From the Director

Big, and not particularly good, news yesterday for those of us concerned about medical records privacy and over-the-top drug marketing that hurts patient health and jacks up drug costs. We update yesterday's media alert on the US Supreme Court decision overturning Vermont's prescription privacy & datamining law with commentary from law professors and others. Read more

PBM issues in the states. Most states have wrapped up their legislative sessions but Texas and Maine continue to slog on as bills to tighten up and repeal PBM regs, respectively, await final action. 

Anti-psychotic drugs issues in the states.  Texas joins Maine, Florida, and Georgia in taking a closer look at the prescribing of anti-psychotic drugs to young people, and Oregon considered legislation that would overhaul prescribing decisions throughout its health plan. We predict this issue will take off in the next year as more states tune into a safety and health issue that can involve conflicts of interest, different treatment standards for children in state and private care, and drug marketing and payments to doctors in key decisionmaking positions. 

A voice for states on trade policy. Communicating the interests of the State of Maine and of state legislators generally on trade policy will be my job as a new member of IGPAC, the Intergovernmental Policy Advisory Committee of the USTR. As a legislator, my interests and those of my state go beyond pharmaceutical policy, but you can be sure that health policy impacts of trade deals will be at the top of my list of issues to discuss, including PDLs, 340B, Medicaid and marketing issues. Read more.

Check out summer legislative conferences of interest including NCOIL, which will focus on trade issues, including impacts on pharmaceutical policy, on July 14 during its Annual Meeting in Newport, and NCSL which has meetings on trade August 8 and on health policy throughout its Legislative Summit in San Antonio.

Other articles of interest from around the pharmaceutical world are posted regularly on our Facebook page, which you should check for more up-to-the-minute news and resources.   Sincerely, Sharon Treat    

 Will Supreme Court Decision in Sorrell v. IMS Tie States' Hands in Medical Records Privacy Efforts? 

Yesterday, the United States Supreme Court struck down a Vermont law that limited the sale of physician-identifiable prescription data for marketing purposes. In a 6-3 decision in Sorrell v. IMS Health, the Court held that the law was a violation of the First Amendment's free speech protections. The decision is a huge disappointment to legislators who have sought to protect the confidentiality of private prescription records, not limited to the states of Vermont, New Hampshire and Maine, that have already adopted such laws, or Massachusetts which has considered adopting protections. 

The information Vermont tried to protect comes from private medical records. It is being used to profile doctors to help drug companies in their marketing efforts. These records are not used in speech nor is the data in these records 'speech' as we have come to understand the term. The expansive decision by the U.S. Supreme Court, which extends new protections to commercial speech, should be a concern to anyone interested in keeping private information private. 

Sean Fiil-Flynn, Associate Director of the Program on Information Justice and Intellectual Property at the Washington College of Law, served as counsel for amici NLARx and AARP in the case. Prof. Fiil-Flynn stated: "For the first time in the Court's history it has extended heightened First Amendment protection to the commercial trading of information that is neither from the public sphere nor destined for it. Vermont regulated only the commercial trade in prescription records that were purely for the purpose of targeting marketing to doctors to alter prescriptions toward more profitable outcomes." Read Prof. Fiil-Flynn's full statement.  

What does this mean for the future of data privacy?  This decision raises concerns that extend well beyond medical records.  EPIC, the Electronic Privacy Information Center, filed a brief in the case focusing on the vulnerability of patient data to exposure despite the measures taken to de-identity records. The case is getting attention from internet privacy bloggers as well.

All may not be lost, at least with respect to medical records. Boston University law professor Kevin Outterson, who represented medical association amici in Sorrell, says in his blog "the Vermont statute suffered from self-inflicted wounds, namely some incautious comments in the preamble"  and that "Vermont can fix the statute quite easily with the guidance given by the Court." He suggests one option would be to make the statute a narrow extension of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), giving the privacy right exclusively to the patient and a confidentiality right directly to the physician. Alternatively, he suggests, "Vermont can ban data mining by contract with participating pharmacies through Green Mountain Care," its newly-enacted single payer health program. Finally, Outterson suggests, Vermont could also clarify that pharmacies collect this information only as a state-mandated record. 

Prof. Flynn agrees the Supremes may have left room for states and the federal government to address this issue though more targeted medical records laws, saying "The bright spot in the Court's opinion is its recognition that there is, in fact, an interest of governments in protecting the confidentiality of prescription records," and its reference to HIPAA, "which bans many commercial and other uses of medical records, but does not extend its protection to prescriber-identified prescriptions." His advice is to pass laws that "extend the protections of HIPAA to prescriber identified prescription (and other medical) records." 

Interestingly, states already are going down this path as they look to implement electronic medical records.  New Hampshire law says medical records are deemed the property of patient (§332-I:1) and Maine just enacted Public Law 2011, chapter 347, which gives patients the right to opt out of its electronic health records system. Both of these laws would need amendment to eliminate the loopholes that infect HIPPA, but they show states are already thinking about patient-centered control of medical records.

For more information on Sorrell v. IMS, including Supreme Court Briefs and the full text of the decision, please go to: http://www.wcl.american.edu/pijip/go/rx-data. 

The Latest News From the States

PBM battles in Maine and Texas.  Republican majorities in both the Maine House and Senate have voted for LD 1116 which would repeal the 2003 PBM transparency and fraud-prevention law, although a 10-day temporary adjournment of the Legislature has delayed final action and the Governor's signature. This report has good coverage of the floor debate and the views of proponents and opponents of repeal. 

Anti-psychotic drugs and prescribing to children.  Maine and Texas also share an interest in this issue. According to The Texas Tribune, children on Medicaid under the age of three would not be prescribed powerful anti-psychotic drugs without a special authorization, under new rules the state Health and Human Services Commission (HHSC) implemented last week. In response to widespread concerns about the number of impoverished Texas kids being prescribed drugs like Seroquel and Risperdal - medications that can have serious side effects in children - prescribing doctors would have to get a prior authorization from the state.