Saturday, April 30, 2011
Bryan A. Liang & Tim Mackey, Off Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access and Limiting Inappropriate Pharmaceutical Marketing, SSRN/University of Michigan Journal of Law Reform
Jennifer L. Skeem & John Monahan, Current Directions in Violence Risk Assessment, SSRN/Current Directions in Psychological Science
Margo Kaplan, Restoring Reason to HIV-Exposure Laws, SSRN/Indiana L.J.
Samantha Godwin, Bad Science Makes Bad Law: How Deference Afforded to Psychiatry Undermines Civil Liberties, SSRN
By a 2-1 vote, a panel on the D.C. Circuit overrode an opinion issued last year against federal funding for research on embryonic stem cells. The district court had read the Dickey-Wicker Amendment’s ban on the use of federal funds for research in which embryos are destroyed to apply to research which can be connected to the destruction of embryos. The appellate panel, on the other hand, concluded that it was reasonable for the NIH to interpret Dickey-Wicker as applying only to research in which the embryos are destroyed. Since later research on embryonic stem cells does not entail concurrent destruction of embryos, the NIH had decided that Dickey-Wicker did not apply. Besides its decision on the interpretation of Dickey-Wicker, the opinion includes an analysis of standards for preliminary injunctions and for judicial review of administrative agency actions.
Thursday, April 28, 2011
Sorrell v. IMS Health Inc. was argued before the U.S. Supreme Court on April 26th. The issue in the highly-publicized case is whether Vermont’s statute concerning the sale of provider-identifiable prescribing information is an unconstitutional limitation on speech. Vermont’s Prescription Confidentiality Law, 18 Vt. Stat. Ann. § 4631 (2011), prohibits the sale of provider-identifying information to data miners for marketing purposes unless the provider opts in to the practice. Vermont advanced three state interests in support of the statute: protecting the privacy of physicians and indirectly of patients, reducing health care costs, and protecting patient safety. The Second Circuit, applying the Central Hudson test for commercial speech, concluded that the statute did not further the state’s interests in a sufficiently direct manner. This decision, Vermont claimed, failed to recognize the state’s very strong interest in protecting privacy, especially when the pharmacies are required by the state to collect the information in the first place. In this regard, Vermont’s petition for certiorari implores, “the Second Circuit's decision invalidating Vermont's law calls into question the constitutionality of numerous federal and state laws that protect information privacy by restricting access to or use of private information.”
It should be noted that the First Circuit had upheld New Hampshire’s Prescription Information Law, which prohibited the transfer of prescription information containing provider-identifiable or patient-identifiable information for any commercial purpose, with limited exceptions, see N.H. RSA 318:47-f(2011), IMS Health Inc. v. Ayotte, 550 F.3d 42 (Cir. 2008); and Maine’s prohibition on the sale of provider-identifiable prescription information regarding physicians who file for confidentiality protection, 22 M.R.S. 1711-E (2011), IMS Health Inc. v. Mills, 616 F.3d 7 (2010).
A decision in the Sorrell case is, unsurprisingly, expected by the end of the Supreme Court’s term in late June or early July. It is of course risky to predict how the Court will rule, so I will not. (But four Justices appeared sympathetic to the view that the case was about defending commercial speech—Chief Justice Roberts, Justice Alito, Justice Kennedy, and Justice Scalia—and four asked questions that brought out strengths of the State’s argument, while noting limits as well—Justice Breyer, Justice Ginsburg, Justice Kagan, and Justice Sotomayor. Justice Thomas was silent as is his wont during oral argument.) Those concerned with the implications of any decision for the privacy rights of patients or consumers—or for that matter health care providers—would do well, however, to pay attention to several themes in the oral argument.
First, there’s a difference between privacy and autonomy. The State argued that the statute protects privacy by giving physicians control over certain uses of information about them. Critical Justices did not see the statute in this way. Instead, they pressed the concern that the statute aimed to make certain types of speech—marketing communications to physicians—more difficult. Justice Kennedy asked whether physician-identifiable prescription information could be sold for research and was told by Bridget Asay, arguing the case for the State, that although it was not, it potentially could be (subject to other Vermont statutory restraints). Chief Justice Roberts asked Thomas Goldstein (a sympathetic voice, as he was arguing for the respondents) whether the statute would permit data aggregators to sell provider-identifiable information to journalists interested in exposing physicians who prescribe a great deal of controversial medications, and was told that it would. Petitioners were hard pressed to explain how the statute protects privacy when it requires an opt-in for one, but not for other, uses. They replied by understanding privacy as autonomy in the sense of control over particular uses. Despite the analogy to HIPAA, which also singles out a group of opt-in uses, critical Justices seemed unconvinced. (Careful readers will note that the value at issue here really is confidentiality—control over how information is shared—not privacy; and if the Justices had recognized this, they might have been more sympathetic to the view that some forms of control might be important to people when other forms are not.)
Second, opt-in is not opt-out. Justice Sotomayor asked why a statutory design that allowed providers to opt-out of the commercial use of their identifiable prescribing information wouldn’t be less restrictive and serve the state’s interests equally well. There seemed to be general agreement among all participants that opt-out mechanisms offered to consumers, such as “do not call” and, potentially, “do not track,” would be constitutional. On this reasoning, the Court’s grant of cert. because of a conflict between the First and the Second Circuits would be somewhat misleading; the First Circuit upheld an opt-out statute (Maine’s) and a more general prohibition (New Hampshire’s), rather than Vermont’s targeted opt-in statute.
Third, more may be less. A number of the Justices were troubled by the statute’s targeting of a particular use of the information for the opt-in requirement. Ironically, it may be that more general prohibitions on information sales (perhaps with limited exceptions as for certain research) would be constitutional, when opt-ins for certain uses are not. Another strategy may be state laws concerning data ownership. Justice Ginsburg asked Edwin Kneedler, Deputy Solicitor General arguing as amicus for Vermont, who owns the data. She was told that the data was in the possession of the pharmacy and that the state has recognized that the physician also has a stake in the information. Presumably, states could do more to recognize property rights in data for both providers and their patients.
