Category: Health Law Policy

2012 Global Congress on Intellectual Property and the Public Interest

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By Adriana Benedict

The 2012 Global Congress on Intellectual Property and the Public Interest has just come to a close in Rio de Janeiro, Brazil.  The conference brought together global leaders in intellectual property-related fields like access to medicines, access to knowledge, internet freedom, innovation and development, and open educational resources.  I was invited to participate in the various sessions concerning access to medicines, which focused on two sides of this global health challenge.

The first part of the access discussions focused on best practices and threats in the use of TRIPS flexibilities in developing countries.  Participants emphasized the need to look beyond the usual focus on compulsory licenses to set new priorities for understanding and leveraging less-developed flexibilities such as patentability criteria, patent opposition mechanisms and parallel importation.  An important overarching theme in these discussions was reframing flexibilities as rights, as they carry the same legal status as the intellectual property rights which make them necessary.

The other side of the discussions focused on innovation and research and development (R&D) for the developing world, primarily through recent advances by the WHO CEWG report in promoting a binding convention in this realm.  At the forefront of these proposals is the notion that incentives for innovation should be de-linked from product prices in order to address the needs of the developing world.  Participants emphasized that, moving forward, advocates should be careful to ensure that public and institutional debates on alternative R&D models do not narrow their focus from neglected populations to neglected diseases.

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Is Health Law the Problem Underlying the Physician Shortage?

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By Christopher Robertson

This week, the New York Times Sunday Review has an editorial arguing that the shortage of primary care physicians could be reduced if we drew more heavily upon other professions, including pharmacists and nurse practitioners, who may be able to provide care more efficiently.  The Affordable Care Act’s efforts to increase insurance coverage and eliminate cost-sharing for preventative care, will only exacerbate the shortage of primary care physicians.  More to the point, the editorial alleges that various state and federal laws create barriers to the sort of integration of healthcare professionals to address the shortage.

Those “scope of practice” laws were enacted to either protect consumers from incompetent healthcare or protect physicians from competition in the healthcare marketplace, or likely some mixture of both.  We know where mainstream physicians stand anyway.  In the words of the American Medical Association’s own newsletter,  “physicians [have] fought a blitz of scope-of-practice expansions by other health professionals on legislative, legal and regulatory fronts.”

The shortage of physicians is also a product of the number of young doctors that our medical schools are producing.  Although several new schools have launched in recent years, others are have actually shrunk due to budget cuts.

Dreams Deferred

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By Wendy Parmet

After the November election, President Obama’s executive order implementing parts of the so-called “Dream Act” was widely credited with shoring up his support within the Latino community.  Less often noted was his Administration’s decision to exclude the “Dreamers” from the benefits afforded by the Affordable Care Act.

Last August, the Center for Medicare Services (CMS) issued an interim final regulation stating that individuals who benefitted from the President’s program, more formally known as “Deferred Action for Childhood Arrivals” or DACA, would not be considered “lawfully present” for purposes of eligibility to health benefits established by the Affordable Care Act, including the Pre-Existing Condition Insurance Plan and the subsidies and credits that will be available in 2014 to purchase insurance through the health insurance exchanges. Pre-Existing Condition Insurance Plan Program, 77 Fed. Reg. 52614-01 (Aug. 30, 2012) (to be codified 45 C.F.R. § 152.2), https://www.gpo.gov/fdsys/pkg/FR-2012-08-30/html/2012-21519.htm.

The impact of this little noticed determination is quite significant. Although most of the estimated 1.7 million DACA immigrants are healthy, because of their age (under 30), many lack access to employer-provided health insurance. Moreover, if as expected, employers begin to shift their health insurance programs to the ACA-created exchanges, DACA immigrants may find themselves barred from employer-provided plans, even though under the President’s executive order they have a legal right to work in the United States.

