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What Keeps Me Up At Night – 2013 Edition

Now that Labor Day has come and gone,  I’ve thought about the months ahead and the major challenges I’ll face.

1.  Mergers and Acquisitions

Healthcare in the US is not a system of care, it’s a disconnected collection of hospitals, clinics, pharmacies, labs, and imaging centers.  As the Affordable Care Act rolls out, many accountable care organizations are realizing that the only way to survive is to create “systemness” through mergers, acquisitions, and affiliations. The workflow to support systemness may require different IT approaches than we’ve used in the past. We’ve been successful  to date by leaving existing applications in place and building bidirectional clinical sharing interfaces via  “magic button” viewing and state HIE summary exchange. Interfacing is great for many purposes.  Integration is better for others, such as enterprise appointment scheduling and care management. Requirements for systemness have not yet been defined, but there could be significant future work ahead to replace existing systems with a single integrated application.

2.  Regulatory uncertainty

Will ICD10 proceed on the October 1, 2014 timeline?  All indications in Washington are that deadlines will not be changed. Yet, I’m concerned that payers, providers and government will not be ready to support the workflow changes required for successful ICD10 implementation.    Will all aspects of the new HIPAA Omnibus rule be enforced including the “self pay” provision which restricts information flow to payers?  Hospitals nationwide are not sure how to comply with the new requirements.   Will Meaningful Use Stage 2 proceed on the current aggressive timeline?  Products to support MU2 are still being certified yet hospitals are expected to begin attestation reporting periods as early as October 1.   With Farzad Mostashari’s departure from ONC, the new national coordinator will have to address these challenging implementation questions against a backdrop of a Congress which wants to see the national HIT program move faster.

3.  Meaningful Use Stage 2 challenges

Although attestation criteria are very clear (and achievable), certification is quite complex, especially for a small self development shop like mine.   One of my colleagues at a healthcare institution in another state noted that 50 developers and 4 full analysts are hard at work at certification for their self built systems.   I have 25 developers and a part time analyst available for the task.   I’ve read every script and there are numerous areas in certification which go beyond the functionality needed for attestation.    Many EHR vendors have described their certification burden to me. I am hopeful that ONC re-examines the certification process and does two things – removes those sections that add unnecessary complexity and makes certification clinically relevant by using scenarios that demonstrate a real world workflow supporting the functionality needed for attestation.

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A Powerful Idea From the Nuclear Industry

Where health care has fallen short in significantly improving quality, our peers in other high-risk industries have thrived. Perhaps we can adapt and learn from their lessons.

For example, health care can learn much from the nuclear power industry, which has markedly improved its safety track record over the last two decades since peer-review programs were implemented. Created in the wake of two nuclear crises, these programs may provide a powerful model for health care organizations.

Following the famous Three Mile Island accident, a partial nuclear meltdown near Harrisburg, Pennsylvania in spring 1979, the Institute of Nuclear Power Operators (INPO) was formed by the CEOs of the nuclear companies. That organization established a peer-to-peer assessment program to share best practices, safety hazards, problems and actions that improved safety and operational performance. In the U.S., no nuclear accidents have occurred since then.

A more devastating nuclear incident in Chernobyl, Ukraine in 1986 spurred the creation of the World Association of Nuclear Operators (WANO), which serves a similar purpose but on an international scale. Since WANO’s inception, no severe nuclear accidents had occurred until the nuclear accident in Fukushima, Japan, caused by a devastating earthquake and tsunami in March 2011.

These programs have succeeded because their purpose and approach is very different from review processes by regulatory agencies. Instead of a punitive process that monitors compliance with minimum standards, peer-to-peer evaluations are thorough, confidential and—importantly—voluntary. They are viewed as mutually beneficial and help advance industry best practices, which are shared widely. The goal is to learn and improve rather than judge and shame. The reviews are done by experts, using validated tools and are ruthlessly transparent  yet confidential.

Peer-to-peer review has not been widely used in health care. A couple notable exceptions are the Northern New England Cardiovascular Study, which used organizational peer-to-peer review to improve the care of cardiac surgery patients, and the National Health Service in the UK, which used it to improve the care of patients with lung disease. While provider-level reviews are more common in health care organizations, they fail to capture the scale needed to achieve system-wide improvements.

At the Armstrong Institute, we have been pilot testing peer-to-peer review and early results are encouraging. We have evaluated specific outcomes, like blood stream infections; specific areas, like the operating room; and whole quality and safety programs.

