Robert M. La Follette School of Public Affairs

Smart Regulation: Can New Types of Governance Improve Health?

Friday, Oct. 9, 2009
University of Wisconsin-Madison
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1) Regulating the U.S. Health Care System:  Failure in Motion
Peter D. Jacobson, University of Michigan School of Public Health

2) Conducting a Dissonant Symphony: A Case Study of Network Leadership in the National Quality Forum
Bryce Hoflund, University of Nebraska at Omaha School of Public Administration

3) Improving Health by 'Command & Control': The case of the U.K.'s National Institute for Health & Clinical Excellence
Stirling Bryan,Department of Medicine, University of British Columbia;Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute

4) Health Regulation in a Regulatory Polity: The EU's health policy instruments
Scott L. Greer, University of Michigan

5) Informatics and New Governance:  The evolving role of the federal government in response to the American Recovery and Reinvestment Act (ARRA)
Maya Das, National Opinion Research Center at the University of Chicago, Bethesda, MD

6) Infection Control in the Hospital Setting: An Analysis of Regulatory Governance
Cary Coglianese, University of Pennsylvania; David Lazer, Northeastern University

7) Straddling Administrations: The Health Information Technology Governance Mashup
Nicolas P. Terry

8) Private versus Public Rulemaking: The OPTN as a Model of Evidence-Based Medicine?
David L. Weimer, La Follette School of Public Affairs, University of Wisconsin-Madison

9)  Improving Cancer Detection, Treatment and Survival through New Governance
Thomas R. Oliver, Louise Trubek, Toby Campbell, Matt Mokrohisky, Chih-Ming Liang, University of Wisconsin-Madison

 

1) Regulating the U.S. Health Care System:  Failure in Motion
Peter D. Jacobson, JD, MPH, University of Michigan School of Public Health

The current health care regulatory system is a mess.  Whatever its stated objectives, there is little evidence that it improves quality of care, provides cost-effective benefits to the public, or is a rational way of monitoring health care delivery.  The purposes of this paper are to explain why the regulatory system is failing to meet its objectives and to develop criteria for regulatory reform strategies.

At best, the current health care regulatory structure is a fragmented, ad hocarrangement with little structural or thematic coherence.  Along with separate layers of state and federal regulations, private accreditation entities have developed numerous voluntary standards, especially to enhance quality of care.  In part, the system's incoherence is a function of the accretion of regulatory approaches responding to the different eras of health care delivery—fee-for-service, then managed care, and now consumer-directed health care (CDHC).

The result is a muddle of confusing and inconsistent regulations that provide minimal useful guidance to health care administrators and physicians.  Not surprisingly, regulatory barriers impede health care delivery system innovations, serving neither patients nor health care providers and administrators.  To complicate matters, most health care regulations are written in dense, impenetrable language that is susceptible to myriad interpretations and are difficult and costly to implement. 

Although the country's policy focus on reforming the health care insurance system is appropriate and necessary, transforming the regulatory system should be an integral component of the broader health reform debate.  In this paper, I first discuss the reasons why the regulatory system is dysfunctional.  Then I will consider various alternatives that have been offered.  Finally, I will examine the criteria for reform and suggest an approach that relies on broad guidelines to monitor health care transactions as opposed to micromanaging the system.

2) Conducting a Dissonant Symphony:A Case Study of Network Leadership in the National Quality Forum
Bryce Hoflund, University of Nebraska at Omaha School of Public Administration 

The health care industry is undergoing a regulatory revolution. This transformation can be characterized as the movement away from command and control regulation to responsive regulation. This shift in the regulatory environment has been marked by the creation of new institutions designed to encourage increased participation by diverse stakeholders and the development of consensus-based standards. In 1999 the health care industry created the National Quality Forum, a network administrative organization that embodies the characteristics of this new regulatory order. The NQF is designed to address issues of health care quality in a new way by bringing together organizations from the public and private sectors and providing them with a forum to discuss and debate measures of quality, and ultimately, to effect change. The NQF thus represents a major administrative and regulatory experiment. While networks are an increasingly common aspect of administrative life in almost any policy arena, little is known about a network manager's or, more appropriately for this paper, a network leader's critical tasks in creating a network administrative organization. In addition to providing a picture of what this new type of responsive regulatory institution in health care looks like, the purpose of this paper is to present the results of an empirical study of the critical leadership tasks of the NQF's President and CEO during the NQF's formative stages. This paper identifies and describes three critical leadership tasks of the NQF's President and CEO: defining the NQF's mission, building and maintaining the NQF's social base, and creating the NQF's Consensus Development Process. The findings indicate that leadership is crucial to the formation of a network administrative organization and fill a gap in our understanding of network management by developing the concept of network leadership and exploring the critical tasks a leader undertakes while building a network administrative organization.

