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Reforming the NPDB: An Open Letter

 

Kathleen Sebelius, Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Mary K. Wakefield, Administrator
Health Resources and Services Administration
5600 Fishers Lane
Rockville, MD 20857

Re: Public Use File of the National Practitioner Data Bank

Dear Secretary Sebelius and Administrator Wakefield:

The undersigned are academic researchers who work in the areas of public health, health care quality/patient safety, medical liability, and related fields. (Signatories are listed alphabetically by last name. Academic affiliations are provided for purposes of identification only.)

We write to condemn, in the strongest possible terms, HRSA’s recent decision to make the Public Use File (PUF) of the National Practitioner Data Bank (NPDB) unavailable. We also request that HRSA restore the PUF’s availability immediately.

The NPDB is the only nationwide database of closed medical malpractice claims that is publicly available to researchers. Academics use it extensively. A search on “National Practitioner Data Bank” in Google Scholar’s “articles and patents” database returned a multitude of hits. The same search run in WESTLAW’s “journals and law reviews” database returned 576 articles. In PubMed, the search generated 399 articles. Not all of these articles contain new empirical findings, but many do, and the sheer number of publications attests to the NPDB’s importance.  The NPDB is an indispensable resource for academic researchers.

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Why Drug Company-Doctor Interactions Are Good For Patients

Transparency is a powerful tool. Framed properly to illustrate the collaboration between America’s biopharmaceutical companies and physicians, it can empower patients to become more engaged in the care they receive. Transparency can also lead to misinterpretations, discouraging even the most ethical, unbiased doctors from future collaborations that could improve patient health.

ProPublica, whose reporters, Tracy Weber and Charles Ornstein, penned The Times’ Sept.  8 Op-Ed article, “What the doctor ordered,” recently updated its “Dollars for Docs” database of doctors who have received money from biopharmaceutical companies. By listing only names and compensation figures with limited context, patients may assume their care is compromised by tainted doctors. Such an incomplete picture creates unnecessary confusion and, in most cases, is completely unfounded.

We agree with ProPublica that patients should know that many physicians work with biopharmaceutical companies. To be completely transparent, however, they should also know why it benefits them and how the relationship is closely managed to ensure it remains ethical.Continue reading…

The Rise of Big Data

Health care is in the process of getting itself computerized. Fashionably late to the party, health care is making a big entrance into the information age, because health care is well positioned to become a big player in the ongoing Big Data game. In case you haven’t noticed computerized health care, which used to be the realm of obscure and mostly small companies, is now attracting interest from household names such as IBM, Google, AT&T, Verizon and Microsoft, just to name a few. The amount and quality of Big Data that health care can bring to the table is tremendous and it complements the business activities of many large technology players. We all know about paper charts currently being transformed via electronic medical records to computerized data, but what exactly is Big Data? Is it lots and lots of data? Yes, but that’s not all it is.Continue reading…

Steve Jobs, Health Care Apps & Me

When I heard the news about Steve Jobs on Wednesday, I was surprised at how profoundly sad I felt. Although I had never met him, my company had the thrill of sharing the stage with Steve when Apple announced they would open their platform to third party developers. At the time, I was head of marketing and subscriptions for Epocrates, then best know for our Palm Pilot application for physicians.

At the time, we thought we had done a pretty good job of disproving the old notion that physicians are slow to adopt new technologies.  Steve was about to show us our full potential.

It was a surprise for us to be up on that stage, to say the least. Our fellow presenters were industry giants: EA, AOL, SalesForce, Sega and…us. The Sesame Street song ran through my head – “one of these things is not like the other.” Naturally, we were thrilled, but we had no idea how profoundly our company and industry were about to change.

Before the iPhone, Epocrates had built a great business creating drug, disease and formulary content for mobile devices. We launched our first product in 1999 with the premise that physicians were mobile and wanted to access information anywhere, anytime. Health care professionals loved their Palm Pilots – and I still have a bag of Palm IIIs, VX, Tungsten, Handspring, and Treo devices to prove it! Business was going well and we had grown to 25% of U.S. physicians. But we faced a challenge – we had already saturated the market of physicians with a device – and growth of the mobile device market had stagnated.

To this day, I don’t really know how we ended up that stage. But I like to believe the story we were told. Apparently, Steve asked one of his personal physicians why she wouldn’t switch to an iPhone and she replied “because I can’t use Epocrates on it.” True or not, we got an invitation from Apple to be one of their very first third party developers.Continue reading…

Why Doctors Don’t Like Electronic Health Records


Why are doctors so slow in implementing electronic health records (EHRs)?

The government has been trying to get doctors to use these systems for some time, but many physicians remain skeptical. In 2004, the Bush administration issued an executive order calling for a universal “interoperable health information” infrastructure and electronic health records for all Americans within 10 years.

And yet, in 2011, only a fraction of doctors use electronic patient records.

In an effort to change that, the Obama economic stimulus plan promised $27 billion in subsidies for health IT, including payments to doctors of $44,000 to $64,000 over five years if only they would use EHRs. The health IT industry has gathered at this multibillion-dollar trough, but it hasn’t had much more luck getting physicians to change their ways.

