Benefit Design in Health Care Reform:

Clinical Preventive Services

September 1993

OTA-H-580

NTIS order #PB93-231330

GPO stock #052-003-01340-1
Recommended Citation:

U.S. Congress, Office of Technology Assessment, Benefit Design in Health

Care Reform: Report #1-Clinical Preventive Services, OTA-I-I-580

(Washington, DC: U.S. Government Printing Office, September 1993).
Foreword

H

ealth care is one of the Nation’s preeminent domestic policy concerns. The

contemporary health care reform debate has brought to the fore thorny issues

surrounding the design of health care benefits. The scope and depth of health

insurance coverage can have a substantial impact on the health services people

obtain, on the costs of the health care system, and, ultimately, on the health of the

Nation.

This Report is part of an OTA series on Benefit Design in Health Care Reform

that explores the merits of using information on health effects and cost-effectiveness to

formulate health insurance benefits, When it is complete, the series will include publications on general policy issues, coverage of clinical preventive services, benefits for

mental health and substance abuse treatment, and patient cost-sharing requirements. The

benefit design series is a component of a larger OTA assessment, Technology,

Insurance, and the Health Care System, which was requested by the Senate Committee

on Labor and Human Resources (Edward M. Kennedy, Chairman), and was endorsed

by the House Committee on Energy and Commerce (John D. Dingell, Chairman), the

House Committee on Ways and Means Subcommittee on Health (Willis D. Gradison,

then Ranking Minority Member), and Senator Charles E. Grassley (Committees on

Budget, Finance, Special Committee on Aging). Other publications related to the

assessment include Does Health insurance Make a Difference?-Background Paper

and An Inconsistent Picture: A Compilation of Analyses of Economic Impacts of

Competing Approaches to Health Care Reform by Experts and Stakeholders.

This Report examines the evidence on the effectiveness and cost-effectiveness

of selected clinical preventive services, and whether and how this information might be

used to design insurance benefits. Clinical preventive services, as defined by OTA, are

“interventions comprising medical procedures, tests, or visits with health care providers

that are undertaken for the purpose of promoting health, not for responding to patient

signs, symptoms, or complaints. ” The Report does not aim to provide definitive advice

to Congress or others about whether or not to cover specific clinical preventive services.

Rather, it aims to provide a context for the Nation as it considers how to make such

decisions.

OTA was assisted in the preparation of this Report by the advisory panel for

the Technology, Insurance, and the Health Care System assessment, a group of leading

health care provider, insurer, business, academic, and consumer representatives, and by

numerous other health policy experts. OTA gratefully acknowledges the contribution of

each of these individuals. As with all OTA reports, the final responsibility for the content of this Report rests with OTA.

a+- -

Roger C. Herdman, Director III
Advisory Panel

James C. Hunt, Chair

University Distinguished Professor

University of Tennessee-Memphis

Memphis, TN

Henry Aaron

Director

Economic Studies Program

Brookings Institution

Washington, DC

Robert Brook

Director

RAND Health Sciences program

RAND Corporation

Santa Monica, CA

Arthur CapIan

Director

Center for Biomedical Ethics

University of Minnesota

Minneapolis, MN

Deborah Chollet

Associate Director

Center for Risk Management and

Insurance Research

Georgia State University

Atlanta, GA

Olivia Cousins

Associate Professor

CUNY-Health Education

New York, NY

Jane L. Delgado

President and CEO

National Coalition of Hispanic Health

and Human Services Organizations

Washington, DC

Paula K. Diehr

Professor

Department of Biostatistics

School of Public Health and

Community Medicine

University of Washington

Seattle, WA

M. Joycelyn Elders*

Commissioner of Health

State of Arkansas

Little Rock, AR

Jack Hadley

Co-Director

Center for Health Policy Studies

Georgetown University

Washington, DC

Douglas E. Henley

Physician in Private Practice

Hope Mills, NC

William Hobson

Executive Director

Central Seattle Community Health

Centers

Seattle, WA

John Lewin

Director of Health

State of Hawaii

Honolulu, HI

Barbara J. McNeil

Ridley Watts Professor and Head

Department of Health Care Policy

Harvard Medical School

Boston, MA

David Mechanic

Rene Dubos Professor of

Behavioral Sciences

Director

Institute for Health, Health Care

Policy, and Aging Research

Rutgers University

New Brunswick, NJ

Joseph Morris

Vice President for Information Systems

Delaware Valley Hospital Council

Philadelphia, PA

Patricia Nazemetz

Director of Benefits

Xerox Corporation

Stamford, CT

David G. Pockell

Senior Vice President and

Regional Manager

Kaiser Foundation Health Plan

Oakland, CA

Carl Scott

Senior Vice President

Mutual of Omaha

Omaha, NE

Gordon R. Trapnell

President

Gordon R. Trapnell Consulting

Actuaries, Ltd.

Annandale, VA

Cheryl B. Travis

Professor of Psychology and

Assistant Department Head

Department of Psychology

University of Tennessee

Knoxville, TN

Special Consultant

Stephen H. Long

Senior Economist

RAND Corporation

Washington, DC

* Until May 1993.

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory paoel members. The panel does not,

however, neceswily approve, disapprove, or endorse this Report. OTA assumes full responsibility for the Report and the accuracy of its contents.

iv
Clyde J. Behney

Assistant Director, OTA

ADMINISTRATIVE STAFF

Beckie Erickson

Office Administrator

Carolyn Martin

Word Processing Specialist

Dan Carson

PC Specialist

Eric Gille

Secretary

Preject Staff

PRINCIPAL STAFF

Denise Dougherty

Senior Associate

Project Director for Technology,

Insurance, and the Health Care

System

TAMI L. MARK

Principal Analyst

Matthew Hahn

Douglas Berkson

Research Assistants

OTHER CONTRIBUTING STAFF

PUBLISHING STAFF

Mary Lou Higgs

Manager, Publishing Services

Dorinda Edmondson

Typographer

Sara J. Frey

Analyst

Christine Onrubia

Graphic Designer
1 Summary and Policy Options 1

Introduction and Congressional Request 1

Focus and Organization of the Report 2

Summary of Findings 3

Issues and Options 4

Coverage Options 5

Options Regarding Sources of Information on

Effectiveness and Cost-Effectiveness 8

Options Regarding Specific Benefit Design

Features 9

Access Options 10

Research Options 11

2 Overview of the Issues 13

Defining Clinical Preventive Services 13

Strengths and Weaknesses of Insurance as a Source of

Funding for Preventive Services 14

Criteria for Evaluating Clinical Preventive Services 15

The Role of Evidence on Effectiveness 16

The Role of Costs 17

Other Criteria 18

Insurance Benefit Design 18

Specifying and Circumscribing the Benefits 19

Unit of Payment 21

3 Evidence on the Effectiveness of a Select

Group of Clinical Preventive Services 23

Review of the Evidence 24

Annual General Physical Examination 24

Breast Cancer Screening 24

Colorectal Cancer Screening 27

Cervical Cancer Screening 28

Prostate Cancer Screening 28

Cholesterol Screening 29

Hypertension Screening 30

Smoking Cessation Interventions 31

Adult Immunizations 32

contents

1

vii
Prenatal Care 32

Newborn Screening for Congenital Disorders 33

Childhood Immunizations 33

Well-Child Care 34

■ General Physical Examinations 34

■ Screening for Iron-Deficiency for Anemia 34

 Screening for Amblyopia and Strabismus 35

 Screening for Hearing Impairment 35

■ Developmental Screening 36

■ Urinalysis 36

■ Frequency of Well-Child Care Services 36

 Summary 36

Contraceptive Services 37

Screening for Sexually Transmitted Diseases 37

Summary 38

4 The Role of Costs in Benefit Design

Decisions 39

Use of Cost-Effectiveness Analyses in Benefit

Design 39

Net Costs as a Criterion for Insurance Coverage 41

summary 43

Boxes

1-A Other Publications in the Office of Technology

Assessment’s Series on Benefit Design in Health

Care Reform 2

F-1 Important Concepts for Determining the Efficacy

of a Screening Test 80

Figures

1-1 Policy Issues Concerning Insurance Coverage for

Clinical Preventive Services 4

2-1 Evidence on the Effects of Care: Essential, But Not

Sufficient, For Improving Policies and Decisions in

Health Care 18

2-2 Leading Causes of Death, 1989, All Ages 19

2-3 Leading Causes of Years of Potential Life Lost

(YPLL) Before Age 65,1989 20

E-1 Percent of Enrollees Covered for Well-Baby Care in

Employer-Based Health Insurance Plans by Plan

Type, Various Surveys, Various Years 74

E-2 Percent of Enrollees Covered for Well-Child Care in

Employer-Based Health Insurance Plans by Plan

Type, Various Surveys, Various Years 74

1I n

. . . Vlll
E-3 Percent of Enrollees Covered for Adult Physical

Examinations in Employer-Based Health Insurance

Plans by Plan Type, Various Surveys, Various

Years 75

Tables

1-1

1-2

3-1

3-2

3-3

4-1

4-2

4-3

4-4

4-5

4-6

4-7

4-8

F-1

F-2

G-1

Potential Goals of Policies Concerning Insurance for

Clinical Preventive Services 5

Policy Options for Congressional Consideration 6

Preventive Interventions Recommended By the U.S.

Preventive Services Task Force for Nonpregnant,

Asymptomatic Persons, 1989 25

Preventive Interventions Not Recommended By the

U.S. Preventive Services Task Force for Use on

Asymptomatic Persons, 1989 26

The Number of States Screening for Specific Types of

Newborn Congenital Disorders and Number of Cases

Confirmed with the Diagnosis, 1990 33

Selected Cost-Effectiveness Analyses of Adult

Immunizations 44

Selected Cost-Effectiveness Analyses of Breast

Cancer Screening 46

Selected Cost-Effectiveness Analyses of Cervical

Cancer Screening 47

Selected Cost-Effectiveness Analyses for Childhood

Immunizations 48

Selected Cost-Effectiveness Analyses of Cholesterol

Reduction Interventions 51

Selected Cost-Effectiveness Analyses of Colorectal

Cancer Screening 53

Selected Cost-Effectiveness Analyses of Hypertension

Screening 54

Selected Cost-Effectiveness Analyses of Smoking

Cessation 55

Institute of Medicine Provisional Documentation

Checklist for Practice Guidelines 78

Quality of Evidence Criteria Used By the U.S.

Preventive Services Task Force and the Canadian

Task Force 79

Birth to 18 Months (Schedule: 2,4,6, 15, 18

Months) 83

G-2 Ages 2-6 84

G-3 Ages 7-12 85

G-4 Ages 13-18 86

G-5 Ages 19-39 (Schedule: Every 1-3 Years) 88

ix
G-6 Ages 40-64 (Schedule: Every 1-3 Years) 91

G-7 Ages 65 and Over (Schedule: Every Year) 94

G-8 Pregnant Women 96

H-1 Clinical Preventive Services Included in or Specifically

Excluded from Congressional Health Care Reform

Proposals, 102d Congress 99

APPENDIXES

A

B

c

D

E

F

G

H

Overview of OTA Assessment: Technology, Insurance,

and the Health Care System 57

Method of the Study 60

Acknowledgments 61

Abbreviations and Glossary of Terms 63

Current Coverage of Clinical Preventive Health Care

Services in Public and Private Insurance 72

Synthesizing and Assessing the Evidence and

Determining Practice Policies 77

Summary of the U.S. Preventive Services Task Force’s

(USPSTF) Recommendations for Services To Be

Included in Periodic Health Examinations, by

Age Group 82

Preventive Services in Health Care Reform Proposals

Introduced in the 102d Congress 98

REFERENCES 101

INDEX 113
Summary

and

Policy

Options 1

INTRODUCTION AND CONGRESSIONAL REQUEST

A

s reform of the Nation’s health care system has risen to

the top of the domestic policy agenda, the issue of what

services to cover has increased in importance. Clearly,

the scope and depth of services that are covered in any

health insurance scheme can have a tremendous impact on how

much health care people obtain, on the costs to the system, and,

ultimately, on the health of the Nation’s people. In order to

provide Americans with an optimal level of care, at a reasonable

cost to the Nation, policymakers at all levels have been

rethinking traditional approaches to benefit design and considering the merits of using explicit scientific criteria to more clearly

define the benefit structure.

This report is one of a series of publications on benefit design

in health care reform being issued as part of the Office of

Technology Assessment’s (OTA) assessment, Technology, Insurance, and the Health Care System. The other publications in

the Benefit Design Series are described in box l-A. The overall

assessment is being conducted in response to a request from the

Senate Committee on Labor and Human Resources (Senator

Edward M. Kennedy, Chairman), that was endorsed by the House

Committee on Energy and Commerce (Congressman John D.

Dingell, Chairman), the House Committee on Ways and Means

Subcommittee on Health (then-Ranking Minority Member

Willis D. Gradison), and Senator Charles E. Grassley, a member

of OTA Technology Assessment Board. Chairman Dingell

asked OTA to assess the extent to which a minimum benefit

package could be designed based on information about health

effects and cost-effectiveness. Other requesters agreed that this

was an important question and that OTA should address it by

1
2 I Benefit Design: Clinical Preventive Services

Box l-A-Other Publications in the Office of Technology Assessment’s

Series on Benefit Design in Health Care Reform

SOURCE: U.S. Congress, offiie of Technology AmssmQ@ 1993.

means of an overall brief on the topic, as well as For the most part, the clinical preventive

through examinations of the evidence on clinical

preventive services; mental health and substance

abuse treatment services; and patient costsharing.

This report-Benefit Design in Health Care

Reform: Report #I--Clinical Preventive Services

—addresses issues concerning coverage of clinical preventive services. Preventive services are

often portrayed as providing ‘good investments’

and thus potentially good candidates for health

insurance coverage. This report examines this

perception and considers the role that information

on effectiveness and cost-effectiveness can, and

cannot, play in choosing specific clinical preventive services to include in a benefit package.

FOCUS AND ORGANIZATION OF

THE REPORT

The focus of this report is on selected clinical

preventive services for asymptomatic individuals, that is, individuals who do not exhibit signs

of the health condition or disease the clinical

preventive service is designed to prevent.

services that have been at greatest contention and

subject to the most scrutiny are screening services

designed to detect a disease at an early stage (e.g.,

breast cancer screening, screening for high blood

pressure); thus, most of the clinical preventive

services reviewed in this report are screening

services.

Selected other clinical preventive services have

also been debated and subject to some scientific

scrutiny because of their assumed potential for

preventing unwanted health conditions; several of

these clinical preventive services are also reviewed in this report (e.g., immunizations, contraceptives, smoking cessation interventions, some

physician counseling).

Not all possible clinical preventive services are

reviewed in this report; new clinical preventive

services are discovered or introduced into the

coverage debate regularly. The purpose of the

report is to place the issue of using scientific

evidence at the forefront of the health care reform

and coverage debates.

The report is organized as follows: chapter 1

summarizes the primary findings of the report and
Chapter Summary and Policy Options | 3

presents issues and policy options. Chapter 2

provides an overview of the issues and discusses:

defining clinical preventive services in the context of prevention generally; the use of insurance

as a funding source for clinical preventive services; criteria for choosing which clinical preventive services to include in an insurance package;

and how insurance benefits for clinical preventive

services might be designed once services have

been chosen for coverage (e.g., extent of patient

cost-sharing, unit of payment, limits on the

frequency, limits by patient characteristics). Chapter 3 reviews the evidence on the effectiveness of

a select group of clinical preventive services that

are frequently proposed for insurance coverage.

The last chapter, chapter 4, discusses how information on costs and cost-effectiveness might be

used to design benefits for clinical preventive

services and the evidence on the costs and

cost-effectiveness of selected clinical preventive

services.

SUMMARY OF FINDINGS

Below is a brief synopsis of the report’s major

conclusions:

 Many clinical preventive services have not

been evaluated in terms of their effectiveness

and cost-effectiveness. Therefore, whether they

are effective or relatively cost-effective is

simply not known.

■ Some, but not all, clinical preventive services

for asymptomatic individuals have been found

to be effective in reducing, or delaying, the

incidence and burden of disease for some

patients.

■ Very few clinical preventive services have been

found to be cost-saving to society in terms of

medical care costs when provided to individuals at average risk for the condition.

■ An entity’s finding that a clinical preventive

service is ‘ ‘cost-effective’ should not be interpreted to mean that it is ‘‘cost-saving. ” Costeffectiveness is always a statement about the

costs of an intervention relative to its effectiveness.

■ If policymakers aim to either save money or

improve the health of the population, or both,

they will need to: a) take care to distinguish

among the preventive services that they cause

or encourage to be supported; and b) consider

the patient characteristics, frequency, and fee

schedules for such services. The costs and

cost-effectiveness of clinical preventive services may vary greatly depending on the targeted

population’s underlying risk for the condition

and the circumstances under which the intervention is applied.

■ Examples of clinical preventive services that

evidence shows are effective include: screening

for breast cancer (mammography and clinical

breast examination) in women 50 years of age

and older; screening for cervical cancer (Pap

smears) for women who are or have been

sexually active; cholesterol screening for certain individuals; selected smoking cessation

interventions; hypertension screening for certain individuals; adult immunizations for certain individuals; and screening for sexually

transmitted diseases for certain individuals.

Although these services are effective—in the

sense that they are likely to result in net benefits

to health-all have been found likely to increase financial costs to society when applied

to populations that are at average risk for the

specific condition (with the exception of screening for sexually transmitted diseases which has

not been extensively evaluated using costeffectiveness analysis).

■ Examples of clinical preventive services that

are effective and can reduce aggregate (societal) medical care costs (under certain conditions) include: most childhood immunizations;

newborn screening for some congenital disorders (i.e., one-time screen for congenital hypothyroidism and phenylketonuria); and prenatal

care for poor women.

■ If the aim is to design benefit packages based

on effectiveness and cost-effectiveness, the
4 I Benefit Design: Clinical Preventive Services

Figure l-l—Policy Issues Concerning Insurance Coverage for

Clinical Preventive Services

Should Congress require insurance benefits for Clinical Preventive Services?

0

How else can

Congress

increase the

use of preventive

interventions?

I n

How else can

Congress Increase

the effectiveness

and cost-effectiveness of preventive

interventions?

J

I

t---l YES

n

Locus of analysis

of effectiveness

and costeffectiveness

I

SOURCE: U.S. Congress, Office of Technology Assessment, 1993.

specifications of coverage (e.g., which services

are covered and under what circumstances), are

currently likely to be simpler for clinical

preventive services than for therapeutic interventions (i.e., interventions used to treat disease) primarily because, to date, the indications

for using preventive interventions have been

based on general population characteristics

rather than complex signs and symptoms. For

example, the indication for mammography is

based primarily on the age and gender of the

patient. In contrast, selection of a treatment for

breast cancer might be influenced by the extent

to which the cancer has spread, whether previous treatment has been provided, the number

and severity of other diseases, and the patient’s

tolerance for risks and side effects.

Insurance for clinical preventive services is

provided primarily to encourage the use of

preventive interventions, rather than to protect

against the risk of a catastrophic financial event

associated with medical treatment. Evidence

suggests that insurance coverage will increase

the use of clinical preventive services, but not,

by itself, to optimal levels. Whether insurance

coverage-or some other means-should be

used to help encourage the use of clinical

preventive services is only in part a scientific

question (e.g., does insurance lead to greater

use of services?). It is also a philosophical

question and depends on what one considers

the purpose of health insurance (e.g., to spread

financial risk or to encourage use of services).

ISSUES AND OPTIONS

OTA’s analysis of the implications of any of

the number of alternative approaches to coverage

for preventive services that Congress may or may

not pursue suggests that the question is more

complicated than “to cover or not to cover. ”

Figure 1-1 outlines key prevention-related policy

issues facing Congress as it considers health care
Chapter 1--Summary and Policy Options | 5

reform. Each of these issues, and related options,

are described in this section.1

The first issue Congress must address is

whether insurance plans should be required to

cover clinical preventive services. If the answer to

this question is “yes,” several questions follow.

One question is: what are the criteria for choosing

which specific preventive services to cover? The

criteria evaluated in this report were effectiveness, cost-effectiveness, and net costs. A second

question is: who should provide the information

on effectiveness and costs? A third question is:

how should the specifics of the benefit package be

determined (e.g., patient cost-sharing; limits on

the periodicity of screening)?

Most of the choices related to the issues raised

in this report could be adapted to any of a broad

range of alternative health care reform schemes.

For example, even in a “single payer” system

with a global budget, some entity could determine

which services would be reimbursed. Some choices

related to clinical preventive services may, however, fit better or be associated more with some

approaches to reform than others. The following

section notes when an alternative related to

clinical preventive services is particularly suited

or unsuited, or must be adapted to, a particular

approach to health care reform.

As the implications of insurance for preventive

services and Congressional options are described,

it is useful to consider the possible goals of

policies regarding insurance benefits for clinical

preventive services. Some potential goals are

listed in table 1-1.

It is important to recognize that these goals

may be addressed through means other than

benefit design. The following section discusses

Table l-l—Potential Goals of Policies Concerning

Insurance for Clinical Preventive Services

1. Increase the use of clinical preventive services.

2. Improve and/or maintain the health of the population.

3. Control or minimize health care costs paid by society,

taxpayers, patients, employers, and others.

4. Improve the effectiveness of preventive interventions.

5. Allow flexibility in the provision of services.

6. Allow consumers to exercise their preferences for services.

7. Minimize administrative burden on patients and physicians.

8. Encourage equitable access to services.

SOURCE: U.S. Congress, Office of Technology Assessment, 1993.

options that might aid in pursuing the objectives

of greater utilization and effectiveness of clinical

preventive services, regardless of decisions concerning insurance coverage. Table 1-2 provides

an overview of the options discussed in this

report.

Coverage Options

OPTION 1. Congress could make no statement or

requirement pertaining to coverage of clinical preventive services.

In the absence of a federally mandated benefit

package that includes clinical preventive services, choices about which insurance benefits to

include may continue to be influenced by existing

Federal regulations, State mandates, and market

forces. A potential disadvantage with this decentralized and non-uniform approach is that it

perpetuates variations in benefits. To the extent

that clinical preventive services are effective, this

approach may result in varying incentives for

improving or maintaining health status and may

be viewed as inequitable.2

An advantage of Congress not requiring benefits for clinical preventive services is that individ1 A broad range of health care reform alternatives was being debated while OTA was developing this report (200). This report does not

presume that Congress will pass any particular mtional-level health care reform. To date, there have been few national-level policies related

to health care coverage for specific services. Exceptions have been limited to spedc subsets of populations or to specific types of insurers

and include the HMO Act of 1973, as amended, and coverage for various clinical preventive services under Medicare and Medicaid. For the

most pm-t decisions about coverage for specific services have been made in the private sector or legislated at the State level (202).

z General arguments have been put forth for establishing a uniform benefit package, for example, in the context of some “managed

competition’ plans (172). Uniform benefits are expected to elucidate price differences between plans thus making it easier for consumers to

compare and evaluate insurance plans. In additioq uniform benefits may avoid some of the problems of risk selection (202,172).
6 I Benefit Design: Clinical Preventive Services

Table 1-2—Policy Options for Congressional Consideration

Coverage Options

Option 1: Congress could make no statement or requirement pertaining to coverage of clinical

preventive services.

Option 2: Congress could require that all insurance plans include coverage for clinical preventive

services, or establish a core benefit package that includes coverage for clinical preventive

services.

Option 3: If Congress requires insurance coverage for specific clinical preventive services, coverage

decisions concerning specific clinical preventive Interventions could be based on their

effectiveness, cost-effectiveness, and/or net costs.

Options Regarding Sources of information on Effectiveness and Cost-Eftectiveness

Option 4: Congress could identify one or more U.S. Executive Branch agencies that would determine

whether specific clinical preventive services are effective and the cost-effectiveness of those

clinical preventive services.

Option 5: Congress could identify provider organization(s) that would determine whether specific clinical

preventive interventions are effective and their cost-effectiveness.

Option 6: Congress could determine whether specific clinical preventive services are effective and

evaluate their cost-effectiveness.

Options Regarding Specific Benefit Design Features

Option 7: Congress could identify a Federal agency to determine the specifics of the benefit package

(e.g., periodicity schedules, covered populations),

Option 8: Congress could require full insurance coverage for clinical preventive services for those

individuals with incomes below a given level.

Option 9: Congress could require full insurance coverage for clinical preventive services for the total

insured population.

Access Options

Option 10: Congress could encourage the provision of clinical preventive services by directly allocating

funding to programs that provide clinical preventive services, such as public clinics,

school-based clinics, and work-site programs.

Option 11: Congress could encourage the provision of clinical preventive services by encouraging

programs aimed at reducing nonfinancial barriers to access.

Research Options

Option 12: Congress could encourage the provision of effective clinical preventive services by promoting

research on the efficacy, effectiveness, and cost-effectiveness of clinical preventive services.

Option 13: Congress could encourage the provision of effective clinical preventive services by promoting

the dissemination of information on efficacy.

SOURCE: U.S. Congress, Office of Technology Assessment, 1993.

uals may retain greater control over how their

money is spent. For example, in the absence of

Federal requirements, individuals, employee organizations, or employers could decide whether

they would rather have insurance for clinical

preventive services and thus lower out-of-pocket

costs if they receive clinical preventive services,

or whether they would rather have lower insurance premiums and higher out-of-pocket costs if

they receive clinical preventive services. Whether

decisions by individuals, or their employers, are

“better” than decisions made by government is

debatable. On the one hand, government may

have greater access to information on effectiveness and cost-effectiveness, and therefore, could

better weigh the costs and the benefits of coverage

decisions; on the other hand, government may not

be able to adequately address individual values

and preferences.
Chapter l-Summary and Policy Options | 7

OPTION 2. Congress could require that all insurance

plans include coverage for clinical preventive services, or establish a core benefit package that includes

coverage for clinical preventive services.

Congressionally mandated insurance benefits

for preventive services may directly, or indirectly,

affect the following areas: patients’ out-of-pocket

costs; the demand for, and use of services; the cost

of insurance premiums; total health care costs;

and the insured population’s health. The impact

on each of these areas is reviewed below.

In a private insurance market, one effect of

covering clinical preventive services through

insurance would be the reduction of the out-ofpocket price to patients of preventive care.

Research suggests that reduced out-of-pocket

costs tend to increase the demand for clinical

preventive services, although a substantial percentage of individuals still do not receive the

recommended levels of preventive care, even

when covered under insurance plans.

While insurance coverage for clinical preventive services would reduce patients’ out-ofpocket costs (relative to no coverage) at the time

of service, average insurance premiums will

likely increase. Additionally, the increased use of

services, due to insurance coverage, is likely to be

associated with an increase in total medical

expenditures. With few exceptions, these additional costs are unlikely to be offset by savings

resulting from avoided treatment.

The ultimate goals of encouraging the use of

preventive services are to improve and/or maintain health. A number of clinical preventive

services have been found to reduce or delay the

probability of mortality and morbidity. Therefore,

to the extent that mandated benefits for clinical

preventive services increase the use of effective

clinical preventive services, they are likely to

improve or maintain the insured population’s

health, and for some interventions (e.g., immunizations, screening for sexually acquired disorders) may also provide health benefits to those not

directly receiving the interventions.

OPTION 3. If Congress requires insurance coverage

for specific clinical preventive services, coverage

decisions concerning specific clinical preventive interventions could be based on their effectiveness, costeffectiveness, and/or net costs.

Effectiveness Criteria

The principal advantage of requiring insurance

coverage for clinical preventive interventions

based on their net benefits to health is that this

approach would deter patients from receiving

ineffective or marginally effective clinical preventive services. Preventive interventions are

considered effective if they reduce, or delay, the

probability of mortality and/or morbidity. However, defining what constitutes effective preventive care is a complex endeavor. In order to use

effectiveness as a basis for designing an insurance

benefit package, some entity must review the

relevant research and determine whether a given

preventive intervention is effective, and under

what conditions. It is critical that this entity use

methods which are as evidence-based as possible.

In addition, the rationales and criteria used to

evaluate the evidence and draw conclusions

concerning effectiveness should be made as

explicit as possible.

Cost-effectiveness Criteria

Using cost-effectiveness as a criterion for

coverage decisions may invoke greater recognition of the likely tradeoffs between the goals of

improving or maintaining health and the goal of

limiting aggregate health care costs. In addition,

cost-effectiveness analysis may aid in evaluating

those societal tradeoffs. Finally, cost-effectiveness analysis may encourage policymakers to

consider a broader range of likely consequences

of promoting a preventive intervention (e.g.,

costs associated with follow-up visits to treat

conditions found during screening).
8 I Benefit Design: Clinical Preventive Services

Cost-effectiveness analysis has some limitations and weaknesses. Specifically, cost-effectiveness analyses typically do not measure important but less tangible health benefits and do not

adequately incorporate equity and political issues.

If people rely too heavily on cost-effectiveness,

these political concerns and intangibles may be

undervalued (183). Despite these problems, on

balance cost-effectiveness analysis can be one of

several useful tools for making resource allocation decisions, such as those pertaining to insurance benefits.

Net Cost Criterion

Under the criterion of net cost, clinical preventive services would be covered if the costs

associated with their provision were less than a

given amount. For example, only those services

that lead to a net reduction in medical costs might

be included. Costs could be defined in several

ways, including costs to society, costs to insurance plans, costs to patients, and costs to employers. One problem with this standard is that

services with relatively low effectiveness per

resource consumed may be covered. For example,

a certain intervention may be relatively inexpensive to perform, but may result in few health

benefits. Under a net cost criterion, this intervention might be covered, whereas an intervention

that increased costs but conferred substantial

health benefits might not be covered. This approach, therefore, implicitly returns to the question of cost-effectiveness (191).

Options Regarding Sources of Information

on Effectiveness and Cost-Effectiveness

If Congress decides to make coverage decisions

based on effectiveness and cost-effectiveness

information, Congress could identify a source, or

sources, for this information. The following

options concern organizations which could provide information on effectiveness and costeffectiveness either to Congress or to other

entities and individuals making coverage and/or

purchasing decisions. It is important to note that

independent of the source of information, Congress could outline criteria, or methods, for

evaluating evidence on effectiveness and costs, or

designate some other entity to outline such

criteria or methods.

OPTION 4. Congress could identify one or more U.S.

Executive Branch agencies that would determine

whether specific clinical preventive services are effective and the cost-effectiveness of those clinical preven -

tive services.

Many agencies within the Department of

Health and Human Services have been involved

in efforts to evaluate the effectiveness of specific

clinical preventive interventions and have issued

recommendations regarding their appropriate utilization.3 Congress could use the evaluations by

one or more of these agencies to design and

update a clinical preventive services benefit

package. It would be useful, however to have

more consistency among those agencies in the use

of criteria and methods to evaluate effectiveness.

OPTION 5. Congress could identify provider organization(s) that would determine whether specific clinical preventive interventions are effective and their

cost-effectiveness.

Many organizations representing health care

providers (e.g., the American College of Physicians, the American Academy of Pediatrics) have

issued recommendations regarding the use of

specific clinical preventive services. Although

input from providers seems an appropriate part of

3 FOreXample, tie NatiO~ ~ti~tes of Health have issued recommendations on many types of screening tests, including hypertension and

cholesterol screening. The Centers for Disease Control and Prevention have developed expert panels which have issued recommendations for

screening for sexually transmitted diseases and immunizations. The Agency for Health Care Policy and Research has been involved in

synthesizing the information on the effectiveness of a variety of medical interventions (e.g., screening for sickle cell disease). Finally, the Office

of Disease Prevention and Health Promotion (ODPHP) established, and provides staff support to, the U.S. Preventive Services Task Force

(USPSTF), which evaluated the effectiveness of a number of clinical preventive services.
Chapter l-Summary and Policy Options | 9

effectiveness assessments, there are problems

with relying exclusively on provider groups.

First, provider groups may have an incentive to

encourage the use of services and thus there is a

potential conflict of interest. Second, many provider groups have based their assessments of

clinical preventive services on expert opinion

rather than on comprehensive reviews of the

literature and they have not clearly documented

the basis for their decisions.

OPTION 6. Congress could determine whether specific clinical preventive interventions are effective and

evaluate their cost-effectiveness.

Rather than identifying one or more U.S.

Executive Branch agencies to determine whether

specific clinical preventive interventions are effective, Congress could make this determination.

In the past, Congressional agencies have evaluated the effectiveness of clinical preventive services,4 However, Congressional agencies do not

have the resources to design a comprehensive

benefit package based on effectiveness and costeffectiveness information.

Options Regarding Specific Benefit

Design Features

Designing an insurance benefit package requires a number of decisions beyond the choice of

which clinical preventive services to cover. These

decisions include: whether to circumscribe coverage for particular services based on patient

characteristics, frequency of use, and other parameters; whether to apply cost-sharing and, if so,

to what extent; and whether to reimburse services

as a package or individually. The following

options relate to these decisions.

OPTION 7. Congress could identify a Federal agency

to determine the specifics of the benefit package (e.g.,

periodicity schedules, covered populations).

Seemingly innocuous decisions about the frequency of clinical preventive services, and the

populations who should receive clinical preventive services, can have a large impact on the

overall costs and effectiveness of the service.

Further, information about the costs and benefits

of particular protocols for providing interventions

is constantly changing as new research emerges.

Decisions about the specifics of the benefit

package could be delegated to a Federal agency.

OPTION 8. Congress could require full insurance

coverage for clinical preventive services for those

individuals with incomes below a given level.

If the primary purpose of insurance coverage

for preventive services is to increase the use of

these services, policymakers may want to link the

degree of coverage to the degree to which use is

actually increased, The effect of providing insurance may vary for different segments of the

population; for example, people with lower income may increase their use of services in

response to insurance to a greater extent than

those at higher income levels. Moreover, the

benefits of clinical preventive services may be

greater for those at lower incomes due to their

greater risk for particular conditions. Congress

could require full insurance coverage (i.e., no

cost-sharing) for prevention only for those with

incomes below a given level.5

OPTION 9. Congress could require full insurance

coverage for clinical preventive services for the total

insured population.

Requiring full insurance for the total insured

population reduces some of the administrative

4 For example, as part of its effort to obtain information on the consequences of expanding Medicare benefits for preventive services,

Congress asked OTA to study the effectiveness of selected preventive services for the elderly. OTA subsequently completed evaluations on

pneumococcal vaccines, influenza vaccines, breast cancer screening, glaucoma screening, cholesterol screening, colorectal cancer screening,

and cervical cancer screening in the elderly.

5 patient cost. s~ng for clinical preventive services is described more fully in the OTA Background Paper, Ben@”t Design in Healr~ Care

Reform: Background Paper4atient Cost-Sharing (203).
10 I Benefit Design: Clinical Preventive Services

Neighborhood health centers often provide clinical

preventive health services.

burden associated with determining who would

be eligible for insurance without cost-sharing.

Moreover, it is consistent with the goal of

providing insurance for clinical preventive services to increase utilization. However, because

patient cost-sharing typically reduces the use of

services, this option is likely to be more costly

than imposing cost-sharing on some, or all, of the

insured population (203).

Access Options

Insurance coverage increases the use of services by lowering the out-of-pocket price to

consumers at the time of purchase. There are,

however, other approaches Congress could take

in order to encourage greater use of clinical

preventive services, rather than, or in addition to,

requiring insurance coverage for clinical preventive services. Two of these approaches are outlined below.

OPTION 10. Congress could encourage the provision of clinical preventive services by directly

allocating funding to programs that provide clinical

preventive services, such as public clinics, schoolbased clinics, and work-site programs.

The advantages and disadvantages of this

approach rest on many assumptions concerning

health care reform (e.g., whether the U.S. health

care system continues to be primarily private,

what sort of incentives providers will face,

whether new delivery systems are developed).

Numerous agencies within Federal, State and

local governments allocate funding to programs

that provide clinical preventive services. One

advantage of financing preventive services

through such programs, rather than through insurance, is that prograMmatic approaches may allow

greater flexibility in the delivery, and range, of

interventions. For example, rather than being

delivered in physicians’ offices, preventive interventions could be provided at school and at work,

thereby making them more accessible. In addition, programs may be more easily targeted to

populations that are at

low-income mothers

programs to increase

than other mothers.

There are several

‘‘high risk.’ For example,

may benefit more from

their use of prenatal care

drawbacks with directly

funding individual programs. First, funding may

fluctuate across regions. In contrast, mandated

insurance benefits, to the extent that they apply to

everyone, might allow more equal access to

services. On the other hand, if services were

lacking in certain areas, such as rural or inner-city

locations, insurance coverage might do less to

encourage access than the provision of public

programs.

A second potential problem is that funding

school-based and work-site programs, and public

clinics, might result in a more fragmented delivery system. For example, if people had their blood

pressure and cholesterol measured at work, were

screened for sexually transmitted diseases at

public clinics, and received immunizations at a

physician’s office, documentation and coordination of care might suffer.

The relative costs, and costs to various parties,

of directly funding programs versus providing
Chapter l-Summary and Policy Options I 11

insurance coverage is hard to determine and will

depend on the overall structure of the health care

system, as well as the structure of the individual

programs. Factors such as whether insurance

premiums are capped, whether providers face

global budgets, the presence of other provider

incentives, and the structure of the programs will

affect relative costs,

OPTION 11. Congress could encourage the provision of clinical preventive services by encouraging

programs aimed at reducing nonfinancial barriers to

access.

Nonfinancial barriers have been identified as

important obstacles to receiving clinical preventive services (189). Congress could encourage the

Centers for Disease Control and Prevention, or

other government agencies, to develop programs

aimed at reducing nonfinancial barriers to access

to clinical preventive services. Efforts to reduce

nonfinancial barriers include reminder systems,

improved record-keeping systems, more convenient settings, the use of nonphysician medical

professionals, the use of multilingual and culturally sensitive providers, physician education, and

patient education.

Research Options

OPTION 12. Congress could encourage the provision of effective clinical preventive services by

promoting research on the efficacy, effectiveness, and

cost-effectiveness of clinical preventive services.

A key finding of this report is that many

clinical preventive services have not been evaluated in terms of their efficacy, effectiveness, and

cost-effectiveness. Congress could promote more

research on the efficacy of clinical preventive

services for example, by funding more randomized clinical trials or other types of studies.

OPTION 13. Congress could encourage the provision of effective clinical preventive services by

promoting the dissemination of information on efficacy.

Schools and workplaces are alternative sites for

providing clinical preventive services.

This report focuses on using information on

effectiveness, cost-effectiveness and net costs to

define a benefit package for clinical preventive

services. One of the justifications for this approach is that, in the absence of benefits that detail

the services that will be covered, ineffective

services will be provided and effective services

will not be provided. There are, however, numerous ways in which the effectiveness of preventive

medicine may be improved other than, or in

addition to, using benefit design, Methods for

improving effectiveness include improved methods of disseminating information resulting from

technology assessments, such as through decision

support tools (e.g., reminder systems, algorithms,

practice guidelines), feedback systems to providers on outcomes (e.g., profiling, outcomes measurement), and continuing education. These methods were not explicitly evaluated in this report but

are being evaluated, in part, in the ongoing OTA

study, Prospects for Technology Assessment.

