Health Services Quality and Public Health Issue Area Plan--Fiscal Years
1997-98 (Letter Report, 09/01/96, GAO/IAP-96-25).
GAO provided information on its Health Services Quality and Public
Health issue area plan for fiscal years 1997 through 1998.
GAO plans to: (1) identify opportunities for improving access to health
care services and ensuring accountability for performance in
fee-for-service and managed care systems; (2) identify opportunities for
improving the quality of health care financed with federal dollars; (3)
evaluate the efficiency and effectiveness of pharmaceutical and medical
device product regulation and assess developments in the pharmaceutical
and medical device industries; (4) determine if public health service
agencies are effectively meeting public health needs; and (5) assess
emerging legal, technical, confidentiality, and efficacy issues related
to health care information.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: IAP-96-25
TITLE: Health Services Quality and Public Health Issue Area
Plan--Fiscal Years 1997-98
DATE: 09/01/96
SUBJECT: Health care services
Health services administration
Quality assurance
Public health research
Managed health care
Health care programs
Medical equipment
Pharmaceutical industry
Drugs
Information dissemination operations
IDENTIFIER: Medicaid Program
Medicare Program
SAMHSA Community Partnership Demonstrations for Substance
Abuse Prevention
Early and Periodic Screening, Diagnosis, and Treatment
Program
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Cover
================================================================ COVER
Health, Education, and Human Services Division
September 1996
HEALTH SERVICES QUALITY AND PUBLIC
HEALTH ISSUE AREA PLAN
FISCAL YEARS 1997-98
GAO/IAP-96-25
Abbreviations
=============================================================== ABBREV
FOREWORD
============================================================ Chapter 0
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 ensuring patient and beneficiary access to
quality care in a changing health system 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), 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:
-- identifying opportunities for improving the nation's access to
health care and ensuring accountability for performance in
fee-for-service and managed care systems;
-- identifying opportunities for improving the quality of health
care financed with federal dollars;
-- evaluating the efficiency and effectiveness of FDA's regulation
of pharmaceutical and medical device products and assessing
developments in the pharmaceutical and medical device
industries;
-- determining if the public health service agencies are meeting
the public health needs of the nation efficiently and
effectively; and
-- assessing emerging legal, technical, confidentiality, and
efficacy issues related to health care information.
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
CONTENTS
============================================================ Chapter 1
FOREWORD
---------------------------------------------------------- Chapter 1:1
1
TABLE I: KEY ISSUES
---------------------------------------------------------- Chapter 1:2
4
TABLE II: PLANNED MAJOR WORK
---------------------------------------------------------- Chapter 1:3
8
TABLE III: GAO CONTACTS
---------------------------------------------------------- Chapter 1:4
10
TABLE I: KEY ISSUES
============================================================ Chapter 2
Issue Significance Objectives Focus of Work
-------------------------------------------- -------------------------------------------- -------------------------------------------- --------------------------------------------
Access and accountability in health service As health care is increasingly taking place �Provide the Congress with a better �Increasing the use of screening services
delivery: How can the United States improve in a managed care environment, there are understanding of available management-of- for Medicare diabetics
access to health care and ensure bipartisan concerns about access to care, care techniques. �Enrollment patterns of the chronically ill
accountability for performance in both fee- particularly for vulnerable populations, and �Identify emerging trends regarding access in Medicare managed care plans
for-service and managed care systems? how to hold plans accountable for and quality in managed care and fee-for- �Access to new and costly AIDS drugs
performance. Questions also are being raised service medicine. �Basis for current Health Care Financing
throughout the health system about outcome �Identify alternative approaches to funding Administration subsidies of graduate medical
measurement and how to influence care graduate medical education. education and possible improvements to the
provided to ensure equity--including in payment methodology
rural areas--and efficacy of results. �Impact on the supply of qualified
physicians in restructuring payments for
graduate medical education
Quality of care: Given pressures to control The federal government finances Medicaid and �Identify ways to maintain and improve �Initiatives of state governments to monitor
costs, what measures should be taken to Medicare and public health care systems, quality of care financed with federal and improve quality of care through the use
ensure that the quality of the nation's which provide health care to millions of funds. of quality data reporting
health care is maintained? people each year. In addition, the private �Investigate differences in the quality of �Provider efforts to ensure quality services
sector has launched a number of major care provided in the fee-for-service and for Medicare beneficiaries with end-stage
initiatives in the field of quality of care managed care systems. renal disease
with implications for oversight of health �Identify the quality implications of �Ensuring that quality care is provided to
care programs. These include the growing use anticipated or proposed legislative health residents in assisted living environments
