrive just before they are needed.

In medicine, information like test results and outside reports are the parts we need in order to produce treatment plans, which is the output in our “industry “.

Most of the time today, we get paid only for face-to-face visits, and not for “managing” patients’ care. Even in the future, when Medicare starts paying us for outcomes, efficient information flow is essential. Imagine getting important information in random order versus delivered in context, when it is time to assess a patient’s or an entire population’s health status.

Between the skill and experience of our team members and the vast untapped potential of the expensive information systems we have, we could get to where we touch most incoming information only once, just when we need it. Imagine how much time, energy, frustration and money that could save us all.

Categories: OIG Advisory Opinions

The Orlando Shootings and Homophobia in Healthcare

The Healthcare Blog - Sat, 06/25/2016 - 19:07

After the horrific shooting in in Orlando, the conversation has turned to homophobia—specifically, the homophobia of a man who sees two men kissing, buys an AR-15, goes to a gay nightclub, and killed 49 individuals.  But homophobia does not always come with a high capacity rifle—sometimes it comes with lab coats and syringes.  As the 53 individuals who were critically injured in the shooting receive medical care, we must come to terms with the anti-gay discrimination that pervades our medical system.

Take blood donation for example.  Orlando residents have provided blood with such generosity that local blood centers have reached capacity.  Donors explained that they were giving blood to show solidarity with the victims of the shooting, even if they knew none of them.  They wanted to do something to help.

But some of the closest friends of the victims of the shooting—other gay men—were left feeling powerless, because rules set by the U.S. Food and Drug Administration prohibit them from donating blood.  The rules are a legacy of the early days of the AIDS epidemic: gay men were among the hardest hit by the epidemic, and HIV testing was unreliable.  But today, testing has improved to the point that the American Red Cross, America’s Blood Centers, and the American Medical Association have all declared the ban unnecessary.  Straight individuals from groups with similar risk profiles can continue to give blood.

Yet, instead of abolishing the ban, the FDA has merely ‘relaxed’ it:   men who have sex with men can only donate blood 12 months after their last sexual encounter with another man.  In other words, an HIV negative gay man in a monogamous marriage cannot give blood—unless he stops having sex with his husband for a full year.

Gay people also routinely face discrimination from their medical providers.  Patients, advocacy groups, and even doctors have reported incidents where medical staff condemn their gay patients on religious grounds, or refuse care altogether.

A few years ago, a Florida hospital reportedly informed a woman whose partner had collapsed that she was in an “antigay city and state.”  Accordingly, they would not recognize the same-sex relationship or permit visits.  After she was admitted, the patient died without seeing either her partner or their children.

The discrimination sometimes comes from ignorance rather than malice.  Fewer than half of medical schools and few hospitals  train their students or staff on LGBT issues.  One doctor tells us how a colleague simply assumed that his gay patient’s medical condition was HIV related, and ordered HIV test upon HIV test, all of which turned out negative.  Only when the patient went to a different doctor was the real cause of his complaint uncovered—hypothyroidism.  In a survey, the Centers for Disease Control found that 34% of primary care doctors and nurses had never heard of a drug that, when taken regularly, can prevent HIV transmission.  Because of the substandard care they often receive, many LGBT patients simply stop going to the doctor altogether, or lack a regular provider.

Perhaps most troubling is that the law denies gay individuals in most states—including Florida—the ability to fight anti-gay discrimination.  If the victims of the Orlando shooting suffer discrimination because of their race, sex, national origin, or religion, they can file suit under the antidiscrimination provision of the Affordable Care Act.  But if they suffer anti-gay discrimination, their hands are likely tied.   As the Department of Health and Human Services explained just last month,  the ACA does not conclusively prohibit sexual orientation discrimination in healthcare.

There are signs of change.  Marriage equality addresses many of the problems surrounding spousal visitation.  In 2014, the Association of American Medical Colleges issued recommendations for curricular change so that future doctors are more competent to address LGBT issues.  Providers and the federal government have begun major efforts to collect data about LGBT individuals (over the protest of many providers) so that they can address their unique healthcare needs.

But there is a long way to go.  Acts of discrimination, harassment, or sub-standard care will continue to pervade the healthcare system until providers receive appropriate training in hospitals, and anti-gay discrimination is prohibited. Gay men will still feel like second class citizens until they can provide blood and organs for their loved ones, or even to complete strangers, should they choose to.  As our medical system experiences an influx of queer individuals, it is time to take step back to consider how to extend to them the protections that we provide other vulnerable populations so that the homophobia that brought them there is not perpetuated.

–Craig Konnoth is a Sharswood Fellow and Lecturer at Penn Law School and a Rudin Fellow in the Division of Medical Ethics at NYU Langone Medical Center.  He writes on LGBT health law and health information policy.

Categories: OIG Advisory Opinions

Time to Brexit the Health Care System?

The Healthcare Blog - Fri, 06/24/2016 - 12:57

Can’t. Won’t work. We’re stuck with this. We have to fix it.

But “Brexit” was a great logo/hashtag/campaign meme, with echoes of “Britain, break it, exit” all in one. Falls right off the tongue, it does. And it described fairly exactly the mood behind it, one of breaking, getting out.

So in healthcare? Time to FFSexit — exit the fee for service business model. Nah, doesn’t trip off the tongue. And it has echoes of “sex” and even “sexist.” Next!

Time to ITexit — exit the non-interoprative, non-communicative garbled EHRs and other information systems we have ended up with. Nope, nope. Sounds too much like inviting Texas to re-think this whole annexation thing.

Time to Vexit — exit the volume-based business model. Hmmm, no. Sounds vexatious, vexed.

Time to exit the fragmented, opaque, partial, byzantine, and outright cruel healthcare financing system we have now —FragOpParByzOutCrexit! Sigh.

Wait. Wait. Here’s the core problem of this meme-pondering: We don’t want to “exit” healthcare in any way.

The Congressional Republicans hope to exit the defined benefit Medicare system and make it a defined contribution system, presumably so that sooner or later they can drown the contribution in the bathtub. Republican state legislatures have found as many ways as possible to exit Medicaid, or its expansion.

But we the people can’t exit the healthcare system because unlike political parties and ideologies, we actually have bodies, and those bodies need tending whether we like it or not.

The healthcare economy is hollow. You know the drill. It costs twice as much as it needs to for no good reason, overtreats to the tune of close to $1 trillion per year, at prices that have no real support in the cost basis or the market, still is a major cause of personal bankruptcies, and manages to cut vast numbers of people even people “covered” by high deductible plans, out of any treatment at all because it’s so expensive to use the system.

We don’t need to exit. We need to fix it. Fixit!


Categories: OIG Advisory Opinions

The Great Insurer Fee Disconnect

The Healthcare Blog - Thu, 06/23/2016 - 15:02

A message to health insurance CEOs, COOs, and CFOs.  I believe there to be a fundamental disconnect between typical health insurer provider reimbursement strategies and the long term good of our healthcare delivery system and its financing.

Let me give you some examples which I know, as a former health insurer COO and CEO, to be true.

  • Insurers still pay primary care physicians far less than most specialists.  That perhaps was a function of the RBRVS system adopted by Medicare to “measure” the demands of specific physician activities and pay accordingly.  Specialist activities were rated higher than primary care activities.  They were deemed more complex, often involving surgery and fancy equipment with more training needed, etc.  The gap between primary care and specialist reimbursement grew and grew.  And what happened?  Predictably, the best and brightest are avoiding low paying primary care.  Consequences?
  • Shortage and aging of primary care physicians who are needed to keep us from requiring the much more expensive specialist and hospital care
  • Oversupply of specialists resulting in overuse, because if you build it they will come
  • Keeping the focus on sick care, which is what most specialists specialize in, rather than well care
  • Devaluing E&M (evaluative and maintenance) activity, which is the heart and soul of the practice of medicine, requiring observation, patient knowledge, and perception

  • Not paying for needed counseling and monitoring, which means no one does it and there is no quarterback for a patient’s care
  • Many hospice organizations provide acute care for terminally ill patients in a setting that is far more patient and family friendly than a hospital based ICU, and at tenth of the cost.  What about this is there not to understand?  And yet, many insurers (including Medicare) negotiate with hospice organizations exactly as they do with specialists and other providers, trying to achieve reimbursement at the lowest possible level, without thought to whether that makes overall sense.  Consequences?
  • Shortage of hospice acute care facilities
  • Longer hospice eligible patient stays in hospital ICUs
  • Bloated end of life expenses that could be mitigated
  • Significantly worse patient experience
  • Worse outcomes (and I’m not talking about death, but rather quality of life while still alive)
  • Commoditization of acute care undifferentiated as to its cost
  • Virtually the entire insurer response to behavioral health office visits and counseling is contrary to common sense and the good of the system (financially and otherwise) and its patients.  Insurers squeeze office visit reimbursement, limit the number of office visits, and often resist collocation and integration of behavioral and physical health.  They underpay psychologists and clinical social workers, the front line of counseling. They overpay psychiatrists, who largely are prescribers of meds. Consequences?
  • Mental health parity remains largely a myth in reimbursement, despite claims to the contrary.
  • Limits on behavioral health office visits do tremendous harm.  Behavioral health patients do not overuse office visits!  And limits create emergency situations, particularly during end of year holidays, that glut emergency departments and do tremendous harm to patients
  • Still no collocation and integration of behavioral and physical health
  • The best and brightest become psychiatrists who seldom counsel.  They dispense medications and “monitor.”  All at over inflated costs.
  • Tremendous shortage of professional counselors and burn out of those who are in the field today, because at today’s reimbursement levels, they can’t pay their own bills
  • Insurers paying physicians for telemedicine patient consults (“visits”) at 50% of a regular office visit.  Consequences?
  • Physicians resisting telemedicine visits which are clearly needed, particularly for the elderly and chronically ill for whom travel is a hardship
  • Missed visits and consults that should be occurring
  • Exacerbated inconvenience for patients
  • Lack of recognition of the added cost and hassle factor of technology and other expenses and work flow changes needed for telemedicine and potential additional malpractice exposure
  • Fewer “maintenance” and counseling sessions which are badly needed for the chronically ill
  • Greater emergency room and inpatient use overall

Permit me to share a truth with you.  OFFICE VISITS NEVER BREAK THE BANK!  Never.  It’s the lack of office visits which exacerbate already existing chronic situations that result in in patient hospitalizations and specialist involvement over extended periods that break the bank.  The other item that breaks the bank is the leveraged whammy of untreated combined psychological and physical health maladies which are the single biggest driver of fee for service Medicaid expenditures today.  Again, office visits never break the bank.

Many insurers are not using reimbursement as the strategic tool that it is to better the system and reduce overall costs of its own insured population.  Just the opposite.  The folks in the “Provider Reimbursement Department” who have done trench warfare with physicians for decades are saddled with a Cold War mentality in which they push for the lowest reimbursement possible regardless of whether it makes sense.  Almost a Pavlovian response.  They never saw a negotiation that shouldn’t be “won” by lowering fees.

In some situations, that makes sense.  But not in all situations.  Theirs is a tough, tough job.  But even if they are hammers, not everything is a nail.  Money can be like lubricant or a growth tool, when spent properly.  What types of services do you want to incent and grow?  Presumably, those that might reduce the overall use of services in America and improve patient quality of life.  But many insurers, for negotiation purposes, continue in an undifferentiated pattern to treat office visits exactly the same as knee replacements and open heart surgery.

This is exacerbated by the fact that typically, primary care, behavioral health, and hospice providers do not practice in large groups with negotiating leverage.  So, many insurer negotiators drive reimbursement down simply because they can.   Penny-wise, etc.

What if insurers doubled the per diem reimbursement of hospice inpatient acute care?  It would then perhaps be 20% of hospital-based ICU care. And the additional dollars would help hospice organizations build more facilities and capabilities to start moving more terminally ill out of hospital based ICUs to much kinder and gentler settings at a fifth of the cost.  In fact, it might be good strategy to look at the panoply of hospice care such as home-based palliative care, and incent its growth as well for all the obvious reasons.

What if insurers dramatically increased the compensation of primary care physicians, helped with their technology needs, and had, say, a med school loan forgiveness program?  Some insurers are doing just that, including my  Rhode Island Blue Plan.  What might be the results?  More primary care doing more of the needed things to keep us out of hospitals.

It is not always about driving the lowest reimbursement possible.  Healthcare costs are not just fees.  They also are driven by use and the relative expensiveness of the services.  These last two are today’s biggest contributors to our out of control costs of healthcare and its financing.

I know for a fact that there are many in insurer senior management who, in quieter moments, would totally agree with this.  But whether they drive that message down into their organizations is another thing.  Cold War warriors do not change easily.

Jim Purcell was the CEO of BCBSRI.  Prior to that, he was a trial lawyer in healthcare, and today he mediates and arbitrates complex business disputes and is focused on workplace wellbeing. (healthcare) and

Categories: OIG Advisory Opinions

Where’s the Value in MACRA?

The Healthcare Blog - Thu, 06/23/2016 - 11:06

The intent of Title I of the 2015 Medicare Access and CHIP Reauthorization Act (MACRA) is to improve care quality and reward value. 1  Tying an increasing percent of Medicare fee for service payments to quality or value through alternative payment models such as Accountable Care Organizations (ACOs) is also Department of Health and Human Services Secretary Sylvia Burwell’s goal. 2  However, in the proposed MACRA rule published in May, CMS will measure and score quality and resource use or spending independently. 3  CMS will not measure outcomes in relation to spending.  CMS will not measure for value.  If value is left unaddressed in the final rule the agency can neither meet MACRA’s goals nor Secretary Burwell’s.  CMS cannot also reasonably expect providers to continue to enter into, and succeed under, risk based contacts if they do not know if they are incrementally improving quality or outcomes relative to spending. 

On background, MACRA replaced the 1997 Balanced Budget Act’s Sustainable Growth Formula (SGR) with two new methods to update annually Medicare Part B physician payments: the Merit-based Incentive Payment System (MIPS); and, the Alternative Payment Model (APM) pathway.  The MIPS will consolidate the current Physician Quality Reporting System (PQRS), the Value-based Modifier Program (VM); and, HIT Meaningful Use (MU) and will consist of four component scores: quality; resource use; clinical practice improvement activities (CPIA); and, advanced care information (ACI), formerly MU.  Under the proposed rule beginning in 2017 CMS will require eligible clinicians or groups to select and report on six quality measures from a list of over 250.  One of these six must be cross-cutting and one an outcome measure.  CMS proposes to add to these three global or population-based measures derived from Medicare claims data.  In calculating the resource use component score CMS will calculate in dollars episode based, per capita costs by disease condition and a Medicare spending per beneficiary amount.  Providers will select at least one of 90 CPIA measures that address, for example, beneficiary engagement and expanded practice access.  The ACI measure will consist of a HIT capability base score and a HIT usage performance score.  Providers would earn a MIPS composite score that totals these four, differently weighted, component scores.  MIPS is budget neutral.  Depending on how one’s composite score compares to benchmark scores and other MIPS participant scores, half of providers will receive a positive score and half a negative score ranging from minus to plus four percent beginning in 2019 to minus to plus nine percent in 2022 and beyond.  If a provider group meets the definition of an “advanced APM” providers are exempt from MIPS and will receive beginning in 2019 a Medicare Part B five percent lump sum bonus payment.            

