This post is part of the Health Affairs Blog short series, “Value Assessment: Where Do We Go Post-COVID?” The series explores what we have learned about value assessment and related issues during the coronavirus pandemic, how we might think about value in health care going forward, and how these ideas might translate into policy. The series is produced with the support of the Innovation and Value Initiative (IVI) and grew out of a group of webinars hosted jointly by IVI and ISPOR—The Professional Society for Health Economics and Outcomes Research. Included posts are reviewed and edited by Health Affairs Blog staff; the opinions expressed are those of the authors.
Proposals for a national entity to produce and assess evidence about the relative value of medical technology have found new energy in recent years. Efforts to create such an organization, however, are not new. The history of health policy in the United States includes multiple abandoned efforts to establish this type of body. Within the federal government, these include the National Center for Health Care Technology, established in 1978 and sunsetted in 1981; the Congressional Office of Technology Assessment (OTA), established in 1972 and defunded in 1995; and the Agency for Health Care Policy and Research’s clinical guidelines development program, established in 1989 and ended in 1996 in the wake of controversy surrounding a guideline for treating lower back pain.
But this history is not just limited to discarded efforts. Some examples of federal capabilities that continue to the present include assessments that support Medicare’s National Coverage Determination process, the work of the United States Preventive Services Task Force, and the technology assessment program of the General Accountability Office, among others. At the state level, California and other jurisdictions have established their own programs to review proposed health insurance benefit laws. The many private-sector assessment efforts, whether independent or serving particular stakeholders, as well as examples from other countries, such as the Canadian Agency for Drugs and Technology Technologies and in Health and the UK’s National Institute for Health and Care Excellence, provide clear evidence for the feasibility and benefit of such agencies.
Because of, or perhaps in spite of, this history, proposals for a new value assessing entity emerge somewhat regularly, often articulating evidence needs not currently being fulfilled by existing capabilities. The recent USC Schaeffer Center for Health Policy and Economics/Aspen Institute task force report lays out the market failures that support the idea of a new national entity to assess the value of both new and established health care technologies and services in a credible manner, free from potential real or perceived conflicts of interest. The fundamental argument, largely true, is that such information is not currently available. But the bigger question is likely how such an agency might operate to achieve the aim of providing important information to decision makers without suffering the same fate as its predecessors.
Having spent the first seven years of my professional life at the OTA, and having observed both the successes and shortcomings of past efforts, it is clear that establishing a new entity to guide decision making and public discourse without repeating missteps of the past will require careful attention. Many of the pros and cons of different approaches are laid out well elsewhere, including in the USC/Aspen report. In this post, I briefly explore a few aspects of a potential health technology assessment (HTA) entity that have received less attention.
Public Or Private?
One fundamental question is whether a new organization should be public or private, even if funded with public dollars. Proponents of private solutions cite evidence that such entities are less bound by government hiring and contracting rules, making them nimbler and more efficient. They often point to the National Academy of Medicine and the Patient-Centered Outcomes Research Institute (PCORI) as entities with strong track records of filling evidence gaps to inform decision making. Some, including the USC/Aspen Institute task force, have also expressed concern that the federal government’s additional roles as the largest payer of health care in the US and the largest investor in the innovation that produces many technologies—particularly the early, vital basic research upon which the private sector builds—reduces its ability to produce truly independent analyses that can achieve stakeholder acceptance.
The hyper-partisanship of current national politics may reinforce assumptions about the ability of government agencies to perform. Because the OTA and the other abandoned HTA efforts cited above were all federal agencies, they might be seen as examples of why a public-sector agency is not desirable. In reality, the OTA successfully informed a plethora of health policy decisions with little controversy. Its cost-effectiveness analyses of preventive services as potential Medicare benefits are but one example. While there were some concerns about bias, particularly in the agency’s early years, political scientists and other observers mainly attribute the OTA’s demise to its inability to deliver timely reports and its specific structure, not to its placement within the public sector.
There are multiple examples in health policy of public agencies that successfully provide analytic input, including the Congressional Budget Office, the Centers for Medicare and Medicaid Services Office of the Actuary, the Medicare Payment Advisory Commission, the Medicaid and CHIP Payment and Access Commission, and state-level agencies that advise legislators and regulators about health insurance benefit mandates, among others. They differ in terms of the roles they play and how they assure rigor, accountability, and stakeholder acceptability, but all provide models from which a new federal agency could borrow. One important common denominator among these examples is that they are advisory, leaving any decision making around coverage, regulation, and payment to others. Another is that they all have access to public data not necessarily available outside of government. Such data, including non-public Medicare files or government surveys, could be a valuable resource in trying to understand the current use of technology or needs of different populations.
Moving Beyond QALYs
The roles often suggested for a national HTA agency include analyses of new and existing technologies including devices, pharmaceuticals, diagnostics, and procedures; the collection and organization of data to inform future assessments; and the development or support of methodology with which to conduct assessments. One thorny issue for policy makers and other stakeholders has been the incorporation of economic assessment in HTA, especially the use of cost-effectiveness analysis (CEA). Expressing benefits in quality-adjusted life-years (QALYs) can mask the complexities of assessing human preferences and raise questions about using these measures of value to inform who gets what care.