The advantage of improving effectiveness

through the dissemination of information, in

contrast to attempting to improve practice

through benefit design, is that it allows greater
12 I Benefit Design: Clinical Preventive Services

flexibility and tailoring of services to individual A potential disadvantage of this approach is that

circumstances. Moreover, it places less burden on most efforts to educate providers through guidethe developers of a benefit package to define what lines and other means have not been extensively

are effective clinical practices and to continually evaluated, and their ability to alter practice

make timely adjustments to the benefit packages. patterns is unclear.
Overview

of the

Issues 2

DEFINING CLINICAL PREVENTIVE SERVICES

P

revention aims to prevent or delay the occurrence of

disease or injury or their consequences. A three-tiered

framework has traditionally been used to classify

preventive services based on their ultimate goal and the

point along a disease process at which the preventive intervention is applied.

Primary preventive services are intended to prevent or delay

the onset of disease or health problem. Immunizations and

counseling on lifestyle changes are classic examples of

primary prevention (191).

Secondary preventive services are efforts to detect a disease or

condition before it is clinically recognizable to avoid or delay

its further progression. Secondary prevention focuses on

incipient rather than established disorders (133). Screening

procedures, such as mammography or Pap smears, fall into this

category (191).

Tertiary preventive services attempt to reduce the impact of

already existing disease on the quality of a person’s life by

maintaining or improving his or her ability to function (191).

These would include services such as education for diabetic

patients and rehabilitation for stroke victims.

Preventive interventions have also been classified as clinical

preventive strategies, behavioral strategies (health promotion),

and environmental strategies (health protection) (176). This

classification system distinguishes preventive interventions by

the type and locus of actions taken to prevent disease. Clinical

preventive

Office of

services-the topic of this report-are defined by the

Technology Assessment (OTA) as “interventions

13
14 I Benefit Design: Clinical Preventive Services

comprising medical procedures, tests, or visits

with health care providers that are undertaken for

the purpose of promoting health, not for responding to patient signs, symptoms, or complaints”

(191). They include immunizations and chemoprophylaxis (i.e., the use of chemical agents to

prevent disease or other unwanted health conditions), screening tests, and health education

provided by health care professionals.

Behavioral strategies include a broad array of

strategies to encourage lifestyle changes, such as

exercise, smoking cessation, and healthful diets

(176). Behavioral strategies can be accomplished

in the context of a medical office visitor through

community-based interventions, such as mass

media campaigns. Environmental prevention strategies typically consist of social policies, such as

seat-belt laws, taxes on alcohol and tobacco use,

speed limits, and restrictions on access to firearms, as well as environmental and occupational

regulations.

This report examines the question of benefit

design and health insurance, and therefore is

focused on clinical preventive services. This

narrow focus should not be taken to mean that

clinical preventive services are the only, or best,

way to prevent disease or unwanted health

conditions. Sometimes more than one approach is

available to prevent a particular condition. For

example, smoking, which leads to a number of

diseases, may be prevented through taxes on

cigarettes (environmental strategies), antismoking campaigns (behavioral strategies), and

the use of a nicotine patch (clinical strategies).

Other times, trade-offs may need to be made

between promoting clinical preventive services

(e.g., cancer screening) or behavioral interventions

(e.g., sex education programs). It is often important to view clinical preventive services in the

context of the broader goals of promoting health

and preventing disease, and to recognize that a

specific clinical preventive service may be only

one of a variety of approaches for achieving a

particular goal.

STRENGTHS AND WEAKNESSES OF

INSURANCE AS A SOURCE OF FUNDING

FOR PREVENTIVE SERVICES

The principal function of insurance is to

transfer income across states of the world (e.g.,

from healthy to sick, from young to old) (150).

Individuals who purchase insurance pay premiums to avoid the need to pay for services at the

time of use. By paying a relatively small premium

at regular intervals, individuals avoid the risk of

having to pay a large amount for health care when

the services are needed. Traditionally, clinical

preventive services have been excluded from

insurance benefits. Insurers have argued that

insurance should be limited to unpredictable

expenses and that coverage for predictable expenses, such as routine screens, raises premiums

without increasing the protection from financial

hardship. Advocates of insurance for preventive

care generally contend that these concerns should

not override the public health benefits that would

result from removing immediate cost barriers to

regular preventive care (42). Moreover, it is

sometimes argued that encouraging services which

may prevent or delay episodes of illness and

disability would actually reduce national health

care costs.

The public health argument for insurance for

clinical preventive services rests on the assumption that insurance coverage will increase utilization. A number of studies have demonstrated a

positive relationship between insurance coverage

and the use of preventive services. Uninsured

people have been shown to receive significantly

fewer preventive care services than their insured

counterparts (198). For example, research has

shown that uninsured children receive fewer

well-child visits (148,169,231) and are less likely

to be immunized (231) than insured children.

Uninsured women are less likely to be screened

for cervical cancer (92, 115,233) and breast cancer

(92,233,234) and are less likely to receive prenatal care (25, 152). Uninsured adults are less likely

to be screened for hypertension (233) and glau-
.

coma (233). In addition, Medicare participants

with additional insurance coverage beyond that

provided by Medicare have been found more

likely to receive glaucoma screening, eye exams,

blood pressure measurement, Pap smears, and

breast exams (189).1 Finally, among insured

people, increased cost-sharing has been shown to

be negatively associated with the use of preventive services (134,203). Confounding variables

do not seem capable of explaining away these

findings. In several studies the positive association between having insurance and the use of

preventive services persisted even after controlling for the frequency of physician visits, health

status, education, and income (92,189,231,233).

A caveat regarding this research is that studies

only measured the presence or absence of any

insurance, and not the association between coverage of specific clinical preventive services and the

use of those services. Moreover, in many studies

the extent, or presence, of insurance coverage of

specific clinical preventive services was unknown.2

Although health insurance coverage may result

in greater utilization of preventive services, there

are other, nonfinancial barriers to access as well.

These include geographic barriers, cultural and

language barriers, lack of transportation, lack of

knowledge concerning services, forgetfulness,

inconvenience, and fear of procedures and their

potential complications (103,139,189). In addition, providers often fail to promote clinical

preventive services. Under-provision by providers has been attributed to their lack of adequate

knowledge about preventive interventions, lack

Chapter 2–Overview of the Issues 115

of time, forgetfulness, and their own personal

health promotion and prevention practices (139,

166,171). For these reasons, insurance coverage

for preventive services may be insufficient to

bring about desirable patterns of use., Indeed,

studies have shown that even with free care (i.e.,

no cost-sharing) or Medicaid coverage, many

persons do not receive preventive care at recommended levels (25,134).3

It is also important to note that increased use of

preventive interventions may not be adequate to

improve health outcomes. Many preventive interventions indicate the need for additional followup services (e.g., treatment for cholesterol or

hypertension), If these follow-up services are not

received, for example, because they are not

covered by a person’s insurance plan, increased

coverage of preventive services may not lead to

improved health outcomes. Moreover, preventive

services which are received may be inappropriate

or ineffective. To the extent that health insurance

encourages the use of ineffective preventive

services, insurance may have no effect or a

negative effect on health status.

CRITERIA FOR EVALUATING CLINICAL

PREVENTIVE SERVICES

There is a long list of clinical preventive

services which could potentially be included in

benefit packages and numerous criteria for inclusion or exclusion (202). This report focuses on

three criteria for choosing which clinical preventive services to cover: effectiveness, costeffectiveness, and net costs.

1 This study used 1982 dat% in 1982 Medicare did not cover any preventive services.

2 The Rand Htxdth Insurance Experiment reviewed in Ben@’r Design in Health Care Reform: Background Paper+atienr Cosr-Shuring

was unusual in that the insurance provided in the experiment was designed to include coverage for an atypically comprehensive array of clinical

preventive services (203).

3 Lurie and colleagues considered recommended levels as follows: diphtheria-pertussis-tetanus (DPT) and polio immunizations at 2,4,6 and

18 months; measles-mumps-rubella (MMR) vaccination at 12-18 months; and tuberculosis (TB) skin testing at 12-18 months. For adults these

included: tetanus immunization every 10 years; influenza vaccine yearly for high-risk adults; Pap smears every three years for women over

age 45; sigmoidoscopy every 3 years for men and women over age 45 (134). Braveman and colleagues defined prenatal care as appropriate

if it was initiated during the fust trimester and if an “adequate” number of visits were received, as determined by a complex forrmda (25).
16 I Benefit Design: Clinical Preventive Services

The Role of Evidence on Effectiveness

Using available information on effectiveness to

select specific services for inclusion in a benefit

package is an appealing idea for a range of

reasons. Simply put, it seems logical to pay for

‘‘what works’ rather than for services with little

or no value. Coincident with this concept is the

impression that if coverage is not servicespecific, and based on effectiveness information,

clinicians will provide ineffective care. This

impression has been supported by recent research

documenting that there is apparently a significant

proportion of health care that is unnecessary,

ineffective, or inappropriate.4 Despite the appeal

of using effectiveness criteria to design insurance

benefits, operationalizing this idea is not straightforward. Two practical considerations are addressed in this section: 1) how does one define

effectiveness, and 2) how does one determine

effectiveness? 5

Effectiveness has been defined by OTA as the

probability of a health benefit to individuals in a

defined population from a health technology

applied to a given health problem under ordinary

conditions by the average practitioner for the

typical patient (183).6 Health benefits can include

increased life expectancy, better functional status,

and reduced morbidity and suffering. Negative

health outcomes are the opposites of these qualities.

The term ‘appropriate’ is also frequently used

to describe an effective treatment. Although the

term “appropriate ‘‘ is used in various ways, one

definition from the Rand Corporation (as cited in

105) is as follows:

A procedure is “appropriate” for a given indication when the expected health benefits [exceed]

the expected negative consequences. . .by a sufficiently wide margin that the procedure [is] worth

doing.

The term “appropriate” emphasizes that most

interventions are not risk-free, that their effects

vary by patient and the patient’s condition, and

that the determination of ‘what works’ in health

care often involves weighing the likely benefits

and harms which are typically not known with

certainty. OTA’s definition of effectiveness subsumes this concept of appropriateness.

The determination of effective care is difficult

for several reasons. Knowledge about the effectiveness of health interventions typically advances through the replication and integration of

results, rather than through the dramatic results of

one study (71). The process of integrating and

evaluating research, and determining effectiveness, is neither simple nor straightforward for a

variety of reasons. A source of difficulty is that

people have different methods for identifying,

reviewing, and synthesizing the evidence on

effectiveness. It is increasingly recognized that

the methods for reviewing and synthesizing the

evidence from various studies can critically

influence the validity of the conclusions. For

example, some organizations may only consider

randomized clinical trials as valid evidence, while

other organizations may base their decisions on

the opinions of experts.

A related difficulty is that people often weigh

the risks and benefits from interventions differently. Because organizations may have varying

judgments about whether the potential benefits of

an intervention outweigh the potential for harm,

they may make different statements about the

appropriateness of an intervention. In recognition

of this fact, it is important that statements

concerning appropriateness clearly identify the

4 This literature is reviewed in OTA’s repon Benejit Design in Health Care Reform: Report #3-CeneraJ Policy Issues (202).

5 The ~5esment of tie ~ectivene55 of m intervention is a complex process and is only briefly described in this report. OTA k addressti

these issues in greater depth in an ongoing study, Prospects for Health Technology Assessment (in progress).

6 ~lcacy kbeen def~ed by OTA as tie probability of a health benefit to individuals in a defined POpdation from a health technology

applied to a given population under ideal conditions (183).
Chapter 2-Overview of the Issues 117

magnitude of the risks and benefits and lay out the

rationales for conclusions drawn.

Although tolerance for risk may differ from

person to person, preventive interventions have

generally been held to a higher standard of

evidence regarding their effectiveness than have

other diagnostic and therapeutic interventions.

The principal reason for this difference is that

‘‘unlike diagnostic and therapeutic services, which

are rendered in response to patient complaints or

symptoms, preventive services are offered to

ostensibly healthy individuals and therefore involve an implied promise that they will improve

patients’ health” (191). This is not to say that

diagnostic and treatment services should not be

held to the same criteria of effectiveness; however, it seems harder to resist performin g these

procedures in the face of an apparent symptom or

disease, even in the absence of good data on their

effectiveness.

Any attempt to base insurance benefits for

clinical preventive services on effectiveness information should recognize the difficulty of this

approach and carefully consider the process by

which effectiveness information will be determined. These include the locus of decisionmaking, the methods used to identify, review and

synthesize the evidence, and the explicitness of

the process.

The Role of Costs

Whether and how costs should enter into

decisions about health insurance coverage for

preventive services are contentious issues. The

following section discusses the definition of

cost-effectiveness and the strengths and weaknesses of using cost-effectiveness and net cost

information to make coverage decisions for

preventive services.

Cost-effectiveness analysis is a method by

which the benefits and costs of various interventions can be evaluated. OTA defines costeffectiveness analysis as follows:

An analytic technique that compares the costs of

a projector of alternative projects to the resultant

benefits, with costs and benefits/effectiveness not

expressed by the same measure. Costs are usually

expressed in dollars, but benefits/effectiveness

are ordinarily expressed in terms such as ‘‘lives

saved,” or “disability avoided” (183).

As commonly understood, a “cost-effective”

service is one that is worthwhile, or a good

investment relative to the alternative. However,

the determination of whether the benefit is worth

the cost is highly subjective and will depend on

who is making the comparison, and what is being

compared (55,227). Furthermore, an intervention

that is “cost-effective,” in the sense that it is

preferred to the alternative, will not necessarily

save money (222).

Cost-effectiveness analysis has some inherent

weaknesses. Examples of such weaknesses include: problems with quantifying or valuing

certain important but less tangible health benefits;

the inability of analyses to adequately incorporate

equity and political issues (183); and the potential

of cost-effectiveness ratios to be misleading

because they do not indicate the scale of an

intervention.7 If these limitations are overlooked,

cost-effectiveness analyses can seem to provide

an unambiguous or “bottom-line” answer, when

in reality they may rest on ambiguous data or

assumptions (183).

Because of these limitations, methodologists

have recommended that cost-effectiveness be

used as one tool for policy making rather than as

the primary basis for decisions (183). As a

component of decision-making, cost-effectiveness analysis has several advantages. First, it

7 Forexarnple, suppose program A costs $2,OOO dollars and saves 2,000 lives, while program B CONS $2,000,000 doll~ and saves l,~,o~

lives. The cost-effectiveness ratio for program A is 1 and that for program B is 2. It would seem that program A is more cost-effective. However,

there is no reason to believe that program A can be increased in scale and still maintain the same cost-effectiveness (183). Therefore, program

B might be preferred because it has a greater potential to reduce mortality.
18 Benefit Design: Clinical Preventive Services

Figure 2-l—Evidence on the Effects of Care:

Essential, But Not Sufficient, For Improving

Policies and Decisions in Health Care

Health Care

Policies

1

,7 ,/ /

,—-–-–

/“ \

n

➤ -.—l

RESOURCES PRIORITIES

SOURCE: U.S. Congress, Office of Technology Assessment, adapted

from the Cochrane Collaboration, “Preparing, Maintaining, and Disseminating Systematic Reviews of the Effects of Health Care,” figure

located in promotional brochure, Oxiord, England, 1993.

encourages policymakers to consider all the

consequences of a benefit decision, rather than

those that are most immediate or apparent.

Second, it provides a structured framework for

evaluating this information. Finally, it brings

assumptions out into the open and provides a

means to evaluate their impact. Possible ways in

which cost-effectiveness might be used to design

benefits are described in more detail in chapter 4.

Chapter 4 also presents evidence on the costeffectiveness and costs of specific preventive

interventions.

Other Criteria

Evidence on the health effects and costs of care

may be an essential component of policy and

benefit design decisions regarding preventive

services; although this information is unlikely to

be sufficient for making benefit design decisions

(see figure 2-l). As previously mentioned, decisions regarding insurance coverage for clinical

preventive services must be viewed within the

larger context of the goals of the health care

system. Thus, the burden of illness-as indicated

by the incidence, prevalence, and duration of the

disease or condition, and the resulting mortality

and morbidity-will bean important factor in the

decision to promote specific services (see figures

2-2 and 2-3). Other considerations, such as the

quality of life associated with the disease state,

fear of the disease, and the age at which the

disease or injury usually occurs, may also be

important. For example, interventions targeted at

children may be of higher priority than those

targeted at older adults. Similarly, some types of

interventions may be preferable to other types.

Policies which restrict personal freedoms, such as

smoking regulations, may be perceived as less

desirable than policies which can stimulate people to improve their own health without limiting

their personal choices. Finally, health problems

which are considered the consequence of “personal choices” (e.g., smoking, violence, “unintentional” but avoidable] injuries), may be

viewed as less appropriate for insurance coverage

than health problems which are perceived as

‘‘uncontrollable’ (e.g., cancer); however, society’s judgments about these issues may change

considerably over time (194). For these reasons,

decisions concerning insurance benefits for preventive services probably cannot, and should not,

be made in a completely mechanistic and scientific manner. Nevertheless, information about

effectiveness and costs can be an extremely

important component of the decision process.

INSURANCE BENEFIT DESIGN

The questions concerning benefit design for

clinical preventive services described thus far in

this report include the following: what do we want

to prevent (e.g., what targeted conditions); how

should we prevent it (e.g., should clinical services

or other types of preventive interventions be

used); should the clinical preventive service be

covered by insurance (e.g., will insurance coverage stimulate utilization); and, if so, what criteria

should we use to make coverage decisions

concerning specific services (e.g., effectiveness,
Chapter 2–Overview oft he Issues 119

Figure 2-2—Leading Causes of Death, 1989, All Ages (in Thousands)

Heart disease

Cancer

Cerebrovascular diseases

Accidents

Chronic obstructive pulmonary diseases

Pneumonia and Influenza

Diabetes mellitus

Suicide

Chronic Iiver disease and cirrhosis

Homicide and legal intervention

I I ! 1 I o 200 400 600 800 1000

Number of deaths (in 000s)

SOURCE: U.S. Congress, Office of Technology Assessment, adapted from U.S. Department of Health and Human

Services, Public Health !%rviee, Centers for Disease Control, National Center for Health Statistics, Health United States

1991 and Prevention Profile, DHHS Pub. No. (PHS) 92-1232 (Hyattsville, MD, 1992).

cost-effectiveness)? The following section moves

from consideration of these questions to more

practical, but equally important, issues of how to

design an insurance benefit once decisions have

been made about which interventions to include.

In particular, this section addresses two general

issues regarding benefit design:

■ the specificity and detail of the benefit, and

■ the unit of payment for the benefits.8

Specifying and Circumscribing the Benefits

Insurance benefits can be defined with varying

degrees of specificity. At a very general level,

insurance benefits could cover ‘‘preventive services, ’ “preventive services for children,” or

“services provided during a periodic physical

examination. At a less general level, a benefit

might state that it reimburses for ‘‘breast cancer

screening. ” Alternatively, it could state that it

does “not reimburse for lung cancer screening. ”

At an even more refined level, the benefit could

state that it reimburses for ‘‘breast cancer screening for women aged 50 to 65 every two years

using mammography and physical breast examination.” Thus the insurance benefit could simply

describe the general type of service; it could

describe a condition (e.g., breast cancer) and the

intervention in general terms (e.g., screening); or

it could specify the intervention (e.g., mammography), the patient indications (e.g., sex, age, race,

behavioral characteristics, medical history), and

protocols (e.g., frequency of screening, type of

technology, training of the provider).

Some specific clinical preventive services are

recommended for individuals based only on

gender and age characteristics. These recommendations would be relatively easy to translate into

8 Another important benefit design issue is the presence of cost-sharing. Issues pertaining to cost-sharing are addressed in the OTA

background paper, Ben@”t Design in Health Care Reform: Background Paper4atient Cost-Sharing (203).
20 I Benefit Design: Clinical Preventive Services

Figure 2-3-Leading Causes of Years of Potential Life Lost (YPLL) Before Age 65,1969

(in Thousands)

Unintentional injuries

Malignant neoplasms

Heart disease

Suicide and homicide

Congenital anomalies

HIV infection

Prematurity

Sudden infant death

Cerebrovascular diseases

Chronic liver disease and cirrhosis

Pneumonia and influenza

Diabetes mellitus

Chronic obstructive pulmonary disease

2235

1832

1411

1403

0 500 1000 1500 2000 2500

YPLL before age 65 (in 000s)

SOURCE: U.S. Congress, Office of Technology Assessment, adapted from U.S. Department of Health and Human

Services, Public Health Service, Centers for Disease Control, “Years of Potential Life Lost Before Ages 65 and

8=nited States, 1988-1980,” Morbidity and Mortality Weekly Report, 41 (18):314-328, 1992.

an insurance benefit. Other services are recommended only for individuals identified as at high

risk for developing the disease according to

complex characteristics. For example, the

USPSTF recommends children, ages 2 through 6,

who are at high-risk be screened for hearing

impairment, where high-risk children are defined

as follows:

children with a family history of childhood

hearing impairment or a personal history of

congenital perinatal infection with herpes, syphilis, rubella, cytomegalovirus, or toxoplasmosis;

malformations involving the head or neck (e.g.,

dysmorphic and syndromal abnormalities, cleft

palate, abnormal pinna); birthweight below 1500

g; bacterial meningitis; hyperbilirubinemia requiring exchange transfusion; or severe perinatal

asphyxia (Apgar scores of O-3, absence of spontaneous respirations for 10 minutes, or hypotonia at

2 hours of age) (224).

Insurance contracts could include descriptions

of what constitutes a high-risk individual in the

case of these more complex indications. Alternatively, when the indications are complex, insurance contracts could specify that screening would

be appropriate for high-risk individuals and allow

the clinician to determine who constitutes a

high-risk person. Finally, insurance companies

could indicate that they will cover interventions

provided to high-risk individuals if provided in

accordance with specified guidelines, such as

those of the USPSTF.

Most preventive interventions are not effective, for all patients. Moreover, factors such as the

frequency, type of technology, and training of

providers may greatly influence the effectiveness

of an intervention. Therefore, a broadly defined

benefit may leave more room for ineffective

applications. At the same time, the broader the

benefit, the greater the leeway for clinical judgment and patient preferences. Thus an important

question is whether medical decision-making is

improved when the coverage allows flexibility in

tailoring interventions to individual patients.
Chapter 2–Overview of the Issues | 21

Preventive services are indicated on the basis

of risk factors, such as behavior, medical history,

and race, sex, and age, where a risk factor is a

characteristic which has been found in populations, on average, to be positively associated with

the development of a disease or condition. In

contrast, diagnostic and therapeutic interventions

are indicated by the signs, symptoms, and complaints of individual patients, in addition to the

factors just mentioned. Therefore, indications for

using preventive interventions may be more

easily specified in an insurance policy, and may

require less clinical judgment, than indications

for employing diagnostic and therapeutic procedures. However, it is unclear whether all the

appropriate indications for preventive services

could be adequately captured in an insurance

contract.

The level of specificity of the benefit may also

depend on the degree to which a more specific

benefit allows third party payers to monitor and

control utilization and costs. In general, the less

specific the benefit, the less control third-party

payers may have over utilization and costs.

Therefore, the degree of perceived overuse may

determine the need for more specific criteria. For

example, some might argue that, in the case of

preventive interventions, the threat of overuse

and runaway costs is minimal. The literature

suggests that preventive medicine and public

health focus on encouraging use of clinical

preventive services rather than deterring use.

Because routine visits involve some cost, inconvenience, and discomfort, and are not usually a

response to discomfort or pain, most patients may

not seek enough services rather than receive too

many. On the other hand, even seemingly minor

decisions, such as those pertaining to the frequency of screening, can have an extremely large

impact on the overall costs of the service, and in

the absence of a circumscribed benefit, providers

may err on the side of providing ‘ ‘too much’

preventive care, rather than “too little’ when a

patients seeks routine care.

A third consideration is administrative feasibility. A more detailed benefit could result in a more

complex claims system and potentially greater

administrative costs and errors (192). Even if

overuse, or inappropriate use, are problems, the

ability of detailed insurance plans to limit services depends on the extent to which the system

can be ‘‘gamed, ’ for example, whether clinicians

can falsely describe patients as falling into given

risk categories in order to receive reimbursement.

The salience of these issues may depend, however, on the structure of the delivery system.

A final consideration is the evolving nature of

information on health effects. The greater the

specificity of the benefit, the more responsibility

falls on the designers of the benefit to keep abreast

of changes in information on the best application

of each intervention, and to incorporate these

changes into their insurance contracts.

Unit of Payment

Many preventive interventions are paid for as

separate billable items. Payment is typically made

only for the procedure and not for the physician’s

visit at which the procedure is administered (191).

In contrast to procedure-specific benefits, a packaged benefit would reimburse providers for a

group of specified procedures or activities in a

defined visit schedule.

It has been argued that a packaged benefit

offers potential advantages over the incremental

procedure-specific approach (29,191). One advantage of a packaged benefit is that the freed

costs associated with patient scheduling and

preparation, medical record keeping, and billing

could be spread across a number of specific

interventions (19 1). Another advantage is that it

may allow services to be integrated with one

another (19 1), For example, screening for sexually transmitted disorders could be integrated

with sex education. Finally, it may foster greater

continuity of care and tailoring of services to a

patient’s medical history,
22 I Benefit Design: Clinical Preventive Services

An integrated and more comprehensive ap- more convenient to have some of the preventive

preach also has disadvantages. Specifically, a services provided at that visit rather than having

packaged benefit is less flexible and may necessi- the services provided during a separate primary

tate an additional visit which could ultimately care visit (e.g., blood pressure, cholesterol measlower patients’ use of preventive services (191). urement, vaccinations).

For patients who must visit specialists, it maybe
clinical

T

Evidence on the

Effectiveness of a

Select Group of

Clinical Preventive

Services 3

here is a vast literature on the effectiveness of preventive

health care services. The purpose of this chapter is to

present a general overview of the current state of

knowledge about the effectiveness of a select group of

preventive services in order to address the issue of

whether effectiveness criteria can and should be used to design

insurance benefits for preventive services. The review relies

heavily on previous reviews, particularly those that used a

systematic and explicit approach to evaluating the evidence.

Organizations which have reviewed the evidence on the effectiveness of clinical preventive services include the U.S. Preventive Services Task Force (USPSTF), the Canadian Task Force on

the Periodic Health Examintion (CTFPHE), and the Centers for

Disease Control and Prevention’s (CDC) Immunization Practices Advisory Committee (ACIP) (see appendix F for a

description of these groups and the methods they used to

determine effectiveness). Because research has progressed since

these organizations completed their reviews, subsequent studies

which may have altered previous conclusions about effectiveness

are identified. Conclusions of other groups, such as specialty

societies and other government agencies, are also presented in

order to provide a sense of the degree of consensus about the

effectiveness of a particular intervention. However, most of the

specialty societies, and some of the government agencies, did not

base their conclusions on comprehensive reviews of the evidence, nor clearly link their recommendations to the research

evidence. Therefore, although the recommendations of these

organizations at-e presented, they are not used to draw conclusions about effectiveness.

This chapter reviews the evidence on effectiveness of most of

the services recommended by the USPSTF for asymptomatic

23
24 I Benefit Design: Clinical Preventive Services

individuals on the basis of individuals’ sex and

age, as opposed to other indications of risk such

as family history (see table 3-1 for a list of the

preventive interventions recommended by the

USPSTF and appendix G for the periodic health

examinations recommended by the USPSTF). In

addition, some of the clinical preventive services

which the USPSTF did not recommend for

routine use are also reviewed (table 3-2 lists some

of the interventions which the USPSTF did not

recommend as appropriate for routine use in

asymptomatic populations). Finally, all of the

services included in major congressional health

care reform proposals introduced in the 102d

Congress are reviewed (see appendix H for a

description of these proposals).

REVIEW OF THE EVIDENCE

Annual General Physical Examination

In the 1920s, the American Medical Association (AMA) and the Metropolitan Life Insurance

Company first endorsed the annual physical

examination as conferring long-term benefits

(128). However, over the years the wisdom of this

approach has been questioned. In 1979, the

CTFPHE recommended that annual checkups for

adults be abandoned and that primary care prevention be selectively provided according to

age- and sex-specific packages of health services

(29).

The CTFPHE criticized annual physical examinations on several grounds. First, they argued

that the content and frequency of the examinations bore little relation to the needs of different

age groups. Second, they found that there was

little evidence that the tests and procedures

typically included in the checkup examination

were effective. Third, they found that procedures

were repeated once a year even though many

could have been performed equally effectively at

longer intervals. In sum, they found that “the

routine general annual check-up is nonspecific

and casts a searching net far too broadly, particularly in the adult, is inefficient and, at times, is

potentially harmful” (29).

Although the annual physical examination is

no longer recommended, both the USPSTF and

CTFPHE recommend periodic health examinations. The difference between the periodic health

examination and the annual physical examination

is that the former: 1) is provided less frequently;

2) more specifically details the interventions

which should be included; 3) places a greater

emphasis on tailoring interventions to individual

circumstances; and 4) is limited primarily to those

services which have been shown to be effective.

In large part, the rest of this chapter describes the

evidence on the effectiveness of services which

might be included in the periodic health examination.

Breast Cancer Screening

In 1993, an estimated 183,000 new cases of

breast cancer will be diagnosed and 46,300

people will die from breast cancer (20). Breast

cancer is the most frequently occurrin g cancer in

women in the United States and the second most

common cause of cancer death among women

(20).

There is good evidence from randomized

clinical trials and case-control studies that a

combination of clinical breast ex aminations and

mammography reduce breast cancer mortality in

women aged 50 and older (63,101,187,224). Most

studies, however, have not shown a clear benefit

of mammography and clinical breast examination

for women aged 40 to 49 (see Hurley and Kaldor

for a review of these studies, [101])1 and the

optimal onset for screening is controversial.

Questions also remain about the optimal periodicity of screening and about the independent effects

1 The randomized clinical trials are cited in the references at the end of this report and include refs. 168, 174, 9, 158, 76, 140, 141. The

case-control studies are also cited and include 226, 47, 156.
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services 125

Table 3-l-Preventive Interventions Recommended By the U.S. Preventive Services Task Force for

Nonpregnant, Asymptomatic Persons, 1989a

SCREENING

History

Height and weight

Blood pressure

Breast examination by clinician

Mammogram

Papanicolaou smear

Screening for visual acuity

Eye exam for amblyopia and strabismus

Glaucoma testing by an eye specialist

Screening for hearing loss

Screening for anemia using hemoglobin and hematocrit tests

Screening for phenylketonuria (PKU)

Screening for congenital hypothyroidism

Nonfasting total blood cholesterol

Thyroid function tests

Urinalysis for asymptomatic bacteriuria, hematuria, and proteinuria

For high-risk groups onlyb

Complete skin exam for skin cancer

Clinical testicular exam

Auscultation for carotid bruits

Palpation for thyroid nodules

Complete oral cavity exam for oral cancer

Screening for sickle cell disease

Screening for diabetes using blood glucose measurement

Fecal occult blood test/sigmoidoscopy

Fecal occult blood test/colonoscopy

Screening for lead toxicity

Tuberculin skin test

Rubella antibodies

Syphilis testing

Chlamydia testing

Gonorrhea testing

Counseling and testing for human immunodeficiency virus (HIV)

Resting electrocardiogram

Exercise stress test

Radiologic screening to detect low bone mineral content

COUNSELING

. Counseling about diet, exercise, injury prevention, dental health, smoking cessation, substance use, sexual practices

CHEMOPROPHYLAXIS C AND IMMUNIZATIONS

. Immunizations (Diphtheria-Tetanus- Pertussis [DTP], Oral poliovirus [OPV] Measles-mumps-rubella [MM R], Haemophilus

influenza type b [Hib], Hepatitis B [HBV], Tetanus-diphtheria [Td] booster, Pneumococcal vaccine, influenza vaccine)

● Fluoride supplements

● Aspirin prophylaxis to prevent myocardial infarction

● Chemoprophylaxis with estrogen therapy

a The frquenq of these interventions vary substantially by age and 9ender.

b Factors defining someone as “high risk” are factors other than age and gender, such as fami!y histow or ~havioral~ar~terist~.

c Chemoprophy[=is is the use of chemi~l agents (e.g., aspinn, flouride) to prevent disease.

SOURCE: U.S. Congress, Office of Technology Assessment, 1993, adapted from U.S. Preventive Services Task Force, Guide to C/inica/Prevent/ve

Services (Baltimore, MD: Williams and Wilkins, 1989).
26 I Benefit Design: Clinical Preventive Services

Table 3-2—Preventive Interventions Not Recommended By the U.S. Preventive Services

Task Force for Use on Asymptomatic Persons, 1989

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

●

Routine measurement of blood pressure using intra-arterial catheters

Routine screening for peripheral arterial disease in asymptomatic persons

Screening for prostate cancer using transrectal ultrasound and serum tumor markers (e.g., PSA)

Screening asymptomatic persons for lung cancer by performing routine chest radiography or sputum cytology

Screening of asymptomatic women for ovarian cancer

Routine screening for pancreatic cancer in asymptomatic persons

Screening of asymptomatic persons for risk of low back injury

Routine spinal radiographs of asymptomatic persons to screen for low back injury

Routine prenatal screening for maternal phenylketonuria (PKU)

Routine ultrasound screening of pregnant women at low risk for intrauterine growth retardation

Routine electronic fetal monitoring during labor for women not at increased risk for fetal distress

Screening for cognitive impairment among asymptomatic Personsa

Performance of routine screening tests for depression in asymptomatic personsb

Routine screening for suicidal intentc

Routine screening interviews or examinations for evidence of violent injuriesd

Screening for alcohol or drug abuse using biochemical markers and drug testing

a The USpSTF re~mmends, however, that clinicians “remain alert for” changes in cognitive function in patients ages 65 and over.

b The IJSpSTF r~mmends, however, that clinicians “remain aiert fo<’ depressive Symptoms.

c The USpSTF recommends, however, that clinicians “remain alert for suicidal risk factOr.%

d The USpSTF remmmends, however, that ~linidans “remain alert fofr signs of physical abuse or negkt.

SOURCE: U.S. Congress, Office of Technology Assessment, 1993, adapted from U.S. Preventive Services Task Force, Guide to C/inica/ Preverrtive

Services (Baltimore; MD: Williams and WtlkinS, 1989).

of mammography and clinical breast examination

in reducing breast cancer mortality.

The Canadian National Breast Cancer Screening study was specifically designed to prospectively examine the efficacy of screening with

yearly mammography and clinical breast examination as compared to no screening in women

aged 40 to 49 years old at entry (140,141). The

Canadian National Breast Cancer Screening study

also examined the separate effects of mammography and clinical breast examination. The study

concluded that at 7 years from entry “screening

with yearly mammography and physical examination of the breasts detected considerably more

node-negative, small tumors than the control

group, but it had no impact on the rate of death

from breast cancer” for the 40 to 49 year old age

group (140). Similarly, the study found that

screening women aged 50 to 59 with yearly

mammography in addition to physical examination of the breasts detected considerably more

node-negative, small tumors than screening with

physical examination alone, but it had no impact

on the rate of death from breast cancer (141). The

results of the Canadian trial are still being debated

in the research community (1 16,160) and the

study will follow patients for at least another three

years (140,141).

The screening recommendations of different

organizations reflect the uncertainties about the

optimal protocols for breast cancer screening for

average-risk women under 50 years old. The

USPSTF recommended mammography screening and clinical breast examination for women

age 50 and older every one or two years,

concluding at approximately age 75 unless pathology has been detected. The USPSTF notes

that it maybe ‘prudent’ to begin mammography

at an earlier age for women at high risk for breast

cancer. Most other groups also endorse periodic

mammography screening and clinical breast examination of asymptomatic women for breast

cancer; however, many recommend that screen-
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services I 27

ing begin at age 35 or 40.2 These recommendations were published previous to the recent results

of the Canadian National Breast Cancer Screening study and could change in light of these

results.

Colorectal Cancer Screening

In 1993, an estimated 152,000 new cases of

colorectal cancer will be diagnosed and 57,000

people will die from colorectal cancer in the

United States (20). The detection of neoplasms

(cancers and adenomatous polyps) in the colon or

rectum involves either direct inspection of the

colon and rectum or indirect measurement of

biochemical markers for the presence of cancers

or polyps (193). Today, the most common screening technologies are the fecal occult blood test

(FOBT) and flexible sigmoidoscopy (193).3

The effectiveness of FOBT in reducing colorectal cancer morbidity is still being investigated

and debated. Concerns center on the test’s sensitivity, specificity and predictive capability (2).

Although some medical organizations have recommended FOBT screening of asymptomatic

adults (e.g., American College of Physicians,

1991 [63]; National Cancer Institute, 1991 [219];

American Cancer Society, 1991 [5]; and the

American College Obstetricians and Gynecologists, 1988 [7]), the USPSTF and the CTFPHE

concluded that there is insufficient evidence to

recommend for, or against, FOBT in adults

without risk factors for colorectal cancer (33,224).

OTA concluded that FOBT screening improves

the stage distribution of cancers detected, which

may translate into decreases in cancer mortality;

however, even in the very large trials ongoing at

the time of OTA’s 1990 review, no such mortality

effect had been identified (193).

Results from one large randomized trial, the

Minnesota Cancer Control Study, have recently

been reported (135). The study randomly assigned more than 46,000 participants, 50 to 80

years of age, to either annual FOBT screening,

biennial FOBT screening, or a no-screening

control group. Those with a positive test were

evaluated with colonoscopy. After 13 years,

annual FOBT testing decreased the 13 year

cumulative mortality from cancer by 33 percent.

This trial may alter the previous conclusions of

the USPSTF and other organizations. In addition,

there are several other ongoing randomized control trials of FOBT screening of asymptomatic

adults that should provide more evidence about

its effectiveness (72,90,1 14,123).

The benefits of screening asymptomatic adults

for colorectal cancer using sigmoidoscopy are

also uncertain. The USPSTF concluded that

“there is insufficient evidence to recommend

either for or against fecal occult blood testing with

sigmoidoscopy as effective screening tests for

colorectal cancer in asymptomatic persons’ (224),

although they went on to state that “[it] may be

clinically prudent to offer screening to persons

age 50 and older with known risk factors for

colorecta1 cancer’ (224). Similarly, the CTFPHE

concluded that there is not enough evidence on

the effectiveness of sigmoidoscopy in reducing

mortality to recommend it as a screening procedure in people who have no risk factors for

colorectal cancer (33). In 1990, OTA concluded

that there was inadequate evidence that sigmoidoscopy reduces cancer mortality rates over time;

however, OTA noted that there had never been a

good trial to determine the effect of screening

with the flexible fiberoptic sigmoidoscopy on

cancer mortality, so the lack of evidence on

2 The American College of Physicians, 1991 (63), the American Academy of Family Physicians, 1993 (3), and the CTFPHE, 1979 (29) aho

recommend screening with mammography and breast physical examination beginning at age 50. The American Cancer Society, 1991 (5),

National Cancer Institute, 1991 (219), and the American College of Obstetricians and Gynecologists, 1989 (7), recommend mammography

beginning at age 35 or 40.

3 Colonoscopy has also been recommended as a primary screening technique in people at increased risk of colorectal cancer based on family

history (224).
28 I Benefit Design: Clinical Preventive Services

outcomes should not be equated with the existence of negative evidence (193). Despite the

paucity of direct evidence, some organizations

have recommended regular screening with sigmoidoscopy, in conjunction with FOBT, for asymptomatic individuals who are over 50 years old (e.g.,

American College of Physicians, 1991 [63];

National Cancer Institute, 1991 [219]; American

College of Obstetricians and Gynecologists, 1989

[7]; and American Cancer Society, 1991 [5]).