Though value is mentioned over 150 times in the proposed MACRA rule, CMS fails to link or jointly measure quality and spending.  The need to account for value is also unrecognized in CMS’s recently published “Measure Development Plan” (MDP).  Formally titled, “CMS Quality Measurement Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs),” the report also notes value numerous times but there is no discussion of quality or outcomes relative to spending or value.  For example, the report simply states, “The MDP describes . . . the roles of quality measures in the transition to a value-based health care.” 4  The report’s companion, the Health Care Plan Learning and Action Network’s (HCPLAN) “Performance Measurement” draft white paper, also fails to measure for value. 5  Among other examples, the Institute of Medicine’s 2015 report,”Vital Signs, Core Metrics for Health and Health Care Progress,” identified 15 quality measures but none calculate quality or outcomes relative to spending. 6

The failure to measure for value has not gone unrecognized.  In the Medicare Payment Advisory Commission’s (MedPAC’s) June 2014 report to the Congress, the commissioners stated bluntly, “Medicare’s current quality measurement approach has gone off the tracks.”  With an overemphasis on process measures, providers were left with, the commissioners stated, “fewer resources” to “improve the outcomes of care, such as reducing avoidable hospital admissions.” 7  MedPAC’s comment echoed Michael Porter.  In 2010 Porter argued, “the failures to adopt value as the central goal in health care and to measure value are arguably the most serious failures of the medical community.”  This, he said, has among other things, “resulted in ill advised cost containment, and encouraged micromanagement of physician practices which imposes significant costs of its own.” 8  Per this latter point, a recent study found physician practices in four common specialties spent more than 15 hours per physician per week reporting external quality measures.  This time translated to an estimated $15.4 billion in total costs. 9     

Measuring quality and spending separately can and does produce “ill advised” or perverse results.  Consider, for example, the Medicare Shared Savings Program (MSSP).  In 2014, the most recent year for which performance data is available, CMS paid bonuses or shared savings to 86 MSSP ACOs because their performance year spending was less than their financial benchmark.  These ACOs had a mean quality score that was, however, worse than the mean score for the worst financially performing 67 ACOs, or those that exceeded their negative Minimum Loss Ratio.  (None of these 67 ACOs received shared savings).  In addition, average spending among the 86 ACOs was only $29 less per beneficiary compared to the failed 67 ACOs, or $10,537 versus $10,566 for the performance year.  The 86 ACOs were successful because they had comparatively higher financial benchmarks.  With quality unrelated to spending, CMS effectively rewarded the lowest quality and highest spending or the lowest value performing ACOs. 10  Under the proposed MACRA rule this problem will likely get worse.  Regardless of their quality performance, spending efficiency or the combination thereof, ACOs defined as “advanced APMs” will automatically receive a five percent APM bonus beginning in 2019 simply for participating.

CMS has an opportunity in the agency’s final MACRA rule to begin to measure for value.  Among other opportunities, MACRA funds $15 million annually between 2015 and 2019 to identify gaps in MIPS quality measures.  These funds could be used to develop new measures that align with the Department’s National Quality Strategy’s “efficiency and cost reduction” priority area, or per the proposed rule “measures that reflect efforts to lower costs and significantly improve outcomes.” 11 CMS could look to and work with the International Consortium for Health Outcomes Measurement (ICHOM) to both exploit and develop additional and much needed outcome measures.  Working with ICHOM also provides an opportunity to compare Medicare program performance internationally. 12   CMS could also create a minimum resource use threshold.  For example, California’s Integrated Healthcare Association’s (IHA) value based pay for performance program imposes both quality and spending thresholds.  If both thresholds are not met the provider or provider group’s performance score suffers. 13  As MedPAC suggested in its June 15th MACRA comment letter, CMS could identify and measure comparative performance or performance for all providers via claims data.  CMS could then condition resource use scores based on spending in comparable performance categories. 14  (Conveniently, Medical Care Research and Review just published a review of seven methodological approaches that combine quality and spending to measure for efficiency. 15)  Measuring for value could also be forwarded via how the agency builds out MACRA required care episode and patient condition group codes that are intended to improve resource use measurement.  Lastly, in the proposed rule CMS does not define the agency’s bundled payment demonstrations as APMs.  The agency could find a way to include bundled payment arrangements since the Bundled Payments for Care Improvement (BPCI) and Comprehensive Care for Joint Replacement (CJR) demonstrations are designed to improve value or outcomes achieved over spending.    

Performance improvement or innovation in health care cannot ultimately be achieved via the same conventional thinking that measures quality and spending separately or not simultaneously.  Achieving one without the other and/or defining quality as, or a proxy for, value will continue to produce ACO-like false savings.  Moreover, if CMS expects providers to continue to buy into and succeed in a pay for value, or foregone revenue, world, they need to measure and make known the causal relationship between outcomes and spending.  The foremost MIPS and APM goal ought to be measuring and rewarding value.


1. For example, the House Energy and Commerce Committee’s MACRA summary states, “The new system moves Medicare away from a volume-based system towards one that rewards value, improving the quality of care for seniors.”  At: 

2. The January 2015 press release noting Secretary Burwell’s goals, titled, “Better, Smarter, Healthier: In historic announcement, HHS sets clear goals and timeline for shifting Medicare reimbursements from volume to value,” is at:  See also the related February 2016 press release titled,” HHS reaches goal of tying 30 percent of Medicare payments to quality ahead of schedule,” at: 

3. The MACRA proposed rule is at:

4. The CMS “Measure Development Plan” is at:

5. The HCPLAN report is at:

6. The Institute of Medicine report is at:

7. MedPAC, “Report to Congress: Medicare and the Health Care Delivery System,” (June 2014): 41.  At:

8. Michael E. Porter, “What Is Value In Health Care?” The New England Journal of Medicine (December 23, 2010): 2477-2481.  At:

9. Lawrence P. Casalino, et al., “US Physician Practices Spend More Than $15.4 Billion Annually to Report Quality Measures,” Health Affairs (March 2016): 401-406.  At: 

10. MSSP 2014 results are at:  See also, David Introcaso and Greg Berger, “MSSP Year Two: Medicare ACOs Show Muted Success,” Health Affairs blog (September 24, 2015).  At:  Similar results have been found in the Medicare Hospital Value-Based Purchasing (HVBP) program.  In 2015 CMS paid 231 hospitals financial bonuses for spending efficiency despite the fact their quality scores were “significantly worse” than medium and high quality hospitals that received bonuses.  See, Anup Das, et al., “Adding a Spending Metric to Medicare’s Value-Based Purchasing Program Rewarded Low-Quality Hospitals,” Health Affairs (May 2016): 898-906.

11. Note 3, pg. 28194.

12. For information concerning ICHOM go to:

13. Jill Yegian, et al., “Value Based Pay for Performance in California,” (September 2013).  At:

14. MedPAC’s June 15, 2016 MACRA comment letter is at:’s-proposed-rule-on-the-merit-based-incentive-payment-system-and-alternative-payment-models.pdf?sfvrsn=0.  This approach also avoids the inherent problem of clinicians selecting measures on which providers already perform well and measures that represent only a small percent of a provider or provider group’s overall performance.

15. Andrew M. Ryan, et al., “Linking Cost and Spending Indicators to Measure Value and Efficiency in Health Care,” Medical Care Research and Review (May 23, 2016).  An abstract of the article is at:

Categories: OIG Advisory Opinions

The Mischief and the Good In Precision Medicine

The Healthcare Blog - Wed, 06/22/2016 - 11:17

When The White House announced their Precision Medicine Initiative last year, they referred to precision medicine as “a new era of medicine,” signaling a shift in focus from a “one-size-fits-all-approach” to individualized care based on the specific characteristics that distinguish one patient from another. While there continues to be immense excitement about its game-changing impact in terms of early diagnoses and targeting specific treatment options, the advancements in technology, which underlie this approach, may not always yield the best medical results. In some cases, low cost approaches, based on sound clinical judgment, are still the better option.

For example, tuberculosis (TB) is an infectious disease that continues to pose global burden with 9.6 million new cases and 1.5 million deaths reported in 2014 alone. The large toll is partly due to lack of effective treatments (particularly for drug-resistant cases) but also due to delays in diagnosis. One might think that precision medicine technology leading to improved diagnosis would be effective at minimizing the related death toll but we shouldn’t automatically assume that. It turns out that sometimes the latest technological advancements can be so sensitive that we detect organisms that are not causing disease.

I recently took care of a 50 year old man who was admitted to our hospital with fever and cough. Not a healthy man, he had liver cirrhosis, chronic obstructive pulmonary disease, and substance abuse. He also had a history of latent TB infection based on a positive TB skin test, but he never had active TB manifesting with clinical symptoms.   He never received prophylactic TB medications to prevent the development of active disease. Because of this history, his doctors sent a sputum sample for TB cultures, which usually take 6 weeks to grow the organism. The patient went home since he felt better with treatment for bronchitis.

In the meantime, the laboratory reported that the patient’s sputum cultures were growing a “TB-like” organism.  The laboratory tested this culture using Gene Xpert, a precision medicine tool developed in 2010, which yielded a positive identification of drug resistant TB (along with non-TB mycobacteria). The patient was readmitted for TB treatment. Although the patient informed his doctors that he felt better, the question of active TB persisted.  Prior to treatment, his sputum samples were re-tested and all were negative using GeneXpert and traditional culture tests. The laboratory decided to further use Next Generation sequencing, another tool of precision medicine to test the original sample which had the positive identification. This test showed that a few TB bacteria were present and genomic testing showed the presence of drug-resistance.

The doctors decided to treat the patient with multiple medications for multi-drug resistant TB.   Over the next six months, the patient received an array of antibiotics that produced toxic side effects involving his kidneys, liver and lungs. The doctors conferred with the state health department and it was decided to continue treatment largely on the basis of the testing and the concern for potential infectiousness to the public.  When I became involved in this patient’s care, he was doing poorly and I wondered if we were doing the right thing.

After all, the patient did not show classic signs of active TB (fever, bloody cough, weight loss).  Yet, our precision medicine tools revealed that resistant TB, albeit few in number, were present in his sputum. But did this constitute disease?  In infectious disease, there has always been the concept of “colonization,” where bacteria live on the human body but do not cause disease. But does this concept apply to TB?  The natural history of this infection describes a spectrum of TB ranging from harboring the bacteria in latent form to actual full-blown symptomatic disease when bacteria reach a critical number.  As our tests get more sophisticated, we may pick up earlier and earlier on conditions that do not actually represent disease as defined by the presence of symptoms.  But is there a benefit (to the patient and the public) in treating earlier in the absence of symptoms? Perhaps, but the more we treat, the more potential side effects can ensue.

In the end, our patient suffered multiple toxicities and his quarantine made him “feel like a prisoner.” Eventually, after consultation with local, state, and federal experts, including an institutional ethics consult, we decided to discontinue TB treatment in favor of monitoring him closely as an outpatient.  He died 6 months later.

I’ve always wondered if our prolonged attempt at TB treatment hastened his demise.  He never did show any signs of active TB prior to his death.

The Hippocratic oath is credited with the concept of primum non nocere or  “first do no harm.”   Further stated, physicians pledge that “I will according to my ability and judgment, prescribe a regimen for the health of the sick; but I will utterly reject harm and mischief.” To be sure, new precision medicine technologies can reset the clock on when we can first detect causes of disease and offer guidance on what types of treatment we can use. But how do we figure out how to draw the correct line between health and mischief?  As clinicians, we must learn to balance the promises of technology with a practical wisdom so that we do not put our patients in harm’s way.

Merceditas Villanueva, MD is the Director of the Yale University School of Medicine AIDS Program and a Fellow with the Op Ed Project.

MD, Director Yale University School of Medicine AIDS Program


Categories: OIG Advisory Opinions

Understanding the True Costs of ACOs and Medical Homes

The Healthcare Blog - Wed, 06/22/2016 - 08:01

One of the privileges of being a managed care advocate is that you never have to discuss the unpleasant question of how much your proposed intervention will cost. Whether your proposed intervention is HMOs, report cards, pay-for-performance, ACOs, “medical homes,” or electronic medical records, you never have to estimate what your bright idea will cost. With this privilege comes another: You are free to criticize doctors and hospitals for being “cost unconscious.”

Over the last decade, CMS has become a proponent of this double standard – cost consciousness for doctors and hospitals and cost unconsciousness for the health policy illuminati
. Beginning with the Physician Group Practice Demonstration, which ran from 2005 to 2010, and running through today’s ACO and “medical home” demos, CMS has assiduously avoided reporting the costs that clinics and hospitals incur to participate in these demos. Jeff Goldsmith and Nathan Kaufman  have described CMS’s behavior as “sunny obliviousness to provider economics.” [1]

Cost unconsciousness permeates CMS’s MACRA rule

CMS’s cost unconsciousness is on vivid display in its proposed MACRA rule . About two-thirds of the way into the rule, CMS admits:

it does not know what it costs doctors to implement electronic medical records nor whether the benefits of EMRs exceed the costs (p. 669);

it does not know what it costs doctors to participate in “medical homes” (p. 670);

it will allow ACOs and “homes” to participate in MACRA’s Alternative Payment Model (APM) program even if those entities cannot cut costs (pp. 460-461); and

it cannot say whether the benefits of its MACRA rule will outweigh the costs. (p. 679 and 684)

Moreover, by maintaining throughout the 962-page rule its long-standing silence on the subject of what it costs to start and run ACOs, CMS concedes it doesn’t know or doesn’t care what that cost is either.

And yet CMS gives every indication it intends to impose its rule on the doctors and nurses who treat Medicare patients. Is that not the textbook definition of cost unconsciousness?

All this cost unconsciousness spells trouble for MACRA. CMS’s refusal to acknowledge the costs that doctors incur to join ACOs and “homes,” coupled with CMS’s willingness to let ACOs and “homes” into the APM program regardless of whether they cut Medicare’s costs, suggests MACRA’s APM program will fail one of two ways: Either doctors won’t participate in APMs because their costs will exceed payments they’ll receive from CMS, or they will participate but the APMs they join will raise Medicare spending. [2]

CMS is in this bind because ACOs and “homes” do little or nothing to cut Medicare’s costs despite boasts to the contrary by ACO and “home” proponents. If those entities did save money, the physician’s share of the savings might be big enough to make participation in ACOs and “homes” financially attractive. But that’s not what CMS’s demonstrations have shown.

