bioIP workshop – deadline for abstracts approaching

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioIP), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson,  mko at bu.edu.

House Hearing on Regulation of Laboratory-Developed Tests Displays More Consensus Than Disagreement

The Health Subcommittee of the House Energy & Commerce Committee held a hearing last week on the FDA’s proposed draft guidance regarding laboratory-developed tests (LDTs), as part of its “21st Century Cures” initiative. The hearing, which can be viewed online (here and here), featured representatives from the FDA, industry, and research organizations. And although the various panelists offered differing views on the propriety of the FDA’s decision to begin exercising its regulatory authority over LDTs, there seemed to be more agreement than disagreement among the panelists.

Most interestingly, as Representative Henry Waxman pointed out toward the end of the hearing, “[no]body on the panel [is] arguing that there shouldn’t be a very careful scrutiny of these tests. It seems like the question is who should do it: CLIA or the FDA.” Representative Waxman’s subsequent colloquy with Harvard Medical School Professor Christopher Newton-Cheh on this point particularly helped to differentiate the historical roles of CMS and the FDA in this space. But even those panelists who opposed the FDA’s involvement seemed supportive of expanding CMS’ authority under CLIA to conduct clinical validity analyses. (Anyone interested in the administrative law aspects of this issue should know that problems of shared regulatory jurisdiction have recently received increased scholarly attention, with Jody Freeman and Jim Rossi providing a particularly thorough treatment of the issue in their recent article, Agency Coordination in Shared Regulatory Space.)

Continue reading

Research Assistant III: Work with Professors Eyal, Hammitt, Freedberg, Kuritzkes, and collaborators on HIV cure studies’ risks, risk perceptions, and ethics

The research assistant will work with the principal investigator Nir Eyal and collaborators from the Harvard TH Chan School of Public Health, Duke University, Massachusetts General Hospital, and the Brigham and Women’s Hospital as well as the ACTG HIV trial site network. The multidisciplinary team uses methods of clinical epidemiology, economics, simulation modeling, and normative theory to predict risks in early-phase HIV cure studies, assess how much likely candidates for participation understand those risks, and make ethical recommendations on the conduct of HIV cure studies.

The research assistant will help prepare, conduct and analyze a pilot survey expected to take place in a US site of the AIDS Clinical Trials Group (ACTG). The survey will assess perceptions of HIV cure and of cure study risks. The research assistant will also promote other research and grant-related activities, through literature reviews and assistance in the preparation of abstract, poster, and manuscripts for publication, grant applications, a simple project website (using Harvard’s user-friendly OpenScholar platform), and slides for lectures and seminars. The research assistant will be in touch with top researchers in HIV cure, medical decision making, and ethics from around the country, to facilitate our meetings, a workshop, and regular conversations to plan the research and debate ethical issues around early-phase HIV cure studies.

For the full job ad:
https://jobs.brassring.com/1033/asp/tg/cim_jobdetail.asp?partnerID=25240&siteID=5341&AReq=33776BR

Live Blogging: Post-Trial Responsibilities Conference, Session 2

By Zachary Shapiro

Hello from the Post-Trial Responsibilities conference! I will be live blogging session 2: where speakers will be providing important perspectives on PTA. Barbra Bierer is monitoring the discussion.

We started with Richard Klein calling in from FDA:

Richard is talking about post-trial responsibilities. He points out that there is a justice issue here with ensuring access to health care and up to date interventions. He points out that while the FDA can encourage Post-Trial Access (PTA), it has no authority to require or ensure it. He points to moral authority, rather than legal. Foreign trials, however, are a different story, as the FDA has sway over protocol applications that are submitted in the US. Richard begins highlighting some specific considerations for protocol drafters and IRBs: particularly focusing on determining monitoring plans, as well as figuring out financial responsibilities for the provision of PTA.

He moves on to highlight that there is more of a moral obligation than a legal obligation. FDA is supportive of the provision of PTA. He believes that enthusiasm must be tempered, as there are situations when PTA is not appropriate. These include studies that have significant safety concerns, studies of bio-markers as well as validation studies that do not specifically examine safety and effectiveness. There are also situations where PTA is simply not feasible, particularly if additional drugs do not exist (one thinks of the recent Ebola treatment), if there is insufficient safety data, or if there is no practical capacity or resources to provide safety monitoring. We must also be aware of financial limitations, especially for start-up biotech firms that might not have deep pockets.

