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Month: April 2014

What I Would Do If My Foot Caught Fire

flying cadeuciiI know it seems like the obvious choice, but I would not run a randomized clinical trial.

I have recently lamented the pernicious influence, within my domain of public health practice, of hyperbolic headlines proclaiming “this,” followed unfailingly by equally and oppositely hyperbolic headlines reactively proclaiming “that.”

But we are obligated to acknowledge that there are, generally, research studies underlying the headlines, however extreme the pop culture distortions of the actual findings. So to some extent, the problem originates before ever the headlines are a gleam in an editor’s eye, with our expectant anticipation of the next clinical trial, and the next, and the next.

By all means, bring on the clinical trials! They serve us well. They advance the human condition. I run a clinical research lab — my career is devoted to just such trials.

But still, I wouldn’t conduct one if my foot caught fire.

Of course, there is a very good case for running such a study, as many vitally important questions about the right response to a foot on fire are at present unanswered. What, for instance, would be the ideal volume of water? Should it be hard water, or soft? Fluoridated, or not? A controlled trial is very tempting to address each of these.

The vessel is even more vexing. What would be the best kind of bucket? What size should it be? What color should the bucket be, what composition, and what’s the ideal kind of handle? I think the variations here are the basis for an entire research career.

Perhaps the notion of running randomized, double-blind, controlled intervention trials to determine the right response to a foot on fire seems silly to you. But if so, you must be suggesting that science does not preclude sense.

That’s rather radical thinking in some quarters.

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Rebooting Primary Care From the Bottom Up

Zubin DamaniaFor the better part of a decade, I practiced inpatient hospital medicine at a large academic center (the name isn’t important, but it rhymes with Afghanistan…ford).

I used to play a game with the med students and housestaff: let’s estimate how many of our inpatients actually didn’t need hospitalization, had they simply received effective outpatient preventative care. Over the years, our totals were almost never less than 50%.

For my fellow math-challenged Americans: that’s ONE HALF! Clearly, if there were actually were any incentives to prevent disease, they sure as heck weren’t working.

In a country whose care pyramid is upside down—more specialists than primary care docs, really?—we’re squandering our physical, emotional, and economic health while spending more per capita than anyone else. Four percent of our healthcare dollars go towards primary care, with much of the remaining 95% paying for the failure of primary care. (The missing 1%? Doritos.)

Worse still, the oppressive weight of our non-system’s dysfunction falls disproportionately on the shoulders of our primary care providers—the very instruments of our potential salvation. To them, there’s little solace (and plenty of administrative intrusion) in the top-down reform efforts of accountable care organizations and “certified” patient-centered medical homes.

But what about a bottom-up, more organic effort to reboot healthcare? A focus on restoring the primacy of human relationships to medicine, empowering patients and providers alike to become potent, positive levers on a 2.8 trillion dollar economy? What if we could spend twice as much on effective, preventative primary care and still pull off a net savings in overall costs, improvements in quality, and increased patient satisfaction?

What if George Lucas had just quit after the original Star Wars series? Wouldn’t the world have been better without Jar Jar Binks?

While the latter question is truly speculative, the former ones aren’t. We’re trying to answer them in Las Vegas (hey now, I’m being serious) at Turntable Health, where we’ve partnered with Dr. Rushika Fernandopulle and Cambridge, MA based Iora Health.

We aim to get primary care right by doing the following:

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Virginia Should Take Obamacare’s Money

flying cadeuciiIn September 2012, I said that Republican governors should be expanding their Medicaid programs under Obamacare.

I argued that Republicans have long called for state block grants and the flexibility to run their own Medicaid programs in what are the state “laboratories of democracy.”

I made the point that, given the then recent Supreme Court decision enabling states to opt out of the expansion, the Obama administration would be hard pressed to deny any reasonable proposal from Republican governors.

If Republicans really believed in state responsibility and flexibility for how they run their Medicaid programs, this was the opportunity to prove it. (See here.)

Since then, a few Republican governors have taken that tack and the Obama administration has been very cooperative and flexible.

This is a good place to recognize outgoing HHS Secretary Sebelius for her leadership by being willing to work with state Republicans in order to get millions of people covered who wouldn’t be getting coverage otherwise.

Good faith Republican Medicaid proposals have led to good faith responses from Sebelius’ Department of Health and Human Services (HHS) and a few done deals and other deals still in the works.

Many Republicans have said that Medicaid is not sustainable and that the feds could well cut the new Obamacare funding in future years. Sebelius responded by giving these governors an out if funding were to be cut.

Of course Medicaid is unsustainable, that’s why the states should be given the autonomy to run their own plans and deal with these challenges in any number of different ways the country can learn from.