Fourth, there may be some real play for deceptive or unfair trade practice law in this area. Justice Breyer asked—just as a hypothetical—whether it would be constitutional for the FTC to (after appropriately studying the evidence) to determine that it was a deceptive trade practice to market drugs to physicians on the basis of information about their prior prescribing history, because this information is irrelevant to the safety and efficacy of the drug. Mr. Goldstein was pressed to admit that the FTC, or Vermont, could prohibit “false” (but not “biased”) speech as a deceptive trade practice.
Fifth, bad reasons are worse than no reasons. Arguing for Vermont, Ms. Asay took particularly pointed questions about the state’s goals in enacting the statute. During her rebuttal, she was pressed by Chief Justice Roberts to explain that the statutory finding that “does seem to say that the State is doing this because it doesn’t like an imbalance in the marketplace of ideas” was adopted in support of the statute in a different, more sweeping form. In general, the Justices seemed more inclined to accept legislative findings in support of privacy (as they conceived of it) rather than Vermont’s asserted interests in reducing health care costs and promoting patient safety. Justice Ginsburg, for example, asked why pursuing these goals isn’t really just “lowering the decibel level” of one speaker.
Sixth, there may be more protection for data in the hands of the state than for data in private hands. Vermont tried to make the argument that because the government required the information to be collected in order for prescriptions to be filled, this was an especially favorable case for regulation. The Justices appeared unconvinced by the efforts to draw the analogy between state-required data collection, and state collection of data itself.
Finally, I can’t resist noting two quite unpleasant features of the oral argument. “Prescribers” were identified with physicians, although the statute specifically defines them as any “individual allowed by law to prescribe and administer prescription drugs in the course of professional practice.” And physicians were always referred to with the male pronoun.
This week the Supreme Court heard oral arguments in Sorrell v. IMS Health. The case pits medical data giant IMS Health (and some other plaintiffs) against the state of Vermont, which restricted the distribution of certain "physician-identified" medical data if the doctors who generated the data failed to affirmatively permit its distribution.* I have contributed to an amicus brief submitted on behalf of the New England Journal of Medicine regarding the case, and I agree with the views expressed by brief co-author David Orentlicher in his excellent article Prescription Data Mining and the Protection of Patients' Interests. I think he, Sean Flynn, and Kevin Outterson have, in various venues, made a compelling case for Vermont's restrictions.**
Even if the Court ends up ignoring the NEJM brief and overturning Vermont's statute, the opinion should be the beginning of a long argument about the proper interpretation of the First Amendment in medical contexts.
Privacy Promotes Free Expression
Privacy has repeatedly been subordinated to other, competing values. Priscilla Regan chronicles how efficiency has trumped privacy in U.S. legislative contexts. In campaign finance and citizen petition cases, democracy has trumped the right of donors and signers to keep their identities secret. Numerous tech law commentators chronicle a tension between privacy and innovation. And now Sorrell is billed as a case pitting privacy against the First Amendment.
There is an old tension between privacy and the First Amendment, best crystallized in Eugene Volokh's effort to characterize privacy protections as the troubling right to stop others from speaking about you. Neil Richards hasdissected the flaws in Volokh's Lochneresque effort to reduce the complex societal dynamics of fair data practices to Hohfeldian trump cards held by individuals and corporations. Societies reasonably conclude that certain types of data shouldn't influence certain types of decisions all the time. And courts have acquiesced, allowing much "of the vast universe of speech [to] remain untouched (and thus unprotected) by the First Amendment."
No algorithm can decide what information, or access to information, is protected by the First Amendment. That's a matter of values, and there aremany normative foundations for protecting free expression, including the promotion of personal autonomy, democracy, and truth. An emerging field of scholarship has demonstrated that all those values are promoted by well-crafted privacy laws.
For example, Katherine Strandburg has called for First Amendment regulation of "relational surveillance," including "attempts to use [traffic data] about communications to ferret out suspect groups and investigate their membership and structure:"
Despite the rising importance of digitally mediated association, current Fourth Amendment and statutory schemes provide only weak checks on government. The potential to chill association through overreaching relational surveillance is great. . . . [T]he First Amendment's freedom of association guarantees can and do provide a proper framework for regulating relational surveillance and suggests how these guarantees might apply to particular forms of analysis of traffic data.
As Danielle Citron and I have documented, this kind of surveillance has already had troubling chilling effects for political groups on both left and right. Our co-blogger Dan Solove has also argued convincingly that "there are doctrinal, historical, and normative justifications for developing" First Amendment-based limits on the "countless searches and seizures involving people's private papers, the books they read, the websites they surf, and the pen names they use when writing anonymously." Marc Jonathan Blitz has explored the intersection of free speech and privacy values in Stanley v. Georgia, a case that guaranteed First Amendment protection for obscene materials "when read or viewed by a person in her own home." Paul Schwartz paved the way for much of this work.
The "Privacy as a First Amendment Value" scholarship has so far focused on deterring undue state surveillance, and the casual observer of Sorrell might believe that the same concerns are not raised by IMS Health's data collection. However, the state of Vermont is the very entity requiring collection of the prescription data, as Judge Debra Ann Livingston's eloquent dissent (in thecase granted cert) highlights:
Vermont's law regulates the dissemination of confidential information---specifically, PI data-and the process by which it is collected and sold. Because section 17 [the challenged law] targets that process rather than . . . [publishing and promotion] itself, understanding the sequence of events section 17 regulates---that is, the process by which PI data travels from the prescription pad to the hands of a pharmaceutical detailer---“is crucial to understanding the statute's legal status.”