Continue reading

Live Blogging: Post-Trial Responsibilities Conference, Session I

Holly Fernandez Lynch

Today, the Multi-Regional Clinical Trials Center (MRCT) at Harvard University and the Petrie-Flom Center at Harvard Law School are co-hosting a daylong conference on “Post-Trial Responsibilities: Ethics and Implementation.”  We’ll be live blogging the conference here at Bill of Health, and video/slides from the conference will be available soon.

The conference was kicked off by Mark Barnes, co-director of MRCT, who pointed to two key statements of ethics that refer to post-trial responsibilities, the Declaration of Helsinki’s Paragraph 34 (DoH) – which Mark referred to as “mysterious,” as it could not in practice mean what it literally says – and the Council for International Organizations of Medical Sciences Guideline 10 (CIOMS).

Mark went on to describe the wide spectrum of issues that may be encapsulated in the simple phrase “post-trial access” – for example, over what period of time is access provided, is it provided for chronic diseases or only transient conditions, is it necessary only till a patient is stabilized or for longer, is it a lifetime commitment, does it apply only to research subjects themselves or broader research communities?  How much evidence should we demand of benefit before imposing post-trial responsibilities?  Exactly what should be provided – only the study drug, whatever was offered to the control group, other supportive care?  Must post-trial access be free of charge?  What about improved infrastructure, knowledge, and other benefits as components of post-trial access?  Our goal for the day will be to clarify the ways in which the Declaration of Helsinki, the CIOMS guidelines, and other ethical standards and regulatory requirements require additional guidance for practical application to the complex real-life circumstances of clinical trials.

The conference’s first panel – “Setting the Stage” – had the objective of introducing current ethical and regulatory approaches, as well as key controversies.  The panel was kicked off by Christine Grady (NIH), who gave a talk on the ethics of post-trial responsibilities, including history, models, agreements, and controversies.  Christine explained that compared to the very clear articulation of researchers’ responsibilities before and during a trial, they have very little guidance on what should happen when a trial is over.  Indeed, they had no guidance whatsoever until the 1990s, when there was both an upsurge in international collaborative research, and HIV research more specifically.  In that context, new efforts cropped up to minimize the possibility of exploitation in international research, including development of the concepts of responsiveness to local needs and reasonable availability of research benefits, as well as capacity building, collaboration, and community engagement.

Continue reading

Fall Facebook/OKCupid and Future of Research Tour

Sept. 18 Tweet ChatI’m participating in several public events this fall pertaining to research ethics and regulation, most of them arising out of my recent work (in Wired and in Nature and elsewhere) on how to think about corporations conducting behavioral testing (in collaboration with academic researchers or not) on users and their online environments (think the recent Facebook and OKCupid experiments). These issues raise legal and ethical questions at the intersection of research, business, informational privacy, and innovation policy, and the mix of speakers in most of these events reflect that.  Continue reading

NYULMC: Compassionate Use Could Impact Long-Term Medical Benefits

A new working group at the NYU Langone Medical Center has issued preliminary findings from their studies on the research ethics of compassionate use. Among their findings include:

  • Biotechnology companies have no legal or regulatory obligation to provide access to unapproved treatments on the grounds of compassionate use. Some companies allow access under the guidance of well thought out policies; some companies decline to allow access; some companies grant access but have no set guidelines; and some companies change their practices midstream as a result of public pressure. This lack of uniform policy is confusing to those seeking unapproved treatments.
  • Contrary to widespread perception, the U.S. Food and Drug Administration (FDA) is not an obstacle to those seeking compassionate use. In fact, the FDA almost always defers to the company that is developing the unapproved treatment to decide whether to grant compassionate use acces.
  • The “human impulse” to help patients facing insurmountable odds motivates both the general public’s support for compassionate use and so-called “right to try” laws to help gain access to unapproved treatments. However, increasing access to unapproved therapies may prove detrimental in the long run to longstanding and effective research and clinical trial systems through which interventions are proven effective and safe, and given regulatory approval.

You can learn more about the working group and read more of their findings here.

King v. Governor of the State of New Jersey: Applying the First Amendment to Laws Regulating Physician Speech

[Cross-posted from HealthLawProf Blog.]

Last week’s decision by the U.S. Court of Appeals for the Third Circuit in King v. Governor of the State of New Jersey, provides an insightful addition to the growing body of case law examining the clash between the state’s power to regulate clinical practice andfree speech.