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Pathologizing the Human Condition

The American Psychiatric Association recently published a new version of the Diagnostic and Statistical Manual (DSM). The DSM-5 is what medical, mental health, and chemical dependency professionals use to diagnose developmental, mental health, substance abuse and dependence, learning, and personality “disorders.” Now in its 5th edition, the DSM was first published in 1952. At that time, the DSM was 129 pages containing 106 diagnoses.

Now, 61 years later, the DSM-5 consists of approximately 950 pages and roughly 375 diagnoses. The DSM-5, while researched far more than previous editions, is based on the medical model or the model of disease. Simply put, the medical model finds the causes of disease and illness and then prescribes a treatment to cure the disease or illness. This means a person has a pathology or pathogen that needs to be treated and cured.

The questions that eat at me during my day as a psychologist and at night as a person searching for answers are:

  • Is it possible to accurately identify mental health “issues,” “illness,” or “disorders?” versus extreme ranges within the sphere of the human condition?
  • Even if it is possible to identify these conditions, does it determine the course of “treatment” or “intervention?”
  • If so, is there a “treatment” for every identified “condition?”
  • Does it mean there is a treatment that works?
  • Do you need a diagnosis to get help?

Over the years, many have been critical of this approach to mental “health” issues. Referring to mental “health” is actually a newer name as people have historically been thought to have mental “illness.” This makes more sense for people who are unfortunately compromised by severe conditions termed schizophrenia, bi-polar (manic-depressive), and severe depression and anxiety. But does this make sense for children, adolescents, and adults who are challenged with some other, and possibly less severe, aspect of their functioning and development? Do all human problems warrant a medical or mental health diagnosis? When did a weakness become a “disorder” that requires “intervention” and/or “treatment?”

To be fair, the DSM provided structure and guidelines for approaching the complicated business of determining who had a “problem” that required help. However, it seems things have gone too far. Critics of the DSM believe that this latest edition has taken the business of diagnosing to a new level, one where approximately 50% of the population can be diagnosed with something. Critics also believe that this pathology finding approach supports the continued trend of medication prescribing as the number one mode of treatment, and continued trend of increased health care costs and premiums with increased utilization of individuals who need a “diagnosis” to meet “medical necessity” to receive services. What does that mean? It means if you don’t have a diagnosis, you don’t get help. It means you have to have a problem (pathology) to get help (treatment and intervention).

Without going into detail about some of the changes in the newest edition of the DSM, some diagnostic categories have been added and some diagnosis “thresholds” have been lowered. This means that you need fewer symptoms to “meet diagnostic criteria.” Here are some examples of concerns with the new DSM-5:

  • Temper tantrums will now be diagnosed as Disruptive Mood Dysregulation Disorder
  • Normal forgetting will now be diagnosed as Minor Neurocognitive Disorder
  • Gluttony will be diagnosed as Binge Eating Disorder
  • Grief will be diagnosed as Major Depression
  • First time substance users and college partiers will get a diagnosis of Substance Use Disorder
  • Everyday Worry will be diagnosed as Generalized Anxiety DisorderContinue reading…

When Opting Out Is Not an Option

Henrietta Lacks did not give researchers permission to take her cancer cells and study them. After she died in 1951, her family was not asked permission as her immortalized cells were used in countless laboratories. This month, the National Institutes of Health finally took a step in righting that wrong, announcing that the Lacks family would help decide who can access Henrietta’s DNA.

Today, getting a patient’s permission, often in writing, is standard in experimental medical research. Well, not always. Currently, there are at least nine ongoing studies involving 62 U.S. cities and towns with a combined population of more than 45 million that do not involve getting permission. They take place during emergencies, such as when ambulances arrive at an accident where patients are too injured to give permission.

For example, imagine this scenario based on a recent study sponsored by the University of Washington. You are involved in a car accident. Paramedics find you bleeding severely. They give you fluids to keep your blood pressure up, but they intentionally give you a bag of fluid that is smaller than the standard. Then they monitor your medical outcome and compare it with patients who received the larger amount of fluids. During the emergency, neither you nor your family know about the study.

Vital research

Research on medical emergencies is vital in determining how to care for people with life-threatening injuries because we often do not have proof that standard methods are the best. People involved should be told that is how their records are being used.

In 1996, the Department of Health and Human Services and the Food and Drug Administration passed regulations allowing research about emergency treatment to occur without permission. For a study to qualify, patients need to have a life-threatening conditioncurrent standards of care must be unproven or performing poorly, and obtaining permission must not be feasible (such as an unconscious patient or a patient whose condition does not allow time for informed consent).

