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The Wrong Way to Stop Fake Drugs

In 2007-8, when counterfeit versions of heparin, a blood-thinning drug, were shipped from China to the United States market, 149 people died. In the last few months, bogus versions of the cancer drug Avastin, apparently shipped from the Middle East, have surfaced in clinics in California, Illinois and Texas. Thankfully, so far as we know, they haven’t killed anyone, but more and more cases of dangerous fake drugs are being reported by the Food and Drug Administration. Numerous incidents surely go unreported, the evidence swallowed, the deaths incorrectly attributed to natural causes.

Fighting the fake-drug menace is like playing whack-a-mole. It is technically illegal for individuals to order drugs online from other countries. And yet no sooner does the F.D.A. shut down one dubious online pharmacy than another pops up. According to the National Association of Boards of Pharmacy, only 3 percent of the 9,600 online pharmacies it has reviewed complied with industry standards. Many were based overseas, so their sales to Americans were illegal; others did not require doctors’ prescriptions. And some were very likely peddling dangerous counterfeit drugs.

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Save the Country with Preventive Care

We are entering the season of presidential politics, of bunting and cries of “What about the children?” and star-spangled appeals to full-throated patriotism.

So here’s mine: Do you count yourself a patriot? Do you care about the future of this country? (And while we are at it, the future of your hospital.) If so, bend your efforts to find ways to care for the least cared for, the most difficult, the chronically complex poor and uninsured.

“But we can’t afford compassion!” Wrong, brothers and sisters, we cannot afford to do without compassion. “But why should we pay to take care of people who can’t take care of themselves?” Because we are (you are) already paying for them — so let’s find the way we can pay the least.

The problem of the overwhelming cost of the “frequent fliers,” people with multiple poorly tracked chronic conditions, has always been that the cost was an SEP — “somebody else’s problem.” Now, increasingly, hospitals and health systems are finding that they are unable to avoid the crushing costs of pretending it’s not their problem, are not being paid for re-admits, and are finding themselves in one way or another at risk for the health of whole populations. They’re also facing more stringent IRS 990 demands that they demonstrate a clear, accountable public benefit.

At the same time, employers and payers are realizing that they end up paying the costs of the uninsured as well as those of the insured who are over-using the system because they are not being tracked. These costs become part of the costs of the system, and the costs are (and must be) shifted to those who do pay. There is no magic money well under the hospital.

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How Much Weight Should Anecdotes Really Have In Health Policy?


There’s something compelling about the personal narrative that vast mountains of quantitative data cannot rival. Anecdotes are, quite simply, powerful. They tap into our shared humanity, making something seem somehow more real by putting a face on it. This is why, if you follow politics for very long, you will find numerous cases of policymakers championing issues that have touched their own lives in some way. For example, Senator X doesn’t care about issue Y, until they discover that their son or daughter is affected by it. Then, almost overnight, they seem to care more about issue Y than almost anything else. Such a shift is completely understandable, but often out of proportion to the true scale of the issue in society.

In health policy, the personal narrative can also be very powerful. In fact, the journal Health Affairs routinely runs a “Narrative Matters” section that puts a face on the health care issues of the day. It is absolutely critical that health policymakers, health services researchers, and others, not lose sight of the fact that their work and the subsequent decisions it informs, are based on real people. However, it is equally critical for objectivity to be maintained, and narrative can threaten our work in this regard.

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Should the States Set Up ObamaCare Exchanges?

Under the Patient Protection and Affordable Care Act (PPACA), state governments are expected to set up health insurance exchanges through which individuals will buy their own health insurance, in many cases with substantial subsidies. Should the states comply?

In the following point-counterpoint discussion, Linda Gorman and I give opposing answers to this important question. Leave your thoughts in the comments.

John Goodman: Yes

If the states abdicate their responsibilities under PPACA, the federal government will step in and act in lieu of the state. Under this scenario, states will relinquish all power to make a bad law better. Letting the federal government implement reform almost guarantees bad outcomes.

