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FROM THE FIELDInfluencing Cancer Policy
This paper describes the Institute of Medicine’s (IOM’s) eight-year experiment in examining cancer policy issues through the National Cancer Policy Board and more recently through the early phases of the National Cancer Policy Forum. Both were primarily funded by the National Cancer Institute and Centers for Disease Control and Prevention. The forum identifies and explores issues but, unlike the board, does not author IOM advisory reports. We report on the events that led to the establishment of these activities and discuss the factors that could lead to success in influencing policy, using examples of actual reports and effects on public- and private-sector programs and policies.
ADDRESSING IMPORTANT federal policy questions and managing political controversies are primarily the province of elected officials. Appointees may stand in for their elected sponsors, but the more distant from elected authority, the more likely they are to be disinterested in or actively discouraged from policy or politics. Yet agency leaders recognize that resolving policy or political controversies can be important to their programs’ goals. How can they achieve these objectives without appearing to be engaged in self-serving or defensive behavior? Even though they involve internal and external scientific advisers, because these efforts approach explorations of policy rather than science, they may be perceived to be dependent on agency advantage. Retaining the National Academies’ Institute of Medicine (IOM) is one way for health agencies to bring to bear an entity with the credibility that accompanies independence, reliance on evidence, conflict-of-interest protections, peer review, and experience and expertise in medicine and health—attributes that support evidence-based health policy analyses informed by good science.
In 1996 the leadership of the National Cancer Institute (NCI) and the Centers for Disease Control and Prevention (CDC) discussed with the presidents of the National Academy of Sciences and the IOM the establishment of a National Cancer Policy Board in the IOM but also in the National Research Council’s Board on Life Sciences. The shared board would be the National Academies’ primary focus for work in cancer, involving three of the four parts of the congressionally chartered, nonprofit "adviser to the nation on science, engineering, and medicine."1 Established under a three- and then five-year NCI/CDC contract from 1997 through 2005, the board comprised twenty distinguished, nongovernmental members of the cancer community with expertise in cancer science and care (a total of three chairs and fifty-two members over the board’s lifetime). With institutional independence, expertise, and generous long-term support, the board was expected to tackle cancer issues in candid and convincing ways that would inform programs and policies of the NCI, CDC, and other cancer stakeholders. With an extensive reach, the board would identify emerging policy issues in the nation’s effort to combat cancer, and, through studies that it carried out or referred to IOM consensus committees, its policy findings and recommendations would influence national policies in cancer care, science, and research. Thus, as had been intended, not only did the board carry out its work independently, it also set its own agenda. In an effort to consider the impact of this approach to shaping public policy on cancer-related issues, we as board members and staff review its performance over the eight years of its existence and examine its replacement, the IOM’s National Cancer Policy Forum (in 2005). We evaluate evidence for board-influenced changes of public- or private-sector policy. We consider what effects such changes might have had on cancer care, science, and research, recognizing that good empirical evidence for such effects is infrequent. We also consider the board’s transition to the forum.