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Prostate Cancer: Not a Good Week

The general practice of oncology seems to come in waves of disease.  One week every breast cancer patient is in trouble, another sees multiple new cases of lymphoma or leukemia, the next it as if someone is giving away lung cancer (or perhaps cigarettes) and then three patients with pancreatic cancer end up in the ICU.  This week a portion of the 240,000 yearly USA cases of prostate cancer walked in our door. The rush of cases served as a reminder that when it comes to this illness, we have a long way to go.

First, Allen. He is 73 years old and has prostate cancer in one out of twelve biopsies. The cancer has a Gleason’s Score of 6 (a measure of aggressiveness of the cancer tissue: more then 7 is particularly bad), which means it is not fast growing.  We recommended that given the small amount of slow growing cancer, Allen should be watched without treatment (“Active Surveillance”).  What Allen found so difficult about this recommendation is that his son was diagnosed with prostate cancer just one month ago and his son, who is 49, has a Gleason’s 8 Prostate Cancer on both sides of the prostate, and is scheduled for robotic surgery.  More than having cancer, Allen is hurt by the feeling it should have been him.

Then there was Robert and Mike. Robert was in the office at 10:00am for evaluation of his newly diagnosed prostate cancer, PSA blood test 32 (high), Gleason’s 7, with evidence of invasion through the capsule of the prostate gland.  Fortunately, because prostate cancer likes to spread to bone, his bone scan is normal.  Despite Robert’s relatively young age (66), the surgeon recommends external beam radiation therapy (RT) instead of operating.  What is bizarre and makes my head spin, was that at1:00pm, in the same exam room, in the same chair, I saw Mike.  He has recurrence of prostate cancer, previously treated with surgery.  Now Mike needs RT.  Although Robert and Mike do not know that the other has cancer, they have worked together in the same small company for 28 years, and consider each other friends.
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Data Points: Why Delay of the Employer Mandate May Not Actually Mean That Much

Last month, the Obama Administration announced that it would delay enforcement of the employer mandate component of the Affordable Care Act (ACA) in part due to opposition from the business community.  Opponents of the ACA cited the delay as evidence that the law was collapsing under its own weight, while ACA proponents downplayed the importance of the employer mandate in realizing the primary objective of the law – extending affordable coverage to millions of uninsured Americans.

Will delaying the employer mandate lead to the ACA’s demise?

Using economic modeling, we have found that the primary goals of the ACA will not be impacted by the delay, but the delay may impact one of the law’s key revenue sources designed to offset the costs of the coverage provisions.

Under the ACA, only firms with 50 or more full-time employees can be assessed penalties for not offering coverage under the employer mandate; small businesses with fewer than 50 employees are exempt.  Furthermore, more than 95% of large firms already offer insurance, implying that only a small pool of firms would need to alter their current benefit offerings to comply with the employer mandate.  Our model estimates that less than 1% of firms, employing about 2% of the workforce, would be penalized for not offering insurance to their workers if the employer mandate is enforced.

In fact, only about 300,000 workers (approximately 0.2% of the workforce) would lose their employer’s health insurance as a result of the employer mandate delay, according to our economic analysis. And many of those losing coverage would be able to get affordable coverage through a spouse, the newly created health insurance exchanges, or Medicaid.  Hence, delaying the employer mandate will have only a nominal impact on the ability of workers and their dependents to obtain health coverage.

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What I Need

So, the question has been raised: why am I doing this?  Why re-invent the EMR wheel?  What is so different about what I am doing that makes it necessary to go through such a painful venture?  I ask myself this same question, actually.

Here’s my answer to that question:

What medical records offer:
High focus on capturing billing codes so physicians can be paid maximum for the minimum amount of work.

What I need:
No focus on billing codes, instead a focus on work-flow.

What medical records offer:
Complex documentation to satisfy the E/M coding rules put forth by CMS.This assures physicians are not at risk of fraud allegation should there be an audit.  It results in massive over-documentation and obfuscation of pertinent information.

What I need:
Documentation should only be for the sake of patient care. I need to know what went on and what the patient’s story is at any given time.

What medical records offer:
Focus on acute care and reminders centered around the patient in the office (which is the place where the majority of the care happens, since that is the only place it is reimbursed)

What I need:
Focus on chronic care, communication tools, and patient reminders for all patients, regardless of whether they are in the office or not. My goal is to keep them out of the office because they are healthy.