Linda Gorman: No

Exchanges are required to perform a variety of duties beyond distributing ObamaCare subsidies, and these duties are likely to add significantly to estimated costs. Some of them will damage a state’s business climate by creating new opportunities for crony capitalism. Some require that currently fashionable, but poorly tested, models be forced on health care providers. Some require that state exchanges have expertise equal to private insurers. Others force states to increase the cost of health insurance for people who currently have coverage.

John Goodman continued:

The states should engage in preemptive reform over the next two years. This means enacting responsible, rational reforms — the kind of reforms that they should have enacted all along, in the absence of federal legislation. Where possible, states should try to make their reforms compatible with the new federal law — but only if compatibility does not sacrifice the major goals of the state’s reform.

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Crafting a Social Media Policy

Today’s Computerworld has a great article about the issues of mixing social media and healthcare.

As hospitals and clinics formulate social networking policies, there are three broad considerations.

1.  Given HIPAA and HITECH privacy and breach rules, how can you best prevent the disclosure of protected healthcare information on insecure social media sites?

2.  Given the distraction factor and productivity loss that can occur with social media, how can you best align the benefits of groupware communication while minimizing the negatives?

3.  How can you reduce the security risks of malware embedded in games and other applications that are downloaded from social networking sites?

To date, Beth Israel Deaconess has focused on #1, ensuring that our employees do not post data to social networking sites in violation of state and federal laws.

We’ve not yet completed a  policy covering #2, although several hospital sites and departments are discussing the issue.

We’re developing a pilot for #3, including blocks on selected websites, Facebook add-on applications, and personal email.

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Medicare Advantage Star Ratings: Detaching Pay from Performance

Rewarding quality health plans is an admirable goal for the Medicare Advantage program. Unfortunately, the current system of linking star ratings to bonus payments and rebate adjustments instituted by the Patient Protection and Affordable Care Act (and expanded by the CMS Quality Bonus Payment Demonstration) fails to achieve that goal, and depending on its specific implementation, may even be counterproductive.

Because criteria for evaluation are not published until after the period for which performance will be evaluated, there is no possibility that MA plans will be able to improve their performance to achieve the goals CMS intends to incentivize. Any adjustment plans will be able to make to their bids or plan offerings would have to be aimed at increasing enrollment in counties with the highest bonuses and rebates based on data from performance in previous years, possibly at the expense of improving their performance in the future.

The system rewards beneficiaries for choosing those plans favored by the selected CMS criteria, rather than the plans that best meet their needs. In effect patients whose preferences, health status, and even counties of residence, don’t match the CMS model of a highly rated plan will be at a disadvantage. Simultaneously, the system will likely reduce the scope of choice available to MA-eligible beneficiaries, and reduce competition among MA plans.

Finally, the system rewards beneficiaries for living in counties with low poverty rates (since relatively wealthier counties tend to have more plans with higher ratings), thus adversely impacting poor beneficiaries even more than non-poor beneficiaries.

These impacts are inconsistent with the overall policy purpose. The goal of incentivizing quality health plans is legitimate and admirable; that goal will not be achieved by the rating structure currently being put into place.

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USPSTF – It’s About Time

The numbers are stark. According to the United States Preventive Services Task Force, for every man whose death from prostate cancer is prevented through PSA screening, 40 become impotent or suffer incontinence problems, two have heart attacks and one a blood clot. Then there’s the psychological harm of a “false positive” test result, which is 80 percent of all “positive” tests. They lead to unnecessary worry, follow-up biopsies, physical discomfort and even harm. Final grade: D.

