Will Supreme Court 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 here.

"Marketing Juggernaut" Collides with Children's Safety

"Marketing Juggernaut" Collides with Concerns About Safety and Appropriate Treatment as Legislators in Several States Review Policies Governing Children and Psych Drugs

Monday May 23rd, 2011

Sharon Treat, Executive Director, National Legislative Association on Prescription Drug Prices

At a time when sales and marketing of these drugs is growing exponentially, there is an increasing interest in reviewing the appropriateness of standards for prescribing antipsychotic drugs to children. As the N.Y. Times reports, "Even the most reluctant prescribers encounter a marketing juggernaut that has made antipsychotics the nation's top-selling class of drugs by revenue, $14.6 billion last year, with prominent promotions aimed at treating children." According to the Times, In the last few years, doctors' concerns have led Florida and California to put in place restrictions on doctors who want to prescribe antipsychotics for young children, requiring a second opinion or prior approval, especially for those on Medicaid.

Questionable practices in Texas led to a psychiatric preferred drug program for children being suspended in 2008. The issue has gotten the attention of state Medicaid medical directors, who released a study in July 2010 recommending that more states require second opinions, outside consultation or other methods to assure proper prescriptions. The report found a rapid increase in prescribing of these medications to children or adolescents over the past several years, and that children in foster care (12.4% percent) were prescribed AP medications at much higher rates than those not in foster care (1.4 percent).

The issue has gotten the attention of investigative reporters and doctors alike. See this Frontline Report and the article in the Journal of the American Medical Association on May 19, 2010, which reported children covered by Medicaid are far more likely to be prescribed antipsychotic drugs than children covered by private insurance, and Medicaid-covered kids have a higher likelihood of being prescribed antipsychotics even if they have no psychotic symptoms. Read more.

In Florida, as Pharmalot reports, the state’s Department of Juvenile Justice has ordered a review because of concerns about improper marketing and conflicts of interest leading to over-prescribing. “The questions recently brought to our attention are serious, and deserve answers based on a careful, thorough and independent review of the facts,” DJJ Secretary Wansley Walters tells the paper, which ran a two-part series about the problem (read here and here).

This year Maine Representative Joan Welsh sponsored LD 646," An Act to Ensure the Safety of Children in the MaineCare Program who are Prescribed Antipsychotic Medications." At the public hearing, a young women who had been prescribed multiple medications during many years in foster care gave wrenching testimony about her experiences. Testifying in support, Ann Woloson of Prescription Policy Choices noted that prescribing of psychiatric medications to children in the U.S. has increased dramatically compared to other countries: "In less than a ten-year period the use of potent psychotropic medication in children and adolescents grew by five-fold in the US, nearly double the rate than children living the Netherlands, Germany and other European nations. Some children as young as just one year-old, are being prescribed these medications at increasing rates. Behaviors once considered “normal”, a baby not sleeping through the night or a toddler going the terrible twos are now being diagnosed and medicated as “sleep resistant” or “oppositional-defiant, with mood swings”.

Read the LD 646 Testimony here:

PPC LD 646 Testimony(44 KB PDF)

April 25 Psych testimony foster kid(41 KB PDF)

Representative Welsh's testimony(44 KB PDF)

As amended, the LD 646 establishes a work group to consider the current case management and coordination of care for children in the MaineCare (Medicaid) program who are prescribed antipsychotic medications and to make recommendations for improvement. A positive vote out of committee is anticipated.

Georgia is also launching review of foster kids' psych drugs, after Representative Mary Oliver introduced legislation, House Bill 23, to require the Department of Human Services to establish regulations governing the use of psychotropic medications for foster children in state custody. House Bill 23 was put on hold until next year after the Casey Family Programs stepped forward with $75,000 to develop a pilot program to figure out the best way to conduct an independent clinic exam of children taking mind-altering drugs. According to an article in the Atlanta Journal-Constitution, Georgia spends $7.87 million a year on psychotropic medications. More than a third of foster children are prescribed the drugs, compared with about 4 percent of the general youth population."You are going to save money, and you're going to provide good medical care," said bill sponsor Rep. Oliver.

Data Mining: Could Furnace Info Really be More Protected Than Health Records?

Prescription Records Data Mining Case Could Have Broad & Counterintuitive Implications

by Sharon Treat, NLARx Executive Director

Is it possible that the U.S. Supreme Court could give greater deference to privacy, and greater protection from marketing uses, for records about who has gas furnaces in their homes, than for sensitive prescription records maintained by pharmacies pursuant to government directive?

It seems that could be the counterintuitive (nonsensical?) result if the Supreme Court upholds the Second Circuit decision in Sorrell v. IMS Health invalidating the Vermont prescription records privacy law. I attended the argument Tuesday where the Justices seemed to be voicing support of a prior decision shielding furnace records maintained for public safety purposes from being used for marketing, yet questioning the constitutionality of a Vermont law giving doctors the right to opt to have their prescribing records kept confidential and not used for marketing. Read the transcript of the argument.