Pursuant to Vermont law, every time a pharmacy fills a prescription within the state, it is required to collect certain information about the doctor, the patient, and the medication being prescribed. . . .Troubled by this sequence of events whereby otherwise confidential information ends up in the hands of pharmaceutical detailers. . . .Vermont enacted its prescription confidentiality law. [citations omitted]
In other words, Vermont is trying to control a process of information creation that the state itself began. In his work on the new "information sharing environment" in the anti-terror field, Jon Michaels has shown that private data collection can be almost effortlessly merged with public files to monitor (and ultimately deter) "suspect" advocacy. Just as civil liberties groups have called on more careful and calibrated information sharing between homeland security forces and private data miners, there are also compelling reasons to manage the private sector uses of medical records forced into being by state action.
But even if the state did not force pharmacies to keep these records, there would still be an important free expression rationale for allowing a state to keep them private. Vermont has many rural areas, and it is easy to imagine scenarios where a doctor only treats one or a few patients for sensitive medical conditions. Will a person in small village hesitate to join a mental illness support group on Facebook, once she is aware that a data miner knows that there is only one person on psychotropic drugs in her town? The technological tools for matching digital records are staggering. State restrictions on the use of that data (or other forms of tracking) can be an important step toward giving individuals a chance to form and express opinions and affiliations in peace---without fearing an endlessly ramifying series of classifications made and opportunities possibly denied, on account of faceless and secretive data miners.
Tit for Tat for IMS
The secrecy of the data mining business itself should weigh heavily in the minds of the justices as they consider Sorrell. If the data miners win, privacy interests should follow up the case by lobbying states to force data miners to disclose exactly how they maintain their databases, all the terms of their contracts with clients, and business strategies. If the companies quickly squelch such legislation with trade secrecy claims, they should respect individuals who conceive of themselves as businesses, and consider their medical data among the most important of their "trade secrets."
The Reply Brief from Vermont calls out those challenging its prescriber data law for an opportunistic embrace of the "transparency" mantle:
[W]hile respondents and their amici claim to advocate “transparency,” the commercial trade of prescription data is anything but open. Pharmacies do not tell doctors their information is sold for marketing. Data vendors do not allow dissemination of their “proprietary” data.
The secrecy of the data mining business directly motivates state efforts to limit how much data it can gather. If the state can't understand exactly how credit scoring companies rank and evaluate customers, it has interest in preventing them from even gathering certain suspect data in order to avoid that data's misuse. Similarly, in the medical context, the state has no idea what treatment will be given to certain areas once physician-identified data about them is released. One legal expert recently warned that employers “may develop complex scoring algorithms based on electronic health records to determine which individuals are likely to be high-risk and high-cost workers.” What if the same sort of stigmatizing characterizations are raised to the community level, with marketers selling (possibly inaccurate or otherwise unvetted) aggregate characterizations of prescription drug use on a community-by-community level? The state has a strong interest in delaying the dawn of a brave new world of medical record-based characterizations until far more robust infrastructures assuring data accuracy and accountability are developed.
Individuals often do not realize the multiple paths medical data can take in order to get into critical databases. Recently contributors to the medical website PatientsLikeMe.com found that “Nielsen Co., [a] media-research firm . . . was ‘scraping,’ or copying, every single message off PatientsLikeMe's private online forums.” Had the virtual break-in not been detected, health attributes connected to usernames (which, in turn, can often be linked to real identities) could have spread into numerous databases. All those harboring health data ought to have some certified indication of its legitimate provenance. Such certifications should be regularly audited. Data should not be allowed to persist without certification of its provenance. Until those types of protection are in place, it is in the state's interest to tightly regulate the transfer of health data, much of which the state itself required to be created.
Balancing Interests in Free Expression
While IMS v. Sorrell is often characterized as a direct clash between privacy and the First Amendment, it is better characterized as a more complex struggle over the ethical conduct of commerce, medicine, and marketing. There are First Amendment values that favor Vermont's enterprise, and those which support the efforts of IMS Health to gather physician-identified data. But only one side in the case is serious about constructing a balanced and thoughtful reconciliation of the interests of patient, physician, pharma, and marketing stakeholders here. Vermont's statute may not be perfect, but it at least tries to promote that balance. A victory for the plaintiffs would only accelerate our current trend toward an information environment where powerful corporations create unaccountable databases about individuals and their communities, while cloaking their own practices in trade secrecy.
* "Physician-identified" means that the personally identifiable information about patients is (supposed to be) stripped out of the data, and the data is only associated with particular anonymous patients of particular doctors. One of the key issues in the case is a factual question: how effective is deidentification? Orentlicher observes that, "While the patient’s name is not retrieved [during data aggregation], the data miner does assign a unique number to the patient so that future prescriptions for the patient can be analyzed together." The NEJM brief notes that advances in computer science have compromised extant security techniques, “casting serious doubt on the power of anonymization” and lesser de-identification technologies. Paul Ohm, Broken Promises of Privacy: Responding to the Surprising Failures of Anonymization, 57 UCLA L. Rev. 1701 (2010).
**For the record, the question presented is "Whether a law that restricts access to information in nonpublic prescription drug records and affords prescribers the right to consent before their identifying information in prescription drug records is sold or used in marketing runs afoul of the First Amendment."
X-Posted: Concurring Opinions.
Wednesday, April 27, 2011
Increasing attention is being given to the occurrence of postpartum depression and postpartum psychosis, driven by reports of women who have killed their infants a relatively short time after birth.
For example, in Lakeview, Illinois, a North Side neighborhood of Chicago, a thirty-year-old woman who was reportedly suffering from severe postpartum depression was charged this month with first-degree murder in the suffocation death of her eight-month-old son in February of this year. The woman had a college degree, no prior criminal history, and the Illinois child protective services agency had apparently not received any prior reports of child abuse or neglect as it had no contact with the family preceding this incident. Jason Meisner, Cops: Lakeview Woman Suffocated 8-month-old Son, Chic. Trib., Apr. 14, 2011.
Conjecture has also swirled about the mental state of Lashanda Armstrong, who drove her minivan off a boat ramp in Newburgh, New York, on April 12th, killing herself and three of her four children, ages five, two, and eleven months, with a ten-year-old child able to roll down a window as the vehicle hit the water and escape. James Barron, Woman Tells of Boy’s Plea for Help After 4 Drownings, N.Y. Times, Apr. 13, 2011. This event has sparked a discussion of how often mothers kill their children, what causes it, and how it can be prevented. For a widely circulated report, see Jocelyn Noveck, Moms Killing Kids Not Nearly as Rare as We Think, Assoc. Press, Apr. 16, 2011.
