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Who Owns Patient Data?

Walgreens is being sued by customers who are not happy that their prescription information – even though it has been de-identified – is being sold by Walgreens to data-mining companies.

The data privacy and security concerns surrounding the transfer of de-identified data are significant.  To “de-identify” what is otherwise protected health information under HIPAA, some outfits will simply strip data of 18 types of identifiers listed in federal regulations.  However, the relevant regulation (45 CFR 164.514(b)(2)(ii)) also provides that this only works if “the covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” Thus, the problem with this approach is that, these days, nobody can disclaim knowledge of the fact that information de-identified by removing this cookbook list of 18 identifiers may be re-identified by cross-matching data with other publicly-available data sources. There are a number of reported instances of this sort of thing happening. The bottom line is that our collective technical prowess has outstripped the regulatory safe harbor.

Is this the basis of the lawsuit brought against Walgreens?  An objection to trafficking in health information that should remain private?  No.  The plaintiff group of customers is suing to share in the profits realized by Walgreens from trading in the de-identified data.Continue reading…

What’s The Worst Case Scenario In Japan Nuke Crisis?

This from John Beddington, the United Kingdom’s chief science advisor at its Tokyo embassy:

Let me now talk about what would be a reasonable worst case scenario.  If the Japanese fail to keep the reactors cool and fail to keep the pressure in the containment vessels at an appropriate level, you can get this, you know, the dramatic word “meltdown”.  But what does that actually mean?  What a meltdown involves is the basic reactor core melts, and as it melts, nuclear material will fall through to the floor of the container. There it will react with concrete and other materials … that is likely… remember this is the reasonable worst case, we don’t think anything worse is going to happen.  In this reasonable worst case you get an explosion.  You get some radioactive material going up to about 500 metres up into the air.  Now, that’s really serious, but it’s serious again for the local area.  It’s not serious for elsewhere even if you get a combination of that explosion it would only have nuclear material going in to the air up to about 500 metres.  If you then couple that with the worst possible weather situation i.e. prevailing weather taking radioactive material in the direction of  Greater Tokyo and you had maybe rainfall which would bring the radioactive material down do we have a problem?  The answer is unequivocally no.   Absolutely no issue.  The problems are within 30 km of the reactor.  And to give you a flavour for that, when Chernobyl had a massive fire at the graphite core, material was going up not just 500 metres but to 30,000 feet.  It was lasting not for the odd hour or so but lasted months, and that was putting nuclear radioactive material up into the upper atmosphere for a very long period of time.  But even in the case of Chernobyl, the exclusion zone that they had was about 30 kilometres.   And in that exclusion zone, outside that, there is no evidence whatsoever to indicate people had problems from the radiation.  The problems with Chernobyl were people were continuing to drink the water, continuing to eat vegetables and so on and that was where the problems came from.  That’s not going to be the case here.  So what I would really re-emphasise is that this is very problematic for the area and the immediate vicinity and one has to have concerns for the people working there. Beyond that 20 or 30 kilometres, it’s really not an issue for health.

Merrill Goozner has been writing about economics and health care for many years. The former chief economics correspondent for the Chicago Tribune, Merrill has written for a long list of publications including the New York Times, The American Prospect and The Washington Post. His most recent book, “The $800 Million Dollar Pill – The Truth Behind the Cost of New Drugs ” (University of California Press, 2004) has won acclaim from critics for its treatment of the issues facing the health care system and the pharmaceutical industry in particular. You can read more pieces by Merrill at GoozNews, where this post first appeared.

Death Panels Everyone Can Live With

Chief among Sarah Palin’s assaults on truth and reason is her contention that providing reimbursement for end-of-life planning sessions with a health care provider is tantamount to a “death panel” where a “bureaucrat can decide based on a subjective judgment of [a person’s] ‘level of productivity in society,’ whether they are worthy of health care.”

A Health Affairs article (Palliative Care Consultation Teams Cut Hospital Costs for Medicaid Beneficiaries) makes a far more level-headed and evidence-based contribution to the discussion. The authors studies the use of palliative care teams at four urban hospitals in New York State. To be clear on what these teams do:

Palliative care aims to relieve suffering and improve quality of life for patients with advanced illness and for their families. It does so through assessing and treating pain and other symptoms; communicating about care goals and providing support for complex medical decision making; providing practical, spiritual, and psychosocial support; coordinating care; and offering bereavement services.