The IOM often learns about the effects of its work by word-of-mouth reports or associations of events that are more anecdotal than rigorous evidence, which makes it difficult to prove pivotal effects on policy and discourages efforts to do so. Nevertheless, from the board’s work, including twenty-eight peer-reviewed reports and twenty-one other studies of cancer care, science, and research, we could select examples that generated public- or private-sector policy reaction.2 The forum has only completed its first year, but we can report some of the considerations that entered into its establishment, its early directions, and their implications for policy. Policy impacts of specific reports. In 1999, when the IOM had embarked on a series of analyses of the quality of health care, the board authored Ensuring Quality Cancer Care.3 This report concluded that "for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of their experience with cancer care." It recommended the development of clinical guidelines and a core set of cancer quality measures, better data systems, high-quality palliative care, and delivery of certain services in high-volume settings, among other actions. A follow-up report, Enhancing Data Systems to Improve the Quality of Cancer Care, expanded on the need for a core set of quality metrics and suggested ways in which such a set could be developed.4 These reports validated for cancer care what other IOM work on quality concluded about care in general and had substantial impacts on the federal executive branch, Congress, and the private sector.5 As a result of these reports, the NCI began a Quality of Cancer Care Initiative "designed to make cancer a working model for quality of care research and application...[that would] report regularly to...the National Cancer Policy Board," among other activities.6 The U.S. Department of Health and Human Services (HHS) established the Quality of Cancer Care Committee, chaired by the NCI director, with membership of six HHS agencies and the Departments of Defense and Veterans Affairs. The committee has supported interagency demonstration projects, provided assistance to public agencies and private organizations, and fostered cooperation in support of development of a national cancer data system.7 The deputy director of an NCI division presented a plan to implement the IOM’s recommendation for a national core set of quality-of-cancer-care measures at the board’s 17 January 2001 meeting. He requested a formal board letter (sent 28 January 2001) approving this plan.8 The NCI and other sponsors subsequently contracted with the National Quality Forum to carry out the plan. In the years following the board’s quality reports, Congress took up the cause. Senators Kennedy, Frist, Gregg, Brownback, Feinstein, and others extended the board’s work in proposed legislation that would address many cancer issues including survivorship, surveillance, data systems, and palliative care.9 We and other board members and staff were consulted on some of these bills. In the private sector, the American Society of Clinical Oncology (ASCO) contracted with Harvard and RAND in 2000 for a five-year National Initiative on Cancer Care Quality in response to "a 1999 report by the Institute of Medicine...suggesting that cancer care does not always meet expected standards."10 Results of that initiative, presented at ASCO’s 2005 annual meeting and subsequently published, identified strengths and weaknesses in the quality of care for breast and colorectal cancer.11 ASCO is also supporting the Quality Oncology Practice Initiative (QOPI), which, under the leadership of the board’s last chair, examines ways in which out-patient oncology can perform better.12 The most recent report on QOPI describes this initiative and again credits the board’s 1999 quality-of-cancer-care report.13 In 2005 the IOM released Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia, which extended the board’s earlier quality work.14 The Georgia Cancer Coalition (GCC), created to coordinate spending dedicated to cancer from Georgia’s share of the National Tobacco Settlement Trust Fund, had approached the IOM because of its previous work on cancer care quality. The GCC asked for a set of quality measures to support monitoring of its new program to improve cancer care in Georgia. The report recommended fifty-two such measures divided among the four major cancers—breast, colorectal, lung, and prostate—and suggested overall policies for quality monitoring. Gov. Sonny Perdue received the report 7 April 2005 and immediately ordered its implementation. The GCC and the state have embarked on putting the report’s recommendations into practice.15 The evidence that the board’s work on the quality of cancer care, existing problems, and potential solutions has influenced efforts to address cancer care quality is probably as good as we are likely to get in national policy. What effect this might have had on actual cancer care delivery and outcomes is more speculative and will, at the very least, require more time to assess. We do know, however, that efforts to improve quality have been durable to date. QOPI continues, has expanded, and has identified where improvements can, and likely will, be made. ASCO and the National Coalition for Cancer Survivor-ship have organized federal, academic, payer, and professional stakeholder groups (including liaison membership of forum staff) into a Cancer Quality Alliance to focus efforts to improve quality. The National Quality Forum is delivering quality metrics, which presumably will be put to good use, as will the board’s Georgia quality measures. Federal agencies such as the NCI, CDC, the Agency for Healthcare Research and Quality (AHRQ), the Health Resources and Services Administration (HRSA), and the Centers for Medicare and Medicaid Services (CMS) are sensitive to the issue and are supporting efforts to improve and pay for quality. There thus is some evidence that quality is better, and the board’s work has likely been among the factors influencing progress.16 In 2000 the IOM published Extending Medicare Reimbursement in Clinical Trials, a study requested by Congress that reviewed existing evidence on clinical trial