Health Services Quality and Public Health Issue Area Plan--Fiscal Years 1998 and 1999

Published by the Government Accountability Office on 1997-05-01.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                United States General Accounting Office

GAO             Health, Education, and Human Services

June 1997
                Health Services Quality
                and Public Health Issues

                Issue Area Plan for Fiscal
                Years 1998 and 1999


               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’swork 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,
           •   assessing the implications of emerging health care technologies.

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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
Health Services Quality and Public Health Issues

Page 2                                                        GAO/IAP-97-14

Table I: Key Issues
Table II: Planned
Major Work
Table III: GAO

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

Issue                                                        Significance
Public health: How efficiently and effectively are federal   HHS’ eight major public health agencies are undergoing changes, partly
agencies and public institutions ensuring the public’s       because of budget constraints and interest in devolving federal
health and safety?                                           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      Efforts to control health care spending have implications for the quality of
measures should be taken to ensure the quality of the        health care. While the transition to an increasingly managed care market
nation’s health care?                                        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        Millions of Americans face barriers to health care because they are
access to health care for all Americans?                     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               The development of new knowledge and medical technology in areas
advancements in research, technology, and information        such as human genetics, drug testing, computerized patient records, and
systems affect the public’s health and patients’ rights?     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

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

Objectives                                                                    Focus of work
—Assess the implications for public health of shifting roles and              —Reauthorization of public health agencies.
responsibilities among federal, state, and local governments and the          —Agency development of performance measures and
private sector.                                                               progress toward goals in public health programs.
—Examine various approaches for ensuring the public’s health and              —Public health agencies’ research and services related to
safety, the cost of those approaches, and the levels of protection they       the health of at-risk youth.
afford.                                                                       —Appropriateness, effectiveness, and efficiency of FDA’s
—Assess the capacity of public health agencies and programs to                regulation of drugs, devices, and biologics.
meet public health needs.                                                     —Effectiveness and cost of federal transplantation
—Assess federal oversight activities to ensure accountability and the         programs.
effective use of federal public health dollars.                               —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.   —Managed care organizations’ monitoring of quality of
—Evaluate HCFA’s efforts to maintain and improve quality of care in the       care.
Medicare and Medicaid programs.                                               —Oversight of quality of care in government-financed
—Examine the implications for quality of how health care is financed          health programs.
and structured.                                                               —Use of information on quality by consumers, payers, and
—Identify opportunities for improving quality while reducing health care      providers.
costs of federal programs.                                                    —Comparisons of process and outcome for patients
—Evaluate private sector efforts to improve quality and reduce costs          treated under different financing arrangements.
that could serve as models for federal programs.                              —Opportunities for savings by identifying ineffective
                                                                              treatments and procedures in the Medicare and Medicaid
                                                                              —Federal efforts to improve physician practices.
—Improve understanding of the barriers people face in obtaining               —Access to care by uninsured and medically underserved
health care.                                                                  populations.
—Evaluate the adequacy of the mix and distribution of health care             —Access to preventive services.
providers.                                                                    —Managed care organizations’ provision of services for the
—Assess the health and cost consequences of inadequate access to              chronically ill.
care.                                                                         —Federal and state policies shaping the supply and mix of
—Identify trends in access to specific services under managed care            health providers.
and fee-for-service payment arrangements.                                     —Access to mental health and substance abuse services.

—Examine public and private mechanisms for evaluating medical                 —The movement of therapies from “experimental” to
interventions.                                                                conventional status.
—Assess the implications of the increased availability of health-related      —Patient confidentiality and the trade-offs involved in using
information on individuals.                                                   data for research and quality assurance.
—Review compliance with current federal policies regarding the                —The uses of biogenetic material and information.
conduct of biomedical and behavioral research.

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

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

                      Bernice Steinhardt      (202) 512-7119
                      Marsha Lillie-Blanton   (202) 512-7119
Associate Director
                      Marcia Crosse
Assistant Directors   John Hansen
                      Sandra Isaacson
                      Rosamond Katz
                      James McClyde
                      Frank Pasquier (Seattle)
                      George Silberman

                      Page 7                                   GAO/IAP-97-14
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