Palliative care is provided in conjunction with all other appropriate medical treatments, including curative and life-prolonging therapies. It is optimally delivered through an interdisciplinary team consisting of appropriately trained physicians, nurses, and social workers, with support and contributions from other professionals as indicated.Continue reading…

Direct project heading in right direction

The Direct Project is the lightweight version of moving health data around between providers. While there’s been lots of fuss about NHIN, HIEs and data interoperability, the Direct project has sensibly been dumbed down enough so that it reminds everyone of email. Sure, it’s encrypted, standardized, blah blah, but it looks enough like email that it may just work. Today ONC announced that more or less every vendor has signed on, so that emailing medical records should soon be very common.

Insurance Companies Dancing Without Touching

A story in the Washington Post talks about health insurance companies seeking new lines of unregulated business as the profitability of health insurance falls and as more and more requirements are placed on that line of business as a result of the federal health reform law. Here’s an excerpt: “Insurers have moved into technology, health-care delivery, physician management, workplace wellness, financial services and overseas ventures in wide-ranging efforts to mitigate the new rules imposed by the law.”

I raised some of these issues several months ago, where I also suggested that a merger of the Number 2 and Number 3 Massachusetts health plans might be forthcoming. Well, they tried, but decided not to, as they announced a few weeks ago.

Meanwhile, Blue Cross Blue Shield of Massachusetts is clearly laying the groundwork to shed its non-profit status. And, really, why not? It is in no way a charitable organization of the sort envisioned in earlier years, and the constraints of being a nonprofit bind in a number of ways.

When the HPHC and Tufts merger fell through, the operative statement was: “We have now determined that we are stronger as individual competitors than one company.”

I predict that will turn out to be a strategic error. In the new world order, scale matters. This statement is, to me, revealing in its own way: “Our operations are very different and, in many important aspects, not fully compatible without significant changes to existing processes and applications.” In other words, they chose not to merge because it felt like it was not currently cost-effective to change. This suggests that the operations of the two plans as presently configured are not scalable. But if they don’t merge, they will be left behind by those with stronger market power. For now, that is BCBS of MA. In the future, as the business becomes less about taking on insurance risk and more about other services, it could well include some major national players as well. Now, rather than later, would be a better time to consolidate assets and use the cash on hand to make the investments that will be needed to grab market opportunities in the future.

Unjust Enrichment

A new lawsuit has been filed this month in an attempt to curtail the unconsented and currently legal traffic of de-identified medical records, this time against pharmacy giant Walgreens. The class action suit brought by Todd Murphy, a citizen of the State of California, on behalf of his children, is alleging that the company’s sale of prescription histories to data mining companies, servicing the marketing efforts of pharmaceutical companies, is an unfair, unlawful and deceptive business practice allowing Walgreen Co. to unjustly enrich itself while depriving the rightful owners of the data of their ability to benefit from the commercial value of their prescription records. There is no mention of privacy violations anywhere in the brief, and this is what makes this legal action very unique and potentially a landmark in the effort to control unauthorized sales of medical records.

The deceptive business practices are pretty straight forward to understand, since it seems that Walgreens makes all customers sign a privacy notice stating unequivocally that the company will not disclose patient information without first obtaining authorization from the patient. Furthermore California law prohibits pharmacists from disclosing prescription information to unauthorized third parties, which arguably makes the sale of data also unlawful. The bulk of the brief is describing the injury to plaintiffs caused by “detailing”, i.e. targeted in-person marketing by pharmaceutical reps to physicians, which is substantially aided by information extracted from plaintiffs prescription patterns. Detailing is portrayed as a ruthless drug company strategy to increase sales of newer and more expensive brand-name drugs, thus increasing the costs of health care, endangering patients and harming the doctor-patient relationship.

And here is where the complaint gets interesting.Continue reading…

The Real Cost of Early Elective Deliveries

What if I told you that across the country there’s a procedure being performed on pregnant women that makes their newborns more likely to end up sick and in a $3,000-a-day Neonatal Intensive Care Unit (NICU)?

Too outrageous to believe?

It’s true.