You would think that doctors' privacy interest in medical records would clearly have a level of sensitivity and significance at least comparable with records of who has gas furnaces in their home. The distinction that one set of records is maintained by a government entity and the other by pharmacies at the command of government is as they say, a distinction without a difference. In this era of privatization and electronic health records, are we really saying that the only way government can act to protect its citizens' privacy interest in restricting the use of sensitive and personal information for marketing purposes is to directly carry out all functions that require the maintenance of records containing personal data?

Such a construction flies in the face of other privacy statutes including HIPPA and sounds like... socialized medicine.

It is also worth noting that much was made in the Supreme Court oral argument by IMS attorney Tom Goldstein that industry drug salespersons or detailers are conveying "100 percent" "truthful" information. Statements were also made that all communications are approved by the FDA. This is just not the case. It is ironic that these assertions seemed to be taken at face value when the record in the case showed otherwise, and on a day when newspapers reported on a trial involving misleading and illegal off-label marketing and FDA allegations of attorney coverups. Read about the case involving GlaxiSmithKline.

NLARx has sided with Vermont in the data mining case and submitted, with AARP, our own amicus brief supporting the Vermont law.

Here's what our counsel Sean Flynn has to say about the Oral Argument of Sorrel v. IMS Health in the Supreme Court: (This statement may be quoted or reprinted in part or full with attribution.)

April 27, 2011

"From the argument yesterday, it appears that a key issue in the case is whether regulation of access to government-mandated and government-possessed information are the treated the same under the First Amendment. Under the LAPD decision, the Court upheld a law that restricted access to identifying information in government records for marketing purposes, but not other purposes. The Court showed no inclination to question that holding in this case. IMS argued yesterday that the singling out of commercial marketing for access restrictions in Vermont’s law makes the law illegally discriminatory. Tom Goldstein, the IMS attorney, argued that the distinguishing factor from the LAPD case is that there the government held the information itself whereas in this case prescription records are merely government mandated but privately held. To fall under the LAPD standard allowing the government to block access to government information, including specific restraints from use for marketing, the prescription would have to be held at a government-owned pharmacy, Goldstein argued.

The IMS standard does not square with other federal data confidentiality laws. The Driver Privacy Protection Act, for example, forbids the trade of information from DMV records (government mandated information) even by third parties who later come in possession of the information.

The other big issue appears to be how the intent of the legislature figures. The Court appeared convinced that a primary purpose of the law was to restrain runaway drug prices caused by undue influence of pharmaceutical marketing. Can the state serve this goal through a law that deprives marketers of access to certain non-public information used as a marketing tool? The answer to that question turns on whether use of information to target marketing, as opposed to sharing the information itself, is a form of “speech.” If it is not speech, then the government can regulate it as economic activity for a variety of reasons, including to reduce overall health expenditures.

There was little discussion in oral argument of whether the use of confidential data to target marketing is itself speech. Many of the members of Court appeared to assume that it was, or at least that speech was effected by the law in such a way as to trigger First Amendment scrutiny. But this is new ground for the Court. that the But that issue is likely to figure prominently in any opinion. If every use of information is speech, a very broad range of information confidentiality protections could be threatened by the decision."

Fore more information contact:

Sean M Fiil Flynn

Associate Director

Program on Information Justice and Intellectual Property (PIJIP)

American University Washington College of Law
4801 Massachusetts Ave., NW
Washington, D.C. 20016
(202) 274-4157

202-294-5749 (cell)

Supreme Court Hears Case on State Prescription Record Privacy Laws

SUPREME COURT ARGUMENT TUESDAY IN FIRST AMENDMENT CASE ON MARKETING USES OF MEDICAL RECORDS
Legislators, Seniors, Consumers, and Doctors Among Those Filing
Friend-of-Court Briefs in Sorrell v. IMS Health

FOR IMMEDIATE RELEASE:
April 25, 2011

CONTACT:
Maine Rep. Sharon Treat
NLARx Executive Director
(207) 242-8558
streat@reducedrugprices.org

Meredith Jacob, Esq.
Prof. Sean Flynn, Esq.
NLARx Counsel
Program on Information Justice & Intellectual Property, Washington College of Law
(202) 274-4157
sflynn@wcl.american.edu

WASHINGTON, D.C. - The U.S. Supreme Court hears oral argument Tuesday April 26 in a landmark case, Sorrell v. IMS Health, balancing First Amendment free speech claims with the medical privacy interests of patients and doctors.

Vermont is defending its right to enact laws regulating the use of data on doctors' and other medical professional's prescribing histories for marketing purposes. Similar laws have been upheld in Maine and New Hampshire, and states around the country including Washington State and Massachusetts have considered adopting the privacy protections.