reimbursement and recommended that "Medicare should reimburse routine care for patients in clinical trials in the same way it reimburses routine care for patients not in clinical trials."17 On 7 June 2000 the White House issued an Executive Memorandum "directing the Medicare program to revise its payment policy and immediately begin to explicitly reimburse providers for the cost of routine patient care associated with participation in clinical trials. These actions... follow a recent Institute of Medicine report recommending policy changes to encourage greater use of clinical trials by older Americans."18 A subsequent CMS national coverage decision (NCD) implemented Medicare coverage effective 19 September 2000.19 A number of state Medicaid programs have since extended payment under similar conditions, as have private insurers.20 These new policies likely reduced uncertainties and improved prospects for care payment and possibly even participation in trials. However, since payers reportedly paid unwittingly for a fraction of routine care of patients enrolled in trials before 2000, and payment rules under the NCD were complex, we cannot specify how much more frequently care was reimbursed or participation encouraged by implementation of the report’s recommendation.21 Improving Breast Imaging Quality Standards, an IOM study conducted under the aegis of the board, was requested by Congress to inform the proposed reauthorization of the federal Mammography Quality Standards Act, originally enacted in 1992 to address national problems in the technical and interpretive performance of x-ray mammography.22 The report recommended changes in audit procedures and Food and Drug Administration (FDA) regulations, and policies to improve breast image interpretation (including magnetic resonance imaging, or MRI, and ultrasound) and to address an impending workforce shortage. The American Cancer Society (ACS) formally committed $1.5 million to the NCI Breast Cancer Surveillance Consortium in the fall of 2005 to address directly some of the recommendations in the report.23 The report is undergoing careful scrutiny in the Senate Health, Education, Labor, and Pensions (HELP) Committee with a view to enacting some of the recommendations, and Senators Mikulski, Harkin, and Specter wrote the FDA "request[ing] that FDA adopt the regulatory changes suggested by the IOM which do not require legislative action."24 The report was reviewed at the September 2005 FDA National Mammography Quality Standards Act Advisory Committee meeting, and it is reported as useful input to the restructuring of regulatory policy for breast imaging screening for cancer.25 We have discussed these examples in some detail because we believe that there is reasonably persuasive evidence that they have influenced policy throughout the public and private sectors. Other reports coming from the board focused policy attention; were mentioned as informing policy deliberations; or were associated with policy-relevant federal, state, or private-sector activities. We next discuss these reports, with less extensive evidence for their policy influence. Policy-relevant reports. The IOM released two reports on palliative care, Improving Palliative Care for Cancer and Describing Death in America: What We Need to Know.26 The first encouraged cancer centers to focus on palliative care and research and to improve symptom control and end-of-life care for cancer, and it also included a recommendation for convening a state-of-the-science meeting at the NCI. In response, the NCI established an internal palliative care working group, which reviewed the current status of the ACS, Robert Wood Johnson Foundation (RWJF), and ASCO. The recommended state-of-the-science meeting was convened at the National Institutes of Health (NIH) 15–17 July 2002, and it reached some conclusions similar to those of the board report, stressing the need to better assess and manage cancer symptoms and encourage research.27 The second palliative care report recommended a new National Mortality Followback Survey program to document the extent of morbidity experienced at the end of life and to inform some of the improvements proposed in Improving Palliative Care for Cancer. This recommendation was taken up by the Last Acts Partnership (an RWJF program), and a report was prepared that supported a formal recommendation to the 2005 White House Conference on Aging.28 In 2003 the IOM issued Childhood Cancer Survivorship: Improving Care and Quality of Life.29 This report called for developing national clinical practice guidelines for the care of childhood cancer survivors. This encouraged the Children’s Oncology Group to complete and issue guidelines.30 "The guidelines [originally] grew out of an IOM [board] meeting in January 2002 where the need became apparent as did recognition that the Childhood [sic] Oncology Group possessed the expertise to develop such guidelines."31 The board’s childhood survivorship report was distributed nationwide by Candlelighters Childhood Cancer Foundation to all of its local affiliates. This outreach resulted in the provision of the report to congressional staff who were involved in preparing cancer survivor-ship legislation and led to the inclusion of childhood cancer survivorship issues in that bill.32 It is uncertain what policy implications that might have, as of this writing. We also identified board-initiated reports that were distributed as important information or the subject of special presentations at professional meetings. Meeting Psychosocial Needs of Women with Breast Cancer was distributed at the first annual meeting of the American Psychosocial Oncology Society.33 Other reports were said to be useful resource documents to groups such as small companies developing breast cancer detection technologies (Mammography and Beyond: Developing Technologies for the Early Detection of Breast Cancer) or made proposals that attracted support for implementation (Making Better Drugs for Children with Cancer).34 These kinds of exposures likely increased the visibility and therefore the influence of the board and provided useful information to interested groups, although we cannot yet identify policy impacts.