The insurance gap created by CMS’ determination that the DACA immigrants are not “lawfully present” in the U.S., a decision that is inconsistent with the Administration’s conclusion that other deferred action recipients are eligible for benefits established under the ACA, illuminates the critical relationship between immigration policy and health policy.  To a surprising degree, the health insurance access problem in the U.S. results from laws that bar immigrants (including many with Green Cards) from many government-supported health insurance programs, including Medicaid. In 2010, over 45 % of non-citizens were uninsured, as compared to less than 14 % of native-born Americans. Approximately 65 % of undocumented immigrants are believed to lack health insurance. The ACA is unlikely to reduce those rates, especially regarding undocumented immigrants. Neither, it is now seems, is DACA.

Twitter Round-Up (12/2-12/8)

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By Casey Thomson
This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security.
  • Michelle Meyer (@MichelleNMeyer) retweeted an article about a newly emerging landmark case in the United Kingdom. In the suit, a childless couple denied IVF funding due to the woman’s age is suing Health Secretary Jeremy Hunt (because he is “ultimately accountable for healthcare in England”) on the basis of age discrimination. Thought to be the first venture to sue the Health Secretary concerning decisions about this NHS fund rationing, this case also will be the first instance where age discrimination laws have been employed to try for fertility treatment. (12/3)
  • Alex Smith (@AlexSmithMD) shared an article about a problem patients must deal with when approaching post-hospitalization care: Medicare’s offer to pay for hospice care or for a Skilled Nursing Facility (S.N.F.), but only rarely at the same time. Not only does the choice create a financial predicament, but it also has extensive repercussions for the patient’s health. Calls for a combined benefit process between hospice/palliative care and S.N.F. have been made, including a proposed “concurrent care” demonstration project in the Affordable Care Act. (12/6)
  • Dan Vorhaus (@genomicslawyer) linked to a summary of the Ponemon Institute’s Third Annual Benchmark Study on Patient Privacy & Data Security, reporting on the challenges still being faced to safeguard protected health information (“PHI”). (12/6)
  • Michelle Meyer (@MichelleNMeyer) additionally retweeted a link explaining Brigham and Women’s Hospital’s attempt to deal with the rising difficulty of choosing which research grants to support: an “American Idol-style” public online voting. With almost 6,500 votes cast, the public engagement experiment picked a project hoping to research methods for integrating genomic sequencing into newborns’ routine medical care. When future grant holders are struggling to award between a set of equally deserving project proposals, this push for public involvement (after having confirmed scientific rigor) may have intriguing implications. (12/6)
  • Daniel Goldberg (@prof_goldberg) also linked to a study in Denmark testing the relationship between socio-economic status (SES) and blood pressure levels. Despite having a healthcare system that is free and equal-access regardless of factors like SES, the study found that SES had a “significant effect on BP [blood pressure] control” in this survey. (12/7)
  • Arthur Caplan (@ArthurCaplan) posted a report by UNICEF on the efforts by parents in the Syrian Arab Republic to get their children vaccinated. With many medical centers destroyed by the conflict, and with health practitioners having to operate and transport supplies in the dangerous environment, children have been unable to receive routine vaccinations for several months. This campaign aims to provide such vaccinations (specifically for measles and polio) to children, having advertised via churches, mosques, schools, television, and even by SMS to get greater coverage. (12/7)
  • Frank Pasquale (@FrankPasquale) included a book review of Pharmageddon by David Healy, a look at how pharmaceutical companies are excessively influencing the medical industry particularly with “diagnostic categories and clinical guidelines.” The result, according to Healy: a society where people “think about their bodies as a bundle of risks to be managed by drugs,” with a workforce that is “getting ‘sicker,'” and with “major pharmaceutical companies…banking on further overdiagnosis and overtreatment,” all “undermining universal health care.” (12/8)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Public Health Extremism

The Petrie-Flom Center Staff 5 Comments

By Max Mehlman

In my new book from the Johns Hopkins University Press, Transhumanist Dreams and Dystopian Nightmares: The Promise and Peril of Genetic Engineering, I observe that the government might try to use its power to protect the public health to regulate human genetic engineering, but that given mistakes such as the eugenics sterilization programs of the early 20th century, we must be on guard against the overzealous use of this power.