3) Improving Health by 'Command & Control': The case of the U.K.'s National Institute for Health & Clinical Excellence
Stirling Bryan, Ph.D., Professor, Department of Medicine, University of British Columbia; Director, Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute; Honorary Professor, Health Economics, University of Birmingham, United Kingdom

The topic area for this paper is the challenge posed by high cost health care interventions (i.e. drugs, procedures, devices etc.) and so the focus is on policy decisions by health care organizations to reimburse or cover such interventions.  There are some key questions we need to answer at the outset.  The first is 'Are we willing to set limits on available treatments?' If 'limit setting' is on the agenda then the next step is to decide on the criteria to be applied in setting such limits.  Cost-effectiveness analysis offers one route to making or informing such decisions.

The paper describes a part of the U.K. story in this regard.  An overview of the National Institute for Health & Clinical Excellence (NICE) is provided, with the detail describing the Institute's role in technology appraisal. NICE essentially determines whether selected new technologies will be available as part of routine care in the NHS.  Its technology appraisal decisions are mandatory – it does not merely issue advice, it makes policy.  Examples are given in the paper of decisions taken by NICE (e.g. pemetrexed for the treatment of non-small-cell lung cancer, donepezil for the treatment of Alzheimer's disease), and the impact of those judgements explored.  The key evidence drivers of decisions by NICE are described, and the political context for the Institute and its work is discussed.  For example, whilst NICE has broad cross-party support, the Health Minister, Lord Darzi, in his 2008 Review of the NHS expressed concerns around the delays in the process of issuing guidance and encouraged closer links to frontline NHS staff.

The paper then offers some external observations on how such a regulatory structure might play out in the United States.  Whilst the heterogeneity and complexity of the health care system in the U.S. suggests that simply replicating NICE would be a mistake, there are some positive lessons to be drawn from the U.K. experiment.  A key message is the importance of 'independence' for such a NICE-like body whilst at the same time achieving effective engagement from all key stakeholder groups.  The Institute is at arms-length from both government and industry, and has effective routes to allow the voices of both patients and the public to be heard.

4) Health Regulation in a Regulatory Polity: The EU's health policy instruments
Scott L. Greer, University of Michigan 

The European Union is, first and foremost, a regulatory polity. Its principal policy instrument is regulation; with a budget of 1.1% of the EU's GDP, it cannot redistribute or distribute and its staff is nowhere near adequate to provide significant services. So the greatest achievements of the EU have been in the construction of an internal market, and the mechanism its trademark combination of undermining member state regulations and replacing them with EU-wide regulation.

Its most important role in health policy to date has, quite predictably, been regulatory: the application of laws on cross-border mobility have been the most prominent way in which the Court has begun to structure EU-wide regulation of health care, but we also see a growing role for the EU in the application of competition, public subsidy (state aids), labor and other areas of regulation to health policy.

But to characterize the EU as a simple regulatory polity that applies neoliberal nostrums to heath care is to mischaracterize it. Instead, it is more useful- and more accurate- to view it as a gallery of EU policy instruments, new and old. Some are viewed as effective, others as ineffective; some are unproven, some inspire cynicism. But they are all being extended into health policy (public health and health care), and giving us a comparative opportunity to view them at work.

And that opportunity, this paper argues, is starting to answer the key question: to what extent is the EU only a regulatory state? Does health policy give us any grounds for optimism about the extent to which instruments of new governance and professional networks can enhance positive integration and policymaking? This paper first reviews the range of policy instruments available to the European Union in health policy. Each one is used across multiple policy areas and we can examine its performance over time and various policy areas in order to understand better what effects they have in health. It then draws on original interview research and a review of secondary and EU literature to sketch conclusions about the scope and types of effects that they appear to have been having.  The conclusion returns to the  question: to what extent does health policy suggest that the EU is more than a regulatory polity?