Early elective delivery ‚ when labor is induced 3 to 4 weeks early without medical necessity , is on the rise in the U.S. According to a report released in January 2011 by the Leapfrog Group, between 1992 and 2003 the number of these births increased from 19% to 29%. Seven hospitals across the country perform these deliveries on 100% of women without medical necessity, and over thirty others perform them 50% of the time or more.

The American College of Obstetricians and Gynecologists (ACOG) has long recognized the risks associated with inducing labor when it is not medically needed. One retrospective study found that infants born at 37 weeks are nearly 23 times more likely to suffer severe respiratory distress than those born between 39 and 41 weeks. ACOG thinks this is unacceptable.

So why do hospitals do it? Experts see a few possible explanations:

  1. Obstetricians deliver but don’t care for newborns. They move quickly from birth to birth, and lack a complete understanding of the complications associated with early deliveries.
  2. Natural deliveries are difficult to anticipate. Nature can be fickle and tends to ignore the schedules of busy physicians. Patients may simply agree because they see little harm in early deliveries.

There’s yet another incentive worth pondering. It’s prefaced by a big green $, and followed by plenty of zeros. NICUs – where many pre-term babies end up – are highly profitable for hospitals. John Lantos, a former Chief of General Pediatrics at the University of Chicago, recently wrote in Health Affairs:

The NICU – which represented nearly 4 percent of total admissions [for the hospital] ‚Äì had generated 11 percent of the net revenue. Since most of the academic medical center’s divisions either barely broke even or lost money, that meant that a staggering 69 percent of the net profits of the entire hospital system came from the 4 percent of hospital admissions to the NICU.

In other words, healthy, full-term babies are not nearly as profitable as preemies. The average cost of caring for a premature baby is $41,610 versus just $2,830 for a full term baby. A clear line can be drawn between more early term births and more days spent (and dollars generated) in the NICU. Increasing the numbers of preterm births creates a perceived need for additional NICU beds, thereby increasing the need to fill those beds. A self perpetuating cycle quickly emerges.Continue reading…

A World Without Breast Cancer?

There isn’t a country on this planet where there isn’t someone dreaming of curing cancer. What if there was something even more spectacular than curing cancer? What if you could stop cancer right in its tracks and eliminate its existence. Prevent it. Squash it before it starts.

Vincent Tuohy, PhD, an immunologist at Cleveland Clinic, may be on a path toward living this dream. This month at our hospital’s quarterly meeting, Tuohy was awarded Cleveland Clinic’s F. Mason Sones Award for 2010 Innovator of the Year for his recent breakthrough that may one day prevent breast cancer and perhaps revolutionize our approach to fighting all cancers.

Tuohy has spent the past eight years working to create a vaccine to prevent breast cancer. He and his team have found that vaccination with the protein α-lactalbumin prevents breast cancer in mice. His results were published in Nature Medicine, one of the most respected science journals, last summer.

The study yielded dramatic results. A group of mice that were at high risk to develop cancer according to their genetic profile was selected. Half of the mice were given the vaccine and half were not. All the ones given the vaccine did not develop breast cancer. All the ones not given the vaccine developed breast cancer. Yes, these are mice, and human trials are yet to begin. It may be ten years before we have a finished product, but such overwhelming results are promising and exciting.Continue reading…

The Quest for the “Not For Comfort” Healthcare Organization

The current reorganization of health care could make it better and cheaper for everyone, harnessing real creative and competitive energies to build the “next health care”—or it could lead to local monopolies, higher prices and less real competition where it matters. The many and various moves toward accountability, competition and transparency could defeat themselves.

The theme of the reorganization is clear: new types of cooperation between physicians, hospitals and other providers that cut down on duplication and unnecessary procedures and tests; that make the system accountable both for processes and outcomes; and that share economic risk among the providers. This new and strange cooperation comes in many types, typically labeled “accountable care organizations” (ACOs), “bundling,” “patient-centered medical homes” (PCMHs) and “co-management.”

All these concepts require new structures: complex organizational, contractual, reporting, liability and payment structures that in one way or another stretch across specialties and providers throughout whole regions. What could these new structures (particularly ACOs) look like if they were to turn evil? They could look like monopolies, like regional health care cartels, capable of forcing other providers into disadvantaged relationships and jacking up prices to health plans and employers.Continue reading…

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