Two recent case-control studies concluded that

screening by sigmoidoscopy can reduce mortality

from cancer of the rectum and distal colon

(149,167). Additional evidence about the efficacy

of colorectal cancer screening may be provided

by a large randomized trial being planned by the

National Cancer Institute; however, the results

from this trial will not be available for at least

eight years (80).

Cervical Cancer Screening

In 1993, an estimated 13,500 new cases of

cervical cancer will be diagnosed and 4,400

women will die from cervical cancer in the United

States (20). The principal screening test for

cervical cancer is the Papanicolaou (Pap) smear.

Although there have been no randomized

clinical trials examining the effectiveness of

cervical cancer screening in reducing mortality,

the evidence from many case-control and observational studies over time suggest that screening

is protective (62,193,224).4

Based on its review of the evidence, the

USPSTF recommends regular Pap smears every

one to three years (at the physician’s discretion)

for all women who are or have been sexually

active, until age 65, at which age they may be

discontinued if previous smears have been continuously normal (224). Pap smears have

recommended by a number of other

tions.s

Prostate Cancer Screening6

also been

organizaAmong men, prostate cancer is the second most

common cancer and the second most common

cause of death from cancer in the United States

(6). During 1993, it is estimated that 165,000 new

cases of prostate cancer and 35,000 prostate

cancer related deaths will occur in the United

States (20). Screening tests for prostate cancer

which are currently in clinical use include digital

rectal examination (DRE), measurement of prostatespecific antigen (PSA), and transrectal ultrasound

(TRUS) (95).

None of the screening methods have been

assessed in randomized clinical trials in which the

control group received no screening. This lack of

demonstrated efficacy, in addition to the potential

for false positives, uncertainty about the natural

history of the disease, and treatment of clinically

insignificant disease, has led reviewers to conclude that there is currently insufficient evidence

that detection and treatment of prostate cancer in

its early stages, using any of the three techniques

mentioned, will improve survival (41,95,224).

DRE has not been shown to be effective in

clinical trials and the USPSTF and CTFPHE

made no recommendation either for or against

routine DRE for prostate cancer (38,224). In

contrast, other organizations have advocated its

use for routine screening (e.g., the National

Cancer Institute recommends annual DRE beginning at age 40 [219]).

Most organizations do not recommend serum

tumor markers (e.g., PSA) or transrectal ultrasound for routine screening (e.g., 219). In fact the

4 The studies reviewed by the USPSTF include the following references: 8, 11, 14, 43, 51, 89, 106, 124, 125, 142.

5 The orgtitions which recommend Pap smears include: American Cancer Society, 1991 (5); the National Cancer Institute, 1991 (219);

the American College of Obstetricians and Gynecologists, 1989 (7); the American Academy of Family Physicians, 1993 (3); and the American

College of Physicians, 1991 (63).

6 In a separate study, OTA is examinin g the effectiveness, safety, and costs of screening for prostate cancer in the Medicare population.

The screening technologies to be considered are the digital rectal examina tion and prostate-speci.t7c antigen (PSA) technologies.
Chapter 3--Evidence on the Effectiveness of a Select Group of Clinical Preventive Services I 29

USPSTF and the CTFPHE recommended against

using PSA and transrectal ultrasound for routine

screening (38,224 ).7 However, the American

Cancer Society recently recommended that PSA

screening be done annually in conjunction with

DRE on men 50 years of age and older (22). The

National Cancer Institute is currently conducting

a multicenter randomized trial of the value of

TRUS, DRE and PSA screening, but the results

from this trial will not be available for at least

eight years (80,218 ).8

Cholesterol Screening

Despite the decline in the death rate from

cardiovascular diseases over the past 15 years,

cardiovascular diseases remain the number one

cause of death in the United States (216). The

association between elevated serum cholesterol

level (hypercholesterolemia) and the risk of

contracting and dying from cardiovascular disease is supported by a large body of evidence

from epidemiologic, pathologic, animal, genetic,

and metabolic studies (87,190).

Clinical interventions for preventing diseases

associated with elevated cholesterol involve measuring blood cholesterol levels and, in patients

with hypercholesterolemia, establishing a protocol for lowering cholesterol, either through diet or

medication. Randomized clinical trials reveal a

decrease in the incidence of coronary heart

disease in middle-aged men with high blood

cholesterol who are assigned to cholesterollowering drugs (48,75,130,131). There is also

some evidence from clinical trials, albeit weaker,

that lowering cholesterol through diet reduces the

incidence of coronary heart disease in men

(57,96,147,224).

Published clinical trials of the effects of

lowering cholesterol offer little or no information

about the effects of treatment on women of any

age, men with borderline cholesterol elevations,

children, young adults, and the elderly (39,77).

Similarly, although there is indirect evidence that

high blood cholesterol during childhood may

increase the risk of developing coronary heart

disease in adulthood, the relationship between

lowering cholesterol during childhood and decreased incidence of coronary heart disease during later life has not been demonstrated in

controlled studies, in part due to the difficulty of

performing such studies (224). The lack of direct

evidence about whether routinely screening children, women, young men, and men older than age

65 would lower their mortality must be weighed

against the potential cost and adverse effects of

widespread cholesterol screening of these populations. Therefore, routine cholesterol measurement in these populations is controversial (77,

78,151).

Questions also remain about the association

between reducing cholesterol levels and total

mortality (i.e., mortality for all causes, including

coronary heart disease). None of the randomized

clinical trials of the effectiveness of lowering

cholesterol on health outcomes found a significant effect on total mortality (190). In part, the

failure to affect total mortality was due to a trend

in several studies toward higher rates of death

from noncardiovascular mortality, such as from

violence, accidents, trauma, suicide, and cancer,

in the groups receiving treatment to lower cholesterol (98,143,15 1,153).

Clinical practice guidelines regarding the detection and treatment of hypercholesterolemia are

controversial (122). The USPSTF concluded that

while there is evidence to support screening for

hypercholesterolernia in high-risk groups, such as

middle-aged males, there is no direct evidence

from clinical studies that a policy of routine

screening of the general population would achieve

7 A recent updated review by the USPSTF, not yet published, did not change its previous recommendation concerning DRE, PSA, and TRUS

screening (59).

8 The trial will consist of 74,000 subjects aged 60 to 74 at entry. Each participant will undergo digital rectal exarnina tion and PSA screening

every three years. Those with either a positive DRE or PSA test will then be screened using ultrasound (218).
30 I Benefit Design: Clinical preventive Services

significant reductions in mortality and morbidity

(224). In their recommendations, the USPSTF

stated that periodic measurement of total cholesterol was most important for middle-aged men

and it may also be clinically prudent in young

men, women, and the elderly. They noted that the

optimal frequency for cholesterol measurement in

asymptomatic persons has not been determined

on the basis of scientific evidence and they

recommended leaving the decision regarding

frequency to clinical discretion (224).

In 1985, the National Heart, Lung, and Blood

Institute (NHLBI) organized the National Cholesterol Education Program (NCEP) with the goal of

developing a national policy for cholesterol

reduction in the United States. In 1987, the NCEP

issued their guidelines and stated that all adults

age 20 and older should have their blood cholesterol level measured at least once every 5 years

(more often for those with total cholesterol levels

greater than 200 mg/dL). The NCEP recommended that low density lipoprotein (LDL) cholesterol be measured in persons who are candidates

for intensive interventions (65,84) and also issued

specific treatment recommendations (65). The

NCEP recommended screening blood cholesterol

levels only in those children and adolescents

whose risk of developing coronary vascular

disease as adults could be identified by family

history or by the coexistence of several risk

factors.9

The chief differences between the USPSTF and

the NCEP guidelines are that the USPSTF recommended intensive treatment based primarily on

total cholesterol rather than LDL cholesterol,

made less aggressive recommendations for screening women, and made no specific recommendations for children.

Hypertension Screening

Hypertension is a leading risk factor for coronary artery disease, congestive heart failure,

stroke, renal disease, and retinopathy. As noted

above, heart disease is the leading cause of death

for both men and women in the United States

(216), and in 1989, 733,867 people died from

diseases of the heart (216). Sphygmomanometry

(the blood pressure cuff) remains the most appropriate screening test for hypertension in the

asymptomatic population (224).

After reviewing the evidence on the effectiveness of early detection of hypertension, the

USPSTF concluded that “it is clear from several

large clinical trials that lowering blood pressure is

beneficial and that the population incidence of

several leading causes of death can be reduced

through the detection and treatment of high blood

pressure” (224).

The USPSTF recommends ‘‘regular’ blood

pressure measurement in all persons age 3 and

above (224). They note that the optimal frequency

has not been determined and leave the determination to clinical discretion (224). Most expert

groups recommend blood pressure measurement

in asymptomatic populations, although the recommended frequency of measurement differs

among organizations.10

g The American Academy of Family Physicians recommends that healthy asymptomatic adults with no known risk factors have serum total

cholesterol, fasting or nonfasting, at least every five years stinting at age 20 (3). The American College of Physicians recommends total serum

cholesterol measurement at least once during early adulthood and at intervals of 5 or more years up to age 70 (63).

10 me c~dian TaskFor~ recommends blood pressure measurement for men and women ages 16 to 64 at kast every 5 years and at every

visit for other reasons (29). They recommend blood pressure measurement every two years in males and females aged 65 and older (29). In

contrast, the American College of Physicians recommends blood pressure measurement for all adults ages 18 and older every one to two years

(63). The American Academy of Family Physicians recommends that all adult patients ages 18 and older have their blood pressure cheeked

at every physician visit with a minimum of once every two years (3). The Joint National Committee on Detectioq Evaluation, and Treatment

of High Blood pressure (JNCV) recommends blood pressure measurement every 2 years for people 18 years of age and older with systolic blood

pressure less than 130 mm Hg and diastolic blood pressure less than 85 mm Hg (109), The JNCV recommends more frequent blood pressure

measurement if the initial measurement was shown to be higher than 130 mm Hg and diastolic blood pressure less than 85 mm Hg. For children

age 3 through adolescence, the JNVC recommends that blood pressure be measured once a year.
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services I 31

Smoking Cessation Interventions

In 1990, approximately 46 million adults in the

United States smoked (212). Smoking is the

leading preventable cause of death in the United

States, and it is estimated to account for about

390,000 deaths annually (206). These include 30

percent of all cancer deaths, 21 percent of deaths

from coronary heart disease, 18 percent of stroke

deaths, and 82 percent of deaths from chronic

obstructive pulmonary disease (214).11 In addition, smoking during pregnancy contributes to

low birthweight and fetal and infant mortality

(214). Many of the risks associated with smoking

have been found to diminish after quitting (214).12

Smoking cessation methods fall into two broad

categories: self-help strategies (e.g., quitting on

one’s own) and assisted strategies (e.g., providerinitiated smoking cessation counseling, smokingcessation clinics, nicotine chewing gum or nicotine patch) (213). Ninety percent of successful

quitters used a self-help strategy, most by quitting

abruptly (70). Only ten percent of those who quit

use assisted strategies (70); however, these may

be people who are more severely addicted,

Insurance could cover all or some of the assisted

methods. For example, benefits could cover

physician advice about smoking cessation, smoking cessation classes, or prescriptions for nicotine

patches or nicotine chewing gum.

A meta-analysis of 39 clinical trials of several

different types of smoking cessation interventions

(e.g., counseling, nicotine gum, written self-help

materials) found that the average difference in the

cessation rates between the intervention and the

control group was 8,4 percent after 6 months and

5.8 percent after 1 year (119).13 Meta-analyses

were also done for specific types of smoking

cessation intervention. Programs based on faceto-face advice had the best results, followed by

programs based on nicotine chewing gum and

self-help books. However, the main conclusion

from the overall review was that reinforcement—

by increasing the number of contacts, the types of

contacts, and the number of people making the

contacts—rather than a particular intervention or

delivery system for the smoking cessation method,

produces results (1 19).

The nicotine patch is a relatively new method

of smoking cessation which delivers nicotine

through the skirt to prevent nicotine withdrawal

symptoms. The efficacy of the nicotine patch was

not evaluated in the meta-analysis by Kottke and

colleagues described above, but is now widely

used and has been studied in several clinical trials

(1,27,53,73,102,1 11,144,146, 159,177,178). Both

nicotine gum and patches are recommended by

their manufacturers only for use in conjunction

with behavior modification programs (12,129,136,

157). Other nicotine delivery forms which may

become more widely used are nasal spray. At this

time nicotine containing nasal spray for smoking

cessation has not been approved by the Food and

Drug Administration (54).

Although the average success rates associated

with smoking cessation interventions are low,

smoking cessation programs can result in a large

absolute reduction in the number of smokers. For

example, each year about 28 million of the 46

million smokers visit a physician (i.e., assuming

60 percent of the U.S. population has a physician

office visit each year [216]). If all physicians

counseled their smoking patients to quit and 3

percent of those counseled were able to quit, then

physician-based efforts would potentially result

11 me relative risk calculations for these estimates are based on the results of a prospective study sponsored by the American Cancer Sociev

during the period 1982 to 1986 (79).

12 For ex~ple, several prospective and retrospective epidemiologic studies have demonstrated the reduction in lung Cm= risk Ovm be

following smoking cessation (214). After 10 years of abstinence, the risk of lung cancer is about 30 percent to 50 percent of the risk in continuing

smokers (206), Smoking cessation for 5 or 10 years also reduces the risk of cancers of the larynx, oral cavity, esophagus, pancreas, and_

bladder (214).

13 me 95 percent confidence interval of the studies was plus or minus 2.8 and 2.6 percent, respectively.
32 I Benefit Design: Clinical Preventive Services

in about 800,000 additional smokers quitting each

year. Therefore, the overall effectiveness of

smoking cessation programs, in terms of the

potential to reduce mortality, may be large.

In 1989, the USPSTF recommended that smoking cessation counseling be offered on a regular

basis to all patients who smoke, or use smokeless

tobacco, although they left the frequency of

smoking cessation counseling to clinical discretion (224). The USPSTF also outlined strategies

that can increase the effectiveness of counseling

regarding tobacco use, including: direct, face-toface advice and suggestions; scheduled reinforcement; self-help materials; referral to community

programs; and prescription of nicotine gum (224).

Adult Immunizations

Although the widespread implementation of

childhood vaccination programs has substantially

reduced the occurrence of many preventable

diseases, the CDC has concluded that ‘successful

childhood vaccination alone will not eliminate

specific disease problems’ and that ‘‘a substantial proportion of the remaining morbidity and

mortality from vaccine-preventable diseases presently occurs among older adults and adolescents’

(210).

The Immunization Practices Advisory Committee (ACIP) of the CDC issues recommendations

for adult vaccination. The ACIP’s definition of the

populations who should receive vaccinations varies. Some vaccinations are indicated for persons

who escaped natural infection or were not previously vaccinated (e.g., vaccines against diphtheria,

tetanus, measles, mumps, rubella, and poliomyelitis). Other vaccines are recommended for all older

adolescents and adults (e.g., the ACIP recommends

that all adults receive tetanus and diphtheria

boosters every 10 years). The use of other vaccines

is indicated on the basis of age (e.g., all persons 65

and older should be immunized once for pneumococcal pneumonia and should receive influenza

vaccinations). Finally, other vaccines are indicated

according to individuals’ occupation, environmental situations, lifestyles, immigration status,

and travel to some countries.

Prenatal Care

The five leading causes of infant death in 1989

were: 1) congenital anomalies, 2) sudden infant

death, 3) disorders relating to short gestation and

unspecified low birthweight, 4) respiratory distress syndrome, and 5) newborns affected by

maternal complications of pregnancy (216). Prenatal care encompasses a wide range of preventive, diagnostic, and therapeutic services which

may include screening for potentially harmful

conditions in the mother and fetus, education and

counseling, and nutritional supplements (188).

Evidence suggests that earlier and more comprehensive prenatal care can reduce infant mortality and prevent low birthweight and other perinatal complications, particularly in high-risk groups

(188). However, review groups have concluded

that more information is needed about which

specific components of prenatal care are effective

(188,205).

The USPSTF recommends that the following

preventive interventions be provided to all pregnant women: blood pressure measurement; hemoglobin and hematocrit; ABO/Rh typing; Rh(D)

antibody testing; syphilis screening; hepatitis B

surface antigen (HBsAg); urinalysis for bacteriuria;

gonorrhea culture; counseling about nutrition,

tobacco use, alcohol and other drug use, and

safety belts; maternal serum alpha-fetoprotein

14 me glucose toler~ce test is used to test for gestationrd diabetes. The USPSTF found that the effectiveness of treatment for gestational

diabetes in preventing most of the health risks associated with gestational diabetes (perinatal mortality, neonatal metabolic derangements,

congenital anomalies) had not been demonstrated in well designed clinical trials. The USPSTF argued, however, that since treatment is unlikely

to result in signitlcant maternal or fetal harm routine screening for gestational diabetes may be a reasonable measure. IrI contrast, other

reviewers have concluded that the test is not reliable and because of the lack of demonstrated treatment efllcacy, screening of pregnant women

is unlikely to make a signifkant impact on perinatal mortality (100). Moreover, these authors argue that a positive test may provoke unwarranted

and expensive testing and anxiety.
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services! 33

(MSAFP), and the oral glucose tolerance test.14

For women with selective risk factors they also

recommend the following additional interventions: hemoglobin electrophoresis; rubella antibodies; chlamydia testing; counseling and testing

for human immunodeficiency (HIV); ultrasound

cephalometry; and ultrasound examination. The

USPSTF notes, however, that their list is not

exhaustive and reflects only the topics reviewed

by the USPSTF.

A useful source of information about the

effectiveness of prenatal care is the Cochrane

Collaboration Pregnancy and Childbirth database

(previously called the Oxford Database of Perinatal Trials) which comprises a register of most, if

not all, of the reports of controlled trials in

perinatal medicine. Very complete and systematic reviews of the efficacy of specific components of prenatal care, based on this database,

were published in 1988 (40) and in 1992 (170).

The Cochrane Collaboration Pregnancy and Childbirth database is being continuously updated and

reviews and meta-analyses of perinatal research

are published electronically, every six months, by

the Cochrane Collaboration (24).

Newborn Screening for Congenital

Disorders

About 4,500 cases of detectable diseases causing death or mental retardation occur in newborns

each year (188). Newborn screening seeks to

identify biochemical abnormalities that suggest

the presence of disease in affected but as yet

asymptomatic infants (188).

In most States, newborn screening is mandated

by law, except in the case of parental refusal on

religious or other grounds (188). In some States,

the laws specify what types of testing will be

done; in others, the range of tests included is

determined by the health department, a government official, or a commission (10). The number

of States that screen for various newborn congenital disorders is shown in table 3-3. Recently,

some researchers have raised concerns about the

Table 3-3-The Number of States Screening for

Specific Types of Newborn Congenital Disorders

and Number of Cases Confirmed with

the Diagnosis, 1990

Number of States

(and the District of Number of

Columbia, Puerto Rico, confirmed

Disorder and the Virgin Islands) cases, 1990

Phenylketonuria (PKU)

Congenital hypothyroidism

Galactosemia

Hemoglobinopathy

Maple Syrup Urine Disease

Homocystinuria

Biotinidase deficiency

Congenital Adrenal Hyperplasia

Tyrosinemia

Cystic Fibrosis

52

52

38

42

22

21

14

8

5

2

337

1,190

86

N/A

3

9

15

51

1

14

SOURCE: Council of Regional Networks for Genetic Services (CORN),

New York, NY, “Newborn Screening Report: 1990,” supported in part

by project #MCJ-36101 141-0 from the Maternal and Child Health

Program (Title V, Social Security Act), Maternal and Child Health

Bureau, Health Resources and Services Administration, United States

Department of Health and Human Services, Rockville, MD, February

1992.

process by which States decide what diseases to

require for screening (44,99).

The USPSTF recommends screening all newborns for phenylketonuria (PKU) and congenital

hypothyroidism (224), as does the CTFPHE

(29,36). The USPSTF recommends screening

newborns of Caribbean, Latin American, Asian,

Mediterranean, or African descent for sickle cell

diseases. However, a NIH consensus conference

has recommended universal screening for sickle

cell diseases (49,220). In addition, a panel convened by the Public Health Service’s Agency for

Health Care Policy and Research recently recommended universal sickle cell testing, arguing that

a baby race or ethnic ancestry cannot be inferred

by name or appearance (26). Many of the tests

currently part of State newborn screening programs have not been reviewed by the USPSTF.

Childhood Immunizations

All vaccines must undergo a structured approval process before being licensed for public

use, and the efficacy of most childhood vaccines
34 I Benefit Design: Clinical Preventive Services

in reducing mortality and morbidity has been well

established on the basis of randomized controlled

trials (126). The ACIP recommends that all

children receive nine different vaccines (many in

combination form and all requiring more than one

dose). The nine vaccines are for measles, mumps,

rubella (German measles), diphtheria, tetanus

toxoids, pertussis (whooping cough), polio, haemophilus influenza Type b, and hepatitis B. Recommendations are also issued by the Committee on

Infectious Diseases of the American Academy of

Pediatrics (AAP), and the American Academy of

Family Physicians (AAFP). In contrast to many

other recommendations related to clinical preventive services, these groups attempt to keep their

recommendations consistent with each other and

there are only slight

recommendations. 15

Well-Child Care

When included in

differences among their

health reform proposals,

specific services for children and adolescents are

usually not individually identified, but rather are

covered as a package of services termed “well

child’ or ‘‘well baby’ care which are offered at

various points in a child’s life. The components of

well-child care include developmental screening,

physical examinations, parent counseling, and

immunizations and chemoprophylaxis (224). In

its extensive 1988 review, OTA concluded that,

when evaluated as a whole, there is no evidence

to support the contention that well-child care

(other than immunization) significantly influences mortality or morbidity among children

(188), OTA noted, however, that the sample sizes,

follow-up periods, and outcome measures in these

studies were consistently poor, thus leaving open

the possibility that some medical benefits do

exist. Several individuals and organizations have

reviewed evidence on specific components of

well-child care. Their findings are summarized

below.

General Physical Examination

Physical examination involves a series of

diagnostic procedures intended to detect a variety

of medical conditions (188). In its 1988 report,

OTA found that “all but one of the studies

examining the effectiveness of the general physical examination concluded the exam has little

merit” (188).

Some specific physical diagnostic procedures

are the Ortalani maneuver for identification of

congenital dysplasia of the hip, forward bending

for detection of scoliosis, and abdominal palpation for detection of tumors. Reviews of specific

physical examination procedures have been completed by the CTFPHE and USPSTF. The

CTFPHE concluded that there was good evidence

to recommend screening for congenital dislocation of the hip (37), but did not recommend

screening for scoliosis (29). The USPSTF recently reviewed the evidence for screening for

adolescent scoliosis and concluded that there was

insufficient evidence to recommend for or against

routine screening of asymptomatic adolescents

(225). Given the lack of evidence, the USPSTF

did not recommend routine visits to clinicians for

the specific purpose of screening adolescents for

scoliosis. l6

Screening For Iron-Deficiency For Anemia

Anemia is a condition that exists when hemoglobin levels drop below the normal range of

values for the population (224). In unselected

15 For exmple, the American Academy of Pediatrics recommends that a second dose of MMR vaccine be given at approxfitely 12 Yof age, whereas the ACIP recommends that it be given at school entry, at ages 4 through 6, along with DTP and OPV. The second dose at 4-6

years may have two advantages: prirnaxy vaccine failures are corrected sooner and individuals maybe easier to reach when they are entering

school. The different recommendations may be a result of different views on the prevalence of primary vaccine failure and on the best way

to reach the population.

16 me AAP recommends that a physical e xamination be performed on all children at regular intervals up to age 20 and possibly beyond (4).
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services | 35

populations of children, the overwhelmingly predominant cause of anemia is iron deficiency (74),

and in childhood, screening for anemia is recommended largely as a screen for iron deficiency

(188),

Hemoglobin concentration and hematocrit are

the principal tests for detecting anemia. In their

review, the USPSTF concluded that there was

evidence from prospective studies to support

screening for anemia in infants, and some evidence, although weak, to support screening in

pregnant women. They found no evidence to

support screening in other populations. Therefore, the USPSTF did not recommend routine

testing for anemia for asymptomatic persons,

except for pregnant women and infants (224).

Other groups have found evidence only to support

selective screening of high-risk groups. Based on

their 1988 review, the OTA concluded that

"

. . early identification of high-risk infants (e.g.,

those of low socioeconomic status) with either a

capillary hemoglobin/hematocrit or free erythrocyte protoporphyrin (FEP) appears reasonable,

with a liberal threshold for institution of a trial of

iron therapy’ (188). The CTFPHE suggests

hemoglobin measurement of infants who are

premature, those born of a multiple pregnancy or

of an iron-deficient woman, and those of low

socioeconomic status (29).17

Screening for Amblyopia and Strabismus

Amblyopia is subnormal visual acuity. The

term specifically denotes a developmental disorder of visual function arising from either sensory

stimulation deprivation or abnormal binocular

interaction. In the latter sense amblyopia is

familiarly known as “lazy eye” (137). Strabismus is a misalignment of the eye that the patient

cannot overcome without aid. The condition is a

lack of parallelism of the visual axes of the eyes,

which can result from neuromuscular or visual

disturbances.

The USPSTF review of the literature revealed

only one cohort study that addressed the effects of

preschool screening for vision disorders (68). The

study found that children who had been routinely

screened prior to school entry had less vision

impairment than did those who had not been

screened. The USPSTF also indicated that there is

evidence that interventions for amblyopia and

strabismus are significantly less effective if started

after age 5 and increase the risk of irreversible

amblyopia, ocular misalignment, and other visual

deficits.

The USPSTF recommends testing for amblyopia and strabismus for all children once before

entering school, preferably at age 3 or 4. Screening for amblyopia and strabismus was also

recommended by the CTFPHE (37).

Screening for Hearing Impairment

The USPSTF concluded that although the

detection of hearing loss during infancy appears

to be worthwhile, the screening tests currently

available are too inaccurate for routine screening

of children under age 3 (224). The USPSTF

recommended hearing screening only for neonates at high risk for hearing impairment (e.g.,

family history of hearing impairment, congenital

perinatal infections, low birthweight). In contrast,

a NIH Consensus Development Conference recently recommended universal screening for hearing impairment of all infants shortly after birth

(221).

The USPSTF found insufficient evidence of

benefit to recommend hearing screening of asymptomatic children older than age 3 or in adolescents. Based on their review, OTA concluded in

1988 that the efficacy of screening preschool

children for hearing impairment is unknown

17 me AAP guidelhes Sbte 41 [P]resent medicti evidence su~ests the need for reevaluation of the frequency md timhg of hemoglobfi and

hematocnt tests” (4). The AAP recommends a hematocrit or hemoglobin test once during infancy, early childhood, late childhood, and

adolescence (4).
36 I Benefit Design: Clinical Preventive Services

given the uncertain impact of hearing deficiency

and treatment efficacy (188).

Developmental Screening

OTA reviewed the efficacy of the Denver

Developmental Screening Test (DDST), which is

the developmental screening tool most widely

used and recommended for use by child health

personnel (188). OTA concluded that while the

evidence suggests that the DDST, when administered immediately prior to school entry, has a fair

ability to predict developmental abnormalities

accurately, there is limited evidence that the

detection of a problem will result in improved

school performance. In a 1989 review, the

CTFPHE found only one randomized controlled

trial that examned the effectiveness of the DDST

(28,34). The study found no statistically significant differences in outcome between the control

and screened groups, for example, in terms of

their use of specialized educational services,

academic achievement, cognitive and perceptual

motor tests, and assessment of behavioral, social

and emotional well-being. However, there was a

statistically significant increase in worry about

schoolwork among the parents of children in the

intervention group. The CTFPHE recommended

that the DDST not be included in the periodic

health examination.

Urinalysis

Several conditions, including pyelonephritis

(kidney infection) and renal scarring, are associated with asymptomatic urinary tract infection.

Urinalysis is a common method of screening for

urinary tract infection and is widely performed on

asymptomatic children as apart of routine examinations (1 13). The USPSTF concluded that urine

dipstick to detect the presence of bacteria maybe

beneficial in preschool children, but further studies are needed to establish its effectiveness (224).

A recent review of the effectiveness of urinalysis

found that the test had limited accuracy (113).

Moreover, the reviewers found no evidence of

benefit from early treatment and emphasized the

risks associated with treatment. The reviewers

concluded that periodic screening for the presence of bacteria should not be part of routine

well-child care.18

Frequency of VW//-Child Care Services

Scientific evidence about the optimal frequency of childhood preventive interventions is

lacking (224). The CTFPHE recommended that

healthy term infants have six well-baby visits

within the first two years of life (37). The

USPSTF recommended five visits from birth to

18 months, but stated that clinicians should

exercise discretion in selecting an appropriate

schedule (224). The American Academy of Pediatrics recommends nine visits from birth to age 2,

yearly visits from age two to age six, and biennial

visits from age 6 to age 20 (4).

Summary

In Summary, at present well-child care may

include procedures which have been found effective, ineffective, or whose effectiveness has not

been evaluated. Immunizations are highly effective and are universally recommended as a

component of well-child care. There is some

evidence to support screening for vision impairment (for amblyopia and strabismus), hearing

impairment, congenital dysplasia of the hip, and

hematocrit or hemoglobin testing for anemia in

infants, particularly those at high risk. More

research is needed to confirm the effectiveness of

routine urinalysis, other types of physical examinations (e.g., for scoliosis), developmental behavioral assessments, and to determine the frequency

of well-child care visits. The efficacy of screening

for cholesterol and hypertension was reviewed

elsewhere. Blood pressure measurement in children is recommended by a number of groups,

18 meM~~ttentit[p]re5ent medical evidence suggests the need for reevaluation of the fr~uency and tig of -Ysis’ (4).

In the interim, the AAP recommends that urinalysis be done once during infancy, early childhood, late childhood and adolescence (4).
Chapter 3-Evidence on the Effectiveness of a Select Group of Clinical Preventive Services | 37

although screening for cholesterol is controversial. 19

Contraceptive Services

Contraceptive services include counseling and

the provision of contraception. Contraceptive

methods that are highly efficacious include: oral

contraception (birth control pills), intrauterine

devices (IUDs), condoms, diaphragms, and sterilization (224). The effectiveness of contraception

depends largely on its correct use (196). Counseling is one way to increase the effectiveness of

methods to prevent pregnancy. Counseling can be

provided in several clinical settings, including

physicians’ offices and family planning clinics.

No direct evidence indicates that physician

counseling can lead to more effective contraceptive use or lower pregnancy rates. Despite this

acknowledged lack of evidence, the USPSTF

recommends that clinicians obtain a detailed

sexual history from all adolescents and adult

patients, and based on this information, that

clinicians provide counseling on the level of risk

associated with the patient’s current contraceptive techniques and, when indicated, available

contraceptive methods. The CTFPHE also recommends the inclusion of counseling to prevent

unwanted pregnancy in the periodic health examination of adolescents (32).

Sexually Transmitted Diseases

In the United States, the most prevalent sexually transmitted diseases (STDs) include HIV

infection, genital herpes, genital warts, syphilis,

gonorrhea, and chlamydia. It has been estimated

that, in the United States, 1 million persons are

infected with HIV (208), 20 to 30 million with

genital herpes (108), and 12 to 24 million with

human papillomavirus which causes genital warts

(120). 20 In addition, more than 55,000 cases of

syphilis in the infectious stage, the highest

number in 40 years, were reported in 1990 (112).

In 1990, 700,000 cases of gonorrhea were reported by local health departments. Finally, an

estimated 3 to 4 million men, women, and infants

acquire chlamydia each year (207). While these

prevalence statistics provide an indication of the

enormity of the problem, they may underestimate

the magnitude of the problem and must be viewed

cautiously. Many STDs are not required to be

reported, many are not easily diagnosed, and

many are asymptomatic and unapparent (108,112).

Complications of STDs vary. The most serious

complications from STDs include death, pelvic

inflammatory disease (PID), sterility, ectopic

pregnancy, chronic pelvic pain, gonococcal arthritis, blindness, cancer associated with human

papillomavirus, fetal and infant death, birth defects, and mental retardation (196,206). The

incidence of these complications is not trivial. For

example, AIDS is the third leading cause of death

in persons aged 25-44 (216), and an estimated 1

million cases of symptomatic PID occur annually

in the United States (209).

The most efficacious way of preventing STDs

and their complications is abstinence from sexual

intercourse or maintenance of a mutually monogamous sexual relationship with an uninfected

partner (196,224). For individuals who do engage

in sexual intercourse, the most effective way to

prevent transmission is to prevent the exchange of

blood, semen or vaginal fluid (e.g., by use of a

condom) (224).

Complications associated with STDs may be

prevented and transmission reduced through early

19 me ~erican &ademy of pediatics recommends the following components for well-child care at VariOUS points in a child’s life: height

and weight measurement, head circumference measurement, blood pressure, vision and hearing screening for those at high risk developmental

and behavioral assessment (by history and appropriate physical examina tion and, if suspicious, by spccitlc objective developmental testing),

physical examimtion, hereditary and metabolic screening according to State law, imrnunizatiorL tuberculin testing for high risk groups,

bematocrit or hemoglobm urinalysis, anticipatory guidance, and initial dental referral (4).

ZO More recent studies using advanced screening technologies (i.e., the polymerase chain reaction [pCR] technique) suggest titthe level

of prevalence of subclinical cases of papillomavirus infections is substantially greater (13).
38 I Benefit Design: Clinical Preventive Services

detection and treatment. Recommendations for

STD screening have been balanced by concerns

about the cost of screening, low yield of positive

results due to relative low prevalence, and a high

probability of false-positive results in low prevalence populations (23). The USPSTF recommends screening at-risk individuals for syphilis,

chlamydia, gonorrhea, and HIV. The USPSTF

and most other organizations that issue guidelines

for STD screening (e.g., CDC, CTFPHE) have not

recommended universal screening, but rather a

strategy of assessing patient risk factors, by

taking a history of sexual practices, and then

selectively screening. Criteria identified as risk

factors for certain STDs include the following:

multiple sexual partners, sexual contact with a

proven case, a sexual partner with multiple sexual

contacts, a history of repeated STDs, being a

resident of a high prevalence area, asymptomatic

persons who attend clinics for STDs, asymptomatic persons who attend other high-risk health

care facilities, homosexual or bisexual man or

partner of same, IV drug abuser or partner of the

same, or one who received a blood transfusion

between 1978 and 1985.

SUMMARY

clinical preventive interventions some of which

may be able to prevent or forestall a considerable

amount of mortality and morbidity. The clinical

preventive interventions identified in this chapter

as effective for some asymptomatic individuals,

include breast cancer screening, cervical cancer

screening, smoking cessation interventions, cholesterol screening, hypertension screening, immunizations for adults and children, some components

of prenatal care, screening for some newborn

congenital disorders, some components of wellchild care, contraceptive services, and screening

for sexually transmitted diseases. Other services

have been found to be effective, but only appropriate for persons at high risk (see table 3-1 for a

list of some of these services). Not all clinical

preventive interventions have been found to be

effective. Moreover, even when preventive interventions are found to be effective for certain

populations and applications, questions remain

about their effectiveness when applied to other

populations or in ways not directly studied.

This chapter provides an overview of the

current state of knowledge about a select group of
Costs in

Benefit Design

Decisions 4

w

hether and how costs should enter into decisions

about health insurance coverage for preventive services are contentious issues. The following chapter

discusses ways that information on costs and costeffectiveness might inform benefit design decisions and the

strengths and weaknesses of various uses.

USE OF COST-EFFECTIVENESS ANALYSES IN

BENEFIT DESIGN

Cost-effectiveness analysis provides information that allows

various alternatives to be compared. Comparisons could include

those between:

several different types of interventions for different conditions;

interventions aimed at the same condition;

an intervention and the status quo; or

different magnitudes of the same intervention.

If they are to allow for fair comparisons among interventions,

cost-effectiveness analyses must be calculated using similar

methods and assumptions. Sources of variation in methodology

fall into five main areas:

the perspective taken (e. g., society, patient, third-party

payer);

estimation of treatment effects (e.g., whether estimates

derive from randomized trials or opinion; use of metaanalysis);

valuations of outcomes (e.g., life years saved, quality -

adjusted life years, deaths avoided, or other valuations of

outcomes);

39
40 I Benefit Design: Clinical Preventive Services

■ estimation of costs (e.g., the inclusion of

indirect costs);

■ discounting.

Theoretically, cost-effectiveness analyses of

interventions used to prevent different conditions

(e.g., screening for breast cancer, smoking cessation programs, immunizations, etc.), could be

used to rank all preventive services to make

coverage decisions under a budget constraint (e.g.

cost-effectiveness analysis was initially used in

Oregon’s Medicaid proposal [197]). This would

involve comparing the cost-effectiveness of different interventions and eliminating those that

were the least cost-effective until the budget

constraint was met.

Attempting to rank different types of interventions is a demanding usage of cost-effectiveness

and may be the least viable. A major obstacle is

that few cost-effectiveness analyses have used

similar enough assumptions to allow fair comparisons, Furthermore, even if most of the methods

used to evaluate different interventions were

similar-that is, the discount rate, the types of

costs included, the method used to determine

effectiveness, the perspective taken-it is likely

to prove difficult to incorporate all the outcomes

of interest.1 If people rely too heavily on costeffectiveness to rank interventions, political concerns and intangibles may be undervalued (183).

A more practical use of cost-effectiveness

analysis may be in making comparisons of

different types of preventive interventions for the

same targeted condition, such as different drugs

to treat hypertension (63,132) or for reducing

cholesterol (175). For example, Littenberg and

colleagues found that the cost-effectiveness of

screening for hypertension and treating mild

hypertension can be substantially reduced by

using more expensive treatment regimens (132)

(table 4-7). They found that the cost-effectiveness

of screening and treatment, for a 40 year old man,

would be $2,131 per quality-adjusted life-year

saved when the treatment costs were $50 per year,

while the cost-effectiveness would be $27,599 per

quality-adjusted life-year saved when the treatment cost $500 per year.2 Based on their analysis,

Littenberg and colleagues concluded that ‘‘every

effort should be made to manage hypertension

with the low-cost interventions consonant with

good pressure control, patient acceptability, and

safety” (132).

Finally, cost-effectiveness analysis can provide information about the effects of altering the

magnitude of a given intervention. This is likely

to be the most practical use of cost-effectiveness

analysis for benefit design decisions since the

outcomes being compared are most similar.

