Chapter 51 : The Future of Pathology and Laboratory Medicine: Political, Social, Economic, and Regulatory Impacts

Abstract:

This chapter discusses the major features of the current healthcare environment. It describes the current regulations affecting laboratory practice. The chapter explains future regulations and political and economic events impacting pathology and laboratory practice. A high level of volatility and uncertainty, reflecting the political, economic, and social instability of our current environment, characterizes healthcare in the United States in the second decade of the 21st century. Funding and support for healthcare are diminishing, and the economic future of healthcare is hostage to some identifiable trends and concerns that include: a growing federal deficit and concerns about the future sustainability of Medicare and Medicaid; and a healthcare insurance and delivery system plagued by problems of access, quality, and safety. The “four horsemen” of federal laws and regulations that are particularly pertinent to pathology and laboratory medicine services are CLIA ’88, HIPAA, the Occupational Safety and Health Administration (OSHA) standards for occupational exposure to blood-borne pathogens, and the so-called Stark regulations that prohibit self-referral by healthcare providers. The increasing research and clinical demands for validated biospecimens can be expected to lead to significant growth in the number and size of biorepositories. Two other areas of concern to research and clinical laboratory practice are restrictive patents and excessive restraints on the use of human tissue and data for research and clinical purposes.