Wednesday, July 13, 2011

Lack of Genuine Privacy Interest Doomed Vermont Drug Marketing Law

Deven McGraw        Monday, July 11, 2011  Ihealthbeat

On June 23, the Supreme Court issued its much anticipated decision in Sorrell v. IMS Health, striking down as unconstitutional a Vermont statute that prohibited the use of drug prescribing information for marketing purposes. In a 6-3 decision, the court found that the Vermont law violated the free speech rights of drug marketers. 

A number of privacy advocates had weighed in on the case, seeing it as a showdown between privacy and corporate claims of free speech rights. The Center for Democracy & Technology was skeptical of the privacy arguments made in defense of the law, but we too were worried about its potential impact on a range of health privacy and health IT issues.

After thorough review of the opinion, it is clear that the case should not be read as a threat to well-crafted privacy laws. As interpreted by the Supreme Court, the Vermont statute was an explicit effort to control specific speech by specific speakers -- a double no-no in First Amendment jurisprudence. And, as a privacy law, it was ineffective because it allowed pharmacies to share the covered information with anyone for any reason save one: marketing by drugmakers.

Ironically, a more comprehensive regulation of prescription data -- motivated by a genuine interest in protecting privacy and drawn to serve that interest -- would have been more likely to have been upheld.
Why Did the Supreme Court Strike Down This Law?

To begin with, it is important to recognize that patient privacy was not at issue in Sorrell v. IMS Health because the data at question did not identify patients.  Instead, the data identified prescribers, primarily doctors, and their prescribing patterns. In a process known as "detailing," drug company sales representatives use the data when they visit a doctor's office to persuade the doctor to buy a particular pharmaceutical, which the court noted was almost always a "high-profit brand-name" drug.

The Supreme Court found that the intent of the law was targeted solely at the marketing of brand-name drugs by drugmakers. The law prohibited the sale of prescriber-identifying data without the prescriber's consent, but the exceptions to that prohibition were so broad that they actually allowed sale to anyone except drugmakers. The law also prohibited the use of such data, absent prescriber consent, by pharmacies and drugmakers for marketing purposes. On the face of these provisions alone, the Supreme Court had no trouble finding that the law was a transparent attempt to stop pharmaceutical companies from engaging in effective marketing of their brand-name drugs. 

Matters got worse when the court looked at the findings adopted by the Vermont state Legislature when it passed the law. Those findings expressly said, "the goals of marketing programs are often in conflict with the goals of the state." Since the Supreme Court has long held that marketing is "speech" under the First Amendment, and since the whole point of the First Amendment is to protect speech that the government doesn't like, this statement alone probably doomed the law.

Normally, commercial speech is subject to a relatively weaker form of protection than non-commercial speech. But once the Supreme Court found the Vermont law was targeting a specific kind of speech -- drug marketing -- by a specific kind of speaker -- drug companies -- the law became subject to what the court calls "heightened scrutiny." On top of that, the court found the law appeared to allow the use of prescriber-identifying data to promote less-expensive generic drugs. 

So, in the Supreme Court's view, the law allowed covered information to be used for those marketing messages the state considered to be good, and only prohibited its use for marketing messages the state thought was bad. That kind of control is called "viewpoint" discrimination -- where the government is targeting only one side of an issue -- and that is the ultimate offense under the First Amendment.

With all of that, the Supreme Court said that the Vermont law might have withstood scrutiny if it in fact had been well crafted to serve a legitimate state interest. And, the court assumed that protecting doctor privacy was a legitimate state interest. The problem was that the law totally failed to protect privacy and was not an appropriate response to the other goals the state advanced in its defense.

In rejecting the privacy claim, the Supreme Court emphasized that under the Vermont law, "pharmacies may share prescriber-identifying information with anyone for any reason save one:" marketing. The court noted that the state "all but conceded" that the statute does not advance confidentiality interests. Further, arguments that the law also was intended to protect doctors from aggressive sales tactics carried no weight with a court that had previously held that the First Amendment protects speech even when it "may move people to action, bring them to tears or inflict great pain."

The state also argued that the law advanced legitimate public policy goals by lowering the cost of health care. That is a legitimate goal, the court agreed, but the government cannot pursue it by curtailing speech. Quoting from an earlier decision, the Supreme Court said, "the fear that people would make bad decisions if given truthful information cannot justify content-based burdens on free speech." The court said that if the government wants to control health care costs, it has to do so directly, not by curtailing speech or cutting off access to information that is used in speech the state thinks exacerbates the cost problem.

In sum, because the statute discriminated both on the basis of content and viewpoint, and because it was not actually drawn to serve its stated goal of protecting doctor privacy, it could not survive scrutiny under the First Amendment.

What Are the Potential Implications of This Decision?

The Supreme Court's decision might mean that similar drug marketing laws adopted for similar reasons by Maine and New Hampshire also are unconstitutional. In addition, the case is highly relevant to other laws that try to specifically regulate advertising. Beyond that, however, the case probably sets no new standards for review of health privacy or privacy regulation in general.

Some organizations had urged the court to find that the data at issue could identify patients. This implicated the question of whether the HIPAA de-identification standard provides sufficient protection for patient privacy. The Supreme Court did not take the bait on that issue. It never questioned the premise that the data were adequately de-identified as to patients. Consequently, the important public policy considerations surrounding de-identification should be resolved by legislatures and regulatory bodies, which are better suited to handle them.

Most importantly, the case does not deal a death blow to privacy regulation. To the contrary, the Supreme Court noted that the state could have advanced its asserted privacy interest "by allowing the information's sale or disclosure in only a few narrow and well-justified circumstances." Such a statute, said the court, "would present quite a different case than the one presented here." To illustrate its point, the Supreme Court specifically cited the HIPAA regulations, suggesting they were an example of a more comprehensive privacy regime that would be upheld.

Moreover, the opinion includes strong rhetoric showing the Supreme Court is sensitive to the privacy threats posed by modern IT. In particular, the court noted that "[t]he capacity of technology to find and publish personal information, including records required by the government, presents serious and unresolved issues with respect to personal privacy and the dignity it seeks to secure." 

Like many Supreme Court opinions, Sorrell v. IMS Health includes various broad statements that could be misconstrued if taken out of context. For example, at one point, the opinion says that there is a First Amendment right to collect and disclose facts. But that does not mean that any burden on the collection and dissemination of facts is impermissible under the First Amendment.

To the contrary, as the Court made clear, privacy is a legitimate state interest that can in some contexts be protected consistently with the First Amendment, if the burden on speech is carefully drawn to serve that interest. What the First Amendment will not tolerate is regulatory subterfuge. As the court said, "Privacy is a concept too integral to the person and a right too essential to freedom to allow its manipulation to support just those ideas the government prefers."

·       Supreme Court Decision in Sorrell v. IMS Health
·       "Supreme Court Case on Rx Data Mining Requires Nuanced Understanding of Privacy" (McGraw, iHealthBeat, 4/19).
·       "Sorrell v. IMS Health Has Far-Reaching Privacy Implications" (McGraw, CDT blog, 5/6).
·       "Encouraging the Use of, and Rethinking Protections for, De-Identified (and "Anonymized") Health Data" (McGraw, CDT, 6/25/2009).

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