Medical interventions eventually have diminishing returns, and incremental benefits tend to fall

as the intervention’s scope and frequency rise

(84). For example, Eddy found that the marginal

cost of screening for cervical cancer, in averagerisk asymptomatic women, from age 20 to age 75,

every year as opposed to every two years was

greater than $1,000,000 per year of life gained

(63). Similarly, Fahs and colleagues found that,

for low-income women 65 years of age and older,

the incremental cost-effectiveness of increasing

cervical cancer screening from triennially to

—

1 Attempts have been made to improve comparisons of different interventions for Werent conditions by using a subset of cost-effectiveness

analysis called cost-utility analysis (e.g., comparisons of morbidity from cancer and morbidity from hepatitis). The difference between

cost-effectiveness analysis and cost-utility analysis is in the way outputs are measured (15). In cost-effectiveness measurement is in natural

units (e.g., life years ‘saved’) (15). In cost-utility analysis outputs are measured in terms of both the quantitative aspects of health outcomes

(i.e., lives 10SL number of sick days) and in the form of quality-adjusted life years or healthy years txpivalent (15). The strengths and weaknesses

of cost utility analysis will be described in more detail in a forthcoming OTA study, Prospectsfor Health Technology Assessment (in progress).

z Variations in the cost of treatment were based on differences in the wholesale costs of various common medication regimens, the dosages

of medication, the mark-up by retail pharmacists, the cost of repeat visits to monitor blood pressure and observe for adverse reactions, and the

use of laboratory tests to monitor therapy (132).
—

Chapter 4-The Role of Costs in Benefit Design Decisions | 41

annually was $39,693 per year-of-life-gained

(66).3

Cost-effectiveness analyses may also be informative about the effects of expanding preventive

services to populations with different levels of

risk. In general, the lower the risk of disease, the

less cost-effective the intervention. For example,

Johannesson found that the lower Swedish cut-off

point for treatment of hypertension (diastolic

blood pressure of greater than 95 mm Hg) would

lead to roughly 50 percent higher treatment costs

than the British cutoff point (100 mm Hg) (107).

Similarly, Taylor and colleagues found that

programs to lower cholesterol have costeffectiveness ratios that differ 4- to 12-fold when

the results of a man at high risk are compared to

those for a man at low risk (175) (see table 4-5).

Finally, the Office of Technology Assessment

(OTA) found that screening high-risk women, 65

years old and older, for cervical cancer every 3

years could actually be cost-saving; while screening low-risk women every 3 years would have a

cost-effectiveness ratio of $120,520 (192). Based

on this analysis, OTA concluded that programs to

identify and screen women at high risk for

cervical cancer could reduce the incremental costeffectiveness of screening (192).

Sensitivity analyses can illustrate which factors have a large effect on the cost-effectiveness

of an intervention. For example, Eddy and OTA

examined how the cost of various aspects of

breast cancer screening and treatment influence

the overall cost-effectiveness of breast cancer

screening (e.g., the cost of breast physical examination, mammography, workup, initial treatment,

and terminal care) (63, 187). Eddy and OTA found

the cost-effectiveness ratio to be most sensitive to

the unit price of breast cancer screening (63,187).

Similarly, sensitivity analyses indicated that the

marginal cost-effectiveness of cervical cancer

screening depends greatly on Pap smear charges,

the false positive rate, and the cost of working up

a false-positive test result (63). These sensitivity

analyses may clarify the advantages of setting

reimbursement limits or requiring that tests be

evaluated by laboratories which meet certain

standards. Potential ways to improve the costeffectiveness of other preventive interventions

could be illuminated through similar types of

analyses.

NET COSTS AS A CRITERION FOR

INSURANCE COVERAGE

Rather than limiting benefits based on the

effectiveness and cost-effectiveness of specific

services, one could limit services to those found

to reduce society’s health care costs. The problem

with this criterion is that few preventive services

would be able to meet it. While the evidence

suggests that clinical preventive services can save

lives and prevent suffering, many preventive

services would not result in net savings of

medical costs. This does not imply that clinical

preventive services are not a worthwhile investment in terms of improving health status, but

rather that a criterion which states that clinical

preventive services must be able to reduce the

Nation’s health care costs may be too stringent

(191,228).

OTA’s review of the literature of the costeffectiveness of several major types of clinical

preventive interventions found that none of the

potentially effective cancer screening interventions would reduce medical costs (i.e., breast

cancer, colorectal cancer, cervical cancer) in

3 The high incremental cost-effectiveness of increasing the frequency of cervical cancer screening relates primarily to the assumptions

concerning duration of the preclinical stage of the disease. The longer it takes for atypical cells to progress to cancer, the smaller the benefits

from more frequent screening.
42 I Benefit Design: Clinical Preventive Services

populations at average risk for the disease

(61,63,184,192,193)! In addition, physician counseling on smoking cessation, both with and

without the use of nicotine gum, was not found to

be cost-saving (52,155). Studies have found that

preventive treatment of high cholesterol costs

more than the savings from reduced coronary

heart disease; thus, cholesterol screening is unlikely to be cost-saving (154,175). In addition,

hypertension screening was not found to be

cost-saving (132). Even adult immunizations

have been found to be cost-saving only for subsets

of the general population, or under certain circumstances. For example, influenza vaccines

were cost-saving only for those over 65 years of

age (185). Similarly, pneumococcal vaccines, for

those over 65 years of age, were only cost-saving

under optimistic assumptions (186).

The three preventive services reviewed that are

cost-saving (under certain conditions) are: prenatal care for poor women (188), newborn screening

for some congenital disorders (i.e., phenylketonuria and congenital hypothyroidism) (188), and

most childhood immunizations (188). However,

even childhood immunizations, prenatal care, and

newborn screening may not be universally costsaving. For example, a recent cost-effectiveness

analysis indicated that hepatitis B virus vaccination will be cost-saving only in high-risk adults

and not in newborns or adolescents (17). The

cost-effectiveness analyses reviewed above are

described in greater detail in tables 4-1 through

4-8.

Why is the intuition that ‘an ounce of prevention is worth a pound of cure” incorrect in most

circumstances? A key reason is that most screening tests (e.g., Pap smears, mammography, cholesterol and blood pressure measurement), must be

done on thousands of people, most of whom do

not have, and never will have, the disease, and

tests must be repeated at specified intervals

(161,164). Further, once the disease, or precursor

condition, is detected, treatment must be undertaken and often more expensive follow-up tests

performed. Finally, not everyone will benefit

from preventive interventions. For example, research shows that a relatively small number of

individuals given smoking advice will quit smoking (see chapter 3).

While a zero net cost criterion may be too

stringent a criterion for choosing preventive

services for coverage, attempting to limit net

costs may be appropriate and necessary, particularly in the face of budget constraints and

considering that the net costs associated with

clinical preventive services can be large. For

example, if the guidelines of the National Cholesterol Education Program (NCEP) were fully

implemented, serum cholesterol would be measured on over 150 million American adults every

five years (215). Over 40 percent of these

individuals would require more expensive lipoprotein analysis, after initial measurement of total

cholesterol, on a more frequent basis (232). Over

60 million American adults would require medical advice and intervention, including intensive

dietary counseling and extended use of lipidlowering drugs (232). The annua1 screening costs

alone for all adults ages 20 and older would be

almost $870 million, assuming full compliance

with NCEP protocols (77). If the cost of treatment

is included, the total expenditures might range

from approximately $6 billion to $67 billion,

depending on assumptions about the age group

treated, the effectiveness of diet in lowering

cholesterol, and when diet fails, the medications

used (77).

4 The cost-effectiveness studies reviewed were limited to those which used the following assumptions, unless otherwise noted: (1) all cc]sts

and benefits were discounted at 5 percent (2) the cost-effectiveness analyses took a societal perspective, (3) medical costs associated with

additional years of life were excluded, (4) indirect costs were excluded (e.g., costs due to lost productivity or time costs). However, the results

of these studies are only generalizable to the extent that the circum stances under which the interventions and treatments are applied (e.g., the

population characteristics, price of services, effectiveness) are the same as those assumed in the analyses,
Chapter 4-The Role of Costs in Benefit Design Decisions | 43

SUMMARY

Few clinical preventive services have been

found to be cost-saving when applied to populations at average risk for the condition. Therefore,

the use of most effective clinical preventive

services will involve tradeoffs between improved

health status and increased health care costs.

Using explicit methods to evaluate costs in

relation to benefits, such as cost-effectiveness

analyses, may not make these decisions less

political. However, in an environment of limited

resources, cost-effectiveness analysis may be one

of several useful tools for making better resource

allocation decisions, such as those pertaining to

insurance benefits. In particular, cost-effectiveness analyses may help shed Light on such

questions as: who should receive preventive

services, how often, and using what specific

interventions

5 A nevvpane~ the Cost-Effectiveness Panel on Clinical Preventive Sewices ( CEPCPS), has recently been established and will interact with

the USPSTP and the agencies of the Public Health Service. The goal of the CEPCPS is to develop cost-effectiveness methodology and

guidelines relevant to clinical preventive services; evaluate the adequacy of the literature on cost-effectiveness of selected clinical preventive

services; and identify, and, when possible, direct studies of high priority areas where unresolved questions of cost-effectiveness remain (81).
44 I Benefit Design: Clinical Preventive Services

$

0m
Table 4-l-Selected Cost-Effectiveness Analyses of Adult Immunizations-Continued

Data source(s)

Author a

/ Target Treatment for effectiveness

date population protocols compared information

Mulley et al. Homosexual men Hepatitis B vaccination,

(1982) and surgical resi- with or without prior

dents. screening v. no vaccination.

A randomized ciinical

triai of 1083 homosexual

men; 87.5% efficacy

rate.

Mulley, et al. General popula- Same as above. Save as above.

(1982) tion.

Bloom, et al. U.S. high-risk Compared universal

(1993) adult population hepatitis B vaccination,

and general to screening and vacciadult population. nating high-risk populations, to no vaccination.

Review of the medical

literature and expert

panel. Estimates of efficacy were based on

randomized and historical clinical trials.

Cost-effectiveness

per healthy life

year gained,b case

Other critical costs prevented or year of

assumptions included life saved (YOLS)

6% discount rate; 5-

year duration of immunity; serious reactions to vaccination

would occur at a rate

of 1/100,000 and 10°/0

of these would be fatal.

60% prevalence of HBV

markers and 15°/0 annual attack rate of hepatitis B in the homosexual population in the

absence of screening

or vaccination. Cost of

vaccination was $100.

Same assumptions except 5% prevalence of

HBV markers and O.1%

annual attack rate.

Base case assumption

was 10 years of immunity; no side-effects requiring medical care;

efficacy depended on

the population, doses,

and boosters (i.e., 60°/0

to 90%); vaccine cost

$225 for adults (this

included in administration fee). 5% discounting of benefits and

costs.

Cost of vaccination.

Savings from treatment of HBV infection

and chronic sequelae

of HBV infection.

Same as above.

Direct medical care

costs.

Vaccinations will save

medical costs for populations with attack

rates above 5°/0 (i.e.,

vaccination of homosexual men and vaccination of surgical residents) (1980 dollars).

Vaccination of the general population would

cost $22,469 per case

of hepatitis B prevented

(1980 dollars).

Vaccination without

screening is cost- saving in high-risk

adults; vaccination in

the general adult population would cost

$257,418/YOLS and

$15,001 per case prevented (1989 dollars).

ABBREVIATIONS: YOfS - year of life saved; HBV - Hepatitis B.

aFull ~t= can be found in references at the end of this report.

bHealthy life years were ~lWlat~ as a weight~ average of &ath,d~a~litydays with confinement to bed, disability days without confinement to bd, and fuii functioning.

SOURCE: U.S. Congress, Office of Technology Assessment, 1993.

o

-.

3

m

(D

z-.d

g

0- .

Cn- .

0

2—

*

ul
Table 4-2—Selected Cost-Effectiveness Analyses of Breast Cancer Screening

Cost effectiveness

Authora

/ Target Treatment Effectiveness Other critical costs ratio per year of

date population protocols compared data source(s) assumptions included life saved (YOLS)

U.S. Congress, Women age 65

OTA (1 987) to 74.

Eddy (1991a) Women younger

than 50 at average risk.

Eddy (1991 a) Women older

than 50 at average risk.

Annual Breast Physical Examination (BPE)

and mammography v.

no screening.

Annual BPE and

mammography v. annual

BPE alone.

Annual BPE and

mammography v. annual

BPE alone.

5 controlled trials and

1 uncontrolled study.

Health Insurance Plan

(HIP) and Breast Cancer Detection Demonstration Project

(BCDDP) studies.

HIP and BCDDP

studies.

5%. discount rate.

Screening mammogram

and BPE cost $50. Annual screening will reduce mortality by about

50% after 5 years, 40%

after 10 years and 30%

after 20 years.

BPE costs $25, mammography costs $75,

5%. discount rate.

Screening leads to a

24-60% reduction in

mortality after 10 years

and a 24-580/. reduction after 20 years.

Screening leads to a

30-59% reduction in

mortality after 10 years

and a 25-57% reduction in mortality after

20 years.

Screenlng rests, workup

for false positives, cost

of care for women with

cancer, terminal care

for cancer.

Screening costs, workup

for false positives, cost

of care for women with

cancer, terminal care

for cancer.

Same as above.

$34,600.

$30,000 to $135,000

depending on whether

use HIP or BCDDP.

$20,000 to $90,000

depending on whether

use HIP or BCDDP.

ABBREVIATIONS: BPE. Breast Physical Examination; I-UP - Health Insurance Plan; BCDDP. Breast Cancer Detection Demonstration Project

aFuil cites mn be found in referenc& at the end of this mpoti.

SOURCE: U.S. Congress, Office of Ttindogy Aaaessment, 1993.
Chapter 4-The Role of Costs in Benefit Design Decisions | 47

g

ocow

in
48 I Benefit Design: Clinical Preventive Services

g

g

.-

u

cm

ii

(n

C/j

3

a a

% .

D
Table 4-4—Selected Cost-Effectiveness Analyses for Childhood Immunizations-Continued

Cost-effectiveness

Authora

/ Target Treatment Effectiveness Other critical costs

date

per healthy life

population protocols compared data source(s) assumptions included year gaineda

Massachusetts Massachusetts MMR vaccination proDepartment of population. gram run by State v.

Health (1980) no program.

Koplan and U.S. population. Mumps vaccine in conPreblud (1982) junction with measles

and rubella v. measles

and rubella vaccine

only.

Schoenbaum U.S. population. Rubella vaccination of

et al. (1976) 2-year-old children as

part of measles and

mumps vaccine v. vaccination of 6-year-old

children with monovalent vaccine v. vaccination of 12-year-old

females with monovalent vaccine.

Reported 1978 agespecific mumps incidence rates were used

to estimate the incidence of mumps where

mumps vaccine was

part of routine childhood immunization

and more than 750/. of

children were immunized. Used average

annual incidence of

mumps in prevaccine

years to estimate effects without vaccine.

Frequency of rubella

infection based on two

serologic surveys performed in 1968.

No discounting, calculated cumulative savings since program

began in 1966.

Cost of mumps vaccination = $1.00, discounted at So/o.

Compiiance for all ages

is 80°/0, herd immunity

not considered, 6% discount rate, rubella vaccination costs $3/dose

when administration

alone and $1/dose

when administered

with measles vaccine.

Cost saving.

Direct and indirect Cost saving.

costs.

Direct costs of vacci- Cost saving.

nation, direct and indirect costs of congenital rubella syndrome,

where indirect costs include lifetime earnings

lost.

-.

3

(continued on next page)
mo

Table 4-4-Selected Cost-Effectiveness Analyses for Childhood Immunizations-Continued

Cost-effectiveness

Author’/ Target Treatment Effectiveness Other critical costs per healthy life

date population protocols compared data source(s) assumptions included year gaineda

Koplan et al. U.S. infant popu- Pertussis vaccination

(1979) Iation. in conjunction with

diphtheria and tetanus

(DTP) vaccines v. DT

vaccine only.

Bloom et al. U.S. population of Universal Hepatitis B

(1993) newborns and 10- vaccination compared

year-old adoles- with screening and vac

cents. cinating and compared

with no vaccination.

Incidence rates in a

population with and

without a pertussis

vaccination program

were based on reports

to the Massachusetts

Department of Public

Health. Vaccine complication rates were

based on data from

Sweden and the Netherlands. Vaccine efficacy was based on

“intrafamilial secondary cases.”

Review of the medical

literature and expert

panel. Estimate of efficacy was based on

randomized and historical clinical trials.

90% immunization coverage, 7070 efficacy,

serious vaccine complications 1 in 3,500,

encephalitis, 1 in 50,000;

case fatality from these

complications same as

for pertussis.

Base case assumption

was 10 years of immunity; no side-effects requiring medical care;

efficacy depended on

the population, doses,

and boosters (i.e., 60%

to 90%); vaccine cost

$160 fornewborns (this

included an administration fee). 5% discounting of benefits

and costs.

Direct medical costs. Cost saving.

Direct medical care Universal vaccination

costs. would cost $36,632 for

newborns and $97,256

for adolescents;

screening and vaccination would cost

$42,067 for newborns;

screening and vaccination of high-risk

newborns and all adolescents would cost

$3,695.

ABBREVfATIONS: DT = Diphtheria-tetanus; DTP - Diphtheria-tetanus-pertussis; Hib = Haemophilus lnfluenzae Type b; MMR - Measlss-mumps-rubella;CDC - Centers for Disease Control

g

Cn

g

. .

and Prevention.

aFuli dt~ found in references at the end of this report.

bH~lthy life ~eam were ~~lat~ ~ a ~ebht~ av~~e of &ath, disability d~s #th ~finement to ~, dis~ility &yJ titho~ confinement to bd, and full functioning.

SOURCE: U.S. Congress, Office of Technology Asseesment, 1993 (Adapted and updated from U.S. Congress, Office of T~ndogy

OTA-H-345 (Washington, DC: U.S. Government Printing Office, February 198S)).

Assessment, Healthy Chiidren, Investing in the Future,
Table 4-5—Selected Cost-Effectiveness Analyses of Cholesterol Reduction Interventions

Cost effectiveness

Author a

/ Target Treatment Effectiveness Other critical costs ratio per year of

date population protocols compared data source(s) assumptions included life saved (YOLS)

Taylor, et al. Men with given

(1990) sets of risk factors for developing CHD (i.e., total

serum cholesterol

level, age, blood

pressure, cigarette

smoking,high-densit y lipoprotein

level).

Taylor, et al. Same as above.

(1990)

Taylor, et al. Same as above.

(1990)

Dietary intervention.

Intervention includes 10

visits to registered dietitian, 2 physician visits in the first year.

After first year, 2 annual serum cholesterol

measurements, 1 visit

to physician, 3 visits to

nutritionist. Intervention

continues to age 65.

Compared to no intervention.

Dietary intervention

and drug therapy

(cholestryamine) v. no

intervention.

Dietary intervention

and drug therapy

(Iovastatin) vs. no

intervention.

Computed effectiveness of diet on lowering cholesterol based

on the Multiple Risk

Factor Intervention

Trial (MRFIT), estimated

the effect of lowering

cholesterol on survival

from the Framingham

Heart study. Assumed

no adverse consequences of cholesterol

reduction.

Effectiveness of dietary intervention plus

cholestyramine in reducing cholesterol was

based on the Lipid Research Clinics Coronary Primary Prevention Trial. Effect of

lowering cholesterol on

survival based on the

Framingham Heart

Study.

Effectiveness of dietary intervention plus

cholestyramine in reducing cholesterol was

based on the work of

Hoeg and colleagues.b

Effect of lowering cholesterol on survival

based on the Framingham Heart Study.

Assumed that men with

a given set of risk factors would be

screened when visiting physician for some

other reason. Firstyear dietary program

costs $557 and each

subsequent year costs

$150. 5% discount

rate.

The first year of cholestyramine therapy cost

$803; each subsequent

year cost $755.

The first year of lovastatin therapy cost

$1,291, each subsequent year cost

$1,177.

Serum cholesterol

tests ;visits with physician, nutritionist, lab

test; Costs of initial cholesterol screen were

not included. Savings

from treating consequences of CHD (e.g.,

myocardial infarction).

The costs of the dietary and medication

programs. Medication

program involved additional physician visits, liver chemistry

determination and ocular examination (only

for Iovastatin).

The costs of the dietary

and medication

program. Medication

program involves additional physician visits, liver chemistry

determination and ocular examination (only

for Iovastatin).

Estimates ranged

from $11,000 (40-yearold, high-riskc males

with total serum cholesterol of 300 mg/dL)

to $930,000 (20-yearold males at low risk

with total serum cholesterol level of 180

mg/dL).

Estimates varied from

$24,000 (60-year-old

man at high risk with

total serum cholesterol

of 240 mg/dL) to $1.4

million (20-year-old man

at low risk with total

serum cholesterol of

240 mg/dL).

Estimates varied from

$20,000 (60-year-old

man at high risk with

total serum cholesterol

of 240 mg/dL) to $1

million (20-year-old man

at low risk with total

serum cholesterol of

240 mg/dL).

(continued on next page)

:

n- .

u)- .

0

—z

ul
Table 4-5-Selected Cost-Effectiveness Analyses of Cholesterol Reduction Interventions-Continued

Cost effectiveness

Author a

/ Target Treatment Effectiveness Other critical costs ratio per year of

date population protocols compared data source(s) assumptions included life saved (YOLS)

Oster and Epstein Men in different Cholestyramine, life-time Framingham Heart 5% discount rate. Costs of medication, Cost/YOLS ranged

(1987) age groups (35 treatment vs. no inter- . routine office visits, from $56,100 (for

to 74), without vention. cholesterol tests, vis- 35 to 39-year-olds with

symptomatic cor- its for side-effects. The 315 mg/dL to over

onary artery dis- annual cost of a $1,000,000 (for 65-69-

ease. Base case 16-g/d regimen of year-olds with 265 mg/

assumptions: therapy is $707. Sav- dL) (1985 dollars).

cholesterol levels ings from treating conof 265-,290- and sequences of coronary

315-mg/dL. heart disease (e.g., myocardial infarction).

ABBREVIATIONS: CHD - coronary heart disease; dL -deciliter; mg - milligram.

aFul[ cit~ found in references at the end of this report.

bHWg, J. M., Maher, M. B., Wiky, K. R., et al-t “Comparison of Six Pharmtxmlogic Regimens for Hyperchoiesterolemia,” Amw”can Jouma/ of Canfiology 59:812-15, 1987

(97).

‘%igh risk was defined as cigarette smoking, systolic blood presaure in IOth percentile of age- and Sex=pecific population distribution, highdensity lipoprotein cholesterol at the IOth

per~ntile of age- and sex-population distribution.

-.

H

—

-.

s

SOURCE: U.S. Congress, Office of Technology Aasesament, 1993.
Chapter 4–The Role of Costs in Benefit Design Decisions! 53

I

g)

,-

C

a)

a)

b

(/)

I

8
54 I Benefit Design: Clinical Preventive Services

I

.2

p

m

c.-

!i!

5

(n

ii

v)

ii

u)

CJ o

co
Table 4-8-Selected Cost-Effectiveness Analyses of Smoking Cessation

Cost effectiveness

Author a

/ Target or study Treatment Effectiveness Other critical costs ratio per year of

date population protocols compared data source(s) assumptions included life saved (YOLS)

-— Oster, et al.

(1986)

Oster, et al.

(1986)

Cummings, et al.

(1989)

Cummings, et al.

(1989)

Male patients age

35 to 69 who

smoke.

Female patients

age 35 to 69 who

smoke.

Men 35 to 69

years of age who

smoke.

Women 35 to 69

years of age.

Nicotine chewing gum

as an adjunct to physi -

cians’ advice and counseling against cigarette

smoking.

Same as above.

Brief advice to quit

smoking during a routine office visit and a

self-help booklet.

Same as above.

Efficacy of physician’s

advice was based on

trials which reported

rate of smoking cessation after 12

months. Efficacy of nicotine gum was based

on 7 placebo-controlled

trials of nicotine gum.

The two rates were

multiplied to derive efficacy rate of nicotine

gum in a primary care

setting. Estimate that

6.1 % of patients seen

in primary care practice who use nicotine

gum will quit.

Same as above.

Four randomized trials that compared patients who were given

advice by a physician

to quit smoking and

those who received no

counseling. Found an

average smoking cessation rate atone year

Of 2.7°/0.

Same as above.

5% discount rate. Cost of nicotine gum,

cost of office visit med

ical costs avoided from

quitting smoking.

Same as above. Same as above.

5% discount rate. Cost of physician office visit and a selfhelp booklet. Medical

costs avoided from

quitting smoking.

Same as above. Same as above.

$4,113 to $6,465

(depending on age).

$7,073 to $9,473

(depending on age).

$705 to $988

(depending on age).

$1,411 to $2,058

(depending on age).

0

m

aFull dt= ~n be found in references at the end of this report 6

SOURCE: U.S. Congress, Office of Technology Assessment, 1993.

0- . W- .

0

3

u) —

UI ul
Appendix A: Overview of

OTA Assessment:

Technology, Insurance,

and the Health

Care System

Background

c

ongress has been concerned for many years The assessment was approved by the Technology

with serious and growing problems of health Assessment Board in April 1991, and began in July,

care costs, access, and quality. In response to 1991. In June 1992, the letter was received from

a request from the Senate Committee on Senator Stevens, An advisory panel for the overall

Labor and Human Resources (Edward M. Kennedy, assessment was formed in November 1991. The

Chairman) that was endorsed by the House Committee advisory panel met in January 1992, December 1992,

on Energy and Commerce (John D. Dingell, Chair- and in May 1993.

man), the House Committee on Ways and Means

Subcommittee on Health (Willis D. Gradison, then Documents Produced as Part of the Ranking Minority Member), and Senator Charles E.

Grassley (Committees on Budget, Finance, Special Assessment

Committee on Aging), the Office of Technology The following documents have been or will be

Assessment’s (OTA’s) assessment, Technology, Insur- available as part of the assessment.

ance, and the Health Care System, addresses these

congressional concerns by focusing on the following

issues:

1. What does the available literature say about the

impact of health insurance on access to care and patient

health outcomes?

2. Can a minimum benefit package for uninsured

people be fashioned from the perspective of effectiveness and cost-effectiveness?

In addition, Senator Ted Stevens (as a member of the

Technology Assessment Board) asked OTA to examine an additional question under the auspices of this

assessment:

3. What cost implications do the leading types of

health care reform proposals have in seven areas:

health care spending and savings; Federal, State, and

local budgets; employers (large and small); employment; households (low-, middle-, and upper-income);

Publications Available From the

U.S. Government Printing Office

Does Health Insurance Make a Difference? (OTABP-H-99).

This interim report, requested by the U.S. Senate

Labor and Human Resources Committee, summarizes

the state of the literature on the relationships among

insurance coverage, access, and patient health outcomes; provides a conceptual framework for evaluating access to health care and the health effects of such

access; and provides an overview of insured and

uninsured populations in the United States as of 1990.

The background paper is available from the U.S.

Superintendent of Documents (phone number 202/

275-3030; address: Washington, DC 20402; GPO

stock number 052-003-01301-1, $5.00 per copy) or,

for congressional purposes, from OTA (49241).

other costs in the economy; and administrative costs?

57
58 I Benefit Design: Clinical Preventive Services

An Inconsistent Picture: A Compilation of Analyses of

Economic Impacts of Competing Approaches to

Health Care Reform by Experts and Stakeholders

(OTA-H-540).

This report compiles and summarizes available

analyses of the economic impacts of four major

competing approaches to health care reform (popularly

known as “single payer,” “play or pay,” “individual

vouchers or tax credits, ” and ‘‘managed competition”). The report was requested by Senator Ted

Stevens, and was released in June 1993. The report is

available for public use from the U.S. Superintendent

of Documents (phone number 202/783-3238; address:

P.O. Box 371954, Pittsburgh, PA 15250-7954; GPO

stock number 052-003-01327-4, $8.00 per copy) or,

for congressional purposes, from OTA (49241).

Benefit Design Series

Publications from this series of reports explore

issues involved in designing a benefit package based

on effectiveness and cost-effectiveness, in relation to

other critical factors in benefit design. Two of the

topics (clinical preventive services; mental health/

substance abuse) were chosen in part because of

Congressional interest in them as contentious, ‘‘grey’

areas in benefit design and in part because of OTA’s

already-existing expertise in the topics. Patient costsharing was in some respects a new area for OTA, but

was an issue of particular importance in the benefit

design debates. The general issues report will pull

together lessons learned about benefit design from the

other reports in the Benefit Design Series and from

other sources, including previous work by OTA. The

reports in this series are:

Benefit Design in Health Care Reform: Report #1—

Clinical Preventive Services (September 1993).

This report addresses issues pertaining to insurance

coverage of clinical preventive services. The report

describes how information on effectiveness and costeffectiveness can, and cannot, be used for purposes of

insurance benefit design and for improving access to

effective clinical preventive services.

Benefit Design in Health Care Reform: Background

Paper-Patient Cost-Sharing (September 1993).

This background paper describes what is known,

and not known, about the effects of patient costsharing on the use of health care services, expenditures, and health outcomes based on a review of the

literature.

Benefit Design in Health Care Reform: Report #2—

Mental Health and Substance Abuse Treatment Services (in preparation).

This report addresses issues pertaining to insurance

coverage for mental health and substance abuse

services. The report emphasizes the role that scientific

data on efficacy, effectiveness, and cost-effectiveness

can, and cannot, play in the design of insurance

benefits for mental health and substance abuse treatment.

Benefit Design in Health Care Reform: Report #3-

General Policy Issues (in preparation).

This report reviews policy issues related to the topic

of designing benefit packages based on effectiveness

and cost-effectiveness in relation to other factors such

as public preferences, professional judgment, and

political concerns.

Background Papers Available Only From OTA

These background papers are available from OTA.

For Congressional use call 49241, and for public use,

Call 202/228-6590.

Health Insurance: The Hawaii Experience--Background Paper (OTA-BP-H- 1O8). (June 1993).

This Background Paper provides a detailed look at

the State that is often considered model for what other

States can do to help provide universal or nearuniversal health insurance coverage for their residents.

Unfortunately, valid data were not available to demonstrate either the overall financial costs of Hawaii’s

approach or the health effects on residents,
Appendix A–Overview of OTA Assessment: Technology, Insurance, and the Health Care System 159

Coverage of Preventive Services: Provisions of

Selected Current Health Care Reform Proposals

(OTA-BP-H-1 10). (October 1992).

This background paper summarizes the provisions

of selected congressional (102d Congress) and private

health care reform proposals with respect to the

coverage of clinical preventive services,

Contractor Papers Available From National

Technical Information Service or From the Authors

Primary Care for the Uninsured: A Review of the

Literature

Paper prepared under contract to OTA by David

Blumenthal, M. D., M. P. P., Elizabeth Mort, M. D.,

M. P. H., and Jennifer N. Edwards, M. H. S., Health

Policy Research and Development Unit, General

Internal Medicine, Massachusetts General Hospital

(May 1993).

The Relationship among Insurance Coverage, Access

to Services and Health Outcomes: Case Study of

Depression

Paper prepared under contract to OTA by Thomas

McGuire, Ph. D., Department of Economics, Boston

University, Boston, MA (July 1993).

Nonfinancial Barriers to Access to Health Care

Paper prepared under contract to OTA by Joanne

Lukomnik, M. D., New York, NY (in preparation for

October 1993).

Other Contractor Papers to be Available From OTA

or GPO

Insurance Status and Health Care Utilization: Analysis of Four Data Bases and Cost Implications for

Universal Coverage-Background Paper

Paper in preparation under contract to OTA and

CRS, by Stephen Long and M. Susan Marquis, Rand

Corporation, Washington, DC (in preparation).

This background paper is scheduled to be available

in January 1994; plans for distribution are not yet final.

Lasers in Health Care: Coverage Decisions

The results of this survey, being conducted under

contract to OTA by Neil Powe, M. D., M. B.A., M. P. H.,

and Claudia Steiner, M. D., M. P. H., Johns Hopkins

University, are scheduled to be available in September

1994. Plans for distribution of the results are not yet

final.
Appendix B:

Method of

the Study

T

his report, Benefit Design in Health Care

Reform: Report #1-Clinical Preventive

Services, is one of a series of the Office of

Technology Assessment (OTA) publications

on the uses of effectiveness and cost-effectiveness

information in benefit design in health care reform that

are being published as part of OTA’s assessment,

Technology, Insurance, and the Health Care System,

The report addresses the available evidence on the

health effects and cost-effectiveness of selected clinical preventive services for people without apparent

symptoms for specific diseases, and the implications of

using (and not using) such evidence in the design of a

benefit package for health insurance coverage. Policy

options for congressional considerations are addressed.

This appendix summarizes the method used for this

report.

Information on the health effects of selected clinical

preventive services were based, in large part, on

previous reviews. The reviews used were primarily

limited to those that met the following criteria. They:

1) completed a thorough literature review, 2) provided

explicit assessments of the quality, consistency, clarity, and strength of the scientific evidence, 3) weighed

randomized clinical trials more heavily than observational studies, and evidence from research more

heavily than expert opinion, and 4) explicitly described

the relationship between the scientific evidence and the

conclusions. The reviews of the U.S. Preventive

Services Task Force (USPSTF) were used extensively

throughout the report. In addition, many of the services

discussed in this report had been previously reviewed

in depth by OTA. Additional evidence that has

emerged since the reviews were written was also

presented, and its implications for the conclusions of

the earlier reviews discussed.

The report reviewed the evidence on effectiveness

of most of the clinical preventive services recommended by the USPSTF for asymptomatic individuals

on the basis of individuals’ sex and age, as opposed to

other indications of risk such as family history. In

addition, all of the services included in congressional

health care reform proposals introduced in the 102d

Congress were reviewed.

The evidence on cost-effectiveness was based on a

comprehensive review of published cost-effectiveness

analyses of clinical preventive services. The vast

majority of cost-effectiveness analyses were limited to

those that used the following assumptions: 1) the

analyses took a societal perspective, 2) medical costs

associated with additional years of life were excluded,

and 3) indirect costs were excluded (e.g., costs due to

lost productivity or time costs).

The draft report underwent extensive review by

members of the Advisory Panel for the overall OTA

assessment, as well as by individuals from the health

insurance industry, the academic community, health

care professionals, representatives of patients, research

organizations, businesses, and Federal agencies with

an interest and expertise in clinical preventive services

and in the use of scientific information in health care.

6 0
OTA wishes to thank the

individuals and organizations

Appendix C:

Acknowledgments

Technology, Insurance, and the Health Care System Advisory Panel and the

listed below for their assistance with this Report. These individuals and

organizations do not necessarily approve, disapprove or endorse this Report. OTA assumes full responsibility for

the Report and the accuracy of its content.

Forrest H. Adams

PERS Health Benefits Advisory

Council

Rancho Santa Fe, CA

Sheila Allgood

Centers for Disease Control

and Prevention

Atlanta, GA

Amy Cato

Institute on Health Care for the

Poor and Underserved

Meharry Medical College

Nashville, TN

Iain Chalmers

The Cochrane Center

United Kingdom

Allan Blostin Rose Chu

U.S. Department of Labor Actuarial Research Corporation

Washington, DC Annandale, VA

Lester Breslow

School of Public Health

University of California,

Los Angeles

Los Angeles, CA

Willard Cates, Jr.

Centers for Disease Control

and Prevention

Atlanta, GA

Karen Scott Collins

The Kaiser Commission on the

Future of Medicaid

Baltimore, MD

Murray W. Enkin

Departments of Obstetrics

and Gynecology, Clinical

Epidemiology and

Biostatistics

McMaster University

Hamilton, ON, Canada

Sam Flint

American Academy of Pediatrics

Elk Grove Village, IL

Paul S. Frame

Tri-County Family Medicine

Cohocton, NY

John K. Gohagan

National Cancer Institute

Bethesda, MD

Marthe Gold

Office of Disease Prevention and

Health Promotion

U.S. Department of Health and

Human Services

Washington, DC

Richard B, Goldbloom

Department of Pediatrics

Dalhousie University

Halifax, NS, Canada

61
62 I Benefit Design: Clinical Preventive Services

Lee Goldman

Division of Clinical Epidemiology

Department of Medicine

Brigham and Women’s Hospital

Boston, MA

Hurdis M. Griffith

Office of Disease Prevention and

Health Promotion

U.S. Department of Health and

Human Services

Washington, DC

Stephen C. Hadler

Division of Immunization

National Center for Prevention

Services

Centers for Disease Control

and Prevention

Atlanta, GA

David C. Hadom

Rand Corporation

Santa Monica, CA

Mark A. Hall

College of Law

Arizona State University

Tempe, AZ

Robert W. Hungate

Physician/Patient Partnerships

for Health

Wellesley, MA

Shirley Kelly

Blue Cross/Blue Shield Association

Chicago, IL

Janice L. Krupnick

Department of Psychiatry

Georgetown University School

of Medicine

Washington, DC

F. Marc LaForce

The Genesee Hospital

Rochester, NY

John Ludden

Harvard Community Health Plan

Boston, MA

Anthony B. Miller

Department of Preventive

Medicine and Biostatistics

University of Toronto

Toronto, ON, Canada

Audrey H. Nora

Maternal and Child Health Bureau

Health Resources and Services

Administration

U.S. Department of Health and

Human Services

Washington, DC

Janet O’Keeffe

Public Policy office

American Psychological Association

Washington, DC

Sue Palsbo

Group Health Association

of America

Washington, DC

Brandon Reines

The Center for Health Science

Policy

Washington, DC

William H. Straub

Jackson Hole Group

Teton Village, WY

Steven Teutsch

Epidemiology Program Office

Centers for Disease Control and

Prevention

Atlanta, GA

Kenneth E. Warner

School of Public Health

University of Michigan

Ann Arbor, MI

Paul Widem

National Institute of Mental

Health

Rockville, MD
Abbreviations

—American Academy of Family Physicians

—American Academy of Pediatrics

ACIP —Immunization Practices Advisory

Committee

ACOG —American College of Obstetricians and

Gynecologists

ACP —American College of Physicians

AFDC —Aid to Families with Dependent Children

—American Medical Association

BCDDP —Breast Cancer Detection Demonstration

Project

BLS —Bureau of Labor Statistics

BPE —Breast physical examination

CDC —Centers for Disease Control and

Prevention

CEPCPS —Cost-Effectiveness Panel on Clinical

Preventive Services

CHD -Coronary Heart Disease

CTFPHE —Canadian Task Force on the Periodic

DDST

dL

DT

DTP

DRE

EPSDT

ERISA

FDA

FOBT

Health Examination

—Denver Developmental Screening Test

—Deciliter

—Diphtheria-tetanus

—Diphtheria-tetanus-pertussis

—Digital rectal examination

—Early and Periodic Screening, Diagnostic,

and Treatment services

—Employee Retirement Income Security

Act of 1974

—Food and Drug Administration

—Fecal Occult Blood Test

Appendix D:

Abbreviations and

Glossary of

Terms

FSIG

HBsAG

HBV

HIAA

Hib

HIP

HIV

HMO

IPA

IUDs

LDL

MASFP

Mg

NHLBI

ODPHP

OPV

OTA

NCEP

PKU

POS

PPO

PSA

QALY

RCT

RPR

—Flexible sigmoidoscopy

—Hepatitis B surface antigen

—Hepatitis B

—Health Insurance Association of America

—Haemophilus Influenza Type b

—Health Insurance Plan

—Human Immunodeficiency Virus

—Health maintenance organization

—Independent or individual practice

association

—Intrauterine devices

—Low density lipoprotein

—Maternal Serum Alpha-Fetoprotein

—Milligram

—Measles, Mumps, and Rubella

—Multiple Risk Factor Intervention Trial

—National Heart, Lung, and Blood Institute

—National Institutes of Health

--Office of Disease Prevention and Health

Promotion

-Oral poliovirus vaccine

-Office of Technology Assessment (U.S.

Congress)

—National Cholesterol Education Program

—Phenylketonuria

—Point of service

—Preferred provider organization

—Prostate-specific antigen

-Quality-adjusted life year

—Randomized clinical trials

—Rapid plasma reagin (syphilis screening

test)

63
64 | Benefit Design: Clinical Preventive Services

STD —Sexually transmitted disease

TB —Tuberculosis

Td —Tetanusdiphtheria

TRUS —Transrectal ultrasonography

USPSTF —U.S. Preventive Services Task Force

VDRL —Venereal Disease Research Laboratory

(syphilis screening test)

Terms

ABO blood group: The major classification system

for human blood, which is based on two antigens (A

and B) on the surface of red blood cells. Four blood

types are defined by the presence of one (type A or

B), both (type AB), or neither (type O) of these

antigens.