Our examination of the National Cancer Policy Board suggests that the board authored reports that were perceived as high-quality and evidence-based, and that addressed important policy issues in ways that the NCI and CDC found helpful. As the end of the second NCI/CDC contract drew near in 2005, the IOM, NCI, and CDC conferred to explore whether the board as a policy experiment had come to a natural endpoint, should continue in similar form, or should be replaced by a different approach. At the time of the board’s establishment, we believe that the NCI and CDC saw the value of an independent venue to explore policy issues informed by good science. The NCI contract (to which CDC contributed funds) imposed essentially no restrictions on the National Academies beyond the usual federal accounting requirements. The board enjoyed the unusual privilege of developing an agenda of studies and other activities subject only to the oversight of the National Academies’ procedures. The agencies had only to believe that the board’s analyses would be useful to them and that its independence increased that usefulness and influence—a belief that, as we conclude here, had merit. But other, quite different, approaches could have been considered. By 2005 we believe that the NCI saw a continuing IOM cancer policy activity more as a means to focus (at less expense) on issues relevant to ongoing agency program interests, and this was reflected in a different NCI relationship and the board’s replacement by the forum. As a convening activity, the forum could include representatives of sponsoring federal agencies. Initially, the NCI proposed a forum that would primarily comprise the relevant HHS agencies: NCI, CDC, CMS, FDA, AHRQ, and HRSA, with a few additional members from academe and industry. This proposal was not consistent with National Academies policies and was modified so that the federal participants would constitute a small minority of the membership. The chair of the National Research Council, who determines the membership of National Academies bodies, appointed the federal members and included four private-sector organization members (ACS, ASCO, C-Change, and United-HealthGroup), a chair, and eleven other unaffiliated members from academe and industry. Convening activities cannot conduct or oversee consensus studies. The forum could identify potential studies to be overseen by other units of the IOM. If the federal sponsors agree, forum funds may be contributed to support a study originating in the forum but conducted independently in another part of the IOM. The initial funding commitment to the forum from its sponsors was for two years. Core funding to the board had come 75–80 percent from the NCI and 20–25 percent from the CDC ($9.575 million over the eight years and about $1.8 million in the final year). Core funding to the forum was 38 percent from the NCI, 26 percent from the CDC, 6 percent from the other agencies, and 30 percent from the private sector ($2.65 million over the two years). Both the board and the forum raised additional funds to expand the scope of their work, but total annual funding for the forum supported fewer staff and, as noted, a more restricted work program than the board had had. As its first project, the forum held a major workshop in March 2006 on the technologies used to discover and develop cancer biomarkers. This had implications for academic, industry, and federal (primarily FDA and NCI) policy. The workshop was structured as an input to an IOM consensus committee study. This enabled the information to be used in a study that will offer peer-reviewed findings and recommendations. The forum also scheduled a workshop to follow up on the board’s adult survivorship study. This workshop, supported in part by new private funds, further explored the practical implementation of survivorship care plans. These projects, although not proposed by federal members, were helped by considerable federal consultation and participation. Projects on prevention and quality of care, among others, are also under consideration by the members.