 An example of the excessive use of public health powers, although not aimed specifically at the hazards of genetic engineering, can be found in an article in the November 8, 2012, issue of the New England Journal of Medicine by Harvard professors Michelle Mello and Glenn Cohen, in which they state that the Supreme Court’s upholding of the individual insurance mandate as a tax “has highlighted an opportunity for passing creative new public health laws.” They give an example of the laws that they have in mind: higher taxes on people whose body-mass index falls outside of the normal range, who do not produce an annual health improvement plan with their physician, who do not purchase gym memberships, who are diabetic but fail to control their glycated hemoglobin levels, and who do not declare that they were tobacco-free during the past year.

Some of these suggestions seem ineffectual. It’s hard to imagine what the public health benefit would be from rewarding people for making a health-improvement plan without having to follow it or for joining a gym without having to use it. As for making people swear against the use of the “pernicious weed,” aside from being unenforceable, it is too reminiscent of the loyalty oaths of the McCarthy era to be taken seriously.

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Need Revenue? Taxes that Promote Health

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The Congressional Budget Office just released a comprehensive new report investigating the budgetary effects of a hypothetical increase in the federal excise tax on cigarettes and small cigars from, $1.01 to $1.51 in fiscal year 2013. The report’s level of sophistication is unprecedented in its ability to evaluate the effects this change could have. Given the federal budget’s current state of affairs, perhaps the most significant finding from the analysis is that increasing the excise tax on cigarettes could reduce federal budget deficits by a total of about $42 billion through 2021. The value of the health costs and lives saved goes without saying.

Of course, the same could be said for some other products that can be harmful to health.  Alcohol taxes also suppress consumption and reduce the harms associated with drinking, and thanks to inflation and the absence of indexing in state tax laws, they are generally now at real rates we had in the ’50s and ’60s. See Alex Wagenaar’s systematic review for more on the subject.

So, if a majority of Americans are seeing a need for revenue, why not raise it, in part, where the result will also include saved lives and saved health care costs?

Study Reveals Complexities of Disclosing and Compensating for Medical Mistakes

I. Glenn Cohen Leave a comment

[Editor’s Note, I am guest posting this on behalf of my wonderful colleague Michelle Mello, at the Harvard School of Public Health]

Gridlock in many state legislatures over proposals to reform medical liability by capping noneconomic damages—and growing recognition that caps have only modest success in addressing the problems with the malpractice system—have led  health care providers and other stakeholders across the country to think hard about alternative approaches.  Alternatives that don’t require the passage of legislation are especially appealing.  Attention has focused in the last couple of years on a promising approach pioneered by a handful of hospital systems, including the University of Michigan Health System: “disclosure-and-resolution” programs, or DRPs.  In DRPs, healthcare facilities and their malpractice insurers disclose unanticipated care outcomes to patients and their families; investigate and explain what caused them; apologize; and, where appropriate, offer compensation without waiting for the patient to sue.

Early adopters of this approach report remarkable success in reducing liability costs and believe they have markedly improved patients’ experience following a medical injury.  But they can’t tell how much of the benefit is attributable to disclosing errors and apologizing, versus offering compensation.  Is it the honesty and empathy, or the money, that matters?  And if it’s the money, how much is enough to get the outcomes healthcare providers want: reduced frequency of malpractice claims, lower defense and indemnity costs, quicker disposition, improvements in staff reporting of unanticipated care outcomes, and a clinical culture that supports open communication with patients?