of standardized performance measures by care initiatives. �Public and private sector initiatives to
major public and private purchasers of care. provide purchasers, consumers, and providers
As the Congress considers ways to curb with information about the quality of care
rising health care costs and make further �Private sector efforts to develop
cuts to control the deficit, information performance measures and require their use
about existing quality problems, by health plans and providers to improve
developments in the field of quality of quality of care
care, and ways the Congress can safeguard �Recent legislation intended to better
quality of care will be crucial. ensure access to quality care
Drug and medical device development and In recent years, advances in medical �Analyze and assess the impact of changes in �FDA's regulation of the drug advertising
regulation: How do FDA regulatory processes technology have held promise for providing the pharmaceutical industry on federal and promotion activities of pharmaceutical
and cost factors influence the development better methods to identify diseases and programs and on federal beneficiaries. companies
of and access to drugs, medical devices, and therapies for treating them. However, the �Assess changes in FDA's processes for �FDA's regulation of information on off-
other medical products? drug, device, and biotechnology industries reviewing and approving new medical label uses of approved drugs
claim that excessive FDA regulation causes products. �Clinical drug research in children
unwarranted delays in product approval and, �Determine the adequacy of FDA's post- �FDA's regulatory standards and approval
as a result, delays patient access to these market surveillance programs in identifying processes for new medical devices
new products. These critics have proposed and analyzing adverse product experiences. �Alternative approaches to expedite FDA's
fundamental changes in the role and policies �Provide a factual basis for assessing approval of new drugs and medical devices
of FDA, including increased recognition of various regulatory reform proposals. while maintaining safety and efficacy
drugs and devices approved in other standards
countries. In response, FDA is changing some �FDA's post-market surveillance activities
procedures, and the Congress is considering for medical products, including adverse
a wide range of reforms. The Congress will reaction reporting processes
require the best possible evidence on how �Adequacy of surveillance and enforcement
well these alternatives work and how they operations associated with importing drugs
affect patients and insurers, who must pay �FDA's inspection of foreign drug
the ever increasing costs of new therapies manufacturing facilities
and treatments. �Evaluation of the impact of the
Prescription Drug User Fee Act of 1992
Public health: How effectively are federal Within the context of budget deficit �Assess the ability of public health service �CDC's capacity to respond to public health
agencies and public institutions meeting reduction and reinventing government, many agencies and programs to conduct health threats
public health needs given budget constraints changes are occurring in HHS' eight major service activities after organizational and �The quality of state and local government
and the shift to managed care? public health agencies and their numerous structural changes have been made and in surveillance data provided to CDC and the
subagencies and programs. Specific HHS light of the shift to managed care. risks associated with underreporting of
discretionary programs are to be �Assess the need for and type of federal emerging diseases
consolidated into Performance Partnerships oversight and accountability measures that �Effectiveness of current federal organ
or block grants. These changes will have a can be used to ensure federal dollars are transplantation program in light of shift to
significant impact on community health effectively used under Performance managed care
centers, public hospitals, and other Partnerships. �Development of performance measures for
institutions charged with meeting the �Review the capacity of essential providers block grants or Performance Partnerships
nation's public health needs. Furthermore, to meet public health needs. �Financial and administrative oversight of
the shift to managed care is affecting the �Study the problem of substance abuse, NIH research projects
operation of public health programs and particularly among teens, and the �Impact of health system changes on safety
traditional safety net providers in all effectiveness of the federal response and net providers, teaching hospitals, and
parts of the health system. programs to prevent substance abuse. centers of excellence
�Effectiveness of SAMHSA's Community
Partnership Demonstrations for Substance
Abuse Prevention
�Substance abuse by adolescents
Emerging issues in health information: How With expanded computerization of patient �Explore the impact of recent developments �Patient confidentiality and the trade-offs
will new health information and information data, an increase in demand for assessment in health information on patients and involving uses of data for research and
systems affect patient care and privacy? of the outcomes of patient care, and providers. oversight
research into human genetics, many difficult �Examine the effectiveness of, and barriers �NIH's human genome project
questions are being raised. In the recently to, dissemination of information about �Development and use of automated patient
enacted Kassebaum-Kennedy insurance discoveries and innovations affecting records by integrated health networks and
portability bill, provisions exist for the patient care. managed care organizations
development of an extensive health �Review the safeguards to ensure patients
information network. Of paramount concern in are treated ethically (i.e., maintain
developing such a network are the trade- privacy and obtain informed consent).
offs among ethical issues, cost, privacy,
and efficiency.