The National Legislative Association on Prescription Drug Prices (NLARx), a nonpartisan association of state legislators who support laws to make prescription drugs more affordable, has supported passage of the data confidentiality laws and joined with AARP to file an Amicus brief in the U.S. Supreme Court supporting the Vermont law.

"This is an important case with broad implications for states across the Nation. It pits privacy, specifically the privacy of health records, against assertions by corporations that they have free speech rights to use private data in marketing activities," said Sharon Treat, NLARx Executive Director. "State legislators have a strong interest in this case for reasons of protecting public health and the integrity of the doctor-patient relationship, preserving access to affordable health care, and insuring that private data about health status and diagnosis remains private," Treat stated.

The Sorrell v. IMS Health case is an appeal from a Second Circuit Court of Appeals decision overturning Vermont's prescriber confidentiality law on grounds of free speech. Similar laws in New Hampshire and Maine were upheld by the First Circuit Court of Appeals as constitutional and within the scope of state authority.

"A decision invalidating the Vermont law will affect the viability of the laws in its neighboring northern New England states, and a decision upholding the law will give a green light to states that are weighing whether to adopt similar patient and practitioner protections," said Rep. Treat.

Professor Sean Flynn of the Washington College of Law at American University and NLARx Counsel stated: "The Vermont law directly advances its interest in protecting against disclosure of records containing the most personal of information as well as its interest in protecting individual autonomy in decision making on important personal matters. Protecting the confidentiality of records advances important goals of our health system, including combating undue influence of in person pharmaceutical marketing that raises costs and damages public health interests."

In addition to NLARx and AARP, a separate friend of the court brief in support of the Vermont law has been filed on behalf of Public Citizen, the Center for Science in the Public Interest, Consumer Action, Public Good, U.S. PIRG, and New Hampshire PIRG; and another brief has been filed by the New England Journal of Medicine, the Massachusetts Medical Society, the National Physician's Alliance, and the American Medical Students Association. Read the briefs here.

Free Trade Shouldn't Increase the Cost of Medicine

The National Legislative Association on Prescription Drug Prices (NLARx) endorsed a resolution calling on the U.S. to halt the use of trade agreements to enact international disciplines on pharmaceutical pricing programs. The resolution was passed at the Association's winter meeting in Washington, D.C.

NLARx is a nonpartisan, nonprofit organization of state legislators who work on health issues, with a particular focus on prescription drug pricing and access to medicines.

The resolution specifically targets the ongoing negotiation of the Trans-Pacific Partnership (TPP), a plurilateral trade agreement among eight nations. To date, no negotiating text has been publicly released. But the branded drug lobby has requested the inclusion of a chapter in the agreement that would require countries to "appropriately recognize the value of patented medicines" in public drug reimbursement programs and provide appeals for drug manufactures to challenge listing and reimbursement decisions of public health authorities.

As explained in the resolution, public health programs run by states, including the administration of Medicaid drug benefits for over 40 million Americans, use the same types of price restraining preferred reimbursement formularies (known as preferred drug lists, or PDLs) as foreign governments. Many federal programs, including drug programs for Medicare and veterans hospitals, achieve reductions on drug prices through similar preferred reimbursement programs.

"It is not in the best interest of the United States to promote limitations on the types of evidence-based drug pricing used by private companies, U.S. state governments, the U.S. Department of Veterans affairs - and by foreign governments - to control runaway pharmaceutical prices. At a time when health budgets everywhere are strapped, the federal government should not be promoting a new global regulatory agenda that would attack the most effective tools we have to combat excessive medicine prices in our health programs," said Sharon Treat, NLARx Executive Director.

The resolution recounts that these effective programs would be threatened by the kind of new international restraints on pharmaceutical pricing programs that the drug industry seeks:

"Trade Agreements are reciprocal by nature, and state government policies that violate the terms may lead to foreign government retaliation. The federal government may preempt state law thorough international agreements. And proposals to limit the operation of foreign reimbursement programs are likely to lead to increased foreign pressure to limit similarly operating programs in the U.S."

The first trade agreement to include a pharmaceutical pricing provision was the Australia-US FTA. That program required pharmaceutical company participation and appeal opportunities that state officials warned would cripple Medicaid if applied to states. More

The issue came to the fore again with the Korea - US FTA negotiation, during which the U.S. proposed language in the agreement that would prohibit Korea's "positive list" drug formulary. NLARx opposed that language, warning that such proposals would threaten Medicaid programs that use similar preferential purchasing lists to restrain drug prices. More

The USTR has not thus far backed down from its agenda to craft new international restraints on effective drug price controls. In a public statement in late September 2009, for example, Ambassador Kirk expressed his "support" for broadening the discussion of a proposal by Pfizer to promote new international rules that "discipline" pharmaceutical reimbursement programs in the U.S. and abroad.

The NLARX resolution will be transmitted to the USTR and to members of Congress. NLARx officials will meet with the USTR on January 31 to discuss TPP and drug pricing issues further.

For more on this issue, see the Forum on Democracy & Trade and PIJIP.