Although the common law of informed consent arguably implicates the First Amendment rights of physicians and other health professionals, the conflict between the state’s power to regulate health care and free speech has become more apparent in recent years as state legislatures have increasingly enacted laws prescribing what physicians and other clinicians can and cannot say. Such laws are especially common with respect to abortion, but state legislatures have also required physicians to provide specific information about breast cancer treatments, or refrain from asking patients about gun ownership.

Not surprisingly, these laws are frequently challenged on First Amendment grounds. Some courts, relying on the Supreme Court’s cursory treatment of a First Amendment claim in Planned Parenthood v. Casey, have held that laws pertaining to what is said in the course of treatment regulate clinical practice rather than speech, and are, therefore, not subject to heightened review under the First Amendment. That was essentially the approach followed by the Ninth Circuit in Pickup v. Brown, which upheld a California law banning sexual orientation change efforts (SOCE) for minors, and the Eleventh Circuit in Wollschlaeger v. Governor of the State of Florida, which upheld a Florida law limiting physicians’ ability to inquire about their patients’ gun ownership.  As a result of these decisions, it became easier for states to regulate the speech of physicians than the speech of commercial purveyors of deadly products.  Continue reading

Clinicians, Care, and Conflicts of Interest in the Sports Medicine Environment

By Christine Baugh

A recent British Medical Journal blog post by Dr. Michael Stone sheds insight into the professional trials and tribulations of physicians working with professional soccer teams in England. As described, it is not uncommon that the team physician is recommended by a team manager and hired by the team’s executive board without thorough review. This hiring process, in turn, leads to the implicit expectation that the physician answers to the manager rather than the entire team, making the physician’s employment with the team insecure and the need for him to appease the manager a required condition of his employment. Beyond leading to an uncomfortable and potentially ineffective working environment, it is possible that this type of relationship could compromise care. These types of conflicts of interest within the sports medicine environment have been documented elsewhere.

A 2013 article in the Chronicle of Higher Education written by Brad Wolverton detailed a similar phenomenon in American collegiate sports. According to their survey of collegiate sports medicine clinicians, approximately one-third of clinicians indicated that members of the football coaching staff had influence over their employment and about half of clinicians reported having felt pressure from coaches to prematurely return athletes to play. Wolverton was able to provide striking examples of professional relationships between coaches and clinicians that led to compromised care. He also indicated that the topic was so sensitive that very few of the athletic trainers contacted were willing to talk about the issue for fear of losing their jobs.

Both the Stone and Wolverton articles highlight the complexity of sports medicine as a field and the specific conflicts that can arise when competing interests from multiple stakeholders are in play. However, critical to both authors’ conclusions, is that seemingly simple structural changes could play a major role in positively affecting health outcomes. Namely, to ensure quality of care, it is critical that the clinician’s employment is based upon the care he gives to his patients, not the team manager or team coach’s opinions of him. This is not a novel assertion. For example, the National Athletic Trainers’ Association, the National Collegiate Athletic Association (page 65), and others have put forth guidelines and recommendations indicating that having the coach serve as a primary supervisor for a clinician is inappropriate. However, it is not clear that these best practices are being implemented uniformly across sports, leagues, and teams. Given the health risks faced by athletes, and the role that sports medicine clinicians can play in mediating those risks, taking steps such as implementing an appropriate supervisory structure for sports medicine clinicians is imperative.

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Gilead Announces Access Program for Hepatitis C Drug

For all those who are interested in issues of global health, access to medicines, and drug pricing, yesterday Gilead formally announced its access program for enabling many developing countries to purchase its new Hepatitis C drug, Sovaldi, at low prices. This announcement is particularly noteworthy because Sovaldi represents a significant improvement over the current standard of care for Hepatitis C, as it can cure a much greater percentage of sufferers than could standard therapies, and it does so with many fewer negative side effects. Gilead’s partnership-based program will permit seven Indian generic drug companies to produce and sell the drug in 91 developing countries. The discounts are significant: although Gilead formally charges $1,000 a pill (or $84,000 for a course of treatment) for Sovaldi in the United States, it will charge just 1% of that, or $10 a pill, in India (the total cost there is estimated at $1,800, given the difference in strain prevalence).

The global health community has reacted to the announcement with mixed reviews. The 91 countries in the program include more than half of the world’s Hepatitis C patients. But tens of millions of other patients in large nations like China, Brazil, Mexico, and Thailand are left out of the program. Going forward, some of the excluded nations may seek to issue compulsory licenses in an effort to expand access to Sovaldi.