5) Informatics and New Governance:  The evolving role of the federal government in response to the American Recovery and Reinvestment Act (ARRA)
Maya Das, MD, JD, Research Scientist, National Opinion Research Center (NORC) at the University of Chicago, Bethesda, MD

The passage of the American Recovery and Reinvestment Act of 2009 provides unprecedented funding for health information technology (HIT) initiatives from the federal government.  HIT and health information exchange (HIE) have the potential to improve health care quality, safety, and efficiency.  In the absence of a federal presence in these areas until now, local, state, and regional organizations interested in utilizing HIT and HIE have come together to develop solutions in areas such as health care privacy, security, quality, and costs.  These entities often display features of the new governance model including encouragement of innovation, stakeholder involvement, reliance on broad framework agreements, and the use of self-monitoring and peer review. 

One of the challenges with the proposed larger federal government role will be to maintain this participatory model of governance that has evolved.  The new federal government structures that will need to be created to support the funding initiatives and the statutory requirements should be able to accommodate existing efforts that have already developed and encourage dissemination of successful solutions to promote HIT and HIE adoption   In addition, to achieve the promise of HIT, the governance model will need to: 1) focus on interventions that improve health care outcomes, but also lower costs, 2) promote innovation and local solutions, 3) achieve a balance among existing players, 4) take into account different practice settings, and 5) encourage participation among those who have not adopted health IT. 

This paper will provide a brief overview of the potential of HIT and HIE to reduce health care costs and improve quality.  It will also describe successful local, state, and regional efforts to encourage HIT and HIE adoption.  Finally, this paper will consider the impact of a strengthening federal presence in HIT and HIE on these initiatives, including opportunities for development of a transformational governance structure and ways to overcome barriers that may lead to competition for dominance and thwarted goals.   

6) Infection Control in the Hospital Setting: An Analysis of Regulatory Governance
Cary Coglianese, University of Pennsylvania; David Lazer, Northeastern University

Although media attention most recently has focused much attention on potentially devastating pandemics like the novel H1N1 influenza, more common and less glamorous infections transmitted in the hospital setting have for many years caused numerous fatalities. In the United States, hospital acquired infections affect an average of 7 to 10 percent of adult patients and as high as 30 percent of critically ill patients. The Centers for Disease Control have estimated that, in 1995, hospital acquired infections cost $4.5 billion and contributed to more than 88,000 deaths in the U.S. – one death every six minutes, and more than twice the number of fatalities associated with automobile accidents per year in the U.S. The risks from hospital acquired infections have shown little sign of abating in the intervening decade, demonstrating the need for improvements in hospital management and regulatory governance of the health care setting. This paper takes up the role for regulation in addressing the problem of infection control in health care. It first analyzes traditional liability and conventional regulatory strategies, explaining their significant limitations as effective responses to this pressing problem. It then examines alternative governance strategies, principally management-based regulation, that would encourage hospitals to develop internal systems to increase hand-washing by health workers and adopt other behaviors that can stem the threat of infection transmission in hospitals. The paper concludes that the causes of hospital transmission of infections are sufficiently complex that they call for nuanced management responses, and that only regulatory governance strategies that can induce such responses will be most likely to be effective.

7) Straddling Administrations: The Health Information Technology Governance Mashup
Nicolas P. Terry

As befits the most highly regulated industry in the U.S., healthcare is something of a laboratory for legal, regulatory, and self-regulatory models. The original model for healthcare regulation was resolutely state based and reflective of medicine's once-dominant professional hegemony in its custom-based standards (in medical malpractice) or physician-dominated agencies (medical licensure boards). As the federal government exerted its interests in homogeneity (e.g., with FDA regulation) or increased its role in funding (e.g., with Medicare and Medicaid) traditional administrative command-control models took hold.

Confronted by the accelerated growth of health information technologies, state-based regulation has tended to reflect the technophobic interests of traditional stakeholders, while federal command control (most notably in the case of HIPAA's transactional standards) has taken hold with models that have both offended the traditional stakeholders while proving oblique and unsatisfactory for emerging voices such as privacy advocates and patients.

Post-HIPAA, when the Bush Administration identified itself with the benefits of interoperable electronic medical records, HIT market failures were approached with a non-governmental 'cheerleader' model that utilized established national and international 'standards' organizations and innovative stakeholder groups to attempt to 'lead the market' towards EMR adoption without resorting to a 'son of HIPAA' command-control mechanism (or government funding). These governance organizations (such as the "American Health Information Community") were themselves designed to be 'spun-off' into the private sector.