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
TABLE II: PLANNED MAJOR WORK
============================================================ Chapter 3
Issue Planned Major Job Starts
---------------------------- --------------------------------------------------
Access and accountability in �Examine use of federal practice guidelines in
health service delivery health plans to ensure access to quality care.
�Assess the effectiveness of the 1992 Mammography
Quality Standards Act.
�Evaluate access to specialty services in managed
care plans, particularly for vulnerable
populations.
�Assess cost-effectiveness of federally funded
rural and other underserved area programs.
�Examine how Medicare beneficiaries with diabetes
receive recommended services from managed care and
fee-for-service providers.
�Examine whether managed care's richer benefits
attract and retain chronically ill Medicare
beneficiaries.
�Examine the impact of insurance coverage limits
on access to emergency room services.
�Examine the underlying causes for significant
variations in direct medical education payments
made to hospitals by Medicare.
Quality of care �Identify alternative quality assurance models for
the Medicare program.
�Describe state monitoring of the quality of
managed care organizations.
�Examine current initiatives to provide consumers
with information about the quality of long-term
care services.
�Examine why physicians terminate their contracts
with managed care organizations.
�Assess the effectiveness of Medicaid's Early and
Periodic Screening Diagnosis and Treatment
Program.
�Determine the impact of quality measurement by
insurance purchasers on provider or plan behavior.
Drug and medical device �Examine FDA's regulation of the advertising and
development and regulation promotion activities of pharmaceutical companies.
�Examine FDA's guidance on disseminating
information on off-label uses of approved drugs.
�Examine clinical drug research in children.
�Identify opportunities to increase the efficiency
of drug development research conducted during the
clinical phase.
�Analyze alternative approaches to expedite FDA's
approval of new drugs while maintaining safety and
efficacy standards.
�Examine third-party review and approval of
medical devices.
�Examine the effectiveness of FDA's drug
evaluation and approval process.
�Assess FDA's post-market drug surveillance
activities, including adverse reaction reporting
processes.
�Evaluate the adequacy of surveillance and
enforcement operations associated with importing
human drugs from overseas.
�Examine FDA inspections of foreign drug
manufacturing facilities and imported
pharmaceutical products.
�Examine FDA actions on medical device
surveillance reports.
�Evaluate the impact of the Prescription Drug User
Fee Act of 1992 on expediting FDA drug approvals.
Public health �Evaluate CDC's management and priorities in
responding to public health threats.
�Examine the impact of managed care on organ
transplantation facilities and transplantation
recipients.
�Review the development of performance measures
for block grants/Performance Partnerships.
�Examine the effect of for-profit hospitals
acquiring the assets of not-for-profit
institutions.
�Evaluate SAMHSA's Community Partnership Program
for Substance Abuse.
Emerging issues in health �Review the impact of new technology and new
information research�notably genetic discoveries�on patient
care and access to health insurance.
�Assess the impact on patients of integrated data
systems.
�Examine confidentiality and privacy implications
of, and safeguards for, collection of extensive
patient data by health networks.
--------------------------------------------------------------------------------
TABLE III: GAO CONTACTS
============================================================ Chapter 4
DIRECTOR
-------------------------------------------------------- Chapter 4:0.1
Bernice Steinhardt (202) 512-6868
ASSOCIATE DIRECTOR
-------------------------------------------------------- Chapter 4:0.2
Marsha Lillie-Blanton (202) 512-7119
ASSISTANT DIRECTORS
-------------------------------------------------------- Chapter 4:0.3
Marcia Crosse
John Hansen
Sandra Isaacson
Rosamond Katz
James McClyde
Frank Pasquier (Seattle)
George Silberman
*** End of document. ***