Dissenting Opinion of David Beier, J.D., Senior Vice President of Global Government and Corporate Affairs, Amgen


The committee’s report recommends that the secretary of the Department of Health and Human Services (HHS) undertake the sensible step of evaluating the methods of organizing and delivering care (including important concepts such as the use of “medical homes”). Specifically, tasking HHS with a thorough analysis of the benefits and risks of implementing significant health system changes is a prudent and reasonable measure to inform potential future action by the U.S. Congress and the administration. However, the report moves immediately beyond the needed analytic assessment phase and issues specific and detailed recommendations on the topics of comparative effectiveness and cost-effectiveness assessments.

These majority recommendations are controversial, as recognized by the dissenting views expressed by committee members. Further, the fact that the report, at one point, calls for further analysis and then issues a recommendation to mandate the use of new methods for coverage and reimbursement under Medicare, Medicaid, and other federal health care programs suggests that any recommendations made at this juncture are not fully informed by the necessary research identified by the committee.

The report does not explicitly or implicitly endorse any particular health technology assessment (HTA) model. That said, the current policy debate in Washington has been informed by frequent references to the adoption of HTA models from jurisdictions outside the United States, including most prominently the National Institute for Clinical Excellence (NICE) in the United Kingdom.1 This dissent is a commentary about the risks of adopting those systems. Without acknowledging how comparative effectiveness and cost-effectiveness could be misused, there is substantial risk that the terms of the real policy debate could become obscured.

Below, I discuss three primary areas of concern with the majority’s recommendations.

1

Other nations have over time also used HTA authorities, including—most notably—Australia and Canada. In addition, Wales and Scotland in the United Kingdom have their own HTA authorities. Other nations in Europe, including Germany, are moving toward full adoption and application of HTA authority to limit access or to make coverage or price determinations.



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