What medical records offer:
Patient access to information is fully at the physician’s discretion through the use of a “portal,” where patients are given access to limited to what the doctor actively sends them.

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Is Big Sugar the Next Liability Target?

Growing paranoia is the hallmark of the aging process for me.  Although I am a generally affable sort (I know, it doesn’t always seem that way from my writing), I am also a fairly suspicious person.  I am starting to think that all the food industry’s sweet talk about the innocence of sugar is really just icing on a toxic cake and that we’ve all been sold a bill of goods.  In particular, I wonder — and part of me hopes — that Big Sugar might soon replace Big Tobacco as the favorite target of our most underappreciated and misunderstood national resource…the plaintiff’s bar.  There is no question we eat way too much sugar and that the increase in consumption has coincided nicely with both our rise in obesity and decline in health status even though we are living longer.

Not that I think the Tobacco Settlement (TS) was great social policy.  You can read my full view here; but, to summarize, as an immigrant and a person of color, a part of me resents the TS because all it did is push the burden of fulfillment of the financial terms into the hearts and lungs of people in Africa, Asia, and Latin America.  The smug satisfaction of tobacco opponents in the US and their glib dismissal of the impact on predominantly poor people of color around the world is first order racism.

Any analogous move against Big Sugar (BS) could be quite interesting.  There is, of course, the delectable duality of “what did they know and when did they know it?”.  Recently published opinions and data have forced me to think harder about just what goes on in the labs of companies like Coca Cola, Pepsi, Kellogg’s, Nestle, Domino, Mars, Hershey’s, etc.  No doubt BS defenders will say that sugar is “all natural” (ahem, so is tobacco), and safe when used as intended…and, that is where things will start to go awry for them.

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The Return of the Greater Common Good

Congress is in recess, but you’d hardly know it. This has been the most do-nothing, gridlocked Congress in decades. But the recess at least offers a pause in the ongoing partisan fighting that’s sure to resume in a few weeks.

It also offers an opportunity to step back and ask ourselves what’s really at stake.

A society — any society —- is defined as a set of mutual benefits and duties embodied most visibly in public institutions: public schools, public libraries, public transportation, public hospitals, public parks, public museums, public recreation, public universities, and so on.

Public institutions are supported by all taxpayers, and are available to all. If the tax system is progressive, those who are better off (and who, presumably, have benefitted from many of these same public institutions) help pay for everyone else.

“Privatize” means “Pay for it yourself.” The practical consequence of this in an economy whose wealth and income are now more concentrated than at any time in the past 90 years is to make high-quality public goods available to fewer and fewer.

In fact, much of what’s called “public” is increasingly a private good paid for by users — ever-higher tolls on public highways and public bridges, higher tuitions at so-called public universities, higher admission fees at public parks and public museums.

Much of the rest of what’s considered “public” has become so shoddy that those who can afford to do so find private alternatives. As public schools deteriorate, the upper-middle class and wealthy send their kids to private ones. As public pools and playgrounds decay, the better-off buy memberships in private tennis and swimming clubs. As public hospitals decline, the well-off pay premium rates for private care.

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The Most Effective Obamacare Delay is Defunding

There is nothing controversial about stopping Obamacare. A majority of Americans dislike the law and want it repealed. Obamacare is disastrous for individuals, businesses, and doctors alike. It is unaffordable and unworkable, and the Obama Administration has also made it unfair by giving its pet interest groups waivers and opt-outs.

Conservatives are also united behind full repeal of Obamacare, despite what you may hear from the media and liberal operatives. The debate right now is on how this goal is best achieved.

Debate is healthy for society, and also for a movement. Conservatives should not want to become the empty echo chamber that has become the liberal political/media/academic establishment.

With that in mind, let’s turn to the debate over how to save the country from Obamacare. Our view is that the most effective way to delay Obamacare is to cut off funding. Congress can halt Obamacare’s disastrous impact by defunding it entirely before the law’s health insurance exchanges take effect on October 1.

This approach would prevent further implementation of the law; it is the only tactic that fully achieves the objective that advocates of delay seek to accomplish.

Some conservatives believe they can achieve delay without defunding by postponing the individual mandate and employer mandate for one year while leaving firmly in place the massive federal spending on Obamacare’s new health care entitlements—$48 billion next year, and nearly $1.8 trillion over 10 years. Others, acknowledging that a delay of the mandate is insufficient, are now calling for Congress to delay the mandates and the new entitlements.

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