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Data-miners unite in Maine to block 'opt-out' Rx law

The prescription drug data-mining industry opened yet another legal battlefront, this time in Maine, where no less than six firms are involved in a lawsuit to block a state law that would allow physicians, nurses and other prescribers to “opt out” of having their prescription drug information used for detailing and other pharmaceutical marketing purposes.

Monday was the first day of hearings before U.S. District Court Judge John Woodcock Jr. in Bangor on the request for an injunction filed by the data-miners in August. They are asking to have the Maine Prescription Restraint Law declared unconstitutional. Maine Attorney General Steven Rowe is named the defendant and is arguing in support of the law.

“Legislators in Maine and elsewhere are concerned about the high price of prescription drugs, the role of pharmaceutical marketing in rising drug prices and patient-privacy issues related to prescription data,” said Maine State Rep. Sharon Treat.

“State legislatures have been way ahead of the federal government in protecting patient information—way before HIPAA—and many state laws are more stringent than the federal law,” said Treat, who serves as executive director of the National Legislative Association on Prescription Drug Prices, or NLAPDP. According to Treat, the not-for-profit organization has member legislators in about 20 states, but has contacts with other representatives in virtually all state legislatures. “The issue of data-mining has really caught the attention of some legislators in our group.”

Plaintiffs in the case are drug data-miners IMS Health, Verispan, a consortium formed in 2002 to provide patient-level, longitudinal data by Quintiles Transnational Corp., and pharmaceuticals wholesaler and healthcare information technology systems developer McKesson Corp.; and Source Healthcare Analytics, a subsidiary of Wolters Kluwer Health, which is itself a division of publisher and information provider Wolters Kluwer, based in Amsterdam, Netherlands. Wolters Kluwer made a major move into the pharmaceutical data-mining business in the U.S. in 2005, when it acquired the information management business of data-miner and troubled healthcare IT systems purveyor NDCHealth Corp. The plaintiffs seek to block the Maine law before it goes into effect on Jan. 1, 2008.

Filing “friend of the court” briefs in support of the state are two physicians, family practitioner Bethany Picker and pediatrician Dan Summers, the NLAPDP, the not-for-profit AARP and Community Catalyst, a not-for-profit organization that, according to the court filing, aims to “make prescription drugs more affordable and reform the drug industry using litigation and consumer education.”

The Maine law gives the state licensing board the authority to record prescriber preferences on whether they wanted their prescription information to be transferred and used for drug marketing. Under the Maine law, prescribers must take action to have their prescription writing information not used by the data-miners for commercial purposes. A similar law in Vermont, also targeted with legal action by the data-miners, would require prescribers to “opt in,” that is, take affirmative action to allow their prescription histories to be used.

An even more stringent law passed in New Hampshire in 2006 seeks the outright ban of the collection of physician prescription data for commercial use. This past May, it was struck down by a federal trial court judge as an unconstitutional abridgement of the data-miners’ corporate free-speech rights. New Hampshire is appealing that ruling. Plaintiffs fighting the New Hampshire law were IMS Health and Verispan, but they were joined by “friend of the court” filings by Wolters Kluwer Health; the National Association of Chain Drug Stores, a trade group; SureScripts, a for-profit developer of e-prescribing infrastructure; the not-for-profit National Alliance for Health Information Technology, whose board of directors includes representatives from drugmaker Eli Lilly & Co. and pharmaceutical wholesalers Cardinal Health and McKesson; and the not-for-profit eHealth Initiative, whose Foundation for eHealth Initiative works under several federal contracts to promote health IT.

Twenty states are listed on a Wolters Kluwer Health Web page encapsulating legislative efforts to control the use of prescription drug information. Earlier this year, after pharmacy marketing legislation failed to pass in West Virginia, the state Public Employees Insurance Agency asked its pharmacy-benefit manager, St. Louis-based Express Scripts, to stop providing drug data on plan members to outsiders. The action was championed by a state legislator, Don Perdue, a pharmacist and a Democratic member of the West Virginia House of Delegates and chairman of the House Health and Human Resources Committee, after a bill Perdue co-sponsored that would have banned the sale of patient and provider prescription data failed in the Legislature.

Also Monday, the Austin, Texas-based Patient Privacy Rights Foundation launched a prescription privacy campaign in which it is asking prescription buyers to fill out a form appealing to their drug stores to voluntarily “Take my prescription data off the market” by agreeing not to sell or reuse their personally identifiable prescription information before Congress acts to legislate a ban. The form doubles as a petition to Congress.

Treat’s NLAPDP has been a supporter of the Maine law and similar state laws in New Hampshire and Vermont, she said.

Privacy, she said, is not adequately addressed under the main federal healthcare information privacy rule associated with the Health Insurance Portability and Accountability Act of 1996. "HIPAA doesn’t even begin to address the issue where the prescriber has any ability to keep that information secret,” Treat said. “There is a lot of concern anyway about HIPAA not being enforced.”

Treat said one common objection to state efforts to control the use of prescription data is that it would hamper medical research. That's not true in the New England laws, she said.

"These laws very carefully preserve access to the data for needed research, which may be very different than marketing research," Treat said.

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