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The controversy over patients' access to stem cell interventions is familiar to scholars of the drug regulatory system and the politics of evidence-based medicine. What counts as evidence of a biomedical intervention's safety and effectiveness? Who should define and assess safety and effectiveness, and how? In the first section of the paper we describe the types of stem cells that may be therapeutically effective. We then describe how the US Food and Drug Administration asserted regulatory authority over certain stem cell interventions and the legal challenge to the agency's actions. Next, we place the debate about patients' access to stem cell interventions in the broader context of efforts in the US to promote and implement health technology assessment and the debate about standards of evidence. We then review several proposed initiatives to get stem cell and other new biomedical interventions into the clinic faster and consider the extent to which these policies can resolve the underlying conflicts about evidentiary standards for clinical use. Finally, we consider whether efforts to expedite access to biomedical technologies may undermine countervailing efforts to improve the safety and effectiveness of stem cell interventions. [ABSTRACT FROM AUTHOR]

Health care in the United States is fragmented, inefficient, and rife with quality concerns. These shortcomings have particularly serious implications for adults with disabilities and functionally impaired older adults in need of long-term services and supports (LTSS). Three strategies have been commonly pursued by state governments to improve LTSS: expanding noninstitutional care, integrating payment and care delivery, and realigning incentives through market-based reforms. These strategies were analyzed using an evaluation framework consisting of the following dimensions: ease of access; choice of setting/provider; quality of care/life; support for family caregivers; effective transitions among multiple providers and across settings; reductions in racial/ethnic disparities; cost-effectiveness; political feasibility; and implementability. Although the analysis highlights potential benefits and drawbacks associated with each strategy, the limited breadth of the evidentiary base precludes an assessment of impact across all nine dimensions. More importantly, the analysis exposes the interdependent, complex system of care within which LTSS is situated, suggesting that policy makers will require a holistic and long-term perspective to achieve needed changes. Addressing the nation's LTSS needs will require a multipronged strategy incorporating a range of health and social services to meet the complex care needs of a diverse population in a variety of settings. [ABSTRACT FROM AUTHOR]