What is wrong with doctors that they cannot be persuaded to adopt these wondrous information systems? Everybody knows, after all, that the Internet and mobile apps, powered by Microsoft, Google, and Apple and spread by Facebook, Twitter, YouTube, and the iPhone and iPod, will improve care and cut costs by connecting everybody in real time and empowering health-care consumers.

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How Patients Think

Recently, I had a conversation with Shannon Brownlee (the widely respected science journalist and acting director of the Health Policy Program at the New America Foundation) about whether men should continue to have access to the PSA test for prostate cancer screening, despite the overwhelming evidence that it extends few, if any, lives and harms many more men than it benefits. She felt that if patients could be provided with truly unbiased information and appropriate decision aids, they should still be able to choose to have the test (and have it covered by medical insurance). Believing that one of the most important roles of doctors is to prevent patients from making bad decisions, I disagreed.

After reading Your Medical Mind, the new book by Harvard oncologist and New Yorker columnist Jerome Groopman, I think he would probably side with Brownlee’s point of view. Groopman, whose authoring credits include the 2007 bestseller How Doctors Think, and wife Pamela Hartzband, MD have written a kind of sequel to that book that could have easily been titled How Patients Think. Drawing on interviews with dozens of patients about a wide variety of medical decisions – from starting a cholesterol-lowering drug, to having knee surgery, to accepting or refusing heroic end-of-life interventions – the authors explore many of the factors that influence people’s health-related choices. The result is a compelling narrative that seamlessly blends “rational” factors such as interpreting medical statistics and decision analysis with personal factors such as past experience, emotional states, and personality styles.

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FDA Should Consider Cost in Some Decisions

FDA decides whether drugs, biologics and medical devices are safe and effective and can be marketed legally in the United States. The agency analyzes risk-benefit, but never cost. In contrast, public and private insurers, along with physicians and pharmacists, have the responsibility for cost-benefit decision making.

I have always felt quite strongly that this was the right way to allocate roles. Safety and efficacy determinations are difficult enough without weighing cost, so keeping a barrier between them makes sense. Two events this past week have left me wondering whether there are certain limited circumstances when FDA should be able to take product cost into consideration.

On September 26, 2011, The Oncology Commission of the British medical journal, Lancet, released a report entitled: “Delivering Affordable Cancer Care in High-Income Countries.” The 40-page report is wide-ranging, but its conclusion straightforward: as cancer care grows more expensive (and it is doing so at a rapid pace), affordability, accessibility and value are issues that need to be confronted aggressively.

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Why Do You Care Whether I’m Insured?

If you care a great deal, I’ll give you an account number you can use to make a deposit.

[Note to Self: Send this Alert to the folks at Commonwealth. Also to Nancy Pelosi and Harry Reid. CC Uwe Reinhardt as well. You never know what they might do. They certainly talk about this topic a lot.]

While you’re thinking about the initial question, here are a few follow-up questions:

Do you care whether I have life insurance?

What about disability insurance?

Homeowner’s insurance?

Auto casualty?

Auto liability?

What about retirement insurance? (A pension or savings plan.)

Do you care whether I keep my money at an FDIC-insured institution?

Or whether I bought an extended warranty on my car?

Or whether I bought travel insurance before taking my scuba diving trip to Palau?  (It pays off if you get sick and can’t go.)

I’m sure there are busybodies who would like to run everyone else’s life. But society as a whole has taken a more rational approach. We basically don’t care whether people insure to protect their own assets (at least we don’t care enough to make them do so). But we do care about events that could create external costs for other people.

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More Information Makes You More Confident, If Not More Accurate

Confidence matters.  We are much more likely to act in situations when we are confident.  We make purchases based on confidence.  We are also persuaded by others based on their confidence.  A statement made confidently and forcefully is much more likely to sway our opinion than a statement that is hedged.

Presumably, the power of confidence lies in the belief that when people are more confident in an outcome they are more likely to be correct in their predictions.

There have been many studies over the years that demonstrate that people tend to be overconfident in their judgments about how likely they are to be correct about a prediction or an answer to a question.  But what causes this overconfidence?

A 2008 paper by Claire Tsai, Joshua Klayman, and Reid Hastie in Organizational Behavior and Human Decision Processes suggests one factor that makes people overconfident.  They find that as people get more information about a judgment they are making, it increases their confidence, even if it does not increase the accuracy of their judgment.

In one study in this paper, they found experts in college football and asked them to predict the outcomes of a number of games.  The names of the schools playing the games were not given.  Instead, people were given information about how the teams had performed to that point in the season on a variety of aspects of performance that are useful for predicting the outcome of a game (like the average number of yards that the teams had gained in their games so far that season).

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Lab Results For All!

On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación! All lab results will be made available to patients, just like all other health data.  (See the HHS presser and YouTube video from the recent consumer health summit.  Todd Park, HHS CTO, is also the chief activist for what he calls ¡data liberación!)

Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.

When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule45 CFR § 164.524(a)(1): psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including  “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).Continue reading…

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