Probably the most well-known related case involved Andrea Yates, who drowned her five young children, ages six months to seven years, in the bathtub of her suburban home outside Houston in 2001. Yates had been suffering for years from very severe postpartum depression and psychosis, with a psychiatrist urging her after the birth of her fourth child not to have any more children. Her initial conviction of capitol murder and a sentence of life imprisonment was overturned on appeal. At her second trial, Yates was found not guilty by reason of insanity and committed to a state psychiatric facility, where she remains today. Associated Press, Woman Not Guilty in Retrial in the Deaths of Her 5 Children, N.Y. Times, July 27, 2006. See also Christine Michalopoulos, Filling in the Holes of the Insanity Defense: The Andrea Yates Case and the Need for a New Prong, 10 Va. J. Soc. Pol’y & L. 383 (2002-03; Kristine Esme Nelson, Postpartum Psychosis and Women Who Kill Their Children: Making the Punishment Fit the Crime, 23(2) Dev. Mental Health L. 23, 36 (2004) (“The American legal system as it currently exists is not equipped to respond in an appropriate fashion to these crimes.”).
In 2010, as part of The Patient Protection and Affordable Care Act (PPACA), section 2952, entitled “Support, Education, and Research for Postpartum Depression,” was enacted. This provision was based on the Melanie Blocker Stokes MOTHERS Act, a bill that had been stalled in Congress for a number of years, in part because of concerns that it would result in mandatory mental health screening for all new mothers. As enacted, however, it has a much narrower scope. This section encourages the Secretary of Health and Human services “to continue activities on postpartum depression or postpartum psychosis . . . , including research to expand the understanding of the causes of, and treatments for, postpartum conditions.” Activities that are encouraged include “[t]he development of improved screening and diagnostic techniques” and “[i]nformation and education programs for health care professionals and the public.” Congress authorized $3 million to support these activities for fiscal year 2010. It also charged the Secretary to conduct a study on the benefits of screening for postpartum conditions and to submit a related report to Congress within two years of the enactment of this bill. For the text of just this portion of the PPACA, see PerinatalPro.com, Melanie Blocker Stokes MOTHERS Act Signed Into Law!, Mar. 21, 2010. For the PPACA in full, see here.
An associated Congressional Report states,
In the United States, there may be as many as 800,000 new cases of postpartum conditions each year. . . . Postpartum depression occurs after 10% to 15% of all deliveries and after 26% to 32% of all adolescent deliveries. The majority of patients suffer from this illness for more than 6 months and, if untreated, 25% of patients are still depressed a year later. . . . The most severe postpartum condition is postpartum psychosis. A comparatively rare disease, it complicates only 0.1% to 0.2% of deliveries.
H.R. Rep. No. 111-48, at 4-5 (2009.
This provision had been pursued in memory of Melanie Stokes, who committed suicide in 2001, three http://www.law.virginia.edu/lawweb/faculty.nsf/FHPbI/1169425months after giving birth to a daughter. Stokes, in her late 30s, managed a sales team at a pharmaceutical company and was married to a urologic surgeon. The couple had tried for several years to get pregnant and Stokes purportedly greeted the news with joy. However, after giving birth to her child, she was unresponsive when the doctor told her that her new child was a girl and within days began talking of killing herself. Hospitalized four times, she threw herself from the twelfth floor of a hotel a week after her last discharge. Lisa Pevtzow, Law Gives $3 Million to Educate, Research Post-Partum Depression: Dedicated Mom Spent Nine Years Working to Pass ‘Melanie’s Law’, Chic. Trib., May 21, 2010.
Historically, a diagnosis of postpartum depression has received limited weight in conjunction with criminal justice proceedings. A ruling by the Iowa Supreme Court suggests that courts may be changing their views somewhat. The court noted that the defendant in this case, Heidi Anfinson, had told officers that she had left her two-week-old son alone in the bathtub so that she could use the telephone in another room. When she returned, the baby had drowned. Panicked, she took the body, drove it to a nearby lake, left it in the water, and drove home. Anfinson pled not guilty to charges of first-degree murder and child endangerment. Although her lawyer was aware that Anfinson probably suffered from postpartum depression following her son’s birth, the lawyer summarily dismissed the notion that this condition could http://www.law.virginia.edu/lawweb/faculty.nsf/FHPbI/1169425be used in her defense. Further, he failed to investigate Anfinson’s medical history, or the extent of her symptoms and how they might otherwise explain behavior the jury might find unnatural or unforgiveable. Although the first trial resulted in a mistrial as the jury was unable to reach a unanimous decision, the jury at a second trial convicted her of second-degree murder.
On appeal, Anfinson argued that she had received ineffective assistance of counsel. Upon reviewing the matter, the Iowa Supreme Court determined that Anfinson’s attorney was aware of the probability that she suffered from postpartum depression after her child’s birth, but “categorically rejected any suggestion that this condition be explored in her defense.” The court acknowledged that the evidence of postpartum depression would not have qualified Anfinson for either an insanity or diminished responsibility defense in this particular instance, but determined that it likely would have affected the outcome of her case by bolstering her claim that the death was accidental and by explaining to the jury why a mother would neglect her newborn while it was in the bathtub, why she would irrationally bury the body in a lake following the drowning, and why she would appear emotionless about the ordeal when questioned later that day. Courts are generally reluctant to find a lawyer’s assistance ineffective when it reflects a tactical decision; however, the court in this case determined that the lawyer’s decision to present no evidence of postpartum depression called into doubt the fairness of the outcome of Anfinson’s trial and remanded the case for a new trial. Anfinson v. State, 758 N.W.2d 496 (Iowa 2008),
Anfinson ultimately entered into a plea in October of 2009, a week before her third trial was scheduled to begin. Her original conviction carried a fifty-year mandatory sentence. Under her plea, she received a fifty-year non-mandatory sentence. With time already served, it was reported that she could be paroled within one to four years. EveryPurpose.org, Plea Bargain Reached (Oct. 28, 2009). This website also provides links to accounts by Anfinson’s husband, sister, and brother-in-law.