CMS’s three “home” demos and three ACO demos indicate that the gross savings these entities can achieve (savings before taking into account payments CMS makes to ACOs and “homes”) are at most one percent of CMS’s claims costs, and are sometimes negative (CMS’s costs go up). The small or nonexistent savings cause tiny or zero payouts from CMS to ACOs and “homes.” Those payouts, in turn, are too small to cover the start-up and maintenance costs ACOs and “homes” incur. And yet, to complete my description of the bind CMS is in, those tiny payouts help reduce CMS’s small gross savings to zero or, worse, raise Medicare’s net costs.

CMS has gone out of its way to make it difficult for the public to understand how poorly Medicare ACOs and “homes” have performed. You most definitely will not find evidence on this issue in CMS’s MACRA rule. Allow me, then, to review the limited evidence.

ACOs and “homes” are not cutting Medicare costs

As I reported in a previous comment here , the three “medical home” demonstrations CMS has conducted have shown “homes” cannot cut Medicare’s costs. Evaluations of two of the demos (the [CPCI]  and the Federally Qualified Health Centers demo ) suggest they are raising Medicare’s costs when CMS’s “care-coordination-fee” payments to “homes” are taken into account (the evaluation of the third demo made no attempt to estimate savings). The second-year evaluation of the CPCI by Mathematica is the only one that reports data on the gross savings achieved by the “homes” and the payments CMS sent back to them. CPCI “home” clinics cut Medicare spending by 1 percent but that was swamped by payments CMS made to the “homes” of 1.6 percent. [3]

The results from the three ACO demos are very similar:

PGP demo: According to the final evaluation of the Physician Group Practice Demonstration  (which was a test of the ACO), “[T]he demonstration saved Medicare .3 percent of the claims amounts, while performance payments were 1.5 percent of the claims amounts” over the five years the demo ran, for a net loss of 1.2 percent (p. 64).

Pioneer ACO demo: According to an April 2015 report from CMS, Pioneer ACOs reduced Medicare spending by 1.2 percent in 2012 and 1.3 percent in 2013, but these savings were offset by payments to the ACOs of 1.0 and .8 percent respectively, for net savings of  .2 and .5 percent. (p. 4)

MSSP ACO demo: According to the same April 2015 CMS report, MSSP ACOs reduced Medicare spending by 0.5 percent for the period April 2012 through the end of 2013, but these savings were more than offset by payments to the ACOs of 0.7 percent, for a net loss of 0.2 percent. (p. 4) [4]

Pioneer and MSSP demos together: According to an analysis  done by Kaiser Health News, CMS broke even on the two ACO demos combined after taking into account bonus payments to the ACOs. [5]

To sum up, the evidence indicates Medicare ACOs and “homes” are achieving a gross savings rate of no more than 1 percent, and on a net basis (that is, when CMS’s payments to those entities are taken into account) ACOs and “homes” are saving no money for Medicare or are raising Medicare’s costs.

Are ACOs and “homes” making any money?

So how do the CMS payouts compare with the cost to providers of starting and running ACOs and “homes”? The limited evidence on ACO start-up costs and overhead is easy to summarize, so I’ll start there.

The only evidence I’m aware of appears in transcripts of two MedPAC meetings. According to MedPAC staff, ACOs spend 1 to 2 percent of their Medicare revenues creating and administering ACOs (I’ll refer to these costs hereafter as administrative or overhead costs). The staff claimed they got these estimates from interviews with a few ACOs. These estimates sound low to me. [6] But even if ACO overhead is no more than 1 or 2 percent, the economics don’t work for the doctors and hospitals who finance the ACOs. If ACOs are at most cutting Medicare’s gross costs by less than 1 percent, and if Medicare splits that 50-50 with the ACOs (the split is not necessarily 50-50; I use 50-50 for the sake of illustration), that would mean ACOs are losing somewhere between half a percent and one-and-a-half percent on their Medicare patients. MedPAC’s staff agree. [7]

I am unaware of research (or even conversation at MedPAC meetings) that tells us what the administrative costs of “homes” are as a percent of their Medicare revenues. We do have research on those costs in absolute dollar terms. According to the first-year report on CMS’s Comprehensive Primary Care Initiative by Mathematica, CMS and insurance companies participating with CMS in the initiative paid “homes” $70,000 per doctor, an amount that Mathematica said equaled 19 percent of each doctors’ “total practice revenue.” CMS’s share of that $70,000 came to $45,000 (p. 64 of the Mathematica report). A paper by Magill et al. found the cost of partial implementation of “homes” is much higher; they concluded it is around $105,000.

These numbers are astonishing. Mathematica’s report that insurer payments to CPCI doctors equaled 19 percent of their entire income suggests that “homes” are costing doctors 100 percent or more of their entire Medicare income (Medicare is the source of about 20 percent of physician income in the US). Could it be that “homes” eat up 20 percent or more of physician total revenue and 100 percent or more of their Medicare revenue? If so, something is very wrong with the “home” experiment. It can’t possibly save money for Medicare.

In any event, it is not clear that CMS payments to the clinics in its “home” demos cover the overhead costs those clinics incur to participate in those demos.

CMS ignores some demos, spins others

With the exception of the conclusions of the Magill paper, CMS fails to mention in its proposed rule any of the facts I just gave you. Although CMS acknowledges that the administrative costs of ACOs and “homes” are “substantial” (p. 481), CMS refuses to make any effort to measure those costs and weigh them against the revenues doctors are likely to get from ACOs and “homes” under MACRA. [8] Consequently, CMS has no idea whether doctors will join ACOs and “homes” and, if they do, whether ACOs and “homes” will cut Medicare costs.

CMS’s glib treatment of the administrative costs of ACOs and “homes” is aggravated by its misrepresentation of the results of its own demos. CMS cherry-picks which of the demos it discusses (it discusses only two of its three ACO demos and just one of its three “home” demos) and inflates the results of the three demos it does discuss.

Here, for example, is how CMS misrepresents the results of the Pioneer and MSSP ACO demos. Citing an August 2015 CMS press release, CMS states: “Taken together, Pioneer and Shared Savings Program ACOs yielded $411 million in cost savings in 2014.” (p. 678) But that $411 million figure conveniently failed to take into account the payments CMS made to ACOs. Here is how Kaiser Health News  described the same data: “In August [2015], Medicare officials released 2014 financial details showing that the so far the ACOs have not saved the government money. The 20 ACOs in the Pioneer program and the 333 in the shared savings program reported total savings of $411 million. But after paying bonuses, the ACOs recorded a net loss of $2.6 million to the Medicare trust fund.”

CMS did not have to play the role of enabler

This concludes my three-part comment on CMS’s proposed MACRA rule. In part 1 and part 2  I argued that both programs within MACRA, the Merit-based Incentive Payment System and the APM program, will fail because CMS cannot measure physician value accurately. In this part I have argued that the APM program will fail for an additional reason – it will rely on ACOs and “homes,” neither of which has shown an ability to cut Medicare costs.

I realize that Congress put CMS between a rock and a hard place when it handed the MACRA mess to CMS to decipher and implement. No agency, no matter how dedicated, can make MACRA work. When we as a society finally get around to agreeing MACRA failed, we should blame Congress first, not CMS.

But CMS does deserve to be blamed for acting as a congressional accomplice, a congressional enabler. If CMS had stated clearly – in its proposed rule and in its testimony to Congress and in all other public statements – that it does not have the ability to measure physician cost and quality accurately, and that its ACO and “home” demos have demonstrated that ACOs and “homes” have yet to demonstrate an ability to lower Medicare’s costs, I for one would have been far more reserved in my criticism of CMS.

But CMS has done just the opposite. CMS staff have sold us hype and half-truths when they should have given us facts and the whole truth. For that, they deserve severe criticism.

[1] CMS’s sunny obliviousness to ACO and “home” costs extends to CMS’s own costs as well. CMS often fails to mention the payments it makes to ACOs and “homes,” and it never reports the costs it incurs to administer its ACO and “home” demos.  MedPAC, another proponent of cost conscious for doctors and cost unconscious for managed care advocates, is also totally uninterested in the costs CMS incurs to administer its demos. At MedPAC’s September 11, 2014 meeting, commissioner Mary Naylor inquired what all of CMS’s “efforts” in running ACO programs are costing. “Do we have a sense of the overhead cost for the Medicare program as we’re doing this model development?” she asked. “It’s just something that I think is really important.” (p. 165 of the transcript ) None of the other 16 commissioners supported her. The staff remained silent.

[2] CMS says ACOs and “homes” will qualify as APMs even though they cannot cut costs. In its discussion of what types of entities will qualify as APMs (CMS calls them “advanced APMs”), CMS declared: “[A]n Advanced APM Entity that bears more than nominal financial risk for monetary losses … would be an Advanced APM Entity regardless of whether it actually earns shared savings or generates shared losses under the Advanced APM …. We do not intend to add additional performance assessments on top of existing Advanced APM standards. …” (pp. 460-461)

[3] Peikes et al., authors of the Mathematica evaluation  , reported that the CPCI cut Medicare costs by $11 per “member” per month (PMPM) during its first two years, and that this equaled 1 percent of Medicare spending. Peikes et al. also reported that CMS payments to CPCI “homes” amounted to $18 PMPM (p. xv), but did not translate $18 into a percentage term. I did, and derived 1.6 percent. Last April, Dale and others from Mathematica  reported slightly different results for the first two years of the CPCI. They reported “home” clinics were still not saving money, but the ratio of payments by CMS to savings changed slightly.

[4] In that same April 2015 report , CMS went on to “certify” that Pioneer ACOs will save money in the future, possibly as much as 5 percent per year gross (CMS didn’t bother to say what the net would be). CMS accomplished this magic by ignoring the actual performance of Pioneer ACOs in 2012 and 2013 and relying instead on a simulation of what might happen in the future if CMS measured ACO success using different prices and different Medicare beneficiaries in the ACOs and FFS comparison groups than CMS has actually used. CMS used this same tactic to produce rosy results in a paper published in the Journal of the American Medical Association on May 4, 2015 (see my comment here ).

[5] Here is how Kaiser Health News put it in its October 2015 article : “In August, Medicare officials released 2014 financial details showing that so far the ACOs have not saved the government money. The 20 ACOs in the Pioneer program and the 333 in the shared savings program reported total savings of $411 million. But after paying bonuses, the ACOs recorded a net loss of $2.6 million to the Medicare trust fund….”

[6] One- or 2-percent overhead for ACOs sounds low to me. The typical health insurance company has overhead costs of 15-to-20-percent of revenues. ACOs are risk-bearing entities that must perform many of the functions insurance companies carry out (such as forming and maintaining provider networks, profiling doctors and hospitals, and distributing revenues from ACO activities to participating clinics and hospitals). Is it really possible that they can perform those insurance-related functions and hire more staff to provide the extra medical and social services ACOs allegedly provide with no more than 1 or 2 percent of ACO revenues?

[7] At the September 11, 2014 MedPAC meeting, commissioner David Nerenz asked MedPAC staffer Jeff Stensland if “we know anything about” ACO “overhead.” Stensland replied, “[P]eople we talk to and the data we have seen, it looks like maybe 1 to 2 percent of your spend, that that’s what they’re spending on their ACO

to operate it….” (p. 133 of the transcript A few minutes later, Nerenz asked: “[I]f I could go back to the overhead cost issue, I just want … to see if I’m thinking about this correctly. If, say, Jeff, as you said, two percent of overall spend might be administrative – you said one to two, but let’s just use two – in order, then, for the ACO to make money net, it would have to achieve four percent savings if the  shared savings ratio is about 50 percent. …. [Y]ou’d have to have a savings of four percent to get two percent back and at that point you break even…. [A]re there ACOs who have actually made money net of overhead cost? Do we know that yet?” (pp.143-144) Stensland replied, “[I]f you averaged everybody [that is, all ACOs] so far, at least in the first year of the program, the share of savings, on average, that they get is going to be less than their administrative costs of being in it….”(p. 144)

[8] For example, in its discussion of what should constitute “nominal risk” (bearing “nominal risk” is one of the three criteria MACRA requires APMs to meet), CMS rejected the suggestion that the high cost of starting up and running ACOs and “homes” should count as money at risk. CMS’s rationale was, “The amount of financial investment made by APM Entities may vary widely and may also be difficult to quantify….” (p. 481). Note the double standard: Physician “merit” is not “difficult to quantify” even with patient pools as small as 20, but the money ACOs and “homes” spend to meet CMS’s criteria is just too difficult to measure.

Categories: OIG Advisory Opinions

Will Federal Court Back Rules Treating Health Insurance as a Utility, Not a Luxury?

The Healthcare Blog - Tue, 06/21/2016 - 11:11

On June 14, 2016 a Federal Court ruled that broadband internet is as essential to American as phones, electricity, water and sewer systems and should be available to all Americans as a utility, rather than a luxury that doesn’t need close government supervision.

In the United States, public utilities are often natural monopolies because the infrastructure required producing and delivering a product such as electricity or water is very expensive to build and maintain.  As a result, they are often government monopolies, or if privately owned, the sectors are specially regulated by a public utilities commission which severely limits the profits for the private utility company and the associated costs passed on to consumers of that utility.

There is nothing more essential to the lives and well being of Americans than health insurance and therefore healthcare is the ultimate utility.

Of all the developed nations on the planet, safe quality affordable American health care continues to be a luxury and not a utility for most citizens. Most Americans remain one major illness away from personal financial ruin due to under-insurance and 10’s of millions of Americans are uninsured.  Most American locales have only one or two major Health insurance corporations serving the area creating natural monopoly’s which charge citizens exorbitant premiums and co-payments for healthcare along with rationing of access, diagnostics and treatments.  This lack of capitalistic competition in most major markets among health insurance companies results yearly in hundreds of billions of healthcare dollars redistributed into the pockets of insurance company executives, shareholders, bondholders, 1 million insurance company bureaucrats and their patron politicians.  Unregulated insurance company profits (exactly what the Utility concept prevents) results in limited expensive preventive, medical, surgical and palliative care for a large portion of Americans.

What if we in America treated the health insurance industry like a utility? It’s entirely possible if our country adheres to the industrial utility laws founded in the 1800’s.

Below is a copy of a recently published article from the NY Times (6/14/16), explaining why and how broadband internet became a ‘utility’ instead of a luxury for America.  I have edited just a few words and names in the article, for example, inserting the words “health insurance” for “broadband internet” in order to demonstrate how easily the Utility laws could be applied to Health Insurance industry via the Federal Courts.

