United States General Accounting Office

GAO Health, Education, and Human Services

Division

June 1997 Health Services Quality

and Public Health Issues

Issue Area Plan for Fiscal

Years 1998 and 1999

GAO/IAP-97-14

Foreword

As the investigative arm of the Congress and the nation’s auditor, the

General Accounting Office is charged with following the federal dollar

wherever it goes. Reflecting stringent standards of objectivity and

independence, GAO’s audits, evaluations, and investigations promote a

more efficient and cost-effective government; expose fraud, waste, abuse,

and mismanagement in federal programs; help the Congress target budget

reductions; assess financial and information management; and alert the

Congress to developing trends that may have significant fiscal or

budgetary consequences. In fulfilling its responsibilities, GAO performs

original research and uses hundreds of databases or creates its own when

information is unavailable elsewhere.

To ensure that GAO’s resources are directed toward the most important

issues facing the Congress, each of GAO’s 32 issue areas develops a

strategic plan that describes the significance of the issues it addresses, its

objectives, and the focus of its work. Each issue area relies heavily on

input from congressional committees, agency officials, and subject-matter

experts in developing its strategic plan.

The Health Services Quality and Public Health issue area is responsible for

GAO’s work on national and public health issues. The issue area focuses on

evaluating individuals’ access to high-quality care in a changing health care

environment and on measuring the outcomes and effectiveness of

federally funded programs, research, and regulatory activities. The issue

area’s operational oversight includes the programs of the Food and Drug

Administration (FDA), the National Institutes of Health (NIH), the Health

Resources and Services Administration (HRSA), the Substance Abuse and

Mental Health Services Administration (SAMHSA), the Centers for Disease

Control and Prevention (CDC), and other public health service agencies in

the Department of Health and Human Services (HHS).

GAO’s work on health services quality and public health issues generally

focuses on the following issues:

• determining whether the public health service agencies are ensuring the

public’s health and safety efficiently and effectively,

• assessing opportunities for improving the quality of health care under

fee-for-service and managed care payment arrangements,

• assessing opportunities for improving the nation’s access to health care,

and

• assessing the implications of emerging health care technologies.

Page 1 GAO/IAP-97-14
Foreword

In the pages that follow, we describe our key planned work on these

pivotal issues.

Because events may significantly affect even the best of plans and because

periodic measurement of success against any plan is essential, our

planning process allows for updating and provides flexibility to respond

quickly to emerging issues. If you have any questions or suggestions about

this plan, please call me at (202) 512-7119.

Bernice Steinhardt

Director

Health Services Quality and Public Health Issues

Page 2 GAO/IAP-97-14
Contents

Foreword 1

Table I: Key Issues 4

Table II: Planned

Major Work

6

Table III: GAO

Contacts

7

Page 3 GAO/IAP-97-14
Table I: Key Issues

Issue Significance

Public health: How efficiently and effectively are federal

agencies and public institutions ensuring the public’s

health and safety?

HHS’ eight major public health agencies are undergoing changes, partly

because of budget constraints and interest in devolving federal

responsibilities to states and the private sector. These organizational shifts

occur amid concern about the adequacy of efforts to prevent, control, and

treat public health problems such as AIDS, drug use by adolescents, and

rising rates of chronic disease. There are also concerns about the

regulatory process used to monitor the development and marketing of

new drugs, medical devices, and other medical products. In response to

these concerns and a changing health care environment, some HHS

agencies are modifying their procedures and adopting strategies to

improve performance. By requiring agencies to develop strategic plans

and goals and to measure their performance, the Government

Performance and Results Act provides a useful vehicle for the Congress

for obtaining evidence on how well agency initiatives work.

Quality of care: Given pressures to control costs, what

measures should be taken to ensure the quality of the

nation’s health care?

Efforts to control health care spending have implications for the quality of

health care. While the transition to an increasingly managed care market

has potential benefits, it also introduces risks that providers will use

cost-control measures that compromise access to quality care. These

benefits and risks are faced not only by private purchasers of care but

also by public purchasers, including the Medicare and Medicaid

programs. As the Congress considers ways to curb rising health care

costs, it needs information about the consequences of market changes for

various dimensions of quality, including the appropriateness of care,

health outcomes, and patient satisfaction. The Congress also needs

information on the quality of care provided to Medicare and Medicaid

beneficiaries under existing fee-for-service arrangements.

Access to care: How can the federal government ensure

access to health care for all Americans?

Millions of Americans face barriers to health care because they are

uninsured. Additionally, some people with health coverage may be

inadequately insured for their medical needs or have insurers who place

restrictions on their access to care. Still others face barriers because they

live in areas that have an inadequate supply or mix of health providers.

There is growing concern about the ability of public hospitals, clinics, and

other federally supported providers to continue to serve uninsured and

other vulnerable populations in the increasingly competitive and

cost-conscious health care environment. In addition, it is not clear how

well federal programs intended to improve access are achieving their

goals. The Congress, therefore, will need information on whether these

programs are fulfilling their missions and on how changes in the financing

and delivery of health care affect vulnerable populations’ access to care.

Emerging technologies in health care: How will

advancements in research, technology, and information

systems affect the public’s health and patients’ rights?

The development of new knowledge and medical technology in areas

such as human genetics, drug testing, computerized patient records, and

transplantation raises many ethical and legal issues. The 1996 Health

Insurance Portability and Accountability Act, for example, requires the

development of an extensive health information network that will make

information more readily accessible but less private. Conflicts also arise in

considering how to make available the benefits of new technologies, such

as organ transplantation or new AIDS drugs, when costs are high and

supplies are limited. Providing the Congress with information on how

advancements in science and technology are used and accepted, while

also evaluating the trade-offs involved, will help inform congressional

deliberations.