New genetic evidence confirms a long held suspicion that the armadillo, the official small state mammal of Texas, can pass leprosy to humans. The finding should give clinicians a reason to watch for the disease in patients, say researchers, and hopefully lead to earlier diagnosis of the disease.
“There is no need to slaughter the animals or get panicked,” says Pushpendra Singh, a molecular microbiologist at École polytechnique fédérale de Lausanne (EPFL) in Switzerland and a co-author on the paper published 28 April in The New England Journal of Medicine. “But we proved something which was hypothesized for a long time.”
Leprosy (otherwise known as Hansen's disease) is a highly stigmatized disease caused by the bacterium Mycobacterium leprae and is rare in the United States. Around 150 cases are diagnosed in the US each year, a third of which appear to be contracted locally. Contrary to popular belief, leprosy is treatable with antibiotics and doesn't cause lasting damage as long as it’s caught early. Roughly 95% of humans are immune to the disease, which is so uncommon in the US that when cases do arise, many physicians do not recognize it immediately.
Tuesday, April 26, 2011
Concerns about the health effects of fracking – the controversial method of extracting oil and gas from shale rock formations using explosives – may lead to new legislation.
The concerns arise from reports of contamination arising from operations, and the fact that fracking has received special waivers from environmental regulation. The Energy Policy Act of 2005 excluded hydraulic fracturing for oil and gas production from permitting under the Safe Drinking Water Act’s (SDWA) Underground Injection Control (UIC) Program. In testimony before at Senate Committee hearing on Environment and Public Works on April 12th, the Environmental Protection Agency (EPA) admitted that fracking can cause:
- stress on surface water and groundwater supplies from the withdrawal of large volumes of water used in drilling and hydraulic fracturing;
- potential contamination of drinking water aquifers resulting from faulty well construction and completion;
- compromised water quality due to challenges with managing and disposing of contaminated wastewaters, known as flowback and produced water, where contaminants could include organic chemicals, metals, salts and radionuclides; and
- impaired air quality from hazardous air pollutants such as benzene and the potent greenhouse gas methane.
Last Year, the House of Representatives directed the EPA to conduct a study of fracking to “to better understand any potential impacts of hydraulic fracturing on drinking water and groundwater.” The study has been initiated and a final report is expected in late 2012.
Depending on the results of the study, lawmakers are poised to take action. In an opening statement at the hearing, Senator Benjamin Cardin (D-MD) said: “We need to put the environmental cop back on the beat, take aggressive action against the bad actors in the industry and earn back the public’s confidence. The promise of natural gas will be a promise unfulfilled if the human health and environmental impacts are not properly safe-guarded. It’s long past time that they were.”
Monday, April 25, 2011
The court's order is short, "The petition for a writ of certiorari before judgment is denied" and wasn't a surprise, but the Supreme Court's decision in Virginia, ex rel. Cuccinelli v. Sibelius means that the 4th Circuit will hear the health reform case in May as scheduled. Story from Politico, here or L.A. Times, here. [NPT]
A poignant mini-documentary on a Maryland doctor's general practice, available from the New York Times here. From the rows of paper files to the tight patient schedule to the comments about viability of such a practice today there seem to be plenty of places one could take a basic health law class after viewing this. [NPT]
Friday, April 22, 2011
Clark Havighurst, Still Unfair to the Working Class: Health Care Under the Affordable Care Act, SSRN
Jennifer A. Chandler, Autonomy and the Unintended Legal Consequences of Emerging Neurotherapies, Neuroscience/SSRN
Sara Rosenbaum, Medicaid and Access to the Courts, NEJM
Alicia Ouellette, Hearing The Deaf: Cochlear Implants, The Deaf Community, and Bioethical Analysis, SSRN/Valp. L.Rev.
Paul Krugman twists the knife lodged in the back of consumer driven health care in today's New York Times piece "Patients Are Not Consumers," available here. There are some highly quotable sections such as:
Here’s my question: How did it become normal, or for that matter even acceptable, to refer to medical patients as “consumers”? The relationship between patient and doctor used to be considered something special, almost sacred. Now politicians and supposed reformers talk about the act of receiving care as if it were no different from a commercial transaction, like buying a car — and their only complaint is that it isn’t commercial enough.
Thursday, April 21, 2011
One rare point of elite consensus is that the US needs to reduce health care costs. Frightening graphs expose America as a spendthrift outlier. The President's first OMB director tirelessly tried to "bend the cost curve." The President's opponents are even more passionate about austerity.
Journalists and academics support that political consensus. Andrew Sullivan calls health spending a "giant suck from the rest of the working economy." Gregg Bloche estimates that "the 30% of health care spending that's wasted on worthless care" is "about the price of the $700 billion mortgage bailout, squandered every year." He calls rising health spending an "existential challenge," menacing other "national priorities." Perhaps inspired by Children of the Corn, George Mason economist Robin Hanson compares modern medicine to a voracious brat:
King Solomon famously threatened to cut a disputed baby in half, to expose the fake mother who would permit such a thing. The debate over medicine today is like that baby, but with disputants who won’t fall for Solomon’s trick. The left says markets won’t ensure everyone gets enough of the precious medical baby. The right says governments produce a much inferior baby. I say: cut the baby in half, dollar-wise, and throw half away! Our “precious” medical baby is in fact a vast monster filling our great temple, whose feeding starves our people and future. Half a monster is plenty.
But when you scratch the surface of these sentiments, you have to wonder: is the overall level of health care spending really the most important threat facing the country? Is it one of the most important threats? There are many ways to raise revenue to pay for rising health costs. Aspects of the Affordable Care Act,like ACOs and pilot projects, are designed to help root out unnecessary care.
