This study examines the role of public health laboratories (PHLs) in the changing health care market, with an emphasis on delineating the relationship between PHLs and managed care. The topic is becoming the focus of considerable attention, particularly as the growth of managed care continues to alter the landscape of health care, and as emerging infectious diseases remain priority issues in public health. The current and future role of PHLs in this changing health care environment has not been studied systematically.
The Office of the Assistant Secretary for Planning and Evaluation (ASPE), Office of Health Policy, within the U.S. Department of Health and Human Services initiated this study in order to better understand the relationship between PHLs and managed care organizations (MCOs). Of particular importance to the Department is: a) understanding the role of state PHLs relative to new actors in the health care system; b) identifying and characterizing interactions between PHLs and MCOs (e.g., contracts for testing, information reporting and policy development); and (c) defining the unique value of PHLs in the promotion of public health.
There are three target audiences for this study. The first audience is state PHL directors. Our goal here is to compile a resource for this audience on timely PHL policy issues, and to educate those in the managed care community about the role and unique value of PHLs. We highlight existing and emerging arrangements between MCOs and PHLs as a model to help both the public and private sector develop better working relationships.
The second target audience for this study is state policy makers. We seek to inform state health agency (SHA) and regulatory deliberations that center on laboratory services. As state scrutiny of laboratory services and other expenditures on public health intensifies against the backdrop of cost reduction, identifying ways in which the PHLs add value will be critical. We emphasize the unique value of PHLs, as well as the potential for, and feasibility of, public-private collaboration in clinical laboratory services.
The third audience is federal policy makers. Our intent here is to characterize the federal role in PHL-related issues. We report on the interactions between PHLs and federal health agencies. Among the Public Health Service (PHS) agencies, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been most involved in PHL activities, particularly in the area of disease reporting. The Environmental Protection Agency (EPA) also typically works closely with the labs in many states. Other PHS agencies have been indirectly involved in PHL issues (e.g., testing revenues from Medicaid programs have partially supported state PHLs).
To inform these deliberations, ASPE contracted The Lewin Group to review published and other literature on PHLs and health market change; carry out interviews with key laboratory representatives from the public and private sector; and conduct several case studies of states to characterize PHL efforts and experiences with managed care and health system change. Specifically, we focus on four central questions:
To bound our scope of work, we restricted the focus of this study to state PHLs rather than to the full range of PHLs (e.g., local health department laboratories, EPA laboratories). State PHLs are of particular interest currently because: (1) state health agencies (SHAs) are a central part of the public health infrastructure; and (2) many states are currently grappling with issues related to government management and service delivery of health care (e.g., privatization of public health functions). We acknowledge, however, that many other PHLs (e.g., local and federal) serve critical roles in maintaining and enhancing the public health infrastructure, and should be studied as well in the context of further research efforts.
This document is organized into four main sections. First, we describe our study methodology and analytic approach. Second, we provide an environmental scan of PHLs and the factors in the health care market that are currently affecting or may in the future affect PHLs in order to provide ASPE with some context and background of the clinical laboratory landscape. Third, we present our analytical results derived from our literature review, interviews with laboratory experts, informal poll of PHL directors, and case studies of states. Finally, we discuss our conclusions on the current state of PHLs in the health care market and describe the impact of health market changes on the PHLs' practices and functions.
Due to the novelty of the topic and the consequent paucity of published information, it was necessary to go beyond the available literature by conducting interviews of public and private experts in clinical laboratory issues. We also performed case studies of states with PHLs that have had experience in dealing with health market change in order to better characterize the range of existing interactions between PHLs and other organizations (e.g., private clinical laboratories, MCOs, government organizations).
This study was performed on contract for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), Office of Health Policy, within the Department of Health and Human Services (DHHS). We received input throughout the study from other federal and state government organizations, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). We were also assisted by the leadership of the Association for State and Territorial Public Health Laboratory Directors (ASTPHLD), the primary association for state lab directors. Finally, we also solicited review and support from private sector interests (e.g., the American Clinical Laboratory Association).