Adenomatous polyps: Benign growths usually found

in the colon.

Access to services: Potential and actual entry of a

population into the health care delivery system.

Elements of access include availability, affordability, and approachability.

Amblyopia: Subnormal visual acuity. The term specifically denotes a developmental disorder of visual

function arising from either sensory stimulation

deprivation or abnormal binocular interaction.

Anemia: A condition that exists when the level of

hemoglobin in a person’s blood drops to an

abnormally low level.

Annual physical examinations: Examinations which

are provided annually and are relatively nonspecific in terms of their content.

Antibody: A blood protein (immunoglobulin) produced by lymphocytes, a type of white blood cell,

in response to the introduction of a specific antigen

(e.g., invading bacteria, incompatible red blood

cells, inhaled pollen grains, or foreign tissue grafts).

Once produced, the antibody has the ability to

combine with the specific antigen that stimulated

antibody production thereby rendering it harmless.

This reaction to foreign substances is part of the

immune response.

Antigen: A substance that the body regards as foreign

and that elicits an immune response (generating an

antibody to react against the antigen or increasing

lymphokine production, or both). Antigenic substances may include microorganisms, cells, tissue

grafts, or toxins.

Appropriate (health care): Individuals and organizations define appropriate health care in many different ways. The Rand Corporation defines appropriate care as when “the expected health benefit

[exceeds] the expected negative consequences. . .by

a sufficiently wide margin that the procedure [is]

worth doing” (cited in NAS, IOM Committee to

Advise the PHS, “Clinical Practice Guidelines,

1990).

Bacteriuria: The presence of bacteria in the urine.

Behavioral preventive strategies: A broad array of

strategies to encourage lifestyle changes, such as

exercise, smoking cessation, and healthful diets.

Benefit design: The determination of the terms of the

benefit package.

Benefit package: In this report, benefit package refers

primarily to the services and providers that are

covered by a health insurance plan, and to the

financial and other terms of such coverage (e.g.,

patient cost-sharing, limitations on amounts and

numbers of visits or days). However, a benefit

package can be said to consist in total of the terms

of the contract between the subscriber or enrollee

and the insurer. The terms of payment to health

care providers may also be part of the terms of a

benefit package.

Benefits: The covered health care services and the

amount payable by a health insurance plan to a

beneficiary under the terms of the plan.

Biochemical markers: Substances or processes characteristic of (or indicative of) physiological activity

(e.g., blood in the stool as an indicator of colorectal

cancer).

Biotinidase Deficiency: A congenital disorder caused

by a deficiency of the enzyme needed to metabolize

the B vitamin biotin leading to an overall deficiency

of biotin in the body. If untreated, severe cases of

biotinidase deficiency can lead to necrologic damage, resulting in coma or death in infancy. Less

severe cases (resulting in developmental delay or

hearing loss) and asymptomatic cases also occur.

Capillary hemoglobin/hematocrit: Test for anemia.

Carotid bruits: Clinical sign associated with atherosclerotic disease of the major arteries of the neck,

and is associated with myocardial infarction and

cerebrovascular disease.

Cardiovascular disease: Any of a diverse group of

diseases affecting the heart, blood vessels, and/or
Appendix D–Abbreviations and Glossary of Terms | 65

blood circulation. Cardiovascular disease includes

diseases of the heart muscle itself, ischemic heart

disease, hypertension, cerebrovascular diseases,

and various other conditions.

Case-control study: Also called a retrospective study,

An observational epidemiologic study that starts

with the identification of a group of individuals

with a disease (or other condition or ‘‘outcome

variable’ of interest (“cases”), and a suitable

control group of persons without the disease, but

who are otherwise similar to the cases (’ ‘controls’ ‘).

The relationship of a “risk factor” (which may

include exposures to a chemical or physical agent,

family history of disease, or other personal attribute) to the disease is evaluated by determining how

frequently the risk factor is present, or if quantitative, the levels of the risk factor, in the cases and

controls. Many risk factors may be studied in a

single case control study.

“Categorically needy recipients”: Refers to Medicaid recipients receiving Aid to Families with

Dependent Children (AFDC) benefits and Supplemental Security Income (SSI).

Chemoprophylaxis: The prevention of disease by the

use of drugs or chemicals.

Cholestyramine therapy: Treatment in which cholestyramine medication binds to cholesterol thereby

reducing high levels of cholesterol.

Clinical practice guidelines: Synthesis of literature

and expert opinion for the purpose of making

recommendations regarding health services.

Clinical preventive services: Interventions comprising medical procedures, tests, or visits with health

care providers that are undertaken for the purpose of

promoting health, not for responding to patient

signs, symptoms, or complaints.

Cohort study: Study participants are identified by

whether they are receiving the intervention, and are

then followed over time in an effort to determine

differences in outcome between those who received

the intervention and those who did not receive it.

Coinsurance: A fixed percentage of covered expenses

paid by a health plan and an enrollee for covered

expenses after any deductible has been met; for

example, an 80-20 coinsurance arrangement means

that, after the deductible is reached, 80 percent of

covered expenses are paid by the plan and 20

percent are paid by the person covered by the plan.

Colonoscope: A tube with a light and mirror at the end

which is inserted into the gastrointestinal tract for

direct visualization of its interior. Full visualization

of the entire colon is possible with a 180 cm

colonoscope.

Congenital disorders: Any abnormality, whether

genetic or not, that is present at birth.

Coronary artery disease: Narrowing of the small

arteries leading to the heart. Can lead to heart

attacks or sudden death.

Costs: Expenses incurred in the provision of services

or goods. Many different kinds of costs are defined

and used (e.g., allowable, direct, indirect, and

operating costs).

Cost-effectiveness analysis: An analytic technique

that compares the costs of a project or of alternative

projects to the resultant benefits, with costs and

benefits/effectiveness not expressed by the same

measure. Costs are usually expressed in dollars, but

benefits/effectiveness are ordinarily expressed in

terms such as ‘lives saved,’ or ‘disability avoided.

Cost-sharing: The provisions of a health benefits plan

that require the enrollee to pay a portion of the cost

of services covered by the plan, typically exclusive

of premium cost-sharing (sharing the cost of a

health care plan premium between the sponsor and

the enrollee). Usual forms of cost-sharing include

deductibles, coinsurance, and copayments. These

payments are made at the time the service is

received or shortly thereafter, and are only made by

those insured who seek treatment.

Cystic Fibrosis: A life-shortening, autosomal recessive disorder affecting the respiratory, gastrointestinal, reproductive, and skeletal systems, as well as

the sweat glands. Cystic Fibrosis is caused by

mutations in the Cystic Fibrosis gene.

Deductible: The amount of covered health care

expenses (e.g., $200, $500, $1,000) that must be

incurred by the health plan enrollee and his or her

dependents before any health benefits become

payable by the health plan. Deductible requirements

apply to each individual in a family for a specific

time period (usually a year). Some plans specify

family deductibles after which no additional individual deductibles are required; family deductibles

are typically equivalent to two or three times the

individual deductible.
66 I Benefit Design: Clinical Preventive Services

Diagnostic intervention: Clinical intervention relating to or aiding in diagnosis.

Digital rectal examination: The procedure where the

clinician inspects the interior of the rectum with a

finger in search of a rectal mass.

Diphtheria-Tetanus (DT) Toxoid: A combination

immunization given to prevent diphtheria and

tetanus.

Discounting: A procedure used in economic analysis

to express as “present values” those costs and

benefits that will occur in future years. Discounting

is based on two premises: 1) individuals prefer to

receive benefits today rather than in the future; and

2) resources invested today in alternative programs

could earn a return over time.

Distal colon: Rear area of the colon.

Ectopic pregnancy: A pregnancy that occurs outside

the uterus, usually in a Fallopian tube. Early

symptoms include severe abdominal pain and

vaginal bleeding; if untreated, may lead to rupture

or internal hemorrhage, and shock.

Effectiveness: Effectiveness is a particular application

of efficacy, that is, it reflects the performance of an

intervention under ordinary conditions by the

average practitioner for the typical patient,

Efficacy: The probability of benefit to individuals in

a defined population from health technology applied to a given health problem under ideal conditions of use,

Employee Retirement Income Security Act of 1974

(ERISA): Exempts companies that self-insure, or

fund their own insurance plans, from State regulations.

Environmental preventive strategies: Strategies for

the prevention of disease or promotion of health that

typically consist of social policies, such as seat belt

laws, taxes on alcohol and tobacco use, speed

limits, and restrictions on access to firearms, in

addition to environmental and occupational regulations,

False-positive: A person without the disease who tests

positive for the disease.

Family planning: A general name applied to a range

of services intended to help individuals plan when

to have children, from counseling concerning the

advisability of initiating sexual intercourse to the

provision of contraceptive methods.

Fecal occult blood test: A screening test which

analyzes samples of stool for the presence of blood.

Fecal occult blood tests indirectly test for the

presence of colorectal cancer or polyps.

Fee-for-service: In fee-for-service health care, physicians and other providers bill separately for each

patient encounter or service rendered. This system

contrasts with salary, per capita, or other prepayment systems, where the payment to the practitioner

does not change with the number of services

actually rendered.

Fee schedule: A list of medical services in which each

entry is associated with a specific monetary amount

that represents the approved payment amount for

the service under a given insurance plan.

Financing (of health care): Refers to where the

money to pay health care providers for the delivery

of health care services comes from (e.g., government, taxpayers).

Fixed costs: An operating expense that does not vary,

at least over the short term, with the volume of

services provided.

Flexible sigmoidoscopy: A flexible tube with a light

and mirror at the end inserted into the colon through

the anus to examine the distal end of the large bowl.

Free erythrocyte protoporphyrin (FEP): Refers to a

screening test used to indicate iron deficiency.

Galactosemia: A deficiency of the enzyme needed to

metabolize galactose, a type of sugar found in milk

products. Untreated galactosemia usually leads to

blood poisoning, progressive liver damage, and

death within the first few weeks of life.

Global budget: Generally, an overall budget limit on

health care services. Global budgets can take the

form of a State or national capon total health care

expenditures, but usually imply national limits. In

some contexts, global budgeting has come to mean

setting a limit on spending by sector (e.g., specific

allocations for doctors, hospitals).

Gonococcal arthritis: Complication of gonorrhea in

which the infection involves the joints.

HBV markers: Blood test which detects current or

past hepatitis B virus.

Health benefits: Include increased life expectancy,

better functional status, and reduced morbidity,

pain, and anxiety. Negative health outcomes are the

opposites of these qualities.
Appendix D–Abbreviations and Glossary of Terms | 67

Health care provider: An individual or institution

that provides medical services (e.g., a physician,

hospital, laboratory). This term should not be

confused with an insurance company which ‘‘provides’ insurance.

Health insurance: In this report, the term “health

insurance’ is used broadly to include various types

of health plans that are designed to reimburse or

indemnify individuals or families for the costs of

medical care, or (as in HMOs) to arrange for the

delivery of that care, including traditional private

indemnity fee-for-service coverage, prepaid health

plans such as HMOs, self-funded employment

based plans, Medicaid, and Medicare. Private

health insurance: With respect to health insurance,

refers to a plan run or sponsored by an entity other

than the government. Public health insurance:

With respect to health insurance, refers to a

government-run or -sponsored plan.

Health maintenance organization (HMO)): A health

care organization that, in return for prospective per

capita (cavitation) payments, acts as both insurer

and provider of specified health services.

Hematocrit: The volume occupied by the cellular

elements of blood in relation to the total volume.

Hemocystinuria: A congenital disorder caused by a

deficiency of one of the enzymes involved in the

metabolism of the amino acid homocystine. If left

untreated, homocystinuria can lead to lifethreatening episodes of vascular thrombosis; most

untreated survivors go on to have mental deficiency, and half of them may die in early adulthood.

Hemoglobin: A protein found in red blood cells that

is responsible for the transport of oxygen.

Hemoglobinopathy: A blood disorder caused by

alteration in the genetically determined molecular

structure of hemoglobin, which results in a characteristic complex of clinical and laboratory abnormalities and often, but not always, overt anemia.

Hepatitis B: Viral hepatitis, type B. An acute inflammation of the liver caused by infection with

hepatitis B virus, which is transmitted mainly by

sexual contact, parental exposure (contaminated

needles or administration of blood products), and

from carrier mother to baby. In some cases,

infection may be severe and result in prolonged

illness, destruction of liver cells, cirrhosis, and

death. Formerly known as “serum hepatitis. ”

Haemophilus influenza b: One of six types of

infection with Haemophilus influenza b, a parasitic bacterium that occurs in an encapsulated form.

In children and in debilitated older adults, infection

may result in destructive inflammation of the

larynx, trachea, and bronchi, and may also cause

subacute bacterial endocarditis and purulent meningitis. Immunization against Hib is available through

inoculation with anti-Haemophilus influenzae

serum.

High risk: At greater than normal risk of contracting

a specific disease or condition.

Hypercholesterolemia: An elevation of the blood

cholesterol level.

Hypothyroidism: Diminished production of thyroid

hormone, leading to thyroid insufficiency.

Indemnity: Benefits paid in a predetermined amount

in the event of a covered loss.

Individual practice association (IPA) HMOs: A

form of HMO in which participating physicians

remain in their independent office settings, seeing

both enrollees of the IPA and patients covered by

other health insurance plans. Participating physicians may be reimbursed by the IPA on a fee-forservice or a cavitation basis.

Lipoprotein: Compounds consisting of lipids (fatty

substances such as cholesterol) and proteins, the

form in which lipids are transported in the blood and

lymph fluid. They are classified as very low-density

(VLD), low-density (LD), and high-density (HD).

Mammography: X-ray examination of the breast,

used as both a screening procedure on apparently

healthy females and as a diagnostic procedure in

clinical situations to detect breast cancer.

Managed Competition Plan: An approach to health

care reform that would combine health insurance

market reform with health care delivery system

restructuring. The theory of managed competition

is that the quality and efficiency of health care

delivery will improve if independent groups compete with one another for consumers in a government-regulated market.

Mandated insurance benefits: Minimum health insurance coverage requirements specified by government statute.

Markov model: A quantitative tool useful in describing the movements of members of a population

through different states over time. The model
68 I Benefit Design: Clinical Preventive Services

requires that the distribution of the population

among defined states at the initiation of the model,

and the probability that any one individual move

into a different state between two periods of time,

be known.

Maternal serum alpha-fetoprotein (MSAFP): Blood

test used during pregnancy to detect possible neural

tube defects.

Medicaid: A joint Federal-State program, authorized

by Title XIX of the Social Security Act, of Federal

matching grants to the States to provide health

insurance for categories of the poor and medically

indigent. States determine eligibility, payments,

and benefits consistent with Federal standards.

Medicare: A Federally administered health insurance

program authorized by Title XVIII of the Social

Security Act of 1965 which covers the cost of

hospitalization, medical care, and some related

services for eligible persons over age 65, persons

receiving Social Security Disability Insurance payments for 2 years, and persons with end-stage renal

disease. Medicare consists of two separate but

coordinated programs—hospital insurance (Part A)

and supplementary medical insurance (Part B).

Meta-analysis: A systematic, typically quantitative

method for combining information from multiple

studies.

Morbidity: The condition of being ill or otherwise

afflicted with an unhealthful condition.

Morbidity rate: The rate of illness in a population,

calculated as the number of people ill during a time

period divided by the number of people in the total

population; used to refer to incidence or prevalence

rates of disease.

Mortality rate: The death rate, often made explicit for

a particular characteristic (e.g., age, sex, or specific

cause of death), A mortality rate contains three

essential elements: 1) the number of people in a

population group exposed to the risk of death (the

denominator); 2) a time factor; and 3) the number

of deaths occurring in the exposed population

during a certain time period (the numerator).

Neoplasm: Uncontrolled and progressive growth of

tissue, either benign or malignant; a tumor.

Nicotine gum: Alternative nicotine delivery method

(as opposed to cigarettes) used to ween smokers

from habitual cigarette use. The gum transmits

nicotine by chewing.

Nicotine patch: Alternative nicotine delivery method

(as opposed to cigarettes) used to ween smokers

from habitual cigarette use. The patch transmits

nicotine through the skin.

Node-negative tumors: Cancers which are less likely

to have spread beyond their primary site, as

evidenced by the lack of involvement of lymph

nodes.

Oral glucose tolerance test: Screening test for

diabetes.

Ortalani maneuvers: Manual orthopedic manipulation used to relocate the femur (femoral head) into

the hip joint socket.

Out-of-pocket expense: Payments made by an individual for medical services. These may include

direct payments to providers as well as payments

for deductibles and coinsurance for covered services, for services not covered by the plan, for

provider charges in excess of the plan’s limits, and

for enrollee premium payments.

Papanicolaou (Pap) smear: A screening test for

women for cervical cancer.

Papillomavirus: A virus which causes up to sixty

types of warts. It is recognized as a sexually

transmitted agent and is also believed to be a

contributing factor in cervical, vaginal, and vulvar

carcinoma (cancer).

Pathology: The scientific study of the cause of disease

and of the associated structural and functional

changes that result.

Pelvic inflammatory disease (PID): An infection

involving the endometrium, Fallopian tubes, and

peritoneum, often occurring as a complication of

untreated gonorrhea, Women using intrauterine

contraceptive devices are also at increased risk for

the disease. Bacteria that cause gonorrhea,

chlamydia, or other infections can ascend from the

lower genital tract through the endometrium (causing endometriosis), to the Fallopian tubes (causing

salpingitis), and possibly to the ovaries (causing

oophontis), and if untreated, can result in tubal

scarring, infertility, or ectopic pregnancy. Symptoms include lower abdominal pain, increased

vaginal discharge, and fever.

Periodic health examination: The periodic health

examination is provided in accordance with recommended schedules for specific interventions (usually less frequently than every year). It includes
Appendix D–Abbreviations and Glossary of Terms | 69

relatively specific interventions, emphasizes tailoring interventions to individual circumstances, and

is limited primarily to those services which have

been shown to be effective.

Pertussis: An acute, infectious inflammatory respiratory disease of children caused by the bacterium

Bordetella pertussis. The disease is characterized

by explosive attacks of coughing ending in an

inspiratory whoop or choking on mucus and occurs

in infants and children who have not been immunized against the disease. Also known as ‘‘whooping cough. ‘ ‘

Phenylketonuria (PKU): A genetic disorder of amino

acid metabolism, characterized by the inability to

metabolize the amino acid phenylalanine. Untreated or late treated PKU results in severe mental

retardation in the majority of cases,

Pneumonia: Any one of several types of acute or

chronic inflammation of the lungs due to infection

by viruses, bacteria, or other microorganisms; a

common complication of other serious illnesses and

a common cause of death in the United States.

Point-of-service plan (POS): A hybrid form of

managed care plan based on a mixture of cavitation

and fee-for-service (FFS) payment arrangements,

POS plans permit health plan enrollees to choose a

FFS or HMO provider at the time he or she seeks

services (rather than at the time they choose to

enroll in a health plan).

Predictive capability: In screening and diagnostic

tests, the probability that individuals with positive

test results have the condition in question or that a

person with a negative result does not have it. A

test’s predictive value is determined by its sensitivity and specificity and by the prevalence of the

condition for which the test is used.

Preferred provider organization (PPO): Refers to a

variety of different insurance arrangements under

which plan enrollees who choose to obtain medical

care from a specified group of ‘preferred’ providers receive certain advantages, such as reduced

cost-sharing charges. PPO providers typically furnish services at lower than usual fees in return for

prompt payment by the health insurance plan and a

certain assured volume of patients.

Premium: The price or amount which must be paid

periodically (e.g., monthly, biweekly) to purchase

insurance coverage or to keep an insurance policy

in force. Premiums paid to health maintenance

organizations or similar organizations are often

called cavitation payments.

Preventive interventions: Strategies for health promotion or disease prevention that include counseling, screening, immunization, or prophylactic interventions for individuals in clinical settings.

Preventive services: Services intended to prevent the

occurrence of a disease or its consequences. Preventive health care includes health care programs

aimed at warding off illnesses (e.g., immunizations), early detection of disease (e.g., Pap smears),

or inhibiting further deterioration of the body (e.g.,

exercise or prophylactic surgery). Preventive medicine is also concerned with general preventive

measures aimed at improving the healthfulness of

the environment and with the promotion of health

through altering behavior, especially using health

education, Preventive health services are sometimes categorized as primary, secondary, or tertiary.

Primary prevention is aimed at reducing the

incidence of a disease or health problem; secondary prevention is aimed at reducing the prevalence

of a problem by shortening the duration among

those who have the problem; and tertiary prevention is aimed at reducing complications.

Primary care: A basic level of health care, usually

provided in an outpatient setting, that emphasizes a

patients’ general health needs (e.g., preventive

services, treatment of minor illnesses and injuries,

identification of problems that require referral to

specialists).

Prostate-specific antigen (PSA): A protein produced

exclusively by the prostate gland and present at

elevated levels in men with prostate cancer and

other prostatic diseases. Concentrations of PSA can

be determined using a blood test.

Provider: See health care provider.

Pyelonephritis: Inflammation of the kidney, particularly due to local bacterial infection.

Randomized clinical trial (RCT): An experiment

designed to test the safety and efficacy of a medical

technology in which people are randomly assigned

to experimental or control groups, and outcomes are

compared.

Renal disease: Disease pertaining to the kidney.

Respiratory distress syndrome: Lung problem involving fluid filling air spaces in the lungs.
70 I Benefit Design: Clinical preventive Services

Retinopathy: Noninflammatory degenerative disease

of the retina.

Rh blood group: Genetically determined immunologic antigens (referred to as D or Rh+) on the

surface of the red blood cells capable of inducing

intense antigenic reactions when combined with

blood cells lacking those antigens (no D or Rh-).

The presence or absence of an Rh factor is

especially important in blood transfusions (where it

is a major cause of incompatibility) and in pregnancy when the mother is Rh- and the fetus is Rh+,

which, if untreated, can lead to hemolytic disease of

the newborn.

Risk factor: A characteristic which has been found in

populations to be positively associated with the

development of a disease or condition.

Scoliosis: Lateral curvature of the spine.

Screening services: The use of tests or physical

examinations to detect the existence of one or more

particular diseases or health deviations or to identify for more definitive studies those suspected of

having certain diseases.

Sensitivity: The proportion of persons with a condition who correctly test “positive” when screened.

Sensitivity analysis: An analysis of the effect of

changes in key assumptions or uncertainties on the

findings and outcome of an overall study.

Serum tumor marker: Series of blood tests associated with various cancers.

Sickle-cell anemia: A genetic disorder of hemoglobin

synthesis leading to the production of abnormal red

blood cells. Infants with sickle cell anemia are at

increased risk of overwhelming infection and sudden death in the first few years of life. Painful

episodes of vase-occlusive crises are the hallmark

of sickle cell anemia, although there is wide

variability in expression of the disease in older

patients.

Single-Payer System: Approach to health care reform

that would provide tax-financed universal coverage

with government as the sole purchaser of services.

A single entity, usually government-run, reimburses all medical claims. Consumers typically pay

a uniform tax rather than premiums. Money goes to

a single health care trust fund, used only for health

care expenditures.

Specificity: The proportion of persons without a

condition who correctly test “negative” when

screened.

Sphygmomanometer: Blood pressure cuff.

Sputum cytology: The anatomy, physiology, pathology, and chemistry of sputum cells. Sputum is

mucus and other fluids formed in air passages and

upper food passages (the mouth) and expelled by

coughing.

Staff-model HMO: In this type of HMO, the majority

of health plan enrollees are cared for by physicians

who are typically salaried staff of the HMO.

Strabismus: A misalignment of the eye that the

patient cannot overcome without aid.

Therapeutic intervention: Treatment of disease or

disorders (as opposed to prevention or diagnosis).

Third-party payer: An organization (private or

public) that pays for or insures at least some of the

health care expenses of its beneficiaries. Thirdparty payers include Blue Cross/Blue Shield, commercial health insurers, Medicare, and Medicaid.

The individual receiving the health care services is

the first party, and the individual or institution

providing the service is the second party.

Traditional indemnity plan: A conventional or

fee-for-service health plan that typically reimburses

the health care provider on a “reasonable and

customary’ basis or as billed.

Transrectal ultrasound (TRUS): Using high frequency ultra soundwaves to create a visual picture

which can help to detect cancer in the prostate.

Tyrosinemia: A disorder of tyrosine metabolism

marked by an excess of tyrosine in the blood. It

occurs in two forms; Transient or Neonatal Tyrosinemia: a benign condition of newborns which

responds to ascorbic acid; and Hereditary Tyrosinemia: results in liver failure or severe nodular

cirrhosis, with renal tubular involvement, rickets,

darkening of the skin, and slight mental retardation.

It is transmitted as an autosomal recessive trait.

Ultrasound cephalometry: A procedure that measures the head size of fetus, used to assess fetal

growth.

Urinalysis: Analysis of the urine.
Appendix D–Abbreviations and Glossary of Terms | 71

Well-baby care: Preventive health care for children,

includes immunizations, health education, parental

guidance, physical examinations, and other tests

that screen for illness or developmental problems.

Sometimes defined as care for children less than

one year of age, although the distinction between

well-child care and well-baby care is not a precise

one.

Well-child care: Preventive health care for children,

includes immunizations, health education, parental

guidance, physical examinations, and other tests

that screen for illness or developmental problems.

Sometimes defined as care for children one year of

age and older, although the distinction between

well-child care and well-baby care is not a precise

one.
Appendix E: Current

Coverage of Clinical

Preventive Health Care

Services in Public and

Private Insurance

 o put the debate O Ver insurance for clinical

T

- preventive services in context, this appendix

describes the extent of current coverage of

preventive services in public insurance plans,

specifically, Medicaid and Medicare, and in private

health insurance plans, specifically, employer-based

plans. Within the discussion of private insurance,

current Federal and State mandates for coverage within

employer-based plans and federally qualified HMOs

are also described.

Public Insurance Programs

Medicaid

Federal law requires that all State Medicaid programs provide a standard benefit package to ‘categorically needy recipients’ 1

(179). Required preventive

services include Early and Periodic Screening, Diagnostic, and Treatment services (EPSDT), and family

planning services and supplies, EPSDT services consist of screening and diagnostic services to determine

physical or mental defects in beneficiaries under age

21, and measures to corrector ameliorate any defects

or chronic conditions discovered. At a minimum,

screening services must include: comprehensive health

and developmental history; comprehensive unclothed

physical exam; appropriate vision testing; appropriate

hearing testing; appropriate laboratory tests; and dental

services for children 3 years of age and older (180).

Family planning services include services for women

of childbearing age, including minors who can be

considered to be sexually active (180). In addition,

States that cover medically needy’ individuals must

reimburse health care providers for prenatal care

provided to recipients (179).

States also have the option of covering preventive

services not already required (182). Additional preventive services are covered in 3 States for categorically

needy individuals and in 20 States for both categorically and medically needy individuals (204). Presumably, the scope of these preventive services in the 23

States is fairly unlimited in the sense that Medicaid

permits the health care provider to use his or her own

judgment to determine whether to provide the services

(55).

Federal requirements prohibit States from charging

deductibles or coinsurance for all services provided to

children under 18 years old, for services related to

pregnancy, or for family planning services.

Medicare

Medicare covers very few clinical preventive services. Federal law prohibits Medicare from offering

benefits for preventive services without an amendment

to the Medicare Act (Public Law 89-97). Since 1981,

1 Categorically needy Medicaid recipients are those receiving Aid to Families with Dependent Children (AFDC) benefits and Supplemental

Security Income (SSI).

2 States have the option of offering Medicaid to medically needy people who would be categorically needy for Medicaid but whose income

and resources lie above the standards for eligibility. Each State sets its own medically needy resouree and income standards up to 133.33 percent

of State AFDC income standards.
several screening services and vaccinations have been

added to the list of covered services for Medicare

recipients. These services are: vaccines for pneumococcal pneumonia and Hepatitis B (for those at high

risk for the virus), Pap smears to screen for cervical

cancer, and biannual mammographies to detect breast

cancer (58).

Private Insurance

Publicly and privately funded surveys of employmentbased health plans are the principal source of data on

insurance coverage for clinical preventive services;

however, these surveys have a number of limitations.

First, no one survey provides a completely representative picture of coverage provided to the Nation’s

workforce. Second, surveys report on only a subset of

the clinical preventive services which might be covered, Further, the details of sampling and question

construction in privately funded surveys are typically

proprietary (i.e., not open to public scrutiny) and may

have methodological problems, such as low response

rates for specific questions. Fortunately, comparisons

across surveys tend to provide a relatively consistent

impression of coverage for specific services, thereby

giving more confidence to their results.

Surveys of employer-based plans have been completed by the Health Insurance Association of America

(HIAA); the U.S. Department of Labor, Bureau of

Labor Statistics (BLS); and KPMG Peat Marwick.

Each of these organizations uses slightly different

survey methods. The BLS survey includes private

sector establishments employing 100 workers or more

(223). In 1991, BLS contacted 3,246 establishments

and 2,144 responded (a 66 percent response rate).

Information on benefits was determined from documents provided by each establishment describing their

benefits plans.

HIAA surveyed 3,192 public and private firms in the

spring of 1990 (excluding self-employed individuals

and Federal workers) (173). The sample was nationally

representative of small (defined as fewer than 100

Appendix E–Current Insurance Coverage | 73

employees), medium, and large firms and was stratified and weighted by region and standard industrial

classification. Information on plans was collected

through interviews.

KPMG Peat Marwick’s survey included participants

randomly drawn from Dun and Bradstreet's list of the

Nation’s private or public employers with more than

200 workers (121). KPMG Peat Marwick stratified the

sample by industry, region, and number of workers.

The sample included 1,057 firms, 744 of which were

interviewed in 1991 and the rest in 1990. The overall

response rate was 70 percent. Information on benefits

was collected through telephone interviews with

human resource directors.

The following section reports on the surveys’

findings on coverage of preventive services. The first

section discusses employer-based traditional indemnity plans. The second section discusses State- mandated benefits laws that could affect the coverage of

certain benefits in private insurance plans. The third

section discusses health maintenance organizations.

Traditional Indemnity Plans3

The surveys which included questions about wellbaby care found coverage ranged from one-quarter to

one-half of all employees. Peat Marwick found that 46

percent of employees with traditional indemnity insurance had coverage for well-baby care; HIAA found

that 48 percent had coverage for well-baby care; and

BLS found that 24 percent had well-baby care

coverage (see figure E-1).4

Only two of the surveys asked questions about

well-child care. HIAA reported that 39 percent of

employees with traditional indemnity insurance had

coverage for well-child care, and Peat Marwick

reported that 36 percent had coverage for well-child

care

5 (see figure E-2). All three surveys asked about

coverage of adult physical examinations and results

ranged from 16 percent coverage (in the BLS survey)

to 32 percent coverage (in the Peat Marwick Survey)

(see figure E-3). To summarize, the three studies

reported that roughly one-fifth to one-half of employs In thk discussio~ a traditional indemnity health insurance plan is a conventional or fee-for-service health plan that typically reimburses

the health c,are provider on a 4

‘reasomble and customary’ basis or as billed.

4 HIAA and Peat MarWick define well-baby care as care for children less than 1 year of age. In contxast, BLS defines well-baby care as care

for children under approximately 2 years of age, excluding newborn care (18). Traditional indemnity plans often do not specify the age limits

for well-baby or well-child care; therefore, the distinction is somewhat ambiguous.

5 Peat Marwlcic and HIM defined well-child care as care for children between the ages Of 1 and 4.
74 I Benefit Design: Clinical Preventive Services

Figure E-l—Percent of Enrollees Covered for WellBaby Care in Employer-Based Health Insurance

Plans by Plan Type, Various Surveys,

Various Years

y//fl/y~ Conventional, 48%

HIAA

employer 1

HMO I PA, 980/o

survey, I I HMO Staff, 98?’o

1990

1

PPO, 68Y0

Bureau of ]

Labor

Statistics

survey,

1991

HMO, 98Y0

Conventional, 46°/0 —

employer [ I HMO, 990/0

survey,

1992 PPo/Pos, 75?40

I

o

E’‘~

25 50 75 100

Percent of enrollees

ABBREVIATIONS: HIAA = Health Insurance Association of America;

HMO = health maintenance organization; IPA = independent or

individual practice association; POS = point of service plan; PPO -

preferred provider organization.

SOURCES: Health Insurance Association of America, Source Book of

Hea/th hwuran~ Data (Washington, DC: 1991); KPMG Peat Marwick,

Hea/th Benefits in 7992 (Washington, DC: October 1992); U.S.

Department of Labor, Bureau of Labor Statistics, En’rp/oyee Berrel?ts in

Medium and Large Firms, 7997 (Washington, DC: U.S. Government

Printing Office, 1993).

ees with employer-based traditional indemnity plans

had coverage for routine adult physical examinations,

well-baby, and well-child care.

The HIAA survey, which was the only study to

report on coverage for screening services, found that

about half of all employees with traditional indemnity

plans had coverage for Pap smears (55 percent) and

mammographies (57 percent). The HIAA survey

found that 47 percent of employees had coverage for

childhood immunizations.

State Mandates

Many States have adopted mandated health insurance benefit laws for individual or group private

insurance plans. The content of these mandates varies

from State to State. Some laws may require that

insurance carriers make certain benefits available as an

option in employer-based plans. Others stipulate that

these benefits must be covered in all plans sold to

employers. Under the Employee Retirement Income

Security Act (ERISA) of 1974, employers that selffund their insurance plans are exempt from these

mandates.

Currently nearly all States report at least one law

mandating coverage of at least one clinical preventive

service. The most frequently mandated preventive

service is mammography screening (43 States) (19).

Cervical cancer screening is mandated by 12 States;

PKU testing is mandated in 3 States; prostate cancer

screening and blood lead screening is mandated in 2

States; and 1 State requires coverage for newborn

hearing testing (19), In the area of children’s preventive services, 20 States currently require well-child

care benefits (19). According to the Blue Cross and

Blue Shield Association, States have varying definitions of well-child care; however, most include prenaFigure E-2—Percent of Enrollees Covered for WellChild Care in Employer-Based Health Insurance

Plans by Plan Type, Various Surveys,

HIAA

employer

survey,

1990

KPMG

Peat Marwick

employer

survey,

1992

Various Years

7

Conventional, 39%

HMO I PA, 960/o

O Staff, 97%

90%

0/0

o 25 50 75 100

Percent of enrollees

ABBREVIATIONS: HIAA = Health Insurance Assoaation of America;

HMO = health maintenance organization; IPA = independent or

individual practice association; POS - point of service plan; PPO -

preferrd provider organization.

SOURCES: Health Insurance Association of America, Source f%wk of

Hea/th /nsurancs Data (Washington, DC: 1991); KPMG Peat Marwick,

Hea/th Benefits in 1992 (Washington, DC: October 1992); U.S.

Department of Labor, Bureau of Labor Statistics, Ernp/oyeeBenefits in

Medium and Large Firms, 1997 (Washington, DC: U.S. Government

Printing Office, 1993).
Appendix E–Current Insurance Coverage | 75

Figure E-3—Percent of Enrollees Covered for Adult

Physical Examinations in Employer-Based Health

Insurance Plans by Plan Type, Various Surveys,

Various Years

HIAA

employer

survey,

1990

KPMG

Peat Marwlck

employer

survey,

1992

Bureau of

Labor

Statlstlcs

survey,

1990

Cofiventlonal, 30Y0

HMO I PA, 940/0

HMO Staff, 97?4.

PPO, 49?40

HMO, 980/o

0/0

1 1

HMO, 96Y0

Non-HMO, 16Y0

t- 1 1 I 1 0 25 50 75 100

Percent of enrollees

ABBREVIATIONS: HIAA - Health Insurance Association of America;

HMO - health maintenance organization; IPA - independent or

individual practice association; POS = point of service plan; PPO =

preferred provider organization.

SOURCES: Health Insurance Association of America, Source Book of

Hea/th /nsurance Data (Washington, DC: 1991); KPMG Peat Marwick,

/+ea/fh Benefits in 1992 (Washington, DC: October 1992); U.S.

Department of Labor, Bureau of Labor Statistics, Ernp/oyee Benefits in

Medium and Large Firms, 1991 (Washington, DC: U.S. Government

Printing Office, 1993).

tal services, well-baby care and childhood immunizations as elements of well-child care (127).

Health Maintenance Organizations

Health maintenance organizations are health care

organizations that, in return for prospective per capita

(cavitation) payments, act as both insurer and provider

of specified health services. The Health Maintenance

Organization Act of 1973 (Public Law 93-222) requires that most employers include a federally- qualified HMO, if one is available, among its health benefits

options. In 1990 about 34 million individuals, or 14

percent of Americans, were enrolled in HMOs (85).

About 75 percent of HMO members belong to

federally-qualified HMOs (86).

The HMO Act of 1973 also established guidelines

for benefit design, rating practices, and operations.

Federally-qualified HMOs must provide pediatric and

adult immunizations, well-baby and well-child care,

periodic health evaluations for adults, abroad range of

family planning services, and children’s ear and eye

examinations, up to age 17, to determine the need for

vision and hearing correction (42 CFR 417. 101(a) (8)(i

- vi)). Not all HMOs are federally qualified, however,

and thus not all offer the full range of ‘basic services’

specified under Federal law (202).

Partially as a result of Federal requirements, HMOs

are far more likely than traditional indemnity plans to

cover clinical preventive services. According to four

national surveys of employer-based health insurance

benefits, the vast majority (over 90 percent) of

employees enrolled in HMOs had coverage for routine

adult physical examinations, prenatal care, well-baby

and well-child care, screening services and immunizations (93,223,121) (see figures E-1, E-2, E-3), The

HIAA survey found slight differences between IPA

HMOS

6 and staff-model HMOS.7 The IPA HMOs were

slightly less likely to cover adult physical exams (94

percent versus 97 percent), and childhood immunizations (97 percent versus 99 percent) than the staffmodel HMOs. Nevertheless, the vast majority of

employees in all HMOs had coverage for these

services.

Hybrid Organizations

During the past decade, various new financing and

delivery models have been developed that blur the

distinction between pure insurance plans that pay bills

for services received and traditional HMOs that

combine service delivery systems with a financing

organization. These include preferred provider organizations (PPOs) and point of service plans (POS). A

PPO refers to a variety of different insurance arrangements under which plan enrollees who choose to

obtain medical care from a specified group of ‘ ‘preferred” providers receive certain advantages, such as

reduced cost-sharing charges. PPO providers typically

6 ~dlvldu~ ~actiw A~~wi~tion ~0~ we ~o~e hat con~act ~~ a n~~r of fidivid~ physic~ns in independent pmctices Or with

associations of independent physicians, Often independent physicians will contract with more than one HMO (93).

7 A staff-model HMO is one in which the health care providers are employees of the organization. This contrasts with other arrangements

where providers or groups of providers contract with an HMO.
76 I Benefit Design: Clinical Preventive Services

furnish services at lower than usual fees in return for

prompt payment by the health insurance plan and a

certain assured volume of patients. A POS is a hybrid

form of managed care plan based on a mixture of

cavitation and fee-for-service (FFS) payment arrangements. POS plans permit health plan enrollees to

choose a FFS or HMO provider at the time he or she

seeks services (rather than at the time they choose to

enroll in a health plan).