I am happy to join the crusade against waste. But why focus on total health spending as particularly egregious or worrisome? Let's explore some of the usual rationales.
Wednesday, April 20, 2011
On April 12th, Senators John Kerry and John McCain introduced the “Commercial Privacy Bill of Rights Act of 2011.” Whatever its limits (and there are some), the Act represents an important re-direction for U.S. privacy law. It also represents a noteworthy example of bi-partisanship that might actually result in Congressional action.
In 1973, the then-Department of Health, Education, and Welfare published a report that has become the basis for privacy laws all over the world—but not in the United States. The report, Records, Computers, and the Rights of Citizens, proposed a comprehensive privacy framework for what were then called “automated personal data systems.” The report was written “in response to growing concern about the harmful consequences that may result from uncontrolled application of computer and telecommunications technology to the collection, storage, and use of data about individual citizens.” It proposed a version of what have become known as Fair Information Practice Principles: transparency about record-keeping, access to records, purpose-limitation and use specification, rights to correct or maintain records, data integrity and security, and precautions to prevent misuse. Congress passed the Privacy Act in 1974, but applied privacy protections only to information possessed by the federal government, 5 U.S.C. § 552a, Public Law No. 93-579, (Dec. 31, 1974) Since that time, the U.S. (unlike the EU, for example) has taken a sectoral approach to privacy, applying different statutes and regulations to some types or holders of information such as health information or consumer credit information. The primary federal law applying to information collection generally is the Federal Trade Commission Act’s prohibition of unfair or deceptive trade practices. While this Act certainly provides some privacy protection, it was not designed for this purpose.
The Kerry-McCain Act rests on Fair Information Practice Principles: security and accountability; the right to notice, consent, access to and correction of information; data minimization; and data integrity. The Act would apply to all personally identifiable information and information stored in connection with personally identifiable information. There are exceptions for information obtained from public records and not merged with covered information, for information obtained from a public forum where information is voluntarily shared by individuals, and for information obtained from public media. “Sensitive personally identifiable information” is information that, if compromised, carries a significant risk of economic of physical harm, information related to medical conditions or health records, and information about religious affiliation.
The Act would require the FTC to engage in rule-making regarding security measures to be applied to covered information. It would require the implementation of a “privacy by design” framework by all entities covered by the Act to ensure the maintenance of data management processes proportional to the type of information collected. Protecting Consumer Privacy in an Era of Rapid Change: A Proposed Framework for Businesses and Policymakers (“Privacy by design” was proposed by the FTC staff in December, 2010. This report detailed the limits of “harm protection” and “notice and choice” methods for protecting privacy. It recommended consideration of a universal “do not track” mechanism for consumers to use in protecting themselves against tracking of their online behavior).
The Act would also require FTC rule-making to require all covered entities to provide consumers with clear notice of their privacy practices and to offer a clear and conspicuous mechanism for opt-out consent for any unauthorized use of personally identifiable information. Opt-in consent would be required for the collection, use, or transfer of sensitive personally identifiable information, with exceptions for services requested by the individual, fraud prevention, and security of the physical or virtual environment.
To be sure, there are concerns about the Act. It stops short of proposing a uniform do-not-track mechanism and thus may not provide mechanisms that are sufficiently easy for consumers to use. It encourages the establishment of safe harbors where participation is voluntary but the standards are as rigorous as those in the Act. Mechanisms such as these can become loopholes if they are not vigorously monitored and enforced. At the same time, the proposed Act represents a welcome step towards the comprehensive implementation of Fair Information Practice Principles that the U.S. proposed but stepped away from almost 40 years ago.
- Guest Blogger Leslie P. Francis
The Health Law Prof Blog is very proud to introduce our new guest blogger Professor Leslie P. Francis. Here is a short bio for Professor Francis:
Leslie P. Francis is Distinguished Professor of Law and Philosophy and Alfred C. Emery Professor of Law at the University of Utah. At Utah, she also holds adjunct appointments in the Division of Medical Ethics in the Department of Internal Medicine, in the Public Health program in the Department of Family Medicine, and in the Political Science Department. Francis received her Ph.D. in Philosophy from the University of Michigan in 1974 and her J.D from the University of Utah in 1981. She was a law clerk to Judge Abner Mikva of the United States Court of Appeals for the District of Columbia Circuit in 1981-82.
Professor Francis specializes in Ethics, Bioethics, Philosophy of Law, Health Law, and Disability Law. At present, she is leading the College of Law’s efforts to develop the Biolaw Project. Francis’s most recent books are The Patient as Victim and Vector: Ethics and Infectious Disease (with Margaret Battin, Jay Jacobson, and Charles Smith; Oxford University Press 2009); and the Blackwell Guide to Medical Ethics (edited with Rosamond Rhodes and Anita Silvers; Blackwell’s 2006). She also has edited (with Anita Silvers), Americans With Disabilities: Implications of the Law for Individuals and Institutions (Routledge, 2000). Articles published within the past year deal with topics such as syndromic surveillance, patient trust and electronic medical records, race and genetic discrimination, disability discrimination and access to health care, the intersection between disability discrimination and discrimination based on aged-ness, and federalism and the recognition of new legal rights. She is currently a member of the American Law Institute (elected 1986), the ethics committee of the American Society for Reproductive Medicine, and the National Committee on Health and Vital Statistics where she serves as cochair of the committee on Security, Privacy, and Confidentiality. In the spring of 2000, she was awarded the University of Utah’s Rosenblatt Prize for overall excellence in research, teaching, and academic service.