WASHINGTON — Health Insurance can be defined as a utility, a federal court has ruled in a sweeping decision clearing the way for more rigorous policing of health insurance companies and greater protections for patients.

The decision affirmed the government’s view that quality affordable health insurance is as essential as the phone and power and should be available to all Americans, rather than a luxury that does not need close government supervision.

The 2-to-1 decision from a three-judge panel at the United States Court of Appeals for the District of Columbia Circuit on Tuesday came in a case about rules applying to a doctrine known as “safe quality health care for all”, which prohibit health insurance companies from blocking access or rationing the delivery of healthcare to consumers.

Those rules, created by the Department of Health and Human Services in early 2015, started a huge legal battle as health insurance companies, pharmaceutical companies, electronic medical records companies and hospitals sued to overturn regulations that they said went far beyond the HHS and would hurt their businesses. On the other side, millions of health care consumers (patients) and their physicians rallied in favor of the regulations. President Obama also called for the strictest possible mandates on health insurers.

The court’s decision upheld the HHS on the declaration of health insurance as a utility, which was the most significant aspect of the rules. That has broad-reaching implications for health care consumers and physicians that have battled for five decades over the need for regulation to ensure that all American patients get full and equal access to all preventive, medical, surgical, home health and palliative care.

“After 5 decades of debate and legal battles, today’s ruling affirms the commission’s ability to enforce the strongest possible health insurance protections — both on local and nationwide insurance networks — that will ensure that quality healthcare remains affordable and accessible, now and in the future,” Tom Wheeler, chairman of the HHS, said in a statement.

The two judges who ruled in favor of the HHS emphasized the importance of health insurance as an essential part of healthcare for consumers.

“Over the past five decades, healthcare and illnesses have transformed nearly every aspect of our lives, from profound actions like choosing a leader, building a career or nest egg, and falling in love to more quotidian ones like hailing a cab and watching a movie,” wrote David Tatel and Sri Srinivasan, the judges who wrote the opinion.

But the legal battle over the regulations is most likely far from over. The health insurance, pharmaceutical, hospital and electronic medical records industries have signaled their intent to challenge any unfavorable decision, possibly taking the case to the Supreme Court.

Aetna Health Insurance, Blue Shield Blue Cross, United Healthcare, Merk, The HCA and Kaiser Permanente immediately said they would continue to fight.

“We have always expected this issue to be decided by the Supreme Court and we look forward to participating in that appeal,” said the senior executive vice president and general counsel for Blue Shield Blue Cross.

For now, the decision limits the ability of health insurance providers like Untied Healthcare to shape the experience of healthcare consumers by rationing access, prevention, diagnostics, treatments or palliative care. Without quality affordable healthcare for all rules, the insurance companies could be inclined to ration access to providers or medications for example, making the consumers more ill or poor. Such business decisions by health insurers would have created poor quality health care and sub-optimal health for most in America, subjecting health care consumers to extra charges and limited access to providers, diagnostics, treatments and palliative care, the HHS has argued.

“This is an enormous win for health care consumers,” said Gene Kimmelman, president of the public interest group Public Knowledge. “It ensures the right to safe quality affordable healthcare with no gatekeepers.”

Dan Munro, chairman of the HHS said the court’s ruling would “ensure healthcare in America remains open, accessible, and affordable now and in the future.”

The 184-page ruling also opens a path for new limits on health insurers beyond rationing, co-payments and premiums. Already, the HHS has privacy rules for health insurers, curbing the ability of companies like United and Aetna to collect and share data about patients.

The American College of Physicians, AARP and the  PNHP all support quality affordable healthcare for all rules and have warned government officials that without regulatory limits, health insurers will have an incentive to create business models that could harm health care consumers (patients). They argue that health insurers could degrade the quality of access to providers, preventive care, diagnostics, treatments and palliative care to extract tolls from physicians and patients or to promote unfairly their own competing services or the insurance of partners.

The court’s ruling was a certainty for the H.H.S.  Two of the three judges who heard the case late last year agreed that  health insurance services were also common utility services that were subject to anti-blocking and discrimination rules, a decision protested by insurance companies including Cigna and Kaiser Permanent.

In the opinion, the two judges in favor of the rules said health care consumers (patients) users don’t feel the difference between physician’s access, physical examinations, diagnostics and treatment suggestions. To patient who may seek care in different parts of the Country, the government’s oversight of those health insurance companies should not differ, they said.

Doctors cheered the decision, which they said would be particularly helpful to small practice physicians that did not have the resources to fight health insurance companies.

“Today marks a huge victory for the hundreds of thousands of small practice physicians who depend on the health insurance market to reach health care consumers (patients), produce optimal clinical outcomes with patients and compete in the healthcare marketplace,” said the senior director of healthcare policy at the AMA.

In a statement, the health insurance industry’s biggest lobbying group, AHIP, highlighted the comments of the dissenting judge, Stephen Williams, and said that its members were reviewing the opinion. The group also said healthcare legislation by Congress was a better alternative to the HHS classification of the health insurance business as a utility.  The health insurance industry however did not comment on the 10’s of millions of dollars in direct and indirect payments they give Congress people and Hillary Clinton each year.  Nor did the AHIP comment on the lack of quality affordable health care for all Americans.

“While this is unlikely the last step in this decades-long debate over health insurance regulation, we urge bipartisan leaders in Congress to renew their efforts to craft meaningful legislation that can end ongoing uncertainty, promote healthcare investment and protect patients,” America’s Health Insurance Plans said in a statement.

In his lengthy dissenting opinion, Mr. Williams called the rules an “unreasoned patchwork” that will discourage instituting competition based on costs and clinical outcomes in the health insurance industry.  Mr. Williams did not comment when asked if competition amongst health insurance companies based on costs and clinical outcomes of insured patients existed anywhere in America today.

The biggest threat to health insurers is the potential of any regulations to hurt the premiums and co-payments they charge for the service, and their ability to ration access to providers and health care institutions, analysts said. The HHS has promised it will impose premium and co-payment regulations on the firms similar to what public utilities commissions do to phone and electric companies.  In addition, the HHS said that if layoffs were to be expected among the 1.2 million insurance bureaucrats currently employed by the health insurance industry these same people could subsequently be hired to deliver health care via home health, Alzheimer and elderly home assistance and other non-skilled health care occupations with the expected increased number of citizens now receiving health insurance and eligible for healthcare.

“The pendulum has today swung a bit further in the direction of long-term price regulation,” said Craig Moffett, an analyst at the research firm MoffettNathanson.

The HHS was divided along party lines on the rules. It began its quest for quality affordable healthcare rules in 2009, with two previous attempts at creating rules overturned by the same court.

In a statement, Ajit Pai, a Republican commissioner who was among a minority who opposed the regulation of health insurance as a utility, pressed insurance firms to keep going with their legal challenge.

“I continue to believe that these regulations are unlawful, and I hope that the parties challenging them will continue the legal fight,” he said.

Correction: June 14, 2016

An earlier version of this article misattributed a statement by the health insurance industry lobbying group. The statement was made by the America’s Health Insurance Plans; it was not made by the group’s president, Wendell Potter.

Howard Green, MD is a dermatologist based in West Palm Beach. He is the founder of Skinphototextmatch Inc, a maker of dermatology-focused mobile apps

Categories: OIG Advisory Opinions

Time to Put a Stop to Workplace Bullying

The Healthcare Blog - Mon, 06/20/2016 - 15:30

Civility is a system value that improves safety in health care settings. The link between civility, workplace safety and patient care is not a new concept. The 2004 Institute of Medicine report, “Keeping Patients Safe: Transforming the Work Environment of Nurses,” emphasizes the importance of the work environment in which nurses provide care.1 Workplace incivility that is expressed as bullying behavior is at epidemic levels. A recent Occupational Safety and Health Administration (OSHA) report on workplace violence in health care highlights the magnitude of the problem: while 21 percent of registered nurses and nursing students reported being physically assaulted, over 50 percent were verbally abused (a category that included bullying) in a 12-month period. In addition, 12 percent of emergency nurses experienced physical violence, and 59 percent experienced verbal abuse during a seven-day period.2

Workplace bullying (also referred to as lateral or horizontal violence) is repeated, health-harming mistreatment of one or more persons (the targets) by one or more perpetrators.3 Bullying is abusive conduct that takes one or more of the following forms:3

Verbal abuse

Threatening, intimidating or humiliating behaviors (including nonverbal)

Work interference – sabotage – which prevents work from getting done3

There are five recognized categories of workplace violence:4

1. Threat to professional status (public humiliation)

2.  Threat to personal standing (name calling, insults, teasing)

3.  Isolation (withholding information)

4. Overwork (impossible deadlines)

5. Destabilization (failing to give credit where credit is due)

In the scientific literature, several types of bullying have been studied: intimidation, harassment, victimization, aggression, emotional abuse, and psychological harassment or mistreatment at workplace, among others.5

Bullying does not include illegal harassment and discrimination, and while bullying can create a hostile work environment, it is not the same as the organization allowing an illegal hostile work environment (for example, the employer tolerating inappropriate jokes). Other examples that are not bullying include setting high work standards, having differences of opinion or providing constructive feedback.

The Workplace Bullying Institute estimates that 65.6 million U.S. workers are directly impacted by or have witnessed bullying. A 2014 Workplace Bullying Institute survey found that 69 percent of bullies are men and 57 percent of targets are women, and that women bullies target women in 68 percent of cases. It is more common than sexual harassment, and can be direct physical, verbal or indirect bullying (such as social isolation).4 Bullying is typically deliberate, causes negative effects on the victim, and is an attempt to control employees. Bullying is behavior that is aggressive, intentional, and frequent. Bullies tend to target employees who have inadequate support or are not able to defend themselves from the aggression. An essential component of bullying is that it is perceived as a hostile act by the target.

Some examples of bullying are a manager who is never pleased with performance, gossiping or spreading rumors, intentionally excluding an employee from team meetings, being told “you are too thin skinned,” or being repeatedly called to unplanned meetings with the manager where the employee is denigrated. Factors that contribute to this problem include a culture that allows bullying (normalization of deviance), poor staffing levels, excessive workloads, power imbalances and poor management skills. Specific organizational factors that can lead to workplace bullying are role conflict and ambiguity, work overload, stress, lack of autonomy and a lack of organizational fairness.6,7

In the health care setting, 44 percent of nursing staff members have been bullied. Nurses tend to accept nurse-on-nurse bullying as part of the job, particularly the new or novice nurse, thus the coining of the phrase “nurses eat their young.”8 In a study of 284 health care workers, it was found that 38 percent of U.S. health care workers reported psychological harassment.5

The most common health care settings where bullying is prevalent are behavioral health units, emergency departments and intensive care units. In long term care settings, bullying occurs more frequently during evenings and night hours. The targets of bullying are employees who are typically under 40 years old; female physicians; and unmarried, female employees with less education and who have children at home.

Impact of workplace bullying

The impact of bullying behaviors on the organization are lower morale, lower productivity and increased absenteeism (due to physical, psychological and emotional harm), followed by rapid and increased turnover, which compromises patient safety. Workplace bullying also leads to lawsuits, compensation for disability, loss of profits, negative impact on organizational reputation, and a corrosion of the patient to health care worker relationship. Employees, patients and families who witness behaviors that are not civil are concerned about how care can be impacted. For example, a nurse who is openly critical of another nurse, or a physician who is openly critical of a nurse.

The impacts on patient and care team safety include under-reporting of safety and quality concerns, and increases in harm, errors, infections and costs. As an example, the estimated cost of replacing a nurse is $27,000 to $103,000.9 Bullying exacerbates the stress and demands of already stressful and demanding professions. Bullying contributes to burnout and drives talented and caring people out of the health professions. The kinds of improvements needed in patient safety and health care cannot be achieved if talented people are lost.

Battling workplace bullying

Gerry Hickson, MD, and his colleagues at Vanderbilt University Medical Center (VUMC) have recognized that a significant barrier to eliminating bullying is under-reporting of the problem by health care professionals. Dr. Hickson includes a risk event reporting system in the VUMC set of “surveillance tools.”10

A team led by Dr. Hickson is implementing a Co-Worker Observation Reporting SystemSM (CORSSM) at VUMC. The CORSSM project aims to encourage collegial respect and accountability and to couple safe, contemporaneous reporting with consistent, timely delivery of the captured stories.11 The indications are that self-reporting of unprofessional and disrespectful behaviors increases self-regulation and civility.

Alan Rosenstein, a physician and leading expert in unprofessional behavior, states that, with respect to eliminating behaviors that undermine a safety culture, “The primary goal should be to improve care relationships by increasing understanding and responsiveness to individual (physician, staff, patient) needs (emotional Intelligence), provide training in diversity, stress, anger, and conflict management, improve communication and collaboration skills, and enhance an organizational culture that respects and supports physicians, staff, and patient-centered care.”12

A method used to prevent bullying of novice nurses is cognitive rehearsal. In the original 2004 study,13 26 newly licensed nurses hired by a large acute care tertiary hospital in Boston, Massachusetts, participated in an exploratory descriptive study. They were taught about lateral violence in nursing.

practice and the use of cognitive rehearsal techniques as a shield from the negative effects of lateral violence on learning and socialization. Knowledge of lateral violence in nursing appeared to allow newly licensed nurses to depersonalize it, thus allowing them to ask questions and continue to learn. The learned cognitive responses helped them confront the lateral violence offender. Confrontation was described as difficult, but it resulted in the resolution of the lateral violence behavior. Overall, the retention rate in this study population was positively affected.13

Safety Actions to Consider:

In the 2013 Joint Commission publication, “Improving Patient and Worker Safety,” civility is described as a necessary precursor for a safety culture in which care teams and patients must be treated with respect.14 Civility matters, which means behaviors that undermine a culture of safety are not tolerated. W. Edwards Deming stated that “quality is everyone’s responsibility.” Leaders especially have a critical role in battling bullying behaviors, including:

Establishing a safety system and culture that does not tolerate bullying behaviors. Make this a core value of all leaders in the organization.

Confronting bullies and supporting the targets of bullying.

To correct bullying behaviors that can undermine a safety culture, all health care facilities should consider taking the following specific safety actions, which are highlighted in The Joint Commission’s Sentinel Event Alert, Issue 40:15

Educate all team members on appropriate professional behaviors that are consistent with the organization’s code of conduct

Hold all team members accountable for modeling desirable behaviors

Develop and implement policies and procedures/processes that address:

  1. Bullying

    2. Reducing fear of retaliation

    3. Responding to patients and families who witness bullying

    4. Beginning disciplinary actions (how and when)

In developing these policies and procedures, solicit input from an inter-professional team that includes representation of medical and nursing teams, administrators, and other employees.15

Ronald M. Wyatt, MD, MHA, is the patient safety officer and medical director in the Division of Healthcare Improvement at The Joint Commission.