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What a Physician-Led ACO Can Teach Us about Getting It Right

Farzad MostashariSeveral of the provisions included within the Affordable Care Act in 2011 designate Accountable Care Organizations (ACOs) as formal, contractual entities.

However, in the real world ACOs come in a variety of shapes and sizes.

When compared to larger, hospital-sponsored ACOs, rural and small physician-led ACOs face a tough challenge, because despite limited resources they need to come up with substantial upfront capital and infrastructure investment to establish a strong ACO foundation.

To help ease this burden, 35 ACOs were selected to participate in the Advanced Payment Model ACO demonstration through a grant program from the Center for Medicare and Medicaid Innovation (CMMI). The grants provided a portion of upfront capital to determine whether or not this financial assistance would help ease the startup burden for smaller ACOs, and increase their success rate.

One of those 35 organizations includes the central Florida-based Physicians Collaborative Trust ACO, LLC (PCT-ACO). They are participants in the January 2013 Medicare Shared Savings Program (MSSP) ACO cohort, along with 106 other ACOs.

Larry Jones, PCT-ACO’s CEO, describes his personal mission as an effort to “preserve and protect the independent practice of medicine.” For over 25 years he has been advocating for physicians through their efforts to organize, negotiate with health plans, and other challenges.

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An Example of Bad Design: This App’s Interface for Entering Blood Pressure

Screen Shot 2014-04-14 at 7.24.01 PM

Here’s a design approach that I really, really dislike: the scrolling wheel that is often used for number entry in iOS apps:

I find that the scrolling wheel makes it very tiresome to enter numbers, and much prefer apps that offer a number pad, or another way to touch the number you need. (Or at least decrease the number at hand in sensible increments.)

You may think I’m being too picky, but I really think our ability to leverage technology will hinge in part on these apps and devices being very usable.

And that usability has to be considered for everyone involved: patients, caregivers, and clinicians.

Why am I looking at an app to enter blood pressure?

Let me start by saying that ideally nobody should be entering vitals data manually. (Not me, not the patient, not the caregivers, not the assisted-living facility staff.)

Instead, we should all be surrounded by BP machines that easily send their data to some computerized system, and said system should then be able to display and share the data without too much hassle.

But, we don’t yet live in this world, to my frequent mild sorrow. This means that it’s still a major hassle to have regular people track what is probably the number one most useful data for us in internal medicine and geriatrics: blood pressure (BP) & pulse.

Why is BP and pulse data so useful, so often?

To begin with, we need this data when people are feeling unwell, as it helps us assess how serious things might be.

And of course, even when people aren’t acutely ill, we often need this data. That’s because most of our patients are either:

  • Taking medication that affects BP and pulse (like cardiovascular meds, but many others affect as well)
  • Living with a chronic condition that can affect BP and pulse (such as a-fib)
  • All the above

As we know, the occasional office-based measurement is a lousy way to ascertain usual BP (which is relevant for chronic meds), and may not capture episodic disturbances.

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Health IT: The Coming Regulation

flying cadeuciiThe Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?

The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.

Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.

I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:

  • The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
  • A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
  • A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.

Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.

A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.

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It’s Raining Cataracts, Hallelujah

flying cadeuciiCMS released new data, shrouded thus far in needless secrecy: how much it pays individual physicians.

Unlike the Shroud of Turin, no one will question its authenticity. But authenticity doesn’t guarantee the data won’t intrigue, confuse, anger, perplex, confound and burn a few innocents at the stakes. That is before we conclude that more research is needed, or more colloquially stated, we still don’t have a clue.

Medicare bounty hunters, the modern day witch finders, are licking their lips for their share of the looted spoils. Academic researchers will be dissecting both wings of the bell-shaped curve of variation in payment to set the next battle between good and evil. But all eyes (pun intended) are upon Florida; specifically one particular provider.

The provider, an ophthalmologist, (you can look up the name) billed CMS for $21 million.

CMS paid ophthalmologists $ 5.6 billion. That’s more than the GDP of Burundi. CMS paid over a billion dollars for treatment of macular degeneration with Lucentis (Genentech).

Take a deep breath now. The treatment of one organ in over 65 year old American citizens is equal to the GDP of one African nation. Gini would have turned beetroot with embarrassment.

Diabolical? Scandalous? Shocking? Surprising?

None of the above, actually. If you think about it.

As we age, and age we do thanks to our lives being constantly “saved” by prevention, regulation and cures, arteries harden, brain atrophies and bones thin. And eyesight falters. Lens fog. Macula degenerates, reducing central vision making it difficult to read.

As we age, we consume more medical services. Yes, take that as an economic truism. And no, I’m not applying for membership of the Death Panel.

Here’s the thing. It’s nice to be able to see when you’re 75. It’s also nice to see when 85, and damn essential when 90.