Nicholas P. Terry - Certification and Meaningful Use: Reframing Adoption of Electronic Health Records as a Quality Imperative
Nicholas P. Terry, Professor of Law at St. Louis University School of Law and blogger extraordinaire here at the Health Law Prof Blog, has posted - Certification and Meaningful Use: Reframing Adoption of Electronic Health Records as a Quality Imperative on SSRN. Here is the abstract:
This article examines the promise of the Health Information Technology for Economic and Clinical Health Act to reduce or eliminate the market failures that have impeded the adoption of electronic health records. Specifically, the article considers a key provision of the statute, a condition for receiving EHR subsidy funds: meaningful use. This deceptively simple requirement, that a health care provider must make “meaningful use of certified EHR technology,” has become both the regulatory core and the talisman for the next decade’s implementation of health information technology. The article describes the background to the subsidy program and examines the specifics of the “Certification” and “Meaningful Use” regulations that have followed. The article concludes by taking a broader view of Meaningful Use and relating it to the concept of more fundamental health care reform. [KVT]
This article examines the promise of the Health Information Technology for Economic and Clinical Health Act to reduce or eliminate the market failures that have impeded the adoption of electronic health records. Specifically, the article considers a key provision of the statute, a condition for receiving EHR subsidy funds: meaningful use. This deceptively simple requirement, that a health care provider must make “meaningful use of certified EHR technology,” has become both the regulatory core and the talisman for the next decade’s implementation of health information technology. The article describes the background to the subsidy program and examines the specifics of the “Certification” and “Meaningful Use” regulations that have followed. The article concludes by taking a broader view of Meaningful Use and relating it to the concept of more fundamental health care reform.
Monday, April 18, 2011
The Association of Climate Change Officers (ACCO) is hosting a conference on June 12-13 in Washington, DC entitled “Healthy Hospitals: Changing Climate in Healthcare Facilities and Institutions.” According to the conference website, it will consist of a series of interactive discussions examining opportunities to modernize healthcare institutions and facilities with respect to energy consumption, greenhouse gas emissions and improved patient response.
“Industry and government organizations in the healthcare sector are increasingly addressing the impacts of climate change and energy on operations. The sector is amongst the more intensive users of energy and natural resources in support of its operations. As energy costs rise and availability of natural resources declines, the healthcare community will face significant challenges and opportunities related to procurement, facilities management and design.
“Recent studies indicate a convergence of interests related to climate change, energy, and medical and global health. This workshop will examine the role of supply chain programs, green building design and retrofits, and facilities management in improving patient health and response to treatment, and reducing energy consumption, operational costs and greenhouse gas emissions.”
Invited speakers include Clayton Boenecke of the Office of the Assistant Secretary of Defense, Health Affairs, Gary Cohen, the President of Health Care Without Harm, Anna Gilmore Hall of Practice Greenhealth and many others. Kudos to ACCO for focusing the health care industry on the health of the planet.
Sadly, this is not a new story, but it may be getting worse. Most states have cut their mental health budgets, with outpatient services designed to prevent psychiatric crises being the hardest hit, although states also continue to trim the number of state psychiatric beds. They have done so notwithstanding that the need for mental health services continues to increase. See Ted Lutterman, NASMHPD Research Institute, Inc., The Impact of the State Fiscal Crisis on State Mental Health Systems Fall 2010 Update (Feb. 12, 2011).
Individuals experiencing acute psychiatric distress often approach the emergency department (ED) of a local hospital when they are in need of care, either because they need emergency services or because they lack adequate health care coverage and these are the only services available to them. Once there, however, they often experience extensive delays while waiting to obtain needed services.
Of course, it is not only this population that experiences such delays. The most recent findings of an ongoing national survey found that there were 117 million visits to hospital EDs in 2007, or 39 visits per 100 persons. This was an increase of 23% and 11%, respectively, over the past ten years. Citing a report by the Institute of Medicine, these changes were attributed to “an increase in ED visits along with a decrease in the number of EDs.” Citing a report by the Government Accountability Office, it was also noted that “the main issue contributing to overcrowding of EDs has been delays in moving the sickest patients to inpatient beds. Admitted patients have often been boarded in EDs or hospital hallways for hours to days, resulting in overcrowding and diversion of incoming ambulances to other hospitals.” Richard Niska et al., U.S. Dep’t Health & Human Services, Centers for Disease Control & Prevention, National Center for Health Statistics, National Hospital Ambulatory Medical Care Survey: 2007 Emergency Department Summary (Aug. 6, 2010).
But perhaps hardest hit by these delays are those individuals experiencing acute psychiatric distress. As a recent account noted:
Mentally ill patients often languish in hospital emergency rooms for several days, sometimes longer, before they can be moved to a psychiatric unit or hospital. At most, they get drugs but little counseling, and the environment is often harsh.
“The inside of the ER is kind of like Las Vegas,” with a “24/7, 365 flow of activity,” says Dr. Gary Bubly, an emergency physician . . . and president of the Rhode Island Medical Society. While the ER staff does its best to care for mentally ill patients, he says, it’s the wrong place for someone in the midst of a psychiatric crisis.
Jenny Gold, Mentally Ill Languish in Hospital Emergency Rooms, NPR, Apr. 13, 2011.
A 2010 survey by a firm that manages emergency departments across the country found that 70% of ED administrators report that they hold patients with a mental illness for twenty-four hours or longer, with 10% of them holding some patients for a week or more. In addition, 56% of the respondents said they were often unable to transfer “mental/behavioral patients” to inpatient facilities in a timely manner and another 30% said they were sometimes unable to do so, while only 3% said they were always able to transfer these patients in a timely fashion. Sixty percent of these administrators acknowledged that delays in transferring these patients compromises patient care in the ER. Schumacher Group, Emergency Department Challenges and Trends: 2010 Survey of Hospital Emergency Department Administrators 6 (2010).
These findings parallel those from a survey of ED directors released in 2008 by the American College of Emergency Physicians (ACEP). They also reported that such individuals can wait twenty-four hours or longer for an inpatient bed after being deemed to be in need of hospitalization, principally because of a lack of available psychiatric beds. Almost 80% said their hospital “boards” patients with a psychiatric disorder in the ED. This boarding may include placing the patient in an ED hallway, with 60% of these directors stating that their ED did not have a dedicated area for patients with a psychiatric disorder. The main reasons given for boarding were the lack of in-house inpatient psychiatric beds and no other facility being able or willing to accept transfers of these patients. Only half of the hospitals had psychiatric units, with the number of psychiatric beds in the community dropping 12% in the United States since 2000 (the number of hospital beds overall fell by 4% during this period). Hospitals were said to be closing their units because of inadequate payments from government and insurers, unpaid costs for the uninsured, and too few psychiatrists willing to work in hospitals.