1. Institute of Medicine. Keeping Patients Safe: Transforming the Work Environment of Nurses. Nov. 3, 2003 (accessed May 24, 2016)

2. Occupational Safety and Health Administration. Workplace violence in health care: Understanding the challenge. OSHA 3826, 12/2105 (accessed May 18, 2016)

3. Workplace Bullying Institute. The Healthy Workplace Campaign. Healthy Workplace Bill website (accessed May 14, 2016)

4. Rayner C and Hoel H. A summary review of literature relating to workplace bullying. Journal of Community & Applied Social Psychology, 1997;7:181-191

5. Ariza-Montes A. Workplace bullying among healthcare workers. International Journal of Environmental Research & Public Health, 2013;10:3121-3139

6. Bowling NA and Beehr TA. Workplace harassment from the victim’s perspective: A theoretical model and meta-analysis. Journal of Applied Psychology, Sept. 2006;91(5):998-1012

7. Topa G, et al. Acoso laboral: Meta-analisis y modelo intergrador de sus antecedents y consecuencias. Psicotherma, 2007;19:88-94 (English translation available online)

8. Meissner JE. Nursing, Mar. 1996;16(3):51-3

9. Li Y and Jones CB. A literature review of nursing turnover costs. Journal of Nursing Management, 2012;21(3):405-418

10. Hickson GB, et al. From front office to front line. 2nd edition. Oakbrook Terrace, Illinois: Joint Commission Resources, 2012:1-36

Categories: OIG Advisory Opinions

Does Arnold Schwarzenegger Deserve Better Care Than Our Veterans Do?

The Healthcare Blog - Sun, 06/19/2016 - 23:59

When Arnold Schwarzenegger was governor, he decided that you and I don’t need to have physicians in charge of our anesthesia care, and he signed a letter exempting California from that federal requirement. Luckily most California hospitals didn’t agree, and they ignored his decision.

When he needed open-heart surgery to replace a failing heart valve, though, Governor Schwarzenegger saw things differently. He chose Steven Haddy, MD, the chief of cardiovascular anesthesiology at Keck Medicine of USC, to administer his anesthesia.

Now some people in the federal government have decided that veterans in VA hospitals all across the US should not have the same right the governor had—to choose to have a physician in charge of their anesthesia care.

That’s right. The VA Office of Nursing Services has proposed a new policy to expand the role of advanced practice nurses, including nurse anesthetists, in the VA system. This new policy in the Nursing Handbook would make it mandatory for these nurses to practice independently. Physician anesthesiologists wouldn’t be needed at all, according to this proposal, even in the most complicated cases – such as open-heart surgery.

If this misguided policy goes into effect, the standard of care in VA hospitals will be very different from the standard of care other patients can expect. In all 100 of the top hospitals ranked by US News & World Report, physician anesthesiologists lead anesthesia care, most often in a team model with residents and/or nurses. Physician-led care teams have an outstanding record of safety, and they have served veterans proudly in VA hospitals for many years.

The new policy isn’t a done deal yet. The proposal is open for comment in the Federal Register until July 25. Already thousands of veterans, their families, and many other concerned citizens have visited the website and submitted strongly worded comments in opposition. I urge you to join them.

Many of our veterans aren’t in good health. They suffer from a host of service-related injuries, and they have high rates of chronic medical disease. Some have been among the most challenging patients I’ve ever anesthetized. Their care required all the knowledge I was able to gain in four years of medical school, four years of residency training in anesthesiology, and countless hours of continuing medical education.

It’s clear, of course, why the VA is proposing the change in the Nursing Handbook. The reason is the scandal over long waiting times for primary care. Proponents argue that giving nurses independent practice will expand access to care for veterans.

But there’s no shortage of physician anesthesiologists or nurse anesthetists within the VA system. The shortages exist in primary care. A solution that might help solve the primary care problem shouldn’t be extended to the complex, high-tech, operating room setting, where a bad decision may mean the difference between life and death.

The VA’s own internal assessment has identified shortages in 12 medical specialties, but anesthesiology isn’t one of them. The VA’s own quality research questioned whether a nurse-only model of care would really be safe for complex surgeries, but this question was ignored. The proposed rule in the Federal Register lists as a contact “Dr. Penny Kaye Jensen”, who in fact is not a physician but an advanced practice nurse who chooses not to list her nursing degrees after her name. The lack of transparency in the proposal process is disturbing.

In 46 states and the District of Columbia, state law requires physician supervision, collaboration, direction, consultation, agreement, accountability, or direction of anesthesia care. The proposed change to the VA Nursing Handbook would apply nationally and would override all those state laws, which were put in place to protect patients.

In Congress, many senators and representatives on both sides of the aisle recognize the need to continue physician-led anesthesia care for veterans. Representatives Julia Brownley of California’s 26th District and Dan Benishek, MD, of Michigan’s 1st District are strong advocates for veterans’ health. They have co-authored a letter (signed by many in Congress) to VA Secretary Robert McDonald, urging him not to allow the destruction of the physician-led care team model as it currently exists within the VA system.

Governor Schwarzenegger’s heart surgery is a matter of public record. He has spoken about it openly on television, and he graciously invited the whole operating room team to his next movie premiere. I was lucky enough to go to the premiere too, because his anesthesiologist, Dr. Haddy, happens to be my husband.

But I didn’t set out to write this column on behalf of my husband. I’m writing on behalf of my father, who is now 93, landed on the beach at Normandy on D-Day, and miraculously survived the rest of the war as a sniper. And I’m writing on behalf of all the men and women who have served our country, and who deserve the best possible anesthesia care from physicians and nurses who want to work together to take care of them. If we don’t defeat the proposed change in the VA Nursing Handbook, they all lose.

Karen Sibert, MD, practices anesthesiology at UCLA Health in Los Angeles, and blogs at

Categories: OIG Advisory Opinions

The Patient Data Positioning System – A GPS for Patient Data

The Healthcare Blog - Sun, 06/19/2016 - 23:21

First of all I have to admit that I am a convert and not an original believer in the Data Lake and late binding approaches to data analytics. I do not think it is my fault or at least I have a defense of sorts. I grew up in a world where my entrepreneurial heroes were people like Bill Gates, Larry Ellison, and Steve Jobs and it seemed that structured systems like operating systems that allowed many developers to work against a common standard were the way to go.

I grew up in a world where UNIX was fragmented into 12 types making us compile our code on a number of different boxes just so people could use our scripts to provide the semblance of a dynamic web site. So when it came time to figure out a way to make health care better I worked with our team to build a model of how to standardize and structure data into a schema that had a home for almost any data we could encounter. We built a data model and called it the Data Trust because we wanted to be sure that the data in that healthcare data model was clean and trusted as a single source of the truth. We had some success as well.

Last week I was watching “The Big Short”. I read the book and so I felt smug enough to wait for the movie to come out on streaming media. As I watched the beginning of the movie something was made clear. The people who discovered that there was a bubble did something that others did not do. They looked back to the original information underlying all of the layers of cleaning and rating. They saw that the base loans in bonds were not what they seemed to be and when others visited places like Florida, they found that people were in the open taking out loans that couldn’t possibly be paid back. The risk in having clean information with many layers of transformation and analytical filters is that you can get into the conundrum of “The Big Short”. People who can make sense of the underlying signals may lose the fidelity of the signals in what is eliminated in the cleansing or data could be transposed as a matter of well-intentioned organizational policy. Essentially it is very important that smart people with the right mind set to figure out whether their hypotheses are right are able to get to original data to look at it and think through the meaning of that data. What they need may be a Data Lake but it maybe something more.

What most people tell me when I am working on a data project, even in very advanced organizations – “We don’t know where our data is?” along with “Even when we know where our data is we don’t have any way to get to it.” This is the essence of the concept of dark data. The old me would tell them that they needed to grab a hold of it all and map it into a standardized enterprise data warehouse.

But now I am wiser. In the mantra of Scrooge McDuck I prefer to work smarter not harder. Now what I think is really needed is to make maps of where the data is in place. For most of the data out there the map will be the only way to get to it and that is fine because as long as data can be geo-cached (those of you with kids; who have mosquito bites to prove you have wandered in the wilderness looking for Tupperware™ boxes know what I mean) then the data consumers who are interested in finding it can slowly migrate it from dark data into enterprise data at the appropriate pace. The first thing we need then is not an enterprise data warehouse and is not an enterprise data lake but a Patient Data Positioning System, a GPS for data that can help to get to the underlying location of information of interest.

If we take that analogy a bit further we can build the many layers or the map views including data in motion from one system to the next on top of that initial Data Positioning System (DPS) based view. This would align well with the maps drawn of the many layers of patient data for the precision medicine project, but instead of layering by type the layers would be by process level with the base layer of the map just ‘where the data is.’

In some situations we may recommend that the data source simply ‘go away’ because it is causing more trouble than good. Especially if it is an intermediate form that is creating lots of work to maintain but not generating more truth. In other cases it may be important to migrate the data in a full copy to the Data Lake so that it can be analyzed ‘hot’ as it is entered. In still other scenarios it may be best to join that data with the other hundreds of data sets like it of the same type but different format into a unified format, or at least unified identifier framework so that it can be easily used without having to be cleansed every time someone tried to access it.

Now there is another problem that this can help to solve. It is the issue of annotations. In many types of patient data the underlying information stays the same but the annotations change over time based on the changing body of knowledge of how to interpret the underlying data. For example – Genomics struggles with this challenge in that annotation even at the level of ‘what is a variant’ changes as we discover new patterns of the genome that can vary. Additionally the layers of which of those variants have biological or clinical significance is a constantly moving target both from research done locally, what the literature has published, and how the organization wants to interpret the literature. Annotations, like in the Talmud, need to stay live even when the underlying information is static.

This is true in most complex high dimensional data sets including imaging (photos, xrays, MRIs, and slides), wave analysis such as EEG and ECG, audio files with associated transcripts, free text notes with NLP outputs, and mappings between structured concepts such as lab tests and LOINC codes or ICD9 and ICD10 codes. Among the things that the DPS should solve for is how to continuously update the annotations based on acquired knowledge while keeping the location of the data in place. So rather than looking to transform the data into a common format we should be solving for the continuous ‘expansion of understanding’ about the meaning of the data in the context of a world of information outside of the organization. That is a different system from how the traditional data warehouse has been laid out but the DPS can focus on using the position of data to map the annotation on top of it just like in a map as a layer. The system may need to potentially maintain the annotations over time in the way that a weather pattern can be seen developing from day 1 to 10 of a storm.

So for those of you who are still frustrated that you have not even gotten to a data lake and now I am asking for some new thing I want to encourage you that building a data map and a DPS will likely be much easier than building all of the pipes to move the data around and transform it into final forms. So this should offer an even easier way to get started on the path to ideal information, help groups understand that governance can help move the ball forwards, and enable the Michael Burry in your organization—the man who first saw the underlying flaw in mortgage bonds and derivatives—to look into the data and find something that surprises us and maybe helps our patients.

Dan Housman is CTO for ConvergeHealth by Deloitte.

Categories: OIG Advisory Opinions

The Black List Part II (Features Which Should Be In Every EHR, But For Some Reason Aren’t)

The Healthcare Blog - Sat, 06/18/2016 - 19:38

I have been involved in HIT for 2.5 decades as a designer and primary programmer of a commercial EMR which I developed for my practice and was sold from 2000 until 2015. As a result of that experience, and 15 years of interactions with the physicians who used my EMR, I developed some insights about which features have real utility to the practicing physician and how to design an EMR so that it is efficient and intuitively obvious how to use the EMR. I have since learned that many of those useful features and design considerations have not been incorporated into all EMRs.

In my previous posting on The Health Care Blog , I discussed some EMR features which would be expected to appear in the Progress Notes and Labs section of the EMR. In this posting, I will discuss some other useful features/EMR insights which, I hope, will eventually be incorporated into all EMRs.

Again, I want to reiterate that my list is not intended to be comprehensive and it is totally subjective. While I expect that some of the items on this list may already be in some EMRs, I am certain that they are not in all EMRs.

Search functionality:

The user should have the ability to search the entire database, on any indexed field, such as demographic data, providers, Problem list, Medicine List, Allergy list, old problem list, old medicine list, PCP and associated MDs, insurance, race, language, ethnicity, date of visits, Vital signs, Flow sheet data, radiology data, legal documents (HCP, Advanced directives, HIPAA) smoking status, etc. For example, “Find all male patients, <65 yo, who have DM-2 and albuminuria and hypertension, and have not been seen in the last year, and whose most recent HBA1c>9, and is managed by Dr. XXX, is on lisinopril, and last SBP>160” or find all patients who are on 2 specified medications. Once a search is conducted, the resultant information should be able to be easily exported out of the EMR into an Excel or cvs document, for use as the physician feels is necessary.

Search functionality:

Any physician should be able to assembly a list of patients, based on any indexed text field then automatically add a note to the chart of each of those patients (with the option to add a “To do” or a “Reminder.”)  For example, if a publication shows that a specific medication has a new side effect when it is used in patients of a certain age or gender or in conjunction with another medication, it is useful to be able to add a note to the relevant patients chart that says something like “At next visit remember to discuss the newly reported side effect of medicine XYZ, see AIM 2016;214:123”)

Search functionality:

When test results return, it should be very easy for the physician to send an order to the lab that says “Please add this additional blood test to the current sample in the lab.”

Medicine List:

The accuracy of the medicine list is crucial to patient care. The process of altering an existing medicine on the medicine list, adding medications to the medicine list, removing medications from the medicine list should be able to be accomplished with a maximum of 1-2 clicks.

Problem List, Medicine List:

There should be a “comment” field associated with the Problem list and Medicine list so as to allow to the user to enter any ancillary information they feel is necessary.

Problem List, Medicine list, Allergy list

The user should be able to add data to these essential elements of the patient’s chart in every location where the data is displayed and the data should be displayed in every location where a practicing physician might be expected to want to see those data elements, such as in the Progress Notes, Flowsheet, Labs, Orders, etc. It is irrational to make the user navigate to another location in the EHR in order to modify these data elements.

Clinical Summary:

There should be an option to keep a list of all physicians who are involved in the care of the patient and their assigned roles such as cardiologist, surgeon, etc

Graphing data:

One should be able to graph any numeric data, print the graph (for the patient) as well as incorporate the graph directly into the patient’s Progress Notes as an essential component of the medical narrative.

Referral letters:

The user should have complete freedom to decide which data elements will be included in any printed / faxed document, down to the level of an individual lab test, radiology report and Progress Note.

