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   ï¿½Provide the Congress with a better           ï¿½Increasing 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.                              ï¿½Enrollment patterns of the chronically ill
accountability for performance in both fee-   particularly for vulnerable populations, and  ï¿½Identify 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-      ï¿½Access to new and costly AIDS drugs
                                              performance. Questions also are being raised  service medicine.                             ï¿½Basis for current Health Care Financing
                                              throughout the health system about outcome    ï¿½Identify 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.                                                       ï¿½Impact 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  ï¿½Identify ways to maintain and improve        ï¿½Initiatives 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    ï¿½Investigate differences in the quality of    ï¿½Provider 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     ï¿½Identify the quality implications of         ï¿½Ensuring 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.                             ï¿½Public 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                                                   ï¿½Private 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                                                   ï¿½Recent 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          ï¿½Analyze and assess the impact of changes in  ï¿½FDA'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     ï¿½Assess changes in FDA's processes for        ï¿½FDA'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.                                     ï¿½Clinical drug research in children
                                              unwarranted delays in product approval and,   ï¿½Determine the adequacy of FDA's post-        ï¿½FDA'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.    ï¿½Alternative approaches to expedite FDA's
                                              fundamental changes in the role and policies  ï¿½Provide 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                                                ï¿½FDA'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                                                   ï¿½Adequacy of surveillance and enforcement
                                              well these alternatives work and how they                                                   operations associated with importing drugs
                                              affect patients and insurers, who must pay                                                  ï¿½FDA's inspection of foreign drug
                                              the ever increasing costs of new therapies                                                  manufacturing facilities
                                              and treatments.                                                                             ï¿½Evaluation of the impact of the
                                                                                                                                          Prescription Drug User Fee Act of 1992

Public health: How effectively are federal    Within the context of budget deficit          ï¿½Assess the ability of public health service  ï¿½CDC'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   ï¿½The 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              ï¿½Assess the need for and type of federal      emerging diseases
                                              consolidated into Performance Partnerships    oversight and accountability measures that    ï¿½Effectiveness 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.                                 ï¿½Development of performance measures for
                                              institutions charged with meeting the         ï¿½Review the capacity of essential providers   block grants or Performance Partnerships
                                              nation's public health needs. Furthermore,    to meet public health needs.                  ï¿½Financial and administrative oversight of
                                              the shift to managed care is affecting the    ï¿½Study the problem of substance abuse,        NIH research projects
                                              operation of public health programs and       particularly among teens, and the             ï¿½Impact 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
                                                                                                                                          ï¿½Effectiveness of SAMHSA's Community
                                                                                                                                          Partnership Demonstrations for Substance
                                                                                                                                          Abuse Prevention
                                                                                                                                          ï¿½Substance abuse by adolescents

Emerging issues in health information: How    With expanded computerization of patient      ï¿½Explore the impact of recent developments    ï¿½Patient 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  ï¿½Examine the effectiveness of, and barriers   ï¿½NIH's human genome project
                                              questions are being raised. In the recently   to, dissemination of information about        ï¿½Development 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            ï¿½Review 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  ï¿½Examine use of federal practice guidelines in
health service delivery       health plans to ensure access to quality care.
                              ï¿½Assess the effectiveness of the 1992 Mammography
                              Quality Standards Act.
                              ï¿½Evaluate access to specialty services in managed
                              care plans, particularly for vulnerable
                              populations.
                              ï¿½Assess cost-effectiveness of federally funded
                              rural and other underserved area programs.
                              ï¿½Examine how Medicare beneficiaries with diabetes
                              receive recommended services from managed care and
                              fee-for-service providers.
                              ï¿½Examine whether managed care's richer benefits
                              attract and retain chronically ill Medicare
                              beneficiaries.
                              ï¿½Examine the impact of insurance coverage limits
                              on access to emergency room services.
                              ï¿½Examine the underlying causes for significant
                              variations in direct medical education payments
                              made to hospitals by Medicare.

Quality of care               ï¿½Identify alternative quality assurance models for
                              the Medicare program.
                              ï¿½Describe state monitoring of the quality of
                              managed care organizations.
                              ï¿½Examine current initiatives to provide consumers
                              with information about the quality of long-term
                              care services.
                              ï¿½Examine why physicians terminate their contracts
                              with managed care organizations.
                              ï¿½Assess the effectiveness of Medicaid's Early and
                              Periodic Screening Diagnosis and Treatment
                              Program.
                              ï¿½Determine the impact of quality measurement by
                              insurance purchasers on provider or plan behavior.

Drug and medical device       ï¿½Examine FDA's regulation of the advertising and
development and regulation    promotion activities of pharmaceutical companies.
                              ï¿½Examine FDA's guidance on disseminating
                              information on off-label uses of approved drugs.
                              ï¿½Examine clinical drug research in children.
                              ï¿½Identify opportunities to increase the efficiency
                              of drug development research conducted during the
                              clinical phase.
                              ï¿½Analyze alternative approaches to expedite FDA's
                              approval of new drugs while maintaining safety and
                              efficacy standards.
                              ï¿½Examine third-party review and approval of
                              medical devices.
                              ï¿½Examine the effectiveness of FDA's drug
                              evaluation and approval process.
                              ï¿½Assess FDA's post-market drug surveillance
                              activities, including adverse reaction reporting
                              processes.
                              ï¿½Evaluate the adequacy of surveillance and
                              enforcement operations associated with importing
                              human drugs from overseas.
                              ï¿½Examine FDA inspections of foreign drug
                              manufacturing facilities and imported
                              pharmaceutical products.
                              ï¿½Examine FDA actions on medical device
                              surveillance reports.
                              ï¿½Evaluate the impact of the Prescription Drug User
                              Fee Act of 1992 on expediting FDA drug approvals.

Public health                 ï¿½Evaluate CDC's management and priorities in
                              responding to public health threats.
                              ï¿½Examine the impact of managed care on organ
                              transplantation facilities and transplantation
                              recipients.
                              ï¿½Review the development of performance measures
                              for block grants/Performance Partnerships.
                              ï¿½Examine the effect of for-profit hospitals
                              acquiring the assets of not-for-profit
                              institutions.
                              ï¿½Evaluate SAMHSA's Community Partnership Program
                              for Substance Abuse.

Emerging issues in health     ï¿½Review the impact of new technology and new
information                   researchï¿½notably genetic discoveriesï¿½on patient
                              care and access to health insurance.
                              ï¿½Assess the impact on patients of integrated data
                              systems.
                              ï¿½Examine 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. ***