Two of the three surveys also asked questions about

PPOs and POSs. The Health Insurance Association of

America and KPMG Peat Marwick surveys both found

that PPOs and POSs were more likely than traditional

indemnity plans, but less likely than HMOs, to cover

clinical preventive services. The KPMG Peat Marwick

survey found that in 1992, among PPOs and POSs

plans combined, 54 percent offered coverage for

routine adult physical examinations, 75 percent covered well-baby care, and 63 percent covered well-child

care (figures E-1, E-2 and E-3). The HIAA survey

found similar results. About half of employees with

PPO plans were covered for adult physicals, 68 percent

had well-baby care benefits, and 58 percent had

well-child care benefits (figures E-1, E-2 and E-3).

Also, about 70 percent had coverage for mammographies and Pap smears.

Summary

The levels of coverage for clinical preventive

services within public and private health insurance

plans vary by type of health plan. A summary of the

discussion follows:

State Medicaid programs are relatively generous in

their coverage of preventive services, especially for

children and pregnant women; many States offer

services in excess of the Federally-defined basic

services. Also, Medicaid programs are prohibited by

law from imposing patient cost-sharing requirements on most preventive services.

Since its inception in 1965, Medicare has covered

very few preventive services, although in the past

decade the Medicare Act has been amended to

include some screening tests and immunizations.

The scope of preventive benefits within private

health insurance plans varies by service and type of

plan. Evidence from employer surveys suggests that

coverage for preventive benefits in traditional indemnity plans is lower than within HMO plans.

Well-baby care and well-child care benefits are

covered by about a quarter to half of traditional

indemnity plans, while nearly 100 percent of HMOs

provide these services, Also, a third, or less, of

traditional indemnity plans cover routine screening

adult physical examinations, while over 90 percent

of HMOs offer this service.
Appendix F:

Synthesizing and

Assessing the Evidence

and Determining

Practice Policies

s

yntheses of effectiveness research on clinical

preventive services and clinical practice policies have been issued by a number of different

organizations, including professional societies, government agencies, third-party payers, and

private researchers. The specialty societies that have

issued specific recommendations on prevention include the American College of Physicians, the American Academy of Pediatrics, the American Academy of

Family Physicians, the American College of Obstetricians and Gynecologists, the American College of

Radiology, and the American Medical Association,

Other private organizations include the Rand Corporation, the American Cancer Society, the American

Heart Association, and the Institute of Medicine,

National Academy of Sciences.

Several United States government agencies have

organized external panels to synthesize the evidence

on preventive medicine, or completed their own

reviews of the evidence, often with input from outside

experts. The National Institutes of Health (NIH) in the

Public Health Service (PHS) in the Department of

Health and Human Services (USDHHS), the National

Cancer Institute in the NIH, the National Heart, Lung,

and Blood Institute in the NIH, the Congressional

Office of Technology Assessment (OTA), the Agency

for Health Care Policy and Research, the Centers for

Disease Control and Prevention (CDC), and the Office

of Disease Prevention and Health Promotion (ODPHP),

all have been involved in efforts to synthesize and

evaluate effectiveness information.

Although the process of synthesizing the evidence

on clinical practice is currently characterized by a

diversity of decentralized efforts, there has been

tremendous growth in interest in the methods used to

synthesize and evaluate the evidence and, in general,

these methods are becoming more rigorous and

sophisticated. The Institute of Medicine has provisionally identified several attributes of good practice

guidelines (see table F-l—Provisional Documentation

Checklist for Practice Guidelines).

To assess the state of knowledge about the effectiveness of clinical preventive services, OTA looked to

those organizations whose methods most reflected the

criteria outlined by the Institute of Medicine. The

methods employed by three different organizations,

which generally took a relatively rigorous and systematic approach to reviewing the evidence on the

effectiveness of preventive services, are described

below. These organizations are the Canadian Task

Force on the Periodic Health Examination (CTFPHE),

the US. Preventive Services Task Force (USPSTF),

and the Immunization Practices Advisory Committee

(ACIP) of the CDC.

The Canadian Task Force on the Periodic

Health Examination

The Canadian Task Force on the Periodic Health

Examination (CTFPHE) was established in 1976 to

recommend periodic health assessments for Canadian

residents (29). The landmark contribution of CTFPHE

was their use of a rigorous set of criteria to evaluate the

evidence for or against the effectiveness and efficacy

of any preventive intervention (83). The explicit

criteria used by CTFPHE to rate the evidence on

77
78 I Benefit Design: Clinical Preventive Services

Table F-l—Institute of Medicine Provisional Documentation Checklist for

Practice Guidelines

Attribute Item

Validity

Reliability/

reproducibility y

Clinical

applicability

Clinical

flexibility

Clarity

Multidisciplinary

process

Scheduled

review

Projected health outcomes if guidelines are followed. Information required to

evaluate outcomes.

Projected rests if guidelines are followed, information required to evaluate costs.

Description of data, methods, and assumptions used to make projections,

Explicit description of the relationship between the scientific evidence and the

guidelines and explanations for any differences between the guidelines and the

evidence. Explanations for any important differences between the guidelines in

question and those developed by others.

Thorough literature review describing scientific research including sponsors,

settings, methodologies, findings, and qualifications.

Description of methodology for evacuating the scientific literature and the results.

Explicit assessment of the quality, consistency, clarity, and strength of the scientific

evidence.

Description of methodology for using expert or group judgment as a basis for

evacuating scientific evidence or, in the absence of evidence, reaching a

consensus based on expert opinion.

Explicit description of the strength of expert consensus.

Description of procedures, participants, and findings of review by experts and

others not involved in the original development process.

Description of methods, settings, and results of any protests of the guidelines,

Description of methods and results of testing (1) the reliability of the development

method and (2) the reproducibility of the clinical decisions reached by users of

the guidelines.

Specifications by age, sex, race, clinical diagnosis, and other factors of the

populations to which a set of guidelines apply.

Description and analysis of the scientific literature or expert consensus that forms

the basis for statements about the age, sex, and other factors of the populations

to which a set of guidelines apply.

Description and analysis of the scientific literature or expert consensus that forms

the basis for statements about major foreseeable exceptions to applications of

the guidelines.

Listing of the basic information to be provided to patients and the kinds of patient

preferences that may be appropriately considered.

Listing of the data needed to document exceptions based on clinical circumstances,

patient preferences, or delivery system characteristics.

Methods and results of any testing of readability, logic, or understanding.

Description of the parties involved in developing the guidelines, their credentials

and interests, and the methods used to solicit their views or to arrive at group

judgments.

Description of the procedures used to subject guidelines to review and criticism by

experts not involved in the original development process, with summary of

results.

Timetable and method for the scheduled review.

Description of the basis for arriving at the timetable or specific date.

SOURCE: Institute of Medicine, Clinical Practice Guidelines, Directions fora New Program, Field, M.J. and Lohr, K.N.

(eds), (Washington, DC: National Academy Press, 1990).
Appendix F-Synthesizing and Assessing the Evidence and Determining Practice Policies | 79

effectiveness are shown in table F-2, ranked from the

most to least credible.1

Each CTFPHE recommendation was assigned a

letter grade, indicating the quality of the evidence

which supported the recommendation (e.g., “A’

indicated good evidence supporting the inclusion of a

service, “C” indicated the evidence was poor, and

“E” indicated there was good evidence that the

service should be excluded). In their initial 1979

report, the Canadian Task Force issued recommendations for preventive services related to 78 potentially

preventable conditions. Since their first report,

CTFPHE has issued a number of updates and additional evaluations; for example, in 1993 CTFPHE

issued an update on cholesterol screening (39).

CTFPHE is in the process of updating the majority of

their recommendations made since the original 1979

report and these will be published in mid-1994 (82).

The US. Preventive Services Task Force

In 1984, the Office of Disease Prevention and Health

Promotion (ODPHP), in the U.S. Department of

Health and Human Services, recommended the formation of the U.S. Preventive Services Task Force

(USPSTF), a non-Federal, multidisciplinary panel of

prevention experts (83). A 20-member panel was

established in 1985 and in 1989 USPSTF published

guidelines for the use of 169 preventive interventions,2

USPSTF is working with CTFPHE to update their

recommendations, which are scheduled for release in

1994.

The USPSTF’s 1989 recommendations were based

on a comprehensive literature search and the methods

used to evaluate each study were systematic and

explicit. To be considered effective by the USPSTF,

screening tests, such as those used in cancer screening,

had to be able to detect the target condition earlier than

would have been the case without screening and with

sufficient accuracy to avoid producing large numbers

of false-positive and false-negative results (where

accuracy refers to the test sensitivity, specificity, and

positive predictive value) (see box F-1 for definitions

of these terms). In addition, the test had to be reliable,

Table F-2—Qualit y of Evidence Criteria Used by t he

U.S. Preventive Services Task Force and the

Canadian Task Force

1:

11-1 :

II-2:

II-3:

Ill:

Evidence obtained from at least one properly randomized

controlled trial.

Evidence obtained from well-designed controlled trials

without randomization.

Evidence obtained from well-designed cohort or casecontrol analytic studies, preferably from more than one

center or research group.

Evidence obtained from multiple time series studies with

or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin in the 1940s) could also be regarded as

this type of evidence.

Opinions of respected authorities, based on clinical

experience, descriptive studies or reports of expert

committees.

SOURCE: U.S. Preventive Services Task Force, Guide to Clinical

Preventive Services.’ An Assessment d the Effectiveness of 169

/nfervenb?s (Baltimore: Williams and Wilkins, 1989).

that is, able to produce the same results when repeated.

Even if a test accurately and reliably detected the

disease at an early stage, it was not considered effective

unless its use led to a better clinical outcome than

would have occurred otherwise. That is, the interventions which followed a positive diagnosis for a

condition had to be effective in preventing or delaying

progress of the disease.

The USPSTF also used an explicit approach for

evaluating the quality of the scientific evidence

concerning the effectiveness of an intervention, and

they placed the greatest confidence in evidence from

randomized clinical trials (see table F-2). When there

were no well-designed studies that supported an

intervention, the USPSTF would recommend interventions that had demonstrated consistent benefits in a

large number of studies of weaker design.

In making recommendations, the USPSTF evaluated the degree of efficacy of an intervention, the

burden of illness, and the potential for negative

consequences associated with its widespread, routine

1 Note that table F-2 shows the criteria now used by the USPSTF and the CTFPHE. They arc a slightly revised version of the original criteria

used by the CTFPHE in 1979. Specifically, category II-1, ‘‘evidence obtained from well-designed controlled trials without randomizatio~”

was absent in the original criteria.

2 ODPHP provides staff support for USPSTP, including background research on specific topics (232).
80 I Benefit Design: Clinical Preventive Services

Box F-l—Important Concepts for Determining the Efficacy of

a Screening Test

Sensitivity: The proportion of persons with a condition who correctly test positive when screened.

Specificity: The proportion of persons without a condition who correctly test “negative” when screened.

False Positives: A person without the disease who tests positive for the disease.

False Negatives: A person with the disease who tests negative for the disease.

Positive Predictive Value: The proportions of people correctly labeled diseased by the test. The positive

productive value increases as the prevalence of the target condition in the screened population increases.

Accuracy: The USPSTF uses the term accuracy to refer to the performance of a test in terms of its sensitivity,

specificity, positive predictive value, and negative predictive value.

Reliability: The ability of a test to obtain the same result when repeated.

Incidence: The number of new occurrences of the event in a specified time for a given population.

Prevalence: The ratio of the total number of all individuals who have an attribute or disease at a particular time,

or during a particular period, to the population at risk for having the attribute or diseases.

SOURCES: U.S. Reventive Services ‘lhsk Forcq Guide to Clinical Preventive Serw”ces (Ihkimore, MD: Williams and

Wilkins, 1989); Maxcy-Rosenauj Last, JIM. ed. Public Health and Preventive Medicine, 12th Edition (NorwallG CT:

AppletomCentury-Crofts, 1986).

use. These negative effects may have included discom- sions relating to the widespread promotion of a

fort and physical injury, invasiveness, inconvenience,

a longer period of morbidity due to early detection,

overtreatment of borderline abnormalities, and anxiety

from being falsely, or correctly, labeled as having the

condition. For some preventive services no recommendation was made because the evidence was inadequate

to decide for or against the procedure. In these cases,

clinicians were advised to use their judgment to guide

the application of the intervention.

Finally, interventions were often recommended for

selected high-risk groups even though there was no

evidence of greater effectiveness in these individuals

than in the general population. The USPSTF argued

that this policy was based on the recognition that the

absence of evidence of effectiveness does not rule out

effectiveness and if, in fact, the intervention is

effective, individuals at increased risk of developing

the disease are most likely to benefit.

There are several potential limitations to the

USPSTF’s methods. In choosing which target conditions to evaluate, the USPSTF considered both the

burden of suffering from the target condition and the

potential for effectiveness, but not the magnitude of the

reduction in morbidity and mortality. Ideally, decipreventive intervention may depend not only on

whether the intervention is effective, but the expected

magnitude of the effect, For example, the USPSTF

assessed the effectiveness of cervical cancer screening,

but not how many years of life would be saved if every

women was routinely screened for cervical cancer.

A second limitation of the USPSTF recommendations is that they focus on interventions performed by

physicians. For example, smoking education programs

were not evaluated, with the exception of physician

advice about smoking cessation. Other types of health

education programs, such as labor and delivery and sex

education classes, were not considered. In addition,

preventive dental services were given little consideration, except as something which physicians should

encourage. Similarly, the USPSTF’s report does not

explicitly evaluate the role of nonphysician providers.

Nurses, social workers, physician assistants, and other

health care providers may be able to provide many of

the services described as appropriate by the USPSTF

with equal effectiveness, and probably at lower cost,

than can primary care physicians (e.g., advice regarding smoking cessation, blood pressure measurement,

cholesterol measurement).
Appendix F-Synthesizing and Assessing the Evidence and Determining Practice Policies | 81

The Immunization Practices Advisory

Committee

The Immunization Practices Advisory Committee

(ACIP), an advisory group established by the CDC,

issues recommendations on the use of new and existing

vaccines. Recommendations typically describe the

populations which should receive the vaccine, a

schedule for vaccinations, and vaccine precautions and

contraindications.

The ACIP meets several times during a year to

review the evidence about the benefits and risks of

vaccines and then issues its recommendations, ACIP

members are selected from nominations made by

professional and academic societies and represent

experts in relevant disciplines (e.g., epidemiology,

microbiology, public health, immunology, and public

health practice). Representatives of the Food and Drug

Administration (FDA) and the NIH act as ex-officio

members, and the ACIP has liaison representatives

from professional and governmental organizations.3

Draft policy statements and background information

are prepared by the CDC staff prior to the meetings. An

attempt is made to gather all relevant background

material, including both published and unpublished

studies, such as unpublished studies from the vaccine

manufacturer and the FDA.

The vaccines evaluated by the ACIP are licensed by

the FDA, which does its own assessment of vaccine

efficacy. The Center for Biologics Evaluation and

Research of the FDA grants licensure for use of

vaccines based upon demonstration of safety and

efficacy. The approval process is complex and typically involves several sequential phases of evaluation,

including initial testing of the vaccine in a small

number of persons to determine its safety and immunogenicity; administration of the vaccine to a larger

number of persons to obtain further data on adverse

effects and the immune response; and controlled field

trials with sufficient study subjects to develop reasonable estimates of safety and efficacy (104). The efficacy

of a vaccine is usually measured in terms of protection

against clinical disease (104). Although the FDA has

primary responsibility for determining the safety and

efficacy of vaccines, they do not issue recommendations concerning vaccine use, although they do provide

input into the recommendations issued by the ACIP.

3 These organizations include the American Academy of Family Physicians, American Academy of Pediatrics, the American College of

Physicians, the American Hospital Associatio~ the American Medical Association the Canadian National Advisory Committee on

hmnunizatiom the Department of Defense, and the NationaI Vaccine Program.
Appendix G: Summary of the U.S.

Preventive Services Task Force%

(USPSTF) Recommendations for

Services To Be Included in Periodic

Health Examinations, by Age Group

T

he preventive services recommended by the USPSTF for

inclusion in periodic health examinations are summarized in

this appendix in eight tables, organized by age group. The

preventive services listed reflect only those topics evaluated

by the Task Force. The USPSTF specifically noted that clinicians

should use individual judgment to determine what is most appropriate

for each patient. The U.S. Preventive Services Task Force report, Guide

to Clinical Preventive Services, gives more detailed information on the

proper indications for specific preventive services than that provided in

the tables (224).

8 2
Table G-l—Birth to 18 Months (Schedule: 2,4, 6, 15, 18 Monthsa

)

—-.

Screening

Height and weight

Hemoglobin and hematocritb

High-risk groups

Hearingc (HR1)

Erythrocyte protoporphyin (HR2)

This list of preventive services is

not exhaustive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians may wish to add other preventive services after considering

the patient’s individual arcumstances.

Parent counseling

Diet

Breastfeeding

Nutrient intake, especially iron-rich

foods

Injury prevention

Child safety seats

Smoke detector

Hot water heater temperature

Stairway gates, window guards,

pool fence

Storage of drugs and toxic

chemicals

Syrup of ipecac, poison control

telephone number

Dental health

Baby bottle tooth decay

Other primary preventive

measures

Effects of passive smoking

Immunization and

chemoprophylaxis

Diphtheria-tetanus-pertussis (DTP)

vaccined

Oral poliovirus vaccine (OPV)e

Measles-mumps-rubella (MMR)

vaccinef

Haemophilus influenza type b (Hib)

conjugate vaccineg

High-risk groups

Fluoride supplements (HR3)

First week

Ophthalmic antibiotics

Hemoglobin electrophoresis (HR4)h

T4/TSH I

Phenaylaninel

Hearing (HR1)

Remain alert for:

Ocular misalignment

Tooth decay

Signs of child abuse or neglect

High-risk categories

HR1 Infants with a family history of childhood hearing

impairment or a personal history of congenital perinatal

infection with herpes, syphilis, rubella, cytomegalovirus,

or toxoplasmosis; malformations involving the head or

neck (e.g., dysmorphic and syndromal abnormalities,

cleft palate, abnormal pinna); birthweight below 1500 g;

bacterial meningitis; hyperbilirubinemia requiring exchange transfusion; or severe perinatal asphyxia (Apgar

scores of O-3, absence of spontaneous respirations for

10 minutes, or hypotonia at 2 hours of age).

HR2 Infants who live in or frequently visit housing built

before 1950 that is dilapidated or undergoing renovation;

who come into contact with other chiIdren with known

lead toxicity; who live near lead processing plants or

whose parents or household members work in a leadrelated occupation; or who live near busy highways or

hazardous waste sites.

HR3 Infants living in areas with inadequate water

fluoridation (less than 0.7 parts per million).

HR4 Newborns of Caribbean, Latin American, Asian,

Mediterranean, or African descent.

afive “i~its are rqujr~ for immunizations- B~ause of ]ack of data and differing patient risk profi]es, the scheduling of additional vis;b and the frequency of the individual preventive

services listed in this table are left to clinical discretion (except as indicated in other footnotes): bOn@ du~ng infancy.

CAt age 1 &mOnth visit, if not tested earlier.

dAt ag= 2, 4, 6, and 15 months.

(3At ag= 2, 4, and 15 months.

fAt age 15 months.

9At age 18 months.

hAt birth.

I Days 3 t. 6 preferred for testin9.

SOURCE: U.S. Preventive Services Task Force, Guide to C/inica/Preventive Servkxs (Baltimore, MD: Williams and Wilkins, 1989).
Table G-2—Ages 2-6a

Screening

Height and weight

Blood pressure

Eye exam for amblyopia and

strabismus

Urinalysis for bacteriuria

High-risk groups

Erythrocyte protoporphyrinc (HR1)

Tuberculin skin test (HR2)

Hearingd (HR3)

This Iist of preventive services Is

not exhauetive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient% medical history and other individual circumstances.

Patient and parent counseling

Diet and exercise

Sweets and between-meal snacks,

iron-enriched foods, sodium

Caloric balance

Selection of exercise program

Injury prevention

Safety belts

Smoke detector

Hot water heater temperature

Window guards and pool fence

Bicycle safety helmets

Storage of drugs, toxic chemicals,

matches, and firearms

Syrup of ipecac, poison control

telephone number

Dental health

Tooth brushing and dental visits

Other primary preventive

measures

Effects of passive smoking

High-risk groups

Skin protection from ultraviolet

light (HR4)

Immunizations and

chemoprophylaxis

Diphtheria-tetanus-pertussis (DTP)

vaccinee

Oral poliovirus vaccine (OPV)e

High-risk groups

Fluoride supplements (HR5)

Remain alert for:

Vision disorders

Dental decay, malalignment,

premature loss of teeth, mouth

breathing

Signs of child abuse or neglect

Abnormal bereavement

High-risk categories

HR1 Children who live in or frequently visit housing built

before 1950 that is dilapidated or undergoing renovation;

who come in contact with other children with known lead

toxicity; who live near lead processing plants or whose

parents or household members work in a lead-related

occupation; or who live near busy highways or hazardous waste sites.

HR2 Household members of persons with tuberculosis or

others at risk for close contact with the disease; recent

immigrants or refugees from countries in which tuberculosis is common (e.g., Asia, Africa, Central and South

America, Pacific Islands); family members of migrant

workers; residents of homeless shelters; or persons with

certain underfying medical disorders.

HR3 Children with a family history of childhood hearing

impairment or a personal history of congenital perinatal

infection with herpes, syphilis, rubella cytomegalovirus,

or toxoplasmosis; malformations involving the head or

neck (e.g., dysmorphic and syndromal abnormalities,

cleft palate, abnormal pinna); birthweight below 1500 g;

bacterial meningitis; hyperbilirubinemia requiring exchange transfusion; or severe perinatal asphyxia (Apgar

scores of O-3, absence of spontaneous respirations for

10 minutes, or hypotonia at 2 hours of age).

HR4 Children with increased exposure to sunlight.

HR5 Children living in areas with inadequate water

fluoridation (less than 0.7 parts per million).

-.

d

—

aQne visit is required for immunizations. Because of lack of data and differing patient risk profiles, the scheduling of additional visits and the frequency of the individual preventive

services listed in this table are left to clinical discretion (except as indicated in other footnotes).

bAges 3-4.

cAnnually.

dBefore age 3, if not tested earlier.

e~~between ages 4 and 6.

SOURCE: U.S. Preventive Services Task Force, Guide to C/inica/ Preventive Services (Baltimore, MD: Williams and Willdns, 19S9).
Table G-3—Ages 7-1 2a

Screening

Height and weight

Blood pressure

High-risk groups

Tuberculin skin test (HR1 )

This list of preventive services is

not exhaustive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

Parent and patient counseling

Diet and exercise

Fat (especially saturated fat),

cholesterol, sweets and

between-meal snacks, sodium

Caloric balance

Selection of exercise program

Injury prevention

Safety belts

Smoke detector

Storage of firearms, drugs, toxic

chemicals, matches

Bicycle safety helmets

Dental health

Regular tooth brushing and

dental visits

Other primary preventive

measures

High-risk groups

Skin protection from ultraviolet

light (HR2)

Chemoprophylaxis

High-risk groups

Fluoride supplements (HR3)

Remain alert for:

Vision disorders

Diminished hearing

Dental decay, malalignment, mouth

breathing

Signs of child abuse or neglect

Abnormal bereavement

High-risk categories

HR1 Household members of persons with tuberculosis or

others at risk for close contact with the disease; recent

immigrants or refugees from countries in which tuberculosis is common (e.g., Asia, Africa, Central and South

America, Pacific Islands); family members of migrant

workers; residents of homeless shelters; or persons with

certain underlying medical disorders.

HR2 Children with increased exposure to sunlight.

HR3 Children living in areas with inadequate water

fluoridation (less than 0.7 parts per million).

aBWause of la& of data and differing patient risk profiles, the scheduling of additional visits and the frequency of the individual preventive services listed in this table are left to

clinical discretion (except as indicated in other footnotes).

SOURCE: U.S. Preventive Services Task Force, Guide to Clinical Preventive Services (Baltimore, MD: Williams and Wilkins, 1989).

o

-.

0

“z
Table G-4-Ages 13-18°

Screening

History

Dietary intake

Physical activity

Tobacco/alcohol/drug use

Sexual practices

Physical exam

Height and weight

Blood pressure

High-risk groups

Complete skin exam (HR1)

Clinical testicular exam (HR2)

Laboratory/diagnostic procedures

High-risk groups

Rubella antibodies (HR3)

VDRL (HR4)

Chlamydial testing (HR5)

Gonorrhea culture (HR6)

Counseling and testing for HIV (HR7)

Tuberculin skin test (PPD) (HR8)

Hearing (HR9)

Papanicolaou smear (HR 1O)b

Parent and patient counseling

Diet and exercise

Fat (especially saturated fat),

cholesterol, sodium, iron,c

calciumc

Caloric balance

selection of exercise program

Substance use

Tobacco: cessation/primary

prevention

Alcohol and other drugs: cessation/

primary prevention

Driving/other dangerous activities while under the influence

Treatment for abuse

High-risk groups

Sharing/using unsterilized needles

and syringes (HR12)

Sexual practices

Sexual development and

behaviord

Sexually transmitted diseases:

partner selection, condoms

Unintended pregnancy and

contraceptive options

Injury prevention

Safety belts

Safety helmets

Violent behaviore

Firearms e

Smoke detector

Dental health

Regular tooth brushing, flossing,

dental visits

Other primary preventive

measures

High-risk groups

Discussion of hemoglobin testing

(HR13)

Skin protection from ultraviolet

light (HR14)

Immunizations and

chemoprophylaxis

Tetanusdiphtheria (Td) boosterf

High-risk groups

Fluoride supplements (HR15)

High-risk categories

HR1 Persons with increased recreational or occupational

exposure to sunlight a family or personal history of skin

cancer, or clinical evidence of precursor lesions (e.g.,

dysplastic nevi, certain congenital nevi).

HR2 Males with a history of cryptorchidism, orchiopexy,

or testicular atrophy.

HR3 Females of childbearing age lacking evidence of

immunity.

HR4 Persons who engage in sex with multiple partners in

areas in which syphilis is prevalent, prostitutes, or

contacts of persons with active syphilis.

HR5 Persons who attend clinics for sexually transmitted

diseases; attend other high-risk health care facilities (e.g.

adolescent and family planning clinics); or have other risk

factors for chlamydial infection (e.g., multiple sexual partners or a sexual partner with multiple sexual contacts).

HR6 Persons with multiple sexual partners or a sexual

partner with multiple contacts, sexual contacts of persons with culture-proven gonorrhea or persons with a

history of repeated episodes of gonorrhea

HR7 Persons seeking treatment for sexually transmitted

diseases; homosexual and bisexual men; past or present

intravenous (IV) drug users; persons with a history of

prostitution or multiple sexual partners; women whose

past or present sexual partners were HIV infected,

bisexual, or IV drug users; persons with long-term

residence or birth in an area with high prevalence of HIV

infection; or persons with a history of transfusion between 1978 and 1985.

HR8 Household members of persons with tuberculosis or

others at risk for close contact with the disease; recent

immigrants or refugees from countries in which tuberculosis is common (e.g., Asia, Africa Central and South

America Pacific Islands); migrant workers; residents of

correctional institutions or homeless shelters; or persons

with certain underlying medical disorders.

HR9 Persons exposed regularly to excessive noise in

recreational or other settings.

HR1O Females who are sexually active or (if the sexual

history is thought to be unreliable) aged 18 or older.

HR11 Recent divorce, separation, unemployment depression, alcohol or other drug abuse, serious medical

illnesses, living alone, or recent bereavement.

HR12 Intravenous drug users.

HR13 Persons of Caribbean, Latin American, Asian,

Mediterranean, or African descent

HR14 Persons with increased exposure to sunlight.

mm3

CD

- .

d
Table G-4-Ages 13-18a--Continued

— —.—

Screening Parent and patient counseling

This list of preventive services Is

not exhaustive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

Immunizations and —

chemoprophylaxis

Remain alert for:

Depressive symptoms

Suicidal risk factors (HR11 )

Abnormal bereavement

Tooth decay, malalignment,

gingivitis

Signs of child abuse and neglect

Health risk categories

HR15 Persons living in areas with inadequate water

fluoridation (less than 0.7 parts per million).

%3ne visit is required for immunization. -use of lack of data and differing patient risk profiles, the scheduling of additional visits and the frequency of the individual preventive n

services listed in this ta~e are left to clinical discretion (excerX as indicated in other footnotes). p

bEvery 1-3 years.

. .

c

For females. A

d~w b-t peflo~early in adolescence and with the involvement of parents.

eFor males. 5

3

f-beween ages 14 and 16. m

SOURCE: U.S. Preventive services Task Force, Guide b Clinical Preventive Services (Baltimcwe, MD: Williams and Wiltins, 1989). 4

0

c

u)

m

~

n

g

n

s

g

3

a

B1

- .

0

“z

<=

g

:

z

G
m

Table G-5-Ages 19-39 (Schedule: Every 1-3 Years8) m—

Screening

History

Dietary intake

Physical activity

Tobacco/alcohol/drug use

Sexual practices

Physical exam

Height and weight

Blood pressure

High-risk groups

Complete oral cavity exam (HR1 )

Palpation for thyroid nodules (HR2)

Clinical breast exam (HR3)

Clinical testicular exam (HR4)

Complete skin exam (HR5)

Laboratory/diagnostic

procedures

Nonfasting total blood cholesterol

Papanicolaou smear

High-risk groups

Fasting plasma glucose (HR6)

Rubella antibodies (HR7)

VDRL (HR8)

Urinalysis for bacteriuria (HR9)

Chlamydial testing (HRIO)

Gonorrhea culture (HR11)

Counseling and testing for HIV (HR12)

Hearing (HR13)

Tuberculin skin test (PPD) (HR14)

Electrocardiogram (HR15)

Mammogram (HR3)

Colonoscopy(HR16)

Counseling

Diet and exercise

Fat (especially saturated fat),

cholesterol, complex carbohydrates, fiber, sodium, ironc

,

calciumc

Caloric balance

Selection of exercise program

Substance abuse

Tobacco: cessation/primary

prevention

Alcohol and other drugs:

Limiting alcohol consumption

Driving/other dangerous activities while under the influence

Treatment for abuse

High-risk groups

Sharing/using unsterilized needles

and syringes (HR18)

Sexual practices

Sexually transmitted diseases:

partner selection, condoms,

anal intercourse

Unintended pregnancy and

contraceptive options

Injury prevention

Safety belts

Safety helmets

Violent behaviord

Firearmsd

Smoke detector

Smoking near bedding or

upholstery

High-risk groups

Back-conditioning exercises

(HR19)

Prevention of childhood injuries

(HR20)

Falls in the elderly (HR21 )

Dental health

Regular tooth brushing, flossing,

dental visits

Immunizations

Tetanus-diphtheria (Td) boostere

High-risk groups

Hepatitis B vaccine (HR24)

Pneumococcal vaccine (HR25)

Influenza vaccinef (HR26)

Measles-mumps- rubella vaccine

(HR27)

High-risk categories y

HR1 Persons with exposure to tobacco or excessive CD

amounts of alcohol, or those with suspicious symptoms - . &

or lesions detected through self-examination. g

HR2 Persons with a history of upper-body irradiation.

HR3 Women aged 35 and older with a family history of 0

E“ premenopausally diagnosed breast cancer in a first- 3

degree relative. . .

HR4 Men with a history of cryptorchidism, orchiopexy, or ~

testicular atrophy.

- .

3

HR5 Persons with family or personal history of skin

- .

0

cancer, increased occupational or recreational exposure m—

to sunlight, or clinical evidence of precursor lesions (e.g., u

dysplastic nevi, certain congenital nevi). ~

HR6 The markedly obese, persons with a family history m

of diabetes, or women with a history of gestational 3

diabetes. - .

HR7 Women lacking evidence of immunity. s

HR8 Prostitutes, persons who engage in sex with C?3

multiple partners in areas in which syphilis is prevalent, ~

or contacts of persons with active syphilis. c- .

HR9 Persons with diabetes. o

HR1O Persons who attend clinics for sexually transmitted %

diseases; attend other high-risk health care facilities

(e.g., adolescent and family planning clinics); or have

other risk factors for chlamydial infection (e.g., multiple

sexual partners or a sexual partner with multiple sexual

contacts, age less than 20).

HR11 Prostitutes, persons with multiple sexual partners

or a sexual partner with multiple contacts, sexual contacts of persons with culture-proven gonorrhea, or persons with a history of repeated episodes of gonorrhea.

HR12 Persons seeking treatment for sexually transmitted diseases; homosexual and bisexual men; past or

present intravenous (IV) drug users; persons with a

history of prostitution or multiple sexual partners; women

whose past or present sexual partners were HIV- infected, bisexual, or IV drug users; persons with longterm residence or birth in an area with high prevalence of

HIV infection; or persons with a history of transfusion

between 1978 and 1985.

HR13 Persons exposed regularly to excessive noise.
Table G-5-Ages 19-39 (Schedule: Every 1-3 Yearsa

)-Continued

Screening Counseling

Other primary preventive

measures

High-risk groups

Discussion of hemoglobin testing

(HR22)

Skin protection from ultraviolet

light (HR23)

Immunizations High-risk categories

HR14 Household members of persons with tuberculosis

or others at risk for close contact with the disease (e.g.,

staff of tuberculosis clinics, shelters for the homeless,

nursing homes, substance abuse treatment facilities,

dialysis units, correctional institutions); recent immigrants or refugees from countries in which tuberculosis is

common; migrant workers; residents of nursing homes,

correctional institutions, or homeless shelters; or persons with certain underlying medical disorders (e.g., HIV

infection).

HR15 Men who would endanger public safety were they

to experience sudden cardiac events (e.g., commercial

airline pilots).

HR16 Persons with a family history of familial polyposis

coli or cancer family syndrome.

HR17 Recent divorce, separation, unemployment, depression, alcohol or other drug abuse, serious medical

illnesses, living alone, or recent bereavement.

HR18 Intravenous drug users.

HR19 Persons at increased risk for low back injury

because of past history, body configuration, or type of

activities.

HR20 Persons with children in the home or automobile.

HR21 Persons with older adults in the home.

HR22 Young adults of Caribbean, Latin American, Asian,

Mediterranean, or African descent.

HR23 Persons with increased exposure to sunlight.

HR24 Homosexually active men, intravenous drug users,

recipients of some blood products, or persons in healthrelated jobs with frequent exposure to blood or blood

products.

HR25 Persons with medical conditions that increase t he

risk of pneumococcal infection (e.g., chronic cardiac or

pulmonary disease, sickle cell disease, nephrotic syndrome, Hodgkin’s disease, asplenia, diabetes mellitus,

alcoholism, cirrhosis, multiple myeloma, renal disease,

or conditions associated with immunosuppression).

HR26 Residents of chronic care facilities or persons

suffering from chronic cardiopulmonary disorders, metabolic diseases (including diabetes mellitus), hemoglobinopathies, immunosuppression, or renal dysfunction.

HR27 Persons born after 1956 who lack evidence of

immunity to measles (receipt of live vaccine on or after

first birthday, laboratory evidence of immunity, or a

history of physician-diagnosed measles.)

(continued on next page)

D

u

u

m

2—. x

o

c

g

u’)

-1

n
C9

o

Table G-5-Ages 19-39 (Schedule: Every 1-3 Yearsa)-Continued —

w

Screening I Counseling

This list of preventive services is

not exhaustive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

Immunizations High-risk categories

m

3

m

Remain alert for:

Depressive symptoms

Suicide risk factors (HR17)

Abnormal bereavement

Malignant skin lesions

Tooth decay, gingivitis

Signs of physical abuse

a~e ~=mmen~ ~h~ule awlie~ only to the pen~ic visit itse~. The fr~uen~ of the indi~duai preventive ser~c~ list~ in this table is left to clinical discretion, except aS indicated o

m

in other footnotes.

bEvery 1-3 years.

=-

-u

c

For women.

dFor young males.

g

eEvery 10 years. m

‘Annually.

3

- .

SOURCE: U.S. Preventive Services Task Force, Guide to C/inica/ Preventive Services (Baltimore, MD: Wiiliams and Wilkins, 1989). s

m

m

:.

8

w
Table G-6—Ages 40-64 (Schedule: Every 1-3 Yearsa

)

Screening

History

Dietary intake

Physical activity

Tobacco/alcohol/drug use

Sexual practices

Physical exam

Height and weight

Blood pressure

Clinical breast examb

High-risk groups

Complete skin exam (HR1)

Complete oral cavity exam (HR2)

Palpation for thyroid nodules (HR3)

Auscultation for cartoid bruits (HR4)

Laboratory/diagnostic

procedures

Nonfasting total blood cholesterol

Papanicolaou smearc

Mammogramd

High-risk groups

Fasting plasma glucose (HR5)

VDRL (HR6)

Urinalysis for bacteriuria (HR7)

Chlamydial testing (HR8)

Gonorrhea culture (HR9)

Counseling and testing for HIV (HR1O)

Tuberculin skin test (PPD) (HR11)

Hearing (HR12)

Electrocardiogram (HR13)

Fecal occult blood/Sigmoidoscopy

(HR14)

Fecal occult blood/Colonoscopy

(HR15)

Bone mineral content (HR16)

Counseling

Diet and exercise

Fat (especially saturated fat),

cholesterol, complex carbohydrates,

fiber, sodium, calciume

Caloric balance

Selection of exercise program

Substance use

Tobacco cessation

Alcohol and other drugs:

Limiting alcohol consumption

Driving/other dangerous activities while under the influence

Treatment for abuse

High-risk groups

Sharing/using unsterilized needles

and syringes (HR19)

Sexual practices

Sexually transmitted diseases:

partner selection, condoms,

anal intercourse

Unintended pregnancy and

contraceptive options

Injury prevention

Safety belts

Safety helmets

Smoke detector

Smoking near bedding or

upholstery

High-risk groups

Back-conditioning exercises

(HR20)

Prevention of childhood injuries

(HR21)

Falls in the elderly (HR22)

Dental health

Regular tooth brushing, flossing,

and dental visits

immunizations

Tetanus-diphtheria (Td) boosterf

High-risk groups

Hepatitis B vaccine (HR26)

Pneumococcal influenza vaccine

(HR27)

influenza vaccine (HR28)g

Hiqh-risk categories

HR1 Persons with a family or personal history of skin

cancer, increased occupational or recreational exposure

to sunlight, or clinical evidence of precursor lesions (e.g.,

dysplastic nevi, certain congenital nevi).

HR2 Persons with exposure to tobacco or excessive

amounts of alcohol, or those with suspicious symptoms

or lesions detected through self-examination.

HR3 Persons with a history of upper-body irradiation.

HR4 Persons with risk factors for cerebrovascular or

cardiovascular disease (e.g., hypertension, smoking,

CAD, atrial fibrillation, diabetes) or those with necrologic

symptoms (e.g., transient ischemic attacks) or a history

of cerebrovascular disease.

HR5 The markedly obese, persons with a family history

of diabetes, or women with a history of gestational

diabetes.

HR6 Prostitutes, persons who engage in sex with

multiple partners in areas in which syphilis is prevalent,

or contacts of persons with active syphilis.