Patient Portal:

The physician should have the ability to decide what type of information appears on the patient portal, e.g., Labs, Radiology, Problem list, Medicine List, Allergy List, Progress Notes, Flowsheet, Vaccinations. The physician should have the option to turn off the patient portal for an individual patient, ”hide” an individual Progress Note from being displayed on the patient portal and “hide” a particular lab test from appearing on the Patient Portal. The physician should also have the option to decide when a result will appear on the Patient Portal, for example, immediately after the data is added to the EMR or 3 or 7 days after the data is put into the patient’s chart.

To Do List:

It should be possible for the user to create a “future To Do,” which disappears from the system until a specified date in  future when the item reappears on the user’s “To Do list.”  It should also be possible for the user to ask the system to display all their  “future To Dos” with a single click. This gives the physicians an easy way to track items that will happen in the future and helps them maintain an uncluttered screen.

To Do List:

It should be possible for the user to provide various “priorities” to each of the items on their “To Do” list and allow them to sort their “To Do” list by date, patient name, priority, creator of “To Do”, type of “To Do.”

Ordering test:

When ordering tests, it should be easy to tell the lab that a copy of the test results should be sent to another physician (or to the patient) and this process should require no more than one click.

Ordering test:

When ordering tests, the user should be immediately presented with the date and results from the last time the test was done. In addition, the (relative) cost of the test should also be presented to the user and an estimate of the patient’s expected incurred cost.

Miscellaneous feature:

It should be possible to print an envelope addressed to the patient at all locations in the EMR where such a feature might reasonably be needed, such as on the Clinical Summary layout, Orders layout, Lab results, Progress Notes, X-rays, Prescriptions, etc. Similarly, at the location which contains a physician’s or pharmacy’s address, there should be a button that prints a pre-addressed envelope.

Miscellaneous feature:

One should be able to create letters or emails, based on templates, and these templates should give the user the ability to automatically incorporate various bits of information in the form of “macros,” as discussed above. For example, it should be possible to build a “template letter,”, that can be used to write a letter or email to a patient, which says something like “Your recent tests are normal. Here are the results. Please see me as planned on DDD/MMM/YYYY” and this can be either printed (with an envelope) or emailed with one click.

Miscellaneous feature:

In all locations where this information might reasonably be needed by the physician, the date of the patient’s next appointment should be displayed, such as on the prescription layout, labs layout, Progress Note layout and where the physician reviews incoming data (test results, email) etc.

Miscellaneous feature:

The user should have the ability to easily redirect any notifications, like newly received lab results, to another individual in the EHR.

Miscellaneous feature:

On the fax cover page, the user should be able to include (and easily alter) a default message like “Current guidelines for DM-2 recommend that tight control is not appropriate in the elderly.” This will facilitate the ability of one physician to educate other physician.

Miscellaneous feature:

EMRs which are used in an emergency room should be able to send a message to the patient’s primary care physician, when the patient arrives in the emergency room. In addition, physicians need to be able to turn on and off these notifications both at the individual patient level and at a global level. In addition, the physician should have the ability to redirect these notifications to a surrogate.

Miscellaneous feature:

The physician should be able to determine the sort order of the Problem list and Medicine list. For example, they may want to have the list for the medicines sort alphabetically or by time of day they are administered or based on importance or toxicity, or any other way that the user wishes to have the problem list and medicine list sorted.  This can easily be accomplished by adding a numeric “sort order” field for each diagnosis and medicine.  This sort order will then be retained wherever Problem list or Medicine list is displayed.  To facilitate medicine reconciliation, it should require no more than a single click to change the Medicine list sort order to “alphabetical” and to return the Medicine list to the preferred sort order.

Miscellaneous feature:

It should be possible for the user to create a “future letter” to a patient, which is retained in the EHR until a specified date in the future, when the letter is automatically printed (with an envelope) or emailed to the patient.

Miscellaneous feature:

It is absolutely imperative that the EMR be designed to minimize the number of clicks and the need to change locations within the EMR. This situation can occur when the physician needs to see a “type” of data that is located at another section of the EMR.  One way to bring information to the physician, without requiring them to navigate to another location in the EMR, is to use the “color” of the buttons to convey information to the physician. For example, if the physician is viewing the Progress Notes, the “go to labs button” could be red if there is no lab data on the EMR.  If the patient has lab results in the EMR, the “go to labs button” could be green.  Thus, by looking at the “go to labs button”  the physician would immediately know if there was/was not lab data on file. One can use multiple colors to convey more nuanced information. For example, the “go to the appointments button” could be red if the patient’s next appointment is “today,” while yellow implies the next appointment is within 1 week, blue might imply the next appointment is more than 1 week in the future while grey means that the patient has no scheduled upcoming appointments.

Miscellaneous feature:

Another way to bring information to the physician, without requiring them to navigate to another screen, is the use of the “hover over” option.  If the physician wants to know the date of the patient’s next appointment, they simply hover the mouse over the “go to the appointments button” and  pop-up window immediately appears with the date of the upcoming appointment appointment(s).  The same feature can be used to display the most recent lab data, chart of vital signs, radiology data, the patient demographic data like phone number, etc.  Thus, it is possible to deliver information to the physician, when/where they need it, without requiring them to navigate to a different section of the EMR.  This will reduce the amount of data sent over the network, speed up the EMR and improve the EMR’s usability.

Miscellaneous feature:

Physicians should be able to generate a list of all of a patient’s previously prescribed and discontinued medications and sort the list by generic name, brand name, date entered into the EMR, date prescribed, date discontinued, prescriber and class.

Miscellaneous feature:

To reduce the possibility that a physician would click on a button that they did not intend to click on, when the mouse hovers over a  navigation button, that button should change colors to indicate that is the active choice.

Miscellaneous feature:

All EMRs should have a location in the EMR where physicians can store copies of patient handouts, medical articles, protocols, PDFs, text information, pictures and other items which they will believe will be helpful to their practice. The physician should be able to organize this information into logical sections, subsections and sub-subsections. They should also be able to search this information, print the date and copy / paste the information into a patient Progress Note, as they see fit.

Miscellaneous feature:

At the same location on the computer screen, in all locations throughout the EMR, there should be a “suggestion” button. When clicked, a text window opens and the dialog box reads “Enter you suggestion to improve this EMR below. Your suggestion, along with your location in the EMR and other relevant EMR data will be sent to the CIO, MD, who should be a practicing physician that uses the EMR on a regular basis. The CIO, MD should assemble an “EMR re-design” team to sort through these suggestions and prioritize which changes should be made to the EMR by the CTO and his/her team. It is imperative that the power to decide whether and when a new feature should be added to the EMR should reside with the clinicians, not with the technologists.

In my opinion, a suggested new feature should be added to the EMR if it creates no unresolvable security issues and proposed feature meets any of these criteria:

1) will likely be used by many users

2) has the potential to improve the efficiency of the health care provider

3) has the potential to reduce the cost of healthcare

4) has the potential to improve the quality of healthcare

5) has the potential to promote patient engagement

Technical issues, like it is “too technically difficult” or “the IT department has other priorities” or “it cannot be done” are not acceptable reasons to fail to add a new feature to an EMR. As a programmer, I know that there is always a way to circumvent almost all technical issues.

Finally, I want to again encourage you to add your EMR suggestions to this list. Maybe the large EMR vendors will read your suggestion and add the feature to your EMR.

Categories: OIG Advisory Opinions

VA and CMS are Leading From Behind

The Healthcare Blog - Fri, 06/17/2016 - 19:21

Instead of empowering patients, VA and CMS are building-in rent-seeking intermediaries like NATE and DirectTrust based on obsolete security protocols and effectively legitimizing data blocking practices.

Four years ago Stage 2 was still open on the table and I wrote A Fork in the Road to Meaningful Use. It foretold pretty accurately the information blocking characterized by VP Biden recently as: “Taxpayers did not spend $30 Billion to create five data silos.” I was certainly not alone. Independent expert panels like JASON and PCAST saw it coming too. Regulatory capture might explain, but not excuse, the actions of federal regulators around Stage 2 but it does not explain why our federal health system, VA and CMS, continues to promote policies that enable information blocking today.

John Halalmka’s wish list and the Massachusetts Medical Society wish list approach health IT from different perspectives but they both imply a need for a patient-centered perspective. To get there, we need to give real market power to physicians and to patients. That power depends on unmediated control over how personal health information flows away from the current institutional EHR silos. HIPAA allows unmediated patient control. The recently concluded API Task Force endorsed unmediated control. VA and CMS need to take the correct fork this time.

VA and CMS, however, are announcing policies that put practice and technology innovators at a huge economic disadvantage. At a time when Google and Apple are giving users total control over personal information such as emails, calendars, messaging, and health information using modern web standards, VA and CMS are building around rent-seeking intermediaries like NATE and DirectTrust that effectively legitimize the information blocking practices we see today.

Patient health records are the most strategic asset in health care today because they are the Big Data of tomorrow. Patient records are the essential ingredient for machine learning systems like IBM Watson. They are also the foundation decision-support databases that predict treatment outcomes by clustering patients with similar health records. Patient records also control the ability to form and manage accountable care organizations. For all of these reasons, patient records are key to health reform, including payment reform.

A handful of large hospital systems and their even more consolidated EHR system vendors (Epic, Cerner, and hardly any others) now control the goldmine of patient health records and they are not going to give them up without a fight. That fight is currently happening in the HL7-FHIR standards group over, obviously, patient consent. The only other large-scale source of patient health records are VA and CMS. The tragedy is that although VA and CMS clearly have no strategic incentive to enhance information blocking they are effectively doing the same thing by introducing security intermediaries instead of empowering patients to direct our records as we see fit. Further damage is being done by the VA in the HL7-FHIR Consent discussions where they are favoring control of health records by the information blocking hospital networks and EHR vendors.
As we move from Meaningful Use to MACRA and from one administration to another, our federal institutions – VA, DoD, CMS, and ONC – face the same fork in the road as they did four years ago. Will they take the patient branch or the institutional branch. The patient branch gives patients and their physicians the economic power of independent decision support at the point of care. The institutional branch further consolidates the power and regulatory capture of the information blockers. ONC has done what it could with the API Task Force. It’s time for VA and CMS to step up and do their share by empowering patients and innovators instead of rent-seekers.

Adrian Gropper, MD is Chief Technology Officer of  Patient Privacy Rights.

Categories: OIG Advisory Opinions

An Epidemic of Septicemia?

The Healthcare Blog - Fri, 06/17/2016 - 01:26

While prevention efforts have largely been focused on chronic disease, spurred in part by the Centers for Disease Control and Prevention’s (CDC) insistence that 86% of healthcare dollars are spent on patients with chronic illness, it turns out that the largest, fastest-growing and possibly most preventable diagnosis is arguably the most acute diagnosis of all: septicemia.

Septicemia is any persistent systemic blood-borne bacterial infection, generally caused by contamination from an invasion of the bloodstream by an outside pathogen, and generally not easily addressed with antibiotics. Its many complications include death, 13% of the time. (There is some confusion about the various definitions of and distinctions among sepsis, septicemia and septic shock.)

The Statistics

The statistics below are drawn from the Agency for Health Research and Quality’s Healthcare Cost and Utilization Project (HCUP) database, and as such are easily replicated by entering ICD-9 “038.9” as “principal diagnosis.” The most recent year available, 2013, is the source of the screenshots.

According to the most recent statistic available, septicemia is not only #1 in total spending, but it’s also almost twice as costly as the next-highest ICD9.

Taking the long view yields an even more concerning picture.  This is the same analysis, run for 1999 — the year the Institute of Medicine published To Err is Human, bringing errors and infections into the public consciousness.

In 1999, septicemia was #20.  So septicemia is both the largest and the fastest-growing ICD9.  As it grew in incidence, it drew a little attention from AHRQ when it became #6 in 2009…but AHRQ has not mentioned anything since then. 

And yet, besides being #1, growth in septicemia has actually been accelerating. For contrast, we are graphing septicemia diagnosis rates against heart attacks (ICD9 410xx) and diabetes (ICD9 250xx), the current emphasis of most government and private sector (workplace wellness) prevention efforts. The dotted line represents an index of all non-birth admissions over the same period.

The Magnitude of the Problem in Perspective

The number of suicides in the US has increased from 29,000 to 42,000 since 1999, a 24% increase adjusted for population.  The fastest-growing segment, middle-aged men, has suffered a 50% increase in the rate over that period.

Not to underestimate the implications of or be insensitive to that problem (which included one of my relatives), but the septicemia rate is 20 times higher and has jumped sixfold. So however much of a national priority it is to understand what is driving the suicide rate, it should be a much greater priority to understand the dramatic increase in septicemia.

Or put another way, while you are reading this article, 5-10 more people have been diagnosed and probably one person died.

What’s causing this dramatic increase?

Many septicemia cases — complications of burns, needle contamination, AIDS — originate outside the hospital. However, those cases are flat-to-declining. Burn admissions have remained unchanged at 32,000/year this century.  Non-sterilized needle-sharing is presumably also on the decline, while AIDS has likewise responded to improved treatments this century. Further, if cases originated outside the hospital one would expect discharges from the ER to be increasing at the same rate as admissions to the hospital from the ER, but treat-and-release ER visits have increased far more slowly.

Another hypothesis could be that due to the progress made in prolonging life for people with chronic disease, patients are dying of this rather than directly due to their chronic disease.  If that were the case, inpatient deaths due to septicemia would be high and increasing. Instead, inpatient septicemia deaths have declined, according to HCUP, from 22% of all septicemia diagnoses to 13%.

Yet another hypothesis could be that these diagnoses are some kind of Medicare revenue-maximization coding scheme. That is unlikely. Starting around 2001-2002, CMS became pretty good at shutting those down, while this one has been going on for years.

Failure to seek care for suspected infections in a timely way due to insurance status is another hypothesis worth exploring. It’s possible that people are waiting longer to seek care if they don’t have insurance or have high-deductible plans.  Using lack of insurance as a proxy for lack of coverage, a suggestive statistic is that roughly 3.7% of all non-maternal admissions are septicemia for uninsured people, while the comparable statistic for insured people is 3.4%. A noticeable difference to be sure, but far from a definitive explanation. (It is not possible to track high-deductible plans in the HCUP database.)

The only remaining hypothesis is that hospitals have increasingly harbored increasingly hardy bacteria that increasingly find their way into patients’ blood, at a rate more than six times greater than in 1999. (The Centers for Disease Control and Prevention writes that hospital-acquired infections have been declining, but didn’t reconcile that finding with the definitive HCUP Nationwide Inpatient Sample, which reports only roughly a 2% standard error. In research, it’s one thing to explain why a conclusion conflicts with the “hard data.” It’s another thing to ignore that conflicting hard data altogether.)

This hypothesis is a bit different from “superbugs,” which the CDC is addressing. True superbugs are still rare. Septicemia is very common.