Global economic pressures overtook this market-based model. The incoming Obama administration identified the HIT market failure as a "shovel-ready" target for economic stimulus. The HITECH Act, included in The American Recovery and Reinvestment Act of 2009, attempts to retool the new governance models of the Bush administration to effect government-funded rather than market-led approaches to EMR adoption. This approach continues to leverage non-governmental standards organizations in addition to related governmental institutions (e.g., the National Institute of Standards and Technology) while pulling back stakeholder governance from privatized organizations to more traditional agency advisory bodies (e.g., the "Health IT Policy" and "Health IT Standards" Committees).

This article examines these various governance models in the context of the requirements for a functioning EMR system and assesses their role in contrast to the more direct command-control model utilized for HIPAA's transactional standards and HITECH's "HIPAA 2.0" designed to reform the administrative response to EMR privacy and security.

8) Private versus Public Rulemaking: The OPTN as a Model of Evidence-Based Medicine?
David L. Weimer

Private rulemaking, the delegation of responsibility for developing rules to non-governmental organizations of stakeholders, potentially offers greater technical efficiency than traditional public regulation in the application of expertise in areas, such as medicine, with rapidly changing knowledge.  Specifically, it may allow the more effective and timely use of relevant evidence in rule development and the acceptance of rules by stakeholders.  Private rulemaking may also be politically attractive in distancing decisions with unfavorable balances of credit and blame from elected officials.  The Organ Procurement and Transplantation Network (OPTN) is a prominent example of such private rulemaking.  Case studies of the use of both scientific and tacit knowledge in rules governing the allocation of scarce kidneys, livers, and lungs suggest that these potential advantages have been realized.  In particular, the OPTN and the associated Scientific Registry of Transplant Recipients (SRTR) show not only exemplary implementation of evidence-based medicine, but also a reasoned balancing of social values and stakeholder interests.  The assessment of the OPTN identifies eight features that appear to contribute to OPTN effectiveness: professional engagement, continuity, meaningful stakes, decision-making by voting, specialization with consultation, transparency, data for creating evidence, and strategic oversight. Could these features be replicated in other areas of medicine?  As a thought experiment, one can imagine creating an OPTN-like organization to create incentives for economy and effectiveness in the reimbursement of surgery under Medicare.  More broadly, the assessment of the OPTN and its possible replication informs the choice of medical governance arrangements generally and private rulemaking specifically. 

9)  Improving Cancer Detection, Treatment and Survival through New Governance
Thomas R. Oliver, Professor of Population Health Sciences, University of Wisconsin School of Medicine and Public Health; Louise Trubek, Clinical Professor Emerita, University of Wisconsin Law School; Toby Campbell, Assistant Professor of Medicine, University of Wisconsin School of Medicine and Public Health; Matt Mokrohisky, Medical Student, University of Wisconsin School of Medicine and Public Health; Chih-Ming Liang, S.J.D. student, University of Wisconsin Law School

The Obama administration's commitment to a renewed campaign against cancer provides a timely platform to examine how new forms of regulation and governance can be utilized to improve cancer detection, treatment and survivorship.  "New governance" is a regulatory model that differs from top-down, command and control regulation and from professional self-regulation.  Instead, it relies on effective collaboration from multiple stakeholders, and emphasizes improved efficiency and innovation through data collection, monitoring and benchmarking.  This paper discusses the emergence of new resources and strategies in the U.S. campaign against cancer as well as recent cancer initiatives in the European Union, and investigates the potential benefits and challenges of their implementation.  In particular, we explore the role of new evidence, new technology, new participation and new institutions.  For example, we examine the conditions under which new guidelines for cancer detection and treatment are adopted and implemented into standard bedside practice, and we investigate the capacity of voluntary networks such as the Wisconsin Collaborative for Healthcare Quality and the National Quality Forum to facilitate this process.  In addition, we consider how the broader application of electronic medical records can strengthen analysis and communication among patients, clinicians, researchers and policy makers.  We also investigate the comparative incentives and results of using public reporting of cancer outcomes versus direct financial incentives for improved performance.  Finally, we examine how increased participation by patients, their families and advocacy groups can be translated into a new culture of clinical research and practice, resulting in expanded cancer registries, greater participation and representation in clinical trials, and improved focus on follow-up care and quality of life for cancer survivors.