HR7 Persons with diabetes.

HR8 Persons who attend clinics for sexually transmitted

diseases, attend other high-risk health care facilities

(e.g., adolescent and family planning clinics), or have

other risk factors for chlamydial infection (e.g., multiple

sexual partners or a sexual partner with multiple sexual

contacts).

HR9 Prostitutes, persons with multiple sexual partners or

a sexual partner with multiple contacts, sexual contacts

of persons with culture-proven gonorrhea, or persons

with a history of repeated episodes of gonorrhea.

HR1O Persons seeking treatment for sexually transmitted diseases; homosexual and bisexual men; past or

present intravenous (IV) drug users; persons with a

history of prostitution or multiple sexual partners; women

whose past or present sexual partners were HIV infected,

bisexual, or IV drug users; persons with long-term

residence or birth in an area with a high prevalence of

HIV infection; or persons with a history of transfusion

between 1978 and 1985.

o

d

- .

0

“z

(continued on next page)
Screening

Table G-6-Ages 40-64 (Schedule: Every 1-3 Yearsa)-Continued mN

Counseling

Other primary preventive

measures

High-risk groups

Skin protection from ultraviolet

light (HR23)

Discussion of aspirin therapy

(HR24)

Discussion of estrogen

replacement therapy (HR25)

Immunizations High-risk categories

HR11 Household members of persons with tuberculosis

or others at risk for close contact with the disease (e.g.,

staff of tuberculosis clinics, shelters for the homeless,

nursing homes, substance abuse treatment facilities,

dialysis units, correctional institutions); recent immigrants or refugees from countries in which tuberculosis is

common (e.g., Asia, Africa, Central and South America,

Pacific Islands); migrant workers; residents of nursing

homes, correctional institutions, or homeless shelters; or

persons with certain underlying medical disorders (e.g.,

HIV infection).

HR12 Persons exposed regularly to excessive noise.

HR13 Men with two or more cardiac risk factors (high

blood cholesterol, hypertension, cigarette smoking, diabetes mellitus, family history of CAD); men who would

endanger public safety were they to experience sudden

cardiac events (e.g., commercial airline pilots); or sedentary or high-risk males planning to begin a vigorous

exercise program.

HR14 Persons aged 50 and older who have first-degree

relatives with colorectal cancer; a personal history of

endometrial, ovarian, or breast cancer; or a previous

diagnosis of inflammatory bowel disease, adenomatous

polyps, or colorectal cancer.

HR15 Persons with a family history of familial polyposis

coli or cancer family syndrome.

HR16 Perimenopausal women at increased risk for

osteoporosis (e.g., Caucasian race, bilateral oopherectomy before menopause, slender build) and for whom

estrogen replacement therapy would otherwise not be

recommended.

HR17 Recent divorce, separation, unemployment depression, alcohol or other drug abuse, serious medical

illnesses, living alone, or recent bereavement.

HR18 Persons over age 50, smokers, or persons with

diabetes mellitus.

HR19 Intravenous drug users.

HR20 Persons at increased risk for low back injury

because of past history, body configuration, or type of

activities.

HR21 Persons with children in the home or automobile.

HR22 Persons with older adults in the home.

HR23 Persons with increased exposure to sunlight.

HR24 Men who have risk factors for myocardial infarction

(e.g., high blood cholesterol, smoking, diabetes mellitus,

famiIy history of early-onset CAD) and who lack a history

of gastrointestinal or other bleeding problems, and or her

risk factors for bleeding and cerebral hemorrhage.
Table G-6—Ages 40-64 (Schedule: Every 1-3 Yearsa

)—Continued

Screening

This iist of preventive services is

not exhaustive. it reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

Counseling Immunizations

Remain alert for:

Depressive symptoms

Suicide risk factors (HR17)

Abnormal bereavement

Signs of physical abuse or neglect

Malignant skin lesions

Peripheral arterial disease (HR18)

Tooth decay, gingivitis, loose teeth

High-risk categories

HR25 Perimenopausal women at risk for osteoporosis

(e.g., Caucasian, low bone mineral content, bilateral

oopherectomy before menopause or early menopause,

slender build) and who are without known contraindications (e.g., history of undiagnosed vaginal bleeding,

active liver disease, thromboembolic disorder, hormonedependent cancer).

HR26 Homosexually active men, intravenous drug users,

recipients of some blood products, or persons in healthrelated jobs with frequent exposure to blood or blood

products. >

u

HR27 Persons with medical conditions that increase the m

risk of pneumococcal infection (e.g., chronic cardiac or m

pulmonary disease, sickle cell disease, nephrotic syn- 2—.

drome, Hodgkin’s disease, asplenia, diabetes mellitus, x

alcoholism, cirrhosis, multiple myeloma, renal disease or 0

conditions associated with immunosuppression).

HR28 Residents of chronic care facilities and persons L

suffering from chronic cardiopulmonary disorders, metabolic diseases (including diabetes mellitus), hemoglobin- 5

opathies, immunosuppression, or renal dysfunction. 3

D

0

aThe r-remended sch~ule applies only to the periodic visit itse~. The fr~uency of the individual preventive services li.st~ in this table is left to dinic.al discretion, except SS indicated G

in other footnotes.

bAnnualiy for women.

C&ey 1-3 YCW.S for women.

dEveV 1-2 years for women beginning at a9e ‘.

‘For women.

fEvery 10 years.

9Annually.

SOURCE: U.S. Preventive Services Task Force, Guide to Clinical Preventive Services (Baltimore, MD: Williams and Wilkins, 1989).
Table G-7—Ages 65 and Over (Schedule: Every Yeara

)

Screening

History

Prior symptoms of transient

ischemic attack

Dietary intake

Physical activity

Tobacco/alcohol/drug use

Functional status at home

Physical exam

Height and weight

Blood pressure

Visual acuity

Hearing and hearing aids

Clinical breast exam

High-risk groups

Auscultation for carotid bruits (HR1 )

Complete skin exam (HR2)

Complete oral cavity exam (HR3)

Palpation for thyroid nodules (HR4)

Laboratory/diagnostic

procedures

Nonfasting total blood cholesterol

Dipstick urinalysis

MammogramF

Thyroid function testsd

High-risk groups

Fasting plasma glucose (HR5)

Tuberculin skin test (PPD) (HR6)

Electrocardiogram (HR7)

Papanicolaou smear (HR8)

Fecal occult blood/Sigmoidoscopy

(HR9)

Fecal occult bloodbionoscopy

(HR1O)

Counseling

Diet and exercise

Fat (especially saturated fat),

cholesterol, complex carbohydrates, fiber, sodium, calciumd

Caloric balance

Selection of exercise program

Substance use

Tobacco cessation

Alcohol and other drugs:

Limiting alcohol consumption

Driving /other dangerous activities

while under the influence

Treatment for abuse

Injury prevention

Prevention of falls

Safety belts

Smoke detector

Smoking near bedding or

upholstery

Hot water heater temperature

Safety helmets

High-risk groups

Prevention of childhood injuries

(HR12)

Dental health

Regular dental visits, tooth brushing,

flossing

Other primary preventive

measures

Glaucoma testing by eye

specialist

High-risk groups

Discussion of estrogen

replacement therapy (HR13)

Discussion of aspirin therapy

(HR14)

Skin protection from ultraviolet

light (HR15)

Immunizations

Tetanus+ diphtheria (Id) booster

Influenza vaccineg

Pneumococcal vaccine

High-risk groups

Hepatitis B vaccine (HR16)

High-risk categories g

HR1 Persons with risk factors for cerebrovascular or ~

cardiovascular disease (e.g., hypertension, smoking, - .

d

CAD, atrial fibrillation, diabetes) or those with necrologic g

symptoms (e.g., transient ischemic attacks) or a history

of cerebrovascular disease. Cn

HR2 Persons with a family or personal history of skin ~.

cancer, or clinical evidence of precursor lesions (e.g., . .

dyplastic nevi, certain congenital nevi), or those with ~

increased occupational or recreational exposure to sun- - .

3

light. - .

0

HR3 Persons with exposure to tobacco or excessive ~

amounts of alcohol, or those with suspicious symptoms m

or lesions detected through self-examination. z

HR4 Persons with a history of upper-body irradiation. <

CD

HR5 The markedly obese, persons with a family history 3

of diabetes, or women with a history of gestational - .

diabetes.

<

m

HR6 Household members of persons with tuberculosis or g

others at risk forclose contact with the disease (e.g., staff

of tuberculosis clinics, shelters for the homeless, nursing g.

homes, substance abuse treatment fatalities, dialysis o

CD

units, correctional institutions); recent immigrants or u)

refugees of countries in which tuberculosis is common

(e.g., Asia, Africa Central and South America, Pacific

islands); migrant workers; residents of nursing homes,

correctionai institutions, or homeless shelters; or persons with certain underlying medical disorders (e.g., HIV

infection).

HR7 Men with two or more cardiac risk factors (high

blood cholesterol, hypertension, cigarette smoking, diabetes mellitus, family history of CAD); men who would

endanger public safety were they to experience sudden

cardiac events (e.g., commercial airline pilots); or sedentary or high-risk males planning to begin a vigorous

exercise program.

HR8 Women who have not had previous documented

screening in which smears have been consistently

negative.

HR9 Persons who have first-degree relatives with colorectal cancer; a personal history of endometrial, ovarian, or breast cancer; or a previous diagnosis of inflammatory bowel disease, adenomatous polyps, or colorectal

cancer.

HR1O Persons with a family history of familial polyposis

coli or cancer family syndrome.

HR11 Recent divorce, separation, unemployment, depression, alcohol or other drug abuse, serious medical

illnesses, living alone, or recent bereavement.
Table G-7—Ages 65 and Over (Schedule: Every Yeare

)---Continued

Screening

This Iist of preventive services is

not exhaustive. It reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

Counseling Immunizations

Remain alert for:

Depressive symptoms

Suicide risk factors (HR11)

Abnormal bereavement

Changes in cognitive function

Medications that increase risk of

falls

Signs of physical abuse or neglect

Malignant skin lesions

Peripheral arterial disease

Tooth decay, gingivitis, loose teeth

High-risk categories

HR12 Persons with children in the home or automobile.

HR13 Women at increased risk for osteoporosis (e.g.,

Caucasian, low bone mineral content, bilateral oopherectomy before menopause or early menopause, slender

bui Id) and who are without known contraindications (e.g.,

history of undiagnosed vaginal bleeding, active liver

disease, thromboembolic disorders, hormone-dependent cancer).

HR14 Men who have risk factors for myocardial infarction

(e.g., high blood cholesterol, smoking, diabetes mellitus,

family history of early-onset CAD) and who lack a history

of gastrointestinal or other bleeding problems, or other

risk factors for bleeding or cerebral hemorrhage.

HR15 Persons with increased exposure to sunlight.

HR16 Homosexually active men, intravenous drug users,

recipients of some blood products, or persons in healthrelated jobs with frequent exposure to blood or blood

products.

a~e remmmen~ ~h~ule applies only to the period~visit itse~. The frequency of the individual preventive services listed in this table is left to clinical discretion, except as indicated

in other footnotes.

bAnnua[~ for women until age 75, unless pathology detected.

cEve~ I -2 years for women untii age 75, unlass pathology detected.

dFor women.

eEvery 1-3 years.

fEvery 10 years.

9Annually.

SOURCE: U.S. Preventive Services Task Force, Guide to Clinical Preventive Services (Baltimore, MD: Williams and Wilkins, 1989).

-.

x

u

o

c

u)

z-in

—

co

UI
Table G-8-Pregnant Women

Screening

First prenatal visit

History

Dietary intake

Tobacco/alcohol/d rug use

Risk factors for intrauterine growth

retardation and low birthweight

Prior genital herpetic lesions

Physical exam

Blood pressure

Laboratory/diagnostic

procedures

Hemoglobin and hematocrit

ABO/Rh typing

Rh(D) antibody test

VDRL

Hepatitis B surface antigen (HBsAg)

Urinalysis for bacteriuria

Gonorrhea culture

High-risk groups

Hemoglobin electrophoresis (HR1 )

Rubella antibodies (HR2)

Chlamydial testing (HR3)

Counseling and testing for HIV

(HR4)

Counselinq

Nutrition

Tobacco use

Alcohol and other drug use

Safety belts

High-risk groups

Discuss amniocentesis (HR5)

Discuss risks of HIV infection

(HR4)

Hiqh-risk categories

HR1 Black women.

HR2 Women lacking evidence of immunity (proof of vaccination after the first birthday or

laboratory evidence of immunity).

HR3 Women who attend clinics for sexually transmitted diseases, attend other high-risk health

care facilities (e.g., adolescent and family planning clinics), or have other risk factors for

chlamydial infection (e.g., multiple sexual partners or a sexual partner with multiple sexual

contacts).

HR4 Women seeking treatment for sexually transmitted diseases; past or present intravenous (IV)

drug users; women with a history of prostitution or multiple sexual partners; women whose past

or present sexual partners were HIV-infected, bisexual, or IV drug users; women with long-term

residence or birth in an area with high prevalence of HIV infection in women; or women with a

history of transfusion between 1978 and 1985.

HR5 Women aged 35 and eider.

HR6 Women who continue to smoke during pregnancy.

HR7 Women with excessive alcohol consumption during pregnancy.

HR8 Women with uncertain menstrual histories or risk factors for intrauterine growth retardation

(e.g., hypertension, renal disease, short maternal stature, low prepregnancy weight, failure to gain

weight during pregnancy, smoking, alcohol and other drug abuse, and history of a previous fetal

death or growth-retarded baby).

HR9 Unsensitized Rh-negative women.

HR1O Women with multiple sexual partners or a sexual partner with multiple contacts, or sexual

contacts of persons with culture-proven gonorrhea.

HR11 Women who engage in sex with multiple partners in areas in which syphilis is prevalent, or

contacts of persons with active syphilis.

HR12 Women who engage in high-risk behavior (e.g., intravenous drug use) or in whom exposure

to hepatitis B during pregnancy is suspected.

HR13 Women at high risk (see HR4) who have a nonreactive HIV test at the first prenatal visit.

HR14 Women with risk factors for intrauterine growth retardation (see HR8).
Table G-8--Pregnant Women—Continued

Screening

Follow-up visits

(Schedule: weeks 6-8,8-10,414-

16, 24-28, 32, 36, 38,” 39,b

40,’ 41”)

Blood pressure

Urinalysis for bacteriuria

Screening tests at specific

gestational ages

14-16 weeks:

Maternal serum alpha-fetoprotein

(MSAFP)d

Ultrasound cephalometry (HR8)

24-28 weeks:

50 g oral glucose tolerance test

Rh(D) antibody (HR9)

Gonorrhea culture (HR1O)

VDRL(HR11)

Hepatitis B surface antigen (HBsAg)

(HR12)

Counseling and testing for HIV

(HR13)

36 weeks:

Ultrasound exam (HR14)

This list of preventive services is

not exhaustive. it reflects only those

topics reviewed by the U.S. Preventive Services Task Force. Clinicians

may wish to add other preventive

services after considering the patient’s medical history and other individual circumstances.

— .

Counseling

Nutrition

Safety belts

Discuss meaning of upcoming

tests

High-risk groups

Tobacco use (HR6)

Alcohol and other drug use

(HR7)

Remain alert for:

Signs of physical abuse

High-risk categories

aNulliparas only.

bMultiDaras onlv.

~he ;ecomme&W scheduie applies only to the periodic visit itself. The frequency of the individual preventive services listed in this table is ieft to dinicai discretion, except for

services indicated at specific gestationai “ages.

dwomen ~ith aa.s t. ~unselin~ and foilo~-up se~v~es, s~ll~ hi~h+esolution Ultrasound and amniocentesis capabilities, and reliabie, standardized laboratories.

SOURCE: U.S. Preventive Services Task Force, Guick to Clinical Preventive Servbs (Baltimore, MD: Williams and Wilkins, 1989).

-.0

“z
Appendix H: Preventive

Services in Health

Care Reform Proposals

Introduced in the

102d Congress

T

able H-1 lists the preventive services explicitly specified for coverage in the major

congressional health care reform proposals

introduced in the 102d Congress that outlined

a benefit package.

All major congressional reform proposals that

outlined a benefit package included coverage for

prenatal care. The details of this coverage, however,

were seldom clear. Several plans would have required

that the Department of Health and Human Services or

a quasi-public board establish a periodicity schedule or

standards of care. Five proposals would have covered

postnatal services and four proposals would have

included family planning services. As with prenatal

care, the nature of coverage for postnatal care and

family planning care (i.e., the particular items and

services covered, types of health care providers who

could be reimbursed, or potential restrictions on

coverage) was generally not specified in the proposed

legislation.

All of the congressional proposals that outlined a

benefit package included well-baby or well-child

care.

1 Some were more specific than others in regard

to the scope and details of covered services. For

example, S. 1177 would have included a comprehensive set of examinations, screening tests, and immunizations, in accordance with standards set by the

Secretary of the Department of Health and Human

Services. On the other end of the spectrum, S. 1872

would have included only well-baby care (for infants

under one year of age), including those services that

‘‘are consistent with recommendations and periodicity

schedules developed by appropriate medical experts. ’

A few of the congressional proposals would have

provided coverage of immunizations. Other proposals

that did not explicitly identify immunizations as a

covered service may have considered immunizations

as covered under well-child or well-baby care.

Most, but not all legislative proposals would have

included breast cancer and cervical cancer screening;

six proposals would have covered colorectal cancer

screening; and three proposals would have covered

prostate cancer screening.

Several congressional proposals had provisions for

coverage of health promotion, education or counseling

services. S. 1446, and its companion bill H.R. 8, would

have covered “health care and health promotion

services designed to prevent or minimize the effect of

illness, disease, or medical condition.” H.R. 5514

included in its basic benefits package counseling for

the purpose of promoting health and preventing illness

or injury, as well as health education for children under

19 years old. H.R. 3229 would have included unspecified health promotion and health education, as well as

advocacy, as part of a national delivery system. The

guidelines for this coverage would have been established by a national oversight board created by the bill.

Few major congressional health care reform proposals explicitly excluded some or all preventive services

from coverage. Exceptions were S. 1227 and S. 1872

which would have excluded routine physical examinations from the minimum benefit package.

1 Well-baby care generally refers to care delivered to infants under one year of age. The range of ages for well-child care coverage was from

7 and younger (HR. 5936) to 23 and younger (H.R. 8).

98
Appendix H-Preventive Services in Health Care Reform Proposals Introduced in t he 102d Congress | 99

Table H-l-Clinical Preventive Services Included in or Specifically Excluded froma

Congressional Health Care Reform Proposals, 102d Congress

Intervention Proposals

Prenatal care H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

S. 1227 (Mitchell, D-ME)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

H.R. 5524 (Dingell, D-Ml; Waxman, D-CA)

S. 2320 (WeIlstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

H.R. 3229 (Dellums, D-CA)

Family planning H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

S. 1446 (Kerrey, D-NE)

H.R. 3229 (Dellums, D-CA)

Well-baby care and well-childcare H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

S. 1227 (Mitchell, D-ME)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

H.R. 5524 (Dingell, D-Ml; Waxman, D-CA)

S. 2320 (WeIlstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

H.R. 3229 (Dellums, D-CA)

Immunizations H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

Breast cancer screening H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

S. 1227 (Mitchell, D-ME)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

S. 2320 (Wellstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

(continued on next page)
100 I Benefit Design: Clinical Preventive Services

Table H-l-Clinical Preventive Services included in or Specifically Excluded froma

Congressional Health Care Reform Proposals, 102d Congress-Continued

Intervention Proposals

Cervical cancer screening

Colorectal cancer screening

Prostate cancer screening

Routine physical examinations

Postnatal care

H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

S. 1227 (Mitchell, D-ME)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

S. 2320 (Wellstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

H.R. 3205 (Rostenkowski, D-IL)

S. 1177 (Rockefeller, D-WV)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

S. 2320 (WeIlstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

H.R. 8 (Oakar, D-OH)

S. 1446 (Kerrey, D-NE)

S. 2320 (WeIlstone, D-MN)

Excluded from S. 1227 (Mitchell, D-ME)

and S. 1872 (Bentsen, D-TX)

H.R. 3205 (Rostenkowski, D-IL)

S. 1446 (Kerrey, D-NE)

S. 2320 (Wellstone, D-MN)

S. 2513 (Daschle, D-SD; Wofford, D-PA)

H.R. 3229 (Dellums, D-CA)

a All mentions are i~[usions unless specifically noted (see routine physical examinations).

SOURCE: Adapted from U.S. Congress, Office of Technology Assessment, Coverage of Preventive Serwbes:

Provisions of Se/ected Hea/th Care Reform proposals, OTA-BP-H-110 (Washington, DC: U.S. Congress, Office of

Technology Assessment, Ootober 1992).
References

1. Abeline, T., Ehrsam, R., Buhler-Reichert, A., et

al., “Effectiveness of a Transdermal Nicotine

System in Smoking Cessation Studies,” Methods and Findings in Experimental and Clinical

Pharmacology 11(3):205-14, 1989.

2. Ahlquist, D. A., Wieand, H. S,, Moertel, C. G., et

al., “Accuracy of Fecal Occult Blood Screening

for Colorectal Neoplasia: A Prospective Study

Using Hemoccult and HemoQuant Tests, ’ Journal of the American Medical Association 269(10):

1262-7, 1993.

3. American Academy of Family Physicians, AAFP

Positions on the Clinical Aspects of Medical

Practice Kansas City, MO: January 1993).

4. American Academy of Pediatrics, Recommendations for Preventive Health Care: Committee on

Practice and Ambulatory Medicine (Elk Grove,

IL: July 1991).

5. American Cancer Society, Summary of Current

Guidelines for the Cancer-Related Checkup,

Recommendations and Rationale (Atlanta, GA:

1991).

6. American Cancer Society, Cancer Facts and

Figures—1992 (Atlanta, GA: 1992).

7. American College of Obstetricians and Gynecologists, Committee on Professional Standards,

“Report of Task Force on Routine Cancer

Screen ing,” Standards for Obstetric- Gyneco -

logic Services, 7th ed. (Washington, DC:

1989).

8. Anderson, G, H,, Boyes, D. A., Benedet, J.L,, et

al., “Organisation and Results of the Cervical

Cytology Screening Programme in British Columbia, 1955 -85,” British Medical Journal

296(6627):975-8, 1988.

9. Andersson, I., Aspegren, K., Janzon, L., et al,,

“Mammographic Screening and Mortality from

Breast Cancer: The Malmo Mammographic

Screening Trial, ” British Medical Journal

297(6654): 943-8, 1988.

10. Andrews, L.B. (cd.), State Laws and Regulations

Governing Newborn Screening (Washington,

DC: American Bar Foundation, 1985).

11, Aristizabal, N., Cuello, C., Correa, P., et al.,

“The Impact of Vaginal Cytology on Cervical

Cancer Risks in Cali, Colombia,’ International

Journal of Cancer 34:5-9, 1984.

12. Basel Pharmaceuticals, Habitrol (nicotine transdermal system): Finally the End of Smoking Dependence May Be at Hand. . . . prescribing information accompanying advertisement (Summit, NJ:

February 1992).

13. Bauer, H. M,, Greer, C, E., Chambers, J. C., et al.,

“Genital Human Papillomavirus Infection in

Female University Students as Determined by a

PCR-Based Method,” Journal of the American

Medical Association 265:472-7, 1991.

14. Berrino, F., Gatta, G., d’Alto, M., et al., “Efficacy of Screening in Preventing Invasive Cervical Cancer: A Case-Control Study in Milan,

Italy,’ ‘ International Agency for Research on

Cancer Scientific Publications 76:111-23,1986.

15. Birch, S., and Gafni, A., “Cost-Effectiveness/

Utility Analyses. Do Current Decision Rules

Lead Us to Where We Want to Be?’ Journal of

Health Economics 11:279-96, 1992.

101
102 I Benefit Design: Clinical Preventive Services

16. Bloch, A. B., Orenstein, W. A., Stetler, H. C., et

al., “Health Impact of Measles Vaccination in

the United States,” Pediatrics 76(4):524-32,

1985.

17. Bloom, B. S., Hillman, A.L., Fendrick A.M., et

al., “A Reappraisal of Hepatitis B Virus Vaccination Strategies Using Cost-Effectiveness Analysis,” Annals of Internal Medicine 118(4):298-

306, 1993.

18. Blostin, A., Supervisory Labor Economist, Division of Occupational Pay and Employee Benefits

Levels, Bureau of Labor Statistics, U.S. Department of Labor, personal communication, June

20, 1993.

19. Blue Cross Blue Shield Association, “Update on

State Mandated Benefits,’ Issue Review, Washington Report 8-92 (Washington, DC: February

1992).

20. Boring, C. C., Squires, ‘T.S., and Tong, T.,

“Cancer Statistics, 1993,” CA: A Cancer Journal for Clinicians 43(1):7-26, 1993.

21. Boss, L. P., and Guckes, F. H., “Medicaid Coverage of Screening Tests for Breast and Cervical

Cancer,” American Journal of Public Health

82(2):252-3, 1992.

22. Bowersox, S., ‘‘American Cancer Society Adopts

New Prostate Cancer Screening Guidelines,”

Journal of the National Cancer Institute 84(24);

1857, 1992.

23. Bowman, M. A., Fredman, L., English, D. K., et

al., “Screening for Sexually Transmitted Diseases by Primary Care Physicians, ” Southern

Medical Journal 84(3):294-8, 1991.

24. Bracken, M. B., Professor and Vice Chairman,

Department of Epidemiology and Public Health,

Yale University School of Medicine, New Haven,

CT, personal communication, June 15, 1993.

25. Braveman, P., Bennett, T., Lewis, C., et al.,

“Access to Prenatal Care Following Major

Medicaid Eligibility Expansions,” Journal of

the American Medical Association 269(10):1285-

9, 1993.

26. Brown, D., “Experts on Sickle Cell Urge Universal Testing, Preventive Medication, ” Washington Post, p, A3, April 28, 1993.

27. Buchkremer, G., Minneker, E., and Block, M.,

‘ ‘Smoking-Cessation Treatment Combining Transdermal Nicotine Substitution with Behavioral

Therapy,” Pharmacopsychiatry 24(3):96-102,

1991.

28. Cadman, D., chambers, L.W., Walter, S.D., et

al., “Evaluation of Public Health Preschool

Child Developmental Screening: The Process

and Outcome of a Community Program, American Journal of Public Health 77:45-51, 1987.

29. Canadian Task Force on the Periodic Health

Examination, “The Periodic Health Examination,” Canadian Medical Association Journal

121:1193-254, 1979.

30. Canadian Task Force on the Periodic Health

Examination, “The Periodic Health Examination: 2.1984 Update,” Canadian Medical Association Journal 130(10):1278-85, 1984.

31. Canadian Task Force on the Periodic Health

Examination, “The Periodic Health Examination: 2.1985 Update,” Canadian Medical Association Journal 134:724-7, 1986.

32. Canadian Task Force on the Periodic Health

Examination, “The Periodic Health Examination: 2.1987 Update,” Canadian Medical Association Journal 138(7):618-26, 1988,

33. Canadian Task Force on the Periodic Health

Examination, “The Periodic Health Examination: 2. 1989 Update” Canadian Medical Association Journal 141:209-16, 1989.

34. Canadian Task Force on the Periodic Health

Examination, “Periodic Health Examination,

1989 Update: 3. Preschool Examination for

Developmental, Visual and Hearing Problems, ’

Canadian Medical Association Journal 141(11):

113640, 1989.

35. Canadian Task Force on the Periodic Health

Examination, “1989 Update: 4. Intrapartum

Electronic Fetal Monitoring and Prevention of

Neonatal Herpes Simplex,” Canadian Medical

Association Journal 141(12):1233-40, 1989.

36. Canadian Task Force on the Periodic Health

Examination, “Periodic Health Examination,

1990 Update: 1. Early Detection of Hyperthyroidism and Hypothyroidism in Adults and

Screening of Newborns for Congenital Hypothyroidism,” Canadian Medical Association Journal 142(9):955-61, 1990.

37. Canadian Task Force on the Periodic Health

Examination, “Periodic Health Examination,

1990 Update: 4. Well-Baby Care in the First 2
References | 103

38.

39.

40.

41.

42.

43.

44.

45.

46.

47.

Years of Life,” Canadian Medical Association

Journal 143(9):867-72, 1990.

Canadian Task Force on the Periodic Health

Examination, “Periodic Health Examination,

1991 Update: 3. Secondary Prevention of Prostate Cancer, ” Canadian Medical Association

Journal 145(5):413-28, 1991.

Canadian Task Force on the Periodic Health

Examination, “Periodic Health Examination,

1993 Update: 2. Lowering the Blood Total

Cholesterol Level to Prevent Coronary Heart

Disease, ” Canadian Medical Association Journal 148(4):521-38, 1993.

Chalmers, I., Enkin, M., and Keirse, M.J.N.C.

(eds.), Effective Care in Pregnancy and Childbirth (Oxford, England: Oxford University Press,

1989).

Chodak, G. W., and Schoenberg, H. W., “Progress and Problems in Screening for Carcinoma of

the Prostate,” World Journal of Surgery 13(1):60-

4, 1989,

Chollet, D., “Minimum Health Insurance Benefits, ” Improving Health Po!icy and Management: Nine Critical Research Issues for the

1990s, S.M. Shorten and U.E. Reinhardt (eds.)

(Ann Anbor, MI: Health Administration Press,

1992).

Clarke, E. A., and Anderson, T. W., ‘Does Screening by Pap Smears Help Prevent Cervical

Cancer? A Case-Control Study, ’’Lancet 2(8l32):l4, 1979.

Clayton, E. W., ‘‘Issues in State Newborn Screening Programs, ’ Pediatrics 90(4):641-6, 1992.

Cochi, C. L., Broome, C. V., and Hightower,

A. W., “Immunization of U.S. Children With

Haemophilus Influenza Type b Polysaccharide

Vaccine: A Cost-Effectiveness Model of Strategy Assessment, ’ Journal of the American

Medical Association 253(4):521-9, 1985.

Cochrane Collaboration, “Preparing, Maintaining, and Disseminating Systematic Reviews of

the Effects of Health Care, ” figure located in

promotional brochure, Oxford, England, 1993.

Collette, H. J., Day, N. E., Rombach, J. J., et al.,

‘‘Evaluation of Screening for Breast Cancer in a

Non-Randomised Study (the DOM Project) by

Means of a Case-Control Study,’ Lancet 1: 1224-

6, 1984.

48.

49.

50.

51.

52.

53.

54.

55.

56.

Committee of Principal Investigators, “W.H.O.

Cooperative Trial on Primary Prevention of

Ischaemic Heart Disease with Clofibrate to

Lower Serum Cholesterol: Final Mortality Follow-Up,” Lancet 2(8403):600-4, 1984.

Consensus Conference, Sickle Cell Disease,

‘‘Newborn Screening for Sickle Cell Disease and

Other Hemoglobinopathies, ” Journal of the

American Medical Association 258(9):1205-9,

1987.

Council of Regional Networks for Genetic Services (CORN), New York, NY, ‘Newborn Screening Report: 1990, Final Report, ” supported in

part by project #MCJ-361011-01-0 from the

Maternal and Child Health Program (Title V,

Social Security Act), Maternal and Child Health

Bureau, Health Resources and Services Administration, U.S. Department of Health and Human

Services, Rockville, MD, February 1992.

Cramer, D. W., “The Role of Cervical Cytology

in the Declining Morbidity and Mortality of

Cervical Cancer,” Cancer 34:2018-27, 1974.

Cummings, S, R., Rubin, S. M., and Oster, G.,

“The Cost-Effectiveness of Counseling Smokers To Quit,’ Journal of the American Medical

Association 261(1):75-9, 1989.

Daughton, D. M., Heatley, S.A., Prendergast, J, J.,

et al., ‘‘Effect of Transdermal Nicotine Delivery

as an Adjunct to Low-Intervention Smoking

Cessation Therapy: A Randomized, PlaceboControlled, Double-Blind Study,” Archives of

Internal Medicine 151(4):749-52, 1991.

Davis, H., Executive Secretariat, Center for Drug

Evaluation and Research, Food and Drug Administration, Public Health Service, U.S. Department of Health and Human Services, Rockville,

MD, personal communication, July 10, 1993.

Davis, K., Bialek R,, Parkinson, M,, et al.,

“Reimbursement for Preventive Services: Can

We Construct an Equitable System?’ Journal of

General Internal Medicine 5(5 Suppl.):S93-8,

1990.

Davis, K., Collins, K., Rodriguez, M., et al.,

‘‘Health Care Reform and Preventive Services,’

contract report to the Centers for Disease Control, Public Health Service, U.S. Department of

Health and Human Services, August 21, 1992.
104 I Benefit Design: Clinical Preventive Services

57. Dayton, S., Pearce, M.L., Hashimoto, S., et al.,

“A Controlled Clinical Trial of a Diet High in

Unsaturated Fat in Preventing Complications of

Atherosclerosis, Circulation 40(Suppl. 11):1-

63, 1%9.

58. Detlefs, D. R., and Myers, R. J., 1992 Mercer

Guide to Social Security and Medicare (Washington, DC: William M. Mercer, Inc., 1991).

59. DiGuiseppi, C. G., Science Advisor, Office of

Disease Prevention and Health Promotion, U.S.

Department of Health and Human Services,

Washington, DC, personal communication, Dec.

23, 1992.

60. Dryfoos, J,, Putting Boys in the Picture: A

Review of Programs To Promote Sexual Responsibility Among Young Males (Santa CrUz, CA:

Network Publications, 1988).

61. Eddy, D. M., “Screening for Breast Cancer, ”

Annals of Internal Medicine 111(5):389-99,

1989.

62. Eddy, D. M., “Screening for Cervical Cancer, ”

Annals of Internal Medicine 113(3):214-26,

1990.

63. Eddy, D.M. (cd.), Common Screening Tests

(Philadelphia, PA: American College of Physicians, 1991).

64. Edelson, J.T., Weinstein, M. C., Tosteson A. M.,

et al,, “Long-Term Cost-Effectiveness of Various Initial Monotherapies for Mild to Moderate

Hypertension,’ Journal of the American Medical Association 263(3):407-13, 1990,

65. Expert Panel, “Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood

Cholesterol in Adults,” Archives of Internal

Medicine 148(1):36-69, 1988.

66. Fahs, M. C., Mandelblatt, J., Schechter, C., et al.,

‘‘Cost Effectiveness of Cervical Cancer Screening for the Elderly, Annals of Internal Medicine

117(6):520-7, 1992.

67. Feldman, W., “Unwanted Teenage Pregnancy:

A Canadian Perspective,” Preventing Disease:

Beyond the Rhetoric, R.B. Goldbloom and R.S.

Lawrence (eds.) (New York, NY: SpringerVerlag, 1990).

68. Feldman, W., Milner, R., Sackett, B., et al.,

“Effects of Preschool Screening for Vision and

Hearing on Prevalence of Vision and Hearing

Problems 6-12 Months Later,” Lancet 2: 1014-6,

1980.

69. Fielding, J. E., and Williams, C.A., “Unwanted

Teenage Pregnancy: A Canadian Perspective,”

Preventing Disease: Beyond the Rhetoric, R.B.

Goldbloom and R.S. Lawrence (eds.) (New

York NY: Springer-Verlag, 1990).

70. Fiore, M. C., Novotny, TE., Pierce, J. P., et al,,

“Methods Used To Quit Smoking in the United

States. Do Cessation Programs Help?” Journal

of American Medical Association 263(2):2760-

5, 1990.

71. Fiske, D. W., “The Meta-Analytic Revolution in

Outcome Research,” Journal of Consulting and

Clinical Psychology 51(1):65-70, 1983.

72. Flehinger, B.J., Herbert, E., Winawer, S.J., et al.,

“Screening for Colorectal Cancer With Fecal

Occult Blood Test and Sigmoidoscopy: Preliminary Report of the Colon Project of Memorial

Sloan-Kettering Cancer Center and PMI-Strang

Clinic,’ Screening for Gastrointestinal Cancer,

J. Chamberlain and A.B. Miller (eds.) (Lewiston,

NY: Hans Huber Publishers, 1988).

73. Foulds, J., Stapleton, J., Fayerabend, C., et al.,

“Effect of Transdermal Nicotine Patches on

Cigarette Smoking: A Double-Blind Crossover

Study,’ ‘ Psychopharmacology 106(3):421-

7, 1992.

74. Foxman, B., Lohr, K.N., and Brook, R.H.,

Measurement of Physiologic Health for Children, Vol. 5: Anemia (Santa Monica, CA: Rand

Corp., 1983).

75. Frick, M. H., Elo, O., Haapa, K., et al., “Helsinki

Heart Study: Primary-prevention Trial With

Gemfibrozil in Middle-Aged Men With Dyslipidemia," New England Journal of Medicine

317(20):1237-45, 1987.

76. Frisell, J., Eklund, L., Hellstrom, E., et al.,

“Randomized Study of Mammography Screening-preliminary Report on Mortality in the

Stockholm Trial, Breast Cancer Research and

Treatment 18(1):49-56, 1991.

77. Garber, A.M., and Wagner, J.L., “Practice Guidelines and Cholesterol Policy,” Health Affairs

10(2):52-66, 1991.

78. Garber, A. M., Littenberg, B., Sex, H. C., et al.,

‘‘Costs and Health Consequences of Cholesterol

Screening for Asymptomatic Older Adults,”
References I 105

79.

80.

81.

82.

83.

84.

85.

86.

87.

88.

89.

90.

Archives of Internal Medicine 151(6):1089-95,

1991.

Garfinkel, L., and Stellman, S. D., “Smoking and

Lung Cancer in Women: Findings in a Prospective Study,” Cancer Research 48(23):6951-5,

1988.

Gohagan, J., Chief, Early Detection Branch,

Early Detection and Community Oncology Program, Division of Cancer Prevention and Control, National Cancer Institute, Bethesda, MD,

personal communication, November 17, 1992.

Gold, M., Director, Special Studies Staff, Office

of Disease Prevention and Health Promotion,

Public Health Service, U.S. Department of

Health and Human Services, personal communication, March, 1993.

Goldbloom, R. B., Professor of Pediatrics, Department of Pediatrics, Dalhousie University,

Halifax, N. S., personal communication, March

15, 1993.

Goldbloom, R. B., and Lawrence, R.S. (eds.),

Preventing Disease: Beyond the Rhetoric (New

York, NY: Springer-Verlag, 1990).

Goldman, L., Gordon, D.J., Rifkind, B. M., et al.,

“Cost and Health Implications of Cholesterol

Lowering,” Circulation 85(5):1960-8, 1992.

Group Health Association of America, Inc.,

GHAA HMO Industry Profile 1991 (Washington, DC: 1991).

Group Health Association of America, Inc.,

HMO Industry Profile, Vol 1: Benefits, Premiums, and Market Structure in 1991 (Washington,

DC: 1992).

Grundy, S. M., ‘‘Cholesterol and Coronary Heart

Disease: A New Era, ” Journal of the American

Medical Association 256(20):2849-58, 1986.

Hadorn, D.C. (cd.), Basic Benefits and Clinical

Practice Guidelines (Boulder, CO: Westview

Press, 1992).

Hakama, M., “Mass Screening for Cervical

Cancer in Finland,” Screening in Cancer: A

Report of the UICC Workshop in Toronto, A.B,

Miller (cd.), UICC Technical Report Series Vol.