Response to date and proposed solutions

A specific set of infections, such as catheter line infections and post-surgical infections for certain surgeries, fall into the category of “serious, reportable events” (formerly and still colloquially referred to as “never-events”) that Medicare won’t pay for.  (They still pay for the cases, but not for the extra resources needed to control the infection.)   However, these events don’t cover remotely the entirety of septicemia.

Septicemia is the second-biggest diagnosis (behind knee replacements) for the employed population, and arguably the most preventable. While some major companies and regional business coalitions have been working closely with Leapfrog Group and are addressing patient safety issues and infections in many ways, including using Hospital Safety Scores to guide network and benefits design, even Leapfrog can’t track septicemia yet. 

Instead, most large employers are focused instead on wellness programs, widely believed to be ineffective.  Employers should refocus their efforts away from these programs and instead start demanding safety improvements from their providers. It might be something as simple as not paying for certain medical errors (and paying a bit more for other cases, to compensate), as Medicare does.

Medicare, in turn, should expand its never-event categories to include more infections. This would put more risk back on the hospitals, and should motivate them to emphasize safety.

Next, caregiver-to-patient transmission of bacteria must be curtailed.  Hand-washing simply isn’t taking place as often as it should.  Notably, the increase in infections has coincided with the increase in the use of hand sanitizers. Perhaps sanitizers are being used as a substitute for hand-washing instead of a complement…and don’t work as well. The FDA is raising this issue too. Apparently the alleged safety and effectiveness of these dispensers are based on 1994 standards.

Finally, everyone could name hospitals known for cancer or transplants. But could anyone name hospitals known for safety?  One of the safest hospitals, according to Leapfrog, is Virginia Mason Medical Center.  Being a leader in cancer treatment or transplants creates high visibility. The large, high-technology investments are often displayed in advertisements. But being the leader in safety?  That means doing a million little things right that only the cognoscenti would ever notice. If somehow more attention were paid to “safest” rather than “highest-tech,” the basis for hospital preferences could change. Yet Congress has consistently blocked more transparent hospital reporting requirements.

Following the well-publicized and completely preventable death of a 12-year-old boy from sepsis, New York State implemented Rory’s Regulations, which require hospitals to implement a set of protocols to predict, identify, communicate and treat bacterial infections. Other states should follow suit, without waiting for a similarly well-publicized tragedy to spur them to action. (In 2013, the first nearly complete year of Rory’s Regulations, New York septicemia cases still rose 15%–but would have risen 17% had they simply tracked the country as a whole. So the law has already made a difference, though not a major one.) 

Unfortunately, since no patient expects to get an infection, no one selects a hospital whose expertise is avoiding them. Hence, few hospitals attempt to “compete” with VMMC and a handful of others for this distinction nationally.  Locally, though, business leaders could highlight the safest hospitals in their regions, and perhaps steer more employees towards them.

A better working hypothesis, and more detailed solutions, are for others to propose and implement. The focus of this column is to identify this as an unappreciated but presumably addressable epidemic. It should be treated as such.

Al Lewis is the CEO of

Categories: OIG Advisory Opinions

In Silico Medicine

The Healthcare Blog - Fri, 06/17/2016 - 00:39

Could computers develop the drugs of the future?  The short answer: probably, but not yet.

Computer simulation is a cornerstone in the development and optimization of “mission-critical” elements in industries ranging from aerospace to finance.  Even the smooth functioning of nuclear reactors – where failure would be catastrophic – relies on a computational model called a Virtual Reactor, which allows scientists and engineers to observing the reactor’s real-time response to operating conditions.

The analogous model in medicine – a “virtual human” – doesn’t yet exist.  We still rely on living, breathing animals and humans to test drugs and devices.  Discoveries are made largely by trial and error.  But the age-old approach that led to the discovery of antibiotics, cardiac catheterization, and organ transplantation is becoming increasingly unsustainable.

According to the Tufts Center for the Study of Drug Development, the development of a new drug now exceeds $2.5 billion, 75% of which is spent in various phases of development.  Lesser known than the price tag of successful drugs is the failure of most:  90% of potential drugs that are backed by funding of this magnitude fail in late-stage clinical trials before making it to market.  Perhaps most worrisome of all is that when a drug or device fails, no one really understands why.  The traditional clinical trial simply isn’t designed to tell us why an adverse event occurred, or why the expected efficacy was strikingly less than predicted.  The failed therapeutics are largely abandoned in an all-or-nothing mentality that ultimately dampens the innovative process.

Enter in silico clinical trials.  Avicenna, the European Commission-funded coalition dedicated to the support and development of in silico technology, defines in silico clinical trials (ISCT) as “the use of individualized computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention.”  In other words, test the idea on a computer, not a person.

In all fairness, computer modeling in drug and device development isn’t particularly groundbreaking.  A handle of pharmaceutical companies uses computational methods to model pharmacodynamics and pharmacokinetics in pre-clinical studies.  And medical device companies use computational fluid dynamics to blood moves around an implanted device.

What’s missing is a model that can be tailored to each patient, with the option to punch in a patient’s physiologic parameters and learn how the individual will respond.  The goal is it to create – you guessed it – a Virtual Physiologic Human, or VPH.

Although the VPH model is far from attaining the reliability needed to meaningfully transform the clinical trial process, it isn’t just science fiction.  A recent UCSF computer model, for instance, correctly predicted side effects of over 650 drugs.  Another study of 300 virtual type-I diabetics accurately predicted trends in blood glucose after “meals” and with “insulin.”  And a computer model in patients with sepsis identified subgroups of virtual patients for whom TNF-alpha inhibitors could be life-saving, and those in whom the immunomodulatory drug did more harm than good .

In the not-so-distant future, ISCT could be used to answer questions that current clinical trials can’t.  How will the effect of the drug change if the body weight is 20%?  What genetic profile is most likely to respond best to the drug?  What would happen if the dose were doubled, or halved?  Ultimately, the hope is that ISCT technology could reduce the size and duration of clinical trials, refine clinical outcomes with greater explanatory power, and even partially replace clinical trials in cases where ISCT can generate sound and reliable evidence.

If successful, the implications of in silico trials – from individualized drug development to massive cost savings to much-needed and overdue development of orphan drugs – are hard to overestimate.

Nicole Van Groningen is an internal medicine physician in New York City.  She tweets from @NVanGroningenMD and blogs at

Categories: OIG Advisory Opinions

All Risk is Local

The Healthcare Blog - Thu, 06/16/2016 - 12:55

We all knew how this was going to go, or thought we did.   Fee-for-service payment for health services was going to disappear, and be replaced by population health risk-based payment (or as some term it, “capitation”- fixed payment for each enrolled life).  Hospitals and care systems invested substantial time and dollars building capacity to manage the health of populations, yet many are discovering a shortage of actual revenues for this complex new activity.  Was population health a mirage, or an actual opportunity for hospitals, physicians and health systems?   

The historic health reform law passed by Congress and signed by President Obama in March, 2010 was widely expected to catalyze a shift in healthcare payment from “volume to value” through multiple policy changes.  The Affordable Care Act’s new health exchanges were going to double or triple the individual health insurance market, channeling tens of millions of new lives into new “narrow network” insurance products expected to evolve rapidly into full risk contracts.   

In addition, the Medicare Accountable Care Organization (ACO) program created by ACA would succeed in reducing costs and quickly scale up to cover the entire non-Medicare Advantage population of beneficiaries (currently about 70% of current enrollees) and transition provider payment from one-sided to global/population based risk.   Finally, seeking to avoid the looming “Cadillac tax”  created by ACA, larger employers would convert their group health plans to defined contribution models to cap their health cost liability, and channel tens of millions of their employees into private exchanges which would, in turn, push them into at-risk narrow networks organized around specific provider systems. 

Three Surprising Developments

Well, guess what?   It is entirely possible that none of these things may actually come to pass or at least not to the degree and pace predicted.  At the end of 2015, a grand total of 8.8 million people had actually paid the premiums for public exchange products, far short of the expected 21 million lives for 2016.  As few as half this number may have been previously uninsured.   It remains to be seen how many of the 12.7 million who enrolled in 2016’s enrollment cycle will actually pay their premiums, but the likely answer is around ten million.    Public exchange enrollment has been a disappointment thus far, largely because the plans have been unattractive to those not eligible for federal subsidy. 

Moreover, even though insurers obtained deep discounts from frightened providers for the new narrow network exchange products (70% of exchange products were narrow networks, the discounts weren’t deep enough to cover the higher costs of the expensive new enrollees who signed up.  Both newly launched CO-OP plans created by ACA and experienced large carriers like United and Anthem were swamped in poor insurance risks, and lost hundreds of millions on their exchange lives.   As for the shifting of risk, it looks like 90% plus of these new contracts were one-sided risk only, shadowing and paying providers on the basis of fee-for-service, with bonuses for those who cut costs below spending targets. Only 10% actually penalized providers for overspending their targets.   

The Medicare Accountable Care Organization/Medicare Shared Savings Program, advertised as a bold departure from conventional Medicare payment policy, has been the biggest disappointment among the raft of CMS Innovation Center initiatives. ACO/MSSP enrollment appears to have topped out at 8.3 million of Medicare’s 55 million beneficiaries.   The first wave, the Pioneer ACOs, lost three-fourths of their 32 original participating organizations, including successful managed care players like HealthCare Partners, Sharp Healthcare, and Presbyterian Healthcare of New Mexico and others. The second, much larger wave of regular MSSP ACO participants lost one third of their renewal cohort .  Only about one-quarter of ACO/MSSP participants generated bonuses, and those bonuses were highly concentrated in a relative handful of successful participants. 

Of the 477 Medicare ACO’s, a grand total of 52, or 11%, have downside risk, crudely analogous to capitation.   As of last fall,   CMS acknowledged that factoring in the 40% of ACO/MSSP members who exceeded their spending targets and the costs of the bonuses paid to the ACOs who met them, the ACO/MSSP programs have yet to generate black ink for the federal budget.   And this does not count the billions care systems have spent in setting up and running their ACOs.   It is extremely unlikely that the Medicare ACO program will be made mandatory, or voluntarily grow to replace DRGs and the Medicare Part B fee schedule. 

And the Cadillac Tax, that 40% tax imposed by ACA on high cost employee benefit plans, a potentially transformative event in the large group health insurance market, which was scheduled to be levied in 2018, was “postponed” for two years (to 2020) by an overwhelming Congressional vote.  In the Senate, a 90-10 bipartisan majority actually voted to kill the tax outright, strongly suggesting that strong opposition from unions and large employers will prevent the tax from ever being levied.   Presumptive Democratic nominee Hillary Clinton has announced her support for killing the tax.    So the expected transformative event in the large group market has proven too heavy a lift for the political system. 

As a result, the enrollment of large group workers in private health exchanges, the intended off-ramp for employers with Cadillac tax problems, has arrested at about 8 million, one- fifth of a recent forecast of 40 million lives by 2018. Thus, the conversion of the enormous large group market members to narrow network products seems unlikely to happen.   As a recent New York Times investigation revealed, the reports of the demise of traditional group health insurance coverage (based on broad network PPO models) have been greatly exaggerated).

Can Care Systems Return to Business as Usual?   

Does this mean that the forecast rise of at-risk population health payment was a mirage and that health care managers can return to business as usual?   We would say, “Depends on the Local Market”.   We think the most effective strategies will be specific to individual payers and depend a lot on local insurance markets, the state political environment and the state of the local economy.  Judging the capacity for and interest by public and private payers in delegating risk to care systems is an art form.   

Our advice:

  1. Understand Your Local Market’s Demand for Risk Arrangements and Respond Accordingly

  2. Focus on operational excellence and improving the patient experience

Keep An Eye on Medicaid

1. Understand your Local Market’s Demand for Risk and Respond Accordingly. Our experience tells us that executing a risk assumption strategy successfully is highly dependent on local market conditions.  Local market forces are far more powerful than alleged national trends.    For example, in Portland Oregon, a mature highly penetrated managed care market, state policymakers compelled care systems to organize into so-called Co-ordinated Care Organizations and take population-level financial risk for state employees and the state’s Medicaid population.  In contrast, in nearby Seattle, also a mature managed care market, the demand for care systems to assume population-level financial risk has been extremely limited.

In markets such as St. Louis, Phoenix, Milwaukee and Chicago, commercial payers like Aetna and CIGNA have aggressively experimented with risk contracts with dominant healthcare systems to grow their market share in the commercial market, and attempt to claw business away from Blue Cross plans.   In other states, notably Massachusetts and Maryland, state health policy is encouraging all payers to delegate population-level economic risk to care systems.  Reading these local market trends accurately and responding intelligently to them is the key to an effective payment strategy.

2. Focus on Operational Excellence and Improving the Patient’s Care Experience.  Under any payment model, strategies which reduce waste (particularly of caregiver and patient time) and that reduce variation in how physicians manage common but costly problems will best position care systems to survive market transitions.  Assuring an optimal patient experience becomes paramount in defining a network and its brand.  For those in risk-based contracts, care systems will be working assiduously to divide the affected populations into manageable clusters with common problems (mental health, obesity, chemical dependency, etc.) and create medical-home style care models to address the unique needs of each segment.

3. Keep Your Eye on Medicaid.  Thanks to the 25% expansion of Medicaid by the Affordable Care Act, it is possible that by the bottom of the next recession, one in four Americans will be Medicaid patients!  Medicaid funding is highly volatile and tends to dry up in recessions, just as the number of Medicaid lives grows!   While Medicare and commercial payers have struggled to make the turn toward risk, we see state Medicaid programs as the most likely payer segment to adopt risk-based methodologies.  In some cases, the risk shift will stop at outsourcing to insurance carriers like Molina (now part of HealthNet), AmeriGroup (now part of Wellpoint/Anthem) and United Healthcare.  But in many others, population-level risk may be delegated directly to care systems by state Medicaid agencies, albeit at rates far below the actual incurrent cost of caring for Medicaid patients.  Organizing to respond to the next recession’s entirely predictable Medicaid funding crisis will probably require robust population health management strategies like medical homes and closer collaboration with community health centers and other public health entities.

We have both been in this field long enough to be skeptical about “megatrends”.   We should keep our eyes peeled for transformative events.  But, to paraphrase Tip O’Neill’s comment about politics, almost all the important things about healthcare markets are local.  Paying attention to the ecology of risk in your local market, and calibrating your strategy to the actual demand for new payment models is vital.  And while you are doing that, delivering care you are proud of and are willing to use yourself is the key to maintaining or growing your market presence. 

Jeff Goldsmith is National Advisor to Navigant Healthcare and Associate Professor, Public Health Sciences at the University of Virginia.  Bruce Henderson is Managing Director of Navigant Healthcare and Head of the Firm’s Payer Provider consulting practice.