Because our subject matter has not been widely studied, we initiated a broad literature review consisting of four components: (1) search of peer reviewed literature; (2) search of grey literature; (3) internet search; and (4) review of the CDC's Morbidity and Mortality Weekly Report (MMWR). We also accessed literature by asking our interviewees for additional sources, as described below.
We searched peer-reviewed sources using bibliographic databases of the National Library of Medicine (MedLARS). We performed direct search of MedLINE (citations of peer-reviewed journal literature), HealthSTAR (citations of journal literature and other sources in health services research, technology assessment, and health planning), and HSRProj (citations of recent and ongoing health services research funded by government and the private sector). The search covered English-language publications. We used a number of the MeSH (Medical Subject Headings)(1) terms and key word combinations to identify relevant articles:
We also searched grey literature from newsletters, press releases, specialty business and medicine journals, on-line materials, and other sources, including:
Lexis/Nexis -- Contains major archives of federal and state case law, statutes of all 50 states, state and federal regulations, and public records from major U.S. states. Lexis/Nexis contains national and international newspapers, newswires, magazines, trade journals, and business publications.
DialogTM -- An on-line service that contains over 450 electronic libraries covering a broad range of disciplines. These libraries contain documents from the scientific and technical literature, trade journals, newspapers, and newswires (includes HSRProj, a database of ongoing health services research activities).
Lexis/Nexis searches were restricted to the past two years and the search terms had to appear in either the abstract, leading paragraph, or title.
The search strategy and key words for these searches were as follows:
For the Internet searches, we scanned the Yahoo! and Infoseek search engines for articles using the following keyword search terms:
We also wanted to identify literature pertaining to the involvement of managed care relative to PHLs in the areas of disease surveillance and outbreaks. To facilitate this, we manually searched the MMWR from 1994 through the end of 1996 for titles related to managed care and disease outbreaks. Overall, we found two articles describing outbreaks in WA and NM that precipitated limited interaction between MCOs and public health agencies involved in responding to the outbreaks.
We also requested relevant literature on PHLs from the Association of State and Territorial Public Health Lab Directors (ASTPHLD); the Clinical Laboratory Management Association (CLMA); and from Dr. Michael Skeels, the Director of the Oregon State PHL, who is actively engaged in relevant research. The counts presented below include relevant articles identified by examining the bibliographies of articles located through the search engines.
In total, we identified 140 articles in our literature search. We excluded articles that did not contain information relevant to our key study questions. We found a total of 24 relevant articles that were directly applicable to clinical laboratories, health system change, and PHLs (see Figure 4 below).
| Source of Information | Number of Articles Identified | Number of Relevant Articles Summarized | ||
| MedLARS | 40 | 4 | ||
| Nexis/Lexis and DialogTM | 81 | 5 | ||
| Internet Sources | 4 | 4 | ||
| MMWR | 2 | 2 | ||
| Other Sources* | 13 | 9 | ||
| Total | 140 | 24 |
*Literature from ASTPHLD, Oregon State PHL Director, Clin. Lab Manufact. Association, and Goldman Sachs
A complete bibliography is contained in Appendix A. Key points from the literature with specific relevance to our study are footnoted throughout this report.
Interviews of Clinical Laboratory Experts
During the course of the project, we conducted interviews B in person when possible, or else by telephone B in order to supplement information from other sources. We used these interviews to help define and direct our selection of case studies, to better characterize the range of interactions assumed by PHLs, and to get a balanced perspective on trends in this industry.