Gilead has also drawn fire in the United States for Sovaldi’s $84,000 sticker price (which, for various reasons, very few if any will actually pay), to the degree that members of both houses of Congress have asked Gilead to justify the price of the drug. Those opposing Sovaldi’s price have generally not come out publicly against the high price of many orphan drugs, which can cost $250,000-$350,000 per year. But because Hepatitis C afflicts about 2.7 million people in the US, as compared to the few thousand people with one of the relevant orphan diseases, its impact on insurers (both public and private) is likely to be much larger (as this very blog has previously noted).  Continue reading

Defining Public Health Emergencies

[Cross-posted from HealthLawProf Blog.]

What makes a public health threat an emergency? In this week’s New England Journal of Medicine, Rebecca Haffajee, Michelle M. Mello and I ask this question in connection with Massachusetts Governor Deval Patrick’s decision last spring to declare the opioid-addiction epidemic a “public health emergency.”  In our Perspective we do not question the seriousness of the opioid-addiction problem; or the specific policies Patrick implemented. Rather, we ask whether the epidemic warranted the invocation of emergency powers.

In the years since 9/11, in the name of public health legal preparedness, public health officials and scholars have focused much attention on the need for so-called emergency laws to strengthen the response to a public health emergency. Although the exact parameters of emergency laws vary, they typically allow for the suspension of some or most ordinary legal procedures and protections. Thus when an emergency is declared, the rules of the legal system are suspended. Executives can take action without awaiting legislative approval, or following the typical administrative process. Judicial review may also be significantly curtailed. As my co-authors and I discuss, this has enormous costs, not only on the individuals and entities whose interests are affected, but on the credibility of public health officials who must ultimately depend on the public’s trust. If the public comes to believe that declarations are issued too easily, its support for public health may diminish. In addition, in the absence of legislative and judicial checks, executive powers may easily be turned against vulnerable populations, as they have been too often in history.

Yes precisely because emergency laws are designed to give officials flexibility to respond to unexpected crises, for which existing policies are insufficient, public health emergency laws grant officials extremely broad, usually unreviewable, discretion to decide what constitutes a “public health emergency.” For example, the Massachusetts law that Governor Patrick invoked provides no definition of a public health emergency whatsoever, leaving its determination solely to the Governor’s judgment. Likewise no definition appears in the 2005 federal Public Readiness and Emergency Preparedness Act (PREPA), which preempts most state tort claims against and a vaccines and countermeasures once the Secretary of Health and Human Services declares an emergency.  Continue reading

Of Morals and Smartphones

By Emily Largent

Although many lament that the ubiquity of smartphones has contributed to a recent decline in etiquette, a study published this week in Science suggests that smartphones’ ubiquity may make them a valuable–if surprising–tool for studying modern morality.

Most moral judgment experiments are lab-based and driven by hypotheticals. By contrast, this was a field experiment that focused on the moral judgments people make in their daily lives. The authors recruited 1,252 adults from the U.S. and Canada. Participants were contacted via text message five times each day over a three-day period. Each time, they were asked “whether they committed, were the target of, witnessed, or learned about a moral or immoral act within the past hour.” For each moral or immoral event, participants described via text what the event was about; provided situational context; and provided information about nine moral emotions (e.g., guilt and disgust). Political ideology and religiosity were assessed during an intake survey.

Participants reported a moral or immoral event on 28.9% of responses (n = 3,828). Moral and immoral events had similar overall frequencies.  The authors found political ideology was reliably associated with the types of moral problems people identified.  Liberals mentioned events related to Fairness/Unfairness, Liberty/Oppression, and Honesty/Dishonesty more frequently than did conservatives.  By contrast, conservatives were more likely to mention events related to Loyalty/Disloyalty, Authority/Subversion, and Sanctity/Degradation.  Continue reading

What Is (or Isn’t) a Public Health “Emergency”?

In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.

State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.

Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.

Petrie-Flom Center Executive Director Appointed to SACHRP

Holly Fernandez Lynch, J.D., M.Bioethics, Executive Director of the Petrie-Flom Center at Harvard Law School, has been appointed by Secretary of Health and Human Services Sylvia Burwell to a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP).  SACHRP is a Federal Advisory Committee charged with providing expert advice and recommendations to the Secretary on issues and topics pertaining to the protection of human research subjects. To date, SACHRP has focused its attention on areas such as research involving children, prisoners, and individuals with impaired decision-making capacity; informed consent and the use of biospecimens; harmonization of human subjects regulations and guidance; the reduction of regulatory burden; the HIPAA Privacy Rule; community-engaged research, and accreditation.  Continue reading

Can Someone’s Sex be Situational?

by Vadim Shteyler

Dutee Chand’s career was rising quickly—in 2012 she was the Under-18 Indian National Champion for the 100-meter race. In 2013, she became National Champion in the 100 and 200-meter races as well as the first Indian to reach the final at the World Youth Championships. However, on July 15, 2014, her career was placed abruptly on hold when she was banned from all national and international competitions as a female competitor. Testing revealed that she had hyperandrogenism, that is her body naturally produced elevated levels of the male hormone, testosterone.