Categories: OIG Advisory Opinions

The Team Sport of Diagnosis: A Culture Shift Can Reduce Missed Diagnoses

The Healthcare Blog - Wed, 06/15/2016 - 12:27

Every American will experience a missed or delayed diagnosis at some point in his or her lifetime. Saying that is not a scare tactic — it’s a reality, according to a 2015 National Academy of Medicine report titled “Improving Diagnosis in Healthcare.” Yet we have not made effective use of a simple solution: teamwork.

Among U.S. adults seeking outpatient care each year, 12 million are misdiagnosed. One in 20 hospital deaths results from a diagnostic error. Estimates suggest that costs of unnecessary tests, harms from misdiagnosis and legal payouts exceed $100 billion per year in the U.S. In short, inaccurate diagnoses are the most common, catastrophic and costly medical errors.

From a public health standpoint, we are in crisis.

Medicine is complex, and diagnosis is not an exact science, so we can’t always be right. But there is strong evidence that we can do a lot better than we do now. When we don’t follow best diagnostic practices, we tend to undertest patients who need it most, missing chances to provide prompt treatments for dangerous disorders.  

At the same time, we overtest patients who don’t need it, wasting precious diagnostic resources on those with benign conditions. With more accurate diagnostic assessments, we can fix both problems ― eliminating harms and reducing costs of care. For example, if we routinely followed evidence-based protocols for diagnosing dizziness in the ED, we could prevent 45,000 to 75,000 missed strokes each year and simultaneously save an estimated $1 billion per year.

The hospital and health care environments don’t help either. High patient volumes, time pressures, interruptions, distractions and failed communication can all lead to a missed or delayed diagnosis. Then there is the fact that we are human. At times, we make a mistake in clinical reasoning, such as when we are presented with a unique clinical problem that is outside of our clinical expertise.

Physicians are tasked with diagnosing the patient’s medical condition, but they are not the only ones who can ensure a correct diagnosis. Nurses, physical therapists, physician assistants and even family members may be the first to notice a change in the patient’s condition that indicates a wrong diagnosis. Sometimes nonphysicians have specialized knowledge critical to correct diagnosis. When armed with evidence-based diagnostic protocols and empowered to help physicians, these team members can ensure optimal diagnostic testing to maximize the odds of a correct diagnosis.

The National Academy of Medicine’s report offers an immediate suggestion to improve health care diagnosis today: teamwork. The same principle that rules sporting arenas and playgrounds across the world can reduce the number of diagnostic errors. The practice of medicine has traditionally been a lonely and risky competition. Doctors are used to calling the odds and making diagnoses without input from other members of the team, and nurses and physician assistants are taught not to question them. If a physician makes a mistake, there is a culture of blame, shame and fear of litigiousness, which makes it less likely that individuals will speak up or report a diagnostic error.

But better teamwork achieves much more than merely changing professional norms or local work culture. I have witnessed its benefit to patients.

In an endeavor to challenge health care cultural norms and combat diagnostic errors, I mentored a colleague from another medical center, a physical therapist with 24 years of experience specializing in vestibular and balance disorders. In a paper published online May 31 in Diagnosis, we highlight five case studies where the physical therapist’s expertise proved paramount in correcting a misdiagnosis in patients who showed up to the ED with dizziness. Her expertise in performing a physical therapy vestibular assessment resulted in better treatment, better patient satisfaction and quicker discharge.

Initially, her relationship with physicians was strained, and they didn’t value her input. She felt the pressure that many nonphysician health professionals feel in the face of doctors’ authority: a need to back down or tread lightly to avoid the perception of disrespect. Over time, however, her position improved, and she built trust with her physician colleagues who now value her input, routinely consider her diagnostic findings and even ask to learn her techniques.

Shaking up health care culture to improve patient care isn’t a new concept, and there is proof that it can be done. Peter Pronovost, M.D., Ph.D., director of the Johns Hopkins Armstrong Institute for Patient Safety and Quality and senior vice president for patient safety and quality at Johns Hopkins Medicine, created a comprehensive system that successfully reduced central line-associated bloodstream infections around the world. Empowering nurses to speak up was a critical yet simple component of the intervention. This system — now in place in 1,100 intensive care units across the nation and at hospitals in more than 20 countries — has reduced these infections by 40 percent.

While nurturing more effective relationships and communication between physicians and other members of the health care team won’t prevent all diagnostic errors, this shift is a simple and affordable step in the right direction. A less hierarchical approach to “team diagnosis” would empower nurses, physician assistants and physical therapists to speak up and develop more collaborative relationships with physicians, who in turn will begin to rely on their input to help prevent misdiagnosis.

To my physician colleagues, I’ll end with this simple advice: Pair up and offer mentorship to other members of your clinical team. Encourage them to pass along their expertise. Otherwise, we will miss a key opportunity to provide the best care to our patients, starting with an accurate diagnosis.

David E. Newman-Toker, M.D., Ph.D., is associate professor of neurology and director of the neuro-visual and vestibular division of the department of neurology at the Johns Hopkins University School of Medicine

Categories: OIG Advisory Opinions

Confession of a Liberal

The Healthcare Blog - Wed, 06/15/2016 - 09:24

TRIGGER WARNING: Long read, Trump

Reason #1: Feeling the Bust. I am a woman and I am an immigrant to this country. I am Jewish by birth and atheist by faith. I am fairly well educated, borderline socialist and straight Democratic ticket voter. I have no use for guns, I despise hunting, and I believe the death penalty is state sponsored murder. I think abortions are perfectly fine and I think everybody should be free to choose how they use their own body for their own happiness and joy. I have no respect for authority, strength, power or large wads of cash. Come to think of it, I have no respect for anything or anyone in particular.
On November eighth, barring any natural disasters, I will be voting for Donald Trump and according to my liberal bible, I will be doing so for all the wrong reasons.

There was a brief moment there when I thought Bernie Sanders may just pull it off. He didn’t, and I should have known he wouldn’t. The first time I heard Bernie speak, it felt like he was reading my mind. The billionaire class, big corporations, a rigged economy, tax funded college and health care, and the list goes on and on. It was too good to be true. Bernie did not speak about foreign policy that day, and when he finally did, I found some things I could disagree with. I have a feeling that Bernie himself may disagree with some of his own foreign policy positions.

I was fairly sure that a President Sanders would have been able to cross off very few, if any, items on his to-do list, but that was not the point. A political revolution (unlike the real one coming down the pike) takes time, and I was willing to be patient, because I thought I would sleep better at night knowing that the person in the White House is on my side, and sleep is very important. In addition to nuclear codes and veto power, the President of the United States has that nifty tool invented by Theodore Roosevelt and named after his own self: the bully pulpit. Can you imagine a President Sanders State of the Union address, blasting the billionaire class and the greed of Wall Street? No? Try it. It’s very therapeutic. Well, that’s all over now, so what’s next?

Reason #2: I’m not with HER

This may be one of those divisive cultural issues, but in the place where I come from, an American woman became Commander in Chief almost half a century ago, and all across the globe many other women have served or are currently serving in similar positions. I must beg forgiveness for my lack of appreciation for this historic moment when America came one step closer to catching up with Bangladesh. If you believed in Bernie Sanders’ words long before you heard Bernie speak, and I mean really and truly believed, with both your heart and your brain, there is absolutely no way you can wake up one morning and be with HER, because she is the embodiment of everything you want to blow to smithereens.

Yes, President Obama endorsed HER because he doesn’t “think there’s ever been someone so qualified to hold this office”, and yes, I wholeheartedly agree, because the last few decades have transformed the United States Presidency into “this office”, which fits HER like a glove. Obviously, HER unique, and truly historic, qualification is that, according to President Obama’s own spokesman, she is currently under “criminal investigation” by the FBI. Neither Bernie Sanders nor Donald Trump has anything remotely as qualifying as that little jewel. Unfortunately, I am not looking for someone to “hold this office”, but for someone to refurbish and restore “this office” to its Teddy Roosevelt condition.

Reason #3: I’m a Racist

I didn’t think I was a racist, but it seems that I am. If I say that black lives matter, I’m a racist because how about white lives and Asian lives and Native American lives? Don’t they matter? Of course they do. All lives matter. Oops. Now I’m a racist because all lives matter is code words for black lives don’t matter. If I say “radical Islam” instead of “radical Islamism”, I’m a racist, because without the “ism” I’m offending our friends and allies in the fight against terror (i.e. the largest clients of our military industrial complex). If I support school vouchers, I’m a racist, because I propose to defund inner city schools where children are mostly black. If I oppose school vouchers, I am also a racist because I am trying to deny black children the same opportunities that privileged white children have. So I must be a racist. I don’t think I know what racist means anymore, but I hear that Bernie Sanders is a racist and Mr. Trump is also a racist, so as a racist, I should probably stick with my own kind.

Reason #4: The Copperheads

Let me tell you a little story, folks. Back when Abe Lincoln was leading the nation through its most painful fight for survival as a truly free nation, a group of conservative Democrats, called the Copperheads, came within inches of destroying everything Lincoln and his Republican party ultimately achieved. The Copperheads were strict constitutional constructionists espousing a philosophy practically identical to that of sanctimonious conservative ideologues who are viciously fighting the Trump candidacy today.  The party of Lincoln, and the party of Teddy, has been slowly and stealthily hijacked by the Copperheads.  To my immense delight, Donald Trump, who during a recent rally blurted out that “this is called the Republican Party, it’s not called the Conservative Party”, is prying the party of Lincoln out of the cold grip of the Copperheads, and they loathe him for it.

Reason #5: FDR said so

The other President Roosevelt asked the country to judge him, not by his deeds, but by the enemies he has made, and that was good advice. Donald Trump has accumulated the most excellent team of enemies I have ever seen in modern politics (by my liberal standards, of course). Here is just the latest statement from Mr. Trump, after being snubbed by the Grand Copperhead and his brother: “I think the American public will be happy to know that the Koch brothers will not have influence over a Trump administration or the lives of the American people”, and this is just the cherry on top.

From the corporate raider who used 47 percent of our nation as his personal spittoon, to the avid Ayn Rand disciple who proposed to give old people two dollars for health care and let them go figure it out, to the Silicon Valley artificially intelligent extraction machine, and all the way through the calcified remains of the Copperheads themselves, the righteous indignation coalition for the preservation of global capital rights is raining fire and brimstone on Donald Trump and anyone who won’t publicly disavow him. Without knowing anything else about Mr. Trump, this would be sufficient information for me, but there is more. When the stars of corruption align so perfectly, there is always more.

Reason #6: The Media

Throughout history, the press was never impartial. It was never just about reporting the news. In fact the First Amendment reference to the press is precisely about protecting the freedom of journalists to attack politicians as they see fit. From the dawn of the Republic, there has never been a President or a candidate for political office that has not been chewed up, or promoted and endorsed, by this or that media outlet. This was all fine and dandy when each newspaper was a small business, and when public TV stations maintained a modicum of decorum in return for being granted free use of public airwaves. But the framers of the constitution did not and could not foresee a day when all media is owned by a handful of global corporations, and that’s where we are today.

The problem is not that the media is too liberal. Just ask Bernie Sanders how well the liberal media served his liberal campaign. The media looks and sounds liberal because it is targeting liberals. People who consider themselves conservative are already indoctrinated into corporate servitude. Liberals need to be cajoled by other liberals pointing to imaginary streams of racism, bigotry, misogyny and xenophobia, punctuated by indignant exhortations of “this is not who we are”, until they internalize the egalitarian benefits of free trade and open borders (i.e. an endless just-in-time supply of cheap slave labor for global corporations). I don’t know about other liberals, but I oppose slave labor, which leaves me very little wiggle room here.

Reason #7: Health Care is like Football

I work in health care. Health care is like football now, and I play on the losing team. We lose every time we show up, and we show up every day. We used to win most of the time, but they changed the rules. They change the rules in mid game now, in mid pass even. My favorite rule is where they get to move the goalposts two years after we kick the ball. The guys on the other team are big and strong and they are legion. Our team is shriveling and dwindling and aging rapidly. Nobody wants to join our team and I can’t blame them.  I run interference for a dying breed of quarterbacks. We pretend to know the rules and some of us pretend to like the rules. It’s a rigged game of survival of the crookedest.

We don’t have universal health care. We are not on the road to universal health care. These are not growing pains. These are not unintended consequences that need to be incrementally tweaked. This is not incompetence of well-meaning, but clueless, bureaucrats. Nobody can possibly be that incompetent. Donald Trump wants to win with health care. I am fairly confident that Mr. Trump knows very little about the health care football right now, but he seems to be an obsessive-compulsive winner, and I want him on our team. No football team can win with lousy management (believe me, I’m from St. Louis). We want Mr. Trump to manage our team, and we’ll leave it all on the field for America.

Reason #8: I Love our Conmen

Thomas Jefferson was elected President based on his very public opposition to strong Federal government. Then he went and bought half a continent without asking anybody’s permission. I guess he was a conman. Teddy Roosevelt was put in the White House by his wealthy buddies, and then he turned around and chose to throw them under the bus in favor of the “working man”. He must have been a conman too. Abraham Lincoln was most certainly not elected President based on his promise to launch a civil war that will kill half a million Americans, but he did that anyway. He was the ultimate conman. I voted for Bill and I got NAFTA and “the era of big government is over”. I voted for Barack Obama twice, and I got no hope and barely any change. I think I have a peculiar predilection for conmen, and my liberal friends say that Mr. Trump is a conman.

I’m a little worried about this conman thing though. I made it my business to watch dozens of Trump rallies, interviews and press conferences. Daniel Webster would be rolling on the floor laughing at Mr. Trump’s oratory skills, because he has this plebeian way of talking to his audience, instead of directing soaring sophistry down at them. His body language is concerning too, because he seems way too relaxed and comfortable chatting away (gaffes and foot-in-mouth and all that) in front of thousands of regular people, but tenses up like crazy during media interviews or when they bring out those godawful teleprompters for more upscale audiences. I fear that he may not be a genuine conman after all, but at this point I’m running out of options.

Reason #9: Teddy made me do it

So come November I will be voting for a xenophobe who is married to an immigrant, a racist bigot whose grandchildren are little Jews, an old fashioned misogynist who calls strange women “darling” and puts his daughter in charge of his own company, a dangerous man who wants to build schools and hospitals and bridges instead of financing foreign wars, a rabid Republican who wants to preserve and strengthen Medicare and Social Security, an authoritarian who wants to negotiate good deals, a sleek conman who couldn’t finesse his message if his life depended on it. And I will be voting for a bully, because whereas being a bully in third grade is a bad thing, bullying from the pulpit is in the President of the United States job description. Teddy put it there, and I adore Teddy. I want a Bull Moose for President this year.

Categories: OIG Advisory Opinions