The committee found no evidence that beneficiaries or physicians are encountering difficulties in obtaining needed laboratory tests. The Health Care Financing Administration (HCFA) has not received any complaints about access problems. Laboratory services are not a significant concern of consumer groups that speak for Medicare beneficiaries. There is no evidence of even limited problems, for example, in rural areas.

The number of laboratories has increased nationally since the fee schedule was established in 1984. A study by the Office of the Inspector General (OIG) assessed the impact of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) on the number of laboratories, and their distribution, with particular attention to rural areas. In 1995, CLIA had issued 151,658 certificates for laboratories, including multiple certificates for the same site—for example, two or more separate laboratories located at the same hospital center. In its analysis, which counted only one of the multiple laboratories located at the same site, the OIG found an average of 51 clinical laboratories for every 100,000 persons and nearly one site for every four physicians. Of the more than 3,000 counties in the country, only 66 had no laboratory site (38 of these had no physician medical practice site). Rural counties had nearly the same number of laboratories per capita as non-rural counties (OIG, 1995).

Between 1985 and 1995, the number of Medicare beneficiaries increased by less than 3 percent a year. The number of laboratory tests performed on beneficiaries grew an average of 17 percent annually (OIG, 1995). The OIG found no evidence of an insufficient supply of laboratories or access problems. Between 1995 and March 2000, the number of CLIA-certified laboratories nationally grew from 151,658 (including multisite laboratories if registered or certified separately) to 170,000 (Dyckman and Cassidy, 2000).

Although approximately 5,000 short-stay hospitals participate in Medicare (HCFA, 1998), there are currently 8,560 hospital-based laboratories, almost 5,000 independent laboratory sites, and 105,000 physician office laboratories (POLs) certified by CLIA (Table 2.1). Virtually all participate in Medicare. The committee found no evidence that POLs are denying access to Medicare beneficiaries, that beneficiaries are having difficulty finding a POL, or that physicians have reduced access since 1995.

For beneficiaries who have difficulty reaching one of the 170,000 certified laboratories, independent laboratories run specimen collection stations.1 At such stations, there are staff who draw and collect specimens and transport them to the laboratory that performs the tests. Often the test is run overnight, and the physician has the results in the morning. Similarly, most physicians, even if they do not have a laboratory in their office, generally are willing to have their staff collect specimens for the convenience of their patients. A laboratory service picks up the specimens from the physician’s office on a daily basis. Collection


Because these stations are not certified under CLIA, there are no federal statistics available on their numbers.

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