40 (Geneva, Switzerland: Union Internationale

Contre le Cancer, 1978).

Hardcastle, J. D., Thomas, W. M., Chamberlain,

J., et al., ‘‘Randomized, Controlled Trial of Fecal

91.

92.

93.

94.

95.

96.

97.

98.

99.

100.

101.

102.

Occult Blood Screening for Colorectal Cancer,’

Lancet 1(8648):1160-4, 1989.

Harris, J. R., Lippman, M. E., Veronesi, U., et al.,

“Breast Cancer,” Medical Progress, 327(5):319-

28, 1992.

Hayward, R. A., Shapiro, M. F., Freeman, H.E., et

al., ‘Who Gets Screened for Cervical and Breast

Cancer? Results From a New National Survey,’

Archives of Internal Medicine 148(5):1177-81,

1988.

Health Insurance Association of America,

Source Book of Health Insurance Data (Washington, DC: 1991).

Hinman, A. R., and Koplan, J.P., “Pertussis and

Pertussis Vaccine: Reanalysis of Benefits, Risks,

and Costs,’Y .Journal of the American Medical

Association 251(23):3109-13, 1984.

Hinman, F., “Screening for Prostatic Carcinoma, ’ Journal of Urology 145(1):126-

30, 1991.

Hjermann, I., Velve Byre, K., Holme, I., et al.,

‘‘Effect of Diet and Smoking Intervention on the

Incidence of Coronary Heart Disease: Report

From the Oslo Study Group of a Randomized

Trial in Healthy Men,” Lancet 2:1303-10, 1981.

Hoeg, J. M., Maher, M. B., Bailey, K. R., et al.,

“Comparisons of Six Pharmacologic Regimens

for Hypercholesterolemia,” American Journal

of Cardiology 59:812-15, 1987.

Holme, Ingar, “An Analysis of Randomized

Trials Evaluating the Effect of Cholesterol Reduction on Total Mortality and Coronary Heart

Disease,” Circulation 82:1916-24, 1990.

Holtzman, N. A., ‘‘What Drives Neonatal Screening Program,” New England Journal of Medicine 325(1 1):802-4, 1991.

Hunter, D.J.S., and Keirse, M.J.N.C., “Gestational Diabetes,” Effective Care in Pregnancy

and Childbirth, I. Chalmers, M. Enkin, and

M.J.N.C. Keirse (eds.) (Oxford, England: Oxford University Press, 1989).

Hurley, S.F., and Kaldor, J. M., “The Benefits

and Risks of Mammographic Screening for

Breast Cancer,’ Epidemiologic Reviews, 14: 101-

30, 1992.

Hurt, R. D., Lauger, G. G., Offord, K. P., et al.,

“Nicotine-Replacement Therapy with Use of a

Transdermal Nicotine Patch: A Randomized
106 Benefit Design: Clinical Preventive Services

Double-Blind Placebo-Controlled Trial,” Mayo

Clinic Proceedings 65(12):1529-37, 1990.

103. Hyman, D.J., Maibach, E.W., Flora, J. A., et al.,

“Cholesterol Treatment Practices of Primary

Care Physicians,’ Public Health Reports 107(4):

441-8, 1992.

104. Institute of Medicine, Vaccine Supply and Innovation (Washington, DC: National Academy

Press, 1985).

105, Institute of Medicine, Clinical Practice Guidelines, Directions for a New Program, M.J. Field

and K.N. Lohr (eds.) (Washington, DC: National

Academy Press, 1990).

106. Johanneson, G., Geirsson, G., and Day, N., “The

Effect of Mass Screening in Iceland, 1965-1974,

on the Incidence of Mortality of Cervical Carcinoma, ’ International of Cancer 21:418-25,

1978.

107. Johannesson, M., “Economic Evaluation of

Hypertension Treatment,” International Journal of Technology Assessment in Health Care

8(3):506-23, 1992.

108. Johnson, R. E., Nahmias, A.J., Magder, L. S., et

al., “A Seroepidemiologic Survey of the Prevalence of Herpes Simplex Virus Type 2 Infection

in the United States,’ New England Journal of

Medicine 321(1):7-12, 1989.

109. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure,

“The 1988 Report of the Joint National Committee on Detection, Evaluation, and Treatment of

High Blood Pressure, ” Archives of Internal

Medicine 148:1023-38, 1988.

110. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure, The

Fifth Report of the Joint National Committee on

Detection, Evaluation, and Treatment of High

Blood Pressure (JNCV), National High Blood

Pressure Education Program, National Heart,

Lung, and Blood Institute, National Institutes of

Health, Public Health Service, U.S. Department

of Health and Human Services, Bethesda, MD,

Oct. 30, 1992.

111. Jordan, W. P., “Clinical Evaluation of the Contact Sensitization Potential of a Transdermal

Nicotine System (Nicoderm),’ Journal of Family Practice 34(6):709-12, 1992.

112. Kassler, W. J., and Cates, W. C., “The Epidemiology and Prevention of Sexually Transmitted

Diseases,” Urologic Clinics of North America

19(1):1-12, 1992.

113, Kemper, K.J., and Avner, E.D., “The Case

Against Screening Urinalysis for Asymptomatic

Bacteriuria in Children,” American Journal of

Diseases of Children 146(3):343-6, 1992.

114. Kewenter, J., Bjork, S., Haglind, E., et al.,

“Screening and Rescreening for Colorectal Cancer: A Controlled Trial of Fecal Occult Blood

Testing in 27,000 Subjects,” Cancer 62(3):645-

851, 1988.

115. Kirkman-Liff, B., and Kronenfeld, J.J., “Access

to Cancer Screening Services for Women, ”

American Journal of Public Health 82(5):733-5,

1992.

116. Kolata, G., “New Data Revive the Debate Over

Mammography Before 50,” New York Times,

p. C16, Jan. 12, 1992.

117. Koplan, J.P., and Preblud, S.R., “A Benefit-Cost

Analysis of Mumps Vaccine,” American Journal of Diseases of Children 136(4):3624, 1982.

118. Koplan, J.P., Schoenbaum, S. C., Weinstein,

M. C., et al., ‘‘Pertussis Vaccine: An Analysis of

Benefits, Risks, and Costs, ” New England

Journal of Medicine 301(17):906-11, 1979.

119. Kottke, T.E., Battista, R. N., DeFriese, G. H., et

al., “Smoking Cessation: Attributes of Successful Interventions,” Preventing Disease: Beyond

the Rhetoric, R.B. Goldbloom and R.S. Lawrence (eds.) (New York, NY: Springer-Verlag,

1990).

120. Koutsky, L. A., Galloway, D. A., and Holmes,

K. K., “Epidemiology of Genital Human Papillomavirus Infection, ” Epidemiological Review

10:1222-63, 1988.

121. KPMG Peat Marwick, Health Benefits in 1992

(Washington, DC: October 1992).

122. Krahn, M., Naylor, D., Basinski, A. S., et al.,

“Comparison of an Aggressive (U. S.) and a Less

Aggressive (Canadian) Policy for Cholesterol

Screening and Treatment,” Annals of Internal

Medicine 115(4):248-55, 1991.

123. Kronberg, O., Fenger, C., Sondergaard, P., et al.,

“Initial Mass Screening for Colorectal Cancer

with Fecal Occult Blood Test, ’ Scandinavian
124.

125.

126.

127.

128.

129.

130.

131.

132,

133,

Journal of Gastroenterology 22(6):677-

86, 1987.

La Vecchia, C., Decarli, A., Gentile, A., et al.,

‘‘Pap Smear and the Risk of Cervical Neoplasia:

Quantitative Estimates With Organized Screening Programmed, “ Lancet 1:1247-9, 1985.

Laara, E., Day, N., and Hakama, M., “Trends in

Mortality From Cervical Cancer in the Nordic

Countries: Association with Organized Screening Programmed, ’ Lancet l@544):1247-

9, 1987.

LaForce, F. M., “Immunization, Immunoprophylaxis, and Chemoprophylaxis to Prevent

Selected Infections, ” Journal of the American

Medical Association 257(18):2464-70, 1987.

Laudicina, S. S., Director of State Services Research, Blue Cross Blue Shield Association,

Washington, DC, personal communication, November 18, 1992,

Lawrence, R. S., and Mickalide, A. D., “Preventive Services in Clinical Practice: Designing the

Periodic Health Examination,” Journal of the

American Medical Association, 257(16):2205-7,

1987.

Lederle Laboratories, Prostep (Nicotine Transdermal System), prescribing information accompanying advertisement (Wayne, NJ: August 1992).

Lipids Research Clinics Program, “The Lipid

Research Clinics Coronary Primary Prevention

Trial Results: I. Reduction in Incidence of

Coronary Heart Disease,’ Journal of the American Medical Association 251(3):351-64, 1984.

Lipids Research Clinics Program, “The Lipid

Research Clinics Coronary Primary Prevention

Trial Results: II. The Relationship of Reduction

in Incidence of CHD to Cholesterol Lowering,’

Journal of the American Medical Association

251(3):365-74, 1984.

Littenberg, B., Garber, A., and Sex, H. C.,

‘ ‘Screening for Hypertension, ’ Common

Screening Tests, D.M. Eddy (cd.) (Philadelphia,

PA: American College of Physicians, 1991).

Lorion, R. P., ‘‘Research Issues in the Design and

Evaluation of Preventive Interventions, ’ Education for Primary Prevention in Social Work, J.P.

Bowker (cd.) (New York, NY: Council on Social

Work Education, Inc., 1983).

134.

135.

136.

137.

138.

139.

140.

141.

142.

143.

References | 107

Lurie, N., Manning, W. G., Peterson, C., et al.,

“Preventive Care: Do We Practice What We

Preach,” American Journal of Public Health

77(7):801-4, 1987.

Mandel, J. S., Bond, J.H., Church, T.R., et al.,

“Reducing Mortality from Colorectal Cancer by

Screening for Fecal Occult Blood,” New England Journal of Medicine 328(19):1365-

71, 1993.

Marion Merrell Dow Inc., Membrane -

Controlled Nicoderm Assures Reproducible Delivery of Nicotine, prescribing information

accompanying advertisement (Kansas City, MO:

November 1991).

Martyn, L.J., “Disorders of the Eye and Ear,”

Nelson Textbook of Pediatrics, Thirteenth Edition, R.E. Behrman and V.C. Vaughan (eds.)

(Philadelphia, PA: W.B. Saunders Company,

1987).

Massachusetts Department of Health, “Report

on the Measles, Mumps, and Rubella Immunization Programs,’ Boston, MA, March 1980.

McPhee, S.J., and Schroeder, S. A., “Promoting

Preventive Care: Changing Reimbursement Is

Not Enough,” American Journal of Public

Health 77(7):780-1, 1987.

Miller, A. B., Baines, C. J., To, T, et al., “Canadian National Breast Cancer Screening Study, 1.

Breast Cancer Detection and Death Rates Among

Women Aged 40 to 49 Years,” Canadian

Medical Association Journal 147(10):1437-9,

1992,

Miller, A. B., Baines, C. J., To, T., et al., “Canadian National Breast Cancer Screening Study, 2.

Breast Cancer Detection and Death Rates Among

Women Aged 50 to 59 Years,” Canadian

Medical Association Journal 147(10):1477-88,

1992.

Miller, A. B., Lindsay, J., and Hill, G. B., ‘ ‘Mortality From Cancer of the Uterus in Canada and

its Relationship to Screening for Cancer of the

Cervix,’ International Journal of Cancer 17@2-

12, 1976.

Muldoon, M. F., Manuck, S. B., and Matthews,

K. A., “Lowering Cholesterol Concentrations

and Mortality: A Quantitative Review of Primary Prevention Trials, ’ British Medical Journal 301(6747):309-14, 1990.
108 I Benefit Design: Clinical Preventive Services

144.

145.

146.

147.

148.

149.

150.

151.

152.

153.

154.

155.

Muller, P., Abelin, T., Ehrsanm, R., et al., ‘‘The

Use of Transdermal Nicotine in Smoking Cessation,” Lung 168(Suppl.):445 -53, 1990.

Mulley, A. G., Silverstein, M. D., and Dienstag,

J. L., “Indications for the Use of Hepatitis B

Vaccine, Based on Cost-Effectiveness Analysis,’ New England Journal of Medicine 307(11);

644-52, 1982.

Mulligan, S. C., Masterson, J. G., Devan, J. G., et

al., “Clinical and Pharmacolkinetic Properties

of a Transdermal Nicotine Patch, ” Clinical

Pharmacology and Therapeutics 47(3):331-7,

1990.

Multiple Risk Factor Intervention Trial Research

Group, ‘Multiple Risk Factor Intervention Trial:

Risk Factor Changes and Mortality Results,”

Journal of the American Medical Association

248(12):1465-77, 1982.

Newacheck, P. W., and Halfon, N., “Preventive

Care Use by School-Aged Children: Differences

by Socioeconomic Status,” Pediatrics 82(3, Pt,

2):462-8, 1988.

Newcomb, P. A., Norfleet, R. G., Storer, B. E., et

al., “Screening Sigmoidoscopy and Colorectal

Cancer Mortality,” Journal of the National

Cancer Institute 84(20):1572-5, 1992.

Newhouse, J. P., “Medical Care Costs: How

Much Welfare Loss?’ Journal of Economic

Perspectives 6(3):3-22, 1992.

Newman, T. B., Warren, S. B., and Stephen, B. H.,

“Childhood Cholesterol Screening: Contraindicated,” Journal of the American Medical Association 261(1):100-1, 1992.

Oberg, C.N., Lia-Hoagberg, B., Hodkinson, E,,

et al., “Prenatal Care Comparisons Among

Privately Insured, Uninsured, and MedicaidEnrolled Women,’ Public Health Reports 105(5):

533-5, 1990.

Oliver, M, F., “Might Treatment of Hypercholesterolaemia Increase Non-Cardiac Mortality?” Lancet 337(8756):1529-31, 1991.

Oster, G., and Epstein, A. M., ‘‘ Costeffectiveness of Antihyperlipemic Therapy in the

Prevention of Coronary Heart Disease, ’ Journal

of the American Medical Association 258(17):

2381-7, 1987.

Oster, G., Huse, D.M., Delea, T.E., et al.,

“Cost-Effectiveness of Nicotine Gum as an

156.

157.

158.

159.

160.

161.

162.

163.

164.

165.

166.

167.

Adjunct to Physician’s Advice Against Cigarette

Smoking,” Journal of the American Medical

Association 256(10):1315-8, 1986.

Palli, D., Del Turco, M. R., Buiatti, E., et al,, “A

Case-Control Study of the Efficacy of a NonRandomized Breast Cancer Screening Program

in Florence (Italy),” International Journal of

Cancer 38(4):501-4, 1986.

Parke-Davis Co., Nicotrol (Nicotine Transdermal System), prescribing information accompanying advertisement (Morris Plains, NJ: March

1992).

Roberts, M. M., Alexander, F. E., Anderson, T. J,,

et al., ‘‘Edinburgh Trial of Screening for Breast

Cancer: Mortality at Seven Years, ” Lancet

335(8695):968-9, 1990.

Rose, J. E., Levin, E. D., Behm, F. M., et al.,

“Transdermal Nicotine Facilitates Smoking

Cessation,” Clinical Pharmacology and Therapeutics 47(3):323-30, 1990.

Russell, C., “Do Younger Women Need Mammograms? Debate Swirls in Medical Circles

About Usefulness of Routine Screening Under

Age 50, ’ Washington Post, p. 6, Health Section,

Feb. 9, 1993.

Russell, L. B., Is Prevention Better than Cure?

(Washington, DC: Brookings Institution, 1986).

Russell, L. B., Evaluating Preventive Care, Report on a Workshop (Washington DC: Brookings Institution, 1987).

Russell, L.B., “Opportunity Costs in Modern

Medicine,” Health Affairs 11(2): 162-9, 1992.

Russell, R. B., “Some of the Tough Decisions

Required by a National Health Plan,” Science

246(17):892-5, 1989.

Schoenbaum, S. C., Hyde, J. N., Jr., Bartoshevsky,

L., et al., “Benefit-Cost Analysis of Rubella

Vaccination Policy, ” New England Journal of

Medicine 294(6):306-10, 1976.

Schwartz, J. S., Lewis, C. E., Clancy, C., et al.,

“Internists’ Practices in Health Promotion and

Disease Prevention: A Survey,’ Annals of Internal Medicine 114(1):46-53, 1991.

Selby, J. V., Friedman, G. D., Queensbury, C. P.,

et al., “A Case-Control Study of Screening

Sigmoidoscopy and Mortality from Colorectal

Cancer, ’ New England Journal of Medicine

326(10):653-5, 1992.
References I 109

168.

169.

170.

171.

172,

173.

174.

175.

176.

177.

178.

179.

Shapiro, S., Venet, W., Strax, P., et al., Periodic

Screening for Breast Cancer: The Health Insurance Plan Project and its Sequelae (Baltimore,

MD: Johns Hopkins University Press, 1988).

Short, P. F., and Lefkowitz, D. C., “Encouraging

Preventive Services for Low-Income Children:

The Effect of Expanding Medicaid,” Medical

Care 30(9):766-80, 1992.

Sinclair, J. C., and Bracken, M. B., Effective Care

of the Newborn Infant (New York, NY: Oxford

University Press, 1992).

Smith, RA., and Haynes, S., “Screening Barriers

for Breast Cancer, ” Cancer 1:69(7 Suppl):

1968-78, 1992

Starr, P., and Zelman, W. A., “A Bridge to

Compromise: Competition Under a Budget,”

Health Affairs 12( Suppl.):7-23, 1993,

Sullivan, C. B., and Rice, T., “The Health

Insurance Picture in 1990,” Health Affairs

104-15, Summer 1991.

Tabar, L., Fagerberg, G., Duffy, S.W., et al.,

“Update of the Swedish Two-Country Programme of Mammographic Screening for Breast

Cancer,’ Radiologic Clinics of North America

30(1):187-210, 1992.

Taylor, W. C., Pass, T. M., Shepard, D. S., et al.,

“Cost-Effectiveness of Cholesterol Reduction

for the Primary Prevention of Coronary Heart

Disease in Men,” Preventing Disease: Beyond

the Rhetoric, R.B. Goldbloom and R.S. Lawrence (eds.) (New York, NY: Springer-Verlag,

1990).

Teutsch, S. M., ‘‘A Framework for Assessing the

Effectiveness of Disease and Injury Prevention,” Morbidity and Mortality Weekly Report,

Report 41 (No. RR-3), Mar, 27, 1992,

Tonnesen, P., Norregaard, J., Simonsen, K., et

al., ‘A Double-Blind Trial of a 16-HourTransdermal Nicotine Patch in Smoking Cessation, ’ New

England Journal of Medicine 325(5):311-5,

1991.

Transdermal Nicotine Study Group, “Transdermal Nicotine for Smoking Cessation: Six-month

Results from Two Multicenter Controlled Clinical Trials, ” Journal of the American Medical

Association 266(22):3133-8, 1991.

U.S. Congress, House of Representatives, Committee on Ways and Means, Overview of Entitle180.

181.

182.

183.

184.

185.

186.

187,

ment Programs: 1992 Green Book: Background

Material and Data on Programs within the

Jurisdiction of the Committee on Ways and

Means, WMCP: 102-44 (Washington, DC: U.S.

Government Printing Office, 1992).

U.S. Congress, Library of Congress, Congressional Research Service, Medicaid Source Book:

Background and Analysis (Washington, DC:

U.S. Government Printing Office, 1989).

U.S. Congress, Library of Congress, Congressional Research Service, ‘‘Health Insurance:

Approaches for Universal Coverage,” prepared

by B. Fuchs and J. Sokolovsky, Washington,

DC, November 1990.

U.S. Congress, Library of Congress, Congressional Research Service, Medicaid Source Book:

Background Data and Analysis, 1993 Update

(Washington, DC: U.S. Government Printing

Office, 1993).

U.S. Congress, Office of Technology Assessment, The Implications of Cost-Effectiveness

Analysis of Medical Technology, OTA-H-126

(Washington, DC: U.S. Government Printing

Office, August 1980).

U.S. Congress, Office of Technology Assessment, The Implications of Cost-Effectiveness

Analysis of Medical Technology, Background

Paper #2: Case Studies of Medical Technologies, Case Study #7: Allocating Costs and

Benefits in Disease Prevention Programs: An

Application to Cervical Cancer Screening, OTABP-H-9(7) (Washington, DC: U.S. Government

Printing Office, June 1981).

U.S. Congress, Office of Technology Assessment, Cost-Effectiveness of Influenza Vaccination, OTA-H-152 (Washington, DC: U.S. Government Printing Office, December 1981).

U.S. Congress, Office of Technology Assessment, Update of Federal Activities Regarding

the Use of Pneumococcal Vaccine-+1 Technical

Memorandum, OTA-TM-H-23 (Washington, DC:

U.S. Government Printing Office, May 1984).

U.S, Congress, Office of Technology Assessment, Breast Cancer Screening for Medicare

Beneficiaries: Electiveness, Costs to Medicare

and Medical Resources Required-A Staff Paper

(Washington, DC: November 1987).
110

188

189,

190.

191.

192.

193.

194.

195.

196.

197.

I Benefit Design: Clinical Preventive Services

U.S. Congress, Office of Technology Assessment, Healthy Children: Investing in the Future,

OTA-H-345 (Washington, DC: U.S. Government Printing Office, February 1988).

U.S. Congress, Office of Technology Assessment, The Use of Preventive Services by the

Elderly Staff Paper (Washington, DC: January 1989).

U.S. Congress, Office of Technology Assessment, Costs and Effectiveness of Cholesterol

Screening in the Elderly-A Staff Paper (Washington, DC: April 1989).

U.S. Congress, Office of Technology Assessment, Preventive Health Services for Medicare

Beneficiaries: Policy and Research Issues, OTAH-416 (Washington, DC: U.S. Government Printing Office, February 1990).

U.S. Congress, Office of Technology Assessment, The Costs and Effectiveness of Screening

for Cervical Cancer in Elderly WomenBackground Paper, OTA-BP-H-65 (Washington, DC: U.S. Government Printing Office,

February 1990).

U.S. Congress, Office of Technology Assessment, Costs and Electiveness of Colorectal

Cancer Screening in the Elderly-Background

Paper, OTA-H-74 (Washington, DC: U.S. Government Printing Office, September 1990).

U.S. Congress, Office of Technology Assessment, Adolescent Health--Volume I: Summary

and Policy Options, OTA-H-468 (Washington,

DC: U.S. Government Printing Office, April

1991).

U.S. Congress, Office of Technology Assessment, Adolescent Health--Volume III: Crosscutting Issues in the Delivery of Health and Related

Services, OTA-H-467 (Washington, DC: U.S.

Government Printing Office, June 1991).

U.S. Congress, Office of Technology Assessment, Adolescent Health-Volume II: Background

and the Effectiveness of Selected Prevention and

Treatment Services, OTA-H466 (Washington,

DC: U.S. Government Printing Office, November 1991).

U.S. Congress, Office of Technology Assessment, Evaluation of the Oregon Medicaid Proposal, OTA-H-531 (Washington, DC: U.S. Government Printing Office, May 1992).

198.

199,

200,

201.

2020

203.

204.

205.

206.

U.S. Congress, Office of Technology Assessment, Does Health Insurance Make a Difference?-Background Paper, OTA-BP-H-99 (Washington, DC: U.S. Government Printing Office,

September 1992).

U.S. Congress, Office of Technology Assessment, Coverage of Preventive Services: Provisions of Selected Current Health Care Reform

Proposals, OTA-BP-H-11O (Washington, DC:

U.S. Government Printing Office, October 1992).

U.S. Congress, Office of Technology Assessment, An Inconsistent Picture: A Compilation of

Analyses of Economic Impacts of Competing

Approaches to Health Care Reform by Experts

and Stakeholders, OTA-H-540 (Washington,

DC: U.S. Government Printing Office, June

1993).

U.S. Congress, Office of Technology Assessment, Benefit Design in Health Care Reform:

Report #2-Mental Health and Substance Abuse

Services (Washington, DC, in preparation).

U.S. Congress, Office of Technology Assessment, Benefit Design in Health Care Reform:

Report#3-General Policy Issues (Washington,

DC, in preparation).

U.S. Congress, Office of Technology Assessment, Benefit Design in Health Care Reform:

Background Paper-Patient Cost-Sharing

(Washington, DC, September 1993).

U.S. Department of Health and Human Services,

Health Care Financing Administration, Intergovernmental Affairs Office, Medicaid Bureau,

Medicaid Services State by State, HCFA Pub No.

02155-92 (Washington, DC: U.S. Government

Printing Office, October 1991).

U.S. Department of Health and Human Services,

Public Health Service, Caring for Our Future:

The Content of Prenatal Care: A Report of the

Public Health Service Expert Panel on the

Content of Prenatal Care (Washington, DC:

1989).

U.S. Department of Health and Human Services,

Public Health Service, Healthy People 2000:

National Health Promotion and Disease Prevention Objectives, DHHS Pub. No. (PHS) 91-

50212, (Washington, DC: U.S. Government

Printing Office, 1991).
References I 111

207. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, ‘‘Chkunydia Trachomatis Infections: Policy

Guidelines for Prevention and Control,” Morbidity and Mortality Weekly Report 34(Suppl.):

53s-74s, 1985.

208, U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, “Estimates of the Prevalence and Projected

AIDS Cases: Summary of Workshop, October

31-November 1, 1989,” Morbidity and Mortality Weekly Report 39(7):110-2,117-9, 1990.

209. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, ‘Pelvic Inflammatory Disease: Policy Guidelines for Prevention and Management,’ Morbidity and Mortality Week/y Report 40(N0. RR-5),

1991.

210. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, “Update on Adult Immunization: Recommendations of the Immunization Practices Advisory Committee (ACIP),’ Morbidity and Mortality

Weekly Report 40(No. RR-12), 1991.

211. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, “Years of Potential Life Lost Before Ages

65 and 85—United States, 1989- 1990,’ Morbidity and Mortality Weekly Report 41(18):314-28,

1992.

212. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, “Cigarette Smoking Among Adults—

United States, 1990,” Morbidity and Mortality

Weekly Report 41(20):354-5,361-2, 1992.

213. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, “public Health Focus: Effectiveness of

Smoking-Control Strategies—United States,”

Morbidity and Mortality Weekly Report 41(35):

645-53, 1992.

214. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, Center for Chronic Disease Prevention and

Health Promotion, Office on Smoking and

Health, Reducing the Health Consequences of

Smoking: 25 Years of Progress. A Report of the

Surgeon General, DHHS Pub. No. (CDC) 89-

8411 (Rockville, MD: 1989).

215, U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, National Center for Health Statistics, Prevalence of Selected Chronic Conditions, United

States, 1979-81, Vital and Health Statistics,

Series 10, No. 155, DHHS (PHS) Publication

No. 86-1583 (Washington, DC: Government

Printing Office, 1986).

216. U.S. Department of Health and Human Services,

Public Health Service, Centers for Disease Control, National Center for Health Statistics, Health

United States 1992, DHHS Pub. No. (PHS)

92-1232 (Hyattsville, MD, 1992).

217. U.S. Department of Health and Human Services,

Public Health Service, National Institutes of

Health, National Cancer Institute, Division of

Cancer Prevention and Control, Early Detection

Branch, Working Guidelines for Early Cancer

Detection Rationale and Supporting Evidence

To Decrease Mortality (Bethesda, MD: 1987).

218. U.S. Department of Health and Human Services,

Public Health Service, National Institutes of

Health, National Cancer Institute, Division of

Cancer Prevention and Control, Early Detection

Branch, DCPC Project Review, provided to OTA

by John R. Gohagan, Jan. 31, 1991.

219. U.S. Department of Health and Human Services,

Public Health Service, National Institutes of

Health, National Cancer Institute, Supportive

Care Statements, ‘Early Cancer Detection Guidelines, ’ PDQ Editorial Board, Bethesda, MD,

1991.

220. U.S. Department of Health and Human Services,

Public Health Service, National Institutes of

Health, Office of Medical Applications Research, “Newborn Screening for Sickle Cell

Disease and Other Hemoglobinopathies,” Consensus Development Conference Statement, Vol.

6, No. 9, Bethesda, MD, Apr. 6-8, 1987.

221. U.S. Department of Health and Human Services,

Public Health Service, National Institutes of

Health, Office of Medical Applications of Research, National Institute on Deafness and Other

Communication Disorders, National Institute of

Child Health and Human Development, National

Institute of Neurological Disorders and Stroke,
112

222

223.

224.

225.

226.

227.

I Benefit Design: Clinical Preventive Services

“Early Identification of Hearing Impairment in

Infants and Young Children: Programs and

Abstracts,” NIH Consensus Development Conference, Bethesda, MD, March 1-3, 1993.

U.S. Department of Health and Human Services,

Public Health Service, Office of Disease Prevention and Health Promotion, The Comparative

Benefits Modeling Project: A Framework for

Cost-Utility Analysis of Government Health

Care Programs, report produced in cooperation

with the Foundation for Health Services Research (Rockville, MD: 1992).

U.S. Department of Labor, Bureau of Labor

Statistics, Employee Benefits in Medium and

Large Firms, 1991 (Washington, DC: U.S.

Government Printing Office, 1993).

U.S. Preventive Services Task Force, Guide to

Clinical Preventive Services: An Assessment of

the Effectiveness of 169 Interventions (Baltimore, MD: Williams and Wilkins, 1989).

U.S. Preventive Services Task Force, “Screening for Adolescent Idiopathic Scoliosis: Policy

Statement,” Journal of the American Medical

Association 269(20):2667-72, 1993,

Verbeek A. L. M., Hendricks, J. H, C. L., Hollan,

P. R., et al., ‘‘Reduction of Breast Cancer Mortality Through Mass Screening with Modem Mammography: First Results of the Nijmegen Project,

1975 -1981,” Lancet 1(8388):1222-4, 1984.

Warner, K., and Luce, B. R., Cost-Benefit and

Cost-Effectiveness Analysis in Health Care:

228.

229.

230.

231.

232.

233<

234.

Principles, Practice and Potential (Ann Arbor,

MI: Health Administration Press, 1982).

Weinstein, M, C., “Economics of Prevention:

The Costs of Prevention,” Journal of General

Internal Medicine 5(5 Suppl.):s89-92, 1990.

White, C.C., Koplan, J.P., and Orenstein, W. A.,

‘‘Benefits, Risks and Costs of Immunization for

Measles, Mumps and Rubella,’ American Journal of Public Health 75(7):73944, 1985.

Witte, J., and Axnick, N., “The Benefits From 10

Years of Measles Immunization in the United

States,” Public Health Reports 90(3):205-7,

1975.

Wood, D.L., Hayward, R. A., Corey, C. R., et al.,

“Access to Medical Care for Children and

Adolescents in the United States, ” Pediatrics

86(5):666-73, 1990.

Woolf, S.H., and Sex, H. C., “The Expert Panel

on Preventive Services: Continuing the Work of

the U.S. Preventive Services Task Force,’ American Journal of Preventive Medicine 7(5):326-

30, 1991.

Woolhandler, S., and Himmelstein, D. U., “Reverse Targeting of Preventive Care Due to Lack

of Health Insurance,” Journal of the American

Medical Association, 259(19):2872-4, 1988.

Zapka, J. G., Stoddard, A., Maul, L., et al.,

“Interval Adherence to Mammography Screening Guidance, ’ Medical Care 29(8):697-707,

1991.
Index

Access issues and options, 5, 10-11, 14-15, 21

ACIP. See Immunization Practices Advisory

Committee

Administrative feasibility, 21

Adolescents, 86-87. See also Childhood immunizations; Well-child care

Adult immunizations, 32, 44-45

Adults, periodic health examinations for, 88-95, See

also specific types of screening services

Age-specific charts for periodic health examinations,

83-95

Amblyopia screening, 35

American Academy of Family Physicians, 34

American Academy of Pediatrics, 34, 36

American Cancer Society, 28, 29

Anemia screening, 34-35

An Inconsistent Picture, 58

Annual general physical examination, 24. See also

Periodic health examinations

Behavioral strategies, 13-14. See also Smoking cessation interventions

Benefit Design in Health Care Reform publications,

1-2,58, 60

Blood cholesterol level measurement, 29-30, 51-52

Blood pressure screening, 30, 54

Breast cancer screening, 24, 26-27,46

Canadian National Breast Cancer Screening study,

26-27

Canadian Task Force on the Periodic Health Examination

annual general physical examinations, 24

colorectal cancer screening, 27-29

contraceptive services, 37

effectiveness evidence, review of, 23, 77, 79

methods of the study, 77, 79

newborn screening, 33

prostate cancer screening, 28-29

well-child care, 34-37

Cancer screening, See Breast cancer screening; Cervical cancer screening; Colorectal cancer screening; Prostate cancer screening

CDC. See Centers for Disease Control and Prevention

Centers for Disease Control and Prevention, 11,23,32

Cervical cancer screening, 28,47

Childhood immunizations, 33-34,48-50

Children, 20, 32-37,48-50, 84-85

Cholesterol screening, 29-30, 51-52

Cochrane Collaboration Pregnancy and Childbirth

database, 33

Colorectal cancer screening, 27-28,53

Congressional health care reform proposals, 98-100

Congressional agencies as sources of information, 9

Contraceptive services, 37

Cost-effectiveness of clinical preventive services. See

also Net cost of clinical preventive services

cancer screening, 46-47, 53

cholesterol reduction interventions, 51-52

cost-effectiveness analyses, 17-18, 39-41

coverage options based on, 7-8

findings, summary, 3-4,43

hypertension screening, 54

immunizations, 44-45, 48-50

smoking cessation interventions, 55

sources of information on, 8-9

113
114 I Benefit Design: Clinical Preventive Services

Counseling services, 31-32,37

Coverage in public and private insurance programs,

72-76

Coverage of Preventive Services, 59

CITFPHE. See Canadian Task Force on the Periodic

Health Examination

Defining clinical preventive services, 2, 13-14

Denver Developmental Screening Test, 36

Developmental screening, 36

Digital rectal examinations, 28-29

Dissemination of information on efficacy, 11-12

Does Health Insurance Make a Difference?, 57

Effectiveness of clinical preventive services. See also

Cost-effectiveness of clinical preventive

services

annual general physical examinations, 24

cancer screening, 24, 26-29

cholesterol screening, 29-30

contraceptive services, 37

coverage options based on, 7

evidence on effectiveness, 16-17, 23-38, 77-81

findings, summary of, 34,38

hypertension screening, 30

immunizations, 32, 33-34

newborn screening for congenital disorders, 33

prenatal care, 32-33

research options, 11-12

sexually transmitted diseases, 37-38

smoking cessation interventions, 31-32

sources of information on, 8-9

well-child care, 34-37

Elderly persons, 94-95. See also specific types of

screening service

Employment-based health plan coverage, 73-76

Environmental prevention strategies, 13-14

Executive branch agencies as sources of

information, 8

Family planning services, 37

Fecal occult blood tests, 27-28

Federal agency design of benefit package, 9

Findings, summary of, 1-4

Funding issues and options, 10-11, 14-15

General physical examinations, 24, 34. See also

Periodic health examinations

Goals of policies concerning coverage, 5, 18

Health Insurance: The Hawaii Experience, 58

Health Maintenance Organization Act of 1973,75

Health maintenance organizations, 75

Hearing impairment screening, 20,35-36

Heart disease, 29-30

Hypertension screening, 30,54

Immunization Practices Advisory Committee, 23,32,

33-34,81

Immunizations, 32,33-34,44-45,48-50

Income-based cost-sharing, 9

Indemnity insurance coverage, 73-74

Infants, 32-33,83. See also Childhood immunizations;

Well-child care

Institute of Medicine, 77,78

Insurance, funding for preventive services through,

14-15

Iron-deficiency screening, 34-35

Insurance Status and Health Care Utilization, 59

Lasers in Health Care, 59

Mammography, 24, 26-27. See also Breast cancer

screening

Medicaid coverage, 72

Medicare Act, 72

Medicare coverage, 15,72-73,76

Methods of study, 60,77-81

Minnesota Cancer Control Study, 27

National Cancer Institute, 28,29

National Cholesterol Education Program, 30,42

National Heart, Lung, and Blood Institute, 30

Net cost of clinical preventive services, 3, 8, 17-18,

41-42

Newborn screening for congenital disorders, 33

Nicotine delivery forms, 31

NIH consensus conference, 33,35

Nonfinancial barriers to access, 11, 15

Nonfinancial Barriers to Access to Health Care, 59

Office of Technology Assessment, publications, 57-59

Packaged benefits, 21-22

Papanicolaou (Pap) smear, 28. See also Cervical

cancer screening
Index ! 115

Patient characteristics, service recommendations and,

19-20, 23-26. See also Periodic health examinations; Risk factors

Payment for benefits, 21-22

Periodic health examinations, 24

age-specific charts, 83-95

pregnant women, 96-97

Point of service plans, 75-76

Policy issues and options

access options, 10-11

benefit design issues and options, 9-10, 18-22

cost considerations, 17-18

coverage options, 5-8

criteria for evaluating services, 15, 18, 79

defining clinical preventive services, 2, 13-14

effectiveness considerations, 16-17

insurance as funding source, 14-15

introduction, 4-5

research options, 11-12

sources of information on effectiveness, 8-9

Practice guidelines, 77, 78

Preferred provider organizations, 75-76

Pregnant women, 96-97

Prenatal care, 32-33,96-97

Preventive interventions, 13-14. See also specific types

of service

Primary Care for the Uninsured, 59

Primary preventive services, 13, See also specific types

of service

Private insurance coverage, 73-76

Programmatic funding approaches, 10-11

Prospects for Technology Assessment,

Prostate cancer screening, 28-29

Provider organizations as sources of information, 8-9

Public health argument for insurance funding, 7,14-15

Public Health Service, 33

Public insurance program coverage, 72-73

Ranking preventive services, 40

The Relationship Among Insurance Coverage, Access

to Services and Health Outcomes, 5 9

Research options, 11-12

Risk factors, 20-21,23-24, 38,41

Scope and frequency of interventions, 40-41

Screening services, 2, 13,80. See also specific types of

screening service

Secondary preventive services, 13. See also specific

types of service

Sensitivity analyses, 41

Sexually transmitted diseases, screening for, 37-38

Sigmoidoscopy, 27-28

Smoking cessation interventions, 31-32,55

State mandates for insurance coverage, 74-75

Strabismus screening, 35

Technology, Insurance, and the Health Care System,

1-2, 57-59, 60

Tertiary preventive services, 13

Third-party payers, 21

Tobacco use, 31-32

Transrectal ultrasound, 28-29

Unit of payment for benefits, 21-22

Urinalysis, 37

U.S. Preventive Services Task Force

breast cancer screening, 26-29

cervical cancer screening, 28

cholesterol screening, 29-30

colorectal cancer screening, 27

contraceptive services, 37

hypertension screening, 30

methods of the study, 60, 79-80

newborn screening, 33

periodic health examination age-specific charts, 24,

82-97

prenatal care, 32-33

prostate cancer screening, 28-29

recommendations for services, 20, 23-26

sexually transmitted diseases, screening for, 38

smoking cessation counseling, 32

well-child care, 34-37

USPSTF. See U.S. Preventive Services Task Force

Utilization of services. See Access issues and options

Vaccinations. See Immunizations

Vision disorder screening, 35

Well-child care, 34-37

Zero net cost criterion, 42