Three men close to me have been diagnosed with prostate cancer late in life. Each was around 70. My dad, already in throes of advancing Alzheimer’s disease, did what the doctor ordered (actually, I suspect my mom told my dad to do what the doctor ordered). He had surgery. And for the last six years of his life, which until his final three months was at home, she cleaned up after him because of his incontinence. My neighbor made the same choice. He quietly admitted to me one day that he suffers from similar symptoms, but he is grateful because he believes his life was saved by the operation. And my friend Arnie? I’ve written about him in this space before. He was diagnosed at 70, and being a psychiatrist with a strong sense of his own sexual being, understood the potential tradeoffs. He decided to forgo treatment. He died a few years ago at 90. I never learned the cause.

So what does it mean that PSA testing gets a D rating?

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Sex Sells (or at Least Leads to Some Interesting Analytics)


One guarantee in the healthcare sector is that when it comes to personal health information (PHI), there is no lack of issues and pundits to discuss security and privacy of such information/data. If one does not jump up and down bleating on about the sanctity of PHI and the need to protect it at all costs, well then you may be labeled a heretic and burned at the proverbial stake.

Now don’t get us wrong. Here at Chilmark Research we firmly believe that your PHI is arguably the most personal information you have and you do have a right to know exactly how it is used. Whether or not you own it remains to be seen for we have seen, read and heard one more than one occasion – some healthcare providers believe that it is their data, not yours, and may only begrudgingly give you access to some circumscribed portion of your PHI that they have stashed in their vast HIT fortress, or worse, scattered in a number of chart folders.

But where we do differ with many on the sanctity of PHI is that the collective use of our de-identified PHI on a community, regional, state or even national level can give us some amazing insights into what is working and what is not in this convoluted thing we call a healthcare system in the US and needs to be strongly supported. Unfortunately, we do a terrible job as a country in educating the populace on the collective value of their data to understand health trends, treatments and ultimately ascertain accurate comparative effectiveness. This leaves the door wide open for others to use the old FUD (fear uncertainty and doubt) factor to keep patients from actively sharing their de-identified PHI.

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New York Digital Health Accelerator: Last Call for Applications

Just recently, the New York eHealth Collaborative and the New York City Investment Fund held an awesome information session for the New York Digital Health Accelerator at the chic digs of the TimesCenter in NYC. The Accelerator is a program for early — and growth — stage digital health companies that are developing cutting-edge technology products in the areas of care coordination, patient engagement, analytics and message alerts. The event was open to the public and provided thorough detailing of the accelerator, insights as to the types of solutions that participating providers hope to receive and – of course – some networking. If you missed this exciting event, you can check out the recorded stream. If you are interested in the program, access the application.

Twelve companies will be invited to participate in the nine-month program. A review committee — comprised of hospital leadership, technology experts, clinicians and investors — will select the companies. The committee will evaluate applicants on their product innovation in the four focus areas, the track record of their management team and their company life-cycle stage.

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How Bad Is Azithromycin’s Cardiovascular Risk?

The paper from the New England Journal of Medicine that reports azithromycin might cause cardiovascular death is not new to electrophysiologists tasked with deciding antibiotic choices in patients with Long QT syndrome or in those who take other antiarrhythmic drugs.   Heck, even the useful Arizona CERT QTDrugs.org website could have told us that.

What was far scarier to me, though, was how the authors of this week’s paper reached their estimates of the magnitude of azithromycin’s cardiovascular risk.

Welcome to the underworld of Big Data Medicine.

Careful review of the Methods section of this paper reveals that “persons enrolled in the Tennessee Medicaid program” were the subjects, and that the data collected were “Computerized Medicaid data, which were linked to death certificates and to a state-wide hospital discharge database” and “Medicaid pharmacy files.”   Anyone with azithromycin prescribed from 1992-2006 who had “not had a diagnosis of drug abuse or resided in a nursing home in the preceding year and had not been hospitalized in the prior 30 days.”  Also, they had to be “Medicaid enrollees for at least 365 days and have regular use of medical care.”

Hey, no selection bias introduced with those criteria, right?  But the authors didn’t stop there.

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