A new study that I published with my colleagues, Lindsey Murtagh, Penny Andrew, and Tom Gallagher, in Health Affairs this week begins to answer these questions.  We used an experimental survey design to investigate the relative effects of disclosure, explanation, and apology on the one hand, and different kinds of compensation offers on the other, on people’s responses to learning that they were the victim of a medical error.  We fielded an online survey in which 2,112 American adults randomly received one of 16 vignettes in which they were informed of a medical error.  In all vignettes, a physician and administrator explained how the error occurred, took full responsibility, and apologized.  Some vignettes also included an offer of compensation—either waiver of medical bills, limited reimbursement of out-of-pocket expenses, or full compensation—while others included no compensation offer.  Respondents answered several questions about how they would react to the disclosure.  The survey sample was drawn from KnowledgePanel, a standing, probability-based panel of U.S. adults maintained by GfK (formerly Knowledge Networks).  The survey response rate was 65%.

What did we find?

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Twitter Round-Up (11/25-12/1)

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By Casey Thomson

From policy adoption at the federal level to debate over the health concerns of political figures, this week’s round-up focuses largely on the news for bioethics and health law in the realm of politics.

  • Dan Vorhaus (@genomicslawyer) posted a feature on the history of gene patent litigation and implications for next-generation sequencing technologies. (11/26)  He also included a link summarizing key information on H.R.6118, newly passed in the House and Senate and now being presented to the President. Otherwise known as the Taking Essential Steps for Testing (TEST) Act 2012, the bill gives the Centers for Medicare and Medicaid Services (CMS) “greater flexibility in enforcing CLIA [Clinical Laboratory Improvement Amendments] proficiency testing violations” (as noted by Vorhaus). (11/26)
  • Daniel Goldberg (@prof_goldberg) included a post on the inequality in self-rated health as considered by gender. The study, done in Spain, found that females’ lower sense of self-rated health is a reflection of the higher burden of disease in women, and encouraged systems of health to reconsider the approach towards afflictions with lesser impact on mortality that are possibly receiving less attention than is deserved. (11/26)
  • Daniel Goldberg (@prof_goldberg) additionally included a report on the problems parents with disabilities are facing in terms of retaining (or even gaining) their right to be a parent. Such bias against parents, the article notes, may not recognize that ensuring essential support may be all that is needed to discourage problems or eradicate risks for the majority of cases. (11/26)
  • Frank Pasquale (@FrankPasquale) linked to a blog post on the recent protests by AIDS activists in the office of House Speaker John Boehner. The protesters, stripped naked in order to reveal the painted “AIDS Cuts Kill” written on their chests, were there to protest the possible cuts to HIV/AIDS program funding that may follow a fiscal cliff deal.  (11/28)
  • Arthur Caplan (@ArthurCaplan) featured his talk with Boston Public Radio on the fine line politicians must walk when balancing their struggle with a health crisis along with the responsibilities of being a public official. The recent health concerns facing Boston’s Mayor Thomas Menino served as inspiration for this discussion. (11/28)
  • Frank Pasquale (@FrankPasquale) added a news article detailing the recent speech made by principal deputy national coordinator David Muntz of HHS’ Office of the National Coordinator for Health Information Technology. Muntz, in addition to discussing the need to better incorporate technology for fostering stronger communication between patient and doctor, mentioned some striking statistics: “only 15% of patients have renewed a prescription online,” while “just 10% have a personal health record.” (11/29)
  • Arthur Caplan (@ArthurCaplan) posted a link to a new feature on concierge medicine, where appointments can be paid for solely through cash and not through insurance. While previously considered an option only for the rich, concierge medicine has possible implications for the greater body of patients: as the article noted, it may become a more viable option especially as threats of regulation and backlash in a doctor shortage encourage traditionally high-priced firms to backtrack. (11/29)
  • Arthur Caplan (@ArthurCaplan) also shared a video by Canadian comedian Rick Mercer on getting flu shots. (12/1)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

You Have to Read This

Temple University Center for Public Health Law Research 7 Comments

By Scott Burris

Australian public health law savant Chris Reynolds recently stopped by Temple Law School to discuss the South Australia Public Health Act of 2011.  It is a fresh look at how to write a basic public health law statute, but one provision took my breath away.

62—Minister may issue code of practice

(1) The Minister may issue a code of practice in relation to preventing or reducing the incidence of a non-communicable condition.