In April 2011, the International Olympic Committee (IOC) and the International Association of Athletics Federations (IAAF) had instituted policies banning all athletes with testosterone levels at or above the lower limit for males from competing in the female category. The policy allows women to requalify if they are shown to be resistant to the effects of testosterone or if they undergo one of a number of medical interventions to decrease their testosterone levels. This policy was a change from the extensive medical and psychological testing used for sex verification. (Read more about Caster Semenya, whose experiences catalyzed the policy change.)

Supporters of the new policy argued that a male competing among females has unfair advantage and, as such, furthers his career undeservingly and wins medals for his country unjustly. If increased testosterone levels largely contribute to the better athletic performance of males, then athletes with male-range testosterone should be banned from female competitions. Further, the IAAF cutoff for female testosterone levels is greater than 10 times the mean for average women, ensuring that the vast majority of women, even those with elevated testosterone, would not be disqualified based on these criteria. (Read more in The Journal of Sex Research.)  Continue reading

Questioning Quorn

By Diana R. H. Winters
[Cross-posted on HealthLawProfBlog.]

There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.”   The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.

But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.  Continue reading

Discrimination on the Basis of Health Status in Health Insurance: “Market-Norm or Necessity”?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

In recent months, advocates have alleged that discrimination on the basis of health status in health insurance continues, notwithstanding the Affordable Care Act’s attempts to level the playing field for people with chronic health conditions. How the government and industry should respond to the allegations is not clear, however, in part because what constitutes “discrimination” is not clear in this context. As Jessica Roberts has noted, there is an “intrinsic tension between an antidiscrimination framework and the practices of the private, for-profit health-insurance industry.” This tension makes it difficult to pinpoint where permissible cost-consciousness ends and impermissible discrimination begins.

As has been widely reported, at the end of May, the National Health Law Program, along with the Tampa-based organization The AIDS Institute, filed an administrative complaint with the United States Department of Health and Human Services’ Office of Civil Rights in which they allege that four qualified health plans offered through the federally-facilitated marketplace in Florida discriminate by “charg[ing] inordinately high co-payments and co-insurance for medications used in the treatment of HIV and AIDS.” The complainants go on to allege that because “[o]ther issuers vary tiering or place HIV drugs on more affordable tiers,” “the practice of placing all anti-retrovirals on the highest tier is not a market-norm or necessity.”

The complaint’s emphasis on whether the plans’ actions reflect a “market-norm or necessity” tracks the Centers for Medicare & Medicaid Services’ 2015 Letter to Issuers in the Federally-Facilitated Marketplaces, in which CMS writes that “to ensure nondiscrimination in [qualified health plan ("QHP")] benefit design, CMS will perform an outlier analysis on QHP cost sharing (e.g., co-payments and co-insurance) as part of the QHP certification application process.” CMS goes on to specify that, with regard to prescription drugs, a plan will be considered an “outlier” if it has “an unusually large number of drugs subject to prior authorization and/or step therapy requirements in a particular category and class.”

As Sarah Rosenbaum has noted, “CMS does not provide a review methodology or define what is ‘unusually large’.” Even if it had, what if subjecting a large number of drugs to prior authorization or step therapy requirements did not make a plan unusual? Would that mean that doing so was not “discrimination”? Continue reading

What’s to become of population health?

When the accountable care organization (ACO) model was initially conceptualized, many in the health policy world hoped it could provide a platform for real transformation of US health care.

Among the ACO model’s most promising innovations was its explicit orientation towards achieving “the Triple Aim.” First articulated by Don Berwick and the Institute for Healthcare Improvement (IHI), the Triple Aim is a strategy for optimizing the health care delivery system and achieving the best of all worlds. It outlines three goals: high quality health care, lower costs, and population health. The Center for Medicare and Medicaid Services adopted this goal and still describes a version of the Triple Aim on its webpage titled “Innovation.”

Continue reading