Page 4 GAO/IAP-97-14
Table I: Key Issues

Objectives Focus of work

—Assess the implications for public health of shifting roles and

responsibilities among federal, state, and local governments and the

private sector.

—Examine various approaches for ensuring the public’s health and

safety, the cost of those approaches, and the levels of protection they

afford.

—Assess the capacity of public health agencies and programs to

meet public health needs.

—Assess federal oversight activities to ensure accountability and the

effective use of federal public health dollars.

—Reauthorization of public health agencies.

—Agency development of performance measures and

progress toward goals in public health programs.

—Public health agencies’ research and services related to

the health of at-risk youth.

—Appropriateness, effectiveness, and efficiency of FDA’s

regulation of drugs, devices, and biologics.

—Effectiveness and cost of federal transplantation

programs.

—Condition of the public health infrastructure at the state

and local levels.

—Substance abuse prevention and treatment.

—Evaluate the validity, reliability, and utility of information on quality.

—Evaluate HCFA’s efforts to maintain and improve quality of care in the

Medicare and Medicaid programs.

—Examine the implications for quality of how health care is financed

and structured.

—Identify opportunities for improving quality while reducing health care

costs of federal programs.

—Evaluate private sector efforts to improve quality and reduce costs

that could serve as models for federal programs.

—Managed care organizations’ monitoring of quality of

care.

—Oversight of quality of care in government-financed

health programs.

—Use of information on quality by consumers, payers, and

providers.

—Comparisons of process and outcome for patients

treated under different financing arrangements.

—Opportunities for savings by identifying ineffective

treatments and procedures in the Medicare and Medicaid

programs.

—Federal efforts to improve physician practices.

—Improve understanding of the barriers people face in obtaining

health care.

—Evaluate the adequacy of the mix and distribution of health care

providers.

—Assess the health and cost consequences of inadequate access to

care.

—Identify trends in access to specific services under managed care

and fee-for-service payment arrangements.

—Access to care by uninsured and medically underserved

populations.

—Access to preventive services.

—Managed care organizations’ provision of services for the

chronically ill.

—Federal and state policies shaping the supply and mix of

health providers.

—Access to mental health and substance abuse services.

—Examine public and private mechanisms for evaluating medical

interventions.

—Assess the implications of the increased availability of health-related

information on individuals.

—Review compliance with current federal policies regarding the

conduct of biomedical and behavioral research.

—The movement of therapies from “experimental” to

conventional status.

—Patient confidentiality and the trade-offs involved in using

data for research and quality assurance.

—The uses of biogenetic material and information.

Page 5 GAO/IAP-97-14
Table II: Planned Major Work

Issue Planned major job starts

Public health —Examine the capacity of federal, state, and local government agencies to conduct public health

surveillance activities.

—Identify opportunities to increase the efficiency of the clinical phase of drug development.

—Examine FDA’s regulation of the advertising and promotion activities of pharmaceutical companies.

—Evaluate the adequacy of surveillance and enforcement operations associated with importing human

drugs from overseas.

—Examine third-party review and approval of medical devices.

—Evaluate how FDA has used the revenues obtained from prescription drug user fees.

—Review FDA’s oversight of human tissue banking. 

—Evaluate the appropriateness of federal reimbursement of organ acquisition charges.

—Assess the effectiveness of federal programs in increasing organ donations.

—Evaluate the effectiveness of adult and youth drug treatment programs.

—Examine the capability of public health agencies to deter drug epidemics.

—Identify strategies states are using to prevent teen pregnancies and out-of-wedlock births in light of

welfare reform incentives.

Quality of care —Examine validity and reliability of commonly used performance measurement systems.

—Compare treatments and outcomes of heart attack patients under Medicare managed care and

fee-for-service plans.

—Identify cost savings available through elimination of unnecessary treatments and tests in the

Medicare fee-for-service program.

—Examine impact of restrictive formularies and “drug switching” programs on quality of care for

Medicare and Medicaid beneficiaries enrolled in risk HMOs.

—Examine the nature and extent of problems related to consumer protection and quality of care in

assisted living facilities.

—Examine the quality of care available to end-stage renal disease patients in Medicare HMOs.

—Examine the effectiveness of HCFA’s approach for improving quality through Peer Review

Organizations.

—Examine implementation of the Nursing Home Quality Standards Act.

—Examine quality assurance and improvement systems that managed care organizations have in place

to ensure that enrollees obtain necessary and appropriate care.

Access to care —Examine the health and cost consequences for children lacking insurance coverage.

—Examine the impact of federal financing of graduate medical education on the mix and distribution of

health providers in medically underserved communities.

—Assess differences in access to specialized hospital services for Medicare beneficiaries enrolled in

fee-for-service and HMOs.

—Examine the implications of Medicaid’s transition to managed care on the care available to the

uninsured.

—Assess how Medicaid managed care affects the quality of and access to mental health services.

—Examine implications of not-for-profit hospital conversions on availability of care for the uninsured and

other vulnerable populations.

Emerging technologies in

health care

—Determine how payers decide when to reimburse for an “experimental” therapy.

—Evaluate HHS’ implementation of the data confidentiality and access provisions of the Health

Insurance Portability and Accountability Act.

—Determine the prevalence of genetic testing as a condition of employment or acquiring health

insurance.

Page 6 GAO/IAP-97-14
Table III: GAO Contacts

Director Bernice Steinhardt (202) 512-7119

Associate Director Marsha Lillie-Blanton (202) 512-7119

Assistant Directors Marcia Crosse

John Hansen

Sandra Isaacson

Rosamond Katz

James McClyde

Frank Pasquier (Seattle)

George Silberman

Page 7 GAO/IAP-97-14
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