Is The Vermont Data Mining Law Unconstitutional?
6 CommentsBy Ed Silverman // April 25th, 2011 // 9:27 am
The US Supreme Court tomorrow will review a highly controversial issue - the constitutionality of a Vermont law that restricts the sale of prescription drug info identifying prescribers and patients for commercial marketing purposes. The practice is known in the pharma world as data mining and has been building for some two decades ever since data was gathered by market research firms, but has since sparked heated arguments over free speech, health care costs and information privacy.
The information at issue includes the name of a prescribing physician, patient age and sex, the type and strength of each drug prescribed, and the date and location of prescription. Pharmacies, of course, are required by law to collect and maintain data about each prescription that is filled, and are allowed can to sell the information, which the research firms gather and repackage. Patient names are encrypted, but drugmakers are able to track types of patients and prescribing patterns.
Consumer advocates maintain the law can protect doctor-patient relationships and consumer privacy, promote patient safety and also contain the rising expense of medications (here is the Vermont brief). Vermont, in fact, passed its law three years ago and then amended it in hopes of staving off court challenges. Nonetheless, a federal appeals court ruled against the state law last November (back story). Only two other states enacted such legislation - New Hampshire and Maine - and both survived efforts to have them overturned.
But the Vermont law was challenged by healthcare research firms, IMS Health and Wolters Kluwer health, as well as the PhRMA trade group, which argue the legislation would hurt public access to healthcare info and violate commercial speech (read filings here). Numerous other groups have lined up to support the challenge by filing briefs, including the US Chamber of Commerce (read here); the National Association of Chain Drug Stores (see this); the BIO trade group (look here); and media companies, such as the Associated Press and Bloomberg News (look here).
On the other side of the table, briefs have been filed in support of the Vermont law by the federal government (read this); nearly three dozen states (read this); The New England Journal of Medicine and its publisher (read this); the AARP (look here); the AFSCME union (see here), and the Electronic Frontier Foundation (read this).
“It’s very powerful data and it’s easy to understand why drug companies want it,” Norman Ward, a family physician in Burlington, Vermont, tells The New York Times. “If they know the prescribing patterns of physicians, it could be very powerful information in trying to sway their behavior - like, why are you prescribing a lot of my competitor’s drug and not mine?” Adds Wells Wilkinson, a staff lawyer at the Community Catalyst nonprofit group that filed a brief supporting Vermont: ““If the court is not going to protect personal and confidential health records, how could any consumer transaction be protected?”
But we spoke with the former IMS exec who developed and launched the controversial database nearly 20 years ago and he says physicians are off the mark. “It’s really showing the increasing desperation of physicians to avoid having their behaviors monitored. The law was initiated by the Vermont Medical Society, but has two flawed premises,” says Bob Merold, who is now a consultant with Knowledgent, a business information insights consulting firm. “One, this (the database) is used in pharma marketing to drive up medical costs, when in fact, the law does nothing to stop drug companies from marketing or talking to doctors. The law does nothing to reduce or impact the actual marketing. It does nothing to effect the behaviors the physicians say they are trying to curtail.”
“Second, physicians says it invade their privacy, yet the law allows the collection of data for things like outcomes analysis and fraud detection. And in Obama health care reform, there are many provisions for collection of doctor behavior for best practices, so the notion that physicians have privacy is totally erroneous. This boils down to doctors would like a world where no one is looking over their shoulder at their practice of medicine, but there is plenty of data to suggest that many doctors fail to adhere to best practices,” he continues.
However, Merold also chastises the research firms for allowing this legal battle to exist. “It’s a shame the data vendors have not developed the database for purposes other than pharma marketing, such as outcomes. If they had, there would have been no question about the public value of this data and there would have been no need for the law to have been passed.”
The Supreme Court will not issue an immediate decision, of course, but what do you think?
Is The Vermont Law Unconstitutional?
- Yes (52%, 71 Votes)
- No (50%, 68 Votes)
Total Voters: 137
pic thx to newtown graffiti on flickr
GovtFraudLawyer
This is a significant case. One, the fact that the Supreme Court took the case indicates its importance. Two, the number of amicus briefs filed by very powerful groups shows that many stakeholders have a “dog in this fight”. Three, the case presents counter intuitive and competing interests (for example, one the one hand we value a free exchange of information but on the other hand we also want to protect patient privacy and prevent the collection of data that would allow some companies to exploit that data for their own financial gain, which is usually to the detriment to the fiscal integrity of government health care programs). I’ll post the oral arguments on my blog when the Supreme Court releases the recordings. It will take the Supreme Court about 6 to 12 months to issue its opinion. Stay tuned . . . this is a big case.
outcomes guru®
and the impact on Facebook, Twitter, etc?
I am a college professor. When I buy a book on line these days, lots of people know lots about me. They know I am a Mets fan. They send me a Mets gift with my order. Should this be allowed? Did they “influence” me or “buy” future business?
a BIG case indeed
HCAddict
Thinking in a broader sense than simply marketing patient data to companies… HIPPA is the law that prevents any person involved in a patient’s care from disclosing any information about that patient, except for to the patient himself, to the doctors involved in his care, and to process the claim(s) to whomever will be paying for the care (certain oversight and quality of care boards also use this information, but generally the patient name is not used and is instead identified by MR number). Does my right to free speech say that I can broadcast that patient’s information to others not involved in the patient’s care? That is essentially what this lawsuit is about at its core. The only difference is, it is about many patients (in contact with many physicians), and it is being PAID for in a commercial exchange. Frankly, if this is practice is to be found protected by the First Amendment, HIPPA might also bite the dust. Hope you don’t mind everyone knowing that you were treated for herpes last year at the free clinic….
Former IMS'er
HCAddict, your lack of knowledge around physician prescribing data and APLD (anonymous patient level data) is astonishing. IMS uses various “firewalls” to enssure that HIPAA regulations are NEVER violated. Patient information is NEVER disseminated to pharmaceutical representatives and there are restrictions on the use of APLD data in cities below a certain size so that a patient may never be identified. The use of this data can be extremely valuable not just to pharmaceutical companies but to organizations like the DEA which uses it to help root out prescription drug abuse and as well as academic researchers. This issue has little to do with patient privacy and everything to do with the state governments misguided attempts to try to impact the cost of healthcare in a rather illogical manner.
Salient point
Not sure if the implications of this case reach far beyond the Rx market, which has distinct peculiarities. There are essentially 3 “customers”: the doctor who chooses the med; the patient who obtains it & usually makes a copay; & the insurance company that pays the rest. If the doctor Rx’s but the patient never fulfills, it’s as if no decision to obtain has ever been made (even though it has). If the MCO bounces the Rx’d drug for something cheaper, the doctor Rx’s something else, but it’s not truly reflective of his choice. Therefore, there’s a lot of “noise” in IMS data, accurate as it is, & needs to be evaluated with these eccentricities in mind.
To extrapolate this to purchasing some Mets’ memorabilia online may not be completely valid.
Healthcare Data Mining
I don’t know that I would want my personal information released to anyone let alone pharm companies who may later target me for new script marketing.