The authors of this survey noted that a mental health specialist is rarely involved in the care of these boarded patients and the environment of a busy emergency department may exacerbate their symptoms, often requiring them to be sedated. The then-President of the ACEP noted that “‘[b]oarding’ is an appalling fact of life in our nation’s emergency departments, and too often our most vulnerable patients—psychiatric patients in this instance—bear the biggest burden.” She added that “[p]eople with psychiatric emergencies have nowhere else to turn, and they are suffering.” American College of Emergency Physicians, Psychiatric Patients, Including Children, Routinely Boarded in Emergency Departments (2008); Julie Appleby, Mentally Ill Face Extra-Long ER Waits, USA TODAY (June 16, 2008),
A Past President of the Emergency Nurses Association has written that:.
Providing safe and effective care for psychiatric patients in the emergency department (ED) has become an increasing challenge in recent years. Crowded, chaotic EDs have experienced a rising number of visits by patients in need of mental health services. . . . Despite this large number of visits, fewer than 20% of EDs have a mental health center. . . . Utilization of ED resources by psychiatric patients has reached crisis. . . . The chaotic physical environment in the ED may exacerbate the psychiatric patient’s behavior. . . . It is essential that the healthcare system recognizes the need to reduce the disparity of emergency care for psychiatric patients.
Patricia Howard, Psychiatric Care in the Emergency Department—Chaos or Crisis? Emergency Med. & Critical Care Rev. 41, 41-42 (2006). The President of the American Association of Emergency Psychiatry has expressed similar sentiments. Anthony T. Ng, Overcrowded Psychiatric Emergency Rooms, MIWatch.org: News About Mental Illness, Nov. 17, 2008. See also Alan Judd, Desperate Psychiatric Patients Wait: Some Wait Days in ERs, Get No Help, Atlanta-Journal Const., June 20, 2010 (“Hundreds of psychiatric patients have spent hours, days—as long as a week—in emergency rooms awaiting admission to state hospitals or other mental health facilities. . . . Few patients receive psychiatric care in the emergency rooms. Some get no more than a chair to sit through the delay.”).
Public attention was briefly focused on these issues when a woman by the name of Esmin Green collapsed and died unnoticed on the emergency room floor of a Brooklyn hospital after waiting for almost twenty-four hours for a psychiatric bed. For an account of what happened to Esmin Green, see Jim Dwyer, After a Death Seen on Tape, Change Is Promised, N.Y. Times, July 12, 2008; Anemona Hartocollis, Video of Dying Mental Patient Being Ignored Spurs Changes at Brooklyn Hospital, N.Y. Times, July 2, 2008. Excerpts of a recording made by the hospital’s surveillance camera that captures Ms. Green collapsing on the floor and being left unattended can be found here. For a description of the subsequent investigation into the services provided at the facility and the resulting findings, see Anemona Hartocollis, Abuse Is Found at Psychiatric Unit Run by City, N.Y. Times, Feb. 5, 2009. To review a copy of the report resulting from this investigation by the Civil Rights Division of the U.S. Department of Justice dated January, 20, 2009, see here. For an account of the wrongful death suit settlement reached between New York City and the family of Ms. Green, see Sewell Chan, City to Pay $2 Million in Death After Hospital Wait, N.Y. Times, May 28, 2009, at A24.
For other cases of interest that have addressed the liability of emergency departments for a failure to respond adequately to the needs of patients experiencing psychiatric distress, see Moses v. Providence Hsp. & Med. Ctrs., Inc., 561 F.3d 573 (6th Cir. 2009) (holding that a mental health emergency could qualify as an “emergency medical condition” under EMTALA, that the patient’s behavior and statements provided sufficient evidence to raise the possibility that the patient was experiencing a mental health emergency when he came to the hospital, and that there was evidence that the hospital physicians believed the patient had an emergency medical condition when he was discharged and that the discharge decision was driven by the unwillingness of the patient’s insurance plan to provide coverage); Card v. Amisub (SFH) Inc., No. 03-2528, 2006 WL 889430 (W.D. Tenn. Mar. 30, 2006) (ruling that a patient who sought “medical care to avert danger of harm to himself due to depression, suicidal tendencies, and substance and alcohol abuse” can proceed with his EMTALA and medical malpractice claims where an emergency room employee recommended that the man call an outpatient treatment center for services and gave him a list of such centers, the patient called each center on the list but was refused treatment by each because of his health insurance status, and the hospital employee then told the patient “they had done all they could possibly do” and subsequently discharged the patient from the hospital, after which the patient attempted to kill himself).
--Thomas L. Hafemeister
Saturday, April 16, 2011
Is Massachusetts once again pointing to the future of healthcare with cost curve-bending proposals described in the Washington Post, here? Governor Patrick favors an ACO-like "integrated care" system that would replace fee for services. The proposals date back to the Massachusetts Special Commission, available here
Friday, April 15, 2011
On May 20-21, 2011 The Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School will host a conference on the Globalization of Health Care. Please refer to the conference schedule for further information. We will bring together leading scholars and policy-makers in the fields of law, public health, public policy, medicine, and government, to discuss several overlapping and diverging instances of health care globalization, including topics on medical tourism, research and development and telemedicine, medical worker migration, globalization and health care equity, and organ transplantation. Though the event is a closed door forum, we have a limited number of spaces available for outside attendees doing research on these topics. If you are interested in attending, please email Kathy Paras, with a sentence or two describing your research background and your specific interest in attending. Please submit your requests no later than May 6, 2011. The availability of space is very limited, but we will do our best to accommodate requests. While there is no registration charge to attend, approved attendees are responsible for their travel expenses.