(2) A code of practice may relate to—

(a) an industry or sector;
(b) a section or part of the community;
(c) an activity, undertaking or circumstance.

(3) Without limiting subsection (1) or (2), a code of practice may relate to the manner in which, for the purposes of public health—

(a) specified goods, substances or services are advertised, sponsored, promoted or marketed (including through the provision of certain information to consumers of certain goods, substances, or services);
(b) specified goods or substances are manufactured, distributed, supplied or sold (including the composition, contents, additives and design of specified goods or substances);
(c) buildings, infrastructure or other works are designed, constructed or maintained;
(d) the public, or certain sections of the public, are able to access specified goods, substances or services.

(4) The Minister must, before issuing or amending a code of practice, insofar as is reasonably practicable, consult with any person or organisation that the Minister considers to be representative of any industry or sector affected by the proposed code or amendment.

(5) The Minister may publish a report on the performance of an industry, sector or person in relation to a code.

(6) The Minister must, before publishing a report under subsection (5) that would reasonably be expected to have an adverse impact on a person specifically identified in the report, provide a copy of the report to the person and then allow the person at least 14 days to make written representations in relation to the contents of the report.

(7) No action lies against the Minister in respect of the contents of a report published under this section.

A code of practice is enforceable under a “general duty clause” that stipulates that  “a person must take all reasonable steps to prevent or minimise any harm to public health caused by, or likely to be caused by, anything done or omitted to be done by the person.”

Here’s a law, passed by actual legislators, that gives a health minister sweeping powers to directly, comprehensively, creatively and flexibly regulate products and activities that create both risks and benefits to the public.

We’ll wait with baited breath to see whether it works or not, but it’s already got me wondering whether they have any decent industry lobbyists in Australia.

The Ethics of Bike Shares: Some Tough Distributive Justice Questions about Helmets, Fatalities, and Obesity/Heart Disease

I. Glenn Cohen 8 Comments

Boston recently followed many other world cities in implementing a bike share program. As the New York Times recently reported, North American cities face a dilemma: if the European experience is any guide, for bike shares to take off the city must do away with the helmet requirement. That turns out to be not a health versus leisure trade-off, but a complex health vs. health trade-off. As the New York Times puts it:

In the United States the notion that bike helmets promote health and safety by preventing head injuries is taken as pretty near God’s truth. Un-helmeted cyclists are regarded as irresponsible, like people who smoke. Cities are aggressive in helmet promotion. But many European health experts have taken a very different view: Yes, there are studies that show that if you fall off a bicycle at a certain speed and hit your head, a helmet can reduce your risk of serious head injury. But such falls off bikes are rare — exceedingly so in mature urban cycling systems. On the other hand, many researchers say, if you force or pressure people to wear helmets, you discourage them from riding bicycles. That means more obesity, heart disease and diabetes. And — Catch-22 — a result is fewer ordinary cyclists on the road, which makes it harder to develop a safe bicycling network.

Suppose hypothetically we came to the conclusion that more life years would be lost to obesity/heart disease related injuries from forbidding helmet laws than would be saved from putting helmets in place, would that justify doing away with our helmet laws? Does it matter that the injuries cause immediate death/injury in the un-helmeted case but are gradual to accumulate as to obesity and heart disease in the helmet case? That might in turn depend on whether we believe in the “rule of rescue” and whether we think of it as merely a rule about allocating aid versus preventing harm in the first place. If most bicyclists who are injured are younger, given the typical profile of the city biker, is there a dimension of age-weighting that might be relevant. Or, in fact, given that those who do not use bikes now due to the helmet laws will be older when they suffer from obesity/heart disease give us a reason to think age-weighting is inappropriate in this domain. This is somewhat similar to the arguments offered in the Age Discrimination in Employment Act (ADEA) context, that unlike Title VII or the ADA we will ALL (if things go well) eventually be old, so protection for the old benefits everyone. However, those who get hit by cars without helmets will likely die young. Finally, what role for choice, responsibility, resistance to the nanny state, etc?