Differences in the amount and duration of support, capacity, and membership in principle, although perhaps not in practice, might affect the influence of the forum as compared with that of the board. The board benefited from long-term support, which provided time for deliberation, better understanding of its mission and potential, and better productivity. It developed and explored themes in more than one report and perspective. Strengthened policy impacts often emerged from the various report series. In contrast, the forum’s two-year schedule should provide for enough work to allow some assessment of the value of this new policy effort, but it is less likely to result in thematic development unless extended. Agency advisory groups, staffed by agency personnel, are likely to work on agency agendas. With the financial stability of long-term funding and staff, the board looked at new agendas. When it produced Ensuring Quality Cancer Care, criticism of the quality of cancer care was not a cancer organization characteristic. The IOM’s series on general quality of care also benefited the board, as an IOM activity, in developing quality-of-cancer-care findings and recommendations in Ensuring Quality Cancer Care and Assessing the Quality of Cancer Care: An Approach to Measurement in Georgia and, we suspect, made those reports more credible and influential on cancer policy. Similarly, the forum might follow up its work on biomarkers with explorations of qualifying assays in new cancer treatments or policy work on the FDA’s Critical Path Initiative, and the forum is also the appropriate venue for a survivorship project extending the board’s survivorship report. There are many inputs to the formation of cancer policy. Those with the most solid evidence and careful peer review will likely be the most credible and influential, other things being equal. This explains why advocates often approach policymakers with IOM committee reports in support. The board reports cited here benefited from the careful marshalling of evidence required by board members and enforced by the mandatory peer review process of the National Academies. IOM committee studies that are suggested and that could undergo some preliminary planning or use information generated by the forum will also be evidence based and peer reviewed. Forum workshop summary reports will be reviewed based on what is presented by participants at the event, although forum members will insist on evidentiary standards at workshops that are as strict as possible. The forum’s lesser funding and capacity could lead to an emphasis on convening and informing as opposed to output of the more expensive and influential IOM consensus committee studies. Judging from the variety of public- and private-sector sponsors of the forum, these sectors must have concluded that a cancer policy focus within the IOM had value and that it would be advantageous to participate in the forum. The board had broad authority to conduct studies and initiate activities, thus providing many opportunities to influence policy. The forum has a more limited role of convening and raising issues. This inevitably means that its influence will be less direct and measurable. However, as an incubator of ideas for studies, the forum still can play a role in policy. The forum’s first workshop project will result in an independent IOM consensus report overseen by the IOM Executive Office, and its second will be a follow-up to implement the recommendation of a board report. Experience to date has also shown that there are viewpoints and information brought to the forum from its institutional members that can broaden perspectives and may be helpful. WE CONCLUDE THAT retaining an entity with a cancer policy focus, the National Cancer Policy Board, at the IOM usefully affected cancer policy in the public and private sectors. We further conclude that the forum, as a successor to the board, although more limited in its role and resources, has already generated useful projects with the potential to affect cancer policy. Whether the forum influences cancer policy as the board did will only be determined as its work emerges.
Roger Herdman (rherdman{at}nas.edu) is director of the National Cancer Policy Forum (and was director of the National Cancer Policy Board) at the Institute of Medicine in Washington, D.C. William McGuire is chairman and chief executive officer of UnitedHealth Group in Minnetonka, Minnesota. Joseph Simone is president of Simone Consulting in Dunwoody, Georgia, and was the board’s last chair. This paper reflects the views of the authors and not necessarily those of the Institute of Medicine.
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The National Cancer Policy...
Measuring Policy Impact