Otherwise you might trip over the walking stick, fracture the neck of the femur, develop a clot in the deep veins, then a clot in the pulmonary arteries, then a raging pneumonia in ICU, followed by septic shock and a cardiac arrest. Then perhaps you may rest in peace. But not before a few interns have fractured half a dozen ribs during a well-intentioned but hopelessly misguided cardiopulmonary resuscitation that family members lobbied for to assuage their guilt for never visiting you in your nursing home.

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SuperDocs and Quality Talks: Notes from the Annual Meeting of the Society of Hospital Medicine

Bob Wachter

I’m just back from the annual meeting of the Society of Hospital Medicine and, as usual, I was blown away. I’ve not seen a medical society meeting that is remotely like it.
As Win Whitcomb, who co-founded SHM, wrote to me, the meeting is “a mix of love, deep sense of purpose, community, mission, changing-the world, and just plain sizzle,” and I completely agree. I was also amazed by the size: having hosted the first hospitalist meeting in 1997, with about 100 people, seeing an audience of 3,600 fill a Las Vegas mega-ballroom was just plain awesome.

This enthusiasm did not equal smugness. Folks know that change is the order of the day, and with it will come upheaval and some unpleasantness. But the general attitude I sensed at the meeting was that change is likelier to be good for patients – and for the specialty – than bad. Whether this will ultimately be true is up in the air, but the mindset is awfully energizing to be around.

Here, in no particular order, is my take on a few of the issues that generated hallway buzz during the SHM meeting.

The Closing of Hospitals

While much is uncertain in the era of health reform, the number of hospitals is clearly going to shrink, perhaps by a lot. A healthcare system that tolerated the inefficiency of having two mediocre 125-bed hospitals in adjacent towns will no longer do so: one 200-bed hospital will be left standing when the dust settles.

If that.

The betting is that 10-20% of hospital bed capacity will be taken out of the system in the next few years. It could be even more, depending on the answers to several questions. Will electronic monitoring and telemedicine allow increasing numbers of sick patients to be cared for at home or in sub-acute settings?

Will payments for non-hospital care (home care, SNFs) be enough to expand their capacity to care for acutely ill patients?

Will ACOs, bundling, and other similar interventions truly flourish? Will a shift to population health and a new focus on wellness make a dent in the prevalence of chronic disease?

These are just some of the known unknowns.

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Ok, I Have Insurance Now. But I Can’t Use It.

flying cadeucii

THCB reader Jillian writes in with this troubling report from the marketplace:

“I got my new member ID card, but I can’t use my insurance because “there is a delay in the system” and Blue Cross needs to get an official letter from the Marketplace.

I don’t know what the real problem is, I get a different answer every time. But I can’t get authorized to see my doctor. What do I?”

Open Notes: Is Sharing Mental Health Notes with Patients a Good Idea?

flying cadeuciiWould allowing patients to read their mental health notes provide more benefits than risks?

In a recent article in JAMA  my colleagues and I argue that it would.  While transparent  medical records are gaining favor in primary care settings throughout the country through the OpenNotes initiative, there has been reluctance to allow patients to see what their treaters say about their mental health issues. While this reluctance is understandable and deserves careful consideration, we suggest that several benefits could result from patients reading their mental health notes.

First of all, accuracy would be enhanced  by allowing patients to cross-check what their clinicians say about their symptoms, medication doses, and so forth. Second, allowing patients to review assessments and treatment decisions privately might help to promote a richer dialogue between patient and clinician. Third, patients might learn that their clinician sees them more as a complete person, rather than as a collection of symptoms.

Many patients silently fear that their treater  “will think I’m crazy/whining/lazy/boring”; seeing in print that the treater does not see them  that way—and in fact recognizes and documents their strengths—can be an enormous relief and might therefore enhance the therapeutic alliance.

Clinicians have their own worries about transparent mental health notes that must be considered. Will patients feel objectified by the medical language commonly used in documentation? Will they break off treatment if they don’t like what they read? Will too much time be spent wrangling over details of what has been documented? Will vulnerable patients be psychologically harmed by reading their notes? Although our article briefly addresses these issues, only a trial of transparent mental health notes will provide the data needed to assess them.

Such a trial has just begun at the Beth Israel Deaconess Medical Center in Boston. Culminating many months of careful planning by my colleagues in the ambulatory psychiatry clinic, the Social Work department, as well as the OpenNotes team, we began a pilot project of transparent notes in our psychiatry clinic on March 1. So far almost all clinicians have chosen to participate in the project, and have identified 10% of their caseloads to be included. It’s too early to gauge results yet, but we hope to more fully evaluate the effects of making mental health notes fully transparent to our patients.

Michael W. Kahn, MD is an assistant professor of psychiatry at Harvard Medical School and Harvard Medical Faculty Physician at Beth Israel Deaconess Medical Center (BIDMC).