We identified our interview candidates through our literature review, conversations with national membership associations (e.g., ASTPHLD, ACLA, CLMA), by recommendation of our project officer and other ASPE staff, and by recommendation of key opinion leaders, including some of the interviewees (i.e., we asked interviewees to recommend additional interview candidates). Overall, we completed 54 interviews of clinical laboratory experts in addition to the interviews conducted during the three case studies. Interviewees included the following:
| Interviewees | # of Interviews | |
| State public health lab directors | 19 | |
| State or county epidemiologists | 5 | |
| Federal officials from among CDC, FDA, HHS | 9 | |
| Commercial laboratory executives and hospital lab executives | 7 | |
| MCO lab services directors | 4 | |
| Membership organizations of labs, county and city health officials | 6 | |
| Academic researchers in the area of clinical laboratories | 2 | |
| Health care consultants with experience in PHLs | 2 | |
| Total | 54 |
For consistency across interviews, we developed a structured interview protocol that covered the central aspects of our study. The protocol was designed to ensure that the same topics were covered in each interview, but also to allow the interviewees to respond freely to relatively open-ended questions. The purpose of this approach was to facilitate the capture of as much information as possible. Given the limited literature on the central topics, we wanted to avoid creating an overly narrow tool that failed to elicit relevant information.
A list of our interviewees, along with a copy of our interview protocol, is included in Appendix B.
Informal Poll of PHL Directors
As the study progressed, we needed to ensure that we were obtaining broad coverage of the central study questions from all 51 state and territorial public health laboratories. Therefore, we initiated a brief informal poll of PHL directors. The poll consisted of three questions directly relevant to our study:
Has managed care's presence in laboratory services changed/affected the practices and/or functions of public health laboratories in the state? If so, how?
The ASTPHLD reviewed the questions before we sent it out, kindly agreed to endorse the poll, and provided a list of state contacts. Our efforts were supported by Dr. Michael Skeels of the Oregon Public Health Laboratory, who conducted a similar brief poll in 1995, using a somewhat different set of questions.
We initially mailed and faxed the questions to all 51 PHL directors, and then followed up with multiple telephone calls to ensure a strong response. In total, we received 49 out of 51 possible responses (a 96% response rate).
Once gathered, responses for each question were categorized along two dimensions: (1) actor: the agent or organization having the effect on the PHL, and (2) impact: the nature of the effect being described. Grouping responses into these categories allowed the detection of general trends across states for each of the three main question topics. The categorized responses were coded, and statistical analysis software was used to perform tabulations, cross-tabulations, and other simple summary statistics on the data to describe and quantify the observable trends. Some simple multivariate analyses (e.g., logistic regressions) were used to control for important factors (census region and degree of managed care penetration) that may underlie some of the trends observed.
The key findings from the informal poll are featured in the Study Findings: Analytical Results section of this report. A detailed methodology is provided in Appendix C.
Case Studies of States: Michigan, Tennessee, and Washington
The purpose of the case studies was to inform key study results by examining three state PHLs that have developed relationships with MCOs. After consulting with our Project Officer, the CDC, and the ASTPHLD Board of Directors, we chose Michigan, Tennessee, and Washington. As the Case Study states, it is important to note that the small sample involved preclude either a representative study or assurance that we identified Abest practices. Instead, our primary goal in selecting case study sites was to describe the range of types of interactions among these organizations.
We created a formal case study protocol covering six topic areas:
As with the interview protocol, the case study questions were designed to provide a general framework to the case studies and ensure that the same basic topic areas were covered, while simultaneously eliciting a broad range of responses from the interviewees. Since both organizational structure and individual audiences varied across states, questions were tailored for each interview.
For each case study, we provide a report containing notes from each of the interviews conducted. These notes, along with a copy of our case study protocol, are contained in Appendix D, and information gathered from these case studies appears throughout this report.
(1) MeSH is the controlled vocabulary of some 18,000 terms used by the National Library of Medicine for its bibliographic databases, including MEDLINE and HealthSTAR. MeSH is a hierarchical controlled vocabulary arranged in a tree structure, in which broader MeSH headings lead to more specific MeSH headings.