There is also the concern that value determinations averaged over large populations do not adequately capture heterogeneity in the need, benefits, risks, and preferences associated with a given technology. While single quantitative estimates are easier to understand and use in decision making, they mask complexity. Stratifying populations may make quantitative estimates of value more accurate for a given patient, but numbers alone can still convey greater understanding and certainty than is warranted by quantitative methods alone. Recent methodological advances in quantitative methods have begun to address some of these problems. In addition, other economic analyses, focusing on the costs associated with a technology, who bears those costs, and affordability can still be useful components of HTA even if CEA is not.
These efforts notwithstanding, HTA represents an important opportunity to bolster our understanding of value through qualitative research techniques. Greater use of case studies, interviews, ethnographic observation, and other approaches could not only provide context for understanding quantitative estimates of costs and benefits, they could provide decision makers with nuanced characterizations of patient and provider preferences, differences across populations, an understanding of how technology is actually used in care settings, and insight into the interaction of culture, social determinants, and technology. If well done and clearly presented, qualitative research might prove more useful to decision makers and acceptable to stakeholders than continued efforts to refine cost-effectiveness ratios. Although qualitative methods have always been central to fields such as anthropology, they have made their way into health services and policy research more slowly. The explicit adoption of this approach by a new HTA organization could help demonstrate its value and set standards for its rigorous application more broadly in health services research.
Another area where an HTA entity could play a pioneering role is in the use of data from sources other than traditional clinical trials or other research. The pervasiveness of data collection in all areas of our lives creates the potential for social media and other data to join electronic health records and administrative claims as sources of “real world” health care evidence. Establishing standards and furthering methods for the use of such data would advance the application of real-world evidence in health research generally while providing new insights into technologies assessed.
We usually think of technology assessment as a tool to assure the appropriate use of existing technology. In establishing the OTA, however, the Technology Assessment Act of 1972 (Public Law 92-484) noted that because “technology continues to change and expand rapidly…it is essential that, to the fullest extent possible, the consequences of technological applications…be anticipated….” Indeed, in pushing for the agency’s creation, Senator Edward Kennedy (D-MA) suggested that the OTA could have saved lives if the dangers of children ingesting lead paint were recognized before its use became widespread 30 years prior. Another potentially beneficial role that an HTA agency could play would be to scan the scientific horizon to identify developments in basic research with implications for health care delivery and to identify emerging technologies before they are diffused. The Pharmaceutical Research and Manufacturers of America (PhRMA) has had its “Medicines in Development” series for many years, but these reports are limited to pharmaceutical technology, focus on scientific developments only after they have entered clinical trials, do not reflect the independence envisioned for a new HTA agency, and do not attempt a comprehensive assessment of the implications of the scientific advances they identify.
Scans from a new agency would not be able to predict the ultimate effectiveness or risks of a technology, and the analysis would be more general and less certain the more basic the research. However, given the difficulty in lowering the use of low-value care once a technology has diffused, this sentinel function would allow patients, providers, manufacturers, and payers to anticipate uses, costs, and other implications. It would give stakeholders an opportunity to work together to assure appropriate, fair access. A 1987 publication exploring emerging technologies to detect genetic mutations is but one of many OTA reports that played this role.
For a new HTA agency, these reports could comprise a mix of both regular assessments of the state of biomedical research and special reports focused on specific technologies. As an independent body, the HTA agency could also serve a convening role to bring stakeholders together for the types of early deliberations envisioned above. As the nation considers a new Advanced Research Projects Agency for Health (ARPA-H) to “rapidly transform breakthroughs into tangible solutions for all patients,” one could envision this scanning of the scientific landscape as a joint undertaking of the ARPA-H and the HTA agency.
Leading On Equity
The events of the past two years have underscored the urgent need to address systemic biases and disparities in US health care. Here, too, a national HTA organization has an important leadership role to play. The connections between technology and equity are multifaceted. Technology can be a tool to reduce disparities, as telehealth has shown in its ability to provide remote access in rural and other underserved areas. But at the same time, the most common forms of telehealth require broadband, which itself is less available in areas where health-related disparities also exist. A tool for potentially lessening disparities can actually perpetuate them with profound results as COVID-19 has demonstrated. Recent research has also demonstrated how new technologies such as artificial intelligence can create new disparities.
By fully unpacking the equity implications of technologies and considering how they may help ameliorate disparities—or at least avoid them—the HTA enterprise can make equity a central focus. Like all health-related organizations, a new agency can play an important role in supporting a diverse workforce in hiring, contracting, and governance and in creating internship and training opportunities for underrepresented groups.
HTA is about more than technology. It intersects with all of the major challenges facing US health care: cost, quality, access, equity, social determinants, and the tensions between the country’s dual commitments to innovation and health care. The evolving technological landscape continually provides new opportunities to consider each of these issues. A national HTA could be an important new public forum for that work.
The author is a full-time employee of AcademyHealth, a nonprofit professional association of health services and policy researchers and organizations. AcademyHealth takes no positions on issues of health policy but does advocate for funding for health services research and other issues key to the creation of evidence around health care. AcademyHealth has taken no position on the creation of a national technology assessment agency.